CN113038862B

CN113038862B - Devices used to retract tissue under endoscopy

Info

Publication number: CN113038862B
Application number: CN201980060518.5A
Authority: CN
Inventors: P·乔汉; S·肯特塞沃伊; J·米尔索姆; S·沙马
Original assignee: Lumendi Ltd
Current assignee: Lumendi Ltd
Priority date: 2018-07-16
Filing date: 2019-07-16
Publication date: 2025-03-07
Anticipated expiration: 2039-07-16
Also published as: JP2021530306A; EP3823513A4; CA3106405A1; WO2020018566A1; CN113038862A; EP3823513A1

Abstract

A device for retracting tissue under endoscopy, the device comprising: a sleeve, the sleeve being adapted to slide on the exterior of an endoscope; a balloon, the balloon being movably mounted to the sleeve; and at least one connector extending from the balloon and configured to be fixed to the tissue to be retracted; wherein the balloon is configured to move relative to the sleeve so as to retract the tissue.

Description

Device for endoscopically retracting tissue

Citation of pending patent applications

The patent application:

(1) A portion of pending U.S. patent application serial No. 16/477,789, filed by kanell university and Jeffrey Milsom et al at 7/12 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(Attorney's Docket No.CORN-43PCT US)( for manipulating the side walls of body lumens or cavities to provide increased visualization of and/or increased access to body lumens or cavities and/or for stabilizing an instrument relative to body lumens or cavities (lawyer litigation event list number CORN-43PCT US)), continues to apply:

(i) Methods and apparatus (lawyer litic event list number CORN-43PCT US)) "filed by kanell university and Jeffrey Milsom et al at 1/16 of 2018, 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(Attorney's Docket No.CORN-43PCT)( for manipulating the side walls of body lumens or cavities to provide increased visualization of and/or increased access to body lumens or cavities and/or for stabilizing instruments relative to body lumens or cavities (PCT) enter national phase application number PCT/US18/13894, which in turn claims the benefits of the following patent applications:

(a) Balloon tissue retraction (lawyer litic event list number CORN-43 pro) filed by kanell university and Jeffrey Milsom et al at 13, 1, 2017, under the name "BALLOON TISSUE RETRACTION USING HOOP AND CLIP WITH VARIABLE LENGTH CAPABILITY,WITH SPECIMEN RETRIEVAL POUCH IN BALLOON(Attorney's Docket No.CORN-43PROV)( using clips and clamps with variable length capability and sample retrieval bags in the balloon, "U.S. provisional patent application serial No. 62/446,167, and

(B) U.S. provisional patent application Ser. No. 62/462,241, entitled "BALLOON SPECIMEN RETRIEVAL (Attorney's socket No. CORN-41 PROV) (BALLOON sample retrieval (lawyer's litigation event Table No. CORN-41 PROV))," filed by Kaneler university and Jeffrey Milsom et al at 22, 2017, and

(Ii) Is part of the continuation application of U.S. patent application serial No. 14/000,104 to kanell university and John Frederick Comhill et al, filed on 5th 6 th 2018, 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(Attorney's Docket No.CORN-34CON)( for manipulating the side walls of body lumens or cavities to provide increased visualization of and/or increased access to body lumens or cavities and/or for stabilizing instruments relative to body lumens or cavities (lawyer litigation event list number CORN-34 CON)), which is also a continuation application of U.S. patent application serial No. 14/845,619 to kanell university and John Frederick Comhill et al, filed on 11 th 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(Attorney's Docket No.CORN-34)( for manipulating the side walls of body lumens or cavities to provide increased visualization of and/or increased access to body lumens or cavities and/or for stabilizing instruments relative to body lumens or cavities (lawyer litigation event list number CORN-34)) ", which is also a continuation application of U.S. patent application serial No. 14/845,619 to kanell university and John Frederick Comhill et al, filed on 11 th 2015.

(A) Is part of the continuation application of U.S. patent application serial No. 14/540,355, filed on 11/13 at 2014, university of kanell, jeffrey Milsom et al, entitled 3424 for stabilizing, straightening, expanding and/or flattening the side walls of body lumens and/or cavities to provide increased visualization and/or increased access to body lumens or cavities and/or for stabilizing instruments relative to body lumens or cavities (lawyer's litigation event list number CORN-17 CON)), which is also part of the continuation application of U.S. patent application serial No. 38 Jeffrey Milsom for stabilizing the side walls of body lumens and/or cavities (35/12) filed on 15 at 2010, and which is 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's Docket No.CORN-17)( for stabilizing, straightening, expanding and/or flattening the side walls of body lumens and/or cavities to provide increased visualization and/or increased access to body lumens or cavities and/or for stabilizing instruments relative to body lumens or cavities (lawyer's litigation event list number CORN-17)), which is also filed on 3832 et al, 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's Docket No.CORN-17)( for stabilizing the side walls of body lumens and/or cavities (35) for stabilizing instruments relative to body lumens and cavities and/or cavities (35, and/or for providing increased access to body lumens and/or cavities) with increased access to body lumens and/or for legal patent application number of legal patent application (24, which is filed on 12, and/or is filed on 11, which is filed on 11, and is entitled "for stabilizing and for stabilizing instruments and/or can be increased access to be increased

(B) U.S. provisional patent application Ser. No. 61/938,446 (attorney docket number CORN-34 PROV)), entitled "METHOD AND APPARATUS FOR MANIPULATIN G 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(Attorney's Docket No.CORN-34PROV)(, filed on 11, 2, 2014, university of Conneler and John Frederick Comhill et al, for methods and apparatus for manipulating side walls of body lumens or cavities to provide increased visualization of and/or increased access to body lumens or cavities and/or for stabilizing instruments relative to body lumens or cavities, and

(2) Pending U.S. provisional patent application serial No. 62/698,583 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(Attorney's Docket No.LUMENDI-20PROV)(, filed by Lumendi, et al, peter Johann et al, 7, 16 for manipulating the side walls of body lumens or cavities to provide increased visualization of and/or increased access to body lumens or cavities and/or for stabilizing instruments relative to body lumens or cavities, and lawsuit event list No. LUMENDI-20pro of lawyers).

The above-mentioned eleven (11) 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 sidewall of a body lumen and/or body cavity to provide increased visualization of and/or increased access to the body lumen and/or body cavity and/or for stabilizing an instrument relative to the body lumen and/or body cavity.

Background

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

In many instances, it may be desirable to endoscopically and/or treat a disease process or abnormality located within or on a side wall of a body lumen and/or body cavity. 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, resect and/or otherwise treat the lesions.

Endoscopy and/or treatment of the side walls of the body lumen and/or body cavity may be complicated by the anatomical configuration (regional and localized) of the side walls of the body lumen and/or body cavity and/or by the uniformity of tissue that makes up the side walls of the body lumen and/or body cavity and/or by tethering the side walls of the body lumen and/or body cavity to other anatomical structures.

By way of example and not limitation, the intestine is an elongated tubular organ having an inner lumen and is characterized by frequent turns (i.e., regional anatomical configuration of the intestine) and side walls characterized by a number of folds (i.e., regional anatomical configuration of the intestine), wherein the side wall tissue has a relatively soft, pliable consistency, and wherein, in particular, the colon is tethered to the abdomen and/or other abdominal structure via soft tissue. Because of this different sidewall anatomy (both regional and localized), its relatively soft, pliable consistency, and its tethering to other anatomical structures via soft tissue, it may be difficult to fully visualize the sidewall of the intestine and/or treat lesions formed on the sidewall of the intestine. By way of example, but not limitation, in the case of colonoscopy, it has been found that about 5% to about 40% of patients have a lateral wall anatomy (regional and/or local) and/or tissue consistency and/or tethering to the colon on other anatomy, which makes it difficult to fully visualize the anatomy (including pathological conditions of the anatomy such as polyps or tumors) using conventional endoscopes and/or fully access the anatomy using instrumentation introduced through conventional endoscopes.

In addition to the foregoing, it has also been found that some body lumens and/or cavities may spontaneously cramp and/or contract, but particularly when an endoscope or other instrument is inserted into the body lumen and/or 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 instrumentation introduced through conventional flexible endoscopes. In addition, during a colonic examination (which is typically performed while the endoscope is inserted and withdrawn through the colon), the endoscope may clamp and/or otherwise accumulate the colon during insertion and withdrawal, and then suddenly slide and release the colon. This results in the endoscope moving rapidly through a considerable length of the colon, making accurate examination of the colon challenging.

It would therefore be highly advantageous to provide a novel device that is capable of 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 are initially hidden or out of view) for examination and/or treatment during an endoscopic procedure.

It would also be highly advantageous to provide novel devices that are capable of stabilizing and/or stabilizing the distal tip and/or working end of instruments (e.g., endoscopes, articulating and/or non-articulating devices such as graspers, cutters or dissectors, cautery tools, ultrasound probes, etc.) inserted into body lumens and/or cavities with respect to the side walls of the body lumens and/or cavities, thereby facilitating precise use of those instruments.

In addition, it would be highly advantageous to provide novel devices that are capable of stabilizing and/or stabilizing the distal tip and/or working end of an endoscope (and thus, also the distal tip and/or working end of other instruments (such as graspers, cutters or dissectors, cautery tools, ultrasound probes, etc.) inserted through the working channel of those endoscopes).

Moreover, it would be highly advantageous to provide novel devices that are capable of stabilizing and/or stabilizing the distal tip and/or working end of instruments (such as graspers, cutters or dissectors, cautery tools, ultrasonic probes, etc.) advanced to the surgical site by means other than the working channel of an endoscope.

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

Disclosure of Invention

The present invention includes the provision and use of a novel apparatus for manipulating the side walls of a body lumen and/or 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 endoscopic surgery.

The present invention also includes providing and using a novel device that is capable of stabilizing and/or stabilizing the distal tip and/or working end of instruments (e.g., endoscopes, articulating and/or non-articulating devices such as graspers, cutters or dissectors, cautery tools, ultrasound probes, etc.) inserted into body lumens and/or cavities with respect to the side walls of the body lumens and/or cavities, thereby facilitating precise use of those instruments.

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

Moreover, the present invention includes the provision and use of a novel device that is capable of stabilizing and/or stabilizing the distal tip and/or working end of an instrument (such as graspers, cutters or dissectors, cautery tools, ultrasonic probes, etc.) advanced to a surgical site by means other than the working channel of an endoscope.

Moreover, the present invention includes the provision and use of a novel device that is capable of straightening curved, "ironing" lumen surface folds, and creating substantially static and stable side walls of a body lumen and/or body cavity, which enables more accurate visual inspection (including visualization of areas initially hidden or outside of the field 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 proximal balloon secured to the sleeve;

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

A push tube slidably mounted to the sleeve, and

A distal balloon secured to a distal end of the push tube, an interior of the distal balloon in fluid communication with the push tube, wherein the distal balloon is capable of assuming a deflated state and an inflated state, and further wherein an axial opening extends therethrough when the distal balloon is in its deflated state, the axial opening being sized to receive an endoscope therein, and the axial opening is closed when the distal balloon is in its inflated state.

