Methods and apparatuses for cholangioscopy

Abstract

Methods and apparatuses for using an endoscope with a rigidizing device having one or more lateral suction ports for securing to a wall of a lumen to perform a reduction. The one or more lateral suction ports may preferably be on a distal end region of the rigidizing device, and / or may be arranged as a plurality of suction ports that are radially arranged around the rigidizing device. The rigidizing device may be configured to transition between a rigid (e.g., less flexible) and a flexible (or less rigid) configuration.

Description

'METHODS AND APPARATUSES FOR CHOLANGIOSCOPYCLAIM OF PRIORITY

[0001] This patent application claims priority to U.S. provisional patent application no. 63 / 649,374, titled “METHODS AND APPARATUSES FOR CHOLANGIOSCOPY,” and filed on May 18, 2024, herein incorporated by reference in its entirety.INCORPORATION BY REFERENCE

[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

[0003] Cholangioscopy is a noninvasive endoscopic method used for both direct visual diagnostic evaluation and simultaneous therapeutic intervention of the bile ducts.Pancreatoscopy is the direct visual evaluation of the pancreatic ducts. For example, endoscopic retrograde cholangiopancreatography (ERCP) is an endoscopic procedure used to identify the presence of stones, tumors, or narrowing in the biliary and pancreatic ducts. After the endoscope is properly placed, a catheter may be advanced to inject a contrast agent through the ducts. ERCP may be used to treat problems of the bile and pancreatic ducts.Doctors also use ERCP to diagnose problems of the bile and pancreatic ducts if they expect to treat problems during the procedure. ERCP may be performed when the bile or pancreatic ducts are leaking or have become narrowed or blocked because of gallstones that form in the gallbladder and become stuck in the common bile duct.

[0004] However, currently available techniques and apparatuses for performing cholangioscopy (e.g., “cholangioscopes”) are technically difficult to perform, particularly given the relatively small diameters of the regions. Accordingly, there is an unmet clinical need for a device that permits easier and faster navigation within the bile ducts while providing a stable platform for operation.SUMMARY OF THE DISCLOSURE

[0005] Described herein are methods and apparatuses, including systems and devices, for performing cholangioscopy. These methods may include coordinating movement of a rigidizing overtube, a steerable redirector that fits through a lumen of the rigidizing overtube,and an endoscope (e.g., a small outer-diameter endoscope) that fits through the steerable redirector. Additional tools (manipulators, suction, etc.) may be used and passe through the endoscope. Optionally, these apparatuses may be used with a guidewire.

[0006] For example described herein are apparatuses (e.g., systems, devices, etc.) for performing any of these methods that may include: a rigidizing overtube having an elongate body comprising a plurality of layers surrounding a lumen, wherein the rigidizing overtube is configured to convert between a rigid configuration and a flexible configuration by the application of pressure to the plurality of layers, wherein the plurality of layers includes: a support layer a rigidizing layer and a compression layer; and a steerable redirector configured to insert through the lumen of the rigidizing overtube, the steerable redirector having an elongate body, a lumen extending through the elongate body, a steerable distal end region, and a distal redirector head distal to the steerable distal end region that is configured to deflect an elongate member that is extended through the lumen of the steerable redirector.

[0007] The apparatus may include an endoscope configured to pass through the lumen of the steerable redirector. For example, described herein are apparatuses comprising: a rigidizing overtube having an elongate body comprising a plurality of layers surrounding a lumen, the elongate body comprising a support layer, a rigidizing layer and a bladder layer, wherein the rigidizing overtube is configured to convert between a rigid configuration and a flexible configuration by an application of pressure to drive the bladder layer against the rigidizing layer; and a steerable redirector configured to insert through the lumen of the rigidizing overtube and extend distally from the rigidizing overtube, the steerable redirector having an elongate body, a lumen extending through the elongate body, a steerable distal end region, and a distal redirector head distal to the steerable distal end region having a lateral opening facing a first direction, wherein the distal redirector head is configured to deflect an elongate member that is extended through the lumen of the steerable redirector out of the lateral opening.

[0008] Any of these apparatuses may include a steerable distal end region that is configured to deflect in a plane that is parallel with the first direction. The steerable redirector may include a proximal handle having a control configured to deflect the steerable distal end region. The steerable redirector comprises a deflection wire configured to defect the steerable distal end region when tension is applied to the deflection wire.

[0009] The distal redirector head may comprise a distal ramp extending from a wall of the lumen opposite to the lateral opening to a distal end of the lateral opening. In some examples the steerable redirector is configured to extend at least 5 cm from the rigidizingovertube (e.g., at least 6 cm, at least 7 cm, at least 8 cm, at least 9 cm, at least 10 cm, at least 12 cm, at least 15 cm, etc.).

[0010] Any of these apparatuses may include an endoscope configured to pass through the lumen of the steerable redirector. The overtube, steerable redirector and endoscope may be configured to nest within each other as described herein, so that they may be readily manipulated and positioned by the user (e.g., doctor, nurse, technician, etc.). The inner surface of the overtube, the outer and / or inner surfaces of the steerable redirector and / or the outer surface of the endoscope may be lubricious, e.g., may be coated with a lubricious material and / or may include a lubricious coating. In some cases the rigidizing overtube may be configured to convert between a rigid configuration and a flexible configuration by an application of positive pressure. Any of the method and apparatuses described herein may include a rigidizing steerable redirector and / or a rigidizing endoscope.

[0011] The rigidizing layer may comprise a tubular layer having a plurality of lengths of filaments crossing over each other, which may be adjacent to a tubular bladder configured to be driven against the rigidizing layer when pressure is applied. The pressure may be positive or negative pressure.

[0012] For example, an apparatus (e.g., system) as described herein may include: a rigidizing overtube having an elongate body comprising a plurality of layers surrounding a lumen, the elongate body comprising a support layer, a rigidizing layer and a bladder layer, wherein the rigidizing overtube is configured to convert between a rigid configuration and a flexible configuration by an application of pressure to drive the bladder layer against the rigidizing layer; a steerable redirector configured to insert through the lumen of the rigidizing overtube, the steerable redirector having an elongate body, a lumen extending through the elongate body, a steerable distal end region, and a distal redirector head distal to the steerable distal end region that is configured to deflect an elongate member that is extended through the lumen of the steerable redirector; and an endoscope configured to extend though the steerable redirector and be deflected between 40-90 degrees relative to the rigidizing overtube when the steerable redirector is extended out of the rigidizing overtube.

[0013] Also described herein are methods, including methods of performing a cholangioscopy using any of these apparatuses. For example, a method may include: positioning a rigidizing overtube adjacent to a duct opening in a flexible configuration; rigidizing the rigidizing overtube by applying pressure within the rigidizing overtube to drive a bladder against a plurality of lengths of filaments; extending a steerable redirector distally out of the rigidizing overtube; steering the steerable redirector so that a lateral opening in a distal redirector head of the steerable redirector is facing the duct opening; extending anendoscope through the steerable redirector while maintaining the rigidizing overtube in a rigid configuration and while steering the steerable redirector to align an end region of the endoscope within the duct; and advancing the endoscope into the duct.

[0014] In any of these methods, positioning the rigidizing overtube may comprise advancing the rigidizing overtube over a guidewire or guide catheter.

[0015] The duct may comprise a bile duct.

[0016] In general, steering the steerable redirector may comprise deflecting the steerable redirector towards the duct. For example, steering the steerable redirector may comprise manipulating a handle control at a proximal end of the steerable redirector to adjust an angle between the distal redirector head and the duct. In any of these methods, steering the steerable redirector may comprise: rotating and / or advancing and retracting the steerable redirector.

