Systems and methods for urinary stone capture and removal

Abstract

The present technology includes stone removal devices for capturing, fragmenting, dusting, and / or removing pathological objects such as urinary stones from within a patient. The removal devices may include an expandable distal complex that can capture and isolate some or all of a target stone. The distal complex may further include a combination of energy sources, including laser energy, ultrasonic energy, mechanical energy, hydraulic energy (e.g., high pressure water jets), and / or other energy sources and features for fragmenting or dusting the captured target stone. The fragmented or dusted target stone can then be removed via an aspiration lumen extending through an elongated shaft of the removal device.

Description

SYSTEMS AND METHODS FORURINARY STONE CAPTURE AND REMOVALCROSS-REFERENCE TO RELATED APPLICATION^ )

[0001] The present application claims the benefit of U.S. Provisional Patent Application No. 63 / 650,841, filed May 22, 2024, the disclosure of which is incorporated herein by reference in its entirety.TECHNICAL FIELD

[0002] The present technology' relates to systems and methods for capturing, fragmenting, dusting, and / or removing urinary stones (e.g., bladder stones or kidney stones) from within a patient.BACKGROUND

[0003] Urinary stones are solid collections of minerals that can form in a patient’s urinary tract, most often occurring in patients who are dehydrated or otherwise have concentrated urine. Urinary’ stones can be formed from various minerals including calcium, magnesium, or ammonium salts. Depending on the size, shape, location, and / or material properties, urinary stones may cause various symptoms in a patient, including adnominal and / or back pain, difficult urination, frequent urination, painful urination, and blood in the urine. Further, and also depending on the size, shape, location, and / or material properties of the stone, some urinary stones will pass naturally, while other urinary stones may remain trapped in the patient’s urinary tract. Current techniques for treating and removing urinary stones that are too large to pass naturally include use of mechanical force, ultrasonic energy , or laser lithotripsy to fragment the stones into small pieces, and then flushing the fragmented pieces, in a procedure known as cystolitholapaxy. Other cases may require cystohthotomy, a surgical procedure for excising the stone.BRIEF DESCRIPTION OF THE DRAWINGS

[0004] Many aspects of the present technology can be better understood with reference to the following drawings. The components in the drawings are not necessarily drawn to scale. Instead, emphasis is placed on illustrating clearly the principles of the present technology'. Furthermore, components can be shown as transparent in certain views for clarity of illustrationonly and not to indicate that the component is necessarily transparent. Components may also be shown schematically.

[0005] FIGS. 1A-1E are perspective, side, side cross-sectional, front, and rear views, respectively, of a stone removal device in a first configuration and configured in accordance with select embodiments of the present technology.

[0006] FIG. 2 is a perspective view of the stone removal device of FIG. 1 in a second configuration.

[0007] FIGS. 3A and 3B are perspective views of another stone removal device configured in accordance with select embodiments of the present technology.

[0008] FIG. 4 is a perspective view of another stone removal device in a first configuration and configured in accordance with select embodiments of the present technology7.

[0009] FIGS. 5A and 5B are perspective and rear views, respectively, of a sheath included in the stone removal device of FIG. 4.

[0010] FIGS. 6A and 6B are perspective and distal end views, respectively, of the sheath and a catheter included in the stone removal device of FIG. 4.

[0011] FIGS. 7A and 7B are perspective and enlarged perspective views, respectively, of the stone removal device of FIG. 4 in a second configuration.

[0012] FIGS. 8A and 8B are rear and cross-sectional views, respectively, of another sheath configured in accordance with select embodiments of the present technology.

[0013] FIG. 9 is a cross-sectional view of another stone removal device in a first configuration and configured in accordance with select embodiments of the present technology7.

[0014] FIG. 10 is a schematic diagram of the stone removal device of FIG. 9.

[0015] FIGS. HA and 11B are cross-sectional and rear views, respectively, of the stone removal device of FIG. 9 in a second configuration.

[0016] FIGS. 12A and 12B are cross-sectional and rear views, respectively, of another stone removal device in a second configuration and configured in accordance with select embodiments of the present technology.

[0017] FIG. 13 is a cross-sectional view of yet another stone removal device in a first configuration and configured in accordance w ith select embodiments of the present technology7.

[0018] FIGS. 14A and 14B are cross-sectional and rear views, respectively, of the stone removal device of FIG. 13 in a second configuration.

[0019] FIG. 15A is a partially schematic view of a urinary stone removal system configured in accordance with select embodiments of the present technology and being used to treat a kidney stone. FIG. 15B is an enlarged view of a portion of the system of FIG. 15 A, and FIG. 15C is a partially schematic end-view of a distal end of the system of FIG. 15 A.

[0020] FIG. 16 is a schematic illustration of a urinary stone removal system having a filtering unit and configured in accordance with select embodiments of the present technology7.

[0021] FIG. 17 is a schematic illustration of another urinary7stone removal system having a filtering unit and configured in accordance with select embodiments of the present technology7.

[0022] FIG. 18 is a schematic illustration of another urinary7stone removal system having a filtering unit and configured in accordance with select embodiments of the present technology.DETAILED DESCRIPTION

[0023] The present technology is directed to systems and methods for treating and removing urinary stones (e.g., bladder stones, kidneys stones, etc.) and / or other pathological objects from a patient. For example, many embodiments described herein are directed to urinary7stone removal devices, simply referred to as “removal devices.” The removal devices generally include an expandable and collapsible distal complex and an elongated shaft or catheter coupled to the distal complex that is sized and shaped to enable transurethral access to the bladder, ureters, and / or kidneys. The removal devices described herein include various features expected to simplify or otherwise improve current lithotripsy approaches, such as by minimizing patient trauma and increasing the efficiency of procedures.

[0024] For example, in some embodiments the distal complex of the removal devices described herein can have an isolation element that can be used to surround a target stone or seal against a portion of the stone to isolate at least a portion of the target stone within an isolation chamber. As described in greater detail below, this can be accomplished using an annular skirt, a manipulatable basket, or other suitable feature. In some embodiments, the distal complex may have a low-pressure source (e.g., an aspiration lumen) or other mechanism to assist with capturing and / or retaining the target stone within the isolation chamber. Isolating a target stone (or a portion thereof) during a fragmenting process can (i) reduce trauma to the patient bycontaining delivered energy and resulting fragments of the stone, thus reducing errant energy' delivery to patient tissue, and (ii) increase the efficacy of fragment collection.

[0025] The removal devices can also include a mechanical force applicator and / or a high energy source at the distal complex configured to fragment and / or dust any particulates, including stones, captured within the isolation chamber. Example high energy sources include, but are not limited to, photo-energy sources (e.g., lasers), sonic energy' sources (e.g., ultrasonic and / or shockwave energy), electromagnetic energy' sources (e.g., radiofrequency), and / or combinations thereof. In some embodiments, the removal devices further include one or more energy source actuators for selectively controlling a path or target of the emitted energy. The removal devices may also include fangs or other mechanical features for directly interacting with and breaking down the urinary stones.

[0026] In some embodiments, the distal complex includes fluid jets or other high pressure fluid sources positioned inside of, or otherwise fluidly coupled to, the isolation chamber, in addition to or in lieu of having other high energy sources. The high-pressure fluid sources can be configured to provide jetting fluid (e.g., water, saline, etc.) at velocities between, e.g., 25-250 meters per second (m / s) and / or at pressures of 1,000 PSI or higher. In operation, the jets can stir the target stone or stone fragments in the isolation chamber. Without intending to be bound by theory, the stirring by the jets is expected to provide several advantages. First, the stirring may increase the contact between stone fragments, which may further fragment the stone into smaller pieces. Second, the stirring may repeatedly move the stone and / or stone fragments into the path of, or in close proximity7with, the high energy source, which may also further fragment the stone into smaller pieces. The jetting fluid may itself also assist with fragmenting, dusting, or dissolution of the stone, e.g.. via changes in pH or tonicity and / or the addition of abrasives to the jetting fluid. Without intending to be bound by theory, the ability of the removal device to capture the stones within an isolated chamber (e.g., in a closed environment) may enable the use of various fragmentation materials (e.g., pH alternating agents, abrasive elements) that would not be suitable for use if the stone were being fragmented in the open environment of the patient’s bladder.

