Medical Systems and Devices

Abstract

A method for removing one or more objects or substances from a body lumen includes delivering a tube and an expandable device into the body lumen to a location proximal to the one or more objects or substances. The expandable device is disposed within a lumen of the tube, the expandable device including a lumen extending from a distal portion to a proximal portion. The method includes retracting the tube proximally so that the expandable device remains proximal to the one or more objects or substances, advancing the expandable device distally so that a distal portion of the expandable device at least partially surrounds the one or more objects or substances, at least partially closing the distal end of the expandable device, and moving the expandable device proximally to remove the expandable device and the one or more objects or substances from the lumen.

Description

[Technical Field]

[0001] The present disclosure relates generally to medical systems, medical devices, and related methods. More specifically, at least 44 certain embodiments of the present disclosure relate to systems, devices, and related methods for endoscopic medical procedures, such as grasping, moving, retrieving, and / or removing one or more objects or substances from a body lumen, organ, or cavity, among other aspects. [Background technology]

[0002] Advances in technology enable users of medical systems, devices, and methods to perform increasingly complex procedures on subjects. One challenge in the field of minimally invasive surgery relates to removing objects or materials from within a subject, such as removing gallstones from the subject's bile duct. Such procedures may require the use of multiple instruments to remove gallstones, such as a device for dilating the bile duct, a device for trawling the bile duct, and a device for extracting the gallstones. Requiring the use of multiple instruments during a procedure can lead to various procedural problems, increased procedure time, and / or increased risk of injury to the subject. Therefore, there is a need for systems, devices, and methods that address one or more of these challenges or other related issues. Summary of the Invention

[0003] Examples of the present disclosure relate, inter alia, to systems, devices, and methods for performing one or more medical procedures using medical systems and medical devices. Each of the examples disclosed herein may include one or more of the features described in connection with any of the other disclosed examples.

[0004] According to a particular method for removing one or more objects or substances from a body lumen, the method includes delivering a tube and an expandable device into a body lumen to a location proximal to the one or more objects or substances, the expandable device being disposed within a lumen of the tube, the expandable device including a lumen extending from a distal portion to a proximal portion; retracting the tube proximally so that the expandable device remains proximal to the one or more objects or substances; advancing the expandable device distally so that a distal portion of the expandable device at least partially surrounds the one or more objects or substances; at least partially closing the distal end of the expandable device; and moving the expandable device proximally to remove the expandable device and the one or more objects or substances from the lumen.

[0005] Any of the examples described herein may have any of the following features in any combination. The method may further include expanding a distal portion of the expandable device with a balloon prior to advancing the expandable device distally. At least a distal portion of the expandable device may be formed from a shape-memory material that expands on its own when not disposed within the lumen of a tube. At least partially closing the distal end of the expandable device may include proximally retracting one or more pull lines coupled to the distal end of the expandable device. Proximally retracting the one or more pull lines may taper the distal end of the expandable device radially inward, causing the distal end of the expandable device to at least partially close.

[0006] The method may further include delivering a medical device or scope through the lumen of the tube and through the lumen of the expandable device, the medical device or scope including one or more visualization devices. Distally advancing the expandable device may include abutting a distal end of the scope with one or more radially inward extensions on an inner surface of the expandable device and advancing the scope distally to distally advance the expandable device.

[0007] The method may include delivering an energy delivery device through a lumen of the tube and a lumen of the expandable device after at least partially occluding the distal end of the expandable device, and actuating the energy delivery device one or more times to direct energy toward the object or substance one or more times. In some embodiments, the tube and expandable device may be delivered to the body lumen through an incision.

[0008] The method may include depositing one or more objects or substances into a mesh basket positioned proximal to the lumen. Depositing the one or more objects or substances into the mesh basket may include delivering a fluid through a lumen of a tube into the expandable device. In some embodiments, the lumen may be a bile duct, and the one or more objects or substances may include one or more gallstones.

[0009] In an additional or alternative method for removing one or more gallstones from a bile duct, the method may include making an incision in a subject adjacent to the bile duct; delivering a tube and an expandable device through the incision into the bile duct to a location proximal to the one or more gallstones, the expandable device being disposed within a lumen of the tube, the expandable device including a lumen extending from a distal portion to a proximal portion; retracting the tube proximally so that the expandable device remains in a location proximal to the one or more gallstones; advancing the expandable device distally so that a distal portion of the expandable device at least partially surrounds the one or more gallstones; at least partially closing the distal end of the expandable device; and moving the expandable device proximally to remove the expandable device and the one or more gallstones or material from the bile duct.

[0010] The method may further comprise, prior to distally advancing the expandable device, expanding a distal portion of the expandable device and dilating a portion of the bile duct by expanding a balloon disposed within a distal portion of the lumen of the expandable device. In some embodiments, at least partially closing the distal end of the expandable device includes proximally retracting one or more pull lines coupled to the distal end of the expandable device, wherein proximally retracting the one or more pull lines tapers the distal end of the expandable device radially inward, at least partially closing the distal end of the expandable device.

[0011] The method may further include delivering a medical device or scope through the lumen of the tube and through the lumen of the expandable device, the medical device or scope including one or more visualization devices, and distally advancing the expandable device includes abutting a distal end of the scope with one or more radially inward extensions on an inner surface of the expandable device and advancing the scope distally to advance the expandable device distally. The method may further include delivering an energy delivery device through the lumen of the tube and the lumen of the expandable device after at least partially closing the distal end of the expandable device and before moving the expandable device proximally, and actuating the energy delivery device one or more times to direct energy at the one or more gallstones to fragment or break up the one or more gallstones. The method may further include depositing the one or more fragmented or fragmented gallstones into a mesh basket positioned proximally of the lumen.

[0012] In an alternative embodiment, a medical system may include a tube having a lumen and an expandable device having a proximal portion, a distal portion, and an intermediate portion between the proximal and distal portions. The expandable device may include a lumen extending from the proximal portion to the distal portion. In a first configuration, the expandable device may be disposed within the lumen of the tube and may be in an unexpanded state, and the distal end of the distal portion may be open. In a second configuration, the expandable device may be at least partially extended from the lumen of the tube and in an expanded state, and the distal end of the distal portion may be open or larger than the distal end in the first configuration. In a third configuration, the expandable device may be at least partially extended from the lumen of the tube and in an expanded state, and the distal end of the distal portion may be at least partially closed. In the third configuration, the expandable device may be configured to be retracted proximally to retain one or more objects or substances within the expandable device. The medical system may further include a scope configured to be delivered through the lumen of the tube and at least partially through the lumen of the expandable device. The scope may include one or more visualization devices. An energy delivery device may be configured to be delivered through the lumen of the tube and at least partially through the lumen of the expandable device. The energy delivery device may be configured to at least partially fragment or fragment one or more objects or substances. [Brief explanation of the drawings]

[0013] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various exemplary embodiments and, together with the description, serve to explain the principles of the disclosed embodiments. [Figures 1A-1E] 1A-1E are cross-sectional side views of an exemplary medical system / device at least partially within a body lumen at various times or steps in an exemplary procedure, according to embodiments of the present disclosure. [Figure 2]FIG. 2 is a flow diagram of an exemplary method according to an aspect of the present disclosure. [Figure 3] FIG. 3 is a side view of an alternative exemplary medical device according to an embodiment of the present disclosure. [Figure 4] FIG. 4 is a perspective view of a section of an alternative exemplary medical device according to an embodiment of the present disclosure. [Figure 5] FIG. 5 is a side view of an alternative exemplary medical device according to an embodiment of the present disclosure. [Figures 6A-6B] 6A and 6B are perspective views of an exemplary medical device in an open configuration (FIG. 6A) and a closed configuration (FIG. 6B) according to an embodiment of the present disclosure. [Figures 7A-7B] 7A and 7B are perspective views of alternative configurations of exemplary medical devices according to embodiments of the present disclosure. [Figure 8A-8B] FIG. 8A is a perspective view and FIG. 8B is a side view of an exemplary medical device according to an embodiment of the present disclosure. [Figure 9] FIG. 9 is a perspective view of another exemplary medical device according to aspects of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0014] Reference will now be made in detail to aspects of the present disclosure, examples of which are illustrated in the accompanying drawings. Wherever possible, the same or like reference numerals will be used in the drawings to refer to the same or like parts. The term "distal" refers to the portion of the device that is furthest from a user when introducing the device into a subject (e.g., a patient). Conversely, the term "proximal" refers to the portion of the device that is closest to a user when placing the device within a subject.

