CN113038862A

CN113038862A - Methods and apparatus for manipulating a sidewall of a body lumen or cavity to provide increased visualization of and/or access to the body lumen or cavity and/or for stabilizing an instrument relative to the body lumen or cavity

Info

Publication number: CN113038862A
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: 2021-06-25
Also published as: EP3823513A4; JP2021530306A; CA3106405A1; WO2020018566A1; EP3823513A1

Abstract

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 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 so as to retract the tissue.

Description

Methods and apparatus for manipulating a sidewall of a body lumen or cavity to provide increased visualization of and/or access to the body lumen or cavity and/or for stabilizing an instrument relative to the body lumen or cavity

Reference to pending patent application

The patent application:

(1) is filed on 12.7.2019 by Connell university AND Jeffrey Milsom et al, entitled "METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASED VIUALIZATION OF THE SAME AND/OR INCREASED ACCESS TO SAME, THE pending U.S. patent application serial No. 16/477,789, part of AND/OR FOR standing in INSTRUMENTS related TO SAME (Attorney's pocket number core-43 PCT US) (method AND apparatus FOR manipulating THE side walls of a body lumen OR cavity TO provide increased visualization of AND/OR increased access TO AND/OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE body lumen OR cavity (Attorney's litigation incident sheets No. corr-43 PCT US)) ", filed FOR:

(i) international patent application No. PCT/US 18/13894 filed on 2018, 16.1.7, by Connell university AND Jeffrey Milsom et al, entitled "METHOD AND APPARUS FOR MANIPULATING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVISION INCREASED VILIZATION OF THE SAME AND/OR INCREASED ACCESS TO THE SAME, AND/OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME (Attorey's Docket number CORN-43 PCT) (a national phase OF entry application PCT/US 18/13894 FOR MANIPULATING THE side walls OF a BODY LUMEN OR CAVITY TO PROVIDE INCREASED VISUALIZATION OF AND/OR access TO a BODY LUMEN OR CAVITY AND/OR METHODs AND APPARATUS FOR STABILIZING an instrument RELATIVE TO a BODY LUMEN OR CAVITY (litigation event Listing FOR Attorney), this patent application further claims the benefit of the following patent applications:

(a) the nomenclature "BALLOON TISSUE USING VARIABLE LENGTH capable cuffs and clips and sample RETRIEVAL pockets IN BALLOONs (Attorney's litigation event table number CORN-43 adv))" united states provisional patent application serial No. 62/446,167 filed 2017 on 13.1.2017, entitled "BALLOON TISSUE retransmission USING HOOP AND CLIP WITH variant LENGTH cap, WITH specialty polymer pocket IN BALLOON" (Attorney's litigation event table number CORN-43 adv); and

(b) U.S. provisional patent application serial No. 62/462,241, entitled "BALLOON SPECIMEN RETRIEVAL (Attorney's pocket number corr-41 PROV) (litigation event table number CORN-41 PROV of Attorney))" filed on 22.2.2017 at cornel university and Jeffrey Milsom et al; and

(ii) is part OF THE United states patent application Serial No. 16/000,104 entitled "METHOD AND APPLICATION FOR MANIPULATED THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVISION INFOREDIATED VISUALIZATION OF THE SAME AND/OR INCREASED ACCESS TO THE SAME, AND/OR FOR STABILIZING INSTRUMENT RELATIVE TO THE SAME" (Attorey's Docket number CORN-34 CON) filed by Conn university AND John Frederick Comilier, Inc. on 6/5.2018, also part OF THE United states patent application Serial No. 16/000,104 entitled "METHOD AND APPLICATION FOR THE CONNECTOR AND/OR FOR STABILIZING INSTRUMENT 2015 TO THE CON) (also filed by John Fridarian AND John, et al, on THE JUN, 2 on Comider, Japan, 11) A continuation OF U.S. patent application Ser. No. 14/619,845 OF FOR MANIPULATING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASED VISUALIZATION OF THE SAME AND/OR INCREASED ACCESS TO THE SAME, AND/OR FOR STABILIZING INSTRUMENTS RELATED TO THE SAME (Attorey's Docket number CORN-34) (a method AND apparatus FOR MANIPULATING THE side walls OF a BODY LUMEN OR CAVITY TO PROVIDE INCREASED VISUALIZATION OF AND/OR INCREASED access TO THE BODY LUMEN OR CAVITY AND/OR FOR STABILIZING an instrument RELATIVE TO THE BODY LUMEN OR CAVITY (Attorney's litigation incident List CORN-34)) ", which also applies TO a continuation OF U.S. patent application Ser. No. 14/619,845:

(a) part OF THE application serial number 84 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 PROVISION INCREASED VISION OF THE SAME AND/OR INCREASED ACCESS TO THE SAME, AND/OR FOR STABIZING INSTRUMENT RELATIVE TO THE SAME filed at 11/13.2014 by CONNER university AND Jeffrey Milsom et al (patent application serial number 14/540,355 FOR STABILIZING, STRAIGHTENING, EXPANDING AND/OR flattening THE sidewalls OF BODY LUMENs AND/OR BODY LUMENs TO PROVIDE INCREASED VISUALIZATION AND/OR INCREASED access TO BODY LUMENs OR BODY LUMENs AND/OR FOR STABILIZING INSTRUMENTS RELATIVE TO BODY LUMENs OR LUMENs), this application is also a METHOD AND APPARATUS FOR STABILIZING AND/OR increasing access TO AND/OR continuing VISUALIZATION OF BODY LUMENs AND/OR BODY LUMENs TO THE SAME (Attorney's Docket event number) filed by Jeffrey Milsom et al on 12, 15.2010 under THE names "METHOD AND APPARATUS FOR STABILIZING, STRAIGHTENING, EXPANDING AND/OR FLATTENING THE SIDE WALL OF A BODY LUMEN AND/OR BODY CAVITY SO AS TO PROVISION INCREASED VISION OF THE SAME AND/OR INCREASED ACCESS TO THE SAME, AND/OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME (Attney's Docket number CORN-17) (FOR STABILIZING, STRAIGHTENING, EXPANDING AND/OR flattening THE sidewalls OF BODY LUMENs AND/OR bodies TO PROVIDE INCREASED access TO AND/OR continued VISUALIZATION OF BODY LUMENs AND/OR bodies RELATIVE TO BODY LUMENs OR bodies), the patent application claims Jeffrey Milsom et al filed 12, 15 of 2009 under the name "METHOD AND APPARATUS FOR standarizing, STRAIGHTENING, EXPANDING AND/OR FLATTENING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASED VIUALIZATION OF THE SIDE WALL OF THE BODY LUMEN OR BODY CAVITY, AND/OR FOR stable interior instrumentation related TO THE SAME (Attorney's pocket number core-17 pro) (methods AND apparatus FOR STABILIZING, straightening, expanding AND/OR flattening THE sidewalls of a body lumen AND/OR body cavity TO provide increased visualization of AND/OR increased access TO THE body lumen OR body cavity AND/OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE body lumen OR body cavity (Attorney's litigation event table number core-17 pro)) "; and

(b) U.S. provisional patent application serial No. 61/938,446 entitled "METHOD AND APPARATUS FOR managing AND using G THE SIDE WALL OF a BODY CAVITY OR BODY CAVITY AS TO PROVIDE improved visibility OF THE SAME AND/OR INCREASED ACCESS TO SAME, AND/OR FOR building interior RELATIVE TO SAME, filed at 11.2.2014 at 2014 at university OF cornell AND John Frederick Comhill et al (Attorney's litique Docket number OF Attorney-34) FOR manipulating THE side walls OF BODY LUMENs OR cavities TO PROVIDE INCREASED VISUALIZATION OF AND/OR 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 managing THE SIDE WALL OF BODY LUMEN OR BODY CAVITY AS TO METHOD information obtained viscosity OF THE SAME AND/OR INCREASED ACCESS TO SAME, AND/OR FOR standing APPARATUS related TO SAME (Attorey's number lumenundi-20 adv) filed on 2018, 7, 16, by lumenda, Inc. AND Peter Johann et al, AND entitled" METHOD AND APPARATUS FOR managing management OF multiple functions OF multiple.

The above-mentioned eleven (11) patent applications are incorporated herein by reference.

Technical Field

The present invention relates generally to surgical methods and devices, and more particularly to surgical methods and devices for manipulating a sidewall of a body lumen and/or body cavity in order to provide increased visualization of and/or 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 tract, fallopian tubes, bronchi, bile ducts, and the like. By way of further example, and not limitation, the human body includes a body cavity, such as a head, chest, abdomen, sinus, bladder, cavity within an organ, and the like.

