EXTERNAL WORKING CHANNEL FOR ENDOSCOPIC DEVICES - Patent application

Abstract

Apparatus (e.g., devices, systems, etc.) and methods that may provide access for one or more tools to a remote site within the body, including an expandable and external working channel that may be a portion of a tube that is coupled to the outer surface of an elongated medical device, such as an endoscope.

Description

[Technical field]

[0001] Claiming priority

[0001] This patent application claims priority to U.S. Provisional Patent Application No. 63 / 342,618, entitled "EXTERNAL WORKING CHANNELS FOR ENDOSCOPIC DEVICES," filed May 16, 2022. Incorporation by Reference

[0002]

[0002] All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. [Background technology]

[0003]

[0003] The invention of the endoscope, the ability to see inside the body with medical instruments, was considered revolutionary. The addition of a working channel to the endoscope was a significant improvement to the endoscope: the working channel could be used to insert a tool through the proximal end of the endoscope, move the tool through a lumen through the body of the endoscope (and through the patient's anatomy), and exit at the distal end of the endoscope at a target location in the patient. Once the tool exits the endoscope, it can be used for many different clinically significant actions, including, for example, biopsy, grasping, manipulation, cutting, snaring, suturing, spraying, suctioning, clipping, or applying treatments to tissue, which may include heat, cold, energy, RF, or radiation.

[0004]

[0004] Flexible endoscopy has further expanded its clinical utility by allowing the interrogation of tortuous anatomical structures.

[0005]

[0005] As endoscopists attempted to do more ("interventional endoscopy"), dual working channel endoscopes were created. These proved to be much less effective than expected, as they only increased girth (and therefore stiffness) and allowed for one more working channel, but proved kinematically limited since both lumens were typically parallel and central. The resulting tool exit trajectory from such a system is inherently kinematically limited.

[0006]

[0006] External working channels have also been proposed, which supposedly offer several advantages. However, rigid external channels add significant girth and are limited in number, and therefore of moderate utility, or are often not used, with more numerous and proportionately larger. External working channels also typically increase system stiffness, which adversely affects navigability and access. Currently available external channels are typically short and straight, i.e., single channels that are applied only on rigid scopes.

[0007]

[0007] In general, there is a need for increased working channel diameter and / or an increased number of working channels. Increased working channel diameter allows for larger tools that may be more complex, stronger, easier to construct, and may have increased clinical utility. Larger tools for aspirating and nebulizing can simply accomplish more faster. As endoscopic procedures become more advanced, the use of multiple working channels may be particularly beneficial. While most endoscopes have a single working channel and some have two working channels, there may be high clinical utility in having three, four, five, or even more working channels.

[0008]

[0008] As endoscopes are used for increasingly complex procedures, there is also a need for a working channel that can be moved or actuated relative to the endoscope. A working channel that can be moved independently of the endoscope, including being incorporated into a separate device (e.g., an overtube), would allow for additional levels of kinematic control, such as independent axial control, the ability to be positioned at different radial positions, and the ability to remain stable while the bending section of the endoscope is angled.

[0009] It would be advantageous to have a working channel that functions over long lengths and among high tortuosities while maintaining low advancement forces and minimizing the adverse effects of capstan drag.

[0010]

[0010] It may also be advantageous to be able to deploy multiple tools (including large diameter tools) through the working channel without perturbing the shape of the endoscope and how it is positioned within the anatomy, ensuring a more consistent distal appearance at the care site. This may be particularly useful in devices (e.g., endoscopes) that may be selectively stiffened during use. These devices may be referred to as dynamically stiffening devices. Summary of the Invention [Problem to be solved by the invention]

[0011]

[0011] Described herein are external working channel apparatus (eg, devices, systems, etc.) that can address this shortcoming and need. [Means for solving the problem]

[0012]

[0012] Generally, apparatus (e.g., instruments, tools, devices, systems, etc.) and methods are described herein that may provide access for one or more tools to a remote site within the body. In particular, working channel sleeve apparatus (devices, systems, etc.) are described herein that may include an inner tube (tubular region) configured to fit over an elongated medical device and one or more (e.g., multiple) outer working channels along the length of the inner tube. Any of these outer working channel sleeve apparatuses may be equivalently referred to as a working channel sleeve, an outer working channel sleeve, or the like. Any of these working channel sleeves may include a core portion configured to surround an elongated member (e.g., a catheter, an endoscope, an overtube, etc.) and one or more expandable working channels coupled to and / or integrally formed with the core portion. These working channels may be stretchable, deflectable, elastic, and / or lubricious. The working channel(s) may be formed of one or more filaments, particularly including inelastic filaments. In some examples, the working channel(s) may be formed as a knitted, braided, and / or woven structure. In some examples, the working channel(s) may be sewn or bonded. In some examples, the working channel(s) may be formed of one or more laminated sheets of material. The material forming the working channel and core region (e.g., the elongated tubular body of a working channel sleeve) may be formed of one or more filaments, fibers, or wires.

[0013] As noted, the material forming the working channel may be braided, knitted, woven, or laminated. In some instances, the material may be formed with non-intersecting elements. The material may be precisely oriented, or the material may be relatively randomly oriented. In some instances, the working channel may be an expandable working channel, may be formed as part of a tubular device, or may be bonded to the outer surface of a flexible elongated member, such as an elongated medical device, e.g., a catheter, overtube, or endoscope.

[0014] In some examples, a braided, knitted, or woven (particularly knitted) working channel sleeve is described herein. The knitted working channel sleeve described herein is similar to and may improve upon the lay-flat working channel described in International Patent Application (e.g., PCT Patent Publication No. WO2021 / 242884 A1), which is incorporated herein by reference in its entirety.

[0015] For example, the working channel sleeves described herein include a core region, such as a central tube (e.g., sleeve, sock, or cover portion), that may be formed of the same or different material as the material forming the working channel portions. The material may be elastic, inelastic, and / or lubricious. In some cases, one or more external working channels may be formed on (woven into) the central tube such that the entire working channel sleeve is attached to and / or secured to an elongated medical device, including highly flexible medical devices. In some instances, the medical device may be part of the same system as the working channel sleeve. In some instances, the working channel sleeve may be permanently, semi-permanently, or removably attached to the elongated medical device.

[0016] As noted, either or both of the elongate tubular body and the external working channel may be formed of one or more filaments (or bundles of filaments) that may be braided, woven, or knitted together. As such, the external and expandable working channels described herein may be braided, braided, woven, sewn, or laminated together, may be manufactured from multiple parts that are assembled together, or they may be extracted in substantially complete form from a piece of automated and computer-controlled equipment.

[0017]

[0017] The working channel sleeves described herein may be attached, mounted, or otherwise associated with an elongated flexible member / medical device (e.g., catheter, endoscope, overtube, etc.). The tubular body may be attached to the outer surface of the elongated medical device at discrete locations along the length of the elongated medical device, for example, at the distal and proximal end regions, every 1 mm (or every 2 mm, or every 3 mm, or every 4 mm, 5 mm, 10 mm, 15 mm, 20 mm, etc.), or continuously along the entire length of the inner tube (tubular body).

[0018]

[0018] In some instances, the outer working channels described herein may be configured to easily allow relative sliding of adjacent devices, materials, and anatomical structures. In some instances, the working channel sleeve devices herein may be configured to allow precise termination of exit from the working channel(s). For example, the working channels described herein may be configured to direct one or more devices leaving the working channel in a predefined direction (e.g., radially inward, radially outward, etc.). Any of the devices described herein may be configured to allow the device to be easily inserted proximally into the working channel.

[0019] In any of the working channel sleeve devices described herein, the one or more external working channels may be internally configured to allow tools to enter the working channel from small apertures, including through small incisions or orifices. In some examples, the external working channel may be configured to have a small initial profile and only expand as needed. In any of the working channel sleeve devices described herein, the external working channel may be pre-installed as part of the device. Alternatively, the working channel sleeve may be mounted or installed by a user on an endoscope or other elongated member. The working channel may be configured to be lubricious and elastic, thus allowing easier sliding of tools within the working channel(s). As tortuosity increases, the capstan drag equation typically governs an exponential decrease in device performance, and the elastic and lubricious working channels described herein may allow tools inserted into the working channel(s) to slide with the lowest possible drag. Similarly, the capstan drag equation may govern the ease with which an endoscope slides against anatomy, and the elastic and lubricated working channel described herein may be configured to provide the lowest possible drag against the patient's anatomy.

[0020]

[0020] A working channel sleeve including either or both of the tubular body and / or outer working channel described herein formed of a resilient and lubricious material may be used in conjunction with an endoscope. In general, the methods and devices described herein may be used with endoscopes adapted for use across a wide range of endoscopic procedures, including colonoscopy, small enteroscopy, upper gastrointestinal endoscopy (EGD), small enteroscopy, endoscopic retrograde cholangiopancreatography (ERCP), interventional endoscopic procedures (including ESD (Endoscopic Submucosal Dissection) and EMR (Endoscopic Mucosal Resection)), robotic flelible endoscopy, trans-oral robotic surgery (TORS), altered anatomy cases (including Roux-en-Y), and procedures in Natural Orifice Transluminal Endoscopic Surgery (NOTES). Any of the methods and devices described herein may be configured for use with an endoscope for manual and / or robotically operated configurations.

[0021]

[0021] As the device travels through the anatomy, it may be configured in a highly tortuous path and may be torqued or manipulated. It may be advantageous to configure the working channel sleeve apparatus described herein such that the working channel is expandable and configured to prevent kinking, wrinkling, or buckling with respect to the inner diameter (id) and / or outer diameter (od). In some cases, preventing kinking, wrinkling, or buckling may be advantageous for the passage of the device within the channel. Prevention of puncture through the wall is also important; the methods and apparatus described herein, including the use of matched tools described below, may be particularly helpful. In some instances, these external working channels may be formed of a material that is both lubricious (e.g., slippery) and elastic (e.g., stretchable). This configuration may be advantageous for the easiest insertion, passage, sliding, and manipulation of medical tools.

[0022] In some instances, a tool may be inserted directly through the outer working channel (eg, an expandable working channel) of the working channel sleeve.

[0023] In some examples, a liner insert tube ("liner") may be utilized within the working channel of the working channel sleeve. In some examples, the working channel(s) is an expandable working channel configured to be used with a liner insert tube that maintains patency of a channel or lumen through the outer working channel. The liner insert tube may be coupled to a proximal end region of the device and a distal end region of the device. The liner insert tube may be a closed tube or an open channel. The liner insert tube may be inserted into the outer working channel of the working channel sleeve after the elongated medical device to which the working channel sleeve is applied (e.g., mounted, attached, etc.) is positioned at or near a target area within the body.

[0024]

[0024] The liner insert tube may be configured to be inserted into the outer working channel to form an uninterrupted and open inner channel through the elastic outer working channel. The liner insert tube may be aligned with the outer working channel, for example, using one or more wings and / or engaging (e.g., locking) with the distal and / or proximal end regions of the elongated medical device and / or tube. Precise attachment at the distal end allows for precise movement of tools used within the liner. Precise diameter of the liner tool aids in more precise movement of the tool through its lumen. Utilization of a high performance material or coating on the liner allows for precise movement of the tool through its lumen.

[0025]

[0025] In general, the inner lumen or channel of the liner insert tube may include a lubricious surface (e.g., a surface having low friction) to allow for easy passage of a medical tool within the expandable channel as well as ease of sliding of the liner within the expandable channel. In one example, the inner surface is hydrophilic. In another example, the inner surface is a low COF (coefficient of friction) plastic, including fluoropolymers, or polyethylene, polypropylene, or plastics with slip additives. The liner insert tube may include distal and / or proximal engagement members (clips, locks, etc.) for securing to the elongated medical device and / or tube. Thus, in some examples, the liner insert tube may be configured to engage a distal end region of the elongated medical device to secure (e.g., lock onto) the distal end region of the elongated medical device. In some examples, the liner insert tube includes one or more protrusions (e.g., wings) at one or more locations along the length of the liner insert tube or along the entire length of the liner insert tube. These protrusions may help maintain the liner insert tube oriented relative to the elongated medical device.

[0026] The liner insert tube may be specifically designed as a matching set for the working channel, so that the two work together with enhanced functionality. When positioned, the two may work together to collectively form a channel or lumen that is held open along the length of the elongated medical device. A variety of different liner insert tubes having different sizes / dimensions may be used. For example, different liner insert tubes may have different diameters to allow different medical devices to pass through. Tools or "instruments" may be inserted through the liner insert tube, including custom endoscope tools and "standard" endoscope tools. Standard endoscope tools are typically designed to pass through working channels with the following inner diameters: 4.2 mm, 3.8 mm, 3.2 mm, 2.8 mm, 2.0 mm. Multiple liner insert tubes may be inserted into different outer working channels of the working channel sleeve device described herein. The working channel of the tube is typically maintained in a collapsed configuration, but may be allowed to slide slightly against the outer surface of the elongate medical device, so that the resulting structure may remain highly flexible when positioned within the body, while still having a relatively small outer profile. Once positioned, the profile may be expanded by inserting one or more liner insert tubes and / or tools (e.g., directly, without the need for a liner insert tool).

[0027]

[0027] The liner insert tube may be constructed using a variety of different techniques. For example, the liner insert tube may typically be a plastic or elastomer extrusion. The liner insert tube may be a composite catheter shaft, including having braids or having a fluoropolymer or ePTFE layer. In some instances, the liner insert tube comprises a coiled tubing, or the liner insert tube may utilize laser cut tubing. The liner insert tube may be configured to have a key combination of parameters that are best achieved through the use of composite construction: excellent lubricity, good "pushability" (e.g., high column strength and high axial stiffness), low bending stiffness, good hoop stiffness, and a very tightly circular cross section (even when the tube is bent through a tight radius of curvature).

[0028]

[0028] In some examples, the distal end of the liner insert tube may include a deflector. The deflector may be a blunt or rounded extension of the liner insert tube that may be configured to allow for improved passage through the outer working channel. The deflector may be configured to prevent snagging when the liner insert tube is inserted into the outer working channel. In some examples, the deflector at the distal end of the liner insert tube is configured to have an atraumatic geometry so that it does not cause anatomical damage when exiting the working channel. The deflectable tip portion may be useful to orient the tool as it exits the distal end region, thereby steering the tool in a particular direction (e.g., radially inward relative to an elongated medical tool). In some examples, the deflector may include an eccentrically secured pull wire.

[0029]

[0029] For example, a system is described herein that includes a tube having one or more working channels configured to receive a medical tool inserted therethrough, each working channel being positioned longitudinally along an outer surface of the tube. The tube may be elastically expandable. Surprisingly, the working channel may be expandable without the use of elastic material (i.e., the working channel may effectively expand and contract utilizing a non-elastic material). Both the tube and the one or more working channels may be constructed of a fabric material. The same material may be used for the body of the tube and the expandable (e.g., elastically or non-elastically expandable) working channel, or different materials may be used.

[0030]

[0030] Generally, as used herein, the term "expandable" may refer to an expandable structure (e.g., a tube, an outer working channel, etc.) being elastically expandable such that it can return from an expanded configuration to a collapsed configuration. In some instances, the expandable tube may provide ease of sliding through the use of a coating applied to the outside of the elastic component. For example, the coating may be a hydrophilic coating.

[0031] In some examples, the working channel sleeve device described herein may achieve the dual goal of high elasticity and low friction through the outer working channel by using a composite material, e.g., a low friction material that covers, surrounds, and / or coats the elastomeric core. In some examples, the low friction material is a material (e.g., yarn) that may cover or wrap around the elastomeric core. Typically, elastomers have high sliding friction. The low friction yarn may be, for example, polyethylene, polypropylene, or a fluoropolymer (e.g., PTFE). The composite material may be in a single layer or in multiple layers. For example, the composite material may include a knit structure of filament(s) (e.g., between 10 and 80 filaments, between 12 and 40 filaments, between 10 and 36 filaments, etc.) with a lubricious outer region over an elastic core.

[0032]

[0032] The elasticity of the elastic material used may vary in some cases within the same device. For example, different elastic element materials may be used and / or filament count, filament thickness, etc. may vary between different elastic materials within the same or different devices. In general, elastic materials (50%, 100%, 200%, 400%, 600%, 800%, 100% stretch) including silicone, spandex, and LYCRA tend to have high friction. In general, plastics tend to have much less elasticity (e.g., 2%, 4%, 6%, 8%, 10% stretch, referred to herein as "non-elastic") and dramatically lower friction. In some instances, materials such as spandex may be used. Spandex is a type of urethane that is a synthetic fiber known for its exceptional elasticity. Silicone may be used because it is highly biocompatible. It should be noted that, as described in more detail below, in some instances it may be particularly advantageous to provide inelastic materials, and in particular inelastic filaments, to form either or both of the working channels and / or core regions of the devices described herein.

[0033] In some instances, the necessary elasticity may be achieved by a material that is both sufficiently elastic and sufficiently slippery.

[0034]

[0034] In some instances, however, the necessary elasticity of the working channel (e.g., the entire structure) may be achieved by a structure utilizing materials that are not elastic ("inelastic"), but that can handle repeated deflections, including deformations of large magnitude. Inelastic materials may be "plastic" materials, such as, but not limited to, PTFE, Polyester, UHMWPE, HDPE, and / or Polypropylene. These materials are in contrast to traditional elastic materials, such as (but not limited to): Spandex / Elastane / Latex and Silicone. For example, the inelastic material forming the working channel(s) may have a modulus of elasticity greater than about 20,000 psi (e.g., 20,000 psi or more, 30,000 psi or more, 40,000 psi or more, 60,000 psi or more, 100,000 psi or more, 200,000 psi or more, 500,000 psi or more, 750,000 psi or more, etc.). The non-elastic material forming the working channel(s) may have a relatively low coefficient of friction (e.g., less than about 0.5, 0.5 or less, less than 0.45, 0.4 or less, 0.35 or less, 0.3 or less, 0.25 or less, 0.2 or less, 0.15 or less, 0.1 or less, etc.), especially compared to more elastic materials.

[0035] Alternatively or additionally, the working channel sleeve devices described herein may achieve the dual goal of high elasticity and low friction through the working channel(s) by positioning or arranging the material having an elastomeric core of filaments forming the working channel such that it is spaced away from (e.g., facing outwardly from) a material having low sliding friction. For example, the elastomeric "core" may not be enclosed, but may be positioned within the cross-section of the structure (working channel) to ensure that devices moving within the working channel do not slide directly against the elastomeric material.

[0036] In instances where the device (e.g., tubing and / or elastic external working channel) is knitted, the device may be knitted on a computer controlled knitting machine. Any suitable needle gauge and / or stitch pattern may be used. For example, the needle gauge of the knitting machine can be, for example, 10-14 or 16-18 (10 and 16 refer to the needle gauge, 14 and 18 refer to the machine gauge). The 16-18 machine allows for much finer knitting.

[0037]

[0037] The working channel sleeve apparatus described herein may generally include a tube (e.g., a tubular body) configured to extend over an exterior surface of an elongated medical device (e.g., a catheter), and one or more exterior working channels formed along the length of the tube configured to receive a medical tool inserted through the working channel. The one or more exterior working channels may be referred to herein as a type of layflat tube. The elongated tubular body may be referred to herein as an inner tube. The exterior working channel may equivalently be referred to herein as an exterior pocket. In some cases, the working channel (e.g., an exterior pocket) may be configured as an exterior working channel that includes an elastic element, e.g., formed of a woven material that includes an elastic core, while in some instances the exterior working channel (e.g., an exterior pocket) does not include an elastic element. As such, the working channels described herein may be elastic or inelastic.

