Devices, systems, and methods for kidney stone and dust removal

Abstract

Devices, systems, and methods for removing renal calculi or other debris using a spinner device and a ureteroscope or sheath. The ureteroscope includes proximal and distal ends, a lumen extending therebetween, and a plurality of slits through the distal end. The spinner device includes a spinner head on a second end of a flexible shaft received in the lumen. The spinner head includes a hollow body including an inlet communicating with a cavity and a plurality of slits configured to generate localized suction adjacent the inlet of the spinner head when the shaft rotates to capture renal calculi or other debris within the cavity. Optionally, the devices may include one or more of a camera, a laser probe, and a source of vacuum.

Description

[0001] DEVICES, SYSTEMS, AND METHODS FOR KIDNEY STONE AND DUST REMOVAL

[0002] STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH AND DEVELOPMENT

[0003] None.

[0004] RELATED APPLICATION DATA

[0005] The present application claims benefit of co-pending U.S. provisional applications Serial Nos., 63 / 572,556, filed April 1, 2024, 63 / 675,209, filed July 24, 2024, and 63 / 720,677, filed November 14, 2024, the entire disclosures of which are expressly incorporated by reference herein.

[0006] TECHNICAL FIELD

[0007] The present application relates to medical devices and, more particularly, to devices, systems, and methods for removing renal calculi, e.g., entire kidney stones, fragmented kidney stones, or residual dust, and / or other debris.

[0008] BACKGROUND

[0009] Kidney stones are mineral deposits that form in the renal system, potentially causing severe pain, bleeding, and complications such as chronic kidney disease and, in severe cases, life-threatening kidney failure (FIG. 1). Several surgical interventions are available for kidney stone removal, including retrograde intrarenal surgery (RIRS) (FIG. 2A), percutaneous nephrolithotomy (PCNL) (FIG. 2B), and extracorporeal shock wave lithotripsy (ESWL) (FIG. 2C). Among these treatment strategies, RIRS, a minimal invasive procedure that uses a laser to fragment kidney stones for removal, is often recommended as the first or second-line treatment due to its lower complication rate compared to PCNL and its relatively higher stone-free rate (SFR) compared to EWSL. During RIRS, a ureteroscope is inserted through the urethra, passing through bladder and ureter to reach the kidney, allowing direct visualization of the kidney stone. Laser lithotripsy is then performed, breaking large stones into fragments (2-4 mm) or fine dust (<250 um), which are expected to be naturally expelled through urine. To enhance stone clearance, RIRS often incorporates basketing to remove stone fragments, a technique in which a nitinol basket retrieves stone fragments one by one. Although basketing achieves a higher reported SFR (defined as number of patient who achieve stone free out of total patient population, and stone free is defined as no residual stone fragments) of approximately 78%, it requires a significant number of ureteroscope passes, potentially reaching hundreds during a single procedure. These repeated insertions and extractions can substantially extend the operation, often times accounting for more than half of the procedure time.

[0010] More recently, vacuum-assisted dedusting lithotripsy has been developed, demonstrating enhanced stone removal efficiency and a higher SFR compared to basketing. This technique utilizes aspiration, either through a sheath or ureteroscope, to remove tiny stone fragments (<1 mm) during or after laser lithotripsy. However, large stone fragments (1~3 mm), which constitute the majority of the stone, still require repeated ureteroscope retrieval for stone fragment extraction, which significantly limits the overall efficiency of the technique. Nonetheless, the effectiveness of stone fragment and dust removal in vacuum-assisted dedusting lithotripsy relies heavily on maintaining close proximity to the stone fragments or dust, requiring extensive navigation within the kidney and precise targeting of stone fragments for complete stone removal, which further limits the operation efficiency. Despite these recent advancements in kidney stone removal technologies, up to 30% to 50% of patients still require retreatment, which is attributed in part to residual fragments or dust in the kidney. The need for retreatment not only increases the overall cost of the procedure but also imposes additional burdens on patients, physicians, and healthcare facilities. Thus, the development of new stone removal mechanisms and technologies that can enhance stone removal efficiency, reduce operation time, and achieve a high SFR remains an urgent need.

[0011] Therefore, improved devices and methods for removing renal calculi would be useful.

[0012] SUMMARY

[0013] The present application is directed to medical devices. More particularly, the present application is directed to devices, systems, and methods for removing kidney stones or other hard deposits of minerals and salts and / or dust or debris after breaking up such kidney stones or deposits.

[0014] To address the challenges discussed above, devices, systems, and methods are provided that involve a novel kidney stone collection technology that utilizes spinning- induced localized suction to enhance the stone removal efficiency. This innovative approach enables the rapid capture and collection of large numbers of stone fragments in a single ureteroscope pass, significantly improving stone clearance speed. In one example, for l~3mm fragments, the spinner devices herein may collect ~60 fragments (l~2mm) or ~40 fragments (2~3mm) per pass, compared to basketing and vacuum-assisted methods, which remove one fragment at a time. This dramatic increase in capture capacity may substantially reduce procedure time. The spinner mechanism utilizes a rotating component that generates a three-dimensional rotating and circulating flow to effectively dislodge and capture stone fragments. This unique flow dynamic creates localized suction within the spinner cavity, enabling the rapid attraction and capture of stone fragments for efficient and effective stone removal. Beyond its large capture capacity, the spinner devices herein may effectively draw in stone fragments from distances up to twenty millimeters (20 mm) away from a distal tip of the devices, eliminating the need to chase fragments, which is a limitation in basketing and vacuum-assisted techniques. This further accelerates the stone removal process, enhancing overall efficiency of the procedure.

[0015] In one example, a milli-spinner device may be provided that effectively collects stones during spinning. The working mechanism of the spinner device is based on the spin- induced vortex flow and highly localized suction for accurate and safe extraction of kidney stones. The approach aims to achieve complete clearance of stones with varying sizes, reduce the treatment time, and reduce the risk of recurrence.

[0016] In accordance with another example, the milli-spinner is a device that effectively draws, captures, and removes kidney stones by generating suction through rotational motion. As the milli-spinner is spinning, due to the unique geometry features of the milli- spinner, circulation of flow is generated allowing fluid to enter through the front and exit through side slits of a spinner head, generating aspiration towards the milli-spinner (FIG. 3). This mechanism is highly advantageous in kidney stone applications as the generated aspiration may effectively draw stones into the milli-spinner cavity and realize stone removal. Compared to conventional wire basketing devices, the milli-spinner devices herein may provide one or more of the following advantages.

[0017] 1. The milli-spinner may capture multiple stone fragments through one operation, which may reduce the need for device retrieval required by basketing thus significantly reducing operation time.

[0018] 2. The milli-spinner may capture stone fragments from far distances (FIG. 4) and have an expansive working area (capture fragments from a wide region of the kidney), thus eliminating the need to chase after stone fragments which further improve operation efficiency.

[0019] Additionally, compared to vacuum-assisted kidney stone or fragments / dust removal techniques that utilize vacuum to aspirate stones or fragments / dust, the milli-spinner devices herein may provide one or more of the following advantages.

[0020] 1. The milli-spinner devices may be capable of influencing flow field at a far distance which draws and captures stones or fragments / dust at a relatively far distance, e.g., greater than ten millimeters (10 mm) away from a distal tip of the devices, as shown in FIGS. 4 and, in contrast to aspiration techniques that require an aspiration sheath to remain at a close distance to stone or fragments / dust for removal.

[0021] 2. The milli-spinner devices may generate aspiration through fluid circulation; thus, the devices do not remove kidney fluid in contrast to vacuum aspiration, which constantly removes kidney fluid thus requiring sophisticated control of vacuum pressure and saline irrigation for well-balanced kidney pressure. The milli- spinner devices may eliminate such needs.

[0022] 3. For vacuum-assisted kidney stones or fragments / dust removal techniques, unbalanced irrigation and vacuuming suction can cause increased kidney pressure that could lead to renal backflow, causing sepsis or even kidney loss. The milli-spinner devices may not be associated with such issues.

