Devices and methods for at least partially occluding a body lumen

Abstract

To provide a device and related method for occluding at least a portion of a body lumen during a procedure.SOLUTION: The device includes an inner shaft defining a lumen therethrough and a first aperture, and an outer shaft including a flexible member and defining a lumen therethrough and a second aperture disposed on the outer shaft proximal to the flexible member. The inner shaft extends through the lumen of the outer shaft and at least a portion of the outer shaft is axially translatable toward or away from a distal portion of the inner shaft. The flexible member is transitionable between an unexpanded configuration and an expanded configuration when at least a portion of the outer shaft is axially translated toward or away from the distal portion of the inner shaft.SELECTED DRAWING: Figure 13

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority to U.S. Provisional Patent Application No. 62 / 993,192, filed March 23, 2020, the contents of which are incorporated herein by reference in their entirety.

[0002] FIELD OF THE DISCLOSURE The present disclosure relates generally to the field of endoscopy, and more particularly to the field of endoscopic ultrasound. Described herein are systems and methods for at least partially occluding a body lumen during a procedure. [Background technology]

[0003] Currently, endoscopic ultrasound-guided procedures (e.g., entero-enterostomy (including gastro-enterostomy)) are limited by the quality of ultrasound imaging and luminal distensibility of the target intestinal region. The gastrointestinal region is flooded with fluid to allow imaging. However, fluid quickly passes through the gastrointestinal tract, limiting the time available for imaging and distending the lumen for the targeted intervention. While it is possible to inject large volumes of fluid to keep up with the fluid outflow, too much fluid injected into the intestine (more than 500 ml) can lead to metabolic disorders. Therefore, better devices and methods are needed to limit fluid outflow from the target gastrointestinal region, allowing for improved imaging quality, longer imaging times, and luminal distensibility. Summary of the Invention [Problem to be solved by the invention]

[0004] The present invention has been made to solve the problems in the prior art described above. [Means for solving the problem]

[0005] There is a need for new and useful devices and methods for at least partially occluding a body lumen (e.g., during an endoscopic procedure). One aspect of the present disclosure relates to a device configured to occlude at least a portion of a lumen of the gastrointestinal tract during an endoscopic procedure. In some embodiments, the device includes an inner shaft having a proximal portion and a distal portion, the inner shaft 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, the outer shaft defining a lumen therethrough. In some embodiments, the outer shaft further includes a flexible member and defines a second aperture disposed on the outer shaft proximally relative to the flexible member. In some embodiments, the inner shaft extends through the lumen of the outer shaft, and at least a portion of the outer shaft is axially translatable toward or away from the distal portion of the inner shaft. In some embodiments, the flexible member is transitionable 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.

[0006] In any of the foregoing embodiments, the flexible member is located proximal to the distal end of the outer shaft.

[0007] In any of the foregoing embodiments, the flexible member is approximately 0.1 to 5 inches from the distal end of the outer shaft.

[0008] In any of the foregoing embodiments, the flexible member is approximately 0.8 to 1.2 inches from the distal end of the outer shaft.

[0009] In any of the foregoing embodiments, the inner shaft further includes a stop configured to limit movement of the outer shaft relative to the inner shaft (and thus the flexible member).

[0010] In any of the above embodiments, the inner shaft further includes an elongation indicator on a surface of the inner shaft, the elongation indicator indicating the axial translation length that the outer shaft must be moved to expand the flexible member from the unexpanded configuration to the expanded configuration.

[0011] In any of the foregoing embodiments, the elongation indicator further includes a negative elongation indicator to indicate an over-expansion condition of the flexible member.

[0012] In any of the foregoing embodiments, the inner shaft further includes a tip at a distal portion of the inner shaft, the distal tip including a valve configured to prevent liquid from exiting the distal tip of the inner shaft.

[0013] In any of the foregoing embodiments, the device further includes a fluid injection port coupled to the proximal portion of the inner shaft.

[0014] In any of the foregoing embodiments, the device further includes an injection device coupled to the liquid injection port, the injection device configured to deliver liquid from the liquid injection port through the first and second apertures and into the patient's gastrointestinal tract proximal to the flexible member.

[0015] In any of the foregoing embodiments, the flexible member includes a proximal end and a distal end, the proximal end of the flexible member being coupled to the outer shaft and the distal end of the flexible member being coupled to the inner shaft.

[0016] In any of the foregoing embodiments, the device includes a handle having a proximal end coupled to the inner shaft and a distal end coupled to the outer shaft, whereby the distal end of the handle is axially translatable to move the proximal end of the outer shaft toward or away from the distal portion of the inner shaft.

[0017] In any of the foregoing embodiments, at least a first half of the flexible member includes a plurality of struts.

[0018] In any of the foregoing embodiments, the flexible member further includes a cover configured to house the plurality of struts.

[0019] In any of the foregoing embodiments, the plurality of struts surrounds the filler material.

[0020] In any of the foregoing embodiments, the flexible member includes a plurality of hydratable beads that are configured to expand from an unexpanded state to an expanded state.

[0021] In any of the foregoing embodiments, the plurality of hydratable beads are configured to expand when a liquid is injected through one or both of the inner and outer shafts.

[0022] In any of the foregoing embodiments, the flexible member includes or is formed of a braided material.

[0023] In any of the foregoing embodiments, the flexible member further includes a cover configured to contain the braided material.

[0024] In any of the foregoing embodiments, the braided material surrounds the filler material.

[0025] In any of the foregoing embodiments, the braided material comprises Nitinol.

[0026] In any of the foregoing embodiments, the first aperture is generally aligned with the second aperture when the flexible member is in the expanded configuration.

[0027] In any of the foregoing embodiments, the flexible member comprises a balloon.

[0028] In any of the foregoing embodiments, the flexible member is coated with an expandable material.

[0029] In any of the foregoing embodiments, the expandable material comprises a thermoplastic polyurethane.

[0030] In any of the foregoing embodiments, the inner and outer shafts are substantially rotationally fixed relative to one another.

[0031] In any of the above embodiments, the flexible member expands to a diameter of approximately 2-4 cm.

[0032] Another aspect of the present disclosure relates to a device configured to occlude at least a portion of a lumen of the gastrointestinal tract during an endoscopic 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 disposed on the elongate body proximally from the flexible member and a second aperture configured to expand the flexible member. In some embodiments, the flexible member can expand from an uninflated configuration to an inflated configuration when a fluid flows through the lumen of the elongate body and out the second aperture of the elongate body.

[0033] In any of the foregoing embodiments, the elongate body further defines a second lumen configured to receive and pass a guidewire therethrough.

[0034] In any of the foregoing embodiments, the first aperture is configured to deliver a liquid into the gastrointestinal tract.

[0035] Another aspect of the present disclosure relates to a method for occluding at least a portion of a lumen of the gastrointestinal tract during an endoscopic procedure. In some embodiments, the method includes the steps of positioning a distal end of an elongate member proximal and adjacent to a stricture in a patient's gastrointestinal tract, advancing a flow restriction device through a lumen defined by the elongate member and through the stricture in the patient's gastrointestinal tract, the flow restriction device including a flexible member and defining one or more apertures, expanding the flexible member of the flow restriction device from an uninflated configuration to an inflated configuration distal to the stricture in the gastrointestinal tract, advancing an ultrasound endoscope into the patient's gastrointestinal tract, injecting a liquid into the gastrointestinal tract through the one or more apertures of the flow restriction device, wherein the flexible member is in the expanded configuration to restrict flow of the liquid past the flexible member, and imaging at least a portion of the patient's gastrointestinal tract with the ultrasound endoscope.

[0036] In any of the foregoing embodiments, the elongate member is an endoscope.

[0037] In any of the foregoing embodiments, the method further includes reducing the flow rate of liquid around the flexible member and through the patient's downstream gastrointestinal tract to less than 230 ml / min.

[0038] In any of the foregoing embodiments, the lower gastrointestinal tract includes one or more of the patient's esophagus, stomach, small intestine, and large intestine.

[0039] In any of the foregoing embodiments, the placing step further includes advancing the elongate member into the patient's gastrointestinal tract such that the distal end of the elongate member is positioned proximally adjacent the stricture.

[0040] In any of the foregoing embodiments, the method further includes advancing a guidewire through the lumen of the elongate member and through a stricture in the patient's gastrointestinal tract, wherein the flow suppression device is passed over the guidewire and through the stricture.

[0041] In any of the foregoing embodiments, the method may further include removing the elongate member from the gastrointestinal tract before advancing the ultrasound endoscope into the gastrointestinal tract.

[0042] In any of the foregoing embodiments, the injecting step further includes coupling a liquid injection port to the proximal end of the flow suppression device, the liquid injection port configured to deliver liquid from one or more apertures of the flow suppression device through a lumen defined by the flow suppression device and into the gastrointestinal tract.

[0043] In any of the foregoing embodiments, the digestive tract includes one or more of the esophagus, stomach, small intestine, and large intestine.

[0044] In any of the foregoing embodiments, the method further includes advancing the entero-enterostomy device through the lumen of the ultrasound endoscope.

[0045] In any of the foregoing embodiments, the method further includes the step of performing an entero-enterostomy procedure.

[0046] In any of the foregoing embodiments, the method further includes folding the flexible member from the expanded configuration to the unexpanded configuration.

[0047] In any of the foregoing embodiments, the method further includes the step of removing the flow suppression device from the gastrointestinal tract.

[0048] In any of the foregoing embodiments, the method further includes attaching a handle to the flow suppression device that facilitates expansion or contraction of the flexible member.

[0049] In any of the foregoing embodiments, the method further includes manipulating the outer shaft relative to the inner shaft by actuating a handle.