[0015] Both the foregoing general description and the following detailed description are exemplary and explanatory and are not limited to the features set forth in the claims. As used herein, the words "comprises," "comprising," "having," "including," or any other variation thereof, are intended to imply a non-exclusive inclusion. That is, a process, method, article, or apparatus consisting of a list of elements does not include only those elements, but may include other elements not expressly listed or elements inherent in such process, method, article, or apparatus. In this disclosure, relative terms such as "about," "generally," "generally," and "approximately" are used to indicate a possible variation of ±10% in a stated numerical value or characteristic.

[0016] Embodiments of the present disclosure may solve these problems or one or more limitations of the art. However, the scope of the disclosure is defined by the appended claims, not by the ability to solve a particular problem. In certain embodiments, the present disclosure relates to inserting a medical device into a body lumen (e.g., a duct). The duct may include, for example, the common bile duct, the cystic duct, or the hepatic duct, among others.

[0017] 1A-1E illustrate side cross-sectional views of an exemplary medical system 100 at various times, stages, or steps during an exemplary procedure, according to one embodiment of the present disclosure. As described in detail below, medical system 100 includes a primary device or outer tube 102 (hereinafter, "tube" 102) and a secondary device or expandable device 104 (hereinafter, device 104). Furthermore, tube 102 and / or device 104 may be at least partially movable relative to one another, e.g., to enable the inclusion and / or removal of one or more objects or substances from a lumen 150 of a subject. For example, tube 102 may be movable relative to device 104, and / or vice versa. Furthermore, FIG. 2 illustrates an exemplary method or process 200 that may be implemented by one or more users using any of the medical systems, medical devices, or portions of a medical system, e.g., medical system 100, described herein.

[0018] Specifically, FIG. 1A illustrates the medical system 100 as it is inserted into a lumen 150 of a subject. As shown in FIG. 1A, the tube 102 can be at least partially cylindrical. The tube 102 can be formed from a rigid or semi-rigid material (e.g., polypropylene plastic, high-density polyethylene plastic, Nitinol, stainless steel, elgiloy (e.g., a non-magnetic cobalt-chromium-nickel-molybdenum alloy), nylon (Grilamid®, Crystalmid®), Pebax®, etc.) and, in at least some embodiments, is a straight, unbent structure. While not shown, it should be understood that in some embodiments, the tube 102 can include one or more bends or curves along its longitudinal length between the proximal end 106 and the distal end 108. For example, one or more portions of the tube 102 can be S-shaped or U-shaped. Additionally or alternatively, one or more surfaces or portions of the tube 102 may be at least partially coated with any biocompatible material known to one of ordinary skill in the art (i.e., silicone-based lubricants, coatings, gels, liquids, anticoagulants (heparin), polytetrafluoroethylene (PTFE), etc.). For example, coating one or more exterior surfaces or portions of the tube 102 may facilitate insertion, positioning, and / or removal of the medical system 100 into / from the lumen 150. Additionally or alternatively, the tube 102 may further include a pull line (not shown) extending proximally from the proximal end of the tube 102. For example, the pull line (not shown) may be used to facilitate insertion, positioning, and / or removal of the tube 102 and / or the medical system 100 into / from the lumen 150.Additionally or alternatively, coating one or more interior surfaces or portions of the tube 102 may facilitate insertion, positioning, and / or removal of the device 104 through the lumen 103 of the tube 102, as further described herein.

[0019] The longitudinal length of tube 102 may range from about 10 centimeters to about 30 centimeters, for example, about 20 centimeters. However, it should be understood that tube 102 may have a variety of other shapes, sizes, and / or lengths other than those illustrated and described herein. For example, tube 102 may be inserted into a subject through opening 154 (e.g., an incision made through the subject's tissue). Thus, tube 102 may be sized such that at least proximal end 106 of tube 102 remains outside the subject, while at least distal end 108 of tube 102 is located within lumen 150.

[0020] As described above, the tube 102 further includes a lumen 103 extending from the proximal end 106 to the distal end 108 of the tube 102. The lumen 103 may be sized to accommodate a secondary device (e.g., a stent) 104, as described in further detail below. By way of example, in some embodiments, the tube 102 of the medical system 100 may have an outer diameter of about 4 millimeters to about 10 millimeters, and the lumen 103 may have an inner diameter of about 3 millimeters to about 9 millimeters. Accordingly, the wall thickness of the tube 102 may range from about 0.5 millimeters to about 3.5 millimeters. The outer and / or inner diameters of the tube 102 may be constant along the entire longitudinal length of the tube 102. In another example (not shown), the outer and / or inner diameters of the tube 102 may vary along the longitudinal length. For example, the outer and / or inner diameter of the tube 102 may decrease along its longitudinal length, such that the inner and / or outer diameter is larger at a proximal portion of the tube 102 compared to a distal portion of the tube 102. In another example (not shown), the wall thickness of the tube 102 may vary along its longitudinal length. For example, the wall thickness of the tube 102 may be larger at a proximal portion of the tube 102 compared to a distal portion of the tube 102, or vice versa. Increasing the wall thickness at one or more portions of the tube 102 can help provide greater stability during a procedure. In some embodiments, the tube 102 may have a cross-sectional shape such as, for example, an oval, a circle, a square, a rectangle, a star, or any shape known to one of skill in the art.

[0021] The outer surface of the tube 102 may further include one or more various features (not shown), such as indentations, raised surfaces, markings (e.g., radiopaque markings), or the like, or any combination thereof. These features can serve a variety of purposes. For example, the indentations and / or raised surfaces can help the tube 102 remain in place during a procedure, e.g., by increasing the surface area of ​​the outer surface of the tube 102. Additionally or alternatively, the one or more markings may provide visual cues or indicators for a user to ensure that the medical system 100 is properly positioned within the lumen 150, e.g., when using one or more visualization devices, fluoroscopy, or the like.

[0022] The medical system 100 further includes a secondary or expandable device 104. The device 104 may include any device having expandable and / or shape-memory (or shape-memory) properties, such as, for example, a stent. A device including a shape-memory material may be configured to "remember" an original or specific shape and return to that same shape, for example, upon receiving an external stimulus (e.g., a mechanical force or temperature change) and / or after the stimulus or constraint is removed. Thus, the device 104 may be formed from one or more flexible or semi-flexible materials, such as, for example, plastic, nitinol, stainless steel, elgiloy (e.g., a non-magnetic cobalt-chromium-nickel-molybdenum alloy), a shape-memory polymer, or any material known to those skilled in the art. In a first configuration, the device 104 may be positioned within the lumen 103 in an unexpanded state such that the distal end 112 of the device 104 is located proximal to the distal end 108 of the tube 102. The proximal end 110 of the device 104 may be located distal to the proximal end 106 of the tube 102. This positioning of the device 104 allows the device 104 to be delivered or placed within the lumen 150.

[0023] In an alternative configuration, the proximal end 110 of the device 104 may be aligned with or extend proximally beyond the proximal end 106 of the tube 102. Accordingly, the longitudinal length of the device 104 may range from about 5 centimeters to about 30 centimeters. Similarly, the outer diameter of the device 104 may range from about 2 millimeters to about 15 millimeters in the first, unexpanded configuration. In the first, unexpanded configuration, the device 104 may be at least partially cylindrical. However, it should be noted that the device 104 may include various other shapes, sizes, and / or lengths other than those illustrated and described herein. For example, the device 104 may have a cross-sectional shape that is oval, circular, square, rectangular, star-shaped, or any shape known to one of ordinary skill in the art.

[0024] Furthermore, device 104 may include one or more features similar to those described above with respect to tube 102. For example, the exterior surface of device 104 may further include various features (not shown). These features may include, for example, indentations, raised surfaces, markings, etc., or any combination thereof. Additionally, device 104 need not be the same shape as tube 102. For example, device 104 may include a circular cross-section, while tube 102 may be oval or square in cross-section, or vice versa. Alternative combinations are also possible.

[0025] Device 104 includes a lumen 107 extending from a proximal end 110 to a distal end 112. Similar to tube 102, one or more surfaces of device 104 may be at least partially coated with any material known to those skilled in the art to facilitate insertion, positioning, and / or removal of device 104 through lumen 103 of tube 102, or insertion, positioning, and / or removal of an additional device (not shown) through lumen 107 of device 104. Additionally or alternatively, one or more surfaces of device 104 may be at least partially coated to facilitate insertion, positioning, and / or removal of device 104 through lumen 150. The walls (e.g., inner walls) forming lumen 107 of device 104 may additionally or alternatively be insulated, coated, or otherwise formed to help prevent damage to surrounding tissue in or around lumen 150 during certain procedures, such as, for example, lithotripsy. Additionally or alternatively, the walls forming lumen 107 may be at least partially porous and / or may include cavities that facilitate absorption of shock waves through elastic deformation. In some embodiments, the material comprising the walls forming lumen 107 may be elastic, for example, formed of silicone.

