System for minimally invasive gastrointestinal surgery

Abstract

A system for performing minimally invasive surgery in a working space located inside a body cavity of a patient includes a flexible catheter configured to receive a working instrument therethrough. The flexible catheter has a working space expansion system at a distal portion including a first flexible element and a second flexible element movable from a non-expanded insertion position to an expanded position to form an expanded region for expanding the working space inside the body. The first and second flexible elements are connected at a distal region with a coupling structure. A stabilizing member stabilizes the distal portion of the flexible catheter.

Description

[0001] (Case number 201780055738.X)

[0002] Cross-reference to related applications

[0003] This application claims priority to patent application serial number 15 / 261,930, filed on September 10, 2016, which is a continuation-in-part of patent application serial number 14 / 622,831, filed on February 14, 2015; which is a continuation-in-part of patent application serial number 13 / 913,466, filed on June 9, 2013, now patent number 9,186,131; which is a continuation-in-part of patent application serial number 12 / 970,604, filed on December 16, 2010, now patent number 8,506,479; which claims priority to provisional patent application serial number 61 / 287,077, filed on December 16, 2009; and is a continuation-in-part of patent application serial number 13 / 531,477, filed on June 22, 2012, now patent number 8,932,211. The full contents of each of these patent applications are incorporated herein by reference. Technical Field

[0004] This application relates to endoscopic systems and methods for expanding body cavities and for treating tissues within body cavities. Background Technology

[0005] Endoscopic procedures related to the gastrointestinal system offer advantages over conventional surgeries because they are less invasive and provide visualization.

[0006] One current problem includes the lack of techniques for optimized minimally invasive expansion of a stable working space adjacent to a target tissue that may collapse near the target lesion or defect during surgical treatment. The ability to effectively expand and optimally reconstruct or reshape the working space could significantly simplify endovascular procedures. A better-expanded, stable, and optimally constructed working space allows for independent manipulation of instruments and endoscopes and appropriate visualization near the target tissue.

[0007] Another current problem includes the lack of endoscopic techniques for not only expanding both the target and surrounding tissues but also fixing and reshaping them. For example, such a stable surgical space in the intestine can include a non-closable or minimally closable space with limited or no peristalsis and / or fixed to a specific point in the abdominal cavity. This fixed point can be considered fixed to, for example, a fixed body point in the patient (e.g., the patient's hip). Prominent bowel movement during endovascular surgery on the intestine is considered highly undesirable because, for example, it promotes a complex and unstable surgical environment. Of course, such bowel movement is normal, even in anesthetized patients, and can result, for example, from bowel collapse due to gas leakage, peristalsis, respiration, and movement of the endoscope and instruments. Techniques that address this problem would help provide a stable surgical space, which is clinically necessary in the surgical setting.

[0008] Another current problem includes the lack of endoscopic techniques for dynamically tractioning tissue (e.g., using adjustable tissue traction structures) that allow control over the degree of expansion or contraction of the structure to further position the workspace near instruments and target tissue as needed. This control can effectively provide methods for adjusting the traction device and placing tissue in and around the workspace. For example, during surgery, the amount of tissue placed in the workspace can be better measured and controlled by increasing and releasing tension on the traction device. Furthermore, it can facilitate tissue traction, especially traction counter-traction, thereby helping to create an ideal anatomical plane or better tissue positioning during the procedure. Techniques addressing this problem would contribute to creating a more ideal surgical environment for tissue anatomy and the traction, cutting, and removal of tissue.

[0009] Another current problem includes a lack of endoscopic techniques for maximizing the workspace available for treatment by arranging endoscopes, instruments, and the workspace itself. A larger workspace enhances the ability to manipulate instruments and endoscopes minimally invasively from outside the body. That is, a workspace skilled in the art would include an instrument entry point as far away from the target tissue as possible to provide additional flexibility in approaching and visualizing the target tissue, and perhaps more maneuvering space for selecting the trajectory of the instrument toward the target tissue, i.e., at least substantially perpendicular to the anatomical plane of the target tissue. Techniques addressing this problem would provide those skilled in the art with a more desirable system and procedure for tissue clearance.

[0010] In light of at least the above, those skilled in the art of endoscopic and gastrointestinal surgery will understand the techniques taught herein, which provide one or more of the following: (i) minimally invasive expansion of the endoscopic workspace; (ii) fixation of both the target tissue and surrounding tissues, particularly including fixation with or without stretching during reconstruction, thereby contributing to a stable surgical space; (iii) dynamic traction of tissue, allowing for partial or complete expansion or retraction to further establish the workspace between the instruments and the target tissue; and (iv) arrangement of endoscopic instruments (such as retractors and blades) to maximize workspace and maneuverability, thereby allowing for maximum flexibility in access to and visualization of the target tissue. It should be understood that such improvements will reduce the technical complexity of complex endoscopic procedures and improve efficacy and safety. Furthermore, performing this at low cost using a non-invasively introduced, affordable system within the body and without significantly hindering routine colonoscopy workflows will be considered by those skilled in the art a very significant advancement in the field of endoscopic surgery.

[0011] In endoscopic surgery, sufficient flexibility is necessary for the catheter to travel non-invasively through the anatomical structures to the target site. However, sufficient stability is also necessary to limit the buckling of the catheter in the distal region of the target site, where an expansion working space is formed. It is advantageous to provide a catheter that achieves an effective balance between these conflicting objectives. Summary of the Invention

[0012] The teachings provided herein generally relate to improved methods and apparatus for minimally invasively treating gastrointestinal diseases using endoscopy in a stable but dynamic surgical environment. The system includes, for example, an endoscopic surgical kit. This kit may have a reversibly expandable retractor that expands to provide a stable surgical environment within the body. This expansion may be asymmetrical near the stabilizer subsystem to maximize space for use with the blades (endoscopes in some embodiments), allowing for independent manipulation of each blade (endoscope) to visualize the target tissue and treat the target tissue minimally invasively from outside the patient. Among other improvements, the embodiments disclosed herein provide an increased distance between the blade port and the target tissue, thereby improving blade maneuverability and triangulation of the target tissue, as well as a larger field of view.

[0013] In some embodiments, floating channels are provided to increase the flexibility of the system compared to the use of fixed channels. The floating channels receive flexible instrument guides that provide passage for the working instruments. Alternatively, the working instruments can be inserted directly into the floating channels.

[0014] According to one aspect of the invention, a system is provided for performing minimally invasive surgery in a workspace within a patient's body cavity. The system includes a flexible catheter configured to receive a working instrument therethrough, the flexible catheter having a proximal portion, a distal portion, and a workspace expansion system located in the distal portion. The workspace expansion system includes a first flexible element and a second flexible element, both movable from a non-expanded insertion position to an expanded position to form an expansion region for expanding the workspace within the body. The first and second flexible elements are connected to a connecting structure in the distal region. An expandable stabilizing member is axially movable relative to the connecting structure to stabilize the distal portion of the flexible catheter.

[0015] In some embodiments, a cover is situated on top of a first flexible element and a second flexible element, the cover having an opening for receiving body tissue.

[0016] In some embodiments, the stabilizing member may be moved from a first position further away from the connecting structure to a second position closer to the connecting structure. In some embodiments, in the second position, the stabilizing member is positioned above the connecting structure; in other embodiments, in the second position, the stabilizing member is positioned adjacent to the distal end of the connecting structure.

[0017] In some embodiments, the stabilizing member is an inflatable balloon, and in some embodiments may have an annular shape to form a gap for receiving the connecting structure within the gap. In other embodiments, the stabilizing member includes a mesh structure. In other embodiments, the stabilizing member includes a vascular stent-like structure.

[0018] In some embodiments, the stabilizing member is connected to a second conduit that extends through a lumen in a flexible conduit.

[0019] The system may also include one or more flexible guides slidably located within the flexible catheter, wherein the distal portion of the flexible guide is movable to an oblique position within the dilation zone and the flexible guide is configured and sized to receive endoscopic working instruments therethrough.

[0020] In some embodiments, the bridging member extends laterally between the first flexible element and the second flexible element to improve stability.

[0021] According to another aspect of the invention, a system is provided for performing minimally invasive surgery in a workspace located within a patient's body cavity; the system includes a flexible catheter configured to receive a working instrument therethrough, the flexible catheter having a proximal portion, a distal portion, and a workspace expansion system located in the distal portion. The workspace expansion system includes a first flexible element and a second flexible element, which are movable from a non-expanded insertion position to an expanded position to form an expansion region for expanding the workspace within the body. The first and second flexible elements are connected to a coupling structure in the distal region. An expandable stabilizing member is located on the coupling structure and is movable from the non-expanded position to the expanded position to stabilize the distal portion of the flexible catheter.

[0022] In some embodiments, the stabilizing member includes a mesh structure. In other embodiments, the stabilizing member includes a vascular stent-like structure. In other embodiments, the stabilizing member includes an inflatable balloon.

[0023] In some embodiments, the stabilizing member is connected to a second conduit that extends through a lumen in a flexible conduit.

[0024] According to another aspect of the invention, a system is provided for performing minimally invasive surgery in a workspace within a patient's body cavity; the system includes a flexible catheter configured to receive a working instrument therethrough, the flexible catheter having a proximal portion, a distal portion, and a workspace expansion system located on the distal portion. The workspace expansion system includes a first flexible element and a second flexible element movable from a non-expanded insertion position to an expanded position to form an expansion zone for expanding the workspace within the body. An expandable stabilizing member is located on the distal portion of the flexible catheter. The first and second flexible elements are connected to the stabilizing member, wherein the stabilizing member is expandable to expand from a small-profile insertion position to an expanded position to stabilize the distal portion of the flexible catheter.

[0025] In some embodiments, the stabilizing member is an inflatable balloon. The stabilizing member may be axially fixed near the coupling structure and may be inflatable to move from a reduced insertion position to an inflated stabilizing position. In some embodiments, the inflatable balloon includes a rigid element supported therein, and a first flexible element and a second flexible element are connected to the rigid element.

[0026] In some embodiments, the first flexible element has a lumen extending therethrough, which is connected to the stabilizing member for conveying fluid that inflates the stabilizing member.

[0027] According to another aspect of the invention, a method for performing minimally invasive surgery in a patient's body cavity is provided; the method includes: (a) providing a flexible catheter having a workspace expansion system and an expandable stabilizing member; (b) providing a flexible endoscope for visualizing target tissue; (c) traveling the flexible catheter within a body cavity adjacent to the target tissue to be treated; (d) visualizing the target tissue using the flexible endoscope; (e) expanding the workspace expansion system from a non-expanded insertion position to an expanded position to increase the workspace within the body cavity; and (f) expanding the stabilizing member before or after step (e).

[0028] In some embodiments, the method further includes a step of pulling the stabilizing member closer to the workspace expansion system. This pulling step can occur before or after the step of expanding the workspace expansion system.

[0029] In some embodiments, the step of expanding the stabilizing member includes inflating the expandable member. In other embodiments, the step of expanding the stabilizing member includes expanding the mechanical structure.

[0030] In some embodiments, the workspace expansion system includes a first flexible element and a second flexible element, which are connected at a distal end by a coupling. In some embodiments, the step of pulling the stabilizing member moves the stabilizing member to a position on the coupling, and in other embodiments, the step of pulling the stabilizing member moves the stabilizing member to a position adjacent to the distal end of the coupling. Attached Figure Description

[0031] Figure 1 The illustrations depict a system, according to some embodiments, for the minimally invasive treatment of gastrointestinal diseases using an endoscope in a stable but dynamic surgical environment.

[0032] Figure 2A and Figure 2B The illustrations show how, according to some alternative embodiments, the system disclosed herein can be positioned for treating lesions in the ascending colon.

[0033] Figures 3A-3L The illustration shows how the system disclosed herein can be used to remove lesions in the colon according to some embodiments, with the colon shown in a cross-sectional view to illustrate the system in a perspective view. Figure 3A The diagram illustrates a system with a cannula inserted into the colon and covering the retractor; Figure 3B The diagram illustrates the traction device in the non-expanded position; Figure 3CThe illustrations show a retractor in an expanded position to create an asymmetrical workspace and an endoscope in an articulated position. Figure 3D It is similar to Figure 3C The view shows two endoscopic instruments extending from their respective tool channels; Figure 3E The illustration shows the blade channel and the endoscopic instrument that bends toward the target lesion; Figure 3F The illustration shows a lesion being removed from the colon wall using endoscopic instruments; Figure 3G The illustration shows the lesion that has been removed from the colon wall and is located inside the traction device; Figure 3H The illustration shows an endoscopic instrument that extends from the cutting channel and curves toward the colonic wall to repair defects in the colonic wall caused by lesion removal; Figure 3I The illustration shows the placement of a clamp used to close tissue defects in the colon wall; Figure 3J The illustration shows a retractor in a closed position used to capture lesions for removal from the colon; Figure 3K The illustration shows a retractor encased inside a cannula for removal from the colon. Figure 3L The illustration shows the tissue defect that closed after the surgical procedure was completed.

[0034] Figures 4A-4E The illustrations depict details of the system disclosed herein according to some alternative embodiments, and show side, axial, and oblique views of expanded and contracted configurations, the system including a stabilizer subsystem; wherein Figure 4A This is a side view of the system with the traction device in the non-expanded (retracted) position. Figure 4B This is an axial view of the system with the traction device in the non-expanded position. Figure 4C This is an axial view of the system with the traction device in the expanded position. Figure 4D Is in Figure 4A A perspective view of the system's location. Figure 4E It is similar to Figure 4D The view shows the traction device in the extended position.

[0035] Figures 5A-5D Side and top views of the system disclosed herein according to some alternative embodiments are shown, including side and top views of an expanded configuration and a collapsed configuration, wherein... Figure 5A This is a side view of the system in which the traction device is in the non-expanded (retracted) position; Figure 5B It is similar to Figure 5A A side view showing the traction device in the extended position; Figure 5C The traction device is located in Figure 5A A top view of the system in its non-expanded position; Figure 5D The traction device is located in Figure 5BA top view of the system at its expanded location.

[0036] Figures 6A-6D The diagram shows a side view of the system disclosed herein according to some other alternative embodiments, including side views and cross sections of the system in an expanded configuration and a contracted configuration, wherein... Figure 6A This is a side view of the system in which the traction device is in the non-expanded (retracted) position; Figure 6B It is similar to Figure 6A A side view, in which the half-shell is removed to reveal the internal components of the system; Figure 6C It is similar to Figure 6A A side view showing the traction device in the extended position; Figure 6D It is similar to Figure 6B The side view shows the traction device in the extended position.

[0037] Figure 7 The illustration shows a cross-sectional view of the distal end of the outer tube of the system disclosed herein according to some embodiments, and shows the expansion and retraction components of the traction device.

[0038] Figure 8 It shows Figure 7 The diagram shows a cross-sectional view and illustrates the distal end of the outer tube of the system disclosed herein according to some embodiments, wherein components of the system can float within the outer tube to increase flexibility for positioning the system within the body.

[0039] Figure 9A and Figure 9B The illustration shows a side view of the working channel and / or floating channel of the tool disclosed herein, according to some embodiments.

[0040] Figures 10A-10E The figure illustrates an alternative embodiment of the system according to some embodiments, wherein the traction sleeve covers the traction device of the system disclosed herein, wherein Figure 10A This is a top view of the system in which the traction device is in the non-expanded (retracted) position; Figure 10B It is a perspective view of the system in a non-expanded position; Figure 10C This is a side view of the system in which the traction device is in the non-expanded position; Figure 10D This is a top view of the system and shows the traction device in the extended position; Figure 10E This is a side view of the system and shows the traction device in the extended position.

[0041] Figure 11 This is a perspective view of an alternative embodiment of the system, showing the conduit and two tool channels.

[0042] Figure 12 Is Figure 13The endoscope was inserted above the proximal end (before inserting the endoscope into the colon). Figure 11 A perspective view of the catheter, showing the traction system in the retracted position.

[0043] Figure 13 The illustration shows the insertion of an endoscope through the colon.

[0044] Figure 14 It is shown in Figure 13 Further progress on the endoscope Figure 11 A perspective view of the catheter, showing the traction system in the retracted position.

[0045] Figure 15 This is a perspective view showing a catheter fully advanced above the endoscope to the desired position adjacent to the target tissue, with the traction system shown in the retracted (non-expandable) position.

[0046] Figure 16 yes Figure 11 A perspective view of the proximal end of the catheter.

[0047] Figure 17A and Figure 17B It is a partial cross-section side view, showing the actuator moving from a proximal position to a distal position to allow the rigidified structure to travel, thereby rigidifying the traction system.

[0048] Figure 17C It is similar to Figure 15 The perspective view shows an alternative embodiment of the rigid structure.

[0049] Figure 17D It is similar to Figure 17C A perspective view, showing the movement over the flexible element. Figure 17C A rigid structure.

[0050] Figure 18 It shows the insertion through which and Figure 11 A perspective view of two adjacent tool channels (guide devices) at the proximal end of the catheter.

[0051] Figure 19A The illustration was inserted. Figure 11 A perspective view of the tool channel in the conduit. Figure 19B This is a perspective view illustrating an alternative embodiment of the tool path.

[0052] Figure 20A and Figure 20B It is a partial cross-sectional side view, showing the actuator moving from the proximal position to the distal position to move the traction system to the extended position.

[0053] Figure 21A It is similar to Figure 15 The view shows the traction system in the expanded position and further shows the tool passage moving into the workspace (chamber) formed by the expansion of the traction system.

[0054] Figure 21B It is similar to Figure 21A The view shows an alternative embodiment in which the tool channel is advanced from the guide tube before the expansion of the traction system.

[0055] Figure 22 It is similar to Figure 21A The view shows the first endoscopic instrument (blade) traveling through the first blade channel.

[0056] Figure 23 It is similar to Figure 22 The view shows a second endoscopic instrument (blade) traveling through a second blade channel.

[0057] Figure 24 It is similar to Figure 23 The view shows two endoscopic instruments that travel further through the tool channel.

[0058] Figure 25 It is similar to Figure 24 The image shows a view of an endoscopic instrument that advances further through a cutting channel to remove lesions on the colon wall.

[0059] Figure 26 It is similar to Figure 25 The image shows a view of the lesion that has been removed from the colon wall using resection instruments placed inside a traction system.

[0060] Figure 27 It is a perspective view of the proximal end of the catheter and shows the actuator moving proximally to return the traction system to a closed position for removal from the colon.

[0061] Figure 28 It is similar to Figure 26 The view shows the traction system in the retracted position.

[0062] Figure 29 It is similar to Figure 28 The view shows a covering component that is closed to enclose the lesion for removal.

[0063] Figure 30 This is a front view of the system in its expanded position, showing two tool channels extending from the conduit.

[0064] Figure 31A and Figure 31BIt is a cross-sectional view showing the switch used to secure the sutures so as to close the cover (bag).

[0065] Figure 32 This is a perspective view of the distal end of the outer tube (conduit) of an alternative embodiment of the system, showing two floating channels within it.

[0066] Figure 33 Yes Figure 32 A perspective view of the proximal part of the system.

[0067] Figure 34 It is a myopic sectional view, and shows... Figure 32 One of the floating channels.

[0068] Figure 35A It is similar to Figure 34 The view shows an alternative embodiment of the floating channel.

[0069] Figure 35B It is similar to Figure 35A The view shows a floating channel traveling inside a fixed distal tube.

[0070] Figure 35C It is similar to Figure 35B The view shows the movement of the floating channel beyond the fixed distal tube.

[0071] Figure 36 It is shown in the diagram inside the colon. Figure 32 and Figure 33 The front view of the system.

[0072] Figure 37A and Figure 37B It is a transverse cross-sectional view through the outer tube, and shows the radial movement of the middle part of the floating channel inside the cavity of the outer tube.

[0073] Figure 38 This is a diagram. Figures 35A-35C A cross-sectional view of the bending of the outer tube and the movement of the floating channel.

[0074] Figure 39A and Figure 39B yes Figure 38 The system is shown in a side perspective view of the distal part, and the effects of the outer tube bending and floating channel movement are shown, as well as the traction system illustrated in a non-expanding configuration.

[0075] Figure 39C yes Figure 39A A bottom-view perspective view of the traction system.

[0076] Figure 40This is a longitudinal sectional view of an alternative embodiment of the system, showing the traction system in the retracted insertion position.

[0077] Figure 41 yes Figure 40 The system is shown from below in a perspective view, where the traction system is in a non-expanded configuration.

[0078] Figure 42 yes Figure 41 A side perspective view of the system.

[0079] Figure 43A This is a bottom perspective view of another alternative embodiment of a system with two flexible elements and a balloon stabilizer, showing the balloon in the distal, non-expanded position.

[0080] Figure 43B yes Figure 43A A perspective view of the distal portion of the system, showing the balloon in the proximal non-expanded position.

[0081] Figure 43C yes Figure 43A The diagram shows a perspective view of the distal portion of the system, and also shows a balloon at a proximal dilation position adjacent to the distal connector, and a traction system for dilation within the patient's colon.

[0082] Figure 43D It is similar to Figure 43B The view shows the cover on top of the flexible element.

[0083] Figure 44A This is a perspective view of another alternative embodiment of a system with a balloon stabilizer, showing an annular balloon in a distal, non-expanded position.

[0084] Figure 44B yes Figure 44A A perspective view of the distal portion of the system, showing the balloon in its expanded position distal to the distal connector.

[0085] Figure 44C It is similar to Figure 44B A perspective view showing the inflatable balloon on the distal connector.

[0086] Figure 45A This is a perspective view of the distal portion of another embodiment of the system, showing an annular sac in a non-expanded position on the distal connector.

[0087] Figure 45B It is similar to Figure 45A A perspective view showing an annular balloon in an expanded position above the distal connector.

[0088] Figure 46A This is a perspective view of the distal portion of another alternative embodiment of the system, showing the mesh structure inside the catheter in a non-expanded position.

[0089] Figure 46B It is similar to Figure 46A A perspective view, showing the catheter in a proximal position.

[0090] Figure 46C It is similar to Figure 46B A perspective view, showing the mesh structure in its expanded position.

[0091] Figure 47A This is a perspective view of the distal portion of another alternative embodiment of the system, showing a vascular stent-like structure in a non-dilated position inside the catheter.

[0092] Figure 47B yes Figure 47A A perspective view of the system, showing the catheter located proximally inside the patient's intestine.

[0093] Figure 47C It is similar to Figure 47A A perspective view showing the stent structure in its dilated position, and also showing the dilated traction system inside the patient's colon.

[0094] Figure 48 This is a perspective view of the distal portion of another alternative embodiment having four flexible elements for symmetrical expansion, and shows the balloon in the expanded position.

[0095] Figure 49A This is a perspective view of the distal portion of another alternative embodiment of the system, showing the flexible element directly attached to the balloon and the balloon in a non-expanded position.

[0096] Figure 49B It is similar to Figure 49A The view shows the balloon in its expanded position. Detailed Implementation

[0097] The teachings provided herein generally relate to improved methods and apparatus for minimally invasively treating gastrointestinal diseases using endoscopy in a stable but dynamic surgical environment. The system includes, for example, an endoscopic surgical kit formed by the systems disclosed herein. The surgical kit may have a reversibly expandable retractor that expands to provide a stable surgical environment within the body. In some embodiments, this expansion may be asymmetrical near the stabilizer subsystem to maximize space for use with the blades and endoscope, each independently maneuverable to visualize and treat the target tissue minimally invasively from outside the patient. Among other improvements, the embodiments disclosed herein may provide an increased distance between the blade port and the target tissue to enhance independent maneuverability and triangulation of each blade relative to the target tissue. This increased distance may also provide a method for obtaining a larger field of view. The system disclosed herein can, for example, (i) dynamically position the workspace near target tissue and orifices (such as the gastrointestinal tract) located in a tortuous body cavity using controls from outside the body; (ii) provide flexible channels for multiple surgical instruments and tools (such as endoscopes and grippers) to pass through from outside the body toward the target tissue; (iii) arrange and / or confine instruments in the workspace; (iv) at least substantially fix and / or stabilize the target tissue and surrounding tissue for treatment; and / or (v) control the geometry and orientation of instruments (such as grippers) in the workspace from outside the body.

[0098] In some embodiments disclosed herein, an articulated endoscope is inserted through a catheter channel; in other embodiments, the system is mounted on a flexible endoscope (such as a conventional colonoscope), and the endoscope is then inserted into a position adjacent to the target tissue, and the catheter is then advanced over the flexible endoscope such that the remodeling (traction) system (cage) is in close proximity to the target tissue.

[0099] In some embodiments disclosed herein, endoscopic instruments (blades) for treating target tissue are directly inserted through the lumens or channels of a multi-lumen catheter. In these embodiments where the instruments (blades) are directly inserted into the lumens of the catheter channels, the instruments may have a distal bend that automatically bends towards the target tissue upon exposure from the catheter; alternatively, the instruments may have a mechanism that is actively controlled by the user to hinge / deflect the distal tip. In other embodiments, instead of the endoscopic instruments (blades) being directly inserted into the channels or lumens of the catheter, flexible tubes are inserted through the lumens or channels of the catheter and serve as instrument guides. That is, the flexible tube is first inserted into the lumen or channel of the catheter, and then the endoscopic instruments are inserted through the flexible tubes. The flexible tubes may have a distal bend that automatically bends towards the target tissue upon exposure from the catheter; alternatively, the flexible tubes may have a mechanism that is actively controlled by the user to hinge / deflect the distal tip. In these embodiments employing flexible tubes, the bending and maneuverability of the flexible tubes control the positioning and operation of the endoscopic instruments, thus eliminating the need for pre-bent tips or articulated mechanisms on the endoscopic instruments.

[0100] In a preferred embodiment, the system disclosed herein includes a traction device that forms an asymmetric workspace within a body cavity. More specifically, when working in a confined body cavity (such as the colon), luminal expansion is limited because overexpansion is inappropriate; such stiff expansion can stretch the lumen beyond its ability to return to its normal state or, more dangerously, can cause luminal rupture. The asymmetric workspace disclosed herein is designed to reconstruct or reshape the body cavity to transform a cylindrical space within the body cavity into a non-cylindrical asymmetric space (i.e., altering the geometry), thereby changing the space near the target tissue and thus creating more workspace near the target tissue, providing visual and mechanical improvements. In other words, in a cylindrical workspace, there are many areas of unused space, and in the reshaping of the embodiments disclosed herein, the space is moved or altered to reduce unused space and create a larger area for tissue access and treatment.

