Gastrojejunostomy bypass methods and apparatuses

Abstract

Methods and apparatuses (e.g., devices, systems, etc.) for forming a bypass between different luminal body regions. The methods and apparatuses described herein may be used to join different portions of a patient's GI tract, including but not limited to forming a bypass to reduce nutritional uptake, decrease weight, and / or improve diabetes control. In some cases these methods and apparatuses may be used for performing a gastrojejunostomy bypass.

Description

GASTROJEJUNOSTOMY BYPASS METHODS AND APPARATUSESCLAIM OF PRIORITY

[0001] This patent application claims priority to U.S. provisional patent application no. 63 / 648,641, titled “GASTROJEJUNOSTOMY BYPASS METHODS AND APPARATUSES,” and filed on May 16, 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] A number of medical procedures require forming an anastomosis between adjacent body lumens. For example, a number of procedures may be performed by entering the gastrointestinal (GI) tract through a first organ or structure, such as the esophagus, stomach, duodenum, small intestine, large intestine, or peritoneal cavity, and delivering the anchor or stent to adjacent organs and lumen or tissue structures such as an adjacent portion of the GI tract, the bile duct, the pancreatic duct, the gallbladder, the pancreas, cysts, pseudocysts, abscesses, and the like. Such methods and apparatus can also be used for access to and from portions of the urinary tract, such as the urinary bladder and ureter, the pulmonary tract, such as the trachea and bronchi, and the biliary tract, such as the bile duct and gallbladder, and vascular applications, as well.

[0004] Tissue anchors may be used to secure adjacent tissues or organs. Inter-luminal tissue anchors, which include a central lumen, are used to facilitate fluid communication between adjacent ducts, organs or lumens. Often, the precise placement of the tissue anchor or stent is necessary, especially when the tissue anchor or stent has well defined anchoring elements at the proximal and / or distal ends, and the device is used to secure adjacent lumens. When deploying a stent or other tissue anchor between adjacent body lumens, organs, or other structures, it is typically necessary to penetrate both a wall of the first body lumen through which access is established and a wall of a second body lumen which is the target for the procedure. However, different body regions, particularly those connected by a long lumen, may shift within the body during the procedure, which may increase the chance for complications of the procedure, including leakage (e.g., from either or both of the accessbody lumen and the target body lumen into the surrounding space including, but not limited to the peritoneal cavity). This can present a substantial risk to the patient. It is important to form a tight anastomosis between the different regions of the body being joined. Described herein are apparatuses and methods that may address these needs.SUMMARY OF THE DISCLOSURE

[0005] In general, described herein are rigidizable apparatuses (e.g., devices, accessories, systems, etc.) that may be controlled to transition between rigid and flexible configurations as part of a procedure to secure adjacent body regions together, e.g. to placate or form an ostomy therebetween. This transition can occur through multiple means, including by the application of or release of positive and / or negative pressure, links with cables, phase change materials, magnetic materials, electrostatics, nitinol actuation, etc. In some examples, the apparatus may be configured to transition between a highly flexible configuration in which the elongate device (e.g., catheter, tube, rod, etc.) may be flexible or floppy and a highly rigid (or selectively rigid) configuration that is many times (e.g., 2x, 3x, 5x, 7x, lOx, 12x, 15x, 20x, 30x, 40x, 50x, 75x, lOOx etc.) more rigid than the flexible configuration. Also described herein are nested sets of two or more devices, of which at least one or more may be rigidizable. These devices may be used to advance or retract the nested set along a tortuous pathway. By selectively rigidizing and un-rigidizing dual rigidizable devices, a shape may be propagated through the tortious pathway.

[0006] In particular, described herein are methods and apparatuses for forming an ostomy between different regions of a body that are body accessible through natural or surgically induced channel or passage (e.g., lumen). Although many of the examples described herein refer to methods and apparatuses for gastrojejunostomy, the methods described herein may be applied to other procedures. The methods described herein include methods for forming an anastomosis that may include accessing a stomach of a patient with an overtube and, in some cases, an endoscope, and / or a guidewire. In some cases the overtube may be used with an obturator. These methods may include the use of a rigidizing device, which may be configured as a rigidizing overtube and / or a rigidizing endoscope that may be positioned on either sides of the regions of the body to be joined, such as on either side of a first target luminal region and into a second target luminal region. The methods and apparatuses may be configured to prepare both sides so that they may be optimally positioned, and in particular so that the walls of either side may be optimally positioned including securely holding them in position prior to performing the procedure and / or holding the tissue regions to be connected taut, and / or clearing them of debris. In some cases the methods described herein may alsoinclude one or more devices (e.g., a catheter) carrying a stent, that are configured to make an incision in a wall of the first target luminal region and / or the second target luminal region (e.g., the stomach and small intestine). The apparatus may also include one or more occluders (e.g., expandable occluders, such as balloons) that may be used to isolate the region of the body including the second target luminal region the second target luminal region may then be expanded and / or rinsed by the application of a fluid to prepare for connection to the first target luminal region. The method may include holding the first and second target luminal regions near each other by using the rigidizing apparatus. Any of these methods may include placing the connector (e.g., stent) between the first and second luminal regions by advancing an endoscope (and / or catheter) device to form an incision and moving the endoscope and / or catheter through the incision in either the first and / or second target luminal regions and deploying a first end of the stent (e.g., from the wall of the small intestines), and deploying a second end of the stent (e.g., from a wall of the stomach) to form a connection between the first target luminal region and the second target luminal region.

[0007] In any of these methods and apparatuses, the first and / or second target luminal regions may include target location in the intestines is a jejunum, ileum, duodenum. The first and / or second target luminal regions may include the stomach, and / or a fundal pouch formed during a gastric bypass procedure. In any of the embodiments disclosed herein, the methods include forming the fundal pouch as part of a gastric bypass procedure before endoscopically accessing the GI tract with the catheter device. For example, the first target luminal region may be the stomach, and the second target luminal region may be the jejunum (e.g., a Gastrojejunostomy bypass, as mentioned above).

[0008] In any of the methods described herein the rigidizing apparatus (e.g., the rigidizing overtube, rigidizing endoscope, etc.) may be used to move and / or secure the first and / or second target luminal regions in apposition.

[0009] Any appropriate sent may be used. For example, the stent may be a self-expanding stent including a first double-walled flange structure on the first end and a second doublewalled flange structure on the second end. The stent may be a lumen-apposing selfexpandable metal stent (LASEMS), such as the AXIOS™ Stent (Boston Scientific), or as described in U.S. patent no. 11,020,214, and US patent applications no. US20240016639 and US20240016638, each of which is herein incorporated by reference in its entirety.

[0010] For example, described herein are methods of forming a surgical bypass, the method comprising: positioning a rigidizing overtube through a first target luminal region and into a second target luminal region; occluding the second target luminal region and filling the second target luminal region with a fluid either before, during or after rigidizing the rigidizingovertube by applying a pressure between two or more layers of the rigidizing overtube to maintain the relative positions of the first target luminal region and the second target luminal region; and maintaining the rigidizing overtube in a rigid configuration while connecting a stent between the first target luminal region and the second target luminal region.

[0011] Any of these methods may include sequentially de-rigi dizing the rigidizing overtube, repositioning the rigidizing overtube and rigidizing the rigidizing overtube until the first target luminal region is adjacent to the second target luminal region. Any of these methods may include occluding the second target luminal region comprises passing an expandable occluder through the rigidizing overtube and distal to the second target region, expanding the expandable occluder to form an enclosed region of the second target luminal region. Positioning the rigidizing overtube may comprise passing a guidewire through the first target luminal region within the patient’s stomach, through a stricture, and into the second target luminal region within the patient’s small intestine and passing the rigidizing overtube over the guidewire. In some cases positioning the rigidizing overtube may comprise inserting the rigidizing overtube with an obturator extending distally from the rigidizing overtube through the first target luminal region within the patient’s stomach, through a stricture, and into the second target luminal region within the patient’s small intestine.

[0012] In general, any of these methods may include visualization, e.g., using fluoroscopy and / or ultrasound (e.g., endoscopic ultrasound (EUS)). For example, any of the steps of positioning, occluding and / or maintaining may further comprise visualizing the second target luminal region and / or the first target luminal region while performing the step. Occluding the second target luminal region may include extending an expandable occluder through the rigidizing overtube and distal to the second target region. The method may include filling the second target luminal region with a fluid, e.g., by filling the second target luminal region with the fluid from the rigidizing overtube. Occluding the second target luminal region may include inflating a proximal balloon on an outer surface of the rigidizing overtube.