[0026] 1A and 2 , in step 202, the medical system 100 may be inserted into the lumen 150, for example, via the opening 154. The opening 154 may be, for example, an incision or a natural orifice in the subject. In some examples, step 202 may include, for example, making an incision to access the lumen 150. The incision may be adjacent to a bile duct and / or a target site. The lumen 150 may contain, for example, one or more objects and / or substances 160 (hereinafter, “objects 160”). In some embodiments, the objects 160 may be stones, for example, gallstones. The medical system 100 may be inserted into the lumen 150 via the opening 154, such that the distal end 108 of the tube 102 is positioned proximal to or adjacent to the object 160. It should be noted that, although not shown, medical system 100 may also be inserted into lumen 150 via a trocar, sheath, cannula, or any other device commonly used in the art for forming and / or maintaining opening 154. Additionally, as previously described, at least a portion of proximal end 106 of tube 102 may remain outside of or extend proximally from opening 154. In some embodiments, medical system 100 may be delivered to the target site using a delivery device (not shown), such as, for example, a scope. Once medical system 100 is in place, the delivery device (not shown) can be removed.

[0027] Once the medical system 100 is positioned in the desired location, step 204 may include removing or at least partially retracting the tube 102 from the lumen 150, while leaving the device 104 within the lumen 150, as shown in FIG. 1B . The tube 102 can be retracted or removed by grasping the proximal end 106 and pulling the proximal end 106 proximally. In some embodiments, prior to removing the tube 102, a scope 130 (described in further detail below) may be inserted through the lumen 103 of the tube 102 and the lumen 107 of the device 104. The inner surface of the device 104 may include one or more features 145 extending radially inward. For example, the one or more features 145 may include one or more bumps, ledges, lips, hooks, or any other feature known to one of skill in the art that may extend (e.g., extend radially inward) over part or all of the inner surface of the device 104. In this embodiment, the distal end of the scope 130 (e.g., the distal end face (tip face) and / or outer periphery of the scope 130) can be used to press or abut one or more features 145, which can help maintain the position of the device 104 while the tube 102 is being retracted.

[0028] Upon removal of tube 102, proximal portion 114 (e.g., the cross-sectional area of ​​proximal portion 114) and distal portion 116 (e.g., the cross-sectional area of ​​distal portion 116) of device 104 may each expand (e.g., radially outward). For example, as described above, due to the shape memory properties / material of device 104, device 104 may expand on its own when it is released / removed from lumen 103 of tube 102 and / or when it is no longer disposed within lumen 103 of tube 102. Device 104 may expand such that one or more outer surfaces of device 104 contact, abut, or press against one or more inner surfaces of lumen 150. Intermediate portion 118 (e.g., the cross-sectional area of ​​intermediate portion 118) may remain unchanged or may expand as well.

[0029] In an alternative configuration, tube 102 may be inserted into lumen 103 without pre-loading (deploying) device 104 within lumen 150. In such a configuration, device 104 may be loaded (deployed) or inserted into lumen 150 of tube 102, for example, once tube 102 is positioned at a desired location within lumen 103. Thus, once device 104 is in place within lumen 103, tube 102 can be retracted and / or removed, as previously described.

[0030] Before, during, or after removal of tube 102, scope 130 may be inserted through lumen 107 of device 104. Scope 130 may include one or more visualization devices (e.g., cameras), one or more illumination devices (e.g., light sources), and / or one or more lumens (not shown) to aid in visualization during the procedure and / or the delivery, positioning, and / or removal of auxiliary medical devices.

[0031] 1B , proximal portion 114 and / or distal portion 116 may be expanded by the shape memory or shape memory material properties comprising device 104. For example, proximal portion 114 and / or distal portion 116 may be naturally biased into the expanded configuration. However, in some forms, method 200 may include an optional step 206 in which proximal portion 114 and / or distal portion 116 may be manually expanded, for example, with a balloon inserted radially within one or more portions of device 104. In the expanded configuration, the outer walls of proximal portion 114, intermediate portion 118, and / or distal portion 116 may press against the inner walls of opening 154 and / or lumen 150, respectively. The radially outward force imparted by the outer walls of proximal portion 114 and distal portion 116 against the respective tissue may help secure device 104 in place within opening 154 and / or lumen 150. The radially outward force of proximal portion 114 may help to further open or maintain opening 154. The radially outward force of distal portion 116 may also help to expand lumen 150, further facilitating capture and / or removal of object 160, as described in further detail below.

[0032] When the tube 102 is removed, the proximal portion 114, the intermediate portion 118, and the distal portion 116 may have a circular cross-section. The proximal portion 114, the intermediate portion 118, and / or the distal portion 116 may assist in widening or dilating the opening 154 and / or the lumen 150. The proximal portion 114 and the distal portion 116 may have a variable shape. For example, the inner and / or outer walls of the proximal portion 114 and / or the distal portion 116 may taper in size (e.g., radially) toward the intermediate portion 118. The inner and / or outer walls of the proximal portion 114 and / or the distal portion 116 may alternatively have a shape that provides additional stability within the lumen 150 when the device 104 is deployed. Additionally or alternatively, the proximal portion 114 and the distal portion 116 may differ in size and shape relative to one another. For example, the proximal portion 114 may be longer (e.g., longitudinally) than the distal portion 116, or vice versa. Additionally or alternatively, the proximal portion 114 may include a greater change and / or a steeper taper compared to the distal portion 116, or vice versa.

[0033] In some embodiments, the proximal portion 114, the distal portion 116, and / or the intermediate portion 118 may be formed of the same material. Alternatively, one or more of the proximal portion 114, the distal portion 116, and / or the intermediate portion 118 may be formed of different materials with different properties, or the same material with different properties. For example, if the device 104 is comprised of woven nitinol threads or wires, such as a stent, the threads or wires forming the proximal portion 114 have a different size and / or pitch compared to the threads or wires forming the distal portion 116 and / or the intermediate portion 118. Many other combinations are possible.

[0034] When device 104 is deployed (e.g., by removing tube 102), the longitudinal length of device 104 may decrease overall. This may be the result of expansion of one or more of proximal portion 114, distal portion 116, and / or intermediate portion 118. For example, as the outer diameter of one or more of proximal portion 114, intermediate portion 118, and / or distal portion 116 increases, the length of one or more of the same proximal portion 114, intermediate portion 118, and / or distal portion 116 may decrease. Thus, the overall length of device 104 decreases when device 104 is deployed. Thus, the longitudinal length of device 104 in the expanded, deployed configuration may range from about 3 centimeters to about 29 centimeters, e.g., from about 5 centimeters to about 20 centimeters, e.g., about 10 centimeters. In the deployed state, the outer diameter of at least a portion of the proximal portion 114, the intermediate portion 118, and the distal portion 116 can be in the range of about 2.5 millimeters to about 30 millimeters, for example, about 5 millimeters to about 25 millimeters, for example, about 15 millimeters.

[0035] As distal portion 116 expands radially, lumen 150 also expands radially, thereby allowing device 104 to surround object 160. For example, radial expansion may cause one or more openings to be formed between object 160 and the inner wall of lumen 150, and device 104 may then at least partially surround object 160 through the formed opening or openings.

[0036] Additional devices may be used to assist in positioning object 160 within device 104. For example, in some embodiments, devices having screws, piercing components, and / or suction elements may be used to attach to the proximal side of object 160 to draw or reposition object 160 within lumen 107 of device 104. Additionally or alternatively, a trawling device may be passed around object 160 and released or deployed distally of object 160. The trawling mechanism may include, for example, a cage, a net, a stent, a balloon, or any combination thereof. Once the trawling mechanism is released or deployed, the trawling mechanism is retracted proximally, whereby the trawling mechanism draws object 160 toward or into lumen 107 of device 104. Additionally or alternatively, a device having an array of rods, protrusions, and / or splines may be passed around the object 160 and released or deployed distally of the object 160. The device may include a suture that can be tightened around the object 160. As the suture tightens around the object 160, the device can be pulled or otherwise urged proximally, thereby drawing the object 160 into the lumen 107 of the device 104. Additionally or alternatively, a device including a spiral or coil may be used to reposition the object 160. For example, the spiral or coil can rotate around the object 160. The continued rotation draws the object 160 proximally, similar to a corkscrew action.

