Method and apparatus for manipulating sidewall of body lumen

Abstract

An apparatus for accessing a body lumen, the apparatus comprising: a hollow shaft wherein the lumen of the hollow shaft is configured to receive an endoscope, and wherein a distal end of the hollow shaft comprises an adjustable portion configured to articulate between: (i) a straight configuration parallel to a longitudinal axis of the shaft; and (ii) an angled configuration in which the adjustable portion is disposed at an angle relative to the longitudinal axis of the shaft, thereby bending an endoscope disposed within the lumen of the hollow shaft; a cannula configured to receive the hollow shaft and an endoscope disposed therein; and a balloon mounted to the cannula.

Description

[0001] References to pending prior patent applications

[0002] This patent application:

[0003] INCREASED VISUALIZATION OF THE SAME AND / OR INCREASED ACCESS TO THESAME,AND / OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME” (Attorney Docket No. LUMENDI-32), filed on May 24, 2021 by Lumendi Ltd., which in turn (a) claims a prior pending U.S. patent application Ser. No. 17 / 328,494 (Attorney Docket No. LUMENDI-32), filed on May 22, 2020 by Lumendi Ltd., entitled “METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASED VISUALIZATION OF THE SAME AND / OR INCREASED ACCESS TO THESAME,AND / OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME” (Attorney Docket No. LUMENDI-33), which in turn (a) claims a prior pending U.S. patent application Ser. No. 17 / 328,494 (Attorney Docket No. LUMENDI-32), filed on May 24, 2021 by Lumendi Ltd., entitled “METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASED VISUALIZATION OF THE SAME AND / OR INCREASED ACCESS TO THE SAME, AND / ORFOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME” (ATTORNEY DOCUMENT NO. LUMENDL32 PROV); and

[0004] (ii) Claiming the benefit of pending prior U.S. provisional patent application serial number 63 / 339,115 (attorney docket number LUMENDI-48PROV), filed on May 6, 2022 by Lumendi Ltd., entitled “METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASED VISUALIZATION OF THE SAME AND / OR INCREASED ACCESS TO THESAME, AND / OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME”.

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

[0006] The present invention relates generally to surgical methods and apparatus, and more particularly to surgical methods and apparatus for manipulating the sidewalls of a body lumen and / or body cavity to provide increased visualization of and / or increased access to the sidewalls and / or for stabilizing an instrument relative to the sidewalls. Background Art

[0007] The human body includes many different body lumens and body cavities. By way of example and not limitation, the human body includes body lumens such as the gastrointestinal (GI) tract, blood vessels, lymphatic vessels, urinary tract, fallopian tubes, bronchi, bile ducts, etc. By way of further example and not limitation, the human body includes body cavities such as the head, chest, abdomen, sinuses, bladder, cavities within organs, etc.

[0008] In many cases, it may be desirable to endoscopically inspect and / or treat a disease process or abnormality located within or on the sidewalls of a body lumen and / or body cavity. By way of example and not limitation, it may be desirable to inspect the sidewalls of the gastrointestinal tract for lesions, and if lesions are found, it may be desirable to biopsy, remove, and / or otherwise treat the lesions.

[0009] The anatomical configuration (both regionally and locally) of the sidewalls of a body lumen and / or body cavity, and / or the compactness of the tissue comprising the sidewalls of a body lumen and / or body cavity, and / or the tethering of the sidewalls of a body lumen and / or body cavity to other anatomical structures may complicate endoscopic examination and / or treatment of the sidewalls of a body lumen and / or body cavity.

[0010] By way of example and not limitation, the intestine is an elongated tubular organ with an inner lumen and is characterized by frequent turns (i.e., the regional anatomy of the intestine) and a sidewall characterized by numerous folds (i.e., the local anatomy of the intestine), wherein the sidewall tissue has a relatively soft, pliable compactness, and wherein the colon is particularly tethered to the abdomen and / or other abdominal structures via soft tissue. Due to this varying sidewall anatomy (both regional and local), its relatively soft, pliable compactness, and its tethering to other anatomical structures via soft tissue, it can be difficult to fully visualize the sidewall of the intestine and / or treat lesions formed on the sidewall of the intestine. By way of example and not limitation, in the context of colonoscopy, it has been found that approximately 5-40% of patients have an anatomical configuration of the sidewall (regional and / or local) and / or tissue compactness and / or tethering of the colon to other anatomical structures that makes it difficult to fully visualize the anatomical structure (including pathological conditions of the anatomical structure, such as polyps or tumors) using a conventional endoscope and / or to fully access the anatomical structure using instruments introduced through a conventional endoscope.

[0011] In addition to the foregoing, it has been found that some body lumens and / or body cavities may spontaneously spasm and / or contract, but this is particularly true when an endoscope or other instrument is inserted into a body lumen and / or body cavity. Such spasms and / or contractions may cause the body lumen and / or body cavity to contract and / or otherwise move and / or change its configuration, which may further complicate and / or impair endoscopic visualization of anatomical structures, and / or further complicate and / or impair access to anatomical structures using instruments introduced through conventional flexible endoscopes. In addition, during inspection of the colon (which is typically performed when both the endoscope is inserted and withdrawn through the colon), the endoscope may clamp and / or otherwise retract the colon during insertion and / or withdrawal and then suddenly slip and release the colon. This results in the endoscope moving rapidly across a significant length of the colon, thereby making accurate inspection of the colon challenging.

[0012] It would therefore be highly advantageous to provide novel devices that are capable of manipulating the sidewalls of body lumens and / or body cavities to better present sidewall tissue (including visualization of areas initially hidden from or out of view) for inspection and / or treatment during endoscopic surgery.

[0013] It would also be highly advantageous to provide novel devices that are capable of securing and / or stabilizing the distal tips and / or working ends of instruments (e.g., endoscopes, articulated and / or non-articulated devices such as graspers, cutters or dissectors, cautery tools, ultrasound probes, etc.) inserted into body lumens and / or body cavities relative to the side walls of the body lumens and / or body cavities, thereby facilitating the precise use of those instruments.

[0014] Among other things, it would be highly advantageous to provide a novel device that is capable of securing and / or stabilizing the distal tip and / or working end of an endoscope (and thereby also securing and / or stabilizing the distal tips and / or working ends of other instruments inserted through the working channels of those endoscopes (such as graspers, cutters or dissectors, cautery tools, ultrasound probes, etc.)).

[0015] Furthermore, it would be highly advantageous to provide novel devices that are capable of securing and / or stabilizing the distal tip and / or working end of instruments (such as graspers, cutters or dissectors, cautery tools, ultrasound probes, etc.) that are advanced to a surgical site by means other than through a working channel of an endoscope.

[0016] It would also be highly advantageous to be able to straighten bends, "iron out" inner luminal surface wrinkles and create substantially static or stable sidewalls of a body lumen and / or body cavity, thereby enabling more accurate visual inspection (including visualization of areas that were initially hidden from or out of view) and / or therapeutic intervention. Summary of the invention

[0017] The present invention includes providing and using novel devices for manipulating the side walls of body lumens and / or body cavities to better present side wall tissue (including visualization of areas initially hidden from or out of view) for inspection and / or treatment during endoscopic surgery.

[0018] The present invention also includes providing and using the following novel device, which is capable of stabilizing and / or stabilizing the distal tip and / or working end of instruments (e.g., endoscopes, articulated and / or non-articulated devices such as graspers, cutters or dissectors, cauterization tools, ultrasound probes, etc.) inserted into body lumens and / or body cavities relative to the side walls of the body lumens and / or body cavities, thereby facilitating the precise use of those instruments.

[0019] Among other things, the present invention includes providing and using a novel device that is capable of securing and / or stabilizing the distal tip and / or working end of an endoscope (and thereby also securing and / or stabilizing the distal tip and / or working end of other instruments inserted through the working channels of those endoscopes (such as, graspers, cutters or dissectors, cautery tools, ultrasound probes, etc.).

[0020] Furthermore, the present invention includes providing and using novel devices that are capable of securing and / or stabilizing the distal tip and / or working end of instruments (such as graspers, cutters or dissectors, cautery tools, ultrasound probes, etc.) that are advanced to a surgical site by means other than through a working channel of an endoscope.

[0021] Furthermore, the present invention includes providing and using novel devices that are capable of straightening bends, "ironing out" wrinkles and creating substantially static or stable sidewalls of body lumens and / or body cavities, thereby enabling more accurate visual inspection (including visualization of areas initially hidden from or out of view) and / or therapeutic intervention.

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

[0023] a cannula adapted to slide over the exterior of the endoscope;

[0024] a proximal balloon secured to the cannula;

[0025] an inflation / deflation tube carried by the sleeve and in fluid communication with the interior of the proximal balloon;

[0026] a push tube slidably mounted to the sleeve; and

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

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

[0029] Provide equipment, the equipment comprising:

[0030] a cannula adapted to slide over the exterior of the endoscope;

[0031] a proximal balloon secured to the cannula;

[0032] an inflation / deflation tube carried by the sleeve and in fluid communication with the interior of the proximal balloon;

[0033] a push tube slidably mounted to the sleeve; and

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

[0035] positioning the device in a body lumen and / or body cavity;

[0036] inflating the proximal balloon;

[0037] advancing the push tube distally;

[0038] inflating the distal balloon; and

[0039] Perform the surgery.

[0040] In another preferred form of the present invention, there is provided an apparatus comprising:

[0041] a cannula adapted to slide over the exterior of the endoscope, the cannula including a passageway integrally formed therewith and a lumen integrally formed therewith for receiving an instrument;

[0042] a proximal balloon secured to the cannula;

[0043] an inflation / deflation tube carried by the sleeve and in fluid communication with the interior of the proximal balloon;

[0044] a push tube slidably mounted in the passageway of the sleeve; and

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

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

[0047] Provide equipment, the equipment comprising:

[0048] a cannula adapted to slide over the exterior of the endoscope, the cannula including a passageway integrally formed therewith and a lumen integrally formed therewith for receiving an instrument;

[0049] a proximal balloon secured to the cannula;

[0050] an inflation / deflation tube carried by the sleeve and in fluid communication with the interior of the proximal balloon;

[0051] a push tube slidably mounted in the passageway of the sleeve; and

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

[0053] positioning the device in a body lumen and / or body cavity;

[0054] inflating the proximal balloon;

[0055] advancing the push tube distally;

[0056] inflating the distal balloon; and

[0057] Perform the surgery.

[0058] In another preferred form of the present invention, there is provided an apparatus comprising:

[0059] a sleeve adapted to slide over the exterior of the endoscope so as to substantially cover the endoscope from a point adjacent the distal end of the endoscope to a point adjacent the handle of the endoscope;

[0060] a proximal balloon secured to the cannula;

[0061] an inflation / deflation tube carried by the sleeve and in fluid communication with the interior of the proximal balloon;

[0062] a push tube slidably mounted to the sleeve; and

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

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

[0065] Provide equipment, the equipment comprising:

[0066] a sleeve adapted to slide over the exterior of the endoscope so as to substantially cover the endoscope from a point adjacent the distal end of the endoscope to a point adjacent the handle of the endoscope;

[0067] a proximal balloon secured to the cannula;

[0068] an inflation / deflation tube carried by the sleeve and in fluid communication with the interior of the proximal balloon;

[0069] a push tube slidably mounted to the sleeve; and

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

[0071] positioning the device in a body lumen and / or body cavity;

[0072] inflating the proximal balloon;

[0073] advancing the push tube distally;

[0074] inflating the distal balloon; and

[0075] Perform the surgery.

[0076] In another preferred form of the present invention, there is provided an apparatus comprising:

[0077] a cannula adapted to slide over the exterior of the endoscope;

[0078] a proximal balloon secured to the cannula;

[0079] an inflation / deflation tube carried by the sleeve and in fluid communication with the interior of the proximal balloon;

[0080] a pair of push tubes slidably mounted to the sleeves; and

[0081] A distal balloon is fixed to the distal ends of the pair of push tubes, and the interior of the distal balloon is in fluid communication with the pair of push tubes.

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

[0083] Provide equipment, the equipment comprising:

[0084] a cannula adapted to slide over the exterior of the endoscope;

[0085] a proximal balloon secured to the cannula;

[0086] an inflation / deflation tube carried by the sleeve and in fluid communication with the interior of the proximal balloon;

[0087] a pair of push tubes slidably mounted to the sleeves; and

[0088] a distal balloon fixed to the distal ends of the pair of push tubes, the interior of the distal balloon being in fluid communication with the pair of push tubes;

[0089] positioning the device in a body lumen and / or body cavity;

[0090] inflating the proximal balloon;

[0091] advancing the pair of push tubes distally;

[0092] inflating the distal balloon; and

[0093] Perform the surgery.

[0094] In yet another form of the invention, there is provided a device for accessing a body lumen or cavity, the device comprising:

[0095] A hollow shaft having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, wherein the lumen of the hollow shaft is configured to receive an endoscope, and further wherein the distal end of the hollow shaft includes an adjustable portion configured to articulate between: (i) a straight configuration, wherein the adjustable portion is parallel to a longitudinal axis of the hollow shaft; and (ii) an angled configuration, wherein the adjustable portion is disposed at an angle relative to the longitudinal axis of the hollow shaft, thereby bending an endoscope disposed within the lumen of the hollow shaft;

[0096] a cannula having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, wherein the lumen of the cannula is configured to receive the hollow shaft and the endoscope disposed therein;

[0097] a posterior balloon mounted to the cannula;

[0098] a pair of push tubes slidably mounted to the sleeves; and

[0099] A front balloon is mounted to the distal ends of the pair of push tubes so that the front balloon can move relative to the rear balloon.

[0100] In another form of the invention, there is provided a method for accessing a body lumen and / or body cavity of a patient, the method comprising:

[0101] Provide equipment, the equipment comprising:

[0102] A hollow shaft having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, wherein the lumen of the hollow shaft is configured to receive an endoscope, and further wherein the distal end of the hollow shaft includes an adjustable portion configured to articulate between: (i) a straight configuration, wherein the adjustable portion is parallel to a longitudinal axis of the hollow shaft; and (ii) an angled configuration, wherein the adjustable portion is disposed at an angle relative to the longitudinal axis of the hollow shaft, thereby bending an endoscope disposed within the lumen of the hollow shaft;

[0103] a cannula having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, wherein the lumen of the cannula is configured to receive the hollow shaft and the endoscope disposed therein;

[0104] a posterior balloon mounted to the cannula;

[0105] a pair of push tubes slidably mounted to the sleeves; and

[0106] a front balloon mounted to the distal ends of the pair of push tubes so that the front balloon can move relative to the rear balloon;

[0107] inserting an endoscope into the lumen of the hollow shaft;

[0108] inserting the hollow shaft and the endoscope into the lumen of the cannula;

[0109] positioning the device in a body lumen and / or body cavity of a patient;

[0110] advancing the hollow shaft and the endoscope beyond the distal end of the cannula; and

[0111] The adjustable portion of the hollow shaft is moved to its angled configuration in order to bend the distal end of the endoscope to a desired angle.