[0027] Once the stones are fragmented to a size sufficiently small to pass through an aspiration lumen extending through the elongated shaft and terminating at the distal complex (e.g., at the isolation chamber formed by the isolation element), the stones can be removed therethrough. In some embodiments, the fluid jets can assist with evacuating the stone fragmentsvia the aspiration lumen. In addition to or in lieu of the fluid jets, the removal devices may further include one or more irrigation lumens for assisting with pushing or otherwise transporting the stone fragments into and / or through the aspiration lumen. The irrigation lumens can provide irrigation fluid at a lower velocity than the fluid jets, but can increase the total irrigation fluid volume. The removal devices can provide improved control of rebound, which can lead to less expensive systems and more effective fragmentation. Effective removal of debris can be important for preempting or at least reducing the risk of seeding future stones. Also, the removal devices can allow for the use of additives specific to the dissolution of particular stone compositions.

[0028] The removal devices described herein may include additional or alternative features beyond those described above. For example, the removal device may be at least partially flexible and / or steerable to improve transurethral access to the bladder, the ureter, and / or the kidney. The removal device may also include a camera or other visuahzation / navigation system that provides a clinician with real-time or substantially real-time feedback during the procedure. Furthermore, the removal device may include an expandable catheter.

[0029] FIGS. 1A-1E are perspective, side, side cross-sectional, front, and rear views, respectively, of a stone removal device 100 (“the removal device 100’') in a first configuration and configured in accordance with select embodiments of the present technology. Referring first to FIGS. 1A and IB. the removal device 100 includes an elongated catheter or shaft 110 and a distal complex 120. The elongated shaft 1 10 can be sized and shaped for transurethral access to a patient’s bladder. In some embodiments, the elongated shaft 110 may have an outer diameter between about 9 French and 15 French (e.g., for access past the kidneys), between about 15 French and about 25 French, or between 9 French and 25 French, although in other embodiments the elongated shaft 1 10 may have an outer diameter outside the foregoing range. The elongated shaft 110 can be composed of an at least partially flexible and / or steerable material.

[0030] The distal complex 120 can include a plurality of mechanical features or spines 121 and a membrane 122. The distal complex 120 is expandable from a collapsed delivery configuration (not shown) and an expanded deployed configuration (shown). The distal complex 120 can be self-expanding (e.g., via use of superelastic spines 121) or selectively expandable (e g., via an actuation mechanism such as a pull-wire actuator; not shown). A distal edge 124 of the distal complex can be configured to seal or at least partially seal against a target surface (e.g., an interior surface of a patient's bladder or a surface of a bladder stone). For example, the distaledge 124 can be composed of a soft or malleable skirt (e.g., a silicone skirt). In other embodiments, the distal edge 124 can be an inflatable annulus or skirt. The distal edge 124 can therefore also be referred to as an engagement feature 124 which can form an isolation chamber within an interior of the membrane 122 when sealed to a target surface. In some embodiments, the distal edge 124 forms a partially isolated chamber to purposefully provide leakage.

[0031] Referring next to FIGS. 1C-1E, FIG. 1C is a cross-sectional view of the removal device 100 taken along a longitudinal axis of the removal device 100, FIG. ID is a front view of the removal device 100 (e.g., looking at the “proximal” end of the of removal device 100), and FIG. IE is a rear view of the removal device 100 (e.g., looking at the “distal” end of the removal device 100). As shown, the removal device 100 can further include a plurality of actuatable features 125. The actuatable features 125 can be selectively pivotable or otherwise moveable from a periphery of the distal complex 120 toward a center of the distal complex 120. That is, the actuatable features 125 can be moveable from a non-depl oyed position in which they are generally parallel with an outer surface of the distal complex 120, to a deployed position in which the actuatable features 125 extend at least partially radially inward into the chamber defined within the distal complex 120. One or more of the actuatable features 125 can comprise an energysource (e.g., laser, ultrasound, etc.) for fragmenting, dusting, or otherwise macerating a target stone. Additionally or alternatively, one or more of the actuatable features 125 may include a high pressure fluid jet for stirring the fluid within the distal complex 120, and / or for introducing one or more abrasive or corrosive agents to further break apart a target. In addition to or in lieu of carrying an energy- source or a high-pressure waterjet, the actuatable features 125 may form fangs or other mechanical cutting features that may further assist with fragmenting and / or dusting the target stone positioned within the distal complex 120.

[0032] Referring to FIGS. ID and IE, the removal device 100 includes an aspiration lumen 128 extending through a center of the elongated shaft 110. The aspiration lumen 128 can be used to remove fragmented stone from within the distal complex 120. For example, a negative pressure source can be coupled to the aspiration lumen 128 at the proximal end to “suck” fragmented stone or other debris out of the distal complex 120. In some embodiments, the actuatable features 125 can be oriented around an opening to the aspiration lumen 128 in the distal complex 120. In this way, the actuatable features 125 can further fragment or cut the target stone before it is removed via the aspiration lumen 128.

[0033] The removal device can also include one or more irrigation lumens 129 (FIG. ID) extending through the elongated shaft 110. The irrigation lumens 129 can be fluidly isolated from the aspiration lumen 128 along the length of the elongated shaft 110, and can terminate within the distal complex 120. In some embodiments, multiple irrigation lumens 129 are spaced around the aspiration lumen 128. In operation, fluid can be injected into the distal complex 120 via the one or more irrigation lumens 129. This may assist with removing of fragmented stone via the aspiration lumen 128. In some embodiments, the one or more irrigation lumens 129 are incorporated into the spines 121. Moreover, in some embodiments, the walls defining the irrigation lumens 129 are flexible enough such that when the irrigation lumens 129 are not in use, fluid, stone fragments, etc. in the aspiration lumen 128 can push against the walls to at least partially compress the irrigation lumens 129 and expand the cross-sectional dimension of the aspiration lumen 128.

[0034] In the first configuration of the removal device 100, the expandable distal complex 120 has a funnel shape having a first length LI and a first width W1 (FIGS. 1 A and IB). FIG. 2 is a perspective view of the stone removal device 100 in a second configuration in which the distal complex 120 has a second length L2 that is less than the first length LI, and a second width W2 that is greater than the first width Wl. The interior of the distal complex 120 is also less tapered when the removal device 100 is in the second configuration than when in the first configuration. In some embodiments, the removal device 100 can be selectively transitioned between the first configuration shown in FIGS. 1A-1E and the second configuration shown in FIG. 2 by inducing a negative pressure within an interior of the distal complex 120 (e.g., via the aspiration lumen 128). The negative pressure can cause the spines 121 and the membrane 122 to bend and / or fold. In other embodiments, the removal device 100 can be selectively transitioned between the first and second configurations via other suitable mechanisms, including actuators (e.g., pull-wire actuators, shape memory actuators, electromechanical actuators, or the like).

[0035] FIGS. 3A and 3B are perspective views of another stone removal device 300 (“the removal device 300”) configured in accordance with select embodiments of the present technology. Similar to the removal devices 100 and 200 of FIGS. 1 and 2, the removal device 300 includes an elongated shaft 310 and an expandable distal complex 320 with spines 321 and a membrane 322. However, instead of being configured to sealably interface w ith target tissue, the distal complex 320 is configured to capture and isolate a target stone. For example, the distal complex 320 can be selectively transitionable between (1) a first (e.g., open) configuration shown in FIG. 3A in which the membrane 322 of the distal complex 320 has an opening 323such that a chamber defined by an interior of the membrane 322 is open to (e.g., in fluid communication with) the environment external to the distal complex 320. and (2) a second (e.g., closed or isolation) configuration shown in FIG. 3B in which the outer membrane 322 is axially collapsed about a central hub 327 to form an enclosed chamber 324 (e.g., an isolation chamber). In some embodiments, the enclosed chamber 324 is fluidly or at least substantially fluidly isolated from the environment external to the distal complex.

[0036] In some embodiments, the removal device 300 can be selectively transitioned between the first configuration shown in FIG. 3A and the second configuration shown in FIG. 3B by inducing a negative pressure within an interior of the distal complex 320 (e.g., via an aspiration lumen extending through the elongated shaft 310; not shown). The negative pressure causes the spines 321 to bend and the membrane 322 to fold inwardly (e.g., collapse / foreshorten in the axial direction) and contact the central hub 327. In other embodiments, the removal device 300 can be selectively transitioned between the first and second configurations via other suitable mechanisms, including actuators (e.g., pull-wire actuators, shape memory actuators, electromechanical actuators, or the like). In some embodiments, such mechanisms can induce at least partial collapse of the spines 321 and forces applied during an aspiration process (e.g., fluid pressure) can continue the closure of the spines 321.