[0017] Extending the endoscope through the steerable redirector while steering the steerable redirector to align an end region of the endoscope within the duct may comprise rotating the steerable redirector axially and / or advancing the steerable redirector distally. In some cases extending the endoscope through the steerable redirector while steering the steerable redirector to align an end region of the endoscope within the duct comprises deflecting adjusting an angle between the distal redirector head and the duct. Extending the endoscope through the steerable redirector may comprise deflecting the endoscope out of the lateral opening in the distal redirector head by deflecting a distal end of the endoscope against a deflection surface within a lumen of the distal redirector.

[0018] Any of these methods may include positioning a guidewire in the duct before extending the endoscope through the steerable redirector, wherein extending the endoscope through the steerable redirector comprises advancing the endoscope over the guidewire.

[0019] Also described herein are methods comprising: positioning a rigidizing overtube proximal to a duct opening in a flexible configuration; rigidizing the rigidizing overtube by applying pressure within the rigidizing overtube; extending a steerable redirector distally out of the rigidizing overtube; steering the steerable redirector so that a gap in a distal redirector head is transverse to the duct opening; extending an endoscope through the steerable deflector while maintaining the rigidizing overtube in the rigid configuration, and while steering the steerable redirector to align the endoscope within the duct; and advancing the endoscope into the duct.

[0020] Any of these methods may include steering the steerable redirector by manipulating a handle control at a proximal end of the steerable redirector to adjust the anglebetween the distal redirector head and the duct. In some cases steering the steerable redirector comprises: rotating and / or advancing and retracting the steerable redirector.

[0021] All of the methods and apparatuses described herein, in any combination, are herein contemplated and can be used to achieve the benefits as described herein.BRIEF DESCRIPTION OF THE DRAWINGS

[0022] A better understanding of the features and advantages of the methods and apparatuses described herein will be obtained by reference to the following detailed description that sets forth illustrative embodiments, and the accompanying drawings of which:

[0023] FIG. 1 shows a first example of a system including a rigidizing overtube, a steerable redirector, an endoscope and a manipulator tool.

[0024] FIGS. 2A-2B illustrate one example of a steerable redirector configured to fit through the rigidizing overtube. FIG. 2A shows a view of the steerable distal end region and FIG. 2B shows a view of a proximal handle region.

[0025] FIGS. 3A-3C illustrate one example of a proximal handle region of a steerable redirector such as the steerable redirector of FIGS. 2A-2B.

[0026] FIGS. 4A-4B illustrate one example of a distal end region of a steerable redirector.

[0027] FIGS. 5A-5B illustrate one example of a distal end region of a steerable redirector.

[0028] FIG. 6 is a side view of an example of a distal end region of a steerable redirector.

[0029] FIGS. 7A-7G illustrate an example of a method of operating an apparatus (e.g., system) as described herein for positioning an endoscope within a bile duct.

[0030] FIGS. 8A-8F illustrate an example of a method of operating an apparatus (e.g., system) as described herein for positioning an endoscope within a bile duct, using a guidewire.

[0031] FIG. 9A is a section through an elongate rigidizable device (e.g., rigidizing overtube) that may be rigidized by the application of negative pressure.

[0032] FIG. 9B is an enlarged view showing one example of the arrangement of layers within the elongate rigidizable device of FIG. 9A.

[0033] FIG. 10A is a section through an elongate rigidizable device (e.g., rigidizing overtube) that may be rigidized by the application of positive pressure.

[0034] FIG. 10B is an alternative sectional view showing one example of the arrangement of layers within the elongate rigidizing device of FIG. 10 A.

[0035] FIG. 11 A shows an example of a rigidizable device (e.g., rigidizing overtube) including a knit rigidizing layer, shown with the knit rigidizing layer exposed.

[0036] FIG. 11B shows an example of a rigidizable device (e.g., rigidizing overtube) such as the one shown in FIG. 11 A with the outer layer(s) covering the knit rigidizing layer.

[0037] FIG. 11C is an enlarged view of one example of a knit.

[0038] FIG. 11D shows a section view through an example of a knit over an inner tubular member.

[0039] FIG. 12A shows an example of a weft knit.

[0040] FIG. 12B shows an example of a warp knit.

[0041] FIG. 12C shows an example of a knit material formed of a single continuous filament.

[0042] FIG. 13 A is an example of a woven rigidizing layer formed of filament; this woven rigidizing layer may be used as part of a rigidizable device (e.g., rigidizing overtube) as described herein.

[0043] FIG. 13B is an example of a woven rigidizing material formed of monofilaments that are woven together; this woven rigidizing layer may be used as part of a rigidizable device (e.g., rigidizing overtube) as described herein.

[0044] FIG. 13C shows another example of a woven material.

[0045] FIGS. 14A and 14B show examples of braided material that may be used as (or as part of) a rigidizing layer of a rigidizable device (e.g., rigidizing overtube) as described herein. FIG. 14B shows a braided layer that is discontinuous.

[0046] FIG. 15 illustrates one example of a robotic system for performing any of the methods described herein.DETAILED DESCRIPTION

[0047] Apparatuses, including devices and systems, for positioning an endoscope in anatomical regions in which are traditionally difficult to access, are very narrow and / or extend at high angles (e.g., greater than 60 degrees, greater than 70 degrees, greater than 80 degrees, greater than 90 degrees, greater than 100 degrees, greater than 110 degrees, etc.). In particular, these methods and apparatuses may include a rigidizing and stabilizing overtube and a steerable redirector that is configured to operate in combination with the rigidizing overtube to direct an endoscope and / or a tool in very precise manner. The use of the rigidizing overtube in combination with the steerable redirector may provide a much greater degree of maneuverability and control that has been previously possible.

[0048] These methods and apparatuses may be used for any appropriate procedure within a body, including, but not limited to, cholangioscopy. The anatomy of the bile ducts is knownto be particularly difficult to access and / or treat. In some cases the methods and apparatuses described herein may be particularly well suited for performing cholangioscopy.

[0049] For example, FIG. 1 shows one example of an apparatus as described herein. In some cases this apparatus may be configured as a system for performing cholangioscopy. In general these systems may include a rigi dizing overtube 1001, a steerable redirector 1003 and an endoscope 1005. Optionally, one or more additional tools 1007, such as graspers, aspiration tubes, fluid application tubes, probes, needles, electrocautery tools, or the like may be included. In general, these components (e.g., the rigi dizing overtube, steerable redirector, endoscope, and / or tools) are configured to be nested within each other and may be manually or robotically controller. In some cases the steerable redirector may be configured to slide through the lumen of the rigidizing overtube and may extend distally beyond the rigidizing overtube by at least 5 cm or more (e.g., 10 cm, 15 cm, 20 cm, 30 cm, 40 cm, 50 cm, 60 cm, 100 cm, etc. or more). The endoscope may be configured to fit through and extend from out of a lumen within the steerable redirector. Thus the rigidizing overtube, steerable redirector and endoscope may be configured to operate as a triaxial apparatus. In some cases the steerable redirector and / or the endoscope may also be rigidizing. Any of these apparatuses may be used with and may include as part of the apparatus (e.g., system) one or more guidewires.