In another preferred form of the invention, there is provided a method of 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 proximal balloon secured to the sleeve;

A push tube slidably mounted to the sleeve, and

A distal balloon secured to a distal end of the push tube, an interior of the distal balloon in fluid communication with the push tube, wherein the distal balloon is capable of assuming a deflated state and an inflated state, and further wherein an axial opening is therethrough when the distal balloon is in its deflated state, the axial opening being sized to receive an endoscope therein, and the axial opening is closed when the distal balloon is in its inflated state;

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

Inflating the proximal balloon;

advancing the push tube distally;

inflating the distal balloon, and

Surgery is performed.

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

A sleeve adapted to slide over an exterior of an endoscope, the sleeve including a passageway integrally formed with the sleeve and a lumen integrally formed with the sleeve for receiving an instrument;

A proximal balloon secured to the sleeve;

a push tube slidably mounted in said passageway of said sleeve, and

A distal balloon secured to a distal end of the push tube, an interior of the distal balloon being in fluid communication with the push tube.

providing an apparatus, the apparatus comprising:

A proximal balloon secured to the sleeve;

a push tube slidably mounted in said passageway of said sleeve, and

A distal balloon secured to a distal end of the push tube, an interior of the distal balloon in fluid communication with the push tube;

Inflating the proximal balloon;

advancing the push tube distally;

inflating the distal balloon, and

Surgery is performed.

a sleeve adapted to slide over the exterior of the endoscope so as to substantially cover the endoscope from a point adjacent the distal end of the endoscope to a point adjacent the handle of the endoscope;

A proximal balloon secured to the sleeve;

A push tube slidably mounted to the sleeve, and

providing an apparatus, the apparatus comprising:

A proximal balloon secured to the sleeve;

A push tube slidably mounted to the sleeve, and

Inflating the proximal balloon;

advancing the push tube distally;

inflating the distal balloon, and

Surgery is performed.

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

A proximal balloon secured to the sleeve;

a pair of push tubes slidably mounted to the sleeve, and

A distal balloon secured to distal ends of the pair of push tubes, an interior of the distal balloon being in fluid communication with the pair of push tubes.

providing an apparatus, the apparatus comprising:

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

A proximal balloon secured to the sleeve;

a pair of push tubes slidably mounted to the sleeve, and

A distal balloon secured to distal ends of the pair of push tubes, an interior of the distal balloon being in fluid communication with the pair of push tubes;

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

Inflating the proximal balloon;

advancing the pair of push tubes distally;

inflating the distal balloon, and

Surgery is performed.

In another preferred form of the present invention, there is provided an endoscopic tissue retraction system comprising:

An element configured to be movably mounted to an endoscope, and

A connector configured to be secured to the element and tissue to be retracted.

In another preferred form of the invention, there is provided a method of endoscopically retracting tissue, the method comprising:

positioning an endoscope and an element movably mounted to the endoscope adjacent to tissue to be retracted;

Securing a connector to the element and tissue to be retracted, and

The connector is used to urge tissue away from the endoscope.

In another preferred form of the invention, there is provided an apparatus for endoscopic tissue retrieval comprising a balloon configured to be movably mounted to an endoscope, and

An aperture formed in the balloon.

positioning an endoscope and an element movably mounted to the endoscope adjacent to tissue to be retracted, wherein a connector is secured to the element;

securing the connector to the tissue to be retracted, and

The connector is used to urge tissue away from the endoscope.

positioning the endoscope and the element movably mounted to the endoscope adjacent to tissue to be retracted;

Fixing the tissue to be retracted to the element, and

The tissue is urged away from the endoscope by the moving element.

In another preferred form of the invention, there is provided an apparatus for endoscopic tissue retrieval, the apparatus comprising:

A balloon configured to be movably mounted to the endoscope, wherein the balloon is capable of assuming a deflated state and an inflated state, and further wherein the axial opening extends therethrough when the balloon is in its deflated state and is closed when the balloon is in its inflated state, and

A tab is mounted in the axial opening of the balloon so as to form, with the surrounding portion of the balloon, a pocket for receiving anatomical tissue.

In another preferred form of the invention, there is provided a method for removing endoscopic tissue, the method comprising:

Positioning a distal end of a balloon assembly distal to tissue to be removed, the balloon assembly being movably mounted to the endoscope, and the balloon assembly including (i) a balloon capable of assuming a deflated state and an inflated state, wherein the axial opening extends therethrough when the balloon is in its deflated state and is closed when the balloon is in its inflated state, and (ii) a tab mounted in the axial opening of the balloon so as to form with a surrounding portion of the balloon for receiving the tissue to be removed;

positioning the tissue to be removed into the pocket, and

The balloon assembly is withdrawn proximally to remove tissue contained within the pocket.

In other preferred forms of the invention, additional systems for endoscopically retracting tissue are provided.

Also, in other preferred forms of the invention, additional methods of endoscopically retracting tissue are provided.

In a preferred form of the invention there is provided apparatus for endoscopically retracting tissue, the apparatus comprising:

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

A balloon movably mounted to the sleeve, and

At least one connector extending from the balloon and configured to be secured to tissue to be retracted;

wherein the balloon is configured to move relative to the sleeve in order to retract tissue.

there is provided an apparatus for endoscopically retracting tissue, the apparatus comprising:

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

A balloon movably mounted to the sleeve, and

positioning an endoscope disposed within the sleeve adjacent to tissue to be retracted;

securing at least one connector to the balloon and tissue to be retracted, and

By moving the balloon away from the endoscope, tissue is retracted away from the endoscope.

In another preferred form of the invention, there is provided apparatus for endoscopically retracting tissue, the apparatus comprising:

A sleeve adapted to slide over the exterior of the endoscope, and

A tensioning tool extending through the sleeve and configured to be secured to tissue to be retracted.

A sleeve adapted to slide over the exterior of the endoscope, and

A tensioning tool extending through the sleeve and configured to be secured to tissue to be retracted;

attaching a tensioning tool to the tissue to be retracted, and

By moving the tensioning tool relative to the endoscope, the tissue is retracted.

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

A pair of push tubes slidably mounted to the sleeve, the pair of hollow push tubes being connected to each other at their distal ends with a bridge, and at least one connector extending from the bridge and configured to be secured to tissue to be retracted;

Wherein the pair of push tubes are configured to move relative to the sleeve to retract tissue.

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

A pair of push tubes slidably mounted to the sleeve, the pair of push tubes being connected to each other at their distal ends with a bridge, and at least one connector extending from the bridge and configured to be secured to tissue to be retracted;

Securing at least a connector to the pair of push tubes and tissue to be retracted, and

By moving the pair of push tubes relative to the endoscope, tissue is retracted away from the endoscope.

Drawings

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

FIG. 1 is a schematic diagram illustrating a novel apparatus formed in accordance with the present invention, wherein the novel apparatus further includes, among other things, a sleeve disposed on an end of an endoscope, a rear balloon mounted to the sleeve, a pair of push tubes slidably mounted to the sleeve, a front balloon mounted to a distal end of the push tubes, and a push tube handle mounted to a proximal end of the push tubes;

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;

fig. 7 and 8 are schematic diagrams showing further details of the anterior balloon;

FIG. 8A is a schematic diagram showing a push tube handle;

fig. 9 and 10 are schematic views showing construction details of the front balloon;

FIG. 11 is a schematic diagram illustrating one form of an inflation mechanism provided in accordance with the present invention;

FIG. 11A is a schematic diagram illustrating another form of inflation mechanism provided in accordance with the present invention;

FIGS. 12 and 13 are schematic views showing another form of inflation mechanism provided in accordance with the present invention;

FIG. 14 is a schematic diagram showing a pressure relief valve that may be used to ensure that the pressure within the anterior and/or posterior balloons does not exceed a predetermined level;

FIG. 15 is a schematic diagram illustrating a slack retraction system that may be used to tighten the flexible tubing of the apparatus shown in FIG. 1;

fig. 16 to 30 are schematic views showing a preferred manner of using the apparatus of fig. 1;

FIG. 30A is a schematic diagram showing an alternative configuration of the push tube and push tube handle of the present invention;

FIG. 31 is a schematic view showing another form of sleeve, wherein the sleeve includes an additional lumen for receiving an instrument;

FIGS. 32-35 are schematic views showing how an instrument may be advanced through an additional lumen of the sleeve;

FIG. 36 is a schematic diagram showing an instrument catheter that may be disposed in an additional lumen of the sleeve, wherein an instrument may be advanced through the instrument catheter;

FIGS. 37-42 are schematic diagrams illustrating an endoscopic tissue retraction system formed in accordance with the present invention;

FIGS. 43-45 are schematic views illustrating another endoscopic tissue retraction system formed in accordance with the present invention;

FIG. 46 is a schematic diagram illustrating yet another endoscopic tissue retraction system formed in accordance with the present invention;

FIG. 47 is a schematic diagram illustrating yet another endoscopic tissue retraction system formed in accordance with the present invention;

FIG. 48 is a schematic diagram illustrating another endoscopic tissue retraction system formed in accordance with the present invention;

FIG. 49 is a schematic diagram illustrating yet another endoscopic tissue retraction system formed in accordance with the present invention;

FIG. 50 is a schematic diagram illustrating yet another endoscopic tissue retraction system formed in accordance with the present invention;

FIGS. 51-52 are schematic views illustrating another endoscopic tissue retraction system formed in accordance with the present invention;

FIGS. 52A-52B are schematic views illustrating yet another endoscopic tissue retraction system formed in accordance with the present invention;

FIGS. 53-60 are schematic views illustrating an endoscopic tissue retrieval system formed in accordance with the present invention;

FIG. 61 is a schematic diagram illustrating another endoscopic tissue retraction system formed in accordance with the present invention;

FIGS. 62-65 are schematic views illustrating a preferred manner of using an endoscopic tissue retraction system formed in accordance with the present invention;

FIG. 66 is a schematic diagram illustrating yet another endoscopic tissue retraction system formed in accordance with the present invention;

FIGS. 66A-66C are schematic views illustrating other endoscopic tissue retraction systems formed in accordance with the present invention;

FIGS. 67-70 are schematic diagrams illustrating yet another endoscopic tissue retraction system formed in accordance with the present invention, and

Fig. 71 is a schematic diagram illustrating yet another endoscopic tissue retraction system formed in accordance with the present invention.

Detailed Description

(As used herein, the term "endoscopic surgery" is intended to refer to any minimally invasive or limited access procedure, diagnosis and/or treatment and/or surgery that is used to access the body lumen and/or the interior of the body cavity, either endoluminally or transluminally or otherwise, to view, biopsy and/or treat tissue (including removal of lesions and/or resected tissue, etc.).

In addition, the present invention includes providing and using 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 strippers, cautery tools, ultrasound probes, etc.) inserted through the working channel of those endoscopes).

Moreover, the present invention includes the provision and use of a novel apparatus that is capable of straightening bends, "ironing" lumen surface folds and creating substantially static and stable side walls of body lumens and/or cavities, enabling more accurate visual inspection (including visualization of areas initially hidden or outside of the field of view) and/or therapeutic intervention.

Novel device

In accordance with the present invention, and referring now to fig. 1, a novel apparatus 5 is shown that is capable of manipulating (e.g., stabilizing, straightening, dilating, and/or flattening) a side wall of a body lumen and/or body cavity to better present side wall tissue (including visualization of areas initially hidden or out of view) for examination and/or treatment using an endoscope 10 (e.g., an articulating endoscope) during an endoscopic procedure, and/or for stabilizing a distal tip and/or working end of the endoscope 10 and/or other instruments (e.g., graspers, cutters or dissectors, cautery tools, ultrasonic probes, etc., not shown in fig. 1).