[0038] In a working channel sleeve device including an inner tube and one or more outer working channels, the outer working channel may be formed of one or more filaments (or bundles of filaments) that form the outer working channel, and the inner tube may be formed of the same or different one or more filaments (or bundles of filaments) that form the inner tube, e.g., tubular body.

[0039]

[0039] In particular, a knitted working channel sleeve device is described herein. In some examples, the working channel sleeve device is formed by weft knitting. The working channel sleeve device may be formed by warp knitting, including, but not limited to, tricot, Milanese knit, Raschel knit, and stitch bonding. Any appropriately sized filament(s) may be used. For example, in some examples, the filament(s) forming the outer working channel(s) may be about 100 denier to 6000 denier for the outer wrap. The fiber(s) for the inner elastic core may be 400 to 6000 denier for the inner wrap. As described herein, one or more filaments (or bundles of filaments) forming all or a portion of the working channel sleeve device may be equivalently referred to as one or more fibers (or bundles of fibers). These filaments may be natural or artificial, and / or may be hybrid filaments as described herein.

[0040]

[0040] The expandable tube of the working channel sleeve apparatus may be configured to slide over the elongate medical device. The expandable tube may be unfixed between its distal and proximal ends. The expandable tube may be fixed at one or more points on the exterior surface of the elongate medical device, such as at the distal end region and / or the proximal end region. In some instances, the tube may be secured at discrete points or intervals, every 1-300 mm (e.g., every 1-2 mm, 1-3 mm, 1-4 mm, 1-5 mm, 1-7 mm, 1-10 mm, 1-15 mm, 1-20 mm, 1-25 mm, 5-10 mm, 5-15 mm, 5-20 mm, 5-25 mm, 5-30 mm, 5-35 mm, 5-40 mm, 10-20 mm, 20-30 mm, 10-100 mm, 10-200 mm, 100 mm-200 mm, 100 mm-300 mm, etc.). The expandable tube may be attached circumferentially or at one or more points or lines. The expandable tube may be attached locally and continuously. The expandable tube may be configured to slide against the outer surface of the elongate medical device in areas where it is not attached, which may help prevent wrinkling and / or closure of the outer working channel(s). The expandable tube may be configured to have a frictional adhesion against the outer surface of the elongate medical device in areas where it is not attached, which may prevent the expandable tube from moving and wrinkling and clumping. Wrinkling can occur when the material forming the outer working channel clumps and in some cases folds over on itself, which may reduce the effective size of the channel and / or may result in jamming of tools (including liner tools) inserted into the channel.

[0041] In some examples, the working channel may be made as a sewn structure from a flat fabric. The fabric may be an expandable fabric, such as a stretchable mesh. A lubricious coating may be used with the fabric (e.g., mesh) so that tools can slide easily within the working channel. The fabric (e.g., mesh) may have openings or holes. The holes may change shape when stretched or compressed, including the fabric expanding and contracting and distorting from the original shape of the hole. The material may be polyester or polypropylene or Teflon with an elastic stretch core, which may be, for example, urethane (including spandex) or silicone. In general, the hole size of the working channel (and / or inner tubular body) may vary from about 0.05 mm to about 4 mm in knitted, woven, and / or fabric embodiments.

[0042] As mentioned, any of these working channel sleeve devices may include or be used with a liner, including but not limited to a liner insert tube. In any of the devices described herein, a liner may be used within the external working channel. The material forming the working channel may be stretchy enough to hold and control the liner. If the fabric material forming the working channel is too stretchy, the liner may distort the material and may protrude from the working channel and / or may buckle or wrinkle when the device is threaded around a curve. If the fabric material forming the working channel is not stretchy enough, the liner insertion force may be too high, making it difficult, if not impossible, to insert, and the liner may wrinkle and get stuck when trying to advance around corners or tortuous paths. The performance of materials, such as knitted and / or fabric materials, may be adjusted by changing the weft and warp orientation. For example, woven fabrics may be sewn in-line or sewn on a 45 degree bias. In some instances, a fabric can be constructed from yarns having a given filament count, which can range, for example, from 5 to 100. High filament count yarns can produce fabrics with high lubricity.

[0043] In any of these examples of working channel sleeve devices, the working channel may be made as a laminated structure. For example, by inserting a layer of thermoplastic elastomer between layers of fabric, the working channel may be attached so as to be non-penetrating and elastic. Bonding may occur with the aid of heat, pressure, and time. Similarly, the structure may be laminated with other material layers. For example, an elastomer layer may be laminated with a fiber layer and a layer that is selectively cut out (e.g., by laser, die cutting, or CNC knife cutting profile).

[0044] Any of the working channel sleeve devices described herein may be used with an elongated medical device. For example, the elongated medical device may include a catheter, an endoscope, an overtube, etc. In some examples, the elongated medical device is a hardenable device (e.g., a hardenable system). Examples including hardenable members (e.g., selectively hardenable members), including but not limited to those described in International Patent Application No. PCT / US2019 / 042650 (filed July 19, 2019, “DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES”), which is incorporated herein by reference in its entirety, are provided herein and are incorporated by reference in their entirety, although the systems and methods described herein are not limited to hardenable devices or any particular type of hardenable device.

[0045]

[0045] The working channels described herein may be elastically expandable and may be configured to contour to the shape of a medical tool or liner insert tube inserted therethrough. As mentioned, in some instances, it may be advantageous to include a liner insert tube that may be inserted into the working channel, particularly an expandable working channel, to maintain patency of the working channel for insertion of one or more medical tools. The liner insert tubes described herein may include closed or open lumens (e.g., open along all or a portion of the elongated length of the liner insert tube). The liner insert tube may be equivalently referred to herein as a liner insert or a liner insert channel. In any of these instances, the liner insert tube may include a lubricious inner lumen extending therethrough. The outer surface of the liner insert tube may be lubricious and / or may include a lubricious coating or material. In some instances, the inner lumen may be hydrophilic or hydrophobic (e.g., may include a hydrophilic or hydrophobic coating) on ​​the inner and / or outer surface of the liner insert tube. The liner insert tube may be used when inserting a tool into the outer working channel, particularly when it would be beneficial to expand or hold open the expandable working channel to insert a tool, particularly a tool that might otherwise get caught or snagged in the outer working channel (e.g., when the outer working channel is formed of a knit, woven, or braided material, or any other material with holes / openings).

[0046] The liner insert tube may be inserted into one of the one or more working channels from a proximal end to a distal end of the working channel. Once inserted, a medical tool may be passed through the lumen of the liner insert tube for use at or near the distal end of the elongate medical device.

[0047] As noted above, the outer working channel may generally be constructed of one or more filaments (e.g., knit, woven, etc.) having a low friction outer region at least partially enclosing an elastic inner region. In any of these devices, the outer working channel may include one or more filaments that do not include an elastic core (and / or may be inelastic). For example, the outer working channel may be a mix of elastic and inelastic (or less elastic) filaments.

[0048]

[0048] The body and / or working channel of the tube of the working channel sleeve device may be formed as a non-uniform weave, braid, or knit pattern. In some examples, the weave pattern of the tube body and one or more external working channels are the same. In some examples, the weave pattern of the one or more external working channels is different from the weave pattern of the body of the tube. Furthermore, the tube may comprise two or more segments defined by a change in the weave pattern of the tube body (e.g., along the length of the tube). Similarly, one or more working channels may have two or more segments defined by a change in the weave pattern of the fabric, which may allow for elastic adjustment of the length of the tube and / or may bias a tool or liner insert tube to be held in a particular longitudinal position of the tube.

[0049] As noted, the tubular body of the working channel sleeve device may be formed of a woven braid of one or more filaments. The one or more filaments may be formed of a core of elastic material configured to resiliently expand and retract, and a lubricious coating, winding, wrapping, and / or layer over the elastic core. In some instances, the lubricious coating / winding / wrapping / layer may be a wrap that substantially or completely encompasses the elastic core forming a coiled filament.

[0050] The tube may include any suitable number of external working channels, such as between 1 and 12 (e.g., between 1 and 10, between 1 and 9, between 1 and 8, between 1 and 7, between 1 and 6, between 1 and 5, between 1 and 4, between 1 and 3, between 1 and 2, or just one). The channels can be the same shape or size, or the channels may be different shapes or sizes.

[0051]

[0051] The tube body of the working channel sleeve device may generally conform to the shape of the elongated medical device as it is bent or otherwise navigated through the body. The device including the tube with the external working channel may be configured to allow bending without substantially increasing the stiffness of the elongated medical device. Each of the external working channels of the working channel sleeve device may be expandable to accommodate a tool and / or a liner insert tube inserted through the working channel. The channels may expand independently of each other and the expandable tube. The channel expansion of one channel may have a relationship to the possible channel expansion of another channel because of the cooperating structures. Each of the channels may be positioned around the circumference of the expandable tube. In some examples, when the working channel sleeve has multiple external working channels, the external working channels can be equidistant from each other on the outer surface of the tube body of the working channel sleeve device. For example, if there are four channels, each of the channels may be separated by 90 degrees around the longitudinal axis of the expandable tube. The tube and working channels of the working channel sleeve device may include or be composed of a material that is an elastomer, a plastic, and / or a fabric. The channels may have spaces between them, or the channels may be immediately adjacent to one another. In some instances, the channels may overlap. The channels may be attached along their entire length. The channels may be attached at discrete points or lines. The channels may be attached midway between points or lines and along their entire length.

[0052] Any of the described elongated medical devices (e.g., catheters, endoscopes, etc.) may include an imaging element positioned at the distal end, whereby the imaging element may be used to identify and aid in the operation of a tool passing through the outer working channel of the working channel sleeve apparatus during a medical procedure. The elongated medical devices may also have a corresponding imaging element positioned at the proximal end.

[0053] For example, a working channel sleeve apparatus including an expandable outer working channel is described herein, the system comprising an elongated medical device, a tube extending over an outer surface of the elongated medical device, and one or more outer working channels formed along the length of the tube and configured to receive a medical tool inserted through the working channel. As such, the working channel sleeve apparatus may include an elongated medical device on which an elongated body of the working channel sleeve is mounted or applied, forming an elongated outer channel extending down the length of the elongated medical device.

[0054]

[0054] In any of these devices, the tube may comprise a woven, knitted, or braided tube, or a combination thereof. In some examples, the tube is formed of one or more elastic and lubricious filaments. The tube may be slidably connected to the elongate medical device. The tube may be bonded to the proximal and distal end regions of the elongate medical device.

[0055] Any of the apparatus (eg, devices, systems, etc.) described herein may be formed of one (or more) materials that are laminated together.

[0056]

[0056] In any of these systems, the elongated medical device may comprise a catheter, an overtube, or an endoscope. In some instances, the elongated medical device comprises a selectively curable device.

[0057] Any of these systems may include a liner insert tube configured to be inserted into one of the one or more expandable working channels and removably coupled to the distal end of one or both of the elongated medical device and the tube. The liner insert tube may have a hydrophilic inner and / or outer surface. In some examples, the liner insert tube includes one or more wings extending out of the sides of the liner insert tube configured to limit torque of the liner insert tube within the one of the one or more expandable working channels. The wings may provide distal to axial alignment and may prevent torque application and lateral movement. In some examples, the liner insert tube may include a deflector at the distal end opening of the liner insert tube configured to deflect a tool exiting the liner insert tube away from a radially outward direction relative to the elongated medical device.

[0058]

[0058] The inner tube of the working channel sleeve device may be formed of one or more filaments, particularly including filaments that include an inner elastic material and an outer lubricious material. The tube may be formed of a coiled filament with an elastic core surrounded by a lubricious material. In this case, the combined entity has the resulting important properties: the elasticity of an elastomer and the surface-contacting lubricity of the lubricious material. In some examples, the lubricious material includes polypropylene, polyethylene, or polytetrafluoroethylene. The tube may have a non-uniform weave pattern or a uniform weave pattern. In some examples, the tube may be a sheet of elastomer (e.g., elastomeric material) with cutouts, thus resembling a fine mesh, which would likely work well for this application.

[0059]

[0059] For example, a working channel sleeve system including an expandable external working channel may include an elongated medical device having a flexible or selectively rigidizable body, a knitted or woven tube extending over an outer surface of the elongated medical device, the knitted or woven tube being coupled to distal and proximal end regions of the elongated medical device and being slidable against the outer surface over at least a portion of the flexible or selectively rigidizable body between the distal and proximal end regions, and one or more external working channels formed along the length of the tube and configured to receive a medical tool inserted through the working channel.

[0060]

[0060] In some examples, a system (e.g., a working channel sleeve system including an expandable external working channel) includes an elongate medical device, a knitted or woven tube extending over an outer surface of the elongate medical device, the tube having one or more external working channels extending along the length of the tube and configured to receive a medical tool inserted through the working channel, and a liner insert tube configured to be inserted within one of the one or more expandable working channels and removably coupled to the distal ends of one or both of the elongate medical device and the tube.

[0061]

[0061] Methods of using any of these working channel sleeve apparatus (e.g., systems, devices, etc.) are also described herein. For example, a method of positioning a tool within a body may include inserting an elongated medical device into the body in a flexible configuration, inserting a liner insert tube into an expandable working channel of a knitted or woven tube extending over an exterior surface of the elongated medical device, whereby the exterior working channel expands to accommodate the liner insert tube, and inserting a working tool through the liner insert tube and out a distal end of the liner insert tube.

[0062] Any of these methods may include performing a medical procedure within the body with the working tool.

[0063] In some examples, the method may include locking a distal end of the liner insert tube at a distal end region of the elongate medical device. Alternatively or additionally, the liner insert tube may be locked at a proximal end of the elongate medical device. A length of the liner insert tube may be allowed to slide against an inner surface of the working channel as the elongate medical device is navigated within the body, while the liner insert tube is secured at the distal (and / or proximal) end of the elongate medical device.

[0064] Any of these methods may include maintaining patency of the liner insert tube while the liner insert tube is inserted into the expandable working channel.

[0065]

[0065] The methods described herein may be used with an elongated, cured medical device. For example, any of these methods may include curing the elongated medical device. In some examples, the methods may include curing the elongated medical device prior to inserting the liner insert tube. Any of these methods may include using a deflector at a distal end region of the liner insert tube to radially inwardly deflect the working tool as it is extended from the distal end of the liner insert tube. Inserting the liner insert tube into the expandable working channel may include engaging one or more wings on the liner insert tube with the expandable working channel. In some examples, inserting the liner insert tube includes sliding the liner insert tube against a lubricated outer surface of one or more filaments forming the expandable working channel of the knitted or woven tube.

[0066] As noted above, the expandable working channel of the knitted or woven tube may be formed of one or more filaments that include an inner elastic material and an outer lubricious material. Inserting a liner insert tube may expand the expandable working channel from a collapsed configuration in which the expandable working channel fits snugly against the outer surface of the elongated medical device.

[0067]

[0067] For example, a method of positioning a tool within the body includes inserting an elongated medical device into the body in a flexible configuration whereby a knitted or woven tube extending over an outer surface of the elongated medical device may slide against the outer surface; positioning a distal end of the elongated medical device near a target area of ​​the body; and inserting a liner insert tube into an expandable working channel of the tube whereby the outer working channel expands to accommodate the liner insert tube; and locking the distal end of the liner insert tube to the distal end of the elongated medical device and / or tube, whereby the liner insert tube maintains patency of a lumen extending through the liner insert tube.

[0068]

[0068] A method of positioning a tool within a body may include inserting an elongated medical device with a stiffening member into the body while the stiffening member is in a flexible configuration, whereby a knitted or woven tube extending over an outer surface of the elongated medical device may slide against the outer surface, positioning a distal end of the elongated medical device near a target area of ​​the body, stiffening the elongated medical device, inserting a liner insert tube into an expandable working channel of the tube, whereby the outer working channel expands to accommodate the liner insert tube, and inserting a working tool through the liner insert tube and out the distal end of the liner insert tube. Alternatively, stiffening may occur at a different step in the process.

[0069]

[0069] The described methods and apparatus are disclosed in International Patent Application No. PCT / US2016 / 050290, filed September 2, 2016, entitled "DEVICE FOR ENDOSCOPIC ADVANCEMENT THROUGH THE SMALL INTESTINE," published as WO2017 / 041052; International Patent Application No. PCT / US2018 / 042946, filed July 19, 2018, entitled "DYNAMICALLY RIGIDIZING OVERTUBE," published as WO2019 / 018682; International Patent Application No. PCT / US2019 / 042650, filed July 19, 2019, entitled "DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES," published as WO2020 / 018934; The present invention may be used in conjunction with and / or modify any of the methods and devices described in International Patent Application No. PCT / US2020 / 013937, filed January 16, 2020, entitled "RIGIDIZING DEVICES," and International Patent Application No. PCT / US2021 / 034292, filed May 26, 2021, entitled "RIGIDIZING DEVICES," all of which are incorporated herein by reference.

[0070] For example, described herein are outer working channel assemblies. These assemblies include a core region configured to extend over an outer surface of an elongate flexible member, and an outer working channel extending along the outer surface of the core region, the outer working channel formed of one or more inelastic filaments configured to slide over one another to expand the outer working channel to accommodate a tool inserted through the outer working channel. In some examples, the core region and the outer working channel may be collectively referred to as a working channel assembly.

[0071]

[0071] In some examples, an external working channel assembly is described herein, the assembly including a core region configured to extend over an outer surface of an elongate flexible member, and an external working channel extending along the outer surface of the core region, the external working channel formed of one or more inelastic filaments forming a plurality of hole openings, the one or more inelastic filaments configured to slide over each other to expand the external working channel and change dimensions of the hole openings of the plurality of hole openings to accommodate a tool inserted through the external working channel.

[0072]

[0072] In some cases, the working channel assembly may include an elongated flexible member to which the core region and outer working channel are attached. For example, an outer working channel assembly described herein includes an elongated flexible member, a core region extending over an outer surface of the elongated flexible member, the core region being coupled to a proximal end region of the elongated flexible member and a distal end region of the elongated flexible member, and an outer working channel extending along the outer surface of the core region, the outer working channel being formed of one or more inelastic filaments configured to slide over one another to expand the outer working channel to accommodate a tool inserted through the outer working channel.

[0073]

[0073] The outer working channel may include a plurality of pore openings formed by one or more inelastic filaments and configured to change dimensions when the one or more inelastic filaments slide over one another. The outer working channel may be braided or woven. The one or more inelastic filaments include a plastic material having a modulus of elasticity greater than 344.74 MPa (50,000 psi). For example, the one or more inelastic filaments may include one of polytetrafluoroethylene (PTFE), polyester, ultra-high molecular weight polyethylene (UHMWPE), high density polyethylene (HDPE), and polypropylene. The one or more inelastic filaments may include a plastic material having a coefficient of friction of 0.5 or less. The core region may be formed of one or more filaments. The core region may be formed of at least a portion of the filaments of the one or more filaments that form the outer working channel.

[0074] Any of these devices (e.g., assemblies) may include a plurality of external working channels extending along an outer surface of the core region. In any of these devices, the external working channels may be configured to have an anisotropic stretch profile having a lower hoop stretch than an axial stretch.

