Methods and apparatus for manipulating a body lumen or a sidewall of a body cavity

Abstract

An endoscopic tissue retraction system includes an element configured to be movably mounted to an endoscope, and a connector configured to be secured to the element and to tissue to be retracted.

Description

[0001] Citation of pending prior patent applications

[0002] This patent application:

[0003] (i) is a continuation-in-part of pending prior U.S. Patent Application Serial No. 14 / 619,845, filed February 11, 2015, by Cornell University and John Frederick Cornhill et al., entitled "METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OF A BODY LUMEN OR BODYCAVITY SO AS TO PROVIDE INCREASED VISUALIZATION OF THE SAME AND / OR INCREASEDACCESS TO THE SAME, AND / OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME" (Attorney's Case No. CORN-34), which claims a partial continuation-in-part of the same application filed February 11, 2014, by Cornell University and John Frederick Cornhill et al., entitled "METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OF A BODY LUMEN OR BODYCAVITY SO AS TO PROVIDE INCREASED VISUALIZATION OF THE SAME". The rights of SAME AND / OR INCREASEDACCESS TO THE SAME, AND / OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME (Attorney's Case No. CORN-34 PROV) to the prior U.S. Provisional Patent Application Serial No. 61 / 938,446; and

[0004] (ii) Claim the benefit of prior pending U.S. Provisional Patent Application No. 62 / 446,167, filed on January 13, 2017, by Cornell University and Jeffrey Milsom et al., entitled “BALLOON TISSUE RETRACTION USING HOOP AND CLIP WITH VARIABLE LENGTHCAPABILITY, WITH SPECIMEN RETRIEVAL POUCH IN BALLOON” (Attorney’s Case No. CORN-43 PROV).

[0005] The three (3) patent applications mentioned above are incorporated herein by reference. Technical Field

[0006] The present invention generally relates to surgical methods and apparatus, and more particularly, to surgical methods and apparatus for manipulating body cavities and / or the sidewalls of body cavities to provide enhanced visualization of the sidewalls and / or enhanced access to the sidewalls, and / or for stabilizing instruments relative to the sidewalls. Background Technology

[0007] The human body includes many different body cavities and tubules. For example, but not limited to, the human body includes body cavities such as the gastrointestinal tract (GI), blood vessels, lymphatic vessels, urethra, fallopian tubes, bronchi, bile ducts, etc. As another example, but not limited to, the human body includes body cavities such as the head, thoracic cavity, abdominal cavity, sinuses, bladder, and internal organ cavities.

[0008] In many cases, it is desirable to use endoscopy to examine and / or treat disease processes or abnormalities located in or on the walls of body cavities. For example, but not limited to, it is desirable to examine the walls of the gastrointestinal tract to locate lesions, and if lesions are found, to perform biopsy, removal, and / or other treatment of said lesions.

[0009] Endoscopic examination and / or treatment of the lateral walls of the body lumen and / or body cavity can be complicated by the anatomical structure (both regional and local), and / or by the density of the tissues that make up the lateral walls of the body lumen and / or body cavity, and / or by the confinement of the lateral walls of the body lumen and / or body cavity to other anatomical structures.

[0010] For example, but not in a limiting sense, the intestine is an elongated tubular organ with an internal lumen, characterized by frequent turns (i.e., regional anatomy of the intestine) and lateral walls characterized by numerous folds (i.e., local anatomy of the intestine), wherein the lateral wall tissue has a relatively soft, flexible consistency, and wherein the colon is particularly bound to the abdominal cavity and / or other abdominal structures via soft tissue. Due to the varying lateral wall anatomy of the intestine (both regional and local), its relatively soft, flexible consistency, and its binding to other anatomical structures via soft tissue, it can be difficult to fully visualize the lateral walls of the intestine and / or treat lesions forming on the lateral walls of the intestine. For example, but not limited to, in the case of colonoscopy, approximately 5–40% of patients have anatomical structures of the lateral wall (regional and / or local), and / or tissue density, and / or the colon bound to other anatomical structures, which makes it difficult to fully visualize the anatomical structures (including pathological conditions of the anatomical structures, such as polyps or tumors) using conventional endoscopy and / or to fully approach the anatomical structures using instruments introduced through conventional endoscopy.

[0011] In addition to the above, some body lumens and / or cavities have been found to spontaneously spasm and / or contract, especially when an endoscope or other instrument is inserted into the body lumen and / or cavity. This spasm and / or contraction causes the body lumen and / or cavity to contract and / or otherwise move and / or alter its structure, which further complicates and / or impairs endoscopic visualization of anatomical structures, and / or further complicates and / or impairs access to anatomical structures using instruments introduced via conventional flexible endoscopes. Furthermore, during examination of the colon (which is typically performed during both insertion and withdrawal of the endoscope through the colon), the endoscope may grip and / or otherwise converge the colon during insertion and withdrawal and then abruptly slip and release it. This results in the endoscope moving rapidly through a considerable length of the colon, thus making accurate examination of the colon challenging.

[0012] Therefore, it would be highly advantageous to provide novel devices that can manipulate the body lumen and / or the lateral walls of the body cavity to better expose the lateral wall tissues (including visualizing areas that were initially hidden or out of sight) for examination and / or treatment during endoscopic procedures.

[0013] It will also be highly advantageous to provide novel devices that can be securely and / or stably inserted into the distal end and / or working end of an instrument (e.g., endoscope, articulated and / or non-articulated device, such as a gripper, cutter or peeler, cauterization tool, ultrasonic probe, etc.) relative to the sidewall of the body lumen and / or body cavity, thereby facilitating the precise use of those instruments.

[0014] Among other things, it would be highly advantageous to provide new devices that can secure and / or stabilize the distal tip and / or working end of an endoscope (and thus also secure and / or stabilize the distal tip and / or working end of other instruments inserted through the working channel of those endoscopes, such as grippers, cutters or peelers, cauterization tools, ultrasonic probes, etc.).

[0015] Furthermore, it would be highly advantageous to provide new devices that can securely and / or stably advance instruments (such as grippers, cutters or dissectors, cauterization tools, ultrasonic probes, etc.) to the surgical site via means other than through the working channel of the endoscope.

[0016] It will also be highly advantageous to be able to straighten bends, "iron" wrinkles on the surface of the inner lumen, and create substantially static or stable sidewalls for the body lumen and / or body cavity, thereby enabling more precise visual examination (including visualization of areas that were initially hidden or out of sight) and / or therapeutic interventions. Summary of the Invention

[0017] The present invention includes providing and using novel devices for manipulating body cavities and / or the sidewalls of body cavities to better visualize sidewall tissues (including areas that are initially hidden or out of sight) for examination and / or treatment during endoscopic procedures.

[0018] The invention also includes providing and using novel devices capable of being securely and / or stably inserted into the distal end and / or working end of an instrument (e.g., an endoscope, articulated and / or non-articulated device, such as a gripper, cutter or peeler, cauterization tool, ultrasonic probe, etc.) relative to the sidewall of the body lumen and / or body cavity, thereby facilitating precise use of those instruments.

[0019] Among other things, the present invention includes providing and using novel devices capable of securing and / or stabilizing the distal tip and / or working end of an endoscope (and thus also securing and / or stabilizing the distal tip and / or working end of other instruments inserted through the working channels of those endoscopes, such as grippers, cutters or peelers, cauterization tools, ultrasonic probes, etc.).

[0020] Furthermore, the present invention includes providing and using novel devices capable of securing and / or stabilizing the distal end and / or working end of an instrument (such as a gripper, cutter or dissector, cauterization tool, ultrasonic probe, etc.) that advances to the surgical site via a route other than through the working channel of an endoscope.

[0021] Furthermore, the present invention includes providing and using novel devices capable of straightening bends, "ironing out" wrinkles, and creating substantially static or stable sidewalls of body cavities and / or body chambers, which enables more precise visual examinations (including visualization of areas that were initially hidden or out of sight) and / or therapeutic interventions.

[0022] In a preferred embodiment of the invention, an apparatus is provided comprising:

[0023] A cannula suitable for sliding on the outside of an endoscope;

[0024] The proximal sac is fixed to the cannula;

[0025] An expansion / depression tube carried by the cannula and in fluid communication with the interior of the proximal cyst;

[0026] A push tube that can be slidably mounted to the sleeve; and

[0027] A distal capsule is fixed to the distal end of the push tube, the interior of the distal capsule being in fluid communication with the push tube, wherein the distal capsule is capable of being in a deflated state and an inflated state, and further wherein, when the distal capsule is in its deflated state, an axial opening extends through it, the axial opening being sized to receive an endoscope therein, and when the distal capsule is in its inflated state, the axial opening is closed.

[0028] In another preferred embodiment of the invention, a method for performing a procedure in a body lumen and / or body cavity is provided, the method comprising:

[0029] Provide equipment, the equipment including:

[0030] A cannula suitable for sliding on the outside of an endoscope;

[0031] The proximal sac is fixed to the cannula;

[0032] An expansion / depression tube carried by the cannula and in fluid communication with the interior of the proximal cyst;

[0033] A push tube that can be slidably mounted to the sleeve; and

[0034] A distal capsule is fixed to the distal end of the push tube, the interior of the distal capsule being in fluid communication with the push tube, wherein the distal capsule is capable of being in a deflated state and an inflated state, and further wherein, when the distal capsule is in its deflated state, an axial opening extends through it, the axial opening being sized to receive an endoscope therein, and when the distal capsule is in its inflated state, the axial opening is closed;

[0035] Position the device within a body lumen and / or body cavity;

[0036] Inflate the proximal cyst;

[0037] Propel the push tube to the distal side;

[0038] Inflate the distal cyst; and

[0039] Run the program.

[0040] In another preferred embodiment of the invention, a device is provided comprising:

[0041] A cannula adapted to slide on the outside of an endoscope, the cannula including a channel integrally formed with the cannula and a lumen integrally formed with the cannula for receiving instruments.

[0042] The proximal sac is fixed to the cannula;

[0043] An expansion / depression tube carried by the cannula and in fluid communication with the interior of the proximal cyst;

[0044] A push tube slidably mounted in the channel of the sleeve; and

[0045] A distal capsule is fixed to the distal end of the push tube, the interior of which is in fluid communication with the push tube.

[0046] In another preferred embodiment of the invention, a method for performing a procedure in a body lumen and / or body cavity is provided, the method comprising:

[0047] Provide equipment, the equipment including:

[0048] A cannula adapted to slide on the outside of an endoscope, the cannula including a channel integrally formed with the cannula and a lumen integrally formed with the cannula for receiving instruments.

[0049] The proximal sac is fixed to the cannula;

[0050] An expansion / depression tube carried by the cannula and in fluid communication with the interior of the proximal cyst;

[0051] A push tube slidably mounted in the channel of the sleeve; and

[0052] A distal capsule fixed to the distal end of the push tube, the interior of the distal capsule being in fluid communication with the push tube;

[0053] Position the device within a body lumen and / or body cavity;

[0054] Inflate the proximal cyst;

[0055] Propel the push tube to the distal side;

[0056] Inflate the distal cyst; and

[0057] Run the program.