[0050] In any of the foregoing embodiments, the method further includes removing the ultrasound endoscope from the gastrointestinal tract.

[0051] In any of the foregoing embodiments, the flow suppression device further includes an inner shaft having a proximal portion and a distal portion, the inner shaft defining a lumen therethrough and a first 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, the outer shaft defining a lumen therethrough. In some embodiments, the outer shaft defines a second of the one or more apertures disposed on the outer shaft proximally from the flexible member. In some embodiments, the inner shaft extends through the lumen of the outer shaft, and at least a portion of the outer shaft is axially translatable toward or away from the distal portion of the inner shaft to manipulate the flexible member.

[0052] In any of the foregoing embodiments, the method further includes contacting the inner surface of the lumen of the alimentary canal with at least a portion of the outer periphery of the flexible member.

[0053] Another aspect of the present disclosure relates to a method of occluding at least a portion of a lumen of the gastrointestinal tract during an endoscopic procedure. In some embodiments, the method includes advancing a flow restriction device through a stricture in a patient's gastrointestinal tract, the flow restriction device including a flexible member and defining one or more apertures, expanding the flexible member of the flow restriction device from an uninflated configuration to an inflated configuration distal to the stricture in the gastrointestinal tract, advancing an ultrasound endoscope into the patient's gastrointestinal tract, injecting a liquid into the gastrointestinal tract through the one or more apertures of the flow restriction device, wherein the flexible member is in the inflated configuration to restrict flow of the liquid past the flexible member, and imaging at least a portion of the patient's gastrointestinal tract with the ultrasound endoscope.

[0054]

[0013] As this is a summary, details are by definition limited. These and other aspects, features, and advantages of the present technology will now be described with respect to various embodiments and with reference to the accompanying drawings.

[0055] The depicted embodiments are examples only and are not intended to limit the present disclosure. The diagrams are drawn to illustrate illustrative features or concepts and are not necessarily drawn to scale. [Brief explanation of the drawings]

[0056] [Figure 1] 10A-10C are schematic illustrations of an endoscopic ultrasound procedure without the use of the devices and methods described elsewhere herein. [Figure 2] 1 shows a schematic representation of an endoscope being advanced through a patient's digestive tract. [Figure 3] Optionally, a guidewire is shown schematically advanced through the lumen of the endoscope of FIG. 2 and past a stricture in the patient's digestive tract. [Figure 4] 10A and 10B are schematic illustrations of a flow restriction device in an uninflated configuration being advanced through a patient's gastrointestinal tract and past a stricture. [Figure 5] 5A-5C are schematic illustrations of the flexible member of the flow restriction device of FIG. 4 deployed from an uninflated configuration to an inflated configuration to at least partially occlude the patient's gastrointestinal tract; [Figure 6] 1 shows a schematic representation of an endoscope being removed from the patient's digestive tract. [Figure 7] 1 shows a schematic diagram of an ultrasound endoscope being advanced through a patient's digestive tract. [Figure 8] 10A and 10B are schematic diagrams illustrating a fluid injection port and injection device attached to the inner shaft of the flow control device for delivering fluid into the patient's gastrointestinal tract. [Figure 9] 9 shows a schematic view of the liquid injection port and injection device of FIG. 8 removed from the flow suppression device. [Figure 10] 10A and 10B schematically illustrate the flow suppression device being deflated from an expanded configuration to an unexpanded configuration. [Figure 11]10A and 10B show schematic diagrams of the flow restriction device removed from the patient's gastrointestinal tract. [Figure 12] 1 illustrates an embodiment of a flow suppression device in an unexpanded configuration. [Figure 13] 13 shows the expanded configuration of the flow suppressor device of FIG. 12. [Figure 14] 1 illustrates one embodiment of a flexible member of a flow suppression device, the flexible member including or formed of a braided material. [Figure 15] 15 illustrates an embodiment of the flexible member of FIG. 14 including a cover that contains at least a portion of the braided material. [Figure 16] 15 shows an enlarged view of the flexible member of FIG. 14 in its expanded configuration. [Figure 17A] 15 shows an enlarged view of the flexible member of FIG. 14 in its unexpanded form. [Figure 17B] 10 shows a close-up view of one or more friction locks between the inner and outer shafts of the flow suppression device. [Figure 18] 10 illustrates another embodiment of a flexible member of a flow suppression device, the flexible member in an unexpanded configuration. [Figure 19] 19 illustrates the flexible member of FIG. 18 in an expanded configuration. [Figure 20] 20 shows a view of the flexible member of FIG. 19 along line BB. [Figure 21] 20 shows an exploded view of the flow suppression device of FIG. 19. [Figure 22] 22 shows an exploded view of another embodiment of a flow suppression device similar to the flow suppression device of FIG. 21. [Figure 23] 23 shows an enlarged view of a flexible member of the flow suppressor device of FIG. 22. [Figure 24] 13 illustrates an expanded configuration of another embodiment of a flexible member of a flow suppression device. [Figure 25] 25 shows a cross-sectional view of the flexible member of FIG. 24. [Figure 26] 1 illustrates one embodiment of a handle configured for use with any of the flow suppression devices described herein. [Figure 27] The handle of Figure 26 is shown in an actuated state with the flexible member in an expanded configuration. [Figure 28] 27 shows how a user manipulates the handle in FIG. 26. [Figure 29A] 27 shows a cross-sectional view of a clamp securing the handle of FIG. 26 to the inner shaft of the flow suppression device, taken along line AA of FIG. 27. [Figure 29B] 29B shows an enlarged view of the clamp of FIG. 29A. [Figure 30] 1 illustrates one embodiment of a handle configured for use with any of the flow suppression devices described herein. [Figure 31] 31 shows the handle of FIG. 30 in an actuated state when the flexible member is in an expanded configuration. [Figure 32] 1 illustrates one embodiment of a handle configured for use with any of the flow suppression devices described herein. [Figure 33] 33 shows the handle of FIG. 32 in an actuated state when the flexible member is in an expanded configuration. [Figure 34] 1 illustrates one embodiment of a handle configured for use with any of the flow suppression devices described herein. [Figure 35] 35 shows the handle of FIG. 34 in an actuated state when the flexible member is in an expanded configuration. [Figure 36] 35 shows an isometric view of the handle of FIG. 34. [Figure 37] 1 illustrates one embodiment of a handle configured for use with any of the flow suppression devices described herein. [Figure 38] 38 shows the handle of FIG. 37 in an actuated state when the flexible member is in an expanded configuration. [Figure 39] 10 illustrates an unexpanded configuration of another embodiment of a flexible member of a flow suppression device. [Figure 40] 39A shows an enlarged view of a plurality of hydratable elements of the flexible member of FIG. 39. [Figure 41] 40 shows an enlarged view of the flexible member of FIG. 39 with a cover having perforations on the distal surface thereof. [Figure 42] 40 shows a cross-sectional view of the lumen of the flow suppression device of FIG. 39. [Figure 43]40 shows the expanded configuration of the flow suppression device of FIG. 39. [Figure 44] 10 illustrates another embodiment of a flow suppressor. [Figure 45] 44, showing a close-up of section E of FIG. 44, which shows the flexible member of the flow suppression device of FIG. [Figure 46] 45 shows a cross-sectional view of the various lumens of the flow suppression device of FIG. 44. [Figure 47] 45 shows another cross-sectional view of the various lumens of the flow suppression device of FIG. 44. [Figure 48] 54 shows one embodiment of a stopcock for the handle and / or device of FIGS. [Figure 49] 48 shows a perspective view of a handle for the flow restrictor of FIGS. 39-47, the handle configured to receive the plug of FIG. [Figure 50] 49 shows the outer portion of the handle. [Figure 51] 49-50 show the handle in an open configuration, which is configured to receive a liquid to expand the flexible member. [Figure 52] 49-50 in a closed configuration. [Figure 53] 49-50 show the handle of FIG. 48 with the plug inserted into the lumen of the handle. [Figure 54] 10 illustrates a method of occluding at least a portion of a body lumen using any of the previously described embodiments of a flow restriction device. [Figure 55] A method of restricting flow through a body lumen using a flow restriction device that includes two or more flexible members is presented. DETAILED DESCRIPTION OF THE INVENTION

[0057] The foregoing is a summary, and therefore, by definition, limited in detail. The above-mentioned aspects, as well as other aspects, features, and advantages of the present technology, will now be described with reference to various embodiments. The inclusion of the embodiments described below is not intended to limit the disclosure to those embodiments, but rather to enable one of ordinary skill in the art to make and use the contemplated invention. Other embodiments may be utilized, and modifications may be made without departing from the spirit or scope of the present subject matter. The aspects of the present disclosure described and illustrated herein may be arranged, combined, modified, and designed in various ways, all of which are expressly contemplated and made a part of this disclosure.

[0058] Described herein are devices and methods for at least partially occluding a body lumen in a body, which may include, but is not limited to, blocking the body lumen, placing an obstacle in the body lumen, inhibiting the flow of fluid through the body lumen, and trapping or blocking particles, masses, objects, etc., moving through the body lumen.

[0059] As used herein, a body lumen may include, but is not limited to, the digestive tract, oral cavity, esophagus, stomach, small intestine, large intestine, blood vessels, arteries, veins, cardiac cavities, renal cavities or ducts, kidneys, urinary tract, bladder, urethra, vaginal canal, uterus, cervix, trachea, bronchial branches, bronchi, bronchioles, airways, lymphatic trunks, bile ducts, pancreatic ducts, etc.

[0060] The devices and methods described herein, and obvious variations thereof, may be used in a variety of procedures, exemplary, non-limiting examples of procedures or areas of medical practice include endoscopy, ultrasound imaging, thrombectomy (e.g., capturing blood clot particles), gastrojejunostomy, biopsy (e.g., capturing tissue samples), imaging, diagnosis, ablation, stenting (e.g., lumen-apposing metal stents), and the like.

