Patent Publication Number: US-2023149020-A1

Title: Devices and methods for at least partially occluding a bodily lumen

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims the priority benefit of U.S. Provisional Patent Application Ser. No. 62/993,192, filed Mar. 23, 2020, the contents of which are herein incorporated by reference in their entirety. 
    
    
     TECHNICAL FIELD 
     This disclosure relates generally to the field of endoscopy, and more specifically to the field of endoscopic ultrasound. Described herein are systems and methods for at least partially occluding a bodily lumen during a procedure. 
     BACKGROUND 
     Currently, endoscopic ultrasound guided procedures, for example entero-enterostomy (includes gastro-enterostomy), are limited by the quality of the ultrasound imaging and lumen distensibility of the targeted portion of bowel. Portions of the gastrointestinal tract are flooded with liquid so that imaging can be performed. However, liquid rapidly passes through the gastrointestinal (GI) tract, limiting the available time for imaging and distensibility of the lumen for targeted intervention. Large quantities of liquid can be infused in an effort to counter the egress, but excessive liquid infusion (more than 500 ml) into the bowel may lead to metabolic disturbances. As such, better devices and methods are needed for reducing fluid egress from the targeted portion of the GI tract to enable improved imaging quality, longer imaging time, and lumen distensibility. 
     SUMMARY 
     There is a need for new and useful devices and methods for at least partially occluding a bodily lumen, for example during an endoscopy procedure. One aspect of the present disclosure is directed to a device configured to block at least a portion of a lumen of a GI tract during an endoscopy procedure. In some embodiments, the device includes an inner shaft having a proximal portion, a distal portion, and defining a lumen therethrough and a first aperture; and an outer shaft having a proximal end and a distal end coupled to the distal portion of the inner shaft, and defining a lumen therethrough. In some embodiments, the outer shaft further includes a flexible member and defines a second aperture positioned proximally on the outer shaft relative to the flexible member. In some embodiments, the inner shaft extends through the lumen of the outer shaft, such that at least a portion of the outer shaft is axially translatable toward and away from the distal portion of the inner shaft. In some embodiments, the flexible member is movable between an unexpanded configuration and an expanded configuration when at least a portion of the outer shaft is translated axially toward or away from the distal portion of the inner shaft. 
     In any of the preceding embodiments, the flexible member is positioned proximal to the distal end of the outer shaft. 
     In any of the preceding embodiments, the flexible member is about 0.1 inches to 5 inches from the distal end of the outer shaft. 
     In any of the preceding embodiments, the flexible member is about 0.8 inches to 1.2 inches from the distal end of the outer shaft. 
     In any of the preceding embodiments, the inner shaft further includes a stop configured to restrict movement of the outer shaft relative to the inner shaft and thus the flexible member. 
     In any of the preceding embodiments, the inner shaft further includes an extension indicator on a surface of the inner shaft that indicates an axial translation length required to move the outer shaft to expand the flexible member from the unexpanded configuration to the expanded configuration. 
     In any of the preceding embodiments, the extension indicator further includes a negative extension indicator indicating a state of over-expansion of the flexible member. 
     In any of the preceding embodiments, the inner shaft further includes a tip on the distal portion of the inner shaft, such that the distal tip includes a valve configured to prevent liquid from exiting the distal tip of inner shaft. 
     In any of the preceding embodiments, the device further includes a liquid injection port coupled to the proximal portion of the inner shaft. 
     In any of the preceding embodiments, the device further includes an infusion device coupled to the liquid injection port configured to deliver the liquid through the liquid injection port, through the first and second apertures, and into the GI tract of the patient proximal to the flexible member. 
     In any of the preceding embodiments, the flexible member includes a proximal end and a distal end, such that the proximal end of the flexible member is coupled to the outer shaft and the distal end of the flexible member is coupled to the inner shaft. 
     In any of the preceding embodiments, the device includes a handle having a proximal end coupled to the inner shaft and a distal end coupled to the outer shaft, such that the distal end of the handle is axially translatable to move the proximal end of the outer shaft toward and away from the distal portion of the inner shaft. 
     In any of the preceding embodiments, at least a first half of the flexible member includes a plurality of struts. 
     In any of the preceding embodiments, the flexible member further includes a cover configured to encase the plurality of struts. 
     In any of the preceding embodiments, the plurality of struts encloses a filler material. 
     In any of the preceding embodiments, the flexible member comprises a plurality of hydratable beads, such that the beads are configured to swell from an unexpanded state to an expanded state. 
     In any of the preceding embodiments, the plurality of hydratable beads is configured to expand when a liquid is applied through the one or both of the inner shaft and the outer shaft. 
     In any of the preceding embodiments, the flexible member includes or is formed of a braided material. 
     In any of the preceding embodiments, the flexible member further includes a cover configured to encase the braided material. 
     In any of the preceding embodiments, the braided material encloses a filler material. 
     In any of the preceding embodiments, the braided material comprises Nitinol. 
     In any of the preceding embodiments, the first aperture is substantially aligned with the second aperture when the flexible member is in the expanded configuration. 
     In any of the preceding embodiments, the flexible member comprises a balloon. 
     In any of the preceding embodiments, the flexible member is coated with an expandable material. 
     In any of the preceding embodiments, the expandable material includes thermoplastic polyurethane. 
     In any of the preceding embodiments, the inner shaft and outer shaft are substantially rotationally fixed relative to one another. 
     In any of the preceding embodiments, the flexible member expands to a diameter of substantially 2 cm to 4 cm. 
     Another aspect of the present disclosure is directed to a device configured to block at least a portion of a lumen of a GI tract during an endoscopy procedure. In some embodiments, the device includes an elongate body having a proximal end and a distal end and defining a lumen therethrough. In some embodiments, the elongate body further includes a flexible member and defines at least two apertures, a first aperture positioned proximally on the elongate body relative to the flexible member and a second aperture being configured to inflate the flexible member. In some embodiments, the flexible member is inflatable to an expanded configuration from an unexpanded configuration when a liquid flows through the lumen of the elongate body and out the second aperture of the elongate body. 
     In any of the preceding embodiments, the elongate body further defines a second lumen configured to receive a guidewire therethrough. 
     In any of the preceding embodiments, the first aperture is configured to deliver liquid into the GI tract. 
     Another aspect of the present disclosure is directed to a method for occluding at least a portion of a lumen of a GI tract during an endoscopy procedure. In some embodiments, the method includes: positioning a distal end of an elongate member adjacent to a proximal side of a stricture in a GI tract of a patient; advancing a flow reducing device through a lumen defined by the elongate member and through the stricture in the GI tract of the patient, such that the flow reducing device includes a flexible member and defines one or more apertures; expanding the flexible member of the flow reducing device from an unexpanded configuration to an expanded configuration distal to the stricture in the GI tract; advancing an ultrasound endoscope (echoendoscope) into the GI tract of the patient; infusing a liquid into the GI tract through the one or more apertures in the flow reducing device, such that flow of the liquid past the flexible member is restricted when the flexible member is in the expanded configuration; and imaging at least a portion of the GI tract of the patient with the echoendoscope. 
     In any of the preceding embodiments, the elongate member is an endoscope 
     In any of the preceding embodiments, the method further includes reducing a rate of flow of the liquid around the flexible member and through the downstream GI tract of the patient to less than 230 ml/minute. 
     In any of the preceding embodiments, the downstream GI tract includes one or more of: esophagus, stomach, a small intestine, a large intestine of the patient. 
     In any of the preceding embodiments, positioning further includes advancing the elongate member down the GI tract of the patient such that the distal end of the elongate member is positioned adjacent to the proximal side of a stricture. 
     In any of the preceding embodiments, the method further includes advancing a guidewire through the lumen of the elongate member and through the stricture of the GI tract of the patient, such that the flow reducing device is passed over the guidewire and through the stricture. 
     In any of the preceding embodiments, the method further includes removing the elongate member from the GI tract before advancing the echoendoscope into the GI tract. 
     In any of the preceding embodiments, infusing further includes coupling a liquid injection port to a proximal end of the flow reducing device, such that the liquid injection port is configured to deliver the liquid through a lumen defined by the flow reducing device and out the one or more apertures of the flow reducing device into the GI tract. 
     In any of the preceding embodiments, the GI tract includes one or more of: an esophagus, a stomach, a small intestine, a large intestine. 
     In any of the preceding embodiments, the method further includes advancing a entero-enterostomy device through a lumen of the echoendoscope. 
     In any of the preceding embodiments, the method further includes performing a entero-enterostomy procedure. 
     In any of the preceding embodiments, the method further includes collapsing the flexible member from the expanded configuration to the unexpanded configuration. 
     In any of the preceding embodiments, the method further includes removing the flow reducing device from the GI tract. 