[0013] Maintaining the rigidizing overtube in a rigid configuration while connecting a stent between the first target luminal region and the second target luminal region may comprise heating a wall of the first target luminal region and the second target luminal region to form a stoma between the two and inserting the stent into the stoma. In general, cutting through the wall of the first and / or second target luminal region may be performed by an optical (e.g., laser), electrical (e.g., electrosurgical, cautery, etc.), mechanical (e.g., blade, knife, etc.) or any other appropriate technique and / or device for performing the cutting.

[0014] For example, a method of forming a surgical bypass may include: positioning a rigidizing overtube through a first target luminal region within a patient’s stomach, through a stricture, and into a second target luminal region within the patient’s small intestine with the rigidizing overtube in a flexible configuration; rigidizing the rigidizing overtube into a more rigid configuration by applying pressure between two or more layers of the rigidizing overtube to maintain the relative positions of the first target luminal region and the second target luminal region; passing an expandable occluder through the rigidizing overtube and distal to the second target region, expanding the expandable occluder to form an enclosed region between the stricture and the expandable occluder and filling the enclosed region with a filling solution, wherein the rigidizing overtube is rigidized by applying pressure between two or more layers of the rigidizing overtube to maintain the relative positions of the first target luminal region and the second target luminal region either before, during or after passing the expandable occluder through the rigidizing overtube; and maintaining the rigidizing overtube in the rigid configuration while connecting a stent between the first target luminal region and the second target luminal region.

[0015] As mentioned, the method may include positioning and / or securing the two target luminal regions adjacent to each other. For example, by sequentially de-rigi dizing the rigidizing overtube, repositioning the rigidizing overtube, and rigidizing the rigidizing overtube until the first target luminal region is adjacent to the second target luminal region.

[0016] Positioning the rigidizing overtube may include passing a guidewire through the first target luminal region within the patient’s stomach, through the stricture, and into the second target luminal region within the patient’s small intestine and passing the rigidizing overtube over the guidewire. Positioning the rigidizing overtube may comprise inserting the rigidizing overtube with an obturator extending distally from the rigidizing overtube through the first target luminal region within the patient’s stomach, through a stricture, and into the second target luminal region within the patient’s small intestine. Any of the steps of positioning, rigidizing, passing and / or maintaining may further comprise visualizing the second target luminal region and / or the first target luminal region while performing the step.

[0017] As mentioned, any of these method may include occluding or isolating the first and / or second target luminal regions. In particular, the second target luminal region (e.g., in some cases, within the intestines) may be isolated by occluding one or both ends of the region. For example, occluding the enclosed region may comprise inflating a proximal balloon on an outer surface of the rigidizing overtube. In some cases, only the distal region may be occluded, e.g., in cases in which there is a stricture or blockage (through which the overtube may be passed). In some cases the rigidizing overtube may include a balloon orother expandable occlusive member (e.g., basket, etc.). Tho isolated region may be filled with a fluid (e.g., saline, contrast, etc.) and / or may be rinsed or washed, e.g., to remove debris or other material within the target luminal region. In some cases the isolated region may be filled to expand the wall of the target luminal region to allow more effective joining of the two target luminal regions. Thus, any of these methods may include filling the enclosed region with a fluid; in some cases the fluid may be provided from the rigidizing overtube.

[0018] The rigidizing overtube may be maintained in a rigid configuration while connecting a stent between the first target luminal region and the second target luminal region comprises heating a wall of the first target luminal region and the second target luminal region to form a stoma between the two and inserting the stent into the stoma.

[0019] In any of these methods and apparatuses the rigidizing overtube may be rigidized by the application of one or more of negative pressure or positive pressure.

[0020] A method of forming a surgical bypass may include: passing a guidewire through a first target luminal region within a patient’s stomach, through a stricture, and into a second target luminal region within the patient’s small intestine; positioning an obturator within a lumen of a rigidizing overtube through the first target luminal region, through the stricture, and into the second target luminal region with the rigidizing overtube in a flexible configuration; rigidizing the rigidizing overtube by applying pressure between two or more layers of the rigidizing overtube to convert the rigidizing overtube to a more rigid configuration to maintain the relative positions of the first target luminal region and the second target luminal region; passing an expandable occluder through the rigidizing overtube and distal to the second target region, expanding the expandable occluder to form an enclosed region between the stricture and the expandable occluder and filling the enclosed region with a filling solution, wherein the rigidizing overtube is rigidized by applying pressure between two or more layers of the rigidizing overtube to maintain the relative positions of the first target luminal region and the second target luminal region either before, during or after passing the expandable occluder through the rigidizing overtube; and maintaining the rigidizing overtube in the rigid configuration while connecting a stent between the first target luminal region and the second target luminal region.

[0021] The methods and apparatuses described herein may improve upon the methods and apparatuses described and suggested in U.S. patent application 17 / 604,203, titled “DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES,” filed on Jan. 16, 2020, and herein incorporated by reference in its entirety.

[0022] Also described herein are apparatuses (e.g., systems, devices, etc.). These apparatuses may be used to perform any of these methods. For example, a system for forminga surgical bypass may include: a rigidizing overtube comprising a tubular body surrounding a lumen extending through the tubular body, the tubular body comprising a bladder layer, a rigidizing layer and a reinforced layer, wherein the bladder layer is configured to be drive the rigidizing layer against the reinforced layer to rigidize the rigidizing overtube when pressure is applied against the bladder layer; and an expandable occluder extending through the lumen and configured to extend distally out of the lumen, the expandable occluder having a distal end region configured expand radially outward to occlude a body region.

[0023] In any of these apparatuses the distal end region of the expandable occluder may comprise a balloon. The expandable occluder may have an elongate flexible body extending proximally from the distal end region.

[0024] In any of these apparatuses, the rigidizing overtube may include a handle (e.g., handle region) at a proximal end of the apparatus. The handle may have an inlet for a flush line and / or an inlet for a pressure line. The handle may include one or more controls, including a control for controlling rigidization (e.g., to switch between a flexible state and a rigid state), a control for rotating the distal tip region (in variations including a rotatable distal tip), etc.

[0025] Any of these systems may include one or more guidewires. Any of these systems may include an obturator. The obturator may be configured to fit relatively snugly (at least over the distal end region at and / or extending from the obturator distal end) to the distal end region, to prevent fish mouthing at the distal end opening of the rigidizing overtube. For example, the obturator may have an outer diameter over the distal end region (e.g., the distal 1-20 cm, distal 1-15 cm, distal 1-10 cm, distal 1-5 cm, etc.) configured to fit within the lumen of the rigidizing overtube with a clearance of less than 1 mm (e.g., less than 0.9 mm, less than 0.8 mm, less than 0.7 mm, less than 0.6 mm, less than 0.5 mm, less than 0.4 mm, less than 0.3 mm, less than 0.2 mm, less than 0.1 mm, less than 0.05 mm, etc. around the circumference of the obturator). Any o of these obturators may include a lumen configured to pass a guidewire. In some cases the obturator may have a tapered distal end region.

[0026] The rigidizing overtube may comprise a proximal seal over the lumen of the rigidizing overtube, that may be configured to allow insertion of guidewire or other tool into the lumen of the overtube but may otherwise limit or prevent leakage out of the overtube lumen.

[0027] The overtube may be any appropriate size and may have any appropriate inner diameter. For example, the diameter of the lumen of the rigidizing overtube may be between about 2 and 20 mm (e.g., between about 2-15 mm, between about 2-10 mm, etc.).

[0028] The rigi dizing layer may comprise a plurality of lengths of filaments that cross over each other. These lengths of filament may be part of a mesh, woven, knit, braid, etc. The length of filaments may be individual (e.g., separate) lengths or the lengths of filaments may be part of a single filament or of a plurality of longer filaments having different regions forming the lengths of filaments.

[0029] Also described herein are rigidizing overtubes having deflection tips and / or rotating tips (e.g., rotating deflection tips). For example, described herein are rigidizing overtubes comprising: a tubular body surrounding a lumen extending through the tubular body, the tubular body comprising a bladder layer, a rigidizing layer and a reinforced layer, wherein the bladder layer is configured to be drive the rigidizing layer against the reinforced layer to rigidize the second rigidizing overtube when pressure is applied against the bladder layer; and a deflection tip at the distal end of the tubular body, the deflection tip having a lateral, side-facing opening and an internal ramp oriented to deflect a tool distally from the out of the lumen of the second rigidizing overtube through the lateral, side-facing opening. Any of these rigidizing overtubes may include a rotating distal tip (e.g., rotating deflection tip) and may include a torque member configured to rotate the deflection tip independently of the tubular body of the rigidizing overtube (including independently of the state, e.g., rigid or flexible, of the overtube). The torque member may be coupled to the deflection tip and to a control (e.g., rotation control) on a handle of the second rigidizing overtube. The torque member may be at least partially enclosed in a slip layer or lubricious layer / coating.

