Device and method for at least partially occluding a body lumen

Abstract

Described herein are devices and related methods for occluding at least a portion of a body lumen during a surgical procedure. In some embodiments, 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 positioned on the outer shaft proximally relative to the flexible member. The inner shaft extends through the lumen of the outer shaft such that at least a portion of the outer shaft is axially translatable toward and away from a distal portion of the inner shaft. The flexible member is movable 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. In some embodiments, the devices and methods are used for endoscopic surgical procedures.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Patent Application Serial No. 62 / 993,192, filed March 23, 2020, the contents of which are incorporated herein by reference in their entirety. Technical Field

[0003] This disclosure relates generally to the field of endoscopy, and more specifically to the field of endoscopic ultrasound. It describes systems and methods for at least partially occluding internal body cavities during surgery. Background Technology

[0004] Currently, endoscopic ultrasound-guided procedures, such as enterostomies (including gastrostomies), are limited by ultrasound imaging quality and the luminal dissipation of the target portion of the intestine. The gastrointestinal tract is submerged in fluid, allowing for imaging. However, the rapid passage of fluid through the gastrointestinal (GI) tract limits the available time for imaging and the luminal dissipation for targeted intervention. Large volumes of fluid can be infused to counteract outflow, but excessive fluid infusion (over 500 ml) into the intestine can lead to metabolic disturbances. Therefore, better devices and methods are needed to reduce fluid outflow from the target portion of the gastrointestinal tract to improve imaging quality, extend imaging time, and enhance luminal dissipation. Summary of the Invention

[0005] There is a need for new and useful devices and methods for, for example, at least partially occluding a body lumen during endoscopic procedures. One aspect of this disclosure relates to a device configured to obstruct at least a portion of the lumen of the gastrointestinal tract during endoscopic procedures. In some embodiments, the device includes an inner shaft having a proximal portion, a distal portion, and defining a lumen and a first orifice therethrough; and an outer shaft having a proximal end and a distal end coupled to the distal portion of the inner shaft, and defining a lumen therethrough. In some embodiments, the outer shaft further includes a flexible member and defines a second orifice positioned proximally on the outer shaft relative to the flexible member. In some embodiments, the inner shaft extends through the lumen of the outer shaft such that at least a portion of the outer shaft is axially translatable toward and away from the distal portion of the inner shaft. In some embodiments, the flexible member is movable between an undeployed configuration and an deployed configuration when the at least a portion of the outer shaft is axially translated toward or away from the distal portion of the inner shaft.

[0006] In any of the foregoing embodiments, the flexible member is positioned near the distal end of the outer shaft.

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

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

[0010] In any of the foregoing embodiments, the inner shaft further includes an extension indicator on the surface of the inner shaft, the extension indicator indicating the axial translation length required to move the outer shaft to extend the flexible member from a non-deployed configuration to a deployed configuration.

[0011] In any of the foregoing embodiments, the extension indicator further includes a negative extension indicator that indicates the over-extension state of the flexible member.

[0012] In any of the foregoing embodiments, the inner shaft further includes an end on the distal portion of the inner shaft, such that the distal end includes a valve configured to prevent liquid from leaving the distal end of the inner shaft.

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

[0014] In any of the foregoing embodiments, the device further includes an infusion device coupled to the liquid injection port, the infusion device being configured to deliver the liquid through the liquid injection port, through the first orifice and the second orifice, into the gastrointestinal tract of a patient adjacent to the flexible member.

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

[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, such that the distal end of the handle is axially translatable to move the proximal end of the outer shaft toward and away from the distal portion of the inner shaft.

[0017] In any of the foregoing embodiments, at least the 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 enclose the plurality of pillars.

[0019] In any of the foregoing embodiments, the plurality of pillars are sealed with filler material.

[0020] In any of the foregoing embodiments, the flexible member comprises a plurality of hydratable beads, such that the beads 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 unfold when liquid is applied through one or both of the inner and outer axes.

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

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

[0024] In any of the foregoing embodiments, the woven material encloses the filling material.

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

[0026] In any of the foregoing embodiments, when the flexible member is in the deployed configuration, the first hole and the second hole are substantially aligned.

[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 a deployable material.

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

[0030] In any of the foregoing embodiments, the inner and outer shafts are fixed in a substantially rotatable manner relative to each other.

[0031] In any of the foregoing embodiments, the flexible member unfolds to a diameter of approximately 2 cm to 4 cm.

[0032] Another aspect of this disclosure relates to an apparatus configured to obstruct at least a portion of the lumen of the gastrointestinal tract during an endoscopic procedure. In some embodiments, the apparatus includes an elongated body having a proximal end and a distal end and defining a lumen therethrough. In some embodiments, the elongated body further includes a flexible member and defines at least two orifices, a first orifice positioned proximally on the elongated body relative to the flexible member, and a second orifice configured to expand the flexible member. In some embodiments, the flexible member can expand from a non-expanded configuration to an expanded configuration as fluid flows through the lumen of the elongated body and out of the second orifice of the elongated body.

[0033] In any of the foregoing embodiments, the elongated body further defines a second inner cavity configured to receive a guidewire passing through it.

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

[0035] Another aspect of this disclosure relates to a method for occluding at least a portion of the lumen of the gastrointestinal tract during an endoscopic procedure. In some embodiments, the method includes: positioning a distal end of an elongated member adjacent to a proximal side of a narrowing in a patient's gastrointestinal tract; advancing a flow-reducing device through the lumen defined by the elongated member and through the narrowing in the patient's gastrointestinal tract, such that the flow-reducing device includes a flexible member and defines one or more orifices; deploying the flexible member of the flow-reducing device from a non-deployed configuration to a deployed configuration away from the narrowing in the gastrointestinal tract; advancing an echo endoscope (echo endoscope) into the patient's gastrointestinal tract; infusing fluid into the gastrointestinal tract through the one or more orifices in the flow-reducing device such that fluid flow through the flexible member is restricted when the flexible member is in the deployed configuration; and imaging at least a portion of the patient's gastrointestinal tract with the echo endoscope.

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

[0037] In any of the foregoing embodiments, the method further includes reducing the flow rate of the fluid surrounding 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 downstream gastrointestinal tract includes one or more of the following: the patient's esophagus, stomach, small intestine, and large intestine.

[0039] In any of the foregoing embodiments, positioning further includes advancing the elongated member along the patient’s gastrointestinal tract such that the distal end of the elongated member is positioned adjacent to the narrow proximal side portion.

[0040] In any of the foregoing embodiments, the method further includes advancing a guidewire through the lumen of the elongated member and through the narrowing of the patient's gastrointestinal tract, such that the flow-reducing device passes over the guidewire and through the narrowing.

[0041] In any of the foregoing embodiments, the method further includes removing the elongated member from the gastrointestinal tract before advancing the echo endoscope into the gastrointestinal tract.

[0042] In any of the foregoing embodiments, the infusion further includes coupling a liquid injection port to a proximal end of the flow reduction device, such that the liquid injection port is configured to deliver the liquid through a lumen defined by the flow reduction device and out of the one or more orifices of the flow reduction device into the gastrointestinal tract.

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

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

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

[0046] In any of the foregoing embodiments, the method further includes shrinking the flexible member from an deployed configuration to an undeployed configuration.

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

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

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

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

[0051] In any of the foregoing embodiments, the flow reduction device further includes: an inner shaft having a proximal portion, a distal portion, and defining an inner cavity therethrough and a first hole among the one or more holes; and an outer shaft having a proximal end and a distal end coupled to the distal portion of the outer shaft, and defining an inner cavity therethrough. In some embodiments, the outer shaft defines a second hole among the one or more holes, the second hole being positioned proximally on the outer shaft relative to the flexible member. In some embodiments, the inner shaft extends through the inner cavity of the outer shaft, such that at least a portion of the outer shaft is axially translatable toward and away from the distal portion of the inner shaft to manipulate the flexible member.

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

[0053] Another aspect of this disclosure relates to a method for occluding at least a portion of the lumen of the gastrointestinal tract during an endoscopic procedure. In some embodiments, the method includes: advancing a flow-reducing device through a narrow passage in a patient's gastrointestinal tract such that the flow-reducing device includes a flexible member and defines one or more orifices; deploying the flexible member of the flow-reducing device from a non-deployed configuration to a deployed configuration away from the narrow passage in the gastrointestinal tract; advancing an echo endoscope into the patient's gastrointestinal tract; infusing fluid into the gastrointestinal tract through the one or more orifices in the flow-reducing device such that the flow of fluid through the flexible member is restricted when the flexible member is in the deployed configuration; and imaging at least a portion of the patient's gastrointestinal tract with the echo endoscope. Attached Figure Description

[0054] The foregoing is an overview and therefore necessarily limited in detail. The following description, in conjunction with various embodiments and with reference to the accompanying drawings, describes the foregoing aspects, as well as other aspects, features, and advantages of the invention.