[0023] 4. For vacuum-assisted kidney stones or fragments / dust removal techniques, unbalanced irrigation and vacuuming suction can cause a decrease in kidney pressure that could lead to kidney collapsing affecting the surgical field of view.

[0024] 5. Optionally, the milli-spinner devices herein may be combined with aspiration techniques so that the rotating flow field (FIG. 6) generated by the milli-spinner devices may bring stone or fragment / dust closer to an aspiration sheath for improved aspiration techniques on stone removal.

[0025] Considering these advantages, the milli-spinner devices described herein may provide the next generation of technologies for kidney stone removal.

[0026] Optionally, the devices herein may be used with a steerable ureteroscope and sheath or a sheath alone. Methods and procedures for using spinner devices with a ureteroscope are also included. The spinner devices may be designed to move through the complex pathways of the kidney, e.g., to reach and remove kidney stones from various sections, including but not limited to the ureter and different calyx. The devices may target different sizes of kidney stones, including tiny dust, fragments, or entire stones. This extraction of kidney stones is achieved by a spinning motion, which manipulates the flow and creates a vortex to provide localized suction without the need of removing fluid from the patient’s body, which would not affect the kidney's internal pressure. This strategy surpasses existing vacuuming-base devices, which require irrigation fluid as the operation continuously removes fluid from the kidney.

[0027] In accordance with one example, a device is provided for removing renal calculi or other debris that includes a flexible shaft comprising a proximal end configured to be coupled to a controller to spin the shaft, a distal end sized for introduction into a body lumen of a patient, and a longitudinal axis extending therebetween, the shaft configured to rotate about the axis; and a spinner head on the distal end configured to generate localized suction adjacent an inlet of the spinner head when the shaft rotates to capture renal calculi or other debris within an interior of the spinner head.

[0028] In accordance with another example, a system is provided for removing renal calculi or other debris that includes a flexible shaft comprising a proximal end, a distal end sized for introduction into a body lumen of a patient, and a longitudinal axis extending therebetween, the shaft configured to rotate about the axis; a motor coupled to the proximal end of the shaft to rotate the shaft about the axis; a controller coupled to the motor to control operation of the motor; and a spinner head on the distal end configured to generate localized suction adjacent the distal end when the shaft rotates to capture renal calculi or other debris within an interior of the spinner head. Optionally, the system may include a tubular member, e.g., a ureteroscope including a proximal end, a distal end sized for introduction into a body lumen of a patient, and a lumen extending between the proximal and distal ends, the spinner head and shaft configured to be received in the lumen to position the spinner head adjacent an outlet at the distal end of the tubular member.

[0029] In accordance with still another example, a method is provided for removing renal calculi or other debris that includes introducing a spinner device into a body lumen to position an inlet of a spinner head of the spinner device adjacent a target object; and rotating the spinner device to generate localized suction adjacent the inlet to capture the target object within an interior of the spinner head.

[0030] In one example, the medical device is designed to move through the complex pathways of the kidney to reach and remove kidney stones from various sections, including but not limited to the ureter and different calyces. The device may target different sizes of kidney stones, including tiny dust, fragments, or stones. This extraction of kidney stones is achieved by a spinning motion, which manipulates the flow and creates a vortex to provide localized suction that may draw distanced stones without the need of removing fluid, which would not affect the kidney internal pressure. This strategy surpasses the existing vacuuming-base device, which must be close to the kidney stones and requires irrigation fluid as the operation continuously removes fluid from the kidney.

[0031] In accordance with one example, a milli-spinner device is provided that effectively collects stones during spinning. Its working mechanism is based on spin-induced vortex flow and highly localized suction for accurate and safe extraction of kidney stones. The approach aims to achieve complete clearance of stones with varying sizes, reduce the treatment time, and reduce the risk of recurrence.

[0032] The devices, systems, and methods herein may effectively capture kidney stones or fragments / dust by generating aspiration through rotational motion. The generated aspiration may be effective in expansive areas and will not affect pressure in the kidney. Optionally, the devices herein may be integrated with a ureteroscope for accessing and steering in the kidney for thorough kidney stone capturing. Optionally, the devices may also be integrated together with a camera and laser fiber for targeted lasering of stone. Additionally optionally, the devices may be coupled with vacuum aspiration for enhanced stone capture. The possible milli-spinner system assembly, operation method, and procedure are included. It is anticipated that the milli-spinner may be able to effectively remove kidney stones of any size and in any location in the kidney or in the ureter.

[0033] Other aspects and features of the present invention will become apparent from consideration of the following description taken in conjunction with the accompanying drawings.

[0034] BRIEF DESCRIPTION OF DRAWINGS

[0035] It is believed the present invention will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings, in which like reference numerals identify the same elements and in which:

[0036] FIG. 1 shows an example of obstructing and non-obstructing kidney stones in the ureter and calyx. FIG. 2A-2C present examples of existing technologies that break kidney stones into fragments and dust.

[0037] FIG. 3 shows simulation results demonstrating flow velocity distribution and streamline generated by a spinner device, depicting flow circulation.

[0038] FIG. 4 shows experimental results of a spinning milli-spinner capturing kidney stone fragments spaced about fourteen millimeters (14 mm) away from the spinner device.

[0039] FIG. 5 shows simulation results demonstrating flow velocity field distribution at varied distances from the milli-spinner front surface in a fifteen millimeter (15 mm) diameter tube.

[0040] FIG. 6 shows simulated 3D streamlines generated by a spinning spinner showing spiral flow.

[0041] FIGS. 7A-7D show examples of cylindrical milli-spinner heads that may be provided on a spinner device, including different numbers of slits and different slit widths.

[0042] FIGS. 8 A and 8B show an example of a milli-spinner device operating inside a sheath and including an exemplary modification of creating slits on the sheath distal end to ensure both safety and milli-spinner functionality.

[0043] FIGS. 9A and 9B compare flow streamline and pressure distribution generated by milli-spinner devices spinning inside a sheath with slits (FIG. 9A) and without slits (FIG. 9B).

[0044] FIG. 10 is a graph comparing pressure drops generated by the milli-spinner devices of FIGS. 9A and 9B, spinning inside a sheath with and without slits.

[0045] FIG. 11 A and 11B show an experimental comparison of a milli-spinner device capturing a stone when operating inside a sheath with slits (FIG. 11 A) and without slits FIG. 11B).

[0046] FIGS. 12A and 12B show examples of milli-spinner systems including a sleeve with slits attached to a distal end of a sheath that receives a spinner device.

[0047] FIGS. 13A and 13B show exemplary sleeve designs with varied slit numbers and slit widths, which may be provided on the sheaths shown in FIGS. 12A and 12Bs.

[0048] FIGS. 14A-14C show an exemplary method for using a milli-spinner system with concentric sleeve including slits, with relatively large slit widths on the milli-spinner head and small slit widths on the sleeve allowing stones to exit the milli-spinner head for substantially continuous stone removal under vacuum aspiration. FIGS. 15A and 15B show exemplary methods for using a rotation shaft to resolve stone clogging issues inside a sheath to ensure continuous aspiration and removal of kidney stones.

[0049] FIGS. 16A and 16B show an exemplary milli-spinner device including a sleeve, a hollow milli-spinner head, and a hollow shaft that are connected to vacuum aspiration to substantially continuously aspirate out captured kidney stones or fragments / dust.

[0050] FIG. 17A shows an exemplary milli-spinner device with a sleeve attached to a distal end of a ureteroscope.

[0051] FIG. 17B shows the steerability of the milli-spinner device of FIG. 17A while ensuring safety.

[0052] FIGS. 18A-18C show an experimental demonstration of a milli-spinner system with a sleeve on a ureteroscope capturing kidney stones.

[0053] FIG. 19 shows experimental results of a spinner system capturing a rigid ball in a horizontal tubular environment.

[0054] FIGS. 20A-20C show experimental results of a spinner system capturing a kidney stone in a vertical tubular environment.

[0055] FIG. 21 A shows experimental results of a spinner system capturing stone fragments in a vertical tubular environment.