In many instances, it may be desirable to endoscopically and/or treat a disease process or abnormality located within and/or on the side walls of a body lumen. By way of example and not limitation, it may be desirable to inspect the side walls of the gastrointestinal tract for lesions, and if a lesion is found, to biopsy, resect, and/or otherwise treat the lesion.

Endoscopy and/or treatment of the side walls of body lumens and/or body cavities can be complicated by the anatomical configuration (regional and local) of the side walls of the body lumens and/or cavities and/or by the consistency of the tissue making up the side walls of the body lumens and/or cavities and/or by tethering the side walls of the body lumens and/or cavities to other anatomical structures.

By way of example and not limitation, the intestine is an elongated tubular organ with an inner lumen, and is characterized by frequent turns (i.e., regional anatomical configuration of the intestine) and a sidewall characterized by a large number of folds (i.e., local anatomical configuration of the intestine), wherein the sidewall tissue has a relatively soft, pliable consistency, and wherein, in particular, the colon is tethered to the abdomen and/or other abdominal structures via soft tissue. Due to this different sidewall anatomy (both regional and local), its relatively soft, flexible consistency, and its tethering to other anatomical structures via soft tissue, it may be difficult to fully visualize the sidewall of the bowel and/or treat lesions formed on the sidewall of the bowel. 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 anatomical configurations (regional and/or local) and/or tissue consistency of the sidewall and/or the colon tethered to other anatomical structures, which makes it difficult to fully visualize the anatomy (including pathological conditions of the anatomy, such as polyps or tumors) using a conventional endoscope and/or fully access the anatomy using instruments introduced through a conventional endoscope.

In addition to the above, it has also been found that some body lumens and/or cavities may spontaneously spasm and/or contract, but particularly when an endoscope or other instrument is inserted into the body lumen and/or cavity. Such spasm and/or contraction can cause the body lumen and/or body cavity to contract and/or otherwise move and/or change its configuration, which can further complicate and/or impair endoscopic visualization of the anatomy, and/or further complicate and/or impair entry into the anatomy using instruments introduced through conventional flexible endoscopes. In addition, during a colonoscopy (which is typically performed when inserting and withdrawing the endoscope through the colon), the endoscope may pinch and/or otherwise gather the colon during insertion and withdrawal, and then abruptly slide and release the colon. This results in rapid movement of the endoscope through a substantial length of the colon, making accurate inspection of the colon challenging.

It would therefore be highly advantageous to provide novel devices that are capable of manipulating the side walls of body lumens and/or cavities in order to better present the side wall tissue (including visualization of regions that are initially hidden or outside the field of view) for examination and/or treatment during endoscopic surgery.

It would also be highly advantageous to provide novel apparatus capable of stabilizing and/or stabilizing the distal tip and/or working end of instruments (e.g., endoscopes, articulated and/or non-articulated devices such as graspers, cutters or dissectors, cauterizing tools, ultrasound probes, etc.) inserted into body lumens and/or cavities relative to the sidewalls of those cavities, thereby facilitating the delicate use of those instruments.

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

Moreover, it would also be highly advantageous to provide novel apparatus that can stabilize and/or stabilize the distal tip and/or working end of instruments (such as graspers, cutters or dissectors, cauterizing tools, ultrasound probes, etc.) advanced to a surgical site by means other than through the working channel of an endoscope.

It would also be highly advantageous to be able to straighten bends, "flatten" luminal 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 that are initially hidden or out of view) and/or therapeutic intervention.

Disclosure of Invention

The present invention includes the provision and use of a novel device for manipulating the sidewall of a body lumen and/or body cavity to better present the sidewall tissue (including visualization of the region that is initially hidden or out of view) for examination and/or treatment during endoscopic surgery.

The present invention further includes the provision and use of a 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 dissectors, cauterizing tools, ultrasound probes, etc.) inserted into body lumens and/or cavities relative to the sidewalls of those cavities, thereby facilitating the delicate use of those instruments.

In addition, 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 endoscopes (and, thus, the distal tip and/or working end of other instruments inserted through the working channel of those endoscopes (such as graspers, cutters or dissectors, cauterization tools, ultrasound probes, etc.)).

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

Moreover, the present invention includes the provision and use of a novel apparatus capable of straightening bends, "ironing" lumen surface folds, and creating substantially static and stable sidewalls of body lumens and/or body cavities that enable more accurate visual inspection (including visualization of regions that are initially hidden or outside 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 configured to assume a deflated state and an inflated state, and further wherein when the distal balloon is in its deflated state, an axial opening extends therethrough, the axial opening being sized to receive an endoscope therein, and when the distal balloon is in its inflated state, the axial opening is closed.

In another preferred form of the invention, there is provided a method of performing a procedure in a body lumen and/or 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 the distal end of the push tube, an interior of the distal balloon being in fluid communication with the push tube, wherein the distal balloon is configured to assume a deflated state and an inflated state, and further wherein when the distal balloon is in its deflated state, an axial opening passes therethrough, the axial opening being sized to receive an endoscope therein, and when the distal balloon is in its inflated state, the axial opening is closed;

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

the operation is performed.

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

a sleeve adapted to slide over the exterior of an endoscope, the sleeve including a passage 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 the passageway of the 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 the passageway of the 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;

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

the operation is performed.

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

a proximal balloon secured to 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

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

the operation 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 the distal ends of the pair of push tubes, the 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 the distal ends of the pair of push tubes, the 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

the operation is performed.

In another preferred form of the 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 tissue is urged away from the endoscope using the connector.

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

a balloon configured to be movably mounted to an endoscope; and

an eyelet formed on 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 tissue is urged away from the endoscope using the connector.

securing 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 extraction, the apparatus comprising:

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

a flap mounted in an axial opening of the balloon to form, with a surrounding portion of the balloon, a pocket for receiving anatomical tissue.

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

positioning a distal end of a balloon assembly distal to a tissue to be removed, the balloon assembly being movably mounted to an endoscope, and the balloon assembly including (i) a balloon capable of assuming a deflated state and an inflated state, wherein an 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 flap mounted in the axial opening of the balloon so as to form with a surrounding portion of the balloon a pocket for receiving the tissue to be removed;

positioning tissue to be removed into the pocket; and

the balloon assembly is proximally withdrawn to extract the 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 one 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 so as to retract tissue.

providing a device for endoscopically retracting tissue, the device 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 the tissue to be retracted; and

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

In another preferred form of the invention, there is provided a device for endoscopically retracting tissue, the device 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.

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

providing a device for endoscopically retracting tissue, the device 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;

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 distal ends thereof 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 in order to retract tissue.

providing a device for endoscopically retracting tissue, the device comprising:

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 distal ends thereof with a bridge; and

securing at least a connector to the pair of push tubes and tissue to be retracted; and

retracting the tissue away from the endoscope by moving the pair of push tubes relative to the endoscope.

Drawings

These and other objects and features of the present invention will be more fully disclosed in, or rendered obvious by, the following detailed description of the preferred embodiments of the invention, which is to be considered together with the accompanying drawings, in which like numerals refer to like parts, and further in which:

FIG. 1 is a schematic diagram showing a novel apparatus formed in accordance with the present invention, wherein the novel apparatus includes, among other things, a sleeve disposed over 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 views showing further details of the anterior balloon;

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

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

FIG. 11 is a schematic view showing one form of inflation mechanism provided in accordance with the present invention;

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

FIGS. 12 and 13 are schematic views illustrating 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 view showing a retraction system that may be used to take up slack in the flexible tube of the device shown in FIG. 1;

figures 16 to 30 are schematic views showing a preferred way of using the apparatus of figure 1;

FIG. 30A is a schematic view showing an alternative configuration of a 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;

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

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

figures 37-42 are schematic views illustrating endoscopic tissue retraction systems formed in accordance with the present invention;

figures 43-45 are schematic diagrams illustrating another endoscopic tissue retraction system formed in accordance with the present invention;

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

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

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

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

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

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

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

figures 53-60 are schematic diagrams illustrating an endoscopic tissue retrieval system formed in accordance with the present invention;

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

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

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

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

figures 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 procedure" is intended to refer to any minimally invasive or limited access surgery, diagnostic and/or therapeutic and/or surgical procedure for accessing a body lumen and/or interior of a body cavity, either endoluminally or transluminally or otherwise, to view, biopsy and/or treat tissue (including removing lesions and/or excising tissue, etc.).

The present invention further includes the provision and use of a 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 dissectors, cauterizing tools, ultrasound probes, etc.) inserted into body lumens and/or cavities relative to the sidewalls of those body lumens and/or cavities, thereby facilitating the delicate use of those instruments.

In addition, 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 endoscopes (and, thus, also the distal tip and/or working end of other instruments (such as graspers, cutters or dissectors, cauterizing tools, ultrasonic probes, etc.) that are 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 sidewalls of body lumens and/or cavities that enable more accurate visual inspection (including visualization of areas that are initially hidden or out of view) and/or therapeutic intervention.

