Devices used to retract tissue under endoscopy

Abstract

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

Description

[0001] Citations to Pending Patent Applications

[0002] The patent application:

[0003] (1) is a continuation-in-part of pending U.S. patent application Ser. No. 16 / 477,789 filed on July 12, 2019 by Cornell 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 VISUALIZATION OF THE SAME AND / OR INCREASED ACCESS TO THE SAME, AND / OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME (Attorney's Docket No. CORN-43 PCT US)”, which:

[0004] (i) is an application filed on January 16, 2018, by Cornell 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 VISUALIZATION OF THE SAME AND / OR INCREASED ACCESS TO THE SAME, AND / OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME (Attorney’s Docket No. CORN-43PCT)” filed on January 16, 2018 US))”, which patent application further claims the benefits of the following patent applications:

[0005] (a) U.S. Provisional Patent Application Serial No. 62 / 446,167, filed on January 13, 2017, by Cornell University and Jeffrey Milsom et al., entitled “BALLOONTISSUE RETRACTION USING HOOP AND CLIP WITH VARIABLE LENGTH CAPABILITY, WITH SPECIMEN RETRIEVAL POUCH IN BALLOON (Attorney's Docket No. CORN-43PROV)”; and

[0006] (b) U.S. Provisional Patent Application Serial No. 62 / 462,241, entitled “BALLOONSPECIMEN RETRIEVAL (Attorney's Docket No. CORN-41PROV),” filed on February 22, 2017, by Cornell University and Jeffrey Milsom et al.; and

[0007] (ii) is a continuation-in-part of U.S. patent application Ser. No. 16 / 000,104 filed on June 5, 2018 by Cornell University and John Frederick Comhill et al., entitled “METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OF A BODY LUMEN ORBODY CAVITY SO AS TO PROVIDE INCREASED VISUALIZATION OF THE SAME AND / OR INCREASED ACCESS TO THE SAME, AND / OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME (Attorney's Docket No. CORN-34CON)” and is also a continuation-in-part of U.S. patent application Ser. No. 16 / 000,104 filed on June 5, 2018 by Cornell University and John Frederick Comhill et al., entitled “METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OF A BODY LUMEN ORBODY CAVITY SO AS TO PROVIDE INCREASED VISUALIZATION OF THE SAME AND / OR INCREASED ACCESS TO THE SAME, AND / OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME (Attorney's Docket No. CORN-34CON)” Continuation of U.S. Patent Application Serial No. 14 / 619,845 filed on February 11, 2015 by Comhill et al., entitled “METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASED VISUALIZATION OF THESAME AND / OR INCREASED ACCESS TO THE SAME, AND / OR FOR STABILIZING INSTRUMENTS RELATED TO THE SAME (Attorney's Docket No. CORN-34)” which also:

[0008] (a) is the patent application filed by Cornell University and Jeffrey Milsom et al. on November 13, 2014, 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 PROVIDEINCREASED VISUALIZATION OF THE SAME AND / OR INCREASED ACCESS TO THE SAME, AND / ORFOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME (Attorney’s Docket No. 201406-0100)”. No. CORN-17CON)))" is a continuation-in-part of U.S. patent application Ser. No. 14 / 540,355, filed Dec. 15, 2010 by Jeffrey Milsom et al., entitled “METHOD AND APPARATUS FOR STABILIZING, STRAIGHTENING, EXPANDING AND / OR FLATTENING THE SIDE WALL OF A BODY LUMEN AND / OR BODY CAVITY SO AS TO PROVIDE INCREASED VISUALIZATION OF THE SAME AND / OR INCREASED ACCESS TO THE SAME, AND / OR FOR STABILIZING INSTRUMENTS”. RELATIVE TO THE SAME(Attorney's Docket No.CORN-17)) (METHOD AND APPARATUS FOR STABILIZING, STRAIGHTENING, EXPANDING AND / OR FLATTENING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASED VISUALIZATION OF AND / OR INCREASED ACCESS TO AND / OR FOR STABILIZING INSTRUMENTS RELATIVE TO THESAME (Attorney's Docket No. CORN-17))) filed on December 15, 2009 by Jeffrey Milsom et al., entitled “METHOD AND APPARATUS FOR STABILIZING, STRAIGHTENING, EXPANDING AND / OR FLATTENING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASED VISUALIZATION OF THE SIDE WALL OF THE BODY LUMEN OR BODY CAVITY, AND / OR FOR STABILIZING INSTRUMENTS RELATIVE TO THESAME (Attorney's Docket No. CORN-17) ... No. CORN-17PROV))" (Methods and apparatus for stabilizing, straightening, dilating and / or flattening the sidewalls of a body lumen and / or body cavity to provide increased visualization of and / or increased access to a body lumen or body cavity and / or for stabilizing an instrument relative to a body lumen or body cavity (Attorney's Docket No. CORN-17PROV)); and.

[0009] (b) claiming the benefit of U.S. Provisional Patent Application Serial No. 61 / 938,446, filed on February 11, 2014, by Cornell University and John Frederick Comhill et al., entitled “METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OF A BODY LUMEN ORBODY CAVITY SO AS TO PROVIDE INCREASED VISUALIZATION OF THE SAME AND / OR INCREASED ACCESS TO THE SAME, AND / OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME (Attorney's Docket No. CORN-34PROV)”; and

[0010] (2) Claiming the benefit of pending U.S. Provisional Patent Application Serial No. 62 / 698,583, filed on July 16, 2018, by Lumendi Inc. and Peter Johann et al., entitled “METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OF A BODY LUMEN ORBODY CAVITY SO AS TO PROVIDE INCREASED VISUALIZATION OF THE SAME AND / OR INCREASED ACCESS TO THE SAME, AND / OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME (Attorney's Docket No. LUMENDI-20PROV)”.

[0011] The above eleven (11) patent applications are incorporated herein by reference. Technical Field

[0012] The present invention relates generally to surgical methods and apparatus, and more particularly to surgical methods and apparatus for manipulating the sidewalls of a body lumen and / or body cavity to provide increased visualization of and / or increased access to a body lumen and / or body cavity and / or for stabilizing an instrument relative to the body lumen and / or body cavity. Background Art

[0013] The human body includes many different body lumens and body cavities. By way of example and not limitation, the human body includes body lumens such as the gastrointestinal (GI) tract, blood vessels, lymphatic vessels, urinary tract, fallopian tubes, bronchi, bile ducts, etc. By way of further example and not limitation, the human body includes body cavities such as the head, chest, abdomen, sinuses, bladder, cavities within organs, etc.

[0014] In many cases, it may be desirable to use an endoscope to examine and / or treat a disease process or abnormality located within or on the sidewalls of a body lumen and / or cavity. By way of example and not limitation, it may be desirable to examine the sidewalls of the gastrointestinal tract for lesions and, if found, to biopsy, resect, and / or otherwise treat the lesions.

[0015] Endoscopic inspection and / or treatment of the side walls of the body lumens and / or body cavities may be complicated by the anatomical configuration (regional and local) of the side walls of the body lumens and / or body cavities and / or by the consistency of the tissues comprising the side walls of the body lumens and / or body cavities and / or by tethering the side walls of the body lumens and / or body cavities to other anatomical structures.

[0016] By way of example and not limitation, the intestine is an elongated tubular organ having an inner lumen and is characterized by frequent turns (i.e., the regional anatomy of the intestine) and a sidewall characterized by numerous folds (i.e., the local anatomy of the intestine), wherein the sidewall tissue has a relatively soft, pliable consistency, and wherein the colon, in particular, is tethered to the abdomen and / or other abdominal structures via soft tissue. Due to this varying sidewall anatomy (both regional and local), its relatively soft, pliable consistency, and its tethering to other anatomical structures via soft tissue, it can be difficult to fully visualize the sidewall of the intestine and / or treat lesions formed on the sidewall of the intestine. By way of example, and not limitation, in the context of colonoscopy, it has been found that approximately 5% to approximately 40% of patients have a sidewall anatomical configuration (regional and / or localized) and / or tissue consistency and / or a colon that is tethered to other anatomical structures that makes it difficult to fully visualize the anatomical structure (including pathological conditions of the anatomical structure, such as polyps or tumors) using a conventional endoscope and / or to fully access the anatomical structure using instruments introduced through a conventional endoscope.

[0017] In addition to the above, it has been found that some body lumens and / or body cavities can spontaneously spasm and / or contract, but particularly when an endoscope or other instrument is inserted into a body lumen and / or body cavity. Such spasms and / or contractions 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 anatomical structures, and / or further complicate and / or impair access to anatomical structures using instruments introduced through conventional flexible endoscopes. In addition, during a colon examination (which is typically performed while inserting and withdrawing an endoscope through the colon), the endoscope can clamp and / or otherwise gather the colon during insertion and withdrawal, and then suddenly slide and release the colon. This causes the endoscope to move rapidly through a considerable length of the colon, making accurate examination of the colon challenging.

[0018] It would therefore be highly advantageous to provide novel devices capable of manipulating the sidewalls of a body lumen and / or cavity to better present sidewall tissue (including visualization of areas that are initially hidden or out of view) for inspection and / or treatment during endoscopic surgery.

[0019] It would also be highly advantageous to provide novel devices that are capable of securing and / or stabilizing the distal tips and / or working ends of instruments (e.g., endoscopes, articulated and / or non-articulated devices such as graspers, cutters or dissectors, cautery tools, ultrasonic probes, etc.) inserted into body lumens and / or body cavities relative to the side walls of the lumens and / or body cavities, thereby facilitating the precise use of those instruments.

[0020] In addition, it would be very advantageous to provide novel devices that are capable of securing and / or stabilizing the distal tip and / or working end of an endoscope (and therefore, also securing and / or stabilizing the distal tips and / or working ends of other instruments inserted through the working channels of those endoscopes (such as graspers, cutters or dissectors, cautery tools, ultrasound probes, etc.)).

[0021] Moreover, it would be very advantageous to provide novel devices that are capable of securing and / or stabilizing the distal tip and / or working end of an instrument (such as a grasper, cutter or dissector, cautery tool, ultrasonic probe, etc.) that is advanced to a surgical site by means other than the working channel of an endoscope.

[0022] It would also be highly advantageous to be able to straighten bends, "iron-out" luminal surface wrinkles, 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 were initially hidden or out of view) and / or therapeutic intervention. Summary of the invention

[0023] The present invention includes providing and using a novel apparatus for manipulating the sidewalls of a body lumen and / or cavity to better present sidewall tissue (including visualization of areas that are initially hidden or out of view) for inspection and / or treatment during endoscopic surgery.

[0024] The present invention also includes providing and using a novel device that is capable of stabilizing and / or stabilizing the distal tip and / or working end of an instrument (e.g., an endoscope, an articulated and / or non-articulated device such as a grasper, a cutter or dissector, a cauterizing tool, an ultrasonic probe, etc.) inserted into a body lumen and / or body cavity relative to the side walls of the body lumen and / or body cavity, thereby facilitating the precise use of those instruments.

[0025] Among other things, the present invention includes providing and using a novel device that is capable of securing and / or stabilizing the distal tip and / or working end of an endoscope (and, therefore, also securing and / or stabilizing the distal tip and / or working end of other instruments inserted through the working channels of those endoscopes (such as graspers, cutters or dissectors, cautery tools, ultrasound probes, etc.)).

[0026] Furthermore, the present invention includes providing and using a novel device that is capable of securing and / or stabilizing the distal tip and / or working end of an instrument (such as a grasper, cutter or dissector, cautery tool, ultrasonic probe, etc.) that is advanced to a surgical site by means other than the working channel of an endoscope.

[0027] Furthermore, the present invention includes providing and using a novel device that is capable of straightening bends, "ironing" luminal surface wrinkles, and creating substantially static and stable sidewalls of body lumens and / or body cavities, which enables more accurate visual inspection (including visualization of areas that are initially hidden or out of view) and / or therapeutic intervention.

[0028] In a preferred form of the present invention, there is provided an apparatus comprising:

[0029] a sleeve adapted to slide over the exterior of the endoscope;

[0030] a proximal balloon secured to the sleeve;

[0031] an inflation / deflation tube carried by the sleeve and in fluid communication with the interior of the proximal balloon;

[0032] a push tube slidably mounted to the sleeve; and

[0033] A distal balloon is fixed to the distal end of the push tube, the interior of the distal balloon is connected to the push tube fluid, wherein the distal balloon is capable of assuming a deflated state and an inflated state, and further, when the distal balloon is in its deflated state, an axial opening extends therethrough, the axial opening is sized to accommodate an endoscope therein, and when the distal balloon is in its inflated state, the axial opening is closed.