[0056] FIG. 2 IB shows exemplary images of captured renal fragments and their sizes.

[0057] FIGS. 22A-22C show experimental results of a spinner system capturing dust (<1 mm) in a 3D-printed open -tank kidney flow model.

[0058] FIGS. 23A-23C show experimental results of a spinner system capturing fragments (1-2 mm) in a 3D-printed open-tank kidney flow model.

[0059] FIG. 24A-24C show an example of a spinner system with the spinner positioned distal to ureteroscope (FIG. 24A) a slotted sleeve (FIG. 24B), and the sleeve mounted on the ureteroscope (FIG. 24C).

[0060] FIG. 25 shows an example of a spinner system with a spinner device inside a ureteroscope.

[0061] FIG. 26 shows another example of a spinner system that includes a spinner device including a laser fiber.

[0062] FIG. 27 shows yet another example of a spinner system including a dual lumen ureteroscope to couple laser lithotripsy with a spinner device. FIG. 28A shows still another example of a spinner system design including a dual lumen ureteroscope, a spinner device, and a laser fiber oriented towards the spinner distal end to fragment captured large stones so that the fragments may be successfully captured inside the spinner cavity.

[0063] FIGS. 28B-28D show an exemplary method for capturing a kidney stone using the system of FIG. 28 A.

[0064] FIG. 29 shows yet another example of a spinner system that includes a triple lumen ureteroscope system to couple with laser fiber and allow for irrigation.

[0065] FIG. 30 is a schematic showing features of an exemplary spinner device for removing kidney stones or other debris.

[0066] FIG. 31 shows the working mechanism of the FIG. 30 device that generates localized suction and creates a recirculating flow pattern.

[0067] FIG. 32A shows an example of a spinner device including a filter for preventing dust from falling out of the device during an operation.

[0068] FIG. 32B shows the mechanism for retaining dust within the spinner’s hole and filtering out the renal fluid using the FIG. 32A device.

[0069] FIG. 33A shows a schematic of an exemplary milli-spinner system.

[0070] FIG. 33B shows an example of a zoom-in schematic of the milli-spinner head system of FIG. 33A, including a spinner head, shaft, ureteroscope, and sheath.

[0071] FIGS. 34A and 34B show the flexibility of a spinner system head, which may adapt to different pathways in a renal environment.

[0072] FIGS. 35A and 35B show another example of a deployable head of a spinner device that may be unfolded (FIG. 35 A) and folded (FIG. 35B) during a procedure.

[0073] FIGS. 35C and 35D show the deployable spinner mechanism of FIGS. 35A and 35B folded for insertion through a sheath and unfolded after being deployed from the sheath.

[0074] FIG. 36A and 36B show an example of a milli-spinner integrated with a ureteroscope and sheath.

[0075] FIGS. 37A-37C show an exemplary method for using a spinning milli-spinner, such as the device shown in FIGS. 35A-35D, showing the device being used to draw, capture, and remove kidney stone fragments / dust.

[0076] FIG. 38 shows an example of a foldable milli-spinner device that is deformed to fit into a sheath when it is pulled back. FIG. 39A and 39B show examples of milli-spinner heads that may be included in a spinner device including slits with slit widths less than two millimeters (2 mm), and including a mesh slit design for trapping stones larger than about two millimeters (2mm) and trapping fragments / dust, respectively.

[0077] FIG. 40A-40D show alternative spinner systems including spinner devices deployable from a ureteroscope including an angled milli-spinner (FIG. 40A), a camera with an angled field of view (FIG. 40B), and a retracted milli-spinner (FIG. 40C), and an extended milli-spinner (FIG> 40D), allowing full vision of kidney stones and the milli- spinner by the camera.

[0078] FIG. 41 A and 41B show another example of a spinner system including a hollow shaft that allows a portable camera or laser fiber to enter through and reach out of cavity of a spinner head.

[0079] FIGS. 42A-42C show an example of a spinner device capturing a kidney stone directly lasered into dust inside a cavity of the spinner head using a laser fiber introduced through the hollow shaft.

[0080] FIGS. 43 A and 43B show another example of a spinner device that includes a hollow shaft that is connected to a source vacuum aspiration to aspirate out captured kidney stones or fragments / dust.

[0081] FIGS. 44 A and 44B show an experimental demonstration of flow patterns generated by aspiration and milli-spinner.

[0082] FIGS. 45 A and 45B show an experimental demonstration of flow patterns generated by milli-spinner coupled with aspiration.

[0083] FIGS. 46A-46D show an experimental demonstration of milli-spinner coupled with aspiration to remove stone dust.

[0084] FIGS. 47 A and 47B show an example of a milli-spinner device spinning inside a sheath and using circulation flow to draw distanced stone, fragments / dust close to aspiration sheath for enhanced stone fragments / dust removal.

[0085] FIGS. 48A-48C show an example of a milli-spinner device spinning outside of a sheath that draws kidney stones, fragments / dust close to aspiration sheath for improved aspiration technique performance.

[0086] The drawings are not intended to be limiting in any way, and it is contemplated that various examples of the invention may be carried out in a variety of other ways, including those not necessarily depicted in the drawings. The accompanying drawings incorporated in and forming a part of the specification illustrate several aspects of the present invention, and together with the description serve to explain the principles of the invention; it being understood, however, that this invention is not limited to the precise arrangements shown.

[0087] DETAILED DESCRIPTION

[0088] The following description of certain examples of the invention should not be used to limit the scope of the present invention. Other examples, features, aspects, embodiments, and advantages of the invention will become apparent to those skilled in the art from the following description, which is by way of illustration, one of the best modes contemplated for carrying out the invention. As will be realized, the invention is capable of other different and obvious aspects, all without departing from the invention. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not restrictive.

[0089] Before the examples are described, it is to be understood that the invention is not limited to particular examples described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular examples only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims.

[0090] Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limits of that range is also specifically disclosed. Each smaller range between any stated value or intervening value in a stated range and any other stated or intervening value in that stated range is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included or excluded in the range, and each range where either, neither or both limits are included in the smaller ranges is also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the invention.

[0091] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, some potential and exemplary methods and materials are now described. It must be noted that as used herein and in the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a compound” includes a plurality of such compounds and reference to “the polymer” includes reference to one or more polymers and equivalents thereof known to those skilled in the art, and so forth.

[0092] Certain ranges are presented herein with numerical values being preceded by the term “about.” The term “about” is used herein to provide literal support for the exact number that it precedes, as well as a number that is near to or approximately the number that the term precedes. In determining whether a number is near to or approximately a specifically recited number, the near or approximating unrecited number may be a number which, in the context in which it is presented, provides the substantial equivalent of the specifically recited number.

[0093] The present application provides devices, systems, and methods for removing kidney stones or other hard deposits of minerals and salts and / or dust or debris after breaking up such kidney stones or deposits. Generally, the spinner devices herein include a flexible shaft 30 and a spinner head 40. The flexible shaft includes a proximal end configured to be coupled to a controller to spin the shaft, a distal end sized for introduction into a body lumen of a patient, and a longitudinal axis extending therebetween, the shaft configured to rotate about the axis. The spinner head, which may be any of the spinner heads described herein, is mounted or otherwise provided on the distal end of the shaft and is configured to generate localized suction adjacent an inlet of the spinner head when the shaft rotates to capture renal calculi or other debris within an interior of the spinner head.

[0094] In addition, the device or system may include a motor coupled to the proximal end of the shaft, and a controller coupled to the motor to operate the motor to spin the shaft and, thereby rotate the spinner head. In addition, the system may include a tubular member, e.g., a ureteroscope, sheath, and the like, including a lumen through which the spinner head and shaft may be introduced or otherwise positioned. Optionally, the system may include a source of vacuum, e.g., coupled to a port or otherwise provided on a handle or hub on the tubular member, if desired to apply aspiration to the lumen of the tubular member and / or to an optional lumen in the shaft.