Novel device

In accordance with the present invention, and looking now at FIG. 1, there is shown a novel apparatus 5 that is capable of manipulating (e.g., stabilizing, straightening, dilating and/or flattening) the side walls of a body lumen and/or body cavity so as to better present the side wall tissue (including visualization of the area that is initially hidden or outside the field of view) for examination and/or treatment during endoscopic surgery using an endoscope 10 (e.g., an articulated endoscope), and/or for stabilizing the distal tip and/or working end of the endoscope 10 and/or of other instruments (e.g., graspers, cutters or dissectors, cauterization tools, ultrasound probes, etc., not shown in FIG. 1).

More specifically, device 5 generally comprises a sleeve 15 adapted to slide over the exterior of the shaft of endoscope 10, a proximal (or "rear") balloon 20 (the terms "proximal" and "rear" will be used interchangeably hereinafter) fixed to sleeve 15 near the distal end of the sleeve, and a base 25 fixed to sleeve 15 at the proximal end of the sleeve. The apparatus 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 fixed 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 a push tube handle 37, see below). See fig. 1 and 2-4. The apparatus 5 also 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 posterior balloon 20 and the anterior 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 make a tight fit therewith, wherein the sleeve is sized and configured so that it will easily slide back over the endoscope during installation thereon (preferably in the case of an endoscope "dry") but will have sufficient residual friction with the endoscope exterior surface (when grasped by the hand of a physician or other operator or user) so that the sleeve will remain in place to allow twisting (i.e., rotational turning) and pushing/pulling of the endoscope (e.g., within the colon of a patient) during use. In a preferred form of the invention, sleeve 15 is somewhat circumferentially movable about endoscope 10 (and rotatable with the shaft of the endoscope when firmly grasped by the hand of the physician or other operator or user); but sleeve 15 can only nominally move in an axial direction relative to endoscope 10. Sleeve 15 is sized such that when its distal end is substantially aligned with the distal end of endoscope 10, sleeve 15 (along with mount 25) will substantially cover the shaft of the endoscope. In any event, sleeve 15 is sized such that when it is mounted to endoscope 10 and endoscope 10 is inserted into a patient, sleeve 15 extends out of the patient's body. In one preferred form of the invention, the device 5 is provided in accordance with the particular endoscope with which it is intended to be used, wherein the device 5 is sized such that when the foot 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 proximal to, the distal end of the endoscope.

If desired, the distal end of sleeve 15 may be provided with a radially inwardly extending stop (not shown) to forcibly engage the distal surface of endoscope 10, thereby preventing the distal end of sleeve 15 from moving proximally beyond the distal surface of endoscope 10. Such radially inwardly extending detents 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.

Sleeve 15 preferably has a smooth outer surface so as to be non-traumatic to tissue, and is preferably made of a highly flexible material so that the sleeve does not inhibit bending of the endoscope during use. In a preferred form of the invention, sleeve 15 comprises polyurethane, polyethylene, polyvinyl chloride (PVC), Polytetrafluoroethylene (PTFE), or the like, and is preferably transparent (or at least translucent) so as to allow distance markings on endoscope 10 to be visualized through sleeve 15. Also, in a preferred form of the invention, sleeve 15 preferably has a nominal hoop strength such that a physician (or other operator or user) can grasp endoscope 10 through sleeve 15, for example, to twist the endoscope. If desired, the sleeve 15 may include a lubricious coating (e.g., a liquid such as a perfluoropolyether synthetic oil, a powder, etc.) on some or all of its interior and/or exterior surfaces to facilitate placement of the sleeve over the 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 at a point intermediate the sleeve 15. By way of further example but not limitation, it should also be appreciated that removal of sleeve 15 from endoscope 10 (e.g., at the end of a procedure) may be facilitated by introducing a fluid (e.g., air or a liquid lubricant) into the space between sleeve 15 and endoscope 10 (e.g., at the proximal end of sleeve 15 (i.e., at base 25) or at intermediate sleeve 15).

Referring still now to fig. 1-6, a rear balloon 20 is secured to sleeve 15 just proximal to the articulation joint at which the endoscope is proximal to but spaced from the distal end of the sleeve. The rear balloon 20 is concentrically disposed about the sleeve 15 and, therefore, about the endoscope 10 disposed within the sleeve 15. Thus, the rear balloon 20 has a generally annular shape. The rear balloon 20 can be selectively inflated/deflated by means of a proximal inflation/deflation line 45, the proximal inflation/deflation line 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 be connected 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. Inflation/deflation line 45 may be secured to an outer surface of sleeve 15, or more preferably, inflation/deflation line 45 may be contained within a lumen 47 formed within sleeve 15.

Preferably, the rear balloon 20 is disposed a short distance back 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, so 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 posterior balloon 20 has been inflated in the anatomical configuration to stabilize the adjacent non-articulated portion of the endoscope relative to the anatomical configuration, as will be discussed in further detail below. Thus, when inflated, the rear balloon 20 provides a safe platform for maintaining the endoscope 10 in a stable position within a body lumen or cavity in which the endoscope 10 is centered. As a result, the endoscope 10 may provide improved visualization of the anatomy. In addition, because the endoscope 10 is safely retained within a body lumen or cavity by the inflated rear balloon 20, instruments advanced through the internal lumen (sometimes referred to as the "working channel" or "working channels") of the endoscope 10 will also be provided with a safety platform for supporting those instruments within the body lumen or cavity.

When the posterior balloon 20 is properly inflated, it may non-invasively engage and form a sealing relationship with the sidewall 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 barrel 15. Mount 25 engages endoscope 10 and helps secure the entire assembly (i.e., device 5) to endoscope 10. The mount 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 the sleeve 15 over the distal end of the endoscope 10 and then back proximally 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, base 25 is pulled proximally along the endoscope until base 25 seats against the handle of the endoscope, thereby inhibiting further proximal movement of base 25 (and thus sleeve 15). In a preferred form of the invention, the base 25 is brought into sealing engagement with the endoscope 10.

The push tube 30 is slidably mounted to the sleeve 15, whereby a 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 a 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 an 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") in order to minimize resistance to movement of the push tube 30 relative to the support tube 50 (and, thus, to movement of the push tube 30 relative to the sleeve 15). In this regard, it should be appreciated that when the push tube 30 is used to manipulate the anterior balloon 35, resistance to movement of the push tube 30 relative to the support tube 50 is minimized, improving the tactile feedback to the user. In one form of the invention, support tube 50 is flexible (so as to allow endoscope 10, and in particular the articulating portion of steerable endoscope 10, to flex as desired during a procedure); however, the support tube 50 also provides some column strength. Thus, when the support tube 50 is installed within the lumen 52 formed in the sleeve 15, the assembly of the sleeve 15 and the support tube 50 is flexible but has a degree of column strength (while the sleeve 15 itself is flexible but has substantially no column strength). In the case where the push tube 30 is contained within the 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 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, pushing distally on the push tube handle 37 causes the distal end of the push tube 30 to move distally (at the same speed) relative to the sleeve 15 (thereby moving the forward balloon 35 distally relative to the rearward balloon 20), and pushing proximally on the push tube handle 37 causes the distal end of the push tube 30 to retract proximally (at the same speed) relative to the sleeve 15 (thereby moving the forward balloon 35 proximally relative to the rearward balloon 20). It is noted that by moving the push tubes 30 distally or proximally at the same speed, the distal ends of the push tubes are maintained parallel to each other. A clamp 53 (fig. 12 and 15) is provided at the base 25 for maintaining the push tube 30 in a selected arrangement relative to the base 25 (and thus the sleeve 15).

The push tube 30 is preferably formed of a relatively flexible material that provides good fracture strength, such as a polyethylene resin (such as Isoplast)^TMAvailable from lubri corporation of vickliff, 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 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 resiliently 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 inflating/deflating the anterior balloon 35. By forming the remainder of the distal end of the push tubeWith the more flexible push tube 30, the push tube 30 and the forward balloon 35 may together act as a guide wire (with a soft atraumatic tip) for the device 5 and endoscope 10, as discussed further below.

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

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

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

It should also be appreciated that, if desired, the push tube 30 may be marked with an indicator, such as a colored indicator or a radiopaque indicator, that includes a distance marker (not shown in the figures), such that the relative placement of the push tube 30 with respect to the sidewall of the body lumen and/or other body cavity, both longitudinally and/or circumferentially of the surgical site, may be determined via the endoscope 10 or by a physician (or other operator or user) viewing the surgical site through radiological guidance (e.g., X-ray fluoroscopy).

