Method and apparatus for manipulating side wall of body lumen or body cavity

Abstract

To provide a surgical method and apparatus for manipulating a side wall of a body lumen and / or body cavity, so as to increase visualization of the same and / or facilitate access to the same and / or stabilize instruments relative to the same.SOLUTION: An apparatus comprises: an element configured to be movably attached to an endoscope; and a connector configured to be secured to the element and to the tissue which is to be retracted.SELECTED DRAWING: Figure 41

Description

[Technical Field]

[0001] This application is (i) a continuation-in-part of prior pending U.S. patent application Ser. No. 14 / 619,845, filed February 11, 2015, by Cornell University and John Fredrick Cornhill et al., for methods and apparatus for manipulating the side walls of a body cavity and / or body cavity to improve visualization and / or access thereto and / or stabilize instruments against the exterior wall, which U.S. patent application claims the benefit of priority to U.S. Provisional Patent Application Ser. No. 61 / 938,446, filed February 11, 2014, by Cornell University and John Fredrick Cornhill et al., for methods and apparatus for stabilizing, straightening, expanding and / or flattening the side walls of a body cavity and / or body cavity to improve visualization of and / or access thereto and / or stabilize instruments against the exterior wall. This application also provides (ii) a balloon tissue traction system with a balloon specimen retrieval pouch using hoops and clips with adjustable length capabilities, as described by Cornell University and Jeffrey Milsom. This application claims the benefit of priority to pending U.S. Provisional Patent Application No. 62 / 446,167, filed January 13, 2017, by Milsom et al.

[0002] The three aforementioned patent applications are incorporated herein by reference.

[0003] The present invention relates generally to surgical methods and surgical devices, and more particularly to surgical procedures for treating a body cavity and / or The present invention relates to surgical methods and devices for manipulating the side walls of body cavities to improve visualization thereof and / or facilitate access thereto and / or stabilize instruments thereagainst. [Background technology]

[0004] The human body has many different body cavities and cavities. By way of example only and not limitation, the human body has cavities such as the gastrointestinal (GI) tract, blood vessels, lymphatic vessels, ureters, fallopian tubes, bronchi, bile ducts, etc. By way of further example and not limitation, the human body has body cavities such as the head, chest, abdomen, nasal sinuses, bladder, sinuses within organs, etc.

[0005] It may often be desirable to endoscopically examine and / or treat diseased protrusions or abnormalities present in or on the sidewalls of body cavities and / or body cavities. By way of example only, and not by way of limitation, it may be desirable to examine the sidewalls of the gastrointestinal tract for the presence of lesions, and, if detected, to biopsy, remove, and / or otherwise treat the lesions.

[0006] Endoscopic examination and / or treatment of the side walls of body cavities and / or body cavities can be complicated by the morphology (both local and regional) of the body part of the side walls of the body cavities and / or body cavities and / or by the stiffness of the tissues that make up the side walls of the body cavities and / or body cavities and / or by the attachment of the side walls of the body cavities and / or body cavities to other body part structures.

[0007] By way of example only and not limitation, the intestine is a long, tubular organ having a lumen, characterized by frequent bends (i.e., the morphology of the local body part of the intestine), and has a sidewall characterized by numerous folds (i.e., the morphology of the local body part of the intestine), the sidewall tissue has a relatively flexible and pliable consistency, and the colon, in particular, is attached to the abdomen and / or other abdominal structures via flexible tissue. Full visualization of the intestinal sidewall and / or treatment of lesions formed in the intestinal sidewall can be achieved by visualizing the different morphologies (local and local) of the body part of the sidewall. (both locally and locally) and its relatively soft and flexible stiffness and flexible tissue allow it to be attached to other parts of the body. By way of example only and not limitation, in the case of colonoscopy, it has been found that approximately 5-40% of patients have sidewall body part morphology (both local and regional) and / or tissue stiffness and / or colonic attachments to other body part structures that make it difficult to fully visualize the body part (including pathological conditions in that body part, such as polyps or tumors) using a conventional endoscope and / or to fully access the body part using instruments introduced through a conventional endoscope. Summary of the Invention [Problem to be solved by the invention]

[0008] In addition to the above, it has been found that some body cavities and / or spaces may naturally spasm and / or contract, particularly when an endoscope or other instrument is introduced into the cavity and / or space. This spasm and / or contraction may cause the cavity and / or space to narrow and / or otherwise move and / or change its shape, which may further complicate and / or impair visualization of the body part with an endoscope and / or access to the body part using instruments introduced through a conventional flexible endoscope. Furthermore, during colonic examination, which typically occurs while both inserting and withdrawing an endoscope through the colon, the endoscope may grasp and / or otherwise gather the colon during insertion and withdrawal, and then suddenly slip and release the colon. As a result, the endoscope may move rapidly through a significant length of the colon, making it difficult to accurately examine the colon.

[0009] Therefore, it would be highly beneficial to provide novel devices that can manipulate the sidewalls of body cavities and / or body cavities during endoscopic procedures to better expose the sidewall tissue for examination and / or treatment (including visualization of areas that are initially hidden or out of view).

[0010] It would be highly advantageous to provide a novel device that can anchor and / or stabilize the distal tips and / or working ends of instruments inserted into body cavities and spaces (e.g., endoscopic, articulating and / or non-articulating devices such as graspers, cutters, or resectors, cauterizing instruments, ultrasonic probes, etc.) against the side walls of the body cavities and / or spaces, thereby facilitating accurate use of these instruments.

[0011] In particular, it would be highly advantageous to provide a novel device that can calm and stabilize the distal tip and / or working end of endoscopes (and thus calm and / or stabilize the distal tip and / or working channel of graspers, cutters, or other instruments inserted through the working channels of these endoscopes, such as resectors, cauterizing instruments, ultrasound probes, etc.).

[0012] It would also be highly beneficial to provide a novel device that can stabilize and stabilize the distal tip and / or working end of an instrument (such as a grasper, cutter or resector, cauterizing instrument, ultrasonic probe, etc.) advanced to a surgical site by means other than through the working channel of an endoscope.

[0013] It would also be highly beneficial to straighten bends, "ironing" folds in the inner luminal surface, and creating substantially static or stable side walls of body cavities and lumen, thereby allowing for more accurate visual inspection (including more accurate visualization of areas that are initially hidden or out of view) and / or therapeutic intervention. [Means for solving the problem]

[0014] The present invention comprises providing and using novel devices for manipulating the sidewalls of body cavities and / or bodily cavities during endoscopic procedures to better present the tissue of the sidewall for examination and / or treatment (including visualization of areas that are initially hidden or out of view).

[0015] The present invention also includes providing and using novel devices that can anchor and / or stabilize the distal tips and / or working ends of instruments inserted into body cavities and hollows (e.g., endoscopes, articulating instruments and / or non-articulating instruments such as graspers, cutters, or resectors, cauterizing instruments, ultrasonic probes, etc.) against the side walls of the body cavities and / or hollows, thereby facilitating accurate use of these instruments.

[0016] In particular, the present invention comprises providing and using novel devices that can stabilize and / or stabilize the distal tip and / or working end of endoscopes (and thus the distal tip and / or working end of other instruments inserted through the working channels of these endoscopes, such as, for example, graspers, cutters, or resectors, cauterizing instruments, ultrasonic probes, etc.).

[0017] The present invention also provides and includes steps for using novel devices that can stabilize and / or stabilize the distal tip and / or working end of an instrument (such as a grasper, cutter or resector, cauterizing instrument, ultrasonic probe, etc.) advanced to a surgical site by means other than through the working channel of an endoscope.

[0018] The present invention also includes providing and using novel devices that can straighten bends, "iron" bends, and form substantially static or stable side walls of body cavities and / or allow for more accurate visual inspection (including visualizing areas that are initially hidden or out of sight), and / or allow for therapeutic intervention.

[0019] In one preferred embodiment of the present invention, 1. An apparatus comprising: a sleeve adapted to slide over the exterior of the endoscope; a proximal balloon secured to the sleeve; an inflation / deflation tube carried by the sleeve and in fluid communication with the interior of the proximal balloon; a push tube slidably mounted on the sleeve; and 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, the distal balloon being capable of assuming a deflated state and an inflated state, wherein an axial opening extends therethrough when the distal balloon is in its deflated state, the axial opening being sized to receive an endoscope, and the axial opening is closed when the distal balloon is in its inflated state.

[0020] In another preferred form of the invention, there is provided a method for performing a process within a body cavity and / or body cavity, comprising the steps of: 1. An apparatus comprising: a sleeve adapted to slide over the exterior of the endoscope; a proximal balloon secured to the sleeve; an inflation / deflation tube carried by the sleeve and in fluid communication with the interior of the proximal balloon; a push tube slidably mounted on the sleeve; a distal balloon fixed to the distal end of the push tube, the interior of the distal balloon being providing a distal balloon in fluid communication with the push tube, the distal balloon having a deflated state and an inflated state, the distal balloon having an axial opening extending therethrough when the distal balloon is in its deflated state, the axial opening being sized to receive an endoscope, and the axial opening being occluded when the distal balloon is in its inflated state; positioning the device within a body cavity and / or body cavity; inflating the proximal balloon; advancing the push tube distally; inflating the distal balloon; and performing said process.

[0021] In another preferred embodiment of the present invention, 1. An apparatus comprising: a sleeve adapted to slide over the exterior of an endoscope, the sleeve having a passageway integrally formed therewith and a lumen integrally formed therewith for receiving an instrument; a proximal balloon secured to the sleeve; an inflation / deflation tube carried by the sleeve and in fluid communication with the interior of the proximal balloon; a push tube slidably mounted within the passage of the sleeve; and 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.

[0022] In another preferred embodiment of the present invention, 1. A method for performing a process within a body cavity and / or body cavity, comprising: 1. An apparatus comprising: a sleeve adapted to slide over the exterior of an endoscope, the sleeve having a passageway integrally formed therewith and a lumen integrally formed therewith for receiving an instrument; a proximal balloon secured to the sleeve; an inflation / deflation tube carried by the sleeve and in fluid communication with the interior of the proximal balloon; a push tube slidably mounted within the passage of the sleeve; providing the device as described above, the device including a distal balloon secured to a distal end of the push tube, the interior of the distal balloon being in fluid communication with the push tube; positioning the device within a body cavity and / or body cavity; inflating the proximal balloon; advancing the push tube distally; inflating the distal balloon; and performing said process.

[0023] In another preferred embodiment of the present invention, 1. An apparatus comprising: a sleeve adapted to slide over the exterior of the endoscope and substantially cover the endoscope from adjacent the distal end of the endoscope to adjacent the handle of the endoscope; a proximal balloon secured to the sleeve; an inflation / deflation tube carried by the sleeve and in fluid communication with the interior of the proximal balloon; a push tube slidably mounted on the sleeve; 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.

[0024] In another preferred embodiment of the present invention, 1. A method for performing a process within a body cavity and / or body cavity, comprising: 1. An apparatus comprising: a sleeve adapted to slide over the exterior of the endoscope and substantially cover the endoscope from adjacent the distal end of the endoscope to adjacent the handle of the endoscope; a proximal balloon secured to the sleeve; an inflation / deflation tube carried by the sleeve and in fluid communication with the interior of the proximal balloon; a push tube slidably mounted on the sleeve; providing the device as described above, the device including a distal balloon secured to a distal end of the push tube, the interior of the distal balloon being in fluid communication with the push tube; positioning the device within a body cavity and / or body cavity; inflating the proximal balloon; advancing the push tube distally; inflating the distal balloon; and performing said process.

