CN117677335A

CN117677335A - Method and device for manipulating a body lumen or a side wall of a body cavity

Info

Publication number: CN117677335A
Application number: CN202280032638.6A
Authority: CN
Inventors: P·约翰; A·克鲁兹; D·加迪; R·卢洛; E·柯立芝
Original assignee: Lumendi Ltd
Current assignee: Lumendi Ltd
Priority date: 2021-03-02
Filing date: 2022-03-02
Publication date: 2024-03-08
Also published as: WO2022187384A1; EP4326136A1

Abstract

An apparatus comprising: a flexible sleeve adapted to slide over an exterior of an endoscope, wherein the endoscope includes a proximal end and a distal end; and a handle disposed at a proximal end of the endoscope, and wherein the sleeve includes a proximal end, a distal end, and a sleeve lumen extending therebetween, and further wherein the sleeve is configured to slide over an exterior of the endoscope so as to substantially cover the exterior of the endoscope from a point adjacent the distal end of the endoscope to a point adjacent the handle of the endoscope; a balloon secured to the distal end of the sleeve; an inflation/deflation tube carried by the sleeve and in fluid communication with the interior of the balloon; and a pair of push tubes mounted to the sleeve.

Description

Method and device for manipulating a body lumen or a side wall of a body cavity

Citation of pending prior patent application

This patent application:

(1) THE pending partial continuation applications of U.S. patent application Ser. No. 17/392,897 (attorney docket No. LUMENDI-010203040708091013CON 2), entitled "METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASEDVISUALIZATION OF THE SAME AND/OR INCREASED ACCESS TO THE SAME, AND/OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME", filed by Lumendi Ltd. AND John Frederick Cornhill et al at day 12, month 11, AND U.S. patent application Ser. No. 16/215,843 (attorney docket No. LUMENDI-010203040708091013 CON), entitled "METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASEDVISUALIZATION OF THE SAME AND/OR INCREASED ACCESS TO SAME, AND/OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME", filed by Lumendi Ltd. AND John Frederick Cornhill et al at day 12, month 11, year 2021, AND continuing TO be entitled "METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASEDVISUALIZATION OF THE SAME AND/OR INCREASED ACCESS TO THE SAME, AND/OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME", AND continuing TO be filed by Lumendi Ltd. AND John Frederick Cornhill et al at day 6, month 3, AND entitled "METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASEDVISUALIZATION OF THE SAME AND/OR INCREASED ACCESS TO SAME, AND/OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME", continuing TO be filed by Lumendi-010203040708091013 ".

(A) Is a continuation-in-part of THE prior U.S. patent application Ser. No. 14/619,845 (attorney docket number CORN-34) filed by Cornell University AND John Frederick Cornhill et al at 11/2/2015 entitled "METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASEDVISUALIZATION OF THE SAME AND/OR INCREASED ACCESS TO THE SAME, AND/OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME," incorporated herein by reference in its entirety:

(i) Is a continuation of THE partial continuation-in-progress application entitled "8238 AND/OR FLATTENING THE SIDE WALL OF A BODY LUMEN AND/OR BODY CAVITY SO AS TO PROVIDE INCREASEDVISUALIZATION OF THE SAME AND/OR INCREASED ACCESS TO THE SAME, AND/OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME" filed 11/13 on 2014 by Cornell University AND Jeffrey Milsom et al (attorney docket number CORN-17 CON), entitled "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 INCREASEDVISUALIZATION OF THE SAME AND/OR INCREASED ACCESS TO THE SAME, AND/OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME" (attorney docket number CORN-17), filed 15 on 2010 by Jeffrey Milsom et al, requiring a continuation-in-progress application entitled "METHOD AND APPARATUS FOR STABILIZING, STRAIGHTENING, EXPANDING AND/OR FLATTENING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASEDVISUALIZATION OF THE SIDE WALL OF THE BODY LUMEN OR BODY CAVII, AND TY/OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME" (attorney docket number CORN-17 PROV) filed on 2009 12/15 by Jeffrey et al; and is also provided with

(ii) THE benefit of prior U.S. provisional patent application Ser. No. 61/938,446 (attorney docket number CORN-34 PROV), entitled "METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASEDVISUALIZATION OF THE SAME AND/OR INCREASED ACCESS TO THE SAME, AND/OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME", filed by Cornell University AND John Frederick Cornhill et al at 11/2/2014;

(B) Claims of THE prior U.S. provisional patent application Ser. No. 62/170,476 (attorney docket No. LUMENDI-1 PROV) entitled "METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASEDVISUALIZATION OF THE SAME AND/OR INCREASED ACCESS TO THE SAME, AND/OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME", filed by Lumendi Ltd. AND John Frederick Cornhill et al on 3/6/2015;

(C) Claims THE benefit of prior U.S. provisional patent application Ser. No. 62/170,497 (attorney docket No. LUMENDI-2 PROV) entitled "METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASEDVISUALIZATION OF THE SAME AND/OR INCREASED ACCESS TO THE SAME, AND/OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME", filed by Lumendi Ltd. AND Stephen Evans et al at 5, 6/3;

(D) Claims THE benefit of prior U.S. provisional patent application Ser. No. 62/244,008 (attorney docket No. LUMENDI-3 PROV) filed by Lumendi Ltd. AND Alan Fortunate et al at 2015, 10 month 20, entitled "METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASEDVISUALIZATION OF THE SAME AND/OR INCREASED ACCESS TO THE SAME, AND/OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME";

(E) THE benefit of prior U.S. provisional patent application Ser. No. 62/244,214 (attorney docket No. LUMENDI-4 PROV), entitled "METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASEDVISUALIZATION OF THE SAME AND/OR INCREASED ACCESS TO THE SAME, AND/OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME", filed by Lumendi Ltd. AND Audrey Bell et al at 10 month 21 2015;

(F) Claims THE benefit of prior U.S. provisional patent application Ser. No. 62/305,773 (attorney docket number LUMENDI-7 PROV) entitled "METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASEDVISUALIZATION 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", filed by Lumendi Ltd. AND Alan Fortunate on day 2016, 3;

(G) Claims THE benefit of prior U.S. provisional patent application Ser. No. 62/305,797 (attorney docket No. LUMENDI-9 PROV) entitled "METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASEDVISUALIZATION 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", filed by Lumendi Ltd. AND Brian David Chouinard on day 3/9 of 2016; and is also provided with

(H) Claims THE benefit of prior U.S. provisional patent application Ser. No. 62/305,804 (attorney docket No. LUMENDI-10 PROV) entitled "METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASEDVISUALIZATION OF THE SAME AND/OR INCREASED ACCESS TO THE SAME, AND/OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME, INCLUDING IMPROVED FORE BALLOON CONSTRUCTION", filed by Lumendi Ltd. AND Brian David Chouinard et al on day 3 AND 9;

(2) Is a continuation of THE section entitled "METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASEDVISUALIZATION OF THE SAME AND/OR INCREASED ACCESS TO THE SAME, AND/OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME" filed by Lumendi Ltd. AND Peter Johann et al at 7.16, 2019, pending prior U.S. patent application Ser. No. 16/513,388 (attorney docket number LUMENDI-2021), which is:

(A) THE pending part of THE prior U.S. patent application Ser. No. 16/477,789 (attorney docket number CORN-43PCT US), filed by Cornell University AND Jeffrey Milsom et al at 2019 at 7, month 12, was filed by International (PCT) patent application Ser. No. PCT/US18/13894 (attorney docket number CORN-43 PCT), entitled "METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASEDVISUALIZATION OF THE SAME AND/OR INCREASED ACCESS TO THE SAME, AND/OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME", filed by Cornell University AND Jeffrey Milsom et al at 2018, month 16, AND entitled "BALLOON TISSUE RETRACTION USING HOOP AND CLIP WITH VARIABLE LETH CAPABILITY, WITH SPECIMEN RETRIEVAL BALLOON", which IN turn claims (a) THE prior U.S. provisional patent application Ser. No. 62/446 (attorney docket number CORN-43 PCT) filed by Cornell University AND Jeffrey Milsom et al at 2017, month 13; and (b) the benefits of the prior U.S. provisional patent application Ser. No. 62/462,241 (attorney docket number CORN-41 PROV) entitled "BALLOON SPECIMEN RETRIEVAL" filed by Cornell University and Jeffrey Milsom et al at 22, 2017; and is also provided with

(B) THE benefit of THE prior U.S. provisional patent application Ser. No. 62/698,583 (attorney docket No. LUMENDI-20 PROV), entitled "METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASEDVISUALIZATION OF THE SAME AND/OR INCREASED ACCESS TO THE SAME, AND/OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME", filed by Lumendi Ltd. AND Peter Johann et al at 7.16 of 2018; and is also provided with

(3) Claim THE benefit of pending prior U.S. provisional patent application Ser. No. 63/155,627 (attorney docket No. LUMENDI-4243 PROV) entitled "METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASEDVISUALIZATION OF THE SAME AND/OR INCREASED ACCESS TO THE SAME, AND/OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME" filed by Lumendi Ltd. AND Peter Johann et al at 2021, 3, 2.

The above-mentioned patent application is incorporated herein by reference.

Technical Field

The present invention relates generally to surgical methods and apparatus, and more particularly to surgical methods and apparatus for manipulating a body lumen and/or a sidewall of a body cavity to provide increased visualization thereof and/or increased access thereto and/or for stabilizing an instrument relative thereto.

Background

The human body includes many different body lumens and body cavities. By way of example and not limitation, the human body includes body lumens such as the Gastrointestinal (GI) tract, blood vessels, lymphatic vessels, urethra, fallopian tubes, bronchi, bile ducts, and the like. By way of further example and not limitation, the human body includes body cavities such as head, chest, abdomen, sinuses, bladder, cavities within organs, and the like.

In many cases, it may be desirable to endoscopically examine and/or treat a disease process or deformity located within and/or on a side wall of a body lumen. By way of example and not limitation, it may be desirable to examine the side wall of the gastrointestinal tract for lesions and if lesions are found, biopsy, remove, and/or otherwise treat the lesions.

Endoscopy and/or treatment of a body lumen and/or side wall of a body cavity may be complicated by anatomy (both regional and localized) of the body lumen and/or side wall of the body cavity, and/or the compactness of tissue constituting the body lumen and/or side wall of the body cavity, and/or tethering of the body lumen and/or side wall of the body cavity to other anatomical structures.

By way of example and not limitation, the intestine is an elongated tubular organ having an internal lumen and is characterized by frequent turns (i.e., regional anatomy of the intestine) and includes a sidewall characterized by a number of folds (i.e., partial anatomy of the intestine), wherein the sidewall tissue has a relatively soft, pliable firmness, and wherein the colon is tethered to the abdomen and/or other abdominal structure, particularly via soft tissue. Due to this varying sidewall anatomy (both regional and localized), its relatively soft, pliable compactibility, and its constraint with other anatomies via soft tissue, it may be difficult to fully visualize the sidewall of the intestine and/or to treat lesions formed on the sidewall of the intestine. By way of example and not limitation, in the case of colonoscopy, it has been found that approximately 5-40% of patients have lateral wall anatomy (regional and/or localized), and/or tissue compactness, and/or colon tied to other anatomy, which makes it difficult to fully visualize an anatomy (including pathological conditions of the anatomy such as polyps or tumors) using conventional endoscopes and/or fully access the anatomy using instruments introduced through conventional endoscopes.

In addition to the above, it has been found that some body lumens and/or body cavities may cramp and/or contract. Such spasticity and/or contractions may occur spontaneously, but are particularly common when an endoscope or other instrument is inserted into a body lumen and/or body cavity. Such spasticity and/or contractions may cause the body lumen and/or body cavity to contract and/or otherwise move and/or change its configuration, which may further complicate and/or impair endoscopic visualization of the anatomy, and/or further complicate and/or impair access to the anatomy using instruments introduced through conventional flexible endoscopes. Furthermore, during examination of the colon (typically performed while advancing and retracting the endoscope through the colon), the endoscope may grip and/or otherwise collapse the colon during advancement and/or retraction, and then suddenly slip and release the colon. This gripping and then abrupt release of the colon can cause the endoscope to move rapidly beyond a significant length of the colon, making accurate examination of the colon challenging.

It would therefore be highly advantageous to provide a novel device capable of manipulating a body lumen and/or a sidewall of a body cavity to better present sidewall tissue (including visualization of areas that may be initially hidden from view or outside the field of view) for examination and/or treatment during an endoscopic procedure.

It would also be highly advantageous to provide a novel device that is capable of stabilizing and/or stabilizing the distal tip and/or working end of an instrument (e.g., an endoscope, an articulating and/or non-articulating device such as a grasper, a cutter or dissector, a cautery tool, an ultrasonic probe, etc.) inserted into a body lumen and/or body cavity relative to a sidewall of the body lumen, thereby facilitating accurate use of such instruments.

Among other things, it would be highly advantageous to provide a novel device that is capable of stabilizing and/or stabilizing the distal tip and/or working end of an endoscope (and thus also of other instruments (such as graspers, cutters or dissectors, cautery tools, ultrasonic probes, etc.) inserted through the working channel of such endoscopes).

And it would be highly advantageous to provide a novel device that is capable of stabilizing and/or stabilizing the distal tip and/or working end of an instrument (such as a grasper, cutter or dissector, cautery tool, ultrasound probe, etc.) advanced to the surgical site by means other than through the working channel of an endoscope.

It would also be highly advantageous to be able to straighten the folds, to "iron" the inner lumen surface folds and create a substantially static or stable sidewall of the body lumen and/or body cavity, thereby enabling more accurate visual inspection (including visualization of areas that may be hidden from view initially or outside the field of view) and/or therapeutic intervention.

Disclosure of Invention

The present invention includes providing and using a novel apparatus for manipulating a body lumen and/or a sidewall of a body cavity to better present sidewall tissue (including visualization of areas that may be initially hidden from view or outside the field of view) for examination and/or treatment during an endoscopic procedure.

The present invention also includes providing and using novel devices that are capable of stabilizing and/or stabilizing the distal tip and/or working end of an instrument (e.g., an endoscope, articulating and/or non-articulating device such as a grasper, cutter or dissector, cautery tool, ultrasonic probe, etc.) inserted into a body lumen and/or body cavity relative to a sidewall of the body lumen, thereby facilitating accurate use of such instruments.

The present invention includes, among other things, providing and using novel devices that are capable of stabilizing and/or stabilizing the distal tip and/or working end of an endoscope (and thus also of other instruments (such as graspers, cutters or strippers, cautery tools, ultrasonic probes, etc.) inserted through the working channel of such endoscopes).

And the present invention includes the provision and use of novel devices capable of stabilizing and/or stabilizing the distal tip and/or working end of an instrument (such as a grasper, cutter or dissector, cautery tool, ultrasonic probe, etc.) advanced to the surgical site by means other than through the working channel of an endoscope.

And the present invention includes the provision and use of novel devices that are capable of straightening bends, "ironing" folds and creating substantially static or stable sidewalls of body lumens and/or body cavities, which enable more accurate visual inspection (including visualization of areas that may be initially hidden from view or out of view) and/or therapeutic intervention.

In a preferred form of the invention there is provided an apparatus comprising:

a sleeve adapted to slide over the exterior of the endoscope;

a rear balloon secured to the sleeve;

an inflation/deflation tube carried by the sleeve and in fluid communication with the interior of the rear balloon;

a pair of hollow push tubes slidably mounted to the sleeve, the pair of hollow push tubes being connected to each other at their distal ends with a raised push tube bridge configured to nest an endoscope therein; and

a front balloon secured to the distal ends of the pair of hollow push tubes, an interior of the front balloon being in fluid communication with an interior of the pair of hollow push tubes, wherein the front balloon is capable of assuming a deflated state and an inflated state, and further wherein (i) an axial opening extends therethrough when the front balloon is in its deflated state, the axial opening being sized to receive an endoscope therein, and (ii) the axial opening is closed when the front balloon is in its inflated state.

In another preferred form of the invention there is provided a method for performing a procedure in a body lumen and/or body cavity, the method comprising:

providing an apparatus, the apparatus comprising:

a sleeve adapted to slide over the exterior of the endoscope;

a rear balloon secured to the sleeve;

a front balloon secured to the distal ends of the pair of hollow push tubes, an interior of the front balloon being in fluid communication with an interior of the pair of hollow push tubes, wherein the front balloon is capable of assuming a deflated state and an inflated state, and further wherein (i) an axial opening extends therethrough when the front balloon is in its deflated state, the axial opening being sized to receive an endoscope therein, and (ii) the axial opening is closed when the front balloon is in its inflated state;

positioning the endoscope in the sleeve such that the endoscope is nested in the push tube bridge;

Positioning the device in a body lumen and/or body cavity;

inflating the rear balloon;

distally advancing the pair of push tubes;

inflating the anterior balloon; and

the program is executed.

In another form of the invention, a new and improved apparatus is provided for stabilizing and/or stabilizing the distal tip and/or working end of an instrument (e.g., an endoscope, articulating and/or non-articulating device such as a grasper, cutter or dissector, cautery tool, ultrasonic probe, etc.) relative to the body lumen and/or side wall of the body lumen when such instrument is inserted into the body lumen and/or body cavity, thereby facilitating accurate use of such instruments.

In another form of the present invention, there is provided an apparatus comprising:

a flexible sleeve adapted to slide over an exterior of the endoscope, wherein the endoscope comprises a proximal end and a distal end and a handle disposed at the proximal end of the endoscope, and wherein the sleeve comprises a proximal end, a distal end, and a sleeve lumen extending therebetween, and further wherein the sleeve is configured to slide over the exterior of the endoscope so as to substantially cover the exterior of the endoscope from a point adjacent the distal end of the endoscope to a point adjacent the handle of the endoscope;

A balloon secured to the distal end of the sleeve;

an inflation/deflation tube carried by the sleeve and in fluid communication with the interior of the balloon; and

a pair of push tubes mounted to the sleeve.

In another 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:

providing an apparatus, the apparatus comprising:

a balloon secured to the distal end of the sleeve;

a pair of push tubes mounted to the sleeve;

positioning the device in a body lumen and/or body cavity;

inflating the balloon; and

the program is executed.

a balloon secured to the distal end of the sleeve;

an inflation/deflation tube carried by the sleeve and in fluid communication with the interior of the balloon;

a pair of push tubes mounted to the sleeve; and

a pair of instrument lumens mounted to the sleeve.

A balloon secured to the distal end of the sleeve;

a pair of push tubes mounted to the sleeve; and

an instrument lumen mounted to the sleeve.

a flexible sleeve adapted to slide over an exterior of the endoscope, wherein the endoscope comprises a proximal end and a distal end and a handle disposed at the proximal end of the endoscope, and wherein the sleeve comprises a proximal end, a distal end, and a sleeve lumen extending therebetween, and further wherein the sleeve is configured to slide over the exterior of the endoscope so as to substantially cover the exterior of the endoscope from a point adjacent the distal end of the endoscope to a point adjacent the handle of the endoscope, wherein the sleeve comprises an atraumatic tip;

a balloon secured to the distal end of the sleeve, wherein (i) when the balloon is in its deflated state, an axial opening extends therethrough, the axial opening being sized to receive an endoscope therein, and (ii) when the balloon is in its inflated state, the axial opening is closed;

A pair of push tubes mounted to the sleeve.

