Methods and apparatuses for enteroscopy

Abstract

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

Description

METHODS AND APPARATUSES FOR ENTEROSCOPYCLAIM OF PRIORITY

[0001] This patent application claims priority to U.S. provisional patent application no. 63 / 649,372, titled “METHODS AND APPARATUSES FOR ENTEROSCOPY,” and filed on May 18, 2024, herein incorporated by reference in its entirety.INCORPORATION BY REFERENCE

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

[0003] Enteroscopy is a procedure to examine your small intestine lining. It can help your healthcare provider diagnose and treat certain gastrointestinal conditions. There are several types of enteroscopy, including upper (through your mouth and throat) and lower (through your anus and rectum). The small intestine is over 20 feet long and just 1 inch wide, which makes it difficult to access. There are several techniques a gastroenterologist may use to gain access deep into the small intestine, including video capsule endoscopy, double balloon enteroscopy, single balloon enteroscopy and spiral enteroscopy. Balloon enteroscopy and spiral enteroscopy are collectively known as deep enteroscopy. However all of these approaches have significant drawbacks including cost, effectiveness and ease of operation.

[0004] Endoscopic insertion into the small intestine is important, for example, for retrieving foreign bodies, obtaining biopsies, removing small intestinal tumors or polyps, diagnosing Chrohn's Disease, performing hemostasis of ulcers, adenomas, arteriovenous malformations, or other GI bleeding, marking for surgeries of the small intestine. However, current endoscopic procedures cannot quickly and reliably advance through the small intestine.

[0005] One system for advancing through the small intestine is described in U.S. patent 11,219,351, which includes the use a pair of grabbing mechanisms on a flexible endoscope device. These devices are particularly well suited for advancing through the GI tract by changing the lateral spacing between the grabbing mechanisms. However these devices may not work well in all instances, particularly where a high level of distal stability is beneficial.

[0006] Accordingly, there is an unmet clinical need for a device that permits easier and faster navigation through the entire length of the small intestine while providing a stable platform for operation.SUMMARY OF THE DISCLOSURE

[0007] Described herein are methods and apparatuses, including systems and devices, for performing enteroscopy. These methods may include coordinating movement of a rigidizing overtube having lateral suction for anchoring to a vessel wall and an endoscope that fits through a lumen of the rigidizing overtube. An of these methods may include reducing the curvature of the vessel (e.g., the small intestine) as part of the procedure.

[0008] In general, the apparatuses described herein may be configured to include lateral suction in combination with rigidization which may more effectively and efficiently (and safely) allow navigation, visualization and treatment within the body lumen, including the small intestine. Thus, any of these apparatuses may include a rigidizing overtube and an endoscope adapted to be nested with the overtube; either the overtube and / or the endoscope may optionally include lateral suction at the distal end. In particular, the overtube may include a distal tip region (which may be integrated or separately attachable) having lateral suction that may be applied while the endoscope is advanced distally from the overtube to improve access and / or visualization.

[0009] For example described herein are apparatuses (e.g., systems, devices, etc.) for performing any of these methods that may include: a rigidizing overtube having an elongate body comprising a plurality of layers surrounding a lumen, wherein the rigidizing overtube is configured to convert between a rigid configuration and a flexible configuration by the application of pressure to the plurality of layers, wherein the plurality of layers includes: a support layer a rigidizing layer and a compression layer; and a plurality of lateral suction ports at a distal end region of the elongate body, wherein the lateral suction ports are configured to apply suction radially out of the ports to couple to a vessel wall. The apparatus may optionally include the endoscope configured to pass through the lumen of the rigidizing overtube.

[0010] An apparatus may include: a rigidizing overtube having an elongate body comprising a plurality of layers surrounding a lumen, wherein the rigidizing overtube is configured to convert between a rigid configuration and a flexible configuration by an application of pressure to the plurality of layers, wherein the plurality of layers includes: a support layer a rigidizing layer and a bladder layer, wherein the bladder layer is configured to drive the rigidizing layer against the support layer to rigidize the rigidizing overtube whenpressure is applied against the bladder layer; and a distal tip at a distal end region of the elongate body, the distal tip comprising a plurality of lateral suction ports, wherein the lateral suction ports are configured to apply suction radially from the lateral suction ports to couple to a vessel wall.

[0011] The distal tip may be a removable cap configured to be coupled to a distal end of the rigidizing overtube, and / or in some cases, an endoscope. Alternatively, the distal tip may be integrally formed at a distal end region of the rigidizing overtube (and / or in some cases, the endoscope). In variations in which the distal tip is connectable to the overtube (and / or endoscope), the distal tip may be secured by a lock (e.g., locking mechanism). For example, the distal tip may be locked onto the distal end region by threads (e.g., locking threads), but a latch, by a pin or pins, etc.

[0012] The plurality of lateral suction ports may be uniformly distributed around a circumference of the distal tip. In some examples the plurality of lateral suction ports are non- uniformly distributed around a circumference of the distal tip. For example, the plurality of lateral suction ports may be arranged between about a 3 o’clock and a 9 o’clock position around a circumference of the distal tip (e.g., between about a 2 o’clock and a 10 o’clock position, between about a 1 o’clock and a ll o’clock position, between about a 4 o’clock and an 8 o’clock position, between about a 5 o’clock and a 7 o’clock position, etc.).

[0013] The plurality of lateral suction ports may be in fluid communication with an aspiration lumen through the rigidizing overtube. In some cases the plurality of lateral suction ports are in fluid communication with the lumen of the rigidizing overtube (though which aspiration may be applied).

[0014] The distal tip may have a smaller inner diameter than the lumen of the rigidizing overtube; for example the distal tip may constrict at the distal end region to more snugly fit an endoscope passing though the overtube. As mentioned, in some examples the distal tip may be configured to secure onto the distal end region of the rigidizing overtube and may be configured to connect the lateral suction ports with either the lumen or with a separate suction line.

[0015] Any of these apparatuses may include an endoscope configured to pass through the lumen of the rigidizing overtube and out of a distal end of the distal tip. In some cases the endoscope may also be rigidizing (or may include a rigidizing shield or sleeve). Alternatively or additionally, the lateral openings may be part of the endoscope as well as, or instead of, the overtube.

[0016] In general, the rigidizing overtube may be rigidized by modifying the pressure within the wall of the overtube. For example, by compressing or constraining the rigidizinglayer within the wall (rigi dizing tube) so that the lengths of filament forming the rigidizing layer are compressed by a bladder layer (bladder tube) so that they cannot slide relative to each other. Thus, in any of these examples the rigidizing layer may be a plurality of lengths of filaments that cross over each other. The length of filament may be part of one or more longer filaments.