[0037] In operation, a target stone can be captured within the distal complex 320 when the removal device 300 is in the first configuration (FIG. 3A), and then isolated within the isolation chamber 324 by transitioning the distal complex 320 to the second configuration (FIG. 3B). Without intending to be bound by theory', isolating the target stone inside the isolation chamber 324 may reduce the likelihood of the target stone from being displaced or rebound when energy is delivered to break up the target stone. Isolating the target stone may also enable a user to (i) deliver irrigant to the isolation chamber 324 to aspirate fragmented bits from within the target stone, (ii) prevent or reduce the likelihood of fluids and materials used to fragment or remove the stone from escaping into the patient’s body, enabling the use of additional materials that would generally not be used in an “open” system (e.g., non-normal pH fluids, grit / abrasive materials for improved dusting / fragmentation, etc.), and / or (lii) enable the use of jets within the funnel to agitate, stir, and / or further fragment the target stone or target stone fragments.

[0038] FIG. 4 is a perspective view of a stone removal device 400 (“the device 400”) in a first configuration and configured in accordance with select embodiments of the present technology. As shown, the device 400 can include a sheath 410, a catheter expander 420 disposedat least partially inside the sheath 410, and a first tool 430 and a second tool 440 disposed at least partially inside the catheter expander 420. The sheath 410 and the catheter expander 420 can extend between a proximal end portion 402a and a distal end portion 402b of the device 400. In some embodiments, the device 400 further includes a handle portion (not shown) configured to facilitate delivery of the catheter expander 420, the first tool 430, the second tool 440, steering mechanisms (e g., pull-wires), etc.

[0039] FIGS. 5 A and 5B are perspective and rear views, respectively, of the sheath 410 in a collapsed or delivery state. More specifically, FIG. 5A shows the sheath 410 extending between a proximal end portion 512a and a distal end portion 512b, and FIG. 5B shows the distal end portion 512b of the sheath 410. As best seen in FIG. 5B, the sheath 410 can include an endoscopic portion 510 and a film or membrane 518 coupled to the endoscopic portion 510. The endoscopic portion 510 can include a sensor 514 (e.g., an imaging device such as a camera or a machine vision device, etc.), first and second lighting devices 516a. 516b (e.g.. LED panels), associated wiring (not shown), and / or a steering mechanism (not shown; e.g., a pull-wire). In the illustrated embodiment, the sensor 514 is generally centered at the distal end portion 512b of the sheath 410 and the two lighting devices 516a, 516b are positioned at either side of the sensor 514. In other embodiments, however, the sensor 514 and the lighting devices 516a. 516b can be arranged differently and / or the sheath 410 can include additional / different features.

[0040] As shown, the membrane 518 can be partially folded on itself, defining the collapsed or delivery state of the sheath 410. The membrane 518 can extend along an entire length of the sheath 410 betw een the proximal end portion 512a and the distal end portion 512b, or along a shorter length therebetw een.

[0041] FIGS. 6A and 6B are perspective and distal end (or rear) views, respectively, of the sheath 410 and the catheter expander 420 disposed inside the sheath 410. As shown, the catheter expander 420 can be inserted in the space bet een the endoscopic portion 510 and the membrane 518 of the sheath 410 (e.g., inserted from the proximal end portion 402a), thereby unfolding or expanding the membrane 518 to define an expanded or operational state of the sheath 410. When the sheath 410 is in the expanded state, the membrane 518 can define a functional aspiration lumen 624. As shown in FIG. 6A, the catheter expander 420 can be longer than the sheath 410 such that when the sheath 410 and the catheter expander 420 are aligned at the distal end portion 402b, the catheter expander 420 extends beyond the sheath 410 towards the proximal end portion 402a. As shown in FIG. 6B, the catheter expander 420 can include afirst lumen 622a (e.g., for receiving the first tool 430 (FIG. 4)) and a second lumen 622b (e.g., for receiving the second tool 440 (FIG. 4)).

[0042] FIGS. 7A and 7B are perspective and enlarged perspective views, respectively, of the device 400 in a second configuration. As shown in FIG. 7A, the catheter expander 420 can translate within the sheath 410 such that the catheter expander 420 extends past the sheath 410 at the distal end portion 402b. Also, the first tool 430 is inserted in the first lumen 622a and the second tool 440 is inserted in the second lumen 622b, as better illustrated in FIG. 7B. FIG. 7B further illustrates the catheter expander 420 including a plurality’ of apertures 726 and a plurality of ribs 728. The apertures 726 can extend between the aspiration lumen 624 and either the first or second lumen 622a, 622b in which the first or second tool 430, 440 is positioned. The apertures 726 can be substantially perpendicular or angled relative to the corresponding lumens 622a. 622b. The ribs 728 are separated by a plurality of gaps or slots that each extend in a direction generally perpendicular to the length of the catheter expander 420, allowing the catheter expander 420 (e g., the distal end thereof) to more easily expand or bend (e.g., for steering) as needed. In some embodiments, the catheter expander 420 includes a dedicated steering mechanism such that the catheter expander 420 can be separately steered. In some embodiments, the catheter expander 420 does not include the apertures 726 (e.g., such that the lumens 622a, 622b are isolated from the aspiration lumen 624) and / or the ribs 728 (e.g., such that the catheter expander 420 comprises a continuous structure).

[0043] Each of the first tool 430 and the second tool 440 can include an irrigation tube, a laser fiber, an actuation element, a high energy' source, etc. Each of the first tool 430 and the second tool 440 can be moved relative to the sheath 410 and / or the catheter expander 420 to reach an irrigation site, a stone to be broken apart, etc. In embodiments providing irrigation, the flow rate, total volume, pressure (as measured at the proximal end portion 402a or the distal end portion 402b), temperature, and other parameters of the irrigation fluid can be controlled via, e.g., a controller and / or an artificial intelligence model. The irrigation can be modulated based on the clarity of the visual field provided by the sensor 514. In some embodiments, the temperature, pressure, and other parameters of the fluid are regulated by controlling the volumetric flow rates through the irrigation and / or aspiration lumens. For example, the volumetric flow rates can be controlled to maintain the parameters at or near equilibrium with the patient. In some embodiments, the volumetric flow rates are regulated by controlling the fluid pressure. In some embodiments, the irrigation is controlled via either or both of an open loop and a closed loop (e.g., via an artificial intelligence model). Also, a single fluid or multipledifferent fluids can be used. For example, a first fluid can be used outside of the aspiration lumen and a second fluid can be used within the aspiration lumen. In some embodiments, the second fluid is more caustic than the first fluid.

[0044] FIGS. 8A and 8B are rear and cross-sectional views, respectively, of another catheter expander 820 configured in accordance with select embodiments of the present technology. Specifically, FIG. 8B is a sectional view taken along the plane 8B-8B shown in FIG. 8A. In some embodiments, the catheter expander 820 can replace the catheter expander 420 to be included in the device 400 or another stone removal device. As shown in FIG. 8B, the catheter expander 820 defines an aspiration lumen 824 and includes a first channel 822a, a second channel 822b, a plurality of apertures 826, and a plurality' of ribs 828. The first channel 822a does not extend all the way to a distal end portion 802b of the catheter expander 820 while the second channel 822b does extend all the way to the distal end portion 802b. Thus, FIG. 8A shows only one aperture leading to the second channel 822b.

[0045] FIG. 8B further shows that the apertures 826 are angled relative to the first and second channels 822a, 822b towards a proximal end portion 802a of the catheter expander 820. This can allow' irrigation fluid to flow' along the first and second channels 822a, 822b from the proximal end portion 802a to the distal end portion 802b, and flow' out of the apertures 826 back towards the proximal end portion 802b to transport stone fragments, debris, etc. in the same direction. Because the first channel 822a is blocked at the distal end portion 802b. the first channel 822a can be particularly suitable for irrigation fluid deliver}', as all of the fluid delivered through the first channel 822a can be pushed out through the apertures 826 and into the aspiration lumen 824. The catheter expander 820 can provide irrigation whether positioned beyond the distal tip of a sheath (e.g.. the sheath 410) or positioned within the sheath. The irrigation fluid can be delivered at a relatively high velocity. The ribs 828 are separated by a plurality of gaps, allowing the catheter expander 820 to more easily expand or bend (e.g., for steering) as needed.