[0030] For example, a rigidizing overtube apparatus may include: a tubular body surrounding a lumen extending through the tubular body, the tubular body comprising a bladder layer, a rigidizing layer and a reinforced layer, wherein the bladder layer is configured to be drive the rigidizing layer against the reinforced layer to rigidize the second rigidizing overtube from a flexible state to a rigid state when pressure is applied against the bladder layer; a rotatable tip rotatably coupled to the distal end of the tubular body, and a torque member extending along the length of the elongate body and configured to rotate the deflection tip independently of the tubular body. The torque member may be coupled to the deflection tip and to a rotation control on a handle of the second rigidizing overtube. The torque member may comprise a torque wire.

[0031] The torque member may comprise a torque braid extending radially inwards of the rigidizing layer and bladder layer, wherein the torque braid is configured to rotate relative to the rigidizing layer and bladder layer independently of the flexible state or the rigid state. The torque member may comprise a torque braid extending radially outwards of the rigidizinglayer and the bladder layer, wherein the torque braid is configured to rotate relative to the rigidizing layer and bladder layer independently of the flexible state or the rigid state.

[0032] 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

[0033] 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:

[0034] FIG. 1 schematically illustrates an example of a method of connecting to luminal regions as described herein.

[0035] FIGS. 2A-2D illustrate one example of a method of forming a surgical bypass as described herein.

[0036] FIG. 3 shows one example of a rigidizing overtube that may be used with any of the methods described herein.

[0037] FIG. 4 is another example of a rigidizing overtube similar to the example shown in FIG. 3.

[0038] FIGS. 5A-5B illustrate enlarged views of the apparatus of FIG. 4. FIG. 5A shows an enlarged view of the distal end region and FIG. 5B shows an enlarged view of the proximal end.

[0039] FIGS. 6A-6B illustrate an example of an expandable occluder as described herein.

[0040] FIG. 7A is a section through an elongate rigidizable device that may be rigidized by the application of negative pressure.

[0041] FIG. 7B is an enlarged view showing one example of the arrangement of layers within the elongate rigidizable device of FIG. 1 A.

[0042] FIG. 8A is a section through an elongate rigidizable device that may be rigidized by the application of positive pressure.

[0043] FIG. 8B is an alternative sectional view showing one example of the arrangement of layers within the elongate rigidizing device of FIG. 8 A.

[0044] FIG. 9 illustrates an example of a robotic system including an external working channel sleeve apparatus as described herein.

[0045] FIG. 10A illustrates one example of a system for forming a surgical bypass.

[0046] FIG. 10B schematically illustrates one example of a distal end region of an overtube having a rotating tip.DETAILED DESCRIPTION

[0047] Described herein are methods and apparatuses (e.g., devices, systems, etc.) for forming a bypass between different luminal body regions. In particular, these methods and apparatuses may be used to join different portions of a patient’s GI tract, including but not limited to forming a bypass to reduce nutritional update, decrease weight, and / or improve diabetes control. In some cases these methods and apparatuses may be used for performing a gastrojejunostomy. These methods generally include the use of one or more dynamically rigidizing overtubes that may be controllably transitions between a highly flexible configuration, which may easily track over a multiply-curved guidewire and / or conform to the tortious anatomy of the body, and a more rigid configuration, which may retain the shape, including the curvature, even when external forces are applied. The use of a dynamically rigidizing apparatus as described herein may provide numerous advantages including increasing the speed and effectiveness of the procedure.

[0048] FIG. 1 schematically illustrates one example of a method of forming a surgical bypass as described herein. In FIG. 1, the method may pass a rigidizing overtube through a first target luminal region and into a second target luminal region 153. In some cases the first target region may be, for example, within the patient’s stomach. The second target region may be within the patient’s small intestine (e.g., jejunum). In some cases positioning may include positioning a guidewire first 151. In some cases a stricture may be present between the first and second target regions, and the guidewire and / or overtube may be passed through the structure. In some cases the overtube may include an obturator extending distally from the overtube to assist in navigating through the GI tract, including through any stricture.

[0049] Once in position the overtube may be rigidized 155 before, during or after occluding and / or filling the second target luminal region. For example, the rigidizing overtube may be rigidized before passing an expandable occluder through the rigidizing overtube so that it extends distally to the second target region 157. Alternatively the rigidizing overtube may be rigidized after this step. The rigidizing overtube may be rigidized before expanding the expandable occluder to form an enclosed region including the second target luminal region 159. In some cases the enclosed region may be formed between a stricture and the expandable occluder; in some cases the enclosed region may be formed between an occluder (e.g., balloon) on the rigidizing overtube and the distally positioned expandable occluder. Alternatively, the rigidizing overtube may be rigidized after this step. The rigidizing overtube may be rigidized before filling the enclosed region with a filling solution (e.g., saline, contrast solution, etc.) 161, or after filling the enclosed region will filling solution.

[0050] At any point during the procedure the position of the rigidizing overtube may be readjusted 163. For example the position the first and second target luminal regions relative to each other may be readjusted by de-rigidizing the rigidizing endoscope (e.g., releasing the pressure applied to rigidize), moving the overtube, and re-rigidizing.

[0051] The rigidizing overtube may be maintained in the rigid configuration while connecting a stent between the first target luminal region and the second target luminal region 165.

[0052] FIGS. 2A-2D illustrate one example of a method as described herein, configured as a gastrojejunostomy bypass method. In FIG. 2A, the stomach 202, duodenum 204 (including an occlusion or stricture 206) and the jejunum 208 are shown. FIG. 2B shows the same anatomy with a rigidizing overtube 210 extending through the stomach, past the stricture and into the small intestine (e.g., duodenum up to the jejunum). In this example, the method may include navigating through the stomach 202 with a gastroscope to the stricture 206; alternatively, the method may include navigating the stomach using a rigidizing overtube 210 which may be used in conjunction with the gastroscope (e.g., endoscope). In some cases a guidewire may be inserted through the gastroscope / endoscope (and / or through the overtube) through the stricture 206. The overtube may then be transitioned over the guidewire by first inserting or installing an obturator through the overtube and / or scope while it is passing through the stricture over the guidewire. Alternatively the rigidizing overtube may with obturator may be inserted through the stricture without guidewire. In some example, the rigidizing overtube with the endoscope may be inserted through the stricture. When an obturator is used, it may be withdrawn once the device has passed the stricture.

[0053] In general, these methods and apparatuses may be used with visualization. For example, using fluoroscopy and / or ultrasound (e.g., endoscopic ultrasound, EUS).

[0054] The overtube may be advanced distally until the distal end region of the rigidizing overtube is positioned at or just distal to a second luminal target region, as shown in FIG. 2B. The second luminal target region may include a region of the lumen wall that is to be coupled with a portion of the lumen wall from the first luminal target region. In FIG. 2A the first luminal target region is a wall of the stomach 202’ and the second luminal target region is a region of the wall of the small intestine 214.

[0055] As shown in FIG. 2C, the second luminal target region may be isolated from the rest of the GI tract by an occluder at a distal end and either or both an occluder on the rigidizing overtube 210 and / or the stricture 206. As shown in FIG. 2C, the method may include advancing an expandable occluder 212 through the rigidizing overtube 210 in a collapsed configuration and expanding (e.g., in some cases inflating) the expandable occluderto block the region distal to the stricture and distal to the second luminal target region. In this example the proximal region is also occluded. Inflation / deflation of the expandable occluder (e.g., balloon catheter) may be monitored through the device with visualization under fluoro or EUS. In some cases fluid may be injected into the balloon catheter for visualization under fluoro or EUS. Alternatively if the device has a balloon (or when the additional / separate expandable occluder is used), fluid may be injected into the balloon as well.

[0056] In some cases saline may be added through a port (e.g. proximal port) of the device such that the space from the stricture to the balloon is flooded with fluid and visible with fluoro or EUS. Alternatively if the device has the proximal and distal balloons only the space between the balloons will be flooded. In general, a user may rigidize the rigidizing overtube device to maintain stability of the duodenum / jejunum between any of the steps described above. Rigidizing may provide a highly stable platform for performing any of these methods.