[0055] Figure 1 schematically illustrates endoscopic ultrasound surgery without using the devices and methods described elsewhere in this document.

[0056] Figure 2 The illustration schematically shows the advancement of the endoscope through the patient's gastrointestinal tract.

[0057] Figure 3 The diagram illustrates the passage of the guidewire. Figure 2 The endoscope is shown to be inserted into the lumen and optionally advanced through narrow passages in the patient's gastrointestinal tract.

[0058] Figure 4 The diagram schematically illustrates a flow-reducing device in an undeployed configuration passing through a patient's gastrointestinal tract and through a narrow passage.

[0059] Figure 5 schematically shown Figure 4 The flexible component of the flow reduction device extends from a never-deployed configuration to a deployed configuration, thereby at least partially occluding the patient's gastrointestinal tract.

[0060] Figure 6 The illustration schematically shows the removal of an endoscope from a patient's gastrointestinal tract.

[0061] Figure 7 The illustration schematically shows the advancement of an echo endoscope through the patient's gastrointestinal tract.

[0062] Figure 8 The diagram schematically illustrates the attachment of the liquid injection port and infusion device to the inner shaft of the flow reduction device to deliver liquid into the patient's gastrointestinal tract.

[0063] Figure 9 It schematically shows that Figure 8 The liquid injection port and infusion device are removed from the flow reduction device.

[0064] Figure 10 The shrinkage of the flow reduction device from an deployed configuration to an undeployed configuration is schematically shown.

[0065] Figure 11 The diagram schematically illustrates the removal of the flow-reducing device from the patient's gastrointestinal tract.

[0066] Figure 12 An embodiment of a flow reduction device in an undeployed configuration is shown.

[0067] Figure 13 It shows Figure 12 The flow reduction device is in the deployed configuration.

[0068] Figure 14 An embodiment of a flexible component of a flow reduction device is shown, the flexible component comprising or being formed of a woven material.

[0069] Figure 15 It shows Figure 14 One embodiment of the flexible component includes a cover for at least partially enclosing the woven material.

[0070] Figure 16 Showing the expanded configuration Figure 14 An enlarged view of the flexible component.

[0071] Figure 17A Showing the unexpanded configuration Figure 14 An enlarged view of the flexible component.

[0072] Figure 17B An enlarged view is shown of one or more friction locks between the inner and outer shafts of the flow reduction device.

[0073] Figure 18 Another embodiment of a flexible component of a flow reduction device is shown, in an undeployed configuration.

[0074] Figure 19 It shows Figure 18 The flexible component is in an unfolded configuration.

[0075] Figure 20 It shows along Figure 19 A view of the line BB of the flexible component.

[0076] Figure 21 It shows Figure 19 Exploded view of the flow reduction device.

[0077] Figure 22 It shows something similar to Figure 21 An exploded view of another embodiment of the flow reduction device.

[0078] Figure 23 It shows Figure 22 An enlarged view of the flexible component of the flow reduction device.

[0079] Figure 24 Another embodiment of the flow reduction device in a deployed configuration of a flexible component is shown.

[0080] Figure 25 It shows Figure 24 A cross-sectional view of the flexible component.

[0081] Figure 26 An embodiment of a handle is shown, which is configured for use with any flow reduction device described herein.

[0082] Figure 27 It shows the state of being actuated. Figure 26 The handle, in which the flexible component is in an unfolded configuration.

[0083] Figure 28 Showing user's Figure 26 The operation of the handle.

[0084] Figure 29A It shows the method for using Figure 26 The handle is fixed to the clamp on the inner shaft of the flow reduction device. Figure 27 AA cross-sectional view.

[0085] Figure 29B It shows Figure 29A An enlarged view of the fixture.

[0086] Figure 30 An embodiment of a handle is shown, which is configured for use with any flow reduction device described herein.

[0087] Figure 31 It shows the state of being actuated. Figure 30 The handle, in which the flexible component will be in an unfolded configuration.

[0088] Figure 32 An embodiment of a handle is shown, which is configured for use with any flow reduction device described herein.

[0089] Figure 33 It shows the state of being actuated. Figure 32 The handle, in which the flexible component will be in an unfolded configuration.

[0090] Figure 34 An embodiment of a handle is shown, which is configured for use with any flow reduction device described herein.

[0091] Figure 35 It shows the state of being actuated. Figure 34 The handle, in which the flexible component will be in an unfolded configuration.

[0092] Figure 36 It shows Figure 34 An isometric view of the handle.

[0093] Figure 37 An embodiment of a handle is shown, which is configured for use with any flow reduction device described herein.

[0094] Figure 38 It shows the state of being actuated. Figure 37 The handle, in which the flexible component will be in an unfolded configuration.

[0095] Figure 39 Another embodiment of the flow reduction device in an undeployed configuration of a flexible member is shown.

[0096] Figure 40 It shows Figure 39 An enlarged view of multiple hydratable elements of a flexible component.

[0097] Figure 41 It shows Figure 39 An enlarged view of the cover of the flexible component, which has a perforated distal surface.

[0098] Figure 42 It shows Figure 39 A cross-sectional view of the internal cavity of the flow reduction device.

[0099] Figure 43 It shows Figure 39 The flow reduction device is in the deployed configuration.

[0100] Figure 44 Another embodiment of the flow reduction device is shown.

[0101] Figure 45 It shows Figure 44 An enlarged view of section E, which shows Figure 44 Flexible components of the flow reduction device.

[0102] Figure 46 It shows Figure 44 Cross-sectional views of the various internal cavities of the flow reduction device.

[0103] Figure 47 It shows Figure 44 Another cross-sectional view of the various internal cavities of the flow reduction device.

[0104] Figure 48 It shows the use of Figures 44 to 53 An embodiment of the handle and / or the plunger of the device.

[0105] Figure 49 It shows the use of Figures 39 to 47 A perspective view of the handle of the flow reduction device, which is configured to receive... Figure 48 The plunger.

[0106] Figure 50 It shows Figure 49 The outside of the handle.

[0107] Figure 51 Showing the configuration in open. Figures 49 to 50 The handle is configured to receive a liquid for inflating the flexible component.

[0108] Figure 52 It shows a closed configuration Figures 49 to 50 The handle.

[0109] Figure 53 It shows Figures 49 to 50 The handle, among which Figure 48 The plunger is inserted into the inner cavity of the handle.

[0110] Figure 54 An embodiment of any of the aforementioned flow-reducing devices is shown as a method for occluding at least a portion of a body cavity.

[0111] Figure 55 A method for reducing flow through body cavities is shown using a flow reduction device comprising two or more flexible members.

[0112] The embodiments shown are merely examples and are not intended to limit this disclosure. The schematic diagrams are for illustrating features and concepts and are not necessarily drawn to scale. Detailed Implementation

[0113] The foregoing is an overview and therefore necessarily limited in detail. The aspects mentioned above, as well as other aspects, features, and advantages of the invention, will now be described in conjunction with various embodiments. The inclusion of the following embodiments is not intended to limit this disclosure to these embodiments, but rather to allow those skilled 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 subject matter presented herein. The aspects of this disclosure as described and illustrated herein can be arranged, combined, modified, and designed in a variety of different conceptual forms, all of which are expressly contemplated and form part of this disclosure.

[0114] This article discloses apparatus and methods for at least partially occluding body cavities. Occlusion may include, but is not limited to, blocking body cavities; obstructing body cavities; reducing the flow of fluids through body cavities; and capturing or blocking particles, substances, objects, etc., moving through body cavities.

[0115] As used in this article, internal cavities of the body may include, but are not limited to, the gastrointestinal tract, mouth, esophagus, stomach, small intestine, large intestine, blood vessels, arteries, veins, intracardiac cavity, renal cavity or renal duct, kidney, urethra, bladder, vagina, uterus, cervix, trachea, bronchi, bronchioles, bronchioles, respiratory tract, lymphatic vessels, bile duct, pancreatic duct, etc.

[0116] The apparatus and methods described herein, and their obvious variations, can be used in a variety of surgical procedures. Exemplary, non-limiting embodiments in the field of surgical or medical practice include: endoscopy, ultrasound imaging, thrombectomy (e.g., capturing clot particles), gastrojejunostomy, biopsy (e.g., capturing tissue samples), imaging, diagnostics, ablation, stent implantation (e.g., luminal connection of a metallic stent), etc.

[0117] As those skilled in the art will understand, the telescopic shaft assembly of any embodiment can be used in any other embodiment described herein without significant deviation from the original design. Similarly, any single-axis embodiment described herein can be used in any other embodiment described herein without significant deviation from the original design. Furthermore, as those skilled in the art will understand, any flexible member described herein can be mechanically deployed, deployed via liquid infusion, deployed via hydration of one or more elements within the flexible member, or by any other method or means of deploying the flexible member. Moreover, as those skilled in the art will understand, although terms such as deployed and undeployed are used, any number of intermediate configurations or intermediate deployed or contracted states between extreme cases are contemplated herein.