[0017] For example, an apparatus (e.g., system) may include: a rigidizing overtube having an elongate body comprising a plurality of layers surrounding a lumen, wherein the rigidizing overtube is configured to convert between a rigid configuration and a flexible configuration by an application of pressure to the plurality of layers, wherein the plurality of layers includes: a support layer a rigidizing layer and a bladder layer, wherein the bladder layer is configured to drive the rigidizing layer against the support layer to rigidize the rigidizing overtube when pressure is applied against the bladder layer; and a distal tip configured to securely couple to a distal end region of the elongate body, the distal tip comprising a plurality of lateral suction ports in fluid communication with the lumen when the distal tip is coupled to the distal end region, wherein the lateral suction ports are configured to apply suction radially from the lateral suction ports to couple to a vessel wall when an endoscope is occluding a distal end opening of the distal tip.

[0018] Also described herein are methods, including methods of performing an enteroscopy using any of the apparatuses described herein. Any of these methods may include reducing the curvature and / or improving access within the lumen of a vessel in the body (such as, but not limited to, the small intestine). For example, a method may include: maintaining a rigidizing overtube in a rigid configuration while advancing an endoscope distally through the rigidizing overtube and into a vessel; advancing the rigidizing overtube distally over endoscope with the rigidizing overtube in a flexible configuration; securing a distal end region of the rigidizing overtube to a wall of the vessel by applying suction through one or more lateral suction ports at a distal end region of the rigidizing overtube; reducing a curvature of the wall of the vessel by withdrawing the rigidizing overtube proximally; and rigidizing the rigidizing overtube while maintaining suction through the one or more lateral suction port(s) and advancing the endoscope distally.

[0019] Any of these methods may include releasing the wall of the vessel by releasing the suction (e.g., to further advance and / or withdraw the overtube.

[0020] In any of these methods, the vessel may comprise a small intestine or other region of the GI tract.

[0021] In any of these methods maintaining the rigidizing overtube in the rigid configuration may comprise applying a pressure (a positive and / or negative pressure) within awall of the rigidizing overtube to drive a tubular bladder layer against a rigidizing layer to limit sliding of a plurality of lengths of filaments forming the rigidizing layer. The pressure may be a fluid pressure. In some cases the pressure may be applied by a fluid such as a gas (e.g., nitrogen, CO2, air, etc.), or liquid (e.g., saline, water, etc.).

[0022] Advancing the rigidizing overtube distally over endoscope with the rigidizing overtube in a flexible configuration may comprise advancing until the rigidizing overtube is positioned just proximal to a distal end region of the endoscope. In some cases the distal tip of the rigidizing overtube (including the removable cap forming the distal tip in some examples) may be positioned adjacent to, but proximal to, the distal end region of the endoscope, so that at least a portion of the endoscope extends distally from the overtube.

[0023] In any of these methods, advancing the endoscope distally into the vessel may include steering a distal end of the endoscope. Any of these methods may include applying insufflation distally of the rigidizing overtube after securing the distal end region of the rigidizing overtube to the wall of the vessel.

[0024] In general, reducing the curvature of the wall of the vessel by withdrawing the rigidizing overtube proximally may include withdrawing both the rigidizing overtube and the endoscope proximally. Any of these methods may include releasing the suction through the one or more lateral suction port(s) and repeating the steps of maintaining, advancing, securing, reducing and rigidizing.

[0025] As mentioned, in any of these examples, applying suction through one or more lateral suction ports may comprise applying suction through a lumen of the rigidizing overtube around the endoscope.

[0026] For example, a method may include: maintaining a rigidizing overtube in a rigid configuration while advancing an endoscope distally through the rigidizing overtube and into a vessel; advancing the rigidizing overtube distally over endoscope with the rigidizing overtube in a flexible configuration until the rigidizing overtube is positioned just proximal to a distal end region of the endoscope; securing a distal end region of the rigidizing overtube to a wall of the vessel by applying suction through one or more lateral suction ports at a distal end region of the rigidizing overtube; reducing a curvature of the wall of the vessel by withdrawing the rigidizing overtube proximally; and rigidizing the rigidizing overtube while maintaining suction through the one or more lateral suction port(s) and advancing the endoscope distally.

[0027] Although these methods and apparatuses are described in the context of the small intestine herein, it should be understood that they may be used in any appropriate vessel inthe body, not limited to the small intestines, including other regions of the GI tract, such as the esophagus, stomach, large intestine, and colon, and / or vessels of the circulatory system.

[0028] 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

[0029] 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:

[0030] FIG. 1 A shows a first example of a rigi dizing overtube that may be used as part of the apparatus and methods described herein.

[0031] FIG. IB shows an example of a distal vacuum attachment that may be coupled to a rigid overtube.

[0032] FIG. 2 shows an example of a rigidizing overtube with a distal vacuum attachment coupled thereto.

[0033] FIG. 3 is a section through a distal end of a rigidizing overtube with a distal vacuum attachment similar to that shown in FIG. 2.

[0034] FIG. 4 schematically illustrates an example of a method of performing an enteroscopy using an apparatus similar to that shown in FIGS. 2 and 3.

[0035] FIGS. 5A-5J illustrate a method of performing an enteroscopy as described herein.

[0036] FIG. 6A is a section through an elongate rigidizable device (e.g., rigidizing overtube) that may be rigidized by the application of negative pressure.

[0037] FIG. 6B is an enlarged view showing one example of the arrangement of layers within the elongate rigidizable device of FIG. 6A.

[0038] FIG. 7A is a section through an elongate rigidizable device (e.g., rigidizing overtube) that may be rigidized by the application of positive pressure.

[0039] FIG. 7B is an alternative sectional view showing one example of the arrangement of layers within the elongate rigidizing device of FIG. 7 A.

[0040] FIG. 8A shows an example of a rigidizable device (e.g., rigidizing overtube) including a knit rigidizing layer, shown with the knit rigidizing layer exposed.

[0041] FIG. 8B shows an example of a rigidizable device (e.g., rigidizing overtube) such as the one shown in FIG. 8A with the outer layer(s) covering the knit rigidizing layer.

[0042] FIG. 8C is an enlarged view of one example of a knit.

[0043] FIG. 8D shows a section view through an example of a knit over an inner tubular member.

[0044] FIG. 9A shows an example of a weft knit.

[0045] FIG. 9B shows an example of a warp knit.

[0046] FIG. 9C shows an example of a knit material formed of a single continuous filament.

[0047] FIG. 10A is an example of a woven rigi dizing layer formed of filament; this woven rigidizing layer may be used as part of a rigidizable device (e.g., rigidizing overtube) as described herein.

[0048] FIG. 10B is an example of a woven rigidizing material formed of monofilaments that are woven together; this woven rigidizing layer may be used as part of a rigidizable device (e.g., rigidizing overtube) as described herein.

[0049] FIG. 10C shows another example of a woven material.

[0050] FIGS. 11 A and 1 IB show examples of braided material that may be used as (or as part of) a rigidizing layer of a rigidizable device (e.g., rigidizing overtube) as described herein. FIG. 1 IB shows a braided layer that is discontinuous.

[0051] FIG. 12 illustrates one example of a robotic system for performing any of the methods described herein.