[0095] The spinner head may be provided within the lumen of the tubular member and may be slidable within the tubular member, e.g., to advance the spinner head from an outlet of the lumen and / or retract the spinner head into the lumen during use. Optionally, the tubular member and / or spinner device may include one or more stops that limit axial movement of the spinner head relative to outlet. Alternatively, the spinner head may be axially fixed relative to the tubular member, e.g., such that the spinner head remains within the lumen adjacent the outlet and / or such that the spinner head extends partially or entirely out of the outlet.

[0096] In the various examples described herein, the spinner head for a milli-spinner device may include one or more fins, slits, and a front or distal hole, which allow for circulating flow when the milli-spinner is under spinning motion. When the spinner head is rotated, fluid enters axially through the hole, e.g., proximally into an interior cavity of the spinner head through the hole and exits through the slits, e.g., radially outwardly, thereby generating a pressure drop inside the milli-spinner cavity which allows for kidney stone capture. In some examples in which a larger milli-spinner front hole and cavity are desired and milli- spinner size is fixed, the milli-spinner may operate without the need of any external fins.

[0097] In some examples, the milli-spinner heads 40 including a hollow cylinder 42 as the overall geometry including an inlet 49 communicating with a cavity 46 within the cylinder 40 and a plurality of slits 48 through a wall of the cylinder 42 communicating with the cavity 46 and configured to generate the localized suction, e.g., as shown in FIGS. 7A-7D. This hollow cylinder design ensures that the milli-spinner heads have larger front hole area; thus, the milli-spinner head is capable of capturing larger and storing more stones. Additionally, this design has greatly reduced the safety concerns that may arise with the blade design as the hollow cylinder is a rounded geometry with no sharp edges and is expected to cause no harm to kidney tissue. It is important to mention that the kidney stone that may be collected and / or removed using the devices herein may include a range of kidney stone sizes from submillimeter to approximately three millimeters (3 mm).

[0098] Another strategy that ensures the safe operation of the milli-spinner is to keep the milli-spinner head inside a sheath 60 so the sheath 60 may act as a protective layer to prevent contact of the milli-spinner head 40 with kidney tissue, e.g., as shown in FIG. 8A. Optionally, under these circumstances, slits 68 may be provided on the sheath 60 to create an outlet for flow leaving the milli-spinner slits to ensure flow circulation (FIG. 8B). FIGS. 9A and 9B demonstrate the 2D flow streamline and pressure distribution generated by the milli-spinner spinning inside the sheath without slits and the sheath with slits. The system with slits on sheath demonstrates flow entering through the front hole and exiting through the milli-spinner slits creating a negative pressure drop inside the milli-spinner cavity. In contrast to a system without slits on the sheath, a system with slits on the sheath system may present a much higher pressure drop (e.g., as shown in FIG. 10) indicating an enhanced stone capture performance.

[0099] An experimental comparison between the two systems presents the superiority of providing slits on the sheath in terms of stone capturing. For example, as shown in FIG. 11 A, a system that includes slits in the external sheath is demonstrated to be able to capture a stone that is located about three centimeters (3 cm) from a distal end of the sheath in about three seconds whereas an external sheath with no slits, e.g., as shown in FIG. 11B, fails to capture a ball that is one centimeter (1 cm) away. It is important to note that the slits on the sheath could exist in varied geometry, size and numbers.

[0100] Another possible system assembly that prevents milli-spinner and kidney stone tissue contact is demonstrated in FIGS. 12A and 12B. Instead of creating slits on the sheath, an additional component called a sleeve is capped onto or otherwise attached to the distal end of the sheath that receives the milli-spinner device. The sleeve is designed to be a hollow cylinder with slits created on the side to allow for flow exiting. An example of 3D- printed sleeves is depicted in FIG. 12B. Similar to the slits on the sheath, the slits on the sleeve can be varied in geometry, size, and numbers. Two examples of sleeve designs are presented in FIGS. 13A and 13B. One shows four big slits, and one shows twelve small slits. The milli-spinner slit width and sleeve slit width may also be strategically designed to enhance the milli-spinner system stone capture ability.

[0101] For example, as shown in FIGS. 14A-14C, a milli-spinner with relatively big slit width is designed to rotate inside a sleeve with relatively small slit width attempting to capture kidney stones of varied sizes. The small stones that are captured within the milli- spinner cavity could exit out the milli-spinner slits but are trapped inside the sleeve as the sleeve slit widths are small. These trapped stones can be subsequently aspirated into the sheath with the assistance of vacuum aspiration. This coupled strategy allows for more effective kidney stone removal.

[0102] In the case that vacuum aspiration is utilized to aspirate out kidney stones, there has been concerns for clogging of working channel by stones, which may result in equipment failure leading to operational failure. The milli-spinner system may prevent this failure as the rotating shaft constantly agitated the aspirated stones to eliminate stone clogging as shown in FIGS. 15A and 15B. In another example, the milli-spinner with sleeve system is designed to have small slits on the milli-spinner and large slits on the sleeve. Under this circumstance, the captured stones are trapped inside the milli-spinner cavity. The milli-spinner system can then be then taken out of the sheath to dump out the capture stone and reinserted into the sheath for another operation run. Optionally, instead of relying on taken out the milli-spinner device to dump the captured stones, the milli-spinner system may be designed to be driven by a hollow shaft that has an inner diameter close to the milli-spinner cavity diameter, e.g., as shown in FIGS. 16A and 16B. This hollow shaft allows vacuum aspiration running through it which constantly removes the stones captured in the milli-spinner cavity. This system setup and operation strategy allows continuous removal of kidney stones which eliminates the need to take out milli-spinner from the sheath. It is important to note that the vacuum aspiration through the hollow shaft can be turned on either before, during, or after the milli- spinner kidney stone capture.

[0103] Additionally, it is important to mention that the milli-spinner is compatible with any type of sheath used for kidney stone treatment. For example, the milli-spinner can operate inside a flexible and steerable sheath with sleeve so that the milli-spinner can be steered to operate in different regions of the kidney for stone removal.

[0104] In another example, instead of having a sleeve mounted on the sheath, the sleeve may be designed to fit onto the distal end of a ureteroscope or any other steerable instrument that can go into a sheath or other tubular member, e.g., as shown in FIG. 17 A. This system design may allow the milli-spinner to operate outside of the sheath and be steered to different regions of kidney, e.g., as shown in FIG. 17B, for thorough kidney stone capture. One example of a sleeve on an ureteroscope is demonstrated in FIG. 18 A. The milli-spinner head is kept inside the sleeve near its distal end and spins to capture kidney stones. The milli-spinner head quickly captures some kidney stones, which fill up its cavity, e.g., as shown in FIGS. 18B and 18C.

[0105] Additional experiments showcase the spinner stone / fragment capture capability. Firstly, FIG. 19 presents the suction of a rigid ball (size 2mm OD and weight 0.01 g) around six centimeters (6 cm) away from a distal tip of a spinner head. The rigid ball size is similar to a regular kidney stone instead of fragments or dust. In this experiment, the spinner spinning speed was 10,000 rpm. The two second (2s) ball capture demonstrates the strong suction and capability to collect the stones at the very far end in a short time. The experimental setup was in the horizontal tube. Then, the experimental setup was moved to a vertical open tank. FIGS. 20A-20C show the capture of an actual kidney stone that was physically extracted from the body, measuring approximately three millimeters (3 mm) in size. The stone was sucked into the spinner lumen within three seconds in a four centimeter (4 cm) OD tank. The stone was about 3.5 centimeters away from a distal tip of the spinner head in this experiment.

[0106] Then, the spinner system was validated to show its capability to collect the dust / fragments in a short time. FIGS. 21 A and 21B show suction in an environment more like the ureter or calyx size (OD around 6mm). FIGS. 21 A and 2 IB show successful dust collection in less than four seconds. After spinning is initiated, the dust is sucked into the spinner cavity through the inlet. The spinner cavity fills with time. After the spinning is off, the dust remains inside the lumen without falling off. FIG. 2 IB shows an exemplary image of captured dust size, each less than two millimeters (2 mm), which meets the standard for dust or fragments. The spinner lumen size can be increased to iterate the design and collect more dust.