[0025] In another preferred embodiment of the present invention, 1. An apparatus comprising: a sleeve adapted to slide over the exterior of the endoscope; a proximal balloon secured to the sleeve; an inflation / deflation tube carried by the sleeve and in fluid communication with the interior of the proximal balloon; a pair of push tubes slidably mounted on the sleeve; and a distal balloon secured to the distal end of the push tube, the interior of the distal balloon being in fluid communication with the pair of push tubes.

[0026] In another preferred embodiment of the present invention, 1. A method for performing a process within a body cavity and / or body cavity, comprising: 1. An apparatus comprising: a sleeve adapted to slide over the exterior of the endoscope; a proximal balloon secured to the sleeve; an inflation / deflation tube carried by the sleeve and in fluid communication with the interior of the proximal balloon; a pair of push tubes slidably mounted on the sleeve; providing the device as described above, the device including a distal balloon secured to a distal end of the push tube, the interior of the distal balloon being in fluid communication with the push tube; positioning the device within a body cavity and / or body cavity; inflating the proximal balloon; advancing the pair of push tubes distally; inflating the distal balloon; and performing said process.

[0027] In another preferred embodiment of the present invention, an element configured to be movably attached to an endoscope; a connector configured to be secured to the element and to the tissue to be retracted; An endoscopic tissue retraction system is provided, comprising:

[0028] In another preferred embodiment of the present invention, A method for endoscopically retracting tissue, comprising: positioning an endoscope and an element movably attached to the endoscope adjacent to the tissue to be retracted; securing a connector to the element and to the retracting tissue; urging the tissue away from the endoscope using the connector; A method is provided.

[0029] In another preferred embodiment of the present invention, a balloon configured to be movably attached to an endoscope; an eyelet formed in the balloon; An apparatus for endoscopic tissue retrieval is provided, comprising:

[0030] In another preferred embodiment of the present invention, 1. A method for endoscopically retracting tissue, comprising: positioning an endoscope and an element movably attached to the endoscope adjacent to tissue to be retracted, wherein a connector is secured to the element; securing the connector to the tissue to be retracted; urging the tissue away from the endoscope using the connector; A method for endoscopic tissue retraction is provided, comprising:

[0031] In another preferred embodiment of the present invention, A method for endoscopically retracting tissue, comprising: positioning an endoscope and an element movably attached to the endoscope adjacent to the tissue to be retracted; Fixing the tissue to be retracted to the element; Moving the element urges the tissue away from the endoscope. A method is provided.

[0032] In another preferred embodiment of the present invention, a balloon configured to be movably attached to an endoscope, the balloon being capable of assuming a deflated state and an inflated state, an axial opening extending therethrough when the balloon is in the deflated state, and the axial opening being closed when the balloon is in the inflated state; a flap attached to the axial opening of the balloon to form, together with a circumferential portion of the balloon, a concave pouch for receiving excised tissue; An apparatus for endoscopic tissue retrieval is provided, comprising:

[0033] In another preferred embodiment of the present invention, 1. A method for endoscopic tissue retrieval, comprising: positioning a balloon assembly distal to the tissue to be retrieved, the balloon assembly being movably attached to an endoscope, the balloon assembly comprising: (i) a balloon capable of assuming a deflated state and an inflated state, an axial opening extending therethrough when the balloon is in the deflated state and an axial opening closed when the balloon is in the inflated state; and (ii) a flap attached to the axial opening of the balloon to form, together with a periphery of the balloon, a concave pouch for receiving the tissue to be retrieved; placing the retrieved tissue into the concave pouch; withdrawing the balloon assembly proximally to retrieve the tissue received within the concave pouch; A method is provided that includes: [Brief explanation of the drawings]

[0034] The above and other objects and features of the present invention will be more fully disclosed or become apparent from the following detailed description of preferred embodiments of the invention, which should be considered in conjunction with the accompanying drawings, in which like parts are designated with like numerals and in which: [Figure 1] FIG. 1 is a schematic diagram illustrating a novel device formed in accordance with the present invention, which device includes, among other things, a sleeve disposed over the end of an endoscope, a rear balloon attached to the sleeve, a pair of push tubes slidably attached to the sleeve, a front balloon attached to the distal ends of the bushing tubes, and a push tube handle attached to the proximal ends of the push tubes. [Figure 2] 10 is a schematic diagram showing the positioning of the front balloon relative to the rear balloon. FIG. [Figure 3] 10 is a schematic diagram showing the front balloon being positioned differently relative to the rear balloon. FIG. [Figure 4] 10 is a schematic diagram showing the front balloon being positioned in yet another position relative to the rear balloon. FIG. [Figure 5] FIG. 2 is a schematic diagram showing further details of the distal end of the device shown in FIG. 1. [Figure 6] FIG. 6 is a cross-sectional view taken along line 6-6 of FIG. 5. [Figure 7] FIG. 10 is a schematic diagram showing further details of the front balloon. [Figure 8] FIG. 10 is a schematic diagram showing further details of the front balloon. [Figure 8A] 8A is a schematic diagram showing a push tube handle. [Figure 9] FIG. 10 is a schematic diagram showing details of the construction of the front balloon. [Figure 10] FIG. 10 is a schematic diagram showing details of the construction of the front balloon. [Figure 11] 1 is a schematic diagram illustrating one form of expansion mechanism provided in accordance with the present invention. [Figure 11A] 11A is a schematic diagram showing another form of expansion mechanism provided in accordance with the present invention. [Figure 12] 10 is a schematic diagram illustrating another form of expansion mechanism provided in accordance with the present invention. [Figure 13] 10 is a schematic diagram illustrating another form of expansion mechanism provided in accordance with the present invention. [Figure 14] FIG. 10 is a schematic diagram illustrating relief valves that can be used to ensure that pressure in the front and / or rear balloons does not exceed a predetermined level. [Figure 15] 2 is a schematic diagram illustrating a retraction system that can be used to take up slack in the flexible tubing of the device shown in FIG. 1. [Figure 16] FIG. 2 is a schematic diagram illustrating a preferred method of using the apparatus of FIG. 1. [Figure 17] FIG. 2 is a schematic diagram illustrating a preferred method of using the apparatus of FIG. 1. [Figure 18] FIG. 2 is a schematic diagram illustrating a preferred method of using the apparatus of FIG. 1. [Figure 19] FIG. 2 is a schematic diagram illustrating a preferred method of using the apparatus of FIG. 1. [Figure 20] FIG. 2 is a schematic diagram illustrating a preferred method of using the apparatus of FIG. 1. [Figure 21] FIG. 2 is a schematic diagram illustrating a preferred method of using the apparatus of FIG. 1. [Figure 22-1] FIG. 2 is a schematic diagram illustrating a preferred method of using the apparatus of FIG. 1. [Figure 22-2] FIG. 2 is a schematic diagram illustrating a preferred method of using the apparatus of FIG. 1. [Figure 23] FIG. 2 is a schematic diagram illustrating a preferred method of using the apparatus of FIG. 1. [Figure 24] FIG. 2 is a schematic diagram illustrating a preferred method of using the apparatus of FIG. 1. [Figure 25] FIG. 2 is a schematic diagram illustrating a preferred method of using the apparatus of FIG. 1. [Figure 26] FIG. 2 is a schematic diagram illustrating a preferred method of using the apparatus of FIG. 1. [Figure 27] FIG. 2 is a schematic diagram illustrating a preferred method of using the apparatus of FIG. 1. [Figure 28] FIG. 2 is a schematic diagram illustrating a preferred method of using the apparatus of FIG. 1. [Figure 29] FIG. 2 is a schematic diagram illustrating a preferred method of using the apparatus of FIG. 1. [Figure 30] FIG. 2 is a schematic diagram illustrating a preferred method of using the apparatus of FIG. 1. [Figure 30A] 30A is a schematic diagram showing an alternative construction of the push tube and push tube handle of the present invention. [Figure 31] 10 is a schematic diagram illustrating another configuration of the sleeve, in which the sleeve includes an additional lumen for receiving an instrument. [Figure 32] 10 is a schematic diagram showing how an instrument may be advanced through an additional lumen of the sleeve. [Figure 33] 10 is a schematic diagram showing how an instrument may be advanced through an additional lumen of the sleeve. [Figure 34] 10 is a schematic diagram showing how an instrument may be advanced through an additional lumen of the sleeve. [Figure 35] 10 is a schematic diagram showing how an instrument may be advanced through an additional lumen of the sleeve. [Figure 36] FIG. 10 is a schematic diagram illustrating an instrument guide tube that can be disposed within an additional lumen of the sleeve, allowing an instrument to be advanced through the instrument guide tube. [Figure 37] 1 is a schematic diagram illustrating an endoscopic tissue retraction system formed in accordance with the present invention; [Figure 38] 1 is a schematic diagram illustrating an endoscopic tissue retraction system formed in accordance with the present invention; [Figure 39] 1 is a schematic diagram illustrating an endoscopic tissue retraction system formed in accordance with the present invention; [Figure 40] 1 is a schematic diagram illustrating an endoscopic tissue retraction system formed in accordance with the present invention; [Figure 41] 1 is a schematic diagram illustrating an endoscopic tissue retraction system formed in accordance with the present invention; [Figure 42] 1 is a schematic diagram illustrating an endoscopic tissue retraction system formed in accordance with the present invention; [Figure 43] 1 is a schematic diagram illustrating another endoscopic tissue retraction system formed in accordance with the present invention. [Figure 44] 1 is a schematic diagram illustrating another endoscopic tissue retraction system formed in accordance with the present invention. [Figure 45] 1 is a schematic diagram illustrating another endoscopic tissue retraction system formed in accordance with the present invention. [Figure 46] 1 is a schematic diagram illustrating yet another endoscopic tissue retraction system formed in accordance with the present invention; [Figure 47] 1 is a schematic diagram illustrating yet another endoscopic tissue retraction system formed in accordance with the present invention; [Figure 48] 1 is a schematic diagram illustrating another endoscopic tissue retraction system formed in accordance with the present invention. [Figure 49] 1 is a schematic diagram illustrating yet another endoscopic tissue retraction system formed in accordance with the present invention; [Figure 50] 1 is a schematic diagram illustrating yet another endoscopic tissue retraction system formed in accordance with the present invention; [Figure 51] 1 is a schematic diagram illustrating another endoscopic tissue retraction system formed in accordance with the present invention. [Figure 52] 1 is a schematic diagram illustrating another endoscopic tissue retraction system formed in accordance with the present invention. [Figure 52A] 1 is a schematic diagram illustrating yet another endoscopic tissue retraction system formed in accordance with the present invention; [Figure 52B] 1 is a schematic diagram illustrating yet another endoscopic tissue retraction system formed in accordance with the present invention; [Figure 53] 1 is a schematic diagram illustrating an endoscopic tissue retrieval system formed in accordance with the present invention. [Figure 54] 1 is a schematic diagram illustrating an endoscopic tissue retrieval system formed in accordance with the present invention. [Figure 55] 1 is a schematic diagram illustrating an endoscopic tissue retrieval system formed in accordance with the present invention. [Figure 56] 1 is a schematic diagram illustrating an endoscopic tissue retrieval system formed in accordance with the present invention. [Figure 57] 1 is a schematic diagram illustrating an endoscopic tissue retrieval system formed in accordance with the present invention. [Figure 58] 1 is a schematic diagram illustrating an endoscopic tissue retrieval system formed in accordance with the present invention. [Figure 59]1 is a schematic diagram illustrating an endoscopic tissue retrieval system formed in accordance with the present invention. [Figure 60] 1 is a schematic diagram illustrating an endoscopic tissue retrieval system formed in accordance with the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0035] The present invention comprises providing and using novel devices for manipulating the sidewalls of body cavities and / or body cavities during endoscopic procedures to better expose the sidewall tissue (including visualization of areas that are initially hidden or out of view) for purposes of tissue visualization, biopsy, and / or treatment, including lesion removal and / or tissue dissection.