[0046] FIG. 9 is a cross-sectional view of a stone removal device 900 (“the device 900") in a first configuration and configured in accordance with select embodiments of the present technology. The device 900 can include a sheath 910, a catheter 920 disposed at least partially inside the sheath 910, a laser fiber 930, a flex portion 940, and a distal complex 950 coupled to a distal end portion of the catheter 920. One or more irrigation channels 912 can extend in the space between the sheath 910 and the catheter 920. The catheter 920 can define an aspiration lumen 914 that extends along the length of the catheter 920. The distal complex 950 can comprisean expandable or deformable membrane (similar to the distal complexes 120, 320) and can include one or more sensors 952 and one or more lighting device 954. In some embodiments, the expandable or deformable membrane can be omitted, the sensors 952 and the lighting device 954 can be directly incorporated into a distal end of the catheter 920. When the device is in the first configuration as shown, the distal complex 950 is at least partially compressed and positioned within the sheath 910.

[0047] FIG. 10 is a schematic diagram of the device 900 illustrating example dimensions. It will be appreciated that the dimensions herein are associated with a particular embodiment of the device 900, and in other embodiment the device 900 and its components may have different dimension(s) / configurations. With reference to FIG. 10, the outer diameter DI of the sheath 910 can be about 5 mm. The thickness D2 of the sheath 910 can be about 0.05 mm such that the inner diameter D3 of the sheath 910 is about 4.9 mm. The outer diameter D4 of the catheter 920 can be about 4.5 mm. The thickness D5 of the catheter 920 can be about 0.05 mm such that the inner diameter D6 of the catheter 920 (e.g., the cross-sectional dimension of the aspiration lumen 914) is about 4.4 mm. Therefore, the cross-sectional dimension of the one or more channels 912 can be about 0.2 mm.

[0048] The example inner diameter D6 of the catheter 920 (e.g., the cross-sectional dimension of the aspiration lumen 914) given (e.g.. 4.4 mm) is greater than the cross-sectional dimension of conventional aspiration lumens (e.g.. about 2.3 mm). Therefore, stone removal devices configured in accordance with embodiments of the present technology are expected to significantly increase the size threshold for stone pieces to fit inside the aspiration lumen as compared with conventional devices, thus shortening the time-consuming process of breaking down stones. This can also lead to reduced use of energy sources (e.g., laser), which is expected to improve patient safety during stone removal procedures.

[0049] The example catheter, sheath, and lumen sizes described herein are dimensions in their neutral state, and can be expanded or compressed during operation as needed. In some embodiments, for example, expansion can be based at least in part on measured exterior fluid resistance associated with such expansion, the device 900 itself, and / or parameters of the irrigation fluid. Also, as noted previously, one of ordinary skill in the art will appreciate that these are merely example dimensions, and that the components of the device 900 can have other dimensions. Moreover, the dimensions described herein can apply to other embodiments of stone removal devices described and / or illustrated herein.

[0050] FIGS. 11A and 11B are partially schematic cross-sectional and rear views, respectively, of the device 900 in a second configuration. Moreover, FIG. 11 A shows the device 900 extending through a patient’ s urethra 1102, bladder 1104, and ureter 1106 such that the distal end portion of the device 900 is positioned inside the patient’s kidney 1108. Compared to when the device 900 is in the first configuration (FIG. 9), the catheter 920 has moved distally towards the interior of the kidney 1108 such that the distal complex 950 is pushed beyond the sheath 910. The distal complex 950 can comprise a mesh of shape memory material (e.g., Nitinol) set to bend outward such that the flex portion 940 can be used to push and expand the distal complex 950, as shown (e.g., having a funnel shape). Referring to FIGS. 11 A and 1 IB together, when the device 900 is in the second configuration and the distal complex 950 is expanded, the sensor 952 and the lighting device 954 can face in a generally distal direction, such as towards a stone 1110.

[0051] During operation of the device 900. once the sensor 952 and the lighting device 954 are used to identify and locate the stone 1110, the laser fiber 930 can be advanced distally towards the stone 1110 and activated to emit a laser, which can fragment or dust the stone 1110 into smaller pieces. The laser fiber 930 can have a diameter of, for example, 0.25 mm-1.5 mm, such as 0.25 mm, 0.5 mm, or 1mm. In some embodiments, the use of the laser is combined with prism control to. e.g., accurately and rapidly control the direction of the laser (e.g.. to quickly sweep the laser across a stone, to avoid hitting non-target patient tissue). In some embodiments, the device 900 further includes baffles (not shown) configured to capture stray or misdirected laser (e.g., or other forms of energy). In some embodiments, the laser is delivered in pulses, and the amount of energy per pulse and / or the frequency of laser pulses are determined based on the size and / or type of stone, which can be identified visually via a camera or other components of the sensor 952. For example, the appropriate laser setting can be selected by referencing a table of stone ty pes and laser settings. Example ty pes of stones include calcium oxalate dihydrate, calcium oxalate monohydrate, uric acid, struvite, cystine, carbonate apatite, brushite, etc. The interval between subsequent laser pulses can be on a millisecond scale. In some embodiments, the sensor 952 feeds data to an artificial intelligence model configured to determine the size and / or ty pe of stones and recommend appropriate laser settings, thereby reducing the manual process for doctors. The artificial intelligence model may also avoid use of the laser when not directed at a stone (e.g., when directed at a kidney wall or other non-target patient tissue). The use of the laser can also be based on parameters of the fluid used. Moreover, the sensor 952 can be operated with computer vision or machine vision to improve targeting and / or imaging of stones, and to distinguish between stones and tissue.

[0052] Irrigation fluid is provided through the irrigation channels 912 at the proximal end portion of the device 900, and can then exit the irrigation channels 912 at the distal end portion of the device 900. As indicated by the arrows in both FIGS. 11A and 11B, the irrigation fluid can flow out of the irrigation channels 912 and into the aspiration lumen 914 to carry the fragmented or dusted stone pieces and / or debris back towards the proximal end portion of the device 900 with it. In some embodiments, a negative pressure source is provided at the proximal end portion of the device 900 to draw / suck back the irrigation fluid and the pieces and / or debris. In some embodiments, the device 900 includes a pressure sensor positioned to measure fluid pressure outside of (external to) the sheath 910 and inside the patient at various points (e.g., near the ureter 1106), and the measured pressure can be used to determine various patient parameters, e.g., ureter stiffness, which can provide useful information for preventing / inhibiting injury during delivery. In some embodiments, irrigation fluid is delivered to the region external to the sheath 910 and the sensor can measure and determine an associated pressure flow relationship to determine ureter stiffness and / or other patient parameters. The determined ureter stiffness (and other patient parameters) can be used to gauge how much the ureter 1106 can be expanded safely without injuring the patient, and subsequently used to determine an appropriate size of, e.g., the catheter expander 420, which may be available in different sizes. Furthermore, in some embodiments, the device 900 further includes sensor(s) that can assist with the estimation of the starting mass and collection mass of the stones.

[0053] FIGS. 12A and 12B are cross-sectional and rear views, respectively, of a stone removal device 1200 ("the device 1200") in a second configuration and configured in accordance with select embodiments of the present technology. The device 1200 can be generally similar to the device 900 illustrated in FIGS. 9-1 IB, including a sheath 1210, a catheter 1220 positioned at least partially inside the sheath 1210, a laser fiber 1230, a flex 1240, and a distal complex 1250. One or more irrigation channels 1212 can extend through the space between the sheath 1210 and the catheter 1220. The catheter 1220 can define an aspiration lumen 1214 extending therethrough. The distal complex 1250 can include one or more sensors 1252 and one or more lighting devices 1254. Unlike the device 900, however, the device 1200 further includes a jet stream channel 1222 and struts 1224 to support the jet stream channel 1222 within the aspiration lumen 1214.