[0058] In another preferred embodiment of the invention, a device is provided comprising:

[0059] A cannula adapted to slide on the outside of the endoscope so as to substantially cover the endoscope from a point adjacent to the distal end of the endoscope to a point adjacent to the handle of the endoscope.

[0060] The proximal sac is fixed to the cannula;

[0061] An expansion / depression tube carried by the cannula and in fluid communication with the interior of the proximal cyst;

[0062] A push tube that can be slidably mounted to the sleeve; and

[0063] A distal capsule is fixed to the distal end of the push tube, the interior of which is in fluid communication with the push tube.

[0064] In another preferred embodiment of the invention, a method for performing a procedure in a body lumen and / or body cavity is provided, the method comprising:

[0065] Provide equipment, the equipment including:

[0066] A cannula adapted to slide on the outside of the endoscope so as to substantially cover the endoscope from a point adjacent to the distal end of the endoscope to a point adjacent to the handle of the endoscope.

[0067] The proximal sac is fixed to the cannula;

[0068] An expansion / depression tube carried by the cannula and in fluid communication with the interior of the proximal cyst;

[0069] A push tube that can be slidably mounted to the sleeve; and

[0070] A distal capsule fixed to the distal end of the push tube, the interior of the distal capsule being in fluid communication with the push tube;

[0071] Position the device within a body lumen and / or body cavity;

[0072] Inflate the proximal cyst;

[0073] Propel the push tube to the distal side;

[0074] Inflate the distal cyst; and

[0075] Run the program.

[0076] In another preferred embodiment of the invention, a device is provided comprising:

[0077] A cannula suitable for sliding on the outside of an endoscope;

[0078] The proximal sac is fixed to the cannula;

[0079] An expansion / depression tube carried by the cannula and in fluid communication with the interior of the proximal cyst;

[0080] A pair of push tubes slidably mounted to the sleeve; and

[0081] A distal bladder is fixed to the distal end of the pair of push tubes, the interior of which is in fluid communication with the pair of push tubes.

[0082] In another preferred embodiment of the invention, a method for performing a procedure in a body lumen and / or body cavity is provided, the method comprising:

[0083] Provide equipment, the equipment including:

[0084] A cannula suitable for sliding on the outside of an endoscope;

[0085] The proximal sac is fixed to the cannula;

[0086] An expansion / depression tube carried by the cannula and in fluid communication with the interior of the proximal cyst;

[0087] A pair of push tubes slidably mounted to the sleeve; and

[0088] A distal bladder is fixed to the distal end of the pair of push tubes, the interior of the distal bladder being in fluid communication with the pair of push tubes;

[0089] Position the device within a body lumen and / or body cavity;

[0090] Inflate the proximal cyst;

[0091] This causes the pair of push tubes to advance further to the distal side;

[0092] Inflate the distal cyst; and

[0093] Run the program.

[0094] In another preferred embodiment of the invention, an endoscopic tissue retraction system is provided, comprising:

[0095] Components configured to be movably mounted onto an endoscope; and

[0096] A connector, configured to be fixed to the element and the tissue to be retracted.

[0097] In another preferred embodiment of the invention, a method for retracting tissue endoscopically is provided, the method comprising:

[0098] Position the endoscope and its movable components adjacent to the endoscope in proximity to the tissue to be retracted;

[0099] Secure the connector to the component and the tissue to be retracted; and

[0100] Use connectors to push the tissue away from the endoscope.

[0101] In another preferred embodiment of the invention, an apparatus for endoscopic tissue retrieval is provided, the apparatus comprising:

[0102] A capsule, configured to be movably mounted onto an endoscope; and

[0103] The openings formed on the cyst.

[0104] In another preferred embodiment of the invention, a method for retracting tissue endoscopically is provided, the method comprising:

[0105] The endoscope and its movably mounted components are positioned adjacent to the tissue to be retracted, wherein a connector is secured to the components;

[0106] Secure the connector to the tissue to be retracted; and

[0107] Use connectors to push the tissue away from the endoscope.

[0108] In another preferred embodiment of the invention, a method for retracting tissue endoscopically is provided, the method comprising:

[0109] Position the endoscope and its movable components adjacent to the endoscope in proximity to the tissue to be retracted;

[0110] Secure the tissue to be retracted to the element; and

[0111] By moving this element, the tissue is pushed away from the endoscope.

[0112] In another preferred embodiment of the invention, an apparatus for endoscopic tissue retrieval is provided, the apparatus comprising:

[0113] A capsule configured for movable mounting to an endoscope, wherein the capsule is capable of being in a deflated and inflated state, and further wherein, when the capsule is in its deflated state, an axial opening extends through it, and when the capsule is in its inflated state, the axial opening is closed; and

[0114] The flaps are installed in the axial opening of the capsule to form a concave bag together with the surrounding portion of the capsule for receiving the dissected tissue.

[0115] In another preferred embodiment of the invention, a method for retrieving endoscopic tissue is provided, the method comprising:

[0116] The capsule assembly is positioned distal to the tissue to be retrieved, the capsule assembly is movably mounted to the endoscope, and the capsule assembly includes (i) a capsule capable of being in a deflated and inflated state, wherein an axial opening extends through the capsule when the capsule is in its deflated state, and the axial opening is closed when the capsule is in its inflated state; and (ii) a flap, which is mounted in the axial opening of the capsule to form a concave pouch together with a peripheral portion of the capsule for receiving the tissue to be retrieved.

[0117] Position the tissue to be retrieved into the concave bag; and

[0118] The capsule assembly is withdrawn proximally to retrieve the tissue received within the concave pouch. Attached Figure Description

[0119] These and other objects and features of the invention will be disclosed or made apparent more fully by the following detailed description of preferred embodiments of the invention, taken in conjunction with the accompanying drawings, in which similar numerals refer to similar parts, and further in the drawings:

[0120] Figure 1 This is a schematic diagram illustrating a novel device formed according to the present invention, wherein, among other things, the novel device includes a cannula disposed on the end of an endoscope, a posterior capsule mounted to the cannula, a pair of push tubes slidably mounted to the cannula, an anterior capsule mounted to the distal end of the push tubes, and a push tube handle mounted to the proximal end of the push tubes.

[0121] Figures 2 to 4 This is a schematic diagram showing various arrangements of the anterior capsule relative to the posterior capsule;

[0122] Figure 5 It is shown Figure 1 A schematic diagram showing further details of the remote end of the device shown;

[0123] Figure 6 It is along Figure 5 A sectional view taken from line 6-6;

[0124] Figure 7 and Figure 8 This is a schematic diagram showing further details of the anterior capsule;

[0125] Figure 8A This is a schematic diagram showing the push tube handle;

[0126] Figure 9 and Figure 10 This is a schematic diagram showing the structural details of the anterior capsule;

[0127] Figure 11 This is a schematic diagram illustrating one form of the expansion mechanism provided according to the present invention;

[0128] Figure 11A This is a schematic diagram illustrating another form of the expansion mechanism provided according to the present invention;

[0129] Figure 12 and Figure 13 This is a schematic diagram illustrating another form of the expansion mechanism provided according to the present invention;

[0130] Figure 14 This is a schematic diagram illustrating a pressure-reducing valve that can be used to ensure that the pressure in the anterior and / or posterior bladder does not exceed a predetermined level;

[0131] Figure 15 It shows that it can be used for tensioning Figure 1A schematic diagram of the relaxed retraction system in the flexible tube of the device shown.

[0132] Figures 16 to 30 It shows the use Figure 1 A schematic diagram of the preferred method for the equipment;

[0133] Figure 30A This is a schematic diagram illustrating an alternative construction of the push tube and push tube handle used in the present invention;

[0134] Figure 31 This is a schematic diagram illustrating another form of the cannula, wherein the cannula includes an additional lumen for receiving instruments;

[0135] Figures 32 to 35 This is a schematic diagram showing how the instrument can advance through the additional lumen of the sleeve;

[0136] Figure 36 This is a schematic diagram showing an instrument guide tube that can be placed in an additional lumen of the sleeve, wherein the instrument can advance through the instrument guide tube;

[0137] Figures 37 to 42 This is a schematic diagram illustrating an endoscopic tissue retraction system formed according to the present invention;

[0138] Figures 43 to 45 This is a schematic diagram illustrating another endoscopic tissue retraction system formed according to the present invention;

[0139] Figure 46 This is a schematic diagram illustrating another endoscopic tissue retraction system formed according to the present invention;

[0140] Figure 47 This is a schematic diagram illustrating yet another endoscopic tissue retraction system formed according to the present invention;

[0141] Figure 48 This is a schematic diagram illustrating another endoscopic tissue retraction system formed according to the present invention;

[0142] Figure 49 This is a schematic diagram illustrating another endoscopic tissue retraction system formed according to the present invention;

[0143] Figure 50 This is a schematic diagram illustrating yet another endoscopic tissue retraction system formed according to the present invention;

[0144] Figures 51 to 52 This is a schematic diagram illustrating another endoscopic tissue retraction system formed according to the present invention;

[0145] Figure 52A and 52B This is a schematic diagram illustrating another endoscopic tissue retraction system formed according to the present invention; and

[0146] Figures 53 to 60 This is a schematic diagram illustrating an endoscopic tissue retrieval system formed according to the present invention. Detailed Implementation

[0147] The present invention includes providing and using novel devices for manipulating body cavities and / or the sidewalls of body cavities to better visualize sidewall tissues (including areas that are initially hidden or out of sight) for examination and / or treatment during endoscopic procedures.

[0148] (As used herein, the term "endoscopic procedure" is intended to mean essentially any minimally invasive or limited access procedure for diagnosis and / or treatment and / or surgery, for intracavitary or transcavitary or otherwise access to the interior of body cavities and / or body tubes, for the purpose of observation, biopsy and / or treatment of tissue, including removal of lesions and / or resection of tissue.)

[0149] The invention also includes providing and using novel devices capable of being securely and / or stably inserted into the distal end and / or working end of an instrument (e.g., an endoscope, articulated and / or non-articulated device, such as a gripper, cutter or peeler, cauterization tool, ultrasonic probe, etc.) relative to the sidewall of the body lumen and / or body cavity, thereby facilitating precise use of those instruments.

[0150] Among other things, the present invention includes providing and using novel devices capable of securing and / or stabilizing the distal tip and / or working end of an endoscope (and thus also securing and / or stabilizing the distal tip and / or working end of other instruments inserted through the working channels of those endoscopes, such as grippers, cutters or peelers, cauterization tools, ultrasonic probes, etc.).

[0151] Furthermore, the present invention includes providing and using novel devices capable of securing and / or stabilizing the distal end and / or working end of an instrument (such as a gripper, cutter or dissector, cauterization tool, ultrasonic probe, etc.) that advances to the surgical site via a route other than through the working channel of an endoscope.