[0057] As shown in FIG. 2D, once in position and help fixed relative to each other, the first and second regions may be coupled together to form the ostium between the two. In FIGS. 2C-2D, this may be performed using a separate scope 220 to may but the tissue of both the first and second target regions. In FIG. 2D, for example, the second scope tool 220 may be configured as an endoscope that may be inserted adjacent to the overt tube and into the stomach, wherein the second scope tool 220 may perform the cutting (e.g., using a cautery needle or other element) and insertion of a stent 216 between the first and second luminal target regions. The stent may be placed on the second luminal target region and may target any space in the flooded zone including near the rigidizing sheath, the balloon catheter shaft, or even the balloon itself. The second scope may be a rigidizing overtube 218 that may be positioned in place and rigidized (by the application of pressure) to facilitate cutting and / or placement of the stent or other device. In some cases, this rigidizing overtube includes a deflection tip 221 as shown in FIGS. 2C and 2D. the deflection tip may be coupled to the distal end of this second rigidizing overtube and may include a side-facing opening and may be closed off at the distal end. The deflection tip may include an internal ramp or curvature (deflection surface) so that a tool, guidewire, etc. may be deflected laterally out of the side opening

[0058] In some cases the deflection tip is rotatable and may be rotated independently of the elongate body of the rigidizing apparatus. For example, the deflection tip may be coupled to a torque member extending within the lumen and / or wall of the elongate body of the rigidizing overtube. The tip may be coupled to the distal end region of the rigidizing overtube by a rotatable coupling, preventing the tip from separating from the distal end but allowingradial movement. The torque member may extend, e.g., over an outer surface of the elongate body of the rigidizing overtube, such as outside of the rigidizing layer and / or bladder layer within the wall of the elongate body of the rigidizing overtube) and may be separated from the by a lubricous layer. Alternatively, the torque member may be radially inward of the bladder layer and rigidizing layer in the elongate body (or within the lumen). For example, the torque member may be a braided tube (having a relatively high braid angle along the length to allow torque) that is rotatable relative to the rest of the elongate body, and which can be rotated regardless of the state of rigidization of the elongate body. In some cases the torque member may be a torque wire that extends within the lumen and / or wall of the rigidizing member and may be coupled to the rotatable tip, e.g., at a central attachment region within the rotatable tip. Any of these apparatuses may include a rotation / torque control on the handle that may allow torquing / rotation of the distal deflection tip and is coupled to the torque member.

[0059] In FIG. 2C a tool is shown extending laterally from the deflection tip 221; this tool may pass through the lumen of the second rigidizing overtube, and the distal end of the tool may be deflected laterally out of rigidizing overtube. In some cases the tool may be configured to cut or help form the anastomosis, as shown. The stent 216 may also be passed through the rigidizing overtube for insertion into the tissue.

[0060] Thus, also described herein are apparatuses, including systems, for performing any of these methods. For example, a system may include a rigidizing overtube 210, an expandable occluder that is configured to pass through the rigidizing overtube, and in some examples a guidewire and / or obturator. The stent may be included as part of the system or may be separately provided. In some cases a second scope, e.g., gastroscope, may also be included. In some cases the systems described herein may include a rigidizing overtube with a deflection tip at the distal end (e.g., closed at the distal end and having a lateral opening into / out of the lumen). The distal tip may be rotatable independently of the elongate body of the rigidizing overtube, as described above.

[0061] For example, FIG. 3 illustrates one example of a rigidizing overtube 310 apparatus that includes a shaft that may be reinformed and constructed as described in greater detail below. In some cases the shaft may contain metal coils with possible addition of marker bands for fluoro or EUS. The shaft tip 439 at the distal end may be atraumatic. In general, the shaft mab be configured to convert from a highly flexible configuration to a highly rigid configuration based on the application of pressure (e.g. positive pressure or negative pressure, e.g., vacuum). The shaft outer jacket may be heat and / or puncture resistant. The apparatus also includes a handle 335 that may include a rigidization line 331. The handle may alsoinclude a flush line 333 and proximal seal which may allow fluid to exit only towards the distal tip 339. In some cases the shaft outer diameter (OD) may be sized to fit through a gastroscope working channel e.g., having a diameter of 2.8 mm or smaller. The shaft inner diameter (ID) may be sized to accommodate an additional scope (e.g., 5.8 mm or larger). In some cases the shaft may include an expandable occluder (e.g., balloon) on the distal end region (not shown). FIG. 4 shows another example of a rigidizing overtube apparatus similar to that shown in FIG. 3. FIGS. 5A-5B show enlarged views of the distal end region of the overtube and the proximal handled.

[0062] Any of these apparatuses may include or may be configured to work with an expandable occluder 600 (e.g., balloon, frame, etc.). For example, FIGS. 6A-6B illustrate an example of an expandable occluder and the expandable distal end of the occluder, respectively. In FIGS. 6A-6B the expandable occluder is configured as an inflatable balloon that may be deflated and passed through the lumen of the rigidizing overtube and out of the distal end, as shown in FIGS. 2C-2D, discussed above. The expandable occluder 600 shown in this example as a balloon catheter, may include a shaft containing one or more marker bands for fluoroscopy or EUS. The tip region may be atraumatic and / or tapered. In some cases the shaft outer jacket may be heat or puncture resistant. The occluder may include a handle that may include a connector (e.g., luer). The shaft OD may be sized to fit through the ID of the overtube. The shaft may contain A guidewire channel. In some cases the balloon material may be compliant and may inflate in a round profile. In some cases the balloon material may be semi compliant and inflate in a non-round profile. For example, the balloon may be around 25-40 mm in diameter when inflated. In some cases the shaft may contain multiple balloons.

[0063] The rigidizable apparatuses 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”), PCTUS2021024582 (titled “LAYERED WALLS FOR RIGIDIZING DEVICES”), PCTUS2021034292 (titled “RIGIDIZING DEVICES”), PCTUS2022014497, titled “DEVICES AND METHODS TO PREVENT INADVERTENT MOTION OF DYNAMICALLY RIGIDIZING DEVICES,”PCTUS2022019711, titled “CONTROL OF ROBOTIC DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES,” U.S. provisional patent application 63 / 265,934, “METHODS AND APPARATUSES FOR REDUCING CURVATURE OF A COLON,” U.S. provisional patent application 63 / 296,478, titled “RECONFIGURABLE STRUCTURES,” U.S. provisional patent application 63 / 308,044, “DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES,” U.S. provisional patent application 63 / 324,011, “METHODS AND APPARATUSES FOR NAVIGATING USING A PAIR OF RIGIDIZING DEVICES, U.S. provisional patent application 63 / 342,618, “EXTERNAL WORKING CHANNELS FOR ENDOSCOPIC DEVICES,” U.S. provisional patent application 63 / 335,720, “HYGIENIC DRAPING FOR ROBOTIC ENDOSCOPY,” and U.S. provisional patent application 63 / 332,686, “MANAGING AND MANIPULATING A LONG LENGTH ROBOTIC ENDOSCOPE,” each of which is herein incorporated by reference in its entirety.

[0064] 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.

[0065] 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 ormore, 30 or more, etc.). Any of these apparatuses may also be configured so that at least some 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).

[0066] FIG. 7A 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. 7B 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.

[0067] Another example of a rigidizable device is shown in FIGS. 8A-8B. In this example the device may also be an elongate, e.g., catheter or tubular-shaped device similar to that in FIGS. 7A-7B but may be rigidized by the application of positive pressure. For example, FIG. 8A 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 rigidizinglayer and an outer layer 2101. The outer layer in this example (similar to the inner layer 2115) 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.

[0068] Both examples of a devices shown in FIGS. 7A-7B and 8A-8B 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.Rigidizing Apparatuses

[0069] The rigidizable apparatuses (e.g., rigidizing overtubes and / or endoscopes) described herein that may be used as part of the systems and for any of these methods may include rigidizing layers or regions that engage with a compression layer (which may be or may include a bladder) that applies force to the rigidizing layer to rigidize the rigidizing layer or in some cases to de-rigidize (e.g., release from rigidization) the rigidizing layer. In some examples, these rigidizable apparatuses may include a layer that could include a braid, knit, woven, chopped segments, randomly distributed or randomly oriented filaments or strands, engagers, links, scales, plates, segments, particles, granules, crossing filaments, or other materials forming the rigidizing layer.