Drawings

These and other objects and features of this invention will be more fully disclosed or will become apparent from the following detailed description of the preferred embodiments of the invention, which are to be considered in conjunction with the accompanying drawings in which like numerals designate like parts, and further in which:

FIG. l is a schematic diagram illustrating a novel apparatus formed in accordance with the present invention, wherein the novel apparatus generally includes a sleeve for placement over an end of an endoscope, a rear balloon mounted to the sleeve, a pair of hollow push tubes slidably mounted to the sleeve, a front balloon mounted to a distal end of the hollow push tubes, and a push tube handle mounted to a proximal end of the hollow push tubes, the pair of hollow push tubes being connected to each other at their distal ends with a raised push tube bridge configured to nest the endoscope therein;

fig. 2-4 are schematic diagrams illustrating various arrangements of the anterior balloon relative to the posterior balloon;

FIG. 5 is a schematic diagram showing further details of the distal end of the device shown in FIG. 1;

FIG. 6 is a cross-sectional view taken along line 6-6 of FIG. 5;

FIGS. 7 and 8 are schematic views showing a pair of hollow push tubes, a raised push tube bridge and a front balloon;

Fig. 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;

FIG. 12 is a schematic diagram illustrating another pair of hollow push tubes and raised push tube bridges formed in accordance with the present invention;

FIG. 13 is a schematic diagram illustrating another pair of hollow push tubes and raised push tube bridges formed in accordance with the present invention;

FIG. 14 is a schematic diagram illustrating another pair of hollow push tubes and raised push tube bridges formed in accordance with the present invention;

fig. 15 and 16 are schematic diagrams showing further details of the anterior balloon;

FIG. 17 is a schematic diagram showing a push tube handle;

fig. 18 and 19 are schematic views showing constructional details of the anterior balloon;

FIGS. 20-34 are schematic views showing another form of handle mechanism for the novel apparatus of the present invention;

FIG. 35 is a schematic diagram illustrating one form of inflation mechanism provided in accordance with the present invention;

FIG. 36 is a schematic diagram illustrating another form of inflation mechanism provided in accordance with the present invention;

FIGS. 37 and 38 are schematic views illustrating another form of inflation mechanism provided in accordance with the present invention;

fig. 39-58 are schematic diagrams illustrating another form of inflation mechanism provided in accordance with the present invention;

FIG. 59 is a schematic diagram showing a safety valve that may be used to ensure that the pressure within the anterior and/or posterior balloon does not exceed a predetermined level;

FIG. 60 is a schematic diagram showing a retraction system that may be used to take up slack in the flexible tubing of the apparatus shown in FIG. 1;

fig. 61-82 are schematic diagrams illustrating a novel apparatus for inflating and deflating a balloon;

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;

FIG. 84 is a schematic diagram showing details of a novel inflation mechanism formed in accordance with the present invention;

fig. 85-88 are schematic diagrams showing further details of the new package of fig. 83 and further details of the new inflation mechanism of fig. 84;

fig. 89 to 107 are schematic diagrams showing a preferred manner of using the apparatus of fig. 1;

FIG. 108 is a schematic cross-sectional view showing how a gap is created between (i) the sleeve, (ii) the pusher lumen, and (iii) the post-balloon inflation lumen of the apparatus of FIGS. 1-106;

FIG. 109 is a schematic cross-sectional view similar to FIG. 108, illustrating a plurality of novel extrusion inserts filling the aforementioned gaps between the sleeve, push rod lumen and rear balloon inflation lumen, thereby facilitating airtight bonding of the rear balloon to the assembly;

FIGS. 110, 111 and 112 are schematic diagrams illustrating novel extrusion inserts formed in accordance with the present invention;

Fig. 113 and 114 are schematic diagrams illustrating the novel extrusion insert of fig. 110, 111 and 112 disposed along the sheath of the apparatus of fig. 1-106 so as to fill the gap between the sleeve, the push rod lumen and the rear balloon inflation lumen;

fig. 115-122 are schematic views showing alternative configurations of the anterior balloon;

FIG. 123 is a schematic diagram showing another alternative configuration of the anterior balloon;

FIGS. 124 and 125 are schematic diagrams illustrating alternative configurations of the rear balloon;

FIG. 126 is a schematic diagram showing an alternative configuration of the hollow push tube and push tube handle of the present invention;

FIG. 127 is a schematic diagram illustrating another form of a sleeve, wherein the sleeve includes an additional lumen for receiving an instrument;

FIGS. 128-131 are schematic views showing how an instrument may be advanced through an additional lumen of the sleeve;

FIG. 132 is a schematic diagram illustrating an instrument guide tube that may be disposed in an additional lumen of a sleeve, wherein an instrument may be advanced through the instrument guide tube;

fig. 133, 133A, 134 and 134A are schematic views illustrating a novel apparatus formed in accordance with the present invention, wherein the novel apparatus basically includes a sleeve for placement over an end of an endoscope, a rear balloon mounted to the sleeve, an inflation line for inflating the rear balloon, a pair of instrument lumens mounted to the sleeve and a pair of support tubes mounted to the sleeve;

FIGS. 135 and 136 are schematic views showing a novel apparatus formed in accordance with the present invention, wherein the novel apparatus basically includes a sleeve for placement over an end of an endoscope, a rear balloon mounted to the sleeve, an inflation line for inflating the rear balloon, a pair of instrument lumens mounted to the sleeve, a pair of support tubes mounted to the sleeve, and a pair of push tubes movably disposed within the pair of support tubes;

FIGS. 137-140 are schematic views showing a novel apparatus formed in accordance with the present invention, wherein the novel apparatus generally includes a sleeve for placement over an end of an endoscope, a rear balloon mounted to the sleeve, an inflation line for inflating the rear balloon, a pair of instrument lumens mounted to the sleeve, a pair of support tubes mounted to the sleeve, and a pair of push tubes movably disposed within the pair of support tubes, the pair of push tubes being connected to each other at distal ends thereof with a raised push tube bridge configured to nest the endoscope therein;

FIGS. 141 and 142 are schematic views showing a novel apparatus formed in accordance with the present invention, wherein the novel apparatus basically includes a sleeve for placement on an end of an endoscope, a first rear balloon mounted to the sleeve, a second rear balloon mounted to the sleeve, an inflation line for inflating the first and second rear balloons, a pair of instrument lumens mounted to the sleeve, and a pair of support tubes mounted to the sleeve;

FIGS. 143 and 144 are schematic diagrams illustrating a novel apparatus formed in accordance with the present invention, wherein the novel apparatus generally includes a sleeve for placement over an end of an endoscope, a first rear balloon mounted to the sleeve, a second rear balloon mounted to the sleeve, an inflation line for inflating the first and second rear balloons, a pair of instrument lumens mounted to the sleeve, a pair of support tubes mounted to the sleeve, and a pair of push tubes movably disposed within the pair of support tubes;

FIGS. 145 and 146 are schematic views showing a novel apparatus formed in accordance with the present invention, wherein the novel apparatus basically includes a sleeve for placement over an end of an endoscope, a first rear balloon mounted to the sleeve, a second rear balloon mounted to the sleeve, an inflation line for inflating the first and second rear balloons, a pair of instrument lumens mounted to the sleeve, a pair of support tubes mounted to the sleeve, and a pair of push tubes movably disposed within the pair of support tubes, the pair of push tubes being connected to each other at distal ends thereof with a raised push tube bridge configured to nest the endoscope therein;

FIGS. 146A, 146B, 147 and 148 are schematic views illustrating a novel apparatus formed in accordance with the present invention, wherein the novel apparatus basically includes a sleeve for placement over an end of an endoscope, a rear balloon mounted to the sleeve, an inflation line for inflating the rear balloon and a pair of support tubes mounted to the sleeve;

FIGS. 149 and 150 are schematic views illustrating a novel apparatus formed in accordance with the present invention, wherein the novel apparatus basically includes a sleeve for positioning over an end of an endoscope, a rear balloon mounted to the sleeve, an inflation line for inflating the rear balloon, a pair of support tubes mounted to the sleeve, and a pair of push rods movably disposed within the pair of support tubes;

FIGS. 151 and 152 are schematic views showing a novel apparatus formed in accordance with the present invention, wherein the novel apparatus basically includes a sleeve for placement over an end of an endoscope, a rear balloon mounted to the sleeve, an inflation line for inflating the rear balloon, a pair of support tubes mounted to the sleeve, and a pair of push tubes movably disposed within the pair of support tubes, the pair of push tubes being connected to each other at distal ends thereof with a raised push tube bridge configured to nest the endoscope therein;

FIGS. 153 and 154 are schematic views showing a novel apparatus formed in accordance with the present invention, wherein the novel apparatus basically includes a sleeve for placement on an end of an endoscope, a first rear balloon mounted to the sleeve, a second rear balloon mounted to the sleeve, an inflation line for inflating the first and second rear balloons, and a pair of support tubes mounted to the sleeve;

FIGS. 155 and 156 are schematic diagrams illustrating a novel apparatus formed in accordance with the present invention, wherein the novel apparatus generally includes a sleeve for placement over an end of an endoscope, a first rear balloon mounted to the sleeve, a second rear balloon mounted to the sleeve, an inflation line for inflating the first and second rear balloons, a pair of support tubes mounted to the sleeve, and a pair of push tubes movably disposed within the pair of support tubes;

FIGS. 157 and 158 are schematic diagrams illustrating a novel apparatus formed in accordance with the present invention, wherein the novel apparatus generally includes a sleeve for placement over an end of an endoscope, a first rear balloon mounted to the sleeve, a second rear balloon mounted to the sleeve, an inflation line for inflating the first and second rear balloons, a pair of support tubes mounted to the sleeve, and a pair of push tubes movably disposed within the pair of support tubes, the pair of push tubes being connected to each other at distal ends thereof with a raised push tube bridge configured to nest the endoscope therein;

fig. 159-162, 162A and 163 are schematic diagrams illustrating a novel apparatus formed in accordance with the present invention, wherein the novel apparatus basically includes a sleeve for placement over an end of an endoscope, a rear balloon mounted to the sleeve, an inflation line for inflating the rear balloon, a single instrument lumen mounted to the sleeve, a pair of support tubes mounted to the sleeve, and a pair of push tubes secured within the pair of support tubes, wherein a distal end of the sleeve is formed with a nose cone;

FIGS. 164-166 are schematic diagrams illustrating a novel apparatus formed in accordance with the present invention, wherein the novel apparatus generally includes a sleeve for placement over an end of an endoscope, a rear balloon mounted to the sleeve, an inflation line for inflating the rear balloon, a single instrument lumen mounted to the sleeve, a pair of support tubes mounted to the sleeve, and a pair of push tubes secured within the pair of support tubes, wherein a distal end of the sleeve is formed with a nose cone, and wherein a distal end of the instrument lumen is collapsible;

FIG. 166A is a schematic diagram showing a sleeve for placement over an end of an endoscope, with an instrument lumen formed on an inner surface of the sleeve;

FIG. 167 is a schematic diagram illustrating a novel apparatus formed in accordance with the present invention, wherein the novel apparatus generally includes a sleeve for placement over an end of an endoscope, a rear balloon mounted to the sleeve, an inflation line for inflating the rear balloon, a pair of support tubes mounted to the sleeve, and a pair of push tubes secured within the pair of support tubes, wherein a distal end of the sleeve is formed with a nose cone; and

fig. 168-170 are schematic diagrams illustrating the novel apparatus formed in accordance with the present invention, wherein the posterior balloon is formed with a torus configuration.

Detailed Description

The present invention includes the provision and use of novel devices for manipulating the body lumen and/or side wall of the body cavity to better present the side wall tissue (including visualization of areas initially hidden or outside the field of view) for examination and/or treatment during an endoscopic procedure.

(As used herein, the term "endoscopic procedure" is intended to mean essentially any minimally invasive or limited access procedure (diagnostic and/or therapeutic and/or surgical) for endoluminal or transluminal or other access to the interior of a body lumen and/or body cavity for the purpose of viewing, biopsy and/or treating tissue, including removal of lesions and/or resected tissue, etc.)

Novel equipment

In accordance with the present invention, and looking now at fig. 1, a novel apparatus 5 is illustrated that is capable of manipulating (e.g., stabilizing, straightening, expanding, and/or flattening, etc.) a body lumen and/or a sidewall of a body cavity to better present visualization of sidewall tissue (including areas that may be initially hidden from view or out of view) for examination and/or treatment during an endoscopic procedure using an endoscope 10 (e.g., an articulating endoscope), and/or for stabilizing a distal end and/or working end of an endoscope 10 and/or other instrument (e.g., a grasper, cutter or stripper, cautery tool, ultrasound probe, etc., not shown in fig. 1).

More particularly, the device 5 generally comprises a sleeve 15 adapted to slide over the exterior of the shaft of the endoscope 10, a proximal (or "forward") balloon 20 secured to the sleeve 15 near the distal end of the sleeve (the terms "proximal" and "forward" will be used interchangeably hereinafter), and a base 25 secured to the sleeve 15 at the proximal end of the sleeve. The device 5 further comprises: a pair of hollow push tubes 30 slidably mounted to the sleeve 15, the pair of hollow push tubes being connected to each other at their distal ends by a raised push tube bridge 31, the raised push tube bridge 31 being configured to nest an endoscope therein, as will be discussed below; and a distal (or "forward") balloon 35 (the terms "distal" and "forward" will be used interchangeably hereinafter) that is secured to the distal end of the hollow push tube 30 such that the spacing between the rear balloon 20 and the forward balloon 35 can be adjusted by the physician (or other operator or user) by moving the hollow push tube 30 relative to the sleeve 15 (e.g., by simultaneously advancing two hollow push tubes at the push tube handle 37, see below). See fig. 1 and 2-4. The device 5 further includes an associated inflation mechanism 40 (fig. 1) for enabling selective inflation/deflation of one or both of the rear balloon 20 and the front balloon 35 by a physician (or other operator or user).

Sleeve barrel

Looking now at fig. 1-6, the sleeve 15 generally comprises an elongated thin-walled tube configured to slide over the exterior of the shaft of the endoscope 10 (e.g., retrograde from the distal tip of the endoscope) so as to mate therewith, wherein the sleeve is sized and configured such that it will easily slide back over the endoscope during installation on the endoscope (preferably if the endoscope is "dry"), but will have sufficient residual friction with the exterior surface of the endoscope (when gripped by a doctor or other operator or user's hand) such that the sleeve will remain in place to allow twisting (i.e., rotational rotation) and pushing/pulling of the endoscope during use (e.g., within the colon of a patient).

In a preferred form of the invention, sleeve 15 is movable circumferentially about endoscope 10 to some extent (and is rotatable in conjunction with the shaft of the endoscope when held firmly by the hands of a physician or other operator or user); the sleeve 15 is nominally movable in an axial direction only with respect to the endoscope 10. The sleeve 15 is sized such that when its distal end is substantially aligned with the distal end of the endoscope 10, the sleeve 15 (in combination with the base 25) will substantially cover the shaft of the endoscope. In any event, sleeve 15 is sized such that when sleeve 15 is mounted to endoscope 10 and endoscope 10 is inserted into a patient, sleeve 15 extends out of the patient's body. In one preferred form of the invention, the device 5 is provided according to the particular endoscope for which it is intended, wherein the device 5 is sized such that the distal end of the sleeve 15 will be properly positioned at the distal end of the endoscope, i.e., substantially aligned with or slightly proximal to the distal end of the endoscope, when the base 25 is engaged with the handle of the endoscope.

If desired, the distal end of the sleeve 15 may be provided with a radially inwardly extending stop (not shown) to positively engage the distal surface of the endoscope 10, thereby preventing the distal end of the sleeve 15 from moving proximally beyond the distal surface of the endoscope 10. Such radially inwardly extending stops may also help prevent "torsional slippage" of sleeve 15 relative to endoscope 10 during twisting (i.e., rotational rotation) of the endoscope while in the colon and/or "thrust slippage" of sleeve 15 relative to endoscope 10 during forward pushing of the endoscope while in the colon.

The sleeve 15 preferably has a smooth outer surface so as to be atraumatic to tissue and is preferably made of a highly flexible material so that the sleeve does not inhibit bending of the endoscope during use. In a preferred form of the invention, the sleeve 15 comprises polyurethane, polyethylene, polyvinylchloride (PVC), polytetrafluoroethylene (PTFE), or the like, and is preferably transparent (or at least translucent) to allow the distance markings on the endoscope 10 to be visualized through the sleeve 15. And in one preferred form of the invention, sleeve 15 preferably has a nominal hoop strength such that a physician (or other operator or user) can grip endoscope 10 through sleeve 15, for example, to twist the endoscope. If desired, the sleeve 15 may include a lubricious coating (e.g., a liquid such as a perfluoropolyether synthetic oil, a powder, etc.) on some or all of its inner and/or outer surfaces to facilitate placement of the sleeve over the endoscope and/or movement of the device 5 through the body lumen and/or body cavity. Alternatively, the sleeve 15 may be formed of a material that is itself lubricious, such as Polytetrafluoroethylene (PTFE) or the like. It will be appreciated that the inner surface of the sleeve 15 may include features (e.g., ribs) that prevent the sleeve from rotating relative to the endoscope during use.

If desired, a vacuum may be "pulled" between sleeve 15 and endoscope 10, thereby securing sleeve 15 to endoscope 10 and minimizing the profile of sleeve 15. By way of example and not limitation, vacuum may be introduced at the proximal end of the sleeve 15 (i.e., at the base 25), or vacuum may be introduced at a point intermediate the sleeve 15. By way of further example and not limitation, it should also be appreciated that removal of the sleeve 15 from the endoscope 10 (e.g., at the end of the procedure) may be facilitated by introducing a fluid (e.g., air or a liquid lubricant) into the space between the sleeve 15 and the endoscope 10, e.g., at the proximal end of the sleeve 15 (i.e., at the base 25) or intermediate the sleeve 15.

Rear balloon

Referring still now to fig. 1-6, the rear balloon 20 is secured to the sleeve 15 just proximal to the articulation joint of the endoscope, near the distal end of the sleeve, but spaced apart from the distal end of the sleeve. The rear balloon 20 is disposed concentrically about the sleeve 15, and thus the endoscope 10 disposed within the sleeve 15. Thus, the posterior balloon 20 has a generally toroidal shape. The rear balloon 20 may be selectively inflated/deflated by means of a proximal inflation/deflation tube 45, the distal end of the proximal inflation/deflation tube 45 being in fluid communication with the interior of the rear balloon 20 and the proximal end thereof being in fluid communication with a fitting 46 mounted to the base 25. Fitting 46 is configured for connection to the previously described associated inflation mechanism 40. Fitting 46 is preferably a luer activated valve that allows inflation mechanism 40 to be disconnected from fitting 46 without losing pressure in rear balloon 20. The inflation/deflation tube 45 may be secured to the outer surface of the sleeve 15, or more preferably, the inflation/deflation tube 45 may be contained within a lumen 47 formed within the sleeve 15.

Preferably, the rear balloon 20 is disposed at a short distance rearward from the distal end of the sleeve 15 (i.e., approximately the same distance as the length of the articulating portion of the steerable endoscope 10) such that when the steerable endoscope is disposed in the sleeve 15, the articulating portion of the steerable endoscope will be disposed distally of the rear balloon 20. This configuration allows the flexible portion of the steerable endoscope to be articulated even when the rear balloon 20 has been inflated in the anatomy in order to stabilize the adjacent non-articulating portion of the endoscope relative to the anatomy, as will be discussed in further detail below. Thus, when inflated, the rear balloon 20 provides a reliable platform within the anatomy for holding the endoscope 10 in a stable position within a body lumen or body cavity in which the endoscope 10 is centered. As a result, endoscope 10 may provide improved visualization of the anatomy. Furthermore, since endoscope 10 is securely held within the body lumen or body cavity by inflated rear balloon 20, instruments advanced through the interior lumen (sometimes referred to as a "working channel") of endoscope 10 will also be provided with a secure platform for supporting those instruments within the body lumen or body cavity.

When the rear balloon 20 is properly inflated, the rear balloon can atraumatically engage and form a sealing relationship with the side walls of the body lumen in which the device 5 is disposed.

In a preferred form of the invention, the rear balloon 20 is formed of polyurethane.

Base seat

A base 25 is secured to the proximal end of the sleeve 15. The base 25 engages the endoscope 10 and helps secure the entire assembly (i.e., the device 5) to the endoscope 10. The base 25 preferably comprises a substantially rigid or semi-rigid structure that can be gripped and pulled proximally by a physician (or other operator or user), thereby allowing the physician (or other operator or user) to pull the sleeve 15 over the distal end of the endoscope 10, and then pulled proximally back along the length of the endoscope 10, thereby mounting the sleeve 15 to the outer surface of the shaft of the endoscope. In a preferred form of the invention, the base 25 is pulled proximally along the endoscope until the base 25 seats against the handle of the endoscope, thereby inhibiting further proximal movement of the base 25 (and thus of the sleeve 15). In a preferred form of the invention, the base 25 is in sealing engagement with the endoscope 10.

A pair of hollow push tubes and push tube handles

A pair of hollow push tubes 30 are slidably mounted to the sleeve 15, whereby the distal ends of the hollow push tubes (and a 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 the sleeve 15 (e.g., by advancing or retracting the hollow push tubes via a push tube handle 37, see below) and thus relative to the distal end of an endoscope 10 disposed in the sleeve 15. Preferably, the hollow push tube 30 is slidably disposed within a support tube 50, the support tube 50 being secured to the outer surface of the sleeve 15, or more preferably contained within a lumen 52 formed within the sleeve 15. The support tube 50 is preferably formed of a low friction material (e.g., polytetrafluoroethylene, also referred to as "PTFE") so as to minimize resistance to movement of the hollow push tube 30 relative to the support tube 50 (and thus to minimize resistance to movement of the hollow push tube 30 relative to the sleeve 15). In this regard, it should be appreciated that minimizing resistance to movement of the hollow push tube 30 relative to the support tube 50 improves tactile feedback to the user when the hollow push tube 30 is used to manipulate the front balloon 35. In one form of the invention, the support tube 50 is flexible (so as to allow the endoscope 10 and in particular the articulating portion of the steerable endoscope 10 to flex as needed during a procedure); however, the support tube 50 also provides some column strength (sometimes referred to as fracture strength). Thus, when the support tube 50 is installed within the lumen 52 formed in the sleeve 15, the assembly of the sleeve 15 and the hollow support tube 50 is flexible, but has some degree of column strength (while the sleeve 15 is only flexible, but has substantially no column strength). In the case where the hollow push tube 30 is contained within a lumen 52 formed in the sleeve 15, and in the case where the support tube 50 is not disposed between the hollow push tube 30 and the lumen 52, the lumen 52 is preferably lubricated so as to minimize friction between the hollow push tube 30 and the lumen 52.