[0034] In another preferred form of the present invention, there is provided a method of performing surgery in a body lumen and / or cavity, the method comprising:

[0035] Provide equipment, the equipment comprising:

[0036] a sleeve adapted to slide over the exterior of the endoscope;

[0037] a proximal balloon secured to the sleeve;

[0038] an inflation / deflation tube carried by the sleeve and in fluid communication with the interior of the proximal balloon;

[0039] a push tube slidably mounted to the sleeve; and

[0040] a distal balloon secured to the distal end of the push tube, the interior of the distal balloon being in fluid communication with the push tube, wherein the distal balloon is capable of assuming a deflated state and an inflated state, and further wherein, 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;

[0041] positioning the device in a body lumen and / or cavity;

[0042] inflating the proximal balloon;

[0043] advancing the push tube distally;

[0044] inflating the distal balloon; and

[0045] Perform the surgery.

[0046] In another preferred form of the present invention, there is provided an apparatus comprising:

[0047] a sleeve adapted to slide over the exterior of the endoscope, the sleeve comprising a passageway integrally formed with the sleeve and a lumen integrally formed with the sleeve for receiving an instrument;

[0048] a proximal balloon secured to the sleeve;

[0049] an inflation / deflation tube carried by the sleeve and in fluid communication with the interior of the proximal balloon;

[0050] a push tube slidably mounted in the passageway of the sleeve; and

[0051] A distal balloon is fixed to the distal end of the push tube, and the interior of the distal balloon is in fluid communication with the push tube.

[0052] In another preferred form of the present invention, there is provided a method of performing surgery in a body lumen and / or cavity, the method comprising:

[0053] Provide equipment, the equipment comprising:

[0054] a sleeve adapted to slide over the exterior of the endoscope, the sleeve comprising a passageway integrally formed with the sleeve and a lumen integrally formed with the sleeve for receiving an instrument;

[0055] a proximal balloon secured to the sleeve;

[0056] an inflation / deflation tube carried by the sleeve and in fluid communication with the interior of the proximal balloon;

[0057] a push tube slidably mounted in the passageway of the sleeve; and

[0058] a distal balloon fixed to the distal end of the push tube, the interior of the distal balloon being in fluid communication with the push tube; positioning the device in a body lumen and / or cavity;

[0059] inflating the proximal balloon;

[0060] advancing the push tube distally;

[0061] inflating the distal balloon; and

[0062] Perform the surgery.

[0063] In another preferred form of the present invention, there is provided an apparatus comprising:

[0064] a sleeve adapted to slide over the exterior of the endoscope so as to substantially cover the endoscope from a point adjacent the distal end of the endoscope to a point adjacent the handle of the endoscope;

[0065] a proximal balloon secured to the sleeve;

[0066] an inflation / deflation tube carried by the sleeve and in fluid communication with the interior of the proximal balloon;

[0067] a push tube slidably mounted to the sleeve; and

[0068] A distal balloon is fixed to the distal end of the push tube, and the interior of the distal balloon is in fluid communication with the push tube.

[0069] In another preferred form of the present invention, there is provided a method of performing surgery in a body lumen and / or cavity, the method comprising:

[0070] Provide equipment, the equipment comprising:

[0071] a sleeve adapted to slide over the exterior of the endoscope so as to substantially cover the endoscope from a point adjacent the distal end of the endoscope to a point adjacent the handle of the endoscope;

[0072] a proximal balloon secured to the sleeve;

[0073] an inflation / deflation tube carried by the sleeve and in fluid communication with the interior of the proximal balloon;

[0074] a push tube slidably mounted to the sleeve; and

[0075] a distal balloon fixed to the distal end of the push tube, the interior of the distal balloon being in fluid communication with the push tube; positioning the device in a body lumen and / or cavity;

[0076] inflating the proximal balloon;

[0077] advancing the push tube distally;

[0078] inflating the distal balloon; and

[0079] Perform the surgery.

[0080] In another preferred form of the present invention, there is provided an apparatus comprising:

[0081] a sleeve adapted to slide over the exterior of the endoscope;

[0082] a proximal balloon secured to the sleeve;

[0083] an inflation / deflation tube carried by the sleeve and in fluid communication with the interior of the proximal balloon;

[0084] a pair of push tubes slidably mounted to the sleeves; and

[0085] A distal balloon is fixed to the distal ends of the pair of push tubes, and the interior of the distal balloon is in fluid communication with the pair of push tubes.

[0086] In another preferred form of the present invention, there is provided a method of performing surgery in a body lumen and / or cavity, the method comprising:

[0087] Provide equipment, the equipment comprising:

[0088] a sleeve adapted to slide over the exterior of the endoscope;

[0089] a proximal balloon secured to the sleeve;

[0090] an inflation / deflation tube carried by the sleeve and in fluid communication with the interior of the proximal balloon;

[0091] a pair of push tubes slidably mounted to the sleeves; and

[0092] a distal balloon fixed 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;

[0093] positioning the device in a body lumen and / or cavity;

[0094] inflating the proximal balloon;

[0095] advancing the pair of push tubes distally;

[0096] inflating the distal balloon; and

[0097] Perform the surgery.

[0098] In another preferred form of the present invention, there is provided an endoscopic tissue retraction system, the endoscopic tissue retraction system comprising:

[0099] an element configured to be removably mounted to an endoscope; and

[0100] A connector is configured to be secured to the element and to the tissue to be retracted.

[0101] In another preferred form of the present invention, there is provided a method for endoscopically retracting tissue, the method comprising:

[0102] positioning an endoscope and an element movably mounted to the endoscope adjacent tissue to be retracted;

[0103] securing a connector to the element and to the tissue to be retracted; and

[0104] Use the connector to encourage tissue away from the endoscope.

[0105] In another preferred form of the invention, there is provided an apparatus for endoscopic tissue retrieval, the apparatus comprising: a balloon configured to be removably mounted to an endoscope;

[0106] An eyelet is formed on the balloon.

[0107] In another preferred form of the present invention, there is provided a method for endoscopically retracting tissue, the method comprising:

[0108] 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;

[0109] securing a connector to the tissue to be retracted; and

[0110] Use the connector to encourage tissue away from the endoscope.

[0111] In another preferred form of the present invention, there is provided a method for endoscopically retracting tissue, the method comprising:

[0112] positioning an endoscope and an element movably mounted to the endoscope adjacent to tissue to be retracted;

[0113] securing the tissue to be retracted to the element; and

[0114] The tissue is urged away from the endoscope by the moving element.

[0115] In another preferred form of the present invention, there is provided an apparatus for endoscopic tissue retrieval, the apparatus comprising:

[0116] a balloon configured to be removably 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

[0117] A wing is mounted in the axial opening of the balloon so as to form a concave pocket for accommodating anatomical tissue together with the surrounding portion of the balloon.

[0118] In another preferred form of the present invention, there is provided a method for removing endoscopic tissue, the method comprising:

[0119] Positioning the distal end of the balloon assembly distal to the tissue to be removed, the balloon assembly being movably mounted to the endoscope and comprising (i) a balloon capable of assuming a deflated state and an inflated state, wherein when the balloon is in its deflated state, an axial opening extends therethrough, and when the balloon is in its inflated state, the axial opening is closed, and (ii) a fin mounted in the axial opening of the balloon so as to be formed together with a surrounding portion of the balloon for accommodating the tissue to be removed;

[0120] positioning the tissue to be removed into the pocket; and

[0121] The balloon assembly is withdrawn proximally to remove tissue contained within the pocket.

[0122] In other preferred forms of the present invention, additional systems for endoscopically retracting tissue are provided.

[0123] And, in other preferred forms of the present invention, additional methods of endoscopically retracting tissue are provided.

[0124] In one preferred form of the invention, there is provided an apparatus for endoscopically retracting tissue, the apparatus comprising:

[0125] a sleeve adapted to slide over the exterior of the endoscope;

[0126] a balloon movably mounted to the sleeve; and

[0127] at least one connector extending from the balloon and configured to be secured to tissue to be retracted;

[0128] Wherein, the balloon is configured to move relative to the sleeve to retract tissue.

[0129] In another preferred form of the present invention, there is provided a method for endoscopically retracting tissue, the method comprising:

[0130] An apparatus for endoscopically retracting tissue is provided, the apparatus comprising:

[0131] a sleeve adapted to slide over the exterior of the endoscope;

[0132] a balloon movably mounted to the sleeve; and

[0133] at least one connector extending from the balloon and configured to be secured to the tissue to be retracted;

[0134] positioning an endoscope disposed within the sleeve adjacent to the tissue to be retracted;

[0135] securing at least one connector to the balloon and to the tissue to be retracted; and

[0136] By moving the balloon away from the endoscope, tissue is retracted away from the endoscope.

[0137] In another preferred form of the present invention, there is provided an apparatus for endoscopically retracting tissue, the apparatus comprising:

[0138] a sleeve adapted to slide over the exterior of the endoscope; and

[0139] A tensioning tool extends through the sleeve and is configured to be secured to tissue to be retracted.

[0140] In another preferred form of the present invention, there is provided a method for endoscopic tissue retraction, the method comprising:

[0141] An apparatus for endoscopically retracting tissue is provided, the apparatus comprising:

[0142] a sleeve adapted to slide over the exterior of the endoscope; and

[0143] a tensioning tool extending through the sleeve and configured to be secured to the tissue to be retracted;

[0144] positioning an endoscope disposed within the sleeve adjacent to the tissue to be retracted;

[0145] connecting a tensioning tool to the tissue to be retracted; and

[0146] By moving the tensioning tool relative to the endoscope, the tissue is retracted.

[0147] In another preferred form of the present invention, there is provided an apparatus for endoscopically retracting tissue, the apparatus comprising:

[0148] a sleeve adapted to slide over the exterior of the endoscope;

[0149] a pair of push tubes slidably mounted to the sleeve, the pair of hollow push tubes 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 the tissue to be retracted;

[0150] Wherein, the pair of push tubes are configured to move relative to the sleeve to retract tissue.

[0151] In another preferred form of the present invention, there is provided a method for endoscopically retracting tissue, the method comprising:

[0152] An apparatus for endoscopically retracting tissue is provided, the apparatus comprising:

[0153] a sleeve adapted to slide over the exterior of the endoscope;

[0154] a pair of push tubes slidably mounted to the sleeve, the pair of push tubes being connected to each other at their distal ends with a bridge; and at least one connector extending from the bridge and configured to be secured to the tissue to be retracted;

[0155] positioning an endoscope disposed within the sleeve adjacent to the tissue to be retracted;

[0156] securing at least a connector to the pair of push tubes and the tissue to be retracted; and

[0157] Tissue is retracted away from the endoscope by moving the pair of push tubes relative to the endoscope. BRIEF DESCRIPTION OF THE DRAWINGS

[0158] These and other objects and features of the present invention will be more fully disclosed or apparent from the following detailed description of the preferred embodiments of the present invention, which should be read in conjunction with the attached Figure 1 Considered together, in the drawings, like numerals refer to like parts, and further in the drawings:

[0159] Figure 1 is a schematic diagram showing a novel device formed according to the present invention, wherein, among other things, the novel device includes a sleeve disposed on the 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 the distal end of the push tubes, and a push tube handle mounted to the proximal end of the push tubes;

[0160] Figures 2 to 4 is a schematic diagram showing various arrangements of the anterior balloon relative to the posterior balloon;

[0161] Figure 5 It shows Figure 1 a schematic diagram showing further details of the distal end of the device;

[0162] Figure 6 is along Figure 5 a cross-sectional view taken along line 6-6;

[0163] Figure 7 and Figure 8 is a schematic diagram showing further details of the anterior balloon;

[0164] Fig. 8A is a schematic diagram showing a push tube handle;

[0165] Fig. 9 and Fig.10 is a schematic diagram showing the construction details of the anterior balloon;

[0166] Fig.11 is a schematic diagram showing a form of an inflation mechanism provided according to the present invention;

[0167] Fig.11A is a schematic diagram showing another form of an inflation mechanism provided according to the present invention;

[0168] Fig.12 and Fig.13 is a schematic diagram showing another form of an inflation mechanism provided according to the present invention;

[0169] Fig.14 is a schematic diagram showing a pressure relief valve that can be used to ensure that the pressure within the front balloon and / or the rear balloon does not exceed a predetermined level;

[0170] Fig.15 It is shown that it can be used to tighten Figure 1 A schematic diagram of a slack retraction system in a flexible tube of the device shown;

[0171] Figures 16 to 30 It shows the use of Figure 1 A schematic diagram of a preferred embodiment of the device;

[0172] Fig. 30A is a schematic diagram showing an alternative configuration of the push tube and push tube handle of the present invention;

[0173] Fig.31 is a schematic diagram showing another form of a sleeve, wherein the sleeve includes an additional lumen for accommodating an instrument;

[0174] Figure 32 to Figure 35 is a schematic diagram showing how an instrument may be advanced through an additional lumen of a sleeve;

[0175] Fig.36 is a schematic diagram showing an instrument catheter that may be disposed in an additional lumen of a sleeve, wherein an instrument may be advanced through the instrument catheter;

[0176] Figures 37 to 42 is a schematic diagram showing an endoscopic tissue retraction system formed in accordance with the present invention;

[0177] Figure 43 to Figure 45 is a schematic diagram showing another endoscopic tissue retraction system formed in accordance with the present invention;

[0178] Fig.46 is a schematic diagram showing yet another endoscopic tissue retraction system formed according to the present invention;

[0179] Fig.47 is a schematic diagram showing yet another endoscopic tissue retraction system formed according to the present invention;

[0180] Fig.48 is a schematic diagram showing another endoscopic tissue retraction system formed in accordance with the present invention;

[0181] Fig.49 is a schematic diagram showing yet another endoscopic tissue retraction system formed according to the present invention;

[0182] Fig.50 is a schematic diagram showing yet another endoscopic tissue retraction system formed according to the present invention;

[0183] Figure 51 to Figure 52 is a schematic diagram showing another endoscopic tissue retraction system formed in accordance with the present invention;

[0184] FIG. 52A to FIG. 52B is a schematic diagram showing yet another endoscopic tissue retraction system formed according to the present invention;

[0185] Figures 53 to 60 is a schematic diagram showing an endoscopic tissue retrieval system formed in accordance with the present invention;

[0186] Fig.61 is a schematic diagram showing another endoscopic tissue retraction system formed in accordance with the present invention;

[0187] Figure 62 to Figure 65 is a schematic diagram showing a preferred manner of using an endoscopic tissue retraction system formed according to the present invention;

[0188] Fig.66 is a schematic diagram showing yet another endoscopic tissue retraction system formed according to the present invention;

[0189] Figures 66A to 66C is a schematic diagram showing another endoscopic tissue retraction system formed according to the present invention;

[0190] Figures 67 to 70 is a schematic diagram showing yet another endoscopic tissue retraction system formed according to the present invention; and

[0191] Fig.71 is a schematic diagram showing yet another endoscopic tissue retraction system formed according to the present invention. DETAILED DESCRIPTION

[0192] The present invention includes providing and using a novel apparatus for manipulating the sidewalls of a body lumen and / or cavity to better present sidewall tissue (including visualization of areas that are initially hidden or out of view) for inspection and / or treatment during endoscopic surgery.