[0036] (As used herein, the term "endoscopic procedure" is intended to mean substantially any minimally invasive or limited access, diagnostic and / or therapeutic and / or surgical procedure for endoluminal, transluminal or otherwise accessing the interior of a body cavity and / or void for the purposes of tissue visualization, biopsy and / or treatment, including lesion removal and / or tissue dissection.)

[0037] The present invention also includes providing and using novel devices that can anchor and / or stabilize the distal tips and / or working ends of instruments inserted into body cavities and spaces (e.g., endoscopes, articulating instruments and / or non-articulating devices such as graspers, cutters or resectors, cauterizing instruments, ultrasonic probes, etc.) against the side walls of the body cavities and / or spaces, thereby facilitating accurate use of these instruments.

[0038] In particular, the present invention also includes providing and using novel devices that can stabilize and / or stabilize the distal tips and / or working ends of endoscopes (and thus the distal tips and / or working ends of graspers, cutters, or other instruments inserted through the working channels of these endoscopes, such as dissectors, cauterizing instruments, ultrasonic probes, etc.).

[0039] The present invention also provides and includes steps for using novel devices that can stabilize and / or stabilize the distal tip and / or working end of an instrument (such as a grasper, cutter or resector, cauterizing instrument, ultrasonic probe, etc.) advanced to a surgical site by means other than through the working channel of an endoscope.

[0040] The present invention also includes providing and using novel devices that can straighten bends, "iron" folds, and create substantially static or stable side walls of body cavities and bodily cavities, thereby allowing for more accurate visual inspection (including more accurate visualization of areas that are initially hidden or out of sight) and / or therapeutic intervention.

[0041] Novel Device In accordance with the present invention and with reference to FIG. 1, a novel device 5 is illustrated that can manipulate the sidewall of a body cavity and / or bodily cavity during an endoscopic procedure using an endoscope 10 (e.g., an articulating endoscope) to better present the sidewall tissue for examination and / or treatment (including visualization of areas that are initially hidden or out of view), as well as stabilize the distal tip and / or working end of the endoscope 10 and / or other instruments (e.g., graspers, cutters or resectors, cauterizing instruments, ultrasound probes, etc., not shown in FIG. 1).

[0042] More specifically, device 5 generally comprises a sleeve 15 adapted to slide over the outside of the shaft of endoscope 10, a proximal (or "rear") balloon 20 secured to sleeve 15 near the distal end of the sleeve (the terms "proximal" and "rear" are used interchangeably hereinafter), and a base 25 secured to sleeve 15 at the proximal end of sleeve 15. As described below, the device 5 includes a pair of push tubes 30 slidably mounted within the sleeve 15 and a distal (i.e., "front") balloon 35 secured to the distal end of the push tubes 30 (the terms "distal" and "front" are used interchangeably hereinafter), allowing a surgeon (or other operator or user) moving the push tubes 30 relative to the sleeve 15 to adjust the spacing between the rear balloon 20 and the front balloon 35 (e.g., by manually moving the two push tubes simultaneously via push tube handle 37; see below). See FIGS. 1 and 2-4. The device 5 also includes an associated inflation mechanism 40 (FIG. 1) to allow the surgeon (or other operator or user) to selectively inflate / deflate one or both of the rear balloons 20 and the front balloon 35.

[0043] 1-6, sleeve 15 generally comprises an elongated, thin-walled tube configured to slide over the outside of the endoscope shaft (e.g., retract from the distal tip of the endoscope) and form a close fit with the endoscope, such that during application (preferably when the endoscope is in a "dry" state), the sleeve slides back easily over the endoscope, yet remains tight against the exterior surface of the endoscope. The sleeve 15 has a sufficient residual friction (when grasped by a surgeon or other operator or user) so that it remains in place and allows torque (i.e., rotationally redirecting) and pushing / pulling forces to be applied to the endoscope during use (e.g., within a patient's colon). In one preferred form of the invention, the sleeve 15 has some circumferential movement around the endoscope 10 (and can rotate with the endoscope shaft when firmly grasped in the hand of a surgeon or other operator or user). However, the sleeve 15 has only nominal axial movement relative to the endoscope 10. The sleeve 15 is dimensioned such that when its distal end is substantially aligned with the distal end of the endoscope 10, the sleeve 15 (together with the base 25) substantially covers the endoscope shaft. In either case, the sleeve 15 is dimensioned such that when the sleeve is attached to the endoscope 10 and the endoscope 10 is inserted into the patient's body, the sleeve 15 extends outside the patient's body. In one preferred form of the invention, device 5 is provided according to the particular endoscope with which it is intended to be used, and is dimensioned so that when base 25 is engaged with the handle of the endoscope, the distal end of sleeve 15 is properly positioned at the distal end of the endoscope, i.e., substantially aligned with or slightly proximal to the distal end of the endoscope.

[0044] If desired, the distal end of sleeve 15 may be provided with a radially inwardly extending stop (not shown) to positively engage the distal surface of endoscope 10, thereby preventing the distal end of sleeve 15 from moving proximally beyond the distal surface of endoscope 10. Such a radially inwardly extending stop may also help prevent sleeve 15 from "torque slipping" relative to endoscope 10 when the endoscope is torqued (i.e., rotationally redirected) while in the colon and / or to prevent sleeve 15 from "thrust slipping" relative to endoscope 10 when the endoscope is pushed forward while in the colon.

[0045] The sleeve 15 preferably has a smooth outer surface so as to be atraumatic to tissue, and is preferably made of a highly flexible material so that the sleeve does not inhibit bending of the endoscope during use. In one preferred form of the invention, the sleeve 15 is made of polyurethane, polyethylene, poly(vinyl chloride) (PVC), polytetrafluoroethylene (PTFE), or the like, and is preferably transparent (or at least translucent) to allow visualization of the distance markings on the endoscope 10 through the sleeve 15. Also, in one preferred form of the invention, the sleeve 15 preferably has a nominal flexural strength so that a surgeon (or other operator or user) can grasp the endoscope 10 through the sleeve 15, for example, to apply torque forces to the endoscope. If desired, the sleeve 15 may include a lubricious coating (e.g., a liquid such as a perfluoropolyether synthetic oil, a powder, etc.) on some or all of its inner and / or outer surfaces to facilitate placement of the sleeve over the endoscope and / or movement of the device through a body cavity and / or void. Alternatively, sleeve 15 may be formed from a material that is inherently lubricious, such as, for example, polytetrafluoroethylene (PTFE). It should be understood that the interior surface of sleeve 15 may include features (e.g., ribs) that prevent the sleeve from rotating relative to the endoscope during use.

[0046] If desired, a vacuum can be "pulled" between the sleeve 15 and the endoscope 10, thereby securing the sleeve 15 to the endoscope 10 and minimizing the outer profile of the sleeve 15. By way of example and not limitation, the vacuum can be introduced at the proximal end (i.e., base 15) of the sleeve 15, or at a location intermediate the sleeve 15. It should also be appreciated that, by way of further example and not limitation, removal of the sleeve 15 from the endoscope 15 (e.g., at the end of a procedure) can be facilitated by introducing a fluid (e.g., air or a liquid lubricant) into the space between the sleeve 15 and the endoscope 10, for example, at the proximal end (i.e., base 25) or intermediate the sleeve 15.

[0047] 1-6, the rear balloon 20 is secured to the sleeve 15 proximal to, but spaced from, the distal end of the sleeve, proximal to the endoscope's articulating joint. The rear balloon 20 is concentrically disposed about the sleeve 15, and thus about the endoscope 10 disposed therein. This gives the rear balloon a generally toroidal shape. The rear balloon 20 can be selectively inflated and deflated by a proximal inflation / deflation tube 45, which is in fluid communication at its distal end with the interior of the balloon 20 and at its proximal end with a connector 46 attached to the base 25. The connector 46 is configured to be connectable to the associated inflation mechanism 40 described above. The connector 46 is preferably a luer-actuated valve, allowing the inflation mechanism 40 to be disconnected from the connector 46 without losing pressure within the rear balloon 20. The expansion / contraction tube 45 may be secured to the exterior surface of the sleeve 15, or more preferably, the expansion / contraction tube 45 may be retained within a lumen 47 formed within the sleeve 15.

[0048] Preferably, the rear balloon 20 is disposed a short distance rearward from the distal end of the sleeve 15, i.e., a distance approximately equal to the length of the articulating portion of the steerable endoscope 10, so that when the steerable endoscope is disposed within the sleeve 15, the articulating portion of the steerable endoscope 10 is disposed distal to the rear balloon 20. This configuration allows the flexible portion of the steerable endoscope to articulate even when the rear balloon 20 is expanded within the body part, so as to stabilize the adjacent non-articulating portion of the endoscope relative to the body part, as described in more detail below. Thus, when expanded, the rear balloon 20 provides a secure base that maintains the endoscope 10 in a stable position within the body cavity or void, and the endoscope 10 is centered within the body cavity or void. As a result, the endoscope 10 can improve visualization of the body part. Furthermore, so long as the endoscope 10 is securely maintained within the body cavity or cavity by the inflated rear balloon 20, instruments advanced through the inner lumen (sometimes referred to as the "working channel" or "working channels") of the endoscope 10 will have a secure base for supporting them within the body cavity or cavity.

[0049] When rear balloon 20 is properly inflated, it can non-traumatically engage and form a sealing relationship with the sidewall of the body cavity within which device 5 is disposed.

[0050] In one preferred form of the invention, the rear balloon 20 is formed from polyurethane.

[0051] A base 25 is secured to the proximal end of the sleeve 15. The base 25 engages the endoscope 10 and helps secure the entire assembly (i.e., the device 5) relative to the endoscope 10. Preferably, proximal portion 25 comprises a substantially rigid or semi-rigid structure that can be grasped and pulled proximally by a surgeon (or other operator or user) to allow the surgeon (or other operator or user) to pull sleeve 15 over the distal end of endoscope 10 and then back proximally along the length of endoscope 10, thereby securing sleeve 15 against the outer surface of the endoscope shaft. In one preferred form of the invention, proximal portion 25 is pulled proximally along the endoscope until proximal portion 25 seats against the endoscope handle, thereby preventing further proximal movement of proximal portion 25 (and thus, further proximal movement of sleeve 15). In one preferred embodiment of the invention, proximal portion 25 sealingly engages endoscope 10.