     In any of the preceding embodiments, the method further includes attaching a handle to the flow reducing device to facilitate expansion or contraction of the flexible member. 
     In any of the preceding embodiments, the method further includes actuating the handle to manipulate the outer shaft relative to the inner shaft. 
     In any of the preceding embodiments, the method further includes removing the echoendoscope from the GI tract. 
     In any of the preceding embodiments, the flow reducing device further includes: an inner shaft have a proximal portion, a distal portion, and defining a lumen therethrough and a first aperture of the one or more apertures; and an outer shaft having a proximal end and a distal end coupled to the distal portion of the outer shaft, and defining a lumen therethrough. In some embodiments, the outer shaft defines a second aperture of the one or more apertures which is positioned proximally on the outer shaft relative to the flexible member. In some embodiments, the inner shaft extends through the lumen of the outer shaft; such that at least a portion of the outer shaft is axially translatable toward and away from the distal portion of the inner shaft to manipulate the flexible member. 
     In any of the preceding embodiments, the method further includes contacting an inner surface of a lumen of the GI tract with at least a portion of a perimeter of the flexible member. 
     Another aspect of the present disclosure is directed to a method for occluding at least a portion of a lumen of a GI tract during an endoscopy procedure. In some embodiments, the method includes: advancing a flow reducing device through a stricture in a GI tract of a patient, such that the flow reducing device comprises a flexible member and defines one or more apertures; expanding the flexible member of the flow reducing device from an unexpanded configuration to an expanded configuration distal to the stricture in the GI tract; advancing an echoendoscope into the GI tract of the patient; infusing a liquid into the GI tract through the one or more apertures in the flow reducing device, such that flow of the liquid past the flexible member is restricted when the flexible member is in the expanded configuration; and imaging at least a portion of the GI tract of the patient with the echoendoscope. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The foregoing is a summary, and thus, necessarily limited in detail. The above-mentioned aspects, as well as other aspects, features, and advantages of the present technology are described below in connection with various embodiments, with reference made to the accompanying drawings. 
         FIG.  1    schematically illustrates an endoscopic ultrasound procedure without the use of the devices and methods described elsewhere herein. 
         FIG.  2    schematically illustrates advancement of an endoscope through a GI tract of a patient. 
         FIG.  3    schematically illustrates optional advancement of a guidewire through a lumen of the endoscope of  FIG.  2    and past a stricture in a GI tract of a patient. 
         FIG.  4    schematically illustrates advancement of a flow reducing device, in an unexpanded configuration, through a GI tract of a patient and past a stricture. 
         FIG.  5    schematically illustrates deployment of a flexible member of the flow reducing device of  FIG.  4   , from an unexpanded configuration to an expanded configuration, thereby at least partially occluding the GI tract of the patient. 
         FIG.  6    schematically illustrates removal of the endoscope from the GI tract of the patient. 
         FIG.  7    schematically illustrates advancement of an echoendoscope through the GI tract of the patient. 
         FIG.  8    schematically illustrates attachment of a liquid injection port and an infusion device to an inner shaft of the flow reducing device to deliver a liquid into the GI tract of the patient. 
         FIG.  9    schematically illustrates removal of the liquid injection port and the infusion device of  FIG.  8    from the flow reducing device. 
         FIG.  10    schematically illustrates contraction of the flow reducing device from an expanded configuration to an unexpanded configuration. 
         FIG.  11    schematically illustrates removal of the flow reducing device from the GI tract of the patient. 
         FIG.  12    shows one embodiment of a flow reducing device in an unexpanded configuration. 
         FIG.  13    shows the flow reducing device of  FIG.  12    in an expanded configuration. 
         FIG.  14    shows one embodiment of a flexible member of a flow reducing device, the flexible member including or being formed of a braided material. 
         FIG.  15    shows one embodiment of the flexible member of  FIG.  14    including a cover for at least partially encasing the braided material. 
         FIG.  16    shows a zoomed in view of the flexible member of  FIG.  14    in an expanded configuration. 
         FIG.  17 A  shows a zoomed in view of the flexible member of  FIG.  14    in an unexpanded configuration. 
         FIG.  17 B  shows a zoomed in view of one or more friction locks between an inner shaft and an outer shaft of a flow reducing device. 
         FIG.  18    shows another embodiment of a flexible member of a flow reducing device, the flexible member being in an unexpanded configuration. 
         FIG.  19    shows the flexible member of  FIG.  18    in an expanded configuration. 
         FIG.  20    shows a view along line B-B of the flexible member of  FIG.  19   . 
         FIG.  21    shows an exploded view of the flow reducing device of  FIG.  19   . 
         FIG.  22    shows an exploded view of another embodiment of a flow reducing device, similar to that of  FIG.  21   . 
         FIG.  23    shows a zoomed-in view of a flexible member of the flow reducing device of  FIG.  22   . 
         FIG.  24    shows another embodiment of a flexible member, in an expanded configuration, of a flow reducing device. 
         FIG.  25    shows a cross-sectional view of the flexible member of  FIG.  24   . 
         FIG.  26    shows one embodiment of a handle configured for use with any of the flow reducing devices described herein. 
         FIG.  27    shows the handle of  FIG.  26    in an actuated state, with a flexible member in an expanded configuration. 
         FIG.  28    shows manipulation of the handle of  FIG.  26    by a user. 
         FIG.  29 A  shows cross-sectional view A-A of  FIG.  27    of a clamp for securing the handle of  FIG.  26    to an inner shaft of a flow reducing device. 
         FIG.  29 B  shows a zoomed-in view of the clamp of  FIG.  29 A . 
         FIG.  30    shows one embodiment of a handle configured for use with any of the flow reducing devices described herein. 
         FIG.  31    shows the handle of  FIG.  30    in an actuated state, where a flexible member would be in an expanded configuration. 
         FIG.  32    shows one embodiment of a handle configured for use with any of the flow reducing devices described herein. 
         FIG.  33    shows the handle of  FIG.  32    in an actuated state, where a flexible member would be in an expanded configuration. 
         FIG.  34    shows one embodiment of a handle configured for use with any of the flow reducing devices described herein. 
         FIG.  35    shows the handle of  FIG.  34    in an actuated state, where a flexible member would be in an expanded configuration. 
         FIG.  36    shows an isometric view of the handle of  FIG.  34   . 
         FIG.  37    shows one embodiment of a handle configured for use with any of the flow reducing devices described herein. 
         FIG.  38    shows the handle of  FIG.  37    in an actuated state, where a flexible member would be in an expanded configuration. 
         FIG.  39    shows another embodiment of a flexible member, in an unexpanded configuration, of a flow reducing device. 
         FIG.  40    shows a zoomed-in view of a plurality of hydratable elements of the flexible member of  FIG.  39   . 
         FIG.  41    shows a zoomed-in view of a cover of the flexible member of  FIG.  39   , the cover having a perforated distal surface. 
         FIG.  42    shows a cross-sectional view of the lumens of the flow reducing device of  FIG.  39   . 
         FIG.  43    shows the flow reducing device of  FIG.  39    in an expanded configuration. 
         FIG.  44    shows another embodiment of a flow reducing device. 
         FIG.  45    shows a zoomed-in view of section E of  FIG.  44   , which shows a flexible member of the flow reducing device of  FIG.  44   . 
         FIG.  46    shows a cross-sectional view of various lumens of the flow reducing device of  FIG.  44   . 
         FIG.  47    shows another cross-sectional view of various lumens of the flow reducing device of  FIG.  44   . 
         FIG.  48    shows one embodiment of a plug for the handle and/or devices of  FIGS.  44 - 53   . 
         FIG.  49    shows a perspective view of a handle for the flow reducing device of  FIGS.  39 - 47   , the handle configured to receive the plug of  FIG.  48   . 
         FIG.  50    shows an outer portion of the handle of  FIG.  49   . 
         FIG.  51    shows the handle of  FIGS.  49 - 50    in an open configuration, configured to receive a liquid for inflating a flexible member. 
         FIG.  52    shows the handle of  FIGS.  49 - 50    in a closed configuration. 
         FIG.  53    shows the handle of  FIGS.  49 - 50    with the plug of  FIG.  48    inserted in a lumen of the handle. 
         FIG.  54    shows a method of occluding at least a portion of a bodily lumen using any of the preceding embodiments of flow reducing devices. 
         FIG.  55    shows a method of reducing flow through a bodily lumen using a flow reducing device comprising two or more flexible members. 
     
    
    
     The illustrated embodiments are merely examples and are not intended to limit the disclosure. The schematics are drawn to illustrate features and concepts and are not necessarily drawn to scale. 