[0061] As will be understood by those skilled in the art, any embodiment of a telescoping shaft assembly may be used with any other embodiment described herein without significantly deviating from the original design. Similarly, any single-shaft embodiment described herein may be used with any other embodiment described herein without significantly deviating from the original design. Furthermore, as will be understood by those skilled in the art, any flexible member described herein may be expanded mechanically, by liquid injection, by hydration of one or more elements within the flexible member, or by any other method or means for expanding a flexible member. Furthermore, as will be understood by those skilled in the art, although terms such as "expanded" and "unexpanded" are used herein, any number of intermediate forms or states of expansion or contraction between the extremes are contemplated.

[0062] In some embodiments, any one or more components may be manufactured or sold as a kit. For example, a kit may include any one or more of a flow control device, an endoscope, an injection device, a fluid injection port, an ultrasound endoscope, or combinations thereof. A kit may include a flow control device with various interchangeable flexible members, whereby one flexible member can be removed and replaced with another flexible member.

[0063] As described herein, the flexible members of the flow suppression device may act to reduce the flow rate of fluid through a body lumen, occlude at least a portion of a body lumen with a dam or obstruction, impede the flow of fluid through a body lumen, etc. The flexible members described herein may include or be at least partially formed of nitinol, a thermoplastic polymer, a thermosetting polymer, a polymeric ether ketone, or similar materials known in the art.

[0064] As described herein, the flexible member may expand from an unexpanded configuration to an expanded configuration. Herein, expansion may include moving from a first diameter to a second diameter (where the first diameter is smaller than the second diameter). Alternatively or additionally, expansion may include increasing the volume of the flexible member from a first volume to a second volume (where the first volume is smaller than the second volume). The volume may include one or both of the volume of the space enclosed by the flexible member and the volume of the actual coating or material of the flexible member. The volume may include, but is not limited to, the volume of the space enclosed by the expanded member and the volume of material (e.g., flexible member, coating, etc.) that expands with the inflow of filler material or contracts with the outflow of filler material. Alternatively or additionally, expansion may include increasing the surface area in contact with at least a portion of a body lumen (e.g., the digestive tract). The flexible member may be inflated and deflated once during a procedure, or more than once to ensure proper placement of the device during a procedure.

[0065] As used herein, fluid, inflation fluid, filling fluid, etc. may include water, saline, contrast media, drugs (e.g., anticoagulants, thrombolytic agents, etc.), and the like.

[0066] As used herein, fluid may include water, saline, contrast agents, drugs (e.g., anticoagulants, thrombolytic agents, etc.), gases, air, and the like.

[0067] The flow suppression devices described herein can have an exchange length greater than about 1.5 times, greater than about 2 times, greater than about 2.5 times, greater than about 3 times, greater than about 3.5 times, etc., the length of the endoscope working channel. For example, the exchange length of the flow suppression device can be greater than about 3.5 m, greater than about 4 m, greater than about 4.5 m, greater than about 5 m, etc.

[0068] FIG. 1 illustrates a schematic diagram of an endoscopic ultrasound procedure without the use of the devices and methods described elsewhere herein. Fluid is infused into a target region of a gastrointestinal tract (GI) 20 of a patient 10 by any method known in the art (e.g., catheter, endoscope, etc.). Because there are no downstream flow restrictions, the fluid flow rate 18 through the GI tract is high. Those skilled in the art will appreciate that while the fluid flow rate 18 is shown at the exit of the GI tract, the fluid flow rate 18 may be more localized within the GI tract 20 or may represent a volume of fluid passing through the GI tract over a period of time following the procedure. After the target region of the GI tract 20 is sufficiently filled with fluid, the ultrasound endoscope 12 is advanced into the GI tract 20 to image the target region of the GI tract 20 (e.g., distal to a stricture 26 within the GI tract 20). The quality of the ultrasound imaging is limited by the time the GI tract 20 remains filled with fluid, which is directly proportional to the fluid flow rate 18 through the GI tract 20. The devices and methods described herein attempt to solve this problem of fluid flow rate 18 with technological solutions aimed at reducing the fluid flow rate 18 through the GI tract 20, thereby allowing for improved imaging over longer periods of time, more extensive examination of tissue within the GI tract 20, and presenting a larger target for fine needle aspiration, or indeed any body lumen, to which the devices and methods are applicable.

[0069] 2-11 illustrate an exemplary method for implementing embodiments and technical solutions described elsewhere herein. FIG. 2 schematically illustrates an endoscope 22 being advanced through the gastrointestinal tract 20 of a patient 10. Optionally, as shown in FIG. 3, a guidewire 24 is advanced through the working channel of the endoscope 22 and passes through a stricture 26 in the gastrointestinal tract 20 of the patient 10. As shown in FIG. 4, a flow suppression device 28 is advanced in an uninflated configuration over the guidewire 24, or simply through the lumen of the endoscope 22, through the gastrointestinal tract 20 of the patient 10 and passes through the stricture 26. The guidewire 24 is then removed, and the flexible member of the flow suppression device 28 is deployed from the uninflated configuration to an inflated configuration, as shown in FIG. 5, to at least partially occlude the gastrointestinal tract 20 of the patient 10. The endoscope 22 is then removed from the gastrointestinal tract 20 of the patient 10, as shown in FIG. 6. As shown in FIG. 7, an ultrasound endoscope 12 is advanced through the gastrointestinal tract 20 of the patient 10. Next, as shown in FIG. 8 , a handle 30 (e.g., including a fluid injection port (e.g., a Tuuh-Borst, female Luer port, etc.) and an injection device (e.g., an infusion pump, syringe, etc.)) is attached to the proximal portion (e.g., inner shaft or elongated body) of the flow restriction device to deliver fluid into the gastrointestinal tract 20 of the patient 10. The injected fluid remains mostly proximal to the flow restriction device 28, providing an improved imaging environment for the ultrasound endoscope 12 that is not constrained by a schedule determined by fluid exiting the gastrointestinal tract 20. This is because the flow restriction device 28 inhibits or prevents fluid from exiting the gastrointestinal tract 20, as illustrated by fluid 18 exiting the gastrointestinal tract. As shown in FIG. 9 , the handle 30 is removed from the proximal end of the flow restriction device 28, and the flow restriction device 28 is transitioned from an inflated configuration to an uninflated configuration, as shown in FIG. 10 . In embodiments where a gastroenterostomy is being performed, location X indicates where the small intestine (distal duodenum / proximal jejunum) will be connected to the stomach. Next, the flow control device 28 is removed from the gastrointestinal tract 20 of the patient 10, as shown in FIG. 11. In some embodiments, the flow control device 28 is removed together with the ultrasound endoscope 12. In other embodiments, the flow control device 28 and ultrasound endoscope 12 are removed sequentially in any order (e.g., flow control device then ultrasound endoscope, or ultrasound endoscope then flow control device).

[0070] In some embodiments, the flow suppression device includes two or more flexible members between which at least a portion of the fluid infused into the body lumen is retained, as shown in Figure 55. The two or more flexible members may be inflated sequentially, simultaneously, or nearly simultaneously, and may be deflated sequentially, simultaneously, or nearly simultaneously.

[0071] 12 and 13 illustrate the uninflated and inflated configurations, respectively, of one embodiment of a flow suppression device 1200. The device, configured to occlude at least a portion of a body lumen, includes an inner shaft 1210 having a proximal portion 1232 and a distal portion 1230 and defining a lumen 2138 (shown, e.g., in FIG. 21 ) extending therethrough and a first aperture 2118 (shown, e.g., in FIG. 21 ). The lumen 2138 of the inner shaft 1210 is configured to receive and pass a guidewire such that the flow suppression device 1200 can be passed over the guidewire to reach a target or desired location within the body 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, for example, in FIG. 21 ) therethrough. The outer shaft 1212 further includes a flexible member 1214 and defines a second aperture 1216 on the outer shaft 1212 disposed proximally from 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 at least partially form a telescoping assembly, or alternatively, 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 toward or away from the distal portion 1230 of the inner shaft 1210, thereby expanding the flexible member 1214 (moving the outer shaft 1212 toward the distal portion 1230 of the inner shaft 1210) or contracting the flexible member 1214 (moving the outer shaft 1212 away from the distal portion 1230 of the inner shaft 1210). In some embodiments, the inner shaft 1210 and the 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 another embodiment, the inner shaft 1210 and the outer shaft 1212 are rotatable relative to one another, thereby allowing the flexible member 1214 to be torqued in a clockwise or counterclockwise direction. In some embodiments, the torqued configuration of the flexible member 1214 in its expanded configuration provides differential fluid flow or movement characteristics to fluids proximal to the flexible member 1214 entering the gastrointestinal tract.

[0072] 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 approximately 0.1 to 5 inches from the distal end of the inner shaft 1210. In some embodiments, the flexible member 1214 is approximately 0.8 to 1.2 inches from the distal end (shown as cap 1224) of the inner shaft 1210.

[0073] The inner shaft 1210 optionally includes an extension indicator 1213, e.g., a positive extension indicator indicating the axial translation length the outer shaft 1212 must be moved to expand the flexible member 1214 from an unexpanded configuration to an expanded configuration. This prevents, for example, over- or under-extension of the flexible member 1214. In some embodiments, the extension indicator 1213 further includes a negative extension indicator, which indicates an over-expansion state of the flexible member 1214. For example, the flexible member expands to a diameter of approximately or about 2-4 cm, about 1.5-4.5 cm, about 3-5 cm, about 1-3 cm, etc. In another embodiment, a window or notch is defined in the proximal end 1226 of the outer shaft 1212 so that the extension indicator on the inner shaft 1210 is visible through the outer shaft 1212. The elongation indicator 1213 may include one or more of a color, a visual pattern, a tactile pattern (e.g., small bumps, linear protrusions, etc.), haptics, etc. For example, a positive elongation indicator may be green and a negative elongation indicator may be red. Any of the flow suppression devices described herein may optionally include an elongation indicator.