[0052] The push tube 30 is slidably mounted within the sleeve 15 so that the distal end of the push tube can be extended and / or retracted relative to the sleeve 15 (e.g., by advancing and / or withdrawing the push tube via the push tube handle 37; see below), and thus relative to the distal end of the endoscope 10 disposed within the sleeve 15. Preferably, the push tube 30 is slidably disposed within a support tube 50, which is fixed to the outer surface of the sleeve 15, or more preferably, is retained within a lumen 52 formed within the sleeve 15. The support tube 50 is preferably formed from a low-friction material (e.g., polytetrafluoroethylene, also known as "PTFE") to minimize resistance to movement of the push tube 30 relative to the support tube 50 (and thus minimize resistance to movement of the push tube 30 relative to the sleeve 15). In this regard, the push tube 30 may be slidably mounted within a support tube 50, which may be fixed to the outer surface of the sleeve 15, or more preferably, may be retained within a lumen 52 formed within the sleeve 15. The support tube 50 is preferably formed from a low-friction material (e.g., polytetrafluoroethylene, also known as "PTFE") to minimize resistance to movement of the push tube 30 relative to the support tube 50 (and thus minimize resistance to movement of the push tube 30 relative to the sleeve 15). In this regard, the push tube 30 may be slidably mounted within a support tube 50, which ... It should be appreciated that minimizing resistance to movement of the push tube 30 relative to the support tube 50 improves tactile feedback to the user when using the push tube 30 to manipulate the front balloon 25. In one form of the invention, the support tube 50 is flexible (to allow the endoscope 10, particularly the articulating portion of a steerable endoscope 10, to flex as needed during a procedure). However, the support tube 50 provides some longitudinal 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 support tube 50 is flexible but has some longitudinal strength (whereas the sleeve 15 alone is flexible but has substantially no longitudinal strength). When the push tube 50 is held within the lumen 52 formed in the sleeve 15, and when the support tube 50 is not disposed within the push tube 30 and lumen 52, the lumen 52 is preferably lubricated to minimize friction between the push tube 30 and the lumen 52.

[0053] The proximal end of the push tube 50 is connected to the push tube handle 37. As a result of this configuration, pushing the push tube handle 37 distally moves the distal end of the push tube 30 distally relative to the sleeve 15 (to the same extent) (thereby moving the front balloon 35 proximally relative to the rear balloon 20), and pulling the push tube handle 37 proximally retracts the distal end of the push tube 30 proximally relative to the sleeve 15 (to the same extent) (thereby moving the front balloon 35 proximally relative to the rear balloon 20). It should be noted that by moving the push tube 30 distally or proximally by the same extent, the distal ends of the push tube remain parallel to one another. A clamp 53 (FIGS. 12 and 15) is provided on the base 25 to hold the push tube 30 in a selected position relative to the base 25 (and therefore in a selected deployment position relative to the sleeve 15).

[0054] The push tube 30 is preferably formed from a relatively flexible material that provides good longitudinal strength, such as, for example, a thermoplastic polyethylene resin such as Isoplast® (available from The Lubrizol Corporation, Wickliffe, Ohio), polyethylene, polypropylene, nylon, etc. It should be understood that the push tube 30 can be made of a single material or multiple materials, and that the stiffness of the push tube 30 can vary along its length. By way of example only and not limitation, the stiffness of the push tube 30 can be varied along its length. The distal portion can be the same as the remainder of the push tube but made of a lower modulus material, making it more flexible than the remainder of the push tube, or the most distal portion of the push tube 30 can be made of a different, more elastic, flexible material. By way of example and not limitation, the most distal portion of the push tube 30 can be made of nitinol. By way of further example and not limitation, the most distal portion of the push tube 30 can be made of a stainless steel coil coated with a polytetrafluoroethylene (PTFE) outer jacket, with the most distal jacket / more proximal tubing together providing a sealed lumen for inflating / deflating the front balloon 35. By forming the push tube 30 with a more flexible distal end than the remainder of the push tube, the push tube 30 and the front balloon 35 can together function as a lead (with a soft, atraumatic tip) for the device 5 and endoscope 10, as described further below.

[0055] In one preferred form of the invention, the push tube 30 is configured to maintain a parallel orientation when in an unbiased state, i.e., when no force is applied to the push tube 30. This is true whether the front balloon 35 is in an inflated or deflated state.

[0056] The most distal portion of the push tube 30 can be configured to bend inward or outward, if desired. With such a configuration, when the distal tip of the push tube 30 is held stationary (e.g., by an inflated front balloon, as described below) and a sufficient distally directed force is applied to the push tube 30, the intermediate portion of the push tube 30 (i.e., the portion between the inflated front balloon 35 and the sleeve 15) will bend or flex outward, thereby pushing outward against the side walls of the body cavity within which the device 5 is disposed, thereby providing a "tenting" effect against the body cavity and / or cavity within the space between the rear balloon 20 and the front balloon 35. This "tenting" effect, by pushing outward against the side walls of the body cavity and / or cavity within which the device 5 is disposed, can significantly improve visualization and / or tissue stability at the distal end of the endoscope.

[0057] It should be appreciated that by forming the push tubes 30 from a flexible material, their position can be manually adjusted during use (e.g., by using a separate tool and applying a torque to the device, etc.) to prevent the push tubes from interfering with visualization of the patient's body part and / or interfering with diagnostic or therapeutic instruments inserted within the space between the front and rear balloons. By way of example only, and not by way of limitation, once the device 5 is positioned within the body part in a manner such that the push tubes 30 do not obstruct visual or physical access to the target area of ​​the body part, the flexible push tubes 30 can be moved out of the way by using a separate tool or instrument or by rotating the device with a torque action to move the flexible push tubes 30 out of the way. By way of further example only, and not by way of limitation, by constructing the push tubes 30 to be circular, flexible, and of a diameter significantly smaller than the circumference of the circle of the endoscope 10, the movement of the round endoscope, when articulated, can push the push tubes out of the way to provide an unobstructed visual path to the tissue of interest.

[0058] It should also be understood that, if desired, the push tube 30 can be marked with distance markers (not shown in the drawings), such as indicators including color indicators or radiopaque indicators, to enable a surgeon (or other operator or user) viewing the surgical site via the endoscope 10 or under radiological guidance (e.g., X-ray fluoroscopy) to ascertain the relative placement position of the push tube 30 at the surgical site longitudinally and / or circumferentially relative to the sidewalls of the body cavity and / or body cavity.

[0059] As will be explained in more detail below, the bushing tubes 30 are hollow and their ends are The front balloon 35 is in fluid communication with the interior of the front balloon 30 (FIGS. 1-5, 7, and 8), and their inner lumens are in fluid communication with a fitting 56 attached to the base 25. The fitting 56 connects to the associated inflation mechanism 40 described above, allowing the front balloon 35 to be selectively inflated / deflated with air or other fluids (including liquids). The fitting 56 is a luer-activated valve, allowing the inflation mechanism 40 to be disconnected from the fitting 56 without losing pressure within the front balloon 35.

[0060] More specifically, in one preferred form of the invention, and referring to FIG. 8A , the push tube handle 37 has a hollow interior 57. The push tube 30 is attached to the push tube handle 37 so that the push tube 30 moves with the push tube handle 37 and the hollow interior of the push tube 30 is in fluid communication with the hollow interior of the bushing 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 to an interior chamber (not shown) of the base 25, which is in fluid communication with the fitting 56 described above. As a result of this configuration, when the push tube handle 37 is moved distally, the front balloon 35 moves proximally, and when the push tube handle 37 is moved proximally, the front balloon 35 moves proximally. Furthermore, when positive fluid pressure is applied to the connector 56 of the base 25, positive fluid pressure is applied to the interior of the front balloon 35, thereby expanding the front balloon, and when negative fluid pressure is applied to the connector 56 of the base 25, negative fluid pressure is applied to the interior of the front balloon 35, thereby deflating the front balloon 35.

[0061] It should be appreciated that providing two push tubes provides numerous advantages. By way of example only and not limitation, providing two push tubes provides symmetrical forces to the front balloon 35 when the front balloon is advanced distally into a body cavity, as described below. Furthermore, providing two push tubes 30 provides equal outward forces to adjacent body parts when the push tubes are employed to straighten the body part within a region proximal to the distal end of the endoscope 10, thereby improving visualization and / or access to the body part, as described below. Furthermore, providing two push tubes ensures that the front balloon 35 remains centered on the endoscope 10, thereby facilitating decoupling and recoupling of the front balloon 35 on the endoscope 10. Furthermore, providing two push tubes 30 ensures that the front balloon 35 is stable relative to the tip of the endoscope and minimizes rotational movement of the front balloon when inflated. Additionally, providing two hollow push tubes provides a redundant air delivery system for inflating or deflating the front balloon 35.

[0062] The front balloon 35 is fixed to the distal end of the push tube 30, which allows the spacing between the rear balloon 20 and the front balloon 35 to be adjusted by moving the push tube 30 relative to the sleeve 15, i.e., by moving the bushing tube handle 37 relative to the sleeve 15. Furthermore, the hollow push tube 30 provides a conduit between the interior of the front balloon 35 and the connector 56, thereby allowing the front balloon 35 to be selectively inflated / deflated via the connector 56.

[0063] Importantly, the front balloon 35 is constructed so that (i) when it is deflated (or partially deflated) and in its "retracted" position (FIG. 2) relative to the sleeve 15, the front balloon 35 provides an axial opening 63 (FIGS. 7, 8, and 10) sufficient to receive the shaft of the sleeve 15 and endoscope 10, thereby allowing the front balloon 35 to be "coupled" onto the sleeve 15 and endoscope 10, and (ii) when the front balloon 35 is in its "extended" position relative to the sleeve 15 and properly When expanded (FIG. 4), the axial opening 63 is configured to be occluded (preferably completely occluded). At the same time, when properly expanded, the front balloon non-traumatically engages and forms a sealing relationship with the sidewall of the body cavity and / or cavity within which the device 5 is disposed. Thus, when the front balloon 35 is properly expanded, it axially occludes the opening 63 and forms a sealing relationship with the sidewall of the body cavity and / or cavity within which the device 5 is disposed, thereby effectively sealing the body cavity and / or cavity distal to the front balloon 35. Thus, 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 expanded, the two balloons form a sealing region (hereinafter sometimes referred to as the "treatment region") therebetween.

[0064] It will be appreciated that when the front balloon 35 changes configuration from its contracted state to its expanded state, the front balloon 35 expands radially inward (to block the axial opening 63) and also expands radially inward (to engage surrounding tissue).

[0065] Thus, it will be appreciated that the front balloon 35 has a "toroidal" shape when deflated (to allow the balloon to seat over the distal end of the endoscope) and a substantially "solid" shape when expanded (to allow the balloon to occlude a body cavity or cavity).