[0101] As used herein, the terms “treat,” “treatment,” and “treating” include therapeutic and / or preventative uses, for example, in the prevention, suppression, and / or symptom relief of a disease or condition. The terms “subject” and “patient” are used interchangeably and refer to animals, such as mammals, including but not limited to: non-primates such as cattle, pigs, horses, cats, dogs, rats, and mice; and primates such as monkeys or humans.

[0102] In some embodiments, the system disclosed herein may include a dynamically reconfigurable asymmetric traction device structure at the distal end of a flexible and torsionally oriented multichannel shaft having a handle that allows control over both the stiffness and geometry of the workspace formed by the expanding traction device. In some embodiments, the traction device may include a stabilizer subsystem having flexible traction elements in the range of 2-8, 3-5, 4-6, or any of these ranges. In some embodiments, the traction elements may be aligned at least substantially parallel to each other when fully retracted for positioning in a patient. In some embodiments, the traction elements are aligned in planes within the range of about 5-30 degrees, about 10-25 degrees, about 15-20 degrees, about 15 degrees, or any of these ranges. In some embodiments, the traction elements form a frame having a length in the range of about 4-12 cm, 6-10 cm, 7-9 cm, 5-11 cm, or any of these ranges. In some embodiments, the length of the frame is about 8 cm. In some embodiments, the traction elements form a frame having a width in the range of about 1-5 cm, 2-4 cm, or any of these ranges. In some embodiments, the width of the frame is about 3 cm. In some embodiments, the traction element forms a frame having a height in the range of about 1-5 cm, 2-4 cm, or any range therein. In some embodiments, the height of the frame is about 3 cm. Those skilled in the art will understand that there are suitable materials available for manufacturing the traction element for the purposes set forth herein. In some embodiments, the traction element may be made of a nickel-titanium alloy. In some embodiments, the traction element may comprise multifilament metal wire or polymer cord. Polymer materials may include polyetheretherketone (PEEK), nylon, polyester, polycarbonate, polyurethane, or polyethylene. Measurements of the traction element may vary depending on the material. In some embodiments, the traction element may comprise a wire with a diameter in the range of about 0.020” to 0.40”. In some embodiments, the diameter of the traction element is about 0.030”.

[0103] In the teachings herein, the term “about” is used to describe possible variations in the amount or range that may be used in the various embodiments. It may be used in embodiments to include, for example, an exact amount or specified range, and variations that will not result in significant differences in functionality. Differences in functionality may be insignificant, for example, less than 20% in some embodiments, less than 15% in others, less than 10% in still others, or perhaps even less than 5% in yet others. Those skilled in the art will understand that the percentage difference in functionality that is significantly desired will depend on the functionality of the embodiments being compared.

[0104] The methods, apparatus, and systems disclosed herein can be used in minimally invasive surgery. Conversely, non-traumatic surgery can be defined as surgery that does not involve damage to the skin or mucous membranes and does not involve significant damage to any other body tissues. On the other hand, minimally invasive surgery involves minimal entry trauma and minimal damage to collateral tissues during the surgical procedure. In some embodiments, the terms “minimal,” “minimize,” “minimizing,” “minimized,” “avoid,” “avoiding,” and “avoided” may be used interchangeably. Minimally invasive surgery is ideal for, for example, reducing patient trauma, speeding up the healing process, reducing risk, and thus reducing the length and cost of hospital stays by minimizing or avoiding tissue damage or the risk of tissue damage. Tissue damage or its risk can be minimized or avoided, for example, where the surgery is designed to minimize or avoid unnecessary tissue contact that would be associated with the surgery. The gentle surgical procedures disclosed herein are, for example, designed to protect tissues during gastrointestinal surgery.

[0105] In some embodiments, the systems disclosed herein can be dynamic, for example, such that tissue traction may include partial or complete expansion or contraction of the traction device to facilitate increasing or decreasing the distance between the instrument and the target tissue. This can be used for workspace reconfiguration and to facilitate axial movement of the instrument. By increasing and releasing tension, the amount of tissue placed in the workspace can also be better measured during surgery, and tissue traction-reverse traction can be facilitated during tissue removal, thereby helping to form an anatomical plane. Those skilled in the art will understand that the ability to dynamically reconfigure the workspace optimizes traction-reverse traction on the target tissue, as this simplifies surgical procedures.

[0106] The system disclosed in this paper can also perform triangulation. Tissue triangulation, which involves triangulating tissue between two endoscopic instruments, improves accessibility and manipulation.

[0107] Figure 1The illustration depicts a system, according to some embodiments, for minimally invasive endoscopic treatment of gastrointestinal disorders in a stable yet dynamic surgical setting. The system 100 may include a multi-lumen catheter traction system for facilitating positioning within the body, and this system may be designed to provide minimally invasive treatment of the body. The system 100 may have a flexible outer tube 105 configured to guide one or more channels 110 and an endoscope 115 within the system 100. The flexible outer tube 105 may have a lumen (not shown), a proximal end (not shown), and a distal end 108 for accommodating, for example, channels and an endoscope, during use of the system 100. The lumen may extend from the proximal end to the distal end, thus allowing the user to manipulate the tool channel 110 proximally. Alternatively, the outer tube 105 can be a multi-lumen tube, thus a single lumen housing the endoscope and a separate blade channel, and during use of the system 100, the channel 110 can act as a guide, allowing insertion and manipulation of blades 120, 125 in treatment of target tissue 190 within the gastrointestinal tract 195 (or other regions) of the body. The channel 110 can, for example, be operably contacted with independently operable and articulated blades, having lifting components for moving flexible portions. Thus, in some embodiments, the length of the channel is sufficient to extend from the proximal end of the outer tube 105 for user manipulation. These blade channels are flexible or articulated at their distal ends, such that they are deflected from the longitudinal axis toward the target tissue 190. By providing the blade channels (guides) 110 with shape memory material and having shape memory bending states (such as in…), Figure 1 This flexibility (as shown in the diagram) can be achieved. When accommodated within the lumen of the outer tube 105 for insertion, the tool channel 110 will have a generally straightened state, and will return to its original position when traveling from the distal end of the outer tube 105. Figure 1 The tool channel 110 can be bent. Other materials may also be used. In an alternative embodiment, the tool channel 110 may have a mechanism (such as a lifting component or control wire) attached to a distal end, which can be pulled by a user or by an actuator to move the tool channel to a bent state. These different methods of achieving the bendability (hinged) of the tool channel can be used in various embodiments of the system described herein.

[0108] In some embodiments, the cutter inserted through the cutter channel can be any cutter known to those skilled in the art. For example, cutters 120, 125 may include grippers, pliers, snares, scissors, knives, peelers, clamps, endoscopic suture devices, tissue loops, clamp applicators, suture delivery devices, or energy-type tissue coagulants or cutters. The bending capability of the channel 110, used to move the bendable portion (often distal) of the channel 110, manipulates (i.e., bends) the cutter 120, 125 located therein. In some embodiments, at least one channel 110 and / or endoscope 115 may have at least considerable freedom of movement within the outer tube 105 during operation, or "float," and thus system 100 may be considered a floating multi-lumen catheter traction system. It should be understood that in some embodiments disclosed herein, the terms "cutter" and "instrument" may be used interchangeably. As will be understood, cutters 120, 125 may be flexible, at least distally, such that when the cutter channel 110 bends in the manner described above, the cutter channel 110 also bends the cutter located therein. Alternatively, it is conceivable that the tools 120, 125 may be articulated or controllably bendable or made of shape memory material or other materials, so that they bend without relying on the bendability of the tool channel 110.

[0109] Although two tool channels 110 are shown, it should be understood that systems with more than two tool channels or only one tool channel may also be used. Additionally, the endoscope may have a working channel for insertion of working instruments (such as grippers or dissectors).

[0110] It is also conceivable that the cutting tools could be flexible, allowing them to be inserted directly through the lumen of the outer tube 105 without the need for a cutting tool channel. In these embodiments, the cutting tools themselves are flexible or articulated, thus allowing them to bend / deflect toward the target tissue independently of a cutting tool channel.

[0111] In some embodiments, the system may include a stable but dynamic surgical environment because it may include a reversibly expandable traction device 150, as in Figure 1As shown, the traction device 150 expands to form a treatment space or chamber 160 within the body. The traction device 150 can be configured, for example, to cause expansion distal to the distal end 108 of the outer tube 105. In some embodiments, the traction device can at least significantly cause the target tissue 190 to be non-peristaltic for treatment. The traction device 150 can have various configurations to function as a support frame, for example, within the gastrointestinal tract 195. For example, the traction device 150 may include traction elements 151, 152, 153, 154, together with proximal couplings 198 operatively connected to the traction elements 151, 152, 153, 154 (whether or not at least substantially attached to and / or at least slidably engaged to the traction elements 151, 152, 153, 154); and distal couplings or connectors (or couplings) 199 for distal points operatively connected to the traction elements 151, 152, 153, 154.

[0112] exist Figure 1 In one embodiment, the traction element 151 is a flexible element and has a proximal portion 151a extending from the proximal connector 198 at a first angle, a distal portion 151b extending from the distal interface or connector 199 at a second angle preferably different from the first angle, and a tissue-engaging junction 151c extending between the proximal portion 151a and the distal portion 151b. As shown, the proximal portion 151a extends at a larger angle relative to the longitudinal axis than the distal portion 151c, thus providing asymmetrical expansion of the traction element itself. Therefore, the length of the distal portion 151b exceeds the length of the proximal portion 151a. The traction element 152 may be arranged and tilted similarly to the traction element 151, or alternatively may have a different configuration and angle. Alternatively, the traction elements 151 and / or 152 may be configured such that the proximal and distal portions have the same length and angle. It should be noted that the traction elements 151 and 152 expand in a direction toward the longitudinal axis. This asymmetric expansion forms the following asymmetric chamber.

[0113] The traction device 150 may be a reversibly stabilized and reversibly expandable traction device, which, upon expansion, forms an asymmetric treatment space 160. Additionally, the traction device 150 may be configured to reversibly rigidify a flexible arrangement of the traction device 150, designed to facilitate positioning of the system 100 within the body and to reversibly rigidify it for expansion of the traction device 150. In some embodiments, stabilization of the traction device 150 may include a stabilizer subsystem for stabilizing the traction device 150 disclosed herein, the stabilizer having, for example, a beam 175 that is at least substantially rigid to support the expanding traction device 150.

[0114] As disclosed in the various embodiments herein, rigidifying the traction system (i.e., by employing a substantially rigid beam) advantageously stabilizes the traction system, i.e., limits the bending of the distal end that occurs during expansion due to opposing forces on the tissue. Therefore, the stabilizer bears the load and functions to create a more stable chamber. In some embodiments, the beam 175 may have a substantially rectangular, substantially circular, or other cross-sectional shape. It may be made of a material more rigid than the traction element. In some embodiments, the beam may have a cross-sectional dimension larger than that of the traction element. Figure 1 As shown, beam 175 is at the bottom of the chamber formed by the traction element, from which the traction element extends radially (laterally). Beam 175 may be composed of a more rigid element that is exposed when the traction element is exposed from the outer tube for expansion, or alternatively, it may travel independently from inside the outer tube, as in the partial embodiments described in more detail below.

[0115] In some embodiments, the outer tube may have any size that a person skilled in the art would consider suitable for the purposes disclosed herein. For example, the outer tube may have an outer diameter in the range of about 3 mm to about 30 mm, about 5 mm to about 25 mm, about 7 mm to about 22 mm, about 9 mm to about 20 mm, about 11 mm to about 18 mm, about 8 mm to about 15 mm, about 10 mm to about 16 mm, or in any range in increments of 1 mm. The length of the outer tube may be, for example, about 30” to about 72”, about 31” to about 36”, about 28” to about 80”, about 32” to about 40”, about 34” to about 38”, or in any range in increments of 1”.

[0116] The outer tube may be made of any material known to those skilled in the art for use in the purposes disclosed herein. For example, the outer tube may comprise a polymer, or a polymer that may have embedded reinforcing wires. The reinforcing wires may be a mesh, braid, helical coil, or any combination thereof. The reinforcing wires may comprise any material that those skilled in the art would consider suitable for the purposes stated herein. For example, the reinforcing wires may comprise a material having an elastic modulus that is about 1-3 orders of magnitude higher than that of the polymer tube. The wire material may include, for example, stainless steel having a diameter in the range of about 0.003” to about 0.017”, about 0.005” to about 0.015”, about 0.010” to about 0.012”, or in any range in increments of about 0.001”. The hardness of the tube or the hardness tester may be any hardness that a person skilled in the art would find suitable for the purposes stated herein. For example, the hardness may be in the range of, for example, about 50 Shore hardness to about 60 Shore hardness, about 40 Shore hardness to about 80 Shore hardness, about 45 Shore hardness to about 70 Shore hardness, or in any range in increments of 1 Shore hardness. It will be understood by a person skilled in the art that the outer tube should be flexible and resiliently bendable, but sufficiently torsional rigid to transmit torque from the handle or proximal end of the system to the traction or distal end of the system.

[0117] The outer tube can be distally connected to a ring (referred to herein as a proximal connector in some embodiments), which may have an ideal orientation and positioning for the traction element to slide through an inlet formed therethrough, and for channels for the endoscope and at least one tool, thus arranging the traction element, endoscope, and at least one tool relative to each other in a predetermined manner to achieve specific functions, such as increased workspace, better viewing of the anatomical plane, or any other process variables considered of interest to those skilled in the art. For example, in Figure 1 In the illustrated embodiment, the inlet for the traction element is radially outwardly spaced from the inlet for the endoscope and tool channels.

[0118] In some embodiments, the traction device structures disclosed herein are designed to substantially fix the lesion to a degree desirable for treatment. For example, surgical margins resulting from current methods of block removal using loops and flat or broad-pedunculated polyps (e.g., polyps with a pedicle of about 1 cm or more) are often unclear, whereas in some embodiments the systems disclosed herein can fix or anchor the lesion to the full circumference of the intestinal wall near the treatment area and facilitate the formation of clear surgical margins. Those skilled in the art will understand that a workspace can be provided by the systems disclosed herein that is (i) at least substantially non-retractable; (ii) at least substantially free of peristalsis; and (iii) at least substantially fixed at a specific point in the abdominal cavity, for example, relative to any fixed body point (e.g., the hip). This is a significant improvement over existing systems, which have not addressed many existing problems, including, for example, intestinal collapse caused by gas leakage from the workspace; peristalsis, which is normal, even in anesthetized patients; and additional unwanted intestinal movement caused by patient breathing, endoscope movement or other instrument manipulation, or perhaps even by peripheral peristalsis leading to movement in the treatment area. These problems are solved by the system disclosed herein. Therefore, the system disclosed herein provides a rigid, stable structure that offers significant resistance to at least a number of movement forces in the abdomen typically present during gastrointestinal endoscopy. Those skilled in the art will understand that reducing the impact of these movement forces on the workspace helps to reduce inherent technical complexity, limited efficacy, and reduced safety during endoscopic procedures.

[0119] In addition to creating a workspace with the advantages mentioned above, this workspace provides sufficient working distance for the tools used in treatments (e.g., polyp removal), thereby enhancing the manipulation and control of individual tools and enabling tissue triangulation. It also advantageously creates a workspace distance to increase the visibility of the target tissue.

[0120] In some embodiments, the system disclosed herein can be slidably positioned over an endoscope during use. In these embodiments, the endoscope is first inserted into a position adjacent to the target tissue, and then a multilumen cannula or catheter is advanced over the endoscope, with the endoscope sliding over the endoscopic receiving lumen (channel) of the outer cannula or catheter. It should be understood that there are various methods of using the system disclosed herein that have been employed by those skilled in the art in current prior art procedures. For example, the method may include inserting a multilumen cannula into an outer cannula, sheath, or septum. Additionally, in some embodiments, the endoscope may be a colonoscope. In many embodiments, regardless of the method of use, the retractor structure may mechanically retract one side of the colonic wall asymmetrically to increase the distance between the target lesion and the opposing wall, and between the lesion and the instruments in their most retracted but visualized position, thereby increasing the effective working space.

[0121] In some embodiments, the system may include a multi-lumen catheter having at least two working channels for manipulating a cutting tool and an endoscope, each of the two working channels having six degrees of freedom independent of each other and the endoscope. The ability to independently manipulate the endoscope and cutting tool allows, for example, one instrument to pull tissue or lesions away from or substantially perpendicular to another instrument (e.g., a resection instrument), while independently optimizing the position of the endoscope and thus the field of view of the treatment area. This will facilitate tissue removal with clear margins. These channels can manipulate the cutting tool with several degrees of freedom (six degrees of freedom in some embodiments), thereby providing significantly enhanced maneuverability in the working area compared to current prior art systems. In some embodiments, at least one independently maneuverable and articulated cutting tool can be independently rotated in the working area to angles up to about 360 degrees, about 315 degrees, 270 degrees, about 225 degrees, about 180 degrees, about 135 degrees, or about 90 degrees. Furthermore, these cutting tools can be independently bent in at least one direction in the working area to angles up to about 180 degrees, about 135 degrees, about 90 degrees, or about 45 degrees.

[0122] The system disclosed herein can provide for the orientation of floating channels, thereby further enhancing system flexibility. In some embodiments, a proximal connector (a ring that can be attached to the distal end of the outer tube) can be used to arrange the blade and endoscope in a specific arrangement to facilitate specific positioning of the blade as it enters the workspace formed by the retractor from the axis. In some embodiments, the blade channel can be positioned further away from the retractor element at maximum expansion compared to the endoscope. Similarly, the proximal end of the outer tube can also have individual openings for each channel, and these openings can be, for example, part of a handle connector or the handle itself, thereby operably connecting one or more channels to the outer tube. The operable connection between the outer tube and the channels can provide control of the endoscope and blade, for example, from the patient's side. The ring can be made of any material that a person skilled in the art would consider suitable for the purposes described herein. For example, the ring can be made of stainless steel, or perhaps plastics such as polycarbonate or acrylonitrile-butadiene-styrene copolymer (ABS).

[0123] It should be understood that, in some embodiments, the system disclosed herein may include any combination of components, the selected combination of which is designed to be operable with components that are independently available from the system. For example, the system may include an outer tube and a retractor component, the outer tube being operable with at least one independently available channel and an independently available endoscope. Similarly, the system may include an outer tube, a retractor, and an endoscope, with the channel being independently available; or an outer tube, a retractor, a channel, and an endoscope being independently available. Furthermore, the system may include an outer tube, a retractor, an endoscope, and at least one channel; or a handle, an outer tube, a retractor, an endoscope, at least one channel, and at least one tool.

[0124] The terms “significant” and “significantly” can be used, for example, to refer to relative measurements of parameters. In some embodiments, they can be used, for example, to refer to the degree of change or function related to quantity, performance, or some other characteristic. The following is for illustrative purposes in describing a general embodiment: As described above, the system can be considered a floating system, and in some embodiments may have floating channels, floating endoscopes, multiple floating channels, or combinations thereof. For example, the phrase “an arrangement that is at least substantially floating within the system” can refer to an arrangement, such as a channel or endoscope arrangement, that may have some attachments restricting movement in at least one direction, minimal attachments to minimize such movement restrictions, or perhaps no attachments at all to another system component. For example, a channel or endoscope may be arranged to float at least significantly within the outer tube relative to a second such system that does not employ a floating type arrangement to increase flexibility, or inherently achieve an increase in the flexibility of a second such system. Thus, in many embodiments, the endoscope and / or channel may have significant portions of its arrangement that are not attached within the system, thereby allowing that significant portion to “float” or move considerably freely within the outer tube. The “significant portion” can be, for example, an arrangement that must remain unattached within the system to provide performance characteristics (e.g., increased system flexibility compared to a second such system that does not employ a floating type arrangement to improve flexibility, or inherently achieves an increase in the flexibility of the second such system).

[0125] The phrase "at least substantially resulting in no peristalsis in the target tissue for treatment" can, for example, refer to the target tissue having some minimal peristalsis, or perhaps no peristalsis, under normal use conditions, in order to provide performance characteristics, such as controlling the movement of the target tissue for treatment. The phrase "at least substantially attached," such as "at least substantially attached to the lumen of the outer tube," can, for example, refer to a component having a fixed or movable attachment. In some embodiments, the attachment may be between the component and the lumen, thus resulting in a loss of at least one degree of freedom of the component. For example, the component may slide and / or rotate relative to the lumen of the outer tube, provided that the sliding and / or rotation occurs relative to a specific fixed point on the lumen. Similarly, in some embodiments, "at least substantially attached" can of course mean "fixed," "reversibly fixed," etc. Similarly, "at least slidably attached" can refer to an attachment between components that allows sliding at least between components (e.g., between the port and the tube). In some embodiments, the endoscope may be at least slidably attached, for example, allowing the endoscope to slide inside and outside the port in the direction of the endoscope's central axis, thus the distance by which the endoscope extends beyond the port is adjustable. Additionally, in some embodiments, the component may be "at least slidably attached," wherein it can slide and move in other directions. For example, in some embodiments, the port may be significantly larger than the endoscope, allowing the endoscope to slide axially and move laterally, aligning its central axis parallel to the central axis of the outer tube, or perhaps offsetting its central axis so that it is not parallel to the central axis of the outer tube.

[0126] The phrase "at least significantly increases flexibility" can refer to the orientation of the components that increases the flexibility of the system compared to another orientation and design of the components. For example, the phrase "at least significantly improves the flexibility of the system relative to a second such system" can refer to the comparison of the flexibility of the patent-claimed system with a second system that does not have a floating arrangement under normal use conditions, such that the flexibility of the system has been increased to a minimum amount that improves the ease with which the system can be positioned in the body to treat the target tissue.

[0127] The phrase "at least substantially rigid component" can refer to a component that is rigid or sufficiently rigid to achieve its desired function under the forces generated during normal use. For example, the desired function could be preventing or inhibiting the generation of bending moments in the rigid component at one or more points along the length of the tractioner as it expands within the body. In some embodiments, the system disclosed herein may have a tractioner with four traction elements, at least two of which expand within the body to form a workspace for treatment. In this example, the expansion of at least two traction elements toward the target tissue to form the workspace requires sufficient force to traction the tissue and generates opposing forces in opposite directions, which can generate bending moments in the rigid component. Those skilled in the art will understand that such bending moments can be problematic, for example, leading to instability that affects the user's control over the tractioner's state during treatment of the target tissue. In this embodiment, the component that prevents or inhibits the generation of bending moments can be "at least substantially rigid," for example, in which case the user maintains an ideal level of control, or at least sufficient control, over the tractioner's state during traction of the target tissue. In some embodiments, the component that prevents or inhibits the generation of bending moment, whether internal or external to the body, may be at least substantially rigid, wherein bending of the component due to the expansion of the traction device causes a deflection in the range of 0.0 to about 5 degrees, about 1.0 to about 10 degrees, about 2.0 to about 12 degrees, about 3.0 to about 10 degrees, about 1.0 to about 15 degrees, about 1.0 to about 9.0 degrees, about 1.0 to about 8.0 degrees, about 1.0 to about 7.0 degrees, about 1.0 to about 6.0 degrees, about 1.0 to about 5.0 degrees, about 1.0 to about 4.0 degrees, or in any range in increments of about 0.1 degrees. In some embodiments, the deflection of the rigid component may not exceed about 1.0 degrees, about 2.0 degrees, about 3.0 degrees, about 4.0 degrees, about 5.0 degrees, about 6.0 degrees, about 7.0 degrees, about 8.0 degrees, about 9.0 degrees, about 10.0 degrees, or any increment of 0.1 degrees therein. The bending can be measured, for example, as a point where the rigid member deflects from its initial position on the axis of the rigid member due to the force generated by the expansion on the rigid member.

[0128] In some embodiments, the terms "significant" and "significantly" are used interchangeably and can be described using any relative measurement acceptable to those skilled in the art. For example, a significant quantity, significant change, significant difference, significant function, etc., can be expressed using a relative percentage. In some embodiments, the percentage can be greater than 10%, greater than 20%, greater than 30%, greater than 40%, or greater than 50%. In some embodiments, the percentage can be greater than 60%, greater than 70%, or greater than 80%. Additionally, in some embodiments, the percentage can be greater than 90%, greater than 95%, or even greater than 99% in some embodiments. For example, "significant [quantity]" or "significant [change]" can include any quantity or any change relative to a reference parameter. This quantity or change can, for example, include an increase or decrease relative to the reference parameter, which can be compared to a reference point for that parameter. The deviation relative to the reference point can be, for example, a quantity of at least 1%, at least 2%, at least 3%, at least 5%, at least 10%, at least 15%, at least 20%, at least 25%, at least 30%, at least 35%, at least 40%, at least 45%, or any increment of 1% therein. Furthermore, terms such as "significant [function]" or "significantly [perform]" limit... This can be used for comparison with reference functional parameters to indicate deviations from the intended function. Reference functions may include, for example, floating, creeping, attaching, buckling, stiffness, position, or positioning relative to another object. Deviations relative to a reference point can be, for example, amounts less than 1%, less than 3%, less than 5%, less than 10%, less than 15%, less than 20%, less than 25%, less than 30%, less than 35%, less than 40%, less than 45%, or any increment of 0.1%. For example, a component may have acceptable, significant [function] when the deviation from a reference point is less than an acceptable deviation.

[0129] Therefore, the system can include a floating multi-lumen catheter traction system for simplifying positioning within the body, which can be designed to provide minimally invasive treatment of the body. In some embodiments, the system includes a highly flexible outer tube configured to guide a floating channel and / or a floating endoscope in an arrangement that is at least substantially floating within the system. The flexible outer tube may have a lumen, a proximal end, and a distal end. Additionally, during use of the system, the floating channel can act as a guide through which a tool is manipulated during treatment of target tissue located within the body. In some embodiments, the tool may include a gripper, forceps, scissors, a knife, a dissector, an endoscopic anastomosis device, a tissue ring, an applicator, a suture delivery device, or an energy-type tissue coagulant or cutter. Additionally, in some embodiments, the floating channel may have a lifting component for moving a flexible portion to manipulate the tool. In some embodiments, at least one channel and / or endoscope may have at least significant freedom of movement, or "floating," within the outer tube during surgery, and thus the system can be considered a floating multi-lumen catheter traction system as disclosed herein.