The distal ends of a pair of hollow push tubes 30 are connected together by a raised push tube bridge 31 (fig. 7). The raised push tube bridge 31 provides a rounded structure at the distal end of the hollow push tube 30 that serves both (i) to connect the distal ends of the hollow push tube 30 together, and (ii) to eliminate abrupt ends at the distal end of the hollow push tube 30 that may cause trauma to tissue, such as during distal advancement of the hollow push tube 30. The raised push tube bridge 31 is configured to nest an endoscope therein (fig. 8).

In a preferred form of the invention, the raised push tube bridge 31 is also hollow. In this form of the invention, the hollow raised push tube bridge 31 may be integral with the hollow push tube 30, i.e. the hollow push tube 30 and the hollow raised push tube bridge 31 may form one continuous tube (fig. 9-11). Alternatively, in this form of the invention, the hollow raised push tube bridge 31 may be formed separately from the hollow push tube 30, and the hollow raised push tube bridge 31 may be joined to the hollow push tube 30 during manufacture (fig. 12).

In a preferred form of the invention, the raised push tube bridge 31 may be substantially solid and connected to the hollow push tube 30 during manufacture.

If desired, the raised push tube bridge 31 may be angled distally, for example, in the manner shown in fig. 7-12.

Alternatively, if desired, the raised push tube bridge 31 may be set substantially perpendicular to the longitudinal axis of the hollow push tube 30, for example in the manner shown in fig. 13.

Furthermore, if desired, the raised push tube bridge 31 may be in the form of a ring with the endoscope 10 nested within the interior of the ring (e.g., in the manner shown in fig. 14).

The proximal end of the hollow push tube 30 is connected to a push tube handle 37. As a result of this configuration, distal pushing on push tube handle 37 causes the distal end of hollow push tube 30 to move distally (at the same rate) relative to sleeve 15 (thereby moving forward balloon 35 distally relative to rear balloon 20), and proximal pulling on push tube handle 37 causes the distal end of hollow push tube 30 to retract proximally (at the same rate) relative to sleeve 15 (thereby moving forward balloon 35 proximally relative to rear balloon 20). Note that by moving the hollow push tubes 30 distally or proximally at the same rate, the distal ends of the hollow push tubes remain parallel to each other. A clamp 53 (fig. 37 and 60) is provided at the base 25 for holding the hollow push tube 30 in a selected setting relative to the base 25 (and thus relative to the sleeve 15).

The hollow push tube 30 and the raised push tube bridge 31 are preferably formed of a relatively flexible material that provides good column strength, such as Isoplast, for example ^TM Thermoplastic polyethylene resins (available from Lubrizol Corporation of wakeliv, ohio), polyethylene, polypropylene, nylon, and the like. It should be appreciated that the hollow push tube 30 and the raised push tube bridge 31 may comprise a single material or multiple materials, and that the stiffness of the hollow push tube 30 and the raised push tube bridge 31 may vary along their length. By way of example and not limitation, the distal-most portion of the hollow push tube 30 and the raised push tube bridge 31 may be formed of the same material as the remainder of the hollow push tube, but with a lower modulus so as to be more flexible than the remainder of the hollow push tube, or the distal-most portion of the hollow push tube 30 and the raised push tube bridge 31 may comprise different, more resilient, flexible materials. By way of example and not limitation, the distal-most portion of the hollow push tube 30 and the raised push tube bridge 31 may comprise nitinol. By way of further example and not limitation, the distal-most portion of the hollow push tube 30 and the raised push tube bridge 31 may comprise a stainless steel coil covered with an outer sheath of Polytetrafluoroethylene (PTFE), with the distal-most sheath/more proximal tubing together providing a sealed lumen for inflating/deflating the anterior balloon 35. By forming the hollow push tube 30 and the raised push tube bridge 31 with a distal end that is more flexible than the rest of the hollow push tube, the hollow push tube 30, the raised push tube bridge 31, and the anterior balloon 35 can be used together as a guide (with a soft atraumatic tip) for the device 5 and endoscope 10, as discussed further below.

In a preferred form of the invention, the hollow push tubes 30 are configured to remain in a parallel arrangement when they are in an unbiased state (i.e., when no force is applied to the hollow push tubes 30). This is true regardless of the inflated or deflated state of the anterior balloon 35. Providing a raised push tube bridge 31 may help to maintain the parallel arrangement of the hollow push tubes 30.

The distal-most portion of the hollow push tube 30 may be configured to bend inwardly or outwardly (if desired), for example, via their connection to the raised push tube bridge 31. With such a configuration, when the distal end of the hollow push tube 30 is held longitudinally stationary (e.g., by an inflated front balloon, as will be discussed below) and sufficient distally directed force is applied to the hollow push tube 30, a middle portion of the hollow push tube 30 (i.e., the portion between the inflated front balloon 35 and the sleeve 15) may bend or bow outwardly, thereby pushing outwardly the sidewall of the body lumen in which the device 5 is disposed, thereby providing a "bump" effect on the body lumen and/or sidewall of the body cavity in the space between the rear balloon 20 and the front balloon 35. By pushing outwardly on the body lumen and/or the side walls of the body cavity in which the device 5 is disposed, this "doming" effect can significantly enhance visualization and/or tissue stability in the region distal to the endoscope 10.

It should also be appreciated that by forming the hollow push tubes 30 from a flexible material, it is possible to manually adjust their positions during use (e.g., by using separate tools, by twisting the device, etc.) in order to prevent the hollow push tubes 30 from interfering with visualization of the patient's anatomy and/or with diagnostic or therapeutic tools introduced into the space between the anterior balloon 35 and the posterior balloon 20. By way of example and not limitation, if the device 5 is disposed in the anatomy in a manner that the hollow push tube 30 obstructs visual or physical access to the target region of the anatomy, the flexible hollow push tube(s) may be removed by using a separate tool or instrument or by rotating the device with a twisting motion to remove the flexible hollow push tube(s), or the like. By way of further example and not limitation, by constructing the hollow push tubes 30 such that they are circular and flexible and have a diameter substantially smaller than the circumference of the endoscope 10, movement of the circular endoscope when articulated can simply push the hollow push tubes apart and provide an unobstructed visual path to tissue of interest.

It should also be appreciated that the hollow push tube 30 may be marked with an indicator (e.g., a color indicator or a radio-opaque indicator) including distance markings (not shown) if desired, such that a physician (or other operator or user) viewing the surgical site via the endoscope 10 or by radiological guidance (e.g., X-ray fluoroscopy) may determine the relative placement of the hollow push tube 30 at the surgical site in the longitudinal and/or circumferential directions relative to the side walls of the body lumen and/or other body cavities.

The interior lumen of the hollow push tube 30 is (i) in fluid communication with the interior of the anterior balloon 35 (fig. 1-5, 15 and 16), for example, via the plurality of openings 32, and (ii) in fluid communication with a fitting 56 mounted to the base 25. Fitting 56 is configured for connection to the previously described associated inflation mechanism 40 such that the anterior balloon 35 may be selectively inflated/deflated with air or other fluid, including liquid. Fitting 56 is preferably a luer activated valve that allows inflation mechanism 40 to be disconnected from fitting 56 without losing pressure in anterior balloon 35.

More particularly, in one preferred form of the invention, and looking now at FIG. 17, push tube handle 37 includes a hollow interior 57. The hollow push tube 30 is mounted to the push tube handle 37 such that the hollow push tube 30 will move in conjunction with the push tube handle 37 and such that the hollow interior of the hollow push tube 30 is in fluid communication with the hollow interior 57 of the push tube handle 37. Push tube handle 37 also includes a fitting 58 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 that is in fluid communication with fitting 56 as previously described. As a result of this configuration, when push tube handle 37 is moved distally, hollow push tube 30 is moved distally, and thus front balloon 35 is moved distally; and when push tube handle 37 is moved proximally, hollow push tube 30 is moved proximally and thus forward balloon 35 is moved proximally. Further, when positive fluid pressure is applied to fitting 56 in base 25, positive fluid pressure is applied to the interior lumen of hollow push tube 30, and thus to the interior of anterior balloon 35 (i.e., via opening 32), thereby inflating anterior balloon 35; and when negative fluid pressure is applied to fitting 56 in base 25, negative fluid pressure is applied to the interior lumen of hollow push tube 30 and, thus, to the interior of anterior balloon 35 (i.e., via opening 32), thereby deflating anterior balloon 35.

It will 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 a number of advantages. By way of example and not limitation, the arrangement of a pair of hollow push tubes 30 connected together at their distal ends by a raised push tube bridge 31 provides a symmetrical force to the anterior balloon 35 as the anterior balloon is advanced distally into the body lumen, as will be discussed below. Furthermore, when the pair of hollow push tubes are used to straighten anatomy in a region near the distal end of endoscope 10, the provision of a pair of hollow push tubes 30 connected together at their distal ends by raised push tube bridge 31 provides an equal outward force against the adjacent anatomy, thereby enhancing visualization of and/or access to the anatomy as will be discussed below. Furthermore, 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 the front balloon 35 remains centered on the endoscope 10, thereby facilitating undocking of the front balloon 35 from the endoscope 10 and re-docking of the front balloon 35 on the endoscope 10, as will be discussed below. Furthermore, the provision of a pair of hollow push tubes 30 connected together at their distal ends by a raised push tube bridge 31 helps to ensure that the anterior balloon 35 is stable relative to the distal end of the endoscope, thereby minimizing rotational movement of the anterior balloon upon inflation. 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 provides a redundant air delivery system for inflating or deflating the anterior balloon 35. And the arrangement of a pair of hollow push tubes 30 connected together at their distal ends by a raised push tube bridge 31 provides a rounded blunt distal end for the hollow push tubes 30, thereby ensuring atraumatic advancement of the anterior balloon 35 within the anatomy.

Front balloon

The front balloon 35 is secured to the distal end of the hollow push tube 30 with a raised push tube bridge 31 disposed within the interior of the front balloon 35, whereby the spacing between the rear balloon 20 and the front balloon 35 can be adjusted by moving the hollow push tube 30 relative to the sleeve 15 (i.e., by moving the push tube handle 37 relative to the sleeve 15). In addition, hollow push tube 30 provides a conduit between the interior of front balloon 35 and fitting 56, thereby allowing for selective inflation/deflation of front balloon 35 via fitting 56.

Notably, the anterior balloon 35 is configured such that (i) when it is deflated (or partially deflated) and in its "retracted" position (fig. 2) relative to the sleeve 15, the anterior balloon 35 provides an axial opening 63 (fig. 15, 16 and 19) sufficient to receive the sleeve 15 and the shaft of the endoscope 10 therein, with the raised push tube bridge 31 extending concentrically about the axial opening 63, whereby the anterior balloon 35 can be "docked" on the sleeve 15 and the endoscope 10, and (ii) the axial opening 63 is closed (and preferably fully closed) when the anterior balloon 35 is in its "extended" position relative to the sleeve 15 and is properly inflated (fig. 4). At the same time, when properly inflated, the anterior balloon may atraumatically engage and form a sealing relationship with the body lumen and/or side walls of the body cavity in which the device 5 is disposed. Thus, when the anterior balloon 35 is properly inflated, the anterior balloon may effectively seal the body lumen and/or body cavity distal to the anterior balloon 35 by closing the axial opening 63 and forming a sealing relationship with the side wall of the body lumen and/or body cavity in which the device 5 is disposed. In this way, when the hollow push tube 30 is advanced distally to separate the front balloon 35 from the rear balloon 20, and when the front balloon 35 and the rear balloon 20 are properly inflated, the two balloons will form a sealing zone (sometimes referred to as a "treatment zone" hereinafter) therebetween.

It will be appreciated that when the forward balloon 35 is reconfigured from its deflated condition to its inflated condition, the forward balloon 35 expands radially inwardly (so as to close the axial opening 63) and radially outwardly (so as to engage surrounding tissue). Note that the hollow push tube 30 and the raised push tube bridge 31 are disposed within the anterior balloon 35 in such a way that their presence within the anterior balloon does not physically interfere with inflation or deflation of the anterior balloon 35.

Thus, it will be seen that the anterior balloon 35 has a "torus" shape when deflated (to allow it to seat on the distal end of the endoscope) and a substantially "solid" shape when inflated (to allow it to close the body lumen or body cavity).

To this end, and looking now at fig. 18 and 19, the anterior balloon 35 is preferably manufactured as a unitary construction 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 a lobe 74, and a distal extension 76 having a circular cross-section. Note that lobes 74 are provided on proximal extension 73 in a configuration that matches the configuration of hollow push tube 30 (i.e., where device 5 includes two hollow push tubes 30 that are diametrically opposed to each other, proximal extension 73 will include two lobes 74 that are diametrically opposed to each other—for purposes of the present invention, proximal extension 73 and lobe(s) 74 may be collectively referred to as having a "keyed" cross-section). During assembly, proximal extension 73 is inverted into the interior of body 67, hollow push tube 30 is seated in lobe 74 of proximal extension 73 (with the interior of hollow push tube 30 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 inverted into the interior of proximal extension 73, thereby providing anterior balloon 35 with axial opening 63 extending therethrough, with hollow push tube 30 secured to anterior balloon 35 and in communication with the interior of anterior balloon 35, and with raised push tube bridge 31 disposed concentrically about axial opening 63. Notably, the axial opening 63 is sized to receive the distal end of the endoscope 10 therein, and the raised push tube bridge 31 is sized to nest the endoscope 10 in the area below the raised push tube bridge 31. It is also worth noting that by forming the anterior balloon 35 by the foregoing process of everting the proximal extension 73 into the interior of the body 67 and then everting the distal extension 76 into the interior of the proximal extension 73, multiple layers of balloon material are provided around the hollow push tube 30, thereby providing a stronger balloon configuration. Among other things, providing multiple layers of balloon material around the hollow push tube 30 adds cushioning to the distal end of the hollow push tube 30, thereby providing an even more atraumatic distal tip to the hollow push tube 30, and further ensuring that the distal tip of the hollow push tube 30 does not damage adjacent tissue.

In a preferred form of the invention, the anterior balloon 35 is formed of polyurethane.

It will be appreciated that when the front balloon 35 is in its deflated state, the material of the front balloon 35 substantially encloses the distal end of the hollow push tube 30 and the raised push tube bridge 31 (while still allowing the hollow push tube 30 to be in fluid communication with the interior of the front balloon 35 (i.e., via the opening 32)), thereby providing an atraumatic tip for distally advancing the front balloon 35 through the body lumen. Furthermore, the hollow push tube 30, the raised push tube bridge 31 and the deflated anterior balloon 35 may together essentially function as a soft tip guide for the device 5 and endoscope 10, as discussed further below (fig. 93).

If desired, one or both of the posterior balloon 20 and anterior balloon 35 may be marked with an indicator (e.g., a color indicator or a radiopaque indicator) so that a physician (or other operator or user) viewing the surgical site via endoscope 10 or radiological guidance (e.g., X-ray fluoroscopy) can determine the placement of one or both of the balloons at the surgical site.

Alternative constructions for base and push tube handle

As indicated above, and as shown in fig. 1, the device 5 comprises a base 25, which base 25 is secured to the sleeve 15 at the proximal end of the sleeve and carries fittings 46, 56 for inflating/deflating the rear balloon 20 and/or the front balloon 35, respectively. The device 5 further comprises a push tube handle 37, the push tube handle 37 having a hollow push tube 30 mounted thereto, wherein the hollow push tube 30 physically supports the interior of the front balloon 35 (and provides fluid communication to the interior of the front balloon 35). As also noted above, the proximal inflation/deflation tube 45 provides fluid communication between the fitting 46 of the base 25 and the interior of the rear balloon 20; and flexible tube 59 (among other elements) provides fluid communication between fitting 56 of base 25 and the interior of hollow push tube 30 (and thus the interior of forward balloon 35).

With the configuration shown in fig. 1, the base 25 supports and guides the hollow push tube 30 when the hollow push tube 30 is advanced distally or retracted proximally, but the base 25 does not directly support and guide the push tube handle 37 when the push tube handle 37 is advanced distally or retracted proximally.

To this end, if desired, and looking now at fig. 20-25, the device 5 may include a similar but somewhat different base (i.e., base 25A) and a similar but somewhat different push handle (i.e., push handle 37A). The base 25A includes an extension 205, the extension 205 having the aforementioned fittings 46, 56 mounted thereto. Extension 205 includes a central slot 210 and a pair of side slots 215. The push tube handle 37A includes a C-shaped body 220 having a hollow push tube 30 mounted thereto, and having a center locking member 225 and a pair of finger grips 230 mounted thereto. The locking element 225 preferably includes a screw shaft 235 and a screw knob 240 such that the screw knob 240 can be advanced toward or away from the body 220 by rotating the screw knob.

Push tube handle 37A is mounted within extension 205 of base 25A such that screw shaft 235 is slidably received in central slot 210 and finger grip 230 is slidably received in side slot 215, thereby providing support and guidance for push tube handle 37A.

As a result of this configuration, push tube handle 37A may be moved distally or proximally by moving screw shaft 235 and finger grip 230 distally or proximally, thereby moving forward balloon 35 distally or proximally; and push tube handle 37A may be locked in place relative to body 25A by turning screw knob 240 such that it securely engages the outer surface of extension 205, thereby locking front balloon 35 in place relative to body 25A. Note that by applying a twist to the finger grip 230, for example, by moving one side wing 230 distally while pulling the other side wing 230 proximally, a twist may be applied to the anterior balloon 35.

Fig. 26-30 illustrate different configurations of the screw knob 240.

If desired, a lubricating washer 245 may be added to the assembly to reduce friction (FIG. 31), or a texture may be added to the surface (e.g., the underside of the screw knob 240 as shown in FIG. 32) to increase friction. Further, finger grip 230 may be shaped differently than illustrated in fig. 20-30, or moved to a different portion of the assembly. Referring to, for example, fig. 33, a finger grip 230 formed as part of a second knob 250, the second knob 250 being keyed to the slider assembly.

It should also be appreciated that the push tube handle 37A may include a generally C-shaped body having a different configuration than the C-shaped body 220 shown in fig. 23, 25, 31 and 33, if desired. By way of example and not limitation, and looking now at fig. 34, the c-shaped body 220 may include a pair of downwardly extending legs 255 connected by a link 260.

Inflation mechanism

Inflation mechanism 40 provides a means to selectively inflate rear balloon 20 and/or front balloon 35.

In one preferred form of the invention, and looking now at fig. 1 and 35, the inflation mechanism 40 comprises a single line syringe inserter 140, the inserter 140 comprising a body 145 and a plunger 150. Preferably, a spring 153 is provided in the body 145 to automatically return the plunger 150 at the end of the plunger 150 stroke. The syringe inserter 140 is connected to one or the other of the fittings 46, 56 via line 155. Thus, with this configuration, when the single-line syringe inserter 140 is to be used to inflate the rear balloon 20, the syringe inserter 140 is connected to the fitting 46 via line 155 such that the output of the single-line syringe inserter 140 is directed to the rear balloon 20 (i.e., via the proximal inflation/deflation tube 45). Accordingly, when single-line syringe inserter 140 is to be used to inflate front balloon 35, syringe inserter 140 is connected to fitting 56 via line 155 such that the output of single-line syringe inserter 140 is directed to front balloon 35 (i.e., via flexible tube 59 and the interior of hollow push tube 30 and out of opening 32).

In another preferred form of the invention, and looking now at fig. 36, inflation mechanism 40 includes a resilient 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 the first port 157 such that air may only pass through the first port 157 when traveling in an outward direction. Another one-way valve 159 (e.g., a check valve) is disposed in the second port 158 such that air may only pass through the second port 158 when traveling in an inward direction. When the resilient bulb 156 is compressed (e.g., by hand), air within the interior of the resilient bulb 156 is forced out of the first port 157; and when the resilient ball 156 is subsequently released, air is drawn back into the interior of the resilient ball 156 through the second port 158.

As a result of this configuration, when the elastic balloon 156 is to be used to inflate the rear balloon 20, the first port 157 is connected to the fitting 46 via line 155 such that the positive pressure output of the elastic balloon 156 is directed to the rear balloon 20.

Thereafter, the resilient bulb 156 may be used to deflate the rear balloon 20 (i.e., by connecting the second port 158 to the fitting 46 via line 155 such that suction of the resilient bulb 156 is directed to the rear balloon 20). Accordingly, when the elastic balloon 156 is to be used to inflate the front balloon 35, the first port 157 is connected to the fitting 56 via line 155 such that the positive pressure output of the elastic balloon 156 is directed to the front balloon 35. Thereafter, the resilient bulb 156 may be used to deflate the anterior balloon 35 (i.e., by connecting the second port 158 to the fitting 56 via line 155 such that the suction of the resilient bulb 156 is directed to the anterior balloon 35).