More specifically, the device 5 generally comprises a sleeve 15 adapted to slide over the exterior of the shaft of the endoscope 10, a proximal (or "rear") balloon 20 secured to the sleeve 15 near the distal end of the sleeve (the terms "proximal" and "rear" 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 includes a pair of push tubes 30 slidably mounted to the sleeve 15 as will be discussed below and a distal (or "forward") balloon 35 secured to the distal end of the push tubes 30 (the terms "distal" and "forward" will be used interchangeably hereinafter) such that a physician (or other operator or user) can adjust the spacing between the rear balloon 20 and the forward balloon 35 by moving the push tubes 30 relative to the sleeve 15 (e.g., by advancing both push tubes simultaneously 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 a physician or (or other operator or user) to selectively inflate/deflate one or both of the rear balloon 20 and the front balloon 35.

Referring now to fig. 1-6, sleeve 15 generally comprises an elongated thin-walled tube configured to slide over the exterior of the shaft of endoscope 10 (e.g., retrograde from the distal tip of the endoscope) so as to mate therewith, wherein the sleeve is sized and configured so that it will easily slide back onto the endoscope (preferably in the case of an endoscope "dry") during installation on the endoscope, but will have sufficient residual friction with the exterior surface of the endoscope (when grasped by a doctor or other operator or user's hand) so that the sleeve will remain in place to allow twisting (i.e., rotational rotation) and pushing/pulling of the endoscope (e.g., within the colon of a patient) during use. In a preferred form of the invention, the sleeve 15 is movable circumferentially about the endoscope 10 to some extent (and rotatable with the shaft of the endoscope when held firmly by the hands of a physician or other operator or user), but the sleeve 15 is only nominally movable in an axial direction relative 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 (along with the base 25) will substantially cover the shaft of the endoscope. In any event, the sleeve 15 is sized such that when it is mounted to the endoscope 10 and the endoscope 10 is inserted into a patient, the sleeve 15 extends out of the patient's body. In a preferred form of the invention, the device 5 is provided in accordance with a particular endoscope intended for use therewith, wherein the device 5 is sized such that when the base 25 is engaged with the handle of the endoscope, the distal end of the sleeve 15 will be properly positioned at, i.e., substantially aligned with or slightly adjacent, the distal end of the endoscope.

If desired, the distal end of the sleeve 15 may be provided with a radially inwardly extending stop (not shown) to forcibly 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 "torque slippage" of sleeve 15 relative to endoscope 10 during twisting (i.e., rotational rotation) of the endoscope within the colon and/or "thrust slippage" of sleeve 15 relative to endoscope 10 during forward pushing of the endoscope within the colon.

The sleeve 15 preferably has a smooth outer surface so as to render it 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 distance markings on the endoscope 10 to be visualized through the sleeve 15. Also, in a preferred form of the invention, the sleeve 15 preferably has a nominal clip strength so that a physician (or other operator or user) can grasp the endoscope 10 through the 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 interior and/or exterior surfaces to facilitate placement of the sleeve over an endoscope and/or movement of the device 5 through a 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) to prevent rotation of the sleeve 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, a vacuum may be introduced at the proximal end of the sleeve 15 (i.e., at the base 25), or a vacuum may be introduced at the point intermediate sleeve 15. By way of further example and not limitation, it should also be appreciated that the sleeve 15 may be facilitated to be removed from the endoscope 10 (e.g., at the end of the procedure) 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 at the intermediate sleeve 15).

Still referring now to fig. 1-6, the rear balloon 20 is secured to the sleeve 15 just proximal to but spaced apart from the articulation joint of the endoscope proximal to the distal end of the sleeve. The rear balloon 20 is concentrically disposed about the sleeve 15, and thus the endoscope 10 disposed within the sleeve 15. Thus, the rear balloon 20 has a generally annular shape. The rear balloon 20 may be selectively inflated/deflated by means of a proximal inflation/deflation tube 45, the proximal inflation/deflation tube 45 having its distal end in fluid communication with the interior of the rear balloon 20 and having its proximal end in fluid communication with a fitting 46 mounted to the base 25. The fitting 46 is configured to connect to the associated inflation mechanism 40 described above. 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 line 45 may be secured to the exterior surface of the sleeve 15, or more preferably, the inflation/deflation line 45 may be contained within a lumen 47 formed within the sleeve 15.

Preferably, the rear balloon 20 is disposed 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 though the rear balloon 20 has been inflated in the anatomy 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 safety platform for maintaining 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 anatomy. In addition, because endoscope 10 is safely held within the body lumen or body cavity by inflated rear balloon 20, instruments advanced through the interior lumen (sometimes referred to as "working channel" or "working channels") of endoscope 10 will also be provided with a safety platform for supporting those instruments within the body lumen or body cavity.

When the rear balloon 20 is properly inflated, the rear balloon can be atraumatically engaged with and in sealing relationship with the side wall of the body lumen in which such a device 5 is disposed.

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

A base 25 is secured to the proximal end of the sleeve 15. The mount 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 grasped and pulled proximally by a physician (or other operator or user) thereby allowing the physician (or other operator or user) to pull up the sleeve 15 at the distal end of the endoscope 10 and then pull 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 prohibiting further proximal movement of the base 25 (and thus the sleeve 15). In a preferred form of the invention, the mount 25 is in sealing engagement with the endoscope 10.

The push tube 30 is slidably mounted to the sleeve 15, whereby the distal end of the push tube may be extended and/or retracted relative to the sleeve 15 (e.g., by advancing or retracting the push tube via the push tube handle 37, see below), and thus distally relative to the endoscope 10 disposed in the sleeve 15. Preferably, the 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 push tube 30 relative to the support tube 50 (and thus, the push tube 30 relative to the sleeve 15). In this regard, it should be appreciated that minimizing the resistance to movement of the push tube 30 relative to the support tube 50 improves the tactile feedback of the user when the push tube 30 is used to manipulate the forward 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 desired during surgery), however, the support tube 50 also provides some 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 support tube 50 is flexible, but has some degree of fracture strength (while the sleeve 15 itself is flexible, but has substantially no fracture strength). In the case where the 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 push tube 30 and the lumen 52, then the lumen 52 is preferably lubricated so as to minimize friction between the push tube 30 and the lumen 52.

The proximal end of the push tube 30 is connected to a push tube handle 37. With this configuration, distal end of push tube 30 is distally advanced (at the same rate) relative to sleeve 15 (thereby moving forward balloon 35 distally relative to rearward balloon 20) on push tube handle 37, and distal end of push tube 30 is proximally retracted (at the same rate) relative to sleeve 15 (thereby moving forward balloon 35 proximally relative to rearward balloon 20) on push tube handle 37. It is noted that by moving the push tubes 30 distally or proximally at the same speed, the distal ends of the push tubes remain parallel to each other. A clamp 53 (fig. 12 and 15) is provided at the base 25 for holding the push tube 30 in a selected setting relative to the base 25 (and thus relative to the sleeve 15).

The push tube 30 is preferably formed of a relatively flexible material that provides good fracture strength, such as polyethylene resins (such as Isoplast ^TM (available from lebot corporation, wakeli, ohio)), polyethylene, polypropylene, nylon, and the like. It should be appreciated that the push tube 30 may comprise a single material or multiple materials, and that the stiffness of the push tube 30 may vary along its length. By way of example and not limitation, the distal-most portion of the push tube 30 may be formed of the same material as the remainder of the push tube, but with a lower modulus so as to be more flexible than the remainder of the push tube, or the distal-most portion of the push tube 30 may comprise a different, more resilient, flexible material. By way of example and not limitation, the distal-most portion of the push tube 30 may comprise nitinol. By way of further example and not limitation, the distal-most portion of the push tube 30 may comprise a stainless steel coil covered by an outer sheath of Polytetrafluoroethylene (PTFE), wherein the distal-most sheath/more proximal tubing together provide a sealed lumen for inflation/deflation of the anterior balloon 35. By forming the push tube 30 with a distal end that is more flexible than the rest of the push tube, the push tube 30 and the forward balloon 35 can together act as a guide wire (with a soft atraumatic tip) for the device 5 and endoscope 10, as discussed further below.

In a preferred form of the invention, the push tubes 30 are configured to maintain a parallel arrangement when they are in an unbiased state, i.e., when no force is applied to the push tubes 30. This is the case regardless of the inflated or deflated state of the anterior balloon 35.

The distal-most portion of push tube 30 may be configured to bend inwardly or outwardly if desired. With this configuration, when the distal tip of the push tube 30 is maintained stationary (e.g., by an inflated front balloon, as will be discussed below) and sufficient distally directed force is applied to the push tube 30, the intermediate portion of the push tube 30 (i.e., the portion between the inflated front balloon 35 and the sleeve 15) may flex or bow outwardly, thereby pushing outwardly on the side wall of the body lumen in which the device 5 is disposed, thereby providing a "tenting" effect on the body lumen and/or the side wall of the body lumen in the space between the rear balloon 20 and the front balloon 35. The "tenting" effect may significantly improve visibility and/or tissue stability in the region distal to endoscope 10 by pushing outwardly on the side walls of the body lumen and/or body cavity in which device 5 is disposed.

It should also be appreciated that by forming the push tubes 30 from flexible materials, their positions may be manually adjusted during use (e.g., by using separate tools, by twisting devices, etc.) so as to prevent the push tubes from interfering with visualization of the patient's anatomy and/or with diagnostic or therapeutic tools being introduced into the space between the anterior and posterior balloons. By way of example and not limitation, if the device 5 is positioned in the anatomy in such a way that the push tube 30 prevents visual or physical access to the target region of the anatomy, the flexible push tube 30 may be removed by using a separate tool or instrument, or by rotating the device with a twisting motion in order to remove the flexible push tube 30, or the like. By way of further example and not limitation, by configuring push tubes 30 such that they are circular and flexible and have a diameter that is significantly smaller than the circular circumferential portion of endoscope 10, movement of the circular endoscope when articulated may push only the push tubes apart and provide a clear visual path to tissue of interest.

It should also be appreciated that, if desired, the push tube 30 may be marked with an indicator, such as a color indicator or a radio-opaque indicator, including distance markings (not shown), 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 push tube 30 with respect to the body lumen and/or the side walls of other body lumens in both the longitudinal and/or circumferential directions of the surgical site.

As will be discussed in further detail below, push tube 30 is hollow and has its distal end in fluid communication with the interior of forward balloon 35 (fig. 1-5, 7 and 8) and its interior lumen in fluid communication with fitting 56 mounted to base 25. Fitting 56 is configured for connection to the associated inflation mechanism 40 described above so that the forward 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 front balloon 35.

More specifically, in one preferred form of the invention, and looking now at FIG. 8A, push tube handle 37 includes a hollow interior 57. The push tube 30 is mounted to the push tube handle 37 such that the push tube 30 will move with the push tube handle 37 and such that the hollow interior of the 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, wherein such internal chamber in base 25 is in fluid communication with fitting 56 as described above. With this configuration, when the push tube handle 37 is moved distally, the front balloon 35 is moved distally, and when the push tube handle 37 is moved proximally, the front balloon 35 is moved proximally. Further, when positive fluid pressure is applied to the fitting 56 in the base 25, positive fluid pressure is applied to the interior of the front balloon 35, thereby inflating the front balloon 35, and when negative fluid pressure is applied to the fitting 56 in the base 25, negative fluid pressure is applied to the interior of the front balloon 35, thereby deflating the front balloon 35.