As will be discussed in further detail below, the push tube 30 is hollow and its distal end is in fluid communication with the interior of the forward balloon 35 (fig. 1-5, 7 and 8), and its interior lumen is in fluid communication with a fitting 56 mounted to the base 25. The fitting 56 is configured for connection to the associated inflation mechanism 40 described above so that the forward balloon 35 can be selectively inflated/deflated with air or other fluids (including liquids). The fitting 56 is preferably a luer activated valve that allows the inflation mechanism 40 to be disconnected from the fitting 56 without losing pressure in the forward balloon 35.

More specifically, in one preferred form of the invention, and looking now at FIG. 8A, the 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. The push tube handle 37 also includes a fitting 58 in fluid communication with the hollow interior 57 of the push tube handle 37. A flexible tube 59 connects the fitting 58 with an internal chamber (not shown) in the base 25, wherein such internal chamber in the base 25 is in fluid communication with the fitting 56 described above. With this configuration, the forward balloon 35 moves distally when the push tube handle 37 is moved distally, and the forward balloon 35 moves proximally when the push tube handle 37 is moved proximally. Further, when a positive fluid pressure is applied to fitting 56 in base 25, a positive fluid pressure is applied to the interior of forward balloon 35, thereby inflating forward balloon 35, and when a negative fluid pressure is applied to fitting 56 in base 25, a negative fluid pressure is applied to the interior of forward balloon 35, thereby deflating forward balloon 35.

It will be appreciated that the provision of a double push tube provides a number of advantages. By way of example and not limitation, the arrangement of the dual pusher rod provides a symmetrical force to the anterior balloon 35 as the anterior balloon is advanced distally into the body lumen, as will be discussed below. In addition, when the push tubes are used to straighten anatomical structures in the region proximate the distal end of the endoscope 10, the arrangement of the double push tubes 30 provides equal outward force to adjacent anatomical structures, thereby enhancing visibility and/or access to the anatomical structures, as will be discussed below. In addition, the provision of a double 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 on the endoscope 10, as will be discussed below. In addition, the provision of the double pusher 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 when inflated. In addition, 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 secured to the distal end of the push tube 30, whereby the spacing between the rear 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). Further, the hollow push tube 30 provides a conduit between the interior of the forward balloon 35 and the fitting 56, thereby allowing selective inflation/deflation of the forward 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 accommodate the sleeve 15 and the 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 is properly inflated (fig. 4), the axial opening 63 is closed (and preferably completely closed). Also, when properly inflated, the anterior balloon may be non-invasively engaged with and in sealing relation to the side wall of the body lumen in which such device 5 is disposed. Thus, when the forward balloon 35 is properly inflated, the forward balloon can effectively seal the body lumen and/or body cavity distal of the forward balloon 35 by closing the axial opening 63 and forming a sealing relationship with the sidewall of the body lumen and/or body cavity in which the device 5 is disposed. In this manner, 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 sealed region (sometimes referred to below as a "treatment region") therebetween.

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

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

To this end, and looking now at fig. 9 and 10, the anterior balloon 35 is preferably manufactured as a single construction including a main body 67 having a proximal opening 69 and a proximal opening 71, a proximal extension 73 having a "key-shaped" cross-section including a protrusion 74, and a distal extension 76 having a circular cross-section. It is noted that the projections 74 are provided on the proximal extension 73 with a configuration that matches the configuration of the push tube 30 (i.e., where the device 5 includes two push tubes 30 diametrically opposed to each other, the proximal extension 73 will include two projections 74 diametrically opposed to each other; where the device 5 includes three push tubes 30 equally circumferentially spaced about the circumference of the sleeve 15, the proximal extension 73 will include three projections 74 equally circumferentially spaced about the circumference of the proximal extension 73; where the device 5 includes one push tube 30, the proximal extension 73 will include one projection 74; etc. -for purposes of this disclosure, the proximal extension 73 and projection(s) 74 may be collectively referred to as having a "key-shaped" cross-section). During assembly, the push tube 30 is seated in the protuberance 74 of the proximal extension 73, the proximal extension 73 is everted into the interior of the main body 67 (wherein the interior of the hollow push tube 30 is in fluid communication with the interior of the main body 67), and then the distal extension 76 is everted into the interior of the proximal extension 73, thereby providing the forward balloon 35 having the axial opening 63 extending therethrough, wherein the push tube 30 is secured to the forward balloon 35 and is 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 significantly, by forming the anterior balloon 35 by the above-described process of everting the proximal extension 73 into the interior of the body 67 and then everting the distal extension 76 into the interior of the proximal extension 73, multiple layers of balloon material are provided around the push tube 30, providing a more robust balloon construction. In addition, providing multiple layers of balloon material around the push tube 30 increases the cushioning effect on the distal end of the push tube 30, thereby providing an even more atraumatic distal tip for 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 anterior balloon 35 is made of polyurethane.

It will be appreciated that when the forward balloon 35 is in its inflated state, the material of the forward 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 forward balloon 35), thereby providing a non-invasive tip for advancing the forward balloon 35 distally through the body lumen. In addition, the push tube 30 and the deflated forward balloon 35 may essentially act together as a soft-tipped guide 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 radiopaque indicator) so that a physician (or other operator or user) viewing the surgical site via the endoscope 10 or radiological guidance (e.g., X-ray fluoroscopy) can determine the settings of one or both of the balloons at the surgical site.

The inflation mechanism 40 provides a means for selectively inflating the posterior balloon 20 and/or the anterior balloon 35.

In one preferred form of the invention, and referring now to fig. 1 and 11, the inflation mechanism 40 includes a single-line syringe inserter 140, the single-line 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 wire 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 to 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 forward 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 forward 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 disposed in the first port 157 such that air can only pass through the first port 157 when traveling in an outward direction. A one-way valve 159 (e.g., a check valve) is disposed in the second port 158 such that air can only pass through the second port 158 when traveling in an inward direction. When resilient ball 156 is compressed (e.g., by hand), air within the interior of resilient ball 156 is forced out of first port 157; and when the resilient ball 156 is subsequently released, air is drawn into the interior of the resilient ball 156 through the second port 158.

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

Alternatively, and looking now at fig. 12 and 13, the injector 160 may be used to inflate the rear balloon 20 and/or the forward 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 a line 163. With this configuration, the syringe 160 includes a valve 165 for connecting the syringe 160 to the forward or

rearward balloon

35, 20 and a valve 170 for selecting inflation or deflation of the connected balloons.

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 or 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 switching 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 forward balloon 35, the valve 165 is set so that the syringe 160 is connected to the forward balloon 35 through the fitting 56, and the valve 170 is set so that the syringe 160 provides inflation pressure. Thereafter, when the anterior 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, a pressure relief valve 175 may be connected to an inflation/deflation line connected to anterior balloon 35 to ensure that the pressure within anterior 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 inflation status of the balloon during the procedure.

Furthermore, it will be appreciated that the flexible tube 59 connecting the push tube 30 to the base 25 (and thus to the fitting 56) may collect around the base 25 as the front balloon 35 moves between its "retracted" position (fig. 2) and its "extended" position (fig. 4), potentially interfering with the actions of the physician (or other operator or user). Accordingly, if desired, and looking now at FIG. 15, a flexible tube retraction system 185 (e.g., within base 25) may be provided to take up slack in flexible tube 59 when front balloon 35 is extended.

Preferred methods of Using the novel apparatus

The device 5 can be used to manipulate (e.g., stabilize, straighten, expand, and/or flatten, etc.) a body lumen and/or a sidewall of a body cavity in order to better present sidewall tissue (including visualization of regions that are initially hidden or out of view) for examination and/or treatment during endoscopic surgery using the endoscope 10, and/or to stabilize a distal tip and/or working end of an instrument (e.g., grasper, cutter or dissector, cauterization tool, ultrasound probe, etc.), 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 over the distal end of the endoscope 10 and then proximally along the length of the endoscope 10 until the distal end of the sleeve 15 is substantially aligned with the distal tip of the endoscope 10. At this point, the posterior balloon 20 is deflated, the anterior balloon 35 is deflated, and the anterior balloon 35 rests on the distal end of the endoscope 10. The endoscope 10 and device 5 are ready for insertion as a unit into a patient.

Turning next to FIG. 16, the endoscope 10 and device 5 as a whole are inserted into a body lumen and/or body cavity of a patient. By way of example and not limitation, the endoscope 10 and device 5 as a whole are inserted into the Gastrointestinal (GI) tract of a patient. The endoscope 10 and device 5 are advanced along a body lumen and/or body cavity to a desired location within a patient (fig. 17 and 18).

When device 5 is used (e.g., to manipulate the side walls 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), rear balloon 20 is inflated to stabilize device 5 (and thus 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 articulated portion of the endoscope is located distal of 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 the anatomy. Notably, this visualization is enhanced because the rear balloon 20 stabilizes the endoscope 10 within the gastrointestinal tract and dilates and increases the colon to a fixed diameter directly adjacent the rear balloon 20.