[0037] In an alternative embodiment, the spiral or coil may further include ribs 492 extending radially outward from the wire 490 forming the spiral or coil, as shown in FIG. 4. The ribs 492 may, for example, help retain the object 160 (shown in FIGS. 1A-1C) and / or the object fragment 160′ (shown in FIGS. 1D-1E) within the spiral or coil. The ribs 492 may be formed from one or more flexible or semi-flexible materials, such as, for example, polypropylene plastic, high-density polyethylene plastic, nitinol, stainless steel, elgiloy (e.g., a non-magnetic cobalt-chromium-nickel-molybdenum alloy), silicone, or any material known to those skilled in the art. The ribs 492 may extend from the wire 490 to reduce or close gaps or spacing between each of the multiple spirals or coils (e.g., between adjacent wires). In some embodiments, one or more wires 490 may be aligned at least partially transversely or perpendicularly to the longitudinal axis of device 104 (FIGS. 1A-1E), and one or more ribs 492 may extend at least partially proximally from one or more wires 490. Similarly, in alternative configurations, one or more ribs 492 may extend distally to reduce or close gaps between each of the multiple spirals or multiple coils. Additionally or alternatively, ribs 492 may extend radially outward from wire 490 at different lengths. For example, ribs 492 may be longer or extend further (e.g., radially outward) from wire 490 at a first length of wire 490, while ribs 492 may be shorter or not extend as far (e.g., a shorter radially outward distance) from wire 490 at a second length of wire 490. The ribs 492 may extend from the entire length of the wire 490 or may extend from one or more portions of the wire 490 .

[0038] 1B , in some embodiments, the distal end 112 of the distal portion 116 may include one or more features or components to facilitate capture and / or containment of the object 160. While not shown, the distal end 112 may include one or more gripping features extending radially inward, such as, for example, one or more protrusions, barbs, extensions, etc. In some embodiments, the one or more protrusions may extend radially inward and proximally. The one or more protrusions (not shown) may, for example, help prevent distal migration of the object 160 when the object 160 is positioned within the lumen 107 of the device 104.

[0039] However, in some instances, the object 160 may be too large or the user may not be able to at least partially surround or enclose the object 160 within the device 104. In such instances, the object 160 may remain distal to the distal end 112. The method 200 may include an optional step 208, in which the object 160 may be singulated or fractured outside the device 104 to form a plurality of object fragments 160′. As described in more detail below with respect to optional step 214, for example, the optional step 208 may include delivering and activating an energy delivery device 140 within the lumen 150. Activating the energy delivery device 140 may cause the object 160 to be singulated or fractured to form a plurality of object fragments 160′. In that manner, the energy delivery device 140 may be actuated one or more times to, for example, direct energy toward the object 160 and / or the plurality of object fragments 160′. Once the object 160 has been singulated or broken down, for example, to fit within the lumen 107 of the device 104, the object fragments 160′ may be pulled or otherwise urged proximally using any of the devices or with suction, as described above. Alternatively or additionally, optional step 210 may be repeated such that the device 104 may be repositioned or advanced distally to surround the plurality of object fragments 160′. The user may then proceed as described below.

[0040] Additionally, method 200 may include another optional step 210 in which device 104 may be repositioned within lumen 150. For example, during or after removal of tube 102 and / or before, during, or after insertion of scope 130, device 104 may be repositioned so that object 160 is partially or completely located within (e.g., radially surrounded by) lumen 107. In some embodiments, one or more illumination devices of scope 130 may assist the user in visualizing the position of device 104 and object 160 and assist the user in positioning or repositioning device 104 and / or object 160 so that object 160 is at least partially located within lumen 107 of device 104. Device 104 may be repositioned by pushing device 104 distally. For example, the user may push proximal end 110 to move device 104 distally. Additionally or alternatively, the inner surface of device 104 may include one or more features 145 extending radially inward, as previously described. In this embodiment, the distal end of scope 130 may be used to press or abut against one or more features 145 to move device 104 distally. Additionally or alternatively, another medical device (not shown) may be delivered through the internal lumen of scope 130. The other medical device (not shown) may be used to grasp device 104 and advance one or more portions of device 104 distally.

[0041] 1C and 2, when the object 160 is located partially or completely within the lumen 107, the method 200 includes a step 212 in which the distal-most portion 120 of the distal portion 116 is closed. For example, closing the distal-most portion 120 can be similar to fastening a pouch or bag. In the closed configuration, the distal end 112 of the distal portion 116 can form a tip or pointed portion 112'. For example, in the closed configuration, the distal portion of the multiple walls forming the distal-most portion 120 of the distal portion 116 can taper radially inward toward the pointed portion 112'. As described above, the proximal portion of the multiple walls forming the distal portion 116 can taper radially inward toward the intermediate portion 118.

[0042] Distal-most portion 120 can be closed by pulling one or more pull lines 144, for example, by pulling one or more pull lines 144 proximally. One or more pull lines 144 can be coupled to distal end 112 and, for example, surround at least a portion of the circumference of distal-most portion 120. One or more pull lines 144 can extend proximally through lumen 107 or extend around the radial exterior of device 104. In another embodiment, device 104 can include an additional lumen (not shown), for example, in a wall of device 104, extending from proximal end 110 to distal end 112, through which one or more pull lines 144 can extend. One or more pull lines 144 can have a loose proximal end that extends proximally beyond proximal end 110. The relaxed proximal end allows a user to grasp and pull one or more pull lines 144 proximally, thereby closing off distal-most portion 120. For example, pulling one or more pull lines 144 proximally closes distal-most portion 120.

[0043] Before, while, or after the distal-most portion 120 is closed, the method 200 may include an optional step 214 in which an energy delivery device (e.g., an electrohydraulic lithotripsy (EHL) probe or laser) 140 is inserted through the scope 130, as shown in FIG. 1D . The energy delivery device 140 may be inserted such that the distal end 142 of the probe is located distal to the distal end 132 of the scope 130 and proximal to the object 160. In some examples, the energy delivery device 140 may be inserted into the device 104 without the scope 130. The energy delivery device 140 may be used to deliver energy, which may, for example, at least partially singulate or fragment the object 160. Closing the distal-most portion 120 around the object 160 before the object 160 is singulated or fractured into multiple pieces 160′ can, for example, prevent the loss of one or more of the multiple pieces 160′ within the distal portion of the lumen 150. Thus, closing the distal-most portion 120 around the object 160 before the object 160 is fractured can preserve or contain the multiple object pieces 160′ within the device 104 once the object 160 is singulated.

[0044] After the object 160 has been fragmented into multiple object fragments 160′, the scope 130 and / or energy delivery device 140 may be retracted or removed proximally. The device 104 and the multiple object fragments 160′ contained or held within the device 104 may then be removed from the lumen 150.

[0045] To remove device 104 from lumen 150, for example, in step 220 of method 200, a user can use their fingers or a medical device (i.e., forceps, snare, etc.) to grasp proximal end 110 and pull device 104 proximally. In doing so, device 104 may have an elongated shape, similar to that shown in FIG. 1E , and the diameter of device 104 may be reduced. For example, proximal portion 114, intermediate portion 118, and distal portion 116 may be compressed to form a single portion 121. Thus, the multiple outer walls of single portion 121 may apply less force against the multiple inner walls of lumen 150, thereby allowing the user to more easily remove device 104 from the subject. The multiple inner walls of device 104 may also assist in retaining multiple object fragments 160′. Additionally or alternatively, a pull wire (not shown) may extend proximally from the proximal end of device 104. A pull wire (not shown) may be used to allow retraction or removal of device 104 from lumen 150. Once removed, device 104 may be properly discarded and / or multiple object fragments 160′ may be retrieved for further investigation.

[0046] 3 illustrates an alternative embodiment of a medical system 300. This embodiment of the medical system 300 includes a device 304 that may have any of the features of the device 104, except as described below. The medical system 300 may be used to perform one or more steps of the method 200, except as described below.

[0047] The medical system 300 is inserted through the opening 354 and positioned within the lumen 350 similar to the medical system 100. For example, a tube (not shown) similar to the tube 102 described above can be used to deliver and position the device 304 within the lumen 350. The device 304 may further include a basket 375 extending radially from an outer surface of the proximal portion 314 of the device 304. For example, the basket 375 may be positioned proximal to or adjacent to the lumen 350 of the device 304. In an alternative embodiment (not shown), the basket 375 may extend radially from an outer surface of the intermediate portion 318 or the distal portion 316.