[0070] For example, described herein are rigidizing devices that include a knit material (e.g., knit tube) as all or part of the rigidizing layer. Such a device may include: an elongate flexible tube; a rigidizing layer comprising a knit structure; an inlet configured to attach to a source of pressure; and a compression layer configured to be pushed against the rigidizing layer by a pressure differential from the inlet; wherein the rigidizing device is configured to change between rigid and flexible states by the application of or release of pressure.

[0071] In any of these devices the knit layer may be a knit tube. The knit material, which may be referred to herein equivalently as a knit or a knitted material, 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 mono-filament, a plurality of filaments, a strand, a wire, a thread, etc. The fiber may be continuous, in which each of the filament lengths forming the rigidizing layer are partof 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. The knit structure may be configured so that a wale direction of the knit structure extends in a long axis of the flexible tube. Alternatively, the knit structure is configured so that a wale direction of the knit structure is perpendicular to a long axis of the flexible tube.

[0072] The knit configuration may be modified in order to optimize the flexibility of these apparatuses in the non-rigidized configuration and / or the rigidity in the rigidized configuration. For example, the knit structure may comprise an average loop length that is two times or greater (e.g., 3x, 4x, 5x, 6x, 7x, 8x, 9x, lOx, 20x, 40x, 60x, 80x, lOOx or more) the average loop width. As mentioned, the knit structure forming the rigidizing layer may comprise a knit fiber bundle, a single filament, a bundle of filaments, etc. The material (e.g., filaments) forming the knit structure may be any appropriate material, such as a yarn made of a natural or man-made material, a metal, metal alloy, composite material, polymeric material, natural fiber, etc. In some cases the knit is formed from a fiber, including, for example, aramids (Kevlar, Twaron, Technora), Vectran, UHMWPE (Dyneema or Spectra), Zylon, nylon, polyester, or carbon fiber. In some cases the knit is formed of a composite of multiple materials. In some cases the knit is formed of a metal or multiple metals, including for example, nitinol, a stainless steel alloy, a magnesium alloy, tantalum, cobalt-chromium alloys, etc.

[0073] In any of the rigidizing devices described herein the outer layer may be a reinforced outer layer, including but not limited to a coil -reinforced layer. For example, the elongate flexible tube may comprise a coil -reinforced tube. Alternatively, the elongate flexible tube may comprise a non-coil-reinforced tube.

[0074] Any of these apparatuses may include one or more inlets. For example, an apparatus (e.g., rigidizing device) may include one or more inlets coupled to a proximal end of the flexible elongate tube. The inlet(s) may be coupled at the proximal end region to a source of pressure (e.g. positive pressure or vacuum / negative pressure) to apply a pressure differential to rigidize or to relax, make more flexible, or de-rigidize the apparatus. The inlet(s) may be coupled to input the system at the distal end, including through a feed-line. For example, the inlet may be configured to attach to a source of positive pressure. In some examples the compression layer is configured to be pushed against the rigidizing layer when the positive pressure is applied through the inlet. In some examples the inlet may be configured to attach to a source of negative pressure, and the compression layer may be configured to be pushed against the rigidizing layer when the negative pressure is applied through the inlet.

[0075] Any of the apparatuses described herein may also include a second (or more) inlet, such as a secondary inlet, which may be, for example, on the other side of the compression layer than the first (primary) inlet. The secondary inlet could be passive (i.e., a vent), or active (i.e., as a vacuum port, so as to remove mass (for example, air or water) from within a volume so as to provide additional actuation force, or so as to reduce or eliminate the mass from potential inadvertent release within the body). Thereby, for example, a device may simultaneously provide both positive and negative pressure, for example with one force acting on either side of the compression layer, so as to enhance performance, including, but not limited to, rigidization values (e.g., speed of rigidizing / de-rigidizing, pressure applied, etc.).

[0076] The compression layer may be any appropriate layer for applying force against the rigidizing layer to rigidize it. In some examples the compression layer is a bladder. The compression layer may be configured to conform against the rigidizing layer. In some examples the compression layer may be configured so as not to conform to the rigidizing layer. For example, the compression layer may be created so that it pushes but does not appreciably deform into the rigidizing layer. The compression layer may be created so that it pushes against and then deforms or distends into the rigidizing layer. In some examples the compression layer comprises an elastomeric (e.g., stretchy) material. In some cases the compression layer is not elastomeric. The compression layer may be plastic. The compression layer may be a plastomer. The compression layer may be a composite structure. For example, the compression layer may be formed of a less-stretchy material that may be an oversized material (e.g., polyethylene terephthalate (PET), nylon, low density polyethylene (LDPE), or a plastomer). Any of these apparatuses may include multiple different rigidizing regions, e.g., along the length of the apparatus, which may be separately or collectively actuated.

[0077] The compression layer may be formed by multiple methods. Many bladders are extruded as tubes. Sheets can be created (e.g., extruded, solution cast, blown, etc.) and then heat-sealed or bonded into a tubular structure. Tubes can be created by dipping, e.g., over a mandrel into an elastomer bath or a solvated elastomer bath. A layer may be created by blowing a film. In this case, the film starts out as a bubble of material (typically a plastic or a plastomer, but sometimes also an elastomer) that, with high pressure air behind it, expands or stretches into a tube that is then carried (usually vertically) as it cools while it is diametrically constrained. This approach provides leak-proof quality control and may create a structure that is lower cost and thinner.

[0078] The rigidizing device may be configured to have a rigid configuration when positive pressure or negative pressure is applied through the inlet and a flexible configuration when the pressure is not applied through the inlet.

[0079] Examples of rigidizable devices including a knit rigidizable member are described in greater detail herein and may provide numerous advantages as compared to other rigidizing members.

[0080] Also described herein are apparatuses (e.g., rigidizable devices) having an integrated compression layer and rigidizing layer. In some examples the rigidizing layer may include filament lengths that are within (including but not limited to encapsulated within) a compression material. Deforming the compression material, e.g., by applying positive and / or negative pressure, may transition the rigidizing layer between flexible and rigid configurations.

[0081] For example, a rigidizing device may include: an elongate flexible tube; a rigidizing layer comprising an array of filament lengths within a compression material, wherein the array of filament lengths are configured to slide over each other when the compression material is in a first configuration and wherein the array of filament lengths are engaged against each other when the compression material is in a second configuration; an inlet configured to attach to a source of pressure, wherein the compression material is transition between the first configuration and the second configuration by the application by a pressure differential from the inlet to change the rigidizing layer between a rigid state and a flexible state. The first configuration may be an uncompressed configuration and the second configuration may be a compressed configuration. The source of pressure may be a source of positive pressure or a source of negative pressure (e.g., vacuum).

[0082] The array of filament lengths may comprise an array of filaments. For example the array of filament lengths can be part of a single filament or may be multiple lengths. In some examples the filament lengths may be part of a single filament, a bundle of filaments, etc. As mentioned above, the filaments may be wire(s), yam, etc., and the filament material may be any appropriate material, including metal, metal alloys, polymeric material, natural fibers, etc. The filaments may be any appropriate length. In some examples, the filament length may vary and / or may be different lengths, and the filament crossing pattern may be consistent and ordered or it may be more random. For example, the material may be chopped filaments or stainless steel ‘wool’.

[0083] In any of these examples the array of filament lengths may be slideably encapsulated within the compression material in the first configuration. Thus, rather than a layer over or under the rigidizing layer, the compression material may surround and / orencapsulate the strands of the rigi dizing material. For example, the compression material may comprise an elastomeric material; the filament lengths may be fully encapsulated, or they may be within a construct in which they are held within channels or cavities of the elastomeric material and as the material is deformed, e.g., by applying a positive or negative pressure, the ridigizing layer may be made rigid. In general, the compression material may be any appropriate compressible material. In some examples the compression material may be a lubricious material and / or a lubricious material may be within the channels or chambers holding the rigidizing layer. In some examples the compression material forms a bladder.

[0084] In any of these apparatuses the inlet may be configured to couple the source of pressure to a gap between the elongate flexible tube and the rigidizing layer. The elongate flexible tube may be an inner tube and / or an outer tube of the device. Alternatively or additionally, the inlet may be configured to couple the source of pressure to an encapsulation region between the encapsulated filament lengths and the compression material.

[0085] The elongate flexible tube may comprise an inner tube. In any of these examples the device may comprise a reinforced outer layer, such as a coil -reinforced outer layer. The elongate flexible tube may comprise a coil -reinforced tube. The rigidizing device may be configured to have a rigid configuration when positive pressure or negative pressure is applied through the inlet and a flexible configuration when the pressure is not applied through the inlet. Alternatively, the rigidizing layer may be configured to be unrigidized (de-rigidized) in the first configuration when there is no pressure differential between the inlet and atmosphere.