Next, the push tube 30 is advanced distally in the body lumen and/or body cavity by pushing distally on the push tube handle 37 (i.e., to move the rear balloon 20 further in front of the forward balloon 35). Thus, the push tube 30, and thus the forward balloon, moves distally relative to the endoscope 10 (which is stabilized in position within the gastrointestinal tract by the inflated rear balloon 20), and thus, the forward balloon 35 moves distally relative to the endoscope 10. It is noted that during this distal advancement of the anterior balloon 35, the deflated anterior balloon 35 covers the distal end of the push tube 30, thereby ensuring atraumatic advancement of the anterior balloon 35. It is noted that 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 forward balloon 35 to the desired location distal of the endoscope 10, the forward balloon 35 is inflated (fig. 20) to secure the forward 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 in order to stabilize, straighten, expand, and/or flatten the body lumen and/or sidewall of the body cavity to better present sidewall tissue (including visualization of areas that are initially hidden or out of view) for examination and/or treatment using the endoscope 10 during endoscopic procedures. In this regard, it will be appreciated that the inflated forward balloon 35 and the inflated rearward balloon 20 will together expand and tension the body lumen and/or the side walls of the body cavity, and that the push tube 30 will tend to straighten the anatomy between the two inflated balloons as the forward balloon extends distally from the rearward balloon. In this regard, it will also be appreciated that once both the rear balloon 20 and the forward balloon 35 have been inflated, the forward balloon 35 will create a substantially full diameter seal across the body lumen and/or cavity (as the inflated forward balloon closes the axial opening 63 extending through the forward balloon when it is in its deflated state), and the rear balloon 20 will cooperate with the sleeve 15 and endoscope 10 to create another substantially full diameter barrier across the body lumen and/or cavity. Thus, the inflated forward balloon 35 and the inflated rearward balloon 20 together define a substantially enclosed area along the body lumen and/or body cavity (i.e., an isolated treatment area that prevents passage of fluids and/or other liquids through the airtight seal established by the inflated forward balloon 35 and the rearward balloon 20). By inflation of the forward and rearward balloons 35, 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 will be appreciated that the expansion and tensioning of the side walls of the body lumen and/or body cavity by the inflated anterior balloon 35, inflated posterior balloon 20 and push tube 30 may be further enhanced by advancing the anterior balloon as it inflates and gripping 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 forward balloon 35 and the inflated rearward balloon 20 together define a substantially enclosed region (i.e., an isolated treatment area) along the body lumen and/or body cavity, a fluid (e.g., air, CO) may then be used₂Etc.) 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 to facilitate more precise therapeutic intervention.

If desired, the forward balloon 35 may be retracted toward the rear balloon 20 (i.e., by pulling the pusher handle 37 proximally) while remaining inflated (and thus maintaining a grip on the side wall of the body lumen and/or body cavity) in order to move the visible mucosa and further improve visualization and access (see FIG. 22), for example, 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 forward balloon 35 may be inflated so as to grasp the side walls of the body lumen and/or body cavity, and then the push tube 30 may be advanced further distally. This action will cause the flexible push tube 30 to bow outwardly (see fig. 22A-22D), thereby contacting and pushing outwardly the side walls of the body lumen and/or cavity, for example in a "tented" fashion, thereby further enhancing visualization of the side walls of the body lumen and/or cavity by the endoscope 10.

If desired, an instrument 190 (FIG. 23) may be advanced through the working channel of the endoscope 10 to biopsy and/or treat the pathological condition (e.g., resect the pathological anatomy). It will be appreciated that such instruments will extend through the distal end of the endoscope, which is effectively stabilized relative to the anatomy via the rear balloon 20, so that the working end of the instrument 190 will also be highly stabilized relative to the anatomy. This is a significant advantage over prior art practices of advancing instruments out of the unstable end of an endoscope. Preferably, the instrument 190 comprises an articulated instrument having 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 in which 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 at the hemorrhage site with high precision, and thus the anterior balloon 35 (e.g., inflated) may be used to apply local pressure to the hemorrhage site in order to enhance hemorrhage control (see fig. 27). This can be done under visualization provided by the endoscope 10.

If it is desired to reposition endoscope 10 within the anatomy with minimal interference from device 5, forward balloon 35 is returned to its circular configuration (i.e., partially deflated), the forward balloon is retracted proximally and "rested" on the distal end of endoscope 10, rear balloon 20 is deflated, and endoscope 10 (with device 5 carried thereon) is then repositioned within the anatomy. It is noted that in the event that the anterior balloon 35 is to be rested on the distal end of the endoscope 10, the anterior balloon 35 is preferably only partially deflated until the anterior balloon 35 is rested on the distal end of the endoscope, as the partial inflation of the anterior balloon 35 may make the anterior balloon 35 have sufficient "bulk" to facilitate the restating process. Thereafter, if desired, the forward balloon 35 may be fully deflated, e.g., to forcibly grasp the distal end of the endoscope 10.

Alternatively, if desired, the forward balloon 35 may be used as a resistance 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 a 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 optionally therapeutic treatment can then be effected at that location. When the device is to be moved retrograde, the rear balloon 20 is deflated, the forward balloon 35 is partially deflated, and then the endoscope is withdrawn proximally to draw the semi-inflated forward balloon along the body lumen and/or body cavity (fig. 29), wherein the forward 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 better visualization of the anatomy. If this is desired under certain circumstances, the posterior balloon 20 and anterior balloon 35 may be reinflated, as shown in fig. 30, to stabilize, straighten, expand and/or flatten the anatomy, with or without introducing fluid into the "isolated treatment zone" established between the two balloons.

The rear balloon 20 may also be used as a brake when withdrawing the endoscope (and hence the device 5) from the anatomy, either alone or in combination with the above-described braking action from the forward balloon 35.

At the end of the procedure, the endoscope 10 and device 5 are withdrawn from the anatomy. Preferably, this is done by: deflating (or partially deflating) the forward balloon 35, thereby retracting the push tube 30, causing the forward balloon 35 to "re-dock" on the distal end of the endoscope 10, fully deflating the forward balloon 35, causing it to grip the distal end of the endoscope, deflating the rear balloon 20 (if it has not been deflated), and then withdrawing the endoscope 10 and device 5 as a whole from the anatomy.

It should be appreciated that the device 5 may advantageously be used in various ways in addition to those disclosed above. By way of example and not limitation, as endoscope 10 (and device 5) is advanced within the colon, it may be desirable to first project forward balloon 35 distally under visual guidance of the endoscope so that forward balloon 35 guides the distal end of the endoscope. As a result, when the endoscope is advanced distally, with the forward balloon 35 deflated (or partially deflated), the forward balloon and flexible push tube 30 can act as an atraumatic guide wire (guide structure) for the endoscope as the endoscope 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 wall of the colon (e.g., at a turn of the colon), the flexible push tube can be steered 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 apparatus 5 may also be used to advantage in other ways to facilitate further inspection of luminal surfaces that are currently difficult to perform in other ways. An example of this is endoscopic ultrasound examination of a lumen, which would be facilitated by fluid-filled inflated frontal balloon and ultrasound probe examination.

Additional structure

If desired, the apparatus 5 can be configured such that the push tubes 30 can be advanced or retracted independently of one another, as well as in conjunction with one another — such independent advancement or retraction of the push tubes 30 can facilitate guiding the partially or fully deflated forward 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 can facilitate applying a "rotational force" to the anatomy with the inflated forward balloon 35, thereby better presenting the anatomy for visualization and/or treatment.

By way of example and not limitation, in this form of the invention, and looking now at fig. 30A, the push tubes 30 are each independently slidably mounted to a push tube handle 37 such that the push tubes 30 can move independently of the push tube handle 37 and independently of each other. Stop 191 limits 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, when the front balloon 35 is moved distally, the push tubes 30 are moved distally, either together or independently of each other. Also, as the front 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, if the anterior balloon 35 is inflated and engaged with the anatomy, thereby applying a "turning force" to the anatomy, or in the case of an atraumatic tip where the anterior balloon 35 is partially inflated and used as a progression component, thereby to help "steer" the assembly through the anatomy. It is noted that it may be desirable to provide a limiting mechanism to limit the extent to which push rods 30 may move longitudinally, independently of one another, in order to prevent over-rotation of anterior balloon 35, and/or crossing of push rods, and/or twisting of push rods, and/or misalignment of push rods, etc. It is also noted that the push rod 30 may be held in a particular arrangement by mounting the push tube 30 in the clamp 53 described above (fig. 12 and 15).

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

More specifically, and looking now at 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 the instrument 190 therein. It is noted that when inflated, rear balloon 20 provides a safe platform for maintaining endoscope 10 and sleeve 15 within a body lumen or cavity in which endoscope 10 and sleeve 15 are centered. As a result, the distal end of the lumen 195 of the sleeve 15 will also be safely maintained within the body lumen or cavities to provide safe support for instruments advanced through the lumen 195 of the sleeve 15.