[0152] Furthermore, the present invention includes providing and using novel devices capable of straightening bends, "ironing out" wrinkles, and creating substantially static or stable sidewalls of body cavities and / or body chambers, which enables more precise visual examinations (including visualization of areas that were initially hidden or out of sight) and / or therapeutic interventions.

[0153] New equipment

[0154] According to the present invention, and now looking at Figure 1A novel device 5 is shown, capable of manipulating (e.g., stabilizing, straightening, dilating, and / or leveling) the lateral walls of a body lumen and / or body cavity to better visualize lateral wall tissues (including areas that are initially hidden or outside the field of view) for examination and / or treatment using an endoscope 10 (e.g., an articulated endoscope) during endoscopic procedures, and / or for stabilizing the distal end of the endoscope 10 and / or other instruments (e.g., grippers, cutters or dissectors, cauterization tools, ultrasound probes, etc.). Figure 1 The distal end and / or working end (not shown in the image).

[0155] More specifically, the device 5 generally includes a cannula 15 adapted to slide on the outside of the axis of the endoscope 10, a proximal (or "posterior") sac 20 fixed to the cannula near the distal end of the cannula 15 (the terms "proximal" and "posterior" will be used interchangeably below), and a base 25 fixed to the cannula at the proximal end of the cannula 15. The device 5 also includes a pair of push tubes 30 slidably mounted to the cannula 15, as discussed below, and a distal (or "anterior") sac 35 fixed to the distal end of the push tubes 30 (the terms "distal" and "anterior" will be used interchangeably below), such that the spacing between the posterior sac 20 and the anterior sac 35 can be adjusted by a physician (or other operator or user) by moving the push tubes 30 relative to the cannula 15 (e.g., by simultaneously advancing both push tubes at the push tube handle 37, see below). See Figure 1 as well as Figures 2 to 4 Device 5 also includes an associated expansion mechanism 40 ( Figure 1 This allows a physician (or other operator or user) to selectively inflate / deflate one or both of the posterior cyst 20 and the anterior cyst 35.

[0156] Now look Figures 1 to 6The cannula 15 generally comprises an elongated, thin-walled tube configured to slide on the outside of the axis of the endoscope 10 (e.g., retracting from the distal end of the endoscope) for a tight fit with the endoscope. The cannula is sized and constructed such that it will easily slide backward on the endoscope during mounting (preferably when the endoscope is "dry"), but will have sufficient residual friction with the outer surface of the endoscope (when gripped by a physician or other operator or user) to allow torque (i.e., rotational turning) and pushing / pulling (e.g., within the patient's colon) to be applied to the endoscope during use. In a preferred embodiment of the invention, the cannula 15 can move to a certain extent circumferentially about the endoscope 10 (and can rotate with the axis of the endoscope when firmly gripped by a physician or other operator or user); however, the cannula 15 can nominally only move relative to the endoscope 10 in the axial direction. The cannula 15 is sized such that when its distal end is substantially aligned with the distal end of the endoscope 10, the cannula 15 (together with the base 25) will substantially cover the axis of the endoscope. In any case, the cannula 15 is sized such that when it is mounted to the endoscope 10 and the endoscope 10 is inserted into the patient, the cannula 15 extends out of the patient's body. In a preferred embodiment of the invention, the device 5 is provided according to the specific endoscope intended to be used with, wherein the device 5 is sized such that when the base 25 is engaged with the handle of the endoscope, the distal end of the cannula 15 will be suitably positioned at the distal end of the endoscope, i.e., substantially aligned with the distal end of the endoscope, or slightly proximal to the distal end of the endoscope.

[0157] If desired, the distal end of the cannula 15 may be provided with a radially inwardly extending stop (not shown) to actively engage the distal surface of the endoscope 10, thereby preventing the distal end of the cannula 15 from moving proximally beyond the distal surface of the endoscope 10. This radially inwardly extending stop may also help prevent "torque slip" of the cannula 15 relative to the endoscope 10 during torque application (i.e., rotational rotation) while the endoscope is located within the colon, and / or prevent "thrust slip" of the cannula 15 relative to the endoscope 10 during forward pushing of the endoscope while the endoscope is located within the colon.

[0158] The cannula 15 preferably has a smooth outer surface to avoid tissue trauma and is preferably made of a very flexible material so that the cannula will not impede the bending of the endoscope during use. In a preferred embodiment of the invention, the cannula 15 comprises polyurethane, polyethylene, polyvinyl chloride (PVC), polytetrafluoroethylene (PTFE), etc., and is preferably transparent (or at least translucent) to allow distance markings on the endoscope 10 to be visible through the cannula 15. Moreover, in a preferred embodiment of the invention, the cannula 15 preferably has nominal circumferential strength so that a physician (or other operator or user) can grip the endoscope 10 through the cannula 15, for example, to apply torque to the endoscope. If desired, the cannula 15 may include a lubricating coating (e.g., a liquid, such as perfluoropolyether synthetic oil, powder, etc.) on some or all of its inner and / or outer surfaces to facilitate placement of the cannula on the endoscope and / or movement of the device 5 through body lumens and / or body cavities. Alternatively, the cannula 15 may be formed of a self-lubricating material, such as polytetrafluoroethylene (PTFE), etc. It should be understood that the inner surface of the cannula 15 may include features (e.g., ribs) to prevent the cannula from rotating relative to the endoscope during use.

[0159] If desired, a vacuum can be “drawn” between the cannula 15 and the endoscope 10 to secure the cannula 15 to the endoscope 10 and minimize the profile of the cannula 15. For example, but not limitingly, the vacuum can be introduced at the proximal end of the cannula 15 (i.e., at the base 25), or at a point in the middle of the cannula 15. As another example, but not limitingly, it should also be understood that removal of the cannula 15 from the endoscope 10 (e.g., at the end of the procedure) can be facilitated by introducing fluid (e.g., air or liquid lubricant) into the space between the cannula 15 and the endoscope 10, for example, at the proximal end of the cannula 15 (i.e., at the base 25) or in the middle of the cannula 15.

[0160] Still looking towards Figures 1 to 6 The posterior bladder 20 is fixed to the cannula 15 proximal to the endoscope's hinge joint, near but spaced from the distal end of the cannula. The posterior bladder 20 is concentrically positioned around the cannula 15, and thus concentrically positioned around the endoscope 10 housed within the cannula 15. Therefore, the posterior bladder 20 has a generally toroidal shape. The posterior bladder 20 can be selectively inflated / deflated by means of a proximal expansion / deflation tube 45, the distal end of which is in fluid communication with the interior of the posterior bladder 20, and the proximal end of which is in fluid communication with a fitting 46 mounted to the base 25. The fitting 46 is configured for connection to the aforementioned associated expansion mechanism 40. The fitting 46 is preferably a Luer-activated valve, thereby allowing the expansion mechanism 40 to disconnect from the fitting 46 without loss of pressure in the posterior bladder 20. The expansion / deflation tube 45 can be fixed to the outer surface of the cannula 15, or more preferably, the expansion / deflation tube 45 can be contained within a lumen 47 formed within the cannula 15.

[0161] Preferably, the posterior capsule 20 is positioned a short posterior distance from the distal end of the cannula 15, approximately the same distance as the length of the hinge portion of the steerable endoscope 10, such that when the steerable endoscope is positioned in the cannula 15, the hinge portion of the steerable endoscope will be positioned distal to the posterior capsule 20. This configuration allows the flexible portion of the steerable endoscope to be hinged even when the posterior capsule 20 has inflated within the anatomical structure, in order to stabilize the adjacent non-hinged portion of the endoscope relative to the anatomical structure, as will be discussed in further detail below. Thus, when inflated, the posterior capsule 20 provides a robust platform for holding the endoscope 10 in a stable position within the body lumen or cavity, while the endoscope 10 remains centered within the body lumen or cavity. As a result, the endoscope 10 can provide improved visualization of the anatomical structure. Furthermore, since the endoscope 10 is securely held within the body lumen or cavity by the expanded posterior capsule 20, instruments that advance through the internal lumen of the endoscope 10 (sometimes referred to as "working channels" or "multiple working channels") will also be provided with a robust platform for supporting those instruments within the body lumen or cavity.

[0162] When the posterior capsule 20 is properly inflated, it can non-invasively engage with the sidewall of the body lumen in which the device 5 is placed and form a sealing relationship with the sidewall.

[0163] In a preferred embodiment of the invention, the posterior capsule 20 is formed of polyurethane.

[0164] The base 25 is secured to the proximal end of the cannula 15. The base 25 engages the endoscope 10 and helps secure the entire assembly (i.e., device 5) to the endoscope 10. The base 25 preferably comprises a substantially rigid or semi-rigid structure that can be gripped and pulled proximally by a physician (or other operator or user) to allow the physician (or other operator or user) to pull the cannula 15 at the distal end of the endoscope 10 and then pull it proximally and rearward along the length of the endoscope 10 to mount the cannula 15 to the outer surface of the endoscope's axis. In a preferred embodiment of the invention, the base 25 is pulled proximally along the endoscope until it sits against the endoscope's handle, thereby preventing further proximal movement of the base 25 (and thus, consequently, preventing further proximal movement of the cannula 15). In a preferred embodiment of the invention, the base 25 forms a sealing engagement with the endoscope 10.

[0165] The push tube 30 is slidably mounted to the cannula 15, such that the distal end of the push tube can extend and / or retract relative to the cannula 15 (e.g., by advancing or retracting the push tube via the push tube handle 37, see below), and thus extend and / or retract relative to the distal end of the endoscope 10 disposed in the cannula 15. Preferably, the push tube 30 is slidably disposed in a support tube 50, which is fixed to the outer surface of the cannula 15, or more preferably contained within a lumen 52 formed within the cannula 15. The support tube 50 is preferably formed of a low-friction material (e.g., polytetrafluoroethylene, also known as "PTFE") to minimize the resistance to movement of the push tube 30 relative to the support tube 50 (and thus minimize the resistance to movement of the push tube 30 relative to the cannula 15). In this respect, it should be understood that minimizing the resistance to movement of the push tube 30 relative to the support tube 50 improves the tactile feedback to the user when the push tube 30 is used to manipulate the anterior capsule 35. In one form of the invention, the support tube 50 is flexible (to allow the endoscope 10, especially the hinged portion of a steerable endoscope 10, to flex as needed during the procedure); however, the support tube 50 also provides a certain column strength. Thus, when the support tube 50 is mounted within the lumen 52 formed in the sleeve 15, the assembly of the sleeve 15 and the support tube 50 is flexible but has a degree of column strength (while the sleeve 15 alone is flexible but essentially has no column strength). When the push tube 30 is included within the lumen 52 formed in the sleeve 15, and when the support tube 50 is not positioned between the push tube 30 and the lumen 52, the lumen 52 is preferably lubricated to minimize friction between the push tube 30 and the lumen 52.