[0050] In FIG. 1, the rigidizing overtube includes an elongate rigidizing body formed of a plurality of different layers; pressure may be applied (either positive and / or negative pressure) to set the flexibly / rigidity of the elongate body. For example, that elongate body of the rigidizing apparatus may include a support layer (e.g., a cylindrical / tubular support layer that may be reinforced, e.g., by a wire coil or otherwise), a rigidizing layer (which may be formed of multiple lengths of overlapping strands, fibers, filaments, etc., e.g., a knitted, woven, braided, etc. cylindrical layer), and a compression layer (e.g., a bladder layer) that may be compressed by the application of positive and / or negative pressure against the rigidizing layer. In the more flexible configurations of the elongate body, the multiple lengths of strands of the rigidizing layer may slide against each other freely or with little friction. The compression layer may be driven against the lengths of strands of the rigidizing layer to restrict their relative movement (e.g., sliding) which results in an increase stiffness. In general, the greater the pressure applied by the compression layer, which may be function of the applied pressure, the greater the stiffness (e.g., the lower the flexibility) of the rigidizing layer, and therefore the elongate body. Examples of alternative configuration for rigidizing and controlling the stiffness / rigidity are provided below, e.g., in reference to FIGS. 9A-9B, 10A-10B, 11A-11D, 12A-12C, 13A-13C and 14A-14B.

[0051] In FIG. 1, the rigi dizing overtube is shown with distal opening into the lumen of the rigidizing overtube. In some cases the rigidizing overtube may be integrated with the steerable redirector. For example, the rigidizing overtube may have a lateral opening, along one side of the rigidizing overtube, and may include a deflecting distal tip region similar to the distal tip region of the steerable redirector, described in reference to FIGS. 4A-4B, 5A-5B and 6, below. The distal end of the rigidizing overtube may be steerable. In some cases it may be beneficial to use a separate and separately controllable steerable redirector.

[0052] The apparatuses described herein may include one or more endoscopes and / or may be configured for use with one or more endoscopes. Any appropriate scope (e.g., endoscope) may be used, particularly those having a smaller outer diameter (e.g., 10 mm or less, than 9 mm or less, 8 mm or less, 7 mm or less, 6 mm or less, 5 mm or less, 4 mm or less, etc.). In some cases the endoscope may be referred to as a slim endoscope, extraslim, XP, etc.). In general, the steerable redirector is configured to fit through a lumen of the rigidizing overtube, and an endoscope (e.g., a small outer-diameter endoscope) is configured to fit through the steerable redirector lumen and be defected laterally relative to the long axis of the rigidizing overtube. The endoscope may include one or more optical sensors (e.g., cameras), lights, etc. The endoscope may include a working channel for delivery of a tool 1007 and / or for passing fluid (e.g., by applying fluid and / or removing fluid, e.g., by suction). The endoscope may be part of the apparatus, or the apparatus may be configured for use with an endoscope, e.g., a commercially available endoscope that may be separately provided.

[0053] The example apparatus shown in FIG. 1 also shows an example of a tool 1007 that may be used with and / or may be part of an apparatus as described herein. In this example the tool is configured as grasper having a flexible elongate body terminating at the distal end in a pair of grasping jaws 1017. The proximal end may include a control (e.g., button, switch, lever, etc.) that may be actuated to close and / or open the distal jaws. The tool may fit through the working channel (e.g., lumen) of the endoscope 1005.

[0054] FIGS. 2A-2B, 3A-3C, 4A-4B, 5A-5B and 6 illustrate examples of steerable redirectors as described herein. FIG. 2A shows a distal end region of a steerable redirector 2003 including a distal redirector head that is configured to reliably deflect an elongate member that is extended through the lumen of the steerable redirector (not visible) laterally out of the lateral opening 2014 of the distal redirector head 2013. The distal redirector head may include one or more deflection surfaces 2016 within the distal redirector head. FIG. 2B illustrates an example of a proximal handle and control 2022 for a steerable redirector. In this example, the proximal end 2030 is open in-line with the long axis of the steerable redirector elongate body 2018. The control handle 2022 is configured to be rotated clockwise orcounterclockwise to bend the distal end region in a first direction (e.g. left) or a second direction (e.g., right); the example shown in FIG. 2A show the distal end of the steerable redirector steered to bend in a first direction. Any appropriate mechanism may be used to steer the distal end region, including, but not limited to, one or more tendons / pull wires, etc. In some cases the distal end region may be pre-biased in a first or second direction and may be allowed to bend as it is extended distally from out of the rigidizing overtube.

[0055] FIGS. 3A-3C illustrate another example of a control handle 2022 for a rigidizing overtube similar to that shown in FIG. 2B. In this example, the handle 2022 is configured as a rotational spool that may include a feature to lock articulation (e.g., bend angle). In some cases the handle may be configured to rachet in incremental positions that are held until released. For example, the handle may be configured as a ratcheting wheel that can provide controlled incremental articulation. The handle may be configured to switch between a freely moving mode and a ratcheting / incremental mode, in which the bending of the steerable distal end region is configured to move in incremental steps 2026 and hold each step position until moved further or released. In some cases the handle may be configured to automatically reset to a straight configuration when the control is released.

[0056] Two examples of distal tips are shown in FIGS. 4A-4B and 5A-5B. In FIGS. 4A- 4B one example of a distal redirector head 4013 is shown in a perspective view FIG. 4A and a sectional view FIG. 4B through the tip. In FIG. 4Athe distal tip includes a pull wire termination region 4041 (if multiple pull wires are used, then multiple termination regions may be present around the perimeter. For example the steerable redirector may include either one-way or two-way (or three-way) articulation, based on the number of pull wires. A pull wire may be wrapped in a U-bend or may have two or more separate wires that terminate in the tip. In FIG. 4B, the lumen through the distal redirector head 4013 is shown. In this example the lateral opening is shown taking up about half of the side of the tip. A deflector surface 4016 is shown at the distal end. The angle(s) of the deflector surface may be different. In some cases the angle of the ramp (deflector) surface 4016 may be between 100 and 160 degrees (e.g., between 110 and 145 degrees). In some cases the angle may vary over the length (e.g., starting narrow and getting steeper, e.g., increasing in steepness).

[0057] The end of the distal redirector head 4013 shown in FIGS. 4A-4B is closed. In some cases, as shown in FIGS. 5A-5B and 6, the distal end may be open, allowing viewing through the distal redirector head 5013, 6013. In FIGS. 5A-5B and 6 the general shape of the distal redirector head of FIGS. 4A-4B is approximately the same, but the distal end is open 5044, 6044 to allow viewing and / or passage of a tool (e.g., guidewire, etc.). The opening may be eccentrically offset, as shown, so that an endoscope or other tool inserted into the lumen ofthe steerable deflector will preferentially deflect the endoscope / tool laterally, rather than extending distally.

[0058] In FIGS. 5A-5B and 6, as described above for FIGS. 4A-4B, the distal redirector head 5013, 6013 may include one or more attachments 5041 for attaching to a tendon or guidewire. The distal redirector head may also include a lateral opening (cut out region 5014, 6014) and deflector surface 5016, 6016 as described above.

[0059] In use, these apparatuses may be positioned using the rigidizing overtube to insert into / through the body towards a target region, in order to deploy an endoscope. For example, these methods and apparatuses may be configured to perform endoscopic retrograde cholangiopancreatography (ERCP). This is schematically illustrated in FIGS. 7A-7G. In this example, the apparatus is shown navigating through a model 735 of a body region configured to resemble the opening into the pancreatic duct extending off of the duodenum (other anatomical regions such as the opening to the bile duct may be accessed similarly).