[0107] Meanwhile, stone suction is demonstrated inside a 3D-printed kidney flow model, e.g., as shown in FIGS. 22A-22C and FIGS. 23A-23C. The demonstrations reveal the mechanism to remove stones of various sizes, such as dust smaller than one millimeter (1 mm) and fragments measuring one to two millimeters (1-2 mm).

[0108] The spinner system was integrated with a commercial ureteroscope, operating at a spinning speed of 10,000 rpm. In FIGS. 22A-22C, the spinning motion resulted in the removal of a significant amount of dust within 1.5 seconds. Similarly, in FIGS. 23A-23C, the spinning motion leads to the removal of numerous fragments within about 3.5 seconds.

[0109] FIGS. 24A-24C show an exemplary system that includes a spinner device including a spinner head that may introduced through and advanced distally from a ureteroscope. In this example, the spinner head is configured to spin outside of the ureteroscope during use. For safety considerations, an extra component called a sleeve can be added to house the spinner head to prevent contact with the kidney tissue (FIG. 24B). The sleeve is attached to the distal end of the ureteroscope (FIG. 24C). Four slits (as an example) are positioned around the circumference of the sleeve to allow for flow exiting from the sleeve so that flow circulation generated by spinner can occur. Optionally, one or both the spinner and sleeve can be made transparent for a camera to see through them for stone observation.

[0110] In a second example, the system includes a spinner device including a spinner head configured to operate inside a working channel of a ureteroscope or other tubular member, which may involve the modification of a conventional ureteroscope. The modification includes introducing or positioning the ureteroscope within a sleeve that includes one or more slits system, e.g., a plurality of slits spaced apart around a circumference of a distal end of the sleeve, as shown in FIG. 25. In the example shown, four or multiple slits are located around the circumference of the ureteroscope wall to allow for flow exiting from the ureteroscope so that flow circulation generated by the spinner can occur. The wall of the ureteroscope will act like the sleeve wall which shields the spinner from having direct contact with the kidney tissue. The spinner head is controlled to remain inside the ureteroscope working channel, e.g., with a distal tip of the spinner head aligned with the ureteroscope distal end. In some designs, the slits are positioned near one side of the ureteroscope to avoid interference with a camera and LED light wiring.

[0111] There are various possible operation strategies for spinner systems when coupling with laser lithotripsy including a spinner device that is used in unison with laser lithotripsy or used after laser lithotripsy.

[0112] In a first operation method, the spinner device is used in conjunction with laser lithotripsy to capture stone fragments directly after lasering. This strategy requires a laser and spinner to co-exist in a working channel of a ureteroscope, sheath, or other tubular member, e.g., as shown in FIG. 26. The laser will fragment kidney stone(s) and then the spinner device is turned on spinning to capture the fragments. This process may be repeated through the operation. In an alternative method, the spinner device may be continuously spinning during the laser lithotripsy process for substantially continuous collection of stone fragments throughout the operation. Optionally, during the above two spinner operation methods, vacuum suction may be applied through the tubular member to assist in removing kidney stone dust (< 1mm). For the design of the co-existence of a spinner system and laser, it is possible to have a dual -channel system, e.g., including a ureteroscope or other tubular member including two working channels or lumens to separate the spinner device from the laser fiber (FIG. 27). This dual-channel system may also allow separate axial movement and / or other control of the laser and spinner shaft for better stone targeting. One exemplary configuration of the dual channel system is shown in FIGS. 28A-28D. In this configuration, the laser fiber has a bent distal tip positioned adjacent the distal end of the spinner head. In the case the stone fragment captured by the spinner head is too large to directly enter the spinner cavity but is grabbed at the spinner distal end, laser lithotripsy may be performed for fragmenting the captured stone so that the fragments can then enter the spinner cavity realizing stone removal. Optionally, if irrigation is used during the kidney stone removal procedure to provide clear vision, the irrigation may be run through either of the working channels (the channel for laser or for spinner), or an additional channel for irrigation may be provided in the ureteroscope to form a triple channel ureteroscope, e.g., as shown in FIG. 29. Alternatively, irrigation may be delivered through a lumen of the sheath.

[0113] For the other operation strategy in which the spinner is used to perform stone fragments removal post laser lithotripsy, the spinner system may be simplified. A laser fiber may be first inserted through the working channel fragmenting a kidney stone into dust (< 1mm) or fragments (possible fragment size range< 3 mm). Optionally, vacuum aspiration may be applied through a lumen of the sheath in this laser lithotripsy process to actively remove the stone dust whereas the fragments are left behind. Then, the spinner device is inserted into the working channel and operated inside the working channel or backloaded such that the spinner head is placed distal to the ureteroscope (operate outside of working channel). The camera from the ureteroscope may help guide the spinner head to point towards a fragment location and spin for stone fragments collection. Optionally, the spinner head may spin blindly for seconds without aiming specifically for stone fragments. This blind spinning may be initiated at different regions throughout the kidney (from upper pole to low pole guided by x-ray) to ensure thorough stone fragments removal. Once stone fragments have been captured (for example, after spinning 30s), the spinner device is retrieved back out of the sheath to empty out the stone fragments. The emptied spinner head is then inserted back into the kidney to repeat the fragment capturing process.

[0114] Turning to FIG. 30, another example of a specialized 3mm OD milli-spinner head (with fin design) is shown, which is designed to extract kidney stones. This device is configured to facilitate the targeted collection and extraction of renal calculi, or kidney stones, by manipulating fluid dynamics within the renal system in the body. The depicted milli-spinner includes a hollow cylinder with a plurality of slits spaced apart around its circumference. In the cylinder body and between each slit, there is a fin extending outward. Each design feature is not limited to its geometric shape, straight, tapered, helical, etc. The number of fins and slits may be varied as desired. The milli-spinner head may have various designs, not limited to the ones shown in FIG. 30. The spinner heads herein may be fabricated by one or more 3-D printing, molding, casting, machining, and / or other methods.

[0115] FIG. 31 depicts the mechanism of kidney stone extraction in the renal system. During spinning, the milli-spinner head generates a localized suction through its hollow structure. In the region around the milli-spinner head, a distal opening in the head provides an inlet and a plurality of slits in the head provide outlets, thereby creating localized flow circulation through and around the head, which enables suction without the need of removing renal fluid. The flow directs the stones into the inlet of the spinner head, where they are then sucked into a cavity of the head. Due to the small size of fragments or dust, the forces in capillary action tend to keep the fragments or dust adhering to the cylinder's inner layer without falling off during the translational or rotational motion of the milli-spinner head.

[0116] Optionally, as shown in FIGS. 32 and 32B, a dust filter (e.g., a fine mesh with a simple weave pattern) may be attached over or otherwise across the slits to prevent dust from leaking out or otherwise escaping during the spinning motion.

[0117] FIG. 33A and 33B illustrate an example of a system including a spinner head carried on a distal end of a flexible shaft, which may be integrated with or inserted into a commercial ureteroscope, e.g., through its working channel. A proximal end of the flexible shaft may be connected to a motor of the system (not shown), e.g., through an irrigation tube at the proximal end of the ureteroscope. In one example, the motor provides torque to rotate the spinner head at a desired speed, e.g., about 10,000 rpm. In other examples, the spinning speed may range from about one thousand to sixty thousand (Ik to 60k) rpm. As shown, the spinner head is coaxial with a flexible shaft. The entire spinner device assembly may be sized to be introduced through a lumen of a sheath, such as those commonly used in ureteroscopy procedures.

[0118] In one example, the spinner system is integrated with a ureteroscope, forming an all- in-one device. For example, during manufacturing or assembly, after passing the shaft through the working channel of the ureteroscope, a spinner head may be attached to the distal end of the shaft. Alternatively, the spinner head may be sized to be received through the working channel such that the spinner head may be advanced through the working channel to deploy the spinner head during a procedure and may be removed from the working channel, as desired.