[0193] (As used herein, the term "endoscopic procedure" is intended to refer to any minimally invasive or limited access procedure, diagnostic and / or therapeutic and / or surgical procedure that is essentially used to enter a body lumen and / or body cavity intraluminally, transluminally or otherwise for observation, biopsy and / or treatment of tissue (including removal of lesions and / or excision of tissue, etc.).

[0194] The present invention also includes providing and using a novel device that is capable of stabilizing and / or stabilizing the distal tip and / or working end of an instrument (e.g., an endoscope, an articulated and / or non-articulated device such as a grasper, a cutter or dissector, a cauterizing tool, an ultrasonic probe, etc.) inserted into a body lumen and / or body cavity relative to the side walls of the body lumen and / or body cavity, thereby facilitating the precise use of those instruments.

[0195] Among other things, the present invention includes providing and using a novel device that is capable of stabilizing and / or stabilizing the distal tip and / or working end of an endoscope (and, therefore, also stabilizing and / or stabilizing the distal tips and / or working ends of other instruments inserted through the working channels of those endoscopes (such as graspers, cutters or dissectors, cautery tools, ultrasound probes, etc.)).

[0196] Furthermore, the present invention includes providing and using a novel device that is capable of securing and / or stabilizing the distal tip and / or working end of an instrument (such as a grasper, cutter or dissector, cautery tool, ultrasonic probe, etc.) that is advanced to a surgical site by means other than the working channel of an endoscope.

[0197] Furthermore, the present invention includes providing and using a novel device that is capable of straightening bends, "ironing out" luminal surface wrinkles, and creating substantially static and stable sidewalls of body lumens and / or body cavities, which enables more accurate visual inspection (including visualization of areas that are initially hidden or out of view) and / or therapeutic intervention.

[0198] Novel equipment

[0199] According to the present invention, and now see Figure 1 , a novel device 5 is shown that is capable of manipulating the side walls of a body lumen and / or body cavity (e.g., stabilizing, straightening, dilating and / or flattening it) to better present the side wall tissue (including visualization of areas that were initially hidden or out of view) for inspection and / or treatment using an endoscope 10 (e.g., an articulated endoscope) during endoscopic surgery, and / or for stabilizing the distal end of the endoscope 10 and / or other instruments (e.g., graspers, cutters or dissectors, cautery tools, ultrasound probes, etc., during endoscopic surgery Figure 1 ) having a distal tip and / or working end.

[0200] More specifically, the device 5 generally includes a sleeve 15 adapted to slide over the exterior of the shaft of the endoscope 10, a proximal (or "rear") balloon 20 secured to the sleeve 15 near the distal end of the sleeve (the terms "proximal" and "rear" will be used interchangeably hereinafter), and a base 25 secured to the sleeve 15 at the proximal end of the sleeve. The device 5 also includes a pair of push tubes 30 slidably mounted to the sleeve 15 as will be discussed below, and a distal (or "front") balloon 35 secured to the distal ends of the push tubes 30 (the terms "distal" and "front end" 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 front balloon 35 by moving the push tubes 30 relative to the sleeve 15 (e.g., by simultaneously advancing the two push tubes at a push tube handle 37, see below). See FIG. Figure 1 and Figures 2 to 4 The device 5 also includes an associated inflation mechanism 40 ( Figure 1 ) is used to enable a physician or (or other operator or user) to selectively inflate / deflate one or both of the rear balloon 20 and the front balloon 35.

[0201] Watch now Figures 1 to 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 provide a close fit therewith, wherein the sleeve is sized and configured so that it will easily slide back onto the endoscope during installation thereon (preferably with the endoscope "dry"), but will have sufficient residual friction with the outer surface of the endoscope (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 rotation) and pushing / pulling of the endoscope (e.g., within a patient's colon) during use. In one preferred form of the invention, sleeve 15 can move circumferentially to some extent about endoscope 10 (and can rotate with the shaft of the endoscope when firmly grasped by the hand of a physician or other operator or user); but sleeve 15 can only nominally move in an axial direction relative to endoscope 10. The sleeve 15 is sized so that when its distal end is substantially aligned with the distal end of the endoscope 10, the sleeve 15 (together with the base 25) will substantially cover the shaft of the endoscope. In any case, the sleeve 15 is sized so that when it is mounted to the endoscope 10 and the endoscope 10 is inserted into the patient, the sleeve 15 extends out of the patient's body. In a preferred form of the invention, the device 5 is provided in accordance with a particular endoscope with which it is intended to be used, wherein the device 5 is sized so that when the base 25 is engaged with the handle of the endoscope, the distal end of the sleeve 15 will be appropriately positioned at the distal end of the endoscope, i.e., substantially aligned with or slightly proximal to the distal end of the endoscope.

[0202] If desired, the distal end of the sleeve 15 can be provided with a radially inwardly extending stop (not shown) to positively engage the distal surface of the endoscope 10, thereby preventing the distal end of the sleeve 15 from moving proximally beyond the distal surface of the endoscope 10. Such a radially inwardly extending stop can also help prevent "torque slip" of the sleeve 15 relative to the endoscope 10 during twisting (i.e., rotational rotation) of the endoscope within the colon and / or "thrust slip" of the sleeve 15 relative to the endoscope 10 during pushing the endoscope forward within the colon.

[0203] The sleeve 15 preferably has a smooth outer surface so that it is non-traumatic to tissue, and is preferably made of a highly flexible material so that the sleeve does not inhibit the bending of the endoscope during use. In a preferred form of the invention, the sleeve 15 includes polyurethane, polyethylene, polyvinyl chloride (PVC), polytetrafluoroethylene (PTFE), etc., and is preferably transparent (or at least translucent) to allow the distance markings on the endoscope 10 to be visualized through the sleeve 15. And, in a preferred form of the invention, the sleeve 15 preferably has a nominal clamp strength so that the doctor (or other operator or user) can grasp the endoscope 10 through the sleeve 15, for example, to twist the endoscope. If desired, the sleeve 15 can include a lubricating coating (e.g., a liquid, powder, etc. such as perfluoropolyether synthetic oil) on some or all of its inner and / or outer surfaces to facilitate the sleeve being placed on the endoscope and / or moving the device 5 through a body lumen and / or body cavity. Alternatively, the sleeve 15 can be formed of a material that is lubricating itself, such as polytetrafluoroethylene (PTFE), etc. It will be appreciated that the interior surface of the sleeve 15 may include features (eg, ribs) to prevent rotation of the sleeve relative to the endoscope during use.

[0204] If desired, a vacuum may be "pulled" between the sleeve 15 and the endoscope 10, thereby securing the sleeve 15 to the endoscope 10 and minimizing the profile of the sleeve 15. By way of example and not limitation, the 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 and not limitation, it will also be appreciated that removal of the sleeve 15 from the endoscope 10 (e.g., at the conclusion of a procedure) may be facilitated by introducing a fluid (e.g., air or a liquid lubricant) into the space between the sleeve 15 and the endoscope 10 (e.g., at the proximal end of the sleeve 15 (i.e., at the base 25) or at the intermediate sleeve 15).

[0205] Still watching now Figures 1 to 6, the rear balloon 20 is fixed to the sleeve 15, just near the articulated joint at the distal end of the endoscope close to the sleeve but spaced therefrom. The rear balloon 20 is concentrically arranged around the sleeve 15, and therefore around the endoscope 10 arranged within the sleeve 15. Therefore, 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 tube 45, which has its distal end in fluid communication with the interior of the rear balloon 20 and has 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. The fitting 46 is preferably a Luer activated valve, which allows the inflation mechanism 40 to be disconnected from the fitting 46 without losing pressure in the rear balloon 20. The inflation / deflation tube 45 may be secured to an exterior surface of the sleeve 15 , or more preferably, the inflation / deflation tube 45 may be contained within a lumen 47 formed within the sleeve 15 .

[0206] Preferably, the rear balloon 20 is disposed a short distance rearward from the distal end of the sleeve 15, i.e., approximately the same distance as the length of the articulated portion of the steerable endoscope 10, so that when the steerable endoscope is disposed in the sleeve 15, the articulated portion of the steerable endoscope will be disposed distal to the rear balloon 20. This configuration allows the flexible portion of the steerable endoscope to be articulated even after the rear 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 secure platform for maintaining the endoscope 10 in a stable position within a body lumen or cavity, wherein the endoscope 10 is centered within the body lumen or cavity. As a result, the endoscope 10 can provide improved visualization of the anatomical configuration. In addition, because the endoscope 10 is securely held within a body lumen or cavity by the inflated rear balloon 20, instruments that are advanced through the interior lumen of the endoscope 10 (sometimes referred to as the "working channel" or "multiple working channels") will also be provided with a safety platform for supporting those instruments within the body lumen or cavity.

[0207] When the posterior balloon 20 is properly inflated, it can atraumatically engage and form a sealing relationship with the sidewalls of the body lumen within which such device 5 is disposed.

[0208] In one preferred form of the invention, the posterior balloon 20 is made of polyurethane.

[0209] A base 25 is secured to the proximal end of the sleeve 15. The base 25 engages with the endoscope 10 and helps secure the entire assembly (i.e., the device 5) to the endoscope 10. The base 25 preferably comprises a substantially rigid or semi-rigid structure that can be grasped and pulled proximally by a physician (or other operator or user), thereby allowing the physician (or other operator or user) to pull 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, the base 25 is pulled proximally along the endoscope until the base 25 rests against the handle of the endoscope, thereby inhibiting further proximal movement of the base 25 (and therefore inhibiting further proximal movement of the sleeve 15). In a preferred form of the invention, the base 25 is brought into sealing engagement with the endoscope 10.

[0210] The push tube 30 is slidably mounted to the sleeve 15, whereby the distal end of the push tube can be extended and / or retracted relative to the sleeve 15 (e.g., by advancing or retracting the push tube via the push tube handle 37, see below), and thus distally extended and / or retracted relative to the endoscope 10 disposed in the sleeve 15. Preferably, the push tube 30 is slidably disposed in a support tube 50 that is fixed to the outer surface of the sleeve 15, or more preferably contained within a lumen 52 formed within the sleeve 15. The support tube 50 is preferably formed of a low friction material (e.g., polytetrafluoroethylene, also referred to as "PTFE") so as to minimize resistance to movement of the push tube 30 relative to the support tube 50 (and, therefore, minimize resistance to movement of the push tube 30 relative to the sleeve 15). In this regard, it should be appreciated that minimizing resistance to movement of the push tube 30 relative to the support tube 50 improves tactile feedback for the user when the push tube 30 is used to manipulate the front balloon 35. In one form of the invention, the support tube 50 is flexible (so as to allow the endoscope 10, and in particular the articulated portion of the steerable endoscope 10, to flex as needed during a procedure); however, the support tube 50 also provides some breaking strength. Thus, when the support tube 50 is mounted 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 breaking strength (whereas the sleeve 15 itself is flexible but has substantially no breaking strength). Where the push tube 30 is contained within the lumen 52 formed in the sleeve 15, and where the support tube 50 is not disposed between the push tube 30 and the lumen 52, the lumen 52 is preferably lubricated to minimize friction between the push tube 30 and the lumen 52.