[0086] For example, described herein are rigidizing devices comprising: an elongate flexible tube; a rigidizing layer comprising an array of filament lengths within a bladder, wherein the array of filament lengths are configured to move relative to each other when the bladder is in a flexible configuration and, wherein the array of filament lengths are less mobile relative to each other when the rigidizing layer is pressurized against the elongate flexible tube into a more rigidized configuration.

[0087] Also described herein are apparatuses having a rigidizing layer formed of multiple lengths of fibers that cross over and under each other and that are configured to rigidize when positive pressure is applied. Because the lengths of filaments cross over and under each other, the application of positive pressure may be particularly effective and may allow a graded response to positive pressure in which the greater the positive pressure, the more rigid that the device may become.

[0088] For example, a rigidizing device may include: an elongate flexible tube; a rigidizing layer comprising an array of filament lengths crossing over and under each otherand configured to move relative to each other; an inlet configured to attach to a source of positive pressure; a compression layer configured to be pushed against the rigidizing layer by a pressure differential from the inlet to rigidize the rigidizing layer, wherein the rigidizing device is configured to change between rigid and flexible states by the application of or release of pressure. Moving relative to each other may include multiple types, directions, and modes of motion, including sliding, pivoting, shearing, displacing, etc.

[0089] As used herein a plurality of filament lengths may be part of a single strand or may be individual strands of filament. The lengths of filaments may be the same size or may be different sizes. For example, the array of filament lengths may comprise a plurality of discrete filaments. The rigidizing layer may be a tube or other shape that is formed of single fiber or multiple fibers (including a single fiber that is broken / cut at regular or irregular lengths). At least some of the filament lengths of the array of filament lengths may be part of a same filament.

[0090] In general, the compression layers descried herein include structural layers that may be (but are not limited to) a bladder layer(s) and / or sheets of materials that apply a compressive force on or against the rigidizing layer to rigidize the rigidizing layer, or in some cases to release the rigidizing layer from rigidization. For example, the array of filament lengths may comprise a woven, braided or knit tube. Filaments may be chopped segments, and / or may be sewn.

[0091] The array of filament lengths may comprise one or more wires. As mentioned above, the filament lengths may be formed of any appropriate material and may be a single filament, bundles of filaments, e.g., yam, metal, metal alloys, composite materials, polymeric material, natural fiber, etc.

[0092] Any of these apparatuses may include a reinforced inner and / or outer layer, including a coil-reinforced layer. In any of these examples the outer layer is not a coil- reinforced layer, as other outer layers may be used. In some examples the elongate flexible tube comprises a coil-reinforced tube. The elongate flexible tube may comprise a tube that is not coil-reinforced. The elongate flexible tube may comprise a reinforced tube that is not a coil. The elongate flexible tube may comprise a laser cut tube. The elongate flexible tube may comprise a series of linkages. The inlet may be coupled to a proximal end of the flexible elongate tube. The inlet may be configured to attach to a source of positive pressure, further wherein the compression layer is configured to be pushed against the rigidizing layer when the positive pressure is applied through the inlet. The inlet may be configured to attach to a source of negative pressure, further wherein the compression layer is configured to be pushed against the rigidizing layer when the negative pressure is applied through the inlet. In someexamples the compression layer comprises an elastomeric layer. In some examples the compression layer comprises a bladder, or multiple bladders, e.g., for multiple rigidizing regions. In any of the apparatuses described herein the bladders may be elastomeric or may not be elastomeric. For example, they may be plastic, a plastomer, or composite. The rigidizing devices described herein may be configured to have a rigid configuration when positive pressure or negative pressure is applied through the inlet and a flexible configuration when the pressure is not applied through the inlet.

[0093] Also described herein are apparatuses that are actuated by pressure, including high pressure. In some examples the greater the applied pressure, the more rigid the apparatus will become. For example, described herein are positive pressure (e.g., high pressure) apparatuses in which the compressible member (e.g., bladder) deforms, distending and interdigitating into the wires forming the rigidizing layer. A rigidizing device may include: a flexible inner tube created to or reinforced to withstand a radially compressive load; a flexible outer tube reinforced to withstand a radially tensile load; a rigidizing layer between the inner and outer tubes comprising a plurality of filament lengths crossing over and under each other and configured to move relative to each other; a compression layer configured to deform onto or into the rigidizing layer when a positive pressure is applied to the compression layer, wherein the application of pressure restricts (or in some examples reduces) movement of the plurality of filament lengths, thereby increasing rigidization. For example, as a positive pressure device is pressurized, the positive pressure of the inner tube may drive the reduction of the diameter of the inner tube, and / or may cause it to structurally collapse, including radially collapse or through other forms of collapse. The device is configured to resist these failures within normal operating pressures. As the positive pressure device is pressurized, the outer tube may experience the positive pressure applied as an expansive or tensile load to the reinforcing wires, nominally expanding its diameter, and, if the reinforcements are undersized, fracturing the reinforcing elements. The device is configured to resist these failures within normal operating pressures.

[0094] As mentioned, the deformable compression layer may comprise a bladder. The rigidizing layer may be between the flexible outer tube and the compression layer and wherein the compression layer is configured to press the rigidizing layer into the outer tube when the positive pressure is applied to the compression layer. The rigidizing layer may be between the flexible inner tube and the compression layer and wherein the compression layer is configured to press the rigidizing layer into the inner tube when the positive pressure is applied to the compression layer. In some examples the deformable compression layer comprises an elastomeric layer.

[0095] The flexible outer tube may comprise a reinforced (e.g., spiral reinforced, braid reinforced, coil reinforced, etc.) inlaid member(s) and / or layer. Alternatively or additionally, the flexible inner tube may comprise a reinforced layer. The array of filament lengths may comprise a plurality of filaments. These filament lengths may be formed of a single fiber or multiple fibers (including being formed of a single fiber that is broken / cut at regular or irregular lengths). In some examples the array of filament lengths comprises a weave or a braid or a knit. The filament lengths may be ordered or not ordered. The array of filament lengths may comprise one or more wires. For example, the array of filament lengths can be made of a single filament, a bundle of filaments, e.g., yarn, metal, metal alloys, polymeric material, natural fiber, etc.

[0096] Any of these apparatuses (e.g., devices) may include one or more inlets that are in fluid communication with the compression layer and are configured to couple to a source of positive pressure. Different inlets may control the application of a pressure differential (e.g., positive and / or negative pressure) to different regions of the apparatus, to allow selective rigidization of different regions of the apparatus. The inlet may be coupled to either end of the flexible elongate tube (proximal or distal), or to an intermediate location.

[0097] The rigidizing devices described herein may be configured to have a rigid configuration when positive pressure is applied through the inlet and a flexible configuration when the pressure is not applied through the inlet. Alternatively, in some examples the rigidization devices described herein may be configured to have an un-rigidized (flexible) configuration when positive pressure is applied through the inlet and a rigid configuration when the pressure is not applied through the inlet.

[0098] The apparatuses described herein may include one or more rigidizing layers that are actuated by the application of positive pressure, including high pressure. In particular, described herein are rigidizing devices having a rigidizing layer formed of a plurality of particles or granules that may move in a loose configuration in the flexible configuration (e.g., when there is no pressure differential relative to atmosphere) but may be rigid when positive pressure is applied, e.g., via a compression layer. When positive pressure is applied, the rigidizing layer may become consolidated or jammed, thereby making the device less flexible or more rigid. For example, a rigidizing device may include: a flexible inner tube; a flexible outer tube; a rigidizing layer comprising a plurality of granules between the inner and outer tubes; an inlet configured to attach to a source of positive pressure; and a compression layer between the inner and outer tubes that is configured to be pushed against the rigidizing layer when a positive pressure is applied through the inlet to compress and rigidize the rigidizing layer.