[0052] FIG. 13 schematically illustrate another example of an adapter for providing lateral (suction) openings to a device such as a rigidizing overtube and / or endoscope.DETAILED DESCRIPTION

[0053] In general, described herein are methods and apparatuses for using an endoscope with a rigidizing device having one or more lateral suction ports for securing to a wall of a lumen. The one or more lateral suction ports may preferably be on a distal end region of the rigidizing device, and / or may be arranged as a plurality of suction ports that are radially arranged around the rigidizing device. The rigidizing device may be configured to transition between a rigid (e.g., less flexible) and a flexible (or less rigid) configuration. In any of these apparatuses and methods the rigidizing device may be integrated with the one or more suction ports; alternatively in some cases the one or more suction ports may be part of an adapter configured to convert a rigidizing overtube into a rigidizing overtube including one or more lateral suction ports.

[0054] In any of these apparatuses the rigidizing overtube and lateral suction port(s) may be used with an endoscope. The endoscope may be steerable and may include one or more optical / imaging components for imaging from the distal end. Any appropriate endoscope maybe used. The endoscope may be rigidizing or non-rigidizing. The endoscope may be steerable, e.g., at a distal end region. Thus, an apparatus may be a system including a rigidizing overtube having (or adapted to have) one or more lateral suction ports, and an endoscope configured to be inserted through (and distal to) the rigidizing overtube.

[0055] For example, FIGS. 1A-1B illustrate an example of a rigidizing overtube 1001 that is configured to receive pressure (e.g., positive and / or negative pressure) via a pressure port. The apparatus is configured to be used with a lateral suction adapter 1015 (shown in FIG. IB) that may be coupled to the distal end of the rigidizing overtube and converted to apply suction laterally out of the openings (ports 1016) in the lateral suction adapter 1015. The rigidizing overtube may also include one or more proximal connectors or inlets for applying, e.g., suction / vacuum 1003, and / or wash fluid, etc. The lateral suction ports 1016 of the lateral suction adapter 1015 may be in fluid communication with a source of suction (e.g., negative pressure). In some cases the pathway to the source of suction may be integrated into the rigidizing overtube, e.g., within a wall of the rigidizing overtube, or may be over the outside and / or inside of the rigidizing overtube. In some cases the suction may be configured to be applied through the central lumen of the rigidizing overtube. When a tool (e.g., an endoscope) is inserted through the overtube it may block suction through the distal end opening (from which the endoscope may extend) and may direct aspiration laterally through the openings.

[0056] In any of these apparatuses and methods, the lateral suction openings may be distributed uniformly around the circumference of the cap, or non -uniformly. For example, in some cases the lateral openings may be distributed between about the 3 o’clock and 9 o’clock positions (e.g., essentially on one side of the cap), between about the 2 o’clock and 10 o'clock positions, between about the 1 o’clock and 11 o’clock and positions, between about a 4 o’clock and an 8 o’clock position, between about a 5 o’clock and a 7 o’clock position, etc. The number of lateral openings may be between about 2-200 (e.g., 3 or more, 4 or more, 5 or more, 6 or more, 7 or more 8 or more, 9 or more, 10 or more, 12 or more, 15 or more, etc.).

[0057] In any of these apparatuses and methods, the lateral openings may have any appropriate diameter (and may be different diameters or the same diameter), such as between about 3 mm and about 0.01 mm (e.g., between about 2 mm and about 0.01 mm, between about 2 mm and about 0.1 mm, between about 1.5 mm and about 0.1 mm, between about 1 mm and about 0.1 mm, etc.). As mentioned, the lateral openings may be any shape, including round, oval, polygonal (e.g., triangular, rectangular, pentagonal, etc.).

[0058] Although the example shown in FIG. IB is a separate cap 1015 that may be coupled to the distal end region of the overtube, in some cases the lateral suction ports (formthe lateral suction adapter) may be formed integrally with the rigi dizing overtube, e.g., at the distal end region. Thus, any of the apparatuses described herein may include integrated lateral suction ports and / or may include an adapter configured to couple to the distal end of the rigidizing overtube.

[0059] The rigidizing overtube may include a handle 1011 with one or more controls, including a control for converting the rigidizing overtube between rigid and flexible configurations, e.g., by controlling the application of positive and / or negative pressure. Any appropriate rigidizing, and in particular pressure rigidizing, structure may be used, including a layered structure having a support wall (e.g., a cylindrical support layer), a rigidizing layer (e.g., a plurality of lengths of filament that cross over each other), and a bladder layer that is configured to apply pressure to press against and rigidize the rigidizing layer. FIGS. 6A-6B, 7A-7B, 8A-8C, 9A-9C, 10A-10C and 11A-11B, described below in detail, illustrate examples of different rigidizing structures that may be used as part of any of these apparatuses.

[0060] FIG. 2 illustrates an example of a rigidizing apparatus 2000 that includes a plurality of lateral suction ports 2015 at the distal end region, and a proximal handle 2011. The proximal handle also includes a suction connection inlet 2017 for connecting to a source of suction (e.g., syringe, pump, etc.). The device also include a pressure inlet 2003 for connecting to a source or positive and / or negative pressure for rigidizing the apparatus.

[0061] In operation, the apparatus may apply lateral suction through the one or more ports independently of the rigid / flexible state. FIG. 3 shows an example of a section through a distal end region of an apparatus including a plurality of lateral suction ports 3015. In this example flow lines indicate flow paths 3018 when suction is applied through the lateral suction ports. As shown the suction may be applied into the lateral suction ports to draw the wall of the vessel laterally against the lateral suction ports. The pressure applied may be adjusted and / or may be set to a relatively low level of suction, sufficient to lock the lateral suction ports radially against the wall of the lumen, but not enough to cause damage. The suction may be applied thorough one or more suction lines extending the length of the apparatus. In FIG. 3, the suction line extends through the rigidizing overtube. An endoscope 3032 is shown in FIG. 3.

[0062] Also described herein are systems including a rigidizing overtube and an endoscope in which the lateral suction ports are on the endoscope, either permanently or as part of an adapter. This is illustrated in FIG. 13, showing an example of an endoscope 1332 in which an adapter 1315 has been connected. The adapter includes a plurality of lateral openings, similar to those shown in FIG. 3. The lateral openings in any of these examples may be arranged so that or more sides of the adapter allow suction through the lateralopenings in any desired direction (e.g., at the noon and 6 o’clock radial positions, between 10 o’clock and 2 o’clock on the clock dial, between 11 o’clock and 1 o’clock, etc.).

[0063] For example, a method of using a system in which the suction ports are on the endoscope may include: maintaining a rigidizing overtube in a rigid configuration while advancing an endoscope distally through the rigidizing overtube and into a vessel; advancing the rigidizing overtube distally over endoscope with the rigidizing overtube in a flexible configuration; securing a distal end region of the endoscope to a wall of the vessel by applying suction through one or more lateral suction ports at a distal end region of the endoscope; reducing a curvature of the wall of the vessel by withdrawing the rigidizing overtube and the endoscope proximally; and rigidizing the rigidizing overtube while maintaining suction through the one or more lateral suction port(s) and advancing the endoscope distally.