It will be appreciated that the double push tube arrangement provides a number of advantages. By way of example and not limitation, the provision of dual pushrods provides 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 push tube is used to straighten anatomy in a region proximate the distal end of endoscope 10, the placement of double push tube 30 provides equal outward force to adjacent anatomy, thereby enhancing visualization and/or access to the anatomy as will be discussed below. In addition, the provision of the push tube ensures that the forward balloon 35 remains centered within the endoscope 10, thereby facilitating detachment of the forward balloon 35 from the endoscope 10 and re-docking of the forward balloon 35 onto the endoscope 10, as will be discussed below. In addition, the provision of the push tube 30 helps to ensure that the forward balloon 35 is stable relative to the tip of the endoscope, thereby minimizing rotational movement of the forward balloon upon inflation. Furthermore, the provision of a double hollow push tube provides a redundant air delivery system for inflating or deflating the anterior balloon 35.

The forward balloon 35 is fixed to the distal end of the push tube 30, whereby the spacing between the rearward balloon 20 and the forward balloon 35 can be adjusted by moving the push tube 30 relative to the sleeve 15 (i.e., by moving the push tube handle 37 relative to the sleeve 15). Furthermore, the hollow push tube 30 provides a conduit between the interior of the front balloon 35 and the fitting 56, thereby allowing for selective inflation/deflation of the front balloon 35 via the fitting 56.

Notably, the forward balloon 35 is configured such that (i) when it is deflated (or partially deflated) and it is in a "retracted" position relative to the sleeve 15 (fig. 2), the forward balloon 35 provides an axial opening 63 (fig. 7, 8 and 10) sufficient to receive the sleeve 15 and shaft of the endoscope 10 therein, whereby the forward balloon 35 can "rest" on the sleeve 15 and the endoscope 10, and (ii) when the forward balloon 35 is in its "extended" position relative to the sleeve 15 and inflated properly (fig. 4), the axial opening 63 is closed (and preferably fully closed). At the same time, when properly inflated, the anterior balloon may be atraumatically engaged with and in sealing relationship with the sidewall of the body lumen in which such a device 5 is disposed. Thus, when the front balloon 35 is properly inflated, the front balloon may effectively seal the body lumen and/or body cavity distal of the front 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 push tube 30 is advanced distally to separate the anterior balloon 35 from the posterior balloon 20, and when the anterior balloon 35 and the posterior balloon 20 are properly inflated, the two balloons will create a sealing zone (sometimes referred to below as a "treatment zone") therebetween.

It will be appreciated that when the front balloon 35 is reconfigured from its deflated condition to its inflated condition, the front balloon 35 expands radially inwardly (so as to close the axial opening 63) and radially outwardly (so as to engage surrounding tissue).

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

To this end, and referring now to fig. 9 and 10, the forward balloon 35 is preferably manufactured as a single construction comprising a body 67 having a proximal opening 69 and a proximal opening 71, a proximal extension 73 having a "key-shaped" cross-section comprising a protrusion 74, and a distal extension 76 having a circular cross-section. It is noted that the protrusions 74 are provided on the proximal extension 73 with a configuration that matches the configuration of the push tubes 30 (i.e. in case the device 5 comprises two push tubes 30 diametrically opposite each other, the proximal extension 73 will comprise two protrusions 74 diametrically opposite each other, in case the device 5 comprises three push tubes 30 equally circumferentially spaced around the circumference of the sleeve 15, the proximal extension 73 will comprise three protrusions 74 equally circumferentially spaced around the circumference of the proximal extension 73, in case the device 5 comprises one push tube 30, the proximal extension 73 will comprise one protrusion 74, etc. -for the purposes of the present invention, the proximal extension 73 and the protrusion(s) 74 may be collectively referred to as having a "key-shaped" cross-section). During assembly, the push tube 30 is seated in the boss 74 of the proximal extension 73, the proximal extension 73 is everted into the interior of the body 67 (wherein the interior of the hollow push tube 30 is in fluid communication with the interior of the body 67), and then the distal extension 76 is everted into the interior of the proximal extension 73, thereby providing the forward balloon 35 with the axial opening 63 extending therethrough, wherein the push tube 30 is secured to the forward balloon 35 and in communication with the interior of the forward balloon 35. Notably, the axial opening 63 is sized to receive the distal end of the endoscope 10 therein. Also notably, by everting proximal extension 73 into the interior of body 67 and then everting distal extension 76 into the interior of proximal extension 73, the above-described process forms anterior balloon 35, providing multiple layers of balloon material around push tube 30, thereby providing a stronger balloon configuration. In addition, providing multiple layers of balloon material around the push tube 30 also increases the cushioning effect on the distal end of the push tube 30, thereby providing an even more atraumatic distal tip to the push tube 30 and further ensuring that the distal tip of the push tube 30 does not damage adjacent tissue.

In a preferred form of the invention, the forward balloon 35 is made of polyurethane.

It should be appreciated that when the front balloon 35 is in its inflated state, the material of the front balloon 35 substantially contains the distal end of the push tube 30 (while still allowing the push tube 30 to be in fluid communication with the interior of the front balloon 35), thereby providing a atraumatic tip for advancing the front balloon 35 distally through the body lumen. In addition, the push tube 30 and the deflated anterior balloon 35 may essentially act together as a soft-headed wire for the device 5 and endoscope 10, as discussed further below (fig. 20).

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 radio-opaque indicator) so that a physician (or other operator or user) viewing the surgical site via endoscope 10 or radiological guidance (e.g., fluoroscopy) may determine the placement of one or both of the balloons at the surgical site.

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 referring now to fig. 1 and 11, the inflation mechanism 40 includes a single-wire syringe inserter 140, the single-wire syringe inserter 140 including 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 its stroke. The syringe inserter 140 is connected to one or the other of the fittings 46, 56 via a line 155. Thus, with this configuration, when the single-wire syringe inserter 140 is used to inflate the rear balloon 20, the syringe inserter 140 is connected to the fitting 46 via the wire 155 such that the output of the single-wire syringe inserter 140 is directed toward the rear balloon 20 (i.e., via the proximal inflation/deflation line 45). Accordingly, when the single-wire syringe inserter 140 is used to inflate the front balloon 35, the syringe inserter 140 is connected to the fitting 56 via the wire 155 such that the output of the single-wire syringe inserter 140 is directed toward the front balloon 35 (i.e., via the flexible tube 59 and the hollow interior of the push tube 30).

In another preferred form of the invention, the inflation mechanism 40 includes a resilient ball 156 having a first port 157 and a second port 158. A one-way valve 159 (e.g., a check valve) is provided in the first port 157 such that air can pass through the first port 157 only when traveling in an outward direction. A one-way valve 159 (e.g., a check valve) is provided in the second port 158 so that air can pass through the second port 158 only when traveling in an inward direction. When the elastic ball 156 is compressed (e.g., by hand), air within the interior of the elastic ball 156 is forced out of the first port 157, and when the elastic ball 156 is then released, air is drawn into the interior of the elastic ball 156 through the second port 158.

With this configuration, when the elastic balloon 156 is used to inflate the rear balloon 20, the first port 157 is connected to the fitting 46 via the line 155 such that the positive pressure output of the elastic balloon 156 is directed to the rear balloon 20. The resilient ball 156 may then 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 the suction force of the resilient ball 156 is directed toward the rear balloon 20. Accordingly, when the elastic balloon 156 is 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. The elastic ball 156 may then be used to deflate the front balloon 35, i.e. by connecting the second port 158 to the fitting 56 via the line 155, such that the suction force of the elastic ball 156 is directed towards the front balloon 35.

Alternatively, and referring now to fig. 12 and 13, a syringe 160 may be used to inflate rear balloon 20 and/or front balloon 35. The inflation mechanism 160 includes a body 161 and a plunger 162. Preferably, a spring (not shown) is provided in the body 161 to automatically return the plunger 162 at the end of its power stroke. The syringe 160 is connected to the fittings 46, 56 via line 163. With this configuration, the syringe 160 includes a valve 165 for connecting the syringe 160 to the front balloon 35 or the rear balloon 20 and a valve 170 for selecting inflation or deflation of the balloon connected thereto.

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

Accordingly, when the syringe 160 is used to inflate the front balloon 35, the valve 165 is set such that the syringe 160 is connected to the front balloon 35 by the fitting 56, and the valve 170 is set such that the syringe 160 provides inflation pressure. Thereafter, when the front balloon 35 is deflated, the valve 170 is set to its deflated position.

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

If desired, and looking now at fig. 14, relief valve 175 may be connected to an inflation/deflation line connected to front balloon 35 in order to ensure that the pressure within front balloon 35 does not exceed a predetermined level. Similarly, and still referring now to fig. 14, a pressure relief valve 180 may be connected to an inflation/deflation line connected to the rear balloon 20 to ensure that the pressure within the rear balloon 20 does not exceed a predetermined level.

Alternatively and/or additionally, one or more pressure gauges 182 (fig. 1 or 13) may be incorporated into the fluid lines connected to the rear balloon 20 and/or the fluid lines connected to the front balloon 35 to provide information to the physician (or other operator or user) regarding the pressure within the rear balloon 20 and/or the front balloon 35 in order to avoid over-inflation and/or to assist the physician (or other operator or user) in determining the balloon inflation status during surgery.

Further, it will be appreciated that as the forward balloon 35 moves between its "retracted" position (fig. 2) and its "extended" position (fig. 4), the flexible tube 59 connecting the push tube 30 to the base 25 (and thus to the fitting 56) may collect around the base 25, potentially interfering with the actions of the physician (or other operator or user). Thus, if desired, and looking now at fig. 15, 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.

Preferred method of Using novel apparatus

The device 5 may be used to manipulate (e.g., stabilize, straighten, dilate, and/or flatten, etc.) the side walls of the body lumen and/or body cavity to better present the side wall tissue (including visualization of areas that were originally hidden or outside the field of view) for examination and/or treatment using the endoscope 10 during endoscopic surgery, and/or to stabilize the distal tip and/or working end of an instrument (e.g., grasper, cutter or stripper, cautery tool, ultrasound probe, etc.), such as for example, for advancement into a treatment area.

More specifically, in use, sleeve 15 is first mounted to endoscope 10 (FIG. 1). This may be accomplished by pulling the base 25 proximally on 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 rests on the distal end of the endoscope 10. The endoscope 10 and the device 5 are ready to be inserted as a whole into a patient.

Turning next to fig. 16, 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 (GI) tract 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. 17 and 18).

When the device 5 is used (e.g., to manipulate the side wall of the gastrointestinal tract, to provide increased visualization of the gastrointestinal tract and/or to increase access to the gastrointestinal tract and/or for stabilizing the instrument relative to the gastrointestinal tract), the rear balloon 20 is inflated to stabilize the device 5 (and thus the endoscope 10) within the body lumen and/or body cavity. Referring to fig. 19, this may be accomplished using the associated inflation mechanism 40 described above.