[0166] The proximal end of the push tube 30 is connected to the push tube handle 37. Due to this configuration, pushing distally on the push tube handle 37 causes the distal end of the push tube 30 to move distally relative to the cannula 15 (at the same rate) (so that the anterior capsule 35 moves distally relative to the posterior capsule 20), and pulling proximally on the push tube handle 37 causes the distal end of the push tube 30 to retract proximally relative to the cannula 15 (at the same rate) (so that the anterior capsule 35 moves proximally relative to the posterior capsule 20). Note that by moving the push tube 30 distally or proximally at the same rate, the distal ends of the push tube remain parallel to each other. Clamp 53 ( Figure 12 and Figure 15 It is positioned at the base 25 to hold the push tube 30 in a selected placement point relative to the base 25 (and therefore, in a selected placement point relative to the sleeve 15).

[0167] The push tube 30 is preferably formed of a relatively flexible material that provides good column strength, such as thermoplastic polyethylene resins, such as Isoplast™ (available from The Lubrizol Corporation in Wycliffe, Ohio), polyethylene, polypropylene, nylon, etc. It should be understood that the push tube 30 may comprise a single material or multiple materials, and the stiffness of the push tube 30 may vary along its length. For example, but not limited to, the distal portion of the push tube 30 may be formed of the same material as the rest of the push tube, but with a lower modulus to be more flexible than the rest of the push tube, or the distal portion of the push tube 30 may comprise a different, more elastic flexible material. For example, but not limited to, the distal portion of the push tube 30 may comprise nitinol. As another example, but not limited to, the distal portion of the push tube 30 may comprise a stainless steel coil covered with a polytetrafluoroethylene (PTFE) sheath, wherein the distal sheath / proximal tubing together provides a sealed lumen for inflating / deflating the bladder 35. By shaping the push tube 30 to have a more flexible distal end than the rest of the push tube, the push tube 30 and the anterior capsule 35 can together serve as guides (with soft, non-invasive tips) for the device 5 and endoscope 10, as discussed further below.

[0168] In a preferred embodiment of the invention, the push tubes 30 are configured to remain parallel when they are in an unbiased state (i.e., when no force is applied to the push tubes 30). This is true regardless of whether the anterior capsule 35 is inflated or deflated.

[0169] If desired, the distal portion of the push tube 30 can be configured to bend inward or outward. With this configuration, when the distal tip of the push tube 30 remains stationary (e.g., by the inflated anterior capsule, as discussed below) and a sufficient distally directed force is applied to the push tube 30, the middle portion of the push tube 30 (i.e., the portion between the inflated anterior capsule 35 and the cannula 15) can bend outward or bend into an arc shape, thereby pushing outward against the sidewall of the body lumen in which the device 5 is positioned, thus providing a "bulge" effect on the sidewall of the body lumen and / or body cavity in the space between the posterior capsule 20 and the anterior capsule 35. This "bulge" effect, by pushing outward against the sidewall of the body lumen and / or body cavity in which the device 5 is positioned, can significantly enhance visibility and / or tissue stability in the region distal to the endoscope 10.

[0170] It should also be understood that by forming the push tubes 30 from a flexible material, it is possible to manually adjust their position during use (e.g., by using a separate tool, by applying torque to the device, etc.) to prevent the push tubes from interfering with the visualization of the patient's anatomical structures and / or interfering with the diagnostic or therapeutic tool introduced into the space between the anterior and posterior capsules. For example, but not limited, if the device 5 is positioned in an anatomical structure such that the push tubes 30 obstruct the visibility or physical access to a target area of ​​the anatomical structure, the flexible push tubes 30 can be moved unobstructed by using a separate tool or instrument, or by rotating the device with torque to move the flexible push tubes 30 unobstructed, etc. As another example, but not limited, by constructing the push tubes 30 such that they are circular and flexible and their diameter is significantly smaller than the circumference of the endoscope 10, the movement of the circular endoscope during articulation can easily push the push tubes unobstructed and provide an unobstructed visual path to the tissue of interest.

[0171] It should also be understood that, if desired, the push tube 30 may be marked with indicators, including distance markers (not shown in the figures), such as colored indicators or radiopaque indicators, so that a physician (or other operator or user) observing the surgical site via endoscopy 10 or by radiographic guidance (e.g., X-ray fluoroscopy) can determine the longitudinal and / or circumferential relative placement of the push tube 30 at the surgical site relative to the sidewalls of the body lumen and / or other body cavities.

[0172] As will be discussed in further detail below, the push tubes 30 are hollow, and their distal ends are connected to the anterior capsule 35 ( Figures 1 to 5 , Figure 7 and Figure 8 The anterior bladder 35 is in internal fluid communication with the bladder itself, and its internal lumen is in fluid communication with fittings 56 mounted to the base 25. Fittings 56 are configured to connect to the aforementioned associated expansion mechanism 40 so that the anterior bladder 35 can be selectively expanded / deflated with air or other fluids, including liquids. Fittings 56 are preferably Luer-activated valves, thereby allowing the expansion mechanism 40 to disconnect from fittings 56 without loss of pressure in the anterior bladder 35.

[0173] More particularly, in a preferred embodiment of the invention, and now looking towards... Figure 8AThe push tube handle 37 includes a hollow interior 57. A push tube 30 is mounted to the push tube handle 37 such 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 57 of the push tube handle 37. The push tube handle 37 also includes a fitting 58, which is in fluid communication with the hollow interior 57 of the push tube handle 37. A flexible tube 59 connects the fitting 58 to an inner chamber (not shown) in the base 25, which is in fluid communication with the aforementioned fitting 56. Due to this configuration, when the push tube handle 37 moves distally, the anterior capsule 35 moves distally, and when the push tube handle 37 moves proximally, the anterior capsule 35 moves proximally. Furthermore, when positive fluid pressure is applied to the fitting 56 in the base 25, the positive fluid pressure is applied to the interior of the front bladder 35 to inflate the front bladder 35, and when negative fluid pressure is applied to the fitting 56 in the base 25, the negative fluid pressure is applied to the interior of the front bladder 35 to deflate the front bladder 35.

[0174] It should be understood that providing a dual-push tube offers several advantages. For example, but not in a limiting sense, the dual-push tube provides symmetrical force to the anterior capsule 35 as it advances distally into the body lumen, as will be discussed below. Furthermore, the dual-push tube 30 provides equal outward force against adjacent anatomical structures when the tube is used to align anatomical structures in the region proximal to the distal end of the endoscope 10, thereby enhancing visualization and / or accessibility of anatomical structures, as will be discussed below. Additionally, the dual-push tube ensures that the anterior capsule 35 remains centered on the endoscope 10, thereby facilitating the disengagement of the anterior capsule 35 from the endoscope 10 and its re-engagement on the endoscope 10, as will be discussed below. Furthermore, the dual-push tube 30 helps ensure the stability of the anterior capsule 35 relative to the endoscope's tip, minimizing rotational movement of the anterior capsule during inflatation. Moreover, the dual hollow push tubes provide a redundant air delivery system for inflating or deflating the anterior capsule 35.

[0175] The anterior balloon 35 is fixed to the distal end of the push tube 30, wherein the distance between the posterior balloon 20 and the anterior balloon 35 can be adjusted by moving the push tube 30 relative to the cannula 15, i.e., by moving the push tube handle 37 relative to the cannula 15. Furthermore, the hollow push tube 30 provides a conduit between the interior of the anterior balloon 35 and the fitting 56, thereby allowing selective inflation / deflation of the anterior balloon 35 via the fitting 56.

[0176] Importantly, the anterior cyst 35 is configured such that (i) when it is discharged (or partially discharged) and it is in its "retracted" position relative to the cannula 15 ( Figure 2 When the anterior capsule 35 provides an axial opening 63 sufficient to accommodate the cannula 15 and the endoscope 10, the anterior capsule 35 provides an axial opening 63. Figure 7 , 8(ii) the capsule 35 can be "doped" onto the cannula 15 and endoscope 10, and the capsule 35 is currently in its "extended" position relative to the cannula 15 and is properly inflated. Figure 4 When the anterior capsule 35 is properly inflated, the axial opening 63 closes (and preferably completely closes). Simultaneously, when properly inflated, the anterior capsule can non-invasively engage and seal the sidewalls of the body lumen and / or body cavity within which the device 5 is housed. Therefore, when the anterior capsule 35 is properly inflated, the anterior capsule can effectively seal the body lumen and / or body cavity distal to the anterior capsule 35 by closing the axial opening 63 and forming a seal with the sidewalls of the body lumen and / or body cavity within which the device 5 is housed. In this way, when the push tube 30 advances distally to separate the anterior capsule 35 from the posterior capsule 20, and when the anterior capsule 35 and posterior capsule 20 are properly inflated, a sealed area (sometimes referred to hereinafter as the "treatment area") will be created between the two capsules.

[0177] It will be understood that when the anterior cyst 35 is reconfigured from its venting state to its inflated state, the anterior cyst 35 expands radially inward (in order to close the axial opening 63) and radially outward (in order to engage the surrounding tissue).

[0178] Therefore, it will be seen that the anterior cyst 35 has a "toroidal" shape when deflated (to allow it to sit on the distal end of the endoscope) and a substantially "solid" shape when inflated (to allow it to close the body lumen or body cavity).

[0179] Therefore, and now looking towards Figure 9 and 10The anterior capsule 35 is preferably manufactured as a single 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 including a protrusion 74, and a distal extension 76 having a circular cross-section. Note that the protrusion 74 is disposed on the proximal extension 73 in a configuration that matches the push tube 30 (i.e., in the case where the device 5 includes two push tubes 30 that are circumferentially opposite each other along their diameter, the proximal extension 73 will include two protrusions 74 that are circumferentially opposite each other along their diameter; in the case where the device 5 includes three push tubes 30 that are circumferentially equidistant from the periphery of the sleeve 15, the proximal extension 73 will include three protrusions 74 that are circumferentially equidistant from the periphery of the proximal extension 73; in the case where the device 5 includes one push tube 30, the proximal extension 73 will include one protrusion 74, etc. - for the purposes of this invention, the proximal extension 73 and (one or more) protrusions 74 may be collectively referred to as having a "key-shaped" cross-section). During assembly, the push tube 30 is seated in the protrusion 74 of the proximal extension 73, which is then flipped into the interior of the body 67 (wherein the interior of the hollow push tube 30 is in fluid communication with the interior of the body 67), and then the distal extension 76 is flipped into the interior of the proximal extension 73 to provide an anterior capsule 35 having an axial opening 63 extending therethrough, while the push tube 30 is secured to and in communication with the interior of the anterior capsule 35. Importantly, the axial opening 63 is sized to receive the distal end of the endoscope 10 therein. Also importantly, by forming the anterior capsule 35 through the aforementioned process of flipping the proximal extension 73 into the interior of the body 67 and then flipping the distal extension 76 into the interior of the proximal extension 73, a multilayer capsule material is provided around the push tube 30, thereby providing a more robust capsule structure. Among other things, providing a multilayered capsule material around the push tube 30 adds cushioning to the distal end of the push tube 30, thereby providing the push tube 30 with an even more non-invasive distal tip, and also ensuring that the distal tip of the push tube 30 does not damage adjacent tissue.