[0064] In any of these examples the lateral openings may be any appropriate shape and / or may be angled or follow a curved path. For example, in FIG. 13 the openings 1318 are round, but may be oval, triangular, square, rectangular, etc.

[0065] Any of the adapters described herein may be configured to couple to a distal end region of an overtube and / or endoscope and may include a portion configured to insert into a working channel of the endoscope and / or overtube. For example, in FIG. 13, the adapter is configured as a cap that fits over the distal end of an endoscope (which may be rigidizing endoscope) and may include a projection 1335 configured to insert into the working channel of the endoscope, as shown.

[0066] In general, these apparatuses may be used to more efficiently and effectively perform a medical procedure within a body lumen in which it is beneficial to anchor or secure the distal end region (having the lateral suction ports) to the wall(s) of the body lumen (e.g., the GI tract, etc.). For example, any of these apparatuses may be used to perform a reduction of the intestine, e.g., removing twisting, etc. during a procedure to visualize and / or modify tissue within he intestine.

[0067] In particular, described herein are methods of performing an enteroscopy on a patient using an apparatus, such as a rigidizing overtube, having one or more lateral suction ports proximal to the distal end region, in which the rigidizing overtube may be transitioned between a flexible configuration and a rigid configuration using pressure, and an endoscope within the lumen of the rigidizing overtube. The methods described herein may generally include

[0068] advancing an endoscope into the body as far as possible, e.g., extending the endoscope distally out of the (e.g., rigid) rigidizing overtube, while visualizing through theendoscope and steering the endoscope, the rigidizing overtube and / or endoscope may provide insufflation to improve visualization during operation. Once the endoscope is advanced as far as reasonable, e.g., until it reaches a region that is particularly tortious which may be detected optically (e.g., while imaging through the device) and / or by resistance to advancing further (e.g., pressure on the endoscope), its position may be maintained, and the outer rigidizing overtube may be advanced distally, in a flexible configuration, over the endoscope. This may result in looping, e.g., when the resistance to advancing bottoms out for the endoscope. The rigidizing overtube, in the flexible configuration, may be advanced just until the distal steering region of the endoscope. Once the rigidizing overtube is positioned as desired, the rigidizing overtube may be rigidized (e.g., transitioned form the flexible to the rigid configuration), which may shape lock the rigidizing overtube. Suction may then be applied and maintained out of the lateral suction ports in order to advantageously collapse the local region of the wall against the suction port(s) securely. At the same time, it may be particularly advantageous to provide positive pressure out of the distal end of the overtube (e.g., through the overtube lumen) and / or out of the endoscope in order to insufflate the region distal to the collapsed wall around the lateral suction port(s). This may dramatically improve visualization. In some cases either gas (e.g., air, CO2, etc.) and / or liquid (e.g., water, saline, etc.) may be applied.

[0069] The vessel may then be reduced by pulling the rigidizing overtube (and / or the endoscope) proximally while maintaining suction through the lateral suction port(s); the rigidizing overtube may be maintained in a flexible configuration first, before pulling proximally. Reducing the lumen may cause the region of the lumen proximal to the attachment site to the lateral suction port(s) to crease and stack up on itself (e.g., scrunching up), while straightening and pulling taut the region distal to the lateral suction port(s). This may be visualized by the endoscope, which may be provided with a relatively clearer view of the walls of the lumen.

[0070] Once the reduction is complete (e.g., withdrawal of the rigidizing overtube suction locked onto the wall of the lumen is complete), then the rigidizing overtube may be rigidized, e.g., by the application of positive and / or negative pressure, with suction through the lateral suction port(s) still on, and the endoscope may be distally advanced again, until it once more bottoms out (e.g., hits a looped region, preventing further advancement). The earlier steps may be repeated, after removing / stopping suction through the lateral suction port(s).

[0071] FIG. 4 schematically illustrates one example of a method of reducing and imaging with a small intestine (e.g., as part of an enteroscopy procedure). FIGS. 6A-6J show an example of this method on an isolated porcine intestine region. For example, the method mayinclude advancing an endoscope within a lumen of a rigi dizing overtube 401 (see also FIG. 5 A). The overtube may be maintained in a rigid configuration while advancing the endoscope distally (e.g., steering the distal end region of the endoscope, advancing it relative the distal end of the overtube, and imaging and advancing until a threshold level of resistance is met) 403. This is illustrated in FIGS. 5B-5C. Thereafter, the rigidizing overtube may be de- rigidized (e.g., changed into the more flexible configuration) and the rigidizing overtube may be advanced distally over the rigidizing overtube, as shown in FIG. 5D. As shown, the rigidizing overtube may then be made flexible, having a flexible configuration, and advanced over the endoscope (e.g., up to the distal end region of endoscope).

[0072] Once the rigidizing overtube is positioned just proximal to the steerable distal end region of the endoscope, suction may be applied (e.g., through one or more lateral suction ports (e.g., vacuum chuck) on distal end of rigidizing overtube) to grab luminal wall while applying insufflation (distally) to maintain visualization through endoscope 407 (see FIG. 5D). In some cases, the endoscope may then be withdrawn together with the rigidizing overtube, proximally, to perform the reduction of the intestine 409 (see FIG. 5E).

[0073] The rigidizing overtube may then be rigidized (e.g., transition to the more rigid configuration), while maintaining suction through the lateral suction port(s), and the endoscope may be advanced distally (e.g., steering the distal end region of the endoscope, imaging and advancing until a threshold level of resistance is met) 411. This is also shown in FIG. 5F. Suction may then be released through the lateral suction ports 413 and the steps of confirming / converting the rigidizing overtube (405), applying suction (407), withdrawing the overtube (409), rigidizing the overtube and advancing the endoscope (411) may be repeated until the process is complete 413 (see., e.g., FIGS. 5G-5J).

[0074] 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,” PCT / US2021 / 024582, titled “LAYERED WALLS FOR RIGIDIZING DEVICES,” PCT / US2021 / 034292, titled “RIGIDIZING DEVICES,” PCT / US2022 / 014497, titled “DEVICES AND METHODS TO PREVENT INADVERTENT MOTION OF DYNAMICALLY RIGIDIZING DEVICES,”PCT / US2022 / 019711, titled “CONTROL OF ROBOTIC DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES,” U.S. provisional patent application 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.

[0075] 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.

[0076] In general, these apparatuses may include multiple layers, including a rigidizing layer and at least one of an outer or inner layer. Many of these examples also include a compression layer that may engage with the rigidizing layer, and in some examples the apparatus may include a combined rigidizing layer / compression layer. Described herein are rigidizing layers that may be particularly well suited to rapid and precise actuation over a variety of pressures, including in particular positive pressures (e.g., high positive pressures,i.e., atm of about 2 or more, 4 or more, 6 or more, 8 or more, 10 or more, 15 or more, 20 or more, 30 or more, etc.). Any of these apparatuses may also be configured so that at 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).