[0054] During operation of the device 1200, irrigation fluid can be provided through the irrigation channels 1212 and the jet stream channel 1222. In some embodiments, the fluid is provided through the jet stream channel 1222 at a sufficiently high pressure and / or velocity toimpact and break apart stones 1202 that can adhere to the walls of the kidney 1108 as shown. The high pressure fluid from the jet stream channel 1222 can also cause cavitation of the stones 1202. Smaller, fragmented pieces 1204 of the stone 1202 can then be directed into the aspiration lumen 1214 to be carried towards the proximal end portion of the device 1200, as indicated by the arrows in both FIGS. 12A and 12B. In some embodiments, a negative pressure source (not shown) is provided at the proximal end portion of the device 1200 to suck back the irrigation fluid and the smaller, fragmented pieces 1204. In some embodiments, towards the end of the procedure, fluid is pumped to agitate any remaining dust in the kidney 1108. A closed loop analysis can be used to optimize the geometry and / or force of the fluid flow.

[0055] FIG. 13 is a cross-sectional view of a stone removal device 1300 (“the device 1300'’) in a first configuration and configured in accordance with additional embodiments of the present technology. The device 1300 can include a catheter 1310 defining an aspiration lumen 1312. an elongate member 1320 extending along the catheter 1310, and a distal complex 1330 coupled to a distal end portion of the elongate member 1320. The distal complex 1330 can include a foldable substrate 1332, one or more sensors 1334, and one or more lighting devices 1336. When the device 1300 is in the illustrated first configuration, the foldable substrate 1332 is folded such that the distal complex 1330 does not extend beyond the catheter 1310 and. e.g., is positioned within the aspiration lumen 1312. In some embodiments, the catheter 1310 is disposed at least partially inside a sheath (not shown).

[0056] FIGS. 14A and 14B are cross-sectional and rear views, respectively, of the device 1300 in a second configuration. As shown, the elongate member 1320 has been translated distally relative to the catheter 1310 such that the distal complex 1330 is positioned beyond the distal end portion of the catheter 1310. In some embodiments, the foldable substrate 1332 comprises an elastic material or flex such that the foldable substrate 1332 automatically opens to the illustrated expanded state when no longer constrained by the walls of the catheter 1310. In some embodiments, the elongate member 1320 encloses or otherwise carries a pull-wire or other mechanism (not shown) to actuate the distal complex 1330 from the folded state (FIG. 13) to the expanded state (FIGS. 14A and 14B), and vice versa. When the distal complex 1330 is in the expanded state, the sensors 1334 and the lighting devices 1336 can generally face the distal direction for identifying and locating stones.

[0057] Additionally, as shown, the elongate member 1320 can carry' a laser fiber 1340 that is exposed to the environment when the foldable substrate 1332 is in the expanded state. Inoperation, laser can be emitted from the laser fiber 1340 to fragment, dust, mobilize, de-clump, or otherwise break apart stones identified by the sensors 1334 and the lighting devices 1336, and the smaller, fragmented pieces can be carried through the aspiration lumen 1312 towards the proximal end portion of the device 1300 (e.g., via a negative pressure source).

[0058] FIGS. 15A-15C illustrate a urinary stone removal system 1500 (“the system 1500’’) configured in accordance with select embodiments of the present technology7. More specifically, FIG. 15A is a partially schematic view of the system 1500 being used to treat a kidney stone in accordance with the present technology. FIG. 15B is an enlarged view of the portion of the system 1500 indicated in FIG. 15 A, and FIG. 15C is a partially schematic endview of a distal end of the system 1500.

[0059] As shown in FIG. 15 A, the system 500 includes a fluid control assembly or unit 1520 fluidly coupled to an aspiration reservoir 1503 and an irrigation reservoir 1504. The system 1500 further includes an energy source 1530. which can be a thulium fiber laser controller or any other energy source described herein. In some embodiments, the energy source 1530 can be coupled to two or more independently controlled laser fibers, which can be of the same or different type. The system 1500 can further include an imaging apparatus 1540, such as a ureteroscope or other imaging system described herein, and controls 1541 (e.g., buttons, knobs, actuators, foot petals, or other user input devices) for controlling the imaging apparatus 1540. The system 1500 can include additional controllers for controlling the fluid control assembly 1520 and / or the energy source 1530. In some embodiments, at least some of such controllers may be “hands-free,” e.g., voice-controlled, foot petals, or the like.

[0060] A catheter 1510 can be coupled to both the fluid control assembly 1520, the energy source 1530, and / or the imaging apparatus 1540. As shown in FIG. 15A, the catheter 1510 can be sized and shaped to be advanced through the patient’s urinary tract, such as through the patient’s urethra, bladder, and ureter and into the patient’s kidney. As described throughout this Detailed Description, the catheter 1510 can include different lumens (e g., an aspiration lumen for aspirating dusted or fragmented stone particles, an irrigation lumen fortransporting irrigation fluid to the treatment area, an energy transmission line for transmitting energy to dust or fragment the stone, etc. — not shown in FIG. 15 A). As described in detail below with reference to FIG. 15C, the catheter 1510 can also carry various physiological sensors.

[0061] As shown in FIG. 15B, a distal end of the catheter 1510 can be positioned proximate to a target stone (illustrated as being positioned in the major calyx of the kidney). Thecatheter 1510 can include a first expandable or inflatable member 1517 and a second expandable or inflatable member 1518 (referred to herein as "‘the inflatable members 1517-1518”). The inflatable members 1517-1518 can be expanded once the catheter 1510 is positioned at a target position within the patient’s urinary tract. This can assist with centering and holding the catheter 1510 is a desired position. In some embodiments, the inflatable members 1517-1518 can form a partial or complete seal within the patient’s urinary tract (e.g., within the ureter). This may be advantageous by enabling more precise control of fluid flowing into (irrigation) and out of (aspiration) the catheter 1510 during a treatment procedure. Accordingly, the inflatable members 1517-1518 can optionally be referred to herein as How dams.

[0062] As shown in FIG. 15C, a distal end of the catheter 1510 can include an aspiration lumen 1511 fluidly coupled to an aspiration source (e g., an aspiration pump) positioned within the fluid control assembly 1520 (FIG. 15 A), and an irrigation lumen 1512 fluidly coupled to an irrigation source (e.g., an irrigation pump) positioned within the fluid control assembly 1520. In some embodiments, the aspiration lumen 1511 can have a larger cross-sectional area than the irrigation lumen 1512, such as between 2-20 times larger. This is expected to advantageously assist with promoting clearance of relatively larger stone fragments or particles. In some embodiments, an opening to the aspiration lumen 1511 can be positioned along a side of the catheter 1510, in addition to or in lieu of being positioned at the distal end of the catheter 1510. This is expected to further increase the potential size of the opening to the aspiration lumen 1511. The distal end of the catheter 1510 also includes one or more energy transmission elements 1531, e.g., for delivering energy from the energy source 1530 to the target stone (e.g.. a laser fiber). In some embodiments, the laser fiber can translate relative to the catheter 1510 (e.g., in and out of the page in the view shown in FIG. 15C). The distal end of the catheter 1510 can further include a camera 1542 and one or more lights 1543, both of which can be operably coupled to the controls 1541 of the imaging apparatus 1540 (FIG. 15 A).

[0063] Although not shown in FIGS. 15A-15C, the system 1500 can also include one or more physiological sensors. For example, the system 1500 can include any combination of (i) a pressure sensor positioned at a distal end of the catheter 1510, or elsewhere along the catheter 1510, (ii) a temperature sensor positioned at a distal end of the catheter 1510, (iii) one or more flow sensors, such as a first flow sensor positioned to measure flow in the irrigation lumen 1511 and a second flow sensor positioned to measure flow in the aspiration lumen 1512, and / or (iv) or sensor types. Physiological data collected from the sensors can be used to automatically control one or more aspects of the system 1500. For example, data from the sensors can be usedto automatically control the fluid control assembly 1520, e.g.. by adjusting irrigation volume or aspiration rate / pressure to ensure an equal, or roughly equal, amount of fluid exchange occurs during a treatment procedure to avoid over pressuring the kidney or other anatomical structure. This can enable higher rates of irrigation and aspiration, which can better promote fluid exchange to keep the field of view clean, which in turn may increase the speed of the procedure. In some embodiments, the fluid control unit 1520 can automatically control operation of irrigation and aspiration using one or more trained machine learning modules and / or artificial intelligence architectures. The control can be either closed loop or open loop, e.g., requiring physician input and control.