[0118] In some embodiments, any one or more of the components may be manufactured or sold as a kit. For example, a kit may include any or more of the following: a flow reduction device, an endoscope, an infusion device, a liquid injection port, an echo endoscope, or a combination thereof. A kit may include a flow reduction device having various interchangeable flexible members, such that one flexible member is removable and can be replaced with another flexible member.

[0119] As described herein, the flexible components of flow reduction devices can be used to reduce the flow rate of liquid through body cavities, block or obstruct at least a portion of body cavities, prevent liquid from flowing through body cavities, etc. The flexible components described herein may include, or be at least partially formed of, nitinol, thermoplastic polymers, thermosetting polymers, polyetheretherketones, or similar materials known in the art.

[0120] As described herein, the flexible member can be deployed from a non-deployed configuration to a deployed configuration. As used herein, deployment may include movement from a first diameter to a second diameter, the first diameter being smaller than the second diameter. Alternatively or additionally, deployment may include increasing the volume of the flexible member from a first volume to a second volume, the first volume being smaller than the second volume. Volume includes one or both of the following: the volume of the space enclosed by the flexible member and the volume of the actual covering or material of the flexible member. Volume includes, but is not limited to: the volume of the space correspondingly enclosed by the deploying member and the volume of the material (e.g., the flexible member, covering, etc.) that deploys or contracts with or without filling. Alternatively or additionally, deployment may include increasing the surface area in contact with at least a portion of a body cavity, such as the gastrointestinal tract. During surgery, the flexible member may deploy and contract once or multiple times to achieve proper placement of the device during surgery.

[0121] As used herein, liquids, expanding liquids, filling liquids, etc., can include water, saline, contrast agents, drugs (e.g., anticoagulants, thrombolytics, etc.).

[0122] As used herein, fluids may include water, saline solution, contrast agents, drugs (e.g., anticoagulants, thrombolytics, etc.), gases, air, etc.

[0123] The flow reduction device described herein can have an exchange length greater than approximately 1.5X, greater than approximately 2X, greater than approximately 2.5X, greater than approximately 3X, greater than approximately 3.5X, etc., of the endoscope working channel. For example, the exchange length of the flow reduction device can be greater than approximately 3.5m, greater than approximately 4m, greater than approximately 4.5m, greater than approximately 5m, etc.

[0124] Figure 1 schematically illustrates an endoscopic ultrasound procedure without using the devices and methods described elsewhere herein. Fluid is infused into the target portion of the gastrointestinal tract 20 of the patient 10 using any method known in the art (e.g., catheter, endoscope, etc.). Because there is nothing restricting downstream flow, the fluid flow rate 18 through the gastrointestinal tract is high. Those skilled in the art will understand that although the fluid flow rate 18 is shown at the outlet of the gastrointestinal tract, the fluid flow rate 18 can be more present within the gastrointestinal tract 20 and can persist through the gastrointestinal tract for some time after the procedure. After the target portion of the gastrointestinal tract 20 is adequately filled with fluid, an echo endoscope 12 is advanced into the gastrointestinal tract 20 to image the target portion of the gastrointestinal tract 20 (e.g., away from the narrowing 26 in the gastrointestinal tract 20). The quality of the ultrasound imaging is limited by the time it takes for the gastrointestinal tract 20 to fill with fluid, which is proportional to the fluid flow rate 18 through the gastrointestinal tract 20. The apparatus and method described herein attempt to address the problem of fluid flow rate 18 with a technical solution designed to reduce the fluid flow rate 18 through the gastrointestinal tract 20, allowing more time for better imaging and broader study of the tissues within the gastrointestinal tract 20, thereby providing a larger target for fine needle aspiration, or in fact, any body cavity to which this apparatus and method are applicable.

[0125] Figures 2 to 11 Exemplary methods of embodiments and technical solutions described elsewhere in this document are shown. Figure 2 The illustration schematically shows the advancement of the endoscope 22 through the gastrointestinal tract 20 of the patient 10. Alternatively, as... Figure 3 As shown, guidewire 24 is advanced through the working channel of endoscope 22 and through the narrowing 26 in the gastrointestinal tract 20 of patient 10. Figure 4 As shown, the flow reduction device 28 in its undeployed configuration is advanced above the guidewire 24, or just through the lumen of the endoscope 22, through the patient's gastrointestinal tract 20, and through the narrowing 26. Figure 5 As shown, the guidewire 24 is then removed and the flexible member of the flow reduction device 28 is extended from the undeployed configuration to the deployed configuration, thereby at least partially occluding the gastrointestinal tract 20 of the patient 10. Figure 6As shown in the diagram, the endoscope 22 is then removed from the patient's gastrointestinal tract 20. Figure 7 As shown, the echo endoscope 12 is advanced through the gastrointestinal tract 20 of the patient 10. Figure 8 As shown, a handle 30 (e.g., comprising a liquid injection port (e.g., a tuohy borst, concave Luer port, etc.) and an infusion device (e.g., an infusion pump, syringe, etc.)) is then attached to a proximal portion (e.g., an inner shaft or elongated body) of the flow-reducing device to deliver liquid into the gastrointestinal tract 20 of the patient 10. The infused liquid is largely kept close to the flow-reducing device 28 to provide an enhanced imaging environment for the echo endoscope 12, which is not limited by the timeline associated with the liquid leaving the gastrointestinal tract 20, as the flow-reducing device 28 reduces or prevents liquid from leaving the gastrointestinal tract 20, as shown by liquid 18 leaving the gastrointestinal tract. Figure 9 As shown, the handle 30 is moved away from the proximal end of the flow reduction device 28, and the flow reduction device 28 is moved from an deployed configuration to a non-deployed configuration, as... Figure 10 As shown in the illustration. In an embodiment where a gastrostomy is performed, location X indicates the location where the small intestine (distal duodenum / proximal jejunum) will connect to the stomach. Figure 11 As shown, the flow reduction device 28 is then removed from the gastrointestinal tract 20 of the patient 10. In some embodiments, the flow reduction device 28 is removed together with the echo endoscope 12; in other embodiments, the flow reduction device 28 and the echo endoscope 12 are removed sequentially in any order (e.g., flow reduction device then echo endoscope or echo endoscope then flow reduction device).

[0126] In some embodiments, such as Figure 55 As shown, the flow reduction device includes two or more flexible members such that fluid injected into the body's cavities is at least partially retained between the flexible members. The two or more flexible members can deploy and contract sequentially, simultaneously, or substantially simultaneously.

[0127] Figures 12 to 13 Accordingly, one embodiment of the flow reduction device 1200 in both an undeployed and deployed configurations is shown. A device configured to obstruct at least a portion of a body cavity includes an inner shaft 1210 having a proximal portion 1232, a distal portion 1230, and defining an inner cavity 2138 therethrough (e.g., in…). Figure 21 (as shown in the diagram) and the first hole 2118 (e.g., in...) Figure 21(As shown in the diagram). The inner cavity 2138 of the inner shaft 1210 is configured to receive a guidewire passing through it, such that the flow reduction device 1200 can pass over the guidewire to reach a target or desired location within the body cavity. The device 1200 further includes an outer shaft 1212 having a proximal end 1226 and a distal end 1228, the distal end being coupled to the distal portion 1230 of the inner shaft 1210 and defining an inner cavity 2149 passing through it (e.g., ...). Figure 21 (As shown in the diagram). The outer shaft 1212 further includes a flexible member 1214 and defines a second hole 1216 positioned proximally on the outer shaft 1212 relative to the flexible member 1214. The inner shaft 1210 extends through the cavity of the outer shaft 1212 such that the inner shaft 1210 and the outer shaft 1212 form at least partially telescopic assemblies, or the inner shaft 1210 and the outer shaft 1212 form concentric shafts or tubes. For example, at least a portion of the outer shaft 1212 may be axially translated 1240 toward and away from the distal portion 1230 of the inner shaft 1210 to deploy the flexible member 1214 (the outer shaft 1212 moves toward the distal portion 1230 of the inner shaft 1210) and retract the flexible member 1214 (the outer shaft 1212 moves 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 rotatably fixed relative to each other. In some such embodiments, when the flexible member 1214 is in the unfolded configuration, the first hole 1216 and the second hole 2118 are substantially aligned. In other embodiments, the inner shaft 1210 and the outer shaft 1212 are rotatable relative to each other, such that the flexible member 1214 can be twisted in a clockwise or counterclockwise direction. In some embodiments, the torsional configuration of the flexible member 1214 in the unfolded configuration imparts different fluid flow or movement characteristics to fluids approaching the flexible member 1214 and entering the gastrointestinal tract.

[0128] The flexible member 1214 is positioned near the distal end of the inner shaft 1210 (shown as cap 1224). In some embodiments, the flexible member 1214 is positioned about 0.1 inches to about 5 inches from the distal end of the inner shaft 1210. In some embodiments, the flexible member 1214 is positioned about 0.8 inches to about 1.2 inches from the distal end of the inner shaft 1210 (shown as cap 1224).