[0077] FIG. 6A 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. 6B 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.

[0078] Another example of a rigidizable device is shown in FIGS. 7A-7B. In this example the device may also be an elongate, e.g., catheter or tubular-shaped device similar to that in FIGS. 6A-6B but may be rigidized by the application of positive pressure. For example, FIG. 7A 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, shownin this example as a braid layer. A third gap layer 2107 is positioned between the rigi dizing layer 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.

[0079] Both examples of a devices shown in FIGS. 6A-6B and 7A-7B 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.

[0080] Further, any of the rigidizable devices described herein may be configured as nested apparatuses that may be nested to provide enhanced performance. For example, a nested apparatus (system) may include an outer rigidizable device (e.g., rigidizing overtube) and an inner rigidizable device (e.g., rigidizing endoscope). The inner rigidizing device (e.g., scope) can be, for example, configured to receive pressure (positive and / or negative pressure) to rigidize from a more flexible to a less flexible configuration. Any of these rigidizing devices may include an air / water channel and a working channel that can extend with the inner rigidizing device.Knit Rigidizing Layers

[0081] In any of the rigidizable devices described herein (and any nested systems or methods including them) may include a rigidizing layer formed of a knit material or knit layer (e.g., knit tube). The knit rigidizing layer, which may be referred to herein equivalently as a knit rigidizing layer or a knitted rigidizing layer, may be formed of a single fiber or may be knitted from multiple fibers. The fiber forming the knit may be a yam, a filament, a monofilament, a plurality of filaments, a strand, a thread, a wire, etc. The fiber may be made of a natural or synthetic material, including polymeric materials, metals and metal alloys, and a composite or a combinations thereof. In some cases the knit is formed of a polymeric material. The fiber may be continuous, in which each of the filament lengths forming the rigidizing layer are part of a single fiber, or they may be broken up into multiple filamentlengths. For example, the knit material may be single fiber that is broken / cut at regular or irregular lengths.

[0082] FIGS. 8A and 8B illustrate an example of a rigidizable device 500 including a knit rigi dizing layer (e.g., tube) 505. In FIG. 8 A the outermost layer (outer layer 515) is removed for clarity; FIG. 8B shows the rigidizable device with the outer layer 515 covering the other layers. This outer layer may be a reinforced outer layer, such as an outer coil-wound tube. In FIG. 8A the rigidizable device includes the knit rigidizing layer 505 extending over the elongate body of the device, including over a compression layer 507 (e.g., bladder) and an inner layer 509. The inner layer and the outer layer 515 may both be reinforced. This example, which is similar to the configuration shown in FIGS. 7A-7B (with the rigidizing layer 2109 configured as a knit layer 505), may be rigidized by the application of positive pressure between the compression layer 507 and the inner layer 509, which may drive the compression layer radially outward against the outer layer 515. Any of the other layers shown in FIGS. 7A-7B may be optionally included, including the gap regions / layer and the optional slip layer (which may not be necessary). This configuration may alternatively be actuated by the application of negative pressure, e.g., between the outer layer and the compression layer (including the region of the knit), which may draw the compression layer against the knit layer by the vacuum, rigidizing the layer.

[0083] A rigidizable device such as that shown in FIGS. 8A-8B may alternatively be configured so that positive pressure is applied between a compression layer (e.g., bladder) and the outer layer 515 (outer reinforced layer). In some examples the compression layer may be positioned between the outer layer and the knit rigidizing layer, so that positive pressure applied between the outer layer and the compression layer may rigidize the knit layer by driving the compression layer against the knit layer, into the inner (reinforced) layer. As in the configuration shown in FIGS. 8A-8B, the device may alternatively be actuated by the application of negative pressure, e.g., between the inner layer and the compression layer (including the region of the knit).

[0084] Alternatively, the rigidizable device including a knit rigidizing layer may be configured as shown in FIGS. 6A-6B and may be actuated by the application of negative and / or positive pressure. In some examples the outer layer or the inner layer may be configured to as the compression layer (e.g., bladder) and may engage with the knit rigidizing layer when vacuum is applied.

[0085] FIG. 8C illustrates one example of a portion of a knit layer 505 formed of a single filament 518 that forms interlocking loops. In the example shown in FIG. 8C the knit includes a plurality of stich loops each having a length, y, and a curved head and foot regionhaving a length x. The stitch pattern shown in FIG. 8C is a weft knit pattern, but other knit patterns may be used. FIG. 8D shows an example of a transverse section through a knit layer positioned adjacent to a compression layer 507. In this example the knit layer is a tube having 28 strand segments that are formed of the same strand into loops (e.g., 14 loops that are arranged with the wale of the knit in parallel with the long axis of the device). The knit tube has a diameter, z, and the spacing between adjacent loops, n, is approximately equal around the circumference of the knit tube. The spacing between the stitch width, p, and the spacing, n, may vary along the length of the knit tube. The dimensions are illustrative only.

[0086] FIGS. 9A-9B illustrate two different examples of knits 600, 600’ that may be used. FIG. 9A shows a weft knit, similar to that shown in FIG. 8C. In this example the knit is formed of one or more strands (which may be continuous or broken / cut), forming stitch loops 602 that each include a head region 604, a pair of legs 606 and a first and second foot 608 where each foot engages with the head of a stitch loop in a course above or below the original stitch loop course. The connection between the feet of adjacent stitch loops may be referred to as the sinker (the sinker may also correspond to a head when the knit is rotated 180 degrees). In FIG. 9A the wale direct 612 extends up / down, and the course 610 extends right to left. Typically, a wale is a column of loops running lengthwise, corresponding to the warp of woven fabric in FIG. 9 A. The course is a crosswise row of loops, corresponding to the filling of the resulting knit.

[0087] FIG. 9B illustrates an example of a warp knit 600’. In this example the warp knit also has a course 610’ and wale 612’ direction but the feet of each loop engage with the head region of a knit loop in a row (in the course direction) that is offset, as shown, forming a pattern of overlap 612 and underlap 614 lengths. The knit rigidizing layers described herein may use any appropriate pattern and may arrange the direction (course or wale direction) relative to the elongate axis (length) of the device. For example, the knit structure (the knit rigidizing layer) may be configured so that a wale direction of the knit extends in a long axis of the flexible tube. Alternatively, the knit structure may be configured so that a wale direction of the knit structure is perpendicular to a long axis of the flexible tube. Depending on the stitch length (y) relative to the loop diameter (p) and / or the spacing between loops (n), which may be related, it may be beneficial to arrange the knit rigidizing layer so that that either the wale or the course is arranged in parallel or perpendicular to the long axis of the elongate body of the rigidizable device. In any of the examples described herein, the knit structure may comprise an average loop length that is longer than the loop width. For example, the loop length may be two times or greater (e.g., 3x, 4x, 5x, 6x, 7x, 8x, 9x, lOx, 20x, 40x, 60x, 80x, lOOx or more) than an average loop width. Because knits (including knittubes) may be stretched and compressed in bending without buckling or wrinkling, they may be particularly useful in the rigidizable devices described herein.