[0048] The basket 375 may be placed outside or inside the subject. The basket 375 may be used to collect the object and / or object fragments 360′ as they are trawled or otherwise removed from the lumen 350. For example, object fragments 360′ may be deposited within the basket 375 during a procedure. The basket 375 may be constructed of any material commonly used in the art for manufacturing medical baskets. For example, the basket 375 may be constructed of cloth, mesh, plastic, or any combination thereof. Additionally or alternatively, the basket 375 may be constructed at least partially of a porous membrane. Alternatively or additionally, the basket 375 may include an additional outer layer of material, such as, for example, a sealed bag 377. The sealed bag 377 may be constructed of, for example, a non-porous material, which may help prevent leakage. A sealing grommet (not shown) may be positioned proximal to the basket 375. The sealing grommet (not shown) may be used to allow fluid to flow through the basket 375 and / or to aid in the flow of the object and / or object fragments 360′ into the basket 375, for example.

[0049] The basket 375 may further include one or more pull lines 345 that can be used to close or cinched off the basket 375 from the device 304. For example, when the one or more pull lines 345 are pulled proximally or otherwise urged, a portion of the basket may be closed or cinched off. One or more tubes (not shown) may extend from and be fluidly connected to the sealed bag 377. One or more tubes (not shown) may be used for aspiration and / or a saline flush. The aspiration and / or saline flush may assist the user in flushing the object fragments 360′ from the lumen 350. For example, as the object fragments 360′ are flushed from the lumen 350, the object fragments 360′ may be captured by the basket 375. Excess fluid may flow through the basket 375 and be captured by the sealed bag 377.

[0050] 5 shows an alternative embodiment of a distal portion 516 of device 504. Device 504 of this embodiment may have any of the features of device 104, except as described below. Additionally, device 504 may be used to perform one or more steps of method 200, except as described below.

[0051] In this embodiment, the distal portion 516 may include one or more features or components to enable capture and / or encapsulation of an object 560. The distal portion 516 may include, for example, one or more gripping features 517. The one or more gripping features 517 may include one or more wires or hooks extending distally from the distal end 512 of the intermediate portion 518 of the device 504. In some embodiments, the distal end of the one or more gripping features may further include a loop, e.g., eyelets 519a, 519b, 519c. While three eyelets 519a, 519b, 519c are shown in FIG. 5, alternative configurations may include two, four, five, etc. eyelets. The one or more eyelets 519a, 519b, 519c may curl or bend radially inward or radially outward. Pull line 544 can extend through each of eyelets 519a, 519b, and 519c, e.g., sequentially. For example, pull line 544 may begin at eyelet 519a, then extend through eyelet 519b, then through eyelet 519c, etc. The proximal end of pull line 544 extends proximally through lumen 507 of device 504, and in a second configuration, e.g., when object 560 is partially or completely located within lumen 507, pull line 544 can be pulled or otherwise urged proximally to close or purse down the distal-most end of device 504. In an alternative configuration (not shown), pull line 544 can extend radially around the exterior of device 504.

[0052] In further alternative embodiments, a covering 523 may extend between one or more of the one or more gripping features 517. The covering 523 may be made of one or more materials, such as, for example, netting, a silicone material, a mesh material, or any combination thereof. In some embodiments, the covering 523 may help to retain the object 560 within the lumen 507 while also allowing fluid to leak or otherwise exit the device 504.

[0053] 6A and 6B show alternative embodiments of an exemplary medical device 600 deployed in an open configuration (FIG. 6A) and a closed configuration (FIG. 6B). The device 600 may include a proximal basket 604 and a distal basket 608.

[0054] The proximal basket 604 and the distal basket 608 may be formed from one or more flexible or semi-flexible materials, such as, for example, plastic, nitinol, stainless steel, Elgiloy (e.g., a non-magnetic cobalt-chromium-nickel-molybdenum alloy), one or more shape memory polymers, or any material known to one of skill in the art. Additionally or alternatively, the proximal basket 604 and the distal basket 608 may be formed similarly to a stent and comprise, for example, braided thread or wire, mesh, fabric, silicone, or any combination thereof. The proximal basket 604 and the distal basket 608 may be formed from the same material. Alternatively, the proximal basket 604 and the distal basket 608 may be formed from different materials with different properties or from the same material with different properties. For example, if the proximal basket 604 is constructed from braided nitinol threads or wires, similar to a stent, the threads or wires forming the proximal basket 604 may be of a different size and / or pitch compared to the threads or wires forming the distal basket 608. Many other combinations are possible.

[0055] The proximal portion 604A of the proximal basket 604 may be coupled to an outer surface of the inner sheath 606. The proximal basket 604 may be coupled to the inner sheath 606 by, for example, one or more fasteners or adhesives. For example, the proximal basket 604 may be coupled to the inner sheath 606 by one or more adhesives, heat shrinking, crimping, etc.

[0056] The inner sheath 606 can extend through the center of the proximal basket 604, for example, along the longitudinal axis 601. The proximal basket 604 can extend partially or completely around or around the inner sheath 606. The distal portion 604B of the proximal basket 604 is relaxed or unsecured from the inner sheath 606 in the deployed configuration shown in FIGS. 6A and 6B such that the distal portion 604B of the proximal basket 604 expands radially outward. Thus, when the proximal basket 604 is in the deployed configuration, the distal opening of the proximal basket 604 is oriented distally.

[0057] The distal portion of the inner sheath 606 may extend through the proximal portion 608A of the distal basket 608. The distal portion 608B of the distal basket 608 may be coupled to the outer surface of the control wire 610. The distal basket 608 may be coupled to the control wire 610, for example, by one or more fasteners or adhesives. For example, the distal basket 608 may be coupled to the control wire 610 by one or more adhesives, heat shrinking, crimping, etc. In some embodiments, the distal sheath 614 may extend partially or completely around or around the distal portion 608B of the distal basket 608. For example, the distal sheath 614 may resemble a cap. In an alternative configuration, not shown, the control wire 610 may extend through the center of the distal sheath 614 such that the distal portion of the control wire 610 may extend beyond the distal end of the distal sheath 614.

[0058] The control wire 610 can extend through the center of the distal basket 608, for example, along the longitudinal axis 601. For example, the distal basket 608 can extend partially or completely around or around the control wire 610. The proximal portion 608A of the distal basket 608 is relaxed or unsecured from the control wire 610 such that, in the deployed configuration shown in FIGS. 6A and 6B , the proximal portion 608A of the distal basket 608 expands radially outward. Thus, when the distal basket 608 is in the deployed configuration, the proximal opening of the distal basket 608 is oriented proximally.

[0059] The control wire 610 can extend from the proximal end of the device 600 to the distal end of the device 600. For example, the control wire 610 can extend from the proximal end to the distal end of the device 600 through a lumen in the inner sheath 606. The control wire 610 can be independently movable relative to the inner sheath 606. For example, if the control wire 610 is extended distally relative to the inner sheath 606, the inner sheath 606 can remain in place. Although not shown, for example, a proximal portion of the control wire 610 can be coupled to an actuator in the handle such that, when the actuator in the handle is actuated, the control wire 610 and distal basket 608 can be retracted proximally or extended distally relative to the inner sheath 606.

[0060] Similarly, the inner sheath 606 may extend through a lumen of the outer sheath 602 from the proximal end of the device 600 to the distal end of the device 600. The inner sheath 606 may be independently movable relative to the outer sheath 602. For example, when the inner sheath 606 is retracted proximally or advanced distally relative to the outer sheath 602, the outer sheath 602 can remain in place. In some embodiments, the inner sheath 606 may be extended or moved distally relative to the outer sheath 602 to position one or more of the proximal baskets 604 and distal baskets 608. Although not shown, a proximal portion of the inner sheath 606 may be coupled to a second actuator in the handle, for example, such that when the second actuator in the handle is actuated, the inner sheath 606 and the proximal basket 604 can be retracted proximally or advanced distally. Additionally or alternatively, in such a configuration, the proximal portion of the outer sheath 602 may be coupled to a handle.

[0061] Alternatively, the outer sheath 602 may be independently movable relative to the inner sheath 606. For example, the inner sheath 606 can remain in place when the outer sheath 602 is retracted proximally or advanced distally relative to the inner sheath 606. For example, one or more of the proximal baskets 604 and distal baskets 608 may be deployed by retracting or moving the outer sheath 602 proximally relative to the inner sheath 606. In such a configuration, the proximal portion of the outer sheath 602 may instead be coupled to a second actuator in the handle, for example, such that when the second actuator in the handle is actuated, the outer sheath 602 can be moved proximally or distally relative to the inner sheath 606.