[0074] Alternatively or additionally, there may be a tactile indicator (e.g., a mechanical stop) between the inner shaft 1210 and the outer shaft 1212 that prevents the outer shaft 1212 from sliding past a certain length of the inner shaft 1210, which prevents over- or under-extension of the flexible member 1214. As shown in FIG. 17B , one or more friction locks 1413 may be disposed on the outer diameter of the inner shaft 1410 and / or on the inner diameter of the outer shaft 1412, which prevents 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 an inadvertent change in the expanded state of the flexible member 1214. Any of the flow restricting devices described herein may optionally include one or more mechanical stops or locks.

[0075] 16 , the expansion stop 1435 may include one or both of a movable or fixed concentric tube on the inner shaft 1410 against which the distal end 1428 of the outer shaft 1412 abuts upon expansion of the flexible member 1414, and / or one or more fixed protrusions, rings, etc. on the outer diameter of the inner shaft 1410 against which the outer shaft 1412 abuts upon expansion of the flexible member 1414. Alternatively, the distal end 1428 of the outer shaft 1412 may extend beyond the joint 1420, such that the distal end 1428 of the outer shaft 1412 abuts against the joint 1422 between the inner shaft 1410 and the flexible member 1410 upon expansion of the flexible member 1414. 16 , as the flexible member 1414 transitions from its uninflated configuration to its expanded configuration, the distal end 1428 of the outer shaft 1412 presses against an expansion stop 1435. The expansion stop 1435 prevents the outer shaft 1412 from over-inflating the flexible member 1414 as it is deployed. If the flexible member 1414 were to over-inflate, the flexible member 1414 would begin to flatten, creating a thin rim that could irritate or even injure the body lumen in which it is located. The flattened shape may also, or alternatively, fold over, reducing its ability or effectiveness in inhibiting or blocking fluid flow.

[0076] 12-13, the flexible member includes a proximal end and a distal end, with the proximal end 1220 of the flexible member 1214 being coupled to the outer shaft 1212 and the distal end 1222 of the flexible member 1214 being coupled to the inner shaft 1210. The flexible member 1214 is coupled to the outer shaft 1212 at location 1220, and the flexible member 1214 is coupled to the inner shaft 1210 at location 1222. The coupling between the flexible member 1214 and the outer shaft 1212 and between the flexible member 1214 and the inner shaft 1210 may be achieved by adhesives, glues, soldering, welding, brazing, mechanical bonding (e.g., with dowels or complementary surfaces), solvent bonding, or any other method known to one skilled in the art.

[0077] The inner shaft 1210 further includes a distal tip cover 1224, which includes a valve (e.g., a duckbill valve) therein, as shown and as described elsewhere herein, that prevents fluid conveyed through the lumen of the inner shaft 1210 from exiting the distal end or tip of the flow suppression device 1200 while at the same time allowing a guidewire to pass therethrough.

[0078] In some embodiments, a system for at least partially occluding a body lumen includes the flow suppression device 1200, and further includes a fluid injection port (e.g., a Touhy-Borst valve, a female Luer port, etc.) coupled to the proximal portion 1232 of the inner shaft 1210, and an injection device (e.g., a pump, a syringe, etc.) coupled to the fluid injection port, the injection device configured to deliver fluid from the fluid injection port through the first and second apertures 1216, 2118 and into the patient's gastrointestinal tract proximal to the flexible member 1214. The apertures 1216, 2118 can have a diameter of about 0.005 to 0.05 inches, for example, about 0.01 to 0.05 inches.

[0079] 14-17A illustrate another embodiment of a flow control device 1400. The flexible member 1414 of the flow control device 1400 includes or is formed at least in part of an alternative material 1434, such as braided nitinol, stainless steel, cobalt-chromium alloy, titanium, gold, platinum, silver, iridium, tantalum, tungsten, or the like. In some embodiments, the braided material may further surround a filler material or a hydratable material, as described elsewhere herein. Alternatively or additionally, the alternative material 1434 of the flexible member 1414 may be formed of or include a patterned tube or a bundle of generally axially aligned fibers that will expand when axially compressed (similar to a stent). The flexible member 1414 may further be covered by a cover 1436, which may include or be at least partially formed of, for example, a thermoplastic polymer, a thermosetting polymer, or a similar material. The cover 1436 may at least partially or entirely encase the flexible member 1414. For example, in some embodiments, the cover 1436 may cover only the proximal side or portion 1415 of the flexible member 1414. As described above with respect to FIGS. 12-13 , the flow suppression device 1400 further includes an inner shaft 1410, an outer shaft 1412, an aperture 1416, an inner shaft lumen 1428, a flexible member-to-outer shaft junction 1420, and a flexible member-to-inner shaft junction 1422. Further details of the distal tip of the inner shaft 1210 are shown in FIGS. 16-17A. The distal end 1430 of the inner shaft 1210 includes a distal tip 1450, a valve 1446, and a cap 1424 secured to the distal tip 1450. The cap 1424, in some embodiments, defines an aperture 1452 therethrough that allows a guidewire or other elongate device to pass through the lumen 1438 of the inner shaft 1210 and exit through the aperture 1452 defined by the cap 1424.Valve 1446 and cap 1424 prevent fluid conveyed through lumen 1438 from escaping the distal end of flow suppression device 1400, while allowing a guidewire or other elongate device to pass through cap 1424 and aperture 1452. Flexible member 1414 of Figures 16-17A is transitionable between an inflated configuration (Figure 16) and an uninflated configuration (Figure 17A), similar to that described above with respect to Figures 12-13.

[0080] Figures 18-21 illustrate a flexible member 1814 of another embodiment 1800 of a flow suppression device. The flexible member 1814 is transitionable between an uninflated configuration, shown in Figure 18, and an inflated configuration, shown in Figures 19-21. Similar to the embodiments described above, the flow suppression device of Figures 18-21 includes an inner shaft 1810, 2110 (defining lumens 1838, 2138 therethrough) and an outer shaft 1812, 2112 (defining a lumen 2149 therethrough) that are axially translatable (1840) relative to one another, flexible members 1814, 2114, one or more apertures 2116 in the outer shaft 2112, and one or more apertures 2118 in the inner shaft 2110. a first (proximal) joint 1820, 2120 between the outer shaft 1812, 2112 and the flexible member 1814, 2114; a second (distal) joint 1822, 2122 between the inner shaft 1810, 2110 and the flexible member 1814, 2114; and a distal cap 1824, 2124 having similar internal components as described above (e.g., valve 2146 of the inner shaft 2110, guidewire lumen 2152, distal tip 2150). However, in this embodiment, at least a first half of the flexible member 1814, 2114 includes a plurality of struts 1844, 2144. Of course, any number of struts is contemplated, for example, 2, 3, 4, 5, 6, 7, 8, 9, 10, or 12 struts. The plurality of struts 1844, 2144 includes a plurality of joints 1842, 2142. Figure 21 shows an exploded view of the flow suppression device 1800 of Figure 18. For example, each strut may be formed of a proximal strut 2144a and a distal strut 2144b joined to one another at a joint 2142, and a proximal hub 2163a and a distal hub 2163b. The joint 2142 allows the flexible member 2114 to transition from an unexpanded configuration in which the proximal strut 2144a is at approximately or about 180 degrees relative to the distal strut 2144b about the joint 2142, to an expanded configuration in which the proximal strut 2144a is at approximately or about 20-70 degrees relative to the distal strut 2144b about the joint 2142.The flexible member 2114 may further include a cover 2136, which is coupled to the inner shaft 2110 via a distal cover hub 2159, and which is configured to house a plurality of struts 2144. In some embodiments, optionally, the plurality of struts 2144 surrounds a filler material.

[0081] 22-23 show a flexible member 2214 of another embodiment of a flow suppression device, which is similar to the flexible member of FIGS. 18-21. As shown in FIG. 22 , the flow suppression device includes similar components to the flow suppression devices described above, namely, an inner shaft 2210 (defining a lumen 2238 therethrough) and an outer shaft 2212 (defining a lumen 2249 therethrough) that are axially translatable relative to one another, a flexible member 2214, one or more apertures 2216 in the outer shaft 2212, one or more apertures 2218 in the inner shaft 2210, a first (proximal) junction 2220 between the outer shaft 2212 and the flexible member 2214, a second (distal) junction 2222 between the inner shaft 2210 and the flexible member 2214, and a distal cap 2224 having similar internal components as described above (e.g., a valve 2246 of the inner shaft 2210, a guidewire lumen 2252, a distal tip 2250). However, in this embodiment, at least a first half of 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 2244a and a distal strut 2248b connected to each other at a joint 2242, and a proximal hub 2263a and a distal hub 2263b. As shown in FIG. 22, proximal strut 2248a is approximately twice as long as distal strut 2248b (proximal strut:distal strut=2:1), so joint 2242 is located at the length L of proximal strut 2248a. 224822-23 , the proximal struts 2248a are approximately halfway down the joint 2242. In other embodiments, the ratio of the lengths of the proximal struts 2248a to the distal struts 2248b is about 1.5:1, about 3:1, about 2.5:1, about 4:1, etc. The free ends 2251 of the proximal struts 2248a shown in FIGS. 22-23 can be made atraumatic by post-processing methods or can be covered with an atraumatic material in addition to or as an alternative to the covering 2236. The joint 2242 allows the flexible member 2214 to transition from an unexpanded configuration in which the proximal struts 2248a are approximately or about 180 degrees relative to the distal struts 2248b about the joint 2242, to an expanded configuration in which the proximal struts 2248a are approximately or about 20-70 degrees relative to the distal struts 2248b about the joint 2242. The flexible member 2214 may further include a cover 2236 configured to house the plurality of struts 2248, as shown in FIG. 23. The cover 2236 is coupled to the inner shaft 2210 via a distal cover hub 2259b and to the outer shaft 2212 via a proximal cover hub 2259a. The cover 2236 may define a space or enclosure 2256. In some embodiments, the enclosure 2256 may optionally be capable of being filled with a fluid (e.g., gas, water, a drug, etc.) or a filler material.