[0211] The proximal end of the push tube 30 is connected to the push tube handle 37. Due to 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 causing the front balloon 35 to move distally relative to the rear 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 causing the front balloon 35 to move proximally relative to the rear balloon 20). Note 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. Clamp 53 ( Fig.12 and Fig.15 ) is disposed at the base 25 for maintaining the push tube 30 in a selected configuration relative to the base 25 (and therefore in a selected configuration relative to the sleeve 15).

[0212] Push tube 30 is preferably formed of a relatively flexible material that provides good breaking strength, such as a polyethylene resin (such as Isoplast TM (available from The Lubrizol Corporation of Wickliffe, Ohio), polyethylene, polypropylene, nylon, and the like. It should be appreciated that the push tube 30 can include a single material or multiple materials, and that the stiffness of the push tube 30 can vary along its length. By way of example but not limitation, the distal-most portion of the push tube 30 can be formed from 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 can include a different, more resilient, flexible material. By way of example but not limitation, the distal-most portion of the push tube 30 can include a nickel-titanium alloy. By further example but not limitation, the distal-most portion of the push tube 30 can include 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 / deflation of the front balloon 35. By forming the push tube 30 with a distal end that is more flexible than the remainder of the push tube, the push tube 30 and the front balloon 35 can together act as a guide wire (with a soft, atraumatic tip) for the device 5 and the endoscope 10, as discussed further below.

[0213] In a preferred form of the invention, the push tubes 30 are configured to maintain a parallel arrangement when they are in an unbiased state, i.e., when no force is applied to the push tubes 30. This is the case regardless of the state of inflation or deflation of the anterior balloon 35.

[0214] If desired, the distal-most portion of the push tube 30 can be configured to bend inwardly or outwardly. With this configuration, when the distal tip of the push tube 30 is maintained stationary (e.g., by the inflated front 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 front balloon 35 and the sleeve 15) can bend or bow outwardly, thereby pushing outwardly on the sidewalls of the body lumen in which the device 5 is disposed, thereby providing a "tent-like" effect on the sidewalls of the body lumen and / or body cavity in the space between the rear balloon 20 and the front balloon 35. The "tent-like" effect can significantly improve visibility and / or tissue stability in the area distal to the endoscope 10 by pushing outwardly on the sidewalls of the body lumen and / or body cavity in which the device 5 is disposed.

[0215] It should also be appreciated that by forming the push tubes 30 from a flexible material, their position may be manually adjusted during use (e.g., by using a separate tool, by twisting the device, etc.) to prevent the push tubes from interfering with visualization of the patient's anatomy and / or interfering with diagnostic or therapeutic tools introduced into the space between the anterior and posterior balloons. By way of example and not limitation, if the device 5 is positioned in the anatomy in such a way that the push tubes 30 block visual or physical access to a target region of the anatomy, the flexible push tubes 30 may be moved out of the way by using a separate tool or instrument, or by rotating the device using a twisting motion to move the flexible push tubes 30 out of the way, etc. By further example and not limitation, by constructing the push tubes 30 so that they are circular and flexible and have a diameter that is significantly smaller than the circular circumferential portion of the endoscope 10, when articulated, movement of the circular endoscope may simply push the push tubes out of the way and provide an unobstructed visual path to the tissue of interest.

[0216] It should also be appreciated that, if desired, the push tube 30 can be marked with indicators including distance markings (not shown), such as color indicators or radiopaque indicators, so that a physician (or other operator or user) observing the surgical site via the endoscope 10 or through radiographic guidance (e.g., X-ray fluoroscopy) can determine the relative placement of the push tube 30 relative to the side walls of the body lumen and / or other body cavities in both the longitudinal and / or circumferential directions of the surgical site.

[0217] 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 front balloon 35 ( Figures 1 to 5 , Figure 7 and Figure 8), and its internal lumen is in fluid communication with a fitting 56 mounted to the base 25. The fitting 56 is configured to be connected to the associated inflation mechanism 40 described above so that the front 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 front balloon 35.

[0218] More specifically, in a preferred form of the invention, and now referring to Fig. 8A , the push tube handle 37 includes a hollow interior 57. The push tube 30 is mounted to the push tube handle 37 so that the push tube 30 will move with the push tube handle 37 and so 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 above-mentioned fitting 56. Due to this configuration, when the push tube handle 37 moves distally, the front balloon 35 moves distally, and when the push tube handle 37 moves proximally, the front balloon 35 moves proximally. In addition, when positive fluid pressure is applied to the fitting 56 in the base 25, positive fluid pressure is applied to the interior of the front balloon 35, thereby inflating the front balloon 35, and when negative fluid pressure is applied to the fitting 56 in the base 25, negative fluid pressure is applied to the interior of the front balloon 35, thereby deflating the front balloon 35.

[0219] It should be appreciated that the dual push tube arrangement provides a number of advantages. By way of example and not limitation, the dual push tube arrangement provides symmetrical forces to the front balloon 35 as the front balloon is advanced distally into the body lumen, as will be discussed below. In addition, when the push tube is used to correct anatomical structures in an area proximal to the distal end of the endoscope 10, the dual push tube 30 arrangement provides equal outward forces to adjacent anatomical structures, thereby enhancing visibility and / or access to the anatomical structures, as will be discussed below. In addition, the dual push tube arrangement ensures that the front balloon 35 remains in the center of the endoscope 10, thereby facilitating the front balloon 35 to disengage from the endoscope 10 and re-park the front balloon 35 on the endoscope 10, as will be discussed below. In addition, the dual push tube 30 arrangement helps ensure that the front balloon 35 is stable relative to the tip of the endoscope, thereby minimizing the rotational movement of the front balloon when inflated. Furthermore, the provision of dual hollow push tubes provides a redundant air delivery system for inflating or deflating the front balloon 35 .

[0220] The front balloon 35 is fixed to the distal end of the push tube 30, so that the spacing between the rear balloon 20 and the front 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). In addition, the hollow push tube 30 provides a conduit between the interior of the front balloon 35 and the fitting 56, thereby allowing selective inflation / deflation of the front balloon 35 via the fitting 56.

[0221] Notably, the anterior balloon 35 is configured such that (i) when it is deflated (or partially deflated) and in a "retracted" position relative to the sleeve 15 ( Figure 2 ), the front balloon 35 provides an axial opening 63 (large enough to accommodate the shaft of the sleeve 15 and the endoscope 10) therein. Figure 7 , Figure 8 and Fig.10 ), whereby the front balloon 35 can be "docked" on the sleeve 15 and the endoscope 10, and (ii) when the front balloon 35 is in its "extended" position relative to the sleeve 15 and properly inflated ( Figure 4 ), the axial opening 63 is closed (and preferably completely closed). At the same time, when properly inflated, the front balloon can non-traumatically engage with and form a sealing relationship with the side wall of the body lumen in which such a device 5 is disposed. Therefore, when the front balloon 35 is properly inflated, the front balloon can effectively seal the body lumen and / or body cavity distal to the front balloon 35 by closing the axial opening 63 and forming a sealing relationship with the side wall of the body lumen and / or body cavity in which the device 5 is disposed. In this way, when the push tube 30 is advanced distally to separate the front balloon 35 from the rear balloon 20, and when the front balloon 35 and the rear balloon 20 are properly inflated, the two balloons will create a sealing area (sometimes referred to as a "treatment area" below) between them.

[0222] It will be appreciated that when the front balloon 35 is reconfigured from its deflated state to its inflated state, the front balloon 35 expands radially inwardly (so as to close the axial opening 63) and radially outwardly (so as to engage the surrounding tissue).

[0223] Thus, it will be seen that the front balloon 35 has a "donkey" shape when deflated (to allow it to rest on the distal end of an endoscope), and has a substantially "three-dimensional" shape when inflated (to allow it to close a body lumen or cavity).

[0224] For this reason, and now see Fig. 9 and Fig.10, the front balloon 35 is preferably manufactured as a single construction, which includes a 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 protrusion 74 is provided on the proximal extension 73, and its configuration matches the configuration of the push tube 30 (i.e., in the case where the device 5 includes two push tubes 30 diametrically opposed to each other, the proximal extension 73 will include two protrusions 74 diametrically opposed to each other; in the case where the device 5 includes three push tubes 30 equally spaced circumferentially around the circumference of the sleeve 15, the proximal extension 73 will include three protrusions 74 equally spaced circumferentially around the circumference of the proximal extension 73; in the case where the device 5 includes one push tube 30, the proximal extension 73 will include one protrusion 74, etc. - for the purposes of the present invention, the proximal extension 73 and (multiple) protrusions 74 can be collectively referred to as having a "key-shaped" cross-section). During assembly, the push tube 30 is seated in the protrusion 74 of the proximal extension 73, the proximal extension 73 is everted into the interior of the body 67 (wherein the interior of the hollow push tube 30 is in fluid communication with the interior of the body 67), and then the distal extension 76 is everted into the interior of the proximal extension 73, thereby to provide the front balloon 35 having an axial opening 63 extending therethrough, wherein the push tube 30 is secured to the front balloon 35 and in communication with the interior of the front balloon 35. Notably, the axial opening 63 is sized to accommodate the distal end of the endoscope 10 therein. Also notably, the front balloon 35 is formed by the above 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, providing multiple layers of balloon material around the push tube 30, thereby providing a more robust balloon construction. In addition, providing multiple layers of balloon material around the push tube 30 also increases the cushioning effect on the distal end of the push tube 30, thereby providing an even more atraumatic distal tip for the push tube 30 and further ensuring that the distal tip of the push tube 30 will not damage adjacent tissue.

[0225] In one preferred form of the invention, the anterior balloon 35 is made of polyurethane.

[0226] It should be appreciated that when the front balloon 35 is in its inflated state, the material of the front balloon 35 substantially contains the distal end of the push tube 30 (while still allowing the push tube 30 to be in fluid communication with the interior of the front balloon 35), thereby providing an atraumatic tip for advancing the front balloon 35 distally through a body lumen. In addition, the push tube 30 and the deflated front balloon 35 can essentially together act as a soft-tipped guide wire for the device 5 and endoscope 10, as further discussed below ( Fig. 20 ).

[0227] If desired, one or both of the rear balloon 20 and the anterior balloon 35 can be marked with an indicator (e.g., a color indicator or an opaque indicator) so that a physician (or other operator or user) observing the surgical site via endoscope 10 or radiographic guidance (e.g., X-ray fluoroscopy) can determine the placement of one or both balloons at the surgical site.

[0228] Inflation mechanism 40 provides a means to selectively inflate posterior balloon 20 and / or anterior balloon 35 .

[0229] In a preferred form of the invention, and now referring to Figure 1 and Fig.11 , the inflation mechanism 40 includes a single-line syringe inserter 140, which includes a body 145 and a plunger 150. Preferably, a spring 153 is provided in the body 145 to automatically return the plunger 150 at the end of its stroke. The syringe inserter 140 is connected to one or the other of the fittings 46, 56 via a line 155. Therefore, with this configuration, when the single-line syringe inserter 140 is used to inflate the rear balloon 20, the syringe inserter 140 is connected to the fitting 46 via the line 155, so that the output of the single-line syringe inserter 140 is directed to the rear balloon 20 (i.e., via the proximal inflation / deflation tube 45). Accordingly, when the single-line syringe inserter 140 is used to inflate the front balloon 35, the syringe inserter 140 is connected to the fitting 56 via the line 155, so that the output of the single-line syringe inserter 140 is directed to the front balloon 35 (i.e., via the hollow interior of the flexible tube 59 and the push tube 30).

[0230] In another preferred form of the present invention, the inflation mechanism 40 includes an elastic ball 156 having a first port 157 and a second port 158. A one-way valve 159 (e.g., a check valve) is provided in the first port 157 so that air can pass through the first port 157 only when traveling in an outward direction. A one-way valve 159 (e.g., a check valve) is provided in the second port 158 ​​so that air can pass through the second port 158 ​​only when traveling in an inward direction. When the elastic ball 156 is compressed (e.g., by hand), the air inside the interior of the elastic ball 156 is squeezed out of the first port 157; and when the elastic ball 156 is subsequently released, the air is sucked into the interior of the elastic ball 156 through the second port 158.

[0231] Due to this configuration, when the elastic ball 156 is used to inflate the rear balloon 20, the first port 157 is connected to the fitting 46 via the line 155 so that the positive pressure output of the elastic ball 156 is directed toward the rear balloon 20. The elastic ball 156 can then be used to deflate the rear balloon 20, i.e., by connecting the second port 158 ​​to the fitting 46 via the line 155 so that the suction of the elastic ball 156 is directed toward the rear balloon 20. Accordingly, when the elastic ball 156 is used to inflate the front balloon 35, the first port 157 is connected to the fitting 56 via the line 155 so that the positive pressure output of the elastic ball 156 is directed toward the front balloon 35. The elastic ball 156 can then be used to deflate the front balloon 35, i.e., by connecting the second port 158 ​​to the fitting 56 via the line 155 so that the suction of the elastic ball 156 is directed toward the front balloon 35.