[0129] Optionally, the inner shaft 1210 includes an extension indicator 1213, such as a positive extension indicator indicating the movement of the outer shaft 1212 to extend the flexible member 1214 from its un-extended configuration to the required axial translation length, for example, to prevent the flexible member 1214 from being over-extended or under-extended. In some embodiments, the extension indicator 1213 further includes a negative extension indicator indicating an over-extended state of the flexible member 1214. For example, the flexible member is extended to a diameter of approximately 2 cm to approximately 4 cm, approximately 1.5 cm to approximately 4.5 cm, approximately 3 cm to approximately 5 cm, approximately 1 cm to approximately 3 cm, etc. In other embodiments, the proximal end 1226 of the outer shaft 1212 defines a window or cutout such that the extension indicator on the inner shaft 1210 is visible through the outer shaft 1212. The extension indicator 1213 may include one or more of the following: color, visual pattern, tactile pattern (e.g., nodules, ridges, etc.), tactile, etc. For example, a positive extension indicator may be green, while a negative extension indicator may be red. Any flow reduction device described herein may optionally include an extension indicator.

[0130] Alternatively or additionally, a tactile indicator, such as a mechanical stop, may be present between the inner shaft 1210 and the outer shaft 1212 to prevent the outer shaft 1212 from sliding past the inner shaft 1210 by a certain length, thereby preventing the flexible member 1214 from over-extending or under-extending. Figure 17B As shown, one or more friction locks 1413 may be positioned on the outer diameter of the inner shaft 1410 and / or the inner diameter of the outer shaft 1412 to prevent the inner shaft 1410 from slipping over the outer shaft 1412 when the flexible member is in an deployed configuration. The friction locks prevent slippage or sliding between the outer shaft 1412 and the inner shaft 1410 by generating friction between the outer diameter of the inner shaft 1410 and the inner diameter of the outer shaft 1412. This friction prevents unintended changes in the deployed state of the flexible member 1214. Any flow reduction device described herein may optionally include one or more mechanical stops or locks.

[0131] In addition, such as Figure 16As shown, any flow reduction device described herein may include a deployment stop 1435. The deployment stop 1435 includes one or more of the following: a movable or fixed concentric tube on the inner shaft 1410, against which the distal end 1428 of the outer shaft 1412 engages upward when the flexible member 1414 is deployed; and / or one or more fixed protrusions, rings, etc. on the outer diameter of the inner shaft 1410, against which the outer shaft 1412 engages upward when the flexible member 1414 is deployed. Alternatively, the distal end 1428 of the outer shaft 1412 may extend beyond the connector 1420 such that when the flexible member 1414 is deployed, the distal end 1428 of the outer shaft 1412 engages upward against the connector 1422 between the inner shaft 1410 and the flexible member 1410. In one embodiment, as Figure 16 As shown, when the flexible member 1414 moves from a non-deployed configuration to a deployed configuration, the distal end 1428 of the outer shaft 1412 is pushed upward against the deployment stop 1435. The deployment stop 1435 prevents the outer shaft 1412 from over- or excessively deploying the flexible member 1414 during deployment. If the flexible member 1414 is over- or excessively deployed, it may begin to flatten, creating a thin edge that could irritate or even harm the body cavity in which it is located. The flattened shape may also, or alternatively, fold, thereby reducing its fluid flow or obstruction capacity, making it less effective.

[0132] In addition, such as Figures 12 to 13 As shown, the flexible member includes a proximal end and a distal end, such that the proximal end 1220 of the flexible member 1214 is coupled to the outer shaft 1212, and the distal end 1222 of the flexible member 1214 is coupled to the inner shaft 1210. The flexible member 1214 is coupled to the outer shaft 1212 at location 1220, and to the inner shaft 1210 at location 1222. The connections between the flexible member 1214 and the outer shaft 1212, and between the flexible member 1214 and the inner shaft 1210, can be made via adhesives, soldering, welding, brazing, mechanical connections (e.g., keying or complementary surfaces), solvent bonding, or any other method known to those skilled in the art.

[0133] The inner shaft 1210 further includes a distal end cover 1224, which includes a valve (e.g., a duckbill valve), as shown and described elsewhere herein, which prevents liquid delivered through the inner cavity of the inner shaft 1210 from leaving the distal end or end of the flow reduction device 1200 while allowing a guide wire to pass through it.

[0134] In some embodiments, the system for at least partially occluding an internal body cavity includes a flow reduction device 1200, and further includes a liquid injection port (e.g., a Tuohy Borst valve, a concave Luer port, etc.) coupled to a proximal portion 1232 of the inner shaft 1210 and an infusion device (e.g., a pump, a syringe, etc.) coupled to the liquid injection port, the infusion device being configured to deliver liquid through the liquid injection port, through a first orifice 1216 and a second orifice 2118, into the gastrointestinal tract of a patient adjacent to the flexible member 1214. The orifices 1216 and 2118 may have a diameter of about 0.005 inches to about 0.05 inches (e.g., about 0.01 inches to about 0.05 inches).

[0135] Figures 14 to 17A Another embodiment of the flow reduction device 1400 is shown. The flexible member 1414 of the flow reduction device 1400 comprises or is at least partially formed of an alternative material 1434 (e.g., braided nitinol, stainless steel, cobalt-chromium alloy, titanium, gold, platinum, silver, iridium, tantalum, tungsten, etc.). In some embodiments, the braided material further encapsulates a filler material or a hydrateable material, as described elsewhere herein. Alternatively or additionally, the alternative material 1434 of the flexible member 1414 may also be formed of or comprise a patterned tube or a substantially axially aligned bundle of fibers that unfolds (similar to a support) upon axial compression. The flexible member 1414 may be further covered by a cover 1436, for example comprising or at least partially formed of a thermoplastic polymer, thermosetting polymer, or similar material. The cover 1436 may at least partially or completely enclose the flexible member 1414. For example, in some embodiments, the cover 1436 may only cover the proximal side or proximal portion 1415 of the flexible member 1414. The flow reduction device 1400 further includes an inner shaft 1410, an outer shaft 1412, a bore 1416, an inner shaft cavity 1428, a connector 1420 between the flexible member and the outer shaft, and a connector 1422 between the flexible member and the inner shaft, as described above. Figures 12 to 13 As described. Figures 16 to 17A Further details of the distal end of the inner shaft 1210 are shown. The distal end 1430 of the inner shaft 1210 includes a distal end 1450, a valve 1446, and a cap 1424 fixed to the distal end 1450. In some embodiments, the cap 1424 defines a through-hole 1452, allowing a guidewire or other elongated device to pass through the inner cavity 1438 of the inner shaft 1210 and exit through the through-hole 1452 defined by the cap 1424. The valve 1446 and the cap 1424 prevent fluid delivered through the inner cavity 1438 from draining from the distal end of the flow reduction device 1400 while still allowing a guidewire or other elongated device to pass through the through-hole 1452 through the cap 1424. Figures 16 to 17A The flexible component 1414 can be deployed in an arrangement ( Figure 16 ) and unexpanded configuration ( Figure 17A Moving between ) is similar to the combination above. Figures 12 to 13 As described.

[0136] Figures 18 to 21 Another embodiment of the flexible member 1814 of the flow reduction device 1800 is shown. The flexible member 1814 can be, for example, Figure 18 The unexpanded configuration shown and as Figures 19 to 21 Move between the expanded configurations shown. Similar to the embodiments described above, Figures 18 to 21 The flow reduction device includes inner shafts 1810, 2110 (defining inner cavities 1838, 2138 passing through them) and outer shafts 1812, 2112 (defining inner cavities 2149 passing through them), which are axially translatable relative to each other 1840; flexible members 1814, 2114; one or more holes 2116 in the outer shaft 2112; one or more holes 2118 in the inner shaft 2110; and outer shafts 1812, 211... 2. A first or proximal connector 1820, 2120 between the inner shaft 1810, 2110 and the flexible members 1814, 2114; a second or distal connector 1822, 2122 between the inner shaft 1810, 2110 and the flexible members 1814, 2114; and a distal cap 1824, 2124 having similar internal components (e.g., valve 2146, guidewire lumen 2152, distal end 2150 of inner shaft 2110), as described above. However, in this embodiment, at least a first half of the flexible members 1814, 2114 includes a plurality of struts 1844, 2144. As will be understood, 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 It shows Figure 18 An exploded view of the flow reduction device 1800. For example, each support may be formed by a proximal support 2144a and a distal support 2144b joined together at a joint 2142, as well as a proximal hub 2163a and a distal hub 2163b. The joint 2142 allows the flexible member 2114 to move from a non-deployed configuration to a deployed configuration, in which the proximal support 2144a is substantially or about 180 degrees relative to the distal support 2144b around the joint 2142, and in the deployed configuration, the proximal support 2144a is substantially or about 20 degrees to about 70 degrees relative to the distal support 2144b around the joint 2142. The flexible member 2114 may further include a cover 2136 connected to the inner shaft 2110 via a distal cover hub 2159, the cover being configured to enclose the plurality of supports 2144. Optionally, in some embodiments, the plurality of supports 2144 are enclosed in filler material.