[0180] In a preferred embodiment of the invention, the anterior capsule 35 is formed of polyurethane.

[0181] It should be understood that when the anterior capsule 35 is in its deflated state, the material of the anterior capsule 35 substantially surrounds the distal end of the push tube 30 (while still allowing fluid communication between the push tube 30 and the interior of the anterior capsule 35), thereby providing a non-invasive tip for advancing the anterior capsule 35 distally through the body lumen. Furthermore, the push tube 30 and the deflated anterior capsule 35 together can essentially serve as soft-tip guides for the device 5 and endoscope 10, as further discussed below. Figure 20 ).

[0182] If desired, one or both of the posterior capsule 20 and the anterior capsule 35 may be marked with indicators (e.g., color indicators or radiopaque indicators) so that a physician (or other operator or user) viewing the surgical site via endoscopy 10 or radiographic guidance (e.g., X-ray fluoroscopy) can identify the placement of one or both capsules at the surgical site.

[0183] The expansion mechanism 40 provides a means for selectively expanding the posterior cyst 20 and / or the anterior cyst 35.

[0184] In a preferred embodiment of the invention, and now looking towards Figure 1 and 11 The expansion mechanism 40 includes a single-wire syringe inserter 140, which comprises a body 145 and a plunger 150. Preferably, a spring 153 is disposed in the body 145 to automatically return the plunger 150 at the end of its stroke. The syringe inserter 140 is connected to one or the other of fittings 46, 56 via a wire 155. Thus, with this configuration, when the single-wire syringe inserter 140 is to be used to inflate the posterior bladder 20, the syringe inserter 140 is connected to fitting 46 via the wire 155 such that the output of the single-wire syringe inserter 140 is directed to the posterior bladder 20 (i.e., via the proximal expansion / depression tube 45). Accordingly, when the single-wire syringe inserter 140 is to be used to inflate the anterior bladder 35, the syringe inserter 140 is connected to fitting 56 via the wire 155 such that the output of the single-wire syringe inserter 140 is directed to the anterior bladder 35 (i.e., via the hollow interior of the flexible tube 59 and the push tube 30).

[0185] In another preferred embodiment of the invention, the expansion mechanism 40 includes an elastic ball 156 having a first port 157 and a second port 158. A one-way valve 159 (e.g., a check valve) is disposed in the first port 157 such that air can pass through only the first port 157 when traveling in an outward direction. Another one-way valve 159 (e.g., a check valve) is disposed in the second port 158 ​​such that air can pass through only the second port 158 ​​when traveling in an inward direction. When the elastic ball 156 is compressed (e.g., by hand), air inside the elastic ball 156 is forced out of the first port 157; and when the elastic ball 156 is subsequently released, air is drawn back into the interior of the elastic ball 156 through the second port 158.

[0186] Due to this construction, when the elastic ball 156 is used to inflate the rear capsule 20, the first port 157 is connected to the fitting 46 via the wire 155, so that the positive pressure output of the elastic ball 156 is guided to the rear capsule 20. The elastic ball 156 can then be used to deflate the rear capsule 20, i.e., by connecting the second port 158 ​​to the fitting 46 via the wire 155, so that the suction of the elastic ball 156 is guided to the rear capsule 20. Correspondingly, when the elastic ball 156 is used to inflate the front capsule 35, the first port 157 is connected to the fitting 56 via the wire 155, so that the positive pressure output of the elastic ball 156 is guided to the front capsule 35. The elastic ball 156 can then be used to deflate the front capsule 35, i.e., by connecting the second port 158 ​​to the fitting 56 via the wire 155, so that the suction of the elastic ball 156 is guided to the front capsule 35.

[0187] Instead, and now looking towards Figure 12 and 13 The syringe 160 can be used to inflate the rear capsule 20 and / or the front capsule 35. The inflation mechanism 160 includes a body 161 and a plunger 162. Preferably, the syringe (not shown) is disposed in the body 161 to automatically return the plunger 162 at the end of its powered stroke. The syringe 160 is connected to fittings 46, 56 via a line 163. With this configuration, the syringe 160 includes a valve 165 for connecting the syringe 160 to the front capsule 35 or the rear capsule 20, and a valve 170 for selecting the inflation or deflation of the connected capsule.

[0188] Therefore, using this configuration, when the syringe 160 is used to inflate the rear capsule 20, valve 165 (a two-position valve connecting valve 170 to either the front or rear capsule) is set such that the syringe 160 is connected to the rear capsule 20 via fitting 46, and valve 170 (a two-way exchange valve that allows a one-way valve to be arranged to inflate in one configuration and deflate in another) is set such that the syringe 160 provides inflation pressure. Subsequently, when the rear capsule 20 is to be deflated, valve 170 is set to its deflation position.

[0189] Accordingly, when the syringe 160 is used to inflate the pre-bladder 35, the valve 165 is set such that the syringe 160 is connected to the pre-bladder 35 via the fitting 56, and the valve 170 is set such that the syringe 160 provides inflation pressure. Subsequently, when the pre-bladder 35 is to be deflated, the valve 170 is set to its deflation position.

[0190] In another embodiment of the invention, the expansion mechanism 40 may include an automatic fluid pressure source (positive or negative), such as an electric pump.

[0191] If you expect, and look now. Figure 14The pressure relief valve 175 can be connected to the expansion / relief line connected to the anterior bladder 35 to ensure that the pressure inside the anterior bladder 35 does not exceed a predetermined level. Similarly, and still looking at... Figure 14 The pressure relief valve 180 can be connected to the expansion / release line connected to the rear bladder 20 to ensure that the pressure inside the rear bladder 20 does not exceed a predetermined level.

[0192] Alternatively and / or additionally, one or more pressure gauges 182 ( Figure 1 or Figure 13 This can be incorporated into the fluid lines connected to the posterior bladder 20 and / or the anterior bladder 35 to provide the physician (or other operator or user) with information about the pressure inside the posterior bladder 20 and / or the anterior bladder 35 in order to avoid over-inflation and / or to help the physician (or other operator or user) determine the bladder's inflation status during the procedure.

[0193] Furthermore, it will be understood that the current cyst 35 is in its "retracted" position ( Figure 2 ) and its "extended" location ( Figure 4 When moving between the two, the flexible tube 59 that connects the push tube 30 to the base 25 (and thus to the fitting 56) can converge around the base 25, potentially interfering with the physician's (or other operator's or user's) movements. Therefore, if desired, and now looking towards... Figure 15 A flexible tube retraction system 185 (e.g., within the base 25) can be provided to tighten the slack in the flexible tube 59 as the anterior bladder 35 extends.

[0194] Preferred methods for using new equipment

[0195] Device 5 can be used to manipulate (e.g., stabilize, straighten, dilate and / or level) the lateral walls of the body lumen and / or body cavity to better visualize the lateral wall tissue (including areas that are initially hidden or out of sight) for examination and / or treatment with endoscope 10 during endoscopic procedures, and / or to stabilize instruments (e.g., grippers, cutters or dissectors, cauterization tools, ultrasound probes, etc.) for example, to advance to the distal end and / or working end in the treatment area.

[0196] More specifically, in use, the cannula 15 is first installed onto the endoscope 10 ( Figure 1 This can be accomplished by pulling the base 25 proximally on the distal end of the endoscope 10 and then pulling it proximally along the length of the endoscope 10 until the distal end of the cannula 15 is substantially aligned with the distal tip of the endoscope 10. At this point, the posterior cyst 20 is released, the anterior cyst 35 is released, and the anterior cyst 35 is abutted against the distal end of the endoscope 10. The endoscope 10 and the device 5 are then ready to be inserted into the patient as a unit.

[0197] Next, let's look at... Figure 16 The endoscope 10 and device 5 are inserted as a unit into the patient's body lumen and / or body cavity. For example, but not limited to, 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 lumen and / or body cavity to the desired location within the patient. Figure 17 and Figure 18 ).

[0198] When device 5 is to be used (e.g., to manipulate the lateral walls of the gastrointestinal tract to provide enhanced visualization of and / or enhanced access to those lateral walls, and / or to stabilize the instrument relative to those lateral walls), the posterior capsule 20 inflates to stabilize the body lumen and / or the device 5 (and thus the endoscope 10) within the body lumen. See Figure 19 This can be accomplished using the aforementioned associated expansion mechanism 40.

[0199] In this regard, it will be understood that, since the articulated portion of the endoscope resides distal to the posterior capsule 20, the endoscope will be able to articulate distal to the posterior capsule 20 to facilitate visualization of anatomical structures even after the posterior capsule 20 has expanded. Importantly, this visualization is enhanced because the posterior capsule 20 stabilizes the endoscope 10 within the gastrointestinal tract and dilates the colon, and directly enlarges the colon to a fixed diameter adjacent to the posterior capsule 20.

[0200] Next, by pushing distally on the push tube handle 37, the push tube 30 is advanced distally within the body lumen and / or body cavity (i.e., so that the anterior capsule 35 is further moved in front of the posterior capsule 20). Thus, the push tube 30, and therefore the anterior capsule 35, moves distally relative to the endoscope 10 (which is stabilized in place within the gastrointestinal tract by the inflated posterior capsule 20). Note that during this distal advancement of the anterior capsule 35, the depressurized anterior capsule 35 covers the distal end of the push tube 30, thereby ensuring the non-invasive advancement of the anterior capsule 35. Note that the non-invasive advancement of the anterior capsule 35 can be further enhanced by forming the distal end of the push tube 30 with a more elastic material.

[0201] When the push tube 30 advances the anterior capsule 35 to the desired position distal to the endoscope 10, the anterior capsule 35 is inflated ( Figure 20This allows the anterior cyst 35 to be secured to the anatomical structure. Again, this can be accomplished using the aforementioned associated expansion mechanism 40. When the anterior cyst 35 is expanded, the expanded anterior cyst 35, the expanded posterior cyst 20, and the push tube 30 will all complement each other to stabilize, straighten, dilate, and / or smooth the lateral walls of the body lumen and / or body cavity, thereby better exposing the lateral wall tissues (including visualization of areas initially hidden or outside the field of view) for examination and / or treatment using the endoscope 10 during endoscopic procedures. In this regard, it will be understood that the expanded anterior cyst 35 and the expanded posterior cyst 20 will together dilate and tension the lateral walls of the body lumen and / or body cavity, and the push tube 30 will tend to straighten the anatomical structure between the two expanded cysts as the anterior cyst extends distally from the posterior cyst. In this regard, it will also be understood that once both the posterior bladder 20 and the anterior bladder 35 inflate, the anterior bladder 35 will create a substantially full-diameter seal across the body lumen and / or body cavity (due to the inflated anterior bladder closing as it extends through the axial opening 63 of the anterior bladder when in its deflated state), and the posterior bladder 20 will cooperate with the cannula 15 and the endoscope 10 to create another substantially full-diameter barrier across the body lumen and / or body cavity. Thus, the inflated anterior bladder 35 and the inflated posterior bladder 20 will together define a substantially closed area along the body lumen and / or body cavity (i.e., an isolated treatment area, which prevents the passage of fluids and / or other liquids by virtue of the airtight seal established by the inflated anterior bladder 35 and the posterior bladder 20). The sidewalls of the body lumen and / or body cavity will be tensioned by the inflated anterior bladder 35 and the posterior bladder 20 to better expose the sidewalls of the body lumen and / or body cavity for observation through the endoscope 10.