[0088] As shown in FIG. 9C a knit rigi dizing layer 600” may be formed of a single knitted fiber 618. As mentioned above the fiber may be formed of a single filament (monofilament) or a bundle of filaments (multi-filament). The pattern shown therefore includes a plurality of lengths of filaments (e.g., an array of filament lengths) that cross each other in the knit pattern. In FIG. 9C the plurality of lengths of filaments that cross over and under each other are all part of the same fiber or strand. In some examples the knitted fiber or strand may be cut or divided into multiple separate filament lengths. The knit material (e.g., the fiber) may be formed of any appropriate material, such as a metal, metal alloy, polymeric material, natural fiber, etc.Woven and Braided Rigidizing Layers

[0089] In any of the rigidizable devices described herein (and any nested systems or methods including them) may include a rigidizing layer that is woven. FIGS. 10A-10C illustrate an example of a woven a rigidizing layer 705 that may be used as the rigidizing layer of the rigidizable device and may be arranged as shown in FIGS. 6A-6B or 7A-7B. In FIG. 10A the weave includes a plurality of parallel fibers that form a set of intersecting fibers; in FIG. 10A the fibers intersect with each other at 90 degree angles, but this angle may vary (e.g., between about 30 degrees and 150 degrees, 45 degrees and 135 degrees, 50 degrees and 130 degrees, 70 degrees and 110 degrees, 80 degrees and 100 degrees, etc.). The pattern of intersecting filament lengths (e.g., the array of filament lengths) includes individual filament lengths that cross over and under each other as shown; a first filament length 718 crosses over a second filament length 728 and under a third filament length 725. In this example, the pattern shown is an under-over pattern, but this pattern may be different for other examples of rigidizing layers; in FIG. 10A the pattern is one over, one under. In some examples the pattern may be two over two under, or two over and one under, etc. Any appropriate fiber (e.g., strand) may be used to form the rigidizing layer, a mentioned for knit rigidizing layers above. In the woven rigidizing layer shown in FIG. 10A the fiber is a muti- filament fiber including a bundle of multiple filaments forming each strand. FIG. 10B shows an example of a woven rigidizing layer 705’ formed of a monofilament, also arranged with parallel strands 718’, 728’ arranged in a woven pattern similar to that shown in FIG. 10 A. The woven pattern may be any desired tightness (e.g., pore size). In general, as shown in FIG. 10C, multiple different lengths of fibers 718”, 728” are used to form the woven pattern 705”.

[0090] FIGS. 11 A and 1 IB illustrate examples of braided rigidizing layers. In FIG. 11 A, the braid 800 is formed of a plurality of fibers 818, 828 that are arranged in an over-and- under pattern having a braid angle relative to the long axis (e.g., the long axis of the device when included as the rigidizing layer). In general, the braid angle (relative to the centerline along the central axis) of the braided rigidizing layer (tube) may be 45 degrees or less (e.g. less than 45 degrees, 40 degrees or less, less than 40 degrees, 35 degrees or less, less than 35 degrees, 30 degrees or less, 20 degrees or less, less than 20 degrees, etc. In FIG. 11 A, the different filaments forming the braid layer are continuous and unbroken. However in some examples it may be beneficial to include breaks or cuts, as illustrated in FIG. 1 IB. In this example, the material includes a plurality of breaks or cuts 838 in the braided strands. Although such an arrangement may be undesirable in a fabric or even in a braid used as part of a medical device, this disrupted (e.g., broken or cut) arrangement may be beneficial in the context of a rigidizing layer. Thus, in FIG. 1 IB, the braided pattern 800’ forming the rigidizing layer (e.g., rigidizing tube) may enhance flexibility in the un-rigidized configuration, while permitting a high degree of rigidizing in the actuated state. Thus, in FIG. 8 the strands 818, 828’ cross over and under each other in the braid pattern shown but are cut 838 periodically along their lengths. The number or density of the cuts may be varied; in some examples the fibers may be cut after every crossing over or under another fiber, while in other examples the fibers may be cut after every 2 (or 3, or 4, or 5, or more) crossings. The cut pattern may be non-uniform. In some examples it may be beneficial to have the cuts or breaks distributed at a density of between about one cut / break for every third crossing, etc. (e.g., between every second and every 25thcrossing, every third and every 20thcrossing, etc.).

[0091] Other rigidizing layers (e.g., knit, woven, etc.) may also include breaks or cuts. These breaks or cuts may be formed during fabrication by laser cutting, mechanical cutting, or any other appropriate cutting technique.Pressure-driven Rigidization

[0092] As mentioned above, in general, these apparatuses may be configured to be rigidized by the application of pressure. The layers forming the device may be arranged as concentric tubes. See, e.g., FIGS. 8A-8B showing a rigidizing layer (FIG. 8A) and a compression layer (e.g., bladder, FIG. 8B). A gap layer may be present between the outer layer and the rigidizing layer and / or between the rigidizing layer and the compression layer. A port may be present at an end (e.g., a proximal end region) of the device to couple to the source of pressure (e.g., positive pressure). A gap layer may be present between the compression layer and the rigidizing layer, and / or between the rigidizing layer and an inner layer. The device may be flexible as each of these layers may slide relative to each otherwhen bending the device. In particular, the rigidizing layer may flex and slide relative to the inner layer and the compression layer.

[0093] When positive pressure is applied between the outer layer and the compression layer, or alternatively if the compression layer comprises a double-layered bladder into which the positive pressure is applied, the compression layer may be driven against the rigidizing layer, so that it is compressed between the compression layer and the inner layer (and / or any intervening layers) or outer layer. The inner and / or outer layers may be reinforced. Compressing the rigidizing layer rigidizes the device. Any bends or curves are preserved without changing the shape.