[0112] In another form of the invention, there is provided a method for visualizing and / or accessing a bile duct of a patient, the method comprising:

[0113] Provide equipment, the equipment comprising:

[0114] A hollow shaft having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, wherein the lumen of the hollow shaft is configured to receive an endoscope, and further wherein the distal end of the hollow shaft includes an adjustable portion configured to articulate between: (i) a straight configuration, wherein the adjustable portion is parallel to a longitudinal axis of the hollow shaft; and (ii) an angled configuration, wherein the adjustable portion is disposed at an angle relative to the longitudinal axis of the hollow shaft, thereby bending an endoscope disposed within the lumen of the hollow shaft;

[0115] a cannula having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, wherein the lumen of the cannula is configured to receive the hollow shaft and the endoscope disposed therein;

[0116] a posterior balloon mounted to the cannula;

[0117] a pair of push tubes slidably mounted to the sleeves; and

[0118] a front balloon mounted to the distal ends of the pair of push tubes so that the front balloon can move relative to the rear balloon;

[0119] inserting an endoscope into the lumen of the hollow shaft;

[0120] inserting the hollow shaft and the endoscope into the lumen of the cannula;

[0121] advancing the device through the patient's upper gastrointestinal tract until the device is positioned adjacent to the bile duct;

[0122] The pair of push tubes are advanced distally to advance the front balloon to the distal side of the bile duct;

[0123] inflating the front balloon to fluidly seal the front balloon to the gastrointestinal tract distal to the bile duct;

[0124] inflating the posterior balloon to fluidly seal the posterior balloon to the gastrointestinal tract proximal to the bile duct, thereby creating an isolated treatment region between the anterior balloon and the posterior balloon;

[0125] advancing the hollow shaft and the endoscope beyond the distal end of the cannula; and

[0126] The adjustable portion of the hollow shaft is moved to its angled configuration to bend a portion of the endoscope to an angle for accessing and / or visualizing the bile duct.

[0127] In another form of the invention, there is provided a device for accessing a body lumen or cavity, the device comprising:

[0128] A hollow shaft having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, wherein the lumen of the hollow shaft is configured to receive an endoscope, and further wherein the distal end of the hollow shaft includes an adjustable portion configured to articulate between: (i) a straight configuration, wherein the adjustable portion is parallel to a longitudinal axis of the hollow shaft; and (ii) an angled configuration, wherein the adjustable portion is disposed at an angle relative to the longitudinal axis of the hollow shaft, thereby bending an endoscope disposed within the lumen of the hollow shaft;

[0129] a cannula having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, wherein the lumen of the cannula is configured to receive the hollow shaft and the endoscope disposed therein; and

[0130] At least one balloon is mounted to the cannula.

[0131] In another form of the invention, there is provided a method for accessing a body lumen and / or body cavity of a patient, the method comprising:

[0132] Provide equipment, the equipment comprising:

[0133] A hollow shaft having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, wherein the lumen of the hollow shaft is configured to receive an endoscope, and further wherein the distal end of the hollow shaft includes an adjustable portion configured to articulate between: (i) a straight configuration, wherein the adjustable portion is parallel to a longitudinal axis of the hollow shaft; and (ii) an angled configuration, wherein the adjustable portion is disposed at an angle relative to the longitudinal axis of the hollow shaft, thereby bending an endoscope disposed within the lumen of the hollow shaft;

[0134] a cannula having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, wherein the lumen of the cannula is configured to receive the hollow shaft and the endoscope disposed therein; and

[0135] at least one balloon mounted to the cannula;

[0136] inserting an endoscope into the lumen of the hollow shaft;

[0137] inserting the hollow shaft and the endoscope into the lumen of the cannula;

[0138] positioning the device in a body lumen and / or body cavity of a patient;

[0139] inflating the at least one balloon to fluidly seal the at least one balloon to a body lumen and / or body cavity of a patient;

[0140] advancing the hollow shaft and the endoscope beyond the distal end of the cannula; and

[0141] The adjustable portion of the hollow shaft is moved to its angled configuration in order to bend a portion of the endoscope to a desired angle.

[0142] In another form of the invention, there is provided a method for visualizing and / or accessing a bile duct of a patient, the method comprising:

[0143] Provide equipment, the equipment comprising:

[0144] A hollow shaft having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, wherein the lumen of the hollow shaft is configured to receive an endoscope, and further wherein the distal end of the hollow shaft includes an adjustable portion configured to articulate between: (i) a straight configuration, wherein the adjustable portion is parallel to a longitudinal axis of the hollow shaft; and (ii) an angled configuration, wherein the adjustable portion is disposed at an angle relative to the longitudinal axis of the hollow shaft, thereby bending an endoscope disposed within the lumen of the hollow shaft;

[0145] a cannula having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, wherein the lumen of the cannula is configured to receive the hollow shaft and the endoscope disposed therein; and

[0146] at least one balloon mounted to the cannula;

[0147] inserting an endoscope into the lumen of the hollow shaft;

[0148] inserting the hollow shaft and the endoscope into the lumen of the cannula;

[0149] advancing the device through the patient's upper gastrointestinal tract until the device is positioned adjacent to the bile duct;

[0150] inflating the at least one balloon to fluidly seal the at least one balloon to the gastrointestinal tract proximal to the bile duct;

[0151] advancing the hollow shaft and the endoscope beyond the distal end of the cannula; and

[0152] The adjustable portion of the hollow shaft is moved to its angled configuration to bend a portion of the endoscope to an angle for accessing and / or visualizing the bile duct.

[0153] In another form of the invention, there is provided a device for accessing a body lumen or cavity, the device comprising:

[0154] A hollow shaft formed from a single piece of flexible material, the hollow shaft comprising a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, wherein the lumen of the hollow shaft is configured to receive an endoscope, and further wherein the distal end of the hollow shaft comprises an adjustable portion configured to articulate between: (i) a straight configuration, wherein the adjustable portion is parallel to a longitudinal axis of the hollow shaft; and (ii) an angled configuration, wherein the adjustable portion is disposed at an angle relative to the longitudinal axis of the hollow shaft, thereby bending an endoscope disposed within the lumen of the hollow shaft;

[0155] a cannula having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, wherein the lumen of the cannula is configured to receive the hollow shaft and the endoscope disposed therein; and

[0156] A balloon is mounted to the cannula.

[0157] In another form of the invention, there is provided a method for accessing a body lumen and / or body cavity of a patient, the method comprising:

[0158] Provide equipment, the equipment comprising:

[0159] A hollow shaft formed from a single piece of flexible material, the hollow shaft comprising a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, wherein the lumen of the hollow shaft is configured to receive an endoscope, and further wherein the distal end of the hollow shaft comprises an adjustable portion configured to articulate between: (i) a straight configuration, wherein the adjustable portion is parallel to a longitudinal axis of the hollow shaft; and (ii) an angled configuration, wherein the adjustable portion is disposed at an angle relative to the longitudinal axis of the hollow shaft, thereby bending an endoscope disposed within the lumen of the hollow shaft;

[0160] a cannula having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, wherein the lumen of the cannula is configured to receive the hollow shaft and the endoscope disposed therein; and

[0161] a balloon mounted to the cannula;

[0162] inserting an endoscope into the lumen of the hollow shaft;

[0163] inserting the hollow shaft and the endoscope into the lumen of the cannula;

[0164] positioning the device in a body lumen and / or body cavity of a patient;

[0165] advancing the hollow shaft and the endoscope beyond the distal end of the cannula; and

[0166] The adjustable portion of the hollow shaft is moved to its angled configuration in order to bend the distal end of the endoscope to a desired angle.

[0167] In another form of the invention, there is provided a method for visualizing and / or accessing a bile duct of a patient, the method comprising:

[0168] Provide equipment, the equipment comprising:

[0169] A hollow shaft formed from a single piece of flexible material, the hollow shaft comprising a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, wherein the lumen of the hollow shaft is configured to receive an endoscope, and further wherein the distal end of the hollow shaft comprises an adjustable portion configured to articulate between: (i) a straight configuration, wherein the adjustable portion is parallel to a longitudinal axis of the hollow shaft; and (ii) an angled configuration, wherein the adjustable portion is disposed at an angle relative to the longitudinal axis of the hollow shaft, thereby bending an endoscope disposed within the lumen of the hollow shaft;

[0170] a cannula having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, wherein the lumen of the cannula is configured to receive the hollow shaft and the endoscope disposed therein; and

[0171] a balloon mounted to the cannula;

[0172] inserting a first endoscope into the lumen of the cannula;

[0173] advancing the device through the patient's upper gastrointestinal tract until the device is positioned adjacent to the bile duct;

[0174] inflating the balloon to fluidly seal the balloon to the gastrointestinal tract proximal to the bile duct;

[0175] removing the first endoscope from the lumen of the cannula while maintaining the cannula disposed in the anatomical structure;

[0176] inserting a second endoscope into the lumen of the hollow shaft;

[0177] inserting the hollow shaft and a second endoscope into the lumen of the cannula;

[0178] advancing the hollow shaft and the second endoscope beyond the distal end of the cannula; and

[0179] The adjustable portion of the hollow shaft is moved to its angled configuration to bend a portion of the second endoscope to an angle for accessing and / or visualizing the bile duct. BRIEF DESCRIPTION OF THE DRAWINGS

[0180] These and other objects and features of the present invention will be more fully disclosed or rendered apparent through the following detailed description of the preferred embodiments of the present invention, which will be combined with the accompanying drawings. Figure 1 In the drawings, like numerals refer to similar parts, and further in the drawings:

[0181] Figure 1 is a schematic diagram showing a novel device formed according to the present invention, wherein the novel device includes, among other things, a cannula for being disposed over an end of an endoscope, a rear balloon mounted to the cannula, a pair of push tubes slidably mounted to the cannula, a front balloon mounted to a distal end of the push tube, and a push tube handle mounted to a proximal end of the push tube;

[0182] Figure 2-Figure 4 is a schematic diagram showing various arrangements of the anterior balloon relative to the posterior balloon;

[0183] Figure 5 It is shown Figure 1 A schematic diagram of further details of the distal portion of the device shown in;

[0184] Figure 6 It is along Figure 5 a cross-sectional view taken along line 6-6;

[0185] Figure 7 and Figure 8 is a schematic diagram showing further details of the anterior balloon;

[0186] Fig. 8A is a schematic diagram showing a push tube handle;

[0187] Fig. 9 and Fig.10 is a schematic diagram showing the construction details of the anterior balloon;

[0188] Fig.11 is a schematic diagram showing a form of inflation mechanism provided according to the present invention;

[0189] Fig.11A is a schematic diagram showing another form of inflation mechanism provided according to the present invention;

[0190] Fig.12 and Fig.13 is a schematic diagram showing another form of inflation mechanism provided according to the present invention;

[0191] Fig.14is a schematic diagram showing a safety valve that can be used to ensure that the pressure in the front balloon and / or the rear balloon does not exceed a predetermined level;

[0192] Fig.15 is a schematic diagram showing a retraction system that can be used to tighten Figure 1 slack in the flexible tube of the device shown in;

[0193] Figure 16-Figure 22 , Figure 22A-22D as well as Figure 23-Figure 30 It is shown that the use Figure 1 A schematic diagram of a preferred embodiment of the device;

[0194] Fig. 30A is a schematic diagram showing an alternative configuration of the push tube and push tube handle of the present invention;

[0195] Fig.31 is a schematic diagram showing another form of a cannula, wherein the cannula includes an additional lumen for receiving an instrument;

[0196] Figure 32-Figure 35 is a schematic diagram showing how an instrument may be advanced through an additional lumen of a cannula;

[0197] Fig.36 is a schematic diagram showing instrument guide tubes that may be disposed in additional lumens of a cannula, wherein instruments may be advanced through these instrument guide tubes;

[0198] Figure 37-Figure 47 , Fig.47A as well as Fig.48 is a schematic diagram showing a novel system for visualizing the bile duct;

[0199] Figure 49-Figure 53 is a schematic diagram showing a novel method for visualizing the bile duct;

[0200] Figure 54-Figure 58 is a schematic diagram showing another novel method for visualizing the bile duct;

[0201] Figure 59-105 is a schematic diagram showing another novel system for visualizing the bile duct; and

[0202] Figure 106-Figure 111 is a schematic diagram showing another novel method for visualizing the bile duct. DETAILED DESCRIPTION

[0203] The present invention includes providing and using novel devices for manipulating the side walls of body lumens and / or body cavities to better present side wall tissue (including visualization of areas initially hidden from or out of view) for inspection and / or treatment during endoscopic surgery.

[0204] (As used herein, the term "endoscopic procedure" is intended to mean substantially any minimally invasive or limited access procedure (diagnostic and / or therapeutic and / or surgical) that is used to access the interior of a body lumen and / or body cavity, either endoluminally or transluminally or otherwise, for the purpose of observing, biopsy and / or treating tissue, including removal of lesions and / or excision of tissue, etc.)

[0205] The present invention also includes providing and using the following novel device, which is capable of stabilizing and / or stabilizing the distal tip and / or working end of instruments (e.g., endoscopes, articulated and / or non-articulated devices such as graspers, cutters or dissectors, cauterization tools, ultrasound probes, etc.) inserted into body lumens and / or body cavities relative to the side walls of the body lumens and / or body cavities, thereby facilitating the precise use of those instruments.

[0206] Among other things, the present invention includes providing and using novel devices that are capable of securing and / or stabilizing the distal tips and / or working ends of endoscopes (and thereby also securing and / or stabilizing the distal tips and / or working ends of other instruments inserted through the working channels of those endoscopes (such as, graspers, cutters or dissectors, cautery tools, ultrasound probes, etc.)).

[0207] Furthermore, the present invention includes providing and using novel devices that are capable of securing and / or stabilizing the distal tip and / or working end of instruments (such as graspers, cutters or dissectors, cautery tools, ultrasound probes, etc.) that are advanced to a surgical site by means other than through a working channel of an endoscope.

[0208] Furthermore, the present invention includes providing and using novel devices that are capable of straightening bends, "ironing out" wrinkles and creating substantially static or stable sidewalls of body lumens and / or body cavities, thereby enabling more accurate visual inspection (including visualization of areas initially hidden from or out of view) and / or therapeutic intervention.

[0209] New equipment

[0210] According to the present invention, and now looking at Figure 1, showing a novel device 5 capable of manipulating (e.g., stabilizing, straightening, expanding and / or flattening, etc.) the side walls of a body lumen and / or body cavity to better present the side wall tissue (including visualization of areas initially hidden from or out of view) for inspection and / or treatment during endoscopic surgery using an endoscope 10 (e.g., an articulating endoscope), and / or for stabilizing the distal end of the endoscope 10 and / or other instruments (e.g., a grasper, a cutter or dissector, a cautery tool, an ultrasound probe, etc.), Figure 1 The distal tip and / or working end of the device may also be included in the embodiment of the present invention.