[0202] It should be understood that by advancing the anterior cyst body and gripping the sidewalls of the body lumen and / or body cavity during the expansion of the anterior cyst body, the expansion and tension of the sidewalls of the body lumen and / or body cavity achieved by the expanded anterior cyst body 35, the expanded posterior cyst body 20 and the push tube 30 can be further enhanced, thereby tensioning the sidewalls of the body lumen and / or body cavity.

[0203] Importantly, since the inflated anterior capsule 35 and the inflated posterior capsule 20 together define a substantially closed region along the body lumen and / or body cavity (i.e., an isolated treatment area), this region can then be inflated using a fluid (e.g., air, CO2, etc.). Figure 21 This is to further tension the sidewalls of the body lumen and / or body cavity, thereby better exposing the sidewalls of the body lumen and / or body cavity for observation through the endoscope 10, and stabilizing the sidewalls to facilitate more precise therapeutic interventions.

[0204] If desired, the anterior capsule 35 can retract toward the posterior capsule 20 (i.e., by pulling the push tube handle 37 proximally), while remaining inflated (and thus held firmly against the body lumen and / or the sidewalls of the body cavity), in order to move the visible mucosa and further improve visualization and accessibility (see [link to relevant documentation]). Figure 22 For example, to position a specific target area on the body lumen and / or the sidewall of the body cavity at a convenient angle relative to the endoscope and endoscopic tools.

[0205] Alternatively, if desired, once the posterior capsule 35 has been inflated, the push tube 30 may be advanced distally for a portion of its full distal journey—but only a portion—before the anterior capsule 35 can be inflated to grip the body lumen and / or the sidewalls of the body cavity, and then the push tube 30 may be advanced further distally. This action will cause the flexible push tube 30 to bend outward (see...). Figures 22A to 22D This allows the endoscope to contact the sidewalls of the body lumen and / or body cavity and, for example, to push the sidewalls of the body lumen and / or body cavity outward in a "raised" manner, thereby further enhancing the visualization of the sidewalls of the body lumen and / or body cavity through the endoscope 10.

[0206] If desired, Instrument 190 ( Figure 23 The instrument 190 can be advanced through the working channel of endoscope 10 to perform biopsies and / or treatments for pathological conditions (e.g., resection of pathological anatomical structures). It will be understood that this instrument extends through the distal end of the endoscope, which is effectively stabilized relative to the anatomical structure via the posterior capsule 20, such that the working end of the instrument 190 is also highly stable relative to the anatomical structure. This is a significant advantage over prior art practices that involve advancing the instrument beyond the unstable end of the endoscope. Preferably, the instrument 190 includes an articulated instrument with a full range of motion for better access to the target anatomical structure.

[0207] In addition, if bleeding obscures the tissue site, or if bleeding occurs and the surgeon cannot identify the source of bleeding, the isolated treatment area may be rapidly flushed of the anatomical segment within which the treatment area is located (e.g., with a liquid such as saline), followed by rapid removal of the flushing fluid (see [link to treatment area]). Figures 24 to 26 ).

[0208] Furthermore, if it is desired that the anterior capsule 35 can be guided to the bleeding site with high precision, the anterior capsule 35 (e.g., inflated) can be used to apply local pressure to the bleeding site to enhance bleeding control (see...). Figure 27 This can be done under the visualization provided by endoscope 10.

[0209] If it is desired to reposition the endoscope 10 within the anatomical structure with minimal interference from the device 5, the anterior capsule 35 retracts to its toroidal configuration (i.e., partially deflates), retracts proximally, and "re-attaches" to the distal end of the endoscope 10. The posterior capsule 20 deflates, and the endoscope 10 (with the device 5 mounted thereon) is then repositioned within the anatomical structure. Note that in the case where the anterior capsule 35 is to be re-attached to the distal end of the endoscope 10, the anterior capsule 35 is preferably only partially deflated until it is re-attached to the distal end of the endoscope, because the partial inflation of the anterior capsule 35 allows it to have sufficient "body" for the re-attaching process. Subsequently, if desired, the anterior capsule 35 can be fully deflated, for example, to actively grasp the distal end of the endoscope 10.

[0210] Alternatively, if desired, the anterior capsule 35 can be used as a drag brake to control the retracted movement of the endoscope. More specifically, in this form of the invention, the endoscope 10 and device 5 are first advanced as a unit into the body lumen and / or body cavity until the endoscope tip is in place. Next, the posterior capsule 20 is inflated, the push tube 30 is advanced distally, and then the anterior capsule 35 is inflated ( Figure 28 Then, visualization and optional treatment can be achieved at this location. As the device is moved backward, the posterior cyst 20 is deflated, the anterior cyst 35 is partially deflated, and then the endoscope is withdrawn proximally, dragging the semi-inflated anterior cyst 35 along the body lumen and / or body cavity. Figure 29 The anterior capsule 35 acts in a sense as a brake when the endoscope is pulled proximally, thereby enabling more controlled backward movement of the endoscope and thus better visualization of anatomical structures. If desired at a certain point, the posterior capsule 20 and the anterior capsule 35 can be re-inflated, such as... Figure 30 As shown, fluid may or may not be introduced into an "isolated treatment zone" established between two cysts in order to stabilize, straighten, expand and / or flatten the anatomical structures.

[0211] It is also possible to use the posterior capsule 20 as a brake, either alone or in combination with the aforementioned braking action from the anterior capsule 35, when withdrawing the endoscope (and therefore device 5) from the anatomical structure.

[0212] At the end of the procedure, the endoscope 10 and device 5 are withdrawn from the anatomical structure. Preferably, this is done by: depressing (or partially depressing) the anterior capsule 35, retracting the push tube 30 so that the anterior capsule 35 "re-attaches" to the distal end of the endoscope 10, fully depressing the anterior capsule 35 so that it grips the distal end of the endoscope, depressing the posterior capsule 20 (if it has not yet been depressed), and then withdrawing the endoscope 10 and device 5 as a unit from the anatomical structure.

[0213] It should be understood that the device 5 can also be advantageously used in various ways other than those disclosed above. For example, but not limitingly, when the endoscope 10 (and device 5) is to advance into the colon, it may be desirable to first project the anterior cyst 35 distally under the visual guidance of the endoscope, such that the anterior cyst 35 guides the distal end of the endoscope. As a result, as the endoscope advances distally, wherein the anterior cyst 35 is released (or partially released), the anterior cyst and the flexible push tube 30 can serve as a non-invasive guide (guide structure) for the endoscope as it advances through the colon. Importantly, since the distal end of the push tube 30 is preferably very flexible, the flexible push tube can be deflected when the advancing anterior cyst 35 encounters the colonic wall (e.g., at a bend in the colon), allowing the anterior cyst to travel along the colonic path, thereby facilitating non-invasive advancement of the endoscope along the colon. It should also be understood that the device 5 can also be advantageously used in other ways to facilitate further examination of the luminal surface that would otherwise be difficult to perform. Such examples include endoscopic ultrasound examination and ultrasound probe examination of the lumen facilitated by an inflated anterior cyst filled with fluid.

[0214] Additional construction

[0215] If desired, the device 5 can be configured such that the push tubes 30 can advance or retract independently of each other and in combination with each other—such independent advance or retraction of the push tubes 30 can help to orient the partially or fully depressurized anterior capsule 35 through the body lumen and / or body cavity, thereby facilitating the advance or retraction of the endoscope 10 through the body lumen and / or body cavity, and / or such independent advance or retraction of the push tubes 30 can facilitate the application of "rotational force" to the anatomical structures using the inflated anterior capsule 35, thereby better revealing the anatomical structures for visualization and / or treatment.

[0216] For example, but not limitingly, in this form of the invention, and now looking towards Figure 30AEach of the push tubes 30 is independently and slidably mounted to the push tube handle 37, allowing the push tubes 30 to move independently of the push tube handle 37 and independently of each other. A stop 191 restricts the distal movement of the push tubes 30 relative to the push tube handle 37, preventing the push tubes from being completely removed from the push tube handle 37. Due to this configuration, when the current capsule 35 is to move distally, the push tubes 30 move distally together or independently of each other. Furthermore, when the current capsule 35 is to move proximally, the push tubes 30 move proximally together or independently of each other. At any point in the procedure, the push tubes 30 can move independently of each other to "rotate" the anterior capsule, for example, by applying a "rotational force" to the anatomical structure when the anterior capsule 35 is inflated and engaged with it, or by helping to "turn" the component through the anatomical structure when the current capsule 35 is partially inflated and used as a non-traumatic tip of the advance component. Note that a limiting mechanism is expected to limit the extent to which the push tube 30 can move longitudinally independently of each other, in order to prevent excessive rotation of the anterior capsule 35, and / or push rod crossing, and / or push rod tangling, and / or push rod misalignment, etc. Also note that the push tube 30 can be mounted on the aforementioned clamp 53 ( Figure 12 and 15 They are kept in a specific location.

[0217] It should also be understood that the construction of the cannula 15 may be modified to support instruments (or hollow instrument guide tubes) outside the endoscope 10. More specifically, looking further... Figure 5 and Figure 6 You will see that, Figure 5 and Figure 6 In the configuration shown, the cannula 15 includes: a lumen 47 for receiving an expansion / depression tube 45 for inflating / deflating the cyst 20; and a pair of lumens 52 for receiving a support tube 50, which receives a push tube 30 for manipulating and inflating / deflating the cyst 35 before expansion / depression. However, if desired, the cannula 15 may include additional lumens for supporting instruments (or hollow instrument guide tubes) external to the endoscope 10.

[0218] More specifically, and now looking towards Figure 31 The image shows an end view of another form of the cannula 15, which includes multiple lumens 195 for slidably receiving an instrument 190 therein. Note that when inflated, the posterior capsule 20 provides a robust platform for holding the endoscope 10 and the cannula 15 within the body lumen or cavity, while the endoscope 10 and the cannula 15 are centered within the body lumen or cavity. As a result, the distal ends of the lumens 195 of the cannula 15 are also firmly held within the body lumen or cavity to provide robust support for instruments advancing through the lumens 195 of the cannula 15.

[0219] The proximal end of the lumen 195 may extend to and pass through the base 25, in which case the instrument may be inserted into the lumen 195 at the base 25; or the proximal end of the lumen 195 may terminate proximally to the base 25 (but still outside the patient's body), in which case the instrument may be inserted into the lumen 195 in the middle of the cannula 15. For example, but not limitingly, when the length of the endoscope 10 is 180 cm and the length of the instrument 190 is 60 cm, it may be advantageous to insert the instrument 190 into the lumen 195 at a point closer to the capsules 20, 35 (rather than at the base 25). Note that in Figure 31 In this view, the lumen 47 for receiving the expansion / release tube 45 and the expansion / release tube 45 for the post-expansion / release bladder 20 are not visible because the view is oriented distally and is taken at a position distal to where the lumen 47 and the expansion / release tube 45 terminate on the sheath 15.