[0075] As mentioned above, in any of these devices, The core region may be coupled to an outer surface of the elongate flexible member at a distal end region of the elongate flexible member and at a proximal end region of the elongate flexible member, but is not fixed to the elongate flexible member between the distal end region and the proximal end region. The elongate flexible member may include an endoscope or an overtube. The elongate flexible member may include a stiffening device. The core region and the outer working channel may include a multi-lumen braid. The core region and the outer working channel may be formed as a horizontal knit.

[0076] Also described herein are tools that generally include tools forming part of an assembly. In some examples, the devices described herein include a matched pair of tools configured to be inserted together through an outer working channel, with a first tool of the pair of tools having a steerable distal end configured to steer a second tool of the distal tool pair as the first tool exits the outer working channel.

[0077] Any of these devices, particularly the working channels, may include a coating (eg, a lubricious coating). For example, the outer working channel may include a lubricious coating.

[0078]

[0078] Any of these devices may include a deflector at the distal end of the outer working channel configured to deflect a tool extending from the distal end of the outer working channel radially outward from the distal end of the elongated flexible member.

[0079]

[0079] Also described herein are devices (e.g., outer working channel assemblies) that are configured such that the core region and outer working channel do not significantly reduce the flexibility of the medical device to which they are attached, e.g., an elongated flexible member, but prevent bunching or clumping of the core region and outer working channel(s) by controlling the coefficient of friction between the core region and the outer surface of the elongated flexible member. For example, an external working channel assembly is described herein comprising an elongate flexible member, a core region extending over an outer surface of the elongate flexible member, the core region being coupled to the outer surface of the elongate flexible member at a distal end region of the elongate flexible member and a proximal end region of the elongate flexible member but not secured to the elongate flexible member between the distal end region and the proximal end region, and an outer working channel extending along the outer surface of the core region, the outer working channel configured to accommodate a tool inserted through the outer working channel, and further, a coefficient of friction between the core region and the outer surface of the elongate flexible member is between 0.3 and 1 to prevent clumping of the core region and the outer working channel when operating the assembly.

[0080]

[0080] The coefficient of friction may be, for example, between about 0.35 and 1, between about 0.4 and 1, between about 0.45 and 1, between about 0.5 and 1, and the like.

[0081]

[0081] In general, the outer working channel may be formed of one or more inelastic filaments. The outer working channel may include a plurality of pore openings formed by one or more inelastic filaments and configured to change dimensions as the one or more inelastic filaments slide over one another. The outer working channel may be braided or woven. The one or more inelastic filaments may include a plastic material having a modulus of elasticity greater than 50,000 psi. For example, the one or more inelastic filaments may include one of polytetrafluoroethylene (PTFE), polyester, ultra-high molecular weight polyethylene (UHMWPE), high density polyethylene (HDPE), and polypropylene. The one or more inelastic filaments may include a plastic material having a coefficient of friction of 0.5 or less. The core region may be formed of one or more filaments including any of these filaments described above. The core region may be formed of at least a portion of the filaments of the one or more filaments forming the outer working channel.

[0082] Any of these devices may include a plurality of external working channels extending along an outer surface of the core region. The external working channels may be configured to have an anisotropic stretch profile having a hoop stretch lower than an axial stretch. The elongated flexible member may include an endoscope or an overtube. The elongated flexible member may comprise a stiffening device. The core region and the external working channels may comprise a multi-lumen braid. The core region and the external working channels may comprise a horizontal knit.

[0083] As noted, any of these devices may include a matched pair of tools configured to be inserted together through the outer working channel, with a first tool of the pair of tools having a steerable distal end configured to steer a second tool of the distal tool pair as the first tool exits the outer working channel. Alternatively or additionally, any of these devices may include a deflector at the distal end of the outer working channel(s) configured to deflect a tool extending from the distal end of the outer working channel radially outwardly from the distal end of the elongate flexible member.

[0084]

[0084] Apparatus (e.g., systems, devices, assemblies, etc.) including an expandable outer working channel are also described herein. For example, the system may include an elongate medical device, a core tube extending over an outer surface of the elongate medical device, and one or more expandable working channels formed along the length of the tube and configured to receive a medical tool inserted through the working channel, the one or more expandable working channels formed of one or more filaments, each of the one or more filaments including an inner elastic material and an outer lubricious material. As noted above, in some examples, the tube is formed of a coiled filament with an elastic core surrounded by a lubricious material. The lubricious material may include polypropylene, polyethylene, or polytetrafluoroethylene.

[0085]

[0085] As noted above, methods of making and using any of the devices (e.g., assemblies) described herein are also described herein. For example, methods of positioning a tool within a body are described herein, the methods including inserting an elongated medical device into the body in a flexible configuration, inserting a liner insert tube into an expandable working channel of a tube extending over an outer surface of the elongated medical device, whereby the expandable working channel expands to accommodate the liner insert tube, maneuvering a distal end of the liner insert tube, and inserting a working tool through the liner insert tube and out of the distal end of the liner insert tube, the working tool being maneuvered to extend from the distal end of the liner insert tube. The methods described herein may include performing a medical procedure within the body using the working tool. The methods described herein may include locking the distal end of the liner insert tube at a distal end region of the elongated medical device.

[0086]

[0086] In any of these methods, the elongate medical device may be configured to allow at least a portion of the length of the tube to slide and / or limit sliding against the outer surface of the elongate medical device as the elongate medical device is navigated within the body (e.g., by controlling the coefficient of friction between the core region and the outer surface of the elongate medical device).

[0087] Any of these methods may include maintaining patency of the liner insert tube while the liner insert tube is inserted into the expandable working channel. Any of these methods may include stiffening the elongate medical device. For example, the method may include stiffening the elongate medical device prior to inserting the liner insert tube.

[0088] In some examples, the method may include using a deflector at a distal end region of the liner insert tube to deflect the working tool radially inward as the working tool is extended from the distal end of the liner insert tube. Inserting the liner insert tube into the expandable working channel may include engaging one or more wings on the liner insert tube with the expandable working channel. Inserting the liner insert tube may include sliding the liner insert tube against a lubricated outer surface of one or more filaments forming the expandable working channel of the knit or woven tube.

[0089] As noted above, the expandable working channel of the knitted or woven tube may be formed of one or more inelastic filaments. The expandable working channel of the knitted or woven tube may be formed of one or more filaments that include an inner elastic material and an outer lubricious material. In any of these methods, inserting the liner insert tube may expand the expandable working channel from a collapsed configuration in which the expandable working channel fits snugly against the outer surface of the elongated medical device.

[0090]

[0090] Also described herein is a system including an expandable external working channel, the system comprising an elongated medical device having a flexible or selectively rigidizable body, a knitted, woven or braided tube extending over an outer surface of the elongated medical device and formed of one or more inelastic filaments, and one or more knitted, woven or braided external and expandable working channels integrally formed along the length of the tube and configured to receive a medical tool inserted through the working channel, the knitted, woven or braided external and expandable working channels being formed of one or more inelastic filaments.

[0091]

[0091] Methods of positioning a tool within a body are also described herein, the methods including inserting an elongated flexible member into the body whereby an outer working channel is coupled to a core region extending over an outer surface of the elongated flexible member, the outer working channel being formed of one or more inelastic filaments configured to slide over one another, positioning a distal end of the elongated flexible member near a target region of the body, and inserting a tool or liner insert tube into the outer working channel whereby the outer working channel expands to accommodate the tool or liner insert tube by sliding the inelastic filaments over one another. Any of these methods may include locking a distal end of the liner insert tube to the distal end of the elongated flexible member and / or the core region, whereby the liner insert tube maintains patency of a lumen extending through the liner insert tube.

[0092]

[0092] For example, a method of positioning a tool within the body may include inserting an elongated medical device having a stiffened member into the body while the stiffened member is in a flexible configuration whereby a knitted, braided, or woven tube extending over an outer surface of the elongated medical device can slide relative to the outer surface; positioning a distal end of the elongated medical device near a target area of ​​the body; stiffening the elongated medical device; inserting a liner insert tube into an expandable working channel of the tube whereby the expandable working channel expands to accommodate the liner insert tube; and inserting a working tool through the liner insert tube and out the distal end of the liner insert tube.

[0093] All of the methods and apparatus described herein, in any combination, are contemplated herein and may be used to achieve the benefits described herein.

[0094]

[0094] The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.

[0095] A better understanding of the features and advantages of the methods and apparatus described herein will be obtained with reference to the following detailed description and accompanying drawings that set forth illustrative embodiments. [Brief description of the drawings]

[0096] [Figure 1]

[0096] FIG. 1 illustrates an example of a system including an external working channel and an elongated medical device. [Diagram 2]

[0097] FIG. 1 illustrates an example of a system including an external working channel system in combination with an elongated medical device (eg, a rigidizable device) and a liner insert tube. [Figure 3A]

[0098] FIG. 1 is a schematic cross-sectional view of a tube including four expandable outer working channels around the circumference of the tube. [Figure 3B] FIG. 1 is a schematic cross-sectional view of a tube including four expandable outer working channels around the circumference of the tube. [Figure 4]

[0099] FIG. 13 is a schematic showing the expansion of four external working channels around the exterior of the tube. [Figure 5A]

[0100] FIG. 13 illustrates an example of a proximal end of a tube with an exterior channel on an elongate medical device, showing the insertion of a liner insert tube from the proximal end of the exterior working channel. [Figure 5B] FIG. 13 illustrates an example of a proximal end of a tube with an exterior channel on an elongate medical device, showing the insertion of a liner insert tube from the proximal end of the exterior working channel. [Figure 6]

[0101] FIG. 1 shows an example of an elongated medical device, in this example a hardenable device. [Figure 7]

[0102] 1A-1C are schematic diagrams illustrating examples of hybrid or composite fibers that include an elastic core surrounded by a lubricious material. [Figure 8A]

[0103] 13A-13C are schematic diagrams of segments of stiffening tubes illustrating examples of contouring between the outer working channel and the exterior of the stiffening tube. [Figure 8B] 13A-13C are schematic diagrams of segments of stiffening tubes illustrating examples of contouring between the outer working channel and the exterior of the stiffening tube. [Figure 9A]

[0104] FIG. 1 shows a schematic illustration of one example of an elongate medical device coupled to a tube with multiple externally expandable working channels, showing the channels in a collapsed state. [Figure 9B] FIG. 13 shows a schematic illustration of one example of an elongated medical device coupled to a tube with multiple externally expandable working channels, showing the channels in an expanded configuration driven open by a liner insert tube. [Figure 9C] FIG. 1 shows a schematic illustration of an example of an elongated medical device to which a tube having multiple external expandable working channels is coupled, showing an enlarged view of an introducer region or guide for inserting the tube into the external working channel of the device described herein. [Figure 9D] FIG. 13 shows a schematic illustration of one example of an elongated medical device to which a tube having multiple externally expandable working channels is coupled, showing an example of a liner insert tube with a non-circular outer geometry. [Figure 9E] FIG. 1 shows a schematic illustration of one example of an elongated medical device to which a tube with multiple external expandable working channels is coupled, showing a cross section through a portion of the device including the external and expandable working channels. [Figure 10A]

[0105] FIG. 1 shows an example of a liner insert tube. [Figure 10B]

[0106] FIG. 10B shows the distal and proximal ends of the liner insert tube of FIG. 10A. [Figure 10C]

[0107] FIG. 10B illustrates the distal end of the liner insert tube of FIG. 10A showing a deflectable instrument exiting the distal end of the liner insert tube. [Figure 11A]

[0108] FIG. 1 shows an example of a system including a tube having an expandable outer channel coupled to an elongated medical device (in this example, a stiffened overtube), showing the proximal end of the elongated medical device with an instrument in the liner, and an introducer for introducing a tool and / or tool liner tube into the expandable outer channel. [Figure 11B] FIG. 1 illustrates an example of a system including a tube having an expandable outer channel coupled to an elongated medical device (in this example, a stiffened overtube), showing the distal end of the tube and expandable outer channel at the distal end of the elongated medical device with the tool liner tube extending distally out of the working channel. [Figure 11C] FIG. 1 shows an example of a system including a tube having an expandable external channel coupled to an elongated medical device (in this example, a stiffened overtube) and showing a tool extending from a tool liner tube at the distal end of the elongated medical device. [Figure 11D]

[0109] FIG. 13 is a schematic cross-sectional view of a tool liner tube including an engaged deflector extending distally out of an elongate medical device. [Figure 11E]

[0110] FIG. 2 illustrates an example of a tool liner tube. [Figure 11F] FIG. 2 illustrates an example of a tool liner tube. [Figure 11G] FIG. 2 illustrates an example of a tool liner tube. [Figure 11H]

[0111] FIG. 11C illustrates a tool inserted through one of the tool liner tubes shown in FIGS. 11D-11G. [Figure 11I] FIG. 11C illustrates a tool inserted through one of the tool liner tubes shown in FIGS. 11D-11G. [Figure 11J] FIG. 11C illustrates a tool inserted through one of the tool liner tubes shown in FIGS. 11D-11G. [Figure 11K] FIG. 11C illustrates a tool inserted through one of the tool liner tubes shown in FIGS. 11D-11G. [Figure 11L] FIG. 11C illustrates a tool inserted through one of the tool liner tubes shown in FIGS. 11D-11G. [Figure 12A]

[0112] 1 is a scanning electron micrograph showing knitted fibers of an example of a tube having an expandable exterior channel. [Figure 12B]

[0113] Photographs showing examples of knit patterns in cross-section of devices described herein (tubular structures shown in flattened state). [Figure 13]

[0114] FIG. 2 illustrates generally one example of a method of operating the apparatus described herein. [Figure 14A]

[0115] FIG. 1 shows an example of an elongated medical device onto which a tube having multiple external and expandable channels is coupled, showing the entire system including the elongated medical device and the tube having an external working channel that is coded with a colored indicator (e.g., shape, pattern, alphanumeric characters, etc.). [Figure 14B] FIG. 13 shows an example of an elongated medical device onto which a tube having multiple exterior and expandable channels is coupled, and the tool is an aspiration catheter. [Figure 14C] 14A-14B show an example of an elongated medical device onto which a tube having multiple external and expandable channels is bonded; a linear insert tube with a deflector and a gripping instrument; and a distal end of the device of FIGS. 14A-14B with two different instruments (a liner insert tube with a deflector and a gripping instrument) emerging therefrom. [Figure 15A]

[0116] FIG. 1 illustrates an example of a system including multiple external channels. [Figure 15B]FIG. 1 illustrates an example of a system including multiple external channels. [Figure 15C]

[0117] FIG. 15B illustrates the system of FIG. 15A having a variety of different tools extending from the outer working channel. [Figure 16A]

[0118] FIG. 1 illustrates another example of a system described herein including a tool liner tube. [Figure 16B] FIG. 1 illustrates another example of a system described herein including a tool liner tube. [Figure 16C] FIG. 1 illustrates another example of a system described herein including a tool liner tube. [Figure 16D] FIG. 1 illustrates another example of a system described herein including a tool liner tube. [Figure 16E] FIG. 1 illustrates another example of a system described herein including a tool liner tube. [Figure 17]

[0119] 1A-1C show examples of elongated medical devices (eg, rigidizable devices) having an outer tube with multiple expandable channels extending over the outer surface of the elongated medical device. [Figure 18]

[0120] FIG. 13 shows an example of a view from an endoscope with overtube distal quadrant indicators (e.g., multiple colors) corresponding to different exterior channels shown. [Figure 19A]

[0121] 1A-1D illustrate examples of challenges (e.g., sticking, pocket formation, pouch formation, drag, etc.) that may be addressed by the methods and devices described herein. [Figure 19B] 1A-1D illustrate examples of challenges (e.g., sticking, pocket formation, pouch formation, drag, etc.) that may be addressed by the methods and devices described herein. [Figure 19C] 1A-1D illustrate examples of challenges (e.g., sticking, pocket formation, pouch formation, drag, etc.) that may be addressed by the methods and devices described herein. [Figure 19D]1A-1D illustrate examples of challenges (e.g., sticking, pocket formation, pouch formation, drag, etc.) that may be addressed by the methods and devices described herein. [Figure 20A]

[0122] FIG. 1 illustrates an example of a knitted external working channel device, in this example a horizontally knitted device having four external working channels. [Figure 20B] FIG. 1 illustrates an example of a knitted external working channel device, in this example a horizontally knitted device having four external working channels. [Figure 20C]

[0123] FIG. 2C illustrates an example of a braided outer working channel device similar to the device shown in FIGS. 20A-20B, where the outer working channel is shown expanded with a tube inserted therein. [Figure 20D] FIG. 2C illustrates an example of a braided outer working channel device similar to the device shown in FIGS. 20A-20B, where the outer working channel is shown expanded with a tube inserted therein. [Figure 21]

[0124] FIG. 13 shows example pore (gap or opening) sizes for one example horizontal braided outer working channel assembly / device. [Figure 22A]

[0125] 13A-13C show an example of a method for forming an outer working channel assembly as a multi-lumen blade. [Figure 22B]

[0126] FIG. 13 shows a schematic of one example of an outer working channel device / assembly configured as a multi-lumen blade. [Figure 23A]

[0127] 1A-1C are schematic diagrams illustrating an example of a braided outer working channel assembly having inelastic filaments oriented to provide axial tension to prevent snagging of a tool inserted into the working channel. [Figure 23B] 1A-1C are schematic diagrams illustrating an example of a braided outer working channel assembly having inelastic filaments oriented to provide axial tension to prevent snagging of a tool inserted into the working channel. [Figure 24A]

[0128] FIG. 13 shows an example of an outer working channel device formed as a double layer braid. [Figure 24B] FIG. 13 shows an example of an outer working channel device formed as a double layer braid. [Diagram 25]

[0129] 13A-13C show another example of a working channel assembly. [Figure 26A]

[0130] 13A-13C show examples of sewn working channel assemblies. [Figure 26B]

[0131] FIG. 1 illustrates an example of a partially constructed assembly formed from a thermoplastic polyurethane material that may be heat treated. [Figure 27A]

[0132] 1A-1D are schematic diagrams illustrating a working channel assembly / apparatus including a deflector at its distal end as well as a matched pair of tools to be inserted through the working channel, as described herein. [Figure 27B]

[0133] 1A-1C show examples of working channel assemblies including matching pairs of rigid and flexible elongate members and tools. [Figure 27C]

[0134] 1A-1C show examples of the distal end of a device including steering of an inner tool (eg, a grasper tool) by a matching steerable tool. [Figure 27D] 1A-1C show examples of the distal end of a device including steering of an inner tool (eg, a grasper tool) by a matching steerable tool. [Figure 28A]

[0135] FIG. 1 illustrates an example of a handle of a steerable tool of a matching set of tools for use with an external channel as described herein. [Figure 28B]

[0136] 1A-1D illustrate the operation of a handle portion of a steerable tool (eg, a steerable liner) as described herein. [Figure 28C] 1A-1D illustrate the operation of a handle portion of a steerable tool (eg, a steerable liner) as described herein. [Figure 29A]

[0137] FIG. 1 illustrates an example of a suction catheter tool that may be used with any of the devices and methods described herein. [Figure 29B] FIG. 1 illustrates an example of a suction catheter tool that may be used with any of the devices and methods described herein. [Figure 29C] FIG. 1 illustrates an example of a suction catheter tool that may be used with any of the devices and methods described herein. [Figure 30A]

[0138] FIG. 1 illustrates an example of an irrigation catheter tool that may be used with any of the devices and methods described herein. [Figure 30B] FIG. 1 illustrates an example of an irrigation catheter tool that may be used with any of the devices and methods described herein. [Figure 30C] FIG. 1 illustrates an example of an irrigation catheter tool that may be used with any of the devices and methods described herein. [Figure 30D] FIG. 1 illustrates an example of an irrigation catheter tool that may be used with any of the devices and methods described herein. [Figure 30E] FIG. 1 illustrates an example of an irrigation catheter tool that may be used with any of the devices and methods described herein. [Diagram 31]

[0139] FIG. 1 illustrates an example of a robotic system including an external working channel sleeve device as described herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0097]

[0140] Generally, apparatus (e.g., systems, devices, etc.) are described herein that include one or more external working channels. These external working channels may be part of an elongate medical device, or these external working channels may be part of a working channel sleeve apparatus that may be attached, applied, and / or attached to the elongate medical device. Any of the external working channels may be an expandable working channel. The elongate medical device may be part of the apparatus (e.g., part of a working channel sleeve apparatus) or may be separate therefrom.