[0082] In some embodiments of FIG. 23, the concave surface of the struts 2248 may face the proximal end of the flow suppression device, and the cover 2236 covering the struts 2248 may fit more closely to the struts, causing the struts to act more like a cage, for example, to collect biopsy samples, blood clots, etc.

[0083] 24-25 illustrate another embodiment of a flow suppression device 2400, including a flexible member 2414. The flow suppression device 2400 includes similar features to the flow suppression devices described above, namely, 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 the outer shaft 2412, a first (proximal) junction 2420 between the outer shaft 2412 and the flexible member 2414, a second (distal) junction 2422 between the inner shaft 2410 and the flexible member 2414, and a distal cap 2424 having similar internal components (e.g., inner shaft valve, guidewire lumen, distal tip, etc.) as described above. However, in this embodiment, the flexible member 2414 includes or is formed of an alternative material that is coated (2454) (e.g., braided, laser cut, etc.). The braided and coated (2454) flexible member 2414, as described above, defines an enclosure 2456. As such, the flexible member 2414 does not include a cover, but instead includes a coating 2454 over an alternative material, which acts to prevent fluid from exiting the flexible member 2414 after it is injected into the digestive tract through one or more apertures 2416.

[0084] 26-38, which illustrate various handle configurations for the flow restriction devices described herein. As used herein, handle refers to any device configured to manipulate the flow restriction device and actuate (e.g., mechanically, fluidically, etc.) the flexible member to transition the flexible member from an uninflated state to an inflated state and, if desired, return to the uninflated state. The handle may be used for actuation, for transporting fluids or liquids into the flexible member, for plugging one or more ports of the flow restriction device, etc.

[0085]

[00103] Figures 26-29B show one embodiment of a handle 2660 configured for use with any of the flow suppression devices described herein. Figure 26 shows the handle 2660 in an unactuated state with the flexible member 2614 in an unexpanded configuration, and Figure 27 shows the handle 2660 in an actuated state with the flexible member 2614 in an expanded configuration. As shown in Figures 26-27, the flow suppression device includes an inner shaft 2610, an outer shaft 2612, a first (proximal) joint 2620 between the outer shaft 2612 and the flexible member 2614, a second (distal) joint 2622 between the inner shaft 2610 and the flexible member 2614, and a distal cap 2624 having similar internal components as described above (e.g., inner shaft valve, guidewire lumen, distal tip, etc.). The proximal end 2662 of the handle 2660 is coupled to the inner shaft 2610, and the distal end 2664 of the handle 2660 is coupled to the outer shaft 2612. As shown in FIG. 28 , during use, a user's hand 2674 may grasp the handle body 2666 with the fingers 2667 and palm, and the distal end 2664 of the handle 2660 may be manipulated with the thumb 2669. Axial translation 2640 of the distal end 2664 of the handle 2660 relative to the handle body 2666 drives axial translation 2640 of the outer shaft 2612 relative to the inner shaft 2610, such that distal movement of the distal end 2664 of the handle 2660 away from the handle body 2666 causes the flexible member 2614 to expand to an expanded configuration ( FIG. 27 ) and proximal movement of the distal end 2664 of the handle 2660 towards the handle body 2666 causes the expanded flexible member 2614 to transition to an unexpanded configuration ( FIG. 26 ). The proximal end 2662 of the handle 2660 is secured to the inner shaft 2610 by a clamp 2658, details of which are shown in FIGS. 29A-29B. Clamps similar to clamp 2658 are used in some embodiments described elsewhere herein.

[0086] 29A-29B, the clamp 2658 includes an upper clamp body 2658a and a lower clamp body 2658b with a movable wedge 2673 therebetween. Actuating (e.g., rotating) the knob 2668 to actuate the screw 2670 moves the movable wedge 2673 toward the lower clamp body 2658b, exerting a force on the inner shaft 2610 secured between the upper clamping surface 2672a and the lower or bottom clamping surface 2672b. The upper clamping surface 2672a and the lower clamping surface 2672b may each include a complementary groove 2675 sized and shaped to receive and secure the inner shaft 2610 therebetween.

[0087] 30-31 show another embodiment of a handle 3060 configured for use with any of the flow suppression devices described elsewhere herein. A first end (proximal end) 3076 of the handle 3060 is coupled to an inner shaft 3010, and a second end (distal end) 3078 of the handle 3060 is coupled to an outer shaft 3012. The proximal and distal ends 3076, 3078 of the handle 3060 are coupled to each other by a flexible handlebar 3080 and are coupled to each other by a first telescoping tube (proximal tube) 3082 coupled to the first end 3076 and a second telescoping tube (distal tube) 3084 coupled to the second end 3078, the distal tube 3084 being axially translatable within the lumen of the proximal tube 3082. The handle 3060 is actuated by squeezing the flexible handle bar 3080 against (i.e., toward) the telescoping tubes 3082, 3084. In doing so, the flexible handle bar 3080 flattens and elongates, thereby displacing the distal end 3078 away from the proximal end 3076; i.e., the distal end 3078 of the handle 3060 translates (3040) axially relative to the proximal end 3076 of the handle 3060, transitioning the flexible member from an uninflated configuration ( FIG. 30 ) to an inflated configuration ( FIG. 31 ). For example, as shown in FIG. 31 , as the distal end 3078 of the handle 3060 moves distally (and the flexible handle bar 3080 elongates), the distal tube 3084 extends out of the lumen of the proximal tube 3082, causing the flexible member to expand. Conversely, as the distal end 3078 of the handle 3060 moves proximally (and the flexible handle bar 3080 becomes less elongated), the distal tube 3084 enters nearly or completely within the lumen of the proximal tube 3082, resulting in the flexible member being in an unexpanded configuration, as shown in FIG. 30. The inner shaft 3010 is secured within the handle 3060 with a clamp 3058 similar to the clamp 2658 described above, with the inner shaft 3010 being coaxially disposed within the distal tube 3084, which in turn is coaxially disposed within the proximal tube 3082.

[0088] 32-33 show another embodiment of a handle 3260 configured for use with any of the flow suppression devices described herein. The handle 3260 is similar to the handle 3060 described above and includes the following features: a first end (proximal end) 3276 of the handle 3260 coupled to the inner shaft 3210, a second end (distal end) 3278 of the handle 3260 coupled to the outer shaft 3212, the proximal and distal ends 3276, 3278 of the handle 3260 coupled to each other at an upper flexible handle bar 3280a and a lower flexible handle bar 3280b, a proximal tube 3278 coupled to the proximal end 3276, and a distal tube 3284 coupled to the distal end 3278. The handle 3260 is actuated by squeezing the upper and lower flexible handle bars 3280a, 3280b together (i.e., toward each other), causing the upper and lower flexible handle bars 3280a, 3280b to flatten and elongate, thereby displacing the distal end 3278 away from the proximal end 3276, i.e., causing the distal end 3278 of the handle 3260 to translate 3240 axially relative to the proximal end 3276 of the handle 3260, transitioning the flexible member from an uninflated configuration (FIG. 32) to an inflated configuration (FIG. 33). For example, as shown in FIGURE 32, as the distal end 3278 of the handle 3260 moves distally (and the flexible handle bars 3280A, 3280B elongate), the distal tube 3284 extends out of the lumen of the proximal tube 3282, causing the flexible member to expand. Conversely, as shown in FIGURE 32, as the distal end 3278 of the handle 3260 moves proximally (and the flexible handle bars 3280a, 3280b become less elongated), the distal tube 3284 recedes nearly or completely into the lumen of the proximal tube 3282, causing the flexible member to assume an unexpanded configuration. The inner shaft 3210 is secured within the handle 3260 with a clamp 3258 similar to the clamp 2658 described above, with the inner shaft 3210 being coaxially disposed within the distal tube 3284, which in turn is coaxially disposed within the proximal tube 3282.

[0089] Figures 34-36 show another embodiment of a handle 3460 configured for use with any of the flow suppression devices described herein. The handle 3460 is generally similar in construction to the handle shown in Figures 30-33, with some notable differences.

[0090] 30-33, the handle 3460 includes a first (proximal) end 3476 of the handle 3460 coupled to the inner shaft 3410, a second (distal) end 3478 of the handle 3460 coupled to the outer shaft 3412, the proximal and distal ends 3476, 3478 of the handle 3460 coupled to each other by a flexible handle bar 3480, a proximal tube 3482 coupled to the proximal end 3476, and a distal tube 3484 coupled to the distal end 3478. The handle 3460 is actuated by squeezing the flexible handle bar 3480 against (i.e., towards) the telescoping tubes 3482, 3484. In that manner, the flexible handle bar 3480 flattens and elongates, thereby displacing the distal end 3478 away from the proximal end 3476, i.e., the distal end 3478 of the handle 3460 translates 3440 axially relative to the proximal end 3476 of the handle 3460, causing the flexible member to transition from an uninflated configuration (FIGS. 34, 36) to an inflated configuration (FIG. 35). For example, as shown in FIG. 35, as the distal end 3478 of the handle 3460 moves distally (and the flexible handle bar 3480 elongates), the distal tube 3484 extends out of the lumen of the proximal tube 3482, causing the flexible member to expand. Conversely, as the distal end 3478 of the handle 3460 moves proximally (and the flexible handle bar 3480 becomes less elongated), the distal tube 3484 enters nearly or completely within the lumen of the proximal tube 3482, resulting in the flexible member being in an unexpanded configuration, as shown in FIG. 34. The inner shaft 3410 is secured within the handle 3460 with a clamp 3458 similar to the clamp 2658 described above, with the inner shaft 3410 being coaxially disposed within the distal tube 3484, which in turn is coaxially disposed within the proximal tube 3482.