[0130] Similarly, the system can also include a stable but dynamic surgical environment, as it can include a reversibly expanding retractor (workspace expansion system) that expands to form a treatment space within the body. This retractor can be configured, for example, for expansion occurring distal to the distal end of the outer tube and at least substantially causing the target tissue to be non-peristaltic for treatment; wherein, during use of the system within the body, a floating channel can be at least substantially attached to the lumen of the outer tube at first proximal and first distal positions, and at least substantially floats between the first proximal and first distal positions within the lumen of the outer tube. Similarly, during use of the system, a floating endoscope can be at least slidably attached to the lumen of the outer tube at second proximal and second distal positions, and at least substantially floats between the second proximal and second distal positions within the lumen of the outer tube. Furthermore, during the use of this system, the at least substantially floating arrangement can significantly increase the flexibility of the system relative to a second such system, which has a lumen for a cutting tool and an endoscope fixed to the lumen along the entire length of the outer tube between its proximal and distal ends. The increased flexibility of the at least substantially floating arrangement can facilitate system positioning within the body for treatment of target tissue. Additionally, the traction device can be a reversibly stable and reversibly expandable traction device that creates an asymmetric treatment space upon expansion. Furthermore, the traction device can be configured to reversibly rigidify the flexible arrangement of the traction device, which is designed to facilitate system positioning within the body and to reversibly rigidify the traction device for expansion.

[0131] Figure 2A and Figure 2BThe illustrations depict how the system disclosed herein can be used to treat lesions in the ascending colon, according to some embodiments. It should be understood that any series of steps and methods known to those skilled in the art for locating 200 can be used with the system disclosed herein. Figure 2A The illustration shows how the endoscope 215 can be used to locate the lesion, the target tissue 290 in a portion of the ascending colon 295. Figure 2B The illustration shows how to use endoscope 215 as a guide for positioning 200 of the system during treatment of target tissue 290, guiding the multilumen catheter traction system 201 to the target tissue 290. As can be understood, the multilumen catheter is advanced over endoscope 215, as in... Figure 2B As shown in the image.

[0132] Figures 3A-3L The illustrations demonstrate how the system disclosed herein can be used to remove lesions in the colon, according to some embodiments. As stated above, the system can also be used in other areas of the patient's body and for treating other target tissues. The description herein of removing polyps from the colonic wall is disclosed and described by way of example, as the system (and other systems disclosed herein) can be used in other surgical applications and in other body spaces. In the treatment 300 of gastrointestinal lesion 390, the system can be used as follows Figure 2A and Figure 2B The location is determined by the method described in the text, and it allows for multi-directional and multi-angle approach to the lesion. For example, in... Figure 2A and Figure 2B As shown, for example, the approach may include using an endoscope 315 to identify lesions in the main gastrointestinal lumen; and forming a generally rigid and stable intraluminal working area for treating the target tissue, the gastrointestinal lesion 390. Figure 3A In the middle, the system was located at 390 lesions, and in Figure 3B The expandable traction device 350 is exposed for subsequent expansion, thereby creating an asymmetrical workspace 360. Figure 3C ).exist Figure 3A In this configuration, the cannula or sheath 355 is positioned above the traction element for easy insertion, and the distal end of the cannula 355 abuts against or alternatively covers the distal connector 399. After insertion into the target site, the cannula (or outer tube) 355 is removed to expose the traction element for subsequent expansion, as in... Figure 3B As shown in the diagram. It should also be understood that, alternatively, the sleeve 355 can be used to offset the traction element to the expanded position and maintain it in the retracted delivery state. In this embodiment, removing the sleeve 355 to expose the traction element will allow the traction element to automatically expand to... Figure 3C Their expansion states.

[0133] Figure 3C and Figure 3D The illustration shows the formation of a working space 360 ​​within a body cavity and the operation of the endoscope 315 and the instruments 320, 325. After positioning the traction device 350 near the lesion 390, the traction device 350 is expanded to form an asymmetric working space 360 ​​for treating the lesion 390. In some embodiments, the traction device 350 can be expanded by moving the distal connector 399 and the proximal connector 398 relative to each other, wherein the traction element is pushed more laterally relative to the longitudinal axis of the outer tube (catheter) 305 when the distance between the connectors 399, 398 is shortened. In an alternative embodiment, the traction element can be operatively connected to an actuator, such that the actuator moves to bend the traction element, for example, as described in detail below. Figure 11 In one embodiment, the traction elements may be made of shape memory material or other materials, so that when exposed from the outer tube or sleeve, they automatically return to their expanded configuration, such as their shape memory expanded configuration. When such shape memory traction elements are used, they will automatically return to their expanded configuration, such as their shape memory expanded configuration, once exposed. Figure 3B The state is moved to Figure 3C The state.

[0134] The system can have any configuration disclosed herein, such as (i) at least one independently operable and articulated endoscope 315 for viewing lesion 390; (ii) at least one blade channel 310 for at least one independently operable and articulated blade 320, 325 for treating lesion 390; and (iii) a retractor 350, which may be an asymmetrically expandable structure. In some embodiments, the retractor 350 may be asymmetrically expanded toward lesion 390, the expansion including a portion of the retractor 350 pushing tissue around lesion 390 to increase the working area (space) within the body space (lumen) by providing an asymmetric working area and thus facilitating access of lesion 390 to the working area 360 for treatment. The retractor 350 may be located distal to the distal end of the outer tube 305, and the asymmetric working area 360 may be substantially rigid and stable relative to the independently operable and articulated endoscope 315 and at least one blade 320, 325 to facilitate treatment of lesion 390. Treatment of lesion 390 may include, for example, (i) viewing lesion 390 with articulated endoscope 315; and (ii) in the treatment of lesion 390, approaching lesion 390 in an asymmetric working area 360 from multiple directions and angles using at least one tool 320, 325.

[0135] exist Figures 3A-3JIn this embodiment, four traction elements are provided. Two traction elements 353 and 354 are at the base of the traction system and may have an outwardly curved or arcuate shape, or alternatively a generally straight shape, or a precisely and generally straight portion. Two traction elements 351 and 352 expand more radially outward to apply force to the colonic wall where the lesion is located. These traction elements are described in more detail below.

[0136] In some embodiments, the independently operable and articulated endoscope 315 and at least one blade 320, 325 can be independently moved axially within the working area 360, independently rotated within the working area 360, and independently bent in at least one direction within the working area 360. Therefore, in some embodiments, the portion of the retractor 350 that pushes the tissue surrounding the lesion 390 (e.g., retractor elements 351, 352) can be further expanded from the central axis 307 distal to the outer tube 305 compared to other portions of the retractor, thereby providing a working area 360 for treating the lesion 390 that is even larger than a second such structure that expands symmetrically only near the central axis 307 distal to the outer tube 305. This is due to the fact that it is ideal to form the maximum working distance from the instrument tip to the target tissue, which is achieved by altering the colonic configuration in the target area (i.e., remodeling) without overstretching, damaging, or rupturing the colon.

[0137] It should be noted that after expanding the traction system (such as in...) Figure 3C As shown in the diagram, the endoscope 315 can be hinged toward the target lesion 390 in the workspace 360 ​​to improve visibility.

[0138] Figure 3E The illustrations depict multi-directional and multi-angle approach to the lesion 390 and show the steps for positioning the working area 360, endoscope 315, and tools 320, 325 relative to the lesion 390. This is done after dilating the retractor 350 (as in...). Figure 3C As shown in the diagram, the user of the system can observe and approach the lesion 390 from almost any ideal angle using the blades 320 and 325 within the workspace 360. The blade channel 310 travels through the lumens of a multi-lumen catheter or tube, and endoscopic blades or instruments are inserted through the blade channel 310, wherein the distal end of the blade extends distally to the blade channel 310, as shown in... Figure 3D As shown below. Figure 11The embodiments described herein provide a more detailed account of the advantages of these tool channels, and these advantages apply to this embodiment and other embodiments employing tool channels. As mentioned above, it is also conceivable that, in alternative embodiments, endoscopic tools can be inserted directly into the lumen of catheters or tubes without using tool channels, assuming they possess the aforementioned bending / hinged characteristics, which allows them to be operated on without using flexible / hinged tool channels.

[0139] Figure 3F The illustration demonstrates the versatility of the system and shows the steps of removing lesion 390 using blade 320, cutting lesion 390 from an independently selected first angle, while blade 325 can be used to grasp lesion 390 from an independently selected second angle, and endoscope 315 can be used to observe lesion 390 from an independently selected third angle. As shown, the different inclinations of blades 320 and 325 advantageously achieve tissue triangulation to facilitate access, manipulation, and removal of the lesion. After lesion 390 is removed from the gastrointestinal tract 395 using dissecting blade 320, tissue defect 397 remains. It should be noted that in some embodiments, dissecting blade 320 may be in the form of a power surgical instrument, although other resection / cutting blades may also be used. Figure 3G The illustration shows the steps of releasing the excised lesion 390 into the traction device assembly in preparation for the completion of surgery. Figure 3H and Figure 3I The illustration depicts the steps for closing the tissue defect 397, and shows that the blade 320 used for excising the lesion 390 has been replaced by a blade 322 used for closing the lesion. Various methods can be used to close the lesion, such as mechanical (e.g., clamps, staples, or structures), adhesives, electrosurgical energy, etc. Figure 3J and Figure 3K The illustration depicts the steps of using a blade 323 to capture the lesion 390 for removal and to retract the retractor 350 to capture the lesion 390 and contain the lesion 390 within the retractor elements 351, 352, 353, and 354 in preparation for removing the system from the body. This includes the use of an optional retractor sheath 355 or other cannula or sleeve that can slide over the catheter to further encapsulate the lesion held within the retractor elements. Figure 3L It is a view of the closed tissue defect after treatment is completed.

[0140] In some embodiments, such as in Figures 3B-3JAs shown, the system can include a stable but dynamic surgical environment because it can include a reversibly expandable retractor 350 that expands to form a treatment space 360 ​​within the body. The retractor 350 can be configured, for example, to cause expansion distal to the distal end 308 of the outer tube (catheter) 305. In some embodiments, the retractor can at least substantially cause the target tissue 390 to be non-peristaltic for treatment. The retractor 350 can have various configurations to function as, for example, a support structure within the gastrointestinal tract 395. For example, the retractor 350 may include retractor elements 351, 352, 353, 354, together with proximal connectors or interfaces 398 operably connected to the retractor elements 351, 352, 353, 354, whether or not at least substantially attached and / or at least slidably engaged to the retractor elements 351, 352, 353, 354, and a distal connector or interface 399 for distal points operably connected to the retractor elements 351, 352, 353, 354. The distal connector or interface 399 is shown as annular, although it may in practice be any shape ideal to those skilled in the art, such as a cone, hemisphere, sphere, etc., and may or may not include a port for endoscope passage beyond the distal end of the system. As described above, in some embodiments, the proximal connector 398 can be moved toward the distal connector 399, the distal connector toward the proximal connector 398, or the two connectors can be moved toward each other to reduce their distance, thereby pushing the traction element radially outward. The degree of outward expansion of the traction element can be controlled by controlling the distance between the proximal and distal sides of the connectors 398 and 399. As needed, by adjusting the distance between the connectors 398 and 399, the traction device can be repeatedly moved between an expanded position and a retracted position. This controlled expansion of the traction element can also be achieved by operably connecting the proximal end of the traction element to an actuator, as in... Figure 11 In the embodiments described above, the traction element may alternatively be made of a material such as a shape memory material, as described above, so as to automatically expand when exposed from a catheter or cannula.

[0141] In the expanded state of the traction element as shown in the figure, the traction element 351 is a flexible element and has a proximal portion 351a extending from the proximal connector 398 at a first angle, a distal portion 351b extending from the distal interface or connector 399 at a second angle different from the first angle, and a tissue-engaging junction 351c extending between the proximal portion 351a and the distal portion 351b. As shown in the figure, the proximal portion 351a extends at a larger angle relative to the longitudinal axis than the distal portion 351b to provide asymmetrical expansion of the traction element itself. Therefore, the length of the distal portion 351b exceeds the length of the proximal portion 351a. The traction element 352 may be arranged and tilted in a similar manner to the traction element 351, or alternatively, it may have a different configuration and angle. Alternatively, the traction elements 351 and / or 352 may be configured such that the proximal and distal portions have the same length and angle. It should be noted that the traction elements 351 and 352 expand to one side of the longitudinal axis in one direction. This asymmetric expansion forms an asymmetric chamber (working space). The traction elements 351, 352 can extend in an arcuate or curved manner or generally straight, as described above. In some embodiments, the traction elements 351, 352 expand only in one direction relative to the longitudinal axis of the catheter, thus they remain (as in...) Figure 3D (As seen in the orientation) on a longitudinal plane containing the longitudinal axis. In some embodiments, only elements 351 and 352 expand in the expanded state, while elements 353 and 354 constituting the base of the traction device (cage) remain in substantially the same state as when inserted (closed). It should be noted that, as Figure 1 The traction element may be covered with plastic or other materials to form a covered chamber, as described below. Figure 10A In the embodiments described above.

[0142] The traction device 350 can be a reversibly stabilized and reversibly expandable traction device that forms an asymmetric treatment space 360 ​​upon expansion. Additionally, the traction device 350 can be configured to reversibly rigidify a flexible arrangement of the traction device 350, designed to facilitate positioning of the system 300 within the body and for reversible rigidification to allow expansion of the traction device 350. In some embodiments, stabilization of the traction device 350 may include a stabilizer subsystem disclosed herein, having, for example, a generally rigid beam 375 to support the expanding traction device 350. The generally rigid beam 375 may have a generally rectangular, generally circular, or other cross-sectional shape. It may be made of the same or a stiffer material as the traction element. It helps to form a more stable chamber as described herein. As shown, the beam 375 is at the base of the chamber formed by the traction element, from which the traction element extends radially (laterally). The beam 375 may be composed of a rigid element that is exposed when the traction element is exposed from the outer tube for expansion, or alternatively, may travel independently from the outer tube or be formed by the travel of the rigid structure, as described in more detail in the following partial embodiments.

[0143] Figures 4A-4E The figures illustrate details of an alternative system disclosed herein according to some embodiments, showing side, axial, and oblique views of an expanded and contracted configuration, and including a stabilizer subsystem. The figures also illustrate an example of a multi-lumen catheter system similar to... Figures 3A-3K The system is characterized by its reversibly stable and reversibly expandable traction device for minimally invasive treatment of the main body. Figures 4A-4C Side and axial views are shown, illustrating that system 400 may include a flexible outer tube (or catheter) 405 for guiding a tool channel (not shown) and an endoscope (not shown) within system 400 in the same manner as system 300. The flexible outer tube 405 has a lumen, a proximal end (not shown), and a distal end 408. One or more tool channels (not shown) act as guides, through which endoscopic tools (not shown) can be manipulated and positioned in conjunction with the target tissue treatment within the body. Figure 3GThe tool channel 310 manipulates the tools 320, 325 in the same manner. In some embodiments, the traction device 450 may be a reversibly stabilized and reversibly expandable traction device 450, forming a treatment space upon expansion and configured for expansion occurring distal to the distal end 408 of the outer tube 405. The traction device 450 may be designed to reversibly rigidify a flexible arrangement of the traction device 450, which is designed to facilitate positioning of the system in the body and to reversibly rigidify for expansion of the traction device 450. In these embodiments, the reversibly rigidified arrangement of the traction device 450 may be formed by a flexible beam 470 forming at least a substantially rigid beam 475 as structural support for expansion of the traction device 450. In some embodiments, the stabilizer subsystem may include the flexible beam 470 (which may include a flexible tube) and a method for forming at least a substantially rigid beam 475. As disclosed herein, this can include all embodiments disclosed herein, including mechanisms for slidably engaging with at least a substantially rigid rod or beam (e.g., within a flexible rod or beam 470) before the traction device expands. In some embodiments, the terms "rod" and "beam" may be used interchangeably, and in some embodiments, the terms "beam" and "tube" may be used interchangeably. Beam 475 may be constructed and function in the same manner as described above for beam 375 (including alternatives described herein).

[0144] In some embodiments, in each of the disclosed embodiments, the flexible beam disclosed herein may comprise a polymer such as polyimide, polyether block amide (PEBAX), nylon, polyethylene, polyurethane, polyvinyl chloride (PVC), polyether ether ketone (PEEK), or polytetrafluoroethylene (TEFLON). Those skilled in the art will understand that the flexible beam may be a reinforced tube made using components and designs known in the art. The flexible beam may be a flexible tube reinforced, for example, with wire, braid, or coil comprising, for example, a metal (such as stainless steel or nickel-titanium alloy). In some embodiments, the flexible tube may be resistant to torsion and transmit torque. Additionally, in some embodiments, the flexible tube may comprise a combination of flexible and rigid portions. In these embodiments, for example, the flexible portions may be located between the rigid portions. In some embodiments, such a flexible tube may comprise a composite of overlapping tubes joined using any method known to those skilled in the art, including bonding with epoxy resin or cyanoacrylate.

[0145] In some embodiments, any system disclosed herein may include a bridging member for increasing the stability of the traction device. For example, the traction system 450 may include a bridging member 444 configured to maintain the ideal orientation of the traction elements 451, 452, 453, 454 during expansion, the bridging member 444 being operable to stabilize at least two of the four traction elements 451, 452, 453, 454. That is, in Figure 4A In one embodiment, the bridging member 444 is attached to two traction elements 451, 452, which are configured to expand laterally outward to expand or remodel the tissue wall. The bridging member 444 is formed as a transverse structure for the elements 451, 452, thereby restricting lateral movement. As shown, the bridging member 444 may also include a second bridging portion 444a, which connects to the bridge 444 and the traction elements 452 and 453, thereby connecting all four traction elements 451, 452, 453, 454. The upper surface (as shown in...) Figure 4B (As seen from the perspective of the surroundings) can be arc-shaped, as shown in the figure. The bridging member 444 can be a separate component or, on the other hand, integrally formed with one of the two traction elements 451, 452. The bridging member can be made of a material similar to that of elements 451, 452 or can be made of different materials.

[0146] Additional bridging members can be provided on the traction elements 451, 452 to improve stability. It should be noted that one or more bridging members can be used in other traction device embodiments disclosed herein. It should be noted that in some embodiments, the bridging member 444 can be radially outward from the longitudinal axis in the retracted state, as in... Figure 4B and Figure 4D In the middle, but from Figure 4C and Figure 4E The expansion state changes to a more radially downward angle.

[0147] Additionally, another bridging member (or multiple bridging members) may be independent of bridging member 444 in the two lower parts (e.g., in...). Figure 4C (As seen in the orientation) traction elements 453 and 454 extend between each other. These elements 453 and 454 can help to spread the lower part of the traction system, and bridging members, whether independent or connected to bridge 444, can help stabilize these elements, for example, by limiting lateral movement. Such bridging members on the lower traction element can be used in other traction device embodiments disclosed herein.

[0148] In some embodiments, each system disclosed herein may have an outer tube reinforced with wire (such as mesh, braid, etc.) to provide the system with resistance to torsion and torque and to further facilitate the positioning of the system within the body.

[0149] Figure 4D and Figure 4E A perspective view of system 400 in both a convergent and expanded configuration is shown. This multi-lumen concept is presented in these figures for clarity, which show multiple lumens 406a, 406b, 406c in the conduit 405 of system 400. Lumen 406a may accommodate an endoscope (not shown) such as endoscope 315 described above, lumen 406b may accommodate a first working channel 410b for a first endoscopic tool (not shown), and lumen 406c may accommodate a second working channel 410c for a second endoscopic tool (not shown). Lumens 406b and 406c may directly receive the first and second tools therein, or alternatively, receive tool channels (flexible guides) 410b and 410c, such as tool channel 310 described above, for tilting the endoscopic tools slidably positioned therein. Figure 4D The diagram illustrates a system in a convergent configuration. Figure 4E The diagram illustrates the system in an extended configuration. Figure 4E In the illustration, tool channels (flexible guides) 410b and 410c are shown exposed from the catheter 405, thus their distal ends are in a bent state. These tool channels can be further advanced axially to align the bent distal ends with the target tissue.

[0150] System 400 also includes traction elements 451, 452, 453, and 454. The traction system also includes a flexible tube or beam 470 in a collapsing configuration, while in an expanding configuration the traction system has a rigid beam 475 formed by the flexible beam 470. In some embodiments, a rigid beam can be formed from a flexible beam by slidably inserting a rigid rod into the flexible tube constituting the flexible beam. More specifically, in this embodiment, the flexible beam 470 slidably receives a stabilizing or rigidifying structure (such as a rigid rod). This rigidifying (stabilizing) structure can be independently actuated by a user via an actuation control (such as a sliding rod) operably connected to the rigidifying structure, such that distal movement of the actuator causes the rigidifying structure to travel over the flexible beam 470, thereby rigidifying the beam. Alternatively, the flexible beam 470 may have a cavity for slidably receiving the rigidifying structure (such as a rigid rod) therein. Optionally, the structure in either form can be retracted from the flexible beam 470 to restore the system to its original, more flexible state, thereby aiding in the traction system's retraction. The cross-section of beam 470 can be generally circular, although other cross-sectional shapes are conceivable. As in the aforementioned embodiments, the rigid beam restricts the deflection of the distal end of the catheter, which can occur using pressure applied to the distal end by the body cavity wall.

[0151] In many embodiments, the term "tool passage" may be used interchangeably with the terms "working passage" or "tool guide". Additionally, in some embodiments, the passage may be a separate component located inside the outer tube, or it may be a space remaining within the lumen of the outer tube between various separate components located within the outer tube, including, for example, endoscopes, working passages, instruments, guides, etc.

[0152] In example Figures 4A-4E In some embodiments shown, the system may include a stable but dynamic surgical environment because it may include a reversibly expandable traction device 450 that expands to form a treatment space 460 within the body. The traction device 450 may be configured, for example, to cause expansion distal to the distal end 408 of the outer tube 405. In some embodiments, the traction device may at least substantially cause the target tissue 490 to be non-peristaltic for treatment. The traction device 450 may have various configurations to function, for example, as a scaffold within the gastrointestinal tract 495. For example, the traction device 450 may include traction elements 451, 452, 453, 454, together with proximal couplings 498 operably connected to the traction elements 451, 452, 453, 454 (whether at least substantially attached and / or at least slidably engaged to the traction elements 451, 452, 453, 454), and distal couplings or connecting members 499 for distal points operably connected to the traction elements 451, 452, 453, 454. Relative movement of couplings 498, 499 may cause the traction elements to expand as described above. Alternatively, as described above, the traction elements may be operably attached to a proximal actuator that moves the proximal portion relative to a fixed distal portion, thereby bending the traction elements outward. In a preferred embodiment, the traction elements may be made of a hyperelastic material (although other materials are conceivable), or a shape memory traction element may be employed.

[0153] Traction elements 451 and 452 may each have covers 451a and 452a, respectively, which increase the volume of traction elements 451 and 452 by increasing their cross-sectional diameter. (The following is in conjunction with...) Figures 6A-6D The embodiments are described in more detail below.

[0154] Furthermore, the traction device 450 can be a reversibly stabilized and reversibly expandable traction device, which forms an asymmetric treatment space upon expansion. Additionally, the traction device 450 can be configured to reversibly rigidify a flexible arrangement designed to facilitate positioning of the system 400 within the body and to reversibly rigidify it for expansion. In some embodiments, stabilization of the traction device 450 may include stabilizing the traction device 450 using a stabilizer subsystem disclosed herein, the stabilizer having, for example, a beam 475 that is at least substantially rigid, for supporting the expanding traction device 450.

[0155] Figures 5A-5D Side and top views of the system disclosed herein, according to some embodiments, are shown, including side and top views of expanded and contracted configurations. For clarity, tool passages and tools similar to those described herein are omitted. Figure 5A and Figure 5B A side view of system 500 in both a convergent and expanded configuration is shown, and an example of an asymmetric workspace that can be formed during endoscopic surgery using system 500 is illustrated. Additionally, as in Figure 5B As shown in the preceding embodiments, the expansion can occur on the proximal cavity side 559 of the rigid beam 575 by an amount disproportionately larger than that on the cavity side 557 of the rigid beam 575, thereby increasing the treatment or working space 560, which has asymmetrically distributed space in the vicinity of the rigid beam 575. In some embodiments, the various traction systems disclosed herein can expand on the proximal cavity side 559 of the rigid beam 575 by at least five times the amount compared to the distal cavity side 557 of the rigid beam 575. Additionally, in some embodiments, the expansion may occur on the near-cavity side of the beam at least 1.1 times, at least 1.3 times, at least 1.5 times, at least 2.0 times, at least 2.5 times, at least 3.0 times, at least 3.5 times, at least 4.0 times, at least 4.5 times, at least 5.0 times, at least 5.5 times, at least 6.0 times, at least 6.5 times, at least 7.0 times, at least 7.5 times, at least 8.0 times, at least 8.5 times, at least 9.0 times, at least 9.5 times, at least 10.0 times, or any increment of 0.1 times within this range, compared to the outer side of the beam's cavity.

[0156] In example Figures 5A-5DIn some embodiments shown, the system may include a stable but dynamic surgical environment because it may include a reversibly expandable traction device 550 that expands to form a treatment space 560 within the body. The traction device 550 may be configured, for example, to expand distally to the distal end 508 of the outer tube 505. In some embodiments, the traction device may at least substantially cause the target tissue 590 to be non-peristaltic for treatment. The traction device 550 may have various configurations to function, for example, as a scaffold within the gastrointestinal tract 595. For example, the traction device 550 may include traction elements 551, 552, 553, 554, together with proximal couplings 598 operably connected to the traction elements 551, 552, 553, 554 (whether or not at least substantially attached to and / or at least slidably engaged to the traction elements 551, 552, 553, 554), and distal couplings or connectors 599 for distal points operably connected to the traction elements 551, 552, 553, 554. The couplings 588, 599 may be relatively movable to allow the traction elements 551, 552 (and optionally elements 553, 554, in which they are expandable embodiments) to expand in the same manner as the couplings described above (e.g., couplings 198, 199). Alternatively, the traction elements may be fixedly attached at their distal ends to, for example, distal coupling 599, and operably connected at their proximal ends to an actuator, or may be made of a self-expanding material (such as a shape memory material), as in the various embodiments described herein. Figure 5B In the embodiments described above, each traction element 551, 552 expands into a generally uniform (symmetrical) arcuate shape, although alternatively they may each be configured to expand into a non-uniform (asymmetrical) shape, as in the embodiments described above. It should be noted that in this embodiment where traction elements 551, 552 individually expand into a generally symmetrical shape, the expansion is on one side of the multi-lumen outer tube 505, i.e., only to one side of the longitudinal plane through which the longitudinal axis passes. Therefore, their expansion relative to the traction system is asymmetrical, while their individual expansion shapes may be symmetrical. Traction elements 553, 554 have a slightly curved configuration similar to traction elements 353, 354. Positioned as a lower element, such as a cage (e.g., in… Figure 5AThe traction elements 553 and 554 (as seen in the orientation) may have limited expansion or may be configured such that they do not expand when the traction system expands but remain in substantially the same position. In this embodiment, the expanded traction elements 551 and 552 may be operatively connected to an actuator, and the lower elements 553 and 554 may be fixedly (immovably) attached to a conduit, for example, to fixed proximal and distal connectors. This attachment alternative is also applicable to other embodiments disclosed herein, in which the lower traction elements remain substantially the same in both the retracted and expanded states of the traction system.