[0211] More particularly, the device 5 generally includes: a sleeve 15 that is adapted to slide over the exterior of the shaft of the endoscope 10; a proximal (or "front") balloon 20 (the terms "proximal" and "front" will be used interchangeably hereinafter) that is secured to the sleeve near the distal end of the sleeve 15; and a base 25 that is secured to the sleeve at the proximal end of the sleeve 15. The device 5 also includes: a pair of push tubes 30 that are slidably mounted to the sleeve 15, as will be discussed below; and a distal (or "front") balloon 35 (the terms "distal" and "front" will be used interchangeably hereinafter) that is secured to the distal ends of the push tubes 30 so that the spacing between the rear balloon 20 and the front balloon 35 can be adjusted by a physician (or other operator or user) by moving the push tubes 30 relative to the sleeve 15 (e.g., by simultaneously advancing both push tubes at a push tube handle 37, see below). See FIG. Figure 1 as well as Figure 2-Figure 4 The device 5 also includes an associated inflation mechanism 40 ( Figure 1 ), the inflation mechanism is used to enable one or both of the rear balloon 20 and the front balloon 35 to be selectively inflated / deflated by a physician (or other operator or user).

[0212] View Now Figure 1-Figure 6, the sleeve 15 generally comprises an elongated thin-walled tube configured to slide over the exterior of the shaft of the endoscope 10 (e.g., retrograde from the distal tip of the endoscope) to fit closely therewith, wherein the sleeve is sized and constructed so that it will easily slide back over the endoscope during installation on the endoscope (preferably the endoscope is "dry"), but will have sufficient residual friction with the outer surface of the endoscope (when gripped by the hands of a physician or other operator or user) so that the sleeve will remain in place to allow twisting (i.e., rotational turns) and pushing / pulling of the endoscope during use (e.g., within the colon of a patient). In one preferred form of the invention, the sleeve 15 can move circumferentially to some extent about the endoscope 10 (and can rotate in conjunction with the axis of the endoscope when firmly gripped by the hands of a physician or other operator or user); but the sleeve 15 can only nominally move in an axial direction relative to the endoscope 10. The cannula 15 is sized so that when its distal end is substantially aligned with the distal end of the endoscope 10, the cannula 15 (in combination with the base 25) will substantially cover the shaft of the endoscope. In any case, the cannula 15 is sized so that when it is mounted to the endoscope 10 and the endoscope 10 is inserted into the patient's body, the cannula 15 extends out of the patient's body. In a preferred form of the invention, the device 5 is provided in accordance with the particular endoscope with which the device is intended to be used, wherein the device 5 is sized so that when the base 25 is engaged with the handle of the endoscope, the distal end of the cannula 15 will be appropriately positioned at the distal end of the endoscope, i.e., substantially aligned with or slightly proximal to the distal end of the endoscope.

[0213] If desired, the distal end of the sleeve 15 may be provided with a radially inwardly extending stop (not shown) to positively engage the distal end surface of the endoscope 10, thereby preventing the distal end of the sleeve 15 from moving proximally beyond the distal end surface of the endoscope 10. Such radially inwardly extending stop may also assist in preventing "torque slip" of the sleeve 15 relative to the endoscope 10 during twisting (i.e., rotational turns) of the endoscope while in the colon, and / or preventing "thrust slip" of the sleeve 15 relative to the endoscope 10 during forward pushing of the endoscope while in the colon.

[0214] The cannula 15 preferably has a smooth outer surface so as to be non-traumatic to tissue, and is preferably made of a highly flexible material so that the cannula will not inhibit bending of the endoscope during use. In a preferred form of the invention, the cannula 15 comprises polyurethane, polyethylene, poly(vinyl chloride) (PVC), polytetrafluoroethylene (PTFE), etc., and is preferably transparent (or at least translucent) so as to allow visualization of distance markings on the endoscope 10 through the cannula 15. Also, in a preferred form of the invention, the cannula 15 preferably has a nominal hoop strength so that a physician (or other operator or user) can grip the endoscope 10 through the cannula 15, for example, to twist the endoscope. If desired, the cannula 15 may include a lubricating coating (e.g., a liquid, powder, etc. such as a perfluoropolyether synthetic oil) 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 a body lumen and / or body cavity. Alternatively, the sleeve 15 may be formed of an inherently lubricious material, such as polytetrafluoroethylene (PTFE), etc. It will be appreciated that the inner surface of the sleeve 15 may include features (eg, ribs) to prevent the sleeve from rotating relative to the endoscope during use.

[0215] If desired, a vacuum may be "pulled" between the cannula 15 and the endoscope 10, thereby securing the cannula 15 to the endoscope 10 and minimizing the profile of the cannula 15. By way of example and not limitation, the vacuum may be introduced at the proximal end of the cannula 15 (i.e., at the base 25), or the vacuum may be introduced at a point in the middle of the cannula 15. By way of further example and not limitation, it will also be appreciated that the removal of the cannula 15 from the endoscope 10 (e.g., at the conclusion of a procedure) may be facilitated by introducing a fluid (e.g., air or a liquid lubricant) into the space between the cannula 15 and the endoscope 10, such as at the proximal end of the cannula 15 (i.e., at the base 25) or at an intermediate cannula 15.

[0216] Still viewing now Figure 1-Figure 6, the rear balloon 20 is fixed to the sleeve 15 just proximal to the articulated joint of the endoscope, which is near but spaced from the distal end of the sleeve. The rear balloon 20 is concentrically arranged around the sleeve 15, and therefore around the endoscope 10 arranged in the sleeve 15. Therefore, the rear balloon 20 has a generally annular shape. The rear balloon 20 can be selectively inflated / deflated by means of a proximal inflation / deflation tube 45, which puts its distal end in fluid communication with the interior of the rear balloon 20 and its proximal end in fluid communication with a fitting 46 mounted to the base 25. The fitting 46 is configured to be connected to the above-mentioned associated inflation mechanism 40. The fitting 46 is preferably a Luer-activated valve, thereby allowing the inflation mechanism 40 to be disconnected from the fitting 46 without losing pressure in the rear balloon 20. The inflation / deflation tube 45 may be secured to an outer surface of the cannula 15 , or more preferably, the inflation / deflation tube 45 may be contained within a lumen 47 formed within the cannula 15 .

[0217] Preferably, the rear balloon 20 is disposed a short distance rearward from the distal end of the cannula 15 (i.e., a distance approximately the same as the length of the articulated portion of the steerable endoscope 10) so that when the steerable endoscope is disposed in the cannula 15, the articulated portion of the steerable endoscope will be disposed distal to the rear balloon 20. This configuration allows the flexible portion of the steerable endoscope to be articulated even when the rear balloon 20 has been inflated in the anatomical structure so as to stabilize the adjacent non-articulated portion of the endoscope relative to the anatomical structure, as will be discussed in further detail below. Thus, when inflated, the rear balloon 20 provides a reliable platform for maintaining the endoscope 10 in a stable position within a body lumen or body cavity, wherein the endoscope 10 is centered within the body lumen or body cavity. As a result, the endoscope 10 can provide improved visualization of the anatomical structure. In addition, because the endoscope 10 is securely held within the body lumen or body cavity by the inflated rear balloon 20, instruments that are advanced through the internal lumen (sometimes referred to as the "working channel" or "multiple working channels") of the endoscope 10 will also be provided with a reliable platform for supporting those instruments within the body lumen or body cavity.

[0218] When the posterior balloon 20 is properly inflated, it can atraumatically engage and form a sealing relationship with the sidewalls of the body lumen within which the device 5 is disposed.

[0219] In one preferred form of the invention, posterior balloon 20 is formed from polyurethane.

[0220] 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., the 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), thereby allowing the physician (or other operator or user) to pull the cannula 15 over the distal end of the endoscope 10 and then back proximally along the length of the endoscope 10, thereby mounting the cannula 15 to the outer surface of the shaft of the endoscope. In one preferred form of the invention, the base 25 is pulled proximally along the endoscope until the base 25 seats against the handle of the endoscope, thereby inhibiting further proximal movement of the base 25 (and thus thereby inhibiting further proximal movement of the cannula 15). In one preferred form of the invention, the base 25 is in sealing engagement with the endoscope 10.

[0221] The push tube 30 is slidably mounted to the cannula 15, whereby the distal end of the push tube can be extended and / or retracted relative to the cannula 15 (e.g., by advancing or withdrawing the push tube via the push tube handle 37, see below), and thus relative to the distal end of the endoscope 10 disposed in the cannula 15. Preferably, the push tube 30 is slidably disposed in a support tube 50 that 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 referred to as "PTFE") so as to minimize resistance to movement of the push tube 30 relative to the support tube 50 (and thus minimize resistance to movement of the push tube 30 relative to the cannula 15). In this regard, it should be appreciated that minimizing resistance to movement of the push tube 30 relative to the support tube 50 improves tactile feedback to the user when the push tube 30 is used to manipulate the front balloon 35. In one form of the invention, the support tube 50 is flexible (so as to permit the endoscope 10, and in particular the articulated portion of the steerable endoscope 10, to flex as needed during surgery); however, the support tube 50 also provides some column strength. Thus, when the support tube 50 is mounted within the lumen 52 formed in the cannula 15, the assembly of the cannula 15 and the support tube 50 is flexible but has a degree of column strength (whereas the cannula 15 is merely flexible but has substantially no column strength). Where the push tube 30 is contained within the lumen 52 formed in the cannula 15, and where the support tube 50 is not disposed between the push tube 30 and the lumen 52, the lumen 52 is preferably lubricated to minimize friction between the push tube 30 and the lumen 52.

[0222] The proximal end of the push tube 30 is connected to the push tube handle 37. Due to this construction, pushing distally on the push tube handle 37 causes the distal end of the push tube 30 to move distally (at the same rate) relative to the sleeve 15 (thereby causing the front balloon 35 to move distally relative to the rear balloon 20), and pulling proximally on the push tube handle 37 causes the distal end of the push tube 30 to retract proximally (at the same rate) relative to the sleeve 15 (thereby causing the front balloon 35 to move proximally relative to the rear balloon 20). Note that by moving the push tubes 30 distally or proximally at the same rate, the distal ends of the push tubes remain parallel to each other. Clamp 53 ( Fig.12 and Fig.15 ) is provided at the base 25 for maintaining the push tube 30 in a selected configuration relative to the base 25 (and therefore relative to the sleeve 15).

[0223] Push tube 30 is preferably formed of a relatively flexible material that provides good column strength, such as Isoplast TM (available from Lubrizol Corporation of Wickliffe, Ohio), polyethylene, polypropylene, nylon, and the like. It should be understood that the push tube 30 may comprise a single material or a plurality of materials, and that the stiffness of the push tube 30 may vary along their length. By way of example but not limitation, the distal-most portion of the push tube 30 may be formed of the same material as the remainder of the push tube, but having a lower modulus so as to be more flexible than the remainder of the push tube, or the distal-most portion of the push tube 30 may comprise a different, more resilient flexible material. By way of example but not limitation, the distal-most portion of the push tube 30 may comprise nitinol. By way of further example but not limitation, the distal-most portion of the push tube 30 may comprise a stainless steel coil covered with an outer sheath of polytetrafluoroethylene (PTFE), wherein the distal-most sheath / more proximal tubing together provides a sealed lumen for inflating / deflating the front balloon 35. By forming the push tube 30 with a more flexible distal end than the remainder of the push tube, the push tube 30 and front balloon 35 can together act as a guide for the device 5 and endoscope 10 (with a soft atraumatic tip), as discussed further below.

[0224] In a preferred form of the invention, push tubes 30 are configured to maintain a parallel arrangement when they are in an unbiased state (ie, when no force is applied to push tubes 30). This is true regardless of the inflated or deflated state of front balloon 35.

[0225] The distal-most portion of the push tube 30 can be configured to bend inwardly or outwardly (if desired). With such a configuration, when the distal tip of the push tube 30 is held stationary (e.g., by the inflated front balloon, as will be discussed below) and sufficient distally directed force is applied to the push tube 30, the middle portion of the push tube 30 (i.e., the portion between the inflated front balloon 35 and the sleeve 15) can bend or bow outwardly, thereby pushing outwardly the sidewalls of the body lumen in which the device 5 is disposed, thereby providing a "bulging" effect on the sidewalls of the body lumen and / or body cavity in the space between the rear balloon 20 and the front balloon 35. By pushing outwardly the sidewalls of the body lumen and / or body cavity in which the device 5 is disposed, this "bulging" effect can significantly enhance visibility and / or tissue stability in the area distal to the endoscope 10.

[0226] It will also be appreciated 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 twisting the device, etc.) so as to prevent the push tubes from interfering with visualization of the patient's anatomy and / or interfering with diagnostic or therapeutic tools introduced into the space between the anterior and posterior balloons. By way of example and not limitation, if the device 5 is positioned in the anatomy in such a way that the push tubes 30 obstruct visual or physical access to a target area of ​​the anatomy, the flexible push tubes 30 may be moved out of the way by using a separate tool or instrument or by rotating the device in a twisting motion to move the flexible push tubes 30 out of the way, etc. By way of further example and not limitation, by constructing the push tubes 30 so that they are circular and flexible and have a diameter significantly smaller than the circumference of the endoscope 10, movement of the circular endoscope when articulated may simply push the push tubes out of the way and provide an unobstructed visual path to the tissue of interest.

[0227] It should also be understood that, if desired, the push tube 30 can be marked with indicators (e.g., color indicators or radiopaque indicators) including distance markings (not shown) so that a physician (or other operator or user) observing the surgical site via the endoscope 10 or by radiation guidance (e.g., X-ray fluoroscopy) can determine the relative placement of the push tube 30 at the surgical site relative to the side walls of the body lumen and / or other body cavity in both the longitudinal and / or circumferential directions.

[0228] As will be discussed in further detail below, the push tube 30 is hollow and has its distal end in fluid communication with the interior of the front balloon 35 ( Figure 1-Figure 5 , Figure 7 and Figure 8) and having its internal lumen in fluid communication with a fitting 56 mounted to the base 25. The fitting 56 is configured to be connected to the aforementioned associated inflation mechanism 40 so that the front balloon 35 can be selectively inflated / deflated with air or other fluids (including liquids). The fitting 56 is preferably a Luer-activated valve, thereby allowing the inflation mechanism 40 to be disconnected from the fitting 56 without losing pressure in the front balloon 35.

[0229] More particularly, in a preferred form of the present invention, and now referring to Fig. 8A , the push tube handle 37 includes a hollow interior 57. The push tube 30 is mounted to the push tube handle 37 so that the push tube 30 will move in conjunction with the push tube handle 37 and so that the hollow interior of the push tube 30 is in fluid communication with the hollow interior 57 of the push tube handle 37. The push tube handle 37 also includes a fitting 58 in fluid communication with the hollow interior 57 of the push tube handle 37. A flexible tube 59 connects the fitting 58 with an internal chamber (not shown) in the base 25, wherein the internal chamber in the base 25 is in fluid communication with the aforementioned fitting 56. Due to this configuration, when the push tube handle 37 moves distally, the front balloon 35 moves distally, and when the push tube handle 37 moves proximally, the front balloon 35 moves proximally. In addition, when positive fluid pressure is applied to the fitting 56 in the base 25, the positive fluid pressure is applied to the interior of the front balloon 35, thereby inflating the front balloon 35, and when negative fluid pressure is applied to the fitting 56 in the base 25, negative fluid pressure is applied to the interior of the front balloon 35, thereby deflated the front balloon 35.