[0091] 30-33, as best shown in FIG. 36, a latch 3488 extends from the flexible handlebar 3480 and interacts with and couples to a stepped extension 3486, thereby enabling the handle to secure the flow suppression device in the deployed configuration (flexible member in the expanded form). Further, the proximal end 3476 includes a bracket (fork) 3476a configured to receive a hole 3476c secured within the fork 3476a by a pin 3476b. The distal end 3478 includes a similar configuration, with a bracket (fork) 3478a configured to receive a hole 3478c secured within the fork 3478a by a pin 3478b. In this manner, when the flexible handlebar 3480 is actuated (i.e., compressed towards the telescoping tubes 3482, 3484), the distal end 3478 moves away from the proximal end 3476, and when the flexible handlebar 3480 returns to its unactuated state, the distal end 3478 moves towards the proximal end 3476, causing the holes 3476c, 3478c to pivot about the pins 3476b, 3478b within the forks 3476a, 3478a.

[0092] 37-38 show another embodiment of a handle 3760 configured for use with any of the flow suppression devices described herein. The handle 3760 uses a set of clamps similar to those described in FIGS. 29A-29B to manipulate the inner shaft 3710 relative to the outer shaft 3712. A proximal end body 3766a of the handle 3760 is coupled to the inner shaft 3710 and a distal end body 3766b is coupled to the outer shaft 3712 via the mechanism described with respect to FIGS. 29A-29B. For example, a proximal clamp 3758a is coupled to the inner shaft 3710 and a distal clamp 3758b is coupled to the outer shaft 3712. When the distal body 3766b coupled to the outer shaft 3712 is translated axially toward the distal end of the flow suppression device (3740), the flexible member of the flow suppression device expands, and when the distal body coupled to the outer shaft is translated axially toward the proximal end (and thus the proximal body 3766a) (3740), the expanded flexible member transitions to an unexpanded form.

[0093] 39-47 illustrate various embodiments of flow restriction devices, which may include any or all of the features of any other flow restriction device described elsewhere herein (e.g., extension indicators, mechanical stops, expansion stops, materials, etc.). The embodiments illustrated in FIGS. 39-47 may exist in multiple forms. For example, the flow restriction device may include concentric tubes (inner and outer shafts, as described above and elsewhere herein) or a single elongate member (as described in more detail below). Additionally, the flow restriction devices of FIGS. 39-47 may include more than one lumen. For example, in one embodiment, the flow restriction device includes three lumens: one lumen for passing a guidewire, one lumen configured to receive and pass an inflation fluid that inflates the flexible member of the flow restriction device, and one lumen configured to receive a fluid that fills the body lumen for the procedure. In another embodiment, the flow restriction device includes two lumens. One lumen is for passing a guidewire and one lumen is configured to receive a fluid that expands the flexible member and fills the body lumen for the procedure.

[0094] 39-43, which illustrate one embodiment of a flow suppression device 3900. The device 3900, configured to occlude at least a portion of a body lumen during a procedure, includes an elongate body 3990 having a proximal end 3990a and a distal end 3990b and defining a lumen 3992 therethrough. The elongate body 3990 further includes a flexible member 3914 coupled to the elongate body 3990 at a first (proximal) location 3993a and a second (distal) location 3993b. The elongate body 3990 defines at least two apertures 3991, 3998. The first aperture 3991 is disposed on the elongate body 3990 proximally of the flexible member 3914 and is configured to deliver fluid into the body lumen in which the flow suppression device 3900 is disposed. The second aperture 3998 is in the flexible member 3914 and is configured to inflate the flexible member 3914 with an inflation fluid. As the fluid flows through the lumen 3992 of the elongate body 3990 and out the second aperture 3998 of the elongate body 3990, the flexible member 3914 can expand from the uninflated configuration shown in FIG. 39 to the inflated configuration shown in FIG. 43. In some embodiments, the elongate body 3990 further defines a second lumen 3994 configured to receive and pass a guidewire, as shown in FIG. 42. Optionally, in some embodiments, the elongate body 3990 further defines a third lumen configured to receive and pass another fluid, for example, a fluid that fills a body lumen of the patient and / or fills the flexible member 3914 of the flow suppression device 3900. The elongate body 3990 includes a distal cap 3924 that is similar to the distal caps described elsewhere herein and includes similar components (e.g., a valve, a distal tip of the elongate body, a guidewire lumen) and serves to allow passage of a guidewire while preventing fluid from escaping from the distal end 3990b of the flow suppression device 3900.

[0095] 39-43, the flexible member 3914 includes or is formed of an expandable material that includes a plurality of hydratable beads 3996, such that when a liquid is injected into the flexible member 3914 through apertures 3998, the beads 3996 can expand from an unexpanded state to an expanded state. When the plurality of hydratable beads 3996 reaches a hydrated state, they can substantially or completely fill the space defined by the flexible member 3914. In another embodiment of the flow suppression device 3900, as described elsewhere herein, that includes an inner shaft and an outer shaft rather than just one elongate body, the plurality of hydratable beads 3996 is configured to expand when a liquid is injected through one or both of the inner shaft and the outer shaft. The flexible member 3914 may further define one or more small holes 3995 distal to the flexible member 3914 for releasing excess liquid from the flexible member 3914 when the plurality of hydratable beads 3996 reaches a maximum capacity, threshold, or equilibrium state. In some embodiments, instead of a single elongate member, the flow suppression device 3900 includes an inner shaft and outer shaft configuration as described elsewhere herein.

[0096] 44-47 illustrate another embodiment of a flow control device 4400. Similar to flow control device 3900 described above, flow control device 4400 includes an elongate body 4490 defining a guidewire lumen 4494 and an infusion lumen 4492 (and optionally a third lumen, as described elsewhere herein). Elongate body 4490 further defines a first aperture 4491 and a second aperture 4498. First aperture 4491 is disposed on the flow control device proximally relative to flexible member 4414 and serves to fill the body lumen in which the flow control device is disposed. Second aperture 4498 is disposed within flexible member 4414 and serves to expand flexible member 4414 with a fluid. Flexible member 4414 is coupled to elongate body 4490 at a proximal coupling location 4493a and a distal coupling location 4493b. The elongate body 4490 further includes a distal cap 4424, which includes a valve 4446, a distal tip 4450 of the elongate body 4490, and a 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, such as a balloon, thermoplastic polyurethane, thermoset polyurethane, silicone, polyetheretherketone, a non-elastic material (e.g., a material that fills or expands without stretching), etc. In some embodiments, the flow suppression device 4400 includes an inner shaft and outer shaft configuration, as described elsewhere herein, instead of a single elongate member.

[0097] 44 and 48-53 illustrate one embodiment of a plug 4861 configured to be inserted into any lumen of the handle 4960 shown in Figures 49-53. For example, the plug 4861 can be inserted into the guidewire lumen 4994 while insufflation fluid is passing through the inflation lumen 4992, the plug 4861 can be inserted into the inflation lumen 4992 after the flexible member has been inflated (e.g., to prevent backflow of inflation fluid out the proximal end of the assembly), the plug 4861 can be reversibly inserted into the inflation lumens 3992, 4492 until inflation is needed, the plug 4861 can occlude unused lumens in a three-lumen handle, etc. The stopcock 4861 includes a body 4866 coupled to an insert portion 4889 (e.g., tapered or non-tapered), which is coupled to a lead-in portion 4899, and the insert portion 4889 and lead-in portion 4899 are insertable into a lumen (e.g., an infusion lumen) of an elongate member or a handle attached to the elongate member. One embodiment of an infusion handle 4960 is shown in FIGS. 49-53. The handle 4960 includes an inner rotatable body 4965, which includes a proximal portion 4965a, a middle portion 4965b, and a distal portion 4965c. The middle portion 4965b includes an inflation lumen access skive 4985, which is configured to inflate the flexible member when a fluid is injected therethrough and when the outer rotatable body 4967 rotatably overlies it. The outer rotatable body 4967 is coupled with a proximal sealing feature 4987a (e.g., an O-ring) and a distal sealing feature 4987b (e.g., an O-ring). The outer rotatable body 4967 further defines an inflation aperture 4983. As shown in FIG. 51 , when in the fully assembled and open configuration, the inflation lumen access scribing 4985 of the inner rotatable body 4965 is aligned with the inflation aperture 4983 of the outer rotatable body 4967, thereby allowing fluid to be injected through the handle 4960 and through a flow restricting device (e.g., a valve (e.g., a Touhy-Borst) surrounding the handle 4960, a valve attached to the proximal portion 4965c, etc., at the aligned scribing 4985 and aperture 4983).52, in the closed configuration, the inflation lumen access scribing 4985 of the inner rotatable body 4965 is misaligned (misaligned) with the inflation aperture 4983 of the outer rotatable body 4967, thereby preventing fluid from being injected through the handle 4960, past the flow restrictor, and into the flexible member. The handle 4960 may further include extension indicators 4913a, 4913b that indicate alignment of the scribing 4985 with the aperture 4983 (FIG. 53) and misalignment of the scribing 4985 with the aperture 4983 (FIG. 52). The outer rotatable body 4967 is rotatable relative to the inner rotatable body 4965 such that the first (proximal) end 4913a of the extension indicator and the second (distal) end 4913b of the extension indicator are aligned when the infusion lumen is open and misaligned when the infusion lumen is closed. Although the handle 4960 has been described with respect to Figures 39-49, it will be appreciated that the handle 4960 may be used with any of the flow suppression devices described herein (e.g., Figures 12-25) and / or with any of the other handle embodiments described elsewhere herein (e.g., Figures 26-38).