[0062] One or more of the outer sheath 602, inner sheath 606, and distal sheath 614 may each be formed from one or more flexible or semi-flexible materials, such as, for example, plastic, polyvinyl chloride (PVC), polyethylene, thermoplastic elastomers (TPE), nylon, silicone, etc. In some configurations, the outer sheath 602 is transparent or translucent, allowing a user to visualize the position of the proximal basket 604 and / or distal basket 608.

[0063] One or more components of device 600, such as one or more of outer sheath 602, proximal basket 604, inner sheath 606, distal basket 608, and / or control wires 610, may be constructed of or include a material that allows a user to visualize the respective position of one or more components of device 600 during medical imaging, such as fluoroscopy, X-ray imaging, magnetic resonance imaging (MRI), ultrasound, computed tomography (CT) imaging, etc. Additionally or alternatively, one or more components of device 600 may also include one or more radiopaque markers that allow a user to visualize the position of one or more components of device 600. For example, one or more materials or one or more markers may be used to position one or more components of device 600 relative to object 660. For example, a user may desire to position distal basket 608 distal to object 660.

[0064] In the undeployed configuration of device 600 (not shown), outer sheath 602 may extend around or surrounding proximal basket 604, inner sheath 606, distal basket 608, and control wires 610. For example, proximal basket 604, inner sheath 606, distal basket 608, and control wires 610 may be housed within a lumen of outer sheath 602. Outer sheath 602 may extend distally beyond the distal-most portion of distal basket 608 and / or control wires 610, for example, to house other components of device 600. Device 600 may be in the undeployed state, for example, during insertion and / or placement of device 600 into a cavity or lumen.

[0065] In some configurations, the outer sheath 602 may be retracted or pulled back proximally to deploy or release the proximal basket 604 and the distal basket 608. In an alternative configuration, the distal basket 608 may be contained within a lumen of the inner sheath 606 such that only the proximal basket 604 is deployed or released when the outer sheath 602 is retracted or pulled back proximally. In such a configuration, the distal basket 608 may be deployed or released by extending or pushing the control wire 610 distally relative to the inner sheath 606.

[0066] 6A , when the proximal basket 604 and the distal basket 608 are deployed or released, an opening or gap 612 may separate the proximal basket 604 from the distal basket 608. For example, the gap 612 separating the proximal basket 604 from the distal basket 608 may be set large or wide enough so that a distal portion 604B of the proximal basket 604 is proximal to or adjacent to the proximal-most portion of the object 660 and a proximal portion 608A of the distal basket 608 is distal to or adjacent to the distal-most portion of the object 660. In some cases, a user can manipulate the control wires 610 to position the distal basket 608 and / or the proximal basket 604 relative to the object 660. For example, a user can position the object 660 within or adjacent to the gap 612. Additionally or alternatively, inner sheath 606 and control wire 610 may each include one or more flexible materials such that inner sheath 606 and / or control wire 610 may be axially offset from longitudinal axis 601. For example, inner sheath 606 and / or control wire 610 may be positioned against a wall of a lumen. Offsetting inner sheath 606 and / or control wire 610 may, for example, allow device 600 to maneuver around and / or capture object 660. For example, offsetting inner sheath 606 and / or control wire 610 may allow a user to maneuver around and / or capture a larger object 660.

[0067] Additionally or alternatively, the distal portion 604B of the proximal basket 604 and / or the proximal portion 608A of the distal basket 608 may be axially offset from the inner sheath 606, the control wire 610, and / or the longitudinal axis 601. Axially offsetting the distal portion 604B of the proximal basket 604 and / or the proximal portion 608A of the distal basket 608 may allow the device 600 to maneuver around and / or capture an object 660. For example, offsetting the distal portion 604B of the proximal basket 604 and / or the proximal portion 608A of the distal basket 608 may allow a user to maneuver around and / or capture a larger object 660.

[0068] As shown in FIG. 6B , the proximal basket 604 can be moved or advanced distally by extending the inner sheath 606, and / or the distal basket 608 can be retracted or pulled proximally by retracting or pulling the control wire 610 proximally. Thus, the gap 612 can be reduced or eliminated. For example, the distal-most portion of the proximal basket 604 can abut or contact the proximal-most portion of the distal basket 608. Thus, the object 660 can be captured in each of the proximal basket 604 and the distal basket 608. The device 600 and the object 660 can then be removed from the subject. In some configurations, the distal portion 604B of the proximal basket 604 and the proximal portion 608A of the distal basket 608 may at least partially overlap, for example, to assist in containing the object 660. For example, the overlap of the distal portion 604B of the proximal basket 604 and the proximal portion 608A of the distal basket 608 may allow the diameter of the distal basket 608 to decrease as the sheath 602 is extended over the proximal basket 604. Such a configuration may allow for a reduced outer diameter of the device 600 for removal from the subject. Similarly, the object 660 may be singulated before being captured in each of the proximal and distal baskets 604 and 608. Singulating the object 660 may assist in further reducing the outer diameter of the device 600 for removal from the subject.

[0069] FIG. 7A shows an alternative embodiment of an exemplary medical device 700 being deployed. The device 700 may include a flexible or semi-flexible wire 710. The wire 710 may extend through the ring 702 and the basket 708. As shown in FIGS. 7A and 7B, the wire 710 may extend entirely through the basket 708, for example, through the distal portion 708A of the basket 708. Alternatively, the wire 710 may be coupled to an inner wall (not shown) that constitutes the distal portion 708A of the basket 708. The wire 710 may be coupled to the inner wall of the basket 708 with one or more adhesives and / or one or more mechanical fasteners. Additionally or alternatively, the wire 710 may be coupled to a portion of the ring 702 and / or basket 708 such that the wire 710 is oriented off-axis from the body lumen. In this embodiment, for example, the proximal opening of the basket 708 may be larger to allow for capture or manipulation around an object (not shown).

[0070] The ring 702 may form the proximal opening of the basket 708. The ring 702 may be formed from one or more flexible or semi-flexible materials, such as, for example, plastic, nitinol, stainless steel, Elgiloy (e.g., a non-magnetic cobalt-chromium-nickel-molybdenum alloy), a shape memory polymer, or any material known to one of skill in the art. The ring 702 may be round, oval, elliptical, square, rectangular, pentagonal, etc. In some configurations, the ring 702 may be configured to fit the diameter of the lumen when deployed. In some embodiments, the ring 702 may be irregularly shaped.

[0071] The basket 708 may be coupled to the ring 702. For example, a proximal portion of the basket 708 may be coupled to the outer or inner diameter of the ring 702. The basket 708 may be formed similarly to a stent and / or may be composed of, for example, braided thread or wire, mesh, fabric, silicone, or any combination thereof. Additionally or alternatively, the basket 708 (or one or more portions of the basket 708) may comprise a flexible porous membrane and / or include a shape memory material. The one or more materials forming the basket 708 may help maintain the shape of the basket 708 and / or help prevent one or more portions of the basket 708 from collapsing. In some configurations, the basket 708 may be formed around the ring 702. For example, the ring 702 is integral with the basket 708.

[0072] In some configurations, the medical device 700 may include two or more rings 702. For example, two, three, four, or more rings 702 are positioned or spaced along the length of the basket 708. The additional rings 702 may be similarly sized or may have various shapes and sizes. For example, the rings 702 in the proximal portion of the basket 708 may be larger (e.g., have a larger diameter) than the rings 702 in the distal portion of the basket 708 to form a tapered configuration of the basket 708, or vice versa.

[0073] In some configurations, the device 700 may include a control wire 712. The control wire 712 may extend through a lumen of the outer sheath 704 (e.g., from the proximal end to the distal end). In an alternative configuration, the control wire 712 may extend outside of the outer sheath 704 (as shown in FIG. 7A ). The proximal end of the control wire 712 may include a free end (not shown) or be coupled to a handle (not shown) to assist in pulling the control wire 712 proximally or pushing the control wire 712 distally. The distal end of the control wire 712 may be coupled to the distal-most portion of the wire 710, for example, such that at least a portion of each of the ring 702 and the basket 708 is located between the wire 710 and the control wire 712. Thus, when the control wire 712 is retracted proximally or otherwise urged, the ring 702 and the basket 708 can collapse toward the wire 710. This may allow the user to more easily extend and / or retract the outer sheath 704 around the ring 702 and / or basket 708 and / or assist in removing the device 700 from the subject. Additionally or alternatively, distal movement of the control wire 712 may cause the ring 702 and basket 708 to expand.

[0074] Although one control wire 712 is shown, alternative configurations may include two, three, four, or more control wires 712. Additional control wires 712 may be positioned around the ring 702 and basket 708 so that when the control wire 712 is pulled back or otherwise urged proximally, the ring 702 and basket 708 collapse more evenly toward the wire 710. Similarly, additional control wires 712 may assist in the expansion of the ring 702 and basket 708.