Alternatively, and looking now at fig. 37 and 38, a syringe 160 may be used to inflate rear balloon 20 and/or front balloon 35. Inflation mechanism 160 includes 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 the power stroke of plunger 162. The syringe 160 is connected to the fittings 46, 56 via a line 163. With this configuration, the syringe 160 includes a valve 165 for connecting the syringe 160 to either the anterior balloon 35 or the posterior balloon 20, and a valve 170 for selecting inflation or deflation of the balloon to which it is connected.

Thus, with this configuration, when the syringe 160 is to be used to inflate the rear balloon 20, the valve 165 (the two-position valve connecting the valve 170 to the front or rear balloon) is set such that the syringe 160 is connected to the rear balloon 20 by the fitting 46, and the valve 170 (the two-way reversing valve that allows the one-way valve to be arranged to inflate in one configuration and deflate in another configuration) is set such that the syringe 160 provides inflation pressure. Thereafter, when the rear balloon 20 is to be deflated, the valve 170 is set to its deflated position.

Accordingly, when the syringe 160 is to be used to inflate the anterior balloon 35, the valve 165 is set such that the syringe 160 is connected to the anterior balloon 35 by the fitting 56, and the valve 170 is set such that the syringe 160 provides inflation pressure.

Thereafter, when the anterior balloon 35 is to be deflated, the valve 170 is set to its deflated position.

In another preferred form of the invention, and looking now at fig. 39-58, the inflation mechanism 40 includes a manual inflation machine 300 also formed in accordance with the present invention. Manual inflation machine 300 generally includes a housing 305 carrying a bulb or "pump" 310, a rear balloon inflation line 315 (for connection to fitting 46 of device 5, see FIG. 1), a front balloon inflation line 320 (for connection to fitting 56 of device 5, see FIG. 1), and an internal pneumatic device 325 (FIG. 42) for directing air between pump 310 and rear balloon inflation line 315 and front balloon inflation line 320 (and for evacuating air from rear balloon inflation line 315 and front balloon inflation line 320), all of which will be discussed below.

As seen in fig. 42 and 43, the internal pneumatic device 325 includes a check valve 330, a check valve 335, a check valve 340, a multi-way valve 345, a front balloon indicator 350, a rear 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 (fig. 39, 40 and 41) is attached to the multi-way valve 345 to allow a user to set the multi-way valve 345 as desired, and openings 375, 380 (fig. 40) are formed in the housing 305 to expose the front and rear balloon indicators 350, 355, respectively, to the user's field of view.

Looking now at fig. 44-47, the internal pneumatic device 325 is configured such that (i) the rear balloon 20 is selectively inflatable by the pump 310, (ii) the rear balloon 20 is selectively deflatable by the pump 310, (iii) the front balloon 35 is selectively inflatable by the pump 310, and (iv) the front balloon 35 is selectively deflatable by the pump 310.

More particularly, when rear balloon 20 is to be inflated, and looking now at fig. 44, selector knob 370 is set such that multiport valve 345 generates fluid lines connecting "air in" port 367, check valve 340, check valve 335, pump 310, check valve 330, rear balloon indicator 355, check valve 365, rear balloon inflation line 315, and rear balloon 20 such that repeated compression of pump 310 inflates rear balloon 20, with the pressure within rear balloon 20 being indicated by rear balloon indicator 355.

When the rear balloon 20 is to be deflated, and looking now at fig. 45, the selector knob 370 is set such that the multi-way valve 345 creates a fluid line connecting the rear balloon 20, the rear balloon inflation line 315, the check valve 365, the rear balloon indicator 355, the check valve 340, the check valve 335, the pump 310, the check valve 330, and the "air evacuation" port 368 such that repeated compression of the pump 310 deflates the rear balloon 20, wherein the pressure within the rear balloon 20 is indicated by the rear balloon indicator 355.

When the forward balloon 35 is to be inflated, and looking now at fig. 46, the selector knob 370 is set such that the multi-way valve 345 generates a fluid line connecting the "air in" port 367, the check valve 340, the check valve 335, the pump 310, the check valve 330, the forward balloon indicator 350, the check valve 360, the forward balloon inflation line 320, and the forward balloon 35 such that repeated compression of the pump 310 inflates the forward balloon 35, wherein the pressure within the forward balloon 35 is indicated by the forward balloon indicator 350.

When the front balloon 35 is to be deflated, and looking now at fig. 47, the selector knob 370 is set such that the multi-way valve 345 generates fluid lines connecting the front balloon 35, the front balloon inflation line 320, the check valve 360, the front balloon indicator 350, the check valve 340, the check valve 335, the pump 310, the check valve 330, and the "air evacuation" port 368 such that repeated compressions of the pump 310 deflate the front balloon 35, wherein the pressure within the front balloon 35 is indicated by the front balloon indicator 350.

In a preferred form of the invention, and looking now at fig. 48 and 13K, the anterior balloon indicator 350 and the posterior balloon indicator 355 each include a piston 385. The piston 385 is created by attaching two end caps 390, 395 together with a flexible extrusion 400. The end cap 390 is securely mounted to the housing 305 and pneumatically connected to the system pressure to be measured (i.e., to the balloon, front balloon 35 or rear balloon 20, depending on whether the piston 385 is used in the front balloon indicator 350 or the rear balloon indicator 355) via the tube 405. End cap 395 passes along tube 405 and abuts spring 410, which spring 410 engages wall 415 of housing 305. The end cap 395 includes an alignment feature 420 slidably disposed in a guide (not shown) in the housing 305 and a color pressure indicator 425 visible through one or the other of the aforementioned openings 375, 380 depending on whether the piston 385 is used in the front balloon indicator 350 or the rear balloon indicator 355. The end cap 395 acts as a pressure indicator because the longitudinal position of the second end cap 395 along the tube 405 (relative to the wall 415) is an indicator of system pressure. Essentially, the two end caps 390, 395 and the extrusion 400 effectively constitute a piston (i.e., piston 385) that expands and contracts as the system pressure changes, wherein the system pressure is reflected by the placement of the color pressure indicator 425 relative to one or the other of the aforementioned openings 375, 380.

When there is no pressure in the system (i.e., when the front or rear balloon is fully deflated), the indicator remains in the position shown in fig. 50. In this position, the extrusion 400 collapses and folds onto itself. When pressure is introduced into the system (and thus the tube 405) and the balloon (i.e., either the anterior balloon 35 or the posterior balloon 20) begins to inflate, the end cap 395 begins to move relative to the tube 405, compressing the 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 biasing force of the spring. Fig. 51 shows the piston 385 and the extrusion 400 fully extended (i.e., indicating the maximum pressure within the system, or in other words, full inflation of either the front balloon 35 or the rear balloon 20). Desirably, the fully extended position of the color pressure indicator 425 relative to the openings 375, 380 in the housing 305 is related to the maximum allowable pressure of the front balloon 35 or the rear balloon 20.

It will be appreciated that since the position of the color pressure indicator 425 relative to the openings 375, 380 in the housing 305 reflects the pressure within the system (i.e., the pressure within either the front balloon 35 or the rear balloon 20), in one preferred form of the invention, various colors (e.g., green, yellow, and red) are used to correspond to various predetermined pressures within the system.

Thus, the designs shown in fig. 48-53 include a color indicator (i.e., color pressure indicator 425) attached to a "dynamic" (i.e., moving) end cap 395 of the piston 385. The color scheme on each indicator alerts the user of how "full" (i.e., the degree of inflation) each of the balloons (i.e., the anterior balloon 35 or the posterior balloon 20) is. However, it should also be appreciated that the indicator may include a digital pressure value instead of a color, if desired. Alternatively, the pressure level may be indicated by a color bar (or number) secured to the housing (i.e., adjacent openings 375, 380 in the housing 305). In this form of the invention, end cap 395 includes a pointer that extends out of opening 375 or 380 and points to the appropriate pressure indicating mark on housing 305 as the plunger expands (i.e., as flexible extrusion 400 expands and end cap 395 moves toward wall 415 against the force of spring 410) and contracts (i.e., as flexible extrusion 400 contracts and end cap 395 moves away from wall 415 under the force of spring 410).

The designs shown in fig. 48-53 illustrate that the two end caps 390, 395 of the piston 385 are separated by a tubular flexible extrusion 400. However, it should also be appreciated that flexible extrudate 400 may be replaced by a balloon 430 (FIG. 54), if desired. Balloon 430 is preferably spherical (fig. 54), although it may include other shapes if desired (see, e.g., fig. 55 and 56, fig. 55 showing a generally diamond-shaped balloon 430, and fig. 56 showing a generally tubular balloon 430). Alternatively, if desired, the balloon 430 may be used to push the flag up (i.e., perpendicular to the balloon axis) rather than expanding the piston along its axis. See fig. 57 and 58.

In yet another form of the invention, inflation mechanism 40 may include an automatic source of fluid pressure (positive or negative), such as an electric pump.

If desired, and looking now at FIG. 59, a relief valve 175 may be connected to an inflation/deflation line connected to the anterior balloon 35 to ensure that the pressure within the anterior balloon 35 does not exceed a predetermined level. Similarly, and still referring now to fig. 59, a safety valve 180 may be connected to an inflation/deflation line connected to the rear balloon 20 in order to ensure that the pressure within the rear balloon 20 does not exceed a predetermined level.

Alternatively, and/or in addition, one or more pressure gauges 182 (fig. 1 or 38) may be incorporated into the fluid lines connected to the rear balloon 20 and/or to the front balloon 35, thereby providing information to the physician (or other operator or user) regarding the pressure inside the rear balloon 20 and/or the front balloon 35 to avoid over-inflation and/or to assist the physician (or other operator or user) in determining the balloon inflation status during the procedure.

Further, it will be appreciated that the flexible tube 59 connecting the push tube 30 to the base 25 (and thus to the fitting 56) may collapse around the base 25 as the forward balloon 35 moves between its "retracted" position (fig. 2) and its "extended" position (fig. 4), potentially interfering with the actions of a physician (or other operator or user). Thus, if desired, and looking now at fig. 60, a flexible tube retraction system 185 may be provided (e.g., within the base 25) to take up slack in the flexible tube 59 as the front balloon 35 is extended.

Manual inflation machine incorporating novel manifold

As discussed above, in one preferred form of the invention, inflation mechanism 40 includes a manual inflation machine 300 (FIGS. 39-58) for selectively inflating/deflating a selected one of anterior balloon 35 and posterior balloon 20. Manual inflation machine 300 generally includes a manual pump (e.g., balloon 310) for providing a source of air pressure/suction and a multi-way valve 345 for directing air flow from balloon 310 to a selected one of front balloon 35 and rear balloon 20/to balloon 310 from a selected one of front balloon 35 and rear balloon 20.

In one form of the present invention, and looking first at fig. 61 and 62, the multi-way valve 345 preferably takes the form of a novel manifold 500 disposed within the housing 305 of the manual inflator 300. Manifold 500 generally includes a bottom plate 505 fluidly connected to ball 310, a rotatable middle plate 510, and a top plate 515 fluidly connected to front balloon 35, rear balloon 20, front balloon indicator 350, and rear balloon indicator 355. The shaft 520 passes through and connects together the top plate 515, the middle plate 510, and the bottom plate 505, as will be discussed in further detail below. Turning next to fig. 63, the base plate 505 generally includes a body 525, the body 525 having a cavity 530 formed therein. The base plate 505 also includes an inflation port 535 configured to be fluidly connected to an air pressure source (e.g., bulb 310) and a deflation port 540 configured to be fluidly connected to an air intake source (e.g., bulb 310). Inflation port 535 and deflation port 540 are fluidly connected to cavity 530, as will be discussed in further detail below.

The cavity 530 of the base plate 505 includes (i) a central opening 545 through the body 525 of the base plate 505 for rotatably receiving the shaft 520 therein, and (ii) a plurality of O-rings 550 disposed in the cavity 530 and concentrically disposed about the central opening 545. The O-ring 550 defines two annular regions that are coaxially disposed relative to one another and that are fluidly isolated from one another (i.e., when the middle plate 510 is mounted on top of the bottom plate 505 and covers the cavity 530, as will be discussed below). More specifically, the O-ring 550 defines an inner collapse zone 555 and an outer inflation zone 560 disposed coaxially around the inner collapse zone 555. The inner deflation zone 555 includes an opening 565 fluidly connected to the deflation port 540 and the outer inflation zone 560 includes an opening 570 fluidly connected to the inflation port 535. In a preferred form of the invention, the base plate 505 further includes a check valve 575 fluidly connected to the collapse port 540 for allowing the bulb 310 to "reshape" (i.e., draw air through the check valve 575) when air cannot be drawn from the atmosphere through the inner collapse zone 555 (it will be appreciated that the check valve 575 is functionally equivalent to the check valve 340 shown in fig. 65).

Looking next at fig. 64, the intermediate plate 510 includes a body 580 having a smooth bottom surface 585 for sealingly engaging the O-ring 550 disposed in the cavity 530 of the bottom plate 505 (and thus fluidly sealing the inner and outer collapsed regions 555, 560) and a smooth top surface 590 for sealingly engaging the top plate 515, as will be discussed in further detail below. Body 580 of intermediate plate 510 includes a central opening 595 through body 580 of intermediate plate 510 and configured to engage shaft 520 (e.g., central opening 595 may include a non-circular cross-section that matches a portion of shaft 520 having a corresponding non-circular cross-section) such that rotation of shaft 520 results in corresponding rotation of intermediate plate 510. Intermediate plate 510 also includes an inner bore 600 and an outer bore 605 disposed on a common radius and extending through body 580 of intermediate plate 510. When the middle plate 510 is mounted over the bottom plate 505, the internal bore 600 is disposed on a common rail with the internal collapsed region 555 of the bottom plate 505 and fluidly connected to the internal collapsed region 555. When the intermediate plate 510 is mounted over the bottom plate 505, the outer apertures 605 are disposed on a common rail with and fluidly connected to the outer inflatable region 560 of the bottom plate 505.

Referring next to fig. 65-67, the top plate 515 includes a body 610 having a bottom surface 615, a top surface 620, and a central opening 625 through the body 610 for rotatably receiving the shaft 520. The top plate 515 further includes a rear balloon connection port 630 for fluidly connecting the rear balloon 20 to the manifold 500, a rear balloon indicator port 635 for fluidly connecting the rear balloon indicator 355 to the manifold 500, a rear balloon channel 640 extending between the rear balloon connection port 630 and the rear balloon indicator port 635, a front balloon connection port 645 for fluidly connecting the front balloon 35 to the manifold 500, a front balloon indicator port 650 for fluidly connecting the front balloon indicator 350 to the manifold 500, and a front balloon channel 655 extending between the front balloon connection port 645 and the front balloon indicator port 650.

The bottom surface 615 of the body 610 includes a rear balloon inflation port 660 and a rear balloon deflation port 665 that open on the bottom surface 615 and are fluidly connected to the rear balloon channel 640. The bottom surface 615 of the body 610 also includes a front balloon inflation port 670 and a front balloon deflation port 675 that open on the bottom surface 615 and are fluidly connected to the front balloon channel 655. A plurality of O-rings 680 are disposed about the ports 660, 665, 670, 675 for effecting sealing engagement of the ports 660, 665, 670, 675 with the top surface 590 of the intermediate plate 510, as will be discussed in further detail below. In a preferred form of the invention, the bottom surface 615 of the body 610 further includes a counter-balancing O-ring 685 for helping to maintain the O-ring 680 in sealing engagement with the top surface 590 of the intermediate plate 510, as will be discussed in further detail below.

In a preferred form of the invention, the top plate 515 further includes a rear balloon channel check valve 690 disposed in the top plate 515 (it will be appreciated that the check valve 690 is functionally equivalent to the check valve 365 shown in fig. 65). The rear balloon check valve 690 is in fluid communication with the rear balloon channel 640 and prevents over inflation of the rear balloon 20 by releasing air to the atmosphere when the air pressure within the rear balloon channel 640 (which is the same as the air pressure within the rear balloon 20) exceeds a predetermined threshold.

In a preferred form of the invention, the top plate 515 further includes a front balloon channel check valve 695 disposed in the top plate 515 (it will be appreciated that the check valve 695 is functionally equivalent to the check valve 360 shown in fig. 43). The forward balloon channel check valve 695 is in fluid communication with the forward balloon channel 655 and prevents over inflation of the forward balloon 35 by releasing air to the atmosphere when the air pressure within the forward balloon channel 655 (which is the same as the air pressure within the forward balloon 35) exceeds a predetermined threshold.

Assembly of novel manifold

Referring next to fig. 68 and 69, the manifold 500 is assembled such that the intermediate plate 510 is rotatably disposed between the bottom plate 505 and the top plate 515 with the shaft 520 passing through the central opening 625 of the top plate 515, the central opening 595 of the intermediate plate 510, and the central opening 545 of the bottom plate 505. More particularly, the distal end of shaft 520 includes a distal bearing 700, which distal bearing 700 is secured to shaft 520 by retainer clip 705. The proximal end of the shaft 520 includes a proximal bearing 710 secured to the proximal end of the shaft 520, with a spring 715 disposed between the proximal bearing 710 and the top surface 620 of the top plate 515. The selector knob 720 is fixedly mounted to the proximal end of the shaft 520 such that rotation of the selector knob 720 results in corresponding rotation of the shaft 520 (and thus of the intermediate plate 510). The shaft 520 is free to rotate within the central opening 625 of the top plate 515 and the central opening 545 of the bottom plate 505, and is also free to rotate within the proximal bearing 710 and the distal bearing 700. However, the shaft 520 engages the central opening 595 of the intermediate plate 510 such that rotation of the shaft 520 results in corresponding rotation of the intermediate plate 510, thereby allowing the user to selectively rotate the intermediate plate 510 (i.e., by rotating the selector knob 720, which in turn rotates the intermediate plate 510).

It will be appreciated that when the various components are assembled on shaft 520, bottom plate 505, intermediate plate 510, and top plate 515 are "sandwiched" between distal bearing 700 and proximal bearing 710 under compression provided by springs 715, thereby maintaining constant contact between (i) bottom surface 585 of intermediate plate 510 and O-ring 550 of bottom plate 505, (ii) top surface 590 of intermediate plate 510 and O-ring 680 of top plate 515 (i.e., between top surface 590 of intermediate plate 510 and rear balloon inflation port 660, rear balloon deflation port 665, front balloon inflation port 670 and front balloon deflation port 675), and (iii) top surface 590 of intermediate plate 510 and counter-balanced O-ring 685 of top plate 515.

As a result, an airtight air path is maintained through manifold 500 between (i) a selected one of inflation port 535 or deflation port 540 and (ii) a selected one of anterior balloon 35 or posterior balloon 20, such that balloon 310 may be used to selectively inflate or deflate the selected one of anterior balloon 35 or posterior balloon 20, as will be discussed in further detail below.

More particularly, it will be appreciated that rotating the selector knob 720 causes the shaft 520 to rotate, thereby causing the intermediate plate 510 to rotate. When this occurs, the inner bore 600 and outer bore 605 of the middle plate 510 also rotate relative to the bottom plate 505 and top plate 515. Because the inner bore 600 of the middle plate 510 is aligned on a common rail with the inner collapse zone 555 of the bottom plate 505, the inner bore 600 is always aligned with the inner collapse zone 555 regardless of the rotational position of the middle plate 510 (and thus, the inner bore 600 is always fluidly connected to the collapse port 540, i.e., via the opening 565 in the inner collapse zone 555). Similarly, because the outer apertures 605 of the intermediate plate 510 are aligned on a common rail with the outer inflation zone 560 of the bottom plate 505, the outer apertures 605 are always aligned with the outer inflation zone 560 (and thus, the outer apertures 605 are always fluidly connected to the inflation ports 535 via the openings 570 in the outer inflation zone 560).

It will also be appreciated that when the intermediate plate 510 is rotated (i.e., by rotating the selector knob 720), the internal bore 600 of the intermediate plate 510 may be positioned such that it is either (i) aligned with the rear balloon deflation port 665, or (ii) aligned with the front balloon deflation port 675, or (iii) not aligned with the ports 665, 675 (and thus open to the atmosphere). Similarly, the outer aperture 605 of the intermediate plate 510 may be positioned such that it is (i) aligned with the rear balloon inflation port 660, or (ii) aligned with the front balloon inflation port 670, or (iii) not aligned with the ports 660, 670 (and thus open to the atmosphere). In this regard, it will be appreciated that the provision of the O-ring 680 and the counter-O-ring 685 creates a small gap between the bottom surface 615 of the top plate 515 and the top surface 590 of the middle plate 510 such that when either (or both) of the inner bore 600 and/or the outer bore 605 of the middle plate 510 is misaligned with the ports 665, 675, 660, 670, the inner bore 600 and/or the outer bore 605 are connected to atmosphere.