[0098]

[0141] Described herein are external working channel devices that may extend over longer lengths (e.g., greater than 12 inches, 14 inches, 16 inches, 18 inches, 20 inches, 22 inches, 24 inches, 30 inches, 48 ​​inches, 60 inches, 72 inches, 84 inches, etc.) without bunching or binding. These external working channel devices may not significantly reduce the overall flexibility of the tubular member (e.g., catheter, endoscope, etc.) to which the device is attached. These external working channel devices may provide multiple working channels and may be effectively used in conjunction with devices employing large curvatures. In general, external working channel devices may achieve advantages not possible with respect to more traditional external (or internal) working channel systems.

[0099]

[0142] Surprisingly, these devices may be formed of completely inelastic or partially inelastic materials. In some instances, the regions of the outer working channel device that form the "expandable" working channel(s) may be formed primarily of inelastic filaments or fabrics that may expand and contract based on mechanical movement, e.g., sliding, rather than the elastomeric properties of the filaments. This contrasts sharply with most, if not all, of the "expandable" outer working channel devices described above, which may aid in reducing the passive size of the channel instead of a stretchable system that provides for the expansion and collapse of the working channel. However, as described herein, the use of elastic materials in this manner may result in a radially downward force vector (e.g., normal force) only against the channel and not against a tool within the channel. The resulting relatively high normal force results in significant drag, which is particularly problematic at longer lengths and greater curvatures, for example, when inserting a tool having a relatively long length over a tortuous path. This is because the resulting capstan drag rises exponentially with curvature. In contrast, the methods and apparatus described herein may instead rely on the use of relatively inelastic materials that are configured to slide over one another to mechanically expand and contract.

[0100]

[0143] It has also been found that the outer working channel is particularly difficult to implement on highly flexible or dynamic devices, such as flexible and / or rigid elongate members. In addition to possibly limiting flexibility, one possible solution is to allow movement between the outer working channel device (e.g., the "core" portion of the outer working channel assembly) and the elongate tubular member (e.g., catheter, endoscope, etc.) on which the outer working channel assembly is disposed. For example, the outer working channel assembly may be attached to the elongate tubular member at the proximal and distal ends, but may be unattached, or in some instances partially attached, or loosely attached, or simply intermittently attached along all or a predetermined region of the length of the elongate tubular member. However, as described herein, it may be particularly important to control friction between the outer working channel device (e.g., core region) and the elongate tubular member (e.g., catheter, endoscope, etc.) to avoid crowding and / or bunching of the outer working channel device on the elongate tubular member, especially when inserting through a body lumen that may apply drag to the outer working channel device.

[0101]

[0144] In some instances, the engagement between the outer surface of the elongate tubular member and the inner surface of the core region may be configured to provide a shear engagement that effectively increases the friction between the two, for example, allowing limited sliding. For example, the core region may rest within or on a jagged or textured outer surface of the outer tube. The jagged outer surface may be configured to be the outer surface of the elongate tubular member that matches the inner surface (e.g., bore) of the core region.

[0102]

[0145] When inserting one or more tools through the outer working channel, in addition to generally reducing the internal drag within the channel, it may also be important to prevent snagging, catching, pouching, stalling, or perforation of the outer working channel. For example, as a tool passes through the outer working channel, the tip of the tool (which may have a variety of shapes) may stall, snag, or even perforate the working channel. Stalling (complete stall out) may occur when the tool cannot be inserted further, e.g., when the drag on the tool from the working channel walls is sufficiently great, such that further insertion is not possible or is not easily performed. The outer working channel devices described herein may prevent or reduce these problems using one or more features that enhance the overall performance of the outer working channel device, including, for example, in some cases, the use of inelastic filaments to form the outer working channel to allow local siding of the filaments forming the channel and / or to allow anisotropic stretching, controlling the orientation of the filaments, controlling the dry / wet properties of the filaments, controlling the size range of the filaments, using coatings and / or liners within the working channel, and forming the working channel from appropriately oriented and structured knitted, braided, and / or stitched materials. The outer working channel devices described herein may be configured such that the overall elasticity of the device varies in a controlled manner along the length of the device. Each of these factors is an improvement that may be included, and any of these features may be combined with one or more (or all) of the other features. However, it should be understood that it is not necessary for an outer working channel device to include all of these features.

[0103]

[0146] As explained, the outer working channel apparatus described herein may be used with elongate members, particularly (but not limited to) longer and / or more flexible elongate members. These outer working channel apparatus (e.g., devices, systems, etc.) may be used with catheters, endoscopes (including but not limited to colonoscopes, bronchoscopes, colposcopes, cystoscopes, esophagoscopes, gastroscopes, laparoscopes, thoracoscopes, enteroscopes, etc.), overtubes, etc. These apparatus and methods may be used with robotic systems, including robotically controlled endoscopes. The robotic systems may be robotically steered and / or advanced. In some examples, the robotic system may control the movement (e.g., advancement, retraction, and / or actuation) of one or more tools used within the outer working channel, including any of the tools or tool pairs described herein.

[0104]

[0147] The external working channels described herein may be particularly beneficial when used with elongate members (e.g., catheters, endoscopes, overtubes, etc.) that are stiffened, including dynamically stiffened, and may be transformed from a highly flexible member to a relatively rigid member, for example, by the application of external pressure. The stiffened elongate members may provide support and stability, which may prevent unintended or undesired movement of the stiffened members when inserting or manipulating tools through the working channel.

[0105]

[0148] In particular, the working channel sleeve devices described herein may include a tube having one or more external working channels configured to aid in transporting a medical instrument (e.g., a tool or tool liner) through the body, including along a curved or looped path. Any suitable elongated medical device may be used and / or may form part of a device including, but not limited to, a rigidized elongated medical device such as described in PCT / US2021 / 034292, filed May 26, 2021, entitled "RIGIDIZING DEVICES," which is incorporated herein by reference in its entirety. A tube including an expandable external working channel as described herein may include a fabric tube, such as a knitted, woven, braided, etc. In some examples, the tube is a non-woven tube, such as a laminate tube, or a tube formed of an elastic sheet, such as a thin elastomeric sheet, with multiple cutouts that form holes or openings through the tube.

[0106]

[0149] FIG. 1 shows an example of a working channel sleeve apparatus 100 including multiple external working channels and an inner tube. The external working channel for use with an elongate medical device may be formed as part of (e.g., integrated into) an inner tube 135 (e.g., a fabric tube) extending between a proximal end region 125 and a distal end region 130 of the elongate medical device. The proximal end region 125 may be externally accessible when the external expandable working channel 120 is in use and the distal end region 202 is disposed partially or substantially within a vessel. The tubular material forming the inner tube may be expandable and / or flexible to selectively accommodate movement through angled or curved passages. The multiple working channels 120 may be formed on a tube, and in particular may be formed of one or more filaments that are knitted, woven, and / or braided integrally with the tube. The inner tube may include a mesh material. In some examples, the working channel sleeve apparatus includes both an inner tube and multiple external working channels, as shown in FIG. 1.

[0107]

[0150] 1 may include a lumen that may extend from a proximal end region to a distal end region. Tube 135 may be generally flexible in a relaxed configuration and may be collapsible when nothing is positioned within the tube, e.g., when not applied or attached over elongate medical device 200. As mentioned, one or more channels (e.g., expandable working channel 120) may be formed and / or positioned about an outer surface of main tube 135.

[0108]

[0151] Expandable working channel 120 may extend longitudinally from the proximal end 125 of the tube to the distal end 130 of the tube (or from the proximal end region to the distal end region). Working channel 120 may have a lumen that extends the entire length of the working channel 120 to allow for the passage of an object that may slide through working channel 120, into the proximal end 125 of working channel 120, and out through the distal end 130 of working channel 120.

[0109]

[0152] Thus, in any of the working channel sleeve devices described herein, the working channel may be advantageously formed of one or more fibers (e.g., fibers made of braided, woven, knitted, etc.) and may be expandable (e.g., stretchable). These outer working channels may be configured to lie flat (e.g., "layflat") against the outer surface of the elongate medical device until expanded by or with the insertion of a tool. In particular, these devices may include a working channel that may be co-formed as a knit, weave, and / or braid with the tubular body 135. The tubular body may be a fabric tube that includes a knit, woven, or braided tubular body. In some examples, the working channel sleeve device is formed of a mesh material (e.g., braided or woven), such that both the inner tube member and the outer working channel are stretchable and flexible. The working channel sleeve device may be positioned against the elongated medical device such that the entire working channel sleeve device / assembly (including tube 135 and one or more working channels 120) is formed as a braided tube or sleeve sized to fit over the elongated medical device so that the working channel is expanded and used to pass one or more medical tools and / or a liner insert tube which may be inserted to form a more open and lubricious channel for the tools.

[0110]

[0153] The length of the working channel 120 of the working channel sleeve device may be approximately the same length of the inner tube (e.g., tube 135) from the proximal or tip to the distal or tip of the working channel sleeve device. Alternatively, each of the expandable working channels 120 may have a length that is less than the length of the tube 135. For example, the working channel 120 may extend longitudinally along the outer surface of the tube 135, with the proximal end of the working channel 120 positioned on the outer surface of the tube 135 between the proximal and distal ends of the tube 135. Similarly, the distal end of the working channel may be positioned on the outer surface of the tube 135 between the distal end of the tube 135 and the proximal end of that working channel.

[0111]

[0154] Working channel(s) 120 external to tube 135 may begin at or substantially near one another working channel, or may be at or near the proximal end 125 of the tube. Distal end 130 of working channel(s) 120 may be positioned at any point along tube 135 between proximal end 125 and the distal end of tube 135, including at or substantially near where the distal ends of any other working channel(s) and the distal end of tube 135 terminate.

[0112]

[0155] As mentioned, the exterior and expandable working channel(s) 120 may be formed as part of the tube 135 or, in some instances, may be secured to the tube 135 of a working channel sleeve device. A portion of the exterior surface of the working channel(s) 120 may contact the exterior surface of the tube 135 or may be integrally formed as part of the exterior surface of the tube 135. The expandable working channel 120 may have a collapsible cross-sectional geometry. The working channel(s) may have an interior surface that defines the lumen of the working channel, and the exterior surface of the working channel material may be exposed and viewable as the outermost layer of the system 100. The interior of the working channel may be lubricious (e.g., low friction).

[0113]

[0156] In some of the examples described herein, a system 100 including an elongate medical device and a working channel sleeve apparatus (e.g., an inner tube and an outer working channel) may be equivalently referred to herein as an outer working channel system 100 or an outer working channel device. In some examples, for convenience, these apparatus may be referred to herein as working channel sleeve apparatus and may include an elongate medical device.

[0114]

[0157] As mentioned, expandable working channel 120 and tube 135 may be formed of a non-elastic material or, in some instances, a hybrid elastic and lubricious material 210 (shown in more detail in FIG. 7 below), and may be formed by one or more filaments having desired properties. In particular, the one or more filament(s) may be fibers, woven fiber networks, yards, threads, or combinations thereof. In some instances, the filaments may have an elastic inner region (e.g., core) with a lubricious outer region (e.g., coating, wrapping, etc.). The elastic core may be sufficiently elastic to allow for elongation of the knitted, woven, or braided material that forms the working channel. For example, the elasticity of the fibers may allow for elongation of the fibers and dynamic changes in the length of the fibers as the outer working channel system 100 is manipulated. The elastic core may be any suitable biocompatible elastic material, such as silicone, spandex, biocompatible polyurethane elastomers, and / or biocompatible copolymer elastomers. The lubricious outer region may be formed of any suitable biocompatible lubricious material, such as polypropylene, polyethylene, or polyester, or polytetrafluoroethylene (e.g., Teflon). The materials may be used in whole, in part, and / or in combination with other materials.

[0115]

[0158] FIG. 7 shows a schematic example of a hybrid material that is both elastic and lubricious and may be used to form a tube and / or an expandable outer working channel. In this example, a double-covered filament (e.g., "yarn") is shown consisting of an elastic core 736 wrapped with two counter-wound layers 738, 740 of highly lubricious fiber 734. In FIG. 7, the hybrid material includes an elastic (e.g., elastomeric) core 736 that is wrapped by a double wrapping of less elastic but more lubricious fiber 738. The elastic core may be a single fiber or multiple elastic fibers that may be arranged in parallel or may be twisted, braided, etc. In some examples, a single covering 738 of lubricious fiber may be wrapped around the elastic core; in some examples, double 738, 740 or more (e.g., triple, etc.) overlapping wrappings of less elastic but more lubricious material may be used. Although a single covering is possible, a double covering may have more secure coverage.

[0116]

[0159] In another example, the elastic element and the lubricious element are knitted, woven, or braided together such that the elastomeric material (e.g., core) is not completely enveloped by the lubricious material, yet does not increase the drag of the sliding member because the elastomeric member is positioned outward from the sliding surface relative to the working channel. Thus, the elastomeric material (e.g., core) may provide the necessary elasticity, but does not significantly increase drag.

[0117]

[0160] The tube 135 may be formed of the same material as the expandable working channel, or may be formed of a separate material that may be somewhat elastic and / or somewhat lubricious. For example, the lumen 140 of the tube 135, which is configured to fit over an elongated medical device, may have an adjustable circumference, radius, or diameter to be sufficiently elastic to accommodate the elongated medical device (e.g., a stiffening type device) to which the tube is applied. Similarly, each of the expandable working channels may have an expandable lumen 126 with an adjustable circumference, diameter, or radius to receive a liner insert tool and / or to directly accommodate tools of different dimensions. In some examples, the filaments may have a low friction coating and / or low friction wrapping around an elastic core. The coating material may increase the lubricity of the fiber and may reduce friction when the fiber contacts another surface (e.g., the interior of a sliding device or a body vessel). The use of a low friction filament material similarly ensures reduced friction against adjacent sliding materials or surfaces. The lubricious wrapping and / or coating can be a material such as polypropylene or Teflon or a combination thereof. In some examples, one or more filaments forming the expandable working channel may be wrapped with multiple layers of lubricious material. In some examples, the filament(s) may include an elastic core that is wrapped (e.g., coil wrapped) with a wrap material (e.g., a polytetrafluoroethylene material) attached radially to the elastic core (e.g., a silicone core, a spandex core, a urethane core, etc.). The wrap can include a lubricious material and each filament may have two or more layers of wrap.

[0118]

[0161] In some instances, the working channel(s) 210 and / or tubes can compress the elongated medical device because the filaments can expand to accommodate changes in the shape of the elongated medical device (bending, expansion / contraction, etc.) and allow the tubes and / or working channels to compress or retract. Compression / expansion of the flexible tubes and working channels on the elongated medical device may be sufficient to prevent warping, rippling, kinking, wrinkling, buckling, clumping of the tubes and / or working channels as the stiffened device assembly advances through the vessel. A weave or network of filaments can be an example of a knit or woven material forming the expandable working channel 120 and tube 135. The tube 135 can form a continuous lumen 140 into which the elongated medical device fits. Additionally, the lumen 126 of the working channel may be formed of the same (or different) filaments or the same (or different) types of filaments.

[0119]

[0162] Any of the tubes having working channels described herein may be knitted, braided, and / or woven as described above. The result may form pores between the filament(s) forming the fabric. As used in this example, "pore" includes windows, openings, gaps, spaces, etc. between the filament(s) forming the fabric (e.g., weave, knit, etc.). In general, the tubes described herein may have pore sizes that may vary when the working channel expands or collapses. The pores may change shape (i.e., compress, decrease, expand, or elongate) as the working channel geometry changes. Smaller pore sizes may prevent snagging or catching of tools within the expandable working channel(s). Optimal sizing of the pores may depend on the material, including filament size, pore percentage, pore spacing size, pore diameter, etc. For example, in some instances, it is beneficial to have a porosity of greater than <80% (less than 75%, less than 70%, less than 65%, less than 60%, less than 55%, less than 50%, etc.) when the expandable working channel is not expanded ("opened"). The pore sizes of the flexible tubular member may range from 0.05 mm to 4 mm. In general, the flexible tubular member may have a variety of pore sizes and shapes along its length.

[0120]

[0163] The knit may be formed using between 1 and 4 filament ends with fibers of denier (thickness) between about 10 and 200. The knitting machine gauge may be between 10 / 14 and 16 / 18.

[0121]

[0164] The lumen of the outer working channel may be defined by the outer surface of the tube 135 and the inner surface of the channel material, whereby the channel material is connected to the outer surface of the tube 135. When a liner insert tube and / or tool is passed through the outer working channel (which may be an expandable working channel), the material forming the outer working channel may expand while the outer surface of the tube 135 within the channel lumen does not expand. Alternatively, in some examples, the expandable working channel may have an inner surface of knitted, woven, or braided filament(s) that is separate from the filaments forming the tube and may be secured to the outer surface of the tube 135.

[0122]

[0165] FIG. 2 shows an example of a working channel sleeve apparatus 101 similar to the apparatus shown in FIG. 1, including an elongated medical device 200 (in this example, a stiffened tube) installed through a tube 135 having multiple expandable working channels 120. The expandable working channels 120 are visible around the outer surface of the tube 135. The system also includes a liner insert tube 150 having a length that is approximately the same as the distance between the proximal and distal end regions of the tube and / or elongated medical device. In some examples, the liner (e.g., liner insert tube 150) may be longer than the centerline path length of the apparatus, since the distance along the outside of the tube as it curves may be different than the distance along the inside of the tube as it curves, so that the liner insert tube can buckle when extending along the outer curve of the elongated medical tool, while still being long enough to accommodate when the inner curve. The liner insert tube 150 may be configured to fit into the lumen of the expandable working channel and may extend from the proximal end to the distal end. In some examples, the distal end of the liner insert tube 150 may engage the distal end of a tube and / or the distal end of an elongate medical device. The liner insert tube 150 may be configured to receive one or more tools or instruments that pass through the liner insert tube 150 while the liner insert tube 150 holds the working channel open.