[0075] In the undeployed configuration (not shown) of device 700, outer sheath 704 may extend around or circumferentially around ring 702 and basket 708. For example, ring 702 and basket 708 may be within a lumen of outer sheath 704. Outer sheath 704 may be retracted or pulled back proximally and / or wire 710 may be extended or advanced distally to deploy ring 702 and basket 708 from outer sheath 704.

[0076] FIG. 7B illustrates an alternative embodiment of an exemplary medical device 700′ in place. For example, FIG. 7B illustrates an alternative configuration of the ring 702 of the device 700′. Similar to the device 700, the ring 702′ can form a proximal opening of the basket 708. In this configuration, the ring 702′ can be adjustable. For example, the ring 702′ can be comprised of at least two sections 702′A and 702′B. One or more joints 703 can couple section 702′A to section 702′B. For example, one or more joints 703 can include a hinge, swivel, pivot, flexure, etc. to allow section 702′B to move relative to section 702′A, or vice versa. One or more joints 703 can be spring-loaded. A portion of section 702'A can be configured to receive section 702'B, for example, at end 705 of section 702'A. Accordingly, the diameter of ring 702' can be adjustable. For example, section 702'A can include a cavity (not shown) and have a cross-sectional diameter that is larger than the cross-sectional diameter of section 702'B. The cavity (not shown), for example, can be sized to receive section 702'B, for example, at end 705 of section 702'A. Accordingly, when section 702'B is received by section 702'A, the diameter of ring 702' can decrease. When portion 702'B is released from portion 702'A, the diameter of ring 702' can increase.

[0077] The basket 708 may be coupled to the ring 702'. For example, a proximal portion of the basket 708 may be coupled to sections 702'A and / or 702'B. In some configurations, the basket 708 may be formed around the ring 702'. For example, sections 702'A and / or 702'B may be integral with the basket 708.

[0078] Similar to device 700, in an undeployed configuration (not shown) of device 700′, outer sheath 704 can extend around or circumferentially around ring 702 and basket 708. For example, ring 702′ and basket 708 can be within a lumen of outer sheath 704. Outer sheath 704 can be retracted or pulled back proximally and / or wire 710 can be extended or advanced distally to deploy ring 702′ and basket 708 from outer sheath 704.

[0079] Movement of section 702'B relative to section 702'A, or vice versa, may be controlled, for example, by the natural movement of the lumen. For example, as the diameter of the lumen increases, ring 702' may increase in diameter as described above. Similarly, as the diameter of the lumen decreases, ring 702' may decrease in diameter as described above. Although not shown, device 700' may include one or more control wires having the same characteristics as control wire 712 of device 700 shown in FIG. 7A. For example, one or more control wires (not shown) may be coupled to sections 702'A and / or 702'B and may allow ring 702' and basket 708 to expand and / or collapse.

[0080] 7A and 7B, devices 700 and 700' may be used to capture an object (not shown) within a lumen, for example, within basket 708. For example, rings 702 and 702' may be positioned distally relative to the object. Once rings 702 and 702' and basket 708 are released or deployed from outer sheath 704, devices 700 and 700' may be retracted or pulled back proximally to capture the object within basket 708. Once the object is captured, devices 700 and 700' may be removed from the subject.

[0081] 8A and 8B show an alternative embodiment of an exemplary medical device 800 in place. Device 800 may include a basket 808 and a ring 802, which may have any of the features of basket 708 and ring 702 or 702′ of devices 700 and / or 700′, except as described below. Additionally, device 800 may include a flexible or semi-flexible wire 810 having any of the characteristics of devices 700 and / or 700′. For example, as shown in FIGS. 8A and 8B, wire 810 may extend throughout basket 808. Alternatively, wire 810 may be coupled to an interior wall (not shown) comprising basket 808. Wire 810 may be coupled to the interior wall of basket 808 by one or more adhesives and / or mechanical fasteners.

[0082] The distal end of the control wire 812 may be coupled to the ring 802. The control wire 812 may extend through a lumen of the outer sheath 804 (e.g., from the proximal end to the distal end). In an alternative configuration, the control wire 812 may extend outside of the outer sheath 804. The proximal end of the control wire 812 may include a free end (not shown) or be coupled to a handle (not shown) to assist in pulling the control wire 812 proximally or pushing the control wire 812 distally.

[0083] 8A , the distal end of control wire 812 may be coupled to a portion of ring 802. For example, control wire 812 may be coupled to a portion of ring 802 opposite the location of wire 810 relative to ring 802. Alternatively, control wire 812 may be coupled to ring 802 at one or more other locations. For example, control wire 812 may be coupled to one or more sides of ring 802. In some configurations, control wire 812 may allow a user to manipulate, open, and / or close a proximal opening of basket 808.

[0084] 8B , the proximal opening 809 of the basket 808 is angled relative to the control wire 810. For example, a portion of the proximal opening 809 opposite the wire 810 may be more distal to an upper portion of the proximal opening 809. When the control wire 812 is pulled or otherwise urged proximally, the portion of the proximal opening 809 opposite the wire 810 may also be pulled or otherwise urged proximally, such that the portion of the proximal opening 809 opposite the wire 810 is positioned proximal relative to the portion of the proximal opening 809 adjacent the wire 810. In this movement, the basket 808 may be used to "scoop" an object (not shown) into the basket 808. Additionally, because the wire 810 is offset from the center of the basket 808 and / or because the proximal opening 809 is angled relative to the control wire 810, the proximal opening 809 may be larger to allow for capture of larger objects (not shown).

[0085] FIG. 9 shows an alternative embodiment of an exemplary medical device 900 deployed in an open configuration. The device 900 may include a proximal basket 908A and a distal basket 908B. The proximal basket 908A and the distal basket 908B may be oriented similarly to the proximal basket 604 and the distal basket 608 of the device 600 shown in FIGS. 6A and 6B. The proximal basket 908A and the distal basket 908B may have any of the features of the basket 708 of FIGS. 7A and 7B and / or the basket 808 of FIGS. 8A and 8B. Additionally, the device 900 may include a proximal ring 902A and a distal ring 902B that may have characteristics of one or more of the ring 702 of FIG. 7A , the ring 702′ of FIG. 7B , and the ring 802 of FIGS. 8A and 8B . The proximal basket 908A and the distal basket 908B can be formed of the same material. Alternatively, the proximal basket 908A and the distal basket 908B can be formed of different materials with different properties, or the same material with different properties. For example, if the proximal basket 908A is constructed of braided nitinol threads or wires, similar to a stent, the threads or wires forming the proximal basket 908A can be of a different size and / or pitch compared to the threads or wires forming the distal basket 908B. Many other combinations are possible.

[0086] The inner sheath 906 may extend through a portion of the basket 908A. For example, the inner sheath 906 may extend through holes 911 on the outer surface of the proximal basket 908A. A portion of the proximal basket 908A may be coupled to the outer surface of the inner sheath 906 such that the proximal basket 908A moves (e.g., proximally and / or distally) with movement of the inner sheath 906. The proximal basket 908A may be coupled to the inner sheath 906 by, for example, one or more fasteners or adhesives. For example, the proximal basket 908A may be coupled to the sheath 906 by one or more adhesives, heat shrinking, crimping, etc. The proximal basket 908A may extend partially or completely around or around the inner sheath 906. A proximal portion of the proximal basket 908A is loose or unfastened from the inner sheath 906. Thus, when the proximal basket 908A is in the deployed configuration, the ring 902A can expand and the distal opening of the proximal basket 908A is oriented distally.

[0087] A portion of the distal basket 908B can be coupled to the outer surface of the control wire 910. The distal basket 908B can be coupled to the control wire 910, for example, by one or more fasteners or adhesives. For example, the distal basket 908B can be coupled to the control wire 910 by one or more adhesives, heat shrinking, crimping, etc. In some configurations, not shown, the control wire 910 can extend through the distal basket 908B such that a distal portion of the control wire 910 can extend beyond a distal portion of the distal basket 908B. For example, the distal basket 908B can extend partially or completely around or around the control wire 910. Thus, when the distal basket 908B is in a deployed state, the ring 902B can expand and a proximal opening of the distal basket 908B can be oriented proximally.

[0088] The control wire 910 can extend from the proximal end of the device 900 to the distal end of the device 900. For example, the control wire 910 can extend from the proximal end to the distal end of the device 900 through a lumen in the inner sheath 906. The control wire 910 can be independently movable relative to the inner sheath 906. For example, if the control wire 910 is extended distally relative to the inner sheath 906, the inner sheath 906 can remain in place. Although not shown, for example, a proximal portion of the control wire 910 can be coupled to an actuator on the handle such that, when the actuator in the handle is actuated, the control wire 910 and distal basket 908B can be retracted proximally or extended distally relative to the inner sheath 906.