[0098] In some embodiments, the inflation lumen access gouge 4985 also serves as an infusion lumen access gouge 4985 for delivering fluid to the body lumen. In some such embodiments, the cover of the flexible member may include one or more eyelets so that fluid not only fills the flexible member, but also fills the body lumen proximal to the flexible member.

[0099] In some embodiments, the handle 4960 forms part of the proximal portion or end of the inner shaft such that it is fully integrated and continuous with the inner shaft of the flow suppression device. In some such embodiments, the inner rotating body 4965 is a specialized inner shaft, and the outer rotating body 4967 is coupled to the inner shaft via a proximal sealing feature 4987a (e.g., an O-ring) and a distal sealing feature 4987b (e.g., an O-ring). In other embodiments, the handle 4960 can be coupled to the proximal portion or end of the inner shaft such that the various lumens of the handle 4960 are continuous and uninterrupted with the inner shaft of the flow suppression device.

[0100] 54, which illustrates one method 5400 of occluding at least a portion of a body lumen using any of the flow suppression device and / or handle and / or injection device embodiments described above. Any of the steps of method 5400 may be performed in any order, and additional steps may be added or existing steps may be omitted. A method 5400 of occluding at least a portion of a body lumen in preparation for or during a procedure includes advancing (S5410) a flow restriction device into the body lumen, the flow restriction device including a flexible member and defining one or more apertures; expanding (S5420) the flexible member of the flow restriction device from an uninflated configuration to an inflated configuration; advancing (S5430) an instrument into the patient's body lumen; injecting (S5440) a fluid into the body lumen through the one or more apertures of the flow restriction device, wherein the flexible member is in the expanded configuration to restrict the flow of fluid past the flexible member; and performing (S5450) the procedure on at least a portion of the patient's body lumen with the instrument.

[0101] Any of the flow suppression devices described elsewhere herein may be used and / or employed in any embodiment of method 5400. In any embodiment of method 5400, the device may include any medical device, such as, but not limited to, an ultrasound transducer or endoscope, an ablation device, a biopsy device, a ligation device, an imaging device (e.g., camera, microscope, ultrasound), a sensor, a stent, a thrombectomy device, or any other medical device.

[0102] In some embodiments, method 5400 is particularly suited for performing an entero-enterostomy. In some such embodiments, block S5410 includes advancing a flow restriction device through a stricture in the patient's gastrointestinal tract, the flow restriction device including a flexible member and defining one or more apertures. In some embodiments, block S5410 further includes positioning a distal end of an elongate member (e.g., endoscope, catheter, etc.) proximally adjacent to the stricture in the patient's gastrointestinal tract and advancing the flow restriction device through a lumen (e.g., working channel) defined by the elongate member (e.g., endoscope, catheter, etc.) and through the stricture in the gastrointestinal tract.

[0103] In some embodiments, block S5420 further includes expanding the flexible member of the flow restriction device from an uninflated configuration to an inflated configuration distal to the stricture in the gastrointestinal tract.

[0104] In some embodiments, blocks S5430, S5440, and S5450 include advancing an ultrasound endoscope into the patient's gastrointestinal tract; injecting a liquid into the gastrointestinal tract through one or more apertures in the flow suppression device, wherein the flexible member is in an expanded configuration to restrict the flow of liquid past the flexible member; and imaging at least a portion of the patient's gastrointestinal tract with the ultrasound endoscope.

[0105] In some embodiments, the injecting step further includes coupling a liquid injection port (e.g., a Touhy-Borst valve) to the proximal end of the flow inhibition device, the liquid injection port configured to deliver liquid from one or more apertures in the flow inhibition device through a lumen (e.g., an injection lumen) defined by the flow inhibition device and into the gastrointestinal tract, the gastrointestinal tract including one or more of the esophagus, stomach, small intestine, or large intestine.

[0106] In some embodiments, the method 5400 includes positioning a distal end of an elongate member (e.g., an endoscope, a catheter, etc.) adjacent to a proximal side of a stricture in the patient's gastrointestinal tract. For example, in the case of a gastroenterostomy, the stricture is typically located in the proximal side of the small intestine (duodenum), but it can also be distal to the stomach (where contents reflux into the stomach, referred to as a "gastric outlet obstruction").

[0107] In some embodiments, the method 5400 further includes advancing a guidewire through the lumen of the elongate member and through a stricture in the patient's gastrointestinal tract, wherein the flow control device is passed over the guidewire and through the stricture. A guidewire may be used if the endoscope and / or flow control device cannot be advanced beyond the stricture.

[0108] In some embodiments, the method 5400 further includes removing the elongate member from the body lumen before advancing the instrument into the body lumen.

[0109] In some embodiments, the method 5400 includes reducing the flow rate of liquid around the flexible member and through the patient's inferior fluid lumen to less than about 300 ml / min, less than about 230 ml / min, less than about 200 ml / min, between about 200 and 300 ml / min, between about 150 and 250 ml / min, between about 100 and 200 ml / min, etc.

[0110] In some embodiments where the body lumen is the digestive tract, the lower digestive tract includes one or more of the patient's small intestine, large intestine, or colon.

[0111] In some embodiments, the method 5400 includes advancing an entero-enterostomy device through a lumen of an ultrasound endoscope and performing an entero-enterostomy procedure.

[0112] In some embodiments, the method 5400 includes collapsing the expanded flexible member from an expanded configuration to an unexpanded configuration. In some such embodiments, the collapsing includes moving the outer shaft proximally toward a proximal portion of the inner shaft to collapse the expanded flexible member from the expanded configuration to an unexpanded configuration. Alternatively or additionally, suction pressure (negative pressure) may be applied to the infusion lumen (e.g., to remove liquid from the interior of the flexible member) to collapse the expanded flexible member to its unexpanded shape.

[0113] In some embodiments, the method 5400 includes removing the flow control device from the gastrointestinal tract. In the collapsed configuration (after the flexible member is expanded), the diameter of the flexible member may be larger than the diameter of the flexible member in the unexpanded configuration before the flexible member is expanded. Even this increased diameter may be small enough to allow for effective removal from the body lumen.

[0114] In some embodiments, the method 5400 includes attaching a handle to the flow suppression device to facilitate inflation or deflation or control of the flexible member. Any of the handles and / or injection devices described elsewhere herein may be attached to any of the flow suppression devices described elsewhere herein. The method may further include manipulating the outer shaft relative to the inner shaft by actuating the handle. Such actuation may include moving a distal end of the handle coupled to the outer shaft toward the distal end of the device to expand the flexible member. Alternatively, actuating the handle may include rotating the outer rotating body relative to the inner rotating body to open an aperture for fluid injection to expand the flexible member.

[0115] In some embodiments, the method 5400 includes removing the ultrasound endoscope from the digestive tract.

[0116] In some embodiments, any of the systems and devices described herein may be used to prevent loss of a tissue specimen that may migrate downstream due to peristalsis after endoscopic resection (e.g., removal of a polyp in the duodenum). For example, the method may include deploying a flexible member under endoscopic guidance through an elongate member (e.g., an endoscope) downstream from the lesion to be resected, removing the elongate member while leaving the flexible member in place, reinserting the elongate member so that it is positioned alongside, adjacent to, or proximal to the flexible member, resecting the lesion with the elongate member to create a specimen, pulling the flexible member proximally to "scoop" or "grasp" or otherwise collect the specimen, collapsing the flexible member to secure the specimen therein, and removing the flexible member and elongate device from the patient.

[0117] In this specification and claims, the singular forms "a," "an," and "the" include both singular and plural references unless the context clearly contradicts otherwise. For example, the term "aperture" can and is intended to include a plurality of apertures. At times, the claims and disclosure may include the phrases "a plurality," "one or more," or "at least one," but the absence of such words does not mean that a plurality is not intended and should not be interpreted to mean so.

[0118] The words "about" or "approximately," when used before a numerical designation or range (e.g., defining a length or pressure), indicate approximations that may vary by ±5%, ±1%, or ±0.1%. All numerical ranges given herein are inclusive of the stated starting and ending values. The word "substantially" refers to most (i.e., more than 50%) of all or substantially all of a device or method.

[0119] As used herein, the words "comprising" or "comprises" shall mean that the devices, systems, and methods include the recited elements and may further include optional other elements. "Consisting essentially of" shall mean that the devices, systems, and methods include the recited elements and exclude other elements that are essential to the combination for the purpose of the description. Thus, a system or method consisting essentially of the elements defined herein will not exclude other materials, features, or steps that do not materially affect the basic and novel characteristics of the claimed disclosure. "Consisting of" shall mean that the devices, systems, and methods include the recited elements and exclude all more than insignificant or insignificant elements or steps. Embodiments defined by each of these transitional terms are within the scope of this disclosure.

[0120] The examples and specific examples contained herein are illustrative, not limiting, of specific embodiments in which the present subject matter may be practiced. Other embodiments may be utilized or derived therefrom, such that structural or logical substitutions or changes may be made without departing from the scope of the present disclosure. Such embodiments of the present subject matter may be referred to individually herein or collectively in the language of "the present invention," which is merely for convenience and is not intended to intentionally limit the scope of the present application to any single invention or inventive concept, even if more than one is actually disclosed. Thus, while specific embodiments have been shown and described herein, any configuration designed to achieve the same purpose may be substituted for the specific embodiment shown. The present disclosure is intended to encompass all adaptations or variations of various embodiments. Combinations of the above-described embodiments, as well as other embodiments not specifically described herein, will become apparent to those skilled in the art upon reviewing the foregoing description.