[0060] In FIG. 7A the rigidizing overtube is positioned just proximal to the opening to be accessed, which extends at an approximately 90 degree or more angle (e.g., 100 degree angle, relative to the long axis of the rigidizing overtube). The rigidizing overtube may be advanced in a flexible configuration or alternating between flexible and rigid configurations until the distal opening is positioned approximate to the opening to be accessed, such as the pancreatic duct 735. Once the rigidizing overtube is nearby it may be rigidized, e.g., transitioned to a rigid configuration, which may effectively lock it into position, and the steerable redirector 703 may be extended distally out of the rigidizing overtube, as shown in FIG. 7B. The lateral opening of the distal redirector head of the steerable redirector may be oriented into position opposite from the anatomic region being targeted (e.g., the pancreatic duct opening 736). For example, the distal redirector head may be rotated until the lateral opening is aligned with the opening. The redirector may be bent as well, e.g., using the proximal bending control for the steerable redirector.

[0061] As shown in FIG. 7C, with the rigidizing overtube held in a rigid configuration (e.g., by maintaining pressure in the rigidizing overtube) the endoscope 755 is extended distally out and the steerable redirector and the angle of the exit of the endoscope may be adjusted by adjusting the steerable redirector until the endoscope is oriented into the canal of the pancreatic duct opening 736. Once aligned, the endoscope may be advanced distally, as shown in FIGS. 7D and 7E. The steerable redirector may be manipulated by steering, moving in / out of the rigidizing overtube and / or rotating in order to maintain tracking of the endoscope within the target lumen. This may be seen by visualizing using the endoscope. At any point one or more tools 707 may be extended either from the steerable redirector, and / orfrom the endoscope. FIGS. 7F and 7G illustrate an example in which a grasper tool 707 is extended distally from the endoscope within the model pancreatic duct. The tool, endoscope and steerable redirector may be retracted back into the rigidizing overtube, and the apparatus may be transitioned to a flexible configuration and repositioned and / or removed from the body.

[0062] The use of the rigidizing overtube provides an enabling stability in the operation of the apparatus. The rigidizing overtube, by the application of positive and / or negative pressure, may be sufficiently rigid to prevent significant movement, even as the other components (e.g., endoscope, steerable redirector, tool(s)) are operated and apply force against the tissue and / or the rigidizing overtube. This allows the procedure to be performed rapidly and effectively.

[0063] As mentioned, any of these methods may be performed using a guidewire in addition to the rigidizing overtube and steerable redirector. FIGS. 8A-8F illustrate examples of a method using a guidewire that is otherwise very similar or identical to the method shown in FIGS. 7A-7G. In FIGS. 8Athe guidewire 810 is shown extended distally out of the rigidizing overtube 801 and extends into the duct 836. The apparatus (e.g., rigidizing overtube, steerable redirector, endoscope, etc.) may be tracked over the positioned guidewire, as illustrated in FIGS. 8B-8F. In some cases the rigidizing overtube and / or steerable redirector may be used to position / steer the guidewire. In FIGS. 8C and 8D the endoscope 805 is shown extending out of (and deflecting) from the steerable deflector 803. RIGIDIZING OVERTUBES

[0064] The rigidizable apparatuses (e.g., rigidizable overtube) and methods described herein may be part of a medical access system for diagnosing and treating regions of the body that are otherwise hard to access and operate within, particularly during minimally or non- invasive procedures. In particular, these methods and apparatuses may be used in highly tortuous and / or unsupported regions of the body. These methods and apparatuses may be used in combination with, and / or may modify and improve the rigidizable devices and methods of using them described in U.S. Patent No. 11,135,398, titled “DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES,” U.S. Patent Application No. 17 / 604,203, also titled “DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES,” PCT / US2021 / 024582, titled “LAYERED WALLS FOR RIGIDIZING DEVICES,” PCT / US2021 / 034292, titled “RIGIDIZING DEVICES,” PCT / US2022 / 014497, titled “DEVICES AND METHODS TO PREVENT INADVERTENT MOTION OF DYNAMICALLY RIGIDIZING DEVICES,” PCT / US2022 / 019711, titled “CONTROL OF ROBOTIC DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES,”U.S. Provisional Patent Application No. 63 / 265,934, “METHODS AND APPARATUSES FOR REDUCING CURVATURE OF A COLON,” U.S. Provisional Patent Application No. 63 / 296,478, titled “RECONFIGURABLE STRUCTURES,” U.S. Provisional Patent Application No. 63 / 308,044, “DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES,” U.S. Provisional Patent Application No. 63 / 324,011, “METHODS AND APPARATUSES FOR NAVIGATING USING A PAIR OF RIGIDIZING DEVICES,” U.S. Provisional Patent Application No. 63 / 342,618, “EXTERNAL WORKING CHANNELS FOR ENDOSCOPIC DEVICES,” U.S. Provisional Patent Application No. 63 / 335,720, “HYGIENIC DRAPING FOR ROBOTIC ENDOSCOPY,” and U.S. Provisional Patent Application No. 63 / 332,686, “MANAGING AND MANIPULATING A LONG LENGTH ROBOTIC ENDOSCOPE,” each of which is herein incorporated by reference in its entirety.

[0065] Rigidizing apparatuses as described herein may be configured to rigidize when negative pressure and / or positive pressure is applied. These rigidizing apparatuses as described herein may be used in conjunction with other rigidizing devices that rigidize with other methods, including those that do not rely upon the application of positive or negative pressure. For example, a rigidizing device may be configured to include multiple layers arranged into an elongate catheter-like body. The device may include a handle or other manipulator and may include a connection to one or more pressure sources. Applying pressure from the pressure source may be controlled by multiple methods, including operation of a handle or an electronically controlled device. Control may result in a pressure differential that causes the device to transition between a highly flexible configuration, allowing the tubular body to readily bend, when steered or otherwise guided (e.g., over a guidewire, etc.), and one or more (e.g., a continuum) of rigid configurations. In some examples, particularly (but not exclusively) in reference to apparatuses that rigidize based on the application of positive pressure, the rigidity of the elongate body is proportional to the applied pressure differential, so that the greater the pressure differential, the more rigid the device may become over at least a range of pressure differential values.

[0066] In general, these apparatuses may include multiple layers, including a rigidizing layer and at least one of an outer or inner layer. Many of these examples also include a compression layer that may engage with the rigidizing layer, and in some examples the apparatus may include a combined rigidizing layer / compression layer. Described herein are rigidizing layers that may be particularly well suited to rapid and precise actuation over a variety of pressures, including in particular positive pressures (e.g., high positive pressures, i.e., atm of about 2 or more, 4 or more, 6 or more, 8 or more, 10 or more, 15 or more, 20 or more, 30 or more, etc.). Any of these apparatuses may also be configured so that at leastsome of the inner and / or outer layers making up the rigidizable device have different durometers on the inner and outer portion of either the inner or outer layers. Also described herein are apparatuses and methods including nested sets of rigidizable apparatuses, which may include any of these rigidizable devices. Any of these apparatuses may include one or more torsional enhancing layers for improving torsional control, particularly when included as part of a nested pair of rigidizable devices (e.g., as part of the inner, or child, device).