[0094] In some examples, particularly those having elastic (e.g., elastomeric) compression layers and rigidizing layers formed of filament lengths that cross over and under each other, the compression layer may deform into the rigidizing layer, which may enhance the rigidity of the device. For example, as pressure is applied, the compression layer (e.g., bladder) may apply force directly to the rigidizing layer. Depending on the bladder type, the bladder may deform, depress, or interdigitate into the space around and between the elements (e.g., filaments, wires, etc.) of the rigidizing layer. Conforming to the overlapping (over-and- under) fiber or filament lengths may help lock the rigidizing layer relative to the inner layer (or in some examples outer layer) to which it is being compressed. The application of positive pressure in this manner may therefore increase rigidization as positive pressure is increased even beyond what is otherwise expected. Thus a rigidizing layer comprising a plurality of filament lengths crossing over and under each may be generally configured so that, in the flexible configuration, the filament (e.g., fiber) lengths may shear relative to each other. However, when positive pressure is applied, the deformable compression layer may be pushed against the rigidizing layer so that the compression layer may conform to or deform into or between the plurality of filament lengths to prevent shear of the plurality of filament lengths relative to each other.Robotic apparatuses

[0095] As mentioned above, any of the methods and apparatuses described herein may be part of a robotic method / system. For example, the rigidizing apparatuses (e.g., rigidizing overtube) described herein may be configured as part of a robotic system or for use with robotic apparatuses. In some cases the other components (e.g., endoscope, etc.) may also or alternatively be part of the robotic system and the movements of these components may also be robotically controlled and / or implemented. Thus, any of these methods may be performed by a robotic apparatus. In some examples the rigidizing apparatus may be configured as an outer tubular member (overtube) that is robotically controlled, e.g., configured as arobotically controlled overtube and / or endoscope assembly. FIG. 12 shows an exemplary apparatus 3100, including a rigidizing device configured as a rigidizing overtube 3112; the system may optionally include the endoscope 3110. The overtube and endoscope can be separately or collectively robotically controlled or manipulated (e.g., steering, movement, rotation, etc. including in some examples, rigidizing). The overtube and 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. 12, the rigidizing overtube 3112 and the endoscope 3110 may be terminated together into a common structure, such as a cassette 3157, or two (or more) separate cassettes may be used, e.g., one for the overtube and one for the endoscope. In some cases a single controller may coordinate movement of the one or more cassettes. The rigidizing overtube 3100 can be movable with respect to the 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 steerable region of the endoscope 3110 (and / or in some examples the rigidizing overtube 3112). Other steering mechanisms (e.g., pneumatics, hydraulics, shape memory alloys, EAP (electro-active polymers), or motors) are also possible. The cassette 3157 can further include bellows 3103a, 3103b that may connect to the pressure inlet of the rigidizing overtube 3112, to drive fluid through pressure lines 3105z, in some variations for rigidizing the overtube. As shown in this example, the cassette 3157 can include eccentric cams 3174a, b to control bellows 3103a, b. Alternatively, one or more linear actuators can be configured to actuate the bellows. As another alternative, the rigidizing overtube (and / or in some examples the endoscope) can be rigidized and de-rigidized through one or more pumps or pressure sources (e.g., via pressure line 3105z). The cassette and robotic system may also include one or more controls for applying lateral suction to secure to the wall of the vessel, as described above.

[0096] All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. Furthermore, it should be appreciated that all combinations of the foregoing concepts and additional concepts discussed in greater detail below (provided such concepts are not mutually inconsistent) are contemplated as being part of the inventive subject matter disclosed herein and may be used to achieve the benefits described herein.

[0097] 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 bya 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.

[0098] While various embodiments have been described and / or illustrated herein in the context of fully functional computing systems, one or more of these example embodiments may be distributed as a program product in a variety of forms, regardless of the particular type of computer-readable media used to actually carry out the distribution. The embodiments disclosed herein may also be implemented using software modules that perform certain tasks. These software modules may include script, batch, or other executable files that may be stored on a computer-readable storage medium or in a computing system. In some embodiments, these software modules may configure a computing system to perform one or more of the example embodiments disclosed herein.

[0099] As described herein, the computing devices and systems described and / or illustrated herein broadly represent any type or form of computing device or system capable of executing computer-readable instructions, such as those contained within the modules described herein. In their most basic configuration, these computing device(s) may each comprise at least one memory device and at least one physical processor.

[0100] The term “memory” or “memory device,” as used herein, generally represents any type or form of volatile or non-volatile storage device or medium capable of storing data and / or computer-readable instructions. In one example, a memory device may store, load, and / or maintain one or more of the modules described herein. Examples of memory devices comprise, without limitation, Random Access Memory (RAM), Read Only Memory (ROM), flash memory, Hard Disk Drives (HDDs), Solid-State Drives (SSDs), optical disk drives, caches, variations or combinations of one or more of the same, or any other suitable storage memory.

[0101] In addition, the term “processor” or “physical processor,” as used herein, generally refers to any type or form of hardware-implemented processing unit capable of interpreting and / or executing computer-readable instructions. In one example, a physical processor may access and / or modify one or more modules stored in the above-described memory device. Examples of physical processors comprise, without limitation, microprocessors, microcontrollers, Central Processing Units (CPUs), Field-ProgrammableGate Arrays (FPGAs) that implement softcore processors, Application-Specific Integrated Circuits (ASICs), portions of one or more of the same, variations or combinations of one or more of the same, or any other suitable physical processor.

[0102] Although illustrated as separate elements, the method steps described and / or illustrated herein may represent portions of a single application. In addition, in some embodiments one or more of these steps may represent or correspond to one or more software applications or programs that, when executed by a computing device, may cause the computing device to perform one or more tasks, such as the method step.

[0103] In addition, one or more of the devices described herein may transform data, physical devices, and / or representations of physical devices from one form to another. Additionally or alternatively, one or more of the modules recited herein may transform a processor, volatile memory, non-volatile memory, and / or any other portion of a physical computing device from one form of computing device to another form of computing device by executing on the computing device, storing data on the computing device, and / or otherwise interacting with the computing device.

[0104] The term “computer-readable medium,” as used herein, generally refers to any form of device, carrier, or medium capable of storing or carrying computer-readable instructions. Examples of computer-readable media comprise, without limitation, transmission-type media, such as carrier waves, and non-transitory-type media, such as magnetic-storage media (e.g., hard disk drives, tape drives, and floppy disks), optical-storage media (e.g., Compact Disks (CDs), Digital Video Disks (DVDs), and BLU-RAY disks), electronic-storage media (e.g., solid-state drives and flash media), and other distribution systems.

[0105] A person of ordinary skill in the art will recognize that any process or method disclosed herein can be modified in many ways. The process parameters and sequence of the steps described and / or illustrated herein are given by way of example only and can be varied as desired. For example, while the steps illustrated and / or described herein may be shown or discussed in a particular order, these steps do not necessarily need to be performed in the order illustrated or discussed.

[0106] The various exemplary methods described and / or illustrated herein may also omit one or more of the steps described or illustrated herein or comprise additional steps in addition to those disclosed. Further, a step of any method as disclosed herein can be combined with any one or more steps of any other method as disclosed herein.

[0107] The processor as described herein can be configured to perform one or more steps of any method disclosed herein. Alternatively or in combination, the processor can be configured to combine one or more steps of one or more methods as disclosed herein.

[0108] 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.

[0109] 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 " / ".

[0110] Spatially relative terms, such as "under", "below", "lower", "over", "upper" and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as "under”, or "beneath" other elements or features would then be oriented "over" the other elements or features. Thus, the exemplary term "under" can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms "upwardly","downwardly", "vertical", "horizontal" and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.

[0111] 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.

[0112] 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.