As a result of this configuration, it will be appreciated that the intermediate plate 510 is selectively rotatable so as to be in one of five states: (1) A rear balloon inflation state in which the outer aperture 605 of the middle plate 510 is aligned with the rear balloon inflation port 660 of the top plate 515 and the inner aperture 600 of the middle plate 510 is open to atmosphere ("state 1"); (2) A rear balloon collapsed state in which the outer aperture 605 of the middle plate 510 is open to atmosphere and the inner aperture 600 of the middle plate 510 is aligned with the rear balloon collapse port 665 of the top plate 515 ("state 2"); (3) A front balloon inflation state in which the outer aperture 605 of the middle plate 510 is aligned with the front balloon inflation port 670 of the top plate 515 and the inner aperture 600 of the middle plate 510 is open to atmosphere ("state 3"); (4) A forward balloon deflated state in which the outer aperture 605 of the intermediate plate 510 is open to atmosphere and the inner aperture 600 of the intermediate plate 510 is aligned with the forward balloon deflated port 675 ("state 4"); or (5) an inactive state in which neither the outer aperture 605 nor the inner aperture 600 of the middle plate 510 is aligned with the ports 660, 665, 670, 675 in the top plate 515, i.e., in which both the outer aperture 605 and the inner aperture 600 are open to atmosphere, and the ports 660, 665, 670, 675 of the top plate 515 are fluidly sealed against the top surface 590 of the middle plate 510 ("state 5").

Thus, it will be seen that the relative positions of the rear balloon inflation port 660, rear balloon deflation port 665, front balloon inflation port 670, and front balloon deflation port 675 within the bottom surface 615 of the top plate 515 may be arranged such that rotation of the intermediate plate 510 results in selective switching between states 1, 2, 3, 4, and 5 discussed above.

By way of example and not limitation, in one preferred form of the invention, state 1 is achieved when knob 720 is in the "8 o 'clock" position, state 2 is achieved when knob 720 is in the "4 o' clock" position, state 3 is achieved when knob 720 is in the "10 o 'clock" position, and state 4 is achieved when knob 720 is in the "2 o' clock" position. In this form of the invention, state 5 is achieved whenever knob 720 is rotated to a position intermediate the aforementioned positions.

1. The rear balloon is inflated.Looking now at fig. 70-72, there is shown the path of air traveling through the manifold 500 when the intermediate plate 510 is in state 1 discussed above for achieving rear balloon inflation (i.e., when the intermediate plate 510 is rotated such that the outer aperture 605 of the intermediate plate 510 is aligned with the rear balloon inflation port 660 of the top plate 515 and the inner aperture 600 of the intermediate plate 510 is open to atmosphere). In state 1, when the bulb 310 is squeezed and released, free air from the atmosphere is drawn into the inner bore 600 of the middle plate 510, into the inner deflated region 555 of the bottom plate 505, through the opening 565 in the inner deflated region 565, through the deflated port 540, into the bulb 310, and then back out of the bulb 310, into the inflated port 535, through the opening 570, into the outer inflated region 560, through the outer aperture 605 of the middle plate 510, into the rear balloon inflation port 660, through the rear balloon channel 640, out of the rear balloon connection port 630, and into the rear balloon 20. It will be appreciated that when this occurs, and looking now at fig. 72, the rear, front and front balloon inflation ports 665, 670, 675 are all fluidly sealed against the top surface 590 of the middle plate 510 so that air cannot enter or exit via ports 665, 670, 675, and thus, inflation of the rear balloon 20 does not have any effect on the front balloon 35 when the manifold 500 is in state 1.

2. The rear balloon collapses.Turning next to fig. 73 and 74, the path of air traveling through the manifold 500 when the intermediate plate 510 is in state 2 discussed above for achieving rear balloon deflation (i.e., when the intermediate plate 510 is rotated such that the outer holes 605 of the intermediate plate 510 are open to atmosphere and the inner holes 600 of the intermediate plate 510 are aligned with the rear balloon deflation ports 665). In state 2, when the bulb 310 is squeezed and released, air from the rear balloon 20 is drawn into the rear balloon connection port 630, through the rear balloon channel 640, out the rear balloon deflation port 665, through the inner bore 600 of the middle plate 510, into the inner deflation zone 555, out the deflation port 540, into the bulb 310, back out the bulb 310, into the inflation port 535, through the opening 570 in the outer inflation zone 560, into the outer inflation zone 560, through the outer bore of the middle plate 510605, and vented to atmosphere. It will be appreciated that when this occurs, the rear balloon inflation port 660, the front balloon inflation port 670, and the front balloon deflation port 675 are all fluidly sealed against the top surface 620 of the middle plate 510 such that air cannot enter or exit via the ports 660, 670, 675, and thus, the deflation of the rear balloon 20 does not have any effect on the front balloon 35 when the manifold 500 is in state 2.

3. The anterior balloon is inflated.Referring next to fig. 75 and 76, the path of air traveling through the manifold 500 is shown when the intermediate plate 510 is in state 3 discussed above for achieving forward balloon inflation (i.e., when the intermediate plate 510 is rotated such that the outer aperture 605 of the intermediate plate 510 is aligned with the forward balloon inflation port 670 of the top plate 515 and the inner aperture 600 of the intermediate plate 510 is open to atmosphere). In state 3, when the bulb 310 is squeezed and released, free air from the atmosphere is drawn into the inner bore 600 of the middle plate 510, into the inner deflated region 555 of the bottom plate 505, through the opening 565 in the inner deflated region 565, through the deflated port 540, into the bulb 310, and then back out of the bulb 310, into the inflated port 535, through the opening 570, into the outer inflated region 560, through the outer aperture 605 of the middle plate 510, into the front balloon inflated port 670, through the front balloon channel 655, out of the front balloon connection port 645, and into the front balloon 35. It will be appreciated that when this occurs, the rear, rear and front balloon inflation ports 665, 660, 675 are all fluidly sealed against the top surface 590 of the middle plate 510 such that air cannot enter or exit via the ports 665, 660, 675, and thus, inflation of the front balloon 35 does not have any effect on the rear balloon 20 when the manifold 500 is in state 3.

4. The anterior balloon is deflated.Turning next to fig. 77 and 78, the path of air traveling through the manifold 500 when the intermediate plate 510 is in state 4 discussed above for achieving anterior balloon deflation (i.e., when the intermediate plate 510 is rotated such that the outer aperture 605 of the intermediate plate 510 is open to atmosphere and the inner aperture 600 of the intermediate plate 510 is aligned with the anterior balloon deflation port 675). In state 4, when the ball 310 is pressed and released, air from the front balloon 35 is sucked into the front balloon connection port 645, through the forward balloon channel 655, through the forward balloon deflation port 675, through the inner bore 600 of the intermediate plate 510, into the inner deflation zone 555, through the opening 565, through the deflation port 540, into the bulb 310, back out of the bulb 310, into the inflation port 535, through the opening 570 in the outer inflation zone 560, into the outer inflation zone 560, and through the outer bore 605 of the intermediate plate 510, and into the atmosphere. It will be appreciated that when this occurs, the rear balloon inflation port 660, the rear balloon deflation port 665, and the front balloon inflation port 670 are all fluidly sealed against the top surface 590 of the middle plate 510 such that air cannot enter or leave the ports 660, 665, 670, and thus, the deflation of the front balloon 35 does not have any effect on the rear balloon 20 when the manifold 500 is in state 4.

5. The anterior and posterior balloon seals prevent inflation/deflation.When the intermediate plate 510 is disposed in state 5 discussed above (i.e., when the intermediate plate 510 is rotated such that both the inner bore 600 and the outer bore 605 are open to the atmosphere), the rear balloon inflation port 660, the rear balloon deflation port 665, the front balloon inflation port 670, and the front balloon deflation port 675 are sealed against the top surface 590 of the intermediate plate 510. In state 5, compression and release of balloon 310 has no effect on either anterior balloon 35 or posterior balloon 20 (because air is drawn into inner bore 600 of intermediate plate 510, into inner deflated region 555, through opening 565, out through deflated port 540 and into balloon 310, and then from balloon 310, into inflation port 535, through opening 570 and into outer inflated region 560, and then out through outer aperture 605 to atmosphere).

Novel manifold

It should be appreciated that other manifolds may be utilized in inflation mechanism 40 in place of the novel manifold 500 discussed above.

By way of example and not limitation, and looking now at fig. 79, another novel manifold 500A is illustrated for selectively inflating or deflating a selected one of the posterior balloon 20 and the anterior balloon 35. Manifold 500A serves the same function as manifold 500 discussed above (i.e., manifold 500A selectively controls multiple airway paths to allow a user to selectively inflate or deflate a selected one of rear balloon 20 and front balloon 35 using a single user interface), however, manifold 500A adopts a somewhat different configuration than manifold 500.

Looking now at FIG. 80, a manifold 500A generally includes a rotatable control dial and a plurality of tubes (labeled 1-6 in FIG. 80), wherein the control dial is configured to selectively close one or more of the plurality of tubes and to selectively open one or more of the plurality of tubes when the rotatable control dial is rotated. More particularly, and still referring to fig. 80, a rotatable control dial 800 is shown that includes a body 805. The body 805 includes 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.

The plurality of tubes discussed above are fixed in position relative to the rotatable control dial 800 and each of the plurality of tubes passes through one of the first groove 810, the second groove 825, the third groove 840, the fourth groove 850, the fifth groove 860, and the sixth groove 870. More specifically, a first tube 880 fluidly connected to ball 310 and the atmosphere passes through first groove 810, a second tube 885 fluidly connected to ball 310 and the atmosphere passes through second groove 825, a third tube 890 fluidly connected to rear balloon 20 and ball 310 passes through third groove 840, a fourth tube 895 fluidly connected to rear balloon 20 and ball 310 passes through fourth groove 850, a fifth tube 900 fluidly connected to front balloon 35 and ball 310 passes through fifth groove 860, and a sixth tube 905 fluidly connected to front balloon 35 and ball 310 passes through sixth groove 870.

The first groove 810, the second groove 825, the third groove 840, the fourth groove 850, the fifth groove 860, and the sixth groove 870 are sized such that the first tube 880, the second tube 885, the third tube 890, the fourth tube 895, the fifth tube 900, and the sixth tube 905 are "pinched off" such that air cannot flow through the tubes whenever they are disposed in a section of their respective grooves 810, 825, 840, 860, 870 that is not a notched section. As a result, when the tube is disposed in the cutout section formed in the groove in which the tube is disposed, air can flow only through a given tube 880, 885, 890, 895, 900, 905.

More particularly, when the first tube 880 is disposed in the cutout section 815 or the cutout section 820 of the first groove 810, the first tube 880 allows only air to pass therethrough, when the second tube 885 is disposed in the cutout section 830 or the cutout section 835, the second tube 885 allows only air to pass therethrough, when the third tube 890 is disposed in the cutout section 845, the third tube 890 allows only air to pass therethrough, and so forth. With the tubes 880, 885, 890, 895, 900, and 905 fixed in position relative to the control dial 800, the cutout sections 815, 820, 830, 835, 845, 855, 865, and 875 move relative to the tubes 880, 885, 890, 895, 900, and 905 when the control dial 800 is selectively rotated by a user. By controlling the location at which the cutout sections 815, 820, 830, 835, 845, 855, 865, and 875 are formed in the body 805 of the 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 the cutout sections 815, 820, 830, 835, 845, 855, 865, and 875 when the control dial 800 is rotated to a given position. Thus, by selectively moving control dial 800 to a particular location, it is possible to control the flow of air to and from ball 310 while simultaneously controlling the flow of air to and from a selected one of rear balloon 20 and front balloon 35. Further details regarding the flow of air through the manifold 500A are provided in fig. 81 and 82.

Design of balloon venting through packaging

In a preferred form of the invention, and looking now at fig. 83, the novel device 5 is sealed within the sterile package 1000 until the novel device 5 is used. Package 1000 is typically provided in the form of a bottom tray 1005 and a lid 1010, the bottom tray 1005 being sized to hold the novel device 5, the lid 1010 being for mating to and sealing the bottom tray 1005. When the novel device 5 is sealed within the sterile package 1000, the anterior balloon 35 and the posterior balloon 20 are in their deflated state.

Although the anterior and posterior balloons 35, 20 are stored within the package 1000 in their deflated state, it has been found that sometimes small amounts of residual air may remain within the anterior and/or posterior balloons 35, 20 and/or the various fluid pathways leading to the anterior and/or posterior balloons 35, 20 (e.g., the hollow push tube 30, the push tube bridge 31, the proximal inflation/deflation tube 45, etc.). As a result, when the novel apparatus 5 (sealed within the package 1000) is subsequently transported to a recipient via a transport device in which the package 1000 is exposed to significant changes in air pressure (e.g., when the novel apparatus 5 is transported to a recipient via an aircraft), the changes in air pressure may cause residual air remaining within the front balloon 35 and/or the rear balloon 20 (and/or various fluid paths leading to the front balloon 35 and/or the rear balloon 20) to expand. This inflation may cause damage to the front balloon 35, the rear balloon 20, and/or other components of the novel device 5 when the novel device 5 is sealed within the package 1000.

One possible solution to the foregoing problem is to completely empty all air from the front balloon 35, the rear balloon 20, and all paths to the front balloon 35 and the rear balloon 20 before the new device 5 is sealed within the package 1000. However, it has been found that venting all air from the anterior balloon 35, the posterior balloon 20, and the path to the anterior balloon 35 and the posterior balloon 20 can be challenging. Furthermore, it has also been found that it can be challenging to ensure that no air can thereafter leak back into any evacuated components of the new apparatus 5.

Another possible solution is to allow air within the interior of the package 1000 to freely enter and leave the components of the new device 5, e.g., by letting one or both of the fittings 46, 56 open to air flow, etc. However, for such an "open valve" configuration, the recipient (e.g., surgeon) would need to struggle to close any open valve before using the new device 5. It is possible that the recipient may inadvertently open a valve that should be closed prior to use of the new device 5, resulting in failure of the new device 5.

Thus, there is a need for a new and improved way to maintain a free air exchange between the interior of the package 1000 and the front and rear balloons 35, 20, while automatically sealing the free air exchange when a user removes the new device 5 from the package 1000.

To this end, and looking now at fig. 84, a front balloon exhaust check valve 1015 and a rear balloon exhaust check valve 1015A are provided in manual inflation machine 300, wherein front balloon exhaust check valve 1015 is provided in front balloon inflation line 320, and wherein rear balloon exhaust check valve 1015A is provided in rear balloon inflation line 315. For clarity of illustration, only front balloon exhaust check valve 1015 is shown in fig. 85-88 and discussed in detail below, however, it should be appreciated that rear balloon exhaust check valve 1015A is identical in construction and function to front balloon exhaust check valve 1015 (although rear balloon exhaust check valve 1015A is disposed in rear balloon inflation line 315 rather than front balloon inflation line 320).

Looking now at fig. 85-88, front and rear balloon exhaust check valves 1015 and 1015A are disposed in a bottom surface of housing 305 of manual inflation machine 300 such that they are in fluid communication with front and rear balloon inflation lines 320 and 315, respectively, and thus with front and rear balloons 35 and 20, respectively. More particularly, the front balloon exhaust check valve 1015 includes a lumen 1020, the lumen 1020 having a first end in fluid communication with the front balloon inflation line 320 and a second end having an opening 1025 formed in an outer surface of the housing 305. A ball (e.g., rubber ball) 1030 is movably disposed within the lumen 1020 and biased against the opening 1025 by a spring 1035. When the balloon 1030 is biased against the opening 1025, air cannot pass through the opening 1025 and into (or out of) the front balloon inflation line 320, i.e., the front balloon 35 is sealed from free passage of air into (or out of) the front balloon 35.

The bottom tray 505 includes upwardly extending fingers 1040, the fingers 1040 being sized and positioned such that the fingers 1040 are received within the openings 1025 of the housing 305 when the novel apparatus 5 (and more particularly the manual inflator 300) is disposed within the bottom tray 1005 of the package 1000. The finger 1040 is sized such that when it is received within the opening 1025, the finger 1040 engages the ball 1030 and drives the ball 1030 against the force of the spring 1035, thereby removing the ball 1030 from the opening 1025. At the same time, a gap remains between the finger 1040 and the sides of the opening 1025, thereby allowing air to pass from the interior of the package 1000 through the front balloon exhaust check valve 1015, through the front balloon inflation line 320 and into the front balloon 35, and vice versa (fig. 87).

Bottom tray 1005 includes similar fingers 1040A for forcing check valve 1015A open when manual inflation machine 300 is seated in bottom tray 1005 of package 1000.

If desired, an upwardly extending stop (not shown) may also be provided on the bottom tray 1005 of the package 1000 for engaging the bottom surface of the housing 305 of the manual inflator 300 when the manual inflator 300 is disposed within the bottom tray 1005 of the package 1000, thereby ensuring that an air gap is maintained between the bottom surface of the manual inflator 300 and the bottom surface of the bottom tray 1005, and thus ensuring that air freely flows through the check valves 1015, 1015A when the manual inflator 300 is seated in the bottom tray 1005 of the package 1000.

As a result of this configuration, when the novel apparatus 5 is disposed in the bottom tray 1005, the fingers 1040, 1040A open the front and rear balloon exhaust check valves 1015, 1015A, respectively, such that air is allowed to freely enter and exit the front and rear balloons 35, 20 via the front and rear balloon exhaust check valves 1015, 1015A, respectively. This eliminates the aforementioned problems associated with exposing the package 1000 to significant variations in air pressure (e.g., during shipping) and prevents damage to the equipment 5 during shipping.

When the device 5 is to be used, the lid 1010 is removed from the package 1000 and the new device 5 is removed from the bottom tray 1005. When this occurs, fingers 1040, 1040A retract from front balloon exhaust check valve 1015 and back balloon exhaust check valve 1015A, respectively, allowing these check valves to return to their "closed" positions.

Thus, it will be seen that the front and rear balloon exhaust check valves 1015 and 1015A serve to protect the novel apparatus 5 from exposure to air pressure differences during shipping/storage and do so in a passive manner that does not require the recipient to close any valves.

Preferred method of using the novel apparatus

The device 5 may be used to manipulate (e.g., stabilize, straighten, expand and/or flatten, etc.) a body lumen and/or a side wall of a body cavity in order to better present side wall tissue (including visualization of areas that may not be initially visible or outside the field of view) for examination and/or treatment during an endoscopic procedure using the endoscope 10, and/or to stabilize a distal tip and/or working end of an instrument (e.g., grasper, cutter or stripper, cautery tool, ultrasound probe, etc.) that is advanced into a treatment zone, for example.

More particularly, in use, sleeve 15 is first mounted to endoscope 10 (FIG. 1). This may be accomplished by pulling the base 25 proximally over the distal end of the endoscope 10 and then proximally along the length of the endoscope 10 until the distal end of the sleeve 15 is substantially aligned with the distal tip of the endoscope 10. At this point, the rear balloon 20 is deflated, the front balloon 35 is deflated, and the front balloon 35 is docked on the distal end of the endoscope 10 with the endoscope 10 nested in the area below the raised push tube bridge 31. The endoscope 10 and the device 5 are ready to be inserted as a unit into a patient.

Turning next to fig. 89, endoscope 10 and device 5 are inserted as a unit into a body lumen and/or body cavity of a patient. By way of example and not limitation, endoscope 10 and device 5 are inserted as a unit into the gastrointestinal tract (GI) of a patient. The endoscope 10 and device 5 are advanced along the body lumen and/or body cavity to a desired location within the patient (fig. 90 and 91).

When the device 5 is to be used (e.g., to manipulate the side wall of the gastrointestinal tract, to provide increased visualization thereof and/or increased access thereto, and/or to stabilize an instrument relative thereto), the rear balloon 20 is inflated to stabilize the device 5 (and thus the endoscope 10) within the body lumen and/or body cavity. See fig. 92. This may be accomplished using the associated inflation mechanism 40 described previously.

In this regard, it will be appreciated that since the articulating portion of the endoscope resides distally of the rear balloon 20, the endoscope will be able to articulate distally of the rear balloon 20 to facilitate visualization of the anatomy even after inflation of the rear balloon 20. Notably, such visualization is enhanced because the rear balloon 20 stabilizes the endoscope 10 within the gastrointestinal tract and dilates the colon, and increases the colon to a fixed diameter immediately adjacent the rear balloon 20.

Next, by pushing push tube handle 37 distally, hollow push tube 30 is advanced distally within the body lumen and/or body cavity (i.e., to move forward balloon 35 further in front of rear balloon 20). Thus, hollow push tube 30, and thus anterior balloon 35, is moved distally relative to endoscope 10 (endoscope 10 is stabilized in place within the gastrointestinal tract by inflated posterior balloon 20). Note that the raised push tube bridge 31 provides an atraumatic tip to the distal end of the hollow push tube 30, thereby ensuring atraumatic advancement of the anterior balloon 35. Note that during such distal advancement of the anterior balloon 35, the deflated anterior balloon 35 covers the distal end of the hollow push tube 30 and the raised push tube bridge 31, thereby ensuring atraumatic advancement of the anterior balloon 35. Note that atraumatic advancement of the anterior balloon 35 may be further enhanced by forming the distal end of the hollow push tube 30 and the raised push tube bridge 31 from a more resilient material.