In this regard, it will be appreciated that because the articulating portion of the endoscope is distal to the rear balloon 20, the endoscope will be able to articulate the distal side of the rear balloon 20 even after inflation of the rear balloon 20 in order to facilitate visualization of anatomy. Notably, this 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, push tube 30 is advanced distally in the body lumen and/or body cavity (i.e., so as to move rear balloon 20 further in front of front balloon 35) by pushing distally on push tube handle 37. Thus, the push tube 30, and thus the front balloon, is moved distally relative to the endoscope 10 (which is stabilized in place within the gastrointestinal tract by the inflated rear balloon 20), and thus the front balloon 35 is moved distally relative to the endoscope 10. It is noted that during such distal advancement of the forward balloon 35, the deflated forward balloon 35 covers the distal end of the push tube 30, thereby ensuring atraumatic advancement of the forward balloon 35. It is noted that the atraumatic advancement of the anterior balloon 35 may be further enhanced by forming the distal end of the push tube 30 from a more resilient material.

When the 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. 20) to secure the front balloon 35 to the anatomy. Again, this may be accomplished using the associated inflation mechanism 40 described above. When the anterior balloon 35 is inflated, the inflated anterior balloon 35, the inflated posterior balloon 20, and the push tube 30 will all complement one another to stabilize, straighten, expand, and/or flatten the side walls of the body lumen and/or body cavity, thereby better presenting side wall tissue (including visualization of areas initially hidden or out of view) for examination and/or treatment during endoscopic surgery 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 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 seals through the axial opening 63 of the front balloon when the front balloon is in its deflated state), and the rear balloon 20 will cooperate with the sleeve 15 and the 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 zone that prevents the passage of fluids and/or other liquids through the airtight seal established by the inflated front balloon 35 and rear balloon 20). By inflation of the anterior balloon 35 and the posterior balloon 20, the side walls of the body lumen and/or body cavity will be tensioned, thereby better presenting the side walls of the body lumen and/or body cavity for viewing through the endoscope 10.

It should be appreciated that the expansion and tensioning of the side walls of the body lumen and/or body cavity achieved by the inflated front balloon 35, inflated rear balloon 20 and push tube 30 may be further enhanced by advancing the front balloon as it is inflated and grasping the side walls of the body lumen and/or body cavity, thereby tensioning the side walls of the body lumen and/or body cavity.

Notably, because the inflated anterior balloon 35 and the inflated posterior balloon 20 together define a substantially enclosed region (i.e., isolate the treatment zone) along the body lumen and/or body cavity, this region can then be inflated with a fluid (e.g., air, CO ₂, etc.) (fig. 21) to further tension the side walls of the body lumen and/or body cavity, thereby better presenting the side walls of the body lumen and/or body cavity for viewing through the endoscope 10 and stabilizing the side walls, thereby facilitating more accurate therapeutic interventions.

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 maintaining a grip on the side wall of the body lumen and/or body cavity) to move the visible mucosa and further improve visualization and access (see fig. 22), e.g., to locate a particular target area on the side wall of the body lumen and/or body cavity relative to a convenient angle of the endoscope and endoscopic tool.

Alternatively, if desired, once the rear balloon 35 has been inflated, the 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 grasp the side walls of the body lumen and/or body cavity, and then the push tube 30 may be advanced further distally. Such action will cause the flexible push tube 30 to bow outwardly (see fig. 22A-22D) to contact and push outwardly the side walls of the body lumen and/or body cavity, for example in a "tent-like" manner, thereby further enhancing visualization of the side walls of the body lumen and/or body cavity by the endoscope 10.

If desired, an instrument 190 (FIG. 23) may be advanced through the working channel of endoscope 10 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 stable relative to the anatomy. This is a significant advantage over prior art practices that advance the instrument beyond the unstable end of the endoscope. Preferably, the instrument 190 comprises an articulating instrument that has a full range of motion, thereby better accessing the target anatomy.

Furthermore, if bleeding at the tissue site is not visible, or if bleeding occurs and the surgeon cannot determine the source of the bleeding, isolating the treatment area allows for rapid irrigation (e.g., with a liquid such as saline) of the anatomical segment where the treatment area is located, and subsequent rapid removal of the irrigation liquid (see fig. 24-26).

Also, if desired, the anterior balloon 35 may be directed to the bleeding site with high accuracy, and thus the anterior balloon 35 (e.g., inflated) may be used to apply localized pressure to the bleeding site in order to enhance bleeding control (see fig. 27). This may be done 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 forward balloon 35 is returned to its annular configuration (i.e., partially deflated), the forward balloon is retracted proximally and "re-docked" on the distal end of the endoscope 10, the rearward balloon 20 is deflated, and then the endoscope 10 (with the device 5 carried thereon) is repositioned within the anatomy. It is noted that in the event that the forward balloon 35 is to be re-docked on the distal end of the endoscope 10, the forward balloon 35 is preferably only partially deflated until the forward balloon 35 is re-docked on the distal end of the endoscope, as partial inflation of the forward balloon 35 may allow the forward balloon 35 to have sufficient "body" to facilitate the re-docking process. Thereafter, if desired, the forward balloon 35 may be completely deflated, e.g., to forcibly grasp the distal end of the endoscope 10.

Alternatively, if desired, the forward balloon 35 may act as a resistive brake to control retrograde movement of the endoscope. More specifically, 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 tip of the endoscope is in place. Next, the rear balloon 20 is inflated, the push tube 30 is advanced distally, and then the front balloon 35 is inflated (fig. 28). Visualization and optional therapeutic treatment may then be effected at that 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 withdrawn proximally to drag the semi-inflated front balloon along the body lumen and/or body cavity (fig. 29), wherein the front balloon 35 acts as a brake to some extent when the endoscope is pulled proximally, thereby enabling a more controlled retrograde movement of the endoscope and thus a better visualization of the anatomy. If this is desired in some circumstances, the posterior balloon 20 and anterior balloon 35 may be re-inflated, as shown in fig. 30, with or without the introduction of fluid into the "isolated 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, either alone or in combination with the above-described braking action from the front balloon 35.

At the end of the procedure, the endoscope 10 and device 5 are withdrawn from the anatomy. Preferably, this is accomplished by deflating (or partially deflating) the front balloon 35, thereby retracting the push tube 30, so that the front balloon 35 "re-docks" on the distal end of the endoscope 10, completely deflating the front balloon 35 so that it grasps the distal end of the endoscope, deflating the rear balloon 20 (if it is not already deflated), and then withdrawing the endoscope 10 and device 5 as a whole from the anatomy.

It will be appreciated that the device 5 may be advantageously used in various ways in addition to those disclosed above. By way of example and not limitation, as the endoscope 10 (and device 5) is advanced within the colon, it may be desirable to first distally protrude the anterior balloon 35 under the visual guidance of the endoscope such that the anterior balloon 35 guides the distal end of the endoscope. As a result, the forward balloon 35 is deflated (or partially deflated) as the endoscope is advanced distally, and the forward balloon and flexible push tube 30 may act as an atraumatic lead (guide structure) for the endoscope as it is advanced through the colon. Notably, because the distal end of the 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 push tube may be turned so that the forward balloon follows the path of the colon, thereby facilitating atraumatic advancement of the endoscope along the colon. It should also be appreciated that the device 5 may also be used to advantage in other ways to facilitate further inspection of lumen surfaces that are currently difficult to perform in other ways. An example of this is endoscopic ultrasound of the lumen, which would be facilitated by fluid-filled inflated front balloon and ultrasound probe inspection.

Additional structure

If desired, the device 5 may be configured such that the push tubes 30 may be advanced or retracted independently of one another, or in combination with one another—such independent advancement or retraction of the push tubes 30 may help guide the partially or fully deflated 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 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 referring now to fig. 30A, push tubes 30 are each independently slidably mounted to push tube handle 37 such that push tubes 30 can move independently of push tube handle 37 and independently of each other. The stopper 191 limits the distal movement of the push tube 30 relative to the push tube handle 37 so that the push tube cannot move completely out of the push tube handle 37. With this configuration, as the forward balloon 35 moves distally, the push tubes 30 move distally, either together or independently of each other. Moreover, as the forward balloon 35 moves proximally, the push tubes 30 move proximally, either together or independently of each other. At any point in the procedure, the push tubes 30 may be moved independently of one another in order to "turn" the anterior balloon, such as, for example, the anterior balloon 35 inflated and engaged with the anatomy, thereby imparting a "rotational force" to the anatomy, or in the case where the anterior balloon 35 is partially inflated and used as an atraumatic tip for the advancement assembly, thereby "steering" the assembly through the anatomy. It is noted that it may be desirable to provide a limiting mechanism to limit the extent to which the pushers 30 may move longitudinally, independently of each other, so as to prevent over-rotation of the forward balloon 35, and/or pushbar crossover, and/or pushbar entanglement, and/or pushbar misalignment, etc. Note also that by installing the push tube 30 in the clamp 53 described above, the push tube 30 can be held in a particular arrangement (fig. 12 and 15).

It should also be appreciated that the configuration of sleeve 15 may be modified to support the instrument (or hollow instrument catheter) outside of endoscope 10. More specifically, referring again to FIGS. 5 and 6, it will be seen that in the configuration shown in FIGS. 5 and 6, sleeve 15 includes a lumen 47 for receiving inflation/deflation tube 45 for inflating/deflating rear balloon 20, and a pair of lumens 52 for receiving support tube 50, which support tube 50 receives push tube 30 for manipulating front balloon 35 and inflating/deflating it. However, if desired, sleeve 15 may include additional lumens for supporting instruments (or hollow instrument catheters) outside of endoscope 10.

More specifically, and referring now to fig. 31, 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. It is noted that when inflated, the rear balloon 20 provides a safety platform for maintaining the endoscope 10 and sleeve 15 within a body lumen or body cavity, wherein the endoscope 10 and sleeve 15 are centered within the body lumen or body cavity. As a result, the distal end of lumen 195 of sleeve 15 will also be safely maintained within the body lumen or body cavity to provide safe support for instruments advanced through lumen 195 of sleeve 15.

The proximal end of lumen 195 may extend to 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 proximal of base 25 (but still outside the patient), in which case the instrument may be inserted into lumen 195 intermediate sleeve 15. By way of example and not limitation, where the endoscope 10 is 180cm in length and the instrument 190 is 60cm in length, it may be advantageous to insert the instrument 190 into the lumen 195 at a point closer to the balloons 20, 35 (rather than at the base 25). It is noted that in fig. 31, lumen 47 for receiving inflation/deflation line 45 and inflation/deflation line 45 for inflating/deflating rear balloon 20 are not visible, as the view is distally facing and taken at a location distal of where lumen 47 and inflation/deflation line 45 terminate on sleeve 15.

Fig. 32-35 illustrate various instruments 190 extending out of lumen 195. It is noted that the instrument 190 preferably comprises an articulating instrument such as the grasper 190A in fig. 32-35, the cautery device 190B in fig. 32-33, the scissors 190C in fig. 34 and 35, and the suction device 190D in fig. 32-35.