[0113] As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word "about" or “approximately,” even if the term does not expressly appear. The phrase “about” or “approximately” may be used when describing magnitude and / or position to indicate that the value and / or position described is within a reasonable expected range of values and / or positions. For example, a numeric value may have a value that is + / - 0.1% of the stated value (or range of values), + / - 1% of the stated value (or range of values), + / - 2% of the stated value (or range of values), + / - 5% of the stated value (or range of values), + / - 10% of the stated value (or range of values), etc. Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value " 10" is disclosed, then "about 10" is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. It is also understood that when a value is disclosed that "less than or equal to" the value, "greater than or equal to the value" and possible ranges between values are also disclosed, as appropriately understood by the skilled artisan. For example, if the value "X" is disclosed the "less than or equal to X" as well as "greater than or equal to X" (e.g., where X is a numerical value) is also disclosed. It is also understood that the throughout the application, data is provided in a number of different formats, and that this data represents endpoints and starting points, and ranges for any combination of the data points. For example, if a particular data point “10” and a particular data point “15” are disclosed, it is understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 are considered disclosed as well as between 10 and 15. It is also understood that each unit between two particular unitsare also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0114] Although various illustrative embodiments are described above, any of a number of changes may be made to various embodiments without departing from the scope of the invention as described by the claims. Optional features of various device and 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.

[0115] 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. An apparatus, the apparatus comprising: a rigi dizing overtube having an elongate body comprising a plurality of layers surrounding a lumen, wherein the rigidizing overtube is configured to convert between a rigid configuration and a flexible configuration by an application of pressure to the plurality of layers, wherein the plurality of layers includes: a support layer a rigidizing layer and a bladder layer, wherein the bladder layer is configured to drive the rigidizing layer against the support layer to rigidize the rigidizing overtube when pressure is applied against the bladder layer; and a distal tip at a distal end region of the elongate body, the distal tip comprising a plurality of lateral suction ports, wherein the lateral suction ports are configured to apply suction radially from the lateral suction ports to couple to a vessel wall.

2. The apparatus of claim 1, wherein the distal tip comprises a removable cap configured to be coupled to a distal end of the rigidizing overtube.

3. The apparatus of claim 1, wherein the distal tip is integrally formed at a distal end region of the rigidizing overtube.

4. The apparatus of any of claims 1-3, wherein the plurality of lateral suction ports are uniformly distributed around a circumference of the distal tip.

5. The apparatus of any of claims 1-4, wherein the plurality of lateral suction ports are non-uniformly distributed around a circumference of the distal tip.

6. The apparatus of any of claims 1-5, wherein the plurality of lateral suction ports are arranged between a 3 o’clock and a 9 o’clock position around a circumference of the distal tip.

7. The apparatus of any of claims 1-6, wherein the plurality of lateral suction ports are in fluid communication with an aspiration lumen through the rigidizing overtube.

8. The apparatus of any of claims 1-7, wherein the plurality of lateral suction ports are in fluid communication with the lumen of the rigidizing overtube.

9. The apparatus of any of claims 1-8, wherein the distal tip has a smaller inner diameter than the lumen of the rigi dizing overtube.

10. The apparatus of any of claims 1-9, wherein the distal tip is configured to secure onto the distal end region of the rigidizing overtube.

11. The apparatus of any of claims 1-10, further comprising an endoscope configured to pass through the lumen of the rigidizing overtube and out of a distal end of the distal tip.

12. The apparatus of any of claims 1-11, wherein the rigidizing layer comprises a plurality of lengths of filaments that cross over each other.

13. An apparatus, the apparatus comprising: a rigidizing overtube having an elongate body comprising a plurality of layers surrounding a lumen, wherein the rigidizing overtube is configured to convert between a rigid configuration and a flexible configuration by an application of pressure to the plurality of layers, wherein the plurality of layers includes: a support layer a rigidizing layer and a bladder layer, wherein the bladder layer is configured to drive the rigidizing layer against the support layer to rigidize the rigidizing overtube when pressure is applied against the bladder layer; and a distal tip configured to securely couple to a distal end region of the elongate body, the distal tip comprising a plurality of lateral suction ports in fluid communication with the lumen when the distal tip is coupled to the distal end region, wherein the lateral suction ports are configured to apply suction radially from the lateral suction ports to couple to a vessel wall when an endoscope is occluding a distal end opening of the distal tip.

14. A method, the method comprising: maintaining a rigidizing overtube in a rigid configuration while advancing an endoscope distally through the rigidizing overtube and into a vessel; advancing the rigidizing overtube distally over endoscope with the rigidizing overtube in a flexible configuration; securing a distal end region of the rigidizing overtube to a wall of the vessel by applying suction through one or more lateral suction ports at a distal end region of the rigidizing overtube;reducing a curvature of the wall of the vessel by withdrawing the rigidizing overtube proximally; and rigidizing the rigidizing overtube while maintaining suction through the one or more lateral suction port(s) and advancing the endoscope distally.

15. The method of claim 14, further comprising releasing the wall of the vessel by releasing the suction.

16. The method of claim 14, wherein the vessel comprises a small intestine.

17. The method of claim 14, wherein maintaining the rigidizing overtube in the rigid configuration comprises applying a pressure within a wall of the rigidizing overtube to drive a tubular bladder layer against a rigidizing layer to limit sliding of a plurality of lengths of filaments forming the rigidizing layer.

18. The method of claim 14, wherein advancing the rigidizing overtube distally over endoscope with the rigidizing overtube in a flexible configuration comprises advancing until the rigidizing overtube is positioned just proximal to a distal end region of the endoscope.

19. The method of claim 14, wherein advancing the endoscope distally into the vessel comprises steering a distal end of the endoscope.

20. The method of claim 14, further comprising applying insufflation distally of the rigidizing overtube after securing the distal end region of the rigidizing overtube to the wall of the vessel.

21. The method of claim 14, wherein reducing the curvature of the wall of the vessel by withdrawing the rigidizing overtube proximally comprises withdrawing both the rigidizing overtube and the endoscope proximally.

22. The method of claim 14, further comprising releasing the suction through the one or more lateral suction port(s) and repeating the steps of maintaining, advancing, securing, reducing and rigidizing.

23. The method of claim 14, wherein applying suction through one or more lateral suction ports comprises applying suction through a lumen of the rigidizing overtube around the endoscope.

24. A method, the method comprising: maintaining a rigidizing overtube in a rigid configuration while advancing an endoscope distally through the rigidizing overtube and into a vessel; advancing the rigidizing overtube distally over endoscope with the rigidizing overtube in a flexible configuration until the rigidizing overtube is positioned just proximal to a distal end region of the endoscope; securing a distal end region of the rigidizing overtube to a wall of the vessel by applying suction through one or more lateral suction ports at a distal end region of the rigidizing overtube; reducing a curvature of the wall of the vessel by withdrawing the rigidizing overtube proximally; and rigidizing the rigidizing overtube while maintaining suction through the one or more lateral suction port(s) and advancing the endoscope distally.

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