The proximal end of lumen 195 may extend to the mount and through mount 25, in which case the instrument may be inserted into lumen 195 at mount 25, or the proximal end of lumen 195 may terminate proximal of mount 25 (but still outside the patient), in which case the instrument may be inserted into lumen 195 in the middle of sleeve 15. By way of example and not limitation, where the endoscope 10 is 180 cm in length and the instrument 190 is 60 cm 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, the lumen 47 for housing the inflation/deflation line 45 and the inflation/deflation line 45 for inflating/deflating the posterior balloon 20 are not visible because the views are distal-facing and taken at a location distal to where the lumen 47 and inflation/deflation line 45 terminate on the sleeve 15.

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

It should be appreciated that where sleeve 15 includes a central passage for receiving endoscope 10, lumen 47 for receiving inflation/deflation line 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 line 45, lumen 52 for receiving support tube 50 for receiving push tube 30, and/or lumen 195 for slidably receiving instrument 190 may have a fixed configuration (i.e., a fixed diameter) such that sleeve 15 has a fixed outer profile.

In another preferred form of the invention, the lumen 47 for receiving the inflation/deflation line 45, the lumen 52 for receiving the support tube 50 for receiving the push tube 30, and/or the lumen 195 for slidably receiving the instrument 190 may have an expandable configuration (i.e., they may have a minimum profile when empty and, when filled, they may be fully expanded as desired), such that the overall profile of the 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 passage of the push tube 30 and an opening for passage of the instrument 190. It is noted that the opening in such a support collar 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 accommodate a hollow instrument catheter that itself accommodates an instrument therein. Such a hollow instrument catheter may provide greater structural integrity to the distal end of lumen 195 to provide improved support for instrument 190 contained within lumen 195. Also, such hollow instrument catheters may have a fixed geometry or a bendable or articulated 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 catheter 200 may move independently relative to each other (and independently relative to the sleeve 15). Note also that the instrument 190 preferably mates with the hollow instrument catheter 200 to provide excellent instrument support at the distal end of the sleeve 15.

It should also be appreciated that 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), if desired. It will be appreciated that where a plurality of push tubes 30 are provided, it will typically be desirable to circumferentially space the push tubes equidistant from one another, for example where two push tubes 30 are provided, it will typically be desirable to space two push tubes 30 180 degrees apart, where three push tubes 30 are provided, it will typically be desirable to space the push tubes 120 degrees apart, etc.

Tissue retraction and tissue retrieval

Tissue retraction

In some cases, it may be necessary or desirable to exfoliate 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 at one time, even if they are quite large. With ESD, lesions are dissected directly along the submucosal layer of the intestine using a cutting tool (e.g., an electrocautery knife equipped with an energy source) passed through the endoscope, resulting in safer total dissection of even large lesions.

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

In addition to the above, ESD procedures are often time consuming and typically take several hours. Most of this time is usually spent stripping the lesion down the submucosa of the intestine.

Similar problems may occur in other endoluminal tissue dissection procedures.

Endoscopic tissue retraction systems compatible with ESD procedures and other endoluminal tissue dissection procedures will provide surgeons with better visualization of the surgical field and speed up the dissection process.

Tissue retrieval

In addition to the above, due to the technical challenges of (i) locating a stripped lesion (or other stripped tissue) in the intestine and (ii) grasping the stripped tissue (or other stripped tissue) with a removal tool, it may be difficult to remove the lesion (or other stripped tissue) after stripping the lesion from the submucosa of the intestine or after stripping other tissue during an endoluminal tissue stripping procedure. In addition, if stripped lesions (or other stripped tissues) including early stage cancer migrate within the intestine, they may contaminate (e.g., potentially seed with cancer cells) the disease-free areas of the intestine.

An endoscopic tissue retrieval system compatible with ESD procedures and other endoluminal tissue dissection procedures would provide surgeons with greater control and protection of dissected tissue within the bowel.

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 device 5, which device 5 is used in conjunction with an endoscopic tissue retraction system 300 to provide better visualization of the surgical field for the surgeon and to accelerate the dissection process, such as 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 the connector 305 to the anterior balloon 35 (or push tube 30) using a surgical clip 320 and by clamping the connector 305 to the lesion 315 with another surgical clip 320. It will be appreciated that connector 305 and surgical clip 320 can be delivered to the surgical site through the working channel of endoscope 10 (or through instrument lumen 195 of device 5). With the connector 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 (i.e., applying a force to) the lesion 315 in a distal direction. 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 dissect the lesion 315 along the submucosa 330 of the intestine 335. It will be appreciated that after lesion 315 has been cut from the intestinal submucosa, lesion 315 will remain tethered to anterior balloon 35 by way of connector 305 and surgical clip 320.

In one 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 wire, a single strand made of webbing, a single strand made of wire, a single strand made of suture, etc.).

In one preferred form of the invention, the connector 305 is made of an elastomeric material (e.g., an elastomeric wire or ribbon) such that when the lesion 315 is cut from the submucosa 330 of the intestine 335, the connector 305 automatically tightens any slack in the connector 305. In another form of the invention, the connector 305 may be made of a non-resilient flexible material. In yet another form of the invention, the connector 305 may be made of a rigid material that is not elastic.

In one form of the invention, the anterior balloon 35 is advanced distally to tension the connector 305, thereby advancing (i.e., applying force to) the lesion 315 in a distal direction. In an alternative form of the invention, and looking now at 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 lesion 315 in a distal direction (i.e., applying a force thereto) without requiring any movement of anterior balloon 35 in the distal direction. Alternatively, the connector 305 may be stretched, secured (with its stretched condition) to the anterior balloon 35 and lesion 315, and then released, thereby to advance the lesion in the distal direction (i.e., apply a force thereto) without requiring any movement of the anterior balloon 35 in the distal direction.

In another form of the invention, and looking now at FIG. 46, the connector 305 may include a loop 340 having a variable length, for example the 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 clipped to anterior balloon 35 (or push tube 30) with surgical clip 320, and connector 305 is clipped to lesion 315 with another surgical clip 320. Connector 305 is then tensioned (e.g., by pulling on tensioning end 350 of slip knot 345 using a tool advanced through the working channel of endoscope 10 or through instrument lumen 195 of device 5), thereby advancing 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 dissect the lesion 315 along the submucosa 330 of the intestine 335. Again, it will be appreciated that after the lesion 315 has been stripped from the intestinal submucosa, the lesion 315 will remain tethered to the anterior balloon 35 by way of the connector 305 and the surgical 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 loop 340 is tensioned by pulling on one or more tensioning ends 360 using a tool that is advanced through the working channel of the endoscope 10 (or through the instrument lumen 195 of the device 5).

In some cases, and looking now at fig. 48, it may be advantageous to provide connector 305 with a substantially rigid loop 365 at its proximal end (i.e., the diseased side). By way of example and not limitation, where the connector 305 is in the form of a loop, the loop of the connector 305 may pass through the center of the substantially rigid loop 365. The substantially rigid loop 365 may facilitate securing the connector 305 to the lesion 315, for example, making it easier to clip the connector 305 to the lesion 315 using the surgical clip 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 directional 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 loop, 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 in multiple directional vectors and multiple attachment points. Alternatively, 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 lesion 315 to be tensioned distally with multiple directional vectors and multiple attachment points.

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

It should also be appreciated that in some instances it may be possible to secure the anterior 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. See, for example, fig. 52A, which illustrates a surgical clip 320 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 the push tube 30 directly to the lesion 315 without the use of the 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 must typically be removed from the patient's body. Because the stripped tissue is secured to the anterior balloon 35 (or pushrod 30) by way of one or more connectors 305 and/or surgical clips 320, the stripped tissue can be removed from the body by simply removing the novel device 5 from the body of the patient, which will withdraw the stripped tissue from the body of the patient as the anterior balloon 35 is withdrawn from the body of the patient. However, this method involves the risk of: the stripped tissue tears from the anterior balloon 35 (or push tube 30), for example, due to a failure of the surgical clip to attach to the stripped tissue or due to a failure of the surgical clip to attach to the anterior balloon (or push tube), etc. Furthermore, this approach essentially drags the exposed stripped tissue along the length of the intestine (or other body lumen) as the novel device 5 is withdrawn from the patient's body. This can pose a risk to the patient, for example, in areas where the dissected tissue includes disease-free areas that may contaminate (e.g., potentially seed with cancer cells) the bowel (or other body lumen area).