[0119] Optionally, a camera, e.g., CCD, CMOS or other digital camera, may be provided on a distal tip of the ureteroscope, e.g., to provide real-time, high-resolution images of the interior of the urinary system, enabling a surgeon to use the spinner for precise stone extraction. Optionally, the spinner head may be manufactured from transparent resin and / or other transparent materials to enhance the camera’s field of view beyond the spinner head. A distal portion of the ureteroscope may be steerable, e.g., configured to bend to about 270 degrees as shown in FIG. 34A. For example, one or more wires or other steering elements may be received within the ureteroscope that are coupled to an actuator on a handle on the proximal end of the ureteroscope to allow the distal portion to be manipulated as desired. The spinner head and shaft are bendable and flexible, compatible with the ureteroscope. This adaptability allows the system to pass through narrow calyx, e.g., as shown in FIG. 34B. A flexible, bendable tip allows the system to navigate through tight and curved spaces, particularly narrow and winding ureters leading to the kidneys.

[0120] In another example, as depicted in FIGS. 35A and 35B, the spinner head may be expandable between a folded or collapsed configuration and an expanded configuration. For example, as shown, the spinner head may include tilted fins, a straight annular body / hole, with the fins being compressible to a folded configuration and expandable to expand to an unfolded configuration. Thus, the fins may be compressed inwardly to collapse the spinner head, e.g., to allow the spinner head to be introduced into and / or advanced along a lumen of a sheath, ureteroscope, or other tubular member, and deployed from the tubular member, whereupon the fins may resiliently expand outwardly to expand the spinner head. Optionally, the spinner head may be collapsed by withdrawing the spinner head back into the tubular member, e.g., after capturing debris within the spinner head.

[0121] For example, as shown in FIGS. 35C and 35D, before passage through the lumen of a sheath, both translational and rotational displacements may be applied to the spinner head to fold it into a slender configuration. After the spinner head is advanced and deployed from the distal end of the sheath, the spinner head may expand into its free state. The modulus of this example is designated to be within the purely elastic range, for example, 10 MPa. This design flexibility allows for a more extensive collection capacity for stones or fragments without being constrained by the inner diameter of the sheath.

[0122] Optionally, the drive shaft of the device (or any of the spinner devices herein) may feature a hollow structure including a lumen extending between proximal and distal ends of the drive shaft and communicating with a cavity of the spinner head, potentially offering an additional pathway for storing dust or fragments. This design allows for the collection of fragments from the distal end of the spinner head through to the lumen of the drive shaft. Additionally, the length of the spinner head may be adjusted for the same capability. Optionally, the ureteroscope itself may be equipped with an integrated controller. This integrable controller may provide various operational speeds and potentially include a switch for controlling the device on and off. In addition, alternatively, the controller may also direct movements of the spinner system, such as its translational or bending motions.

[0123] An example of the milli-spinner integrated with an ureteroscope is depicted in FIG. 36A and a zoom-in schematic of the milli-spinner and ureteroscope distal end are shown in FIG. 36B. The milli-spinner head and shaft are introduced into a working channel from the proximal end of the ureteroscope and pushed until the milli-spinner head extends out of the working channel. The kidney stone location and milli-spinner head to kidney stone location may be observed by the camera on the ureteroscope. The motor located at the proximal end of the assembled system drives the shaft and milli-spinner head to spin under the desired speed e.g. at about 5,000 rpm. The spinning milli-spinner head captures kidney stones or fragments / dust. Then the ureteroscope and milli-spinner device are retrieved inside the sheath. The captured stones are removed (FIGS. 37A-37C).

[0124] Any of the milli-spinner devices herein may operate under a range of spinning frequencies, e.g., between about one hundred and ten thousand rotations per minute (100 rpm to 10,000 rpm).

[0125] Optionally, the process of initiating spinning and halting spinning motion may be controlled. For example, to reach a desired spinning e.g. 5,000 rpm, the speed may be gradually ramped up, for example, in about five seconds (5s) or may be reached rapidly in less than about one second (Is). The same control process applies to halt the spinning motion. The spinning speed may be gradually ramped down to zero rpm or rapidly stopped.

[0126] Optionally, the milli-spinner device may spin continuously until stones or fragments / dust have been captured in its cavity. Then milli-spinner and ureteroscope may then be taken out of the sheath for stone removal.

[0127] Optionally, the milli-spinner device may be controlled to perform pulsatile spinning. For example, the milli-spinner head may spin for a certain duration of time, e.g., about two seconds (2 s), and if no stone is captured, the milli-spinner device may repeat the spinning motion until stones or fragments / dust are collected.

[0128] Optionally, the spinning speed may be adjusted during spinning operation to increase or decrease the spinning speed.

[0129] Optionally, the milli-spinner head position may remain static as it is spinning. Optionally, the milli-spinner head may be actively moved around in the kidney and chase after stones.

[0130] Optionally, the milli-spinner head may be assembled on the distal end of a ureteroscope before being introduced into the sheath eliminating the need for the milli- spinner head to fit through a working channel of a ureteroscope. Optionally, the milli- spinner head may be fabricated out of soft material and designed with a foldable structure for the milli-spinner head to fit through the working channel and fit into the sheath during retrieval (FIG. 38).

[0131] To ensure that the milli-spinner is effective in capturing kidney stones with a wide range of sizes, e.g., between about three and four millimeters (3-4 mm) to sub millimeters, spinner heads provided on the milli-spinner devices may be designed based on targeted kidney stone sizes. In one example, the stones are relatively large (e.g., greater than about two millimeters (2 mm) in diameter), and the milli-spinner head is designed to have a slit width (FIG. 39A) smaller than about two millimeters (2 mm) to ensure that captured stones do not escape out through the slits. In another example, the milli-spinner head is targeting kidney stone dust that is on the submillimeter scale; the slits are designed to be mesh structure that traps dust but also allows fluid exiting (FIG. 39B).

[0132] Optionally, different configurations of milli-spinner devices may be switched during operation. For example, a milli-spinner head with a large slit may be first used for capturing large kidney stones or fragments, and a milli-spinner head with a mesh slit design may be used sub sequentially to remove stone dust.

[0133] To ensure the camera’s vision during operation, the milli-spinner devices herein may be designed to be placed angled from a ureteroscope axis to leave space for camera vision as shown in FIG. 40A. In this configuration, once stones are spotted, the position of the milli-spinner head may be turned or otherwise adjusted to face the stones and start spinning for stone capturing.

[0134] Optionally, instead of having a milli-spinner head positioned at an angle, a camera may be provided that is configured to view sideways (FIG. 40B), and the position of the milli-spinner head may be adjusted to face target stones for stone capture.

[0135] Optionally, the spinner heads of the milli-spinner devices herein may be fabricated out of transparent material for a camera to see through.

[0136] Optionally, instead of having the milli-spinner head positioned out of the working channel of a ureteroscope or other tubular member, the milli-spinner head may first remain inside the working channel for a camera on the tubular member to have a clear vision of the stones. Once the stones are located, the milli-spinner head is pushed out of the working channel and the spinner device may be activated to start the kidney stone removal process (FIG. 40C).

[0137] Optionally, the milli-spinner head may be extended further out from the working channel of the ureteroscope so that the milli-spinner head is not blocking camera vision (FIG. 40D).

[0138] Optionally, no camera vision is required for a milli-spinner kidney stone operation. Instead, the milli-spinner device may be operated under an x-ray, guiding the milli-spinner head to enter and spin in every calyx. The milli-spinner head draws and captures stones without knowing the exact kidney stone location.

[0139] Optionally, the milli-spinner device may be spun for about ten seconds (10 s) continuously in each location (each calyx) and may spin multiple times, e.g., three times to ensure a more thorough kidney stone, and fragments / dust removal.

[0140] Optionally, the milli-spinner device may be spun under high rpm, e.g., at about 10,000 rpm in the renal pelvis facing calyx. The suction generated may bring kidney stones, fragments / dust out from calyx into pelvis eliminating the need for complex navigation into calyx.