[0157] Furthermore, as described above, the traction device 550 can be a reversibly stabilized and reversibly expandable traction device, forming an asymmetric treatment space 560 upon expansion. Additionally, the traction device 550 can be configured to reversibly rigidify a flexible arrangement designed to facilitate positioning of the system 500 within the body and to reversibly rigidify it for expansion. In some embodiments, stabilization of the traction device 550 may include stabilizing the traction device 550 using a stabilizer subsystem disclosed herein, having, for example, a at least substantially rigid beam 575 for supporting the expanded traction device 550. Figures 5A-5D In the embodiments, the rigid beam 575 can be provided in a permanently rigid state (e.g. Figure 1 The beam (175) can be formed, or alternatively, by using the actuator described above to allow the rigidified (stabilized) structure to travel on the flexible element or enter the cavity of the flexible tubular member. In both cases, the beam rigidifies the traction system in an asymmetric configuration, thereby creating a stable asymmetric workspace to simplify the accessibility and operation of the target tissue.

[0158] Figures 6A-6D Side views of the system disclosed herein, according to some embodiments, are shown, including side views and cross-sections of the system in both expanded and contracted configurations. These figures illustrate an example of a multi-lumen catheter system having a reversibly stabilizing and reversibly expanding traction device for minimally invasive treatment of the main body. Figure 6A and Figure 6BA side view is shown, illustrating that system 600 may include a flexible outer tube 605 within system 600 for guiding one or more tool channels (not shown) similar to those described above, and an endoscope (not shown) similar to those described above. The flexible outer tube 605 has a lumen, a proximal end extending into a handle 680, and a distal end 608. During target tissue treatment within the body, each tool channel acts as a guide through which tools (not shown) can be manipulated. That is, the tool channels are configured to receive and reorient tools inserted therethrough, as in the embodiments described above. In some embodiments, the retractor 650 may be a reversibly stable and reversibly expandable retractor 650, thereby forming a treatment space 660 upon expansion and configured to expand distally to the distal end 608 of the outer tube 605. The retractor 650 may be designed to reversibly rigidify a flexible arrangement of the retractor 650, which is designed to facilitate positioning of the system within the body and to reversibly rigidify the retractor 650 for expansion. In these embodiments, the reversibly rigidified arrangement of the traction device 650 can be formed by flexible beams 670 into at least substantially rigid beams 675, serving as structural support for the expansion of the traction device 650.

[0159] The handle 680 at its proximal end includes an inlet for operatively engaging the system with external components, such as an inlet 609 for an endoscope (not shown) and / or a cutting tool (not shown). The handle 680 is also operatively connected to the proximal end of the outer tube 605 and may have an outlet from the handle 680 into the outer tube 605. In some embodiments, the system may include a stabilizer subsystem. For example, a stabilizer actuator 612 may be included on the handle 680 to reversibly rigidify the flexible beam 670 to form at least a substantially rigid beam 675 for expansion of the traction device 650. A traction device actuator 614 may be included on the handle 680 for reversibly expanding the traction device 650. Figure 6A and Figure 6B The traction device 650 is shown in a retracted (non-expanded) state.

[0160] Figure 6C and Figure 6D A perspective view of system 600 in an expanded configuration is shown. The expanded configuration has a rigid beam 675 formed of a flexible beam, which is typically present in the retracted state for positioning within the body. In some embodiments, the rigid beam 675 is formed of a flexible beam by inserting a rigid member (e.g., a rod) slidably over the flexible member constituting the flexible beam, or alternatively inserting it into the flexible member to transform the flexible beam into a stiffer, more rigid beam. Figure 6B and Figure 6DAs shown, the stabilizer actuator 612 is operably connected to a rigid member (stabilization structure), such as a rigid rod 672, via a rod connector 613. Therefore, movement of the actuator 612 from its proximal position in a first direction (e.g., the distal direction) will cause the stabilization structure 672 to travel over the flexible beam 670 to rigidify it (forming beam 675), thereby stabilizing the traction system. Conversely, movement of the actuator 612 in the opposite direction (e.g., the proximal direction) to its proximal position will retract the stabilization structure 672 from the flexible beam 670, thereby restoring the flexible beam 670 to its more flexible state.

[0161] The traction actuator 614 is operably connected to the traction elements 651, 652 via element coupling 611. In some embodiments, the stabilizer actuator 612 and / or the traction actuator 614 may reversibly engage with the handle 680, such that the stabilizer actuator 612 and / or the traction actuator 614 can be reversibly secured in place relative to the handle 680. In some embodiments, the stabilizer actuator 612 and / or the traction actuator 614 may be multi-positioned, having at least three positions for the expansion and / or retraction of the traction. In some embodiments, the stabilizer actuator 612 and / or the traction actuator 614 may have a plurality of ratchet teeth 616 for providing a plurality of positions for reversibly securing the stabilizer in place during the expansion or retraction of the traction and / or for reversibly securing the traction. Figure 6B As shown, in the proximal position of the traction actuator 614, the coupling 611 is in the proximal position and the traction element is in the non-expanded position. To expand the traction element, the traction actuator 614 is slid distally to move the attached coupling 611 distally (e.g., ...). Figure 6D As shown in the diagram, this causes the attached elements 651, 652 to bend outwards because they are connected to the distal connector 699 at their distal ends.

[0162] Those skilled in the art will understand that the handle can be any of a variety of shapes to provide an ideal or ergonomic position for system operation. By way of example, the traction actuator can be configured as a finger-activated button on the handle 680 that slides back and forth across a groove in the handle 680 to cause the traction element to expand or collapse. Mechanisms for dynamically adjusting or releasing the traction state can be provided along the handle groove to lock the traction element in place when the traction actuator button is not pressed. A button on the opposite side of the handle can be operatively connected to a stabilizer subsystem to convert a flexible beam into a rigid beam or vice versa. The handle can have an axially oriented internal channel, for example within the handle body, and communicate with a port for inserting a cutting tool or endoscope into an outer tube. In some embodiments, the handle can be configured to require activation of the stabilizer actuator before the traction actuator can be activated, thereby acting as a “safety” mechanism in system operation.

[0163] Therefore, in, for example Figures 6A-6D In some embodiments shown, the system may include a stable but dynamic surgical environment because it may include a reversibly expandable retractor 650 that expands to form a treatment space or work chamber 660 within the body. The retractor 650 may be configured, for example, to expand distally to the distal end 608 of the outer tube 605. In some embodiments, the retractor may at least substantially cause the target tissue 690 to be non-peristaltic for treatment. The retractor 650 may have various configurations to function as a scaffold, for example, within the gastrointestinal tract 695. For example, the traction device 650 may include traction elements 651, 652, 653, 654, together with proximal connectors 698 operably connected to the traction elements 651, 652, 653, 654 (whether or not at least substantially attached and / or at least slidably engaged to the traction elements 651, 652, 653, 654), and distal connectors or couplings 699 for distal points operably connected to the traction elements 651, 652, 653, 654. More specifically, at the proximal end of the distal connector 699, the distal ends of the traction elements 651, 652 are attached within a slot or opening. The proximal ends of the traction elements 651, 652 extend proximally through a lumen in a conduit to attach to a movable coupling 611. Thus, with the distal ends of the traction elements 651, 652 fixed, distal movement of the coupling 611 pushes the traction elements outward, as shown in the figure. Traction elements 653, 654 may be attached to distal connector 699 and, in some embodiments, to movable connector 611 if partial expansion of these traction elements 653, 654 is desirable; or alternatively, may be fixedly attached to the catheter if expansion is not desired and expansion is confined to traction elements 651, 652.

[0164] It should be understood that, used for Figures 6A-6D The coupling for expanding the traction element disclosed herein can be used in other embodiments of the traction system disclosed herein. Furthermore, it should be understood that alternative methods of expanding the traction element may be employed, including, for example, providing relatively movable couplings 698, 699 to expand the traction elements 651, 652 (and optionally 653, 654) in the same manner as the couplings described above (e.g., couplings 198, 199). Alternatively, the traction element may also be made of a self-expanding material (such as a shape memory material).

[0165] exist Figures 6A-6D In the embodiments described above, each traction element 651, 652 expands into a generally symmetrical arcuate shape, although alternatively they may be configured to expand into an asymmetrical shape, as in the embodiments described above. It should be noted that in this embodiment where the traction elements 651, 652 expand into a generally symmetrical shape, their expansion is on one side of the longitudinal axis of the multi-lumen outer tube (catheter) 605. Therefore, the expansion of the traction system is asymmetrical, while their individual expansion shapes are generally symmetrical. The traction elements 653, 654 may optionally expand slightly outward in a curved configuration. The traction element 651 may have a cover thereon. Similarly, the traction element 652 may have a cover thereon. This cover extends over the middle portion of the elements 651, 652 and may be in the form of a heat-shrink tube. This cover helps control the expansion by providing a smaller flexible area. This cover is similar to... Figure 4D , Figure 4E Covers 451a and 452a in the embodiments.

[0166] As described herein, the traction device 650 may be a reversibly stabilized and reversibly expandable traction device, which, upon expansion, forms an asymmetric treatment space 660. Additionally, the traction device 650 may be configured to reversibly rigidify a flexible arrangement of the traction device 650, designed to facilitate easy positioning of the system 600 within the body and to reversibly rigidify it for expansion of the traction device 650. In some embodiments, stabilization of the traction device 650 may include a mechanism for stabilizing the traction device 650 using a stabilizer subsystem disclosed herein, the stabilizer having, for example, a at least substantially rigid beam 675 for supporting the expanded traction device 650.

[0167] The rigid rod can be a flat member comprising a rigid material (e.g., stainless steel or another metal or alloy) that can slide inside and outside the inner diameter of the flexible tube (lumen). Therefore, the stabilizer subsystem can have a flexible or rigid beam that slides proximally (i.e., via the anus) into the flexible tube by reverse pulling on the rigid rod via a mechanism operably connected to a handle. The rigid rod can be pushed forward (i.e., via the mouth) into the flexible tube to rigidify and straighten it, as in the embodiments described above. By pushing the rigid rod through the length of the flexible tube, the flexible tube or flexible beam becomes rigid and straight, effectively resulting in the entire traction device structure becoming at least substantially rigid and straight, thereby stabilizing the traction system. Those skilled in the art will understand that in some embodiments, any mechanism that reversibly rigidifies the flexible component within the body can be employed. For example, the flexible tube or flexible beam may also comprise a series of rigid tubes having a flexible, non-stretchable cable passing through the lumen of the tube. When the cable is slack, this series of rigid tubes can independently utilize compressible components (such as springs) between each rigid tube in the series to provide a flexible, non-overlapping configuration. When the cable is taut, the compressible components compress and the rigid tubes overlap, thereby transforming the flexible beam into a rigid beam. This alternative mechanism can be used in any of the embodiments described herein.

[0168] The reversibly stabilized traction device described herein can be used to position the workspace at the treatment site of the target tissue because it can be made flexible for positioning and subsequently rigid for expansion of the traction device. During the introduction of the system disclosed herein into a tortuous body cavity (e.g., the colon), the traction device can be unexpanded and flexible. This flexibility allows the traction device to bend to conform to the curvature in the tortuous body cavity, making it easy to travel without causing trauma to the lumen. The rings holding the traction elements together can also have lumens that allow the passage of a guide device (e.g., an endoscope). In this embodiment, when the traction device is in a flexible mode for introduction, such as when the system is being advanced, these rings can slide freely over the guide device. In some embodiments, the lumen of the rings can be large enough relative to the diameter of the guide device to allow the system to tilt and translate on the guide device, thereby facilitating conformation of the system to the curvature of the guide device during transoral or transanal travel of the system. Once the traction device has been advanced to the target position in the lumen, the flexible beam of the traction device can be straightened and rigidified as described herein. Because the system can be flexible and torsional rigid, the proximal axis of the handle can be easily rotated relative to the position of the target lesion as needed.

[0169] The traction elements may be in at least one pair, which are pre-formed to have their highest points pointing outward at an ideal angle. In some embodiments, the angle between the traction elements and each other on one side of the rigid beam may range from about 45 degrees to about 135 degrees, or from about 60 degrees to about 120 degrees, with the apex of the angle being the central axis of the rigid beam, as can be seen in the accompanying drawings provided herein. In some embodiments, the angle between the traction elements is about 90 degrees. During expansion, these traction elements bulge outward disproportionately on one side compared to the other traction elements, resulting in asymmetrical expansion of the traction device. The at least substantially rigid beam prevents or inhibits deformation of the traction device during the generation of forces on the traction device during expansion and prevents or inhibits bending of the catheter tip. These forces include forces resulting from the asymmetrical outward expansion of tissue, and initial forces applied to the traction elements to create an asymmetrical working space.

[0170] In some embodiments, the target lesion may be located on the side of the most dilated traction element, thereby maximizing or increasing the distance between the lesion to be treated and the entry point for introducing the endoscope and tools into the workspace. The endoscope and tools can be manipulated independently, for example, to approach the lesion at a wider range of angles than currently clinically available using existing technology systems. This enhanced maneuverability improves the field of vision of the lesion and the ability to manipulate and resect it. For example, a gripper can be inserted into the workspace from the instrument channel and bent toward the polyp, gripping the polyp and pulling the tissue to expose the pedicle of the polyp for dissection via the multi-channel system disclosed herein using a dissecting tool. Sometimes, it may also be desirable to reduce the distance between the lesion to be treated and the entry point for introducing the endoscope and tools into the workspace. For example, it may be desirable to position the lesion on at least one side of the dilated traction element to better align the lesion with the endoscope channel, which is generally parallel to the luminal wall. This configuration can be clinically optimized while pulling the polyp toward the most dilated side with the gripper. In this embodiment, the dissecting tool can travel through a channel at the pedicle of the polyp and remove the pedicle of the polyp where the dissecting tool is attached to the lumen wall, while the position of the endoscope provides a close view of the polyp pedicle to help identify the ideal edge for dissection.

[0171] Any system disclosed herein may include a bridging member that provides structural support to increase the stability of the traction device. The bridging member may include any configuration conceivable to those skilled in the art for providing additional support, such as a bracket for enhancing or reinforcing the stability and stiffness of the expansion and closing device. For example, bridging member 644 is configured to maintain the ideal orientation of traction elements 651, 652, 653, 654 during expansion, and bridging member 644 is operable to stabilize at least two of the four traction elements 651, 652, 653, 654. As shown in the figure, the bridging member extends radially outward in the closed state of the traction device 650 and further distally in the expanded state (see Figure 1). Figure 6D (Extended meaning). Although only one bridging member 644 is shown, it is conceivable that more than one bridging member may be provided to connect traction elements 651, 652. Additionally, one or more bridging members may be provided to connect traction elements 653, 654, thereby stabilizing these elements and also limiting their lateral movement. Furthermore, in some embodiments, each system disclosed herein may have an outer tube, such as an outer tube 605, which is reinforced with wire (e.g., mesh, braid, etc.) to provide the system with resistance to torsion and torsional control, and further facilitate the positioning of the system within the body. In some embodiments, the bridging member 644 may be configured to reduce resistance from surrounding tissues during use. For example, as... Figure 6A and 6B As shown, by designing the bridging member 644 to include a forward member 644a that is tilted to facilitate forward movement through the mouth, and a reverse member 644b that is tilted to facilitate reverse movement through the anus, the bridging member 644 can be configured to facilitate the movement of the system in the gastrointestinal tract.

[0172] A bridging member can be connected to the traction elements, for example, to maintain the ideal orientation of the traction elements as they expand to abut against gastrointestinal tissue. The bridging member also expands outward as the traction device expands. In some embodiments, the bridging member is operatively connected only to the traction elements that expand the most, such as traction elements 651, 652 in FIG. 6, which may be the elements that generate the most induced force on the traction device due to the asymmetrical pressure applied, thus creating an asymmetrical working space during expansion. In some embodiments, the bridging may be designed to bend to prevent the traction elements from converging toward each other or bending away from each other, while also providing some elasticity or resilience to gently conform to the tissue. Those skilled in the art will understand that the bridging member can comprise any suitable material that provides the desired properties. For example, in some embodiments, the bridging may be constructed of bent nitinol wire. The ends of the nitinol wire can be connected to the traction elements using any manufacturing process that those skilled in the art deem suitable for in vivo use as disclosed herein, including, for example, tubular connections, adhesives, or welding.

[0173] Figure 7A cross-sectional view of the distal end of the outer tube of the system 700 disclosed herein according to some embodiments is shown, along with the components for the expansion and retraction of the retractor. The figure shows the distal end 708 of the outer tube 705. The distal end 708 includes a slot guide 755 for controlling the orientation of the expanding retractor element 751, and a port 754a for operatively receiving / supporting the lower retractor element 754. Another slot guide (not shown) may be provided for controlling the orientation of another retractor element. A lumen 706c may be provided for receiving a working channel 710c for insertion of a tool channel, which is used for insertion of a working instrument as described above or alternatively for direct insertion of a working instrument in the absence of a tool channel. The lumen 706 of the outer tube 705 may also be used to guide an endoscope (not shown) through an outlet at the distal end 708. In some embodiments, only a portion of the retractor components 751, 754, 770 are shown to partially illustrate the relationship between the outer tube 705 and the retractor. The traction device can be configured, for example, for expansion at the distal end 708 of the outer tube 705. For example, the traction device may include four traction elements, as in the embodiment described above, where traction elements 751 and 754 are shown due to the cross-sectional view and two other traction elements are not shown. A proximal coupling 798 is operatively connected to the four traction elements, whether or not it is at least substantially attached to and / or at least slidably engaged to the traction elements. The traction device can be configured to reversibly rigidify a flexible arrangement of the traction device designed to facilitate positioning of the system 700 within the body and to reversibly rigidify it for expansion of the traction device within the body. In some embodiments, stabilization of the traction device may include stabilizing the traction device using a stabilizer subsystem disclosed herein, having, for example, a flexible beam 770, which can be converted into at least a substantially rigid beam 775 by slidably engaging a rigid or substantially rigid component 772 disclosed herein in an operative connection to support the expanding traction device. The flexible beam 770 can be rigidified in the manner described herein with respect to other embodiments of the flexible beam.

[0174] Figure 8 The embodiments shown are similar except that a floating channel system is provided in this embodiment. Figure 7 A sectional view. That is, Figure 8The distal end of the outer tube of the system disclosed herein, according to some embodiments, is shown, wherein the components of the system can float within the outer tube to increase flexibility for positioning the system within the body. The figure shows the distal end 808 of the outer tube 805. The distal end 808 includes a slot guide 855 for controlling the orientation of the dilation traction element 851, and an opening 811 for the lower traction element 854. A second slot guide and a second opening (not shown) are for receiving another upper and lower traction element, respectively. A lumen 806c may be used to receive a working channel 810c, which receives a tool channel for guiding a working instrument or alternatively, directly receiving a working instrument. The lumen 806 of the outer tube 805 is for guiding an endoscope 815. Only a portion of the tractioner components 851, 854 are shown to partially illustrate one embodiment of the relationship between the outer tube 805 and the tractioner. The tractioner may be configured, for example, to cause dilation distal to the distal end 808 of the outer tube 805. For example, the traction device may include four traction elements in the same manner as described above, with only two (elements 851 and 854) shown. A proximal coupling 898 is operatively connected to the traction elements, whether or not it is at least substantially attached to and / or at least slidably engaged to them. The traction device may be configured to reversibly rigidify a flexible arrangement of the traction device designed to facilitate positioning of the system 800 within the body and to reversibly rigidify it for expansion of the traction device within the body. In some embodiments, stabilization of the traction device may include stabilizing the traction device using a stabilizer subsystem disclosed herein, having, for example, a flexible beam 870, which can be converted into at least a substantially rigid beam in any manner described herein with respect to rigidifying the flexible beam (e.g., slidably engaged with a rigid or substantially rigid component 872 disclosed herein, operatively connected to the flexible beam 870 to support the expansion of the traction device). As in other embodiments described herein, an actuator may be employed that is operatively coupled to the rigidified structure to cause the rigidified structure to travel relative to the flexible beam 870 and to retract it.

[0175] The traction element can move between a retracted insertion state and an expanded state to form an asymmetrical working chamber, as in the embodiments described above.

[0176] During use of system 800, the working channel 810c may be a floating channel that (i) is at least substantially attached to the lumen of the outer tube at a first proximal position (not shown) and a first distal position 806c, and (ii) floats at least substantially between the first proximal position (not shown) and the first distal position 806c in the lumen 806 of the outer tube 805. Similarly, during use of system 800, endoscope 815 may be a floating endoscope 815 that (iii) is at least slidably attached to the lumen 806 of the outer tube 805 at a second proximal position (not shown) and a second distal position 806a, and (iv) floats at least substantially between the second proximal position (not shown) and the second distal position (806a) in the lumen 806 of the outer tube 805. Additionally, during use of the system 800, the working channel 810c and endoscope 815 also constitute independently floating components in a floating arrangement (v), which, relative to the system 800 on a second such system having independent lumens for the cutting tool and endoscope, provides at least significantly increased flexibility. These independent lumens are fixed to the lumen along the entire length of the outer tube between the proximal and distal ends. This increased flexibility facilitates the positioning of the system 800 within the body for easy treatment of target tissue. In some embodiments, by inserting the endoscope 815 through a dedicated port (not shown) for the endoscope 815, the endoscope 815 can be at least slidably attached to the distal end 808 of the outer tube 805, thus the system 800 is configured to be generally limited to sliding in and out of the distal end 808 of the outer tube 805. Additionally, in some embodiments, the endoscope 815 may also be allowed to float in a port 806a that is significantly larger than the endoscope 815, thereby providing space for sliding of the endoscope and for lateral movement.

[0177] Figure 9A and Figure 9B A side view is shown of a working channel and / or floating channel, according to some embodiments, that can be used to guide the tool disclosed herein. As described herein, during the positioning of the system in the body, the working channel can be aligned with... Figure 8 The same or similar method is used to make a portion of it float within the lumen of the outer tube, thereby further increasing the flexibility of the outer tube. In some embodiments, the terms "channel," "floating channel," and "tool channel" may be used interchangeably. Each tool channel may be operatively connected to the handle 980 in the same or similar manner as the operative connections disclosed herein for traction actuators and / or stabilizer actuators. Figure 9A The front end 910a of the tool channel 10 in a generally extended state is shown, while Figure 9BThe tip 910a of the tool channel 910 is shown in a generally bent state, such that the distal tip 910a is deflected in a manner generally perpendicular to the central axis of the tool channel 910. System 900 is consistent with other systems disclosed herein and may include, for example, an inlet 909, a tool channel 91 inserted through the inlet 909, a wire connector 911, ratchet teeth 916, a drawwire 917 for bending or extending the tip 910a of the working channel 910, and a wire actuator 919. The ability to bend the tip 910a of the tool channel 910 facilitates independent positioning of a tool (not shown) in target tissue treatment within the body. In some embodiments, the wire actuator 919 may be multi-positioned, having at least three positions for bending the tip 910a of the tool channel 910. In some embodiments, the wire actuator 919 may have teeth that engage with one of a plurality of ratchet teeth 916 in the handle housing 915 to provide multiple positions for reversibly securing the bent tip 910a in place during use of the tool (not shown) in the treatment of target tissue in the body. More specifically, when the wire actuator 919 is actuated from... Figure 9A As its distal position moves to a more proximal position, it pulls the line 917 attached to the front end 910a of the tool channel 910 proximal to tighten the front end 910a, causing it to bend. Figure 9B The configuration is as follows. The engagement of the teeth 916 of the actuator 919 maintains the position of the actuator 919 and thus maintains the bent state of the front end 910a. It should be noted that although the figure shows the front end bent at approximately 90 degrees relative to the longitudinal axis of the tool passage 910, bending to other angles is conceivable. Furthermore, in some embodiments, the actuator 919 is used to control the angle of the front end 910a by controlling the degree of proximal retraction of the draw wire 917, wherein further retraction causes the front end 910a to bend further and smaller retraction causes the front end 910a to bend to a smaller degree. More than one tool passage can be provided, and multiple tool passages can be controlled using the actuator 919, or alternatively, separate actuators 919 can be provided for each tool passage. Furthermore, various mechanisms can be used to lock the actuator 919 in place to maintain the bent state of the tool passage front end.

[0178] Other mechanisms can also be used to control the tool channels. Alternatively, one or more tool channels may have a pre-bent (pre-curved) tip that is generally straight when in the insertion state to restrict the multilumen tube (conduit) and returns to the pre-bent state when exposed from the conduit's restriction.

[0179] As described herein, these channels can be configured to control the trajectory and position of an instrument (such as a clamp) within a workspace formed by a puller. In some embodiments, the channel can be individually removed from or inserted through the outer tube of the system, either inside or via another channel that can be used as a guide. These channels can have any size that a person skilled in the art would consider suitable for use in the system described herein. For example, the channel can have a diameter ranging from about 1 mm to about 5 mm, from about 2 mm to about 4 mm, from about 1 mm to about 3 mm, or any range therein. Of course, the length of the channel should complement the length of the system. For example, the channel can have a length ranging from about 40” (40 inches) to about 72”, from about 48” to about 60”, from about 42” to about 70”, from about 44” to about 68”, or any range in 1” increments.

[0180] These channels may also include any material or configuration known to those skilled in the art as suitable for use as described herein. For example, these channels may include a single polymer layer, multiple polymer layers, wire reinforcement layers, or combinations thereof. In some embodiments, the channel may include (i) a polymer inner layer for a smooth cavity surface along the inner diameter of the channel, such as polytetrafluoroethylene (TEFLON) or polyethylene; (ii) a metal, such as stainless steel, nickel-titanium alloy, or cobalt-chromium alloy, as reinforcing wires in a configuration of a braided, mesh, or helical coil layer covering the inner layer; and (iii) an outer polymer layer, such as polyether block polyamide (PEBAX), polyurethane, polyethylene, siloxane, polyvinyl chloride (PVC), or nylon.