Endoscopic tissue retrieval

To this end, and looking now at fig. 53-60, the anterior balloon 35 may include a flap 375 disposed within the central bore 380 of the anterior balloon 35. The flaps 375 are configured such that (i) when the anterior balloon 35 is docked on the endoscope 10, the flaps 375 are captured between the endoscope 10 and the anterior balloon 35; (ii) when the front balloon 35 is detached from the endoscope 10 and then protrudes distally away from the endoscope 10, and is then fully inflated, the tabs 375 are captured within the closed central bore 380 of the front balloon 35 (fig. 53 and 54); and (iii) when the forward balloon 35 protrudes distally away from the endoscope 10 and is then partially deflated, such that the central bore 380 of the forward balloon 35 reopens to expose the flaps 375 (fig. 55 and 56), the flaps 375 may be "pulled down" across the central bore 380 of the forward 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 bore 380 of the forward balloon 35 along with the surrounding portions of the forward balloon 35 defining the central bore 380 (fig. 57 and 58). The pocket 385 is configured to receive the dissected 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 manipulated 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 easily and safely removed from the body by simply removing the novel device 5 from the body of the patient, which will withdraw the stripped tissue from the body of the patient as the anterior balloon 35 is withdrawn from the body of the patient. Note that this can be done while the dissected tissue is still connected to the anterior balloon 35 (or push tube 30) via connector(s) 305 and/or surgical clip(s) 320. It is also noted that this approach effectively eliminates the risk of the stripped tissue tearing from the anterior balloon 35 (or push tube 30), for example, due to a failed mounting of the surgical clip to the stripped tissue or due to a failed mounting of the surgical clip to the anterior balloon (or push tube), etc., and reduces disease-free areas of the bowel (or other body lumen) that are contaminated (e.g., potentially seeded with cancer cells) by early cancer lesions, as the stripped tissue is shielded within the recessed 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, such as for stripping purposes.

Connecting the lesion to the non-inflated portion of the anterior balloon 35 by using one or more connectors and moving the anterior balloon Partially balloon to tension lesion

By way of example and not limitation, and looking now at fig. 61, it is also possible to secure the anterior balloon 35 directly to the lesion 315 using a connector 305. 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, for example using a clip 320. The connector 305 passes through a 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 connector 305 is then connected to lesion 315, for example using 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 pass 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 may pass 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) pre-attached to the neck 38 of the anterior balloon 35 (or the non-inflated portion of the anterior balloon 35).

In use, the combination of endoscope 10 and device 5 is advanced over endoscope 10 by device 5 into intestine 335 such that endoscope 10 is just proximal to lesion 315, rear balloon 20 is inflated to stabilize the endoscope relative to the lesion, connector 305 is attached to neck 38 of forward balloon 35 (or another non-inflated portion of forward balloon 35) and connected to lesion 315 by clip 320, and push tube 30 is moved distally to tension lesion 315 away from endoscope 10 (or instrument lumen 195). The lesion 315 is then stripped from the submucosa 330 of the intestine 335 using a 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., using one or more clips 320).

Alternatively, it is possible to clip the connector 305 to a non-inflated portion of the anterior balloon 35 (e.g., the non-inflated neck 38 of the anterior balloon 35) using a clip (e.g., clip 320), and then connect the connector 305 to the lesion 315. In addition, 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 looking now at fig. 62-65, a first connector 305 can be connected to the anterior balloon 35 (e.g., by passing the connector 305 through the neck 38 (or another non-inflated portion) of the anterior balloon 35, thereby clipping the connector 305 to the non-inflated portion of the anterior balloon 35, etc.), and a second connector 305 can be connected to (i) the first connector 305 and (ii) the lesion 315 so as to form an extension loop 305A extending from the first connector 305.

The extension loop 305A is particularly useful when the lesion is located just proximal to a sharp colon turn. By way of example and not limitation, when lesion 315 (e.g., a polyp) is located just proximal of a sharp colon turn (e.g., just proximal of a liver, spleen, or other colon curve), it may be difficult to connect anterior balloon 35 to lesion 315 (e.g., using connector 305 and clip 320) and then tension lesion 315 by advancing anterior balloon 35 distally within the colon. More specifically, when the lesion 315 is just proximal to an apparent colon turn, the anterior balloon 35 will push against the colon wall at the turn as it moves distally within the colon to tension 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 of the colon turn and the rear balloon 20 is positioned proximal of the colon turn (see fig. 63). The second connector 305 is then advanced into the colon, with one end of the second connector 305 connected to the proximal side of the lesion 315 (e.g., using an endoscopic clip 320) (see fig. 64), and the other end of the second connector 305 connected to the first connector 305 (e.g., using a second endoscopic clip 320) to form an extension loop 305A (see fig. 65). Now, the frontal balloon 35 can be pushed distally along the straight part of the colon as long as it is 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 distal 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 diameter smaller than the diameter of the lumen of sleeve 15 may be used, such that a space is created between the inner wall of the lumen of sleeve 15 and the exterior 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 but not limitation, and looking now at fig. 66, a tensioning tool 400 may be advanced down through the instrument lumen 195 of the device 5 (or the working lumen of the endoscope 10) to the surgical site and then used to bias the lesion 315, e.g., for dissecting the lesion. It is noted that the tensioning tool 400 may directly engage and grasp the lesion 315, such as shown in fig. 66, or the tensioning tool 400 may engage and grasp a connector 305, which connector 305 itself is secured to the lesion 315 (e.g., via a clip 320). Alternatively, the tensioning tool 400 may engage and grasp the connector 305, the connector 305 being connected to the rigid loop 365 (fig. 48-50), wherein the rigid loop 365 is secured to the lesion 315 (e.g., via the clip 320).

In use, device 5 is pulled up endoscope 10, the combination of endoscope 10 and device 5 is advanced into intestine 335 such that endoscope 10 is just proximal to lesion 315, rear balloon 20 is inflated to stabilize the endoscope relative to the lesion, forward balloon 35 is inflated to create a sealed treatment area between rear balloon 20 and forward balloon 35, tensioning tool 400 is advanced through instrument lumen 195 (or a working lumen of endoscope 10) into the treatment area to grasp lesion 315, and tensioning tool 400 is moved to tension lesion 315. The lesion 315 is then stripped from the submucosa 330 of the intestine 335 using a 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, tensioning tool 400 may be passed down through the working lumen of the endoscope. Alternatively, an endoscope having a diameter smaller than the diameter of the lumen of sleeve 15 may be used, such that a space is created between the inner wall of the lumen of sleeve 15 and the exterior of the endoscope. Tensioning tool 400 may then be passed through the space between sleeve 15 and endoscope 10 and secured to lesion 315.

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

By way of example and not limitation, when it is desired to tension a lesion without creating a sealed treatment zone between the 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 can be done by: pulling the simplified form of 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 stripping the lesion 315 from the submucosa 330 of the intestine 335 using the cutting tool 325 (e.g., advanced through the working lumen of the endoscope 10 or instrument lumen 195).

By way of further example but not limitation, the device 5 may be further simplified by eliminating the anterior balloon 35 and the push tube 30 described above, and then this further simplified form of the device 5 may be used to tension the lesion (see fig. 66B). More specifically, this can be done by: pulling the further simplified form of the device 5 over the endoscope 10, 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 dissecting the lesion 315 from the submucosa 330 of the intestine 335 using the cutting tool 325 (e.g., advanced through the working lumen or instrument lumen 195 of the endoscope 10).

By way of additional example but not limitation, the device 5 may be simplified even further by eliminating the above-described posterior balloon 20 and the above-described anterior balloon 35 and the above-described push tube 30, and then this even further simplified form of the device 5 may be used to tension 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 on the endoscope 10 the device 5 in this even further simplified form, advancing the combination of the endoscope 10 and the 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 stripping the lesion 315 from the submucosa 330 of the intestine 335 using the cutting tool 325 (e.g., advanced through the working lumen of the endoscope 10).

By way of additional example but not limitation, the device 5 may be simplified even further by eliminating the instrument lumen 195 described above, the posterior balloon 20 described above, and the anterior balloon 35 described above and the push tube 30 described above, and then this further simplified form of the device 5 may be used to tension 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 dimensioned 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 the device 5 of this further simplified form over the endoscope 10, 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, advancing the tensioning tool 400 between the sleeve and the endoscope to engage and tension the lesion 315, and then stripping the lesion 315 from the submucosa 330 of the intestine 335 using the cutting tool 325 (e.g., advanced through the working lumen of the endoscope 10 or through the space between the sleeve and the endoscope).