[0066] To this end, and with reference to Figures 9 and 10, the front balloon 35 is preferably manufactured as a unitary structure comprising a body 67 having a proximal opening 69 and a distal opening 71, a proximal extension 73 having a "key-shaped cross-section" with lobes 74, and a distal extension 76 having a circular cross-section. The lobes 74 are disposed on the proximal extension 73 in a configuration that matches the configuration of the push tubes 30 (i.e., if the device 5 includes two push tubes 30 diametrically opposed to one another, the proximal extension 73 will have two lobes diametrically opposed to one another; if the device 5 includes three push tubes 30 equally circumferentially spaced about the periphery 45 of the sleeve 15, the proximal extension 73 will have three lobes 74 equally circumferentially spaced about the periphery of the proximal extension 73; if the device 5 includes one push tube 30, the proximal extension 73 will have one lobe 74, etc., and for purposes of the present invention, the proximal extension 73 and the lobes 74 may collectively be referred to as having a "key-shaped" cross-section). During assembly, the push tube 30 is seated within the lobes 74 of the proximal extension 73, the proximal extension 73 is everted into the interior of the body 67 (the interior of the hollow push tube 30 is in fluid communication with the interior of the body 67), and the distal extension 76 is then everted into the interior of the proximal extension 73, thereby providing a front balloon 35 having an axial opening 63 extending therethrough, with the push tube 30 secured to the front balloon 35 and in communication with its interior. Importantly, the axial opening 63 is sized to receive the distal end of the endoscope 10. Also importantly, forming the front balloon 35 by the above-described process of everting the proximal extension 73 into the interior of the body 67 and then everting the distal extension 76 into the proximal extension 73 provides multiple layers of balloon material around the push tube 30, thereby providing a more robust balloon structure. In particular, providing multiple layers of balloon material around the push tube 30 provides additional cushioning to the distal end of the push tube 30, thereby providing a more atraumatic distal tip for the push tube 30 and further ensuring that the distal tip of the push tube 30 does not damage adjacent tissue.

[0067] In one preferred form of the invention, the front balloon 35 is formed from polyurethane.

[0068] When the front balloon 35 is in its deflated state, the material of the front balloon 35 It should be appreciated that the push tube 30 substantially encloses the distal end of the push tube 30 (while allowing the push tube 30 to be in fluid communication with the interior of the front balloon 35), thereby providing an atraumatic tip for distally advancing the front balloon 35 through the body cavity. Furthermore, the push tube 30 and deflated front balloon 35 together can essentially function as a flexible distal lead for the device 5 and endoscope 10, as further described below (FIG. 20).

[0069] If desired, one or both of the rear balloon 20 and the front balloon 35 may be marked with an indicator (e.g., a color indicator or a radiopaque indicator) to enable a surgeon (or other operator or user) viewing the surgical site via endoscope 10 or radiological guidance (e.g., X-ray fluoroscopy) to verify the placement of one or both balloons at the surgical site.

[0070] The expansion mechanism 40 provides a means for selectively expanding the rear balloon 20 and / or the front balloon 35.

[0071] 1 and 11, inflation mechanism 40 includes a single-line syringe inserter 140 having a body 145 and a plunger 150. Preferably, body 145 is provided with a spring 153 for automatically returning plunger 150 at the end of its stroke. Syringe inserter 140 is connected to one or the other of fittings 46, 56 via tubing 155. Thus, in this configuration, when single-line syringe inserter 140 is used to inflate rear balloon 20, syringe inserter 140 is connected to fitting 46 via tubing 155, and the output of single-line syringe inserter 140 is directed to rear balloon 20 (i.e., via proximal inflation / deflation tubing 45). Correspondingly, when the single-line syringe inserter 40 is to be used to inflate the front balloon 35, the syringe inserter 140 is connected to the connector 56 via tubing 155, and the output of the single-line syringe inserter 140 is directed to the front balloon 35 (i.e., via the flexible tubing 59 and the hollow interior of the push tube 30).

[0072] In another preferred form of the present invention, the expansion mechanism 40 includes a resilient valve 156 having a first port 57 and a second port 58. A one-way valve 159 (e.g., a check valve) is disposed in the first port 157 such that air can only flow through the first port 157 when flowing outward. Another one-way valve 159 (e.g., a check valve) is disposed in the second port 158 ​​such that air can only flow through the second port 158 ​​when flowing inward. When the resilient valve 156 is compressed (e.g., by hand), air inside the resilient valve 156 is forced out through the first port 157. When the resilient valve 156 is subsequently released, air is drawn back into the resilient valve 156 through the second port 158.

[0073] As a result of this construction, when elastic valve 156 is to be used to inflate rear balloon 20, first port 157 is connected to fitting 46 via tube 155, and the positive pressure output of elastic valve 156 is directed toward rear balloon 20. Elastic valve 156 can then be used to deflate rear balloon 20, i.e., second port 158 ​​is connected to fitting 46 via tube 155, and the suction force of elastic valve 156 is directed toward rear balloon 20. Correspondingly, when the elastic valve 156 is to be used to inflate the front balloon 35, the first port 157 is connected to the fitting 56 via the tube 155, and the positive pressure output of the elastic valve 156 is directed towards the front balloon 35. The elastic valve 156 can then be used to deflate the front balloon 35, i.e., the second port 158 ​​is connected to the fitting 56 via the tube 155, and the elastic valve 156 is The suction force of the balloon is directed towards the front balloon 35.

[0074] Alternatively, and referring to Figures 12 and 13, a 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, the body 161 is provided with a spring (not shown) for automatically returning the plunger 162 at the end of its stroke. The syringe 160 is connected to the connectors 46, 56 via a tube 163. In this configuration, the syringe 160 includes a valve 165 that connects the syringe 160 to the front balloon 35 or the rear balloon 20, and a valve 170 that selects inflation or deflation of the associated balloon.

[0075] Thus, with this configuration, when syringe 160 is to be used to inflate rear balloon 20, valve 165 (a two-position valve connecting valve 170 to either the front or rear balloon) is set so that syringe 160 is connected to rear balloon 20 through connector 46, and valve 170 (a one-way valve) is set to inflate in one configuration and deflate in the other. The valve 170 (a two-way crossover valve that allows the valve 170 to be positioned) is set so that the syringe 160 provides inflation pressure. Then, when the rear balloon 20 is to be deflated, the valve 170 is set to its deflated position.

[0076] Correspondingly, when the front balloon 35 is to be inflated using the syringe 160, the valve 160 is set to connect the syringe 160 to the front balloon 35 through the connector 56, and the valve 170 is set to allow the syringe 160 to provide the inflation pressure. Then, when the front balloon 35 is to be deflated, the valve 170 is set to its deflated position.

[0077] In yet another aspect of the invention, the expansion mechanism 40 can include an automatic source of fluid pressure (either positive or negative), such as an electric pump.

[0078] 14, a relief valve 175 can be connected to the inflation / deflation tubing that connects to the front balloon 35 to ensure that the pressure in the front balloon 35 does not exceed a predetermined level. Similarly, with further reference to FIG. 14, a relief valve 180 can be connected to the inflation / deflation tubing that connects to the rear balloon 20 to ensure that the pressure in the rear balloon 20 does not exceed a predetermined level.

[0079] Alternatively and / or additionally, one or more pressure gauges 182 (FIG. 1 or FIG. 13) may be incorporated into the fluid line connecting the rear balloon 20 and / or into the fluid line connecting the front balloon to provide the surgeon (or other operator or user) with information regarding the pressure in the rear balloon 20 and the front balloon 35 to avoid over-inflation and / or to assist the surgeon (or other operator or user) in verifying the inflation status of the balloons during the procedure.

[0080] It will further be appreciated that as the front balloon 35 moves between its "retracted" position (FIG. 2) and its "extended" position (FIG. 4), the flexible tubing 59 connecting the push tube 30 to the base 25 (and thus the connector 56) may bunch up around the base 25 and interfere with the surgeon's (or other operator's or user's) movements. Therefore, if desired, and with reference to FIG. 15, a flexible tubing retraction system 185 may be provided (e.g., within the base 25) to take up slack in the flexible tubing 59 when the front balloon 35 is extended.

[0081] Preferred Methods of Use of the Novel Device The device 5 manipulates (e.g., soothes, straightens, expands) the side walls of body cavities and body cavities. The endoscope 10 may be used to: (e.g., stretch and / or flatten) better present sidewall tissue for examination and / or treatment during an endoscopic procedure using the endoscope 10 (including visualization of areas initially hidden or out of view); and / or to stabilize the distal tip and / or working end of an instrument (e.g., grasper, cutter or resector, cauterizing instrument, ultrasound probe, etc.) advanced into the treatment area.

[0082] More specifically, during use, sleeve 15 is first attached to endoscope 10 (FIG. 1). This can be accomplished by pulling base 25 proximally over the distal end of endoscope 10 and then pulling proximally along the length of endoscope 10 until the distal end of sleeve 15 is substantially aligned with the distal tip of endoscope 10. At this point, rear balloon 20 is deflated, front balloon 35 is deflated, and front balloon 35 is coupled over the distal end of endoscope 10. Endoscope 10 and device 5 are then ready to be inserted as a unit into a patient's body.

[0083] 16, the endoscope 10 and device 5 are inserted as a unit into a patient's body cavity and / or sac. By way of example only, and not limitation, the endoscope 10 and device 5 are inserted as a unit into the patient's gastrointestinal (GI) tract. The endoscope 10 and device 5 are advanced along the body cavity and / or sac to a desired location within the patient's body (FIGS. 17 and 18).

[0084] When the device 5 is to be used (e.g., to manipulate the sidewall of the gastrointestinal tract to improve visualization and / or access to the site and / or stabilize the instrument relative to the site), the rear balloon 20 is inflated to stabilize the device 5 (and thus the endoscope 10) within the body cavity and / or void. See FIG. 19. This can be accomplished using the associated inflation mechanism 40 described above.

[0085] In this regard, it will be appreciated that the endoscope can be articulated distal to the rear balloon 20 to facilitate visualization of the body part, even after the rear balloon 20 has been inflated, so long as the articulating portion of the endoscope is located distal to the rear balloon 20. Importantly, such visualization is enhanced insofar as the rear balloon 20 stabilizes the endoscope 10 within the gastrointestinal tract and allows the colon to expand and increase in diameter directly adjacent the rear balloon.

[0086] The push tube 30 is then advanced distally within the body cavity and / or void (i.e., to move the front balloon 35 further forward of the rear balloon 20) by pushing distally on the push tube handle 37. This causes the push tube 30, and thus the front balloon 35, to move distally relative to the endoscope 10 (which is stabilized in a desired position within the gastrointestinal tract by the inflated rear balloon 20). It should be noted that the deflated front balloon 35 covers the distal end of the push tube 30 during such distal movement of the front balloon 35, thereby ensuring atraumatic advancement of the front balloon 35. It should be noted that atraumatic advancement of the front balloon 35 can be improved by forming the distal end of the push tube 30 from a more elastic material.