[0230] It should be appreciated that providing a double push tube provides numerous advantages. By way of example but not limitation, providing a double push tube provides symmetrical forces to the front balloon 35 when the front balloon is advanced distally into the body lumen, as will be discussed below. In addition, when the double push tubes 30 are employed to straighten anatomical structures in an area near the distal end of the endoscope 10, providing these push tubes provides equal outward forces against adjacent anatomical structures, thereby enhancing visualization of the anatomical structures and / or access to the anatomical structures, as will be discussed below. In addition, providing a double push tube ensures that the front balloon 35 remains centered on the endoscope 10, thereby facilitating the front balloon 35 to disengage from the docking on the endoscope 10 and the front balloon 35 to re-dock on the endoscope 10, as will be discussed below. In addition, providing a double push tube 30 helps ensure that the front balloon 35 is stable relative to the tip of the endoscope, thereby minimizing the rotational movement of the front balloon when inflated. Additionally, provision of dual hollow push tubes provides a redundant air delivery system for inflating or deflation of the front balloon 35 .

[0231] The front balloon 35 is fixed to the distal end of the push tube 30, whereby the spacing between the rear balloon 20 and the front balloon 35 can be adjusted by moving the push tube 30 relative to the sleeve 15 (i.e., by moving the push tube handle 37 relative to the sleeve 15). In addition, the hollow push tube 30 provides a conduit between the interior of the front balloon 35 and the fitting 56, thereby allowing the front balloon 35 to be selectively inflated / deflated via the fitting 56.

[0232] It is noteworthy that the front balloon 35 is configured so that (i) when it is deflated (or partially deflated) and it is in its "retracted" position ( Figure 2 ), the front balloon 35 provides an axial opening 63 (large enough to accommodate the shaft of the cannula 15 and the endoscope 10 therein. Figure 7 , Figure 8 and Fig.10 ), whereby the balloon 35 may previously be "docked" onto the cannula 15 and the endoscope 10, and (ii) the balloon 35 is currently in its "extended" position relative to the cannula 15 and is appropriately inflated ( Figure 4 ), the axial opening 63 is closed (and preferably completely sealed). At the same time, when properly inflated, the front balloon can atraumatically engage and form a sealing relationship with the sidewalls of the body lumen and / or body cavity in which the device 5 is disposed. Therefore, when the front balloon 35 is properly inflated, the front balloon can effectively seal the body lumen and / or body cavity distal to the front balloon 35 by closing the axial opening 63 and forming a sealing relationship with the sidewalls of the body lumen and / or body cavity in which the device 5 is disposed. In this way, when the push tube 30 is advanced distally to separate the front balloon 35 from the rear balloon 20, and when the front balloon 35 and the rear balloon 20 are properly inflated, the two balloons will create a sealing area (hereinafter sometimes referred to as a "treatment area") between them.

[0233] It will be appreciated that when the front balloon 35 is reconfigured from its deflated state to its inflated state, the front balloon 35 expands radially inwardly (so as to close the axial opening 63) and radially outwardly (so as to engage the surrounding tissue).

[0234] It will thus be seen that the front balloon 35 has a "torus" shape when deflated (to allow it to rest over the distal end of an endoscope), and has a substantially "solid" shape when inflated (to allow it to close off a body lumen or cavity).

[0235] To do this, and now check Fig. 9 and Fig.10, the front balloon 35 is preferably manufactured as a unitary structure including 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 convex corner 74, and a distal extension 76 having a circular cross-section. Note that the convex corner 74 is disposed on the proximal extension 73 in a configuration that matches the configuration of the push tube 30 (i.e., where the device 5 includes two push tubes 30 diametrically opposed to each other, the proximal extension 73 will include two convex corners 74 diametrically opposed to each other; where the device 5 includes three push tubes 30 equally circumferentially spaced around the periphery of the sleeve 15, the proximal extension 73 will include three convex corners 74 equally circumferentially spaced around the periphery of the proximal extension 73; where the device 5 includes one push tube 30, the proximal extension 73 will include one convex corner 74, etc. - for purposes of the present invention, the proximal extension 73 and the convex corner(s) 74 may be collectively referred to as having a "key-shaped" cross-section). During assembly, the push tube 30 is seated in the convex corner 74 of the proximal extension 73, the proximal extension 73 is 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, thereby providing a front balloon 35 having an axial opening 63 extending therethrough, wherein the push tube 30 is secured to the front balloon 35 and in communication with the interior of the front balloon 35. Notably, the axial opening 63 is sized to receive the distal end of the endoscope 10 therein. Also, notably, the front balloon 35 is formed by 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, providing multiple layers of balloon material around the push tube 30, thereby providing a more robust balloon construction. Among other things, providing multiple layers of balloon material around push tube 30 adds cushioning to the distal end of push tube 30 , thereby providing push tube 30 with an even more atraumatic distal tip and further ensuring that the distal tip of push tube 30 does not damage adjacent tissue.

[0236] In one preferred form of the invention, front balloon 35 is formed from polyurethane.

[0237] It should be appreciated that when the front balloon 35 is in its deflated state, the material of the front balloon 35 substantially surrounds the distal end of the push tube 30 (while still allowing the push tube 30 to be in fluid communication with the interior of the front balloon 35), thereby providing an atraumatic tip for advancing the front balloon 35 distally through a body lumen. In addition, the push tube 30 and the deflated front balloon 35 can together essentially serve as a soft-tipped guide for the device 5 and endoscope 10, as discussed further below ( Fig. 20 ).

[0238] If desired, one or both of the rear balloon 20 and the front balloon 35 can be marked with an indicator (e.g., a color indicator or an opaque indicator) so that a physician (or other operator or user) observing the surgical site via endoscope 10 or radiation guidance (e.g., X-ray fluoroscopy) can determine the placement of one or both balloons at the surgical site.

[0239] Inflation mechanism 40 provides a means for selectively inflating posterior balloon 20 and / or anterior balloon 35 .

[0240] In a preferred form of the invention, and now looking at Figure 1 and Fig.11 , the inflation mechanism 40 includes a single-line syringe inserter 140, which includes a body 145 and a plunger 150. Preferably, a spring 153 is provided in the body 145 to automatically return the plunger 150 at the end of its stroke. The syringe inserter 140 is connected to one or the other of the fittings 46, 56 via a line 155. Thus, with this configuration, when the single-line syringe inserter 140 is to be used to inflate the rear balloon 20, the syringe inserter 140 is connected to the fitting 46 via the line 155, so that the output of the single-line syringe inserter 140 is directed to the rear balloon 20 (i.e., via the proximal inflation / deflation tube 45). Accordingly, when the single-line syringe inserter 140 is used to inflate the front balloon 35, the syringe inserter 140 is connected to the fitting 56 via line 155 so that the output of the single-line syringe inserter 140 is directed to the front balloon 35 (i.e., via the flexible tube 59 and the hollow interior of the push tube 30).

[0241] In another preferred form of the present invention, the inflation mechanism 40 includes an elastic bulb 156 having a first port 157 and a second port 158. A one-way valve 159 (e.g., a check valve) is provided in the first port 157 so that air can only pass through the first port 157 when traveling in an outward direction. Another one-way valve 159 (e.g., a check valve) is provided in the second port 158 ​​so that air can only pass through the second port 158 ​​when traveling in an inward direction. When the elastic bulb 156 is compressed (e.g., by hand), the air within the interior of the elastic bulb 156 is squeezed out of the first port 157; and when the elastic bulb 156 is thereafter released, the air is drawn back into the interior of the elastic bulb 156 through the second port 158.

[0242] Due to this configuration, when the elastic bulb 156 is to be used to inflate the rear balloon 20, the first port 157 is connected to the fitting 46 via the line 155 so that the positive pressure output of the elastic bulb 156 is directed to the rear balloon 20. Thereafter, the elastic bulb 156 can be used to deflate the rear balloon 20 (i.e., by connecting the second port 158 ​​to the fitting 46 via the line 155 so that the suction force of the elastic bulb 156 is directed to the rear balloon 20). Accordingly, when the elastic bulb 156 is to be used to inflate the front balloon 35, the first port 157 is connected to the fitting 56 via the line 155 so that the positive pressure output of the elastic bulb 156 is directed to the front balloon 35. Thereafter, the elastic bulb 156 can be used to deflate the front balloon 35 (i.e., by connecting the second port 158 ​​to the fitting 56 via the line 155 so that the suction force of the elastic bulb 156 is directed to the front balloon 35).

[0243] Alternatively, and now view Fig.12 and Fig.13 , the syringe 160 can be used to inflate the rear balloon 20 and / or the front balloon 35. The inflation mechanism 160 includes a body 161 and a plunger 162. Preferably, a spring (not shown) is provided in the body 161 to automatically return the plunger 162 at the end of the power stroke of the plunger 162. The syringe 160 is connected to the fittings 46, 56 via a line 163. With this configuration, the syringe 160 includes a valve 165 for connecting the syringe 160 to the front balloon 35 or the rear balloon 20, and a valve 170 for selecting inflation or deflation of the balloon to which it is connected.

[0244] Thus, with this configuration, when the syringe 160 is to be used to inflate the rear balloon 20, the valve 165 (a two-position valve that connects the valve 170 to either the front or rear balloon) is set so that the syringe 160 is connected to the rear balloon 20 via the fitting 46, and the valve 170 (a two-way reversing valve that allows the one-way valve arrangement to be inflated in one configuration and deflated in another configuration) is set so that the syringe 160 provides the inflation pressure. Thereafter, when the rear balloon 20 is to be deflated, the valve 170 is set to its deflated position.

[0245] Accordingly, when syringe 160 is to be used to inflate front balloon 35, valve 165 is set so that syringe 160 is connected to front balloon 35 via fitting 56, and valve 170 is set so that syringe 160 provides inflation pressure. Thereafter, when front balloon 35 is to be deflated, valve 170 is set to its deflated position.

[0246] In yet another form of the invention, inflation mechanism 40 may include an automatic source of fluid pressure (positive or negative), such as an electric pump.

[0247] If necessary, and view now Fig.14, the safety valve 175 can be connected to the inflation / deflation line connected to the front balloon 35 to ensure that the pressure within the front balloon 35 does not exceed a predetermined level. Similarly, and now still looking at Fig.14 , a safety valve 180 may be connected to the inflation / deflation line connected to the rear balloon 20 to ensure that the pressure within the rear balloon 20 does not exceed a predetermined level.

[0248] Alternatively and / or additionally, one or more pressure gauges 182 ( Figure 1 or Fig.13 ) can be incorporated into the fluid line connected to the rear balloon 20 and / or into the fluid line connected to the front balloon 35, thereby providing the physician (or other operator or user) with information related to the pressure inside the rear balloon 20 and / or the front balloon 35 so as to avoid overinflation and / or help the physician (or other operator or user) determine the inflation state of the balloon during surgery.

[0249] Furthermore, it will be appreciated that the current balloon 35 is in its "retracted" position ( Figure 2 ) and its "extended" position ( Figure 4 ), the flexible tube 59 connecting the push tube 30 to the base 25 (and thus to the accessory 56) may collapse around the base 25, thereby potentially interfering with the actions of the physician (or other operator or user). Fig.15 , a flexible tube retraction system 185 may be provided (eg, within the base 25) to take up the slack in the flexible tube 59 when the front balloon 35 is extended.

[0250] Preferred method for using new equipment

[0251] Device 5 can be used to manipulate (e.g., stabilize, straighten, expand and / or flatten, etc.) the side walls of a body lumen and / or body cavity to better present the side wall tissue (including visualization of areas initially hidden from or out of view) for inspection and / or treatment during endoscopic surgery using endoscope 10, and / or for stabilizing the distal tip and / or working end of an instrument (e.g., a grasper, cutter or dissector, a cautery tool, an ultrasound probe, etc.) being advanced into a treatment area.

[0252] More specifically, in use, the cannula 15 is first mounted to the endoscope 10 ( Figure 1 ). This can be accomplished by pulling the base 25 proximally over the distal end of the endoscope 10 and then proximally along the length of the endoscope 10 until the distal end of the cannula 15 is substantially aligned with the distal tip of the endoscope 10. At this point, the rear balloon 20 is deflated, the front balloon 35 is deflated, and the front balloon 35 docks over the distal end of the endoscope 10. The endoscope 10 and device 5 are ready to be inserted into the patient as a unit.

[0253] View next Fig.16 , the endoscope 10 and the device 5 are inserted as a unit into a body lumen and / or body cavity of a patient. By way of example and not limitation, the endoscope 10 and the device 5 are inserted as a unit into the gastrointestinal (GI) tract of a patient. The endoscope 10 and the device 5 are advanced along the body lumen and / or body cavity to a desired location in the patient's body ( Fig.17 and Fig.18 ).

[0254] When the device 5 is to be used (e.g., to manipulate the sidewall of the gastrointestinal tract to provide increased visualization of and / or increased access to the sidewall and / or for stabilizing the instrument relative to the sidewall), the rear balloon 20 is inflated to stabilize the device 5 (and thus the endoscope 10) within the body lumen and / or body cavity. Fig.19 This may be accomplished using the associated inflation mechanism 40 described above.

[0255] In this regard, it will be appreciated that since the articulated portion of the endoscope resides distal to the rear balloon 20, the endoscope will be able to articulate distal to the rear balloon 20 to facilitate visualization of the anatomical structures even after the rear balloon 20 is inflated. Notably, such visualization is enhanced since the rear balloon 20 stabilizes the endoscope 10 within the gastrointestinal tract and dilates the colon and increases the colon to a fixed diameter immediately adjacent to the side balloon 20.

[0256] Next, by pushing the push tube handle 37 distally, the push tube 30 is advanced distally in the body lumen and / or body cavity (i.e., so as to move the front balloon 35 further in front of the rear balloon 20). Thus, the push tube 30 and therefore the front balloon 35 are moved distally relative to the endoscope 10 (which is stabilized in a suitable position in the gastrointestinal tract by the inflated rear balloon 20). Note that during such distal advancement of the front balloon 35, the deflated front balloon 35 covers the distal end of the push tube 30, thereby ensuring atraumatic advancement of the front balloon 35. Note that by forming the distal end of the push tube 30 from a more elastic material, the atraumatic advancement of the front balloon 35 can be further enhanced.

[0257] When the push tube 30 has advanced the front balloon 35 to the desired position distal to the endoscope 10, the front balloon 35 is inflated ( Fig. 20) in order to secure the front balloon 35 to the anatomical structure. Again, this can be accomplished using the aforementioned associated inflation mechanism 40. When the front balloon 35 is inflated, the inflated front balloon 35, the inflated rear balloon 20, and the push tube 30 will all complement each other to stabilize, straighten, expand, and / or flatten the sidewalls of the body lumen and / or body cavity, thereby to better present the sidewall tissue (including visualization of areas that were initially hidden from view or out of view) for inspection and / or treatment during endoscopic surgery using the endoscope 10. In this regard, it will be appreciated that the inflated front balloon 35 and the inflated rear balloon 20 will together expand and tension the sidewalls of the body lumen and / or body cavity, and that as the front balloon extends distally from the rear balloon, the push tube 30 will tend to straighten the anatomical structure between the two inflated balloons. In this regard, it will also be appreciated that once both the rear balloon 20 and the front balloon 35 have been inflated, the front balloon 35 will create a substantially full-diameter seal across the body lumen and / or body cavity (because the inflated front balloon closes the axial opening 63 that extends through the front balloon when the front balloon is in its deflated state), and the rear balloon 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 front balloon 35 and the inflated rear balloon 20 will together define a substantially closed area along the body lumen and / or body cavity (i.e., an isolated treatment area that prevents the passage of fluids and / or other liquids due to the airtight seal established by the inflated front balloon 35 and the rear balloon 20). The sidewalls of the body lumen and / or body cavity will be tensioned by the inflation of the front balloon 35 and the rear balloon 20, thereby better presenting the sidewalls of the body lumen and / or body cavity for viewing through the endoscope 10.