[0064] In some embodiments, the systems described herein can filter and / or recycle aspiration fluid to reduce the volume of irrigation fluid needed for a treatment procedure. FIG. 16, for example, is a schematic illustration of a urinary’ stone removal system 1600 (‘"the system 1600”) configured in accordance with select embodiments of the present technology. The system 1600 can includes certain features generally similar to features of the system 1500 of FIGS. 15A-15C. For example, the system 1600 can include an aspiration reservoir 1603 and an irrigation reservoir 1604. The aspiration reservoir 1603 can be in communication with an aspirant reservoir sensor 1601 (e.g., a first mass sensor) for monitoring an amount of fluid in the aspirant reservoir 1603, and the irrigation reservoir 1604 can be in communication with an irrigation reservoir sensor 1602 (e.g., a second mass sensor) for monitoring an amount of fluid in the irrigation reservoir 1604.

[0065] The system 1600 includes a catheter 1610, which can be generally similar to or the same as the catheter 1510 described with reference to FIGS. 15A-15C. The system 1600 further includes an irrigation pump 1607 for directing fluid from the irrigation reservoir 1604 to an irrigation lumen 1612 in the catheter 1610. In some embodiments, the system 1600 includes an irrigation check valve 1605 (e.g., a one-way valve) positioned between the irrigation reservoir 1604 and the irrigation pump 1607, e g., to prevent fluid from flowing in a distal-to-proximal direction and into the irrigation reservoir 1604. The system 1600 further includes an aspiration pump 1608 for inducing a negative pressure, vacuum, or suction force in an aspiration catheter 1611 of the catheter 1610. The aspiration pump 1608 and the aspiration lumen 161 1 can be fluidly coupled to the aspiration reservoir 1603. In some embodiments, the system 1600 includes a first aspiration check valve 1609a and / or a second aspiration check valve 1609b, e.g., for preventing fluid from flowing through the aspiration catheter in a proximal -to-distal direction.

[0066] The system 1600 can include a waste collection subsystem 1620. For example, the system 1600 can include a switch valve 1615 positioned between the aspiration pump 1608 and the aspiration reservoir 1603. In a first configuration, the switch valve 1615 fluidly couples the aspiration pump 1608 with the aspiration reservoir 1603, such that aspirated fluid travels from the aspiration lumen 1611 into the aspiration reservoir 1603. In a second configuration, the switch valve 1615 fluidly couples the aspiration pump 1608 with the irrigation pump 1607, and fluidly disconnects the aspiration pump 1608 from the aspiration reservoir 1603. such that aspirated fluid can be recycled and reused as irrigation fluid. The system 1600 can include a filter 1606 positioned between the aspiration pump 1608 and the irrigation pump 1607 to filter the aspiration fluid (e.g., to remove stone particles, fragments, etc.) before the aspiration fluid is recycled and reused as irrigation fluid. Filtering and re-using the aspiration fluid in this manner is expected to reduce the amount of irrigation fluid required during a treatment procedure.

[0067] The system 1600 further includes one or more sensors 1613 coupled to the catheter 1610. The sensors 1613 can include any of the sensors described herein, such as the temperature, pressure, and / or flow sensors described with reference to FIGS. 15A-15C. Data from the sensors 1613 can be used to provide feedback to an operator of the system 1600, and / or control operation of the system 1600 (e.g., in a closed loop or open loop manner), as described throughout this Detailed Description. In some embodiments, the irrigation pump 1607 and / or the aspiration pump 1608 can monitor flow therethrough (e.g., such as for positive displacement pumps), in addition to or in lieu of having standalone flow sensors.

[0068] FIG. 17 is a schematic illustration of a urinary stone removal system 1700 (“the system 1700"’) configured in accordance with additional embodiments of the present technology'. The system 1700 can be similar to the system 1600 described above with reference to FIG. 16, and can include an aspiration reservoir 1703, an aspiration reservoir mass sensor 1701, an aspiration pump 1708, a first aspiration check valve 1709a, a second aspiration check valve 1709b, and an aspiration lumen 1711. The system 1700 can also include an irrigation reservoir 1704, an irrigation reservoir mass sensor 1702, an irrigation pump 1707. an irrigation check valve 1705, and an irrigation lumen 1712.

[0069] The system 1700 also includes one or more sensors 1714, positioned proximal to the catheter 1710 instead of coupled to the catheter as described with reference to FIG. 16. The one or more sensors 1714 can include one or more temperature sensors, flow sensors, and / or pressure sensors. In some embodiments, some of the one or more sensors 1715 (e.g., the flowsensors) can be positioned proximal to the catheter 1710, while others (e.g., the temperature and / or pressure sensors) are carried by or positioned at a distal end of the catheter 1710.

[0070] The system 1700 can be configured to optionally filter and reuse aspiration fluid as irrigation fluid, similar to the system 1600. For example, the system 1700 includes a filter assembly 1706 positioned between the aspiration pump 1708 and the aspiration reservoir 1703. Similar to the system 1600, the system 1700 includes a first switch valve 1715a for switching between fluidly connecting the aspiration lumen 1711 with the aspiration reservoir 1703 (for non-recycling use) and the irrigation pump 1707 (for recycled use). However, relative to the system 1600, the system 1700 is designed to enable back flow filter washout. For example, the system 1700 includes a second switch valve 1715b between the aspiration pump 1708 and the filter assembly 1706, and a third switch valve 1715c between the filter assembly 1706 and the first switch valve 1716a. The second switch valve 1715b and the third switch valve 1715c can be selectively controlled to control the direction of fluid flow through the filter assembly 1706, thus enabling a user to flow fluid through the filter assembly 1706 in a reverse direction to provide a filter washout. In some embodiments, the filter assembly 1706 and the associated switches / valves can be a modular unit that can easily be coupled to and / or removed from the system 1700. In this way, the filter assembly 1706 can be configured as a disposable, single-use feature. In other embodiments, the filter assembly 1706 can be integrally installed with other aspects of the system 1700.

[0071] FIG. 18 is a schematic illustration of a urinary stone removal system 1800 (“the system 1800") configured in accordance with further embodiments of the present technology'. The system 1800 can be similar to the systems 1600 and 1700 of FIGS. 16 and 17, and can include an aspiration reservoir 1803, an aspiration reservoir mass sensor 1801, an aspiration pump 1808, a first aspiration check valve 1809a, and an aspiration lumen 1811. The system 1800 can also include an irrigation reservoir 1804, an irrigation reservoir mass sensor 1802, an irrigation pump 1807, an irrigation check valve 1805, and an irrigation lumen 1812. The system 1800 can be configured to optionally filter and reuse aspiration fluid as irrigation fluid, similar to the system 1800. For example, the system 1800 can include a first switch valve 1815a and a second switch valve 1815b positioned on opposite sides of a filter 1806.

[0072] Any of the systems described herein, such as the systems described with reference to FIGS. 15A-18, can have intelligent control for automating or semi-automating control of one or more aspects of the systems. For example, in some embodiments the systems can haveautomated or semi-automated control of irrigation and / or aspiration, e.g., via the fluid control assembly 1520 (FIG. 15 A). The control of the system can be based on various measurements including pressure, temperature, flow, mass, and / or compliance. For example, pressure within the calyx can be measured during any combination of various states of operation for the irrigation pump (on or off) and the aspiration pump (on or off). Temperature can be measured to assist with calculation of fluid viscosity, as described in greater detail below. Temperature can also be measured to monitor and adjust heating of patient tissue caused by delivery of laser or other energy, e g., to fragment or dust the target stone. Flow can be measured to estimate and compare the volume of fluid entering the patient’s urinary' tract (via irrigation) and the volume of fluid leaving the urinary tract (via aspiration).

[0073] In some embodiments, pressure sensors are positioned at a distal end of the system (e.g., at a distal end of the catheter) to directly measure a pressure proximate the treatment area. In other embodiments, particularly in those in which the aspiration and irrigation pump operate in a pulsatile or noncontinuous manner, the pressure sensors can be positioned elsewhere in the system, including at a proximal portion. In such embodiments, the pressure sensors can indirectly measure pressure at the treatment area, e.g., during periods in which the aspiration and irrigation pumps are inactive. In some embodiments, both a proximal and distal pressure sensor are included. In such embodiments, the measured pressure drop across the aspiration lumen in conjunction with the flow through the lumen can be used to estimate the viscosity of the aspiration fluid. When the measured viscosity is greater than a predetermined threshold, such as greater than 5% or 10% that of water, the system can be flushed with irrigation fluid until the viscosity drops to normal levels (e.g., 0.83 cSt. at 37 degrees Celsius).