[0087] When the push tube 30 advances the front balloon 35 to a desired location distal to the endoscope 10, the front balloon 35 expands (FIG. 20) to secure the front balloon 35 to the body site. Again, this can be accomplished using the associated expansion mechanism 40 described above. When the front balloon 35 expands, the expanded front balloon 35, the expanded rear balloon 20, and the push tube 30 all complement each other to stabilize, straighten, expand, and / or flatten the sidewall of the body cavity and / or void to better present the sidewall tissue for examination and / or treatment during an endoscopic procedure using the endoscope ( (including visualization of areas that are initially hidden or out of view). In this regard, it will be appreciated that the inflated front balloon 35 and the inflated rear balloon 20 together distend and tension the sidewalls of the body cavity and / or body cavity, and that the push tube 30, as the front balloon extends distally from the rear balloon, tends to straighten the body region between the two inflated balloons. In this regard, it will be appreciated that once both the rear balloon 20 and the front balloon 35 are inflated, the front balloon 35 forms substantially a full diameter across the body cavity and / or body cavity (because the inflated front balloon occludes the axial opening 63 extending through the front balloon when the front balloon is in its deflated state), and that the rear balloon 20, in cooperation with the sleeve 15 and endoscope 10, forms another substantially full diameter barrier across the body cavity and / or body cavity. It will also be appreciated that the inflated front balloon 35 and the inflated rear balloon 20 thus together form a substantially occluded area along the body cavity and / or void (i.e., an isolated treatment area that prevents the passage of fluids and / or other liquids due to the airtight seal established by the inflated front balloon 35 and rear balloon 20). The sidewalls of the body cavity and / or void are tensioned by the inflation of the front balloon 35 and rear balloon 20, which may better present the sidewalls of the body cavity and / or void as viewed through the endoscope 10.

[0088] It will be appreciated that the expansion and tensioning of the side walls of the body cavity and / or body cavity performed by the expanded front balloon 35, the expanded rear balloon 20, and the push tube 30 can be further enhanced by advancing the front balloon as it expands and grips the side walls of the body cavity and / or body cavity, thereby applying tension to the side walls of the body cavity and / or body cavity.

[0089] Importantly, so long as the inflated front balloon 35 and the inflated rear balloon 20 together define a substantially closed area (i.e., an isolated treatment area) along the body cavity and / or body cavity, this area can then be inflated with a fluid (e.g., air, CO2, etc.) to further tension the side walls of the body cavity and / or body cavity, thereby better presenting the side walls of the body cavity and body cavity for viewing through the endoscope 10 and stabilizing the side walls to facilitate more precise therapeutic intervention.

[0090] If desired, while remaining in an expanded state (and thus maintaining a grip on the side wall of the body cavity and / or body cavity), the front balloon 35 can be retracted toward the rear balloon 20 (e.g., by pulling the push tube handle 37 proximally) to move the visible mucosa and further enhance visualization and access (see, e.g., FIG. 22), for example, to locate a particular target area on the side wall of the body cavity and body cavity at a conventional angle relative to the endoscope and endoscopic instrument.

[0091] Alternatively, if desired, once the rear balloon 35 has expanded, the push tube 30 can be advanced distally a portion of its total stroke, then the front balloon 35 can be expanded to grip the side wall of the body cavity and / or cavity, and then the push tube 30 can be further advanced distally. This action will cause the flexible push tube 30 to bend outward (see FIGS. 22A-22D), contact the side wall of the body cavity and / or cavity, and push the side wall of the body cavity and / or cavity outward, e.g., in a “tenting” manner, thereby further enhancing visualization of the side wall of the body cavity and / or cavity by the endoscope 10.

[0092] If desired, an 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., excise a pathological body part). Such an instrument extends through the distal end of the endoscope, which is effectively stabilized relative to the body part via the rear balloon 20, so that the working end of the instrument 190 is highly stabilized relative to the body part. It will be appreciated that the instrument 190 is stabilized, providing a significant advantage over prior art methods of advancing the instrument from an unstabilized end of the endoscope. Preferably, the instrument 190 comprises an articulating instrument with a full range of motion, thereby providing better access to the target body part.

[0093] Additionally, if bleeding obscures the tissue site, or if bleeding occurs and the surgeon is unable to identify the source of the bleeding, an isolated treatment area allows for rapid irrigation (e.g., with a liquid such as saline) of the body part within which the treatment area is located, followed by rapid removal of the irrigation liquid (see Figures 24-26).

[0094] Also, if desired, the front balloon 35 can be very precisely guided to the bleeding site and then used (e.g., inflated) to apply local pressure to the bleeding site for improved bleeding control (see FIG. 27), which can be done under visualization provided by the endoscope 10.

[0095] When it is desired to reposition the endoscope within the body part with minimal interference from the device 5, the front balloon 35 is "retracted" to its toroidal configuration (i.e., partially deflated), the front balloon is retracted proximally and reattached onto the distal end of the endoscope 10, the rear balloon 20 is deflated, and the endoscope 10 (with the device 10 carried thereon) is then repositioned within the body part. When the front balloon 35 is to be reattached onto the distal end of the endoscope 10, it is preferred that the front balloon 35 be only partially deflated until it is reattached onto the distal end of the endoscope, as partial expansion of the front balloon 35 allows it to maintain sufficient "body" to facilitate the reattachment process. Thereafter, the front balloon 35 can be fully deflated, if desired, to, for example, provide a firm grip on the distal end of the endoscope 10.

[0096] Alternatively, if desired, the front balloon 35 can be used as a dragging brake to control the retraction of the endoscope. More specifically, in this form of the invention, the endoscope 10 and device 5 are first advanced as a unit into the body cavity and / or cavity until the tip of the endoscope is properly positioned. Next, the rear balloon 20 is inflated, the push tube 30 is advanced distally, and then the front balloon 35 is inflated (FIG. 28). Visualization and, optionally, therapeutic procedures can then be performed at that location. To move the device back, the rear balloon 20 is deflated, the front balloon 35 is partially deflated, and the endoscope is then withdrawn proximally, dragging the semi-inflated front balloon 35 along the body cavity and / or cavity (FIG. 29), with the front balloon 35 acting like a brake as the endoscope is pulled proximally, thereby allowing for more controlled retraction of the endoscope and better visualization of the body part. At some point, if desired, the rear balloon 20 and the front balloon 35 can be re-inflated to stabilize, straighten, expand and / or flatten the body part, with or without introducing fluid into the "isolated treatment area" established between the two balloons, as shown in FIG. 30.

[0097] It is also possible to use the rear balloon 20 as a brake when withdrawing the endoscope (and therefore the device 5) from the front balloon 35, either alone or in combination with the braking action described above.

[0098] At the end of the procedure, the endoscope 10 and device 5 are withdrawn from the body site. Preferably, this involves deflating (or partially deflating) the front balloon 35, retracting the push tube 30, allowing the front balloon 35 to be "reattached" onto the distal end of the endoscope 10, and fully deflating the front balloon 35 so that it grips the distal end of the endoscope and the rear balloon 20 (which This should be accomplished by deflat- ing the endoscope (if not already deflated) and then withdrawing the endoscope 10 and device 5 from the body site as a single unit.

[0099] It should be understood that device 5 can be beneficially used in a variety of ways other than those described above. By way of example and not limitation, when endoscope 10 (and device 5) is to be advanced within the colon, it is desirable to first project front balloon 35 distally under the visual guidance of the endoscope, so that front balloon 35 leads the distal end of the endoscope. As a result, when the endoscope is advanced distally with front balloon 35 in a deflated (or partially deflated) state, the front balloon and flexible push tube 30 can function as an atraumatic lead for the endoscope as it advances through the colon. Importantly, insofar as the distal end of 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 deflects and the front balloon follows the path of the colon, thereby facilitating atraumatic advancement of the endoscope along the colon. It should also be appreciated that device 5 can be beneficially used in other ways to facilitate further inspection of luminal surfaces that are currently difficult to perform, such as endoscopic ultrasound examination of the lumen, which may be facilitated by a fluid-filled, expanded front balloon, and ultrasound probe examination.

[0100] Additional Structures If desired, device 5 can be configured so that push tubes 30 can be advanced or retracted independently of one another and together—such independent advancement or retraction of push tubes 30 can aid in steering a partially or fully deflated front balloon 35 through a body cavity and / or void, thereby facilitating advancement or retraction of an endoscope through the body cavity and / or void, and / or such independent advancement or retraction of push tubes 30 can facilitate application of a "redirection force" by an expanded front balloon 35 to a body part, thereby better presenting the body part for visualization and / or treatment.

[0101] By way of example only, and not limitation, in this version of the invention, and referring to FIG. 30A , each of the push tubes 30 is slidably mounted independently of one another on the push tube handle 37, allowing the push tubes 30 to move independently of the push tube handle 37 and each other. A stop 191 limits distal movement of the push tubes 30 relative to the push tube handle 37, so that the push tubes cannot move completely out of the push tube handle 37. As a result of this configuration, when the leading balloon 35 is to be moved distally, the push tubes 30 move distally either together or independently of one another. At any point in the procedure, the push tubes 30 may be moved independently of one another, for example, to "redirect" the leading balloon 35 as it expands and engages the body part, thereby applying a "redirection force" to the body part, or, if the leading balloon 35 is used as an atraumatic tip for the partially expanded and advancing assembly, to help "steer" the assembly through the body part. It should be 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, to prevent excessive deflection of the front balloon 35, and / or push rod crossover and / or push rod entanglement and / or push rod misalignment, etc. It should also be noted that the push tube 30 can be held in a particular position by mounting the push tube 30 within the clamp 53 (FIGS. 12 and 15) described above.

[0102] It should also be understood that the construction of sleeve 15 can be modified to support an instrument (or hollow instrument guide tube) outside of endoscope 10. More specifically, 5 and 6, it can be seen that in the configuration shown in Figures 5 and 6, sleeve 15 includes a lumen 47 for receiving inflation / deflation tube 45 for inflating / deflating rear balloon 20, and a pair of lumens 52 for receiving support tubes 50 for receiving push tube 30 for manipulating and inflating / deflating front balloon 35. However, if desired, sleeve 15 can include additional lumens for supporting instruments (or hollow instrument guide tubes) outside of endoscope 10.

[0103] 31 , an end view of another embodiment of sleeve 15 is shown that includes multiple lumens 195 for slidably receiving instrument 190. When expanded, rear balloon 20 provides a secure platform that maintains endoscope 10 and sleeve 15 within the body cavity and / or body cavity, and centered within the body cavity and / or body cavity. As a result, the distal ends of lumens 195 of sleeve 15 are securely maintained within the body cavity and / or body cavity, providing secure support for instruments advanced through lumens 196 of sleeve 15.

[0104] The proximal end of lumen 195 extends to and through base 25, in which case an instrument can be inserted into lumen 195 at base 25, or the proximal end of lumen 195 terminates proximal to base 25 (but still outside the patient's body), in which case an instrument can be inserted into lumen 195 midway through sleeve 15. By way of example and not limitation, if endoscope 10 is 180 cm long and instrument 190 is 60 cm long, it may be beneficial to insert instrument 190 into lumen 195 at a point closer to balloons 20, 35 (rather than at base 25). In FIG. 31 , lumen 45 that receives inflation / deflation tube 45 and inflation / deflation tube 45 that inflates / deflates rear balloon 20 are not visible because the view is facing distally and depicted in a distal position where inflation / deflation tube 45 terminates on sleeve 15.

[0105] 32-35 illustrate various instruments 190 extending out of lumen 195. It should be noted that instrument 190 preferably comprises an articulating instrument, such as grasper 190A of FIGS. 32-35, cauterization device 190B of FIGS. 32-33, scissors 190C of FIGS. 34 and 35, and suction device 190D of FIGS. 32-35.