[0258] It should be understood that the expansion and tensioning of the side walls of the body lumen and / or body cavity achieved by the inflated front balloon 35, the inflated rear balloon 20 and the push tube 30 can be further enhanced by advancing the front balloon and clamping the side walls of the body lumen and / or body cavity when the front balloon is inflated, thereby tensioning the side walls of the body lumen and / or body cavity.

[0259] Notably, because the inflated front balloon 35 and the inflated rear balloon 20 together define a substantially closed region (i.e., an isolated treatment zone) along the body lumen and / or body cavity, the region can then be treated with a fluid (e.g., air, CO 2 etc.) inflation ( Fig.21 ) in order to further tension the sidewalls of the body lumen and / or body cavity, thereby better presenting the sidewalls of the body lumen and / or body cavity for observation through the endoscope 10, and stabilizing the sidewalls to facilitate more precise therapeutic intervention.

[0260] If desired, the anterior balloon 35 can be retracted toward the posterior balloon 20 (i.e., by pulling the push tube handle 37 proximally) while remaining inflated (and thus maintaining a grip on the sidewall of the body lumen and / or body cavity) in order to mobilize the visible mucosa and further improve visualization and access (see Fig. 22 ), for example, in order to position a specific target area on the side wall of a body lumen and / or body cavity at a convenient angle relative to the endoscope and endoscopic tools.

[0261] Alternatively, if desired, once the rear balloon 35 has been inflated, the push tube 30 can be advanced distally for a portion (but only a portion) of its full distal travel, then the front balloon 35 can be inflated to grip the sidewall of the body lumen and / or body cavity, and then the push tube 30 can be further advanced distally. This action will cause the flexible push tube 30 to bow outward (see FIG. Figure 22A-22D ), thereby contacting the side walls of the body lumen and / or body cavity and pushing the side walls of the body lumen and / or body cavity outward, for example in a "bulging" manner, thereby further enhancing the visualization of the side walls of the body lumen and / or body cavity by the endoscope 10.

[0262] If necessary, instrument 190 ( Fig.23 ) can be advanced through the working channel of the endoscope 10 in order to biopsy and / or treat a pathological condition (e.g., to resect a diseased anatomical structure). It will be appreciated that such an instrument will extend through the distal end of the endoscope, which is effectively stabilized relative to the anatomy via the rear balloon 20, so that the working end of the instrument 190 will also be highly stabilized relative to the anatomy. This is a significant advantage over the prior art practice of pushing instruments out of the unstable end of the endoscope. Preferably, the instrument 190 comprises an articulated instrument with a full range of motion, thereby better accessing the target anatomy.

[0263] Additionally, if bleeding will obscure the tissue site, or if bleeding will occur and the surgeon cannot identify the source of the bleeding, isolating the treatment area permits rapid irrigation of the anatomical segment in which the treatment area is located (e.g., with a fluid such as saline), followed by rapid removal of the irrigation fluid (see Figure 24-26 ).

[0264] Furthermore, if desired, the front balloon 35 can be guided to the bleeding site with high precision, whereupon the front balloon 35 can be used (e.g., inflated) to apply localized pressure to the bleeding site to enhance bleeding control (see Fig. 27 ). This can be done under the visualization provided by the endoscope 10.

[0265] If it is desired to reposition the endoscope 10 within the anatomical structure with minimal interference from the device 5, the front balloon 35 is returned to its toroidal configuration (i.e., partially deflated), the front balloon is proximally retracted and "re-docked" at the distal end of the endoscope 10, the rear balloon 20 is deflated, and the endoscope 10 (with the device 5 carried thereon) is then repositioned within the anatomical structure. Note that in the event that the front balloon 35 is to be re-docked at the distal end of the endoscope 10, it is preferred that the front balloon 35 be only partially deflated until the front balloon 35 is re-docked at the distal end of the endoscope, as the partial inflation of the front balloon 35 may give the front balloon 35 sufficient "body" to facilitate the re-docking process. Thereafter, if desired, the front balloon 35 may be fully deflated, e.g., to positively grip the distal end of the endoscope 10.

[0266] Alternatively, if desired, the front balloon 35 can be used as a drag brake to control retrograde motion of the endoscope. More particularly, in this form of the invention, the endoscope 10 and the device 5 are first advanced as a unit into a body lumen and / or body cavity until the tip of the endoscope is in the proper position. Next, the rear balloon 20 is inflated, the push tube 30 is advanced distally, and the front balloon 35 is then inflated ( Fig.28 ). Visualization and optionally therapeutic treatment can then be achieved at this location. When the device is to be moved retrogradely, the rear balloon 20 is deflated, the front balloon 35 is partially deflated, and the endoscope is then withdrawn proximally, thereby dragging the semi-inflated front balloon 35 along the body lumen and / or body cavity ( Fig.29 ), wherein the front balloon 35 acts as a brake to some extent when the endoscope is pulled proximally, thereby achieving a more controlled retrograde movement of the endoscope and thus achieving better visualization of the anatomical structure. If necessary at some point, the rear balloon 20 and the front balloon 35 can be re-inflated, such as Fig.30 , where fluid is or is not introduced into an "isolated treatment zone" created between two balloons in order to stabilize, straighten, expand and / or flatten the anatomical structure.

[0267] It is also possible to use the rear balloon 20 as a brake (either alone or in combination with the aforementioned braking action from the front balloon 35) when withdrawing the endoscope (and therefore the device 5) from the anatomy.

[0268] At the conclusion of the procedure, the endoscope 10 and the device 5 are withdrawn from the anatomy. Preferably, this is accomplished by deflation (or partially deflation) of the front balloon 35, retraction of the push tube 30, "re-docking" the front balloon 35 onto the distal end of the endoscope 10, fully deflation of the front balloon 35 so that it grips the distal end of the endoscope, deflation of the rear balloon 20 (if it has not already been deflated), and then withdrawal of the endoscope 10 and the device 5 from the anatomy as a unit.

[0269] It should be appreciated that the device 5 may also be advantageously used in various ways other than those disclosed above. By way of example but not limitation, when the endoscope 10 (and the device 5) is to be advanced within the colon, it may be desirable to first protrude the front balloon 35 distally under the visual guidance of the endoscope so that the front balloon 35 guides the distal end of the endoscope. As a result, when the endoscope is advanced distally, with the front balloon 35 deflated (or partially deflated), the front balloon and the flexible push tube 30 may act as an atraumatic guide (guiding structure) for the endoscope as it is advanced through the colon. It is noteworthy that, since the distal end of the push tube 30 is preferably highly flexible, when the advanced front balloon 35 encounters the colon wall (e.g., at a bend in the colon), the flexible push tube may be deflected so that the front balloon tracks the path of the colon, thereby assisting the atraumatic advancement of the endoscope along the colon. It should also be appreciated that the device 5 may also be advantageously used in other ways to facilitate further inspection of the luminal surface that is otherwise currently difficult to perform. An example of this is endoscopic ultrasound examination of the lumen, which would be facilitated by an inflated anterior balloon filled with fluid and ultrasound probe examination.

[0270] Additional construction

[0271] If desired, the device 5 can be configured so that the push tubes 30 can be advanced or retracted independently of each other and in conjunction with each other - such independent advancement or retraction of the push tubes 30 can assist in turning the partially deflated or fully deflated front balloon 35 through the body lumen and / or body cavity, thereby facilitating the advancement or retraction of the endoscope 10 through the body lumen and / or body cavity; and / or such independent advancement or retraction of the push tubes 30 can facilitate the use of the inflated front balloon 35 to apply a "turning force" to the anatomical structure, thereby better presenting the anatomical structure for visualization and / or treatment.

[0272] By way of example and not limitation, in this form of the invention, and now viewing Fig. 30A, the push tubes 30 are each independently slidably mounted to the push tube handle 37 so that the push tubes 30 can move independently of the push tube handle 37 and independently of each other. The stopper 191 limits the distal movement of the push tube 30 relative to the push tube handle 37 so that the push tube cannot be completely moved out of the push tube handle 37. Due to this configuration, when the front balloon 35 is to move distally, the push tubes 30 move distally together or independently of each other. And, when the front balloon 35 is to move proximally, the push tubes 30 move proximally together or independently of each other. At any time during the operation, the push tubes 30 can move independently of each other to make the front balloon "turn", for example, such as when the front balloon 35 is inflated and engages the anatomical structure, thereby applying a "turning force" to the anatomical structure, or when the front balloon 35 is partially inflated and used as an atraumatic tip for advancing the assembly, thereby helping to "turn" the assembly through the anatomical structure. Note that it may be desirable to provide a limiting mechanism to limit the extent to which the push rods 30 may move longitudinally independently of one another in order to prevent excessive turning of the front balloon 35, and / or push rod crossing, and / or push rod entanglement, and / or push rod misalignment, etc. Note also that by mounting the push tube 30 in the aforementioned clamp 53 ( Fig.12 and Fig.15 ), the push tube 30 can be maintained in a specific setting.

[0273] It should also be appreciated that it is possible to modify the configuration of the cannula 15 so as to support instruments external to the endoscope 10 (or a hollow instrument guide tube). Figure 5 and Figure 6 , you will see that in Figure 5 and Figure 6 In the configuration shown in FIG. 1 , the sleeve 15 includes: a lumen 47 for receiving an inflation / deflation tube 45 for inflating / deflation of the rear balloon 20; and a pair of lumens 52 for receiving a support tube 50, which receives a push tube 30 for manipulating and inflating / defl ucing the front balloon 35. However, if desired, the sleeve 15 may include an additional lumen for supporting an instrument (or a hollow instrument guide tube) external to the endoscope 10.

[0274] More specifically, and now looking at Fig.31 , shows an end view of another form of cannula 15, which includes a plurality of lumens 195 for slidably receiving instruments 190 therein. Note that when inflated, the rear balloon 20 provides a secure platform for maintaining the endoscope 10 and cannula 15 within a body lumen or body cavity, wherein the endoscope 10 and cannula 15 are centered within the body lumen or body cavity. As a result, the distal end of the lumen 195 of the cannula 15 will also be securely maintained within the body lumen or body cavity to provide secure support for instruments being advanced through the lumen 195 of the cannula 15.

[0275] The proximal end of lumen 195 may extend to and through base 25, in which case instruments may be inserted into lumen 195 at base 25, or the proximal end of lumen 195 may terminate proximal to base 25 (but still outside the patient's body), in which case instruments may be inserted into lumen 195 in the middle of cannula 15. By way of example and not limitation, where endoscope 10 is 180 cm in length and instrument 190 is 60 cm in length, it may be advantageous to insert instrument 190 into lumen 195 at a point closer to balloon 20, 35 than at base 25. Note that in Fig.31 , the lumen 47 for receiving the inflation / deflation tube 45 and the inflation / deflation tube 45 for inflating / deflation the rear balloon 20 are not visible because the view is facing distally and is obtained distally of the position where the lumen 47 and the inflation / deflation tube 45 terminate on the sleeve 15.

[0276] Figure 32-Figure 35 Various instruments 190 are shown extending from lumen 195. Note that instruments 190 preferably include articulated instruments, such as Figure 32-Figure 35 Grasper 190A, Figure 32-Figure 33 The cautery device 190B, Fig.34 and Fig.35 Scissors 190C, and Figure 32-Figure 35 The suction device 190D in.

[0277] It should be understood that where the sleeve 15 includes a central passage thereof for receiving the endoscope 10, a lumen 47 for receiving the inflation / deflation tube 45, a lumen 52 for receiving the support tubes 50 (which receive the push tubes 30), and / or a lumen 195 for slidably receiving the instrument 190 therein, the sleeve 15 is preferably formed by an extrusion process.

[0278] In a preferred form of the invention, the lumen 47 for receiving the inflation / deflation tube 45, the lumen 52 for receiving the support tubes 50 (which receive the push tubes 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 profile.

[0279] In another preferred form of the invention, the lumen 47 for receiving the inflation / deflation tube 45, the lumen 52 for receiving the support tubes 50 (which receive the push tubes 30), and / or the lumen 195 for slidably receiving the instrument 190 may have an expandable configuration (i.e., they may have a minimal profile when empty and expand in diameter as needed when filled) so that the overall profile of the cannula 15 is minimized.

[0280] It should also be appreciated that where the cannula 15 includes a plurality of lumens 195 for slidably receiving an instrument 190 therein, it may be desirable to provide greater structural integrity to the distal end of the lumens 195 in order to provide improved support for the instrument 190 received within the lumens 195. To this end, a support ring may be provided at the distal end of the cannula 15, wherein the support ring provides an opening for passage of the push tube 30 and an opening for passage of the instrument 190. Note that the opening in such a support ring for passage of the instrument 190 is preferably a close fit with the instrument in order to provide excellent instrument support at the distal end of the cannula 15.

[0281] Alternatively and / or additionally, lumen 195 may house hollow instrument guide tubes that themselves house instruments therein. Such hollow instrument guide tubes may provide greater structural integrity to the distal end of lumen 195 to provide improved support for instrument 190 received within lumen 195. Furthermore, such hollow instrument guide tubes may have a fixed geometry or a bendable or articulated geometry. See, e.g. Fig.36 , which shows a hollow instrument guide tube 200 extending from lumen 195 and receiving instrument 190 therein. Note that the hollow instrument guide tubes 200 can be independently movable relative to each other (and independently movable relative to cannula 15). Also note that instrument 190 preferably fits tightly with hollow instrument guide tube 200 to provide excellent instrument support at the distal end of cannula 15.

[0282] It will also be appreciated that, if desired, the two push tubes 30 may be replaced by a single push tube 30 or more than two push tubes 30, such as three push tubes 30. It will be appreciated that where multiple push tubes 30 are provided, it will generally be desirable to have the push tubes equally spaced circumferentially from one another, such as where two push tubes 30 are provided, it will generally be desirable to have the two push tubes 30 spaced 180 degrees apart, where three push tubes 30 are provided, it will generally be desirable to have the push tubes spaced 120 degrees apart, and so forth.

[0283] application

[0284] It will thus be seen that the present invention includes the provision and use of novel devices for manipulating the sidewalls of a body lumen and / or body cavity to better present the sidewall tissue (including visualization of areas initially hidden from or out of view) for inspection and / or treatment during endoscopic procedures, such as straightening bends, "ironing out" folds in the inner luminal surface and creating a substantially static or stable sidewall of a body lumen and / or body cavity, thereby enabling more accurate visual inspection (including visualization of areas initially hidden from or out of view) and / or therapeutic intervention. By way of example and not limitation, the novel devices may be used to stabilize, straighten, expand and / or flatten bends and / or curves and / or folds in the sidewall of the intestine to better present the sidewall tissue (including visualization of areas initially hidden from or out of view) for inspection and / or treatment during endoscopic procedures.