[0123]

[0166] In some instances, the liner insert tube 150 can have a substantially thin wall around the lumen. The liner insert tube 150 can have an inner surface surrounding the lumen and an outer surface that can be in contact with the inner surface of the working channel 120. The liner insert tube 150 can resist compression by the expandable working channel to facilitate advancement through the outer working channel device 100. Additionally, the liner insert tube 150 can be bendable and can advance along a path defined by the interior of the channel 120 that curves or bends based on the path of the elongated medical device within the body. The outer working channel can be disposed on the same path as the elongated medical device 200, and the liner insert tube 150 can be inserted after the distal end of the elongated medical device is positioned near the target tissue area to be treated or examined. Advantageously, the elongated medical device can be positioned within the body with a small profile that is later expanded to a larger profile to fit one or more tools by inserting and engaging the liner insert tube 150 into the expandable working channel. Each liner insert tube 150 may have a tapered distal end with one or more engagers (e.g., engaging elements) that may engage the distal end region of the external working channel, tube, and / or elongated medical device. The tool liner engaging elements 165 may be configured to communicate with a complementary engaging region or element on the elongated medical device or tube or both. In some examples, the proximal engager (engaging element 165) on the proximal end of the liner insert tube 150 is configured to engage the external geometry of the tube and / or external working channel and / or elongated medical device. As mentioned, the distal end 160 of the liner insert tube may also or alternatively have a distal engager (e.g., distal engaging element 166) configured to engage or otherwise communicate with the distal end region of the tube and / or elongated medical device. These engagers may be different shapes, including wing-like.

[0124]

[0167] According to some examples, the material forming the outer working channel 120 may form a continuous circumference with the circumferential region affixed to the outer surface of the tube 135. Thus, the portion of the tube 135 forming or in communication with the outer side of the working channel may be at a single point up to halfway around the circumference of the working channel. The amount of the working channel that connects to the tube 135 may be described as a percentage of the circumference of the working channel. For example, 1%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, or more of the working channel circumference may be formed by the tube 135. In the relaxed configuration, the cross-sectional area of ​​the working channel may collapse against the working channel when a liner insert tube or medical tool is inserted into the working channel. The working channel may be formed in discrete regions along the outer surface of the tube (as shown in FIG. 3B) or the working channel may extend across the entire outer surface of the tube (as shown in FIG. 3A). In some examples, the working channels may be integral with the tube. In FIG. 3A, the outer working channel 120 is formed of the same material (e.g., from the same filament or sharing a filament) as the tube 135. In some examples (not shown), the working channels may be formed of separate filaments and attached to the tube 135 (e.g., by simultaneous weaving, braiding, local stitching or bonding, or the like). In some examples, the working channels may be secured to adjacent working channels because they share a common attachment point 110. Alternatively, the outer working channel 120 may be integrally formed with the tube 135 (e.g., woven, braided, or braided into a tube). In some examples, the outer working channels may be radially spaced apart from one another and do not contact one another (see, e.g., FIG. 3B), with a portion of the outer surface of the tube 135 being visible.

[0125]

[0168] Generally, as shown in Figures 3A and 3B, the outer working channel may be in a collapsed configuration (e.g., flat on the outer surface of the elongate medical device) until something is inserted into the lumen or channel formed by the outer working channel.

[0126]

[0169] In general, the outer working channel may increase its cross-sectional area to accommodate a tool and / or a liner insert tube that may be slid or advanced into the working channel, as illustrated by FIG. 4. In FIG. 4, the working channel 120 is shown on the left in a collapsed configuration, with a clear and empty lumen through the working channel. The right side shows the working channel expanded, for example, when a tool or a liner insert tube is inserted into the working channel. In some instances, in contrast to FIGS. 3A and 3B, the channel may only be locally attached, for example, at a given junction or tangent. The channel may be attached at its entire contact circumference or partial contact location, from end to end at a single junction. The flexible nature of the working channel may be adapted to the dimensions and geometry of the liner insert tube. The liner insert tube 150 may be inserted into the proximal end of the working channel. For example, the distal end 160 of the liner insert tube may be inserted into the proximal opening of the working channel 120 at the proximal end 125. The length of the liner insert tube may be slid into and through the working channel 120 towards the working channel distal end 130. The liner insert tube 150 may be advanced to any position within the length of the working channel 120. In particular, the liner insert tube may be fully inserted into the outer working channel and locked into position. For example, the liner insert tube 150 may be advanced through the working channel lumen 126 such that the distal end 160 of the liner insert tube extends beyond the distal end 130 of the working channel 120. The liner insert tube 150 may, in some instances, be inserted through the working channel 120 until the distal end of the liner insert tube 150 is substantially near or beyond the distal end of the tube 135. The distal and / or proximal ends of the liner insert tube may engage the elongated medical device and / or tube.

[0127]

[0170] According to any of the examples described herein, the liner insert tube 150 can have a geometry (e.g., sized and spaced) configured to allow one or more tools to pass through the liner insert tube. The geometry can be circular. In some examples, the cross-sectional geometry of the liner insert tube lumen can provide a specific orientation of the tool as it is inserted and advanced through the tool liner. For example, the liner insert tube lumen can have a cross-sectional geometry that is semicircular or some form of polygon that corresponds to the cross-sectional geometry of the tool passing through the liner insert tube lumen. The liner insert tube can remain open even as the force compressing the liner insert tube by the collapsible working channel increases (e.g., when bent or highly curved).

[0128]

[0171] In any of these examples, the liner insert tube may be visualized by a camera (e.g., a camera associated with the elongated medical device). For example, an imaging element may image the liner insert tube as it exits the distal end region of the working channel during the procedure. The imaging element can provide spatial awareness of the orientation of the liner insert tube inside the vessel, which may be difficult to image. Thus, it may be advantageous to have a primary endoscopic image, and then a secondary endoscopic image, provided by an endoscope passing through an outer working channel or liner. A second endoscope, with a tool passing through its inner working channel, may also be useful for further manipulation and grasping, including.

[0129]

[0172] 5A and 5B show views of the proximal end of an apparatus assembly (e.g., an elongated medical device and an attached flexible tube that includes multiple exterior channels). In FIG. 5A, a liner insert tube 150 is shown inserted into the proximal end 125 of the working channel 120. The insertion of the liner insert tube 150 is near the proximal end 201 of the curable device 200 because this may be the end of the system or assembly that will be most accessible during use. The distal end 160 of the liner insert tube 150 can be seen as being within the working channel 120 (shown in FIGS. 5A and 5B) as the liner insert tube 150 advances through the apparatus through the braided material that forms the working channel in this example. In this example, the working channel and tube are configured as a braided filament with the working channel and tube 135. As shown, the working channel 120 expands when the liner insert tube 150 is initially inserted into the proximal opening in FIG. 5A and continues to expand as the liner insert tube 150 advances from the proximal end 125 toward the distal end of the working channel 120.

[0130]

[0173] The tubes including the working channels described herein may be configured to be mounted onto an elongate member device. For example, the tubes may receive an elongate medical device within the lumen 140 of the tube 135. The elongate medical device may be a generally long, thin, hollow catheter, scope, overtube, or the like. In some instances, the elongate medical device may transition from a flexible configuration (i.e., a configuration that is relaxed, floppy, or pliable) to a rigid configuration (i.e., a configuration that is rigid and / or retains the shape that the elongate medical device assumes when the elongate medical device hardens). The apparatus described herein may be particularly well suited for use with hardenable devices, but may also be used with non-hardenable devices. In some instances, hardenable devices (also referred to as selectively hardenable devices) may include multiple layers (e.g., coiled or reinforced layers, slip layers, braided layers, bladder layers, and / or sealing sheaths) that may together form the walls of the hardenable device. The hardenable device can transition from a flexible configuration to a rigid configuration, for example, by applying positive or negative pressure against or within the walls of the hardenable device. With the positive or negative pressure removed, the layers can easily shear or move relative to each other. With the positive or negative pressure applied, the layers can transition to a state in which they exhibit a substantially improved ability to resist shear, move, bend, torque, and buckle, thereby providing system stiffening. Any suitable hardenable member may be used, including hardenable members that are not formed in layers and / or actuated by pressure (positive and / or negative pressure). For example, the hardenable member described herein may refer to any suitable hardenable device, including members that may be hardened by jamming particles, by phase change and / or shape memory alloys, by interlocking components (such as, for example, cables with disks or cones), EAPs (electro-active polymers), or any other hardenable mechanism.

[0131]

[0174] Elongated medical devices (both rigidized and non-rigidized) that may be used as part of the apparatus described herein may include catheters, sheaths, scopes (e.g., endoscopes), wires, overtubes (e.g., external working channels), trocars, or laparoscopic instruments. The rigidized devices can function as separate add-on devices or may be integrated into the body of a catheter, sheath, scope, wire, or laparoscopic instrument.

[0132]

[0175] According to some examples, a body having an external working channel may be installed with or on the hardenable device. The lumen 140 of the tube may receive a portion or segment of the hardenable device 200. For example, the body of the hardenable elongate device may be contained entirely within the lumen of the tube 135. The distal and proximal ends of the hardenable device 200 may be exposed upon extending beyond the length of the tube 135 of the external working channel. Alternatively, the length of the hardenable device 200 from its distal tip to near its proximal end may be within the external working channel.

[0133]

[0176] An elongated medical device configured as a hardenable device 200 is shown in FIG. 6. The hardenable device 200 in this example has a wall with multiple layers 203 including a braid layer, an outer layer (a portion of which is cut away to show the braid 203 underneath), and an inner layer. The system further includes a handle 201 having a vacuum or pressure inlet to provide vacuum or pressure to the hardenable device 200. An actuation element can be used to turn the vacuum or pressure on and off, thereby transitioning the hardenable device 200 between a flexible configuration and a rigid configuration. The distal tip 202 of the hardenable device 200 can be smooth, flexible, and atraumatic to facilitate distal movement of the hardenable device 200 through the body. Additionally, the tip can be tapered from the distal end to the proximal end to further facilitate distal movement of the hardenable device 200 through the body.

[0134]

[0177] The elongate medical device of FIG. 6 may be used as part of a system that includes one or more external working channels. For example, the external working channel tube 135 may cover the entire length of the exterior surface of the curable device 200. The tube and working channel may be applied over the curable device such that the tube fits over the elongate body of the curable device. In any of these examples, the tube and external working channel may be coupled to the elongate medical device due to the elastic material forming the tube that may contract to be lower on the exterior surface and / or because the tube may be attached to one or more points or regions of the exterior surface of the elongate medical device (or along its entire length). In some examples, the tube forming the external working channel may be secured only to the distal end region or to both the distal and proximal end regions. In some instances, the tubes forming the outer working channel may be attached at various points or regions along the length of the elongate medical device (e.g., approximately between every 10 cm and 50 cm, approximately between every 15 cm and 50 cm, approximately between every 20 cm and 50 cm, approximately between every 25 cm and 50 cm, approximately between every 30 cm and 50 cm, etc.). In general, discrete attachments (and in some cases few attachments) may be preferred to prevent wrinkling, buckling, or kinking of the tubes and outer working channel, and to allow the tubes, and thus the outer working channel, to adjust position slightly as the elongate medical device bends or curves. The tubes and outer working channel may be attached to the outer surface of the elongate medical device by mechanical attachments (e.g., ties, hooks, anchors, etc.), chemical attachments (e.g., adhesives, etc.), or any other suitable attachments.

[0135]

[0178] In some instances, the tube with the outer working channel may be coupled to the elongate medical device in a manner that prevents relative rotation of the outer working channel with respect to the elongate medical device. For example, the outer working channel may be sufficiently resilient to minimize or prevent significant movement, rotation, or other movement between the two. Thus, in some instances, the tube with the resilient (and outer) working channel may move with the elongate medical device in a 1:1 ratio.

[0136]

[0179] The engagement of the tube including the working channel with the elongated medical device may be sufficient to minimize a gap between the inner surface of the tube 135 of the external channel device and the outer surface of the elongated medical device (e.g., the rigidized device 200). The system 100 may include a flexible material, such as having a weave pattern and / or filament(s) with an elastic core and a lubricious exterior. The elastic filaments forming the external working channel and / or tube may facilitate a snug and substantially tight communication with the elongated medical device. As shown in FIGS. 8A and 8B, an elongated medical device including a tube having one or more external working channels may operate when bending or curving through even more tortuous paths. FIG. 8A illustrates the curve of an arc in a segment of the elongated medical device 200. Similarly, FIG. 8B illustrates a sharper bend in a segment of the elongated medical device 200. A tube with an external working channel as described herein may be used in even more tortuous bends without kinking or blocking the passage through the external working channel. As shown in FIGS. 8A and 8B, the tube and / or outer working channel may conform to these bends and curves (e.g., between 0 degrees and 180 degrees or more) with a radius of curvature of about 1.5 times the diameter of the elongated medical device without kinking, wrinkling, or the like. FIG. 8A shows a relatively large radius of curvature, while FIG. 8B shows a very narrow radius of curvature. The tube with the outer working channel described herein may follow both of these curves. In general, when a segment or length of the elongated medical device 200 is curved or bent, the elasticity of the outer working channel of the tube may be sufficient to maintain smooth and consistent contact with the curable device 200 along the entire length that the outer working channels are in communication with each other. The channel of the outer working channel may possess a similar capability to the tube 135 of the outer channel device, such that the channel also continues the smooth outer surface of the outer channel device and the curable device assembly.

[0137]

[0180] In general, the hardenable device can toggle between the rigid and flexible configurations by any number of transition cycles. As interventional medical devices are made longer and inserted deeper into the human body, and as they are expected to perform more demanding treatment procedures, there is an increased need for precision and control. The selectively hardenable devices described herein can advantageously provide both the benefits of flexibility (when needed) and the benefits of rigidity (when needed). Furthermore, the hardenable devices described herein can be used with classical endoscopes, colonoscopes, overtubes, catheters, robotic systems, and / or navigation systems, for example, as described in International Patent Application No. PCT / US2016 / 050290, filed September 2, 2016, entitled "DEVICE FOR ENDOSCOPIC ADVANCEMENT THROUGH THE SMALL INTESTINE," which is incorporated herein by reference in its entirety. The selectable rigid and flexible configurations of the hardenable device may be accommodated by a tube having an external working channel, as described herein.

[0138]

[0181] The elongate medical devices described herein may additionally or alternatively be disclosed in International Patent Application No. PCT / US2016 / 050290, filed September 2, 2016, entitled "DEVICE FOR ENDOSCOPIC ADVANCEMENT THROUGH THE SMALL INTESTINE," published as WO2017 / 041052; International Patent Application No. PCT / US2018 / 042946, filed July 19, 2018, entitled "DYNAMICALLY RIGIDIZING OVERTUBE," published as WO2019 / 018682; International Patent Application No. PCT / US2019 / 042650, filed July 19, 2019, entitled "DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES," published as WO2020 / 018934; The present invention may include any of the features described in International Patent Application No. PCT / US2020 / 013937, filed January 16, 2020, entitled "COMPOSITE MEDICAL STRUCTURES," and International Patent Application No. PCT / US2021 / 034292, filed May 26, 2021, entitled "RIGIDIZING DEVICES," all of which are incorporated herein by reference.

[0139]

[0182] In some examples, the outer working channel may be configured to allow advancement of an instrument or tool (i.e., a working tool), such as a surgical or laparoscopic tool, a grasper, an articulating grasper, a fecal wash device, and / or a fecal suction device, through the outer working channel. In some examples, the tool can be a scope (e.g., allowing for a secondary scope within or along with a primary scope). The outer working channel(s) can allow the tool to be guided along the elongate medical device until it reaches the distal end of the elongate medical device to perform a desired procedure. In some examples, the outer working channel can accept a tool through the outer working channel. For example, an elongate medical device may be coupled to the system 100 including one or more outer working channels.

[0140]

[0183] In some examples, the proximal end of the tube with the external working channel may be configured to engage the channel formed by the external working channel. FIGS. 9A-9C show close-up views of the proximal end of an elongated medical device with a tube with an external working channel 305 bonded thereon. The elongated medical device in this example is a hardened device. The outer tube of the hardened device can be a thin-walled sleeve, such as an elastomeric sleeve, a plastic sleeve, or a fabric sleeve. In some examples, the outer tube of the hardened device can be a sleeve that is fiber-reinforced or wire-reinforced. In one particular example, the outer tube of the hardened device can be a fabric material that inherently has some stretchability and / or is sewn at a 45° angle (e.g., off-bias to provide compliance and / or stretchability). In some examples, the tube with the external working channel can be permanently attached (e.g., bonded, heat-welded, sewn, or ultrasonically welded) to the outer surface of the elongated medical device (e.g., hardened device 200). In any of these devices, the resilient working channels may be linearly disposed down the length of the elongated medical device at rest; for example, the working channels may be straight (i.e., axially aligned with the outer tube 335 of the curable device). In some instances, the resilient working channels 305 may be helical. For example, the resilient working channels may be co-attached (to each other or to the resilient body) by sewing, bonding, or heat sealing.

[0141]

[0184] In some examples, the elastic working channel may be lined with a hydrophilic, hydrophobic, or low friction (e.g., PTFE) coating. The liner insert tube 300 may include an insert (e.g., a molded or extruded insert) configured to be positioned within the outer working channel 305 for use. For example, the liner insert tube 300 may be configured to be inserted into one or more outer working channels 305 after the cured elongated medical device 200 has been placed and / or cured within a body lumen. Each liner insert tube 300 may include a lumen 310 (configured for the passage of a tool) therein. Each liner insert tube 300 may have sufficient rigidity to open or expand the outer working channel 305 as the liner insert tube 300 extends through the outer working channel 305. In some examples, the liner insert tube may have an inner diameter of about 1 mm to 7 mm, such as 3 mm to 5 mm, and a wall thickness of about 0.1 mm to 1 mm, for example. The liner insert tube 300 may be made of a polymer, such as Teflon, FEP, and / or polyethylene (such as HDPE or LDPE). The lumen 310 may be lubricious to help allow passage of tools through the lumen. For example, the lumen 310 may be made of a material that has a low coefficient of friction (e.g., the same material as the liner insert tube 300 itself). As another example, the liner insert tube may be a composite structure that is coated with a separate lubricious coating, such as a hydrophilic coating.

[0142]

[0185] As shown in FIGS. 9D and 9E, in some instances, the liner insert tube 300, which may be equivalently referred to herein as a guide, may include one or more protrusions (e.g., wings) and / or may have a symmetric or asymmetric cross-section. For example, in some instances, the device may include one or more wings 315, which may have an asymmetric cross-section. In some instances, the liner insert tube may include a non-circular shape with wings 315 (e.g., rounded triangular wings) extending from a region around the central lumen. In some instances, the wings 315 may form an angled surface 330 (e.g., having an angle of 110°-130°, such as about 120°) configured to fit snugly around the circumference of the curable device 200. The asymmetric cross-section may advantageously ensure proper radial alignment of the liner insert tube 300 (e.g., such that the distal end of the lumen 310 points radially inward relative to the curable device 200). Additionally, the asymmetric cross-section can advantageously prevent rotational movement of the liner insert tube 300 within the outer working channel 305. This can be particularly advantageous when the elongated medical device is a rigidized device in a rigid configuration as the asymmetric cross-section can help provide rigid and stable access to the desired working area. In other examples, the liner insert tube 300 can be symmetric and / or otherwise configured to be rotatable within the expandable working channel 305. In some examples, the proximal end of the liner insert tube 300 can include indicator marks configured to indicate the rotational position of the distal end of the liner insert tube 300 relative to the working channel 305 and / or relative to the elongated medical device 200.