[0067] FIG. 9A illustrates an example of a transverse section through an elongate rigidizing device, showing the arrangements of the many layers that may be included. In this example the rigidizable device 100 is configured to be actuated by the application of a negative pressure (e.g., vacuum). The device 100 shown includes an inner layer (115) that may be reinforced (e.g., by including one or more reinforming members, such as a helically arranged strip, ribbon or wire), an optional slip layer (113), a gap (111), a rigidizing layer (109), configured in this example as a braid layer, a second gap (107) and an outer layer (101). In some examples a vacuum may be applied between the outer layer and the inner layer to rigidize. For example, a port configured to couple to the source of negative pressure may be located at the proximal end of the device and may be in fluid communication with the gap region 107 between the flexible outer layer 101 and the rigidizing layer 109, e.g., braided layer. Thus, in this example the outer layer may act as a compression layer. FIG. 9B shows a section through one wall region B of the cylindrical-shaped body of the device. Applying suction may allow the outer layer 101 to be drawn onto the rigidizing layer, causing it to rigidize, limiting or preventing bending of the device.

[0068] Another example of a rigidizable device is shown in FIGS. 10A-10B. In this example the device may also be an elongate, e.g., catheter or tubular-shaped device similar to that in FIGS. 9A-9B but may be rigidized by the application of positive pressure. For example, FIG. 10A shows a section transverse to the long axis of an elongate rigidizable device. In this example, the layers forming the device are arranged so that an inner reinforced layer 2115 is the most radially-inward layer and may be reinforced, e.g., by a helically wound ribbon, strip, cable, etc. The device may also include an optional slip layer 2113 which may reduce the friction between the inner layer and the more radially-outward layers. The slip layer may be a powder, or it may be a lubricious layer or a layer of lubricious material. A first gap 2112 layer is shown separating the inner layer 2115 and / or the slip layer 2113 from a compression layer, configured in this example as a bladder layer 2121. A second (or intermediate) gap layer 2111 spaces the bladder layer from the rigidizing layer 2109, shown in this example as a braid layer. A third gap layer 2107 is positioned between the rigidizing layer and an outer layer 2101. The outer layer in this example (similar to the inner layer2115) is reinforced, for example, by a helically wound filament, wire, fiber, band, etc. Although not shown, when actuated by the application of positive pressure between the compression (e.g., bladder) layer and the inner layer, the bladder layer may push the braid layer into the outer layer to rigidize the rigidizing layer.

[0069] Both examples of a devices shown in FIGS. 9A-9B and 10A-10B may include additional optional layers or components. Further, the compositions of the rigidizing layers may be modified in order to improve performance. In particular the rigidizing layer may be modified to include structures (e.g., knits, wovens, braids, scales, plates, arrays of filaments, granules, and combinations thereof, etc.) that may enhance or improve performance. Rigidizing elements may be used as one type alone, or in conjunction with other rigidizing elements. In some examples the inner and / or outer layers may be modified to enhance or improve performance, including the addition of torsional control components, and / or modulating the durometer of the inner and outer regions of these layers.

[0070] Further, any of the rigidizable devices described herein may be configured as nested apparatuses that may be nested to provide enhanced performance. For example, a nested apparatus (system) may include an outer rigidizable device (e.g., rigidizing overtube) and an inner rigidizable device (e.g., rigidizing endoscope). The inner rigidizing device (e.g., scope) can be, for example, configured to receive pressure (positive and / or negative pressure) to rigidize from a more flexible to a less flexible configuration. Any of these rigidizing devices may include an air / water channel and a working channel that can extend with the inner rigidizing device.Knit Rigidizing Layers

[0071] In any of the rigidizable devices described herein (and any nested systems or methods including them) may include a rigidizing layer formed of a knit material or knit layer (e.g., knit tube). The knit rigidizing layer, which may be referred to herein equivalently as a knit rigidizing layer or a knitted rigidizing layer, may be formed of a single fiber or may be knitted from multiple fibers. The fiber forming the knit may be a yam, a filament, a monofilament, a plurality of filaments, a strand, a thread, a wire, etc. The fiber may be made of a natural or synthetic material, including polymeric materials, metals and metal alloys, and a composite or a combinations thereof. In some cases the knit is formed of a polymeric material. The fiber may be continuous, in which each of the filament lengths forming the rigidizing layer are part of a single fiber, or they may be broken up into multiple filament lengths. For example, the knit material may be single fiber that is broken / cut at regular or irregular lengths.

[0072] FIGS. 11 A and 1 IB illustrate an example of a rigidizable device 500 including a knit rigidizing layer (e.g., tube) 505. In FIG. 11A the outermost layer (outer layer 515) is removed for clarity; FIG. 1 IB shows the rigidizable device with the outer layer 515 covering the other layers. This outer layer may be a reinforced outer layer, such as an outer coil-wound tube. In FIG. 11 A the rigidizable device includes the knit rigidizing layer 505 extending over the elongate body of the device, including over a compression layer 507 (e.g., bladder) and an inner layer 509. The inner layer and the outer layer 515 may both be reinforced. This example, which is similar to the configuration shown in FIGS. 10A-10B (with the rigidizing layer 2109 configured as a knit layer 505), may be rigidized by the application of positive pressure between the compression layer 507 and the inner layer 509, which may drive the compression layer radially outward against the outer layer 515. Any of the other layers shown in FIGS. 10A-10B may be optionally included, including the gap regions / layer and the optional slip layer (which may not be necessary). This configuration may alternatively be actuated by the application of negative pressure, e.g., between the outer layer and the compression layer (including the region of the knit), which may draw the compression layer against the knit layer by the vacuum, rigidizing the layer.

[0073] A rigidizable device such as that shown in FIGS. 11 A-l IB may alternatively be configured so that positive pressure is applied between a compression layer (e.g., bladder) and the outer layer 515 (outer reinforced layer). In some examples the compression layer may be positioned between the outer layer and the knit rigidizing layer, so that positive pressure applied between the outer layer and the compression layer may rigidize the knit layer by driving the compression layer against the knit layer into the inner (reinforced) layer. As in the configuration shown in FIGS. 11 A-l IB, the device may alternatively be actuated by the application of negative pressure, e.g., between the inner layer and the compression layer (including the region of the knit).

[0074] Alternatively, the rigidizable device including a knit rigidizing layer may be configured as shown in FIGS. 9A-9B and may be actuated by the application of negative pressure. In some examples the outer layer or the inner layer may be configured to as the compression layer (e.g., bladder) and may engage with the knit rigidizing layer when vacuum is applied.

[0075] FIG. 11C illustrates one example of a portion of a knit layer 505 formed of a single filament 518 that forms interlocking loops. In the example shown in FIG. 11C the knit includes a plurality of stich loops each having a length, y, and a curved head and foot region having a length x. The stitch pattern shown in FIG. 11C is a weft knit pattern, but other knit patterns may be used. FIG. 1 ID shows an example of a transverse section through a knit layerpositioned adjacent to a compression layer 507. In this example the knit layer is a tube having 28 strand segments that are formed of the same strand into loops (e.g., 14 loops that are arranged with the wale of the knit in parallel with the long axis of the device). The knit tube has a diameter, z, and the spacing between adjacent loops, n, is approximately equal around the circumference of the knit tube. The spacing between the stitch width, p, and the spacing, n, may vary along the length of the knit tube. The dimensions are illustrative only.

[0076] FIGS. 12A-12B illustrate two different examples of knits 600, 600’ that may be used. FIG. 12A shows a weft knit, similar to that shown in FIG. 11C. In this example the knit is formed of one or more strands (which may be continuous or broken / cut), forming stitch loops 602 that each include a head region 604, a pair of legs 606 and a first and second foot 608 where each foot engages with the head of a stitch loop in a course above or below the original stitch loop course. The connection between the feet of adjacent stitch loops may be referred to as the sinker (the sinker may also correspond to a head when the knit is rotated 180 degrees). In FIG. 12A the wale direct 612 extends up / down, and the course 610 extends right to left. Typically, a wale is a column of loops running lengthwise, corresponding to the warp of woven fabric in FIG. 12A. The course is a crosswise row of loops, corresponding to the filling of the resulting knit.