[0074] Any of the removal devices / systems described herein, including the stone removal devices 100, 300, 400, 900, 1200, 1300, 1500, 1600, 1700, and 1800 of FIGS. 1A-18, can include one or more mechanical force applicators (e.g., claws) and / or energy' sources for fragmenting, dusting, and / or otherwise eroding a pathological object such as a urinary' stone that is positioned proximate and / or within the distal complex of the device. The energy source can be configured to deliver one or more of ultrasonic energy, optical energy, mechanical energy', and / or heat energy. For example, mechanical energy can include direct mechanical energy in the form of, e.g., a vibrating probe, and / or indirect mechanical energy in the form of a fluid jet stream. In such embodiments, the fluid jet stream can include a suspension of abrasive material, a material having a high refractive index, and / or a material having a pH capable of eroding the pathological object. As described previously, such materials may be suitable for use with theremoval devices described herein because in at least some embodiments the removal devices described herein create a closed environment for degrading and removing target stones. In some embodiments, the removal devices described herein have multiple mechanical force applicators and / or energy sources, such as one of ultrasonic energy or optical energy combined with indirect mechanical energy in the form of one or more high pressure fluid jets. The multiple mechanical force applicators and / or energy’ sources can be configured to fragment or otherwise break apart stones at various positions, such as distal to the aspiration lumen, at the mouth of the aspiration lumen, within the aspiration lumen, etc. For example, a two-stage fragmentation process can include using lasers outside of the aspiration lumen and using ultrasonic energy within the aspiration lumen. In some embodiments, the removal devices described herein can combine both fragmentation and dusting techniques.

[0075] The energy sources can be coupled to the removal devices at any location within or on the expandable distal complex. For example, the energy sources may be positioned around a periphery7of the expandable distal complex. As another example, the energy sources may be positioned at a center of the expandable distal complex. In embodiments with actuatable elements (e.g., the actuatable features 125 shown in FIGS. 1C-1E), the energy sources may be included within the actuatable elements. For example, in addition to or in lieu of providing mechanical cutting features, the actuatable elements can include energy sources (e.g., optical, ultrasonic, high pressure fluid jets, etc.) for fragmenting and / or dusting a target stone. In other embodiments, the energy' source can be delivered to the distal complex via the aspiration lumen extending through the elongated shaft. In such embodiments, the energy source is not incorporated into the removal device itself, which may enable the aspiration lumen to have a larger internal diameter for facilitating stone removal.

[0076] The removal devices described herein may also be sized and shape for use with additional features. For example, the removal devices described herein can have aspiration lumens sized and shaped to permit passage of a basket or other retention feature to the distal complex. Once the basket or other retention feature is positioned within the distal complex, it can grab the target stone or target stone fragment to bring it into contact with the energy source and / or actuatable elements for further fragmentation. The removal devices described herein may also include other mechanisms for holding or capturing stones, such as funnels, grabbers, or a soft toroid balloon.

[0077] Although described as separate devices, one skilled in the art will appreciate that the various embodiments of the stone removal devices described herein, including the removal devices / systems 100, 300, 400, 900, 1200, 1300, 1500, 1600, 1700, 1800 described with reference to FIGS. 1A-18, can be combined without deviating from the present technology. For example, features described with reference to the device 100 of FIG. 1 can be incorporated into the device 1200 of FIGS. 12A and 12B, and vice versa. Additionally, although largely described in the context of fragmenting and removing bladder stones, the removal devices described herein can be used to target other types of urinary stones (e.g., kidney stones) and / or pathological objects in other locations. For example, the removal devices described herein can be designed to capture, fragment, and remove stones positioned within a patient's ureters and / or kidneys.

[0078] The terminology used in the description presented above is intended to be interpreted in its broadest reasonable manner, even though it is being used in conjunction with a detailed description of certain specific embodiments of the present technology. Certain terms may even be emphasized; however, any terminology intended to be interpreted in any restricted manner will be overtly and specifically defined as such in this Detailed Description section. Additionally, the present technology can include other embodiments that are within the scope of the examples and claims but are not described in detail with respect to FIGS. 1A-18.

[0079] Reference throughout this specification to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present technology. Thus, the appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features or characteristics may be combined in any suitable manner in one or more embodiments.

[0080] As used herein, the use of relative terminology, such as “about”, “approximately”, “substantially” and the like refer to the stated value plus or minus ten percent. For example, the use of the term “about 100” refers to a range of from 90 to 110, inclusive. In instances in w hich the context requires otherwise and / or relative terminology is used in reference to something that does not include a numerical value, the terms are given their ordinary meaning to one skilled in the art.Examples

[0081] Several aspects of the present technology are set forth in the following examples.1. A urinary stone treatment system for capturing and removing a target pathological object from within a patient, the system comprising: a catheter sized and shaped for insertion into the patient’s urinary tract, wherein the catheter includes: an irrigation lumen, and an aspiration lumen; an external unit, wherein the external unit includes: an irrigation pump fluidly coupled to the irrigation lumen, wherein the irrigation pump is configured to drive irrigation fluid through the irrigation lumen, and an aspiration pump fluidly coupled to the aspiration lumen, wherein the aspiration pump is configured to generate a suction force within the aspiration lumen; a plurality' of sensors, wherein the plurality of sensors includes: a pressure sensor at a distal end portion of the catheter, a temperature sensor at the distal end portion of the catheter, a first flow sensor configured to measure flow within the irrigation lumen, and a second flow sensor configured to measure flow within the aspiration lumen; and a fluidics control unit configured to control the irrigation pump and the aspiration pump based at least in part on data from the pressure sensor, the temperature sensor, the first flow sensor, and the second flow sensor.2. The system of example 1 wherein the fluidics control unit is configured to automatically control the irrigation pump and the aspiration pump such that a first volume of fluid being delivered to the patient via the irrigation lumen is the same as a second volume of fluid being removed from the patient via the aspiration lumen.3. The system of example 1 or example 2 wherein the fluidics control unit is configured to automatically control the irrigation pump and the aspiration pump to maintain a pressure in the patient within a predetermined pressure range.4. The system of any of examples 1-3, further comprising: a switch valve moveable between (a) a first state in which the aspiration lumen is fluidly coupled to an aspiration reservoir for collecting aspirated fluids, and (b) a second state in which the aspiration lumen is fluidly coupled to the irrigation pump for recycling aspirated fluid as irrigation fluid; and a filter positioned between the aspiration lumen and the irrigation pump to filter the aspirated fluid before it is recycled as the irrigation fluid.5. The system of any of examples 1-4, further comprising an energy' source and an energy transmission fiber, wherein the energy source is part of the external unit and the energy transmission fiber is part of the catheter, and wherein the energy source is configured to provide energy via the energy transmission fiber to dust and / or fragment the target pathological object in the patient.6. The system of any of examples 1-5 wherein the aspiration lumen has a first cross- sectional area, and wherein the irrigation lumen has a second cross-sectional area, and further wherein the first cross-sectional area is between about 2-20 times greater than the second cross- sectional area.7. The system of any of examples 1-6 wherein the fluidics control unit is configured to automatically control the irrigation pump and the aspiration pump in a closed-loop manner.8. A removal device for capturing and removing a target pathological object from within a patient, the removal device comprising: an expandable distal complex, wherein the expandable distal complex includes: a chamber for receiving the pathological object, a high energy source for fragmenting and / or dusting the target pathological object within the chamber, and one or more high pressure jets for providing a jetting fluid for stirring the target pathological object within the chamber; and an elongated shaft extending from the expandable distal complex, wherein the elongated shaft is sized and shaped to be inserted into a lumen of the patient, and whereinthe elongated shaft has an aspiration lumen extending therethrough for removing the fragmented or dusted pathological object from within the chamber.9. The removal device of example 8 wherein the expandable distal complex is configured to isolate the chamber from an environment external to the distal complex.10. The removal device of example 8 or example 9 wherein the expandable distal complex has an engagement feature configured to seal to the pathological object.11. A removal device for capturing and removing a target pathological object from within a patient, the removal device comprising: a sheath having a membrane configurable between a collapsed state in which the membrane is folded and an expanded state in which the membrane is stretched to define an interior space; a catheter configured to be inserted in the interior space defined by the membrane in the expanded state, wherein the catheter includes a channel positioned to receive a removal tool, and wherein the sheath and the catheter define an aspiration lumen; an imaging sensor coupled to a distal end portion of the sheath; and a lighting device coupled to the distal end portion of the sheath and positioned adjacent the imaging sensor.12. The removal device of example 11 wherein the catheter further includes a plurality of apertures extending between the channel and the aspiration lumen, and wherein each of the apertures is extends from the channel at an angle towards the aspiration lumen and a proximal end portion of the catheter.13. A removal device for capturing and removing a target pathological object from within a patient, the removal device comprising: a sheath; a catheter positioned within the sheath and defining an aspiration lumen extending therethrough, wherein the sheath and the catheter define an irrigation channel therebetween;a distal complex coupled to a distal end portion of the catheter, wherein the distal complex includes an imaging sensor and a lighting device; a flex portion extending along the catheter and coupled to the distal complex; and an energy source extending along the catheter, wherein, during operation of the removal device — the flex portion is configured to expand the distal complex upon the catheter moving distally relative to the sheath and pushing the distal complex out of the sheath, the energy source is configured to fragment the target pathological object based on signals provided by the imaging sensor, and the irrigation channel is configured to deliver irrigation fluid to cany’ the fragmented target pathological object through the aspiration lumen.14. The removal device of example 13 wherein a diameter of the aspiration lumen is at least 4 mm.15. The removal device of example 13 or example 14, further comprising ajet stream channel extending through the aspiration lumen and configured to deliver pressurized fluid to further fragment the target pathological object.16. The removal device of any of examples 13-15 wherein the distal complex further includes a foldable substrate configured to unfold and expand upon being pushed out of the sheath.Conclusion