     DETAILED DESCRIPTION 
     The foregoing is a summary, and thus, necessarily limited in detail. The above-mentioned aspects, as well as other aspects, features, and advantages of the present technology will now be described in connection with various embodiments. The inclusion of the following embodiments is not intended to limit the disclosure to these embodiments, but rather to enable any person skilled in the art to make and use the contemplated invention(s). Other embodiments may be utilized, and modifications may be made without departing from the spirit or scope of the subject matter presented herein. Aspects of the disclosure, as described and illustrated herein, can be arranged, combined, modified, and designed in a variety of different formulations, all of which are explicitly contemplated and form part of this disclosure. 
     Disclosed herein are devices and methods for at least partially occluding a bodily lumen of a body. Occluding may include, but not be limited to, blocking the bodily lumen; obstructing the bodily lumen; reducing flow of a liquid through the bodily lumen; and capturing or blocking a particle, mass, object, etc. moving through the bodily lumen. 
     As used herein, a bodily lumen may include, but not be limited to, a GI tract, a mouth, an esophagus, a stomach, a small intestine, a large intestine, a blood vessel, an artery, a vein, a heart chamber, a renal chamber or tract, a kidney, a urinary tract, a bladder, a urethra, a vaginal canal, a uterus, a cervix, a trachea, a bronchial tube, a bronchus, a bronchiole, a respiratory tract, a lymphatic duct, a biliary duct, a pancreatic duct, etc. 
     The devices and methods described herein and obvious variations thereof may be used in a variety of procedures. Exemplary, non-limiting embodiments of procedures or medical practice areas include: endoscopy, ultrasound imaging, thrombectomy (e.g., capturing clot particles), gastrojejunostomy, biopsy (e.g., capturing tissue samples), imaging, diagnostics, ablation, stenting (e.g., lumen-apposing metal stent), etc. 
     As will be appreciated by one of skill in the art, the telescoping shaft assembly of any of the embodiments may be used in any other embodiments described herein without significantly departing from the original design. Similarly, any of the single shaft embodiments described herein may be used in any other embodiments described herein without significantly departing from the original design. Further, as will be appreciated by one of skill in the art, any of the flexible members described herein may be mechanically expanded, expanded via liquid infusion, expanded via hydration of one or more elements within the flexible member, or any other method or means of expanding a flexible member. Further, as will be appreciated by one of skill in the art, although terms like expanded and unexpanded are used, any number of intermediate configurations or intermediate expansion or contraction states between extremes is contemplated herein. 
     In some embodiments, any one or more of the components may be manufactured as or sold as a kit. For example, a kit may include any one or more of: a flow reducing device, an endoscope, an infusion device, a liquid injection port, an echoendoscope, or a combination thereof. A kit may include a flow reducing device with various interchangeable flexible members, such that one flexible member is removable and replaceable with another flexible member. 
     As described herein, the flexible member of the flow reducing devices may function to reduce a flow rate of liquid through the bodily lumen, dam or obstruct at least a portion of the bodily lumen, prevent liquid flow through the bodily lumen, etc. The flexible members described herein may include or at least partially formed of Nitinol, thermoplastic polymers, thermoset polymers, polyether ether ketone, or like materials known in the art. 
     As described herein, the flexible member may expand from an unexpanded configuration to an expanded configuration. As used herein, expansion may include movement from a first diameter to a second diameter, the first diameter being less than the second diameter. Alternatively, or additionally, expansion may include increasing a volume of the flexible member from a first volume to a second volume, the first volume being less than the second volume. Volume includes one or both of: the volume of the space enclosed by the flexible member and the volume of the actual cover or material of the flexible member. Volume includes but is not limited to: a volume of space enclosed by the expanded member and a volume of the material (e.g., flexible member, cover, etc.) that expands or contracts with or without filling, respectively. Alternatively, or additionally, expansion may include increasing a surface area in contact with at least part of a bodily lumen, for example a GI tract. The flexible member may be expanded and contracted once each during a procedure or more than once to achieve proper placement of the device during a procedure. 
     As used herein, a liquid, inflation liquid, filling liquid, etc. may include water, saline, contrast, drugs (e.g., anti-coagulants, thrombolytics, etc.), etc. 
     As used herein, fluid may include water, saline, contrast, drugs (e.g., anti-coagulants, thrombolytics, etc.), gases, air, etc. 
     The flow reducing devices described herein may have an exchange length of greater than about 1.5×, greater than about 2×, greater than about 2.5×, greater than about 3×, greater than about 3.5×, etc. of the endoscope working channel. For example, the exchange length of a flow reducing device may be greater than about 3.5 m, greater than about 4 m, greater than about 4.5 m, greater than about 5 m, etc. 
       FIG.  1    schematically illustrates an endoscopic ultrasound procedure without the use of the devices and methods described elsewhere herein. Liquid is infused into a targeted portion of the GI tract  20  of the patient  10  using any method known in the art (e.g., catheter, endoscope, etc.). Since there is nothing to restrict downstream flow, the liquid flow rate  18  through the GI tract is high. One of skill in the art will appreciate that while liquid flow rate  18  is shown at the exit of the GI tract, the liquid flow rate  18  may be more localized in the GI tract  20  and be passed through the GI tract over a period time after the procedure. After the targeted portion of GI tract  20  is sufficiently filled with liquid, an echoendoscope  12  is advanced into the GI tract  20  to image the targeted portion of the GI tract  20 , for example distal from a stricture  26  in the GI tract  20 . The quality of the ultrasound imaging is limited by the time during which the GI tract  20  is filled with liquid, which is directly proportional to the liquid flow rate  18  through the GI tract  20 . The devices and methods described herein sought to solve this liquid flow rate  18  problem with a technical solution directed toward reducing the liquid flow rate  18  through the GI tract  20  to allow more time for better imaging, more extensive investigation of the tissues in the GI tract  20 , to present a bigger target for fine needle aspiration, etc. or really any bodily lumen to which the devices and methods are applicable. 
       FIGS.  2 - 11    illustrate an exemplary method of the embodiments and technical solutions described elsewhere herein.  FIG.  2    schematically illustrates advancement of an endoscope  22  through a GI tract  20  of a patient  10 . Optionally, as shown in  FIG.  3   , a guidewire  24  is advanced through a working channel of the endoscope  22  and past a stricture  26  in a GI tract  20  of a patient  10 . As shown in  FIG.  4   , a flow reducing device  28 , in an unexpanded configuration, is advanced over the guidewire  24  or just through a lumen of the endoscope  22  through a GI tract  20  of a patient  10  and past a stricture  26 . The guidewire  24  is then removed and the flexible member of the flow reducing device  28  is deployed from an unexpanded configuration to an expanded configuration, as shown in  FIG.  5   , to thereby at least partially occlude the GI tract  20  of the patient  10 . The endoscope  22  is then removed from the GI tract  20  of the patient, as shown in  FIG.  6   . An echoendoscope  12  is advanced through the GI tract  20  of the patient  10 , as shown in  FIG.  7   . A handle  30  (e.g., comprising a liquid injection port (e.g., tuohy borst, female luer port, etc.) and an infusion device (e.g., infusion pump, syringe, etc.) is then attached to a proximal portion (e.g., inner shaft or elongate body) of the flow reducing device to deliver a liquid into the GI tract  20  of the patient  10 , as shown in  FIG.  8   . The liquid that is infused largely remains proximal to the flow reducing device  28  to provide an enhanced imaging environment for the echoendoscope  12  that is not constrained by the timeline associated with liquid exiting the GI tract  20 , since the flow reducing device  28  reduces or prevents liquid from exiting the GI tract  20 , as shown by liquid  18  exiting the GI tract. The handle  30  is removed from the proximal end of the flow reducing device  28 , as shown in  FIG.  9   , and the flow reducing device  28  is moved from an expanded configuration to an unexpanded configuration, as shown in  FIG.  10   . In embodiments where a gastro-enterostomy is performed, location X indicates where the small intestine (distal duodenum/proximal jejunum) would be connected to the stomach. The flow reducing device  28  is then removed from the GI tract  20  of the patient  10 , as shown in  FIG.  11   . In some embodiments, the flow reducing device  28  is removed with the echoendoscope  12 ; in other embodiments, the flow reducing device  28  and the echoendoscope  12  are removed sequentially, in either order (e.g., flow reducing device then echoendoscope or echoendoscope then flow reducing device). 
     In some embodiments, as shown in  FIG.  55   , a flow reducing device includes two or more flexible members such that a liquid infused into the bodily lumen is at least partially retained between the flexible members. The two or more flexible members may be expanded sequentially, simultaneously, or substantially simultaneously and contracted sequentially, simultaneously, or substantially simultaneously. 