[0181] In some embodiments, the channel may be configured such that the outer layer (iv) is most rigid in the proximal portion of the channel (i.e., the first 12” to 24” of the channel) having a hardness of about 60 Shore D to about 80 Shore D; (v) has moderate rigidity in the middle portion (i.e., the next 12” to 36” of the channel) having a hardness of about 50 Shore D to about 72 Shore D; and (vi) is most flexible in the distal portion (i.e., the next 0.5” to 2” of the channel) having a hardness of about 20 Shore D to about 50 Shore D. In some embodiments, the distal portion of the channel may be curved and may be an approximately 1” portion distal to the channel. In some embodiments, these channels may have a rigid portion proximal to the distal portion to keep this flexible portion straight when a bending moment is present at the tip (e.g., when an instrument is inserted through the channel to grip tissue during gastrointestinal treatment). The length of the rigid portion of the channel may range, for example, from about 1 cm to about 10 cm, from about 2 cm to about 8 cm, from about 3 cm to about 7 cm, from about 4 cm to about 6 cm, or any range in increments of 1 cm. The rigid portion may include a rigid tube comprising a reinforcing material, such as stainless steel or nickel-titanium alloy, or a polymer, such as PEEK or polyimide embedded between an outer polymer layer and an inner polymer layer. The rigid portion may have any suitable length for performing its function in the system. In some embodiments, the rigid portion may have a length ranging from about 0.001” to about 0.005”.

[0182] The thickness of the inner channel layer can be in the range of about 0.0005” to about 0.005”, about 0.001” to about 0.004”, about 0.002” to about 0.003”, about 0.001”, or any range thereof in increments of 0.0005”. The thickness of the reinforcing layer can be in the range of about 0.001” to about 0.006”, about 0.002” to about 0.005”, about 0.003” to about 0.005”, about 0.001” to about 0.003”, about 0.002”, or any range thereof in increments of 0.0005”. The thickness of the outer layer can be in the range of about 0.003” to about 0.012”, about 0.004” to about 0.010”, about 0.005” to about 0.009”, about 0.005” to about 0.008”, about 0.010”, or any range thereof in increments of 0.001”.

[0183] With regard to buckling at the distal end of the channel, a side lumen with a drawwire embedded between the inner and outer layers may be present. In some embodiments, the side lumen may be located between the inner and reinforcing layers, or the side lumen may be part of the inner layer. The side lumen may be made of any material that a person skilled in the art would consider suitable for use in the system disclosed herein. For example, the material may include a polymer of flexible tubing, such as polytetrafluoroethylene (TEFLON) or polyethylene. In some embodiments, the side lumen continues in the distal portion of the channel parallel to the channel length and then spirally continues to the proximal portion of the distal portion of the channel. The pitch of the helix may vary, for example, from about 1.0” to about 6.0”, from about 2.0” to about 5.0”, from about 1.0” to about 4.0”, from about 3.0” to about 5.0”, from about 4.0”, or any range therein in increments of 0.1”. By giving the side lumen a spiral path, the wire tension can be distributed around the shaft, allowing the shaft to rotate smoothly in any orientation and remain at least substantially stable. In some embodiments, the pull cable extends from the distal end of the side lumen into the side lumen from the line actuator in the handle, forming a loop near the rigid ring. The rigid ring (stainless steel, 0.002-0.005” thick, 0.040”-0.25” long) returns at its distal end into the side lumen and into the handle, where it is attached to the line actuator. The handle is operably connected to the channel, having a housing and a lumen communicating with the channel. The line actuator is operably attached to the pull cable inside the housing and has a button on the outside of the handle, allowing the line actuator to slide backward (proximal) and forward (distal) on the handle to pull and push the cable. Pulling the cable bends and rigidifies the tip, while pushing the cable relaxes and straightens the tip. The slider has a mechanism for locking the wire actuator in place (e.g., using complementary ratchet teeth and a wire actuator mechanism on the housing). When the wire actuator button is pressed, the ratchet teeth can release and unlock the cable. In some embodiments, the tip can bend from about 0 degrees to about 150 degrees. In another embodiment, the tip can bend from about 45 degrees to about 100 degrees. The tip can be designed to be flexible in bending but rigid in torsion, thereby allowing the channel to bend along the anatomy and allowing the handle to rotate from the outside of the body during use, thereby transmitting torque to rotate the tip in the desired direction.

[0184] The tool (working) passage located within the outer tube provides a multi-lumen conduit with maneuverable channels for independently manipulating tools from outside the body to access the workspace formed by the expansion of the auger. In some embodiments, one to three flexible tubes travel within the outer tube and can be detached from it, as described herein, contributing to the system's flexibility. In some embodiments, these flexible tubes may be attached at two points: (i) a proximal connector to the auger, which may be an annular structure with a port at the distal end of the outer tube; and (ii) at the proximal end of the shaft, for example at the handle. This can provide a floating arrangement within the outer tube, which is unique in that it restricts the ends of the flexible tubes while allowing them to float substantially freely within the outer tube to enhance the system's flexibility.

[0185] In some embodiments, two inner tubes may be located adjacent to the inner surface of the outer tube to effectively provide three independent channels. These two inner tubes may serve as two independent tool channels, while the space between the outer tubes of these first two channels serves as a third channel. This third channel may be significantly larger than the other two channels. Each working channel of the first two tool channels may have an inner diameter, for example, in the range of about 2 mm to about 6 mm, about 3 mm to about 5 mm, or any range therein. In some embodiments, the diameter of the first two tool channels may be about 4 mm. Each channel may be designed to accommodate an endoscope (such as a colonoscope) and endoscopic tools, including, for example, forceps, grippers, applicators, dissectors, snares, motorized surgical probes, or rings. In some embodiments, the largest diameter channel may be the channel for the endoscope.

[0186] Channels for receiving endoscopes may be designed to have an inner diameter, for example, in the range of about 5 mm to about 15 mm, about 6 mm to about 12 mm, about 11 mm to about 14 mm, about 5 mm to about 10 mm, about 8 mm to about 13 mm, or in any range in 1 mm increments. The inner tube may contain any suitable material known to those skilled in the art for use in the purposes stated herein, as well as composites thereof. For example, the inner tube may contain a fluoropolymer (such as TEFLON) to provide lubrication to facilitate the passage and movement of instruments or endoscopes. Other materials that may be used include, for example, polyethylene, polypropylene, polyether block polyamide (PEBAX), nylon, polyurethane, siloxanes, and combinations thereof, each of which may also be used as a lubricating coating. These tubes may also include reinforcing wires, such as braids, meshes, or spiral coils, each of which may be embedded within the tube.

[0187] Those skilled in the art will understand that the systems disclosed herein can be used as surgical kits for floating multi-lumen catheter traction systems, which have reversibly stabilizing and reversibly expanding traction devices for minimally invasive treatment of the main body. In these embodiments, the system may include a flexible outer tube for guiding a floating channel and a floating endoscope in a generally floating arrangement within the system. Due to the structure of the floating system, the system is highly flexible, and thus the flexible outer tube can be highly flexible and have a lumen, proximal end, and distal end; additionally, the floating channel can act as a guide for manipulating instruments during target tissue treatment within the main body. The traction device can be a reversibly stabilized and reversibly expanding traction device that forms a treatment space upon expansion. The traction device can be configured, for example, to expand distally to the distal end of the outer tube and reversibly rigidify the flexible arrangement of the traction device, which is designed to facilitate positioning of the system within the main body and reversibly rigidify for expansion of the traction device. That is, the system may include a stabilizing / rigidifying structure, such as in the above embodiments, which may be slidable to rigidify the components and traction system.

[0188] During use of this system, the floating channel can (i) be slidably attached to the lumen of the outer tube at least in a first proximal position and a first distal position; and (ii) float at least substantially within the lumen of the outer tube between the first proximal position and the first distal position. Similarly, during use of this system, the floating endoscope can (iii) be slidably attached to the lumen of the outer tube at a second proximal position and a second distal position; and (iv) float at least substantially within the lumen of the outer tube between the second proximal position and the second distal position. Furthermore, during use of this system, the floating arrangement can (v) significantly improve the flexibility of the system relative to a second such system having lumens for the instrument and endoscope (which are fixed to the lumen of the outer tube along their entire length between the proximal and distal ends). The increased flexibility can facilitate the ease of positioning the system within the body; additionally, the reversibly rigidified arrangement of the retractor can form at least substantially rigid beams (such as structural supports) for expansion within the body to facilitate treatment of target tissues.

[0189] In some embodiments, the traction device includes at least two expandable traction elements, each having a proximal end and a distal end, the proximal end being slidably engaged with an outer tube, and each element being configured such that an increase in the amount of sliding from the proximal end toward the distal end compresses the element and expands the traction device. These embodiments may also include a distal connector or coupling located distal to the distal end of the outer tube to which the distal ends of the at least two traction elements are fixed; additionally, a stabilizer subsystem connecting the distal connector to the distal end of the outer tube and having at least a substantially rigid component is configured to reversibly rigidify the flexible portion of the traction device to allow for asymmetric expansion of the traction device.

[0190] In some embodiments, the traction device includes four expandable traction elements, each having a proximal end and a distal end, the proximal end being slidably engaged with an outer tube, and each element being configured such that an increase in the amount of sliding from the proximal end toward the distal end compresses the element and expands the traction device. These embodiments may also include a proximal coupling attached to the distal end of the outer tube, the proximal coupling having four traction port for slidably engaging with the four traction elements, the four traction ports being circumferentially located near the proximal coupling and configured to facilitate reversible axial sliding of the traction elements to allow for asymmetric expansion of the traction device. These embodiments may also include distal connectors or couplings located on the distal side of the outer tube fixed to the respective distal ends of the four traction elements, and a stabilizer subsystem connecting the distal connectors to the distal ends of the outer tube, the stabilizer subsystem having (i) a flexible member extending from the proximal connector to the distal connector, and (ii) at least substantially rigid members slidably engaging the proximal connector and reversibly extending from the proximal connector to the distal connector to reversibly rigidify the traction element in asymmetric expansion. The traction elements can be moved to the expanded state in any of the above-described manner. Furthermore, if desired, only two of the traction elements may expand, as in the embodiments described above.

[0191] The flexible and rigid components may each have a central axis that is at least substantially parallel to the central axis at the distal end of the shaft, and the rigid component constitutes at least substantially a rigid beam, such as for structural support for asymmetric expansion, the rigid beam having a proximal cavity side and a distal cavity side.

[0192] The systems described herein can be used in several different treatment methods. For example, these systems can be used to treat gastrointestinal lesions by utilizing multi-directional and multi-angle access to the lesion. The method may include positioning the system within the gastrointestinal tract of a body, which includes: placing a retractor close to the target lesion for treatment; expanding the retractor to create a treatment space for the use of a cutting tool; treating the lesion with the cutting tool; retracting the retractor; and removing the system from the body. Lesions may include, for example, perforations, histopathological polyps, tumors, cancerous tissue, bleeding, diverticula, ulcers, abnormal blood vessels, or the appendix.

[0193] It should be understood that, in addition to those disclosed above, there are several procedures and variations in the application of the system disclosed herein that can be readily used by those skilled in the art. In some embodiments, those skilled in the art may insert an endoscope through the endoscopic channel of the system and extend the distal end of the endoscope to the distal end of the retractor to form an assembly. This assembly may then be inserted into a body cavity or orifice (such as the colon) and advanced orally until the distal end of the endoscope or lens approaches the target tissue (lesion or defect) to be treated. The system may then be advanced over the endoscope until the retractor is positioned above the distal end of the endoscope while viewing an image from the endoscope. The system may be advanced until the target tissue is positioned between the proximal and distal connectors of the retractor while viewing an image from the endoscope. The handle or outer tube may be rotated to rotate the retractor so that the target tissue is in the desired position relative to the retractor assembly while viewing an image from the endoscope. The retractor may then be straightened and stabilized by converting a flexible beam into a rigid beam. Then, by moving the retraction actuator forward on the handle, the retractor can be expanded while viewing images from the endoscope. This action pushes the tissue outward, creating a workspace near the target tissue and fixing and stabilizing it. Optionally, while expanding the retractor, the system can be pulled back to displace the highest point of the most expanding member distally, thereby increasing the working distance between the endoscope and the highest point of the asymmetrical workspace, which is typically recommended to be located near the target tissue. Using an instrument inserted into the working (blade) channel, the working channel is inserted into the proximal port of the system, and the instrument and channel are advanced distally until the tip of the working channel is distal to the proximal connector of the retractor, while viewing images from the endoscope. At this point, the tip of the working channel can be bent at an appropriate angle so that the blade approaches the lesion to be treated. If necessary, the working channel can be rotated and axially moved to the desired position for the blade. Similarly, if necessary, the instrument / blade can be advanced relative to the distal end of the working channel to extend the instrument to reach the target tissue. Various instruments can be inserted through the working channel as needed, and both the endoscope and instruments can be moved and positioned independently in the working area for further manipulation and observation of the target tissue at a closer position or angle. This is because, in some embodiments, the endoscope can also be bent within the working space.

[0194] In some embodiments, it is desirable to provide delivery of the system disclosed herein with an optional sheath, or a cannula covering a portion of the system (including the traction device), during delivery of the traction device to the target site, during treatment of the target tissue at the target site, during removal of the target tissue, and / or during removal of the system from the body, or a combination thereof. Recall that some embodiments of such an optional sheath 355 have been disclosed herein, for example in Figure 3A and Figure 3K In this context, those skilled in the art will understand that the traction device has elements that can capture, grasp, interfere with, or contact tissue during delivery to or removal of the traction device from the target site. Furthermore, treatment of the target tissue may include, for example, tissue stripping that can be performed within the sheath without contaminating the target tissue with surrounding tissue. Additionally, the tissue to be removed may be cancerous tissue or other tissue that is desired to be contained within the sheath during treatment or removal. In many embodiments, the terms "sheath" and "cannula" are used interchangeably, and those skilled in the art will understand that such embodiments are alternatives to improvements as disclosed herein.

[0195] Figures 10A-10E The illustration shows a traction sleeve of a traction device that covers the system disclosed herein, according to some embodiments. Figures 10A-10C Top view, oblique view, and side view are shown, and a flexible transparent cannula 1000 is shown covering a retractor 1050 in a convergent configuration to form at least a generally smooth and / or non-traumatic surface 1005 for delivering the retractor 1050 to a target site (not shown) for treatment of target tissue (not shown). Figures 10A-10C In the middle, the sheath is in a closed configuration, which can be maintained until the traction device 1050 expands for treatment, or the closed configuration can be reversibly obtained after treatment. Figure 10D and Figure 10E The diagram shows a top and side view of an expanded configuration of a traction device in which the sheath is in an open configuration for treatment.

[0196] The cannula 1000 may be designed to prevent or stop the traction elements 1051, 1052, 1053, 1054 and bridging members 1044a, 1044b from capturing, gripping, interfering with, or contacting tissue during the delivery of the retractor 1050 to or from the target site. The cannula 1000 is attached at one end to a distal interface or connector 1099 and extends proximally beyond the proximal connector or interface 1098, and is attached to the outer surface of the catheter 1055. Alternatively, the cannula 100 may be attached proximally to the proximal connector 1098. Retainers may be used at any location around the retractor to facilitate configurational retention of the working space 1060, for example, to maintain configuration under the expansion force of the retractor 1050. During the procedure, the cannula 1000 may also prevent or stop tissue from entering the retractor 1050 until necessary. The cannula 1000 can also serve as a collection mechanism for capturing and / or pulling out resected tissue, which may be particularly suitable in the resection of cancerous tissue in some embodiments. The cannula 1000 may be at least substantially closed around the retractor 1050 during delivery and may be designed to open when the retractor 1050 is expanded to form a working space 1060 for treatment. Alternatively, the expansion of the retractor and the cannula may be independent.

[0197] The flexible beam 1070 can be converted into at least substantially rigid beam 1075 using the conversion methods and structures described above in conjunction with other embodiments. For example, an actuator can be operatively connected to the beam (rigidified structure) 1075 to allow it to travel into the lumen of the flexible beam 1070, or alternatively, to travel on the flexible beam 1070 (as in...). Figure 10D (As shown in the diagram) to rigidify (make more rigid) the flexible beam 1070. Bridging member 1044a can connect expandable traction elements 1051, 1052, and bridging member 1044b can connect elements 1053, 1054 to limit lateral movement and stabilize the traction device, as in other bridging members described herein. In an alternative embodiment, bridging member 1044b extends from bridging member 1044a and connects to elements 1053, 1054 to connect all four elements 1051, 1052, 1053, and 1054 using bridging members 1044a, 1044b. Bridging member 1044c can connect elements 1053, 1054. Covers 1051a and 1052a can be applied to traction elements 1051, 1052, respectively, to control as described below. Figure 11 The expansion described in the embodiments.

[0198] In some embodiments, the sleeve 1000 may be longitudinally perforated (not shown) and designed such that the sleeve 1000 opens by tearing an eyelet at the target site when the retractor 1050 expands. In some embodiments, a tongue-and-groove mechanism (e.g., a ZIPLOCK mechanism) may be used to at least substantially close a slit 1007 at the top of the retractor 1050, which may also open when the retractor 1050 expands at the target site. In some embodiments, a large eyelet or unclosed portion 1001 may be left in the sleeve 1000 to facilitate tearing or opening of the sleeve at the target site when the retractor 1050 expands. In some embodiments, the terms "slit" and "opening" are used interchangeably.

[0199] In some embodiments, the cannula can be reversibly opened, and thus the cannula can be reclosed. For example, a drawstring, cable, or wire can be operably positioned in communication with the opening so that it can be reclosed during treatment by pulling or pushing the drawstring, cable, or wire from the patient's side. In some embodiments, the edge of the opening can be formed with a longitudinal groove or channel for pulling or pushing the drawstring, cable, or wire from the patient's side as needed during treatment, for example by guiding the strip, cable, or wire through the system and perhaps through a handle (as with other actuation mechanisms). In some embodiments, the drawstring is used to reclose the cannula, wherein the drawstring can be tightened at the handle to close or release the slit, thereby allowing the traction device to expand. In some embodiments, the cannula has a rigid strip extending laterally around the middle of the cage to facilitate cage expansion without snagging on the surrounding cannula. The rigid strip can be another layer of the cannula welded or glued to an existing cannula. It can also be formed as a thickened area. Alternatively, a stiffer material can be inserted into the laterally extending groove. The rigid material can be the same as the sleeve material, or it can be a harder material.

[0200] Those skilled in the art will understand that any known materials and / or methods for covering the sleeve can be used for the purposes disclosed herein. For example, the length of the sleeve can range from about 10 mm to about 30 mm at the ends attached to the proximal and distal connectors, each of which can be used to define the end of the puller 1050. Furthermore, the sleeve can be heat-welded, glued, or heat-shrinked to the proximal and / or distal connectors, or perhaps substantially to the proximal or distal side of these components, to secure the sleeve to the puller. In some embodiments, the sleeve can even cover the system for sterilization or cleaning, thus the sleeve is an extension of a usable disposable and / or replaceable component, for example, during sterilization. Additionally, in some embodiments, the sleeve can be larger in the middle, wherein the diameter in a closed configuration can range, for example, from about 20 mm to about 40 mm. The sleeve can be, for example, opaque, translucent, or transparent, and the material constituting the sleeve can be, for example, polyethylene, nylon, fluorinated ethylene propylene copolymer (FEP), polytetrafluoroethylene (TEFLON), polyethylene terephthalate (PET), or polycarbonate. Additionally, in some embodiments, the thickness of the sleeve material can be, for example, about 0.0010” to about 0.0060”, about 0.0020” to about 0.0080”, about 0.0030” to about 0.0050”, about 0.0010” to about 0.0030”, about 0.0005” to about 0.0100”, about 0.0020”, or any range thereof in increments of about 0.0005”.

[0201] During use, when the traction system 1050 is... Figure 10B The collapsing insertion state is moved to Figure 10E When in the expanded state, the dilation traction element is dilated away from the cannula 1000. The cannula 1000 may remain open facing the surface of the treated target tissue (e.g., removed from the patient's body). Alternatively, the cannula 1000 may remain closed and be opened using an endoscopic tool to receive the removed lesion. It should be noted that, as in... Figure 10E As shown, in the expanded state, the sleeve 1000 covers the traction elements 1053, 1054 and the rigid beam 1075 and is separate from the expansion elements 1051, 1052. In an alternative embodiment, the sleeve may also cover the elements 1051, 1052 in their expanded configuration.

[0202] Figures 11-30 The illustration depicts an alternative embodiment of the system typically indicated by reference numeral 1100. System 1100 includes a multilumen conduit or tubular member 1110 configured to receive one or more tool channels or flexible instrument guides. Figure 11Two tool channels 1122 and 1124 are shown. It should be understood that in some embodiments, only one tool channel may be used, and in other embodiments, more than two tool channels may be used, wherein the conduit has a sufficient number of lumens. Tool channels 1122 and 1124 can be packaged as a kit with conduit 1110, as in... Figure 11 As shown in the diagram. Alternatively, the tool channels 1122, 1124 can be packaged separately. In other embodiments, the tool channels have been packaged inside the lumen of the catheter 1110. Each tool channel 1122, 1124 has a lumen (channel) for receiving endoscopic instruments (tools) therethrough.

[0203] The tool channels (also referred to herein as flexible tubes or flexible guides) 1122 and 1124 are inserted through the proximal end of the conduit 1110 and travel through the lumens 1112, 1114 within the conduit 1110 (see...). Figure 12 ). For example in Figure 16 As shown in the figure, the proximal portion 1113 of catheter 1110 is illustrated; catheter 1110 may include ports 1115 and 1117 that cooperate with lumens 1112 and 1114, respectively (see example...). Figure 13 These ports may include valves to maintain airflow when tool channels 1122, 1124 are inserted through them and translated axially therein. Tool channel (tube) 1122 preferably has a pre-bent front end 1122a, as shown in... Figure 11 and Figure 18 The image is best shown to provide a curved distal end. The tool channel (tube) 1124 also preferably has a pre-bent front end 1124a, thereby providing a curved distal end. When the tool channels 1122, 1124 are inserted into the lumens 1112, 1114 of the conduit 1110, the front ends 1122a, 1124a are preferably substantially straightened to facilitate travel through the lumen. When the tool channels 1122, 1124 are advanced sufficiently distally so that the distal front ends 1122a, 1124a are exposed from the confinement of the walls of the conduit lumens 1112, 1114, the front ends 1122a, 1124a return to the predetermined curved state. See also... Figure 18 To understand this situation, Figure 18The straightened states of the tool channels 1122, 1124 for movement within the conduit 1110 are shown in dashed lines. As in other embodiments disclosed herein, the tool channels 1122, 1124 may be constructed of a hyperelastic material, although other materials, such as stainless steel, may also be used to provide a curved tip that recovers from a generally straight insertion shape to a curved shape upon exposure. Furthermore, in other embodiments disclosed herein, the shape memory properties of the material (such as a nickel-titanium alloy) may be used to remember the shape of the curved tip. In alternative embodiments as described above, the tool channels 1122, 1124 may have a mechanism (e.g., a drawwire) that is driven to bend their distal ends. Figures 11-30 In one embodiment, the tool channels 1122, 1124 are not attached to the conduit 1110 during use, so that the user can freely control their axial movement from the proximal ends 1122b, 1124b. However, it is also conceivable that in alternative embodiments the tool channels may be attached to the conduit.

[0204] Tool channels 1122 and 1124 may optionally include markings 1123 and 1125, respectively, in the region proximal to catheter 1110, to provide the user of tool channels 1122 and 1124 with a visual indication of the insertion depth through catheter lumens 1112 and 1114. Tool channels 1122 and 1124 may each have valved Luer connectors 1127 and 1129 at their proximal ends. Figure 11 and Figure 19A This connector can block the backflow of air from the body. This maintains airflow when the endoscopic blade is inserted through blade channels 1122, 1124, as described below. Figure 19B The alternative embodiment shown has hemostatic valves 1121A and 1121B connected to the proximal ends of tool channels 1122' and 1124', respectively, to maintain airflow during tool insertion. As shown, valves 1121A and 1121B are proximal to Luer connectors 1127' and 1129'. In all other respects, tool channels 1124' and 1126' are identical to tool channels 1124 and 1126.

[0205] In one embodiment, the tool channels 1122, 1124 may be constructed of a flexible, soft material, such as polyether block polyamide (PEBAX). In some embodiments, a superelastic nickel-titanium alloy skeleton may be embedded in the walls of the Pebax material, for example, inside the bend. Other materials are also conceivable.

[0206] The catheter 1110 also preferably has a lumen 1116 configured and sized to receive the endoscope 1200 (see, for example) Figure 16In some embodiments, the lumen 1116 is sized to receive a conventional endoscope (e.g., a conventional colonoscope), and the catheter 1110 is then loaded onto the endoscope. This is described in more detail below in conjunction with the method of use. In an alternative embodiment, the lumen 1116 may receive an articulated endoscope. Furthermore, in an alternative embodiment, the endoscope may be inserted into the catheter and inserted into a body cavity.

[0207] Reference Figure 11 and Figure 16 The conduit 1110 includes a handle housing 1130 in the proximal portion 1113, which houses two actuators: an actuator 1132 for controlling the traction system 1150, and an actuator 1134 for controlling the movement of the rigid (stabilized) structure. These are described in more detail below. The conduit 1110 also includes a tube 1139 with a Luer connector 1137, and a control switch 1175 for sealing the internal gasket 1176 (see [link to documentation]). Figure 31A , Figure 31B When switch 1174 is off Figure 31A Move the position to Figure 31B When positioning, the elastic pad 1176 is used to secure the thread (e.g., suture) 1172 used to close the covering 1170. More specifically, in Figure 31A In its initial position, the ball valve 1174, seated in a groove within the housing 1179, does not exert force on the gasket 1176. This allows the suture 1172 to move freely within the lumen of the catheter. When it is desired to lock the suture 1172 in place, i.e., after tightening the suture 1172 to close the cover 1170, the switch 1175 slides forward, thereby causing the ball 1174 to bulge downward (as in...). Figure 31B (As seen in the orientation) to cause the lumen in the liner 1176 to collapse and abut against the suture 1172, thereby securing the suture 1172. This locks the suture 1172 to prevent its movement, thereby holding the cover (bag) in a closed position to encapsulate the target tissue, as described herein. Note that reverse movement of the switch 1175 releases the suture 1172, allowing it to move freely. The catheter 1110 also has a tube 1136 with a one-way stopcock 1138 for providing an inlet port. This port can be used to supplement the inlet gas supplied by the endoscope 1200. The inlet gas flows through the lumen 1116 in the region near the endoscope 1200, because the cross-sectional dimensions of the lumen 1116 exceed those of the endoscope 1200 to allow sufficient clearance. As shown, tubes 1139 and 1136 are located distal to actuators 1132 and 1134.