[0077] FIG. 12B illustrates an example of a warp knit 600’. In this example the warp knit also has a course 610’ and wale 612’ direction but the feet of each loop engage with the head region of a knit loop in a row (in the course direction) that is offset, as shown, forming a pattern of overlap 612 and underlap 614 lengths. The knit rigidizing layers described herein may use any appropriate pattern and may arrange the direction (course or wale direction) relative to the elongate axis (length) of the device. For example, the knit structure (the knit rigidizing layer) may be configured so that a wale direction of the knit extends in a long axis of the flexible tube. Alternatively, the knit structure may be configured so that a wale direction of the knit structure is perpendicular to a long axis of the flexible tube. Depending on the stitch length (y) relative to the loop diameter (p) and / or the spacing between loops (n), which may be related, it may be beneficial to arrange the knit rigidizing layer so that that either the wale or the course is arranged in parallel or perpendicular to the long axis of the elongate body of the rigidizable device. In any of the examples described herein, the knit structure may comprise an average loop length that is longer than the loop width. For example, the loop length may be two times or greater (e.g., 3x, 4x, 5x, 6x, 7x, 8x, 9x, lOx, 20x, 40x, 60x, 80x, lOOx or more) than an average loop width. Because knits (including knit tubes) may be stretched and compressed in bending without buckling or wrinkling, they may be particularly useful in the rigidizable devices described herein.

[0078] As shown in FIG. 12C a knit rigidizing layer 600” may be formed of a single knitted fiber 618. As mentioned above the fiber may be formed of a single filament (monofilament) or a bundle of filaments (multi-filament). The pattern shown therefore includes a plurality of lengths of filaments (e.g., an array of filament lengths) that cross each other in the knit pattern. In FIG. 12C the plurality of lengths of filaments that cross over and under each other are all part of the same fiber or strand. In some examples the knitted fiber or strand may be cut or divided into multiple separate filament lengths. The knit material (e.g., the fiber) may be formed of any appropriate material, such as a metal, metal alloy, polymeric material, natural fiber, etc.Woven and Braided Rigidizing Layers

[0079] In any of the rigidizable devices described herein (and any nested systems or methods including them) may include a rigidizing layer that is woven. FIGS. 13A-13C illustrate an example of a woven a rigidizing layer 705 that may be used as the rigidizing layer of the rigidizable device and may be arranged as shown in FIGS. 9A-9B, 10A-10B. In FIG. 13 A the weave includes a plurality of parallel fibers that form a set of intersecting fibers; in FIG. 13 A the fibers intersect with each other at 90 degree angles, but this angle may vary (e.g., between about 30 degrees and 150 degrees, 45 degrees and 135 degrees, 50 degrees and 130 degrees, 70 degrees and 110 degrees, 80 degrees and 100 degrees, etc.). The pattern of intersecting filament lengths (e.g., the array of filament lengths) includes individual filament lengths that cross over and under each other as shown; a first filament length 718 crosses over a second filament length 728 and under a third filament length 725. In this example, the pattern shown in an under-over pattern, but this pattern may be different for other examples of rigidizing layers; in FIG. 13 A the pattern is one over, one under. In some examples the pattern may be two over two under, or two over and one under, etc. Any appropriate fiber (e.g., strand) may be used to form the rigidizing layer, a mentioned for knit rigidizing layers above. In the woven rigidizing layer shown in FIG. 13 A the fiber is a muti- filament fiber including a bundle of multiple filaments forming each strand. FIG. 13B shows an example of a woven rigidizing layer 705’ formed of a monofilament, also arranged with parallel strands 718’, 728’ arranged in a woven pattern similar to that shown in FIG. 13A. The woven pattern may be any desired tightness (e.g., pore size). In general, as shown in FIG. 13C, multiple different lengths of fibers 718”, 728” are used to form the woven pattern 705”.

[0080] FIGS. 14A and 14B illustrate examples of braided rigidizing layers. In FIG. 14A. In FIG. 14A the braid 800 is formed of a plurality of fibers 818, 828 that are arranged in an over-and-under pattern having a braid angle relative to the long axis (e.g., the long axis of thedevice when included as the rigidizing layer). In general, the braid angle (relative to the centerline along the central axis) of the braided rigidizing layer (tube) may be 45 degrees or less (e.g. less than 45 degrees, 40 degrees or less, less than 40 degrees, 35 degrees or less, less than 35 degrees, 30 degrees or less, 20 degrees or less, less than 20 degrees, etc. In FIG. 14A the different filaments forming the braid layer are continuous and unbroken. However in some examples it may be beneficial to include breaks or cuts, as illustrated in FIG. 14B. In this example, the material includes a plurality of breaks or cuts 838 in the braided strands. Although such an arrangement may be undesirable in a fabric or even in a braid used as part of a medical device, this disrupted (e.g., broken or cut) arrangement may be beneficial in the context of a rigidizing layer. Thus, in FIG. 14B the braided pattern 800’ forming the rigidizing layer (e.g., rigidizing tube) may enhance flexibility in the un-rigidized configuration, while permitting a high degree of rigidizing in the actuated state. Thus, in FIG. 8 the strands 818, 828’ cross over and under each other in the braid pattern shown but are cut 838 periodically along their lengths. The number or density of the cuts may be varied; in some examples the fibers may be cut after every crossing over or under another fiber, while in other examples the fibers may be cut after every 2 (or 3, or 4, or 5, or more) crossings. The cut pattern may be non-uniform. In some examples it may be beneficial to have the cuts or breaks distributed at a density of between about one cut / break for every third crossing, etc. (e.g., between every second and every 25thcrossing, every third and every 20thcrossing, etc.).

[0081] Other rigidizing layers (e.g., knit, woven, etc.) may also include breaks or cuts. These breaks or cuts may be formed during fabrication by laser cutting, mechanical cutting, or any other appropriate cutting technique.Pressure-driven Rigidization

[0082] As mentioned above, in general, these apparatuses may be configured to be rigidized by the application of pressure. The layers forming the device may be arranged as concentric tubes. See, e.g., FIGS. 11 A-l IB showing a rigidizing layer (FIG. 11 A) and a compression layer (e.g., bladder, FIG. 1 IB). A gap layer may be present between the outer layer and the rigidizing layer and / or between the rigidizing layer and the compression layer. A port may be present at an end (e.g., a proximal end region) of the device to couple to the source of pressure (e.g., positive pressure). A gap layer may be present between the compression layer and the rigidizing layer, and / or between the rigidizing layer and an inner layer. The device may be flexible as each of these layers may slide relative to each other when bending the device. In particular, the rigidizing layer may flex and slide relative to the inner layer and the compression layer.

[0083] When positive pressure is applied between the outer layer and the compression layer, or alternatively if the compression layer comprises a double-layered bladder into which the positive pressure is applied, the compression layer may be driven against the rigidizing layer, so that it is compressed between the compression layer and the inner layer (and / or any intervening layers) or outer layer. The inner and / or outer layers may be reinforced. Compressing the rigidizing layer rigidizes the device. Any bends or curves are preserved without changing the shape.