[0143]

[0186] 9A-9B, an outer tube 335 of an elongate medical device can include a proximal manifold 320 attached to the outer tube 335, which can be configured to allow insertion of the liner insert tube 300 into the outer tube 335. For example, the manifold 320 can include ports 325 that allow access to each of the outer working channels 305. In some examples, each port 325 can include a corresponding marker configured to allow identification of the working channel 305 (and thus identification of the distal circumferential location of a tool inserted through the working channel 305). The markers can be a shape, a number, a color, or any one of a variety of input / output matching identifiers. In some examples, the ports 325 can include a valve thereon and / or can be vacuum sealed.

[0144]

[0187] In some examples, the liner insert tube 300 may include a handle or stop 201 (see FIG. 9B ) at the proximal end of the liner insert tube 300 to limit axial movement of the liner insert tube 300 too deep into the working channel 305, and / or a manifold 320 coupled to the outside of the elongated medical device 335 (e.g., the outer tube of a curable device).

[0145]

[0188] Figure 9C shows an example of a liner insert tube 300 (which may also be referred to herein as a guide) that includes a lumen 310 and a pair of wings 315; the liner insert tube is inserted into a port 325 that couples to an exterior and expandable working channel (not visible in the case of Figure 9C). Any of these devices may include a port at the proximal end of the device to help provide entry into a flat (e.g., unexpanded) working channel.

[0146]

[0189] 10A-10C show another example of a liner insert tube 1000 as described herein. The liner insert tube may have a length that is approximately the same as (or only slightly longer than) the length of the elongated medical device and external channel with which it may be used. The liner insert tube may exhibit high radial and axial stiffness while exhibiting low bending stiffness to track through the external channel. FIG. 10B shows an enlarged view of the proximal end region 1033 and distal end region 1035. The proximal end region 1033 and distal end region 1035 of the liner insert tube are shown. The proximal end 1033 may include an engagement portion 1037 that may engage or couple to a connection portion on the proximal end of the elongated medical device and / or the tube that forms the external channel.

[0147]

[0190] The distal end region 1035 in this example includes a deflector 1041 that may be oriented to deflect a medical tool inserted through the elongated channel of the liner insert tube 1000 toward the centerline of the elongated medical device or an endoscope inserted through the elongated medical device. For example, the distal tip may be shaped to deflect a tool exiting through the distal tip toward the centerline of the elongated medical device (e.g., an endoscope). This is shown in FIG. 10C, which shows a deflector 1041 on a liner insert tool, which is designed to deflect a tool 1045 passing through the liner insert tube 1000 toward the axial centerline of the elongated medical device (e.g., an endoscope, not shown).

[0148]

[0191] Both the proximal and distal ends of the liner insert tube 1000 of FIGS. 10A-10C include a pair of wings 1039, 1039′ as described above; the wings may guide and / or secure the liner insert tube 1000 within the expandable channel. These wings (or “fins”) may help keep the liner insert tube 1000 rotationally aligned within the working channel. The fins may help engage distal geometry such that, once fully advanced, the fins are “docked” to prevent axial, lateral, and torsional motion.

[0149]

[0192] 11A-11C show an example of a system described herein that includes a tube 1101 formed of a woven material that is mounted over an elongated medical device 1103 (in this example, a stiffened overtube). The tube 1101 includes at least one expandable outer channel 1105, and the liner insert tube 1104 is inserted into the at least one expandable outer channel 1105 and coupled to the handle of the elongated medical device 1103 at the proximal end 11333. Thus, the liner insert tube may hold the expandable outer channel open and prevent snagging by the medical instrument or tool 1145 as the medical instrument or tool 1145 passes through the liner insert tube 1100 and exits the distal end as shown in FIG. 11C. FIG. 11B shows the distal end of the liner insert tube 1104 that includes a deflector 1141 that directs the medical tool 1145 toward the centerline of the elongated medical device 1103 or in any desired direction.

[0150]

[0193] 11D shows an example of a distal end of a liner insert tube 1104 adjacent to an elongated medical device 1103, configured in this example as an overtube 1103. The liner insert tube also includes a deflector 1141 formed or attached to the distal end region of the liner insert tube 1104, with a slight bend or angle in the distal region that may direct the tool distally (straight) or slightly radially inward, but prevent the tool from exiting radially outward. In some examples, the director may be intentionally rotated to direct the tool radially outward rather than inward.

[0151]

[0194] In use, the working channel sleeve apparatus described herein may include or be a part of an elongated medical device, including but not limited to a stiffening type device, for example, the working channel sleeve apparatus may be positioned or attached onto an outer surface of the elongated medical device. The working channel sleeve apparatus including the elongated medical device may then be positioned at a desired anatomical location. If the user prefers to deploy a tool at the anatomical location, the user may select an outer working channel (e.g., based on a marker, such as a color, symbol, and / or text marker) at the proximal end of the elongated medical device, and the user may then insert a tool or liner insert tube 1104 through the port and into the outer working channel. Inserting the liner insert tube (also referred to herein as a "guide") may expand the outer working channel. A tool may then be inserted through the liner insert tube. After the procedure is completed, the tool and liner insert tube may be removed and the outer working channel may be collapsed back.

[0152]

[0195] The liner insert tubes can come in different sizes (e.g., with different sized lumens, such as lumen 1110 ranging from 1 mm to 7 mm, such as 2 mm to 6 mm in diameter) and can be used interchangeably within the outer working channel(s). In some examples, the liner insert tube can have a lumen without a bend at the distal end. In other examples, the liner insert tube can include a bend and / or an asymmetric jog or turn configured to direct a tool inserted into the lumen of the liner insert tube in a desired direction, for example, toward the center of the elongated medical device or outward from the centerline of the elongated medical device (e.g., to direct the tool radially outward, such as to perform a procedure against the wall of the lumen). As discussed above, in some examples, the liner insert tube includes a deflector 1141.

[0153]

[0196] 11E-11L show examples of liner insert tubes 1104 including an inner lumen 1110 having a distal bend that steers a tool within the liner insert tube in a predefined direction (e.g., the liner insert tube may be configured to steer a tool toward the centerline of the elongate medical device and / or may be oriented in the opposite direction outward from the centerline of the elongate medical device). In any of the liner insert tubes described herein, the distal end of the liner insert tube may have an atraumatic and / or soft distal end 1142 configured to extend distally beyond the working channel (shown in FIGS. 11J-11L). 11F-11I, the lumen 1110 can extend substantially axially within the liner insert tube 1104, but can be curved or angled, for example, radially inward (e.g., at a 30°-60° angle, such as a 45° angle) just proximal to the soft distal end 1142 to direct the tool 1177 in a desired direction, for example, toward the center of the elongated medical device. In some instances, the liner insert tube 1104 can be steerable (e.g., by a pull wire or other steering mechanism) to allow for further manipulation or orientation of a working tool passed through the liner insert tube.

[0154]

[0197] The outer working channel of the working channel sleeve device may include one or more cuffs (e.g., elastic cuffs) or sections that may be configured to keep the outer working channel collapsed against the elongate medical device when a tool or liner insert tube is not inserted into the outer working channel.

[0155]

[0198] 11H-11L show a liner insert tube 1104 having a lumen 1110 into which a tool 1177 may be inserted proximally such that the tool 1177 extends distally from the elongated medical device 1103 at the distal end region after passing through the outer working channel 1181. The "flat" or unexpanded outer working channel 1181' is radially offset from the first outer working channel into which the liner insert tube is inserted. FIGS. 11H-11L also show the liner insert tube 1104 including wings 1115 that may maintain the orientation of the device within the outer and expandable working channel 1181. The tool 1177 is shown extending through the example liner insert tube shown in FIGS. 11D-11E.

[0156]

[0199] As noted above, in some examples, the tubes and / or any of the external channels formed on or as part of the tubes may be formed of knitted, woven, or braided materials. In some examples, knit fibers may be used to form the tubes and channel(s). For example, FIG. 12A shows an example of a knit material forming the tubes and working channels described herein. FIG. 12A is a close-up view of knit fibers 1255 forming a knit sleeve (tube) containing four external channels. The knit pattern includes cross-connected rows of knit filament bundles. The precise knit pattern may be selected to optimize expansion and other properties.

[0157]

[0200] For example, FIG. 12B shows a portion of a template pattern for a knitted working channel sleeve 1200 that includes a knitted inner tube that is knit with an outer channel at the same time. In FIG. 12B, the front of the knitted working channel sleeve is shown flattened (the sleeve may expand to open up to form a tube); the rear of the flattened tube portion is not visible. In this example, the lower region 1203 shows the end of the knitted working channel sleeve before the outer working channels 1220, 1220' begin; this region forms the inner tube of the working channel sleeve. Two outer working channels 1220, 1220' are shown on this side of the (flattened) working channel sleeve; these outer working channels are knit together and integrated with the inner tube body. Each knitted outer working channel 1220, 1220' includes a proximal opening 1232, 1232' at the end of the knitted working channel.

[0158]

[0201] A template pattern, including the stitch pattern shown in FIG. 12B, may be generated and / or used by a knitting machine, such as a flat (e.g., “flatbed”) knitting machine. In the example shown in FIG. 12B, the knit forming the outer working channel 1220, 1220′ may have a different pattern compared to the pattern of the inner tube portion 1203, 1228. For example, the knit pattern for the working channel may be more elastic than the knit pattern for the working channel. In some examples, the knit pattern for the working channel may have larger pores or a higher porosity than that of the knit pattern forming for the inner tube. In some examples, the fiber(s) forming the knit pattern for the outer working channel may be different from the fiber(s) forming the knit pattern for the inner tube portion. For example, the fiber(s) forming the inner tube 1203 may be formed of a hybrid elastic and low friction material such as a hybrid polytetrafluoroethylene (e.g., ePTFE) / spandex material, while the fiber(s) forming the outer channel may be exclusively low friction material (e.g., polytetrafluoroethylene such as ePTFE) or exclusively elastic material (e.g., spandex).

[0159]

[0202] As noted above, any of these working channel sleeve devices may be formed by weft knitting or warp knitting, including, but not limited to, tricot, Milanese knit, raschel knit, and stitch bonding. Any suitable size filament(s) may be used. For example, in some instances, the filament(s) (e.g., one or more fibers) forming the outer working channel(s) may be about 100 denier to 6000 denier for the outer wrap. The fiber(s) for the inner elastic core may be 400 to 6000 denier for the inner wrap.

[0160]

[0203] In some instances, exterior channels using this type of knitting machine (e.g., flat bed knitting machines) may have the advantage of being made completely in one piece with no post-knit assembly or post-stitching required. Knit constructions also lend themselves to creating a fabric that is more stretchy than woven constructions.

[0161]

[0204] In some instances, a higher gauge knitter would be advantageous, as the knit density can be made tighter and smoother, reducing sliding friction and making the fabric more puncture resistant. In FIG. 12A, the knit was formed using between 1 and 4 filament ends with fibers of about 10-200 denier (thickness). The knitter gauge may be between about 10 / 14 and 16 / 18. In the example shown in FIG. 12A, the fibers used for knitting may be, for example, polypropylene, PTFE, UHMWPE (Ultra High Molecular Weight Polyethylene, otherwise known as Spectra or Dyneema), silicone, polyurethane, etc. As explained above, the fibers may be hybrid elastic / lubricious (e.g., an elastic core wrapped with a lubricious material).

[0162]

[0205] Alternatively or additionally, a woven material may be used to form the outer working channel.

[0163]

[0206] In use, an external working channel device (e.g., a tube having one or more external working channels) may be installed over an elongated medical device (e.g., a hardenable device). The main tube lumen of the external working channel device 100 may be expanded sufficiently against the elastic force of the main tube lumen to receive the elongated medical device 200. The assembly including the elongated medical device and the external working channel(s) may then be inserted into the body (e.g., a body lumen, a body vessel, etc.) through a natural or artificial orifice and advanced according to the needs of the procedure to be performed. Once the distal end of the assembly is positioned at a desired location within the body, the working channel of the external working channel device 100 may be selected to directly receive a liner insert tube or tool within the working channel. The tool or liner insert tube may be advanced through the working channel while expanding the working channel. In instances where the elongated medical device is hardenable, the liner insert tube or tool may be inserted after the elongated medical device is hardened to retain the shape of the external working channel and define a path through which the liner insert tube or tool may be passed. The liner insert tube or the distal end of the tool may be advanced to the desired location and the procedure may continue through movement of the tool distal end.

[0164]

[0207] For example, FIG. 13 illustrates a method of positioning a tool within a body. In this example, the method may include inserting 1301 an elongate medical device into the body, where the elongate medical device body includes a tube that forms one or more external working channels. In some examples, the tube is attached to slide or move slightly relative to the outer surface of the elongate medical device. In examples where the elongate medical device is configured as a stiffening member, the stiffening member may be initially in a flexible configuration. The elongate distal end of the elongate medical device may be positioned 1303 at or near the target area of ​​the body to be treated. A liner insert tube and / or a tool may be inserted into the expandable working channel 1305 such that the outer working channel expands to accommodate the liner insert tube. In some examples, the liner insert tube may engage the distal and / or proximal ends of the tube and / or elongate medical device. A working tool may be inserted 1307 through the liner insert tube and out the distal end of the liner insert tube. A procedure may then be performed 1309 on the target area using the working tool. Additionally, curing may occur, for example, between steps 1303 and 1305 (ie, 1304).

[0165] example

[0208] 14A-14C show an example of a system 1400 including an elongated medical device 1403 (e.g., an overtube with an endoscope inserted in Figs. 14B and 14C) including a tube 1401 forming multiple external and expandable working channels. In Fig. 14A, the elongated medical device is shown with the tube mounted on the outer surface of the elongated medical device, and a liner insert tube 1404 extends through one of the expandable channels to exit the distal end. As mentioned, the elongated medical tool is configured as a rigidized overtube with a tube or sleeve 1401 integrated thereon that includes multiple external working channels. The proximal handle 1406 of the rigidized endoscope also includes an access entrance into each of the external working channels. These working channels may be marked (e.g., by a symbol, code, alphanumeric characters, etc.) so that the user knows where around the radius of the distal end the medical tool will exit the working channel.

[0166]

[0209] Figure 14B shows an example of both an exterior working channel 1405 on the stiffened tube shown in Figure 14A, and a tool 1407 inserted at the proximal end of the endoscope and exiting the distal end as shown in Figure 14B. In this example, an endoscope 1413 is also inserted and contained through the overtube, which may itself contain a working channel configured as a traditional interior working channel. In Figure 14A, a second medical tool 1407' is inserted through this interior (endoscope) working channel as shown.

[0167]

[0210] 14C shows an example of a medical tool 1407'' inserted through the liner insert tube 1404, which is itself inserted through the expandable outer working channel 1405. A blunt-ended deflector 1434 on the liner insert tube 1404 is shown deflecting the tool radially inward relative to the overtube and endoscope.

[0168]

[0211] Any of the devices described herein may be used with a robotic system, including a robotic endoscope system. Figures 15A and 15B show the operation of a system that may include a pair of nesting devices including an inner endoscope 1545 ("child") and an outer overtube ("mother") onto which an inner tube 1547 including four outer working channels 1504 may be mounted. Tubes, such as the braided, woven, and / or knitted tubes described above, that form the outer working channels may be kept in a collapsed configuration when navigating the device through a body lumen. Once at or near the target area, the outer working channels may be expanded or allowed to expand as shown in Figure 15B. In this example, Figure 15A shows the device with the outer working channel 1504 in the collapsed configuration.

[0169]

[0212] 15C shows an example of the distal end region of an endoscope and overtube with an external working channel 1504 attached to the outside of the overtube as part of a sleeve or tube. In this example, three tools 1507 are shown extended and may manipulate tissue as described herein.

[0170]

[0213] 16A-16D show another example of a system 1600 including an elongated outer medical device 1646 having multiple outer working channels 1644, 1644′, 1644″ formed thereon as part of a tube or sleeve 1603 (e.g., working channel sleeve). An inner medical device 1645 (e.g., an endoscope) is shown inserted through the outer medical device. The tube or sleeve 1603 is distally coupled to a distal end region of the medical device 1646 and a proximal end is coupled to a proximal end region of the medical device including an introducer region 1616 that provides access into each of the collapsed or partially collapsed outer working channels (shown color coded in this example). In an example including an endoscope 1645 that may visualize the distal end region of the device, the endoscope 1645 may detect when a tool or liner insert tube 1604 exits by correlating which color and / or markings 1688 indicate where a tool 1607 has been inserted or introduced into the working channel. Figure 16C shows another example of the same system as in Figures 16A-16B, but with a second tool 1607' inserted into a second channel of the elongated tube. Figure 16D shows a close-up view of the distal end region of the robotic system including an elongated outer medical device 1646 (configured as a mother or overtube), an elongated inner medical device 1645 (configured as a child and shown as an endoscope), and a tool 1607 configured as a suction tube. In some examples, a liner insert tool (not shown) may be used.

[0171]

[0214] FIG. 17 illustrates the use of the expandable outer channel 1745 described above on a rigid overtube. In this example, a tool 1707 is inserted into the outer channel 1745, which is colored orange at the proximal end, and exits the outer channel at a distal end that is similarly colored (e.g., orange) for identification. For example, FIG. 18 is an example showing a view of the color-coded distal tip from the perspective of the endoscope's camera, showing four color-coded regions 1888, 1888', 1888'', 1888''' that indicate where the outer channel is located (and where the tool will exit) relative to the patient.

[0172]

[0215] As noted above, existing outer working channel devices are not particularly suitable for use with longer and more flexible elongated members (e.g., catheters, endoscopes, overtubes, etc.). Such systems may not address the problem of maintaining the flexibility of the flexible elongated members and / or the problem of bunching or wrinkling of the outer working channel device on the elongated flexible members. In particular, existing outer working channel devices, especially devices made of elastic materials, may lead to looping and "pocketing" or pouch formation of the outer working channel as tools are inserted through the working channel. Simply creating a channel does not inherently create the proper conditions for a long length tool to traverse a highly tortuous path. For example, FIGS. 19A-19C illustrate problems that may arise when inserting and / or passing a tool through an outer working channel, especially an outer working channel made of elastic materials such as silicone, latex, or spandex materials, which may result in the drag problems noted above.

[0173]

[0216] For example, FIG. 19A shows one example of an outer working channel apparatus 1904 applied over an elongate member 1902 shown diagrammatically in cross section. In FIG. 19A, a tool 1906 is inserted into a working channel 1905 formed in the outer working channel apparatus. As the tool 1906 moves forward 1910 (shown in FIG. 19B), the outer working channel apparatus may impede movement, resulting in pocket formation 1908, which may be particularly problematic when the working channel of the outer working channel apparatus is formed of an elastic material and / or if the underlying elongate member 1902 and applied outer working channel apparatus 1904 are bent or curved. Once the tool forms a pocket, application of further force will only serve to buckle the tool shaft while the tip is forced further into the material from which it will not advance.

[0174]

[0217] FIG. 19C illustrates the problem of increased drag due to working channel normal forces as a tool 1906 is inserted into and through the working channel 1905. As shown, even in cases where a tool 1906 is inserted without snagging, pocketing, or pouching (as shown in FIGS. 19A-19B), the outer working channel 1904 may be held against the tool along the length of the tool within the working channel as well as at the tip end of the tool, resulting in normal forces 1914 (again, applied at the tip as well as along the shaft length), both of which result in drag on the tool. This problem is particularly acute when the working channel is formed of an elastic material; further, the longer the channel and the higher the associated tortuosity, the greater the drag, which may make it significantly more difficult (or even impossible) to insert a tool through the working channel and may result in jamming or even buckling of the tool within the working channel.