[0089] Similarly, the inner sheath 906 can extend through a lumen of the outer sheath 904 from the proximal end of the device 900 to the distal end of the device 900. The inner sheath 906 can be independently movable relative to the outer sheath 904. For example, when the inner sheath 906 is retracted proximally or advanced distally relative to the outer sheath 904, the outer sheath 904 can remain in place. In some embodiments, the inner sheath 906 can be extended or moved distally relative to the outer sheath 904 to position one or more proximal baskets 908A and distal baskets 908B. Although not shown, a proximal portion of the inner sheath 906 can be coupled to a second actuator on the handle such that, for example, when a second actuator in the handle is actuated, the inner sheath 906 and proximal basket 908A can be retracted proximally or advanced distally. Additionally or alternatively, in such a configuration, the proximal portion of the outer sheath 904 may be coupled to a handle.

[0090] Alternatively, the outer sheath 904 may be independently movable relative to the inner sheath 906. For example, the inner sheath 906 can remain in place when the outer sheath 904 is retracted proximally or advanced distally relative to the inner sheath 906. For example, one or more of the proximal baskets 908A and distal baskets 908B can be positioned by retracting or moving the outer sheath 904 proximally relative to the inner sheath 906. In such a configuration, the proximal portion of the outer sheath 904 can instead be coupled to a second actuator in the handle, for example, such that when the second actuator in the handle is actuated, the outer sheath 904 can be moved proximally or distally relative to the inner sheath 906.

[0091] The outer sheath 904 and one or more of the inner sheath 906 may each be formed from one or more flexible or semi-flexible materials, such as, for example, plastic, polyvinyl chloride (PVC), polyethylene, thermoplastic elastomers (TPE), nylon, silicone, etc. In some configurations, the outer sheath 904 is transparent or translucent to allow a user to visualize the position of the proximal basket 908A and / or distal basket 908B.

[0092] One or more components of device 900, such as one or more of outer sheath 904, proximal basket 908A, inner sheath 906, distal basket 908B, and / or control wires 910, may be constructed of or include a material that allows a user to visualize the respective positions of the one or more components of device 900 during medical imaging, such as fluoroscopy, X-ray imaging, magnetic resonance imaging (MRI), ultrasound, computed tomography (CT) imaging, etc. Additionally or alternatively, one or more components of device 900 may also include one or more radiopaque markers that allow a user to visualize the positions of the one or more components of device 900. For example, the one or more materials or the one or more markers may be used to position one or more components of device 900 relative to an object (not shown). For example, a user may desire to position distal basket 908B distal to the object.

[0093] In the undeployed configuration of device 900 (not shown), outer sheath 904 can extend around or surrounding proximal basket 908A, inner sheath 906, distal basket 908B, and control wire 910. For example, proximal basket 908A, inner sheath 906, distal basket 908B, and control wire 910 can be housed within a lumen of outer sheath 904. Outer sheath 904 can extend distally beyond the distal-most portion of distal basket 908B and / or control wire 910, for example, to house other components of device 900. Device 900 can be in the undeployed state, for example, during insertion and / or placement of device 900 into a cavity or lumen.

[0094] In some configurations, the outer sheath 904 can be retracted or pulled back proximally to deploy or release the proximal basket 908A and the distal basket 908B. Additionally or alternatively, the inner sheath 906 and / or the control wire 910 can be extended distally to deploy or release the proximal basket 908A and the distal basket 908B. In an alternative configuration, the distal basket 908B can be contained within a lumen of the inner sheath 906 such that only the proximal basket 908A is deployed or released when the outer sheath 904 is retracted or pulled back proximally. In such a configuration, the distal basket 908B can be deployed or released by extending or pushing the control wire 910 distally relative to the inner sheath 906.

[0095] As shown in FIG. 9 , when the proximal basket 908A and the distal basket 908B are deployed or released, an opening or gap 912 can separate the proximal basket 908A from the distal basket 908B. For example, the gap 912 separating the proximal basket 908A from the distal basket 908B can be set large or wide enough so that a distal portion of the proximal basket 908A is located proximal to or adjacent to an object (not shown) and a proximal portion of the distal basket 908B is located distal to or adjacent to the object. In some cases, a user can manipulate the control wire 910 and / or inner sheath 906 to position the distal basket 908B and / or the proximal basket 908A relative to the object. For example, a user can position the object within or adjacent to the gap 912.

[0096] Although not shown, in the closed configuration, the proximal basket 908A may be moved or advanced distally by extending the inner sheath 906, and / or the distal basket 908B may be retracted or pulled proximally by retracting or pulling the control wire 910 proximally. Thus, the gap 912 may be reduced or eliminated. For example, the distal-most portion of the proximal basket 908A may abut or contact the proximal-most portion of the distal basket 908B. Thus, an object or one or more portions of an object (not shown) may be captured in one or more of the proximal basket 908A and the distal basket 908B. Additionally or alternatively, the object may be sandwiched between the proximal basket 908A and the distal basket 908B. The device 900 and the object are then removed from the subject.

[0097] In some configurations, the distal portion of the proximal basket 908A and the proximal portion of the distal basket 908B may at least partially overlap, for example, to assist in enclosing an object within the proximal basket 908A and the distal basket 908B. For example, the overlap between the distal portion of the proximal basket 908A and the proximal portion of the distal basket 908B may allow the diameter of the distal basket 908B to decrease as the outer sheath 904 is extended over the proximal basket 908A. Such a configuration may allow for a reduced outer diameter of the device 900 for removal from a subject.

[0098] It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed apparatus without departing from the scope of the present disclosure. Other embodiments of the present disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.

Claims

1. 1. A health care system comprising: a tube having a lumen; an expandable device having a proximal portion, a distal portion, and an intermediate portion between the proximal and distal portions, the expandable device including a lumen extending from the proximal portion to the distal portion; In a first configuration, the expandable device is disposed within the lumen of the tube in an unexpanded state and a distal end of the distal portion is open; In a second configuration, the expandable device extends at least partially from the lumen of the tube in an expanded state, and the distal end of the distal portion is open and larger than the distal end in the first configuration; In a third configuration, the expandable device is at least partially extended from the lumen of the tube and is in the expanded state, and the distal end of the distal portion is at least partially closed; In the third configuration, the expandable device is configured to be proximally retracted to retain one or more objects or substances within the expandable device.

2. The medical system of claim 1 , further comprising a scope configured to be delivered through the lumen of the tube and at least partially through the lumen of the expandable device.

3. The medical system of claim 2 , wherein the scope includes one or more visualization devices.

4. The medical system of any one of claims 1 to 3, further comprising an energy delivery device configured to be delivered through the lumen of the tube and at least partially through the lumen of the expandable device.

5. 5. The medical system of claim 4, wherein the energy delivery device is an electrohydraulic lithotripsy (EHL) probe configured to at least partially fragment or singulate gallstones.

6. The medical system of any one of claims 1 to 5, wherein the expandable device is formed by a plurality of braided nitinol wires.

7. The medical system of any one of claims 1 to 6, wherein in the second configuration, the distal end of the distal portion is configured to dilate a lumen or duct.

8. The medical system of claim 7 , wherein the duct is a bile duct.

9. further comprising one or more pull lines; 9. The medical system of claim 1, wherein the one or more pull lines are coupled to the distal end of the expandable device and extend proximally, and wherein retracting the one or more pull lines proximally transitions the distal end of the expandable device from an open state in the second configuration to an at least partially closed state in the third configuration.

10. The medical system of any one of claims 1 to 9, wherein the distal portion tapers towards the intermediate portion in the third configuration.

11. The medical system of claim 9 or 10, wherein the one or more pull lines extend proximally outside the expandable device.

12. The medical system of claim 9 or 10, wherein the one or more pull lines extend proximally through the lumen of the expandable device.

13. 13. The medical system of claim 1, wherein the expandable device is configured to transition to a fourth configuration when retracted proximally, and in the fourth configuration, the proximal portion, the intermediate portion, and the distal portion form a single portion.

14. 14. The medical system of claim 1, wherein an inner surface of the expandable device includes a radial extension configured to contact a distal end of the medical device or scope such that distal movement of the medical device or scope advances the expandable device distally.

15. The medical system of any one of claims 1 to 14, further comprising a mesh basket configured to hold the one or more objects or substances to be removed with the expandable device.

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