[0106] It should be understood that when sleeve 15 has its central passage for receiving endoscope 104, lumen 47 for receiving inflation / deflation tube 45, lumen 52 for receiving support tube 50 for receiving push tube 30, and / or lumen 195 for slidably receiving instrument 190, sleeve 15 is preferably formed by an extrusion molding process.

[0107] In one preferred form of the invention, the lumen 47 that receives the expansion / contraction tube 45, the lumen 52 that receives the support tube 50 that receives the push tube 30, and / or the lumen 195 that slidably receives the device 190 have a constant configuration (i.e., a constant diameter), and therefore the sleeve 15 has a constant outer contour.

[0108] In another preferred form of the invention, the lumen 47 that receives the expansion / contraction tube 45, the lumen 52 that receives the support tube 50 that receives the push tube 30, and / or the lumen 195 that slidably receives the device 190 may have an expandable configuration (i.e., they have a minimal outer profile when empty and can expand diametrically as needed when filled), thereby minimizing the overall outer profile of the sleeve 15.

[0109] It will also be appreciated that where sleeve 15 includes multiple lumens 195 for slidably receiving instruments 190, it may be desirable to provide greater structural integrity to the ends of lumens 195 so as to provide improved support for instruments 190 received within lumens 195. For this purpose, a support ring can be provided at the distal end of the sleeve 15, said support ring providing an opening for the push tube 30 to pass through and an opening for the instrument 190 to pass through. It should be noted that such an opening in the support ring for the instrument 190 to pass through provides a close fit with the instrument and excellent support for the instrument at the distal end of the sleeve 15.

[0110] Alternatively and / or additionally, lumen 195 can accommodate hollow instrument guide tubes that themselves house an instrument. Such hollow instrument guide tubes can provide greater structural integrity to the distal end of lumen 195 and improved support for the instrument 190 received within lumen 195. Such hollow instrument guide tubes can also provide fixed geometries, or flexible or articulating geometries. See, for example, FIG. 36 , which shows hollow instrument guide tubes 200 extending out of lumen 195 and receiving instrument 190. It should be noted that hollow instrument guide tubes 200 are independently movable (and independently movable relative to sleeve 15) from one another. It should also be noted that instrument 190 provides a close fit with hollow instrument guide tubes 200, providing excellent instrument support at the distal end of sleeve 15.

[0111] It should also be understood that, if desired, a single push tube 30 can be used instead of two push tubes 30, or more than two push tubes 30 can be used, such as, for example, three push tubes 30. It will also be understood that where multiple push tubes 30 are provided, it is generally desirable for the push tubes to be equally circumferentially spaced from one another, and that, for example, where two push tubes 30 are provided, it is generally desirable for the two push tubes 30 to be 180° apart, where three push tubes 30 are provided, it is generally desirable for the push tubes to be 120° apart, etc.

[0112] Tissue retraction and tissue retrieval Leading the organization In some situations, it may be necessary or desirable to remove tissue within a body cavity or cavity. By way of example and not limitation, endoscopic submucosal dissection (ESD) is an endoscopic dissection procedure for removing a portion of the intestine, even if the lesion is very large. In ESD, the lesion is dissected directly along the submucosa of the intestine using a cutting tool (e.g., an electrocautery device with an energy source) passed through the endoscope, allowing for a safe en bloc dissection of even large lesions.

[0113] Traditional ESD presents many challenges. First, the technique uses a clear plastic cap placed over the tip of the endoscope to push the tip into tissue and stretch the submucosal fibers, aiding in tissue dissection. However, this technique partially obstructs the surgeon's view. Second, fluid, debris, and smoke typically accumulate within the clear plastic cap placed over the endoscope tip, further obstructing the surgeon's view.

[0114] In addition to the above, ESD procedures are generally time-consuming, often taking several hours, the majority of which is often spent resecting the lesion along the submucosal layer of the intestine.

[0115] Similar problems can occur in other intraluminal tissue dissection procedures. An endoscopic tissue retraction system compatible with ESD procedures and other endoluminal tissue dissection procedures would provide surgeons with better visualization of the surgical field and speed up the dissection process.

[0116] Tissue collection In addition to the above, after dissection of a lesion from the submucosa of the intestine, or after dissection of other tissue during an intraluminal tissue dissection procedure, the lesion (or other dissected tissue) may be: (i) the excised lesion (or Retrieval can be difficult due to the technical challenges of (i) positioning the resected tissue (or other resected tissue) within the intestine and (ii) grasping the resected tissue (or other resected tissue) with the retrieval tool. Furthermore, displacing resected lesions (or other resected tissues) containing early-stage cancer within the intestine can contaminate disease-free areas of the intestine (e.g., by seeding cancer cells).

[0117] An endoscopic tissue retrieval system compatible with ESD procedures and other endoluminal tissue dissection procedures would provide surgeons with better control and fixation of resected lesions within the bowel.

[0118] Endoscopic Tissue Retraction System To this end, in one preferred form of the invention, and with reference to Figures 37-42, a novel device 5 is shown that is used in conjunction with an endoscopic tissue retraction system 300 to provide the surgeon with better visualization of the surgical field and accelerate the dissection process, for example, 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 clipping the connector 305 to the front balloon 35 (or push tube 30) with a surgical clip 320 and clipping 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 via the instrument lumen 95 of the device 5). With the connector 305 secured to both the front balloon 35 (or push tube 30) and the lesion 315, the front balloon 35 can be advanced distally and the connector 305 can be pulled, thereby urging (i.e., applying a force) the lesion 315 distally. A cutting tool 325 can then be advanced from the distal end of the endoscope 10 (or through the instrument lumen 95 of the device 5) and used to resect the lesion 315 along the submucosal layer 330 of the intestine 335. After the lesion 315 has been severed from the submucosal layer of the intestine, the lesion 315 remains tethered to the front balloon 35 by the connector 305 and the surgical clip 320.

[0119] In one preferred form of the invention, connector 305 comprises a loop of material (e.g., a loop made from an extruded filament, a loop made from a braid, etc.) Alternatively, connector 305 may comprise a single strand of material (e.g., a single strand made from an extruded filament, a single strand made from a braid, etc.).

[0120] In one preferred form of the invention, connector 305 is formed from an elastomeric material (e.g., an elastomeric filament or braid, etc.) such that connector 305 automatically takes up slack in connector 305 as lesion 315 is excised from submucosal layer 330 of intestine 335. In another form of the invention, connector 305 may be formed from a non-elastic, flexible material. In yet another form of the invention, connector 305 may be formed from a non-elastic, rigid material.

[0121] In one form of the invention, the front balloon 35 is advanced distally to tension the connector 305, thereby urging (i.e., applying a force) the lesion 315 in a distal direction. In another form of the invention, see FIGS. 43-45, 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 urging (i.e., applying a force) the lesion 315 in a distal direction without requiring distal movement of the front balloon 35. Alternatively, the connector 305 may be stretched, secured to the front balloon 35 and the lesion 315 (in a stretched state), and then released, thereby urging (i.e., applying a force) the lesion 315 in a distal direction without requiring distal movement of the front balloon 35.

[0122] 46 , connector 305 may include a loop 340 having a variable length; for example, loop 340 may include a slip knot 345 having a tension end 350. In this form of the invention, with connector 305 in a relaxed state, connector 305 is clipped to balloon 35 (or push tube 30) with a surgical clip 320, and connector 305 is clipped to lesion 315 with another surgical clip 320. Tension is then applied to connector 305 (e.g., by pulling tension end 350 of slip knot 345 using a tool advanced through the working channel of endoscope 10 or instrument lumen 95 of device 5) to urge (i.e., apply force to) lesion 315 in a distal direction. A cutting tool 325 can then be advanced from the distal end of endoscope 10 (or through instrument lumen 95 of device 5) and used to incise lesion 315 along the submucosal layer 330 of intestine 335. Again, once the lesion 315 is severed from the submucosa of the intestine, the lesion 315 remains tethered to the anterior balloon 35 by the connector 305 and the surgical clip 320 .

[0123] In another form of the invention, connector 305 may include loop 340 having a variable length, but slip knot 345 and tension end 350 are replaced with length adjustment clip 355 and one or more tension ends 360. See FIG. 47. In this form of the invention, loop 340 is tensioned by pulling one or more tension ends 360 using a tool advanced through the working channel of endoscope 10 (or through instrument lumen 95 of device 5).

[0124] 48, it may be advantageous in some cases to provide connector 305 with a substantially rigid ring 365 at its proximal (i.e., lesion-side) end. By way of example and not limitation, if connector 305 is in the form of a loop, the loop of connector 305 may pass through the center of substantially rigid ring 365. Substantially rigid ring 365 serves to secure connector 305 to lesion 315, for example, by facilitating clipping of connector 305 to lesion 315 using surgical clip 320.

[0125] In some cases, it may be desirable to use multiple connectors 305 to connect the lesion 315 to the anterior balloon 35. This may allow the lesion 315 to be pulled distally in multiple directional vectors and at multiple attachment points, which may assist in resecting the lesion 315 from the submucosal layer 330 of the intestine 335. See FIG.

[0126] 50, where the connector 305 is in the form of a loop, multiple substantially rigid rings 365 are attached to a single connector 305, and the multiple substantially rigid rings 365 are secured to the lesion 315 at different locations, thereby allowing the lesion 315 to be pulled distally in multiple directional vectors and at multiple attachment points. Alternatively, where the connector 305 is in the form of a loop, different segments of the loop are secured to the lesion 315 at different locations using multiple surgical clips 320, thereby allowing the lesion 315 to be pulled distally in multiple directional vectors and at multiple attachment points.

[0127] In one form of the invention, the connector 305 is attached to the front balloon 35 (or push tube 30) in situ using surgical clips 320. However, if desired, the connector 305 may be pre-attached to the front balloon 35 (or one or more push tubes 30) at the time of manufacture (or at some other time prior to inserting the front balloon 35 into the body). By way of example and not limitation, and seeing FIGS. 51 and 52, the connector 305 may be pre-attached to the front balloon 35 using an eyelet or grommet-lined eyelet 370.

[0128] In some circumstances, the front balloon 35 (or the pusher) may be inserted without using the connector 305. It should also be understood that it is possible to secure the front balloon 35 (or one of the push tubes 30) directly to the lesion 315. By way of example and not limitation, one or more surgical clips 320 may be used to secure the front balloon 35 (or one of the push tubes 30) directly to the lesion 315. See, for example, FIG. 52A, which illustrates a surgical clip 320 securing the front balloon 35 directly to the lesion 315 without the use of a connector 305. See also, for example, FIG. 52B, which illustrates a surgical clip 320 securing the push tube 30 directly to the lesion 315 without the use of a connector 305.