       FIGS.  12 - 13    show one embodiment of a flow reducing device  1200  in an unexpanded and expanded configuration, respectively. A device configured to block at least a portion of a bodily lumen includes an inner shaft  1210  having a proximal portion  1232 , a distal portion  1230 , and defining a lumen  2138  (shown, e.g., in  FIG.  21   ) therethrough and a first aperture  2118  (shown, e.g., in  FIG.  21   ). The lumen  2138  of the inner shaft  1210  is configured to receive a guidewire therethrough, such that the flow reducing device  1200  may be passed over a guidewire to reach a target or desired position in a bodily lumen. The device  1200  further includes an outer shaft  1212  having a proximal end  1226  and a distal end  1228  coupled to the distal portion  1230  of the inner shaft  1210 , and defining a lumen  2149  (shown, e.g., in  FIG.  21   ) therethrough. The outer shaft  1212  further includes a flexible member  1214  and defines a second aperture  1216  positioned proximally on the outer shaft  1212  relative to the flexible member  1214 . The inner shaft  1210  extends through the lumen of the outer shaft  1212 , such that the inner shaft  1210  and the outer shaft  1212  form at least a partially telescoping assembly or the inner shaft  1210  and the outer shaft  1212  form concentric shafts or tubes. For example, at least a portion of the outer shaft  1212  is axially translatable  1240  toward and away from the distal portion  1230  of the inner shaft  1210  to expand the flexible member  1214  (outer shaft  1212  moves towards distal portion  1230  of inner shaft  1210 ) and contract the flexible member  1214  (outer shaft  1212  moves away from distal portion  1230  of inner shaft  1210 ). In some embodiments, the inner shaft  1210  and outer shaft  1212  are substantially rotationally fixed relative to one another. In some such embodiments, the first aperture  1216  is substantially aligned with the second aperture  2118  when the flexible member  1214  is in the expanded configuration. In other embodiments, the inner shaft  1210  and outer shaft  1212  are rotatable relative to one another, such that the flexible member  1214  is torquable in a clockwise or counterclockwise direction. In some embodiments, a torqued configuration of the flexible member  1214  in an expanded configuration imparts differential liquid flow or movement characteristics to the liquid that is proximal to the flexible member  1214  and into the GI tract. 
     The flexible member  1214  is positioned proximal to the distal end, shown as cap  1224 , of the inner shaft  1210 . In some embodiments, the flexible member  1214  is about 0.1 inches to about 5 inches from the distal end of the inner shaft  1210 . In some embodiments, the flexible member  1214  is about 0.8 inches to about 1.2 inches from the distal end, shown as cap  1224 , of the inner shaft  1210 . 
     The inner shaft  1210 , optionally, includes an extension indicator  1213 , for example a positive extension indicator indicates an axial translation length required to move the outer shaft  1212  to expand the flexible member  1214  from the unexpanded configuration to the expanded configuration, for example to prevent hyper or hypo extension of the flexible member  1214 . In some embodiments, extension indicator  1213  further includes a negative extension indicator indicating a state of over-expansion of the flexible member  1214 . For example, the flexible member expands to a diameter of substantially or about 2 cm to about 4 cm, about 1.5 cm to about 4.5 cm, about 3 cm to about 5 cm, about 1 cm to about 3 cm, etc. In other embodiments, a proximal end  1226  of the outer shaft  1212  defines a window or cutout such that an extension indicator on the inner shaft  1210  is visible through the outer shaft  1212 . The extension indicator  1213  may include one or more of: a color, a visual pattern, a tactile pattern (e.g., nodules, ribbing, etc.), haptics, etc. For example, the positive extension indicator may be a green color and the negative extension indicator may be a red color. Any of the flow reducing devices described herein may optionally include an extension indicator. 
     Alternatively, or additionally, a tactile indicator, for example a mechanical stop, may exist between the inner shaft  1210  and the outer shaft  1212 , such that outer shaft  1212  is prevented from sliding past the inner shaft  1210  at a certain length to prevent hyper or hypo extension of the flexible member  1214 . One or more friction locks  1413 , as shown in  FIG.  17 B , may be positioned on an outer diameter of the inner shaft  1410  and/or on an inner diameter of the outer shaft  1412  to prevent the inner shaft  1410  from sliding past the outer shaft  1412  when the flexible member is in the expanded configuration. The friction locks prevent slippage or sliding between the outer shaft  1412  and the inner shaft  1410  by creating friction between the outer diameter of the inner shaft  1410  and the inner diameter of the outer shaft  1412 . Such friction may prevent inadvertent changing of the expanded state of the flexible member  1214 . Any of the flow reducing devices described herein may optionally include one or more mechanical stops or locks. 
     Further, any of the flow reducing devices described herein may include an expansion stop  1435 , as shown in  FIG.  16   . Expansion stop  1435  includes one or more of the following: a movable or fixed concentric tube on the inner shaft  1410  that a distal end  1428  of the outer shaft  1412  butts up against when expanding the flexible member  1414 ; and/or one or more fixed protrusions, rings, or the like on an outer diameter of the inner shaft  1410  that the outer shaft  1412  butts up against when expanding the flexible member  1414 . Alternatively, a distal end  1428  of the outer shaft  1412  may extend beyond coupling  1420 , such that when the flexible member  1414  expands, the distal end  1428  of the outer shaft  1412  butts up against coupling  1422  between the inner shaft  1410  and the flexible member  1410 . In one embodiment, as shown in  FIG.  16   , the distal end  1428  of the outer shaft  1412  pushes up against expansion stop  1435  when moving from the unexpanded configuration to the expanded configuration of the flexible member  1414 . The expansion stop  1435  prevents the outer shaft  1412  from over or hyper expanding the flexible member  1414  during deployment. If the flexible member  1414  is over or hyper expanded, the flexible member  1414  may start to flatten, thereby creating a thin rim that would be irritating or even harmful to the bodily lumen in which it is positioned. The flattened shape may also, or alternatively, fold over rendering its liquid flow reducing or block capacity reduced or less effective. 
     Further, as shown in  FIGS.  12 - 13   , the flexible member includes a proximal end and a distal end, such that the proximal end  1220  of the flexible member  1214  is coupled to the outer shaft  1212  and the distal end  1222  of the flexible member  1214  is coupled to the inner shaft  1210 . The flexible member  1214  is coupled to the outer shaft  1212  at position  1220 , and the flexible member  1214  is coupled to the inner shaft  1210  at position  1222 . The coupling between the flexible member  1214  and the outer shaft  1212  and the flexible member  1214  and the inner shaft  1210  may be via glue, adhesive, soldering, welding, brazing, mechanical linkage (e.g., keyed or complementary surfaces), solvent bonding, or any other method known to one of skill in the art. 
     The inner shaft  1210  further includes a distal tip cover  1224  that includes a valve (e.g., duckbill valve) therein, as shown and described elsewhere herein, that prevents liquid that is transported through the lumen of the inner shaft  1210  from exiting the distal end or tip of the flow reducing device  1200  while allowing a guidewire therethrough. 
     In some embodiments, a system for at least partially occluding a bodily lumen includes a flow reducing device  1200  and additionally, a liquid injection port (e.g., tuohy borst valve, female luer port, etc.) coupled to the proximal portion  1232  of the inner shaft  1210  and an infusion device (e.g., pump, syringe, etc.) coupled to the liquid injection port configured to deliver the liquid through the liquid injection port, through the first and second apertures  1216 ,  2118 , and into the GI tract of the patient proximal to the flexible member  1214 . Apertures  1216 ,  2118  may have a diameter of about 0.005 to about 0.05 inches, for example about 0.01 to about 0.05 inches. 
       FIGS.  14 - 17 A  show another embodiment of a flow reducing device  1400 . Flexible member  1414  of flow reducing device  1400  includes or is at least partially formed of an alternative material  1434 , for example braided Nitinol, stainless steel, cobalt-chrome alloy, titanium, gold, platinum, silver, iridium, tantalum, tungsten, etc. In some embodiments, the braided material further encloses a filler material or hydratable material, as described elsewhere herein. Alternatively, or additionally, the alternative material  1434  of the flexible member  1414  may also be formed of or comprise a tube that is cut in a pattern or a bundle of fibers substantially axially aligned that would expand when compressed axially (similar to a stent). The flexible member  1414  may be further covered by a cover  1436 , for example including or formed at least in part of a thermoplastic polymer, a thermoset polymer, or similar material. The cover  1436  may at least partially or wholly encase the flexible member  1414 . For example, in some embodiments, the cover  1436  may only cover a proximal side or portion  1415  of the flexible member  1414 . Flow reducing device  1400  further includes an inner shaft  1410 , outer shaft  1412 , apertures  1416 , inner shaft lumen  1428 , flexible member to outer shaft coupling  1420 , and flexible member to inner shaft coupling  1422 , as described above in connection with  FIGS.  12 - 13   . Additional detail of the distal tip of the inner shaft  1210  is shown in  FIGS.  16 - 17 A . The distal end  1430  of the inner shaft  1210  includes distal tip  1450 , valve  1446 , and cap  1424  secured to the distal tip  1450 . Cap  1424 , in some embodiments, defines an aperture  1452  therethrough such that a guidewire or other elongate device can be passed through the lumen  1438  of the inner shaft  1210  and out the aperture  1452  defined by cap  1424 . Valve  1446  and cap  1424  prevent liquid that is transported through lumen  1438  from being expelled out of a distal end of the flow reducing device  1400 , while still allowing a guidewire or other elongate device to pass through cap  1424  through aperture  1452 . The flexible member  1414  of  FIGS.  16 - 17 A  is moveable between an expanded configuration ( FIG.  16   ) and an unexpanded configuration ( FIG.  17 A ), similar to that described above in connection with  FIGS.  12 - 13   . 