[0175]

[0218] FIG. 19D shows an example of an outer working channel apparatus 1904 (e.g., a "working channel sleeve apparatus") applied over an elongate member (e.g., an overtube) where the endoscope is bent and the tool has caused a pocket or pouch to form in the working channel, preventing the tool from advancing further. In FIG. 19D, tool 1906' (covered in the outer working channel material) has been advanced through outer working channel 1905, forming a pouch 1934 within the outer working channel material. In this example, the outer working channel is knit formed of elastic filaments (e.g., spandex material). The knit in this example is vertical (e.g., not horizontal).

[0176]

[0219] In general, any of the outer working channel devices described herein may include one or more features configured to address these issues and provide further benefits and advantages. The outer working channel devices described herein may be particularly well suited for flexible and longer elongated members (e.g., endoscopes, catheters, etc.) and may prevent or reduce the issues discussed above, including the issues shown in FIGS. 19A-19D. For example, the outer working channel devices described herein may be configured to prevent reducing the flexibility of the elongated member to which the device is applied, and may be configured to prevent or reduce clumping or bunching, even when inserted through multiple regions of the body that apply radially inward forces. In general, these devices may include one or more features that reduce friction, normal forces, and capstan drag forces when inserting and manipulating tools within the outer working channel. The features described herein may be used individually or in combination to control friction between the working channel and a tool inserted through the working channel (e.g., to reduce normal forces when using the working channel) and / or between the elongate member and the core of the outer working channel device. Siding non-elastic filament

[0177]

[0220] Any of these apparatus (e.g., devices, systems, assemblies, etc.) or methods of using or making these apparatus described herein may include the use of one or more inelastic filaments. For example, one or more working channels and / or core regions may be formed with one or more filaments of inelastic material. These inelastic filaments may be configured to slide relative to one another; this sliding motion may allow the working channel to mechanically expand and / or contract without stretching the individual filaments. As described herein, one or more inelastic filaments may form holes or openings through the outer working channel that can change dimensions (get larger / smaller) when the assembly is flexed and / or when one or more tools are inserted into and / or through the outer working channel. As such, these filaments may be allowed to slide but may not stretch significantly. The filaments may slide or shear relative to one another to allow the working channels (and in some cases the core region) to expand and contract, e.g., providing a "mechanical stretch," thereby changing the overall shape of the assembly without deforming the filaments. This may be helpful as mechanical stretching may prevent snagging.

[0178]

[0221] Examples of suitable non-elastic materials may include "plastic" materials such as, but not limited to: PTFE, Polyester, UHMWPE, HDPE, Polypropylene, etc. (as opposed to Spandex / Elastane / Latex and Silicone, which may be considered "elastic" materials). For example, PET or HDPE may be used. The use of these plastic materials may allow for thermal, ultrasonic, and / or adhesive bonding. In some examples, suitable non-elastic materials may have a modulus of elasticity of 20,000 psi (e.g., 20,000 psi or more, 30,000 psi or more, 40,000 psi or more, 60,000 psi or more, 100,000 psi or more, 200,000 psi or more, 500,000 psi or more, 750,000 psi or more, etc.). Non-elastic materials that may be used may typically have a lower coefficient of friction (e.g., 0.6 or less, 0.55 or less, 0.5 or less, 0.45 or less, 0.4 or less, etc.) compared to more elastic materials. As explained above, the use of these non-elastic materials may prevent the tool from catching or snagging (e.g., "pooching"). In any of these methods, thermal, ultrasonic, welded, or adhesive bonding may be utilized in place of sewing.

[0179]

[0222] Any of the devices described herein may be configured to stretch anisotropically. In particular, any of the devices described herein may be configured to have higher stretch (e.g., mechanical stretch) axially, e.g., along the length of the device, rather than vertically, i.e., radially, particularly when using the inelastic filaments described herein. As such, these devices may have high axial stretch and low hoop stretch. This characteristic may allow the device to allow bending (e.g., flexibility) while limiting radial expansion (which may otherwise result in snagging or pouch formation).

[0180]

[0223] Any of the outer working channel devices described herein may include one or more hydrophilic (or hydrophobic) materials, particularly lubricious coatings, particularly on the interior of the working channel. This may be done through the use of coatings, liners, etc. For example, a hydrophilic coating may be used, including on the outer surface of the tool.

[0181]

[0224] In general, it may be particularly beneficial to use materials for forming the outer working channel assembly that have similar wet / dry behavior. For example, materials forming the working channel and / or core region may have similar wet / dry behavior, such that the percentage change in material behavior (e.g., expansion, friction, etc.) between wet and dry may have a maximum percentage change of 35% difference or less (e.g., 25% or less, 20% or less, 18% or less, 15% or less, 12% or less, 10% or less, 8% or less, 5% or less, etc.). Examples of materials with similar wet / dry behavior include, but are not limited to, PTFE. PTFE and many of the other inelastic materials described herein have essentially the same surface friction (for sliding) when wet as when dry. Furthermore, they do not expand or otherwise change dimensions significantly when wet compared to when dry. Materials having the same or comparable dry / wet properties may be particularly beneficial because the devices described herein may be used in both dry and wet environments (often simultaneously) when inserted into the body.

[0182]

[0225] In general, any of the working channel devices described herein may be configured to be attached to a medical device (e.g., a flexible, elongated member such as a catheter, endoscope, overtube, etc.) at distal and proximal end regions, but relatively unattached to a region of the outer body of the medical device between the proximal and distal end regions. This configuration may help prevent the device from restricting the ability of the underlying medical device to flex. However, this may make such devices easier to bunch, particularly when inserting or positioning the device in a body lumen in an area where radially inward pressure holds the outer working channel or prevents the outer working channel area from moving, which may result in clumping or bunching of the outer working channel against the elongated flexible member (e.g., endoscope, catheter, overtube, etc.).

[0183]

[0226] In any of the devices described herein, this possible clumping or bunching may be addressed by adjusting the friction between the core portion of the working channel and the endoscope. Any of these devices (e.g., devices, systems, assemblies, etc.) may control the coefficient of friction between the core portion of the working channel assembly and the outer surface of the medical device over which the core portion extends. For example, the coefficient of friction between the outer surface of the elongate flexible member and the inner surface of the core region may be between about 0.3 and 1 (e.g., between about 0.35 and 1, between about 0.4 and 1, between about 0.45 and 1, between about 0.5 and 1, between about 0.55 and 1, between about 0.6 and 1, etc.). Having a slightly larger coefficient of friction compared to the coefficient of friction between the interior of the working channel and the tool may prevent the working channel assembly from clumping on the medical device during use. Possible clumping or bunching may be similarly adjusted by localized attachment, discontinuous attachment, regular attachment, temporary attachment, bonding, or shear feature integration.

[0184]

[0227] In any of the devices described herein, the device may be configured to vary the stretch ("mechanical stretch") along the length of the device. For example, in any of these devices, the working channel device may vary its elasticity as it extends along the length of the medical device. In some instances, the working channel assembly (e.g., core region) may be more elastic (grip) at the distal and proximal ends than in the central region, which may allow the working channel assembly to be more flexible. Alternatively, in some instances, the device may be configured to increase the flexibility of the working channel along its length, such that the distal end region is more flexible than the more proximal region.

[0185]

[0228] As noted above, the angle of the filaments forming the working channel assembly (e.g., one or more working channels) may be positioned along the length of the working channel to reduce drag when one or more tools are inserted into the working channel. In some examples, the device may be configured such that one or more axial tensioning members may help prevent snagging / pouching. As described above with reference to FIGS. 19A-19C, one way in which the "pocketing" problem occurs is when an area of ​​loose textile gets stuck under the bottom of the liner tool. As the liner tool continues to advance, the textile that is stuck underneath acts as a tensioning member and begins to restrict tool travel because the textile cannot escape from underneath the tool. Any of the devices described herein may be configured such that the resulting textile (e.g., working channel area) is positioned on the bias of the filaments. For example, the filaments may be positioned in an approximately 45° interlaced pattern. This pattern may also or alternatively be angled above the liner tool to help the filaments forming the device not get stuck on the tool underneath. Additionally, axial tension members may be included as well as horizontal knits as described below.

[0186]

[0229] Alternatively or additionally, any of these devices may be configured such that the filament is biased on the blade to prevent / reduce snagging of the tool on the filament that forms the working channel(s).

[0187]

[0230] In general, the devices described herein may include multiple holes or openings through the working channel portion of the device. The size of the holes may be optimized. In general, if the holes are too large, the tool may get stuck in the holes; if the holes are too small, the working channel may not work effectively because the resulting material may not have a tight enough sliding distance.

[0188]

[0231] Any of these devices may be formed of knitted materials as described and shown above. In some cases, the knit may be a horizontal knit as shown in FIGS. 20A and 20B. The direction of the knit may be horizontally woven. As mentioned, the use of a horizontal knit, especially when using inelastic filaments, may help provide a desirable anisotropic stretch profile having a lower hoop stretch than the axial stretch. The anisotropic stretch profile may prevent pouching ("pooching"), pocketing, snagging, snagging, and the like, and may reduce drag. FIG. 20A shows an outer working channel device 2000 formed by a horizontal knit 2034 to form four outer working channels 2004 over a core region that may be attached proximally and distally on an elongated flexible member (e.g., a catheter, etc.). In this example, the course direction of the knit is horizontal, e.g., in a plane perpendicular to the long axis of the elongated flexible member. The examples shown in Figures 20A and 20B are rib knots as well; the knit may be formed in the opposite direction on a walewise basis. For example, Figure 20B shows that a portion of the length of the tube is knit horizontally along its length (e.g., on a machine) such that it is ≈600 wales by ≈100 courses. Previous tubes were knitted with ≈100 wales by ≈600 courses. The working (tool) channel may then pass along the technical back of the fabric in the direction in which the fabric was knit along the courses. The tool channel slides easily in this direction. The knitting may be flat knit or lap. In any of these examples, the knitting may be performed such that the working channel, including the core region, is produced as a single tubular knit.

[0189]

[0232] Figures 20C and 20D show an example of an outer working channel device similar to the device shown in Figures 20A-20B, where the working channels (in this example there are four) and core region are both formed (in this case as a single knit body) by a woven material formed as a horizontal knit using inelastic (PTFE) fibers. In Figures 20C-20D, three of the outer working channels have been expanded by inserting a tubular form 2064 to show the outer working channels fully expanded. The horizontal knit also forms the core region 2030 in this example, which extends over an elongated member shown as an overtube 2077 in Figures 20C and 20D.

[0190]

[0233] As will be understood by those skilled in the art, the knit has two faces - a technical face and a technical back. In some instances, the device may be configured to orient the knit (technical face / back) such that the inner lumen of the working channel(s) is configured to face the technical face (or technical back). The technical front of the knit may have more ridges / protrusions that may result in slightly more friction. Therefore, in some instances, it may be beneficial to orient the technical front to the outside of the working channel and / or to the inner surface of the core region.

[0191]

[0234] FIG. 21 shows an example of a material (shown here as a knitted material) that is configured to include openings (e.g., holes) formed by a knitting process using a non-elastic knitted material. In this example, the holes may change shape during use, allowing individual strands of filament to slide or shear against one another, which may expand and contract the size of these openings. In FIG. 21, the holes have relative lengths of about 1.4 mm (e.g., 1.487, 1.410, 1.413) and relative widths of about 0.55 mm (e.g., 0.575, 0.546, 0.576).

[0192]

[0235] Any of the devices described herein may include a braided structure as shown in FIGS. 22A-22B, which shows an outer working channel assembly formed as a multi-lumen braid. In FIG. 22A, the braid is shown formed over a first mandrel 2216, which retains the shape of the medical device to form a core region 2220 and a second mandrel 2218, forming an outer working channel pattern 2222. Although the braid pattern shown in FIGS. 22A-22B shows only one working channel, this configuration may be modified to include multiple outer working channels. In FIGS. 22A-22B, the filaments (e.g., yarns) that make up the outer working channels may come from a main core braid and then recombined with the core braid to allow for yarn migration and a cohesive structure.

[0193]

[0236] In general, the external working channel devices described herein may be formed as a unitary structure in which a core region applied over an elongate member (e.g., endoscope, overtube, catheter, etc.) may be integrally formed with one or more working channels. As such, the different regions may be inseparable. For example, a knitted, woven, and / or braided structure (as shown in FIG. 22A) may include both a core and working channel(s) that are formed together, e.g., sharing one or more filaments.

[0194]

[0237] The working channels described herein, particularly for braided deformations, may include one or more axial tension members, which may help prevent the material forming the braid from catching or snagging on an inserted tool. This is shown in FIGS. 23A-23B, where an outer working channel 2304 extends over a flexible elongated inner member 2306. A liner tool 2307 is shown extending through the braid. As the liner tool moves forward, a tension member in the outer working channel may limit the movement. A braid-biased structure may help act as a ramp to prevent the textile from catching under the liner tool.

[0195]

[0238] 24A-24B show another example of a braid configured as a dual layer braid that may be used with any of the methods and devices described herein. In this example, the dual layer braid includes two braids, a core, and a second core that forms a working channel. The outer layer may be a compressed braid externally that is connected through some means (e.g., TPU reflow) along multiple axial lines to create a working channel 2428. In FIG. 24A, the working channel device 2404 is on top of the core 2430. In FIG. 24A-24B, there may be multiple braids, for example, each working channel is its own braid, which may be connected at the distal and proximal ends.

[0196]

[0239] Figure 25 shows another example of a device including multiple (e.g., four shown) channels formed of braids 2564 disposed on an elongated flexible member 2566, with the core region either adjacent or not adjacent (as shown) to the elongated flexible member. In Figure 25, the working channel braided region is only connected to the device at the proximal and distal ends. An outer outer elastomeric outer layer may be included to cover (and in some cases seal off) the elongated inner working channel.

[0197]

[0240] 26A shows another example of a working channel device 2604 formed by stitching. The inner (core) layer may be stitched to the outer (external working channel) layer. The top layer may be sewn with stitches that are robust and small enough to maintain the outer working channel while avoiding snagging. In this example, the discrete layers are sewn or otherwise attached to the discrete layers, i.e., layers that existed as separate entities before the layers were co-bonded. In the example of a knitted structure, there are no clear separable layers.

[0198]

[0241] In some examples, the materials forming the core region and the outer working channel may be selected to allow for heat treatment (e.g., melting), as shown in FIG. 26B. In this example, the core 2630 material may be any suitable material or fabric with sufficient internal support to grip a medical device. The top layer may be thinner and / or more flexible, such as a wrinkle-resistant fabric. In some examples, these materials may be thermoplastic polyurethane materials.

[0199]

[0242] Fabric-based devices such as those shown in Figures 26A-26B may be particularly receptive to coatings (e.g., with hydrophobic materials that are made lubricious). Generally, different fabrics may be used for the core and for the working channels. In some instances, these materials may have different elasticities (e.g., a more elastic material for the core region and a less elastic material for the channels); alternatively, the device may include a less elastic material for the core and a more elastic material for the channels.

[0200]

[0243] In general, as shown in these figures, any of these devices (including knitted, woven, braided, etc.) may include different pore sizes for the core region versus the working channel (e.g., larger pores for the core / smaller pores for the elastic, smaller pores for the core / larger pores for the elastic).

[0201]

[0244] Any of the devices described herein may be adapted to include a narrowed or shaped distal tip region that includes one or more guides or ramps, including a region that is narrowed relative to a more proximal region, to help guide direction out of the distal end of the working channel. For example, the distal tip of the device may include a narrowing at the distal end to help guide direction out of the distal end. Any of these devices may include a deflector at the distal end (e.g., to deflect away from or optionally toward the centerline). These devices may be configured to provide tactile feedback when one or more tools exit the working channel. tool

[0202]

[0245] Also described herein are tools configured for use with the working channels described herein. In particular, described herein are sets of tools (e.g., matched sets) that may travel together through any of the working channels described herein. Generally, one of these tools may be used to steer / guide the other tool. This is shown in Figures 27A-27D. These tools may be designed as a matched set for the working channel, such that the tools have optimized performance when used together and operate in a manner that would not achieve the results that would be achieved if a set of non-matched tools were utilized.

[0203]

[0246] In FIG. 27A, the device includes a deflector 2738 that deflects the tool radially outward and outward from the centerline of the elongate member 2766 (endoscope). The device also includes a working channel 2728 that couples to a core region 2730 carried on the elongate member. A pair of alignment tools 2754, 2750 extend from the distal end of the working channel. In this example, the tool includes a steerable insert liner tool 2754 having a steerable distal end. A second tool in this example is a grasper tool 2750 that may pass through a lumen in the steerable insert liner. FIG. 27B shows a view of the entire assembly of FIG. 27A including the proximal and distal ends. The liner tool 2754 includes a handle 2741 having one or more controls for controlling steering of the liner tool. The proximal end of the grasper tool 2750 passes through the handle and the tool set is inserted through the working channel 2728 from the working channel interface 2716 at the proximal end of the flexible elongate member 2769. In this example, the proximal elongate member is configured as a rigidized endoscope that also includes a flush port / line 2739 and a pressure port / line 2737 for stiffening the device. Figures 27C and 27D show a close-up view of the distal end of the assembly 2740, illustrating the rotational steering of the steerable liner tool 2754 extending from the distal end of the elongate member 2766. The grasper tool 2750 extends from the lumen of the liner tool 2754 and is rotatable 2755 relative to the elongate flexible member (e.g., the endoscope).

[0204]

[0247] 28A-28C show an example of a handle 2841 for a liner tube tool 2854 that may mate with or steer a second tool (e.g., grasper) 2850. The handle includes one or more controls 2846 that steer the deflection and position of the liner and thus the second tool. A second variation of the handle is shown in FIGS. 28B-28C and includes multiple controls 2846, 2846' (e.g., for steering left / right), 2847 (e.g., for locking / unlocking the second tool within the first tool).

[0205]

[0248] The tools described herein may be one-way, two-way, or movable in more than two directions (e.g., multi-orientation use). The nature of the tool liner having an expanding working channel may allow for torquing the tool liner or inner tool by torquing the handle at any angle. To allow for easier use, the controls may be designed to be accessible from both sides. Any of these devices may include markers (e.g., depth markers, etc.) on the shaft for the liner tool. For example, device marker bands may be included as part of the tool liner shaft to indicate various positions (the tip of the distal end of the working channel, optimal use position, etc.). The tool liner may generally be torquable. Generally, the tool liner may be torquable for tool positioning. Any of the tools described herein may include a shape memory / superelastic material such as Nitinol or other wireform. This material may allow for traction without the need for a working channel that allows another tool to be threaded through. Any of these devices may include a concentric tube continuum / active cannula control. Rather than being articulated, the device may be controlled by multiple concentric cubes of varying curvature and stiffness that generate the positioning.

[0206]

[0249] Other tools may include perfusion tools (FIGS. 29A-29C) and irrigation tools (FIGS. 30A-30E). In FIG. 29A, suction catheter 2971 includes an elongate body having a distal (tip) region 2973 and a proximal connector 2977 end. Tip 2973 may be configured as a radial suction tip (FIG. 29B) with a capped distal end 2977 having multiple side openings 2975 for suction. FIG. 29C shows distal opening 2977′ and distal tip 2973′ with side openings. Perfusion device 3074 (FIG. 30A) may include an elongate body having a distal tip region 3073 and a proximal connector 3077. 30B-30E show different variations of distal tip 3083' that may be used, including a radial spray opening 3085 (FIG. 30B) and a closed distal tip 3087, a distal shower opening 3085' (FIG. 30C), a 45° or 90° spray tip 3085'' with angled distal spray openings, or a direct spray tip 3085'' with a single distal opening (FIG. 30E). Other tips and other tools may be used.