[0285] The present invention also includes providing and using the following novel device, which is capable of stabilizing and / or stabilizing the distal tip and / or working end of instruments (e.g., endoscopes, articulated and / or non-articulated devices such as graspers, cutters or dissectors, cautery tools, ultrasound probes, etc.) inserted into body lumens and / or body cavities relative to the side walls of body lumens and / or body cavities during endoscopic surgery, thereby facilitating the precise use of those instruments.

[0286] By way of example but not limitation, the present device can provide a stable platform (i.e., a stable endoscope, stable therapeutic tools, and a stable colon wall, all stable relative to each other) for performing numerous minimally invasive procedures within a body lumen and / or body cavity, including stabilizing an endoscope and / or other surgical instruments (e.g., graspers, cutters or dissectors, cautery tools, ultrasound probes, etc.) within a body lumen and / or body cavity, such as during 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 deformation of the colon wall) to enable more precise visualization, intervention, and / or surgical procedures.

[0287] Notably, the present invention provides a novel device capable of stabilizing and / or stabilizing the distal tip and / or working end of an endoscope relative to the side walls of a body lumen and / or body cavity (and thereby also stabilizing and / or stabilizing the distal tips and / or working ends of other instruments inserted through the working channels of those endoscopes (such as graspers, cutters or dissectors, cauterization tools, ultrasound probes, etc.)) and stabilizing the side walls of a body lumen and / or body cavity relative to these instruments.

[0288] Furthermore, the present invention provides novel devices that are capable of securing and / or stabilizing the distal tip and / or working end of instruments (such as graspers, cutters or dissectors, cautery tools, ultrasound probes, etc.) that are advanced to a surgical site by means other than through a working channel of an endoscope.

[0289] The novel devices of the present invention can be used in essentially any endoscopic procedure to facilitate alignment and presentation of tissue during an endoscopic procedure and / or to stabilize the working end of an endoscope (and / or other instruments advanced through the endoscope) relative to tissue or to assist in advancement of an endoscope during such a procedure.

[0290] The present invention is believed to have the broadest application in the gastrointestinal (GI) tract (e.g., large and small intestines, esophagus, stomach, etc.), which is generally characterized by frequent turns and has side walls characterized by numerous folds and disease processes located on and between these folds. However, the methods and devices of the present invention may also be used inside other body lumens (e.g., blood vessels, lymphatic vessels, urinary tract, fallopian tubes, bronchi, bile ducts, etc.) and / or inside other body cavities (e.g., head, chest, abdomen, sinuses, bladder, cavities within organs, etc.).

[0291] Novel systems and methods for visualizing bile ducts

[0292] According to the present invention, and now looking at Figure 37-Figure 48 , showing a novel system 500 for treating diseases and / or infections of the biliary system, and in particular for visualizing the bile ducts.

[0293] More particularly, in some cases (e.g., cancer, gallstones, inflammation, etc.), the bile duct may become blocked and cause disease or death. It is often desired to visualize the bile duct to determine whether there is blockage in the bile duct. Visualization is usually completed using fluoroscopy, however, the 2-D image from the fluoroscope provides a limited view of the bile duct. In 1978, physicians began to use a surgery called direct oral choledochoscopy (D-POCS) to visualize the bile duct directly using an endoscope. By D-POCS, the physician inserts the endoscope into the patient's mouth, moves the endoscope down along the esophagus, through the stomach and into the duodenum. Once the endoscope is in the duodenum, the distal endoscope is "turned" (i.e., angled away from the longitudinal axis of the endoscope) toward the bile duct to visualize the bile duct directly. However, when entering the bile duct from the stomach side of the duodenum, the turn from the duodenum to the bile duct is a sharp turn (i.e., about 140 degrees), which is difficult to achieve with conventional endoscopes. Thus, the present invention provides a novel system 500 for deflecting an endoscope positioned in the duodenum into the bile duct for visualization of the bile duct.

[0294] The system 500 generally includes the apparatus 5 (as previously discussed above), the endoscope 10 (as previously discussed above), and an endoscope deflection device 505 which will be discussed in further detail below.

[0295] More specifically, if Fig.38 As shown in , the device 5 generally includes: a sleeve 15 having a proximal end 16, a distal end 17, and a tubular cavity 18 extending between the proximal end and the distal end; a rear balloon 20, which is fixed to the sleeve near the distal end of the sleeve 15; and a base 25, which is fixed to the sleeve at the proximal end of the sleeve 15.

[0296] In a preferred embodiment of the present invention, the device 5 also includes: a pair of hollow push tubes 30, which are slidably mounted to the sleeve 1; and a front balloon 35, which is fixed to the distal end of the hollow push tube 30, so that the user can adjust the spacing between the rear balloon 20 and the front balloon 35 by moving the hollow push tube 30 relative to the sleeve 15 (for example, by simultaneously advancing or retracting the two hollow push tubes at the push tube handle 37). As discussed above, the rear balloon 20 and the front balloon 35 can be inflated to create a sealed treatment area between the inflated rear balloon and the inflated front balloon. However, if desired, if the procedure does not require the creation of a sealed treatment area between the inflated rear balloon and the inflated front balloon (for example, if only one end of a body lumen or body cavity needs to be sealed), the hollow push tube 30 and / or the front balloon 35 can be omitted from the device 5. In configurations where the hollow push tube 20 and / or the anterior balloon 35 are omitted from the cannula 15, the distal end of the cannula 15 will need to be formed with an atraumatic tip to ensure that the distal end of the cannula 15 does not damage tissue when being manipulated through the patient's anatomy.

[0297] In one preferred form of the invention, at least one of the posterior balloon 20 and the anterior balloon 35 includes at least one radiopaque marker (not shown) located on at least one of the proximal and distal ends of the posterior balloon 20 and the anterior balloon 35. Preferably, both the proximal and distal ends of the posterior balloon 20 and the anterior balloon 35 include radiopaque markers. Due to this configuration, a user is able to visualize the location of the proximal and distal ends of the posterior balloon 20 and the anterior balloon 35 within the patient's anatomy during a surgical procedure (e.g., via fluoroscopy or other imaging means).

[0298] The device 5 also includes an associated inflation mechanism 40 for achieving selective inflation / deflation of the rear balloon 20. In addition, the device 5 includes an associated inflation device ( Figure 37-Figure 48 not shown).

[0299] If desired, the device 5 may also include one or more instrument lumens 195 ( Fig.36 The instrument lumen 195 may be disposed outside the lumen 18 of the cannula 15 or within the lumen 18 of the cannula 15 .

[0300] like Fig.39 As shown in FIG, endoscope 10 includes a shaft 11 having a proximal end 12 and a distal end 13. A handle 14 is provided at the proximal end of endoscope 10. The distal end of endoscope 10 is configured to visualize the interior of a body lumen or body cavity when the distal end of the endoscope is positioned in the body lumen or body cavity.

[0301] View Now Figure 40-Figure 48 , the endoscope deflection device 505 includes a proximal portion 510, a distal portion 515, and a hollow shaft 520 extending between the proximal and distal portions. The distal portion 515 includes an adjustable ramp 522, and the proximal portion 510 includes an actuator (i.e., a handle 555, a rod 560, and a cable 550) for pivoting the adjustable ramp 522 between a first position and a second position, as will be discussed in further detail below.

[0302] The hollow shaft 520 of the endoscope deflection device 505 is configured to be slidably received within the lumen 18 of the cannula 15 of the apparatus 5, wherein the distal end portion 515 of the hollow shaft 520 is configured to be selectively disposed within and protrude from the distal end portion of the cannula 15. The lumen 524 of the hollow shaft 520 is sized to receive the endoscope 10, wherein the endoscope 10 is configured to be slidably received within the handle 555 and the lumen 524 of the hollow shaft 520, such that the distal end portion of the endoscope 10 can be selectively disposed within and protrude from the distal end portion of the hollow shaft 520.

[0303] If desired, the inner diameter of the lumen 18 of the cannula 15 can be sized to be larger than the outer diameter of the hollow shaft 520, such that when the hollow shaft 520 is disposed within the lumen 18 of the cannula 15, a gap exists between the inner wall of the lumen 18 of the cannula 15 and the exterior of the hollow shaft 520. Additionally, if desired, the inner diameter of the lumen 524 of the hollow shaft 520 can be sized to be larger than the outer diameter of the endoscope 10, such that when the endoscope 10 is disposed within the lumen 524 of the hollow shaft 520, a gap exists between the inner wall of the lumen 524 of the hollow shaft 520 and the exterior of the endoscope 10. As will be discussed in further detail below, the gap between the inner wall of the lumen 18 of the cannula 15 and the exterior of the hollow shaft 520 and / or the gap between the inner wall of the lumen 524 of the hollow shaft 520 and the exterior of the endoscope 10 can be used to pass one or more instruments (e.g., graspers) into a surgical site.

[0304] In a preferred form of the invention, the hollow shaft 520 of the endoscope deflection device 505 includes a flexible coil 525 embedded in the side wall of the hollow shaft 520. The flexible coil 525 enables the hollow shaft 520 to be sufficiently flexible to be maneuvered within the anatomical structure during use, while also providing the hollow shaft 520 with sufficient structural integrity to support the endoscope 10 when the endoscope 10 is disposed within the lumen 524 of the hollow shaft 520.

[0305] It should be appreciated that, if desired, the hollow shaft 520 may include regularly spaced visual markings (not shown), such as in the manner of a ruler, so that a user can visualize how far the distal end 515 of the hollow shaft 520 extends out of the lumen 18 of the cannula 15 of the device 5. To this end, the visual markings are preferably disposed on the proximal end of the hollow shaft 520 (i.e., so as to be visible to a user outside the patient's anatomy). Alternatively and / or additionally, the regularly spaced visual markings may be disposed on the distal end of the hollow shaft 520 (i.e., so as to be visible to an endoscope disposed within the lumen 524 of the hollow shaft 520).

[0306] Preferably, the inner sleeve 530 ( Fig.48 ) extends within the lumen 524 of the hollow shaft 520 for receiving the endoscope 10. The inner sleeve 530 provides a smooth surface within the lumen 524 to reduce friction between the outer surface of the endoscope 10 and the inner wall of the lumen 524 when the endoscope 10 moves within the lumen 524 of the hollow shaft 520.

[0307] To maneuver the hollow shaft 520 through the anatomical structure, when the distal end of the hollow shaft 520 is disposed distal to the distal end of the cannula 15, the distal end of the hollow shaft 520 may be bendable and / or steerable relative to the distal end of the cannula 15. In one form of the invention, the distal end of the hollow shaft 520 may be bent or steered by the endoscope 10 when the endoscope is positioned within the hollow shaft 520. In another form of the invention, the distal end of the hollow shaft 520 may be bent or steered by a cable (not shown) secured to the distal end of the hollow shaft 520.

[0308] In addition, it should also be understood that by selectively rotating the hollow shaft 520 (e.g., by rotating the handle 555 to effect rotation of the hollow shaft 520), the hollow shaft 520 can be selectively rotated relative to the lumen 18 of the cannula 15 of the device 5. If desired, visual markings (not shown) can be provided on the outer surface of the hollow shaft 520 to thereby provide a visual indication of the rotational position of the hollow shaft 520 (and therefore the endoscope 10) relative to the cannula 15 of the device 5.

[0309] As will be discussed in further detail below, the adjustable ramp 522 of the hollow shaft 520 is configured to extend along the longitudinal axis of the hollow shaft 520 in a first position ( Fig.44 ) and a second position ( Fig.45 ), such that when the endoscope 10 is disposed within the lumen 524 of the hollow shaft 520 and the distal end of the endoscope 10 is disposed adjacent to the adjustable ramp 522, moving the adjustable ramp 522 from its first position to its second position will cause the distal end of the endoscope 10 to move away from the longitudinal axis of the hollow shaft 520. In this manner, the distal end 515 of the hollow shaft 520 can be used to bend or turn the distal end of the endoscope 10 when the endoscope 10 is disposed within the lumen 524 of the hollow shaft 520.

[0310] More specifically, the adjustable ramp 522 includes a pivotable portion 535 and a fixed portion 540. The pivotable portion 535 is connected to the fixed portion 540 via a hinge joint 545. A cable 550 connects the pivotable portion 535 to the handle 555 such that when the handle's lever 560 is pulled proximally, the cable 550 will move proximally, thereby lifting the pivotable portion 535 upward.

[0311] It should be understood that the second position (i.e., the raised position) of the adjustable ramp 522 can be changed as needed in order to adjust the angle of the adjustable ramp 522 relative to the longitudinal axis of the hollow shaft 520 (and thereby change the deflection angle of the distal end of the endoscope 10 when the endoscope 10 is disposed within the lumen 524 of the hollow shaft 520).

[0312] To this end, the handle 555 preferably also includes a locking ratchet mechanism 556 ( Fig.47A ), the locking ratchet mechanism is used to selectively lock the lever 560 (and thus the cable 550) in a desired position (i.e., locked in a position that achieves a desired deflection angle of the distal end of the endoscope). Due to this configuration, the lever 560 can be pulled proximally to move the cable 550 proximally, thereby lifting the pivotable portion 535 to a desired extent, and thereafter the locking ratchet mechanism 556 can be used to selectively lock the lever 560 from movement so that the desired position of the pivotable portion 535 can be maintained. Subsequently, the lever 560 can be released from the locking ratchet mechanism 556, and the lever 560 and the cable 550 can be moved distally to return the pivotable portion 535 to its first position.

[0313] In a preferred embodiment, the hollow shaft 520 includes a guide tube 565 for receiving the cable 550. The guide tube 565 extends along the length of the hollow shaft 520 from the handle 555 to the fixing portion 540 at the distal end of the hollow shaft 520 and opens at a hole 570 formed in the fixing portion 540 ( Fig.43 ) so that the cable 550 can pass through the guide tube 565 as it extends from the handle 555 to the fixed portion 540.

[0314] In a preferred method of use, system 500 may be used to visualize a body lumen or body organ within the body, wherein hollow shaft 520 is used to steer an endoscope within the body.

[0315] More specifically, in a preferred method of use, the endoscope 10 is inserted into the lumen 524 of the hollow shaft 520, and then the hollow shaft 520 (carrying the endoscope 10) is inserted into the lumen of the cannula 15 of the device 5 ( Fig.48 ). The apparatus 5, endoscope 10 and endoscope deflection device 505 are then inserted as a unit into a body lumen or body organ of a patient, and the hollow shaft 520 can be used to steer the distal end of the endoscope 10 within the body.

[0316] By way of example and not limitation, and now looking at Figure 49-Figure 53 , the device 5, the endoscope 10 and the hollow shaft 520 can be used to access and / or visualize the bile duct of a patient, wherein the hollow shaft 520 is used to deflect the endoscope from the duodenum into the bile duct.

[0317] More specifically, the apparatus 5 (with the rear balloon 20 and the front balloon 35 deflated), the endoscope 10, and the hollow shaft 520 of the endoscope deflection device 505 are advanced as a unit through the patient's upper gastrointestinal tract (i.e., down the esophagus, through the stomach, and into the duodenum) until the front balloon 35 is disposed distally of the bile duct and the rear balloon 20 is disposed proximally of the bile duct. Next, the rear balloon 20 and the front balloon 35 are inflated so as to seal the rear balloon 20 and the front balloon 35 to the gastrointestinal tract, thereby providing stability to the endoscope 10 and the hollow shaft 520 within the gastrointestinal tract ( Fig.50 ).