[0099] The granules may be any appropriate size or distribution of sizes (e.g., 1 mm diameter or less, 0.8 mm diameter or less, 0.7 mm diameter or less, 0.6 mm diameter or less, 0.5 mm diameter or less, 0.4 mm diameter or less, 0.3 mm diameter or less, 0.2 mm diameter or less, 0.1 mm diameter or less, 0.05 mm diameter or less, 0.01 mm diameter or less etc.). The granules may be any appropriate material, typically a rigid or semi-rigid material (e.g., polymer, metal, mineral, composite material, etc.). The granules may be formed of biocompatible material. In some cases the granules may be bioresorbable. The granules may be crystalline. The granules may have any appropriate shape. For example, the granules may be round, square, faceted, long, oblong, rectangular, obtuse, etc. In some examples the shape of the granules may be regular. In some examples the shape of the granules may be irregular. The granules may include both regular and irregular shapes and may include a variety of different shapes and / or sizes in the same rigidizing layer. The granules may be enclosed within an enclosure, such as a packet, which may be formed into a cylinder. The packet may be sealed or porous (e.g., may include pores that are smaller than the granules). In some examples the compression layer may contain or may partially contain the granules. The compression layer may actuate, urge, push, or consolidate the rigidizing layer. For example, the compression layer may be the enclosure or part of the enclosure. The compression layer may be a bladder. The compression layer may be an elastomeric layer.

[0100] As in any of the examples described herein, the outer tube and / or the inner tube may be or may not be reinforced. It could be a laser cut tube. The laser cut tube could be integrated with a distal bending section, which has a different cut pattern but is part of the same tube. For reinforced versions, for example, the inner and / or outer tube may include a coil reinforcement, for example a material that exhibits high tensile strength. This could be a wire, a polymer, a composite fiber, a yam made of a natural or man-made material, a metal, a metal alloy, a composite material, a polymeric material, a natural fiber, etc. In some cases it could be a fiber, including, for example, aramids (Kevlar, Twaron, Technora), Vectran, UHMWPE (Dyneema or Spectra), Zylon, nylon, polyester, polyethylene, dacron, polypropylene, fiberglass, basalt, or carbon fiber. In some cases it could be formed of a composite of multiple materials. In some instances it could be formed of a metal, including, for example, nitinol, a stainless steel alloy, a magnesium alloy, tantalum, cobalt-chromium alloys, etc.

[0101] Any of the apparatuses including granules as part of the rigidizing layer may be configured to change between rigid and flexible states by the application of or release of pressure. Thus, the application of positive pressure may compress the granules, in someexamples by driving the compression layer against the granules and the inner and / or outer tube to rigidize the granules, without requiring a vacuum to be applied.

[0102] Also described herein are apparatuses (e.g., devices) and methods in which the rigidizing layer comprises a plurality of members (e.g., layers, pieces, parts, sub-layers such as arms, scales, plates, etc.). The application of pressure (e.g., positive pressure) may drive the plurality of sub-layers (e.g., arms, plates, scales, etc.) against the inner (or in some configurations, the outer) tube and / or adjacent sub-layers; as the pressure increases the device may become increasingly rigid. This application of positive pressure may deliver a consolidating force that is substantially higher than that which can be delivered by the one atmosphere of vacuum. Alternatively, in some configurations the device may be configured so that the sub-layers are biased against each other in the un-actuated state (when pressure is not being applied) and the application of positive pressure separates the sub-layers from the inner or outer tube and / or each other, transitioning the device from a rigid state to a flexible state.

[0103] For example, described herein are rigidizing devices comprising: a flexible outer tube; a flexible inner tube; a rigidizing layer comprising a plurality of overlapping members between the inner and outer tubes; an inlet configured to attach to a source of positive pressure; and a compression layer between the outer and inner tubes and configured to be pushed against the rigidizing layer when a positive pressure is applied through the inlet to compress and rigidize the rigidizing layer.

[0104] The overlapping members may comprise a plurality of overlapping sub-layers (e.g., scales or plates). In some examples the overlapping members comprise a plurality of arms extending from one or more radial attachment sections; the radial attachment sections may extend along the length of the device and the plurality of arms may extend either proximally and / or distally from the radial attachment section. The radial attachment section may be a partial or complete ring. In some examples the overlapping members are radially and longitudinally arranged between the inner and outer tubes. Any number of overlapping sub-layers (e.g., arms, scales, plates, etc.) may overlap with each other. For example, the overlapping members may comprise two or more layers of overlapping members. The overlapping members may interdigitate. For example, in some examples the plurality of overlapping members interdigitate along a length of the rigidizing layer. In the flexible configuration the plurality of overlapping members may be configured to slide over each other, while in the rigid configuration the plurality of overlapping members may be inhibited from sliding over each other. For example, in some cases the plurality of overlappingmembers may each comprise one or more engagement features between the overlapping members.

[0105] Any appropriate compression layer may be used. As mentioned, in some examples the compression layer comprises a bladder. The compression layer may be an elastomeric layer or a non-elastomeric layer. The outer and / or inner tube may comprise be reinforced. For example, the flexible inner and / or outer tube may comprise a coil-reinforce layer. In any of these examples the inlet may be coupled to a proximal end of the flexible elongate tube.

[0106] The rigidizing device may be configured to change between rigid and flexible states by the application of or release of pressure (e.g., positive pressure).Robotic apparatuses

[0107] As mentioned above, the rigidizing apparatuses described herein may be configured as part of a robotic system or for use with robotic apparatuses. 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. 9 shows an exemplary apparatus 3100, including a rigidizing device configured as an overtube 3112; the system may optionally include an inner endoscope 3110. The overtube and inner endoscope 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. 9, the outer overtube 3112 and the inner endoscope 3110 may be terminated together into a common structure, such as a cassette 3157. The outer overtube 3100 can be movable with respect to the endoscope 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 tip of the endoscope 3110 (and / or outer overtube 3112). Other steering mechanisms (e.g., pneumatics, hydraulics, shape memory alloys, EAP (electroactive polymers), or motors) are also possible. The cassette 3157 can further include bellows 3103 a, 3103b that may connect to the pressure gap of the endoscope 3110 and the overtube 3112, respectively to drive fluid through pressure lines 3105z, in variations for either the endoscope and / or the overtube that are configured to rigidize when pressure is applied. 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 devices can be rigidized and de-rigidized through one or more pumps or pressure sources (e.g., via pressure line 3105z).

[0108] 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.

[0109] The process parameters and sequence of 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. The various example methods described and / or illustrated herein may also omit one or more of the steps described or illustrated herein or include additional steps in addition to those disclosed.

[0110] FIG. 10A illustrates one example of a system as described herein. In this example, the system includes a first rigi dizing obturator 1001 that include a proximal handle, an elongate body and a distal tip region. The first rigi dizing obturator 1001 also includes an expandable occluder extending through the lumen of the rigi dizing obturator 1001 and configured to extend distally out of the lumen, as shown. The expandable occluder has a distal end region configured expand radially outward (e.g., a balloon 1041) that can occlude a body region as discussed above. The system may also optionally include one or more guidewires 1005 and / or one or more obturators 1007. In some cases that system may also include a second rigi dizing overtube 1010.[OHl] In general, any of the rigidizing overtubes described herein may include a rotatable distal tip region 1015. In the example shown in FIG. 10A and in greater detail in FIG. 10B, the distal tip region 1015 is configured as a deflecting distal tip that include a lateral / side facing opening 1035 into the lumen of the rigidizing overtube. The rotating tip also includes a ramp 1025 that deflect a tool, guidewire, etc. extending through the lumen lateral out of the side-facing opening. The rotatable distal tip may be rotationally coupled 1027 to the elongate body of the rigidizing overtube and may also be coupled to a torque member 1020 shown in this example as a torque braid that is rotatably positioned within the body (or within the lumen) of the rigidizing overtube. The proximal handle of the rigidizing overtube may include a rotation control 1033 that can be operated to rotate the tip.

[0112] 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 methods described 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.

[0113] 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 / or elements 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.

[0114] 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

[0115] 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 devicemay 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.

[0116] 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 one feature / 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.

[0117] 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.

[0118] 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 orequal 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.

[0119] 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. For example, the order in which various described method steps 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 various device and system embodiments 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.

[0120] 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

CLAIMSWhat is claimed is:

1. A system for forming a surgical bypass, the system comprising: a rigidizing overtube comprising a tubular body surrounding a lumen extending through the tubular body, the tubular body comprising a bladder layer, a rigidizing layer and a reinforced layer, wherein the bladder layer is configured to be drive the rigidizing layer against the reinforced layer to rigidize the rigidizing overtube when pressure is applied against the bladder layer; and an expandable occluder extending through the lumen and configured to extend distally out of the lumen, the expandable occluder having a distal end region configured expand radially outward to occlude a body region.

2. The system of claim 1, wherein the distal end region of the expandable occluder comprises a balloon.

3. The system of any of claims 1-2, wherein the expandable occluder comprises an elongate flexible body extending proximally from the distal end region.

4. The system of any of claims 1-3, wherein the rigidizing overtube comprises a handle region having an inlet for a flush line and an inlet for a pressure line.