[0084] In some examples, particularly those having elastic (e.g., elastomeric) compression layers and rigidizing layers formed of filament lengths that cross over and under each other, the compression layer may deform into the rigidizing layer, which may enhance the rigidity of the device. For example, as pressure is applied, the compression layer (e.g., bladder) may apply force directly to the rigidizing layer. Depending on the bladder type, the bladder may deform, depress, or interdigitate into the space around and between the elements (e.g., filaments, wires, etc.) of the rigidizing layer. Conforming to the overlapping (over-and- under) fiber or filament lengths may help lock the rigidizing layer relative to the inner layer (or in some examples outer layer) to which it is being compressed. The application of positive pressure in this manner may therefore increase rigidization as positive pressure is increased even beyond what is otherwise expected. Thus a rigidizing layer comprising a plurality of filament lengths crossing over and under each may be generally configured so that, in the flexible configuration, the filament (e.g., fiber) lengths may shear relative to each other. However, when positive pressure is applied, the deformable compression layer may be pushed against the rigidizing layer so that the compression layer may conform to or deform into or between the plurality of filament lengths to prevent shear of the plurality of filament lengths relative to each other.Robotic apparatuses

[0085] As mentioned above, any of the methods and apparatuses described herein may be part of a robotic method / system. For example, the rigidizing apparatuses (e.g., rigidizing overtube) described herein may be configured as part of a robotic system or for use with robotic apparatuses. In some cases the other components (e.g., steerable redirector, endoscope, etc.) may also or alternatively be part of the robotic system and the movements of these components may also be robotically controlled and / or implemented. Thus, any of these methods may be performed by a robotic apparatus. In some examples the rigidizing apparatus may be configured as an outer tubular member (overtube) that is robotically controlled, e.g., configured as a robotically controlled overtube and / or endoscope assembly. FIG. 15 shows an exemplary apparatus 3100, including a rigidizing device configured as an overtube 3112; thesystem may optionally include the steerable redirector 3110. The overtube and steerable redirector can be separately or collectively be robotically controlled or manipulated (e.g., steering, movement, rotation, etc. including in some examples, rigidizing). The overtube and inner endoscope may be configured as illustrated in any of the examples described above, and may have the same general construction, or may be of different constructions. As shown in FIG. 15, the rigidizing overtube 3112 and the steerable redirector 3110 may be terminated together into a common structure, such as a cassette 3157, or two separate cassettes may be used. In some cases a single controller may coordinate movement of the one or more cassettes. The rigidizing overtube 3100 can be movable with respect to the steerable redirector 3110 by rotation of a driver mounted to the cassette 3157. The system may include actuators 3171a, 3171b that may connect to cables 3163a, b respectively, to steer (e.g., bend or deflect) the steerable region of the steerable redirector 3110 (and / or in some examples the rigidizing overtube 3112). Other steering mechanisms (e.g., pneumatics, hydraulics, shape memory alloys, EAP (electro-active polymers), or motors) are also possible. The cassette 3157 can further include bellows 3103a, 3103b that may connect to the pressure inlet of the rigidizing overtube 3112, to drive fluid through pressure lines 3105z, in some variations for rigidizing the overtube. As shown in this example, the cassette 3157 can include eccentric cams 3174a, b to control bellows 3103a, b. Alternatively, one or more linear actuators can be configured to actuate the bellows. As another alternative, the rigidizing overtube (and / or in some examples the steerable redirector) can be rigidized and de-rigidized through one or more pumps or pressure sources (e.g., via pressure line 3105z).

[0086] 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. Furthermore, it should be appreciated that all combinations of the foregoing concepts and additional concepts discussed in greater 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.

[0087] Any of the methods (including user interfaces) described herein may be implemented as software, hardware or firmware, and may be described as a non-transitory computer-readable storage medium storing a set of instructions capable of being executed by a processor (e.g., computer, tablet, smartphone, etc.), that when executed by the processor causes the processor to control perform any of the steps, including but not limited to: displaying, communicating with the user, analyzing, modifying parameters (including timing, frequency, intensity, etc.), determining, alerting, or the like. For example, any of the methodsdescribed herein may be performed, at least in part, by an apparatus including one or more processors having a memory storing a non-transitory computer-readable storage medium storing a set of instructions for the processes(s) of the method.

[0088] While various embodiments have been described and / or illustrated herein in the context of fully functional computing systems, one or more of these example embodiments may be distributed as a program product in a variety of forms, regardless of the particular type of computer-readable media used to actually carry out the distribution. The embodiments disclosed herein may also be implemented using software modules that perform certain tasks. These software modules may include script, batch, or other executable files that may be stored on a computer-readable storage medium or in a computing system. In some embodiments, these software modules may configure a computing system to perform one or more of the example embodiments disclosed herein.

[0089] As described herein, the computing devices and systems described and / or illustrated herein broadly represent any type or form of computing device or system capable of executing computer-readable instructions, such as those contained within the modules described herein. In their most basic configuration, these computing device(s) may each comprise at least one memory device and at least one physical processor.

[0090] The term “memory” or “memory device,” as used herein, generally represents any type or form of volatile or non-volatile storage device or medium capable of storing data and / or computer-readable instructions. In one example, a memory device may store, load, and / or maintain one or more of the modules described herein. Examples of memory devices comprise, without limitation, Random Access Memory (RAM), Read Only Memory (ROM), flash memory, Hard Disk Drives (HDDs), Solid-State Drives (SSDs), optical disk drives, caches, variations or combinations of one or more of the same, or any other suitable storage memory.

[0091] In addition, the term “processor” or “physical processor,” as used herein, generally refers to any type or form of hardware-implemented processing unit capable of interpreting and / or executing computer-readable instructions. In one example, a physical processor may access and / or modify one or more modules stored in the above-described memory device. Examples of physical processors comprise, without limitation, microprocessors, microcontrollers, Central Processing Units (CPUs), Field-Programmable Gate Arrays (FPGAs) that implement softcore processors, Application-Specific Integrated Circuits (ASICs), portions of one or more of the same, variations or combinations of one or more of the same, or any other suitable physical processor.

[0092] Although illustrated as separate elements, the method steps described and / or illustrated herein may represent portions of a single application. In addition, in some embodiments one or more of these steps may represent or correspond to one or more software applications or programs that, when executed by a computing device, may cause the computing device to perform one or more tasks, such as the method step.

[0093] In addition, one or more of the devices described herein may transform data, physical devices, and / or representations of physical devices from one form to another. Additionally or alternatively, one or more of the modules recited herein may transform a processor, volatile memory, non-volatile memory, and / or any other portion of a physical computing device from one form of computing device to another form of computing device by executing on the computing device, storing data on the computing device, and / or otherwise interacting with the computing device.

[0094] The term “computer-readable medium,” as used herein, generally refers to any form of device, carrier, or medium capable of storing or carrying computer-readable instructions. Examples of computer-readable media comprise, without limitation, transmission-type media, such as carrier waves, and non-transitory-type media, such as magnetic-storage media (e.g., hard disk drives, tape drives, and floppy disks), optical-storage media (e.g., Compact Disks (CDs), Digital Video Disks (DVDs), and BLU-RAY disks), electronic-storage media (e.g., solid-state drives and flash media), and other distribution systems.

[0095] A person of ordinary skill in the art will recognize that any process or method disclosed herein can be modified in many ways. The process parameters and sequence of the steps described and / or illustrated herein are given by way of example only and can be varied as desired. For example, while the steps illustrated and / or described herein may be shown or discussed in a particular order, these steps do not necessarily need to be performed in the order illustrated or discussed.

[0096] The various exemplary methods described and / or illustrated herein may also omit one or more of the steps described or illustrated herein or comprise additional steps in addition to those disclosed. Further, a step of any method as disclosed herein can be combined with any one or more steps of any other method as disclosed herein.