[0137] Figures 22 to 23Another embodiment of the flexible member 2214 of the flow reduction device is shown, which is similar to Figures 18 to 21 Flexible components in [the context]. For example... Figure 22 As shown, the flow reduction device includes components similar to those described above: an inner shaft 2210 (defining an inner cavity 2238 therethrough) and an outer shaft 2212 (defining an inner cavity 2249 therethrough), which are axially translatable relative to each other; a flexible member 2214; one or more holes 2216 in the outer shaft 2212; one or more holes 2218 in the inner shaft 2210; a first or proximal connector 2220 between the outer shaft 2212 and the flexible member 2214; a second or distal connector 2222 between the inner shaft 2210 and the flexible member 2214; and a distal cap 2224 having similar internal components (e.g., valve 2246, guidewire cavity 2252, distal end 2250 of the inner shaft 2210), as described above. However, in this embodiment, at least a first half of the flexible member 2214 includes a plurality of supports 2248. The plurality of supports 2248 include a plurality of joints 2242. For example, each support may be formed by a proximal support 2248a and a distal support 2248b connected together at joint 2242, as well as a proximal hub 2263a and a distal hub 2263b. Figure 22 As shown, the proximal support 2248a is approximately twice the length of the distal support 2248b (proximal support: distal support ratio is 2:1), such that the joint 2242 is approximately at the length L of the proximal support 2248a. 2248 At halfway point. In other embodiments, the length ratio between the proximal strut 2248a and the distal strut 2248b is approximately 1.5:1; approximately 3:1, approximately 2.5:1, approximately 4:1, etc. Figures 22 to 23 As shown, the free end 2251 of the proximal strut 2248a can be made damage-resistant using post-processing methods, or covered with a damage-resistant material in addition to or replacing the cover 2236. The joint 2242 allows the flexible member 2214 to move from a non-deployed configuration to a deployed configuration. In the non-deployed configuration, the proximal strut 2248a is substantially or approximately 180 degrees relative to the distal strut 2248b around the joint 2242. In the deployed configuration, the proximal strut 2248a is substantially or approximately 20 degrees to approximately 70 degrees relative to the distal strut 2248b around the joint 2242. Figure 23 As shown, the flexible member 2214 may further include a cover 2236 configured to enclose the plurality of supports 2248. 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 housing 2256. Optionally, in some embodiments, the housing 2256 may be filled with a fluid (e.g., gas, water, drug, etc.) or a filler material.

[0138] exist Figure 23 In some embodiments, the concave surfaces of the plurality of pillars 2248 may face the proximal end of the flow reduction device, and the covers 2236 on the plurality of pillars 2248 may fit more closely to the pillars, making the plurality of pillars behave more like baskets for collecting, for example, biopsy samples, clots, etc.

[0139] Figures 24 to 25 Another embodiment of a flow reduction device 2400 including a flexible member 2414 is shown. The flow reduction device 2400 includes features similar to those described above: an inner shaft 2410 and an outer shaft 2412 axially translatable 2440 relative to each other; the flexible member 2414; one or more holes 2416 in the outer shaft 2412; a first or proximal connector 2420 between the outer shaft 2412 and the flexible member 2414; a second or distal connector 2422 between the inner shaft 2410 and the flexible member 2414; and a distal cap 2424 having similar internal components (e.g., valves, guidewire cavities, distal ends of the inner shaft, etc.), as described above. However, in this embodiment, the flexible member 2414 comprises or is formed from an alternative material to the coating 2454 (e.g., braided, laser-cut, etc.). As described above, the braided coating 2454 flexible member 2414 defines a housing 2456. Therefore, the flexible member 2414 itself does not include a cover, but rather a coating 2454 on an alternative material. Once the flexible member is infused into the gastrointestinal tract through one or more orifices 2416, the coating functions to prevent liquid from flowing through the flexible member 2414.

[0140] Now go to Figures 26 to 38 The diagram illustrates various handle configurations for the flow reduction device described herein. As used herein, a handle describes any device configured to manipulate the flow reduction device, actuate a flexible member from a non-deployed state (e.g., mechanically, fluidly, etc.) to a deployed state, and return it to a non-deployed state as needed. The handle can be used for actuation, delivery of fluid or liquid into the flexible member, blocking one or more ports of the flow reduction device, etc.

[0141] Figures 26 to 29B An embodiment of a handle 2660 is shown, which is configured for use with any flow reduction device described herein. Figure 26 The handle 2660 is shown in an unactuated state, with the flexible member 2614 in an undeployed configuration, and Figure 27 A handle 2660 in an actuated state is shown, with the flexible member 2614 in an deployed configuration. (See diagram.) Figures 26 to 27As shown, the flow reduction device includes a first or proximal connector 2620 between an inner shaft 2610, an outer shaft 2612, and a flexible member 2614; a second or distal connector 2622 between the inner shaft 2610 and the flexible member 2614; and a distal cap 2624 having similar internal components (e.g., a valve, guidewire lumen, distal end of the inner shaft, etc.), as described above. The proximal end 2662 of a 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. Figure 28 As shown, during use, the user's hand 2674 can grasp the handle body 2666 with fingers 2667 and palm, and manipulate the distal end 2664 of the handle 2660 with thumb 2669. The axial translation of the distal end 2664 of the handle 2660 relative to the handle body 2666 facilitates the axial translation 2640 of the outer axis 2612 relative to the inner axis 2610, such that when the distal end 2664 of the handle 2660 moves distally away from the handle body 2666, the flexible member 2614 unfolds into an unfolded configuration. Figure 27 ), and when the distal end 2664 of the handle 2660 moves proximally toward the handle body 2666, the deployed flexible member 2614 moves to the undeployed configuration. Figure 26 The proximal end 2662 of the handle 2660 is secured to the inner shaft 2610 via a clamp 2658. Figures 29A to 29B A detailed version of clamp 2658 is shown. Clamps similar to clamp 2658 are used in several embodiments described elsewhere herein.

[0142] like Figures 29A to 29B As shown, clamp 2658 includes an upper clamp body 2658a and a lower clamp body 2658b, with a movable wedge 2673 between them. Actuation of knob 2668 (e.g., rotation) and consequently actuation of screw 2670 move the movable wedge 2673 toward the lower clamp body 2658b to apply force to an inner shaft 2610 fixed between the upper clamp surface 2672a and the lower clamp surface or bottom clamp surface 2672b. The upper clamp surface 2672a and the lower clamp surface 2672b may each include a complementary groove 2675, the complementary groove being sized and shaped to receive and secure the inner shaft 2610 between them.

[0143] Figures 30 to 31Another embodiment of the handle 3060 is shown, configured for use with any flow reduction device described elsewhere herein. A first or proximal end 3076 of the handle 3060 is coupled to an inner shaft 3010, and a second or distal end 3078 of the handle 3060 is coupled to an outer shaft 3012. The proximal end 3076 and distal end 3078 of the handle 3060 are coupled together via a flexible handle 3080 and via a first telescopic tube or proximal tube 3082 coupled to the first or proximal end 3076 and a second telescopic tube or distal tube 3084 coupled to the second or distal end 3078, the distal tube 3084 being axially translatable within the cavity of the proximal tube 3082. The handle 3060 is actuated by pressing the flexible handle 3080 relative to (i.e., toward) the telescopic tube 3082 and the telescopic tube 3084. Therefore, the flexible handle 3080 flattens and elongates, thereby displacing the distal end 3078 away from the proximal end 3076, or axially translating the distal end 3078 of the handle 3060 relative to the proximal end 3076, to keep the flexible member in a never-deployed configuration. Figure 30 Move to expanded configuration () Figure 31 For example, when the distal end 3078 of the handle 3060 moves distally, such as... Figure 31 As shown (and the flexible handle 3080 extends), the distal tube 3084 extends out of the cavity of the proximal tube 3082, and the flexible member unfolds. Conversely, when the distal end 3078 of the handle 3060 moves proximally, as... Figure 30 As shown (and the flexible handle 3080 is not extended), the distal tube 3084 is substantially or completely within the cavity of the proximal tube 3082, and the flexible member is in an undeployed configuration. The inner shaft 3010 is secured in the handle 3060 via a clamp 3058 similar to the clamp 2658 described above, and the inner shaft 3010 is coaxially positioned in the distal tube 3084, which is coaxially positioned in the proximal tube 3082.