Claims

1. 1. A device configured to occlude at least a portion of a lumen of the digestive tract during an endoscopic procedure, comprising: an inner shaft having a proximal portion and a distal portion, the inner shaft defining a lumen therethrough and a first aperture; 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, the outer shaft further including a flexible member and defining a second aperture on the outer shaft located proximally of the flexible member, the inner shaft extending through the lumen of the outer shaft; at least a portion of the outer shaft is axially translatable toward or away from the distal portion of the inner shaft; the flexible member is transitionable 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. the outer shaft; An apparatus comprising:

2. The device of claim 1 , wherein the flexible member is disposed proximal to the distal end of the outer shaft.

3. The device of any one of claims 1 to 2, wherein the flexible member is approximately 0.1 to 5 inches from the distal end of the outer shaft.

4. The device of any one of claims 1 to 3, wherein the flexible member is approximately 0.8 to 1.2 inches from the distal end of the outer shaft.

5. The device of any one of claims 1 to 4, wherein the inner shaft further comprises a stopper configured to limit movement of the outer shaft relative to the inner shaft (and therefore the flexible member).

6. 6. The device of claim 1, wherein the inner shaft further comprises an elongation indicator on a surface of the inner shaft, the elongation indicator indicating an axial translation length that the outer shaft must be moved to expand the flexible member from the unexpanded configuration to the expanded configuration.

7. The device of claim 6 , wherein the elongation indicator further comprises a negative elongation indicator that indicates an over-expansion condition of the flexible member.

8. 8. The device of claim 1, wherein the inner shaft further comprises a tip at the distal portion of the inner shaft, the distal tip comprising a valve configured to prevent liquid from exiting the distal tip of the inner shaft.

9. The device of any one of claims 1 to 8, further comprising a fluid injection port coupled to the proximal portion of the inner shaft.

10. 10. The device of claim 1, further comprising an injection device coupled to the liquid injection port, the injection device configured to deliver the liquid from the liquid injection port through the first and second apertures and into the patient's gastrointestinal tract proximal to the flexible member.

11. 11. The device of claim 1, wherein the flexible member includes a proximal end and a distal end, the proximal end of the flexible member being coupled to the outer shaft and the distal end of the flexible member being coupled to the inner shaft.

12. 12. The device of any one of claims 1 to 11, further comprising a handle, the handle having a proximal end coupled to the inner shaft and a distal end coupled to the outer shaft, whereby the distal end of the handle is axially translatable to move the proximal end of the outer shaft toward or away from the distal portion of the inner shaft.

13. The device of any preceding claim, wherein at least a first half of the flexible member comprises a plurality of struts.

14. The apparatus of claim 13 , further comprising a cover configured to house the plurality of struts.

15. The device of any one of claims 13 to 14, wherein the plurality of struts surround a filler material.

16. The device of any preceding claim, wherein the flexible member comprises a plurality of hydratable beads, the beads configured to expand from an unexpanded state to an expanded state.

17. 17. The device of claim 16, wherein the plurality of hydratable beads are configured to expand when a liquid is injected through one or both of the inner shaft and the outer shaft.

18. The device of any preceding claim, wherein the flexible member comprises a braided material.

19. 20. The device of claim 18, further comprising a cover configured to contain the braided material.

20. 20. The device of any one of claims 18 to 19, wherein the braided material surrounds a filler material.

21. The device of any one of claims 18 to 20, wherein the braided material comprises nitinol.

22. 22. The device of any preceding claim, wherein the first aperture is substantially aligned with the second aperture when the flexible member is in the expanded configuration.

23. The device of any preceding claim, wherein the flexible member comprises a balloon.

24. An apparatus according to any preceding claim, wherein the flexible member is coated with an expandable material.

25. 25. The device of claim 24, wherein the expandable material comprises a thermoplastic polyurethane.

26. The device of any preceding claim, wherein the inner shaft and the outer shaft are substantially rotationally fixed relative to each other.

27. 27. The device of any one of claims 1 to 26, wherein the flexible member expands to a diameter of about 2 to 4 cm.

28. 1. A device configured to occlude at least a portion of a lumen of the digestive tract during an endoscopic procedure, comprising: an elongate body having a proximal end and a distal end and defining a lumen therethrough, the elongate body further including a flexible member and defining at least two apertures, a first aperture disposed on the elongate body proximally from the flexible member and a second aperture configured to expand the flexible member; the flexible member is expandable from an unexpanded configuration to an expanded configuration when a liquid flows through the lumen of the elongate body and out the second aperture of the elongate body. the elongated body An apparatus comprising:

29. 30. The device of claim 28, wherein the elongate body further defines a second lumen configured to receive and pass a guidewire therethrough.

30. 30. The device of any one of claims 28 to 29, wherein the first aperture is configured to deliver a liquid into the gastrointestinal tract.

31. 1. A method of occluding at least a portion of a lumen of the digestive tract during an endoscopic procedure, comprising: positioning a distal end of the elongate member proximally adjacent to a stricture in the patient's gastrointestinal tract; advancing a flow restriction device through a lumen defined by the elongate member and through the stricture in the gastrointestinal tract of the patient, the flow restriction device including a flexible member and defining one or more apertures; expanding the flexible member of the flow suppression device from an unexpanded configuration to an expanded configuration within the gastrointestinal tract distal to the stricture; advancing an ultrasound endoscope into the gastrointestinal tract of the patient; injecting a liquid into the gastrointestinal tract through the one or more apertures of the flow suppression device, wherein the flow of the liquid past the flexible member is restricted when the flexible member is in the expanded configuration; imaging at least a portion of the gastrointestinal tract of the patient with the ultrasound endoscope; A method comprising:

32. 32. The method of claim 31 , wherein the elongated member is an endoscope.

33. 33. The method of any one of claims 31 to 32, further comprising reducing the flow rate of the liquid around the flexible member and through the downstream gastrointestinal tract of the patient to less than 230 ml / min.

34. 34. The method of claim 33, wherein the lower gastrointestinal tract comprises the patient's stomach, small intestine, or large intestine.

35. 35. The method of any one of claims 31 to 34, wherein the positioning step further comprises advancing the elongate member into the patient's gastrointestinal tract such that the distal end of the elongate member is positioned adjacent the stricture.

36. 36. The method of any one of claims 31-35, further comprising advancing a guidewire through the lumen of the elongate member and through the stricture in the gastrointestinal tract of the patient, wherein the flow suppression device is passed over the guidewire and through the stricture.

37. The method of any one of claims 31 to 36, further comprising the step of removing the elongated member from the gastrointestinal tract before advancing the ultrasonic endoscope into the gastrointestinal tract.

38. 38. The method of any one of claims 31 to 37, wherein the injecting step further comprises coupling a liquid injection port to a proximal end of the flow suppression device, the liquid injection port configured to deliver the liquid from the one or more apertures of the flow suppression device into the gastrointestinal tract through a lumen defined by the flow suppression device.

39. 39. The method of claim 38, wherein the digestive tract includes one or more of the esophagus, stomach, small intestine, and large intestine.

40. 40. The method of any one of claims 31 to 39, further comprising advancing an entero-enterostomy device through a lumen of the ultrasound endoscope.

41. 41. The method of claim 40, further comprising performing an entero-enterostomy procedure.

42. 42. The method of any one of claims 31 to 41, further comprising folding the flexible member from the expanded configuration to the unexpanded configuration.

43. 43. The method of any one of claims 31 to 42, further comprising the step of removing the flow suppression device from the gastrointestinal tract.

44. 44. The method of any one of claims 31 to 43, further comprising attaching a handle to the flow suppression device to facilitate expansion or contraction of the flexible member.

45. 45. The method of claim 44, further comprising manipulating the outer shaft relative to the inner shaft by actuating the handle.

46. The method of any one of claims 31 to 45, further comprising the step of removing the ultrasound endoscope from the gastrointestinal tract.

47. The flow suppression device further comprises: an inner shaft having a proximal portion and a distal portion, the inner shaft defining a lumen therethrough and a first aperture of the one or more apertures; an outer shaft having a proximal end and a distal end coupled to the distal portion of the inner shaft, the outer shaft defining a lumen therethrough, the outer shaft defining a second aperture of the one or more apertures disposed on the outer shaft proximally from the flexible member, the inner shaft extending through the lumen of the outer shaft; Including, At least a portion of the outer shaft is axially translatable toward or away from the distal portion of the inner shaft to manipulate the flexible member.

47. The method according to any one of claims 31 to 46.

48. 48. The method of any one of claims 31 to 47, further comprising contacting the inner surface of the lumen of the GI tract with at least a portion of the outer periphery of the flexible member.

49. 1. A method of occluding at least a portion of a lumen of the digestive tract during an endoscopic procedure, comprising: advancing a flow restriction device through a stricture in the patient's gastrointestinal tract, the flow restriction device including a flexible member and defining one or more apertures; expanding the flexible member of the flow suppression device from an unexpanded configuration to an expanded configuration within the gastrointestinal tract distal to the stricture; advancing an ultrasound endoscope into the gastrointestinal tract of the patient; injecting a liquid into the gastrointestinal tract through the one or more apertures of the flow suppression device, wherein the flow of the liquid past the flexible member is restricted when the flexible member is in the expanded configuration; imaging at least a portion of the gastrointestinal tract of the patient with the ultrasound endoscope; A method comprising:

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