[0129] Once the lesion 315 is resected from the submucosal layer 330 of the intestine 335 (or other tissue is resected from its location within the body cavity), the resected tissue must generally be removed from the patient's body. Because the resected tissue is secured to the front balloon 35 (or push rod 30) by one or more connectors 305 and / or surgical clips 320, the resected tissue can be removed simply by moving the novel device 5 out of the patient's body, and the resected tissue is withdrawn from the patient's body as the front balloon 35 (or push tube 30) is withdrawn from the patient's body. However, this approach risks the resected tissue being pulled away from the front balloon 35 (or push tube 30), for example, due to the breakage of a surgical clip attached to the resected tissue or due to the breakage of a surgical clip attached to the front balloon (or push tube). Furthermore, this approach essentially drags the exposed resected tissue along the length of the intestine (or other body cavity) as the novel device 5 is withdrawn from the patient's body. This can pose a risk to the patient, for example, if the resected tissue contains early stage cancer that may contaminate disease-free areas of the bowel (or other body cavity) (e.g., seeding of cancer cells).

[0130] Endoscopic tissue retrieval To this end, and with reference to Figures 53-60, the front balloon 35 may include a flap 375 disposed within a central bore 380 of the front balloon 35. The flap 375 (i) is captured between the endoscope 10 and the front balloon 35 when the front balloon 35 is attached to the endoscope 10, (ii) is captured within the closed central bore 380 of the front balloon 35 when the front balloon 35 is detached from the endoscope 10, protrudes distally from the endoscope 10, and is fully inflated (Figures 53, 54), and (iii) is captured within the closed central bore 380 of the front balloon 35 when the front balloon 35 protrudes distally from the endoscope 10 and is subsequently partially deflated. The central bore 380 of the front balloon 35 reopens, exposing the flap 375 ( FIGS. 55 and 56 ), and is configured (e.g., by a tool advanced through the instrument lumen 95 of the endoscope 10 or device 5) such that the flap 375 is “pulled down” across the central bore 380 of the front balloon 35, forming, together with the peripheral portion of the front balloon 35 that defines the central bore 380, a concave pouch 385 ( FIGS. 57 and 58 ) within the central bore 380 of the front balloon 35. This concave pouch 385 is configured to receive the excised tissue ( FIGS. 59 and 60 ).

[0131] Thus, in this form of the invention, after resecting lesion 315 from submucosa 330 of intestine 335 (or after resecting other tissue from a site within a body lumen), the resected tissue can be easily and safely removed by maneuvering the resected tissue into concave pouch 385 (e.g., using a tool advanced through the working channel of endoscope 10 or the instrument lumen of device 5) and simply removing novel device 5 from the patient's body, withdrawing the resected tissue from the patient's body as front balloon 35 is withdrawn from the patient's body. Note that this can be done while the resected tissue is connected to front balloon 35 (or push tube 30) via connector 305 and / or surgical clip 320. This approach also effectively eliminates the risk of the resected tissue being pulled away from the front balloon 35 (or push tube 30) due to, for example, breaking of a surgical clip attached to the resected tissue or breaking of a surgical clip attached to the front balloon (or push tube), and prevents the initial cancerous lesion from contaminating (e.g., seeding of cancer cells) the disease-free portion of the intestine because the resected tissue is protected within the concave pouch 385 as it is pulled out of the patient's body. Note that this reduces the risk of contaminating the body cavity (or other body cavity).

[0132] Application Examples Thus, it will be appreciated that the present invention comprises providing and using novel devices for manipulating the sidewalls of body cavities and / or lumen, e.g., straightening and "ironing" bends in the interior surface of a lumen, and forming substantially static or stable sidewalls of body cavities and lumen, to better present the tissue of the sidewall (including visualization of initially hidden or out-of-view areas) for examination and / or treatment during endoscopic procedures and to enable more accurate visual inspection (including visualization of initially hidden or out-of-view areas) and / or therapeutic intervention. By way of example only, and not by way of limitation, the novel devices can be used to stabilize, straighten, distend, and / or flatten bends and / or folds in the sidewall of the intestine to better present the tissue of the sidewall (including visualization of initially hidden or out-of-view areas) for examination and / or treatment during endoscopic procedures.

[0133] The present invention also provides and employs novel devices that can anchor and / or stabilize the distal tips and / or working ends of instruments inserted into body cavities and / or body cavities (e.g., endoscopes, articulating and / or non-articulating devices such as graspers, cutters, or resectors, cauterizing instruments, ultrasonic probes, etc.) against the sidewalls of the body cavities and / or body cavities during endoscopic procedures, thereby facilitating accurate use of these instruments.

[0134] By way of example only and not limitation, the device can provide a stable base (i.e., a stable endoscope, a stable treatment instrument, and a stable colon wall, all of which are mutually stable) for performing numerous minimally invasive procedures within body cavities and / or body cavities, including stabilizing endoscopes and / or other surgical instruments (e.g., graspers, cutters or resectors, cautery instruments, ultrasound probes, etc.) within body cavities and / or body cavities during, for example, lesion biopsy and / or lesion removal, organ resection, endoscopic submucosal resection (ESD), endoscopic mucosal resection (EMR), while stabilizing the colon (including reducing deformation of the colon wall) to allow for more precise visualization, intervention, and / or surgery.

[0135] Importantly, the present invention provides a novel device that can anchor and / or stabilize the distal tip and / or working end of an endoscope against the side walls of a body cavity and / or cavity (and thus anchor and / or stabilize the distal tip and / or working end of other instruments inserted through the working channels of these endoscopes, such as graspers, cutters, or resectors, cauterizing instruments, ultrasonic instruments, etc.), as well as stabilize the side walls of a body cavity and / or cavity against these instruments.

[0136] The present invention also provides a novel device that can stabilize and / or stabilize the distal tip and / or working end of an instrument (such as a grasper, cutter or resector, cauterizing instrument, ultrasonic probe, etc.) advanced to a surgical site by means other than through the working channel of an endoscope.

[0137] The novel devices of the present invention can be used in virtually any endoscopic procedure to facilitate aligning and presenting tissue and / or to stabilize an endoscope (and / or other instruments advanced through the endoscope) relative to tissue during an endoscopic procedure, or to aid in the advancement of an endoscope during such a procedure.

[0138] The present invention generally relates to a gastrointestinal (GI) tract (e.g., a large intestine) having a sidewall characterized by frequent bends and multiple folds and pathological projections located between the folds. The present invention is believed to have the widest applicability to other body cavities (e.g., blood vessels, lymphatic vessels, ureters, fallopian tubes, bronchi, bile ducts, etc.) and / or other body cavities (e.g., head, chest, abdomen, nasal cavity, bladder, sinuses within organs, etc.).

[0139] Modification example While the present invention has been described with respect to certain exemplary preferred embodiments, those skilled in the art will readily appreciate that the invention is not so limited and that numerous additions, deletions, and modifications can be made to the above-described preferred embodiments within the scope of the present invention.

Claims

1. an element configured to be movably attached to an endoscope; a connector configured to be secured to the element and to the tissue to be retracted; An endoscopic tissue retraction system comprising:

2. The endoscopic tissue retraction system of claim 1 , wherein the element comprises a balloon.

3. The endoscopic tissue retraction system of claim 2 , wherein the balloon is movably attached to the endoscope by at least one push tube.

4. The endoscopic tissue retraction system of claim 1 , wherein the connector comprises a flexible member.

5. The endoscopic tissue retraction system of claim 4 , wherein the flexible member comprises a loop.

6. The endoscopic tissue retraction system of claim 5 , wherein the loop has a variable length.

7. The endoscopic tissue retraction system of claim 6 , wherein the loop comprises a slip knot.

8. The endoscopic tissue retraction system of claim 6 , wherein the loop comprises a length adjustment clip.

9. The endoscopic tissue retraction system of claim 4 , wherein the flexible member comprises a single strand.

10. The endoscopic tissue retraction system of claim 4 , wherein a substantially rigid ring is attached to the flexible member.

11. The endoscopic tissue retraction system of claim 4 , wherein the flexible member comprises an elastomeric material.

12. The endoscopic tissue retraction system of claim 4 , wherein the flexible member comprises an inelastic material.

13. The endoscopic tissue retraction system of claim 1 , wherein the connector is substantially rigid.

14. The endoscopic tissue retraction system of claim 1 , wherein the connector is secured to at least one of the element and the tissue being retracted by a surgical clip.

15. The endoscopic tissue retraction system of claim 1 , wherein the element includes an eyelet, and the connector is secured to the element via the eyelet.

16. The endoscopic tissue retraction system of claim 1 , wherein the tissue being retracted comprises a lesion.

17. The endoscopic tissue retraction system of claim 16, wherein the lesion is attached to the submucosa of the intestine.

18. A method for endoscopically retracting tissue, comprising: positioning an endoscope and an element movably attached to the endoscope adjacent to the tissue to be retracted; securing a connector to the element and to the retracting tissue; urging the tissue away from the endoscope using the connector; method.

19. The method of claim 18 , wherein the element comprises a balloon.

20. 20. The method of claim 19, wherein the balloon is movably attached to the endoscope by at least one push tube.

21. 20. The method of claim 18, wherein moving the element away from the endoscope urges the tissue away from the endoscope.

22. 20. The method of claim 18, wherein the connector has a variable length and the tissue is urged away from the endoscope by shortening the length of the connector.

23. 20. The method of claim 18, wherein the connector comprises an elastomeric material, and the tissue is urged away from the endoscope by stretching the connector prior to securing the connector to the element and the tissue to be retracted.

24. The method of claim 18 , wherein the tissue being retracted comprises a lesion.

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

26. a balloon configured to be movably attached to an endoscope; an eyelet formed in the balloon; 1. An apparatus for endoscopic tissue retrieval comprising:

27. 1. A method for endoscopically retracting tissue, comprising: positioning an endoscope and an element movably attached to the endoscope adjacent to tissue to be retracted, wherein a connector is secured to the element; securing the connector to the tissue to be retracted; urging the tissue away from the endoscope using the connector; A method for traction of tissue using an endoscope, comprising:

28. 28. The method of claim 27, wherein the element comprises at least one from the group consisting of a balloon and a push tube.

29. A method for endoscopically retracting tissue, comprising: positioning an endoscope and an element movably attached to the endoscope adjacent to the tissue to be retracted; Fixing the tissue to be retracted to the element; Moving the element urges the tissue away from the endoscope. method.

30. 30. The method of claim 29, wherein the element comprises at least one from the group consisting of a balloon and a push tube.

31. a balloon configured to be movably attached to an endoscope, the balloon being capable of assuming a deflated state and an inflated state, an axial opening extending therethrough when the balloon is in the deflated state, and the axial opening being closed when the balloon is in the inflated state; The balloon is configured to form a concave pouch with the surrounding portion thereof for receiving excised tissue. a flap attached to the axial opening of the balloon, 1. An apparatus for endoscopic tissue retrieval, comprising:

32. 1. A method for endoscopic tissue retrieval, comprising: positioning a balloon assembly distal to the tissue to be retrieved, the balloon assembly being movably attached to an endoscope, the balloon assembly comprising: (i) a balloon capable of assuming a deflated state and an inflated state, an axial opening extending therethrough when the balloon is in the deflated state and an axial opening closed when the balloon is in the inflated state; and (ii) a flap attached to the axial opening of the balloon to form, together with a periphery of the balloon, a concave pouch for receiving the tissue to be retrieved; placing the retrieved tissue into the concave pouch; withdrawing the balloon assembly proximally to retrieve the tissue received within the concave pouch; A method comprising:

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