[0318] At this point, the inflated front balloon 35 has been sealed to the gastrointestinal tract distal to the bile duct, wherein the inflated front balloon 35 creates a substantially full-diameter seal across the gastrointestinal tract, and the rear balloon 20 has been sealed to the gastrointestinal tract proximal to the bile duct, wherein the inflated rear balloon 20 acts together with the cannula 15 and endoscope 10 to create another substantially full-diameter barrier across the gastrointestinal tract, thereby providing isolated treatment areas distal and proximal to the bile duct.

[0319] View Now Figure 51-Figure 53 , the hollow shaft 520 (carrying the endoscope 10 therein) can be pushed out of the distal end of the cannula 15 and turned toward the bile duct. The trigger 560 can then be pulled back to cause the pivotable portion 535 to move upward to the desired angle, thereby causing the distal end of the endoscope 10 to move upward within the duodenum and into the bile duct. The endoscope 10 can then be used to visualize the interior of the bile duct ( Fig.53 ).

[0320] If necessary, the instrument can be advanced through the endoscope, through the gap between the inner wall of the lumen 18 of the cannula 15 and the outside of the hollow shaft 520, through the gap between the inner wall of the lumen 524 of the hollow shaft 520 and the outside of the endoscope 10, and / or through the instrument lumen 195 provided on the device 5 to perform surgery within the bile duct.

[0321] At the end of the procedure, the device 5, endoscope 10, and hollow shaft 520 of the endoscope deflection device 505 are withdrawn from the anatomical structure. Preferably, this is accomplished by returning the endoscope 10 and adjustable ramp 522 of the hollow shaft 520 to a straight configuration, deflation of the front balloon 35 and rear balloon 20, and then withdrawing the device 5, endoscope 10, and hollow shaft 520 from the anatomical structure as a unit.

[0322] In some cases, it may be desirable to reduce the outer diameter of the device 5, particularly when the device 5 is to be manipulated through the upper gastrointestinal tract of a patient. In such cases, and when it is not necessary to create a sealed treatment zone between the inflated rear balloon and the inflated front balloon, the hollow push tube 30 and / or the front balloon 35 may be removed from the device 5.

[0323] By way of example and not limitation, and now looking at Figure 54-Figure 58 , the device 5 without the hollow push tube 30 and / or the front balloon 35 can be used with the endoscope 10 to access and / or visualize the bile duct of a patient, wherein the hollow shaft 520 is used to deflect the endoscope from the duodenum into the bile duct.

[0324] More specifically, the apparatus 5 (without the push tube 30 and / or the front balloon 35), the endoscope 10, and the hollow shaft 520 of the endoscope deflection device 505 are advanced as a unit (with the rear balloon 20 deflated) through the patient's upper gastrointestinal tract (i.e., down the esophagus, through the stomach, and into the duodenum) until the rear balloon 20 is disposed proximal to the bile duct ( Fig.54 ).

[0325] The rear balloon 20 is then inflated to seal the rear balloon 20 to the gastrointestinal tract proximal to the bile duct ( Fig.55 ), thereby providing stability to the sleeve 15 (and thus the endoscope 10). If necessary, the inflated rear balloon 20 can be pulled proximally to enhance the seal of the rear balloon 20 to the gastrointestinal tract.

[0326] At this point, the inflated rear balloon 20 acts in conjunction with the cannula 15 and endoscope 10 to stabilize the cannula 15 (and therefore the endoscope 10) within the gastrointestinal tract and create a substantially full-diameter barrier across the gastrointestinal tract, thereby preventing fluid or debris (e.g., saline, blood, blood clots, etc.) from flowing "upstream" into the stomach and / or esophagus (i.e., reflux).

[0327] View Now Figure 56-Figure 58 , the hollow shaft 520 (carrying the endoscope 10 inside) can be pushed out of the distal end of the cannula 15 and turned toward the bile duct. The trigger 560 can then be pulled back to cause the pivotable portion 535 to move upward to the desired angle, thereby causing the distal end of the endoscope 10 to move upward within the duodenum and into the bile duct. The endoscope 10 can then be used to visualize the interior of the bile duct.

[0328] If necessary, the instrument can be advanced through the endoscope, through the gap between the inner wall of the lumen 18 of the cannula 15 and the outside of the hollow shaft 520, through the gap between the inner wall of the lumen 524 of the hollow shaft 520 and the outside of the endoscope 10, and / or through the instrument lumen 195 provided on the device 5 to perform surgery within the bile duct.

[0329] At the end of the procedure, the apparatus 5, the endoscope 10, and the hollow shaft 520 of the endoscope deflection device 505 are withdrawn from the anatomical structure. Preferably, this is accomplished by returning the endoscope 10 and the adjustable ramp 522 of the hollow shaft 520 to a straight configuration, deflated the rear balloon 20, and then withdrawing the apparatus 5, the endoscope 10, and the hollow shaft 520 of the endoscope deflection device 505 from the anatomical structure as a unit.

[0330] Alternative systems and methods for visualizing the bile duct

[0331] According to the present invention, and now looking at Figure 59-Figure 111 , a novel system 500A and method of use thereof are shown, which can be used to treat upper gastrointestinal tract diseases and / or infections, and / or to visualize the bile ducts of the biliary system.

[0332] The system 500A generally includes a novel apparatus 5A for securing the system 500A in an anatomical structure, an endoscope 10 (as previously discussed above), and a novel endoscope deflection device 505A for selectively pivoting the distal end of the endoscope, as will be discussed in further detail below.

[0333] Device 5A is generally similar to device 5 discussed above, except that push tube 30 and front balloon 35 have been omitted from device 5A.

[0334] More specifically, and now looking at Figure 59-Figure 79 , the device 5A generally includes a cannula 15A having a proximal end 16A, a distal end 17A, and a lumen 18A extending therebetween ( Fig.63 ).

[0335] In a preferred form of the invention, the rear balloon 20A is secured to the cannula 15A near the distal end 17A of the cannula 15A. The rear balloon 20A may be formed in the same shape as the rear balloon 20 described above (i.e., a generally annular shape), or in the same shape as the front balloon 35 described above (i.e., a "torus" shape when deflated to allow it to rest over the distal end of a cannula / endoscope, and a substantially "solid" shape when inflated to allow it to close a body lumen or body cavity), or in any other shape that will permit the rear balloon 20A to atraumatically engage and form a sealing relationship with the sidewall of a body lumen or body cavity in which the device 5A is disposed.

[0336] The base 25A is secured to the cannula 15A at the proximal end 16A of the cannula 15A. The base 25A includes a central passage 26A having a proximal opening 27A that is in fluid communication with the lumen 18A of the cannula 15A when the cannula 15A is mounted to the base 25A. In a preferred form of the invention, the endoscope seal 615 fluidly seals the passage 26A when the endoscope 10 is not disposed within the passage 26A and the lumen 18A of the cannula 15A and / or seals around the outer surface of the endoscope 10 when the endoscope 10 is disposed within the passage 26A and the lumen 18A.

[0337] The inflation / deflation line 45A extends between the inflation mechanism 40A and the rear balloon 20A for selectively inflating / defl ing the rear balloon 20A, as will be discussed in further detail below. In a preferred form of the invention, the inflation / deflation line 45A is mounted to the outer surface of the cannula 15A ( Fig.63 ) so as to extend alongside the cannula 15A (and therefore alongside the endoscope disposed within the cannula 15A).

[0338] If desired, the cannula 15A may further include one or more instrument lumens 195 for slidably receiving an instrument therein. The instrument lumens 195 may be disposed external to the lumen 18A of the cannula 15A or within the lumen 18A of the cannula 15A.

[0339] Preferably, the sleeve 15A is formed of a flexible material having suitable column strength to prevent the sleeve 15A from collapsing (e.g., kinking) on ​​the endoscope 10 and / or the endoscope deflection device 505A when the device 5A, the endoscope 10 and / or the endoscope deflection device 505A are positioned within or withdrawn from the patient's anatomy.

[0340] If desired, the proximal end 16A of the cannula 15A can be connected to the cannula attachment 610 ( Fig.62 as well as Figure 70-Figure 72 ) is fixed to the base 25A.

[0341] In a preferred form of the invention, the distal end 17A of the cannula 15A is formed with an atraumatic tip (e.g., nose cone 605, see Fig.61 and Fig.62 ), in order to ensure that the distal end 17A of the cannula 15A does not cause trauma to the anatomical structure (e.g., damage tissue) when the cannula 15A is manipulated through the patient's body lumen or body cavity. For this form of the invention, it is particularly important to form the distal end 17A of the cannula 15A with an atraumatic tip because the push rod 30 and the front balloon 35 are no longer provided at the distal end of the cannula 15A (and therefore, neither the push rod 30 nor the front balloon 35 can be used to provide an atraumatic distal end to the device 5A when the device 5A is moved through the anatomical structure).

[0342] As in Figure 59-Figure 62 as well as Figure 73-Figure 79 As can be seen in further detail, the base 25A is generally similar to the aforementioned base 25 discussed above in that it provides a "handle" for the user to grip, however, the push tube handle 37 has been omitted from the base 25A because it is no longer necessary to provide a mechanism for moving the omitted push tube 30 and front balloon 15 relative to the distal end of the sleeve.

[0343] The base 25A is configured to receive the endoscope 10 within the passageway 26A and to help secure the device 5A to the endoscope 10. To this end, the base 25A preferably comprises a substantially rigid or semi-rigid structure that can be gripped and pulled proximally by a physician (or other operator or user), thereby allowing the physician (or other operator or user) to insert the distal end of the endoscope 10 into the proximal opening 27A of the base 25A (penetrating / disengaging the seal 615) and pull the cannula 15A over the distal end of the endoscope 10 and then back proximally along the length of the endoscope 10, thereby mounting the cannula 15A to the outer surface of the shaft of the endoscope. In one preferred form of the invention, the base 25A is pulled proximally along the endoscope 10 until the base 25A seats against the handle of the endoscope, thereby inhibiting further proximal movement of the base 25A (and thus inhibiting further proximal movement of the cannula 15A).

[0344] If desired, the posterior balloon 20A may include at least one radiopaque marker (not shown) on at least one of the proximal and distal ends of the posterior balloon 20A. Preferably, both the proximal and distal ends of the posterior balloon 20A include radiopaque markers. Due to this configuration, the user is able to visualize the position of the proximal and distal ends of the posterior balloon 20A within the patient's anatomy during surgery (e.g., via fluoroscopy or other imaging means).

[0345] View Now Fig.59 as well as Figure 80-Figure 105, shows a novel endoscope deflection device 505A formed according to the present invention. The endoscope deflection device 505A includes a proximal portion 510A, a distal portion 515A, and a hollow shaft 520A defining a lumen 524A extending therebetween. Fig.80 The distal portion 515A includes an adjustable ramp 522A, and the proximal portion 510A includes an actuator (eg, a handle 555A, a lever 560A, and two cables 550A) for selectively pivoting the adjustable ramp 522A, as will be discussed in further detail below.

[0346] The endoscope deflection device 505A is substantially similar to the endoscope deflection device 505 discussed above, except that in the case of the endoscope deflection device 505A, (i) the hollow shaft 520A is formed from a single piece of flexible material having a plurality of slits formed along its length, (ii) the distal end of the hollow shaft 520A includes an adjustable ramp 522A that can be selectively pivoted at a plurality of pivot points, and (iii) two cables are connected to the adjustable ramp 522A for pivoting the adjustable ramp, as will be discussed in further detail below.

[0347] The hollow shaft 520A of the endoscope deflection device 505A comprises a single piece of flexible material having a plurality of slits 620 formed along the length of the hollow shaft. Fig.80 as well as Figure 82-Figure 84 The single piece of flexible material is selected so as to provide sufficient structural integrity to support the endoscope 10 (or a slightly smaller sized endoscope 10A, see below) when the endoscope 10 is disposed within the lumen 524A of the hollow shaft 520A, while the plurality of slits 620 provide the hollow shaft 520A with the flexibility required to maneuver the endoscope deflection device 505A within the anatomy (e.g., along the tortuous path of a body lumen) during use. In a preferred form of the invention, the flexible material selected to form the hollow shaft 520A comprises polytetrafluoroethylene (PTFE).

[0348] The endoscope deflection device 505A is sized to be received within the passage 26A of the base 25A and the lumen 18A of the cannula 15A. The lumen 524A of the hollow shaft 520A of the endoscope deflection device 505A is sized to receive the endoscope 10 (or a smaller sized endoscope 10A) therein. Due to this configuration, the endoscope 10 (or a smaller sized endoscope 10A) can be disposed within the lumen 524A of the hollow shaft 520A of the endoscope deflection device 505A, and then the cannula 15A can be mounted over the endoscope deflection device 505A (carrying the endoscope 10 or endoscope 10A) such that the distal end portion 515A of the hollow shaft 520A of the endoscope deflection device 505A and the distal end portion of the endoscope 10 (or a smaller sized endoscope 10A) extend distally beyond the distal end portion 17A of the cannula 15A. See Fig.91 .

[0349] It will be appreciated that, if desired, the hollow shaft 520A of the endoscope deflection device 505A may include regularly spaced visual markings (not shown), such as in the manner of a ruler, so that a user can visualize how far the distal end 515A of the hollow shaft 520A extends distally out of the lumen 18A of the cannula 15A of the device 5A. To this end, the visual markings are preferably disposed on the proximal end 510A of the hollow shaft 520A (i.e., so as to be visible to a user outside of the patient's anatomy). Alternatively and / or additionally, the regularly spaced visual markings may be disposed on the distal end 515A of the hollow shaft 520A (i.e., so as to be visible to an endoscope disposed within the lumen 524A of the hollow shaft 520A).

[0350] Furthermore, if desired, hollow shaft 520A may include visual markings (not shown) on an outer surface of hollow shaft 520A for providing a visual indication of the rotational disposition of hollow shaft 520A (and thus endoscope) relative to cannula 15A of device 5A.

[0351] View Now Fig.80 as well as Figure 90-94 , the adjustable ramp 522A of the hollow shaft 520A is configured to be in a first straightened position ( Fig.80 ) and an angled (or arced) position ( Figure 90-94), such that when the endoscope is disposed within the lumen 524A of the hollow shaft 520A and the distal end of the endoscope is disposed adjacent to the adjustable ramp 522A, moving the adjustable ramp 522A from its first position to its angled position will cause the distal end of the endoscope to move away from the longitudinal axis of the hollow shaft 520A, i.e., to "bend" the distal end of the endoscope relative to the longitudinal axis of the hollow shaft 520A. In this manner, the distal end 515A of the hollow shaft 520A can be used to bend or steer the distal end of the endoscope when the endoscope is disposed within the lumen 524A of the hollow shaft 520A.

[0352] More particularly, in one preferred form of the invention, the adjustable ramp 522A includes two grooves 625 forming a pivot point 630. Fig.83 and Fig.84 . However, it should be understood that if desired, the adjustable ramp 522A may include more than two grooves 625 to provide the desired pivotability to the adjustable ramp 522A. If desired, the adjustable ramp 522A may further include one or more radiopaque markers so that a physician (or other operator or user) observing the surgical site via an endoscope or by radiographic guidance (e.g., via X-ray fluoroscopy or other imaging means) can determine the relative placement of the adjustable ramp 522A at the surgical site relative to the sidewalls of the body lumen and / or other body cavity in both the longitudinal and / or circumferential directions.