It should be appreciated that where sleeve 15 includes a central passageway for receiving endoscope 10, lumen 47 for receiving inflation/deflation tube 45, lumen 52 for receiving support tube 50 for receiving 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 for 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, lumen 47 for receiving inflation/deflation tube 45, lumen 52 for receiving support tube 50 for receiving push tube 30, and/or lumen 195 for slidably receiving instrument 190 may have an expandable configuration (i.e., they may have a minimal profile when empty and they may fully expand as needed when filled) such that the overall profile of sleeve 15 is minimized.

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 the push tube 30 to pass through and an opening for the instrument 190 to pass through. It is noted that the opening in such a support ring through which the instrument 190 passes preferably mates 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 catheter that itself houses the instrument therein. Such hollow instrument catheters may provide greater structural integrity to the distal end of lumen 195 to provide improved support for instruments 190 housed within lumen 195. Also, such hollow instrument catheters may have a fixed geometry or a bendable or articulating geometry. Referring to, for example, fig. 36, a hollow instrument catheter 200 is shown extending out of lumen 195 and housing instrument 190 therein. It is noted that the hollow instrument tubes 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 catheter 200 to provide superior instrument support at the distal end of the sleeve 15.

It should also be appreciated that if desired, two push tubes 30 may be replaced with a single push tube 30 or more than two push tubes 30 (e.g., three push tubes 30). It will be appreciated that where multiple push tubes 30 are provided, it will generally be desirable to circumferentially space the push tubes equidistant from one another, for example where two push tubes 30 are provided, it will generally be desirable to space two push tubes 30 180 degrees apart, where three push tubes 30 are provided, it will generally be desirable to space push tubes 120 degrees apart, etc.

Tissue retraction and tissue removal

Tissue retraction

In some cases, it may be necessary or desirable to strip tissue within a body lumen or cavity. By way of example and not limitation, endoscopic Submucosal Dissection (ESD) is an endoscopic dissection procedure used to remove intestinal lesions once, even though the intestinal lesions are quite large. With ESD, lesions are peeled directly along the submucosa of the intestine using a cutting tool (e.g., an electrocautery knife equipped with an energy source) through the endoscope, resulting in a safer overall peeling of even large lesions.

Conventional ESD presents a number of challenges. First, this technique involves pushing the endoscope tip into the tissue, using a transparent plastic cap placed over the tip of the endoscope, which stretches the submucosal fibers and aids in tissue dissection. However, this technique may partially obstruct the surgeon's view. Second, fluids, debris and smoke often accumulate within a transparent plastic cap placed over the tip of the endoscope, further obscuring the surgeon's view.

In addition to the above, ESD surgery is often time consuming and typically takes several hours. Most of this time is typically spent on the submucosal dissection of lesions along the intestine.

Similar problems may occur with other intracavitary tissue-stripping procedures.

Endoscopic tissue retraction systems compatible with ESD procedures and other intracavitary tissue removal procedures will provide the surgeon with better visualization of the surgical field of view and speed up the removal process.

Tissue removal

In addition to the above, it may be difficult to remove lesions (or other exfoliated tissue) after the lesions are exfoliated from the submucosa of the intestine or after other tissue is exfoliated during an endoluminal tissue dissection procedure due to (i) the technical challenges of positioning the exfoliated lesions (or other exfoliated tissue) within the intestine and (ii) clamping the exfoliated tissue (or other exfoliated tissue) with a retrieval tool. In addition, if exfoliated lesions (or other exfoliated tissue) including early cancers migrate within the intestine, they may contaminate (e.g., potentially vaccinate with cancer cells) the disease-free regions of the intestine.

Endoscopic tissue retrieval systems compatible with ESD procedures and other endoluminal tissue dissection procedures will provide the surgeon with better control and protection of the dissected tissue within the intestine.

Endoscopic tissue retraction system

To this end, in one preferred form of the invention, and looking now at fig. 37-42, there is shown a novel apparatus 5 for use in conjunction with an endoscopic tissue retraction system 300 to provide a surgeon with better visualization of the surgical field and to accelerate the dissection process, for example during an ESD procedure. In this form of the invention, connector 305 is secured to (i) anterior balloon 35 (or push tube 30) and (ii) lesion 315. This may be accomplished by clamping connector 305 to anterior balloon 35 (or push tube 30) using surgical clip 320 and by clamping connector 305 to lesion 315 with another surgical clip 320. It will be appreciated that the connector 305 and clip 320 can be delivered to the surgical site through the working channel of the endoscope 10 (or through the instrument lumen 195 of the device 5). With the connectors secured to both the anterior balloon 35 (or push tube 30) and the lesion 315, the anterior balloon 35 may be advanced distally to tension the connector 305, thereby advancing the lesion 315 in a distal direction (i.e., applying a force thereto). The cutting tool 325 may then be advanced out of the distal end of the endoscope 10 (or through the instrument lumen 195 of the device 5) and used to strip the lesion 315 along the submucosa 330 of the intestine 335. It will be appreciated that after the lesion 315 has been cut from the submucosa of the intestine, the lesion 315 will remain tethered to the anterior balloon 35 by means of the connector 305 and the surgical clip 320.

In a preferred form of the invention, the connector 305 comprises a loop of material (e.g., a loop made of extruded wire, a loop made of webbing, etc.). Alternatively, the connector 305 may comprise a single strand of material (e.g., a single strand made of extruded filaments, a single strand made of webbing, a single strand made of wire, a single strand made of suture, etc.).

In a preferred form of the invention, the connector 305 is made of an elastomeric material (e.g., an elastomeric wire or elastomeric webbing) such that when the lesion 315 is cut from the submucosa 330 of the intestine 335, the connector 305 automatically takes up any slack in the connector 305. In another form of the invention, the connector 305 may be made of a non-elastic, flexible material. In yet another form of the invention, the connector 305 may be made of a non-elastic, rigid material.

In one form of the invention, the anterior balloon 35 is advanced distally to tension the connector 305, thereby advancing the lesion 315 in the distal direction (i.e., applying a force thereto). In an alternative form of the invention, and referring now to fig. 43-45, where connector 305 comprises an elastomeric material, connector 305 may be secured to one or the other of anterior balloon 35 and lesion 315, stretched, secured to the other of anterior balloon 35 and lesion 315, and then released, thereby advancing (i.e., applying force to) lesion 315 in the distal direction without any movement of anterior balloon 35 in the distal direction. Alternatively, the connector 305 may be stretched, secured (in its stretched condition) to the anterior balloon 35 and the lesion 315, and then released, thereby advancing the lesion in the distal direction (i.e., applying a force thereto) without any movement of the anterior balloon 35 in the distal direction.

In another form of the invention, and looking now at fig. 46, connector 305 may include a loop 340 having a variable length, for example loop 340 may include a slip knot 345 having a tensioning end 350. In this form of the invention, with connector 305 in a relaxed state, connector 305 is clamped to anterior balloon 35 (or push tube 30) with surgical clip 320, and connector 305 is clamped to lesion 315 with another surgical clip 320. The connector 305 is then tensioned (e.g., by pulling on the tensioning end 350 of the slip knot 345 using a tool advanced through the working channel of the endoscope 10 or through the instrument lumen 195 of the device 5), thereby advancing the lesion 315 in the distal direction (i.e., applying a force thereto). The cutting tool 325 may then be advanced out of the distal end of the endoscope 10 (or through the instrument lumen 195 of the device 5) and used to strip the lesion 315 along the submucosa 330 of the intestine 335. Once again, it will be appreciated that after the lesion 315 has been peeled off the submucosa of the intestine, the lesion 315 will remain tethered to the anterior balloon 35 by means of the connector 305 and the clip 320.

In another form of the invention, the connector 305 may include a loop 340 having a variable length, but wherein the slip knot 345 and tensioning end 350 are replaced with a length adjustment clip 355 and one or more tensioning ends 360. See fig. 47. In this form of the invention, the ring 340 is tensioned by pulling on one or more tensioning ends 360 using a tool advanced through the working channel of the endoscope 10 (or through the instrument lumen 195 of the device 5).

In some cases, and referring now to fig. 48, it may be advantageous to provide connector 305 with a substantially rigid collar 365 at its proximal end (i.e., the lesion side). By way of example and not limitation, where the connector 305 is in the form of a ring, the ring of the connector 305 may pass through the center of the substantially rigid ring 365. The substantially rigid loop 365 may facilitate securing the connector 305 to the lesion 315, for example, making it easier to clamp the connector 305 to the lesion 315 using the surgical clamp 320.

In some cases, it may be desirable to use multiple connectors 305 to connect the lesion 315 to the anterior balloon 35. This may allow the lesion 315 to be tensioned distally with multiple direction vectors and multiple attachment points, which may help to strip the lesion 315 from the submucosa 330 of the intestine 335. See fig. 49.

Alternatively, and looking now at fig. 50, where the connector 305 is in the form of a ring, a plurality of substantially rigid loops 365 may be mounted to a single connector 305, and the plurality of substantially rigid loops 365 may be secured to different locations on the lesion 315, thereby allowing the lesion 315 to be tensioned distally with multiple direction vectors and multiple attachment points. Or where connector 305 is in the form of a loop, different segments of the loop may be secured to different locations on lesion 315 using multiple surgical clips 320, thereby allowing distal tensioning of lesion 315 with multiple directional vectors and multiple points of attachment.

In one form of the invention, connector 305 is attached to anterior balloon 35 (or push tube 30) in situ using surgical clip 320. However, if desired, the connector 305 may be pre-attached to the anterior balloon (or the push tube(s) 30) at the time of manufacture (or some other time prior to insertion of the anterior balloon 35 into the body). By way of example and not limitation, and referring now to fig. 51 and 52, connector 305 may be pre-attached to anterior balloon 35 using an eyelet or grommet-lined eyelet 370.

It should also be appreciated that in some cases it may be possible to secure the forward balloon 35 (or one of the push tubes 30) directly to 315 without the use of the connector 305. By way of example and not limitation, one or more surgical clips 320 may be used to secure the anterior balloon 35 (or one of the push tubes 30) directly to the lesion 315. Referring to, for example, fig. 52A, a surgical clip 320 is shown securing the anterior balloon 35 directly to the lesion 315 without the use of a connector 305. Referring also to fig. 52B, a surgical clip 320 is shown securing push tube 30 directly to lesion 315 without the use of connector 305.

Once the lesion 315 has been stripped from the submucosa 330 of the intestine 335 (or other tissue has been stripped from its site within the body lumen), the stripped tissue typically must be removed from the patient's body. Because the dissection tissue is secured to the anterior balloon 35 (or push rod 30) by means of one or more connectors 305 and/or clips 320, the dissection tissue can be removed from the body by simply removing the novel device 5 from the patient's body, which will withdraw the dissection tissue from the patient's body as the anterior balloon 35 is withdrawn from the patient's body. However, this method has a risk that the dissected tissue tears from the anterior balloon 35 (or push tube 30), for example, due to failure of the clip to install the dissected tissue or due to failure of the clip to install the anterior balloon (or push tube), etc. Furthermore, this approach essentially drags the exposed, exfoliated tissue along the length of the intestine (or other body lumen) as the novel device 5 is withdrawn from the patient's body. This may pose a risk to the patient, for example, in dissecting areas where tissue includes disease free regions that may contaminate (e.g., potentially vaccinate with cancer cells) the intestine (or other body lumen region).