[0144] Figures 32 to 33Another embodiment of handle 3260 is shown, configured for use with any flow reduction device described herein. Handle 3260 is similar to handle 3060 described above, and includes the following features: a first or proximal end 3276 of handle 3260 coupled to an inner shaft 3210; a second or distal end 3278 of handle 3260 coupled to an outer shaft 3212; the proximal end 3276 and distal end 3278 of handle 3260 are coupled together via an upper flexible handle 3280a and a lower flexible handle 3280b; the proximal end 3276 and distal end 3278 of handle 3260 are coupled together via a proximal tube 3282 coupled to the proximal end 3276 and a distal tube 3284 coupled to the distal end 3278. Handle 3260 is actuated by pressing the upper flexible handle 3280a and the lower flexible handle 3280b together or toward each other. Therefore, the upper flexible handle 3280a and the lower flexible handle 3280b flatten and elongate, thereby displacing the distal end 3278 away from the proximal end 3276, or axially translating the distal end 3278 of the handle 3260 relative to the proximal end 3276, to keep the flexible member in a never-deployed configuration. Figure 32 Move to expanded configuration () Figure 33 For example, when the distal end 3278 of the handle 3260 moves distally, as... Figure 32 As shown (and with flexible handles 3280a and 3280b extended), the distal tube 3284 extends out of the cavity of the proximal tube 3282, and the flexible member unfolds. Conversely, when the distal end 3278 of the handle 3260 moves proximally, as... Figure 32 As shown (and with flexible handles 3280a and 3280b not extended), the distal tube 3284 is substantially or completely within the cavity of the proximal tube 3282, and the flexible member is in an unextended configuration. The inner shaft 3210 is secured in the handle 3260 via a clamp 3258 similar to the clamp 2658 described above, and the inner shaft 3210 is coaxially positioned in the distal tube 3284, which is coaxially positioned in the proximal tube 3282.

[0145] Figures 34 to 36 Another embodiment of the handle 3460 is shown, which is configured for use with any flow reduction device described herein. Handle 3460 and Figures 30 to 33 The handles shown have the same overall structure, but there are some obvious differences.

[0146] Regarding Figures 30 to 33Similarly, handle 3460 includes: a first or proximal end 3476 of handle 3460 connected to an inner shaft 3410; a second or distal end 3478 of handle 3460 connected to an outer shaft 3412; the proximal end 3476 and the distal end 3478 of handle 3460 connected together via a flexible handle 3480; a proximal tube 3482 connected to the proximal end 3476; and a distal tube 3484 connected to the distal end 3478. Handle 3460 is actuated by pressing the flexible handle 3480 relative to (i.e., toward) the telescopic tubes 3482 and 3484. Therefore, the flexible handle 3480 flattens and elongates, thereby displacing the distal end 3478 away from the proximal end 3476, or axially translating the distal end 3478 of the handle 3460 relative to the proximal end 3476, to keep the flexible member in a never-deployed configuration. Figure 34 , Figure 36 Move to expanded configuration () Figure 35 For example, when the distal end 3478 of the handle 3460 moves distally, as... Figure 35 As shown (and the flexible handle 3480 extends), the distal tube 3484 extends out of the cavity of the proximal tube 3482, and the flexible member unfolds. Conversely, when the distal end 3478 of the handle 3460 moves proximally, as... Figure 34 As shown (and the flexible handle 3480 is not extended), the distal tube 3484 is substantially or completely located within the cavity of the proximal tube 3482, and the flexible member is in an undeployed configuration. The inner shaft 3410 is secured in the handle 3460 via a clamp 3458 similar to the clamp 2658 described above, and the inner shaft 3410 is coaxially positioned in the distal tube 3484, which is coaxially positioned in the proximal tube 3482.

[0147] Regarding Figures 30 to 33 The differences, such as Figure 36As best shown, latch 3488 extends from flexible handle 3480 to interact with and engage with stepped extension 3486, such that the handle can secure the flow reduction device to the extended configuration (the flexible member in the deployed configuration). Furthermore, the proximal end 3476 includes a bracket or fork 3476a shaped to receive an eyelet 3476c therein, which is secured to the fork 3476a by a pin 3476b. The distal end 3478 includes a similar configuration with a bracket or fork 3478a shaped to receive an eyelet 3478c therein, which is secured thereto by a pin 3478b. Therefore, when the flexible handle 3480 is actuated (i.e., squeezed toward the telescopic tube 3482, telescopic tube 3484) or returns to the inactive state, the distal end 3478 moves accordingly away from and toward the proximal end 3476, causing the eyelets 3476c and 3478c to pivot around the pin 3476b and around the pin 3478b in the forks 3476a and 3478a, respectively.

[0148] Figures 37 to 38 Another embodiment of the handle 3760 is shown, which is configured for use with any flow reduction device described herein. Handle 3760 uses a similar... Figures 29A to 29B The clamp assembly described herein is used to manipulate the inner shaft 3710 relative to the outer shaft 3712. Using a combination... Figures 29A to 29B The described mechanism has a proximal end body 3766a of the handle 3760 connected to an inner shaft 3710 and a distal end body 3766b connected to an outer shaft 3712. For example, a proximal clamp 3758a is connected to the inner shaft 3710 and a distal clamp 3758b is connected to the outer shaft 3712. An axial translation 3740 of the distal body 3766b connected to the outer shaft 3712 toward the distal end of the flow reduction device causes the flexible member of the flow reduction device to unfold, while an axial translation 3740 of the distal body connected to the outer shaft toward the proximal end (and therefore toward the proximal body 3766a) moves the unfolded flexible member to an unfolded configuration.

[0149] Figures 39 to 47 Various embodiments of flow reduction devices are illustrated, which may include any or all features of any other flow reduction devices described elsewhere herein (e.g., extension indicators, mechanical stops, deployment stops, materials, etc.). Figures 39 to 47 The embodiments shown can exist in a variety of configurations. For example, the flow reduction device may include concentric tubes (inner and outer shafts, as described above and elsewhere herein) or an elongated member, which will be described in further detail below. Furthermore, Figures 39 to 47The flow reduction device may include two or more cavities. For example, in one embodiment, the flow reduction device includes three cavities: one cavity for a guidewire to pass through; one cavity configured to receive expanding fluid passing through it for inflating the flexible member of the flow reduction device; and one cavity configured to receive fluid for filling a body cavity to perform surgery. In another embodiment, the flow reduction device includes two cavities: one cavity for a guidewire to pass through; and one cavity configured to receive fluid for deploying the flexible member and filling a body cavity to perform surgery.

[0150] Now go to Figures 39 to 43 This illustrates an embodiment of a flow reduction device 3900. A device 3900 configured to obstruct at least a portion of a body cavity during surgery includes an elongated body 3990 having a proximal end 3990a and a distal end 3990b, and defining a cavity 3992 therethrough. The elongated body 3990 further includes a flexible member 3914 coupled to the elongated body 3990 at a first or proximal location 3993a and a second or distal location 3993b. The elongated body 3990 defines at least two orifices 3991 and 3998. The first orifice 3991 is located proximally to the elongated body 3990 relative to the flexible member 3914 and is configured to deliver fluid into the body cavity where the flow reduction device 3900 is located. The second orifice 3998 is located within the flexible member 3914 and is configured to inflate the flexible member 3914 with an expanding fluid. When the liquid flows through the inner cavity 3992 of the elongated body 3990 and out of the second hole 3998 of the elongated body 3990, the flexible member 3914 can flow from... Figure 39 The unexpanded configuration shown expands to, as Figure 43 The unfolded configuration is shown in the figure. In some embodiments, the elongated body 3990 further defines a second cavity 3994, which is configured to receive a guidewire passing through it, as shown in the figure. Figure 42 As shown in the diagram. Optionally, in some embodiments, the elongated body 3990 further defines a third lumen configured to receive another fluid passing through it, such as filling a patient's body cavity and / or the flexible member 3914 of the flow reduction device 3900. The elongated body 3990 includes a distal cap 3924 similar to that described elsewhere herein and includes similar components (e.g., a valve, the distal end of the elongated body, the guidewire lumen) that function to allow the guidewire to pass through it but prevent fluid from escaping from the distal end 3990b of the flow reduction device 3900.

[0151] like Figures 39 to 43As shown, the flexible member 3914 comprises or is formed of a deployable material, which includes a plurality of hydratable beads 3996 such that when liquid is infused into the flexible member 3914 through orifices 3998, the beads 3996 can expand from an undeployed state to a deployed state. When in a hydrated state, the plurality of hydratable beads 3996 can substantially or completely consume the space defined by the flexible member 3914. In other embodiments of the flow reduction device 3900, as described elsewhere herein, in addition to an elongated body, there are inner and outer axes, and the plurality of hydratable beads 3996 are configured to deploy when liquid is applied through one or both of the inner and outer axes. The flexible member 3914 may further define one or more perforations 3995 on its distal side for releasing excess liquid from the flexible member 3914 when the plurality of hydratable beads 3996 have reached maximum capacity, a threshold, or equilibrium. In some embodiments, instead of a single elongated member, the flow reduction device 3900 includes an inner shaft and an outer shaft configuration as described elsewhere herein.