When the hollow push tube 30 has advanced the front balloon 35 to a desired position distal of the endoscope 10, the front balloon 35 is inflated (fig. 93) to secure the front balloon 35 to the anatomy. Again, this may be accomplished using the associated inflation mechanism 40 described previously. When the anterior balloon 35 is inflated, the inflated anterior balloon 35, the inflated posterior balloon 20, and the hollow push tube 30 will all complement each other to stabilize, straighten, expand, and/or flatten the body lumen and/or the side walls of the body lumen, thereby better presenting the side wall tissue (including visualization of areas that may be initially hidden from view or outside the field of view) for examination and/or treatment during an endoscopic procedure using the endoscope 10. In this regard, it will be appreciated that the inflated front balloon 35 and the inflated rear balloon 20 will together expand and tension the side walls of the body lumen and/or body cavity, and that the hollow push tube 30 will tend to straighten the anatomy between the two inflated balloons as the front balloon extends distally from the rear balloon. In this regard, it will also be appreciated that once both the rear balloon 20 and the front balloon 35 have been inflated, the front balloon 35 will create a substantially full diameter seal across the body lumen and/or body cavity (as the inflated front balloon closes the axial opening 63 extending through the front balloon when the front balloon is in its deflated state), and the rear balloon 20 will cooperate with the sleeve 15 and endoscope 10 to create another substantially full diameter barrier across the body lumen and/or body cavity. Thus, the inflated front balloon 35 and the inflated rear balloon 20 will together define a substantially enclosed area along the body lumen and/or body cavity (i.e., an isolated treatment area that prevents the passage of fluids and/or other liquids due to the airtight seal established by the inflated front balloon 35 and rear balloon 20). The side walls of the body lumen and/or body cavity will be tensioned by inflation of the anterior balloon 35 and the posterior balloon 20, thereby better presenting the side walls of the body lumen and/or body cavity for viewing through the endoscope 10.

It will be appreciated that the inflation and tensioning of the side walls of the body lumen and/or body cavity by the inflated front balloon 35, inflated rear balloon 20 and hollow push tube 30 may be further enhanced by advancing the front balloon and gripping the side walls of the body lumen and/or body cavity as the front balloon is inflated, thereby further tensioning the side walls of the body lumen and/or body cavity.

Notably, since the inflated anterior balloon 35 and the inflated posterior balloon 20 together define a substantially enclosed region (i.e., isolating the treatment zone) along the body lumen and/or body cavity, this region may then be treated with a fluid (e.g., air, CO ₂ Etc.) to further tighten the body lumen and/or side wall of the body cavity, thereby better presenting the body lumen and/or side wall of the body cavity for viewing through endoscope 10 and stabilizing the side wall to facilitate more accurate therapeutic intervention.

If desired, the anterior balloon 35 may be retracted toward the posterior balloon 20 (i.e., by pulling the push tube handle 37 proximally) while remaining inflated (and thus held in grip on the body lumen and/or side wall of the body cavity) to move the visible mucosa and further improve visualization and access (see fig. 95), e.g., to position a particular target area on the body lumen and/or side wall of the body cavity at a convenient angle relative to the endoscope and endoscopic tool.

Alternatively, if desired, once the rear balloon 35 has been inflated, the hollow push tube 30 may be advanced distally for a portion (but only a portion) of its full distal stroke, then the front balloon 35 may be inflated to grip the body lumen and/or side walls of the body cavity, and then the hollow push tube 30 may be advanced further distally. This action will cause the flexible hollow push tube 30 to bow outwardly (see fig. 96-99), contact and push outwardly the side wall of the body lumen and/or body cavity, for example in a "bump" manner, thereby further enhancing visualization of the side wall of the body lumen and/or body cavity by the endoscope 10.

If desired, instrument 190 (FIG. 100) may be advanced through the working channel of endoscope 10 in order to biopsy and/or treat a pathological condition (e.g., resect a pathological anatomy). It will be appreciated that such an instrument will extend through the distal end of the endoscope, which is effectively stabilized relative to the anatomy via the rear balloon 20, such that the working end of the instrument 190 will also be highly stabilized relative to the anatomy. This is a significant advantage over prior art practices of advancing the instrument beyond the unstable end of the endoscope. Preferably, the instrument 190 comprises an articulating instrument having a full range of motion, thereby providing better access to the target anatomy.

Furthermore, if bleeding obscures the tissue site, or if bleeding occurs and the surgeon cannot identify the source of the blood, the isolated treatment region allows for rapid irrigation of the anatomical region where the treatment region is located (e.g., with a liquid such as saline) and subsequent rapid removal of the irrigation liquid (see fig. 101-103).

In addition, if desired, the anterior balloon 35 may be directed to the bleeding site with high precision, whereby the anterior balloon 35 may be used (e.g., inflated) to apply localized pressure to the bleeding site in order to enhance bleeding control (see fig. 104). This may be accomplished under the visualization provided by endoscope 10.

If it is desired to reposition the endoscope 10 within the anatomy with minimal interference from the device 5, the anterior balloon 35 is returned to its torus configuration (i.e., partially deflated), the anterior balloon is retracted proximally and "rechecked" at the distal end of the endoscope 10 (where the endoscope 10 is nested in the area below the raised push tube bridge 31), the posterior balloon 20 is deflated, and then the endoscope 10 (with the device 5 carried thereon) is repositioned within the anatomy. Note that when the front balloon 35 is to be re-docked on the distal end of the endoscope 10, the front balloon 35 is preferably only partially deflated until the front balloon 35 is re-docked on the distal end of the endoscope, as partial inflation of the front balloon 35 may leave enough "body" for the front balloon 35 to facilitate the re-docking process. Thereafter, if desired, the anterior balloon 35 may be fully deflated, e.g., to positively grip the distal end of the endoscope 10.

Alternatively, the anterior balloon 35 may be used as a resistive brake to control retrograde movement of the endoscope, if desired. More particularly, in this form of the invention, the endoscope 10 and device 5 are first advanced as a unit into the body lumen and/or body cavity until the distal end of the endoscope is in the correct position. Next, the rear balloon 20 is inflated, the hollow push tube 30 is advanced distally, and then the front balloon 35 is inflated (fig. 105). Visualization and optionally therapeutic treatment can then be effected at this location. When the device is to be moved retrograde, the rear balloon 20 is deflated, the front balloon 35 is partially deflated, and then the endoscope is retracted proximally, dragging the semi-inflated front balloon 35 along the body lumen and/or body cavity (fig. 106), the front balloon 35 acting as some kind of brake when the endoscope is pulled proximally, enabling better control of the retrograde movement of the endoscope and thus better visualization of the anatomy. If desired at some point, as shown in FIG. 107, the posterior balloon 20 and anterior balloon 35 may be re-inflated with or without the introduction of fluid into the "isolation treatment zone" established between the two balloons, in order to stabilize, straighten, expand and/or flatten the anatomy.

The rear balloon 20 may also be used as a brake when retracting the endoscope (and thus the device 5) from the anatomy, alone or in combination with the previously described braking action from the front balloon 35.

At the end of the procedure, the endoscope 10 and device 5 are retracted from the anatomy. Preferably, this is done by: the anterior balloon 35 is deflated (or partially deflated), the hollow push tube 30 is retracted so that the anterior balloon 35 is "re-docked" onto the distal end of the endoscope 10 (with the endoscope 10 nested in the area below the raised push tube bridge 31), the anterior balloon 35 is fully deflated so that it grips the distal end of the endoscope, the posterior balloon 20 is deflated (if it has not been deflated), and then the endoscope 10 and device 5 are withdrawn from the anatomy as a unit.

It will be appreciated that the device 5 may also be advantageously used in a variety of ways other than those disclosed above. By way of example and not limitation, when endoscope 10 (and device 5) is to be advanced within the colon, it may be desirable to first extend front balloon 35 distally under the visual guidance of the endoscope so that front balloon 35 guides the distal end of the endoscope. As a result, with the anterior balloon 35 deflated (or partially deflated), the anterior balloon and flexible hollow push tube 30 (and the raised push tube bridge 31) may act as an atraumatic guide (guide structure) for the endoscope as it advances through the colon as the endoscope is advanced distally. Notably, since the distal end of the hollow push tube 30 is preferably highly flexible, when the advancing forward balloon 35 encounters the colon wall (e.g., at a turn of the colon), the flexible hollow push tube may deflect such that the forward balloon tracks the path of the colon, thereby facilitating atraumatic advancement of the endoscope along the colon. It will also be appreciated that the device 5 may also be advantageously used in other ways to facilitate further inspection of the luminal surface that is otherwise difficult to perform at present. An example of this is endoscopic ultrasound inspection of the lumen, which would be facilitated by a fluid-filled pre-inflation balloon and ultrasound probe inspection.

Improved posterior balloon thermal bonding using insert material

The rear balloon 20 is bonded to the sleeve 15 at least along the distal edge of the rear balloon 20 and the proximal edge of the rear balloon 20 (i.e., the distal and proximal edges where the rear balloon 20 meets the sleeve 15) such that an airtight seal is created between the rear balloon 20 and the sleeve 15. The pusher lumen 52 and the rear balloon inflation lumen 47 are disposed in contact with the sleeve 15 and parallel to the sleeve 15, wherein the pusher lumen 52 passes completely through the rear balloon 20 (i.e., through both the proximal and distal edges of the rear balloon 20 where the rear balloon 20 meets the sleeve 15), and wherein the rear balloon inflation lumen 47 passes through the proximal edge of the rear balloon 20 and extends into the interior of the rear balloon 20. As a result, the rear balloon 20 must be sealingly bonded to the sleeve 15 around a series of components (i.e., the push rod lumen 52 and the rear balloon inflation lumen 47), which collectively present a non-circular cross-sectional profile at the bond site.

In practice, it has been found that achieving an airtight thermal bond of the rear balloon 20 with the sleeve 15 is challenging, as the presence of the push rod lumen 52 and the rear balloon inflation lumen 47 creates an open wedge (or corner) that the material of the rear balloon 20 must fill in order to ensure an airtight bond of the rear balloon 20 with the sleeve 15.

More particularly, and looking now at fig. 108, gap 1100 exists in the space between push rod lumen 52 and sleeve 15, gap 1105 exists in the space between rear balloon inflation lumen 47 and sleeve 15, and gap 1110 exists in the space between push rod lumen 52 and rear balloon inflation lumen 47. The presence of gaps 1100, 1105, and 1110 at the proximal edge of rear balloon 20 and the presence of gap 1100 at the distal edge of rear balloon 20 compromises the airtight seal of rear balloon 20 with sleeve 15 because it is difficult to adhere the material of rear balloon 20 to the irregular perimeter defined by pushrod lumen 52 and rear balloon inflation lumen 47. In other words, it can be challenging to get the material of the rear balloon 20 into the gaps 1100, 1105, and 1110.

Accordingly, it is desirable to provide a new and improved means for filling gaps 1100, 1105, and 1110 so that rear balloon 20 may be thermally bonded to sleeve 15 in airtight sealing engagement.

To this end, and looking now at fig. 109, 110, 111, 112, 113 and 114, a novel extrusion insert 1115 having a cross-sectional profile matching the aforementioned gap 1100 is provided. Extrusion insert 1115 is sized to fill gap 1100 at the location where the proximal edge of rear balloon 20 and the distal edge of rear balloon 20 are bonded to sleeve 15 around pushrod lumen 52. Extrusion insert 1110 is preferably flexible and may have any desired length (e.g., extrusion insert 1115 may extend along substantially the entire length of sleeve 15, or extrusion insert 1115 may extend along only a portion of sleeve 15 where rear balloon 20 is bonded to sleeve 15, or multiple extrusion inserts 1115 may extend along multiple interrupted sections of sleeve 15, etc.). In one preferred form of the invention, extrusion insert 1115 extends from a location immediately distal to rear balloon 20 to a location immediately proximal to rear balloon 20.

A novel extrusion insert 1120 is also provided having a cross-sectional profile that matches the aforementioned gap 1105. Extrusion insert 1120 is sized to fill gap 1105 at the location where the proximal edge of rear balloon 20 and the distal edge of rear balloon 20 are bonded to sleeve 15 around rear balloon inflation lumen 47. The extrusion insert 1120 is preferably flexible and may have any desired length (e.g., the extrusion insert 1120 may extend along substantially the entire length of the sleeve 15, or the extrusion insert 1120 may extend along only a portion of the sleeve 15 where the rear balloon 20 is bonded to the sleeve 15, or multiple extrusion inserts 1120 may extend along multiple interrupted sections of the sleeve 15, etc.). In one preferred form of the invention, extrusion insert 1120 extends from a location at the distal end of rear balloon inflation lumen 47 to a location immediately proximal of rear balloon 20.

A novel extrusion insert 1125 is also provided having a cross-sectional profile that matches the aforementioned gap 1110. Extrusion insert 1125 is sized to fill gap 1110 where the proximal edge of rear balloon 20 and the distal edge of rear balloon 20 are joined to sleeve 15 around rear balloon inflation lumen 47 and pusher lumen 52. Extrusion insert 1125 is preferably flexible and may have any desired length (e.g., extrusion insert 1125 may extend along substantially the entire length of sleeve 15, or extrusion insert 1125 may extend along only a portion of sleeve 15 where rear balloon 20 is bonded to sleeve 15, or multiple extrusion inserts 1125 may extend along multiple interrupted sections of sleeve 15, etc.). In one preferred form of the invention, extrusion insert 1125 extends from a location at the distal end of rear balloon inflation lumen 47 to a location immediately proximal of rear balloon 20.

The inserts 1115, 1120, and 1125 are preferably formed of a material that will thermally bond with the material(s) of (i) the sleeve 15, (ii) the pusher lumen 52, (iii) the rear balloon inflation lumen 47, and (iv) the rear balloon 20, thereby facilitating airtight bonding of the rear balloon 20 with the sleeve 15, pusher lumen 52, and rear balloon inflation lumen 47.

It should be appreciated that where additional components/lumens (e.g., working channels) are coaxially disposed about the sleeve 15, additional extrusion inserts 1115, 1120, 1125, etc. may be provided, and/or other extrusion inserts having different sizes and/or cross-sectional profiles may be provided without departing from the scope of the present invention.

Improved front balloon structure

With the "double everted" anterior balloon configuration discussed above, anterior balloon 35 is formed as a hollow balloon body 67 having two extensions (i.e., proximal extension 73 and distal extension 76) that are both everted inwardly (i.e., proximal extension everted first, distal extension everted second) into the interior of body 67 and thermally bonded together to form anterior balloon 35. With this approach, the anterior balloon 35 includes an annulus, thereby facilitating docking of the anterior balloon 35 on the distal end of the sleeve 15 (i.e., the distal end of the endoscope 10) when the anterior balloon 35 is in its deflated state. At the same time, when the anterior balloon 35 is in its inflated state, the anterior balloon 35 may provide a full diameter barrier across the anatomic passageway.

However, it has been found that achieving a good thermal bond between the inwardly turned proximal extension 73 and the inwardly turned distal extension 76 can be challenging, as both the proximal extension 73 and the distal extension 76 are located within the inner body 67 of the anterior balloon 35 during bonding, and thus can be difficult to access during component bonding.

One solution to this problem (and looking now at fig. 115-119) is to provide an alternative anterior balloon 35A. The anterior balloon 35A is manufactured as a single structure that includes a body 67A having a proximal opening 69A and a distal opening 71A, a proximal extension 73A having a "key-shaped" cross-section that includes a lobe 74A, and a distal extension 76A having a circular cross-section. Note that the lobes 74A of the proximal extension 73A have a configuration that matches the configuration of the hollow push tube 30 (i.e., where the device 5 includes two hollow push tubes 30 that are diametrically opposed to each other, the proximal extension 73A includes two lobes 74A that are diametrically opposed to each other—for purposes of the present invention, the proximal extension 73A and the lobe(s) 74A may be collectively referred to as having a "key-shaped" cross-section). Proximal extension 73A is relatively short and preferably flares outwardly at its proximal end, thereby facilitating docking of anterior balloon 35A on sleeve 15 and/or endoscope 10, as will be discussed in more detail below. Furthermore, proximal extension 73A preferably includes a proximally extending tongue 77 for facilitating docking of anterior balloon 35A on the proximal end of sleeve 15 (and/or the proximal end of endoscope 10).

Thus, it will be appreciated that the anterior balloon 35A is formed in a manner generally similar to the anterior balloon 35 described previously (i.e., by being formed with a shorter length, flared proximal end and tongue 77) except that the proximal extension 73A of the anterior balloon 35A is different than the aforementioned proximal extension 73 of the anterior balloon 73.

The anterior balloon 35A is also assembled in a somewhat different manner than the anterior balloon 35 previously described, as will be discussed in more detail below. More particularly, and looking now at fig. 120-122, hollow push tube 30 is seated in lobe 74A of proximal extension 73A, wherein proximal extension 73A extends proximally away from anterior balloon 35A, and wherein distal extension 76 extends distally away from anterior balloon 35A. The hollow push tube 30 is advanced distally into the interior of the body 67A of the anterior balloon 35A such that the interior of the hollow push tube 30 is in fluid communication with the interior of the body 67A and with the raised push tube bridge 31 disposed within the interior of the body 67A. If desired, the assembly mandrel M may be used during assembly to provide support for the components during insertion of the hollow push tube 30 into the anterior balloon 35A of the anterior balloon 35A (see FIG. 120).

Next, the treatment mandrel M (if used) is removed and the distal extension 76A is flipped into the interior of the body 67A of the anterior balloon 35A and passed proximally through the body 67A and through the interior of the proximal extension 73A until the distal extension 76A extends to the proximal opening of the proximal extension 73A. As a result of this configuration, proximal extension 76A extends through body 67A, and both proximal extension 73A and distal extension 76A extend proximally away from body 67A of anterior balloon 35A, and push tube 30 is disposed between proximal extension 73A and distal extension 76A proximal of body 67A of anterior balloon 35A. Thus, in this form of the invention, proximal extension 73A is not everted into the interior of anterior balloon 35A, rather, proximal extension 73A remains proximally extending away from anterior balloon 35.

The proximal extension 73A and distal extension 76A are then bonded together at their proximal ends with the push tube 30 sealed therebetween, thereby achieving an airtight thermal bond.

As a result of the foregoing, the anterior balloon 35A has a torus configuration that includes a body 67 having a central opening formed by (i) a proximal extension 73A/a everted distal extension 76A on a proximal side of the body 67A and (ii) an everted distal extension 76A within an interior of the body 67A.

Notably, this form of the invention results in the anterior balloon 35A having a torus shape that does not require thermal bonding within the interior of the body 67A of the anterior balloon 35A, thereby simplifying assembly. Furthermore, by forming proximal extension 73A to be a relatively short structure with an outwardly flared proximal end, and by providing tongue 77 on the proximal edge of proximal extension 73A, proximal extension 73A may facilitate docking of anterior balloon 35A on sleeve 15 and/or endoscope 10.

If desired, and looking now at fig. 123, a novel extrusion insert 1130 can be provided alongside the hollow push tube 30 to facilitate bonding of the hollow push tube 30 to the proximal extension 73A and the inverted distal extension 76A.

Further, 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 to provide increased rigidity to those portions of anterior balloon 35A.

Forming a rear balloon with a everting configuration

If desired, the rear balloon 20 may be formed with an inverted configuration. More particularly, and looking now at fig. 124 and 125, a rear balloon 20A is shown that generally includes a distal extension 1135 and a proximal extension 1140. During construction, distal extension 1135 is flipped back through the center of rear balloon 20A to form a generally toroidal balloon structure secured to sleeve 15. In this form of the invention, the tube 1145 has its distal end 1150 disposed outside of the everted distal extension 1135, and inside of the outer wall of the rear balloon 20A, and its proximal end 1155 connected to the aforementioned proximal inflation/deflation tube 45, so that air (or another fluid) may be introduced into the rear balloon 20A and removed from the rear balloon 20A.

Additional structure

If desired, the device 5 may be configured such that the hollow push tubes 30 may be advanced or retracted independently of each other and in combination with each other to a limited extent-such limited independent advancement or retraction of the hollow push tubes 30 may help maneuver the partially or fully collapsed anterior balloon 35 through the body lumen and/or body cavity, thereby facilitating advancement or retraction of the endoscope 10 through the body lumen and/or body cavity, and/or such independent advancement or retraction of the hollow push tubes 30 may facilitate application of a "rotational force" to the anatomy with the inflated anterior balloon 35, thereby better presenting the anatomy for visualization and/or treatment.