[0232] Instead, and now look at Fig.12 and Fig.13 , the syringe 160 can be used to inflate the rear balloon 20 and / or the front balloon 35. The inflation mechanism 160 includes a body 161 and a plunger 162. Preferably, a spring (not shown) is provided in the body 161 to automatically return the plunger 162 at the end of its power stroke. The syringe 160 is connected to the accessories 46, 56 via a line 163. With this configuration, the syringe 160 includes a valve 165 for connecting the syringe 160 to the front balloon 35 or the rear balloon 20 and a valve 170 for selecting inflation or deflation of the balloon to which it is connected.

[0233] Therefore, with this configuration, when the syringe 160 is used to inflate the rear balloon 20, the valve 165 (a two-position valve that connects the valve 170 to either the front balloon or the rear balloon) is set so that the syringe 160 is connected to the rear balloon 20 through the fitting 46, and the valve 170 (a two-way switching valve that allows the one-way valve to be arranged to inflate in one configuration and deflate in another configuration) is set so that the syringe 160 provides the inflation pressure. Thereafter, when the rear balloon 20 is deflated, the valve 170 is set to its deflated position.

[0234] Accordingly, when the syringe 160 is used to inflate the front balloon 35, the valve 165 is set so that the syringe 160 is connected to the front balloon 35 via the fitting 56, and the valve 170 is set so that the syringe 160 provides the inflation pressure. Thereafter, when the front balloon 35 is deflated, the valve 170 is set to its deflated position.

[0235] In yet another form of the invention, inflation mechanism 40 may include an automated source of fluid pressure (either positive or negative), such as an electric pump.

[0236] If you want, and now see Fig.14, then the pressure relief valve 175 can be connected to the inflation / deflation line connected to the front balloon 35 to ensure that the pressure within the front balloon 35 does not exceed a predetermined level. Fig.14 , a pressure relief valve 180 may be connected to the 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.

[0237] Alternatively and / or additionally, one or more pressure gauges 182 ( Figure 1 or Fig.13 ) can be incorporated into the fluid line connected to the posterior balloon 20 and / or the fluid line connected to the anterior balloon 35 to provide the physician (or other operator or user) with information related to the pressure within the posterior balloon 20 and / or the anterior balloon 35 so as to avoid overinflation and / or help the physician (or other operator or user) determine the inflation status of the balloons during surgery.

[0238] Furthermore, it will be appreciated that when the front balloon 35 is in its "retracted" position ( Figure 2 ) and its "extended" position ( Figure 4 ), the flexible tube 59 connecting the push tube 30 to the base 25 (and therefore to the fitting 56) may bunch around the base 25, thereby potentially interfering with the movement of the physician (or other operator or user). Fig.15 , a flexible tube retraction system 185 (eg, within the base 25 ) may be provided to take up the slack in the flexible tube 59 when the front balloon 35 is extended.

[0239] Preferred methods of using the novel device

[0240] Device 5 can be used to manipulate the side walls of a body lumen and / or body cavity (e.g., stabilize, straighten, dilate and / or equalize them) to better present side wall tissue (including visualization of areas that were initially hidden or out of view) for inspection and / or treatment using endoscope 10 during endoscopic surgery, and / or to stabilize the distal tip and / or working end of an instrument (e.g., a grasper, cutter or dissector, a cautery tool, an ultrasound probe, etc.) for advancement, for example, into a treatment area.

[0241] More specifically, in use, the sleeve 15 is first mounted on the endoscope 10 ( Figure 1 ). This can be accomplished by pulling the base 25 proximally over the distal end of the endoscope 10 and then proximally along the length of the endoscope 10 until the distal end of the sleeve 15 is substantially aligned with the distal tip of the endoscope 10. At this point, the rear balloon 20 is deflated, the front balloon 35 is deflated, and the front balloon 35 is resting on the distal end of the endoscope 10. The endoscope 10 and device 5 are ready to be inserted into the patient as a unit.

[0242] Next watch Fig.16 , endoscope 10 and device 5 are inserted as a whole into a body lumen and / or body cavity of a patient. By way of example and not limitation, endoscope 10 and device 5 are inserted as a whole into the gastrointestinal (GI) tract of a patient. Endoscope 10 and device 5 are advanced along the body lumen and / or body cavity to a desired position within the patient ( Fig.17 and Fig.18 ).

[0243] When the device 5 is used (e.g., to manipulate the sidewall of the gastrointestinal tract to provide increased visualization of the gastrointestinal tract and / or to increase access to the gastrointestinal tract and / or to stabilize the instrument relative to the gastrointestinal tract), the rear balloon 20 is inflated to stabilize the device 5 (and thus the endoscope 10) within a body lumen and / or cavity. Fig.19 , which may be accomplished using the associated inflation mechanism 40 described above.

[0244] In this regard, it will be appreciated that because the articulated portion of the endoscope is located distal to the posterior balloon 20, the endoscope will be able to articulate distal to the posterior balloon 20 even after the posterior balloon 20 is inflated to facilitate visualization of the anatomy. Significantly, such visualization is enhanced because the posterior balloon 20 stabilizes the endoscope 10 within the gastrointestinal tract and dilates and increases the colon to a fixed diameter directly adjacent to the posterior balloon 20.

[0245] Next, by pushing distally on the push tube handle 37, the push tube 30 is advanced distally in the body lumen and / or body cavity (i.e., so that the rear balloon 20 moves further in front of the front balloon 35). As a result, the push tube 30 and, therefore, the front balloon moves distally relative to the endoscope 10 (which is stabilized in place in the gastrointestinal tract by the inflated rear balloon 20), and, as a result, the front balloon 35 moves distally relative to the endoscope 10. It is noted that during this distal advancement of the front balloon 35, the deflated front balloon 35 covers the distal end of the push tube 30, thereby ensuring atraumatic advancement of the front balloon 35. It is noted that the atraumatic advancement of the front balloon 35 can be further enhanced by forming the distal end of the push tube 30 with a more elastic material.

[0246] When the push tube 30 has advanced the front balloon 35 to the desired position distal to the endoscope 10, the front balloon 35 is inflated ( Fig. 20), in order to secure the front balloon 35 to the anatomical structure. Again, this can be accomplished using the associated inflation mechanism 40 described above. When the front balloon 35 is inflated, the inflated front balloon 35, the inflated rear balloon 20, and the push tube 30 will all work together to stabilize, straighten, expand, and / or flatten the sidewalls of the body lumen and / or body cavity, thereby better presenting the sidewall tissue (including visualization of areas that were initially hidden or out of view) for inspection and / or treatment using the endoscope 10 during endoscopic surgery. In this regard, it will be appreciated that the inflated front balloon 35 and the inflated rear balloon 20 will together expand and tension the sidewalls of the body lumen and / or body cavity, and that as the front balloon extends distally from the rear balloon, the push tube 30 will tend to straighten the anatomical structure between the two inflated balloons. In this regard, it will also be appreciated that once both the posterior balloon 20 and the anterior balloon 35 have been inflated, the anterior balloon 35 will create a substantially full diameter seal across the body lumen and / or body cavity (because the inflated anterior balloon closes the axial opening 63 extending through the anterior balloon when the anterior balloon is in its deflated state), and the posterior balloon 20 will cooperate with the sleeve 15 and the endoscope 10 to create another substantially full diameter barrier across the body lumen and / or body cavity. Thus, the inflated anterior balloon 35 and the inflated posterior balloon 20 will together define a substantially enclosed region along the body lumen and / or body cavity (i.e., an isolated treatment region that prevents the passage of fluids and / or other liquids by the airtight seal established by the inflated anterior balloon 35 and the posterior balloon 20). By inflating the front balloon 35 and the rear balloon 20 , the sidewalls of the body lumen and / or body cavity will be tensioned, thereby better presenting the sidewalls of the body lumen and / or body cavity for observation through the endoscope 10 .

[0247] It should be appreciated that the expansion and tensioning of the side walls of the body lumen and / or body cavity achieved by the inflated front balloon 35, the inflated rear balloon 20 and the push tube 30 can be further enhanced by causing the front balloon to advance and grasp the side walls of the body lumen and / or body cavity as it is inflated, thereby tensioning the side walls of the body lumen and / or body cavity.

[0248] Significantly, because the inflated anterior balloon 35 and the inflated posterior balloon 20 together define a substantially enclosed region (i.e., an isolated treatment region) along a body lumen and / or body cavity, the inflated anterior balloon 35 and / or body cavity can then be treated with a fluid (e.g., air, CO 2 etc.) to inflate this area ( Fig.21 ) in order to further tension the sidewalls of the body lumen and / or body cavity, thereby better presenting the sidewalls of the body lumen and / or body cavity for viewing through the endoscope 10 and stabilizing the sidewalls, thereby facilitating more precise therapeutic intervention.

[0249] If desired, the anterior balloon 35 can be retracted toward the posterior balloon 20 (i.e., by pulling the push tube handle 37 proximally) while remaining inflated (and thereby maintaining a grip on the sidewalls of the body lumen and / or cavity) in order to mobilize the visible mucosa and further improve visualization and access (see Fig. 22 ), for example, thereby locating a specific target area on the side wall of a body lumen and / or body cavity at a convenient angle relative to the endoscope and endoscopic tools.

[0250] Alternatively, if desired, once the rear balloon 35 has been inflated, the push tube 30 can be advanced distally for a portion (but only a portion) of its full distal stroke, then the front balloon 35 can be inflated to grip the body lumen and / or the sidewalls of the body cavity, and then the push tube 30 can be advanced further distally. This action will cause the flexible push tube 30 to bow outward (see FIG. 22A to FIG. 22D ), thereby contacting the side walls of the body lumen and / or body cavity and pushing the side walls of the body lumen and / or body cavity outward, for example in a "tent-like" manner, thereby further enhancing the visualization of the side walls of the body lumen and / or body cavity through the endoscope 10.

[0251] If desired, the instrument 190 ( Fig.23 ) can be advanced through the working channel of the endoscope 10 to biopsy and / or treat a pathological condition (e.g., resect a pathological anatomical structure). It will be appreciated that such an instrument will extend through the distal end of the endoscope, which is effectively stabilized relative to the anatomical structure via the rear balloon 20, so that the working end of the instrument 190 will also be highly stable relative to the anatomical structure. This is a significant advantage over the prior art practice of advancing the instrument out of the unstable end of the endoscope. Preferably, the instrument 190 comprises an articulated instrument having a full range of motion, thereby better accessing the target anatomical structure.

[0252] In addition, if bleeding from a tissue site is not visible, or if bleeding occurs and the surgeon is unable to determine the source of the bleeding, isolating the treatment area allows for rapid irrigation (e.g., with a fluid such as saline) of the anatomical segment where the treatment area is located, and subsequent rapid removal of the irrigation fluid (see Figure 24 to Figure 26 ).

[0253] Likewise, if desired, the anterior balloon 35 can be directed with high precision to the bleeding site, so that the anterior balloon 35 (e.g., inflated) can be used to apply localized pressure to the bleeding site to enhance bleeding control (see Fig. 27 ). This can be done under the visualization provided by the endoscope 10.

[0254] If it is desired to reposition the endoscope 10 within the anatomy with minimal interference from the device 5, the front balloon 35 is returned to its donut configuration (i.e., partially deflated), the front balloon is proximally retracted and "re-docked" on the distal end of the endoscope 10, the rear balloon 20 is deflated, and then the endoscope 10 (with the device 5 carried thereon) is repositioned within the anatomy. Note that in the event that the front balloon 35 is to be re-docked on the distal end of the endoscope 10, the front balloon 35 is preferably only partially deflated until the front balloon 35 is re-docked on the distal end of the endoscope, because the partial inflation of the front balloon 35 may provide the front balloon 35 with sufficient "body" to facilitate the re-docking process. Thereafter, if desired, the front balloon 35 may be fully deflated, for example, to forcibly grasp the distal end of the endoscope 10.

[0255] Alternatively, if desired, the front balloon 35 can be used as a drag brake to control retrograde motion 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 cavity until the tip of the endoscope is in the proper position. Next, the rear balloon 20 is inflated, the push tube 30 is advanced distally, and then the front balloon 35 is inflated ( Fig.28 ). Visualization and optional therapeutic treatment can then be achieved at this location. When the device is moved retrogradely, the rear balloon 20 is deflated, the front balloon 35 is partially deflated, and the endoscope is then withdrawn proximally to drag the semi-inflated front balloon ( ) along the body lumen and / or body cavity. Fig.29 ), wherein the front balloon 35 acts as a brake to some extent when the endoscope is pulled proximally, thereby allowing more controlled retrograde movement of the endoscope and thus better visualization of the anatomy. If this is desired in some circumstances, the rear balloon 20 and the front balloon 35 can be re-inflated with or without the introduction of fluid into the "isolated treatment zone" established between the two balloons, such as Fig.30 As shown, in order to stabilize, straighten, dilate and / or flatten the anatomical structure.

[0256] The rear balloon 20 may also be used as a brake, either alone or in combination with the above-described braking action from the front balloon 35, when withdrawing the endoscope (and therefore the device 5) from the anatomy.