[0152] Figures 44 to 47 Another embodiment of the flow reduction device 4400 is shown. The flow reduction device 4400 is similar to the flow reduction device described above with respect to 3900, including an elongated body 4490 that defines a guidewire lumen 4494 and an infusion lumen 4492 (and an optional third lumen as described elsewhere herein). The elongated body 4490 further defines a first orifice 4491 and a second orifice 4498. The first orifice 4491 is located proximally to the flow reduction device relative to the flexible member 4414 and functions to fill the body lumen in which the flow reduction device is located. The second orifice 4498 is inside the flexible member 4414 and functions to expand the flexible member 4414 with fluid. The flexible member 4414 is coupled to the elongated body 4490 at a proximal coupling location 4493a and a distal coupling location 4493b. Figure 45 As shown, the elongated body 4490 further includes a distal cap 4424, which includes a valve 4446, a distal end 4450 of the elongated body 4490, and a guidewire lumen 4452. Figures 44 to 47 As shown, the flexible member 4414 includes or is formed of deployable or elastic materials (e.g., balloons, thermoplastic polyurethane, thermosetting polyurethane, silicone, polyetheretherketone), non-elastic materials (e.g., filled or deployed without stretching), etc. In some embodiments, instead of a single elongated member, the flow reduction device 4400 includes an inner shaft and an outer shaft configuration as described elsewhere herein.

[0153] Figure 44 and Figures 48 to 53 An embodiment of plunger 4861 is shown, which is configured for insertion. Figures 49 to 53The plunger 4861 can be inserted into any cavity of the handle 4960 shown. For example, when fluid is infused through the expansion cavity 4992, the plunger 4861 can be inserted into the guidewire cavity 4994; after the flexible member is deployed, the plunger 4861 can be inserted into the expansion cavity 4992 (e.g., to prevent backflow of expansion fluid from the proximal end of the assembly); the plunger 4861 can be reversibly inserted into expansion cavities 3992 and 4492 until deployment is required; in a three-cavity handle, the plunger 4861 can close unused cavities; and so on. The plunger 4861 includes a body 4866 coupled to an insertion section 4889 (e.g., tapered or non-tapered) coupled to an introduction section 4899, which can be inserted into the cavity of an elongated member, such as an infusion cavity, or attached to a handle of an elongated member. Figures 49 to 53 An embodiment of an infusion handle 4960 is shown. The handle 4960 includes an inner rotating body 4965 comprising a proximal segment 4965a, an intermediate segment 4965b, and a distal segment 4965c. The intermediate segment 4965b includes an expansion lumen access slit 4985 configured to expand a flexible member when fluid is applied through it, and is rotatably overlapped by an outer rotating body 4967. The outer rotating body 4967 is coupled to a proximal sealing feature 4987a (e.g., an O-ring) and a distal sealing feature 4987b (e.g., an O-ring). The outer rotating body 4967 further defines an expansion orifice 4983. Figure 51 As shown, when fully assembled and in the open configuration, the expansion cavity of the inner rotating body 4965 aligns with the expansion port 4985 of the outer rotating body 4967, allowing liquid to be dispensed through the handle 4960 and flow reduction devices (e.g., valves (e.g., tuohy borst) around the handle 4960 at the aligned cuts 4985 and ports 4983; valves attached to the proximal section 4965c, etc.). In the closed configuration, as... Figure 52 As shown, the expansion cavity of the inner rotating body 4965 entering the cutout 4985 is misaligned or not aligned with the expansion hole 4983 of the outer rotating body 4967, preventing fluid from being delivered to the flexible member through the handle 4960 and the flow reduction device. The handle 4960 may further include extension indicators 4913a and 4913b to indicate when the cutout 4985 and hole 4983 are aligned. Figure 53 And when cut 4985 and hole 4983 were misaligned ( Figure 52 Since the outer rotating body 4967 can rotate relative to the inner rotating body 4965, the first or proximal end 4913a of the extension indicator becomes aligned or misaligned with the second or distal end 4913b of the extension indicator, depending on whether the infusion lumen should open or close. (See reference...) Figures 39 to 49Handle 4960 has been described, but it should be understood that handle 4960 can be used with any flow reduction device described herein (e.g., Figures 12 to 25 ) and / or any other handle embodiments described elsewhere herein (e.g., Figures 26 to 38 Use them together.

[0154] In some embodiments, the expansion lumen entry incision 4985 further functions as an infusion lumen entry incision 4985 to deliver fluid into a body cavity. In some such embodiments, the cover of the flexible member may include one or more perforations such that fluid not only fills the flexible member but also fills a body cavity adjacent to the flexible member.

[0155] In some embodiments, the handle 4960 forms part of the proximal portion or proximal end of the inner shaft of the flow reduction device, such that the handle 4960 and the inner shaft are fully integrated and continuous. In some such embodiments, the inner rotating body 4965 is a dedicated 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 may be coupled to the proximal portion or proximal end of the inner shaft of the flow reduction device, such that the various cavities of the handle 4960 and the inner shaft are continuous and uninterrupted.

[0156] Now go to Figure 54 This illustrates a method 5400 for occluding at least a portion of a body cavity using any of the foregoing embodiments of a flow reduction device and / or a handle and / or an infusion device. Any step of method 5400 can be used in any order, and additional steps can be added or existing steps can be removed. A method 5400 for occluding at least a portion of a body cavity during or during surgery includes: advancing a flow reduction device through the body cavity such that the flow reduction device includes a flexible member and defines one or more orifices S5410; unfolding the flexible member of the flow reduction device from a non-unfolded configuration to an unfolded configuration S5420; advancing an instrument into the patient's body cavity S5430; infusing fluid into the body cavity through one or more orifices in the flow reduction device such that when the flexible member is in the unfolded configuration S5440, flow of fluid through the flexible member is restricted S5440; and performing surgery in at least a portion of the patient's body cavity using the instrument S5450.

[0157] In any embodiment of method 5400, any flow reduction device described elsewhere herein may be used and / or employed. In any embodiment of method 5400, the device includes any medical device, including but not limited to an ultrasound transducer or endoscope, ablation tool, biopsy tool, ligation tool, imaging tool (e.g., camera, microscope, ultrasound), sensor, stent, thrombectomy device, or any other medical device.

[0158] In some embodiments, method 5400 is particularly suitable for performing enterostomy. In some such embodiments, block S5410 includes advancing a flow-reducing device through a narrowing in the patient's gastrointestinal tract, such that the flow-reducing device includes a flexible member and defines one or more orifices. In some embodiments, block S5410 further includes positioning the distal end of an elongated member (e.g., an endoscope, catheter, etc.) adjacent to the proximal side of the narrowing in the patient's gastrointestinal tract; and advancing the flow-reducing device through a lumen (e.g., a working channel) defined by the elongated member (e.g., an endoscope, catheter, etc.) and through the narrowing in the gastrointestinal tract.

[0159] In some embodiments, block S5420 further includes deploying the flexible member of the flow reduction device from a non-deployed configuration to a narrow deployed configuration away from the gastrointestinal tract.

[0160] In some embodiments, blocks S5430, S5440, and S5450 include: advancing an echo endoscope into a patient's gastrointestinal tract; infusing fluid into the gastrointestinal tract through one or more orifices in a flow reduction device such that fluid flow through the flexible member is restricted when the flexible member is in an deployed configuration; and imaging at least a portion of the patient's gastrointestinal tract with the echo endoscope.

[0161] In some embodiments, infusion further includes coupling a liquid injection port (e.g., a Tuohy Borst valve) to a proximal end of a flow reduction device, such that the liquid injection port is configured to deliver liquid through a lumen defined by the flow reduction device (e.g., an infusion lumen) and out through one or more orifices of the flow reduction device into the gastrointestinal tract, including one or more of the esophagus, stomach, small intestine, or large intestine.

[0162] In some embodiments, method 5400 includes locating the distal end of an elongated member (e.g., an endoscope, catheter, etc.) adjacent to a proximal lateral portion of a narrowing in the patient's gastrointestinal tract. For example, in the case of a gastrostomy, the narrowing is typically located in the proximal small intestine (duodenum), although it can also be in the distal stomach (a condition known as "gastric outlet obstruction" when contents reflux into the stomach).

[0163] In some embodiments, method 5400 further includes advancing a guidewire through the lumen of an elongated member and through a narrowing of the patient's gastrointestinal tract, such that a flow-reducing device passes over the guidewire and through the narrowing. A guidewire may be used when the endoscope and / or the flow-reducing device cannot be advanced through the narrowing.

[0164] In some embodiments, method 5400 further includes removing the elongated member from the body cavity before advancing the instrument into the body cavity.

[0165] In some embodiments, method 5400 includes reducing the flow rate of fluid around the flexible member and through the downstream body cavity of the patient to less than about 300 ml / min, less than about 230 ml / min, less than about 200 ml / min, about 200 to about 300 ml / min, about 150 to about 250 ml / min, about 100 to about 200 ml / min, etc.

[0166] In some embodiments where the body cavity is the gastrointestinal tract, the downstream gastrointestinal tract includes one or more of the following: the patient's small intestine, large intestine, or colon.