       FIGS.  18 - 21    show another embodiment of a flexible member  1814  of a flow reducing device  1800 . The flexible member  1814  is movable between an unexpanded configuration, as shown in  FIG.  18   , and an expanded configuration, as shown in  FIGS.  19 - 21   . Similar to embodiments described above, the flow reducing device of  FIGS.  18 - 21    includes an inner shaft  1810 ,  2110  (defining lumen  1838 ,  2138  therethrough) and an outer shaft  1812 ,  2112  (defining lumen  2149  therethrough) that are axially translatable  1840  relative to one another; a flexible member  1814 ,  2114 ; one or more apertures  2116  in outer shaft  2112 ; one or more apertures  2118  in inner shaft  2110 ; a first or proximal coupling  1820 ,  2120  between the outer shaft  1812 ,  2112  and the flexible member  1814 ,  2114 ; a second or distal coupling  1822 ,  2122  between the inner shaft  1810 ,  2110  and the flexible member  1814 ,  2114 ; and a distal cap  1824 ,  2124  with similar internal components (e.g., valve  2146 , guidewire lumen  2152 , distal tip  2150  of inner shaft  2110 ), as described above. However, in this embodiment, at least a first half of the flexible member  1814 ,  2114  includes a plurality of struts  1844 ,  2144 . As will be appreciated, any number of struts is contemplated: 2, 3, 4, 5, 6, 7, 8, 9, 10, or 12 struts, for example. The plurality of struts  1844 ,  2144  includes a plurality of joints  1842 ,  2142 .  FIG.  21    shows an exploded view of the flow reducing device  1800  of  FIG.  18   . For example, each strut may be formed of a proximal strut  2144   a  and a distal strut  2144   b  coupled together at joint  2142  and a proximal hub  2163   a  and distal hub  2163   b . Joint  2142  enables the flexible member  2114  to move from an unexpanded configuration in which the proximal strut  2144   a  is substantially or about 180 degrees relative to the distal strut  2144   b  about joint  2142  to an expanded configuration in which the proximal strut  2144   a  is substantially or about 20 to about 70 degrees relative to the distal strut  2144   b  about joint  2142 . The flexible member  2114  may further include a cover  2136 , coupled to inner shaft  2110  via distal cover hub  2159 , the cover being configured to encase the plurality of struts  2144 . Optionally, the plurality of struts  2144  encloses a filler material in some embodiments. 
       FIGS.  22 - 23    show another embodiment of a flexible member  2214  of a flow reducing device, the flexible member being similar to that of  FIGS.  18 - 21   . As shown in  FIG.  22   , the flow reducing device includes similar components as the flow reducing devices described above: an inner shaft  2210  (defining lumen  2238  therethrough) and an outer shaft  2212  (defining lumen  2249  therethrough) that are axially translatable relative to one another; a flexible member  2214 ; one or more apertures  2216  in outer shaft  2212 ; one or more apertures  2218  in inner shaft  2210 ; a first or proximal coupling  2220  between the outer shaft  2212  and the flexible member  2214 ; a second or distal coupling  2222  between the inner shaft  2210  and the flexible member  2214 ; and a distal cap  2224  with similar internal components (e.g., valve  2246 , guidewire lumen  2252 , distal tip  2250  of inner shaft  2210 ), as described above. However, in this embodiment, at least a first half of the flexible member  2214  includes a plurality of struts  2248 . The plurality of struts  2248  includes a plurality of joints  2242 . For example, each strut may be formed of a proximal strut  2248   a  and a distal strut  2248   b  coupled together at joint  2242  and a proximal hub  2263   a  and distal hub  2263   b . As shown in  FIG.  22   , the proximal strut  2248   a  is about twice as long as the distal strut  2248   b  (2:1 proximal strut:distal strut), such that the joint  2242  is about half-way down the length L 2248  of the proximal strut  2248   a . In other embodiments, the length ratio between the proximal strut  2248   a  and the distal strut  2248   b  is about 1.5:1; about 3:1, about 2.5:1, about 4:1, etc. A free end  2251  of proximal strut  2248   a , as shown in  FIGS.  22 - 23   , may be rendered atraumatic using post-processing methods or be covered in an atraumatic material in addition to, or alternatively to, cover  2236 . Joint  2242  enables the flexible member  2214  to move from an unexpanded configuration in which the proximal strut  2148   a  is substantially or about 180 degrees relative to the distal strut  2248   b  about joint  2242  to an expanded configuration in which the proximal strut  2248   a  is substantially or about 20 to about 70 degrees relative to the distal strut  2248   b  about joint  2242 . The flexible member  2214  may further include a cover  2236  configured to encase the plurality of struts  2248 , as shown in  FIG.  23   . Cover  2236  is coupled to inner shaft  2210  via distal cover hub  2259   b  and outer shaft  2212  via proximal cover hub  2259   a . Cover  2236  may define space or enclosure  2256 . Optionally, enclosure  2256  may be fillable with a fluid (e.g., gas, water, drug, etc.) or a filler material, in some embodiments. 
     In some embodiments of  FIG.  23   , a concavity of the plurality of struts  2248  may be facing a proximal end of the flow reducing device and a cover  2236  on the plurality of struts  2248  may fit more closely to the struts such that the plurality of struts behave more like a basket for collecting, for example, biopsy samples, clots, etc. 
       FIGS.  24 - 25    show another embodiment of a flow reducing device  2400  including flexible member  2414 . Flow reducing device  2400  includes similar features as those described above: an inner shaft  2410  and an outer shaft  2412  that are axially translatable  2440  relative to one another; a flexible member  2414 ; one or more apertures  2416  in outer shaft  2412 ; a first or proximal coupling  2420  between the outer shaft  2412  and the flexible member  2414 ; a second or distal coupling  2422  between the inner shaft  2410  and the flexible member  2414 ; and a distal cap  2424  with similar internal components (e.g., valve, guidewire lumen, distal tip of inner shaft, etc.), as described above. However, in this embodiment, the flexible member  2414  includes or is formed of an alternative material (e.g., braided, laser cut, etc.) that is coated  2454 . The braided, coated  2454  flexible member  2414  defines enclosure  2456 , as described above. As such, flexible member  2414  does not include a cover per say, but rather a coating  2454  on the alternative material that functions to prevent liquid flow through the flexible member  2414  once it is infused into the GI tract through one or more apertures  2416 . 
     Now turning to  FIGS.  26 - 38   , which show various handle configurations for the flow reducing devices described herein. As used herein, handle describes any device that is configured to manipulate a flow reducing device, actuate (e.g., mechanically, fluidly, etc.) a flexible member from an unexpanded state to an expanded state, and as needed, back to an unexpanded state. The handle may be used for actuation, fluid or liquid transport into the flexible member, plugging one or more ports of the flow reducing device, etc. 