[0207] Robotic Device

[0250] As noted above, the outer working channel device described herein may be configured for use as part of a robotic system or with a robotic device. In some examples, the outer working channel device may be mounted (including removably mounted) onto a robotically controlled outer tubular member, such as a robotically controlled overtube and / or endoscope assembly. FIG. 16 shows an exemplary device 3100 including an outer working channel 3101 (according to any of the examples described herein) extending over an overtube 3112; the system may optionally include an inner endoscope 3110. The overtube and inner endoscope may be robotically controlled or manipulated (e.g., steered, moved, rotated, etc., including stiffening, in some examples) separately or collectively. As shown in FIG. 31, the outer overtube 3100 and inner endoscope 3110 may terminate together in a common structure, such as a cassette 3157. The outer overtube 3100 may be movable relative to the endoscope 3110 by rotation of a driver mounted on the cassette 3157. The system may include actuators 3171a, 3171b that may be connected to cables 3163a, 3163b, respectively, to steer (e.g., bend or deflect) the tip of endoscope 3110 (and / or outer overtube 3112). Other steering mechanisms (e.g., pneumatic, hydraulic, shape memory alloy, EAP (electro-active polymer), or motor) are also possible. Cassette 3157 may further include bellows 3103a, 3103b that may be connected to pressure gaps in endoscope 3110 and overtube 3112, respectively, to force fluid through pressure line 3105z upon deformation of the endoscope and / or overtube configured to stiffen when pressure is applied. As shown in this example, cassette 3157 may include eccentric cams 3174a, 3174b to control bellows 3103a, 3103b. Alternatively, one or more linear actuators may be configured to actuate the bellows.As another alternative, the device can be cured and uncured through one or more pumps or pressure sources (eg, via pressure line 3105z).

[0208]

[0251] The working channel may be configured to allow for the use of one or more outer working channels during operation of the device. Insertion / removal into and out of the outer working channels may be coordinated by a robotic system.

[0209]

[0252] It should be appreciated that all combinations of the above concepts, and further concepts discussed in more detail below (provided such concepts are not mutually inconsistent), are contemplated as being part of the inventive subject matter disclosed herein and may be used to achieve the benefits described herein.

[0210]

[0253] The process parameters and sequences of steps described and / or illustrated herein are given by way of example only and may be varied as desired. For example, although the steps illustrated and / or described herein may be shown or discussed in a particular order, these steps do not necessarily have to be performed in the order shown or discussed. The various example methods described and / or illustrated herein may omit one or more of the steps described or illustrated herein or include additional steps in addition to those disclosed.

[0211]

[0254] When a feature or element is referred to herein as "on" another feature or element, it can be directly on the other feature or element, or there may be intervening features and / or elements present. In contrast, when a feature or element is referred to as "directly on" another feature or element, there are no intervening features or elements present. When a feature or element is referred to as "connected," "attached," or "coupled" to another feature or element, it will be understood that it can be directly connected, attached, or coupled to the other feature or element, and that intervening features or elements are also present. In contrast, when a feature or element is referred to as "directly connected," "directly attached," or "directly coupled" to another feature or element, there are no intervening features or elements present. Although described or illustrated with respect to one example, features or elements so described or illustrated may apply to other examples. It will also be recognized by those skilled in the art that a reference to a structure or feature being disposed "adjacent" to another feature may have portions that overlap or underlie the adjacent feature.

[0212]

[0255] The terms used herein are merely for the purpose of describing particular embodiments and are not intended to limit the present invention. For example, as used herein, the singular forms "a", "an" and "the" are intended to include the plural unless the context clearly dictates otherwise. It will be further understood that the terms "comprises" and / or "comprising", as used herein, specify the presence of stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items and may be abbreviated as " / ".

[0213]

[0256] Spatially relative terms such as "under," "below," "lower," "over," "upper," and the like may be used herein for ease of description to describe the relationship of one element or feature to another element(s) or feature(s) shown in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation shown in the figures. For example, if the device in the figures is inverted, an element described as "under" or "beneath" the other element or feature would then be oriented "over" the other element or feature. Thus, the exemplary term "under" can encompass both an orientation of directly above and directly below. The device may be otherwise oriented (rotated 90 degrees or in other orientations) and the spatially relative descriptors used herein will be interpreted accordingly. Similarly, the terms "upwardly," "downwardly," "vertical," "horizontal," and the like are used herein for descriptive purposes only, unless specifically indicated otherwise.

[0214]

[0257] The terms "first" and "second" may be used herein to describe various features / elements (including steps), but these features / elements should not be limited by these terms unless the context dictates otherwise. These terms may be used to distinguish one feature / element from another. Thus, a first feature / element discussed below could be referred to as a second feature / element, and similarly, a second feature / element discussed below could be referred to as a first feature / element without departing from the teachings of the present invention.

[0215]

[0258] Throughout this specification and the appended claims, unless the context requires otherwise, the words "comprise" and variations such as "comprises" and "comprising" refer to various components that may be used in conjunction together in methods and articles (e.g., devices and method-containing compositions and apparatuses). For example, it will be understood that the term "comprising" implies the inclusion of any stated element or step, but not the exclusion of any other elements or steps.

[0216]

[0259] In general, any of the apparatus and methods described herein should be understood to be inclusive, although all or a subset of the components and / or steps may alternatively be exclusive and may be expressed as "consisting of" or alternatively "consisting essentially of" various components, steps, subcomponents, or substeps.

[0217]

[0260] As used in the specification and claims, including as used in the examples, and unless expressly specified otherwise, all numbers may be read as if they are prefaced with the word "about" or "approximately", even if the term does not explicitly appear. The phrase "about" or "approximately" may be used when describing a magnitude and / or location to indicate that the described value and / or location is within an expected reasonable range of values ​​and / or locations. For example, a numerical value may have a value that is + / -0.1% of the stated value (or range of values), + / -1% of the stated value (or range of values), + / -2% of the stated value (or range of values), + / -5% of the stated value (or range of values), + / -10% of the stated value (or range of values), etc. Any numerical value given herein should be understood to include about or approximately the value, unless the context dictates otherwise. For example, if the value "10" is disclosed, then "about 10" is also disclosed. Any numerical ranges recited herein are intended to include all subranges subsumed in the numerical range. When a value is disclosed, it is also understood that "less than or equal to the value," "greater than or equal to the value," and possible ranges between the values ​​are also disclosed, as would be understood by one of ordinary skill in the art. For example, if a value "X" is disclosed, "less than or equal to X" and "greater than or equal to X" (e.g., when X is a number) are also disclosed. It is also understood that data are provided throughout the application in a number of different formats, and that this data indicates endpoints and starting points, and ranges for any combination of the data points. For example, if a specific data point "10" and a specific data point "15" are disclosed, it is understood that greater than, greater than, less than, less than, and equal to 10, and greater than, greater than, less than, less than, and equal to 15, and between 10 and 15 are also possible. It is also understood that each unit between two specific units is also disclosed.For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0218]

[0261] Although various illustrative embodiments are described above, any of numerous modifications may be made to the various embodiments without departing from the scope of the present invention as described by the claims. For example, the order in which the various method steps described are performed may often be changed in alternative embodiments, and in other alternative embodiments, one or more method steps may be skipped altogether. Optional features of the various device and system embodiments may be included in some embodiments and not in other embodiments. Thus, the above description is provided primarily for illustrative purposes and should not be construed as limiting the scope of the present invention, as the scope of the present invention is set forth in the claims.

[0219]

[0262] The examples and illustrations contained herein show, by way of illustration and not by way of limitation, specific embodiments in which the subject matter may be practiced. As stated, other embodiments may be utilized and derived therefrom, whereby structural and logical substitutions and changes may be made without departing from the scope of the present disclosure. Such embodiments of the subject matter of the present invention may be referred to herein, individually or collectively, simply by the term "invention" for convenience and without any intention of intentionally limiting the scope of the present application to any single invention or inventive concept when more than one is actually disclosed. Thus, although specific embodiments have been shown and described herein, any arrangement presumed to achieve the same purpose may be substituted for the specific embodiments shown. The present disclosure is intended to cover any and all adaptations and variations of the various embodiments. Combinations of the above embodiments, as well as other embodiments not specifically described herein, will be apparent to those skilled in the art upon reviewing the above description.

Claims

1. 1. An outer working channel assembly comprising: a core region configured to extend over an outer surface of the elongated flexible member; an outer working channel extending along an outer surface of the core region; an outer working channel assembly, wherein the outer working channel is formed of one or more inelastic filaments configured to slide over one another to expand the outer working channel to accommodate a tool inserted through the outer working channel.

2. 1. An outer working channel assembly comprising: a core region configured to extend over an outer surface of the elongated flexible member; an outer working channel extending along an outer surface of the core region; an outer working channel assembly, wherein the outer working channel is formed with one or more inelastic filaments forming a plurality of hole openings, the one or more inelastic filaments being configured to slide over one another to expand the outer working channel and change the size of the hole openings of the plurality of hole openings to accommodate a tool inserted through the outer working channel.

3. 1. An outer working channel assembly comprising: an elongated flexible member; a core region extending over an outer surface of the elongated flexible member, the core region being coupled to a proximal end region of the elongated flexible member and a distal end region of the elongated flexible member; an outer working channel extending along an outer surface of the core region, the outer working channel being formed of one or more inelastic filaments configured to slide over one another to expand the outer working channel to accommodate a tool inserted through the outer working channel.

4. 4. The assembly of claim 1 or 3, wherein the outer working channel comprises a plurality of hole openings formed by the one or more inelastic filaments and configured to change dimensions when the one or more inelastic filaments slide over one another.

5. The assembly of claim 1 , wherein the external working channel is braided or knitted.

6. 4. The assembly of claim 1, wherein the one or more inelastic filaments comprise a plastic material having a modulus of elasticity greater than 50,000 psi.

7. 4. The assembly of claim 1, wherein the one or more inelastic filaments comprise one of polytetrafluoroethylene (PTFE), polyester, ultra high molecular weight polyethylene (UHMWPE), high density polyethylene (HDPE), and polypropylene.

8. The assembly of claim 1 , wherein the one or more inelastic filaments comprise a plastic material having a coefficient of friction of 0.5 or less.

9. The assembly of claim 1 , wherein the core region is formed of one or more filaments.

10. The assembly of claim 1 , wherein the core region is formed from at least a portion of the one or more filaments that form the outer working channel.

11. The assembly of claim 1 , further comprising a plurality of external working channels extending along the outer surface of the core region.

12. 4. The assembly of claim 1, wherein the outer working channel is configured to have an anisotropic stretch profile having a lower hoop stretch than an axial stretch.

13. The assembly of claim 1 or 2, further comprising the elongated flexible member.

14. 14. The assembly of claim 3 or 13, wherein the core region is bonded to the outer surface of the elongate flexible member at a distal end region of the elongate flexible member and at a proximal end region of the elongate flexible member, but is not fixed to the elongate flexible member between the distal end region and the proximal end region.

15. The assembly of claim 3 or 13, wherein the elongated flexible member comprises an endoscope or an overtube.

16. The assembly of claim 3 or 13, wherein the elongated flexible member comprises a curable device.

17. The assembly of claim 1 , wherein the core region and the outer working channel comprise multi-lumen blades.

18. The assembly of claim 1 , wherein the core region and the outer working channel comprise a horizontal knit.

19. 4. The assembly of claim 1, further comprising a matched pair of tools configured to be inserted together through the outer working channel, a first tool of the pair of tools comprising a steerable distal end configured to steer a second tool of the pair of distal tools as the first tool exits the outer working channel.

20. The assembly of claim 1 , further comprising a lubricious coating on the outer working channel.

21. 4. The assembly of claim 1, further comprising a deflector at a distal end of the outer working channel configured to deflect a tool extending from the distal end of the outer working channel radially outward from the distal end of the elongate flexible member.

22. 1. An outer working channel assembly comprising: an elongated flexible member; a core region extending over an outer surface of an elongated flexible member, said core region being coupled to the outer surface of the elongated flexible member at a distal end region of the elongated flexible member and at a proximal end region of the elongated flexible member, but not secured to the elongated flexible member between the distal end region and the proximal end region; an outer working channel extending along an outer surface of the core region, the outer working channel configured to accommodate a tool inserted therethrough; and an outer working channel assembly, further comprising: a coefficient of friction between the core region and the outer surface of the elongated flexible member that is between 0.3 and 1 to prevent clumping of the core region and the outer working channel when the assembly is operated.

23. 23. The assembly of claim 22, wherein the coefficient of friction is between 0.4 and 1.

24. The assembly of claim 22, wherein the outer working channel is formed from one or more inelastic filaments.

25. 25. The assembly of claim 24, wherein the outer working channel comprises a plurality of hole openings formed by the one or more inelastic filaments and configured to change dimensions when the one or more inelastic filaments slide over one another.

26. The assembly of claim 22 , wherein the external working channel is braided or woven.

27. 25. The assembly of claim 24, wherein the one or more inelastic filaments comprise a plastic material having a modulus of elasticity greater than 50,000 psi.

28. 25. The assembly of claim 24, wherein the one or more inelastic filaments comprise one of polytetrafluoroethylene (PTFE), polyester, ultra high molecular weight polyethylene (UHMWPE), high density polyethylene (HDPE), and polypropylene.

29. 25. The assembly of claim 24, wherein the one or more inelastic filaments comprise a plastic material having a coefficient of friction of 0.5 or less.

30. The assembly of claim 22 , wherein the core region is formed of one or more filaments.

31. 25. The assembly of claim 24, wherein the core region is formed from at least a portion of the one or more filaments that form the outer working channel.

32. The assembly of claim 22, further comprising a plurality of external working channels extending along the outer surface of the core region.

33. 23. The assembly of claim 22, wherein the outer working channel is configured to have an anisotropic stretch profile having a lower hoop stretch than an axial stretch.

34. The assembly of claim 22 , wherein the elongated flexible member comprises an endoscope or an overtube.

35. The assembly of claim 22 , wherein the elongated flexible member comprises a curable device.

36. The assembly of claim 22 , wherein the core region and the outer working channel comprise multi-lumen blades.

37. The assembly of claim 22 , wherein the core region and the outer working channel comprise a horizontal knit.

38. 23. The assembly of claim 22, further comprising a matched pair of tools configured to be inserted together through the outer working channel, a first tool of the pair of tools comprising a steerable distal end configured to steer a second tool of the pair of distal tools as the first tool exits the outer working channel.

39. 23. The assembly of claim 22, further comprising: the outer working channel including a lubricious coating.

40. 23. The assembly of claim 22, further comprising a deflector at a distal end of the outer working channel configured to deflect a tool extending from the distal end of the outer working channel radially outwardly from the distal end of the elongate flexible member.

41. 1. A system including an expandable external working channel, An elongated medical device; a core tube extending over an outer surface of the elongate medical device; and one or more expandable working channels formed along a length of the tube and configured to receive a medical tool inserted therethrough, the one or more expandable working channels being formed from one or more filaments, each of the one or more filaments comprising an inner elastic material and an outer lubricious material.

42. 42. The system of claim 41, wherein the tube is formed of a coiled filament comprising an elastic core surrounded by a lubricious material.

43. 42. The system of claim 41, wherein the lubricious material comprises polypropylene, polyethylene, or polytetrafluoroethylene.

44. 1. A method of positioning a tool within a body, comprising: inserting an elongate medical device into the body in a flexible configuration; inserting a liner insert tube into an expandable working channel of a tube extending over an exterior surface of the elongate medical device, whereby the expandable working channel expands to accommodate the liner insert tube; steering a distal end of the liner insert tube; and inserting a working tool through the liner insert tube and out a distal end of the liner insert tube, the working tool being manipulated to extend from the distal end of the liner insert tube.

45. 45. The method of claim 44, further comprising performing a medical procedure within the body with the working tool.

46. 45. The method of claim 44, further comprising locking the distal end of the liner insert tube at a distal end region of the elongate medical device.

47. 45. The method of claim 44, wherein the step of inserting the elongate medical device includes allowing at least a portion of the length of the tube to slide against the outer surface of the elongate medical device as the elongate medical device is navigated within the body.

48. 45. The method of claim 44, further comprising maintaining patency of the liner insert tube while the liner insert tube is inserted into the expandable working channel.

49. 45. The method of claim 44, further comprising the step of stiffening the elongate medical device.

50. 45. The method of claim 44, further comprising stiffening the elongate medical device prior to inserting the liner insert tube.

51. 45. The method of claim 44, further comprising using a deflector in a distal end region of the liner insert tube to deflect the working tool radially inward as the working tool is extended from the distal end of the liner insert tube.

52. 45. The method of claim 44, wherein the step of inserting the liner insert tube into the expandable working channel includes engaging one or more wings on the liner insert tube with the expandable working channel.

53. 45. The method of claim 44, wherein the step of inserting the liner insert tube includes sliding the liner insert tube against a lubricious outer surface of one or more filaments forming the expandable working channel of the knitted or woven tube.

54. 45. The method of claim 44, wherein the expandable working channel of the knitted or woven tube is formed from one or more inelastic filaments.

55. 45. The method of claim 44, wherein the expandable working channel of the knitted or woven tube is formed from one or more filaments comprising an inner elastic material and an outer lubricious material.

56. 45. The method of claim 44, wherein inserting the liner insert tube expands the expandable working channel from a collapsed configuration in which the expandable working channel fits snugly against the exterior surface of the elongate medical device.

57. 1. A system including an expandable external working channel, an elongate medical device having a flexible or selectively rigidible body; a knitted, woven, or braided tube extending over an exterior surface of the elongate medical device and formed of one or more inelastic filaments; and one or more knitted, woven or braided exterior and expandable working channels integrally formed along the length of the tube and configured to receive a medical tool inserted through the working channels, the knitted, woven or braided exterior and expandable working channels being formed from one or more inelastic filaments.

58. 1. A method of positioning a tool within a body, comprising: inserting an elongated flexible member into the body whereby an outer working channel is coupled to a core region extending over an outer surface of said elongated flexible member, said outer working channel being formed of one or more inelastic filaments configured to slide over one another; positioning a distal end of the elongated flexible member proximate a target area of ​​the body; and inserting a tool or liner insert tube into the outer working channel, whereby the outer working channel expands to accommodate the tool or liner insert tube by sliding the inelastic filaments relative to one another.

59. 59. The method of claim 58, further comprising the step of locking a distal end of the liner insert tube to the distal end of the elongate flexible member and / or the core region, wherein the liner insert tube maintains patency of a lumen extending therethrough.

60. 1. A method of positioning a tool within a body, comprising: inserting an elongate medical device comprising a rigidizable member into a body while said rigidizable member is in a flexible configuration, whereby a knitted, braided or woven tube extending over an outer surface of said elongate medical device can slide relative to said outer surface; positioning a distal end of the elongate medical device proximate a target area of ​​the body; curing the elongate medical device; inserting a liner insert tube into an expandable working channel of the tube, whereby the expandable working channel expands to accommodate the liner insert tube; and inserting a working tool through the liner insert tube and out a distal end of the liner insert tube.

Images