[0167] In some embodiments, method 5400 includes: advancing an enterostomy device through the lumen of an echo endoscope; and performing an enterostomy.

[0168] In some embodiments, method 5400 includes retracting the deployed flexible member from a deployed configuration to a non-deployed configuration. In some such embodiments, retraction may include proximal movement of the outer axis toward a proximal portion toward the inner axis to retract the deployed flexible member from the deployed configuration to the non-deployed configuration. Alternatively or additionally, suction or negative pressure may be applied to the infusion lumen (e.g., to remove fluid from the interior of the flexible member) to retract the deployed flexible member to the non-deployed shape.

[0169] In some embodiments, method 5400 includes removing the flow-reducing device from the gastrointestinal tract. In the contracted configuration (after the flexible member has deployed), the diameter of the flexible member may be larger than in the undeployed configuration before the flexible member has deployed. Such an increased diameter is still small enough to be effectively removed from the body cavity.

[0170] In some embodiments, method 5400 includes attaching a handle to a flow-reducing device to facilitate the deployment or retraction or control of the flexible member. Any handle and / or infusion device described elsewhere herein may be attached to any flow-reducing device described elsewhere herein. The method may further include actuating the handle to manipulate an outer shaft relative to an inner shaft. Such actuation may include moving a distal end of the handle coupled to the outer shaft toward a distal end of the device to deploy the flexible member. Alternatively, actuating the handle may include rotating an outer rotating body relative to an inner rotating body to open an orifice for infusion of liquid to deploy the flexible member.

[0171] In some embodiments, method 5400 includes removing an echo endoscope from the gastrointestinal tract.

[0172] In some embodiments, any systems and devices described herein can be used to prevent the loss of one or more tissue samples that may migrate downstream with peristalsis after endoscopic resection (e.g., removal of a polyp in the duodenum). For example, the method may include: extending a flexible member downstream of the lesion to be resected via an elongated member (e.g., an endoscope) under endoscopic guidance; removing the elongated member while leaving the flexible member in situ; reinserting the elongated member along, adjacent to, or near the flexible member; resecting the lesion with the elongated member to produce a sample; retrieving the sample by pulling the flexible member proximally to “scoop” or “grab” or otherwise collect the sample; contracting the flexible member in which the sample is fixed; and removing the flexible member and the elongated device from the patient.

[0173] Unless explicitly stated in the context, as used in the specification and claims, the singular forms “a,” “an,” and “the” include both singular and plural references. For example, the term “hole” may include and is considered to include multiple holes. Sometimes, claims and disclosures may include terms such as “multiple,” “one or more,” or “at least one.” However, the absence of these terms is not intended to mean, nor should be construed as, that multiple are not contemplated.

[0174] The terms “about” or “approximately”, when used before a numerical name or range (e.g., specifying length or pressure), indicate an approximate value that may vary by (+) or (-) 5%, 1%, or 0.1%. All numerical ranges provided herein include both the beginning and end figures. The term “substantially” indicates the majority (i.e., greater than 50%) or substantially all of an apparatus or method.

[0175] As used herein, the terms "comprising" or "comprises" are intended to mean that an apparatus, system, or method includes the listed elements and may additionally include any other elements. "Substantially constitutes" means that the apparatus, system, or method includes the listed elements and excludes other elements essential to the combination for this purpose. Therefore, a system or method substantially constitutes the elements defined herein does not exclude other materials, features, or steps that do not materially affect the essential and novel features of the claimed disclosure. "Constitutes" means that the apparatus, system, or method includes the listed elements and excludes any elements or steps that are more than trivial or unimportant. Embodiments defined by each of these transitional terms are within the scope of this disclosure.

[0176] The examples and illustrations included herein are shown by way of illustration and not limitation of specific embodiments from which the subject matter may be practiced. Other embodiments may be utilized and derived therefrom, allowing for structural and logical substitutions and changes without departing from the scope of this disclosure. These embodiments of the subject matter of the invention may be referred to individually or collectively herein by the term "invention," which is merely for convenience, and if more than one invention or inventive concept is actually disclosed, this is not intended to voluntarily limit the scope of this application to any single invention or inventive concept. Thus, although specific embodiments have been shown and described herein, any arrangement intended to achieve the same purpose may replace the specific embodiments shown. This disclosure is intended to cover any and all modifications or variations of the various embodiments. Combinations of the above embodiments and other embodiments not specifically described herein will be apparent to those skilled in the art upon reading the above description.

Claims

1. A catheter device configured to obstruct at least a portion of the lumen of the gastrointestinal tract during endoscopic procedures, said catheter device comprising: An inner shaft having a proximal portion, a distal portion, and defining an inner cavity and a first hole therethrough; and An outer shaft having a proximal end and a distal end coupled to the distal portion of the inner shaft, and defining an inner cavity therethrough, the outer shaft further including a flexible member and defining a second hole positioned proximal to the flexible member on the outer shaft, wherein the inner shaft extends through the inner cavity of the outer shaft; At least a portion of the outer shaft is capable of axial translation toward and away from the distal portion of the inner shaft. When at least a portion of the outer shaft is axially translated toward or away from the distal portion of the inner shaft, the flexible member is capable of moving between an undeployed configuration and a deployed configuration, and At least half of the flexible member comprises a plurality of struts; and A cover, configured to cover the plurality of pillars.

2. The catheter device of claim 1, wherein the flexible member is positioned near the distal end of the outer shaft.

3. The catheter device of claim 1, wherein the flexible member is 0.1 inch to 5 inches away from the distal end of the outer shaft.

4. The catheter device of claim 1, wherein the flexible member is 0.8 inches to 1.2 inches away from the distal end of the outer shaft.

5. The catheter device according to any one of claims 1 to 4, wherein the inner shaft further comprises a stop configured to restrict movement of the outer shaft relative to the inner shaft and thus restrict movement of the flexible member.

6. The catheter device according to any one of claims 1 to 4, wherein the inner shaft further includes an extension indicator on the surface of the inner shaft, the extension indicator indicating the axial translation length required to move the outer shaft to unfold the flexible member from the un-deployed configuration to the deployed configuration.

7. The catheter device of claim 6, wherein the extension indicator further comprises a negative extension indicator indicating an over-extension state of the flexible member.

8. The conduit device according to any one of claims 1 to 4, wherein the inner shaft further includes a distal end on the distal portion of the inner shaft, wherein the distal end includes a valve configured to prevent fluid from flowing out of the distal end of the inner shaft.

9. The catheter device according to any one of claims 1 to 4, further comprising a liquid injection port coupled to the proximal portion of the inner shaft.

10. The catheter device of claim 9, further comprising an infusion device coupled to the liquid injection port, the infusion device being configured to deliver fluid through the liquid injection port, through the first orifice and the second orifice, into the gastrointestinal tract of a patient adjacent to the flexible member.

11. The catheter device according to any one of claims 1 to 4, wherein the flexible member comprises a proximal end and a distal end, wherein the proximal end of the flexible member is coupled to the outer shaft, and the distal end of the flexible member is coupled to the inner shaft.

12. The catheter device according to any one of claims 1 to 4, further comprising a handle having a proximal end coupled to the inner shaft and a distal end coupled to the outer shaft, such that the distal end of the handle is axially translatable to move the proximal end of the outer shaft toward and away from the distal portion of the inner shaft.

13. The conduit device of claim 1, wherein the plurality of support pillars are sealed with filler material.

14. The catheter device according to any one of claims 1 to 4, wherein the flexible member comprises a plurality of hydratable beads such that the beads are configured to expand from an un-deployed state to an deployed state.

15. The conduit device of claim 14, wherein the plurality of hydratable beads are configured to deploy when fluid is applied through one or both of the inner shaft and the outer shaft.

16. The catheter device according to any one of claims 1 to 4, wherein the flexible member comprises a braided material.

17. The catheter device of claim 16, further comprising a cover configured to enclose the braided material.

18. The catheter device of claim 16, wherein the braided material encloses the filler material.

19. The catheter device of claim 16, wherein the braided material comprises nitinol.

20. The conduit device according to any one of claims 1 to 4, wherein when the flexible member is in the deployed configuration, the first hole and the second hole are substantially aligned.

21. The catheter device according to any one of claims 1 to 4, wherein the flexible member comprises a balloon.

22. The catheter device according to any one of claims 1 to 4, wherein the flexible member is coated with a deployable material.

23. The conduit device of claim 22, wherein the deployable material comprises thermoplastic polyurethane.

24. The catheter device according to any one of claims 1 to 4, wherein the inner shaft and the outer shaft are fixed substantially rotatably relative to each other.

25. The catheter device according to any one of claims 1 to 4, wherein the flexible member unfolds to a diameter of 3 cm to 4 cm.

26. The apparatus of claim 1, wherein the apparatus is used in a system comprising: An echo endoscope configured to enter the gastrointestinal tract to image at least a portion of the gastrointestinal tract.

Images