[0208] Now we turn to traction system 1150, which constitutes a workspace expansion system, and in some clinical applications is a cavity remodeling or reconstruction system, and was originally referenced Figure 13 The traction system 1150 is located at the distal portion 1111 of the catheter 1110 (distal to the proximal interface 1140) and includes flexible traction elements 1152 and 1154. The traction system also includes traction elements 1156 and 1158. Traction elements 1152 and 1154 constitute expandable elements that form a working chamber (space) within the body cavity and form an asymmetric cage. Traction elements 1156 and 1158 form the base of the traction system, thus helping to define the traction cage and traction elements 1152 and 1154. In some embodiments, traction elements 1156 and 1158 do not undergo any change when the traction system 1150 moves from a retracted insertion state to an expanded state; in other embodiments, traction elements 1156 and 1158 undergo a slight change in state, i.e., slight expansion or bending, when the traction system 1150 is expanded. The traction elements 1152 and 1154 are expandable to form an asymmetrical workspace, thereby improving visibility and work area, as described in detail above regarding other systems for forming asymmetrical workspaces.

[0209] For example, through the Figure 15 and Figure 21A A comparison shows that traction elements 1152 and 1154 move from a retracted insertion state (where they preferably do not extend beyond or significantly exceed the lateral dimension of catheter 1110) to an expanded state (where they are laterally bent outward and have a lateral dimension extending beyond the lateral dimension of catheter 1110). Furthermore, by... Figure 15 and Figure 21A By comparison, it can be seen that the lower elements 1156, 1158 in the retracted state (as seen in the orientation of these figures) do not extend beyond or significantly exceed the lateral dimension of the catheter 1110, and remain in substantially the same position when the traction device is expanded, thus still not extending beyond or significantly exceeding the lateral dimension of the catheter 1110. In some embodiments, elements 1156, 1158 do not extend beyond the lateral dimension of the catheter 1110 at all. As in the embodiments described above, the traction system 1150 (i.e., traction elements 1152, 1154) expands only to one side of the plane passing through the longitudinal axis of the catheter 1110, thereby forming an asymmetrical workspace 1151 (and an asymmetrical cage), and has the accompanying advantages described herein.

[0210] The traction elements 1152 and 1154 have a bridging member 1155 to increase the stability of the traction device and maintain the ideal orientation of the traction elements during expansion. The bridging member 1155 is attached to the two traction elements 1152 and 1154, preferably in the middle, to form a lateral structure for the elements 1152 and 1154, thereby limiting lateral movement. As shown, the bridging member 1155 has a first arm 1155a connected to the traction element 1152 and a second arm 1155b connected to the traction element 1154. As shown, the upper surface (as in...) Figure 15 (As seen in the range) can be arc-shaped. The bridging member 1155 can be a separate component attached to the traction element using tubular elements 1159a, 1159b, which are respectively mounted on and attached to the traction elements 1152, 1154. In this configuration, the tubular elements 1159a, 1159b have a first opening for receiving the traction element and a second opening for receiving the arm of the bridging member, although alternatively they can both be received in the same opening. It should be noted that the tubular elements 1159a, 1159b also increase the diameter of the traction elements 1152, 1154, as in some embodiments the diameter of the traction elements 1152, 1154 is approximately 0.035 inches (although other sizes are also conceivable). Other methods of attaching the bridging member are also conceivable. On the other hand, the bridging member 1155 can be integrally formed with one or two traction elements 1152, 1154. The bridging member 1155 can be made of a material similar to that of elements 1152, 1154, or it can be made of a different material. The bridging member 1155 may also include legs 1155d and 1155e, which are respectively connected to the lower elements 1158, 1156 to attach the bridging member to the lower elements 1158, 1156 to increase the stability of the traction system. These leg members 1155d and 1155e are preferably made of a soft, elastic material (such as polyurethane tubing) to add more structure to the cage and facilitate cage expansion in a more predictable manner.

[0211] Additional bridging members (not shown) can be provided on the traction elements 1052 and 1054 to improve stability. In some embodiments, in the retracted state, the bridging member 1055 can extend substantially axially, such as in... Figure 15 and Figure 17A In the middle, but the expansion state of the traction elements 1052 and 1054 changes to an angle that points inward (downward) toward the longitudinal axis of the conduit 1010, as in Figure 21A middle.

[0212] Another bridging member 1157 (or alternatively, multiple bridging members) is located at both lower parts (e.g., in...) Figure 15The traction elements 1156 and 1158 extend between each other (as seen from the perspective of the traction system 1150). These elements 1156 and 1158 can help open the lower part of the traction system 1150 and help form a cage for the workspace, and the bridging member 1157 can help stabilize these elements 1156 and 1158, for example, by limiting lateral movement. As shown, the bridging member 1157 has arms 1157a and 1157b respectively connected to the elements 1156 and 1158. The bridging member 1057 can be a separate component attached to the traction elements using tubular elements 1161a and 1161b, which are respectively mounted on and attached to the traction elements 1156 and 1158. Tubular elements 1161a and 1161b may have a first opening for receiving element 1156 or 1158 and a second opening for receiving the arm of bridging member 1157, although alternatively they may both be received in the same opening. Other methods of attaching the bridging member are also conceivable. Alternatively, bridging member 1157 may be integrally formed with one or both traction elements 1156 and 1158. Bridging member 1157 may be made of a material similar to that of elements 1156 and 1158, or it may be made of a different material.

[0213] Additional bridging members (not shown) can be provided on the traction elements 1156 and 1158 to improve stability. In some embodiments, the bridging member 1157 may extend substantially parallel to or substantially axially to the longitudinal axis of the conduit 1110 in the retracted state (e.g., in...). Figure 15 (in the middle), and the traction elements 1152 and 1154 remain in this position in their expanded state (e.g., in the middle). Figure 21A In this embodiment, when the traction system 1150 is expanded, the traction elements 1156 and 1158 remain in substantially the same position.

[0214] The catheter 1110 includes a proximal connector (cap) 1140 through which a traction element extends. The handle housing 1130 includes a longitudinally extending groove 1131. Figure 16 The traction actuator 1132 slides axially along the groove. Traction elements 1152 and 1154 are connected to the actuator 1132 via a connecting block 1146, as shown in... Figure 20A As shown in Figure 220B. That is, each traction element 1152, 1152 has a proximal extension that extends through the respective lumens 1112, 1114 in the conduit 1150 and connects to the block 1146 at its proximal end. Thus, when the actuator 1132 is moved along the axial groove 1131 from... Figure 20A Its proximal position moved to Figure 20BWhen the actuator 1132 is in its distal position, block 1146 is moved distally, thereby laterally pushing traction elements 1152 and 1154 outward, since elements 1152 and 1154 are fixedly attached at their distal ends to distal connector 1148. In this embodiment, elements 1156 and 1158 are fixedly attached at their distal ends to distal connector 1148 and at their proximal ends to proximal connector 1140 (or other portions of conduit 1110), so that movement of actuator 1132 does not affect movement of these elements 1156 and 1158. However, it should be understood that if it is desired to move elements 1156 and 1158 (e.g., slightly bend them outward) when the traction device 1150 expands, these elements 1156 and 1158 can be attached to block 1146 so that they will move when actuator 1132 travels, or alternatively attached to a separate actuator. In one embodiment, elements 1152, 1154, 1156, and 1158 can be secured within a groove formed in the distal connector 1148. It should be noted that the proximal and distal connectors 1140, 1148 may have openings sized to receive the endoscope when the catheter 1110 is subsequently mounted onto the endoscope, as described below. The housing 1130 may include components similar to... Figures 6A-6D Multiple teeth (not shown) of the gear are engaged by teeth connected to actuator 1132, thereby forming a fixing or locking mechanism for holding the traction element in one of several selectable positions. A release mechanism for the holding or locking mechanism may be provided.

[0215] Additionally, it should be understood that alternative methods for expanding the traction elements may be employed, including, for example, providing relatively movable couplings 1140, 1148 to expand the traction elements 1152, 1154 (and optionally 1156, 1158) in the same manner as the couplings described above, such as couplings 198, 199. Alternatively, the traction elements may also be made of a self-expanding material (such as a shape memory material) that expands when exposed from the conduit or cannula.

[0216] Traction elements 1152 and 1154 may optionally have small rolled edges, forming a flattened state adjacent to their distal ends where they are fixed to the distal connector 1148. This reduces the bending stiffness at that point, thus acting like a hinge to create a more predictable direction of expansion, such as upward and slightly outward deflection. This also reduces the amount of force required to induce bending. Such a flattened portion can also be used in traction elements of other embodiments disclosed herein.

[0217] The traction system 1150 can be configured to reversibly rigidify the flexible arrangement of the traction device 1150. In this respect, the traction system 1150 may include a generally rigid beam for supporting the expanding traction device 1150, which helps to form a more stable chamber (or cage), as described herein. (Refer to...) Figure 15 and Figure 17A The flexible tube or beam 1160 is provided in the convergent configuration, while Figure 17B The traction system has a rigid beam formed by a flexible beam 1160. More specifically, in this embodiment, the flexible beam 1160 is in the form of a rod or tube 1165, having a cavity for slidably receiving a stabilizing or rigidifying structure (such as a rigid tube or rod (beam) 1162). The rigidifying (stabilizing) structure 1162 is independently actuated by the user through the movement of an actuator 1134. The actuator 1134 is slidably mounted within a longitudinally extending slot of the housing 1130. Figure 17A In its initial position, the rigidification structure 1162 is retracted within the lumen of the conduit and does not engage with the flexible tube (or rod) 1160, or only partially engages with it. The rigidification structure 1162 is attached at its proximal end to a slider 1164, which is operatively connected to an actuator 1134. To rigidify the tube 1160, the actuator 1134 is slid distally to... Figure 17B The position of the slider 1164 and the attached stabilizing structure 1162 is such that the slider 1164 and the attached stabilizing structure 1162 travel distally. This movement causes the rigidifying structure 1162 to travel through the lumen 1165 of the flexible tube 1160 to the distal end 1160a, thereby rigidifying the beam. Optionally, the rigidifying structure 1162 can be removed from the flexible beam 1060 to restore the system to its original more flexible state by sliding the actuator 1134 in the opposite direction (proximal) within the axial groove, thereby removing the rigidifying structure 1162 from its traveling position inside the flexible tube 1160. In one embodiment, the rigidifying structure 1162 is in the form of a structure having proximal and distal metal tubular structures connected by a flexible braided polyimide tube. However, it should be understood that other structures are also conceivable. It should be noted that the cross-sections of structures 1160, 1162 can be generally circular, although other cross-sectional shapes are also conceivable. As in the aforementioned embodiments, a rigid beam restricts the deflection of the distal end 1111 of the catheter 1110, which can occur due to pressure exerted on the distal end by the body cavity wall.

[0218] As in Figure 17A and Figure 17BAs shown, the actuator may include a connector 1135 having teeth or pawls 1137 for engaging with teeth on a rack 1138 located inside the housing 1130 to hold the rigid structure 1164 in one of several selected locations.

[0219] exist Figure 17C and Figure 17D In an alternative embodiment, instead of having the rigidification structure travel within the cavity of the flexible element, the rigidification structure travels on the flexible element. More specifically, the flexible beam 1160' is rigidified by the movement of the rigidification structure (e.g., tubular member 1162') over the flexible beam 1160'. That is, the rigidification member 1162' has a cavity configured and sized to allow the flexible beam 1160' to travel over the rigidification member 1162'. Figure 17C When passing in the direction of the arrow, the flexible beam 1160' is received. It should be noted that, for clarity, the flexible element 1152 has been removed from... Figure 17C and Figure 17D Remove. Actuator 1134 and alternative methods can be applied to this movement.

[0220] Preferably, the cover or sheath 1170 is positioned at the distal end of the catheter 1110. In the illustrated embodiment, the cover 1170 is mounted around the periphery of the proximal connector 1140 and the distal connector 1148. In some embodiments, the sheath 1170 is folded and sealed near the connectors (caps) 1140, 1148 using a heat-shrinkable film. The sheath 1170 is located near the elements 1152, 1154, 1156, 1158 in their retracted insertion position, and the opening in the sheath 1170 faces the target tissue (e.g., the removed lesion). That is, in Figure 15 In the orientation, the opening in the sheath 1170 faces upward. The sheath 1170 may be configured to have an opening in a closed state, or alternatively, it may have a slit that can be opened by stretching when the traction elements 1152, 1154 are moved to the expanded state. When the traction elements 1152, 1154 are expanded, they move through the sheath 1170 toward the target tissue. Alternatively, the edge of the sheath 1170 may be attached to the traction elements 1152, 1154 and thus move with the traction elements. When the target tissue is removed using the endoscopic instruments described herein, the tissue to be removed is placed inside the sheath 1170, and, for example, using... Figure 29The suture or thread 1172 shown closes the sheath 1170 to encapsulate the tissue and prevent leakage and bleeding during removal of the tissue from the body cavity. The suture 1172 can be embedded in the wall of the sheath 1170 or formed in a groove or channel in the sheath 1170, wherein the suture 1172 is permanently fixed at a distal fixation point and pulled proximally to tighten the suture 1172 and close the sheath 1170.

[0221] As with the sheath (cannula) 1000 in Figure 10, the sheath 1170 provides a smooth and non-invasive surface by covering the traction elements 1152, 1154, 1156, and 1158, which is used to deliver the traction system to the target site. Similar to the sheath 1000, the sheath 1170 also helps prevent tissue (e.g., cavity walls) from entering through the space between the beam 1160 and the elements 1156 and 1158 during the surgical procedure.

[0222] In a preferred embodiment, the two ends of the suture 1172 extend from the tube 1139. Their proximal ends may be covered by a length of tube for easy gripping by the user. The suture 1172 extends through the switch 1137 and the tube 1139, through a dedicated lumen (channel) in the catheter, through the cover 1170, and forms a loop at the distal cap 1148 where the suture 1172 is attached (secured). During this process, the suture 1172 remains taut. After the tissue is placed inside the sheath (bag) 1170, the two proximal ends of the looped suture 1172 are pulled proximally to tighten the suture 1172, thereby closing the sheath 1170. The switch can then be moved to frictionally engage the suture 1172 to secure it, locking it in the taut state and maintaining the closure of the sheath 1170.

[0223] Now, we will refer to the removal of lesions (such as polyps) from the colon wall. Figure 11 The use of the system is described, however it should be understood that the system 1100 can be used in other surgeries inside the colon or gastrointestinal tract, as well as in other surgeries in other body cavities or body spaces of the patient.

[0224] First turn Figure 12 and Figure 13 During the procedure to remove target polyp C from the colon wall B, the distal endoscope 1200 is used for observation (where system 1100 has already been advanced on the proximal end 1201, as in...). Figure 12As shown, or alternatively, system 1100 is backloaded onto the distal end of endoscope 1200 and inserted through lumen A in colon B. In this embodiment, endoscope 1200 is a distal viewing endoscope having a wide distal viewing area in the range of approximately 150-170 degrees, thus allowing visualization of polyp C and the surrounding area. After positioning endoscope 1200 adjacent to the target tissue (i.e., slightly closer to the target polyp C), system 1100 is further advanced on endoscope 1200 (alongside endoscope 1200). Distal connector (cap) 1148 has an opening 1148a, and proximal connector (cap) 1140 has a lumen 1116 of catheter 1110 (…). Figure 16 The interconnected openings enable the post-loading of this endoscope 1200 and the movement of the system 1100 over the endoscope. This allows the catheter 1110 to move over the endoscope 1200 (as in...). Figure 14 (as shown) until it reaches the target site (as shown in) Figure 15 As shown in the figure, the traction system 1050 is aligned with the polyp C. As can be understood, in this inserted state of the catheter 1110, the traction system 1150 is in a non-expanded (or retracted) state, and the traction elements 1152, 1154 preferably do not exceed or only slightly exceed the lateral dimension of the catheter 1110. In this position, the traction elements or at least the traction elements 1156, 1158 are covered by the cover 1170. As shown in the figure, in this position, the distal end 1202 of the endoscope 1200 is preferably located at the end of the proximal connector 1140 and does not extend into the workspace 1151, thereby leaving more space for manipulating endoscopic instruments within the workspace. However, other positions are also conceivable, for example, in some types the endoscope may extend into the workspace 1151. It should be noted that also in this inserted state, the actuators 1134 and 1132 are in their retracted positions, as shown in the figure. Figure 16 As shown in the image.

[0225] Next, in order to rigidify the traction system 1150, the actuator 1134 is moved from... Figure 17A The position moved to the far side Figure 17B Location (see also) Figure 16 The arrow in the diagram indicates that the rigidification structure 1162 travels from the retracted position to a traveling position inside the lumen 1165 of the flexible tube 1160. This rigidifies / stabilizes the traction system 1150, as described above. It should be noted that, as described above, the traction system 1150 can alternatively be rigidified / stabilized by the travel of the rigidification structure over the flexible element, as in... Figure 17C and Figure 17D As shown in the image.

[0226] The traction system 1150 is now expanded. This causes actuator 1132 to... Figure 20A The position moved to the far side Figure 20B The position (see also Figure 19). This causes block 1146 (which is operatively coupled to traction elements 1152 and 1154, as described above) to travel, thereby pushing traction elements 1152 and 1154 laterally outward to Figure 20B The location of these elements creates an asymmetrical workspace (room), as described in detail above.

[0227] Next, the user inserts the tool channels 1122 and 1124 into the guide tube 1110 through ports 1115 and 1117 (see...). Figure 19A The proximal region of the catheter and the catheter travel through the lumen 1112, 1114, such that the tool channels 1122, 1124 extend from the distal openings of the lumen 1112, 1114 and enter the chamber 1151, as in Figure 21A As shown in the diagram. It should be noted that when the tool channels 1122, 1124 are exposed from the lumens 1112, 1114 and from the confinement of the lumen wall of the catheter 1110, the distal ends 1122a, 1124a of the tool channels 1122, 1124 return to their curved (bent) state, thus curving upwards toward the polyp C (as shown in the diagram). Figure 21A (As seen from the direction). It should be noted that in... Figure 21A In this process, the traction element is first expanded, and then the tool channels 1122 and 1124 are inserted into the workspace 1151 through the guide cavities 1112 and 1114. However, it is also conceivable that, in an alternative embodiment, the tool channels 1122 and 1124 may be inserted into the workspace 1151 through the guide cavities 1112 and 1114 before the traction elements 1152 and 1154 are expanded. Figure 21B This alternative method is illustrated, in which the tool channel tips 1122a, 1122b are exposed, but the traction system 1150 remains in a non-expanded state. It should be noted that the tool channels 1122, 1124 can be independently rotated and / or axially moved to adjust their position relative to the polyp C. As will be understood, the terms "up" and "down" as used herein refer to the orientation of the system in the reference figures. If the position of the system changes, the orientation and terminology will also change.

[0228] After insertion of the tool channels 1122 and 1124, the endoscopic instrument (tool) 1210 is passed through the Luer connector 1129 of the tool channel 1124. Figure 19A And it is inserted and travels through the cavity (channel) of the tool path. For example, in Figure 22As shown, a first endoscopic instrument 1210 extends from and along the bend of the cutter channel 1124. A second endoscopic instrument (cutter) 1220 is inserted through the cutter channel 1122 of the Luer connector 1127 and travels through the lumen of the cutter channel 1122. As shown in Figure 2, the second endoscopic instrument follows the bend of the cutter channel 1122. As described above, the cutter channel may include a valve, such as a hemostatic valve (as in...). Figure 19B (As shown in the diagram), therefore the air blowing function is not lost during the insertion and removal of the endoscopic instruments from the tool channel. This allows for further axial movement of the endoscopic instruments 1210, 1220 (as shown in the diagram). Figure 24 and Figure 25 (As shown) so as to extend further from the tool channels 1122, 1124 for contact and treatment, such as removal of polyp C. By means of Figures 23-25 In comparison, this movement of the endoscopic instruments demonstrates the advantages of the blade channels 1122, 1124. As can be seen, once the blade channels 1122, 1124 are in the desired position relative to the polyp C, they can be considered to have a fixed curvature. This means that when the endoscopic instruments 1210, 1220 are axially advanced, they move to a position closer to the target polyp C without a change in curvature or their axial position relative to the polyp C, which provides additional degrees of freedom. The endoscopic instrument 1210 (which is a gripper in the illustrated embodiment) applies tension to the polyp C while the electrically powered surgical resector 1180 removes / cuts the polyp C from the colonic wall B. Other endoscopic instruments for polyp removal can also be used. Additionally, in some embodiments, a single blade channel can be used, and another endoscopic instrument (e.g., a gripper or dissector) can be inserted through the working channel (lumen) of the endoscope. This insertion of instruments through the endoscope can also be applied to embodiments with two or more blade channels.

[0229] It should also be noted that due to the angles of the tool channels 1122 and 1124, and the endoscopic instruments inserted through these channels, tissue triangulation can be achieved, such as using... Figure 30 The dashed line in the middle depicts this.

[0230] After removing polyp C from the colon wall B, it is placed inside the sheath 1170 (as in...). Figure 26 (As shown) is prepared for removal from the body. If necessary, actuator 1134 can be moved proximally to restore the traction system to a more flexible state. Actuator 1132 is positioned... Figure 27 Move proximally in the direction of the arrow to restore the expanded traction elements 1152 and 1154 to their original position. Figure 28 The sutures 1110 are then used to locate the retracted position of the catheters. The thread or suture 1172 is then pulled tight to close the sheath (bag) 1170, as in... Figure 29 As shown, this forms a bag for encapsulating polyp C. Then, switch 1175 can be moved to... Figure 31B The position is such that the line 1172 is locked in place, thereby holding the sheath 1170 in the closed position. Then, the catheter 1110 is removed from the colon B, and the polyp C is protected (encapsulated) inside the sheath 1170. It should be noted that the sheath 1170 is preferably transparent so that the traction elements, bridging members, beams, etc., can be shown in the drawings. However, for the sake of simplicity in understanding the sheath 1170, Figure 29 The shading diagram used on the inside of the bag / shroud 1170 shows the traction element, ridge element, beam, etc.

[0231] Figures 32-42 The illustrations depict alternative embodiments of the system of the present invention. The system includes floating (flexible) channels within an outer tube. In one embodiment, the floating channels are fixed at both their proximal and distal ends; in another embodiment, the floating channels are fixed at their proximal ends but not attached at their distal ends. As will be understood from the description below, the floating channels reduce the overall stiffness of the conduit (outer tube), which would be stiffer if the channels were fixed along their entire length and not floating within the conduit. The floating channels also reduce the buckling when inserting a tool channel (flexible guide) through the floating channels, and reduce the buckling when inserting a tool through the tool channel (or, in embodiments where a tool channel is not used, insertion directly through the floating channels).

[0232] More specifically, in Figures 32-34 In the illustrated embodiment, system 1210 includes a flexible conduit or outer tubular member (main tube) 1212. The proximal portion of the outer tube 1212 is generally designated by reference numeral 1214, while the distal portion is generally designated by reference numeral 1216. A proximal cap 1218 is located on the distal portion 1216 of the outer tubular member 1212.

[0233] Similar to the above Figure 11 The handle housing 1130, handle housing 1251 is composed of two half-shells 1251a, 1251b attached together. Housing 1251b has an actuator 1252 in the form of a sliding button, although other types of actuators may be provided. Actuator 1252 is connected to a wire rod, as described below. Figure 40 and Figure 42The push tubes 1428 and 1430 extend through the outer tube 1212. Movement of the actuator 1252 along the distal side of the slot 1254 causes distal movement of the push tubes 1428 and 1430, thereby causing the flexible element of the cage to bend outward, as described below. At the distal end of the handle housing 1251 are inlet ports 1258a and 1258b for an inflow tube (not shown), which may be part of a component (arranger) fixed inside the handle housing 1251 in the proximal region. At the proximal end of the handle housing 1251 is a handle end cap 1253 having an opening 1262 for allowing the endoscope to enter the outer tube 1212. Ports 1248 and 1250 extend from the proximal end cap 1253 to provide access to the tool channels (flexible guides) 1270 and 1271. Ports 1248 and 1250 preferably include valves for maintaining airflow during insertion and axial translation of the tool channels 1270 and 1271. Markings 1264 may be provided on the handle housing 1251 to indicate to the user the degree of distal travel of the actuator 1252 in order to control the size of the expansion cage. For example, the provided markings could be “4, 5, and 6” to indicate that the cage has expanded to 4, 5, or 6 cm, thus providing the user with a general indication of the increased expansion state. Other markings and / or expansion degrees are also conceivable. The actuator 1252 may have multiple teeth or other retaining structures to hold the actuator 1252 and thus the traction element in the selected extension state.

[0234] The actuator 1256a on the shell 1251 provides a means of rigidifying the cage by rigidifying the flexible beam. As described below, in an alternative embodiment, a separate, sliding beam for rigidifying the cage is provided, not as an alternative rigidification structure. Figure 17A and Figure 17B In the embodiments, in Figure 33 In this embodiment, a rigid member in the form of a rigid beam is operatively connected to the actuator 1256, such that distal movement of the actuator 1256 causes the rigid member to travel distally within the lumen of the flexible element or over the outer surface of the flexible element, thereby providing a stiffer structure. Proximal movement of the actuator 1256 can soften the flexible element, facilitating the retraction of the traction system.