[0257] At the end of the procedure, the endoscope 10 and device 5 are withdrawn from the anatomy. Preferably, this is accomplished by deflation (or partial deflation) of the front balloon 35, thereby retracting the push tube 30, causing the front balloon 35 to "re-dock" on the distal end of the endoscope 10, fully deflating the front balloon 35 so that it grips the distal end of the endoscope, deflating the rear balloon 20 (if it has not already been deflated), and then withdrawing the endoscope 10 and device 5 as a whole from the anatomy.

[0258] It should be appreciated that the device 5 may be advantageously used in various ways in addition to those disclosed above. By way of example and not limitation, as the endoscope 10 (and the device 5) is advanced within the colon, it may be desirable to first distally project the front balloon 35 under visual guidance of the endoscope so that the front balloon 35 guides the distal end of the endoscope. As a result, as the endoscope is advanced distally, wherein the front balloon 35 is deflated (or partially deflated), the front balloon and the flexible push tube 30 may act as a non-traumatic guide wire (guiding structure) for the endoscope as it is advanced through the colon. Significantly, because the distal end of the push tube 30 is preferably highly flexible, when the advancing front balloon 35 encounters the colon wall (e.g., at a bend in the colon), the flexible push tube may be turned so that the front balloon follows the path of the colon, thereby facilitating non-traumatic advancement of the endoscope along the colon. It should also be appreciated that the device 5 may also be advantageously used in other ways to facilitate further inspection of the luminal surface that is currently difficult to perform otherwise. An example of this is endoscopic ultrasound examination of the lumen, which would be facilitated by a fluid-filled, inflatable anterior balloon and ultrasound probe examination.

[0259] Additional construction

[0260] If desired, the device 5 can be configured so that the push tubes 30 can be advanced or retracted independently of each other, or can be advanced or retracted in conjunction with each other - such independent advancement or retraction of the push tubes 30 can help guide the partially deflated or fully deflated front balloon 35 through the body lumen and / or body cavity, thereby facilitating the 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 the use of the inflated front balloon 35 to apply a "rotational force" to the anatomical structure, thereby better presenting the anatomical structure for visualization and / or treatment.

[0261] By way of example and not limitation, in this form of the invention, and now referring to Fig. 30A, the push tubes 30 are each independently slidably mounted to the push tube handle 37 so that the push tubes 30 can move independently of the push tube handle 37 and independently of each other. The stopper 191 limits the distal movement of the push tube 30 relative to the push tube handle 37 so that the push tube cannot be completely moved outside the push tube handle 37. Due to this configuration, when the front balloon 35 moves distally, the push tubes 30 move distally, either together or independently of each other. Moreover, when 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 can move independently of each other to "turn" the front balloon, for example, such as when the front balloon 35 is inflated and engages with the anatomical structure, thereby applying a "turning force" to the anatomical structure, or when the front balloon 35 is partially inflated and used as a non-traumatic tip of the advancement assembly, thereby helping the assembly to "turn" through the anatomical structure. It is noted that it may be desirable to provide a limiting mechanism to limit the extent to which the push rods 30 can move longitudinally, independently of one another, in order to prevent excessive rotation of the anterior balloon 35, and / or push rod crossover, and / or push rod entanglement, and / or push rod misalignment, etc. It is also noted that by mounting the push tube 30 in the clamp 53 described above, the push rods 30 can be retained in a particular configuration ( Fig.12 and Fig.15 ).

[0262] It should also be appreciated that the configuration of sleeve 15 may be modified so as to support an instrument (or hollow instrument conduit) external to endoscope 10. More specifically, referring again to Figure 5 and Figure 6 , you will see that in Figure 5 and Figure 6 In the configuration shown in FIG, the sleeve 15 includes: a lumen 47 for accommodating an inflation / deflation tube 45 for inflating / deflation of the rear balloon 20; and a pair of lumens 52 for accommodating a support tube 50, which accommodates a push tube 30 for manipulating and inflating / deflating the front balloon 35. However, if desired, the sleeve 15 may include additional lumens for supporting an instrument (or hollow instrument catheter) outside the endoscope 10.

[0263] More specifically, and now looking at Fig.31 , shows an end view of another form of sleeve 15, which includes a plurality of lumens 195 for slidably receiving instruments 190 therein. Note that when inflated, the rear balloon 20 provides a secure platform for maintaining the endoscope 10 and sleeve 15 within a body lumen or body cavity, wherein the endoscope 10 and sleeve 15 are centered within the body lumen or body cavity. As a result, the distal end of the lumen 195 of the sleeve 15 will also be securely maintained within the body lumen or body cavity to provide secure support for instruments advanced through the lumen 195 of the sleeve 15.

[0264] The proximal end of lumen 195 may extend to base and through base 25, in which case the instrument may be inserted into lumen 195 at base 25, or the proximal end of lumen 195 may terminate proximal to base 25 (but still outside the patient's body), 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 endoscope 10 is 180 cm in length and instrument 190 is 60 cm in length, it may be advantageous to insert instrument 190 into lumen 195 at a point closer to balloon 20, 35 than at base 25. Note that in Fig.31 , the lumen 47 for accommodating the inflation / deflation tube 45 and the inflation / deflation tube 45 for inflating / deflating the rear balloon 20 are not visible because the view is facing distally and is taken at a position distal to where the lumen 47 and the inflation / deflation tube 45 terminate on the sleeve 15.

[0265] Figure 32 to Figure 35 Various instruments 190 are shown extending out of lumen 195. Note that instruments 190 preferably include articulated instruments, such as Figure 32 to Figure 35 Grasping forceps 190A, Figure 32 to Figure 33 The cautery device 190B, Fig.34 and Fig.35 Scissors 190C and Figure 32 to Figure 35 Suction device 190D in.

[0266] It should be appreciated that where the sleeve 15 includes a central passageway for accommodating the endoscope 10, a lumen 47 for accommodating the inflation / deflation tube 45, a lumen 52 for accommodating the support tube 50 for accommodating the push tube 30, and / or a lumen 195 for slidably accommodating the instrument 190 therein, the sleeve 15 is preferably formed by an extrusion process.

[0267] In a preferred form of the present invention, the lumen 47 for accommodating the inflation / deflation tube 45, the lumen 52 for accommodating the support tube 50 for accommodating the push tube 30, and / or the lumen 195 for slidably accommodating the instrument 190 may have a fixed configuration (i.e., a fixed diameter) such that the sleeve 15 has a fixed outer contour.

[0268] In another preferred form of the present invention, the lumen 47 for accommodating the inflation / deflation tube 45, the lumen 52 for accommodating the support tube 50 for accommodating the push tube 30, and / or the lumen 195 for slidably accommodating the instrument 190 can have an expandable configuration (i.e., when empty, they can have a minimal profile, and when filled, they can fully expand as needed) so that the overall profile of the sleeve 15 is minimized.

[0269] It should also be appreciated that where the 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 end of the lumens 195 in order to provide improved support for the instruments 190 received within the 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 instruments 190. It is noted that the opening in such a support ring for passage of the instruments 190 is preferably tightly fitted with the instruments in order to provide excellent instrument support at the distal end of the sleeve 15.

[0270] Alternatively and / or additionally, lumen 195 may contain a hollow instrument catheter that itself contains 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. Furthermore, such a hollow instrument catheter may have a fixed geometry or a bendable or articulated geometry. See, e.g. Fig.36 , a hollow instrument conduit 200 is shown extending out of lumen 195 and housing instrument 190 therein. Note that hollow instrument conduits 200 can move independently relative to each other (and independently relative to sleeve 15). Note also that instrument 190 preferably fits tightly with hollow instrument conduits 200 to provide excellent instrument support at the distal end of sleeve 15.

[0271] It will also be appreciated that, if desired, the two push tubes 30 may be replaced with a single push tube 30 or more than two push tubes 30, such as three push tubes 30. It will be appreciated that where multiple push tubes 30 are provided, it will generally be desirable to circumferentially space the push tubes equally apart from one another, such as where two push tubes 30 are provided, it will generally be desirable to space the two push tubes 30 180 degrees apart, where three push tubes 30 are provided, it will generally be desirable to space the push tubes 120 degrees apart, and so forth.

[0272] Tissue Retraction and Tissue Removal

[0273] Tissue Retraction

[0274] In some cases, it may be necessary or desirable to strip tissue within a body lumen or cavity. By way of example and not limitation, endoscopic submucosal dissection (ESD) is an endoscopic dissection procedure used to remove intestinal lesions in a single operation, even if the intestinal lesions are quite large. With ESD, a cutting tool (e.g., an electrocautery blade equipped with an energy source) is passed through an endoscope to directly strip the lesion along the submucosal layer of the intestine, resulting in a safer overall dissection of even large lesions.

[0275] Conventional ESD presents many challenges. First, this technique involves pushing the endoscope tip into the tissue, using a clear plastic cap placed on the tip of the endoscope, which stretches the submucosal fibers and aids in tissue stripping. However, this technique partially obscures the surgeon's field of view. Second, fluid, debris, and smoke often collect in the clear plastic cap placed on the tip of the endoscope, further obscuring the surgeon's field of view.

[0276] In addition to the above, ESD procedures are often time consuming and often require several hours. Most of this time is usually spent dissecting the lesion along the submucosal layer of the intestine.

[0277] Similar problems may occur during other intracavitary tissue dissection procedures.

[0278] An endoscopic tissue retraction system compatible with ESD procedures and other endoluminal tissue dissection procedures would provide the surgeon with better visualization of the surgical field and expedite the dissection process.

[0279] Tissue removal

[0280] In addition to the above, lesions (or other detached tissues) may be difficult to remove after lesions are removed from the submucosal layer of the intestine or after other tissues are removed during an intraluminal tissue removal procedure due to the technical challenges of (i) locating the detached lesions (or other detached tissues) within the intestine and (ii) grasping the detached tissues (or other detached tissues) with a removal tool. In addition, if detached lesions (or other detached tissues) including early-stage cancers migrate within the intestine, they may contaminate (e.g., potentially seed) disease-free areas of the intestine with cancer cells.

[0281] An endoscopic tissue retrieval system that is compatible with ESD procedures and other endoluminal tissue dissection procedures would provide the surgeon with greater control and protection of the dissected tissue within the intestine.

[0282] Endoscopic tissue retraction system

[0283] To this end, in a preferred form of the present invention, and now see Figures 37 to 42, shows a novel device 5 that is used in conjunction with an endoscopic tissue retraction system 300 to provide the surgeon with better visualization of the surgical field and to accelerate the dissection process, such as during an ESD procedure. In this form of the invention, a connector 305 is secured to (i) the front balloon 35 (or push tube 30) and (ii) the lesion 315. This can be accomplished by clamping the connector 305 to the front 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 the connector 305 and surgical clip 320 can be delivered to the surgical site through the working channel of the endoscope 10 (or through the instrument lumen 195 of the device 5). With the connector secured to both the front balloon 35 (or push tube 30) and the lesion 315, the front balloon 35 can be advanced distally to tension the connector 305, thereby pushing the lesion 315 in the distal direction (i.e., applying force thereto). The cutting tool 325 can 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 peel the lesion 315 along the submucosal layer 330 of the intestine 335. It will be appreciated that after the lesion 315 has been cut from the submucosal layer of the intestine, the lesion 315 will remain tethered to the anterior balloon 35 by means of the connector 305 and surgical clip 320.

[0284] In a preferred form of the invention, connector 305 comprises a loop of material (e.g., a loop made of extruded filaments, a loop made of webbing, etc.). Alternatively, connector 305 may comprise a single strand of material (e.g., a single strand made of extruded filaments, a single strand made of webbing, a single strand made of wire, a single strand made of suture, etc.).

[0285] In one preferred form of the invention, the connector 305 is made of an elastomeric material (e.g., an elastomeric filament or elastomeric webbing) such that when the lesion 315 is cut from the submucosal layer 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-elastic, flexible material. In yet another form of the invention, the connector 305 may be made of a non-elastic, rigid material.

[0286] In one form of the invention, the front balloon 35 is advanced distally to tension the connector 305, thereby advancing (i.e., applying force to) the lesion 315 in the distal direction. In an alternative form of the invention, and now referring to Figure 43 to Figure 45, where the connector 305 comprises an elastomeric material, the connector 305 may be secured to one or the other of the front balloon 35 and the lesion 315, stretched, secured to the other of the front balloon 35 and the lesion 315, and then released, thereby advancing the lesion 315 in the distal direction (i.e., applying force thereto) without requiring any movement of the front balloon 35 in the distal direction. Alternatively, the connector 305 may be stretched, secured (in its stretched condition) to the front balloon 35 and the lesion 315, and then released, thereby advancing the lesion in the distal direction (i.e., applying force thereto) without requiring any movement of the front balloon 35 in the distal direction.

[0287] In another form of the invention, and now looking at Fig.46 , the connector 305 may include a loop 340 of variable length, for example, the loop 340 may include a slipknot 345 with a tensioning end 350. In this form of the invention, with the connector 305 in a relaxed state, the connector 305 is clamped to the front balloon 35 (or push tube 30) with a surgical clip 320, and the connector 305 is clamped to the lesion 315 with another surgical clip 320. The connector 305 is then tensioned (e.g., by pulling on the tensioning end 350 of the slipknot 345 using a tool advanced through the working channel of the endoscope 10 or through the instrument lumen 195 of the device 5), thereby advancing the lesion 315 in the distal direction (i.e., applying force thereto). The cutting tool 325 can 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 peel the lesion 315 along the submucosal layer 330 of the intestine 335. Again, it will be appreciated that after the lesion 315 has been peeled away from the submucosal layer of the intestine, the lesion 315 will remain tethered to the anterior balloon 35 by means of the connector 305 and surgical clip 320.