Endoscopic tissue retrieval

To this end, and referring now to fig. 53-60, the forward balloon 35 may include a tab 375 disposed within a central bore 380 of the forward balloon 35. The tab 375 is configured such that (i) when the front balloon 35 is docked on the endoscope 10, the tab 375 is captured between the endoscope 10 and the front balloon 35, (ii) when the front balloon 35 is detached from the endoscope 10 and then projects distally away from the endoscope 10 and then fully inflated, the tab 375 is captured within the closed central aperture 380 of the front balloon 35 (fig. 53 and 54), and (iii) when the front balloon 35 projects distally away from the endoscope 10 and then partially deflated such that the central aperture 380 of the front balloon 35 reopens to expose the tab 375 (fig. 55 and 56), the tab 375 may be "pulled down" across the central aperture 380 of the front balloon 35 (e.g., with a tool advanced through the instrument lumen 195 of the endoscope 10 or device 5) to form a pocket 385 within the central aperture 380 of the front balloon 35 with surrounding portions of the front balloon 35 defining the central aperture 380 (fig. 57 and 58). The pocket 385 is configured to contain the tissue (fig. 59 and 60).

Thus, in this form of the invention, after the lesion 315 is stripped from the submucosa 330 of the intestine 335 (or after other tissue is stripped from its site within the body lumen), the stripped tissue is maneuvered into the pocket 385 (e.g., using a tool advanced through the working channel of the endoscope 10 or through the instrument lumen 195 of the device 5), and then the stripped tissue is easily and safely removed from the body by simply removing the novel device 5 from the body of the patient, which will cause the stripped tissue to be withdrawn from the body of the patient as the anterior balloon 35 is withdrawn from the body of the patient. It is noted that this may be accomplished while the dissected tissue is still connected to the anterior balloon 35 (or push tube 30) via the connector(s) 305 and/or the surgical clip(s) 320. It is also noted that this approach effectively eliminates the risk of the dissected tissue tearing from the anterior balloon 35 (or push tube 30), such as due to a clip failing to install the dissected tissue or due to a clip failing to install the anterior balloon (or push tube), etc., and reduces early cancer lesions contaminating (e.g., potentially inoculating with cancer cells) the disease-free areas of the intestine (or other body lumen) because the dissected tissue is shielded within the pocket when withdrawn from the patient's body.

Additional endoscopic tissue retraction

It is also possible to tension the lesion 315 away from the endoscope 10 in various other ways (e.g., for dissection purposes).

Tensioning the lesion by connecting the lesion to the non-inflated portion of the anterior balloon 35 using one or more connectors and moving the anterior balloon

By way of example and not limitation, and looking now at fig. 61, it is also possible to use connector 305 to secure anterior balloon 35 directly to lesion 315. In this form of the invention, the anterior balloon 35 includes an inflated portion 36 and a non-inflated portion (e.g., non-inflated neck 38), and the connector 305 passes through the non-inflated neck 35 of the anterior balloon 35 and connects to the lesion 315, e.g., using a clip 320. The connector 305 passes through the non-inflated portion of the anterior balloon 35 (e.g., the non-inflated neck 38 of the anterior balloon 35) by passing a needle carrying the connector directly through the non-inflated portion of the anterior balloon 35, or by passing the connector through a hole (or eyelet) formed in the non-inflated portion of the anterior balloon 35. The free end of the connector 305 is then attached to the lesion 315, for example using a clip 320. In a preferred form of the invention, the connector 305 is a strand of suture. It should be appreciated that a strand of suture forming the connector 305 may be passed through the neck 38 of the anterior balloon 35 (or another non-inflated portion of the anterior balloon 35) before the device 5 is inserted into the patient's body, or the strand of suture may be passed through the neck 38 of the anterior balloon 35 (or another non-inflated portion of the anterior balloon 35) after the device 5 has been inserted into the patient's body. Alternatively, the anterior balloon 35 may be manufactured with a connector 305 (e.g., a strand of suture) that is pre-attached to the neck 38 of the anterior balloon 35 (or the non-inflated portion of the anterior balloon 35).

In use, the device 5 is advanced over the endoscope 10, the combination of the endoscope 10 and the device 5 is advanced into the intestine 335 such that the endoscope 10 is just proximal to the lesion 315, the rear balloon 20 is inflated to stabilize the endoscope relative to the lesion, the connector 305 is attached to the neck 38 of the front balloon 35 (or another non-inflated portion of the front balloon 35) and connected to the lesion 315 by the clip 320, and the push tube 30 is moved distally to tighten the lesion 315 away from the endoscope 10 (or instrument lumen 195). The lesion 315 is then peeled from the submucosa 330 of the intestine 335 using the cutting tool 325 that has been advanced through the working lumen (or instrument lumen 195) of the endoscope 10.

If desired, a plurality of connectors 305 may be passed through the non-inflated portion of the anterior balloon 35 and used to connect the lesion 315 to the anterior balloon 35. By way of example and not limitation, a plurality of sutures may be passed through the neck 38 (or other non-inflated portion) of the anterior balloon 35, with one or more connectors 305 attached to the lesion 315 (e.g., with one or more clips 320).

Alternatively, it is possible to use a clip (e.g., clip 320) to clip the connector 305 to the non-inflated portion of the anterior balloon 35 (e.g., the non-inflated neck 38 of the anterior balloon 35), and then connect the connector 305 to the lesion 315. Further, a plurality of connectors 305 may be clipped to the non-inflated portion of the anterior balloon 35 and used to connect the lesion 315 to the anterior balloon 35.

In another form of the invention, and referring now to fig. 62-65, a first connector 305 may be connected to the anterior balloon 35 (e.g., by passing the connector 305 through the neck 38 of the anterior balloon 35 (or another non-inflated portion), thereby clamping the connector 305 to the non-inflated portion of the anterior balloon 35, etc.), and a second connector 305 may be connected to (i) the first connector 305 and (ii) the lesion 315 so as to form an extension ring 305A extending from the first connector 305.

The extension ring 305A is particularly useful when the lesion is located just proximal to a significant colon turn. By way of example and not limitation, when a lesion 315 (e.g., polyp) is located just proximal to a significant colon turn (e.g., just proximal to the liver, spleen, or other colon curvature), it may be difficult to connect the anterior balloon 35 to the lesion 315 (e.g., with the connector 305 and clip 320) and then tighten the lesion 315 by advancing the anterior balloon 35 distally within the colon. More specifically, when the lesion 315 is just proximal to a significant colon turn, the anterior balloon 35 will push against the colon wall at the turn as it moves distally within the colon to tighten the lesion (see fig. 62). To prevent the forward balloon 35 from pushing against the colon wall, the device 5 may be advanced into the straight portion of the colon such that the forward balloon 35 (with the first connector 305 attached thereto) is positioned distal to the colon turn and the rear balloon 20 is positioned proximal to the colon turn (see fig. 63). The second connector 305 is then advanced into the colon, wherein one end of the second connector 305 is connected to the proximal side of the lesion 315 (e.g., with an endoscope clip 320) (see fig. 64) and the other end of the second connector 305 is connected to the first connector 305 (e.g., with the second endoscope clip 320) to form an extension ring 305A (see fig. 65). Now, the anterior balloon 35 can be pushed distally along the straight portion of the colon as long as necessary to provide the desired tension to the lesion.

If desired, the first connector 305 and the second connector 305 may be replaced with a single connector that is long enough to extend between the anterior balloon 35 and the lesion 315 when the anterior balloon 35 is positioned distally of the colon turn and the lesion 315 is just proximal of the apparent colon turn.

In another form of the invention, the device 5 may be formed without the instrument lumen 195. In this form of the invention, the tool may be passed down through one or more working lumens of the endoscope. Alternatively, an endoscope having a smaller diameter than the lumen of the sleeve 15 may be used, such that a space is created between the inner wall of the lumen of the sleeve 15 and the outside of the endoscope. One or more tools may then be passed through the space between sleeve 15 and endoscope 10.

Tensioning a lesion by connecting the lesion to a tensioning tool and moving the tensioning tool

By way of further example and not limitation, and looking now at fig. 66, tensioning tool 400 may be advanced down through instrument lumen 195 of device 5 (or the working lumen of endoscope 10) to the surgical site and then used to bias lesion 315, for example, to strip the lesion. It is noted that the tensioning tool 400 may directly engage and grip the lesion 315, such as shown in fig. 66, or the tensioning tool 400 may engage and grip the connector 305, which connector 305 itself is secured to the lesion 315 (e.g., via the clip 320). Or the tensioning tool 400 may engage and grip the connector 305, the connector 305 being connected to the rigid collar 365 (fig. 48-50), wherein the rigid collar 365 is secured to the lesion 315 (e.g., via the clip 320).

In use, the device 5 is pulled up the endoscope 10, the combination of the endoscope 10 and the device 5 is advanced into the intestine 335 such that the endoscope 10 is just proximal to the lesion 315, the rear balloon 20 is inflated to stabilize the endoscope relative to the lesion, the front balloon 35 is inflated to create a sealed treatment zone between the rear balloon 20 and the front balloon 35, the tensioning tool 400 is advanced through the instrument lumen 195 (or working lumen of the endoscope 10) into the treatment zone to grasp the lesion 315, and the tensioning tool 400 is moved to tension the lesion 315. The lesion 315 is then peeled away from the submucosa 330 of the intestine 335 using the cutting tool 325 that has been advanced through the working lumen (or instrument lumen 195) of the endoscope 10 (see fig. 66).

In another form of the invention, the device 5 may be formed without the instrument lumen 195. In this form of the invention, the tensioning tool 400 may be passed down through the working lumen of the endoscope. Alternatively, an endoscope having a smaller diameter than the lumen of the sleeve 15 may be used, such that a space is created between the inner wall of the lumen of the sleeve 15 and the outside of the endoscope. The tensioning tool 400 may then be passed through the space between the sleeve 15 and the endoscope 10 and secured to the lesion 315.

In some cases, it may be desirable to tighten the lesion without creating a sealed treatment area between the two inflated balloons (e.g., without deploying an inflated front balloon and an inflated rear balloon). In this case, it may be possible to use a simplified version of the above-described device 5 with the above-described endoscope 10 and the above-described tensioning tool 400.

By way of example and not limitation, when it is desired to tension a lesion without creating a sealed treatment zone between two inflated balloons, the device 5 may be simplified by eliminating the anterior balloon 35 described above, and the tensioning tool 400 may be used with this simplified form of device 5 to tension the lesion (see fig. 66A). This may be accomplished by pulling the simplified form of the device 5 over the endoscope 10, advancing the combination of the endoscope 10 and the simplified device 5 into the intestine 335 such that the endoscope 10 is just proximal to the lesion 315, inflating the rear balloon 20 to stabilize the endoscope relative to the lesion, advancing the tensioning tool 400 down the instrument lumen 195 (or working lumen of the endoscope 10) to engage and tension the lesion 315, and then using the cutting tool 325 (e.g., advancing through the working lumen of the endoscope 10 or the instrument lumen 195) to peel the lesion 315 from the submucosa 330 of the intestine 335.