[0235] Reference Figure 37AThe cross-sectional view shows that, in this embodiment, the outer tube (catheter) 1212 has a single lumen 1213. The lumen 1213 is sized to receive (1) an endoscope 1200 (e.g., the endoscope described above) and (2) two flexible channels 1222, 1224. These two flexible channels 1222, 1224 are in the form of flexible tubes and float within the lumen 1213. That is, these two floating channels 1222, 1224 have a central portion that can move radially (laterally) within the lumen 1213 of the outer tube 1212. In other words, the floating channels 1222, 1224 are not confined within the outer tube 1212, and therefore they can bend relative to the outer tube 1212, so their bending action does not need to follow the movement of the outer tube 1212. Thus, when the outer tube 1212 is inserted into a body cavity and needs to be bent to accommodate the curvature of the cavity (e.g., the gastrointestinal tract), the flexibility of the outer tube 1212 is maintained because the floating channels 1222, 1224 can move within the lumen 1213. As can be understood, if the two channels were fixed to the outer tube 1212 and therefore there was no bending or movement relative to the outer tube 1212, and the channels were pushed to bend in accordance with the outer tube 1212, then the outer tube 1212 would be much stiffer, because the channels would have to withstand bending stresses, which would limit the bending of the catheter and / or cause buckling of the tool channel or the tool extending through the channel of the catheter. Therefore, in embodiments of the invention including floating channels, these advantages of increased flexibility are achieved. It should be understood that any system disclosed herein may have floating channels. Similarly, any system disclosed herein may have floating channels. Figure 37B The positions of floating channels 1222 and 1224 are illustrated by way of example when the floating channels are moved inside catheter 1212 (e.g., when the catheter is bent). Clearly, as the catheter is bent, floating channels 1222 and 1224 will move to various other positions.

[0236] Furthermore, in this embodiment, a smaller diameter catheter can be provided by offering a single lumen for receiving the endoscope and tool passage, rather than a separate lumen that would require additional wall structures, which also reduces the overall stiffness of the catheter.

[0237] exist Figure 37A In this embodiment, the endoscope 1200 also floats within the lumen 1213. That is, the endoscope occupies only a region of the lumen 1213 and can move radially (laterally) within the lumen 1213 of the outer tube 1212 to improve the flexibility of the system. Therefore, the endoscope 1200 can move relative to the outer tube 1212 in a similar manner to how the floating channels 1222, 1224 can move relative to the outer tube 1212.

[0238] By way of example, in one embodiment, the inner diameter of the lumen 1213 of the outer tube 1212 is between about 5 mm and about 50 mm, preferably between about 10 mm and about 20 mm. Each floating channel preferably has an outer diameter of about 2 mm to about 10 mm, preferably about 5 mm. The endoscope typically has a diameter of about 2 mm to about 20 mm, preferably between about 5 mm and about 12 mm. Thus, as can be understood, the floating channels and endoscope occupy only a small percentage of the internal lumen 1213, leaving ample space for movement. It should be noted that other dimensions and therefore the ratio of the floating channels and endoscope to the inner diameter of the lumen 1213 are also conceivable for the system disclosed herein.

[0239] In one embodiment, by way of example, the outer tube 1212 has a length of about 10 cm to about 200 cm, more preferably about 60 cm to about 90 cm, measured from the distal end of the handle 1251 to the distal edge of the end cap 1218. The floating channels 1222, 1224 have a length of about 10.1 cm to about 204 cm, preferably about 60.5 cm to about 91 cm, and thus exceed the length of the outer tube 1212. Other dimensions are also conceivable. In embodiments where the floating channels are fixed at the proximal and distal ends, this greater length of the floating channels 1222, 1224 enables floating movement.

[0240] Now turn to the details of the floating channels and their fixed position inside the outer tube 1212. Figures 32-34 In the embodiments, channel 1222 (referred herein to as a first flexible channel, a first floating channel, or a first flexible tube) has a proximal end 1238 and an opposite distal end 1239. Channel 1224 (referred herein to as a second flexible channel, a second floating channel, or a second flexible tube) has a proximal end 1246 and an opposite distal end 1249. It should be noted that the terms "first" and "second" used to describe the various components of the system of the present invention are used herein for ease of description. It should be noted that in... Figures 32-42 In this embodiment, two floating channels are provided. It is also conceivable to provide one floating channel, or more than two floating channels.

[0241] Positioned distally by the outer tube 1212 is a first fixed distal tube 1226, which forms an insertion port for the first floating channel 1222. The first distal tube 1226 has an opening 1227, a proximal edge 1236, and a distal edge 1237. In some embodiments, instead of the opening 1227, the distal end can be closed. Preferably, the distal edge 1237 is generally flush with the distal edge of the distal end cap 1218. Proximal to the system, located inside the outer tube 1212 or alternatively in the distal region of the handle housing 1251, is a first fixed proximal tube 1228.

[0242] Also positioned at the distal end of the outer tube 1212 is a second fixed distal tube 1230, which forms an insertion port for the second floating channel 1224. The distal tube 1230 has an opening 1231, a proximal edge 1242, and a distal edge 1243. In some embodiments, instead of the opening 1231, the distal end can be closed. Preferably, the distal edge 1243 is generally flush with the distal edge of the distal end cap 1218. At the proximal end of the system, located inside the outer tube 1212 or alternatively in the distal region of the handle housing 1251, is a second fixed proximal tube 1232 having a proximal edge 1246. Preferably, the first and second proximal tubes 1228, 1232 are attached to the inner wall of the outer tube 1212 or the handle housing 1251 using adhesive, welding, or other attachment methods. Similarly, the first and second distal tubes 1226, 1230 are preferably attached to the inner wall of the outer tube 1212 using adhesive, welding, or other attachment methods. It should be noted that... Figure 33 For clarity, a cross-sectional view (into the semi-cylinder) of the proximal fixing tube 1228 or 1232 is shown. It should be understood that these tubes can be cylindrical in configurations similar to the distal fixing tubes 1226 and 1230. Other configurations of the distal and proximal fixing tubes are also conceivable.

[0243] The distal end of the first flexible channel (tube) 1222 is located inside the first fixed distal tube 1226 and is secured to the interior by means of, for example, adhesive bonding, welding, or other attachment methods. It can terminate at any fixed position inside the distal tube 1226, and in the illustrated embodiment, terminates at the distal tube 1226. The proximal end 1238 of the first flexible channel 1222 is located inside the first fixed proximal distal tube 1228 and is secured to the interior by means of adhesive bonding, welding, or other attachment methods. It can terminate at any fixed position inside the proximal tube 1228, and in the illustrated embodiment, terminates at the proximal end of the proximal tube 1228. Thus, the first flexible channel 1222 is secured relative to the outer tube 1212 at its proximal and distal ends. However, it is still not attached to the middle portion located between the proximal and distal ends, for example, along its length between its two fixed ends, so it can float inside the outer tube 1212. Similarly, the distal end of the second flexible channel (tube) 1224 is located inside the second fixed distal tube 1230 and is secured to the interior by means of, for example, adhesive bonding, welding, or other attachment methods. It can terminate at any fixed position inside the distal tube 1230, and in the illustrated embodiment, terminates at the distal end of the distal tube 1230. The proximal end of the second flexible channel 1224 is located inside the second fixed proximal tube 1232 and is secured to the interior by means of, for example, adhesive bonding, welding, or other attachment methods. It can terminate at any fixed position inside the proximal tube 1232, and in the illustrated embodiment, terminates at the proximal end of the proximal tube 1232. In this way, the second flexible channel 1224 is secured relative to the outer tube 1212 at its proximal and distal ends. However, it remains unattached to the middle portion between the proximal and distal ends, for example, along its length between its two fixed ends, so that it can float inside the outer tube 1212.

[0244] With Figure 19A The flexible guide devices (tool channels) 1122 and 1124 are connected in the same manner as the first and second flexible guide devices or tool channels 1271 and 1270. Figure 33Inserted through ports 1248 and 1250. Flexible guides 1271 and 1270 extend through floating channels 1222 and 1224, respectively, to protrude from the distal end and enter the chamber. It should be noted that in some embodiments, flexible guides 1271 and 1270 may be constructed of a Pebax tube, a covered PVC tube, and a polyolefin shrink tube above the PVC tube. Other flexible guides disclosed herein may also be constructed with this structure. This provides a balance between flexibility and stiffness and also reinforces the proximal end for ease of user operation. It should be noted that flexible guides 1271 and 1270 protrude from the proximal cover 1218 in the same manner as flexible guides (tool channels) 1122 and 1124 and bend at their distal front ends. Therefore, since the flexible guide devices 1271 and 1270 are functionally identical to the guiding / bending working instruments inserted through them, they will not be described further for the sake of brevity, as the above description of the flexible guide devices 1122 and 1124 is entirely applicable to the flexible guide devices 1271 and 1270. It should be noted that, for clarity, the flexible guide devices are not shown in the other figures; it should be understood that they will be shown in Figure 21- Figure 25 It works in a certain way.

[0245] exist Figures 35A-35C In alternative embodiments, the floating (flexible) channels are fixed at their proximal ends but are free (unattached) at their distal ends. More specifically, Figures 35A-13 Figure 5C shows a cross-sectional view of the system, thus only showing one of the floating channels, namely the second floating channel 1324. The first floating channel is attached and configured in a similar manner to the second floating channel 1324. The second floating channel 1324 is attached to its proximal end in the same manner as floating channel 1224, i.e., attached inside the fixed proximal tube. Figures 35A-35C The first floating channel 1322 is not shown in the diagram, but... Figure 38 The diagram shows a first floating channel 1322, which is attached to its proximal end in the same manner as the first floating channel 1222, i.e., attached to the interior of a fixed proximal tube. Floating channels 1322, 1324 and... Figure 32 The floating channels 1222 and 1224 differ in that they are not attached to their distal ends. Therefore, the floating channels 1322 and 1324 constitute a retractable channel inside the outer tube (or conduit) 1312.

[0246] For more specific details, please refer to [link / reference]. Figures 35A-35C and Figure 38A first fixed distal tube 1326 is attached inside the outer tube 1312, adjacent to the proximal cap 1318, and located above the outer tube (conduit) 1312 of system 1310. The first fixed distal tube 1326 forms an insertion port for a first floating channel 1322. The distal tube 1326 has a lumen extending therethrough, a proximal edge 1325, and a distal edge 1329. Preferably, the distal edge 1329 is generally flush with the distal edge of the proximal cap 1318. A second fixed distal tube 1330 is attached inside the outer tube 1312, adjacent to the proximal cap 1318, and forms an insertion port for a second floating channel 1324. The distal tube 1330 has a lumen 1331 extending therethrough, a proximal edge 1333, and a distal edge 1338. Preferably, the distal edge 1338 is generally flush with the distal edge of the proximal cap 1318. The second floating channel 1324 has a distal end 1337, the distal end 1337 Figure 35A The position is entirely inside the second fixed distal tube 1330. When the outer tube 1312 bends in one direction, the second floating channel 1324 moves distally. Figure 35B The position. When further bent, the floating channel 1324 may extend beyond the distal edge 1338 of the second fixed distal tube 1330 (and beyond the distal edge of the proximal cap 1318), as in Figure 35C As shown in the image. Figure 38 (and Figure 39B The outer tube 1312 is shown in Figure 35C The effect of bending in the opposite direction. As shown in the figure, the second floating channel 1324 remains inside the lumen 1331 of the second fixed distal tube 1330, while the distal end 1327 of the first floating channel 1322 extends distally beyond the distal edge 1329 of the first fixed distal tube 1326 (and beyond the distal edge of the proximal cap 1318).

[0247] In other words, the floating channels 1322 and 1324 are not confined within the outer tube (conduit) 1312 and take the shortest path when the outer tube 1312 is bent. Therefore, their positions are moved and repositioned to accommodate length differences during bending of the outer tube 1312. It should be noted that the floating channels 1322 and 1324 can also rotate slightly during bending of the outer tube 1312 to compensate for stresses applied to the floating channels during bending. This prevents the eccentrically positioned channels from being stretched on the outside of the bend and buckling on the inside of the bend. The floating channels can move within the lumen 1315 of the outer tube 1312 and adopt any shape to accommodate bending, thereby increasing the flexibility of the device.

[0248] It should be noted that, Figure 35C The outer tube 1312 bends in the first direction, causing the second floating channel 1324 on the inner side of the bend of the outer tube 1312 to travel distally beyond the distal tube 1330. Figure 38 In the middle, the outer tube 1312 bends in the second opposite direction, such that the first floating channel 1322 on the inner side of the bend of the outer tube 1312 extends beyond the distal tube 1326.

[0249] The dimensions of the fixed distal tubes 1326 and 1330 forming the sockets for the respective floating channels 1322, 1324 are designed such that their lengths exceed the maximum extent of movement due to the maximum curvature of the outer tube 1312 caused by bending during use. This ensures that the floating channels 1322, 1324 will not retract from the proximal ends of the respective fixed distal tubes 1326, 1330. In a preferred embodiment, the lengths of the distal tubes 1326 and 1330 are between about 1.5 cm and about 3 cm, and preferably about 2 cm. Other dimensions are also conceivable.

[0250] will with Figure 33 Flexible guide devices 1270, 1271 and / or Figure 19- Figure 25 The flexible guide devices 1122 and 1124 are inserted through floating channels 1322 and 1324 in the same manner as described above, thus allowing the endoscopic instrument to be inserted into the chamber formed by the flexible element for surgical procedures. It should be noted that, alternatively, the endoscopic instrument can be inserted directly through the floating channel in any embodiment described herein without an intermediate flexible guide device. This direct insertion of the instrument without a flexible guide device (instrument channel) has also been described above as an alternative system and method.

[0251] The instruments may include, for example, grippers. Cutting / removing instruments may be inserted via flexible guides in a floating channel, or alternatively via the working channel of an endoscope. Thus, a variety of instruments can be inserted via both flexible channels and endoscopic channels.

[0252] The flexible guide devices described herein (e.g., flexible guide devices 1270, 1271) can be color-coded to improve system usability. For example, flexible guide device 1270 can have a first color (e.g., red), and flexible guide device 1271 can have a second color (e.g., black). This makes it easier for the user to see the corresponding color-adjusted tip being manipulated inside the expansion cage when operating the flexible guide devices 1270, 1271 proximally from outside the patient's body. It should be noted that the entire flexible guide device can have the same color, or alternatively, matching colors can be used only at the proximal end visible to the user and the distal end visible using the endoscope. It should also be understood that, instead of color coding, other markings can be provided to allow the user to match the proximal end of the flexible tube with the distal end inside the chamber.

[0253] Figures 39A-39C The illustration depicts the distal portion of system 1310 and shows how the traction element in the expanded configuration forms an asymmetrical cage to create a workspace for the surgical procedure. Traction system 1370 and... Figure 21A The traction system 1150 of the embodiment is the same, thus forming a workspace expansion system when expanding from its retracted insertion state and a cavity reshaping system during certain surgical procedures. This cavity reshaping system reshapes the cavity to create an asymmetric space to increase the workspace for manipulating endoscopic instruments via the system's flexible guide. That is, the traction system forms a self-contained "surgical kit" that creates an expansion zone within the cavity, allowing the surgeon to perform surgery within the created space. By reshaping the cavity, the workspace is maximized without overstretching it. This maximization of the workspace increases the distance between the target tissue and the end effector of the endoscopic instrument, thus improving instrument maneuverability during the surgical procedure. It should be noted that, for clarity, the flexible tool channel (flexible guide) and endoscopic instruments are not shown in these figures, but they will be depicted in relation to Figure 21- Figure 25 Operate in the same way as in China. Figure 32 and Figure 33 The traction system of system 1210 is the same as the traction system 1370 of system 1310; therefore, the description of the structure and function of traction system 1370 is entirely applicable to the traction system of system 1210. The following description... Figure 36 The illustration shows an example of reshaping the body cavity into a more elliptical configuration.

[0254] As described above, traction system 1370 is identical to traction system 1150 and includes flexible traction elements 1380 and 1382, which are formed within a chamber (space) inside the body cavity and form an asymmetrical cage. Flexible traction elements 1384 and 1386 constitute the base of traction system 1370. The movement of traction elements 1380, 1382, 1384, and 1386 is the same as that of traction elements 1152, 1154, 1156, and 1158 and / or the same as that described below. Figures 40-42 The movement of the traction elements is the same. The traction system 1370 is also similar to the traction system 1150 and may include bridging members 1390 across traction elements 1380, 1382, and optionally bridging members 1392 across traction elements 1384, 1386. These bridging members have the same construction and function as the aforementioned bridging members 1155, 1157, and therefore will not be described in detail herein for the sake of simplicity, as the above description of bridging members 1155, 1157 and their alternatives is fully applicable to the traction system 1370.

[0255] Traction elements 1380, 1382, 1384, and 1386 can be made of a generally flexible material, and preferably of a wire composed of a nickel-titanium alloy. A layer of soft, compatible material, but preferably PTFE tubing 1387, can be situated on a portion of the wire. A polyolefin heat-shrinkable tube 1389 can be situated on the traction portion of the element and the bridging member to hold the bridging member in place. Note that the traction element is tilted at the distal end, i.e., pivoted from the distal cover 1374. To increase the size of the traction element adjacent to this area, a covering material (such as PTFE tubing) can be provided.

[0256] The flexible tube or beam 1391, in the form of a rod or tube, has a cavity for receiving a stabilizing or rigidifying structure, such as a rigid tube or rod 1393 (which, alternatively, may slide over the beam 1391)). The flexible beam 1391 and the rigidifying structure 1393 are as described above. Figure 17A , Figure 17B The flexible beam 1160 and the rigid beam 1162 are identical. Therefore, for the sake of simplicity, further details of these components are not provided herein, as the structure and function of beams 1160 and 1162, described in detail above, are fully applicable to beams 1391 and 1393. Similar to... Figure 33 The actuator 1256 is operably connected to the rod 1393 so as to slide relative to the beam 1391 to increase the stiffness of the cage. Alternative structures to the aforementioned rigidification structure, such as those that allow the rigidification structure to slide on a flexible beam, are also perfectly suitable for use as... Figure 39A The rigid structure of the traction system 1370 and Figure 32 and Figure 33 The system 1210 is a replacement for the traction system.

[0257] Provided with Figure 28 and Figure 29 The sheath 1378 is the same cover as the sheath 1170. Sheath 1378 covers the traction elements 1380, 1382, 1384, and 1386, and has an opening 1395 for accessing tissue in the expanded state of the traction system 1370. Further details regarding sheath 1395 are not provided herein because sheath 1395 is structurally and functionally identical to sheath 1170. Furthermore, the various embodiments of the sheaths described above are fully applicable to... Figures 32-42 The protective sheath of the system.

[0258] In an alternative embodiment, used to make Figures 32-42The purse-string suture for the sheath 1378 or any of the aforementioned sheaths is excluded and relies on the sheath itself. The exclusion of the purse-string suture simplifies the device by providing fewer components and reducing the number of steps during the procedure. In embodiments without a purse-string suture, the sheath closes on the captured tissue (e.g., the polyp) as tissue (e.g., the severed polyp) is pulled into the cage formed by the traction elements, and the traction elements return to their non-expanded state to cause the cage to collapse, thus preventing or minimizing bleeding from pathological tissue (e.g., cancerous tissue) during removal. The gripper may also maintain its clamping on the severed tissue so that the gripped tissue can be removed from the body cavity along with the catheter. The target tissue (e.g., the polyp) will typically be located inside the cage during the procedure and during its removal from the body, and will be effectively isolated from the surrounding normal tissue by the cage and its sheath.

[0259] Figures 40-42 The diagram illustrates the alternative traction system of the present invention. Besides the rigid structure, the traction system 1415 of system 1410 is similar to... Figure 39A The traction system 1370 (and) Figure 17C The system 1150 is the same. In this embodiment, instead of a movable beam used to rigidify the flexible elements, the elements of the traction system have inherent stiffness characteristics to rigidify the entire traction system 1415. More specifically, the traction system 1415 has flexible traction elements 1412, 1414 that expand (bend outward) to form a chamber (cage) thus forming a workspace in the same manner as the aforementioned traction elements 1380, 1382. This is similar to the actuator 1252 ( Figure 33The movement of the actuator 1416 causes the flexible traction elements 1380 and 1382 to expand in the same way as the movement of the actuator 1412 and 1414. That is, the actuator 1416 is attached to a block or bracket 1426 that houses a slot or opening for attaching the push cable 1428. The push cable 1430 is also attached inside another slot or opening in the block 1426. Thus, the push cables 1428 and 1430 are operatively connected to the actuator 1416 at their proximal ends. Connecting tube 1432 connects the push cable 1428 to the flexible element 1414, and connecting tube 1434 connects the push cable 1430 to the flexible element 1412. Connecting tubes 1432 and 1434 are located at the distal ends of the outer tube 1411 in the region near the side cover 1413. More specifically, the distal end of the actuation cable 1428 is secured inside the connecting tube 1432, and the proximal end of the flexible traction element 1414 is secured inside the connecting tube 1432. The distal end of the actuation cable 1430 is secured inside the connecting tube 1434, and the proximal end of the flexible traction element 1412 is secured inside the connecting tube 1434. The sliding movement of the actuator 1416 within the slot 1436 of the handle housing 1438 causes the actuation cables 1428 and 1430 to move distally, which is due to the attachment of the flexible elements 1412 and 1414 at the distal end cap 1417, causing the flexible elements 1412 and 1414 to bend outward to an expanded state. A mark 1440 may be provided to indicate the expansion of the traction element, as shown in... Figure 33 As shown in the image.

[0260] The traction system 1410 also has flexible elements 1418 and 1420 that form the base of the cage and are identical to the aforementioned traction elements 1384 and 1386. However, the traction system 1415 differs from traction systems 1370 (and 1150) in that it provides a beam 1422 that is sufficiently stiff to maintain the overall stiffness of the expansion cage when relatively light forces are applied (e.g., the weight of a small portion of the intestinal wall, small external intra-abdominal pressure, etc.) and to limit the bending of the cage relative to the outer tube 1422 during use when relatively light forces are applied. That is, the beam 1422, extending from the proximal cover 1413 to the distal cover 1417, maintains the stiffness of the system when relatively light forces are applied because the beam is fixed at both ends and allows the length of the expansion cage to extend. However, the stiffness of the beam 1422 is optimized to have sufficient flexibility when significant forces (e.g., the bending force of the endoscope) are applied to the beam 1422. This rigidification of the beam can be achieved in several ways. In some embodiments, the wire elements constituting the rigidified beam itself have sufficient rigidity to achieve stability of the expansion cage. However, to further increase stiffness while retaining the desired flexibility, in alternative embodiments the rigidified beam may have increased thickness to further optimize the bending of the cage elements (e.g., beam 1422). As shown in the figure, in this embodiment, the diameter (or cross-sectional dimension, if a non-circular beam is used) is larger than the diameter (or cross-sectional dimension, if a non-circular element) of the flexible elements 1412, 1414, 1418, and / or 1420. In other embodiments, the rigidified beam may be made of a material that is stiffer than one or more other flexible elements. This stiffer material may include, for example, steel or plastic.

[0261] It should be noted that, for clarity, Figures 40-42 The flexible tool guide (tool channel) is not shown, but a flexible guide can be used, for example... Figure 33 Flexible guiding devices 1270 and 1271 are provided. Furthermore, in this embodiment, only a single actuator is provided for the expansion of the traction system 1415, as an actuator for rigidifying the structure is not necessary.

[0262] In all other respects, System 1410 is identical to System 1310.

[0263] Figures 43A-47CThe illustrations depict alternative embodiments for stabilizing the chamber. In these embodiments, an expandable stabilizing structure is provided distally, stabilizing the distal portion of the catheter. As will be understood, one method for enhancing stabilization is to fix the distal point of the chamber so that when the flexible element forming the chamber is pushed forward, the flexible element bulges to the side because the fixed distal point does not deviate, thus providing support for the flexible element. In the preceding embodiments, this distal fixation is achieved using an elongated stabilizing bar, which can be fixed relative to the catheter or can be restrictively rigidified to form a more rigid beam from a rigidified member sliding on or within it, as described in detail above. Figures 43A-47C In some embodiments, stabilization is achieved by expanding a stabilizing member at a distal end, which selectively expands to match the lateral dimensions of the body space (e.g., the colon). In some embodiments, the expanded stabilizing member is axially fixed to or onto a distal connecting structure for the flexible element; in other embodiments, the expanded stabilizing member is axially movable to or onto a distal connecting structure. Additionally, in some embodiments, the expanded stabilizing member is an inflatable balloon; in other embodiments, the expanded stabilizing member is a mechanical structure such as a mesh or tubular support structure. Each of these variations is discussed in detail below.

[0264] As can be understood, sufficient flexibility is necessary for the catheter to travel through the anatomical structures to the target site. On the other hand, sufficient rigidity (i.e., distal fixation of the catheter) is required to allow the flexible elements to bend and to maintain the chamber and therefore the working space for the treatment of the target tissue. Figures 43A-47C The embodiments provide a method for achieving this objective by providing fewer flexible elements compared to the previous embodiments, thereby reducing the overall stiffness of the catheter while providing an expandable stabilizing structure at the distal end, which can be retracted and is flexible for insertion and selectively expanded to rigidify and stabilize the system when the catheter is in the desired surgical site.

[0265] It should be noted that, Figures 43A-47C In the embodiments, the flexible element is identical to other components of the flexible conduit and system. Therefore, for ease of understanding, in all figures, it is given as... Figures 43A-47C These similar components (even if they show different stabilizing elements) are given the same reference numerals. However, in cases where these embodiments differ (e.g., expandable stabilizing components), different reference numerals are used for ease of understanding of the differences.

[0266] First turn Figures 43A-43DIn one embodiment, system 1500 includes a multilumen conduit or tubular member 1510 configured to receive one or more tool channels or flexible instrument guides. Figure 43C Two tool channels 1122 and 1124 (identical to the aforementioned tool channels 1122, 1124) are shown. It should be understood that in some embodiments, only one tool channel may be used, and in other embodiments, more than two tool channels may be used, and the conduit has a sufficient number of lumens. It can be used in conjunction with... Figure 11 As shown, the tool channels 1122, 1124 are packaged as a kit with catheter 1510. Alternatively, tool channels 1122, 1124 can be packaged independently. In other embodiments, the tool channels are packaged inside the lumen of catheter 1510. Each tool channel 1122, 1124 has a lumen (channel) for receiving an endoscopic instrument (tool), such as the endoscopic instrument described above, therethrough. The tool channels 1122, 1124 can be provided as floating channels within the catheter lumen, as described in detail above.