[0353] The first and second cables 550A ( Fig.82 ) The distal end of the adjustable ramp 522A is connected to the handle 555A so that when the handle's rod 560A is pulled proximally, the first and second cables 550A will move proximally, thereby causing the adjustable ramp 522A to pivot at the pivot point 630 and lift the adjustable ramp 522A "upwardly" (i.e., pivot the ramp 522A relative to the longitudinal axis of the endoscope deflection device 505A). In a preferred form of the invention, the distal ends of the first and second cables pass through a hole 635 ( Fig.89 ). Preferably, one hole 635 is disposed on the left side of the adjustable ramp 522A and one hole 635 is disposed on the right side of the adjustable ramp 522A (e.g., such that the two holes 635 are diametrically opposite each other). By positioning one hole on the left side of the adjustable ramp 522A and one hole on the right side of the adjustable ramp 522A, the cable 550A will be disposed on the left and right sides of the endoscope (which is disposed within the hollow shaft 520A), and when the adjustable ramp 522A is moved upward, the endoscope extending out of the distal end of the hollow shaft 520A will remain aligned with the pivot point 630.

[0354] In a preferred form of the invention, the cables 550A are formed of stainless steel. If desired, one or both of the cables 550A may be provided with one or more radiopaque markers so that a physician (or other operator or user) viewing the surgical site via the endoscope 10 or by radiographic guidance (e.g., via X-ray fluoroscopy or other imaging means) can determine the relative placement of the cables 550A at the surgical site relative to the sidewalls of the body lumen and / or other body cavity, both longitudinally and / or circumferentially.

[0355] It should be understood that the angle of the adjustable ramp 522A can be changed as needed to adjust the angle of the adjustable ramp 522A relative to the longitudinal axis of the hollow shaft 520A (and thereby change the deflection angle of the distal end of the endoscope when the endoscope is set in the tubular cavity 524A of the hollow shaft 520A).

[0356] To this end, the handle 555A preferably also includes a locking ratchet mechanism 556A ( Figure 102-Figure 105 ), the locking ratchet mechanism is used to selectively lock the lever 560A (and thus the cable 550A) in a desired position (i.e., locked in a position that achieves a desired deflection angle of the distal end portion of the endoscope disposed within the lumen 524A of the endoscope deflection device 505A). More specifically, the locking ratchet mechanism 556A generally includes a gear 557A for selectively rotating the spindle 558A. The cable 550A is mounted to the spindle 558A of the ratchet mechanism 556A such that when one or more cables 550A are wound around the spindle 558A, rotation of the gear 557A in a first direction causes an increase in tension (i.e., a force directed proximally) in the one or more cables 550A, thereby enabling pivoting of the adjustable ramp 522A and maintaining the adjustable ramp 522A in a pivoted state until the locking ratchet mechanism 556A is unlocked, thereby allowing the gear to rotate in a second opposite direction so as to unwind the one or more cables 550A wound around the spindle 558A, thereby eliminating tension in the cable 550A. Due to this configuration, the lever 560A can be pulled proximally to move the cable 550A proximally, thereby pivoting the adjustable ramp 522A to a desired degree, and thereafter the locking ratchet mechanism 556A can be used to selectively lock the lever 560A from movement so that the desired position of the adjustable ramp 522A can be maintained. Subsequently, the lever 560A can be released from the locking ratchet mechanism 556A, and the lever 560A and cable 550A can be moved distally to return the adjustable ramp 522A to its first (i.e., straightened) position.

[0357] Use of the new device 5A for visualization of the bile duct

[0358] In a preferred method of use, the system 500A can be used to visualize a body lumen or body organ within the body, wherein the hollow shaft 520A of the endoscope deflection device 505A is used to steer the endoscope within the body.

[0359] By way of example and not limitation, and now looking at Figure 106-Figure 111 , the apparatus 5A can be used with the endoscope 10 to access and / or visualize the bile duct of a patient, wherein the hollow shaft 520A of the endoscope deflection device 505A is used to deflect the distal end of the endoscope 10 from the duodenum into the bile duct. To this end, it is important to note that when the apparatus 5A is used to deflect the endoscope into the bile duct, an endoscope sized to be received in the bile duct (e.g., an ultra-slim endoscope 10A) should be selected, as standard endoscopes are too large to be received in the bile duct. Thus, when the endoscope 10 is used with the apparatus 5A and / or accesses a body lumen or body cavity, the endoscope 10 refers to a standard endoscope as well as a smaller sized endoscope 10A (e.g., an endoscope having a smaller diameter than the endoscope 10), wherein the size of the endoscope is selected based on where in the anatomy the endoscope will be used to access and / or visualize a body lumen or body cavity, as will be apparent to one of ordinary skill in the art.

[0360] More particularly, endoscope 10 (e.g., a standard-sized endoscope) is inserted into device 5A ( Fig.106 ) (i.e., by passing the base 25A through the distal end of the endoscope 10 and pulling the base 25A / cannula 15A proximally), and advancing the device 5A and endoscope 10 as a unit (with the rear balloon 20A deflated) through the patient's upper gastrointestinal tract (i.e., down the esophagus, through the stomach and into the duodenum) until the rear balloon 20A is disposed proximal to the bile duct ( Fig.107 ).

[0361] The rear balloon 20A is then inflated to seal the rear balloon 20A to the gastrointestinal tract proximal to the bile duct ( Fig.108 ), thereby providing stability to the sleeve 15A (and thus the endoscope 10). If necessary, the inflated rear balloon 20A can be pulled proximally to enhance the seal of the rear balloon 20A to the gastrointestinal tract.

[0362] At this point, the inflated rear balloon 20A acts in conjunction with the cannula 15A and endoscope 10 to stabilize the cannula 15A (and therefore the endoscope 10) within the gastrointestinal tract and create a substantially full-diameter barrier across the gastrointestinal tract, thereby preventing fluid or debris (e.g., saline, blood, blood clots, etc.) from flowing "upstream" into the stomach and / or esophagus (i.e., reflux).

[0363] The endoscope 10 is then removed from the cannula 15A, thereby leaving the cannula 15A in place within the gastrointestinal tract. A second, smaller sized endoscope 10A is then inserted into the hollow shaft 520A of the endoscope deflection device 505A, such that the distal end of the endoscope 10A extends distally from the distal end 515A of the hollow shaft 520A of the endoscope deflection device 505A. The endoscope 10A and the hollow shaft 520A of the endoscope deflection device 505A are then inserted into the passage 26A of the base 25A and the lumen 18A of the cannula 15 (should be "15A") and advanced distally as a unit through the cannula 15A (i.e., down the esophagus, through the stomach and into the duodenum) until the endoscope 10A and the adjustable ramp 522 are disposed at the bile duct ( Fig.109 ).

[0364] View Now Figure 109-111 , the hollow shaft 520A (carrying the endoscope 10A inside) can be pushed out of the distal end of the sleeve 15A distally and turned toward the bile duct. Then, the trigger 560A can be pulled to tighten the cable 550A, thereby causing the adjustable ramp 522A to move upward to the desired angle, thereby causing the distal end of the endoscope 10A to move "upward" in the duodenum (i.e., bend relative to the longitudinal axis of the endoscope 10A) and enter the bile duct. The endoscope 10A can then be used to visualize the interior of the bile duct. The endoscope deflection device 505A can be adjusted as needed during visualization to further advance and guide the endoscope 10A into the bile duct. By way of example but not limitation, the hollow shaft 520A can be longitudinally advanced, retracted or rotated within the sleeve 15A, and / or the angle of the adjustable ramp 522A can be manipulated to adjust the angle of the distal end of the endoscope 10A as needed to advance and guide the endoscope 10A into the bile duct.

[0365] If necessary, the instrument can be advanced through an instrument channel disposed in the endoscope, through the gap between the inner wall of lumen 18A of sleeve 15A and the exterior of hollow shaft 520A and / or through the gap between the inner wall of lumen 524A of hollow shaft 520A and the exterior of endoscope 10A.

[0366] At the end of the procedure, the apparatus 5A, the endoscope 10A, and the hollow shaft 520A of the endoscope deflection device 505A are withdrawn from the anatomical structure. Preferably, this is accomplished by returning the endoscope 10A and the adjustable ramp 522A of the hollow shaft 520A to a straight configuration, deflated the rear balloon 20A, and then withdrawing the apparatus 5A, the endoscope 10A, and the hollow shaft 520A of the endoscope deflection device 505A from the anatomical structure as a unit.

[0367] Revise

[0368] While the present invention has been described in terms of certain exemplary preferred embodiments, those skilled in the art will readily appreciate and understand that the invention is not limited thereto and that many additions, deletions and modifications may be made to the preferred embodiments discussed above while remaining within the scope of the present invention.

Claims

1. A device for entering a body lumen or body cavity, the device comprising: A hollow shaft formed from a single piece of flexible material, the hollow shaft comprising a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, wherein the lumen of the hollow shaft is configured to receive an endoscope, and further wherein the distal end of the hollow shaft comprises an adjustable portion configured to articulate between: (i) a straight configuration, wherein the adjustable portion is parallel to a longitudinal axis of the hollow shaft; and (ii) an angled configuration, wherein the adjustable portion is disposed at an angle relative to the longitudinal axis of the hollow shaft, thereby bending an endoscope disposed within the lumen of the hollow shaft; a cannula having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, wherein the lumen of the cannula is configured to receive the hollow shaft and an endoscope disposed therein; and A balloon is mounted to the cannula.

2. The device according to claim 1, wherein: The proximal end of the hollow shaft includes an actuator for articulating the adjustable portion between the straight configuration and the angled configuration.

3. The device according to claim 2, wherein: The proximal end of the hollow shaft includes a handle, and further wherein the actuator includes two cables extending from the adjustable portion to the handle.

4. The device according to claim 3, wherein: Each of the two cables includes a proximal end portion mounted to the actuator, and a distal end portion mounted to the adjustable portion.

5. The device according to claim 3, wherein: The handle includes a locking mechanism for locking the adjustable portion at a desired angle.

6. The device according to claim 1, wherein: The distal end portion of the hollow shaft is configured to be longitudinally movable relative to the distal end portion of the cannula.

7. The device according to claim 6, wherein: The hollow shaft includes at least one visual marking for indicating how far the distal end of the hollow shaft extends beyond the distal end of the cannula.

8. The device according to claim 1, wherein: The lumen of the hollow shaft is sized to be larger than the outer diameter of the endoscope so that when the endoscope is disposed within the lumen of the hollow shaft, a gap exists between the inner wall of the lumen of the hollow shaft and the outer surface of the endoscope, the gap being large enough to allow instruments to pass therethrough.

9. The device according to claim 1, wherein: The lumen of the cannula is sized to be larger than the outer diameter of the hollow shaft so that when the hollow shaft is disposed within the lumen of the cannula, a gap exists between the inner wall of the lumen of the cannula and the outer surface of the hollow shaft, the gap being large enough to allow an instrument to pass therethrough.

10. The device according to claim 1, wherein: The hollow shaft includes a plurality of slits formed in the flexible material.

11. The device according to claim 1, wherein: The hollow shaft is configured to pivot relative to the distal end of the cannula.

12. The device according to claim 1, wherein: The hollow shaft is steerable relative to the distal end of the cannula.

13. The device according to claim 12, wherein: The hollow shaft is configured to be steerable by articulating an endoscope disposed within the lumen of the hollow shaft.

14. The apparatus according to claim 12, wherein: The hollow shaft is configured to be steered by moving two cables secured to the adjustable portion.

15. The apparatus according to claim 1, wherein: The balloon includes at least one radiopaque marker.

16. The apparatus according to claim 1, wherein: The adjustable portion includes a distal end portion, a proximal end portion, and a plurality of pivot points disposed therebetween.

17. A method for accessing a body lumen and / or body cavity of a patient, the method comprising: A device is provided, the device comprising: A hollow shaft formed from a single piece of flexible material, the hollow shaft comprising a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, wherein the lumen of the hollow shaft is configured to receive an endoscope, and further wherein the distal end of the hollow shaft comprises an adjustable portion configured to articulate between: (i) a straight configuration, wherein the adjustable portion is parallel to a longitudinal axis of the hollow shaft; and (ii) an angled configuration, wherein the adjustable portion is disposed at an angle relative to the longitudinal axis of the hollow shaft, thereby bending an endoscope disposed within the lumen of the hollow shaft; a cannula having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, wherein the lumen of the cannula is configured to receive the hollow shaft and an endoscope disposed therein; and a balloon mounted to the sleeve; inserting an endoscope into the lumen of the hollow shaft; inserting the hollow shaft and the endoscope into the lumen of the cannula; positioning the device in a body lumen and / or body cavity of a patient; advancing the hollow shaft and the endoscope beyond the distal end of the cannula; and The adjustable portion of the hollow shaft is moved to its angled configuration in order to bend the distal end of the endoscope to a desired angle.

18. The method according to claim 17, further comprising: Surgical procedures are performed in body lumens and / or body cavities of a patient.

19. The method according to claim 17, wherein: The body lumen is the gastrointestinal tract.

20. The method according to claim 17, wherein: The device is placed in the duodenum, and the distal end of the endoscope is bent to facilitate visualization of the bile duct using the endoscope.

21. A method for visualizing and / or accessing a bile duct of a patient, the method comprising: A device is provided, the device comprising: A hollow shaft formed from a single piece of flexible material, the hollow shaft comprising a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, wherein the lumen of the hollow shaft is configured to receive an endoscope, and further wherein the distal end of the hollow shaft comprises an adjustable portion configured to articulate between: (i) a straight configuration, wherein the adjustable portion is parallel to a longitudinal axis of the hollow shaft; and (ii) an angled configuration, wherein the adjustable portion is disposed at an angle relative to the longitudinal axis of the hollow shaft, thereby bending an endoscope disposed within the lumen of the hollow shaft; a cannula having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, wherein the lumen of the cannula is configured to receive the hollow shaft and an endoscope disposed therein; and a balloon mounted to the sleeve; inserting a first endoscope into the lumen of the cannula; advancing the device through the patient's upper gastrointestinal tract until the device is positioned adjacent the bile duct; inflating the balloon to fluidly seal the balloon to the gastrointestinal tract proximal to the bile duct; removing the first endoscope from the lumen of the cannula while maintaining the cannula disposed in the anatomical structure; inserting a second endoscope into the lumen of the hollow shaft; inserting the hollow shaft and the second endoscope into the lumen of the cannula; advancing the hollow shaft and the second endoscope beyond the distal end of the cannula; and The adjustable portion of the hollow shaft is moved to its angled configuration to bend a portion of the second endoscope to an angle for accessing and / or visualizing the bile duct.

22. The method according to claim 22, wherein: The second endoscope is smaller than the first endoscope.

23. The apparatus of claim 1, wherein: The cannula further includes at least one instrument lumen.

24. The apparatus of claim 1, wherein: The distal portion of the cannula includes an atraumatic tip.

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