[0082] The above detailed description of embodiments of the technology are not intended to be exhaustive or to limit the technology to the precise form disclosed above. Although specific embodiments of, and examples for, the technology are described above for illustrative purposes, various equivalent modifications are possible within the scope of the technology as those skilled in the relevant art will recognize. For example, any of the features of the removal devices described herein may be combined with any of the features of the other removal devices described herein and vice versa. Moreover, although steps are presented in a given order,alternative embodiments may perform steps in a different order. The various embodiments described herein may also be combined to provide further embodiments.

[0083] From the foregoing, it will be appreciated that specific embodiments of the technology have been described herein for purposes of illustration, but well-known structures and functions associated with removal devices have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the technology. Where the context permits, singular or plural terms may also include the plural or singular term, respectively.

[0084] Moreover, unless the word "or" is expressly limited to mean only a single item exclusive from the other items in reference to a list of two or more items, then the use of "or" in such a list is to be interpreted as including (a) any single item in the list, (b) all of the items in the list, or (c) any combination of the items in the list. Additionally, the term "comprising" is used throughout to mean including at least the recited feature(s) such that any greater number of the same feature and / or additional types of other features are not precluded. It will also be appreciated that specific embodiments have been described herein for purposes of illustration, but that various modifications may be made without deviating from the technology. Further, while advantages associated with some embodiments of the technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the technology. Accordingly, the disclosure and associated technology can encompass other embodiments not expressly show n or described herein.

Claims

CLAIMSI / 'W e claim:

1. A urinary stone treatment system for capturing and removing a target pathological object from within a patient, the system comprising: a catheter sized and shaped for insertion into the patient’s urinary tract, wherein the catheter includes: an irrigation lumen, and an aspiration lumen; an external unit, wherein the external unit includes: an irrigation pump fluidly coupled to the irrigation lumen, wherein the irrigation pump is configured to drive irrigation fluid through the irrigation lumen, and an aspiration pump fluidly coupled to the aspiration lumen, wherein the aspiration pump is configured to generate a suction force within the aspiration lumen; a plurality of sensors, wherein the plurality of sensors includes: a pressure sensor at a distal end portion of the catheter, a temperature sensor at the distal end portion of the catheter, a first flow sensor configured to measure flow within the irrigation lumen, and a second flow sensor configured to measure flow within the aspiration lumen; and a fluidics control unit configured to control the irrigation pump and the aspiration pump based at least in part on data from the pressure sensor, the temperature sensor, the first flow sensor, and the second flow sensor.

2. The system of claim 1 wherein the fluidics control unit is configured to automatically control the irrigation pump and the aspiration pump such that a first volume of fluid being delivered to the patient via the irrigation lumen is the same as a second volume of fluid being removed from the patient via the aspiration lumen.

3. The system of claim 1 wherein the fluidics control unit is configured to automatically control the irrigation pump and the aspiration pump to maintain a pressure in the patient within a predetermined pressure range.

4. The system of claim 1, further comprising: a switch valve moveable between (a) a first state in which the aspiration lumen is fluidly coupled to an aspiration reservoir for collecting aspirated fluids, and (b) a second state in which the aspiration lumen is fluidly coupled to the irrigation pump for recycling aspirated fluid as irrigation fluid; and a filter positioned between the aspiration lumen and the irrigation pump to filter the aspirated fluid before it is recycled as the irrigation fluid.

5. The system of claim 1, further comprising an energy' source and an energy transmission fiber, wherein the energy source is part of the external unit and the energy transmission fiber is part of the catheter, and wherein the energy’ source is configured to provide energy via the energy transmission fiber to dust and / or fragment the target pathological object in the patient.

6. The system of claim 1 wherein the aspiration lumen has a first cross-sectional area, and wherein the irrigation lumen has a second cross-sectional area, and further wherein the first cross-sectional area is between about 2-20 times greater than the second cross-sectional area.

7. The system of claim 1 wherein the fluidics control unit is configured to automatically control the irrigation pump and the aspiration pump in a closed-loop manner.

8. A removal device for capturing and removing a target pathological object from within a patient, the removal device comprising: an expandable distal complex, wherein the expandable distal complex includes: a chamber for receiving the pathological object, a high energy source for fragmenting and / or dusting the target pathological object within the chamber, andone or more high pressure jets for providing a jetting fluid for stirring the target pathological object within the chamber; and an elongated shaft extending from the expandable distal complex, wherein the elongated shaft is sized and shaped to be inserted into a lumen of the patient, and wherein the elongated shaft has an aspiration lumen extending therethrough for removing the fragmented or dusted pathological obj ect from within the chamber.

9. The removal device of claim 8 wherein the expandable distal complex is configured to isolate the chamber from an environment external to the distal complex.

10. The removal device of claim 8 wherein the expandable distal complex has an engagement feature configured to seal to the pathological object.

11. A removal device for capturing and removing a target pathological object from within a patient, the removal device comprising: a sheath having a membrane configurable between a collapsed state in which the membrane is folded and an expanded state in which the membrane is stretched to define an interior space; a catheter configured to be inserted in the interior space defined by the membrane in the expanded state, wherein the catheter includes a channel positioned to receive a removal tool, and wherein the sheath and the catheter define an aspiration lumen; an imaging sensor coupled to a distal end portion of the sheath; and a lighting device coupled to the distal end portion of the sheath and positioned adjacent the imaging sensor.

12. The removal device of claim 11 wherein the catheter further includes a plurality of apertures extending between the channel and the aspiration lumen, and wherein each of the apertures is extends from the channel at an angle towards the aspiration lumen and a proximal end portion of the catheter.

13. A removal device for capturing and removing a target pathological object from within a patient, the removal device comprising: a sheath;a catheter positioned within the sheath and defining an aspiration lumen extending therethrough, wherein the sheath and the catheter define an irrigation channel therebetween; a distal complex coupled to a distal end portion of the catheter, wherein the distal complex includes an imaging sensor and a lighting device; a flex portion extending along the catheter and coupled to the distal complex; and an energy source extending along the catheter. wherein, during operation of the removal device — the flex portion is configured to expand the distal complex upon the catheter moving distally relative to the sheath and pushing the distal complex out of the sheath, the energy source is configured to fragment the target pathological object based on signals provided by the imaging sensor, and the irrigation channel is configured to deliver irrigation fluid to cany' the fragmented target pathological object through the aspiration lumen.

14. The removal device of claim 13 wherein a diameter of the aspiration lumen is at least 4 mm.

15. The removal device of claim 13, further comprising a jet stream channel extending through the aspiration lumen and configured to deliver pressurized fluid to further fragment the target pathological object.

16. The removal device of claim 13 wherein the distal complex further includes a foldable substrate configured to unfold and expand upon being pushed out of the sheath.

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