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

By way of further example but not limitation, and looking now at fig. 67, a further embodiment of the apparatus 5 is shown in which 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 connected 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 angled distally, such as in the manner shown in fig. 68. Alternatively, if desired, the bridge 31 may be disposed substantially perpendicular to the longitudinal axis of the push tube 30, such as in the manner shown in fig. 69. Further, 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 in order to minimize slippage 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, the combination of endoscope 10 and simplified device 5 is advanced into intestine 335 such that endoscope 10 is just proximal to lesion 315, rear balloon 20 is inflated to stabilize the endoscope relative to the lesion, connector 305 is attached to bridge 31 of push tube 30 and connected to lesion 315 by clip 320, and push tube 30 is moved distally to tension lesion 315 away from endoscope 10. The lesion 315 is then stripped from the submucosa 330 of the intestine 335 using a 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 but not limitation, the device 5 may be simplified even further by eliminating the anterior balloon 20 and the posterior balloon 35 described above, and then such further simplified form of the device 5 may be used to tension the lesion. Thus, in this even further simplified form of the invention, the device 5 essentially comprises a sleeve 15, an instrument lumen 195 and a push tube 30 (see fig. 71). In use, the lesion may be tensioned by: pulling the device 5 of this further simplified form over the endoscope 10, 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, 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 dissecting the lesion 31 from the submucosa 330 of the intestine 335 using the cutting tool 325 (e.g., advanced through the working lumen or instrument lumen 195 of the endoscope 10).

By way of additional example but not limitation, the device 5 may be simplified even further by eliminating the instrument lumen 195 described above, the posterior balloon 20 described above, and the anterior balloon 35 described above, and then this even further simplified form of the device 5 may be used to tension a 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 the device 5 of this further simplified form over the endoscope 10, advancing the combination of the endoscope 10 and the device 5 of this even further simplified form 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 stripping the lesion 315 from the submucosa 330 of the intestine 335 using the cutting tool 325 (e.g., advanced through the working lumen of the endoscope 10).

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

Applications of

Thus, it will be seen that the present invention comprises the provision and use of a 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 the region initially hidden or out of view) for inspection and/or treatment during endoscopic surgery, for example to straighten out bends, "iron" luminal surface folds and create a substantially static or stable side wall of the body lumen and/or body cavity, which enables more accurate visual inspection (including visualization of the region initially hidden or out of view) and/or therapeutic intervention. By way of example and not limitation, the novel apparatus may be used to stabilize, straighten, dilate and/or flatten bends and/or folds in the sidewall of the intestine to better present sidewall tissue (including visualization of regions that are initially hidden or out of view) for examination and/or treatment during endoscopic surgery.

The present invention also includes the provision and use of 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 dissectors, cauterization tools, ultrasound probes, etc.) inserted into body lumens and/or cavities during endoscopic procedures with respect to the sidewalls of those body lumens and/or cavities, thereby facilitating the delicate use of those instruments.

By way of example and not limitation, the present device may provide a stable platform (i.e., a stable endoscope, a stable treatment tool, and a stable colon wall, all stable relative to one another) for performing a variety of minimally invasive procedures within body lumens and/or cavities, including stabilizing endoscopes and/or other surgical instruments (e.g., graspers, cutters or dissectors, cauterizing tools, ultrasound probes, etc.) within body lumens and/or cavities, for example, while stabilizing the colon (including reducing deformation of the colon wall) during lesion biopsy and/or lesion removal procedures, organ resection procedures, Endoscopic Submucosal Dissection (ESD), Endoscopic Mucosal Resection (EMR), etc., in order to achieve more precise 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 endoscopes (and thus also the distal tip and/or working end of other instruments (such as graspers, cutters or dissectors, cauterizing tools, ultrasound probes, etc.) inserted through the working channel of those endoscopes) relative to the sidewalls of body lumens and/or cavities.

And the present invention provides novel apparatus that can stabilize and/or stabilize the distal tip and/or working end of instruments (such as graspers, cutters or dissectors, cauterizing tools, ultrasound probes, etc.) advanced to the surgical site by means other than through the working channel of an endoscope.

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

The present invention is believed to have the broadest application in the Gastrointestinal (GI) tract (e.g., large and small intestines, esophagus, stomach, etc.), which is generally characterized by frequent turns, and has a sidewall 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 tract, fallopian tube, bronchus, bile duct, etc.) and/or within other body lumens (e.g., head, chest, abdomen, sinuses, bladder, lumens within organs, etc.).

Modifying

While the present invention has been described in terms of certain exemplary preferred embodiments, those skilled in the art will readily appreciate and appreciate that it is not so limited and that many additions, deletions, and modifications to the above-described preferred embodiments may be made while remaining within the scope of the present 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

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 includes an inflated portion and a non-inflated portion, wherein the at least one connector is connected to the non-inflated portion.

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

4. The apparatus of claim 2, wherein the at least one connector is connected to the non-inflated portion of the balloon by passing the at least one connector through an aperture in the non-inflated portion of the balloon.

5. The apparatus of claim 1, wherein the at least one connector is attached to the tissue with a clip.

6. The apparatus of claim 1, wherein the at least one connector comprises a ring.

7. The apparatus of claim 1, wherein the at least one connector comprises a single strand.

8. The apparatus of claim 1, wherein the at least one connector comprises a first connector and a second connector.

9. The apparatus of claim 8, wherein the second connector is attached to the first connector with a first clip and to the tissue with a second clip.

10. The apparatus of claim 8, wherein the first connector comprises a ring and the second connector is connected to the first connector by looping the second connector through the ring of the first connector.

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

12. A method for endoscopically retracting tissue, the method comprising:

providing 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

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

retracting the tissue away from the endoscope by moving the balloon away from the endoscope.

13. The method of claim 12, wherein the balloon includes an inflated portion and a non-inflated portion, wherein the at least one connector is connected to the non-inflated portion.

14. The method of claim 13, wherein the at least one connector is connected to the non-inflated portion of the balloon with a clip.

15. The method of claim 13, wherein the at least one connector is connected to the non-inflated portion of the balloon by passing the at least one connector through an aperture in the non-inflated portion of the balloon.

16. The method of claim 12, wherein the at least one connector is attached to the tissue with a clip.

17. The method of claim 12, wherein the at least one connector comprises a ring.

18. The method of claim 12, wherein the at least one connector comprises a single strand.

19. The method of claim 12, wherein the at least one connector comprises a first connector and a second connector.

20. The method of claim 19, wherein the second connector is attached to the first connector with a first clip and connected to the tissue with a second clip.

21. The method of claim 19, wherein the first connector comprises a ring and the second connector is connected to the first connector by looping the second connector through the ring of the first connector.

22. The method of claim 12, wherein the balloon is movably mounted to the sleeve by at least one push tube.

23. The method of claim 12, wherein the tissue to be retracted comprises a lesion.

24. The method of claim 23, wherein the lesion is attached to the submucosa of the intestine.

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

a sleeve adapted to slide over an exterior of an endoscope; and

26. The apparatus of claim 25, wherein the sleeve includes at least one instrument lumen, and further wherein the tensioning tool passes through the at least one instrument lumen for retracting tissue.

27. The device of claim 25, further comprising an endoscope, wherein a diameter of the endoscope is smaller than a diameter of the lumen such that a space exists between the sleeve and the endoscope, and wherein the tensioning tool passes through the space for retracting tissue.

28. A method for endoscopically retracting tissue, the method comprising:

a sleeve adapted to slide over an exterior of an endoscope; and

connecting the tensioning tool to the tissue to be retracted; and

retracting the tissue by moving the tensioning tool relative to the endoscope.

29. The method of claim 28, wherein the sleeve comprises at least one instrument lumen, and wherein the tensioning tool passes through the at least one instrument lumen for retracting tissue.

30. The method of claim 28, wherein the endoscope has a diameter smaller than a diameter of the lumen such that a space exists between the sleeve and the endoscope, and wherein the tensioning tool passes through the space for retracting tissue.

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

a sleeve adapted to slide over an exterior of an 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

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

32. The apparatus of claim 31, wherein the at least one connector is attached to the bridge with a clip.

33. The apparatus of claim 31, wherein the at least one connector is attached to the bridge with a ring.

34. The apparatus of claim 31, wherein the at least one connector is attached to the tissue with a clip.

35. The apparatus of claim 31, wherein the at least one connector comprises a ring.

36. The apparatus of claim 31, wherein the at least one connector comprises a single strand.

37. The apparatus of claim 31, wherein the bridge is in the form of a loop.

38. A method for endoscopically retracting tissue, the method comprising:

a sleeve adapted to slide over an exterior of an 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

securing the at least connector to the pair of push tubes and tissue to be retracted; and

39. The method of claim 38, wherein the at least one connector is attached to the bridge with a clip.

40. The method of claim 38, wherein the at least one connector is attached to the bridge with a loop.

41. The method of claim 38, wherein the at least one connector is attached to the tissue with a clip.

42. The method of claim 38, wherein the at least one connector comprises a ring.

43. The method of claim 38, wherein the at least one connector comprises a single strand.

44. The method of claim 38, wherein the bridge is in the form of a loop.