[0288] 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 the tensioning end 350 are replaced with a length adjustment clip 355 and one or more tensioning ends 360. Fig.47 In this form of the invention, the ring 340 is tensioned by pulling on the tensioning end or ends 360 using a tool advanced through the working channel of the endoscope 10 (or through the instrument lumen 195 of the device 5).

[0289] In some cases, and now see Fig.48, it may be advantageous to provide the connector 305 with a substantially rigid ring 365 at its proximal end (i.e., lesion side). By way of example and not limitation, where the connector 305 is in the form of a ring, the ring of the connector 305 may pass through the center of the substantially rigid ring 365. The substantially rigid ring 365 may facilitate securing the connector 305 to the lesion 315, for example, making it easier to clamp the connector 305 to the lesion 315 using a surgical clip 320.

[0290] In some cases, it may be desirable to use multiple connectors 305 to connect the lesion 315 to the anterior balloon 35. This can allow the lesion 315 to be tensioned distally in multiple directional vectors and multiple attachment points, which can aid in peeling the lesion 315 from the submucosal layer 330 of the intestine 335. See Fig.49 .

[0291] Instead, and now look at Fig.50 In the case where the connector 305 is in the form of a ring, a plurality of substantially rigid rings 365 can be mounted to a single connector 305, and the plurality of substantially rigid rings 365 can be secured to different locations on the lesion 315, thereby allowing the lesion 315 to be tensioned distally with multiple directional vectors and multiple attachment points. Alternatively, in the case where the connector 305 is in the form of a ring, different segments of the ring can be secured to different locations on the lesion 315 using a plurality of surgical clips 320, thereby allowing the lesion 315 to be tensioned distally with multiple directional vectors and multiple attachment points.

[0292] In one form of the invention, the connector 305 is attached to the front balloon 35 (or push tube 30) in situ using a surgical clip 320. However, if desired, the connector 305 can be pre-attached to the front balloon (or one or more push tubes 30) at the time of manufacture (or at some other time before the front balloon 35 is inserted into the body). By way of example and not limitation, and now referring to FIG. Fig.51 and Fig.52 , the connector 305 can be pre-attached to the front balloon 35 using an eyelet or an eyelet lined with a grommet.

[0293] It should also be appreciated that in some cases it may be possible to secure the anterior balloon 35 (or one of the push tubes 30) directly to lesion 315 without the use of 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 lesion 315. See, e.g. Fig.52A , which shows a surgical clip 320 that secures the anterior balloon 35 directly to the lesion 315 without the use of a connector 305. See also Fig.52B , which shows a surgical clip 320 securing the push tube 30 directly to the lesion 315 without the use of a connector 305 .

[0294] Once the lesion 315 has been stripped from the submucosal layer 330 of the intestine 335 (or other tissue has been stripped from its location within the body lumen), the stripped tissue must typically be removed from the patient's body. Because the stripped tissue is secured to the front balloon 35 (or push rod 30) by means 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 patient's body, which will withdraw the stripped tissue from the patient's body as the front balloon 35 is withdrawn from the patient's body. However, this approach presents a risk that the stripped tissue tears from the front balloon 35 (or push tube 30), for example due to failure of the surgical clip to be mounted to the stripped tissue or due to failure of the surgical clip to be mounted to the front balloon (or push tube), etc. In addition, 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 may pose a risk to the patient, for example, when the stripped tissue includes disease-free areas of the intestine (or other body lumen area) that may contaminate (e.g., potentially seeded with cancer cells).

[0295] Endoscopic tissue retrieval

[0296] For this reason, and now see Figures 53 to 60 , the front balloon 35 may include a wing 375 disposed within a central hole 380 of the front balloon 35. The wing 375 is configured such that (i) when the front balloon 35 is parked on the endoscope 10, the wing 375 is captured between the endoscope 10 and the front balloon 35; (ii) when the front balloon 35 is detached from the endoscope 10 and then protrudes distally away from the endoscope 10 and then fully inflated, the wing 375 is captured within the closed central hole 380 of the front balloon 35 ( Fig.53 and Fig.54 ); and (iii) when the front balloon 35 protrudes distally away from the endoscope 10 and is then partially deflated, so that the central hole 380 of the front balloon 35 reopens to expose the wing 375 ( Fig.55 and Fig.56 ), the fin 375 can be "pulled down" across the central hole 380 of the front balloon 35 (e.g., using a tool advanced through the instrument lumen 195 of the endoscope 10 or device 5) so as to form a concave pocket 385 within the central hole 380 of the front balloon 35 together with the surrounding portion of the front balloon 35 that defines the central hole 380 ( Fig.57 and Fig.58 The pocket 385 is configured to accommodate the exfoliated tissue ( Fig.59 and Fig.60 ).

[0297] Thus, in this form of the invention, after the lesion 315 is peeled off from the submucosal layer 330 of the intestine 335 (or after other tissue is peeled off from its location within the body lumen), the peeled 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 patient's body, which will cause the peeled tissue to be withdrawn from the patient's body when the front balloon 35 is withdrawn from the patient's body. Note that this can be done while the peeled tissue is still connected to the front balloon 35 (or push tube 30) via the connector(s) 305 and / or the surgical clip(s) 320. Note also that this approach effectively eliminates the risk of the dissected tissue tearing from the anterior balloon 35 (or push tube 30), such as due to failure of a surgical clip to be installed on the dissected tissue or due to failure of a surgical clip to be installed on the anterior balloon (or push tube), etc., and reduces the risk of early cancer lesions contaminating (e.g., potentially seeding) disease-free areas of the intestine (or other body lumen) with cancer cells because the dissected tissue is shielded within the concave pocket as it is withdrawn from the patient's body.

[0298] Additional endoscopic tissue retraction

[0299] It is also possible to tension the lesion 315 away from the endoscope 10 (eg, for dissection purposes) in a variety of other ways.

[0300] By using one or more connectors to connect the lesion to the non-inflated portion of the anterior balloon 35 and moving the anterior A balloon is used to tension the lesion

[0301] By way of example and not limitation, and now see Fig.61It is also possible to fix the front balloon 35 directly to the lesion 315 using the connector 305. In this form of the invention, the front balloon 35 includes an inflatable portion 36 and a non-inflatable portion (e.g., a non-inflatable neck 38), and the connector 305 passes through the non-inflatable neck 35 of the front balloon 35 and is connected to the lesion 315, for example, using a clip 320. The connector 305 passes through the non-inflatable portion of the front balloon 35 (e.g., the non-inflatable neck 38 of the front balloon 35) by passing a needle carrying the connector directly through the non-inflatable portion of the front balloon 35, or by passing the connector through a hole (or eyelet) formed in the non-inflatable portion of the front balloon 35. The free end of the connector 305 is then connected to the lesion 315, for example, using a clip 320. In a preferred form of the invention, the connector 305 is a strand of suture. It should be appreciated that the strand of suture forming the connector 305 may be passed through the neck 38 of the front balloon 35 (or another non-inflated portion of the front balloon 35) before the device 5 is inserted into the patient's body, or the strand of suture may be passed through the neck 38 of the front balloon 35 (or another non-inflated portion of the front balloon 35) after the device 5 has been inserted into the patient's body. Alternatively, the front balloon 35 may be manufactured with the connector 305 (e.g., a strand of suture) pre-attached to the neck 38 of the front balloon 35 (or the non-inflated portion of the front balloon 35).

[0302] In use, the device 5 is placed on the endoscope 10, the endoscope 10 and the device 5 combination is advanced into the intestine 335 so that the endoscope 10 is just proximal to the lesion 315, the rear balloon 20 is inflated to stabilize the endoscope relative to the lesion, the connector 305 is attached to the neck 38 of the front balloon 35 (or another non-inflated portion of the front balloon 35) by the clip 320 and connected to the lesion 315, and the push tube 30 is moved distally to tension the lesion 315 away from the endoscope 10 (or the instrument lumen 195). The lesion 315 is then peeled off from the submucosal layer 330 of the intestine 335 using the cutting tool 325 that has been advanced through the working lumen (or instrument lumen 195) of the endoscope 10.

[0303] If desired, multiple connectors 305 can 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, multiple strands of suture can be passed through the neck 38 (or other non-inflated portion) of the anterior balloon 35, where one or more connectors 305 are attached to the lesion 315 (e.g., using one or more clips 320).

[0304] Alternatively, it is possible to clip the connector 305 to the non-inflated portion of the anterior balloon 35 (e.g., the non-inflated neck 38 of the anterior balloon 35) using a clip (e.g., clip 320), and then connect the connector 305 to the lesion 315. In addition, multiple connectors 305 can be clipped to the non-inflated portion of the anterior balloon 35 and used to connect the lesion 315 to the anterior balloon 35.

[0305] In another form of the invention, and now looking at Figure 62 to Figure 65 , a first connector 305 can be connected to the front balloon 35 (e.g., by passing the connector 305 through the neck 38 (or another non-inflated portion) of the front balloon 35, thereby clamping the connector 305 to the non-inflated portion of the front 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 ring 305A extending from the first connector 305.

[0306] The extension loop 305A is particularly useful when a lesion is located just proximal to a significant colonic turn. By way of example and not limitation, when a lesion 315 (e.g., a polyp) is located just proximal to a significant colonic turn (e.g., just proximal to the liver, spleen, or other colonic flexure), it may be difficult to connect the front balloon 35 to the lesion 315 (e.g., using a connector 305 and a clamp 320) and then tension the lesion 315 by advancing the front balloon 35 distally within the colon. More specifically, when a lesion 315 is located just proximal to a significant colonic turn, the front balloon 35 will push against the colon wall at the turn as it moves distally within the colon to tension the lesion (see FIG. 1 ). Fig.62 To prevent the front balloon 35 from pushing against the colon wall, the device 5 can be advanced into the straight portion of the colon so that the front balloon 35 (with the first connector 305 attached thereto) is positioned distal to the colon bend and the rear balloon 20 is positioned proximal to the colon bend (see Fig.63 ). Then, the second connector 305 is advanced into the colon, wherein one end of the second connector 305 is connected to the proximal side of the lesion 315 (eg, using an endoscopic clip 320) (see Fig.64 ), and the other end of the second connector 305 is connected to the first connector 305 (eg, using a second endoscope clip 320) to form an extension ring 305A (see Fig.65 ). The anterior balloon 35 can now be pushed distally along the straight portion of the colon for as long as necessary to provide the desired tension to the lesion.

[0307] 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 front balloon 35 and the lesion 315 when the front balloon 35 is positioned distal to the colonic turn and the lesion 315 is located just proximal to the pronounced colonic turn.

[0308] In another form of the invention, the device 5 can be formed without the instrument lumen 195. In this form of the invention, tools can be passed down through one or more working lumens of the endoscope. Alternatively, an endoscope with a smaller diameter than the lumen of the sleeve 15 can be used so that a space is created between the inner wall of the lumen of the sleeve 15 and the outside of the endoscope. One or more tools can then be passed through the space between the sleeve 15 and the endoscope 10.

[0309] The lesion is tensioned by connecting the lesion to a tensioning tool and moving the tensioning tool

[0310] By way of further example and not limitation, and now looking at Fig.66 , the tensioning tool 400 can be advanced down to the surgical site through the instrument lumen 195 of the device 5 (or the working lumen of the endoscope 10), and then used to bias the lesion 315, for example, for peeling the lesion. It is noted that the tensioning tool 400 can directly engage and grasp the lesion 315, such as Fig.66 As shown in FIG. 3 , the tensioning tool 400 may engage and grasp the connector 305, which is itself secured to the lesion 315 (e.g., via a clip 320). Alternatively, the tensioning tool 400 may engage and grasp the connector 305, which is connected to the rigid ring 365 ( Figures 48 to 50 ), wherein a rigid loop 365 is secured to a lesion 315 (eg, via a clip 320).

[0311] In use, the device 5 is pulled on the endoscope 10, the combination of the endoscope 10 and the device 5 is advanced into the intestine 335 so that the endoscope 10 is just proximal to the lesion 315, the rear balloon 20 is inflated to stabilize the endoscope relative to the lesion, the front balloon 35 is inflated to create a sealed treatment area between the rear balloon 20 and the front balloon 35, the tensioning tool 400 is advanced through the instrument lumen 195 (or the working lumen of the endoscope 10) into the treatment area to grasp the lesion 315, and the tensioning tool 400 is moved to tension the lesion 315. The cutting tool 325 that has been advanced through the working lumen (or instrument lumen 195) of the endoscope 10 is then used to peel the lesion 315 from the submucosal layer 330 of the intestine 335 (see Fig.66 ).