[0141] In one example, the rotating shaft may be a hollow structure with an inner lumen connected to milli-spinner cavity to create an additional working channel (FIG. 41 A). This working channel is designed to be large enough to allow laser fiber and portable camera to enter through separately or together (FIG. 4 IB).

[0142] In one example, the camera on the ureteroscope is replaced by a portable camera that is inserted through the hollow shaft and reaches out from the milli-spinner cavity. This design enables a clear view of the stone without the need to adjust the milli-spinner position. Once the stone location is spotted by the portable camera, the camera is removed, and the milli-spinner spins and captures the stones for stone removal.

[0143] In one example, a laser fiber may be advanced through a hollow drive shaft of a spinner device and reach out of the milli-spinner head cavity together with a portable camera. The portable camera may be used to observe stones and the laser fiber approaching the stones, whereupon laser energy may be delivered to break the stones into fragments / dusts. The portable camera and laser fiber are then taken out and the milli-spinner is utilized for stone removal. In another example, shown in FIGS. 42A-42C, a portable camera may be used to observe kidney stones, and a milli-spinner device may be utilized to capture them in a cavity of a spinner head (FIG. 42A). Laser fiber is then delivered to the captured stones (FIG. 42B) and laser the stones into fragments / dust directly inside milli-spinner cavity (FIG. 42C). The fragment / dust are kept inside the spinner head cavity and are removed by taking out the ureteroscope and milli-spinner device. This configuration and operation procedure enables targeted stone lasering which reduces the risk of high-energy laser harming kidney tissue.

[0144] In one example, a source of vacuum aspiration may be connected to a lumen of a hollow drive shaft of a spinner device to enhance milli-spinner stone capture performance (FIG. 43 A). The aspiration generated by milli-spinner motion draws far-distanced stones. Under the assistance of vacuum aspiration, stone and fragments / dust are aspirated into the spinner cavity more effectively. The captured stones may also be directly aspirated out through the hollow drive shaft, realizing stone removal (FIG. 43B). This operational setup may eliminate the need to take out the spinner device.

[0145] Optionally, the vacuum aspiration acting on a hollow drive shaft may be selectively activated before kidney stone fragments / dust are captured or after fragments / dust are captured.

[0146] In one example, a milli-spinner device may be coupled with an existing vacuumaspiration device for effective stone capturing and removal. The existing vacuum-aspiration device has aspiration applied on the sheath aspirating fragments / dusts into the sheath. However, a close distance may be required for effective aspiration (FIG. 44A). With a milli- spinner head that can generate rotational flow over a large area (FIG. 44B), distanced stones or fragments and drawn close to the milli-spinner head and sheath. The flow pattern generated by the milli-spinner head spinning coupled with aspiration is shown in FIGS. 45A and 45B.

[0147] As shown in FIGS. 46A-46D, the milli-spinner device is coupled with a vacuum sheath, and vacuum aspiration is applied on the sheath attempting to aspirate distanced stones. The flow field generated by the milli-spinner head draws far-distance stones to the aspiration sheath. The drawn stones are aspirated into the sheath for removal by vacuum aspiration.

[0148] Optionally, the milli-spinner head may be positioned inside the sheath, e.g., as shown in FIGS. 47 A and 47B, half outside the sheath, or completely outside of the sheath, e.g., as shown in FIGS. 48A-48C, to draw stones and help the aspiration sheath remove the stones.

[0149] Optionally, the aspiration applied on the aspiration sheath may range from -1 inHg to -30 inHg. It is fully contemplated that the features, components, and / or steps described with respect to one or more embodiments, methods, or Figures may be combined with the features, components, and / or steps described with respect to other embodiments, methods, or Figures of the present disclosure.

[0150] While the invention is susceptible to various modifications, and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the invention is not to be limited to the particular forms or methods disclosed, but to the contrary, the invention is to cover all modifications, equivalents and alternatives falling within the scope of the appended claims.

Claims

We claim:

1. A system for removing renal calculi or other debris, comprising: a tubular member comprising a proximal end, a distal end sized for introduction into a body lumen of a patient, and a lumen extending between the proximal and distal ends, the distal end comprising a plurality of slits therethrough; a spinner device comprising: a) a flexible shaft received within the lumen and comprising a first end, a second end , and a longitudinal axis extending therebetween, the shaft configured to rotate about the axis, and b) a spinner head on the second end positioned within the lumen adjacent the distal end of the tubular member, the spinner head comprising a hollow body including an inlet communicating with a cavity within the body and a plurality of slits through a wall of the body communicating with the cavity configured to generate localized suction adjacent the inlet of the spinner head when the shaft rotates to capture renal calculi or other debris within the cavity; a motor coupled to the first end of the shaft; and a controller coupled to the motor to operate the motor to spin the shaft and, thereby rotate the spinner head.

2. The system of claim 1, wherein slits in the tubular member are positioned around the cylinder such that fluid passing from the cavity through the slits in the cylinder passes outwardly through the slits in the tubular member.

3. The system of claim 1 or 2, wherein the slits in the tubular member have a smaller cross-section than the slits in the cylinder.

4. The system of claim 1 or 2, wherein the slits in the cylinder have a first circumferential width around a circumference of the cylinder and the slits in the tubular member have a second circumferential width smaller the first circumferential width.

5. The system of claim 1 or 2, wherein the cylinder has fewer slits than the tubular member.

6. The system of claim 1 or 2, wherein the tubular member comprises a sheath and wherein the slits are integrally formed in a wall of the sheath.

7. The system of claim 1 or 2, wherein the slits are provided in a sleeve attached to the distal end of the tubular member.

8. The system of claim 7, wherein the tubular member comprises a ureteroscope.

9. The system of claim 1 or 2, further comprising a filter covering the plurality of slits.

10. The system of claim 1 or 2, further comprising one of a laser fiber and a camera.

11. A system for removing renal calculi or other debris, comprising: a flexible shaft comprising a proximal end, a distal end sized for introduction into a body lumen of a patient, and a longitudinal axis extending therebetween, the shaft configured to rotate about the axis; a motor coupled to the proximal end of the shaft to rotate the shaft about the axis; a controller coupled to the motor to control operation of the motor; and a spinner head on the distal end configured to generate localized suction adjacent the distal end when the shaft rotates to capture renal calculi or other debris within an interior of the spinner head.

12. The system of claim 11, further comprising a tubular member including a proximal end, a distal end sized for introduction into a body lumen of a patient, and a lumen extending between the proximal and distal ends, the spinner head and shaft configured to be received in the lumen to position the spinner head adjacent an outlet at the distal end of the tubular member.

13. The system of claim 12, wherein the tubular member comprises a ureteroscope.

14. The system of claim 12, wherein the tubular member comprises a steering mechanism for deflecting a distal portion of the tubular member.

15. The system of claim 12, further comprising a camera on the distal end of the tubular member for acquiring images beyond the distal end.

16. The system of claim 15, wherein the spinner head comprises transparent materials to minimize obstruction of a field of view of the camera when the spinner head is deployed from the distal end of the tubular member.

17. The system of any one of claims 12-16, wherein the spinner head comprises a hollow cylinder including an inlet communicating with a cavity within the cylinder and a plurality of slits through a wall of the cylinder communicating with the cavity and configured to generate the localized suction.

18. The system of claim 17, wherein the distal end of the tubular member comprises a plurality of slits.

19. The system of claim 18, wherein slits in the tubular member are positioned around the cylinder such that fluid passing from the cavity through the slits in the cylinder passes outwardly through the slits in the tubular member.

20. The system of claim 19, wherein the slits in the tubular member have a smaller cross-section than the slits in the cylinder.

21. The system of claim 19, wherein the slits in the cylinder have a first circumferential width around a circumference of the cylinder and the slits in the tubular member have a second circumferential width smaller the first circumferential width.

22. The system of claim 19, wherein the cylinder has fewer slits than the tubular member.

23. The system of claim 17, wherein the tubular member comprises a sheath and wherein the slits are integrally formed in a wall of the sheath.