       FIGS.  26 - 29 B  show one embodiment of a handle  2660  configured for use with any of the flow reducing devices described herein.  FIG.  26    shows handle  2660  in an unactuated state, with flexible member  2614  in an unexpanded configuration, and  FIG.  27    shows handle  2660  in an actuated state, with flexible member  2614  in an expanded configuration. As shown in  FIGS.  26 - 27   , the flow reducing device includes an inner shaft  2610 , an outer shaft  2612 , a first or proximal coupling  2620  between the outer shaft  2612  and the flexible member  2614 ; a second or distal coupling  2622  between the inner shaft  2610  and the flexible member  2614 ; and a distal cap  2624  with similar internal components (e.g., valve, guidewire lumen, distal tip of inner shaft, etc.), as described above. The proximal end  2662  of handle  2660  is coupled to inner shaft  2610  and distal end  2664  of handle  2660  is coupled to outer shaft  2612 . As shown in  FIG.  28   , during use, a user&#39;s hand  2674  may grasp handle body  2666  with fingers  2667  and palm and manipulate the distal end  2664  of handle  2660  with thumb  2669 . Axial translation  2640  of the outer shaft  2612  relative to the inner shaft  2610  is facilitated by axial translation of distal end  2664  of handle  2660  relative to handle body  2666 , such that when distal end  2664  of handle  2660  is moved distally away from handle body  2666 , the flexible member  2614  expands into the expanded configuration ( FIG.  27   ) and when the distal end  2664  of handle  2660  is moved proximally toward handle body  2666 , the expanded flexible member  2614  moves into the unexpanded configuration ( FIG.  26   ). The proximal end  2662  of handle  2660  is secured to the inner shaft  2610  via clamp  2658 . A detailed version of clamp  2658  is shown in  FIGS.  29 A- 29 B . Similar clamps to clamp  2658  are used in several embodiments described elsewhere herein. 
     As shown in  FIGS.  29 A- 29 B , clamp  2658  includes an upper clamp body  2658   a  and a lower clamp body  2658   b  with movable wedge  2673  therebetween. Actuation (e.g., rotation) of knob  2668  and thereby actuation of screw  2670  moves movable wedge  2673  towards the lower clamp body  2658   b  to apply force to an inner shaft  2610  secured between an upper clamp surface  2672   a  and a lower or bottom clamp surface  2672   b . The upper clamp surface  2672   a  and the lower clamp surface  2672   b  may each include complementary grooves 2675 sized and shaped to receive and secure an inner shaft  2610  therebetween. 
       FIGS.  30 - 31    show another embodiment of a handle  3060  configured for use with any of the flow reducing devices described elsewhere herein. A first end or proximal end  3076  of handle  3060  is coupled to inner shaft  3010  and a second end or distal end  3078  of handle  3060  is coupled to outer shaft  3012 . The proximal end  3076  and distal end  3078  of handle  3060  are coupled together via flexible handlebar  3080  and via a first telescoping tube or proximal tube  3082  coupled to first or proximal end  3076  and a second telescoping tube or distal tube  3084  coupled to second or distal end  3078 , the distal tube  3084  being axially translatable within a lumen of the proximal tube  3082 . Handle  3060  is actuated by squeezing the flexible handlebar  3080  with respect to (i.e., towards) telescoping tubes  3082 ,  3084 . As such, flexible handle bar  3080  flattens and elongates, thereby displacing the distal end  3078  away from the proximal end  3076  or axially translating  3040  the distal end  3078  of handle  3060  relative to the proximal end  3076  of handle  3060  to move a flexible member from an unexpanded configuration ( FIG.  30   ) to an expanded configuration ( FIG.  31   ). For example, as the distal end  3078  of handle  3060  is moved distally, as shown in  FIG.  31    (and flexible handlebar  3080  is elongated), distal tube  3084  extends out of a lumen of proximal tube  3082  and the flexible member is expanded. Conversely, as the distal end  3078  of handle  3060  is moved proximally, as shown in  FIG.  30    (and flexible handlebar  3080  is not elongated), distal tube  3084  is substantially or fully within a lumen of the proximal tube  3082  and the flexible member is in an unexpanded configuration. Inner shaft  3010  is secured in handle  3060  via clamp  3058 , similar to clamp  2658  described above and inner shaft  3010  is coaxially positioned in distal tube  3084 , which is coaxially positioned in proximal tube  3082 . 
       FIGS.  32 - 33    show another embodiment of a handle  3260  configured for use with any of the flow reducing devices described herein. Handle  3260  is similar to handle  3060  described above including the following features: a first end or proximal end  3276  of handle  3260  coupled to inner shaft  3210 ; a second end or distal end  3278  of handle  3260  coupled to outer shaft  3212 ; a proximal end  3276  and distal end  3278  of handle  3260  coupled together via an upper flexible handlebar  3280   a  and a lower flexible handlebar  3280   b ; and a proximal end  3276  and distal end  3278  of handle  3260  coupled together via a proximal tube  3282  coupled to the proximal end  3276  and a distal tube  3284  coupled to the distal end  3278 . Handle  3260  is actuated by squeezing the upper flexible handlebar  3280   a  and the lower flexible handlebar  3280   b  together or towards one another. As such, the upper and lower flexible handlebars  3280   a ,  3280   b  flatten and elongate, thereby displacing the distal end  3278  away from the proximal end  3276  or axially translating  3240  the distal end  3278  of handle  3260  relative to the proximal end  3276  of handle  3260  to move a flexible member from an unexpanded configuration ( FIG.  32   ) to an expanded configuration ( FIG.  33   ). For example, as the distal end  3278  of handle  3260  is moved distally, as shown in  FIG.  32    (and flexible handlebars  3280   a ,  3280   b  are elongated), distal tube  3284  extends out of a lumen of proximal tube  3282  and the flexible member is expanded. Conversely, as the distal end  3278  of handle  3260  is moved proximally, as shown in  FIG.  32    (and flexible handlebars  3280   a ,  3280   b  are not elongated), distal tube  3284  is substantially or fully within a lumen of the proximal tube  3282  and the flexible member is in an unexpanded configuration. Inner shaft  3210  is secured in handle  3260  via clamp  3258 , similar to clamp  2658  described above, and inner shaft  3210  is coaxially positioned in distal tube  3284 , which is coaxially positioned in proximal tube  3282 . 
       FIGS.  34 - 36    show another embodiment of a handle  3460  configured for use with any of the flow reducing devices described herein. Handle  3460  has the same general structure as the handles shown in  FIGS.  30 - 33    with a few identifiable differences. 
     Regarding similarities to  FIGS.  30 - 33   , handle  3460  includes: a first or proximal end  3476  of handle  3460  coupled to inner shaft  3410 ; a second or distal end  3478  of handle  3460  coupled to outer shaft  3412 ; a proximal end  3476  and distal end  3478  of handle  3460  coupled together via a flexible handlebar  3480 ; a proximal tube  3482  coupled to the proximal end  3476 ; and a distal tube  3484  coupled to the distal end  3478 . Handle  3460  is actuated by squeezing the flexible handlebar  3480  with respect to (i.e., towards) telescoping tubes  3482 ,  3484 . As such, flexible handle bar  3480  flattens and elongates, thereby displacing the distal end  3478  away from the proximal end  3476  or axially translating  3440  the distal end  3478  of handle  3460  relative to the proximal end  3476  of handle  3460  to move a flexible member from an unexpanded configuration ( FIG.  34   ,  FIG.  36   ) to an expanded configuration ( FIG.  35   ). For example, as the distal end  3478  of handle  3460  is moved distally, as shown in  FIG.  35    (and flexible handlebar  3480  is elongated), distal tube  3484  extends out of a lumen of proximal tube  3482  and the flexible member is expanded. Conversely, as the distal end  3478  of handle  3460  is moved proximally, as shown in  FIG.  34    (and flexible handlebar  3480  is not elongated), distal tube  3484  is substantially or fully within a lumen of the proximal tube  3482  and the flexible member is in an unexpanded configuration. Inner shaft  3410  is secured in handle  3460  via clamp  3458 , similar to clamp  2658  described above, and inner shaft  3410  is coaxially positioned in distal tube  3484 , which is coaxially positioned in proximal tube  3482 . 
     Regarding differences from  FIGS.  30 - 33   , as best shown in  FIG.  36   , latch  3488  extends from flexible handlebar  3480  to interact with and couple to stepped extension  3486 , so that the handle may secure the flow reducing device into a deployed configuration (flexible member in expanded configuration). Further, proximal end  3476  includes bracket or fork  3476   a  that is shaped to receive eye  3476   c  therein, the eye  3476   c  being secured in fork  3476   a  via pin  3476   b . Distal end  3478  includes a similar configuration with bracket or fork  3478   a  shaped to receive eye  3478   c  therein, which is secured therein by pin  3478   b . As such, when the flexible handlebar  3480  is actuated (i.e., squeezed towards telescoping tubes  3482 ,  3484 ) or returned to an unactuated state, the distal end  3478  moves away from and towards, respectively, proximal end  3476 , such that eyes  3476   c ,  3478   c  pivot in forks  3476   a ,  3478   a  about pins  3476   b ,  3478   b.    