[0312] In another form of the invention, the device 5 can be formed without the instrument lumen 195. In this form of the invention, the tensioning tool 400 can be passed down the working lumen of the endoscope. Alternatively, an endoscope with a smaller diameter than the lumen of the sleeve 15 can be used so that a space is created between the inner wall of the lumen of the sleeve 15 and the exterior of the endoscope. The tensioning tool 400 can then be passed through the space between the sleeve 15 and the endoscope 10 and secured to the lesion 315.

[0313] In some cases, it may be desirable to tension a lesion without creating a sealed treatment zone between two inflated balloons (e.g., without deploying an inflated front balloon and an inflated rear balloon). In such cases, it may be possible to use a simplified version of the above-described apparatus 5 with the above-described endoscope 10 and the above-described tensioning tool 400.

[0314] 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 apparatus 5 can be simplified by eliminating the anterior balloon 35 described above, and a tensioning tool 400 can be used with this simplified form of the apparatus 5 to tension the lesion (see Fig.66A ). This can be accomplished by pulling a simplified form of the device 5 over the endoscope 10, advancing the combination of the endoscope 10 and the simplified device 5 into the intestine 335 so 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 the working lumen of the endoscope 10) to engage and tension the lesion 315, and then using the cutting tool 325 (e.g., advanced through the working lumen or instrument lumen 195 of the endoscope 10) to peel the lesion 315 from the submucosal layer 330 of the intestine 335.

[0315] By way of further example but not limitation, the device 5 may be further simplified by eliminating the aforementioned anterior balloon 35 and the aforementioned push tube 30, and this further simplified form of the device 5 may then be used to tension a lesion (see Fig.66B ). More specifically, this can be accomplished by pulling a further simplified form of the device 5 on the endoscope 10, advancing the combination of the endoscope 10 and the further simplified device 5 into the intestine 335 so 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 into the instrument lumen 195 (or the working lumen of the endoscope 10) to engage and tension the lesion 315, and then using the cutting tool 325 (e.g., advanced through the working lumen or instrument lumen 195 of the endoscope 10) to peel the lesion 315 from the submucosal layer 330 of the intestine 335.

[0316] By way of additional example and not limitation, the device 5 may be even further simplified by eliminating the aforementioned posterior balloon 20 as well as the aforementioned anterior balloon 35 and the aforementioned push tube 30, and this even further simplified form of the device 5 may then be used to tension a 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 can be tensioned by pulling this even further simplified form of the device 5 over the endoscope 10, advancing the combination of the endoscope 10 and this even further simplified device 5 into the intestine 335 so 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 peeling the lesion 315 from the submucosal layer 330 of the intestine 335 using the cutting tool 325 (e.g., advanced through the working lumen of the endoscope 10).

[0317] By way of additional example but not limitation, the device 5 may be even further simplified by eliminating the aforementioned instrument lumen 195, the aforementioned posterior balloon 20, and the aforementioned anterior balloon 35 and the aforementioned push tube 30, and this further simplified form of the device 5 may then be used to tension a lesion. Thus, in this even further simplified form of the invention, the device 5 essentially comprises a sleeve 15 on an endoscope, wherein the diameter of the endoscope is sized to be 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 exterior of the endoscope. In use, the lesion can be tensioned by pulling this further simplified form of the device 5 on the endoscope 10, advancing the combination of the endoscope 10 and this further simplified device 5 into the intestine 335 so that the endoscope 10 is just proximal to the lesion 315, advancing the tensioning tool 400 between the space between the sleeve and the endoscope to engage and tension the lesion 315, and then, using the cutting tool 325 (for example, advanced through the working lumen of the endoscope 10 or through the space between the sleeve and the endoscope) to peel the lesion 315 from the submucosal layer 330 of the intestine 335.

[0318] The lesion is tensioned by connecting it to a pair of push tubes and moving the push tubes

[0319] By way of further example and not limitation, and now looking at Fig.67, shows a further embodiment of the device 5, in which the front balloon 35 has been eliminated. In this embodiment, the distal ends of the push tubes 30 of the sleeve 15 can be connected to each other by a bridge 31, and the connector 305 can 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 the strand of suture forming the connector 305 can be attached to the bridge 31 before the device 5 is inserted into the patient's body, or the strand of suture can be attached to the bridge 31 after the device 5 has been inserted into the patient's body. Alternatively, the bridge 31 can be manufactured with the connector 305 (e.g., a strand of suture) pre-attached to the bridge 31.

[0320] The bridge 31 may be inclined distally, for example Fig.68 Alternatively, if desired, the bridge 31 may be arranged substantially perpendicular to the longitudinal axis of the push tube 30, for example Fig.69 Furthermore, if desired, the bridge 31 may be in the form of a loop, for example 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 depression or indentation (not shown) in the bridge for seating the connector 305 so as to minimize sliding of the connector 305 along the bridge 31 during tensioning of the lesion 315.

[0321] In use, this simplified form of the device 5 is pulled over the endoscope 10, the endoscope 10 and simplified device 5 combination is advanced into the intestine 335 so that the endoscope 10 is just proximal to the lesion 315, the rear balloon 20 is inflated to stabilize the endoscope relative to the lesion, the connector 305 is attached to the bridge 31 of the push tube 30 by the clip 320 and connected to the lesion 315, and the push tube 30 is moved distally to tension the lesion 315 away from the endoscope 10. The lesion 315 is then peeled away from the submucosal layer 330 of the intestine 335 using the cutting tool 325 that has been advanced through the working lumen (or instrument lumen 195) of the endoscope 10.

[0322] Alternatively, if desired, only one pushrod 30 may be provided, and the connector 305 (eg, a strand of suture) may be secured to the one pushrod 30 .

[0323] By way of further example but not limitation, the device 5 may be even further simplified by eliminating the aforementioned anterior balloon 20 and the aforementioned posterior balloon 35, and this further simplified form of the device 5 may then be used to tension a lesion. Thus, in this even further simplified form of the invention, the device 5 essentially comprises the sleeve 15, the instrument lumen 195, and the push tube 30 (see FIG. Fig.71In use, the lesion can be tensioned by pulling this further simplified form of the device 5 on the endoscope 10, advancing the combination of the endoscope 10 and this further simplified device 5 into the intestine 335 so 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 using the cutting tool 325 (e.g., advanced through the working lumen or instrument lumen 195 of the endoscope 10) to peel the lesion 31 from the submucosal layer 330 of the intestine 335.

[0324] By way of additional example but not limitation, the device 5 may be even further simplified by eliminating the instrument lumen 195, the posterior balloon 20, and the anterior balloon 35, and this even further simplified form of the device 5 may then 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 an endoscope. In use, the lesion may be tensioned by pulling this further simplified form of the device 5 on the endoscope 10, advancing the combination of the endoscope 10 and this even further simplified device 5 into the intestine 335 so that the endoscope 10 is just proximal to the lesion 315, connecting the connector 305 from the bridge 31 of the push tube 30 to the lesion 315, and moving the push tube 30 to tension the lesion 315, and then peeling the lesion 315 from the submucosal layer 330 of the intestine 335 using a cutting tool 325 (e.g., advanced through the working lumen of the endoscope 10).

[0325] When sleeve 15 is formed without instrument lumen 195, tools can 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 can be used, and one or more tools can be passed through the space between sleeve 15 and endoscope 10.

[0326] application

[0327] Thus, it will be seen that the present invention includes providing and using novel devices for manipulating the sidewalls of a body lumen and / or body cavity to better present the sidewall tissue (including visualization of areas that are initially hidden or out of view) for inspection and / or treatment during endoscopic procedures, such as to straighten bends, "iron" luminal surface wrinkles and create a substantially static or stable sidewall of a body lumen and / or body cavity, which enables more accurate visual inspection (including visualization of areas that are initially hidden or out of view) and / or therapeutic intervention. By way of example and not limitation, the novel devices may be used to stabilize, straighten, dilate and / or flatten bends and / or bends and / or wrinkles in the sidewall of the intestine to better present the sidewall tissue (including visualization of areas that are initially hidden or out of view) for inspection and / or treatment during endoscopic procedures.

[0328] The present invention also includes providing and using a novel device that is capable of securing and / or stabilizing the distal tip and / or working end of an instrument (e.g., an endoscope, an articulated and / or non-articulated device such as a grasper, a cutter or dissector, a cauterizing tool, an ultrasonic probe, etc.) inserted into a body lumen and / or body cavity during endoscopic surgery relative to the side walls of the body lumen and / or body cavity, thereby facilitating the precise use of those instruments.

[0329] By way of example and not limitation, the present device can provide a stable platform (i.e., a stable endoscope, a stable therapeutic tool, and a stable colon wall, all stable relative to each other) for performing a variety of minimally invasive procedures in body lumens and / or body cavities, including stabilizing an endoscope and / or other surgical instruments (e.g., graspers, cutters or dissectors, cauterization tools, ultrasound probes, etc.) in a body lumen and / or body cavity, for example, during lesion biopsy and / or lesion removal procedures, organ resection procedures, endoscopic submucosal dissection (ESD), endoscopic mucosal resection (EMR), etc., while stabilizing the colon (including reducing deformation of the colon wall) to enable more precise visualization, intervention, and / or surgery.

[0330] Significantly, the present invention provides novel devices that are capable of stabilizing and / or stabilizing the distal tip and / or working end of an endoscope (and thereby also stabilizing and / or stabilizing the distal tips and / or working ends of other instruments inserted through the working channels of those endoscopes (such as graspers, cutters or dissectors, cautery tools, ultrasound probes, etc.)) relative to the side walls of a body lumen and / or body cavity, and stabilizing the side walls of a body lumen and / or body cavity relative to such instruments.

[0331] The present invention also provides novel devices that are capable of securing and / or stabilizing the distal tip and / or working end of an instrument (such as a grasper, cutter or dissector, cautery tool, ultrasonic probe, etc.) that is advanced to a surgical site by means other than the working channel of an endoscope.

[0332] The novel apparatus of the present invention can be used in essentially any endoscopic procedure to facilitate alignment and presentation of tissue during an endoscopic procedure and / or to stabilize the working end of an endoscope (and / or other instruments advanced through the endoscope) relative to tissue, or to assist in advancement of an endoscope during such a procedure.

[0333] 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 sidewalls characterized by numerous 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 tubes, bronchi, bile ducts, etc.) and / or within other body cavities (e.g., head, chest, abdomen, sinuses, bladder, cavities within organs, etc.).

[0334] Revise

[0335] Although the present invention has been described in terms of certain exemplary preferred embodiments, those skilled in the art will readily understand and appreciate that it is not limited thereto and that many additions, deletions and modifications may be made to the preferred embodiments described above while remaining within the scope of the present invention.

Claims

1. A device for retracting tissue under endoscopy, the device comprising: a sleeve adapted to slide over the exterior of the endoscope; a balloon movably mounted to the sleeve; as well as a first connector extending from the balloon, wherein the first connector comprises a loop of suture; and a second connector extending from the first connector and configured to be secured to tissue to be retracted, wherein the second connector comprises a surgical clip; Wherein, the balloon is configured to move relative to the sleeve to retract the tissue.

2. The device according to claim 1, wherein: The balloon includes an inflatable portion and a non-inflatable portion, wherein the first connector is connected to the non-inflatable portion.

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

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

5. The device according to claim 1, wherein: The first connector includes a single strand of suture.

6. The device according to claim 1, wherein: The first connector includes a loop, and the second connector extends from the first connector by looping the second connector through the loop of the first connector.

7. The device according to claim 1, wherein: The balloon is movably mounted to the sleeve via at least one push tube.

8. The device according to claim 7, wherein: The at least one push tube is slidably mounted to the sleeve.

9. The device of claim 1, further comprising a third connector extending from the balloon, wherein: The third connector includes a loop of suture.

10. A device for endoscopically retracting tissue, the device comprising: a sleeve adapted to slide over an exterior of the endoscope, the sleeve having a lumen; as well as a tensioning tool extending through the sleeve and configured to be secured to tissue to be retracted; wherein the diameter of the endoscope is smaller than the diameter of the lumen so that there is a space between the sleeve and the endoscope, and wherein the tensioning tool passes through the space for retracting tissue; wherein the tensioning tool is configured to engage and grasp a connector, the connector being secured to the tissue to be retracted via a clip, or the connector being connected to a rigid loop, wherein the rigid loop is secured to the tissue to be retracted via a clip; Wherein, the connector comprises a loop of suture.

11. A device for endoscopically retracting tissue, the device comprising: a sleeve adapted to slide over the exterior of the endoscope, the sleeve having a lumen, a distal end, and a proximal end; a balloon secured to the sleeve near the distal end of the sleeve; a pair of push tubes slidably mounted to the sleeve, the pair of push tubes being connected to each other at their distal ends by a bridge; a first connector extending from the bridge, wherein the first connector comprises a loop of suture, and a second connector extending from the first connector and configured to be secured to tissue to be retracted, wherein the second connector comprises a clip; Wherein, the pair of push tubes are configured to move relative to the sleeve so as to retract the tissue.

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

13. The device according to claim 11, wherein: The bridge is in the form of a loop.

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