[0220] Figures 32 to 35 Various instruments 190 extending from the lumen 195 are shown. Note that instruments 190 preferably include articulated instruments, for example, Figures 32 to 35 The gripper 190A in the middle, Figures 32 to 33 The calcination apparatus 190B in Figure 34 and Figure 35 The scissors 190C and Figures 32 to 35 The suction device 190D is included.

[0221] It should be understood that, in cases where the cannula 15 includes its central channel for receiving the endoscope 10, a lumen 47 for receiving the expansion / release tube 45, a lumen 52 for receiving the support tube 50 (which receives the push tube 30), and / or a lumen 195 for slidably receiving the instrument 190 therein, the cannula 15 is preferably formed by an extrusion process.

[0222] In a preferred embodiment of the invention, the lumen 47 for receiving the expansion / release tube 45, the lumen 52 for receiving the support tube 50 (which receives the push tube 30), and / or the lumen 195 for slidably receiving the instrument 190 may have a fixed configuration (i.e., a fixed diameter) such that the sleeve 15 has a fixed outer contour.

[0223] In another preferred embodiment of the invention, the lumen 47 for receiving the expansion / drainage tube 45, the lumen 52 for receiving the support tube 50 (which receives the push tube 30), and / or the lumen 195 for slidably receiving the instrument 190 may have an expandable configuration (i.e., they may have a minimum profile when emptied and expand diametrically as needed when filled) such that the overall profile of the sleeve 15 is minimized.

[0224] It should also be understood that, where the sleeve 15 includes a plurality of lumens 195 for slidably receiving the instrument 190 therein, it is desirable to provide greater structural integrity to the distal end of the lumens 195 in order to provide improved support for the instrument 190 received within the lumens 195. For this purpose, a support ring may be provided at the distal end of the sleeve 15, wherein the support ring provides an opening for the passage of the push tube 30 and an opening for the passage of the instrument 190. Note that the opening in such a support ring for the passage of the instrument 190 preferably fits tightly with the instrument to provide excellent instrument support at the distal end of the sleeve 15.

[0225] Alternatively and / or additionally, the lumen 195 may accommodate a hollow instrument guide tube, which itself houses the instrument. Such a hollow instrument guide tube can provide greater structural integrity to the distal end of the lumen 195 to provide improved support for the instrument 190 received within the lumen 195. Furthermore, such a hollow instrument guide tube may have a fixed geometry or a flexible or hinged geometry. See, for example… Figure 36 It shows a hollow instrument guide tube 200 extending out of the lumen 195 and receiving the instrument 190 therein. Note that the hollow instrument guide tube 200 is movable independently of each other (and independently of the sleeve 15). Also note that the instrument 190 preferably fits snugly with the hollow instrument guide tube 200 to provide excellent instrument support at the distal end of the sleeve 15.

[0226] It should also be understood that, if desired, the two push tubes 30 may be replaced by a single push tube 30 or by more than two push tubes 30 (e.g., by three push tubes 30). It will be understood that, in the case of providing multiple push tubes 30, it will generally be desired that the push tubes be circumferentially spaced equidistant from each other, for example, in the case of providing two push tubes 30, it will generally be desired that the two push tubes 30 be spaced 180 degrees apart, in the case of providing three push tubes 30, it will generally be desired that the push tubes be spaced 120 degrees apart, and so on.

[0227] Organization retraction and organization retrieval

[0228] Organizational shrinkage

[0229] In some cases, it may be necessary or desirable to dissect the body lumen or tissue within the body cavity. For example, but not limitingly,

[0230] Endoscopic submucosal dissection (ESD) is an endoscopic dissection procedure used to remove intestinal lesions entirely, even if the lesions are quite large. With ESD, the lesion is dissected directly along the submucosal layer of the intestine using a cutting tool (e.g., an electrocautery knife equipped with a power source) that passes through the endoscope, resulting in safer, whole-piece dissection even for large lesions.

[0231] Routine ESD presents several challenges. First, the technique involves using a transparent plastic cap placed over the tip of the endoscope to push the tip into the tissue. This cap stretches submucosal fibers and facilitates tissue dissection. However, this technique partially obstructs the surgeon's view. Second, fluids, debris, and fumes often accumulate inside the transparent plastic cap placed over the endoscope tip, further obstructing the surgeon's vision.

[0232] In addition to the above, ESD procedures are generally time-consuming, often taking several hours. A significant portion of this time is frequently spent dissecting the lesion along the submucosa of the intestine.

[0233] Similar problems can occur with other intracavitary tissue dissection procedures.

[0234] Endoscopic tissue retraction systems that are compatible with ESD procedures and other endovascular tissue dissection procedures will provide surgeons with better visualization of the surgical field and accelerate the dissection process.

[0235] Organization retrieved

[0236] In addition to the above, after lesions are dissected from the submucosa of the intestine, or after other tissues are dissected during endoluminal tissue dissection procedures, retrieval of lesions (or other dissected tissues) can be difficult due to the following technical challenges: (i) locating the dissected lesions (or other dissected tissues) within the intestine; and (ii) grasping the dissected tissues (or other dissected tissues) using retrieval tools. Furthermore, if dissected lesions (or other dissected tissues) including early-stage cancer migrate within the intestine, they may infect (e.g., potentially seed cancer cells) disease-free areas of the intestine.

[0237] Endoscopic tissue retrieval systems compatible with ESD procedures and other endoluminal tissue dissection procedures will provide surgeons with better control and fixation of dissected lesions within the intestine.

[0238] Endoscopic tissue retraction system

[0239] Therefore, in a preferred embodiment of the invention, and now looking towards... Figures 37 to 42A novel device 5 is shown for use in conjunction with an endoscopic tissue retraction system 300 to provide surgeons with better visualization of the surgical field and to accelerate the dissection process, for example, during ESD procedures. In this form of the invention, the connector 305 is secured to (i) the anterior capsule 35 (or the push tube 30) and (ii) the lesion 315. This is accomplished by clamping the connector 305 to the anterior capsule 35 (or to the push tube 30) using a surgical clamp 320, and by clamping the connector 305 to the lesion 315 using another surgical clamp 320. It will be understood that the connector 305 and the surgical clamp 320 can be delivered to the surgical site through the working channel of the endoscope 10 (or through the instrument lumen 95 of the device 5). With the connector 305 secured to both the anterior cyst body 35 (or push tube 30) and the lesion 315, the anterior cyst body 35 can be advanced distally to tension the connector 305, thereby pushing (i.e., applying force) the lesion 315 distally. The cutting tool 325 can then be advanced and removed distally from the endoscope 10 (or through the instrument lumen 95 of the device 5) and used to dissect the lesion 315 along the submucosa 330 of the intestine 335. It will be understood that after the lesion 315 has been cut from the submucosa of the intestine, the lesion 315 will be held bound to the anterior cyst body 35 by means of the connector 305 and the surgical clamp 320.

[0240] In a preferred embodiment of the invention, the connector 305 comprises a ring of material (e.g., a ring made of extruded filament, a ring made of webbing, etc.). Alternatively, the connector 305 may comprise a single strand of material (e.g., a single strand made of extruded filament, a single strand made of webbing, etc.).

[0241] In a preferred embodiment of the invention, the connector 305 is formed of an elastomeric material (e.g., elastomeric filaments or elastomeric webbing, etc.) such that when the lesion 315 is excised from the submucosa 330 of the intestine 335, any slack in the connector 305 is automatically tightened. In another embodiment of the invention, the connector 305 may be formed of a non-elastic flexible material. In yet another embodiment of the invention, the connector 305 may be formed of a non-elastic rigid material.

[0242] In one form of the invention, the anterior capsule 35 advances distally to tension the connector 305, thereby pushing (i.e., applying force) the lesion 315 in a distal direction. In an alternative form of the invention, and now looking at... Figures 43 to 45When the connector 305 comprises an elastomeric material, the connector 305 may be fixed to one or the other of the anterior capsule 35 and the lesion 315, stretched and fixed to the other of the anterior capsule 35 and the lesion 315, and then released to push (i.e., apply force to) the lesion 315 in a distal direction without requiring any movement of the anterior capsule 35 in the distal direction. Alternatively, the connector 305 may be stretched and fixed (in its stretched state) to the anterior capsule 35 and the lesion 315, and then released to push (i.e. apply force to) the lesion 315 in a distal direction without requiring any movement of the anterior capsule 35 in the distal direction.

[0243] In another form of the invention, and now looking at Figure 46 The connector 305 may include a ring 340 of variable length, for example, the ring 340 may include a slipknot 345 with a tensioned end 350. In this form of the invention, with the connector 305 in a relaxed state, the connector 305 is clamped to the anterior cyst 35 (or push tube 30) using a surgical clamp 320, and to the lesion 315 using another surgical clamp 320. The connector 305 is then tensioned (e.g., by pulling the tensioned end 350 of the slipknot 345 using a tool that advances through the working channel of the endoscope 10 or through the instrument lumen 95 of the device 5) to push (i.e., apply force to) the lesion 315 in a distal direction. The cutting tool 325 can then be advanced out of the distal end of the endoscope 10 (or through the instrument lumen 95 of the device 5) and used to dissect the lesion 315 along the submucosa 330 of the intestine 335. Furthermore, it will be understood that after the lesion 315 has been detached from the submucosa of the intestine, the lesion 315 will be kept bound to the anterior cyst body 35 by means of the connector 305 and the surgical clip 320.

[0244] In another form of the invention, the connector 305 may include a ring 340 with a variable length, but wherein the slip knot 345 and the tensioning end 350 are replaced by a length adjusting clip 355 and one or more tensioning ends 360. See Figure 47 In this form of the invention, the ring 340 is tensioned by pulling one or more tensioning ends 360 through the working channel of the endoscope 10 (or through the instrument lumen 95 of the device 5).

[0245] In some cases, and now looking at Figure 48Advantageously, a connector 305 may be provided with a substantially rigid ring 365 at its proximal (i.e., lesion side) end. For example, but not limitingly, when the connector 305 is in the form of a ring, the ring of the connector 305 may pass through the center of the substantially rigid ring 365. The substantially rigid ring 365 facilitates securing the connector 305 to the lesion 315, for example, by using a surgical clip 320 to make clamping the connector 305 to the lesion 315 easier.

[0246] In some cases, it may be desirable to use multiple connectors 305 to attach the lesion 315 to the anterior cyst 35. This allows the lesion 315 to be stretched distally with multiple directional vectors and multiple attachment points, which can facilitate the dissection of the lesion 315 from the submucosa 330 of the intestine 335. See Figure 49 .