       FIGS.  37 - 38    show another embodiment of a handle  3760  configured for use with any of the flow reducing devices described herein. Handle  3760  uses sets of clamps, similar to that described in  FIGS.  29 A- 29 B , to manipulate an inner shaft  3710  relative to an outer shaft  3712 . Proximal end body  3766   a  of handle  3760  is coupled to inner shaft  3710  and distal end body  3766   b  is coupled to outer shaft  3712 , using the mechanisms described in connection with  FIGS.  29 A- 29 B . For example, proximal clamp  3758   a  is coupled to inner shaft  3710  and distal clamp  3758   b  is coupled to outer shaft  3712 . Axial translation  3740  of the distal body  3766   b  coupled to the outer shaft  3712  towards a distal end of a flow reducing device expands a flexible member of the flow reducing device, while axial translation  3740  of the distal body coupled to the outer shaft towards the proximal end (and thus proximal body  3766   a ) moves an expanded flexible member into an unexpanded configuration. 
       FIGS.  39 - 47    show various embodiments of flow reducing devices that may include any or all of the features (e.g., extension indicator, mechanical stop, expansion stop, materials, etc.) of any of the other flow reducing devices described elsewhere herein. The embodiments shown in  FIGS.  39 - 47    can exist in multiple configurations. For example, the flow reducing devices may include concentric tubes (inner and outer shaft, as described above and elsewhere herein) or one elongate member, as will be described in further detail below. Further, the flow reducing devices of  FIGS.  39 - 47    may include two or more lumens. For example, in one embodiment, a flow reducing device includes three lumens: one lumen for a guidewire to pass therethrough; one lumen configured to receive inflation liquid therethrough for inflating a flexible member of the flow reducing device; and one lumen configured to receive a liquid for filling a bodily lumen for a procedure. In another embodiment, a flow reducing device includes two lumens: one lumen for a guidewire to pass therethrough, and one lumen configured to receive a liquid for expanding the flexible member and filling a bodily lumen for a procedure. 
     Turning now to  FIGS.  39 - 43   , which show an embodiment of a flow reducing device  3900 . A device  3900  configured to block at least a portion of a bodily lumen during a procedure includes an elongate body  3990  having a proximal end  3990   a  and a distal end  3990   b  and defining a lumen therethrough  3992 . The elongate body  3990  further includes a flexible member  3914  that is coupled to the elongate body  3990  at a first or proximal position  3993   a  and a second or distal position  3993   b . The elongate body  3990  defines at least two apertures  3991 ,  3998 . A first aperture  3991  is positioned proximally on the elongate body  3990  relative to the flexible member  3914  and is configured to deliver liquid into a bodily lumen in which the flow reducing device  3900  is positioned. A second aperture  3998  resides within the flexible member  3914  and is configured to inflate the flexible member  3914  with inflation fluid. The flexible member  3914  is inflatable to an expanded configuration, as shown in  FIG.  43   , from an unexpanded configuration, as shown in  FIG.  39   , when a liquid flows through the lumen  3992  of the elongate body  3990  and out the second aperture  3998  of the elongate body  3990 . In some embodiments, the elongate body  3990  further defines a second lumen  3994  configured to receive a guidewire therethrough, as shown in  FIG.  42   . Optionally, in some embodiments, the elongate body  3990  further defines a third lumen configured to receive another liquid therethrough, for example to fill a bodily lumen of a patient and/or to fill a flexible member  3914  of a flow reducing device  3900 . Elongate body  3990  includes distal cap  3924 , similar to that described elsewhere herein and including similar components (e.g., valve, distal tip of elongate body, guidewire lumen), that functions to allow a guidewire to pass therethrough but prevents liquid from escaping from a distal end  3990   b  of the flow reducing device  3900 . 
     As shown in  FIGS.  39 - 43   , flexible member  3914  includes or is formed of an expandable material including a plurality of hydratable beads  3996 , such that the beads  3996  are swellable from an unexpanded state to an expanded state when liquid infused into the flexible member  3914  via aperture  3998 . The plurality of hydratable beads  3996 , when in a hydrated state, may substantially or fully consume the space defined by the flexible member  3914 . In other embodiments of the flow reducing device  3900  where there is not just one elongate body but inner and outer shafts, as described elsewhere herein, the plurality of hydratable beads  3996  is configured to expand when a liquid is applied through one or both of the inner shaft and the outer shaft. The flexible member  3914  may further define one or more perforations  3995  on a distal side of the flexible member  3914  for releasing excess liquid from the flexible member  3914  when the plurality of hydratable beads  3996  have reached maximum capacity, a threshold, or equilibrium. In some embodiments, instead of a single elongate member, a flow reducing device  3900  includes an inner shaft and outer shaft configuration as described elsewhere herein. 
       FIGS.  44 - 47    show another embodiment of a flow reducing device  4400 . Flow reducing device  4400  is similar to that described above for  3900  in that includes an elongate body  4490  defining a guidewire lumen  4494  and an infusion lumen  4492  (and optionally a third lumen as described elsewhere herein). The elongate body  4490  further defines a first aperture  4491  and a second aperture  4498 . The first aperture  4491  is positioned proximally on the flow reducing device relative to the flexible member  4414  and functions to fill a bodily lumen in which the flow reducing device is positioned. The second aperture  4498  is inside the flexible member  4414  and functions to inflate the flexible member  4414  with a liquid. The flexible member  4414  is coupled to the elongate body  4490  at a proximal coupling position  4493   a  and a distal coupling position  4493   b . The elongate body  4490  further includes a distal cap  4424  that includes a valve  4446 , distal tip  4450  of the elongate body  4490 , and guidewire lumen  4452 , as shown in  FIG.  45   . As shown in  FIGS.  44 - 47   , the flexible member  4414  includes or is formed of an expandable or elastomeric material, for example a balloon, a thermoplastic polyurethane, a thermoset polyurethane, silicone, a polyether ether ketone, an inelastic material (e.g., fills or expands without stretching), etc. In some embodiments, instead of a single elongate member, a flow reducing device  4400  includes an inner shaft and outer shaft configuration as described elsewhere herein. 
       FIGS.  44  and  48 - 53    show one embodiment of a plug  4861  configured for insertion into any of the lumens of handle  4960  shown in  FIGS.  49 - 53   . For example, plug  4861  is insertable into guidewire lumen  4994  when infusion liquid is being passed through inflation lumen  4992 ; plug  4861  is insertable into the inflation lumen  4992  after the flexible member is expanded (e.g., prevents backflow of inflation fluid out of a proximal end of the assembly); plug  4861  is reversibly insertable into an inflation lumen  3992 ,  4492  until inflation is needed; in a three lumen handle, plug  4861  may occlude a lumen not in use; etc. Plug  4861  includes body  4866 , coupled to an insertion section  4889  (e.g., tapered or not) coupled to a lead in section  4899 , the insertion section  4889  and lead in section  4899  being insertable into a lumen, for example an infusion lumen, of elongate member or a handle attached to the elongate member. An embodiment of an infusion handle  4960  is shown in  FIGS.  49 - 53   . Handle  4960  includes an inner rotary body  4965  comprising a proximal section  4965   a , a middle section  4965   b , and a distal section  4965   c . The middle section  4965   b  includes an inflation lumen access skive  4985  configured to inflate a flexible member when fluid is applied therethrough and is rotatably overlapped by outer rotary body  4967 . Outer rotary body  4967  is coupled to a proximal sealing feature  4987   a  (e.g., O-ring) and a distal sealing feature  4987   b  (e.g., O-ring). Outer rotary body  4967  further defines an inflation aperture  4983 . When fully assembled and in an open configuration, as shown in  FIG.  51   , an inflation lumen access skive  4985  of inner rotary body  4965  is aligned with an inflation aperture  4983  of outer rotary body  4967 , such that liquid can be infused through the handle  4960  and through the flow reducing device (e.g., valve (e.g., tuohy borst) surrounding handle  4960  at aligned skive  4985  and aperture  4983 ; valve attached to proximal section  4965   c , etc.). In a closed configuration, as shown in  FIG.  52   , an inflation lumen access skive  4985  of inner rotary body  4965  is misaligned or not aligned with an inflation aperture  4983  of outer rotary body  4967 , such that fluid cannot be infused through the handle  4960  and through the flow reducing device into a flexible member. Handle  4960  may further include an extension indicator  4913   a ,  4913   b  to indicate when the skive  4985  and aperture  4983  are aligned ( FIG.  53   ) and when the skive  4985  and aperture  4983  are not aligned ( FIG.  52   ). Since the outer rotary body  4967  is rotatable relative to the inner rotary body  4965 , a first or proximal end  4913   a  of extension indicator becomes aligned or misaligned with a second or distal end  4913   b  of extension indicator depending on whether the infusion lumen should be open or closed, respectively. Although handle  4960  was described with respect to  FIGS.  39 - 49   , it shall be appreciated that handle  4960  can be used with any of the flow reducing devices (e.g.,  FIGS.  12 - 25   ) described herein and/or with any of the other handle embodiments (e.g.,  FIG.  26 - 38   ) described elsewhere herein. 