By way of example and 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 such that hollow push tubes 30 can move somewhat independently of push tube handle 37 and independently of each other. Stop 191 limits the distal movement of hollow push tube 30 relative to push tube handle 37 so that the hollow push tube cannot be completely removed from push tube handle 37. As a result of this configuration, when the anterior balloon 35 is to be moved distally, the hollow push tubes 30 are moved distally either together or independently of each other to the extent permitted by the raised push tube bridge 31. And when the forward balloon 35 is to be moved proximally, the hollow push tubes 30 are moved proximally together or independently of each other to the extent permitted by the raised push tube bridge 31. At any point in the procedure, the hollow push tubes 30 may be moved independently of one another to the extent permitted by the raised push tube bridge 31 in order to "turn" the anterior balloon, such as, for example, when the anterior balloon 35 is inflated and engages the anatomy, thereby applying a "turning force" to the anatomy, or in the case where the anterior balloon 35 is partially inflated and used as an atraumatic tip of a pusher assembly, thereby helping to "steer" the assembly through the anatomy. Note that the raised push tube bridge 31 at the distal end of the hollow push tube 30 provides a limiting mechanism to limit the extent to which the hollow push tubes 30 can move longitudinally independently of each other in order to prevent over-rotation of the anterior balloon 35, and/or crossing of the hollow push tubes, and/or winding of the hollow push tubes, and/or misalignment of the hollow push tubes, etc. Note also that the hollow push tube 30 may be held in a particular arrangement by mounting the hollow push tube 30 in the aforementioned clamp 53 (fig. 37 and 60).

It should also be appreciated that it is possible to modify the configuration of sleeve 15 in order to support instruments (or hollow instrument guide tubes) external to endoscope 10. More particularly, and looking again at fig. 5 and 6, it will be seen that in the configuration shown in fig. 5 and 6, the sleeve 15 includes a lumen 47 for receiving an inflation/deflation tube 45 for inflating/deflating the rear balloon 20, and a pair of lumens 52 for receiving a support tube 50, the support tube 50 receiving the push tube 30 for manipulating the front balloon 35 and inflating/deflating it. However, if desired, sleeve 15 may include additional lumens for supporting instruments (or hollow instrument guide tubes) external to endoscope 10.

More particularly, and looking now at fig. 127, there is shown an end view of another form of sleeve 15, the sleeve 15 including a plurality of lumens 195 for slidably receiving an instrument 190 therein. Note that when inflated, the rear balloon 20 provides a reliable platform for holding the endoscope 10 and sleeve 15 within a body lumen or body cavity, with the endoscope 10 and sleeve 15 centered within the body lumen or body cavity. As a result, the distal end of lumen 195 of sleeve 15 will also be securely held within the body lumen or body cavity to provide secure support for instruments advanced through lumen 195 of sleeve 15.

The proximal end of lumen 195 may extend into and through base 25, in which case the instrument may be inserted into lumen 195 at base 25, or the proximal end of lumen 195 may terminate proximally of base 25 (but still outside the patient's body), in which case the instrument may be inserted into lumen 195 of intermediate sleeve 15. By way of example and not limitation, where endoscope 10 is 180cm in length and instrument 190 is 60cm in length, it may be advantageous to insert instrument 190 into lumen 195 at a point closer to balloons 20, 35 (rather than base 25). Note that in fig. 127, lumen 47 for receiving inflation/deflation tube 45 and inflation/deflation tube 45 for balloon 20 after inflation/deflation are not visible, as the view is distally facing and taken at a location distal to where lumen 47 and inflation/deflation tube 45 terminate at sleeve 15.

Figures 128-131 illustrate various instruments 190 extending out of lumen 195. Note that the instrument 190 preferably comprises an articulating instrument, such as, for example, a grasper 190A in fig. 128-131, a cautery device 190B in fig. 128-129, scissors 190C in fig. 130 and 131, and a suction device 190D in fig. 128-131.

It should be appreciated that where sleeve 15 includes its central passageway for receiving endoscope 10, lumen 47 for receiving inflation/deflation tube 45, lumen 52 for receiving support tube 50 of hollow push tube 30, and/or lumen 195 for slidably receiving instrument 190 therein, sleeve 15 is preferably formed by an extrusion process.

In a preferred form of the invention, lumen 47 for receiving inflation/deflation tube 45, lumen 52 for receiving support tube 50 of hollow push tube 30, and/or lumen 195 for slidably receiving instrument 190 may have a fixed configuration (i.e., a fixed diameter) such that sleeve 15 has a fixed outer profile.

In another preferred form of the invention, the lumen 47 for receiving the inflation/deflation tube 45, the lumen 52 for receiving the support tube 50 of the hollow push tube 30, and/or the lumen 195 for slidably receiving the instrument 190 may have an expandable configuration (i.e., they may have a minimal profile when empty and expand diametrically as needed when filled with instrument or other filling material) such that the overall profile of the sleeve 15 is minimized. If desired, lumen 47 for receiving inflation/deflation tube 45, lumen 52 for receiving support tube 50 of hollow push tube 30, and/or lumen 195 for slidably receiving instrument 190 may be expandable only at their distal ends (i.e., not along the entire length of the instrument lumen).

It should also be appreciated that where sleeve 15 includes a plurality of lumens 195 for slidably receiving instruments 190 therein, it may be desirable to provide greater structural integrity to the distal ends of lumens 195 in order to provide improved support for instruments 190 received within lumens 195. To this end, a support ring may be provided at the distal end of the sleeve 15, wherein the support ring provides an opening for passing through the hollow push tube 30 and an opening for passing through the instrument 190. Note that such openings in the support ring for passing the instrument 190 preferably mate with the instrument to provide excellent instrument support at the distal end of the sleeve 15.

Alternatively and/or additionally, lumen 195 may house a hollow instrument guide tube that itself houses an instrument therein. Such hollow instrument guide tubes may provide greater structural integrity to the distal end of lumen 195 to provide improved support for instrument 190 received within lumen 195.

And such hollow instrument guide tubes may have a fixed geometry or have a bendable or articulating geometry. Referring to, for example, fig. 132, a hollow instrument guide tube 200 is shown extending out of lumen 195 and receiving instrument 190 therein. Note that the hollow instrument guide tube 200 may be independently movable relative to each other (and independently movable relative to the sleeve 15). Note also that the instrument 190 preferably mates with the hollow instrument guide tube 200 to provide excellent instrument support at the distal end of the sleeve 15.

In another form of the invention, the torus configuration of the anterior balloon 35 may be replaced by a "conventional" balloon configuration, i.e., by a balloon having a substantially uniform full diameter cross section. In this form of the invention, the deflated anterior balloon does not "dock" onto the endoscope during insertion-instead, the deflated anterior balloon resides alongside the endoscope during insertion; and in this form of the invention, the anterior balloon does not "re-dock" back onto the endoscope during retraction-instead, the balloon resides distally of (or alongside) the endoscope during retraction. It will be appreciated that in this form of the invention, the raised push tube bridge 31 may help hold the deflated anterior balloon alongside the endoscope.

Simplified form of the device 5

As discussed above, the device 5 generally includes a sleeve 15 for receiving the endoscope 10, the rear balloon 20, an inflation line 45 for inflating the rear balloon 20, a hollow push tube (or shaft) 30, an anterior balloon 35, and one or more instrument lumens 195 preferably for receiving instruments therein.

In alternative forms of the invention, the device 5 may omit certain features if their functionality is not required.

By way of example and not limitation, if it is not necessary to provide a sealed treatment zone, the device 5 may be simplified by omitting the aforementioned anterior balloon 35. In this case, the aforementioned hollow push tube 30 may be retained without the use of the front balloon 35 in order to provide the desired function (as shown in fig. 133, 133A, 134A, and 135-140, and as will be discussed in further detail below), or the hollow push tube 30 (and/or hollow support tube 50) may be omitted from the sleeve 15 (not shown).

Looking now at fig. 133, 133A, 134A and 135-140, the hollow push tube 30 and/or hollow support tube 50 may be retained without the use of the forward balloon 35 to provide the desired function. By way of example and not limitation, the hollow push tube 30 and/or hollow support tube 50 may be reserved for (i) providing column strength to the sleeve 15 (fig. 133, 133A, 134, and 134A), (ii) use in procedures within a body lumen of a patient (fig. 135-140), (iii) delivery of an instrument through the hollow push tube 30, and/or (iv) delivery of an instrument through the hollow support tube 50, and so forth. When the front balloon 35 is omitted and the hollow push tube 30 (and/or hollow support tube 50) is retained, the device 5 includes a sleeve 15 for receiving the endoscope 10, a rear balloon 20 for stabilizing the sleeve 15 (and the endoscope disposed therein) within a body lumen or body cavity, an inflation line 45 for inflating the rear balloon 20, the hollow push tube 30, the hollow support tube 50 for receiving the hollow push tube 30, and an instrument lumen 195 for receiving an instrument therein.

For this reason, it is important to note that the sleeve 15 of the device 5 is formed of a flexible material that is substantially devoid of column strength, and that the push tube 30 and/or support tube 50 provide the column strength required to prevent the sleeve 15 from collapsing (e.g., kinking) on the endoscope 10 when the device 5 and endoscope 10 are positioned within or retracted from the anatomy of the patient. Thus, when the front balloon 35 is omitted from the device 5, it is desirable to retain the push tube 30 and/or support tube 50 along the length of the sleeve 15 in order to maintain the column strength typically provided by the push tube 30 and/or support tube 50. When only the push tube 30 and/or support tube 50 are retained to provide column strength to the sleeve 15, the push tube 30 no longer needs to be movable (i.e., slidable in the distal and proximal directions) relative to the sleeve 15. Thus, when the push tube 30 is secured within the support tube 50, the portion of the push tube 30 and/or support tube 50 that extends distally beyond the rear balloon 20 may be omitted such that the push tube 30 and/or support tube 50 terminates within the rear balloon 20 (fig. 133, 133A, 134, and 134A) or immediately proximal of the rear balloon 20 (if it is desired to provide a distal end of the sleeve 15 that is more flexible than the remainder of the sleeve 15).

Alternatively, if desired, the sleeve 15 may be formed of a material having sufficient column strength to prevent the sleeve 15 from collapsing (e.g., kinking) on the endoscope 10 when the device 5 and endoscope 10 are positioned within or retracted from the anatomy of the patient. In this form of the invention, the push tube 30 and support tube 50 may be omitted entirely from the apparatus 5, if desired.

As described above, and looking now at fig. 135 and 136, when the anterior balloon 35 has been omitted from the device 5, the push tube 30 and/or support tube 50 may still remain for use in procedures within the body lumen of the patient. In this form of the invention, the device 5 includes a sleeve 15 for receiving the endoscope 10, a rear balloon 20 for stabilizing the sleeve 15 (and the endoscope disposed therein) within a body lumen or body cavity, an inflation line 45 for inflating the rear balloon 20, a hollow push tube 30, a hollow support tube 50 for receiving the hollow push tube 30, and an instrument lumen 195 for receiving an instrument therein. In this form of the invention, the push tube 30 is configured to move between a retracted position (fig. 135) and an extended distal advanced position (fig. 136).

In a preferred form of the invention, the distal end of the push tube 30 is formed with an atraumatic (e.g., a "blunt") tip such that the distal end of the push tube 30 does not cause trauma to tissue as the push tube 30 is moved distally within the anatomy. This is particularly important where the anterior balloon 35 is not disposed at the distal end of the push tube 30, as the anterior balloon 35 may be otherwise used to protect the anatomy from trauma caused by distal movement of the push tube 30.

By way of example and not limitation, the distal ends of a pair of hollow push tubes 30 may be connected together with a raised push tube bridge 31 (e.g., a "saddle" push tube as shown in fig. 7-13). The raised push tube bridge 31 provides a rounded structure at the distal end of the hollow push tube 30 that serves primarily to both (i) connect the distal ends of the hollow push tube 30 together, and (ii) eliminate abrupt ends at the distal end of the hollow push tube 30 that may cause trauma to tissue, such as during distal advancement of the hollow push tube 30. As described above, if desired, the raised push tube bridge 31 may be angled distally, for example, in the manner shown in fig. 7-12. Alternatively, if desired, the raised push tube bridge 31 may be disposed substantially perpendicular to the longitudinal axis of the hollow push tube 30, for example, in the manner shown in FIG. 13.

Furthermore, if desired, the raised push tube bridge 31 may be in the form of a ring, for example in the manner shown in fig. 14. See, for example, fig. 137-140, which illustrate a push tube 30 having a raised push tube bridge 31 in the form of a loop, wherein fig. 137 and 138 illustrate the push tube 30 in a retracted position, and wherein fig. 139 and 140 illustrate the push tube 30 in an extended distal advanced position.

For each of the configurations showing the raised push tube bridge 31, the raised push tube bridge 31 is preferably configured to reside near the distal ends of the rear balloon 20 and endoscope 10 when the raised push tube bridge 31 is in its retracted position. Referring to, for example, fig. 8 and 14, fig. 8 shows the distal end of endoscope 10 nested within raised push tube bridge 31 and front balloon 35 when front balloon 35 is disposed at the distal end of endoscope 10, and fig. 14 shows the distal end of endoscope 10 nested within the interior of the ring. Referring also to, for example, fig. 137 and 138 illustrate the device 5 (with the anterior balloon 35 omitted) wherein the distal end of the endoscope 10 is nested within the interior of the ring. In this way, the ring serves to provide an atraumatic tip for the distal end of the sleeve 15 and the distal end of the support tube 50, which makes the device 5 (with the anterior balloon omitted) less traumatic and easier to pass through the body lumen or body cavity.

In an exemplary method of using the simplified apparatus 5 (e.g., the apparatus 5 without the anterior balloon 35), the simplified apparatus 5 may be used to perform a procedure in a body lumen without creating a sealed treatment region between two inflated balloons. By way of example AND not limitation, THE push tube 30 may be used TO tighten lesions TO be excised from body lumens, as described in U.S. patent application Ser. No. 16/513,388 (attorney docket No. LUMENDI-2021), filed by Lumendi Ltd. AND Peter Johann et al at 7.16 of 2019, entitled "METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASEDVISUALIZATION OF THE SAME AND/OR INCREASED ACCESS TO THE SAME, AND/OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME," incorporated herein by reference.

More particularly, as described in U.S. patent application serial No. 16/513,388, the distal ends of push tubes 30 of sleeve 15 may be connected to each other by bridge 31, and a connector (e.g., a strand of suture) may be attached to bridge 31 (either before or during the procedure) and connected to the lesion (e.g., using a clip). The simplified form of the device 5 is pulled over the endoscope 10, the combination of the endoscope 10 and the simplified device 5 is advanced into the body lumen or body cavity (e.g., intestine) such that the endoscope 10 is located immediately proximal of the lesion, the rear balloon 20 is inflated to stabilize the endoscope relative to the lesion, the connector is attached to the bridge 31 of the push tube 30 and connected to the lesion by the clip, and the push tube 30 is moved distally to tighten the lesion away from the endoscope 10. The lesion is then peeled from the body lumen or body cavity (e.g., submucosa of the intestine) using a cutting tool that has been advanced through the working lumen (or instrument lumen 195) of the endoscope 10.

However, it is important to note that the use of push tube 30 without anterior balloon 35 is not limited to a strain lesion. By way of example and not limitation, the push tubes 30 may remain without the front balloon 35 for passing instruments through one or both of the hollow push tubes 30 or through one or both of the support tubes 50. By way of further example and not limitation, push tube 30 may be used to manipulate (e.g., straighten) a body lumen and/or a side of a body cavity to better present sidewall tissue for examination and/or treatment.

In yet another form of the present invention, and looking now at fig. 141 and 142, sleeve 15 may include one or more additional rear balloons 20B for stabilizing sleeve 15 (and an endoscope disposed therein) within the anatomy. Thus, in this form of the invention, the device 5 includes a sleeve 15 for receiving the endoscope 10, a first rear balloon 20 disposed at a generally distal end of the sleeve 15 (e.g., immediately proximal of the distal end of the sleeve 15, or on a portion of the sleeve 15 adjacent a bending section of the endoscope, etc.), a second rear balloon 20B disposed proximally of the rear balloon 20, an inflation line 45 for inflating the rear balloon 20 and the rear balloon 20B (either simultaneously or independently of each other), a hollow push tube 30, a hollow support tube 50 for receiving the hollow push tube 30, and an instrument lumen 195 for receiving an instrument therein.

Where sleeve 15 includes an additional rear balloon 20B, the additional rear balloon 20B may be positioned directly adjacent to rear balloon 20 and in contact with rear balloon 20 (fig. 141), or additional rear balloon 20B may be proximally spaced from rear balloon 20 (fig. 142). If desired, an additional rear balloon 20B may be movably disposed on the sleeve 15 such that the position of the rear balloon 20B may be adjusted relative to the rear balloon 20, thereby providing the desired stability within the anatomy.

For this form of the invention, the push tube 30 may be reserved for a desired function, such as providing column strength to the sleeve 15 (as shown in fig. 141 and 142), or for use in procedures within a body lumen of a patient (as shown in fig. 143-146).

In yet another alternative form of the invention, in addition to the removal of the foregoing anterior balloon 35, the instrument lumen 195 may be omitted from the device 5 if it is also not necessary to provide an additional lumen for receiving an instrument. In this form of the invention, the foregoing hollow push tube 30 may be retained without the use of the forward balloon 35 in order to provide the desired function (as shown in fig. 146A, 146B and 147-152 and as will be discussed in further detail below), or the hollow push tube 30 (and/or hollow support tube 50) may be omitted from the sleeve 15 (not shown), provided that the sleeve 15 is formed with suitable column strength. When the front balloon 35 and instrument lumen 195 are omitted and the hollow push tube 30 and/or support tube 50 are retained, the device 5 includes a sleeve 15 for receiving the endoscope 10, a rear balloon 20 for stabilizing the sleeve 15 (and the endoscope disposed therein) within the body lumen or body cavity, an inflation line 45 for inflating the rear balloon 20, the hollow push tube 30, and the hollow support tube 50 for receiving the hollow push tube 30.

In this form of the invention, when it is desired to pass the instrument along the path followed by the endoscope 10, the instrument may be passed through the endoscope itself, e.g., the instrument may be passed along a working lumen of the endoscope. Alternatively, an endoscope having a smaller diameter than the diameter of the lumen of the sleeve 15 may be used such that there is a gap between the inner wall of the lumen of the sleeve 15 and the outside of the endoscope. The instrument may then be passed through the gap between sleeve 15 and endoscope 10. If desired, and as will be discussed in further detail below, one or more channels may be formed on the interior of sleeve 15 to provide support for instruments that pass through the gap between sleeve 15 and endoscope 10.

As described above, and looking now at fig. 146A, 146B, and 147-152, if desired, the hollow push tube 30 and/or hollow support tube 50 may be retained without the use of the forward balloon 35 to provide the desired functionality. By way of example and not limitation, the hollow push tube 30 and/or hollow support tube 50 may be reserved for (i) providing column strength to the sleeve 15 (fig. 146A, 146B, 147, and 148), (ii) use in procedures within a body lumen of a patient (fig. 149-152), (iii) passing an instrument through the hollow push tube 30, and/or (iv) passing an instrument through the hollow support tube 50, and so forth. When the push tube 30 is secured within the support tube 50, the portion of the push tube 30 and/or support tube 50 that extends distally beyond the rear balloon 20 may be omitted such that the push tube 30 and/or support tube 50 terminates within the rear balloon 20 (fig. 146A, 146B, 147 and 148) or immediately proximal of the rear balloon 20 (if it is desired to provide a distal end of the sleeve 15 that is more flexible than the remainder of the sleeve 15).

Alternatively, and looking now at fig. 149-152, when the push rod 30 and/or support tube 50 are reserved for use in a procedure within a body lumen or body cavity of a patient, the push tube 30 is configured to move between a retracted position (fig. 149 and 151) and an extended distal advanced position (fig. 150 and 152).

Furthermore, if desired, the raised push tube bridge 31 may be in the form of a ring, for example in the manner shown in fig. 14. Referring to, for example, fig. 151 and 152, fig. 151 shows a push tube 30 having a raised push tube bridge 31 in the form of a loop, fig. 151 shows push tube 30 in a retracted position, and fig. 152 shows push tube 30 in an extended distal advanced position.

For each of the configurations showing the raised push tube bridge 31, the raised push tube bridge 31 is preferably configured to reside adjacent the distal end of the endoscope 10 and the rear balloon 20 when the raised push tube bridge 31 is in its retracted position. Referring to, for example, fig. 8 and 14, fig. 8 shows the distal end of endoscope 10 nested within raised push tube bridge 31 and front balloon 35 when front balloon 35 is disposed at the distal end of endoscope 10, and fig. 14 shows the distal end of endoscope 10 nested within the interior of the ring. Referring also to, for example, fig. 151, which illustrates the device 5 (with the anterior balloon 35 and instrument lumen 195 omitted) with the distal end of the endoscope 10 nested within the interior of the ring.