[0247] Instead, and now looking towards Figure 50 When the connector 305 is in the form of a ring, multiple substantially rigid rings 365 can be installed onto a single connector 305, and the multiple substantially rigid rings 365 can be fixed to different positions on the lesion 315, thereby allowing the lesion 315 to be tensioned distally and having multiple directional vectors and multiple attachment points. Alternatively, when the connector 305 is in the form of a ring, multiple surgical clips 320 can be used to fix different segments of the ring to different positions on the lesion 315, thereby allowing the lesion 315 to be tensioned distally and having multiple directional vectors and multiple attachment points.

[0248] In one form of the invention, the connector 305 is attached in situ to the anterior capsule 35 (or the push tube 30) using a surgical clip 320. However, if desired, the connector 305 may be pre-attached to one or more of the anterior capsule 35 (or the push tube 30) during manufacturing (or at some other time before the anterior capsule 35 is inserted into the body). For example, but not limitingly, and now looking at Figure 51 and Figure 52 The connector 305 can be pre-attached to the anterior bladder body 35 using eyelets or eyelets 370 lined with grommets.

[0249] It should also be understood that in some cases, it may be possible to directly fix the anterior capsule 35 (or one of the push tubes 30) to the lesion 315 without using the connector 305. For example, but not limited to, one or more surgical clips 320 may be used to directly fix the anterior capsule 35 (or one of the push tubes 30) to the lesion 315. See example. Figure 52A This illustrates a surgical clip 320 for directly securing the anterior capsule 35 to the lesion 315 without using the connector 305. See also, for example... Figure 52B It shows a surgical clip 320 for directly fixing the push tube 30 to the lesion 315 without using the connector 305.

[0250] Once the lesion 315 has been detached from the submucosa 330 of the intestine 335 (or other tissue has been detached from its location within the body lumen), the detached tissue must typically be removed from the patient's body. Since the detached tissue is secured to the anterior capsule 35 (or push rod 30) by means of one or more connectors 305 and / or surgical clips 320, the detached tissue can be removed from the body simply by removing the novel device 5, which will withdraw the detached tissue from the patient's body when the anterior capsule 35 is withdrawn. However, this method carries the risk of the detached tissue being torn from the anterior capsule 35 (or push rod 30), for example, due to failure of the surgical clip attached to the detached tissue, or due to failure of the surgical clip attached to the anterior capsule (or push rod), etc. Furthermore, when withdrawing the novel device 5 from the patient's body, this method essentially drags the exposed detached tissue along the length of the intestine (or other body lumen). This can pose risks to patients, for example, in cases where the dissected tissue includes disease-free areas of the intestine (or other body cavities) that could become infected (e.g., potentially seeded with cancer cells).

[0251] Endoscopic tissue retrieval

[0252] Therefore, and now looking towards Figures 53 to 60 The anterior capsule 35 may include a flap 375 disposed within a central aperture 380 of the anterior capsule 35. The flap 375 is configured such that: (i) when the anterior capsule 35 is engaged with the endoscope 10, the flap 375 is captured between the endoscope 10 and the anterior capsule 35; (ii) when the anterior capsule 35 is disengaged from the endoscope 10, and then protrudes distally away from the endoscope 10, and then fully inflated, the flap 375 is captured within the closed central aperture 380 of the anterior capsule 35. Figure 53 and Figure 54 (iii) The anterior capsule 35 protrudes distally away from the endoscope 10 and then partially depresses, causing the central opening 380 of the anterior capsule 35 to reopen and expose the flap 375. Figure 55 and Figure 56 When the flap 375 is "pulled down" across the central opening 380 of the anterior capsule 35 (e.g., using a tool that advances through the lumen 95 of the endoscope 10 or device 5), it forms a concave pouch 385 within the central opening 380 of the anterior capsule 35 together with the surrounding portion defining the central opening 380 of the anterior capsule 35. Figure 57 and Figure 58 The concave bag 385 is configured to receive the dissected tissue. Figure 59 and Figure 60 ).

[0253] Therefore, in this form of the invention, after the lesion 315 is peeled from the submucosa 330 of the intestine 335 (or after other tissues are peeled from their sites within the body lumen), the peeled tissue is manipulated into a concave pouch 385 (e.g., using a tool that advances through the working channel of the endoscope 10 or through the instrument lumen 95 of the device 5), and then the peeled tissue can be easily and safely removed from the body by simply removing the novel device 5 from the patient's body, which will withdraw the peeled tissue from the patient's body as the anterior capsule 35 is withdrawn. Note that this can be done while the peeled tissue is still connected to the anterior capsule 35 (or push tube 30) via connector(s) 305 and / or surgical clip(s) 320. It should also be noted that this method effectively eliminates the risk of the dissected tissue tearing out of the anterior capsule 35 (or push tube 30), for example, due to the failure of the surgical clip attached to the dissected tissue, or due to the failure of the surgical clip attached to the anterior capsule (or push tube), and reduces the risk of early cancerous lesions infecting disease-free areas of the intestine (or other body lumen) because the dissected tissue is concealed within the concave bag 385 when it is withdrawn from the patient's body.

[0254] application

[0255] Therefore, it will be seen that the present invention includes providing and using novel devices for manipulating the sidewalls of the body lumen and / or body cavity to better expose the sidewall tissue (including visualization of areas initially hidden or outside the field of vision) for examination and / or treatment during endoscopic procedures, such as straightening bends, "ironing" wrinkles on the surface of the lumen, and creating substantially static or stable sidewalls of the body lumen and / or body cavity, which enables more precise visual examination (including visualization of areas initially hidden or outside the field of vision) and / or therapeutic interventions. For example, but not limitingly, the novel devices can be used to stabilize, straighten, dilate, and / or smooth bends and / or curves and / or wrinkles in the intestinal sidewall to better expose the sidewall tissue (including visualization of areas initially hidden or outside the field of vision) for examination and / or treatment during endoscopic procedures.

[0256] The invention also includes providing and using novel devices that enable the distal end and / or working end of instruments (e.g., endoscopes, articulated and / or non-articulated devices, such as grippers, cutters or dissectors, cauterization tools, ultrasonic probes, etc.) to be securely and / or stably inserted into the body lumen and / or body cavity relative to the sidewalls of the body lumen and / or body cavity during endoscopic procedures, thereby facilitating precise use of those instruments.

[0257] For example, but not limited to, this device can provide a stable platform (i.e., a stable endoscope, stable treatment instruments, and a stable colonic wall, all stable relative to each other) for performing a number of minimally invasive procedures within the body lumen and / or body cavity, including stabilizing the endoscope and / or other surgical instruments (e.g., grippers, cutters or dissectors, cauterization tools, ultrasound probes, etc.) within the body lumen and / or body cavity, such as in lesion biopsy and / or lesion removal procedures, organ resection procedures, endoscopic submucosal dissection (ESD), endoscopic mucosal resection (EMR), etc., while simultaneously stabilizing the colon (including reducing colonic wall deformation) to enable more precise visualization, intervention, and / or surgery.

[0258] Importantly, the present invention provides a novel device capable of securing and / or stabilizing the distal tip and / or working end of an endoscope relative to the body lumen and / or the sidewalls of the body cavity (and thus also securing and / or stabilizing the distal tip and / or working end of other instruments inserted through the working channels of those endoscopes, such as grippers, cutters or dissectors, cauterization tools, ultrasonic probes, etc.), and stabilizing the body lumen and / or the sidewalls of the body cavity relative to these instruments.

[0259] Furthermore, the present invention provides a novel device capable of securing and / or stabilizing the distal end and / or working end of an instrument (such as a gripper, cutter or dissector, cauterization tool, ultrasonic probe, etc.) that advances to the surgical site via a route other than through the working channel of an endoscope.

[0260] The novel device of the present invention can be used in virtually any endoscopic procedure to facilitate alignment and presentation of tissue during the endoscopic procedure, and / or to stabilize the working end of the endoscope (and / or other instruments that advance through the endoscope) relative to the tissue, or to facilitate the advancement of the endoscope during such a procedure.

[0261] It is believed that the present invention will have the widest application in the gastrointestinal (GI) tract (e.g., the large and small intestines, esophagus, stomach, etc.), which is generally characterized by frequent turns and its lateral walls are characterized by numerous folds and disease processes located on and between these folds. However, the methods and devices of the present invention can also be used inside other body cavities (e.g., blood vessels, lymphatic vessels, urethra, fallopian tubes, bronchi, bile ducts, etc.) and / or other body cavities (e.g., head, thoracic cavity, abdominal cavity, sinuses, bladder, organ cavities, etc.).

[0262] Revise

[0263] Although the invention has been described with reference to certain exemplary preferred embodiments, it will be readily understood and appreciated by those skilled in the art that the invention is not limited thereto, and that many additions, deletions and modifications may be made to the preferred embodiments discussed above while still remaining within the scope of the invention.

Claims

1. An endoscopic tissue retraction system, comprising: Endoscope; A cannula adapted to slide on the outside of an endoscope, the cannula having a distal end and a proximal end; The proximal sac of the cannula is fixed near the distal end of the cannula; At least one push tube is configured to be movably mounted to the sleeve; A distal bladder movably mounted to at least one push tube, wherein the distal bladder is capable of being in a deflated state and an inflated state, and further wherein, when the distal bladder is in its deflated state, an axial opening extends through the distal bladder, and when the distal bladder is in its inflated state, the axial opening is closed. A connector configured to be secured to the distal capsule and the tissue to be retracted; and A flap is installed in the axial opening of the distal capsule to form a concave pouch for receiving the dissected tissue together with the surrounding portion of the distal capsule.

2. The endoscopic tissue retraction system according to claim 1, wherein, The connector includes a flexible component.

3. The endoscopic tissue retraction system according to claim 2, wherein, The flexible component includes a ring.

4. The endoscopic tissue retraction system according to claim 3, wherein, The ring has a variable length.

5. The endoscopic tissue retraction system according to claim 4, wherein, The ring includes a live knot.

6. The endoscopic tissue retraction system according to claim 4, wherein, The ring includes a length adjustment clip.

7. The endoscopic tissue retraction system according to claim 2, wherein, The flexible component comprises a single strand.

8. The endoscopic tissue retraction system according to claim 2, wherein, The essentially rigid ring is attached to the flexible member.

9. The endoscopic tissue retraction system according to claim 2, wherein, The flexible component includes an elastomer material.

10. The endoscopic tissue retraction system according to claim 2, wherein, The flexible component includes a non-elastic material.

11. The endoscopic tissue retraction system according to claim 1, wherein, The connector is substantially rigid.

12. The endoscopic tissue retraction system according to claim 1, wherein, The connector is secured to at least one of the at least one push tube and at least one of the tissue to be retracted by a surgical clip.

13. The endoscopic tissue retraction system according to claim 1, wherein, The distal capsule includes an eyelet, and further wherein the connector is secured to the distal capsule via the eyelet.

14. The endoscopic tissue retraction system according to claim 1, wherein, The tissue to be retracted includes lesions.

15. The endoscopic tissue retraction system according to claim 14, wherein, The lesion is attached to the submucosa of the intestine.

Images