     In some embodiments, the inflation lumen access skive  4985  further functions as an infusion lumen access skive  4985  to deliver liquid into the bodily lumen. In some such embodiments, a cover of the flexible member may include one or more perforations, such that liquid not only fills the flexible member but also fills the bodily lumen proximal to the flexible member. 
     In some embodiments, handle  4960  forms part of a proximal portion or end of an inner shaft of a flow reducing device such that handle  4960  and inner shaft are fully integrated and continuous. In some such embodiments, the inner rotary body  4965  is a specialized inner shaft and the outer rotary body  4967  is coupled to the inner shaft via a proximal sealing feature  4987   a  (e.g., O-ring) and a distal sealing feature  4987   b  (e.g., O-ring). In other embodiments, handle  4960  is couplable to a proximal portion or proximal end of an inner shaft of a flow reducing device such that the various lumens of handle  4960  and inner shaft are continuous and uninterrupted. 
     Now turning to  FIG.  54   , which shows a method  5400  of occluding at least a portion of a bodily lumen using any of the preceding embodiments of flow reducing devices and/or handles and/or infusion devices. Any of the steps of method  5400  may be used in any sequence and additional steps may be added or existing steps removed. A method  5400  for occluding at least a portion of a bodily lumen for or during a procedure includes advancing a flow reducing device through a bodily lumen, such that the flow reducing device comprises a flexible member and defines one or more apertures S 5410 ; expanding the flexible member of the flow reducing device from an unexpanded configuration to an expanded configuration S 5420 ; advancing an instrument into the bodily lumen of the patient  55430 ; infusing a liquid into the bodily lumen through the one or more apertures in the flow reducing device, such that flow of the liquid past the flexible member is restricted when the flexible member is in the expanded configuration  55440 ; and performing a procedure in at least a portion of the bodily lumen of the patient with the instrument  5450 . 
     In any embodiments of the method  5400 , any of the flow reducing devices described elsewhere herein may be used and/or employed. In any embodiments of the method  5400 , an instrument includes any medical instrument, including but not limited to, ultrasound transducer or endoscope, ablation tool, biopsy tool, ligation tool, imaging tool (e.g., camera, microscope, ultrasound), sensor, stent, thrombectomy device, or any other medical device. 
     In some embodiments, method  5400  is particularly suited for performing an entero-enterostomy. In some such embodiments, block S 5410  includes advancing a flow reducing device through a stricture in the GI tract of a patient, such that the flow reducing device includes a flexible member and defines one or more apertures. In some embodiments, block S 5410  further includes positioning a distal end of an elongate member (e.g., endoscope, catheter, etc.) adjacent to a proximal side of a stricture in a GI tract of a patient; and advancing a flow reducing device through a lumen (e.g., working channel) defined by the elongate member (e.g., endoscope, catheter, etc.) and through the stricture in the GI tract. 
     In some embodiments, block S 5420  further includes expanding the flexible member of the flow reducing device from an unexpanded configuration to an expanded configuration distal to the stricture in the GI tract. 
     In some embodiments, blocks  55430 ,  55440 , and  55450  include advancing an echoendoscope into the GI tract of the patient; infusing a liquid into the GI tract through the one or more apertures in the flow reducing device, such that flow of the liquid past the flexible member is restricted when the flexible member is in the expanded configuration; and imaging at least a portion of the GI tract of the patient with the echoendoscope. 
     In some embodiments, infusing further includes coupling a liquid injection port (e.g., Tuohy borst valve) to a proximal end of the flow reducing device, such that the liquid injection port is configured to deliver the liquid through a lumen (e.g., infusion lumen) defined by the flow reducing device and out the one or more apertures of the flow reducing device into the GI tract, including one or more of: an esophagus, a stomach, a small intestine, or a large intestine. 
     In some embodiments, method  5400  includes positioning a distal end of an elongate member (e.g., endoscope, catheter, etc.) adjacent to a proximal side of a stricture in a GI tract of a patient. For example, for gastroenterostomy, the stricture is typically located in the proximal small bowel (duodenum), although could also be the distal stomach (called “gastric outlet obstruction” when contents back up into the stomach), 
     In some embodiments, the method  5400  further includes advancing a guidewire through the lumen of the elongate member and through the stricture of the GI tract of the patient, such that the flow reducing device is passed over the guidewire and through the stricture. A guidewire may be used when an endoscope and/or flow reducing device cannot be advanced pass the stricture. 
     In some embodiments, the method  5400  further includes removing the elongate member from the bodily lumen before advancing the instrument into the bodily lumen. 
     In some embodiments, method  5400  includes reducing a rate of flow of the liquid around the flexible member and through the downstream bodily lumen of the patient to less than about 300 ml/minute, less than about 230 ml/minute, less than about 200 ml/minute, about 200 to about 300 ml/minute, about 150 to about 250 ml/minute, about 100 to about 200 ml/minute, etc. 
     In some embodiments where the bodily lumen is the GI tract, the downstream GI tract includes one or more of: a small intestine, a large intestine, or a colon of the patient. 
     In some embodiments, method  5400  includes advancing an entero-enterostomy device through a lumen of the echoendoscope; and performing a entero-enterostomy procedure. 
     In some embodiments, method  5400  includes collapsing the expanded flexible member from the expanded configuration to the unexpanded configuration. In some such embodiments, collapsing may include moving an outer shaft proximally toward a proximal portion of an inner shaft to collapse the expanded flexible member from the expanded configuration to the unexpanded configuration. Alternatively, or additionally, suction or negative pressure may be applied to the infusion lumen (e.g., to remove fluid from an interior of the flexible member) to collapse the expanded flexible member to an unexpanded shape. 
     In some embodiments, method  5400  includes removing the flow reducing device from the GI tract. In the collapsed configuration (after the flexible member was expanded), a diameter of the flexible member may be greater than an unexpanded configuration before the flexible member was expanded. Such increased diameter may still be sufficiently small in diameter to be effectively removed from the bodily lumen. 
     In some embodiments, method  5400  includes attaching a handle to the flow reducing device to facilitate expansion or contraction or control of the flexible member. Any of the handles and/or infusion devices described elsewhere herein may be attached to any of the flow reducing devices described elsewhere herein. The method may further include actuating the handle to manipulate the outer shaft relative to the inner shaft. Such actuation may include moving a distal end of the handle that is coupled to an outer shaft toward a distal end of the device to expand the flexible member. Alternatively, actuating a handle may include rotating an outer rotary body relative to an inner rotary body to open an aperture for infusion of a liquid to expand a flexible member. 
     In some embodiments, method  5400  includes removing the echoendoscope from the GI tract. 
     In some embodiments, any of the systems and devices described herein may be used to prevent loss of a tissue specimen(s) that may migrate downstream with peristalsis after endoscopic resection (e.g., removal of a polyp in the duodenum). For example, the method may include deploying the flexible member through an elongate member (e.g., endoscope) under endoscopic guidance downstream from the lesion to be resected; removing the elongate member while leaving the flexible member in place; reinserting the elongate member alongside, adjacent to, or proximal to the flexible member; resecting a lesion to create a specimen with the elongate member; retrieving the specimen by pulling the flexible member proximally to “scoop” or “grab” or otherwise collect the specimen; collapsing the flexible member with the specimen secured therein; and removing the flexible member and elongate device from the patient. 
     As used in the description and claims, the singular form “a”, “an” and “the” include both singular and plural references unless the context clearly dictates otherwise. For example, the term “aperture” may include, and is contemplated to include, a plurality of apertures. At times, the claims and disclosure may include terms such as “a plurality,” “one or more,” or “at least one;” however, the absence of such terms is not intended to mean, and should not be interpreted to mean, that a plurality is not conceived. 
     The term “about” or “approximately,” when used before a numerical designation or range (e.g., to define a length or pressure), indicates approximations which may vary by (+) or (−) 5%, 1% or 0.1%. All numerical ranges provided herein are inclusive of the stated start and end numbers. The term “substantially” indicates mostly (i.e., greater than 50%) or essentially all of a device or method. 
     As used herein, the term “comprising” or “comprises” is intended to mean that the devices, systems, and methods include the recited elements, and may additionally include any other elements. “Consisting essentially of” shall mean that the devices, systems, and methods include the recited elements and exclude other elements of essential significance to the combination for the stated purpose. Thus, a system or method consisting essentially of the elements as defined herein would not exclude other materials, features, or steps that do not materially affect the basic and novel characteristic(s) of the claimed disclosure. 
     “Consisting of” shall mean that the devices, systems, and methods include the recited elements and exclude anything more than a trivial or inconsequential element or step. Embodiments defined by each of these transitional terms are within the scope of this disclosure. 
     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. Other embodiments may be utilized and derived therefrom, 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.