By way of further example and not limitation, the device 5 may be further simplified by eliminating the anterior balloon 35 and push tube 30 described above, and then this further simplified form of the device 5 may be used to tighten the lesion (see fig. 66B). More specifically, this may be accomplished by pulling up on the endoscope 10 the further simplified form of the device 5, advancing the combination of the endoscope 10 and the further simplified device 5 into the intestine 335 such that the endoscope 10 is just proximal to the lesion 315, inflating the rear balloon 20 to stabilize the endoscope relative to the lesion, advancing the tensioning tool 400 down the instrument lumen 195 (or working lumen of the endoscope 10) to engage and tension the lesion 315, and then using the cutting tool 325 (e.g., advancing through the working lumen of the endoscope 10 or the instrument lumen 195) to peel the lesion 315 from the submucosa 330 of the intestine 335.

By way of additional example and not limitation, the device 5 may be even further simplified by eliminating the posterior balloon 20 described above and the anterior balloon 35 described above and the push tube 30 described above, and then this even further simplified form of the device 5 may be used to tighten the lesion (see fig. 66C). Thus, in this even further simplified form of the invention, the device 5 essentially comprises the sleeve 15 and the instrument lumen 195. In use, the lesion may be tensioned by pulling up on the endoscope 10 such an even further simplified form of the device 5, advancing the combination of the endoscope 10 and such an even further simplified device 5 into the intestine 335 such that the endoscope 10 is just proximal to the lesion 315, advancing the tensioning tool 400 down the instrument lumen 195 to engage and tension the lesion 315, and then using the cutting tool 325 (e.g., advancing through the working lumen of the endoscope 10) to peel the lesion 315 from the submucosa 330 of the intestine 335.

By way of additional example and not limitation, the device 5 may be even further simplified by eliminating the instrument lumen 195, the rear balloon 20, and the front balloon 35 and push tube 30, and this further simplified form of the device 5 may then be used to tighten the lesion. Thus, in this even further simplified form of the invention, the device 5 essentially comprises a sleeve 15 on the endoscope, wherein the diameter of the endoscope is sized smaller than the diameter of the lumen of the sleeve, such that a space is created between the inner wall of the lumen of the sleeve 15 and the outside of the endoscope. In use, the lesion may be tensioned by pulling up on the endoscope 10 such a further simplified form of the device 5, advancing the endoscope 10 and such a further simplified device 5 combination into the intestine 335 such that the endoscope 10 is just proximal to the lesion 315, advancing the tensioning tool 400 between the sleeve and the endoscope to engage and tension the lesion 315, and then, using the cutting tool 325 (e.g., advancing through the working lumen of the endoscope 10 or through the space between the sleeve and the endoscope) to peel the lesion 315 from the submucosa 330 of the intestine 335.

Tensioning lesions by connecting the lesions to a pair of push tubes and moving the push tubes

By way of further example and not limitation, and looking now at fig. 67, a further embodiment of the device 5 is shown wherein the anterior balloon 35 has been eliminated. In this embodiment, the distal ends of the push tubes 30 of the sleeve 15 may be connected to each other by a bridge 31, and the connector 305 may be attached to the bridge 31 and to the lesion 315 using a clip 320. Preferably, the connector 305 is a strand of suture. It should be appreciated that a strand of suture forming the connector 305 may be attached to the bridge 31 before the device 5 is inserted into the patient's body, or the strand of suture may be attached to the bridge 31 after the device 5 has been inserted into the patient's body. Alternatively, the bridge 31 may be manufactured with a connector 305 (e.g., a strand of suture) pre-attached to the bridge 31.

The bridge 31 may be inclined distally, for example in the manner shown in fig. 68. Alternatively, if desired, the bridge 31 may be arranged substantially perpendicular to the longitudinal axis of the push tube 30, for example in the manner shown in fig. 69. Furthermore, if desired, the bridge 31 may be in the form of a loop, for example in the manner shown in fig. 70. The bridge 31 may also be in the form of any other shape or configuration capable of nesting an endoscope therein and/or connecting to the connector 305. If desired, the bridge 31 may be formed with a recess or indent (not shown) in the bridge for seating the connector 305 to minimize sliding of the connector 305 along the bridge 31 during tensioning of the lesion 315.

In use, this simplified form of device 5 is pulled over endoscope 10, advancing the combination of endoscope 10 and simplified device 5 into intestine 335 such that endoscope 10 is just proximal to lesion 315, inflating rear balloon 20 to stabilize the endoscope relative to the lesion, connector 305 is attached to bridge 31 of push tube 30 by clip 320 and connected to lesion 315, and push tube 30 is moved distally to tighten lesion 315 away from endoscope 10. The lesion 315 is then peeled from the submucosa 330 of the intestine 335 using the cutting tool 325 that has been advanced through the working lumen (or instrument lumen 195) of the endoscope 10.

Alternatively, if desired, only one push rod 30 may be provided, and a connector 305 (e.g., a strand of suture) may be secured to the one push rod 30.

By way of further example and not limitation, the device 5 may be simplified even further by eliminating the anterior balloon 20 described above and the posterior balloon 35 described above, and then this further simplified form of the device 5 may be used to tighten the lesion. Thus, in this even further simplified form of the invention, the device 5 essentially comprises the sleeve 15, the instrument lumen 195 and the push tube 30 (see fig. 71). In use, the lesion may be tensioned by pulling up on the endoscope 10 such a further simplified form of the device 5, advancing the combination of the endoscope 10 and such a further simplified device 5 into the intestine 335 such that the endoscope 10 is just proximal to the lesion 315, connecting the connector 305 from the bridge 31 of the push tube 30 to the lesion 315, and moving the push tube 30 to tension the lesion 315, and then peeling the lesion 31 from the submucosa 330 of the intestine 335 using the cutting tool 325 (e.g., advancing through the working lumen or instrument lumen 195 of the endoscope 10).

By way of additional example and not limitation, the device 5 may be even further simplified by eliminating the instrument lumen 195 described above, the rear balloon 20 described above, and the front balloon 35 described above, and then this even further simplified form of the device 5 may be used to tighten the lesion. Thus, in this even further simplified form of the invention, the device 5 essentially comprises a sleeve 15 and a push tube 30 on the endoscope. In use, the lesion may be tensioned by pulling up this further simplified form of device 5 over endoscope 10, advancing the combination of endoscope 10 and this even further simplified device 5 into intestine 335 such that endoscope 10 is just proximal to lesion 315, connecting connector 305 from bridge 31 of push tube 30 to lesion 315, and moving push tube 30 to tension lesion 315, and then peeling lesion 315 from submucosa 330 of intestine 335 using cutting tool 325 (e.g., advanced through the working lumen of endoscope 10).

When sleeve 15 is formed without instrument lumen 195, the tool may be passed down through one or more working lumens of the endoscope. Alternatively, an endoscope having a diameter smaller than the diameter of the lumen of the sleeve 15 may be used, and one or more tools may be passed through the space between the sleeve 15 and the endoscope 10.

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 initially hidden or outside the field of view) for examination and/or treatment during endoscopic surgery, for example to straighten bends, "iron" the 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 initially hidden 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, dilate and/or flatten bends and/or folds in the side wall of the intestine 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 endoscopic surgery.

The present invention also includes providing and using the novel apparatus that is capable of stabilizing and/or stabilizing the distal tip and/or working end of instruments (e.g., endoscopes, articulating and/or non-articulating devices such as graspers, cutters or strippers, cautery tools, ultrasound probes, etc.) inserted into the body lumen and/or cavity during an endoscopic procedure relative to the side walls of the body lumen and/or cavity, thereby facilitating precise use of those 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 stabilized relative to one another) for performing a variety of minimally invasive procedures within a body lumen and/or body cavity, including stabilizing an endoscope and/or other surgical instruments (e.g., graspers, cutters or dissectors, cautery tools, ultrasound probes, 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) for more accurate visualization, intervention, and/or surgery.

Notably, the present invention provides 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, ultrasound probes, etc.) inserted through the working channel of those endoscopes) relative to the side wall of the body lumen and/or body cavity, and stabilizing the side wall of the body lumen and/or body cavity relative to those instruments.

And the present invention provides novel devices that are 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 a surgical site by means other than the working channel of an endoscope.

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

The present invention is believed to have the most widespread application in the Gastrointestinal (GI) tract (e.g., large and small intestine, esophagus, stomach, etc.), which is generally characterized by frequent turns and has side walls characterized by a large number of folds and disease processes located on and between these folds. However, the methods and devices of the present invention may also be used within other body lumens (e.g., blood vessels, lymphatic vessels, urinary tracts, fallopian tubes, bronchi, bile ducts, etc.) and/or within other body lumens (e.g., lumens in 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 appreciate and recognize that it is not so limited and that many additions, deletions and modifications may be made to the above-described preferred embodiments while remaining within the scope of the invention.

Claims

1. An apparatus for endoscopically retracting tissue, the apparatus comprising:

A sleeve adapted to slide over an exterior of an endoscope;

A balloon movably mounted to the sleeve, and

A first connector extending from the balloon, wherein the first connector comprises a loop of suture, and

A second connector extending from the first connector and configured to be secured to tissue to be retracted, wherein the second connector comprises a surgical clip;

Wherein the balloon is configured to move relative to the sleeve so as to retract the tissue.

2. The apparatus of claim 1, wherein the balloon comprises an inflated portion and a non-inflated portion, wherein the first connector is connected to the non-inflated portion.

3. The apparatus of claim 2, wherein the first connector is connected to the non-inflated portion of the balloon with a clip.

4. The apparatus of claim 2, wherein the first connector is connected to the non-inflated portion of the balloon by passing a loop of the suture through a hole in the non-inflated portion of the balloon.

5. The apparatus of claim 1, wherein the first connector comprises a single strand suture.

6. The apparatus of claim 1, wherein the first connector comprises a loop and the second connector extends from the first connector by looping the second connector through the loop of the first connector.

7. The apparatus of claim 1, wherein the balloon is movably mounted to the sleeve by at least one push tube.

8. The apparatus of claim 7, wherein the at least one push tube is slidably mounted to the sleeve.

9. The apparatus of claim 1, further comprising a third connector extending from the balloon, wherein the third connector comprises a loop of suture.

10. An apparatus for endoscopically retracting tissue, the apparatus comprising:

A sleeve adapted to slide over an exterior of the endoscope, the sleeve having a lumen, and

wherein the diameter of the endoscope is smaller than the diameter of the lumen such that there is a space between the sleeve and the endoscope, and wherein the tensioning tool passes through the space for retracting tissue;

Wherein the tensioning tool is configured to engage and grip a connector that is secured to tissue to be retracted via a clip, or the connector is connected to a rigid loop, wherein the rigid loop is secured to tissue to be retracted via a clip;

Wherein the connector comprises a loop of suture.

11. An apparatus for endoscopically retracting tissue, the apparatus comprising:

A sleeve adapted to slide over an exterior of an endoscope, the sleeve having a lumen, a distal end, and a proximal end;

a balloon secured to the sleeve near the distal end of the sleeve;

a pair of push tubes slidably mounted to the sleeve, the pair of push tubes being connected to each other at their distal ends with a bridge;

a first connector extending from the bridge, wherein the first connector comprises a loop of suture, and a second connector extending from the first connector and configured to be secured to tissue to be retracted, wherein the second connector comprises a clip;

wherein the pair of push tubes are configured to move relative to the sleeve to retract the tissue.

12. The apparatus of claim 11, wherein the first connector is attached to the bridge with a clip.

13. The apparatus of claim 11, wherein the bridge is in the form of a loop.