Notably, where the raised push tube bridge 31 is in the form of a loop, and when the loop is retracted, the retracted loop also serves to provide an atraumatic tip for the distal end of the sleeve 15 and the distal end of the support tube 50, so that the device 5 (with the anterior balloon 35 and instrument lumen 195 omitted) does not cause trauma as the device 5 is moved distally through the body lumen or body cavity. This is particularly important in configurations where an endoscope having a smaller diameter than the diameter of the lumen of sleeve 15 is used. More particularly, the gap between the inner wall of the lumen of the sleeve 15 and the exterior of the endoscope having a smaller diameter than the diameter of the lumen of the sleeve 15 creates a "step" between the exterior of the endoscope and the inner wall of the lumen of the sleeve 15, which can be traumatic or can make it difficult for the device 5 to advance through a body lumen (e.g., colon). However, when the ring is in its retracted position, the ring may fill the gap between the inner wall of the lumen of the sleeve 15 and the outside of the endoscope, thereby providing a more gradual "step" between the outside of the endoscope and the inner wall of the lumen of the sleeve 15, which will make it less traumatic and easier for the device 5 to pass through the body lumen.

In an exemplary method of using the simplified apparatus 5 (e.g., the apparatus 5 without the anterior balloon 35 and without the instrument lumen 195), the simplified apparatus 5 may be used to perform a procedure in a body lumen without creating a sealed treatment area between two inflated balloons. By way of example AND not limitation, THE push tube 30 may be used TO tighten lesions TO be excised from body lumens, as described in U.S. patent application Ser. No. 16/513,388 (attorney docket No. LUMENDI-2021), filed by Lumendi Ltd. AND Peter Johann et al at 7.16 of 2019, entitled "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," incorporated herein by reference.

More particularly, as described in U.S. patent application serial No. 16/513,388, the distal ends of push tubes 30 of sleeve 15 may be connected to each other by bridge 31, and a connector (e.g., a strand of suture) may be attached to bridge 31 (either before or during the procedure) and connected to the lesion (e.g., using a clip). The simplified form of the device 5 is pulled over the endoscope 10, the combination of the endoscope 10 and the simplified device 5 is advanced into the body lumen or body cavity (e.g., intestine) such that the endoscope 10 is located immediately proximal of the lesion, the rear balloon is inflated to stabilize the endoscope relative to the lesion, the connector is attached to the bridge 31 of the push tube 30 and connected to the lesion by the clip, and the push tube 30 is moved distally to tighten the lesion away from the endoscope 10. The lesion is then peeled away from the body lumen or body cavity (e.g., submucosa of the intestine) using a cutting tool that has been advanced through the working lumen of the endoscope 10.

However, it is important to note that the use of push tube 30 without anterior balloon 35 and without instrument lumen 195 is not limited to a tensioning lesion. By way of example and not limitation, push tubes 30 may remain without anterior balloon 35 and without instrument lumen 195 for passing an instrument through one or both of hollow push tubes 30 or through one or both of support tubes 50. By way of further example and not limitation, push tube 30 may be used to manipulate (e.g., straighten) a body lumen and/or a side of a body cavity to better present sidewall tissue for examination and/or treatment.

In yet another form of the present invention, and looking now at fig. 153 and 154, sleeve 15 may include one or more additional rear balloons 20B for stabilizing sleeve 15 (and an endoscope disposed therein) within the anatomy. Thus, in this form of the invention, the device 5 includes a sleeve 15 for receiving the endoscope 10, a first rear balloon 20 disposed at a generally distal end of the sleeve 15 (e.g., immediately proximal of the distal end of the sleeve 15, or on a portion of the sleeve 15 adjacent a bending section of the endoscope, etc.), a second rear balloon 20B disposed proximal of the rear balloon 20, an inflation line 45 for inflating the rear balloon 20 and the rear balloon 20B (either simultaneously or independently of each other), a hollow push tube 30, and a hollow support tube 50 for receiving the hollow push tube 30.

Where sleeve 15 includes an additional rear balloon 20B, the additional rear balloon 20B may be positioned directly adjacent to rear balloon 20 and in contact with rear balloon 20 (fig. 153), or additional rear balloon 20B may be proximally spaced from rear balloon 20 (fig. 154). If desired, an additional rear balloon 20B may be movably disposed on the sleeve 15 such that the position of the rear balloon 20B may be adjusted relative to the rear balloon 20, thereby providing the desired stability within the anatomy.

For this form of the invention, the push tube 30 may be reserved for a desired function, such as providing column strength to the sleeve 15 (as shown in fig. 153 and 154), or for use in procedures within a body lumen of a patient (as shown in fig. 155-158).

In yet another alternative form of the invention, in addition to removing the foregoing anterior balloon 35, it may be desirable to provide a sleeve having only one instrument lumen 195 for receiving an instrument, and the other instrument lumen 195 may be omitted from the device 5. The benefit of providing sleeve 15 with only one instrument lumen is to provide an instrument channel for supporting instruments therethrough while also reducing the outer diameter of sleeve 15.

In this form of the invention, and looking now at fig. 159-162, 162A and 163, the apparatus 5 (with the front balloon 35 and one instrument lumen 195 removed) includes a sleeve 15 for receiving the endoscope 10, a rear balloon 20 for stabilizing the sleeve 15 (and the endoscope disposed therein) within a body lumen or body cavity, an inflation line 45 for inflating the rear balloon 20, a hollow push tube 30, a hollow support tube 50 for receiving the hollow push tube 30, and a single instrument lumen 195 for receiving an instrument therein.

In a preferred form of the invention, the hollow push tube 30 remains fixed within the hollow support tube 50 to provide the necessary column strength to the sleeve 15, with the distal end of the push tube 30 and/or support tube 50 terminating at the rear balloon 20 (or within the rear balloon 20 or immediately proximal of the rear balloon 20 if it is desired to provide the distal end of the sleeve 15 with greater flexibility than the remainder of the sleeve 15). However, if the sleeve 15 is formed of a material having sufficient column strength to prevent the sleeve 15 from collapsing (e.g., kinking) on the endoscope 10 when the device 5 and endoscope 10 are positioned within or retracted from the anatomy of the patient, the push tube 30 and/or support tube 50 may be omitted entirely from the device 5.

In yet another alternative form of the invention, the device 5 may be further simplified by omitting the aforementioned rear balloon 20 if it is not necessary to provide a sealed treatment area, or if it is not necessary to provide stability to the endoscope 10. In this form of the invention, sleeve 15 may or may not include push tube 30 and/or support tube 50, and sleeve 15 may or may not include instrument lumen 195.

Omitting certain features (e.g., the anterior balloon 35, push tube 30, support tube 50, and/or instrument lumen(s) 195) to provide a simplified device 5 has the benefit of providing an endoscope sleeve having a reduced outer diameter.

However, those skilled in the art will appreciate that there are other ways of reducing the outer diameter of the sleeve 15. By way of example and not limitation, where it is desired to provide a sleeve having a reduced outer diameter without omitting instrument lumen 195, at least a portion of instrument lumen 195 may be formed of a collapsible material such that the overall profile of sleeve 15 is minimized prior to insertion of the instrument, whereby sleeve 15 may have a reduced profile during navigation of sleeve 15 through a body lumen or body cavity.

In this form of the invention, and looking now at fig. 164-166, the instrument lumen 195 has a minimal profile when empty and expands diametrically when filled with an instrument or other filling material. If desired, the instrument lumens 195 may be expandable only at their distal ends (i.e., not along the entire length of the instrument lumen).

In another embodiment for providing an endoscope sleeve having a reduced outer diameter, and looking now at fig. 166A, one or more instrument lumens 195 may be formed on the interior of sleeve 15 (rather than the exterior of sleeve 15), thereby reducing the outer diameter of sleeve 15 while still providing support for the instrument. To this end, note that when the instrument lumen is disposed on the exterior of the sleeve 15, the instrument lumen 195 is typically formed of a material sufficient to prevent instruments passing through the instrument lumen from piercing the sidewall of the instrument lumen and entering the body lumen or body cavity of the patient where the instruments may cause trauma to the anatomy. However, when the instrument lumen 195 is disposed on the interior of the sleeve 15 and the instrument pierces the instrument lumen, the instrument will enter the interior of the sleeve 15 (and not enter the body lumen or body cavity of the patient). Thus, when the instrument lumen 195 is disposed within the interior of the sleeve 15, the instrument lumen 195 may be formed of a softer material (e.g., teflon) than the instrument lumen 195 formed on the exterior of the sleeve 15.

It is noted above that the raised push tube bridge 31 and/or the front balloon 35 may be used together as a guide for the device 5 and endoscope 10, thereby providing a soft atraumatic tip when the device 5 is advanced within a body lumen or body cavity of a patient. However, in configurations where the anterior balloon 35 is omitted and/or the push tube 30 is secured within the support tube 50, it is desirable to form the sleeve 15 with an atraumatic tip such that the sleeve 15 does not cause trauma to the anatomy as the device 5 is moved through the body lumen or body cavity.

More particularly, and looking now at fig. 162A and 163-166, 166A and 167-169, the distal end of sleeve 15 may be formed with a conical tip 1500. The conical tip 1500 includes a lumen 15 sized to receive the endoscope 1005. Preferably, the conical tip 1500 is formed from a medical grade elastomer (e.g.,) Formed, the elastomer is fixedly attached (e.g., glued) to the distal end of sleeve 15. Thus, in each configuration in which the sleeve 15 is shown as having a blunt distal end, the blunt distal end of the sleeve 15 may be provided with a conical tip 1500, thereby providing an atraumatic tip to the sleeve 15.

If desired, the conical tip 1500 may be formed from a flexible material such that the conical tip 1500 may be configured between a "collapsed" configuration and an "expanded" configuration. In this manner, the conical tip 1500 provides an atraumatic tip to the distal end of the sleeve 15, which may also be configured to a reduced profile during navigation of the sleeve 15 through a body lumen or body cavity.

In one form of the invention, the conical tip 1500 moves from its "collapsed" configuration to its "expanded" configuration as the endoscope 10 passes through the lumen 1505 of the conical tip 1500. In another form of the invention, a pull wire (not shown) extends between the conical end 1500 and the base 25, and the pull wire may be tensioned to widen or close the conical end 1500.

Additionally, if desired, the instrument lumen 195 may be formed with atraumatic tips such that the instrument lumen 195 does not cause trauma to the anatomy as the device 5 is moved through the body lumen or body cavity. Referring to, for example, fig. 163, there is shown an instrument lumen 195 having an angled distal end.

In the foregoing description, the rear balloon 20 is shown as being of a "conventional" balloon configuration (i.e., a balloon having a substantially uniform full diameter cross section). However, the "conventional" balloon configuration may be replaced with the torus configuration of the anterior balloon 35. Referring to fig. 168-170, a posterior balloon 20 having a torus configuration of anterior balloon 35 is shown.

In this form of the invention, the rear balloon 20 is configured such that (i) when it is deflated (or partially deflated), the rear balloon 20 provides an axial opening 63 (fig. 15, 16 and 19) sufficient to receive the sleeve 15 therein, and (ii) when the rear balloon 20 is properly inflated, the axial opening 63 is closed (and preferably fully closed). At the same time, when properly inflated, the rear balloon 20 may atraumatically engage and form a sealing relationship with the side walls of the body lumen and/or body cavity in which the device 5 is disposed. Thus, when the rear balloon 20 is properly inflated, the rear balloon 20 may effectively seal the body lumen and/or body cavity distal to the rear balloon 20 by closing the axial opening 63 and establishing a sealing relationship with the side wall of the body lumen and/or body cavity in which the device 5 is disposed.

It will be appreciated that when the rear balloon 20 is reconfigured from its deflated condition to its inflated condition, the rear balloon 20 expands radially inwardly (so as to close the axial opening 63) and radially outwardly (so as to engage surrounding tissue). Note that hollow push tube 30 and/or instrument lumen 195 (when included on sleeve 15) are disposed within rear balloon 20 in such a way that their presence within the rear balloon does not physically interfere with inflation or deflation of rear balloon 20.

Thus, it will be seen that the rear balloon 20 has a "torus" shape when deflated (to allow it to seat on the sleeve 15) and a substantially "solid" shape when inflated (to allow it to close the body lumen or body cavity).

Application of

It will thus be seen that the present invention includes the provision and use of novel apparatus for manipulating the side walls of a body lumen and/or body cavity so as to better present the side wall tissue (including visualization of areas that may be initially hidden from view or outside the field of view) for examination and/or treatment, for example, to straighten bends, "iron" internal lumen surface folds and create substantially static or stable side walls of the body lumen and/or body cavity, which enables more accurate visual examination (including visualization of areas that may be initially hidden from view or outside the field of view) and/or therapeutic intervention. By way of example and not limitation, the novel device may be used to stabilize, straighten, expand and/or flatten bends and/or curves and/or folds in the sidewall of the intestine in order to better present the sidewall tissue (including visualization of areas that may be initially hidden from view or outside the field of view) for examination and/or treatment during an endoscopic procedure.

The present invention also includes the provision and use of novel devices that are capable of stabilizing and/or stabilizing the distal tip and/or working end of an instrument (e.g., an endoscope, articulating and/or non-articulating device such as a grasper, cutter or dissector, cautery tool, ultrasonic probe, etc.) inserted into a body lumen and/or body cavity relative to a side wall of the body lumen and/or body cavity during an endoscopic procedure, thereby facilitating accurate use of such instruments.

By way of example and not limitation, the present device may provide a stabilized platform (i.e., a stabilized endoscope, a stabilized treatment tool, and a stabilized colon wall, all of which are stabilized relative to one another) for performing a number of minimally invasive procedures within a body lumen and/or body cavity, including stabilizing an endoscope and/or other surgical instrument (e.g., a grasper, cutter or dissector, cautery tool, ultrasound probe, etc.) within a body lumen and/or body cavity, for example, during lesion biopsy and/or lesion removal procedures, organ resection procedures, endoscopic Submucosal Dissection (ESD), endoscopic submucosal resection (EMR), etc., while stabilizing the colon (including reducing deformation of the colon wall) so as to enable more accurate visualization, intervention, and/or surgery.

Notably, the present invention provides novel devices that are capable of stabilizing and/or stabilizing the distal end and/or working end of an endoscope (and thus also of other instruments (such as graspers, cutters or dissectors, cautery tools, ultrasound probes, etc.) inserted through the working channel of such endoscopes) and with respect to the body lumen and/or side wall of the body cavity.

And provides a novel device capable of stabilizing and/or stabilizing the distal and/or working end of an instrument (such as a grasper, cutter or dissector, cautery tool, ultrasound probe, etc.) advanced to the surgical site by means other than through the working channel of an endoscope.

The novel apparatus of the present invention may be used in essentially any endoscopic procedure to facilitate alignment and presentation of tissue during the endoscopic procedure and/or to stabilize the working end of an endoscope (and/or other instruments advanced through the endoscope) relative to the tissue or to aid in advancement of the endoscope during such procedure.

The present invention is believed to have the broadest application with respect to the gastrointestinal tract (GI) (e.g., large and small intestine, esophagus, stomach, etc.), which is generally characterized by frequent turns, and which has side walls 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 within other body lumens (e.g., blood vessels, lymphatic vessels, urethra, fallopian tubes, bronchi, bile ducts, etc.) and/or within other body cavities (e.g., cavities within the head, chest, abdomen, sinuses, bladder, organs, etc.).

Modification of

While the invention has been described in terms of certain exemplary preferred embodiments, those skilled in the art will readily understand and appreciate that the invention 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 invention.

Claims

1. An apparatus, comprising:

a flexible sleeve adapted to slide over an exterior of an endoscope, wherein the endoscope comprises a proximal end and a distal end and a handle disposed at the proximal end of the endoscope, and wherein the sleeve comprises a proximal end, a distal end, and a sleeve lumen extending therebetween, and further wherein the sleeve is configured to slide over the exterior of the endoscope so as to substantially cover the exterior of the endoscope from a point adjacent the distal end of the endoscope to a point adjacent the handle of the endoscope;

a balloon secured to the distal end of the sleeve;

a pair of push tubes mounted to the sleeve.

2. The apparatus of claim 1, wherein the sleeve comprises an atraumatic tip.

3. The apparatus of claim 1, wherein (i) an axial opening extends through the balloon when the balloon is in its deflated state, the axial opening being sized to receive the sleeve therein, and (ii) the axial opening seals around the sleeve when the balloon is in its inflated state.

4. The apparatus of claim 1, wherein a second balloon is secured to the sleeve, wherein the second balloon is proximal to the balloon.

5. The apparatus of claim 4, wherein the second balloon is movable relative to the balloon.

6. The apparatus of claim 1, wherein the pair of push tubes are secured to the sleeve.

7. The apparatus of claim 6, wherein each of the push tubes includes a proximal end and a distal end, wherein the distal ends of the pair of push tubes are secured to the sleeve proximal to the balloon.

8. The apparatus of claim 7, wherein the pair of push tubes are secured within a pair of support channels.

9. The apparatus of claim 1, wherein the pair of push tubes are movably mounted within a pair of support channels.

10. The apparatus of claim 9, wherein each of the pair of support channels comprises a distal end and a proximal end, wherein the proximal ends of the support channels are disposed adjacent the proximal ends of the sleeves, and wherein the distal ends of the support channels are disposed adjacent the distal ends of the sleeves.

11. The apparatus of claim 9, wherein the pair of push tubes are connected to each other 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.

12. The apparatus of claim 11, wherein the raised push tube bridge is in the form of a ring.

13. The apparatus of claim 1, further comprising at least one instrument lumen mounted to the sleeve.

14. The apparatus of claim 13, wherein the sleeve lumen has a central axis, wherein the instrument lumen has a central axis, and further wherein the central axis of the instrument lumen is in a fixed relationship with the central axis of the sleeve lumen.

15. The apparatus of claim 13, wherein the at least one instrument lumen is disposed outside of the sleeve lumen.

16. The apparatus of claim 13, wherein the at least one instrument lumen is disposed inside the sleeve lumen.

17. The apparatus of claim 13, wherein the instrument lumen comprises a distal end and a proximal end, wherein the proximal end of the instrument lumen is disposed adjacent the proximal end of the sleeve, and wherein the distal end of the instrument lumen is disposed adjacent the distal end of the sleeve.

18. The apparatus of claim 13, wherein the distal end of the instrument lumen is disposed distally of the balloon.

19. The apparatus of claim 13, wherein at least a portion of the instrument lumen is collapsible.

20. A method for performing a procedure in a body lumen and/or body cavity, the method comprising:

providing an apparatus, the apparatus comprising:

a balloon secured to the distal end of the sleeve;

a pair of push tubes mounted to the sleeve;

positioning the device in the body lumen and/or body cavity;

Inflating the balloon; and

the program is executed.

21. The method of claim 20, wherein during execution of the procedure, an instrument passes through at least one of the sleeve and the endoscope.

22. An apparatus, comprising:

a balloon secured to the distal end of the sleeve;

a pair of push tubes mounted to the sleeve; and

a pair of instrument lumens mounted to the sleeve.

23. The apparatus of claim 22, wherein the pair of push tubes are secured to the sleeve.

24. The apparatus of claim 22, wherein the pair of push tubes are movably mounted to the sleeve.

25. The apparatus of claim 22, wherein the sleeve comprises an atraumatic tip.

26. The apparatus of claim 22, wherein (i) an axial opening extends through the balloon when the balloon is in its deflated state, the axial opening being sized to receive the endoscope therein, and (ii) the axial opening is closed when the balloon is in its inflated state.

27. An apparatus, comprising:

a balloon secured to the distal end of the sleeve;

a pair of push tubes mounted to the sleeve; and

an instrument lumen mounted to the sleeve.

28. The apparatus of claim 27, wherein the pair of push tubes are secured to the sleeve.

29. The apparatus of claim 27, wherein the sleeve comprises an atraumatic tip.

30. The apparatus of claim 27, wherein (i) an axial opening extends through the balloon when the balloon is in its deflated state, the axial opening being sized to receive the endoscope therein, and (ii) the axial opening is closed when the balloon is in its inflated state.

31. An apparatus, comprising:

a flexible sleeve adapted to slide over an exterior of an endoscope, wherein the endoscope comprises a proximal end and a distal end and a handle disposed at the proximal end of the endoscope, and wherein the sleeve comprises a proximal end, a distal end, and a sleeve lumen extending therebetween, and further wherein the sleeve is configured to slide over the exterior of the endoscope so as to substantially cover the exterior of the endoscope from a point adjacent the distal end of the endoscope to a point adjacent the handle of the endoscope, wherein the sleeve comprises an atraumatic tip;

A balloon secured to the distal end of the sleeve, wherein (i) an axial opening extends through the balloon when the balloon is in its deflated state, the axial opening being sized to receive the endoscope therein, and (ii) the axial opening is closed when the balloon is in its inflated state;

a pair of push tubes mounted to the sleeve.

32. The apparatus of claim 31, further comprising at least one instrument lumen mounted to the sleeve.