[0267] The traction system 1550 (which constitutes a workspace expansion system and, in some clinical applications, a body cavity remodeling or reconstruction system) is positioned at the distal portion 1511 of catheter 1510 in the same manner as the traction system 1150 is positioned at the distal portion 1111 of catheter 1110 described above. Catheter 1510 of the traction system 1550 includes two flexible traction elements 1552 and 1554, although additional flexible elements may be provided in alternative embodiments. The traction elements 1552 and 1554 constitute expandable elements that form a working chamber (space) within the body cavity and form an asymmetric cage. The traction elements 1552 and 1554 are expandable to form an asymmetric working chamber, thereby improving visibility and workspace, as described above in detail with respect to other systems forming asymmetric workspaces. It should be noted that the traction system 1510 differs from the traction system 1150 in that only two traction elements extend from the proximal connector 1540.

[0268] For example, in traction elements 1152 and 1154, traction elements 1552 and 1554 move from a retracted insertion state (where they preferably do not extend beyond or significantly beyond the lateral dimension of catheter 1510) to an expanded state (where they laterally bend outward beyond the lateral dimension of catheter 1510). As in the above embodiment, the traction system 1550 (i.e., traction elements 155, 1554) expands only to one side of the plane passing through the longitudinal axis of catheter 1510, thereby forming an asymmetrical workspace 1551 (and an asymmetrical cage), and has the accompanying advantages described herein.

[0269] Traction elements 1552, 554 may have a bridging member 1555 to increase stability of the traction device (i.e., the flexible traction element) during bending and to maintain the desired orientation of the traction element during expansion, i.e., to facilitate controlled spatial expansion / reshaping. The bridging member 1555 is attached to the two traction elements 1552, 1554, preferably in the middle, to form a lateral structure for the elements 1552, 1554, thereby restricting lateral movement. As shown in the figure, the bridging member 1555 is the same as the bridging member 1155 described above and therefore will not be described in detail for the sake of brevity, as the description and function of the bridging member 1155 are entirely applicable to the bridging member 1555. It should be noted that the bridging member 1555 may be a separate component attached to the traction element using tubular elements (such as the tubular elements 1159a, 1159b described above), which are respectively mounted on and attached to the traction elements 1552, 1554. Other attachment methods for the bridging member are also conceivable. On the other hand, the bridging member 1555 can be integrally formed with one or both traction elements 1552, 1554 to increase the stability of the traction system. In some embodiments, the bridging member 1555 may also include legs 1555a, 1555b to provide additional stability similar to the legs 1155d, 1155e described above.

[0270] The catheter 1510 includes a proximal connector (cap) 1540 through which the traction elements extend in the same manner as the proximal connector 1140. Traction elements 1552 and 1554 are distally attached to a connecting structure, i.e., a distal connector or distal connector 1548 similar to the distal connector 1148. The distal connector 1548 has an opening for receiving the traction elements 1552 and 1554 so that they can be secured to the connector 1548 in the same manner as the aforementioned connector 1148. The traction elements 1552 and 1554 can be moved to an expanded (laterally outwardly bent) state in the same manner as the traction elements 1152 and 1152 (e.g., using a sliding actuator). It should be noted that the proximal and distal connectors 1540, 1548 may have openings sized to receive the endoscope when the catheter 1510 is loaded onto it, as described herein. As mentioned above, a housing similar to [the described details] can be provided. Figures 6A-6D Multiple teeth (not shown) of the device are engaged with teeth of an actuator for use with a flexible element, thereby forming a fixing or locking mechanism for holding the traction element in one of several selectable positions. A release mechanism for the fixing or locking mechanism may be provided.

[0271] Additionally, it should be understood that alternative methods of expanding the traction elements may be employed, including, for example, providing relatively movable couplings 1540, 1548 to expand the traction elements 1552, 1554 in the same manner as described in the alternatives above. Alternatively, the traction elements may also be made of a self-expanding material (such as a shape memory material) that expands when exposed from the conduit.

[0272] A cannula or covering material 1576 can be placed on top of the flexible elements 1552 and 1554 to form a closed space for tissue capture and retrieval. Figure 43D This situation is illustrated in [the image / image]. (For clarity, in [the image / image]...) Figures 43A-43C (The covering is not shown in the image). Covering 1576 can be constructed and function in the same manner as covering 1170 described above, and thus the aforementioned functions and construction of covering 1170 and its alternatives are fully applicable to covering 1576. It should be noted that in other embodiments described herein, covering material 1576 may be placed on top of a flexible element.

[0273] An expandable structure (component) 1570, in the form of an inflatable balloon 1572, is located distal to the distal connector 1548. The balloon 1572 is located distal to the catheter 1574, which has a lumen communicating with the interior of the balloon 1572 for inflation. The catheter 1574 extends through a lumen 1513 in the catheter 1510, which may be a separate lumen or, alternatively, a region of a lumen receiving an endoscope and / or tool passage. In the inserted state of the catheter 1510, the balloon 1572 is in a collapsed, uninflated state, thus presenting a small profile. In the inserted state, the catheter 1574 is in an extended state, and the uninflated balloon 1572 is distal to the connector 1548 (see [link to original text]). Figure 43B After inserting catheter 1510 relative to the target tissue at the desired location, catheter 1574 is retracted proximally within the lumen 1513 of catheter 1510 to axially retract balloon 1572 toward distal connector 1548. When positioned adjacent to distal connector 1548, balloon 1572 is inflated only distal to and slightly spaced from or abutting the distal end of connector 1548, thus expanding balloon 1572 to fill the transverse dimension of the body space (e.g., colon C), as shown in... Figure 43C As shown in the diagram, the traction elements 1552, 1554 are moved to an expanded position in the manner described above (e.g., by moving an actuator operably connected to the traction elements 1552, 1554 to form a chamber for the working instrument), thereby bending outward.

[0274] It should be noted that before or after the expansion of traction elements 1552, 1554, the catheter 1574 and the attached balloon 1572 (as in other balloon or mechanical dilator embodiments described below) can be retracted and positioned adjacent to the distal connector 1548. It should also be noted that the balloon 1572 can be inflated before or after retraction to its proximal position adjacent to the distal connector 1548. This sequence of steps, i.e., the axial movement and / or expansion of the dilable member before or after the expansion of the traction elements, can occur in other embodiments herein.

[0275] It should be noted that, if in Figure 43C As shown, the expanded traction element reshapes a body cavity (e.g., the colon), and the balloon 1572 can be positioned distal to the reshaped lumen area to engage with the lumen wall to provide a fixation and thus a stable distal point for the traction element to stabilize the working chamber.

[0276] exist Figures 44A-44C In an alternative embodiment, instead of retracting the balloon adjacent to the distal connector 1548, the balloon 1582 is retracted to cover the connector 1548. The expandable stabilizer structure 1581 of the system 1580 includes an annular balloon 1582 having an opening 1586 larger than the lateral dimension (outer diameter) of the distal connector 1548, thus allowing the balloon 1582 to be fitted onto the distal connector 1548. The balloon 1582 is attached to the distal end of a conduit 1584, which is slidably received within the lumen of the conduit 1510 in the same manner as the conduit 1574 described above. The balloon 1582 is located at the distal end of the conduit 1584, which has a lumen communicating with the interior of the balloon 1582 for inflation. The conduit 1584 has a bend 1588 to accommodate the opening 1586. It should be noted that the bend 1588 is shown by way of example, and it should be understood that other angles can be used, such as a softer bend, a smaller angle, etc. Except for the stabilization features, system 1580 is identical to system 1510, and therefore, for the sake of brevity, the same features are not described. The inflatable balloon 1582 is initially located distal to the distal connector 1548. Similar to catheter 1574, catheter 1584 slidably extends through the lumen in catheter 1510, which can be a separate lumen or an area of ​​a lumen that alternatively receives an endoscope and / or tool passage.

[0277] At the insertion position of catheter 1510, balloon 1582 is in a retracted, uninflated position, thus presenting a small profile for insertion. In this insertion position, catheter 1584 is in an extended position, and the uninflated balloon 1582 is distal to connector 1548. After catheter 1510 is inserted relative to the target tissue into the desired position, catheter 1584 is retracted proximally into the lumen of catheter 1510 so that balloon 1582 is retracted axially toward and over connector 1548. When positioned over connector 1548 such that connector 1548 sits within opening 1586 in balloon 1582, balloon 1582 is inflated (or further inflated if partially inflated before complete retraction) to fill the transverse dimension within a body space (e.g., colon), similar to the inflation of balloon 1572. Figure 43C The space within. It should be noted that, alternatively, the balloon 1582 can be fully inflated before retraction above the distal connector 1548. In the manner described above, for example by moving an actuator operably connected to the traction elements 1552, 1554 to form a chamber for the working instrument, the traction elements 1552, 1554 are moved to an expanded position, thereby bending outwards. As described above, the traction elements 1552, 1554 can be expanded before or after the inflation of the balloon 1582 and before or after the retraction of the balloon 1582.

[0278] exist Figures 45A-45B In an alternative embodiment, instead of the stabilizing structure, i.e., the balloon retracted to a position adjacent to or covering the distal connector 1548, the balloon 1592 of the stabilizer structure 1591 of system 1590 is axially fixed to the position covering the distal connector 1548. The balloon 1592 is an annular balloon 1582 having an internal opening sized to fit over the distal connector 1548. The balloon 1592 is located at the distal end of the conduit 1594, which is axially fixed inside the lumen of the conduit 1510. The interior of the balloon 1592 communicates with the lumen in the conduit 1594 to allow for balloon inflation. Figure 45A , Figure 45B The system is the same as system 1580, therefore, for simplicity, identical features will not be described again in this document. In use, the catheter 1510 is inserted using the balloon catheter 1594 fixedly positioned therein and the balloon 1592 in a non-inflated position above the distal connector 1548, as in... Figure 45A As shown in the diagram. During this procedure, balloon 1592 is inflated using an inflation chamber that extends through catheter 1594 and communicates with the interior of the balloon, causing balloon 1592 to expand to... Figure 45B The position of the chamber formed by the expansion traction elements 1552 and 1554 is stabilized.

[0279] Figures 46A-47C The illustration depicts an alternative embodiment with a stabilization structure that replaces a mechanical dilator instead of an inflatable balloon. First, turn to... Figures 46A-46C In this alternative embodiment, instead of a balloon retracted to a position adjacent to the distal connector 1548, a mesh structure 1602 is used to stabilize the ventricle. The expandable stabilizer structure 1601 of system 1600 includes a structure made of a series of wires, fibers, or other materials shaped into a sufficiently rigid mesh structure to provide a stabilizing structure for the ventricle. The mesh structure 1602 is located inside the distal end of catheter 1604, which is slidably received in the lumen of catheter 1510 in the same manner as catheter 1574 described above. An actuator 1606 (such as a push rod or pull rod) is slidably received inside the lumen of catheter 1604 and attached to the mesh structure 1602, for example, distally, to expand and collapse the mesh structure. Except for the stabilization features, system 1600 is identical to system 1510; therefore, for the sake of brevity, identical features are not described further. The mesh structure 1602 is initially located distal to the distal connector 1548. Similar to catheter 1574, catheter 1604 extends slidably through lumen 1513 in catheter 1510, which may be a separate lumen or alternatively an area for receiving endoscope and / or tool channels.

[0280] At the insertion position of catheter 1510, the mesh 1602 is in a constricted, non-expanded position, thus presenting a small outline for insertion. At this insertion position, catheter 1604 is... Figure 46A The extension or distal position, and the non-expanding (retracting) mesh 1602 is distal to the connector 1548, i.e., further spaced from the connector 1548. After inserting the tissue catheter 1510 into the desired position relative to the target, the catheter 1604 is retracted proximally within the lumen 1513 of the catheter 1510 to axially retract the mesh structure 1602 toward the distal connector 1548. Figure 46B The position. In the illustrated embodiment, the mesh structure 1602 is retracted to a position adjacent to the distal connector 1548, slightly spaced or close together. In an alternative embodiment, the mesh structure 1602 has a similar position to Figure 44B The opening 1586 of the balloon 1582 is sized to fit over the distal connector 1548, allowing the mesh structure 1602 to retract and cover the distal connector 1548. Once retracted, the push rod / pull rod 1606 is axially pulled (or further pulled if partially pulled before retraction) to expand the mesh 1602 to inflate it in a manner similar to that of the balloon 1572. Figure 43CThe space within the body space (e.g., the colon) is filled in a transverse dimension. In the manner described above, for example, by moving actuators operably connected to traction elements 1552, 1554 to form a chamber for the working instrument, the traction elements 1552, 1554 are moved to an expanded position, thereby bending outwards. As described above, the traction elements 1552, 1554 can be expanded before or after the mesh structure 1602 moves proximally toward the distal connector 1548, and before or after the expansion of the mesh structure 1602.

[0281] It should be noted that, as an alternative to the push rod / pull rod 1606, the conduit 1604 may include a pusher and secure the mesh 1602 in a retracted position located inside the conduit 1604. When the conduit 1604 is moved to the desired location, the pusher travels distally to push the mesh 1602 out of the distal end of the conduit 1604, thereby enabling it to automatically expand due to its spring-like properties or its shape memory material. Figure 46C The expansion location.

[0282] In an alternative embodiment, the conduit 1604 is axially secured inside the conduit 1510, and thus the mesh structure 1602 is axially secured relative to the distal connector 1548, located adjacent to or covering the connector 1548 in the distal direction. Therefore, in this embodiment, the mesh 1602 is in this fixed axial position when retracted and inserted, and remains in this fixed axial position when expanded.

[0283] exist Figures 47A-47C The diagram illustrates an alternative expandable mechanical stabilization structure. In this embodiment, instead of a mesh structure, a vascular stent-like structure 1612 is provided, consisting of multiple struts interconnected to form various geometries. The stent structure 1612 is located inside the distal end of a catheter 1614, which is slidably received in the lumen of catheter 1510 in the same manner as catheter 1574 described above. An actuator 1616 (such as a push rod or pull rod) is slidably received inside the lumen of catheter 1614 and attached to the stent structure 1612, for example, at the distal end, to move the stent structure 1612 between a retracted position and an expanded position. Except for the stabilization features, system 1610 is identical to system 1510, and therefore, for simplicity, identical features are not described. The stent structure 1612 is initially located distal to the distal connector 1548. Similar to catheter 1574, catheter 1614 extends slidably through lumen 1513 in catheter 1510, which may be a separate lumen or alternatively a region of a lumen that receives an endoscope and / or tool passage.

[0284] At the insertion position of catheter 1510, the tubular support structure 1612 is in a constricted, non-expanded position, thus presenting a small profile for insertion. At this insertion position, catheter 1614 is... Figure 47A The extension or distal position, and the non-expanded (retracted) stent structure 1612 is distal to the connector 1548, i.e., further spaced from the connector 1548. After inserting the catheter 1510 into the desired position relative to the target tissue, the catheter 1614 is retracted proximally within the lumen 1513 of the catheter 1510 to axially retract the stent structure 1612 toward the distal connector 1548. Figure 47B The position. In the illustrated embodiment, the stent structure 1612 is retracted to a position adjacent to, slightly spaced apart from or adjacent to, the distal connector 1548. In an alternative embodiment, the stent structure 1612 has an opening 1586 similar to that of the balloon 1583, the opening being sized to fit over the distal connector 1548, thus allowing the stent structure 1612 to be retracted to cover the distal connector 1548. Once retracted, the push rod / pull rod 1616 is axially pulled (or further pulled if partially pulled before retraction) to expand the stent 1612 to fill the lateral dimension (as in) within the body space (e.g., the colon). Figure 47C (As shown) to stabilize the chamber. In the manner described above, for example by moving an actuator operably connected to the traction elements 1552, 1554 to form a chamber for the working instrument, the traction elements 1552, 1554 are moved to an expanded position, thereby bending outward. As described above, the traction elements 1552, 1554 can be expanded before or after the support structure 1612 moves proximally toward the distal connector 1548 and before or after the expansion of the support structure 1612.

[0285] It should be noted that, as an alternative to the lever 1616, the catheter 1614 may include a pusher, and the stent 1612 is held in a retracted position within the catheter 1614. When the catheter 1614 is moved to the desired location, the pusher is advanced distally to push the stent 1612 out of the distal end of the catheter 1614, thereby allowing the stent 1612 to automatically expand due to its spring-like properties or its shape memory material. Figure 47C The expansion location.

[0286] In an alternative embodiment, the catheter 1614 is axially fixed inside the catheter 1510, and thus the stent structure 1612 is axially fixed relative to the distal connector 1548, thereby being located adjacent to or covering the connector 1548 in the distal direction. Therefore, in this embodiment, the stent 1612 is in this fixed axial position when retracted and inserted, and remains in the fixed axial position when expanded.

[0287] Figure 49A and Figure 49B The illustration depicts an alternative embodiment in which the distal balloon forms both the stabilizing structure and the distal connector. As shown, system 1620 has two flexible elements 1622, 1624, which are attached proximally to the proximal connector 1626 of catheter 1628. At their distal ends, the flexible element is attached to the stabilizing balloon 1630. One of the flexible elements 1622, 1624 has a lumen for allowing inflation fluid to pass through in order to inflate the balloon 1630. A C-shaped fixing member 1632 can be disposed within the balloon 1630 to provide the attachment structure for the flexible elements 1622, 1624. In use, utilizing the... Figure 49A The balloon 1630 is positioned at the desired location, through which the catheter 1628 is inserted. When at the desired location, the balloon 1630 is inflated, and the flexible elements 1622 and 1624 are expanded (either after or before balloon inflation). Figure 49B The position, and the balloon 1630 fills the body cavity in lateral dimensions (as in...). Figure 43C (in the middle) and stabilizes the chamber formed by the flexible elements 1622 and 1624. In all other respects, catheter 1628 is the same as catheter 1510 and allows the passage of endoscopes, cutting tools, and working instruments into the chamber.

[0288] In a stable structure Figures 43A-47C and Figures 49A-49B In the foregoing embodiments, two flexible elements are disclosed for forming an asymmetric chamber. It is also conceivable that four flexible elements can be provided to form a symmetrical chamber, for example in… Figure 48 As shown in the figure. In this embodiment, the four flexible elements 1642, 1644, 1646, and 1648 of catheter 1640 are attached proximally to proximal connector 1654 and distally to distal connector 1566. A lateral bridging member 1643 may be provided across the traction element for stabilization. The flexible elements 1642, 1644, 1646, and 1648 are inserted in the retracted position, as shown. When at the desired location, these flexible elements expand to form a generally symmetrical chamber, thereby causing the walls of the body cavity to expand in opposite directions. The stabilizing element attached to catheter 1652 (e.g., balloon 1648 shown) can expand in the same manner as the balloon described above to stabilize the chamber. Alternatively, instead of a balloon, a mechanical dilator as described above can be used to stabilize the chamber.

[0289] The expansion of the stabilizing structure can occur before or after the expansion of the traction elements 1642, 1644, 1646, and 1648. The catheter 1652 can be moved axially in the same manner as described above to adjust the axial position of the balloon 1648, or alternatively, it can be fixed axially.

[0290] It should be noted that in any of the foregoing embodiments, one or more lateral bridging links may be provided between the flexible elements 1522 and 1524 (or 1642-1648) to provide stabilization during bending and to facilitate controlled spacing expansion / reshaping.

[0291] exist Figures 43A-49B The document illustrates the use of systems for removing lesions (such as polyps) from the colonic wall. However, it should be understood that these systems can be used in other procedures performed inside the colon or gastrointestinal tract, as well as in other procedures performed in other body cavities or spaces within the patient's body.

[0292] It should be noted that the movement / actuation of the components in any embodiment can be controlled by a robot, including, for example, the expansion of the traction element, the axial movement of the catheter, the expansion of the stabilizer structure, and / or the inflation of the stabilizer balloon.

[0293] Reference Figure 36 The traction element, constituting an asymmetric cage, in the embodiments disclosed herein forms a workspace or chamber for performing surgical procedures. This chamber simplifies instrument manipulation, such as the triangulation of instruments as described above. It should be noted that, when the body cavity is susceptible to injury (e.g., abrasion by the tensile force), this asymmetric chamber leads to a remodeling of the body cavity or workspace without stretching the cavity walls beyond a single point. (See reference...) Figure 36 This remodeling can be understood in which the body cavity has changed from a generally circular cross-sectional configuration to a slightly elliptical shape, with elongated cavity walls (as shown in the figure). As can be understood, this increases the distance from the tip of the working instrument to the target tissue (such as polyp C on colon wall B). Therefore, the traction element will change the colonic shape at the desired site to a narrower width (especially at the bottom of the chamber) and a higher height (in...). Figure 36 (in the orientation) so as to increase the working space for instruments, thereby reconstructing the colonic lumen.

[0294] The traction element in the embodiments disclosed herein also stabilizes the movement of the cavity wall (which is more pronounced in the gastrointestinal tract). This simplifies the surgical procedure, especially in the gastrointestinal tract.

[0295] It should be noted that the various embodiments of the cage described above are expandable to alter the working space within the body space or body cavity. When the cage is expanded, the working space near the target tissue (e.g., the lesion) increases. More specifically, the distance between the instrument and the target tissue increases, thus facilitating instrument maneuverability and the ability to perform more advanced surgical techniques within the lumen, such as tissue retraction, dissection, and repair. When the cage expands, it compresses and deflects at least a portion of the lumen wall. Therefore, the shape of the lumen can be altered based on the size and shape of the cage, the degree of its expansion, and the size and shape of the body cavity. In smaller diameter body cavities (such as the intestine), expansion of the cage can significantly reshape the cavity, as described above. This reshaping can also occur in larger diameter body cavities. However, it should also be understood that in a larger diameter body cavity (such as the stomach), particularly when aspiration is applied during the surgical procedure, the cavity may not be reshaped. For example, the cage may only contact one side of the cavity wall. However, even in this case, the expanded cage applies radial forces to the body wall to alter the working space. Therefore, regardless of whether the cage is used in a small- or large-diameter workspace / lumen, the cage advantageously allows at least one side of the wall to move, increasing the distance between the instrument tip and the target tissue, thereby acting as a workspace expansion system to facilitate accessibility and maneuverability as described in detail above. As can also be understood, the dynamic characteristics of its controlled expansion cage enable the system to act as an arranger to adjust and optimize the distance between the instrument tip and the target tissue. It should also be noted that symmetrical cages can be used in larger-diameter body cavities, although this is not optimal.

[0296] It should be noted that endoscopic instruments can be used for partial tissue resection, such as submucosal or subserosal resection. Endoscopic instruments can also be used for full-thickness tissue resection. These instruments enable the removal of lesions with good tissue margins, thereby providing complete, bulk removal of pathological lesions.

[0297] It is not intended to limit one to any principle or mechanism of action; the teachings provided above are examples illustrating all possible embodiments and not only possible embodiments. Therefore, it should be understood that several variations exist that will also fall within the scope of the claims and will be conceived by those skilled in the art.

Claims

1. An endoscope system, comprising: A flexible catheter with proximal and distal portions. A first flexible element and a second flexible element extend along the flexible conduit, and the distal portions of the first and second flexible elements are movable to create a working space within the body cavity. An expandable member associated with the distal ends of the first and second flexible elements; The inflatable member is a balloon configured to move from a contracted insertion state to an inflated state; and The first flexible element includes an inner cavity extending through it and in fluid communication with the balloon to inflate and deflate the balloon.

2. The endoscope system of claim 1, wherein the distal portions of the first flexible element and the second flexible element are coupled to a distal connector, and the expandable member is expandable to engage the distal connector.

3. The endoscope system of claim 2, wherein the expandable member has an annular shape and is configured to form a gap therein to receive the distal connector.

4. The endoscope system of claim 1, wherein at least a portion of the expandable member is capable of expanding distally beyond the distal portions of the first flexible element and the second flexible element.

5. The endoscope system of claim 1 further includes a flexible instrument slidably and rotatably disposed within the flexible catheter, wherein the distal portion of the first flexible element is movable to an oblique state to orient the distal end of the flexible instrument within the workspace.

6. The endoscope system of claim 1, wherein the first flexible element and the second flexible element are movable from an insertion position to an expansion position to engage tissues of the body cavity without damage, thereby placing the workspace in an asymmetrical configuration.

7. An endoscope system, comprising: The catheter includes both proximal and distal portions. First flexible element and second flexible element extending along the length of the conduit, The distal portions of the first and second flexible elements can be positioned within the body cavity and can move to create a modified workspace within the body cavity. An expandable member connected to the distal ends of the first flexible element and the second flexible element; The inflatable component is a balloon configured to move from a contracted insertion state to an inflated state; and The first flexible element includes a lumen extending through it and in fluid communication with the balloon to inflate and deflate the balloon.

8. The endoscope system of claim 7, wherein the distal portions of the first flexible element and the second flexible element are coupled to a distal connector, and the expandable member is expandable to engage the distal connector and engage the wall of the body cavity.

9. The endoscope system of claim 8, wherein the expandable member has an annular shape configured to form a gap for receiving the distal connector therein.

10. The endoscope system of claim 7, wherein at least a portion of the expandable member is disposed distal to the distal portion of the first flexible element and the second flexible element.

11. The endoscope system of claim 7, wherein the expandable member is capable of expanding to stabilize the expandable member and the first flexible element and the second flexible element within the body cavity.

12. The endoscope system of claim 7 further includes a flexible instrument slidably and rotatably disposed within the catheter, wherein the distal portion of the first flexible element is movable to an oblique state to orient the distal end of the flexible instrument within the workspace.

13. The endoscope system of claim 12, wherein the first flexible element and the second flexible element are movable from an insertion position to an expansion position to engage tissues of the body cavity without damage, thereby creating an asymmetrical working space.

14. A system comprising: A flexible catheter, comprising a proximal portion, a distal portion, and a workspace expansion system located in the distal portion. The workspace expansion system includes a first flexible element and a second flexible element extending along the length of the flexible conduit. The distal portions of the first and second flexible elements are movable within the body cavity and can move to form a workspace within the body cavity. An inflatable balloon connected to the distal portions of the first and second flexible elements. The expandable balloon can expand from a low-profile insertion state to an inflated state; and The first flexible element includes a lumen extending through it and in fluid communication with the inflatable balloon to inflate the inflatable balloon.

15. The system of claim 14, wherein the distal portions of the first flexible element and the second flexible element are coupled to a distal connector, and the inflatable balloon is capable of expanding to engage the distal connector and the wall of the body cavity.

16. The system of claim 15, wherein the expandable balloon has an annular shape, the annular shape being configured to form a gap to receive the distal connector therein.

17. The system of claim 14, wherein at least a portion of the expandable balloon may be disposed distal to the distal portions of the first flexible element and the second flexible element.

18. The system of claim 14, wherein the first flexible element and the second flexible element are movable from an insertion position to an expansion position to engage tissue of the body cavity without damage, thereby creating an asymmetrical working space.

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