5. The system of any of claims 1-4, further comprising a guidewire.

6. The system of any of claims 1-5, wherein the rigidizing overtube comprises a proximal seal over the lumen of the rigidizing overtube.

7. The system of any of claims 1-6, wherein an inner diameter of the lumen of the rigidizing overtube is between 2 and 15 mm.

8. The system of any of claims 1-7, further comprising an obturator having an outer diameter configured to fit within the lumen of the rigidizing overtube with a clearance of less than 1 mm, further wherein the obturator has a lumen configured to pass a guidewire.

9. The system of any of claims 1-8, wherein the rigidizing layer comprises a plurality of lengths of filaments that cross over each other.

10. The system of any of claims 1-9, further comprising a second rigi dizing overtube, the second rigidizing overtube comprising: a tubular body surrounding a lumen extending through the tubular body, the tubular body comprising a bladder layer, a rigidizing layer and a reinforced layer, wherein the bladder layer is configured to be drive the rigidizing layer against the reinforced layer to rigidize the second rigidizing overtube when pressure is applied against the bladder layer; and a deflection tip at the distal end of the tubular body, the deflection tip having a lateral, side-facing opening and an internal ramp oriented to deflect a tool distally from out of the lumen of the second rigidizing overtube through the lateral, side-facing opening.

11. The system of claim 10, further comprising a torque member configured to rotate the deflection tip independently of the tubular body of the second rigidizing overtube, wherein the torque member is coupled to the deflection tip and to a rotation control on a handle of the second rigidizing overtube.

12. A rigidizing overtube apparatus, the apparatus comprising: a tubular body surrounding a lumen extending through the tubular body, the tubular body comprising a bladder layer, a rigidizing layer and a reinforced layer, wherein the bladder layer is configured to be drive the rigidizing layer against the reinforced layer to rigidize the rigidizing overtube from a flexible state to a rigid state when pressure is applied against the bladder layer; and a deflection tip at a distal end of the tubular body, the deflection tip having a lateral, side-facing opening and an internal ramp within the lumen that is oriented opposite of the lateral, side-facing opening.

13. The apparatus of claim 12, further comprising a torque member extending along a length of the tubular body and configured to rotate the deflection tip independently of the tubular body.

14. The apparatus of claim 13, wherein the torque member is coupled to the deflection tip and to a rotation control on a handle of the rigidizing overtube.

15. The apparatus of any of claims 12-14, wherein the torque member comprises a torque wire.

16. The apparatus of any of claims 12-15, wherein the torque member comprises a torque braid extending radially inwards of the rigidizing layer and bladder layer, wherein the torque braid is configured to rotate relative to the rigidizing layer and bladder layer independently of the flexible state or the rigid state.

17. The apparatus of any of claims 12-16, wherein the torque member comprises a torque braid extending radially outwards of the rigidizing layer and the bladder layer, wherein the torque braid is configured to rotate relative to the rigidizing layer and bladder layer independently of the flexible state or the rigid state.

18. A method of forming a surgical bypass, the method comprising: positioning a rigidizing overtube through a first target luminal region and into a second target luminal region; occluding the second target luminal region and filling the second target luminal region with a fluid either before, during or after rigidizing the rigidizing overtube by applying a pressure between two or more layers of the rigidizing overtube to maintain a relative position of the first target luminal region and the second target luminal region; and maintaining the rigidizing overtube in a rigid configuration while connecting a stent between the first target luminal region and the second target luminal region.

19. The method of claim 18, further comprising sequentially de-rigi dizing the rigidizing overtube, repositioning the rigidizing overtube and rigidizing the rigidizing overtube until the first target luminal region is adjacent to the second target luminal region.

20. The method of claim 18, wherein occluding the second target luminal region comprises passing an expandable occluder through the rigidizing overtube and distal to the second target region, expanding the expandable occluder to form an enclosed region of the second target luminal region.

21. The method of claim 18, wherein positioning the rigidizing overtube comprises passing a guidewire through the first target luminal region within a patient’s stomach, through a stricture, and into the second target luminal region within the patient’s small intestine and passing the rigidizing overtube over the guidewire.

22. The method of claim 18, wherein positioning the rigidizing overtube comprises inserting the rigidizing overtube with an obturator extending distally from the rigidizingovertube through the first target luminal region within a patient’s stomach, through a stricture, and into the second target luminal region within the patient’s small intestine.

23. The method of claim 18, wherein any of the steps of positioning, occluding and maintaining further comprising visualizing the second target luminal region and / or the first target luminal region while performing the steps.

24. The method of claim 18, wherein occluding the second target luminal region comprises extending an expandable occluder through the rigidizing overtube and distal to the second target region.

25. The method of claim 24, wherein filling the second target luminal region with a fluid comprises filling the second target luminal region with the fluid from the rigidizing overtube.

26. The method of claim 18, wherein occluding the second target luminal region comprises inflating a proximal balloon on an outer surface of the rigidizing overtube.

27. The method of claim 18, wherein maintaining the rigidizing overtube in a rigid configuration while connecting a stent between the first target luminal region and the second target luminal region comprises heating a wall of the first target luminal region and the second target luminal region to form a stoma between the two and inserting the stent into the stoma.

28. A method of forming a surgical bypass, the method comprising: positioning a rigidizing overtube through a first target luminal region within a patient’s stomach, through a stricture, and into a second target luminal region within the patient’s small intestine with the rigidizing overtube in a flexible configuration; rigidizing the rigidizing overtube into a more rigid configuration by applying pressure between two or more layers of the rigidizing overtube to maintain a relative position of the first target luminal region and the second target luminal region; passing an expandable occluder through the rigidizing overtube and distal to the second target region, expanding the expandable occluder to form an enclosed region between the stricture and the expandable occluder and filling the enclosed region with a filling solution, wherein the rigidizing overtube is rigidized by applying pressure between two or more layers of the rigidizing overtube tomaintain a relative positions of the first target luminal region and the second target luminal region either before, during or after passing the expandable occluder through the rigidizing overtube; and maintaining the rigidizing overtube in the rigid configuration while connecting a stent between the first target luminal region and the second target luminal region.

29. The method of claim 28, further comprising sequentially de-rigidizing the rigidizing overtube, repositioning the rigidizing overtube, and rigidizing the rigidizing overtube until the first target luminal region is adjacent to the second target luminal region.

30. The method of claim 28, wherein positioning the rigidizing overtube comprises passing a guidewire through the first target luminal region within the patient’s stomach, through the stricture, and into the second target luminal region within the patient’s small intestine and passing the rigidizing overtube over the guidewire.

31. The method of claim 28, wherein positioning the rigidizing overtube comprises inserting the rigidizing overtube with an obturator extending distally from the rigidizing overtube through the first target luminal region within the patient’s stomach, through a stricture, and into the second target luminal region within the patient’s small intestine.

32. The method of claim 28, wherein any of the steps of positioning, rigidizing, passing and / or maintaining further comprising visualizing the second target luminal region and / or the first target luminal region while performing the steps.

33. The method of claim 28, wherein filling the enclosed region with a fluid comprises filling the second target luminal region with the fluid from the rigidizing overtube.

34. The method of claim 28, wherein occluding the enclosed region comprises inflating a proximal balloon on an outer surface of the rigidizing overtube.

35. The method of claim 28, wherein maintaining the rigidizing overtube in a rigid configuration while connecting a stent between the first target luminal region and the second target luminal region comprises heating a wall of the first target luminal region and the second target luminal region to form a stoma between the two and inserting the stent into the stoma.

36. The method of claim 28, wherein applying pressure comprises applying one or more of negative pressure or positive pressure.

37. A method of forming a surgical bypass, the method comprising: passing a guidewire through a first target luminal region within a patient’s stomach, through a stricture, and into a second target luminal region within the patient’s small intestine; positioning a rigidizing overtube, including an obturator extending distally therefrom, over the guidewire and through the first target luminal region, through the stricture, and into the second target luminal region with the rigidizing overtube in a flexible configuration; passing an expandable occluder through the rigidizing overtube and distal to the second target region, expanding the expandable occluder to form an enclosed region between the stricture and the expandable occluder and filling the enclosed region with a filling solution, wherein the rigidizing overtube is rigidized by applying pressure between two or more layers of the rigidizing overtube to maintain a relative positions of the first target luminal region and the second target luminal region either before, during or after passing the expandable occluder through the rigidizing overtube; and maintaining the rigidizing overtube in the rigid configuration while connecting a stent between the first target luminal region and the second target luminal region.

Images