[0097] The processor as described herein can be configured to perform one or more steps of any method disclosed herein. Alternatively or in combination, the processor can be configured to combine one or more steps of one or more methods as disclosed herein.

[0098] When a feature or element is herein referred to as being "on" another feature or element, it can be directly on the other feature or element or intervening features and / orelements may also be present. In contrast, when a feature or element is referred to as being "directly on" another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being "connected", "attached" or "coupled" to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being "directly connected", "directly attached" or "directly coupled" to another feature or element, there are no intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed "adjacent" another feature may have portions that overlap or underlie the adjacent feature.

[0099] Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and / or "comprising," when used in this specification, 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 " / ".

[0100] Spatially relative terms, such as "under", "below", "lower", "over", "upper" and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated 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 depicted in the figures. For example, if a device in the figures is inverted, elements described as "under”, or "beneath" other elements or features would then be oriented "over" the other elements or features. Thus, the exemplary term "under" can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms "upwardly", "downwardly", "vertical", "horizontal" and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.

[0101] Although the terms “first” and “second” may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish onefeature / element from another feature / element. Thus, a first feature / element discussed below could be termed a second feature / element, and similarly, a second feature / element discussed below could be termed a first feature / element without departing from the teachings of the present invention.

[0102] In general, any of the apparatuses and methods described herein should be understood to be inclusive, but all or a sub-set of the components and / or steps may alternatively be exclusive and may be expressed as “consisting of’ or alternatively “consisting essentially of’ the various components, steps, sub-components or sub-steps.

[0103] As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word "about" or “approximately,” even if the term does not expressly appear. The phrase “about” or “approximately” may be used when describing magnitude and / or position to indicate that the value and / or position described is within a reasonable expected range of values and / or positions. For example, a numeric 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 values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value " 10" is disclosed, then "about 10" is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. It is also understood that when a value is disclosed that "less than or equal to" the value, "greater than or equal to the value" and possible ranges between values are also disclosed, as appropriately understood by the skilled artisan. For example, if the value "X" is disclosed the "less than or equal to X" as well as "greater than or equal to X" (e.g., where X is a numerical value) is also disclosed. It is also understood that the throughout the application, data is provided in a number of different formats, and that this data, represents endpoints and starting points, and ranges for any combination of the data points. For example, if a particular data point “10” and a particular data point “15” are disclosed, it is understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 are considered disclosed as well as between 10 and 15. It is also understood that each unit between two particular units are also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0104] Although various illustrative embodiments are described above, any of a number of changes may be made to various embodiments without departing from the scope of the invention as described by the claims. Optional features of various device and systemembodiments may be included in some embodiments and not in others. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the invention as it is set forth in the claims.

[0105] The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived there from, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.

Claims

1. CLAIMSWhat is claimed is:

1. An apparatus, the apparatus comprising: a rigi dizing overtube having an elongate body comprising a plurality of layers surrounding a lumen, the elongate body comprising a support layer, a rigidizing layer and a bladder layer, wherein the rigidizing overtube is configured to convert between a rigid configuration and a flexible configuration by an application of pressure to drive the bladder layer against the rigidizing layer; and a steerable redirector configured to insert through the lumen of the rigidizing overtube and extend distally from the rigidizing overtube, the steerable redirector having an elongate body, a lumen extending through the elongate body, a steerable distal end region, and a distal redirector head distal to the steerable distal end region having a lateral opening facing a first direction, wherein the distal redirector head is configured to deflect an elongate member that is extended through the lumen of the steerable redirector out of the lateral opening.

2. The apparatus of claim 1, wherein the steerable distal end region is configured to deflect in a plane that is parallel with the first direction.

3. The apparatus of claim 1, wherein the steerable redirector comprises a proximal handle having a control configured to deflect the steerable distal end region.

4. The apparatus of claim 1, wherein the steerable redirector comprises a deflection wire configured to defect the steerable distal end region when tension is applied to the deflection wire.

5. The apparatus of claim 1, wherein the distal redirector head comprises a distal ramp extending from a wall of the lumen opposite to the lateral opening to a distal end of the lateral opening.

6. The apparatus of claim 1, wherein the steerable redirector is configured to extend at least 5 cm from the rigidizing overtube.

7. The apparatus of claim 1, further comprising an endoscope configured to pass through the lumen of the steerable redirector.

8. The apparatus of claim 1, wherein the rigidizing overtube is configured to convert between a rigid configuration and a flexible configuration by an application of positive pressure.

9. The apparatus of claim 1, wherein the rigidizing layer comprises a tubular layer having a plurality of lengths of filaments crossing over each other.

10. An apparatus, the apparatus comprising: a rigidizing overtube having an elongate body comprising a plurality of layers surrounding a lumen, the elongate body comprising a support layer, a rigidizing layer and a bladder layer, wherein the rigidizing overtube is configured to convert between a rigid configuration and a flexible configuration by an application of pressure to drive the bladder layer against the rigidizing layer; a steerable redirector configured to insert through the lumen of the rigidizing overtube, the steerable redirector having an elongate body, a lumen extending through the elongate body, a steerable distal end region, and a distal redirector head distal to the steerable distal end region that is configured to deflect an elongate member that is extended through the lumen of the steerable redirector; and an endoscope configured to extend though the steerable redirector and be deflected between 40-90 degrees relative to the rigidizing overtube when the steerable redirector is extended out of the rigidizing overtube.

11. A method, the method comprising: positioning a rigidizing overtube adjacent to a duct opening in a flexible configuration; rigidizing the rigidizing overtube by applying pressure within the rigidizing overtube to drive a bladder against a plurality of lengths of filaments; extending a steerable redirector distally out of the rigidizing overtube; steering the steerable redirector so that a lateral opening in a distal redirector head of the steerable redirector is facing the duct opening;extending an endoscope through the steerable redirector while maintaining the rigidizing overtube in a rigid configuration and while steering the steerable redirector to align an end region of the endoscope within the duct; and advancing the endoscope into the duct.

12. The method of claim 11, wherein positioning the rigidizing overtube comprises advancing the rigidizing overtube over a guidewire or guide catheter.

13. The method of claim 11, wherein the duct comprises a bile duct.

14. The method of claim 11, wherein steering the steerable redirector comprises deflecting the steerable redirector towards the duct.

15. The method of claim 11, wherein steering the steerable redirector comprises manipulating a handle control at a proximal end of the steerable redirector to adjust an angle between the distal redirector head and the duct.

16. The method of claim 11, wherein steering the steerable redirector comprises: rotating and / or advancing and retracting the steerable redirector.

17. The method of claim 11, wherein extending the endoscope through the steerable redirector while steering the steerable redirector to align an end region of the endoscope within the duct comprises rotating the steerable redirector axially and / or advancing the steerable redirector distally.

18. The method of claim 11, wherein extending the endoscope through the steerable redirector while steering the steerable redirector to align an end region of the endoscope within the duct comprises deflecting adjusting an angle between the distal redirector head and the duct.

19. The method of claim 11, wherein extending the endoscope through the steerable redirector comprises deflecting the endoscope out of the lateral opening in the distal redirector head by deflecting a distal end of the endoscope against a deflection surface within a lumen of the distal redirector.

20. The method of claim 11, further comprising positioning a guidewire in the duct before extending the endoscope through the steerable redirector, wherein extending theendoscope through the steerable redirector comprises advancing the endoscope over the guidewire.

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