24. The system of claim 17, wherein the slits are provided in a sleeve attached to the distal end of the tubular member.

25. The system of claim 24, wherein the tubular member comprises a ureteroscope.

26. The system of claim 17, wherein the sleeve is permanently attached to the distal end of the tubular member.

27. The system of any one of claims 11-16, wherein the spinner head comprises a plurality of fins extending from an annular body coupled to the shaft.

28. The system of claim 27, wherein the fins extend between opposite ends of the annular body.

29. The system of any one of claims 11-16, wherein the annular body tapers between its opposite ends.

30. The system of claim 29, wherein a first end of the annular body has a smaller diameter than a second end of the annular body.

31. The system of claim 29, wherein the outer edges of the fins define a uniform outer diameter between the opposite ends of the annular body or wherein the outer edges of the fins taper between the opposite ends of the annular body.

32. The system of claim 29, wherein a distal end of the annular body defining the inlet is larger than a proximal end of the annular body coupled to the shaft.

33. The system of any one of claims 11-16, wherein the spinner head comprises a hollow body including an inlet communicating with a cavity within the body and aplurality of slits through a wall of the body communicating with the cavity and configured such that fluid drawn into the inlet is released through the slits to generate a recirculating flow pattern through the spinner head to generate the localized suction adjacent the inlet.

34. The system of claim 27, wherein the spinner head comprises a plurality of slits on the spinner head located between adjacent fins on the spinner head, the slits spaced apart from the inlet such that fluid drawn into the inlet is released through the slits to generate a recirculating flow pattern through the spinner head to generate the localized suction adjacent the inlet.

35. The system of claim 34, further comprising a filter covering the plurality of slits to prevent debris within the interior of the spinner head from escaping out the plurality of slits.

36. The system of any one of claims 11-16, wherein the spinner head is expandable from a folded or other collapsed configuration to an expanded condition.

37. The system of any one of claims 11-16, further comprising an imaging element on the distal end of the tubular member for observing the spinner head.

38. The system of claim 37, wherein the imaging element comprises a field of view aligned with the longitudinal axis.

39. The system of claim 37, wherein the imaging element comprises a field of view that is offset from the longitudinal axis.

40. The system of claim 38, wherein the shaft comprises a bend adjacent the spinner device for directing the spinner device away from the longitudinal axis.

41. The system of any one of claims 11-16, wherein the flexible shaft comprises a shaft lumen extending between the proximal and distal ends.

42. The system of claim 41, further comprising an imaging element slidably received within the lumen.

43. The system of claim 42, wherein the imaging element comprises a camera carried on an elongate member sized for introduction into the lumen.

44. The system of claim 41, further comprising a laser fiber slidably received within the lumen.

45. The system of claim 41, further comprising a source of vacuum communicating with the shaft lumen to aspirate kidney stones or other debris within the body lumen towards the spinner head.

46. The system of claim 45, wherein the spinner device is configured to be rotated to capture the kidney stones or other debris.

47. The system of claim 46, wherein the source of vacuum is configured to remove the kidney stones or other debris captured within the spinner device through the shaft lumen out of the patient’s body.

48. The system of any one of claims 12-16, further comprising a source of vacuum communicating with the lumen of the tubular member to aspirate kidney stones or other debris within the body lumen towards the spinner head.

49. The system of claim 48, wherein the spinner device is configured to be rotated to draw the kidney stones or other debris into the lumen of the tubular member for removal from the body lumen.

50. The system of claim 48, wherein the source of vacuum is configured to remove the kidney stones or other debris drawn to the spinner device through the lumen around the flexible shaft out of the patient’s body.

51. A device for removing renal calculi or other debris, comprising:a flexible shaft comprising a proximal end configured to be coupled to a controller to spin the shaft, a distal end sized for introduction into a body lumen of a patient, and a longitudinal axis extending therebetween, the shaft configured to rotate about the axis; and a spinner head on the distal end configured to generate localized suction adjacent an inlet of the spinner head when the shaft rotates to capture renal calculi or other debris within an interior of the spinner head.

52. The device of claim 51, further comprising: a motor coupled to the proximal end of the shaft; and a controller coupled to the motor to operate the motor to spin the shaft and, thereby rotate the spinner head.

53. The device of claim 51, wherein the spinner head comprises a plurality of fins extending from an annular body coupled to the shaft.

54. The device of claim 53, wherein the fins extend between opposite ends of the annular body.

55. The device of claim 53, wherein the fins extend along the annular body substantially parallel to the longitudinal axis.

56. The device of claim 33, wherein the fins extend helically around the annular body.

57. The device of claim 53, wherein the annular body tapers between its opposite ends.

58. The device of claim 57, wherein a first end of the annular body has a smaller diameter than a second end of the annular body.

59. The device of claim 57, wherein the outer edges of the fins define a uniform outer diameter between the opposite ends of the annular body or wherein the outer edges of the fins taper between the opposite ends of the annular body.

60. The device of claim 57, wherein a distal end of the annular body defining the inlet is larger than a proximal end of the annular body coupled to the shaft.

61. The device of any one of claims 51-60, wherein the spinner head comprises one or more slits spaced apart from the inlet such that fluid drawn into the inlet is released through the one or more slits to generate a recirculating flow pattern through the spinner head to generate the localized suction adjacent the inlet.

62. The device of any one of claims 63-60, wherein the spinner head comprises a plurality of slits on the spinner head located between adjacent fins on the spinner head, the slits spaced apart from the inlet such that fluid drawn into the inlet is released through the slits to generate a recirculating flow pattern through the spinner head to generate the localized suction adjacent the inlet.

63. The device of claim 61, further comprising a filter covering the one or more slits to prevent debris within the interior of the spinner head from escaping out the one or more slits.

64. The device of claims 51, wherein the spinner head is expandable from a folded or other collapsed configuration to an expanded condition.

65. The device of claim 64, wherein the spinner head has a tapered shape from the inlet to a proximal end of the spinner head.

66. The device of claim 64, wherein the spinner head comprises a plurality of fins extending between opposite ends of the spinner head.

67. The device of claim 66, further comprising one or more slits between the fins.

68. The device of claim 66, wherein the fins are compressible inwardly towards one another to adopt the collapsed configuration.

69. The device of claim 68, wherein the fins are biased to expand away from one another to adopt the expanded configuration.

70. The device of claim 69, wherein distal ends of the fins are biased to flare outwardly to open the inlet in the expanded configuration.

71. A system for removing renal calculi or other debris, comprising: a tubular member comprising a proximal end, a distal end sized for introduction into a body lumen of a patient, and a lumen extending between the proximal and distal ends, the distal end comprising a plurality of slits therethrough; a spinner device comprising: a) a flexible shaft received within the lumen and comprising a first end, a second end , and a longitudinal axis extending therebetween, the shaft configured to rotate about the axis, and b) a spinner head on the second end positioned within the lumen adjacent the distal end of the tubular member, the spinner head comprising a hollow body including an inlet communicating with a cavity within the body configured to generate localized suction adjacent the inlet of the spinner head when the shaft rotates to capture renal calculi or other debris within the cavity; a motor coupled to the first end of the shaft; and a controller coupled to the motor to operate the motor to spin the shaft and, thereby rotate the spinner head, wherein the spinner device is movable axially to deploy the spinner head from the distal end of the tubular member and retract the spinner head into the distal end of the tubular member, and wherein the spinner head is expandable from a folded or other collapsed configuration to an expanded condition.

72. The device of claim 71, wherein the spinner head has a tapered shape from the inlet to a proximal end of the spinner head.

73. The device of claim 71 or 72, wherein the spinner head comprises a plurality of fins extending between opposite ends of the spinner head.

74. The device of claim 73, further comprising one or more slits between the fins.

75. The device of claim 73, wherein the fins are compressible inwardly towards one another to adopt the collapsed configuration.

76. The device of claim 75, wherein the fins are biased to expand away from one another to adopt the expanded configuration.

77. The device of claim 75, wherein distal ends of the fins are biased to flare outwardly to open the inlet in the expanded configuration.

78. The device of claim 71, wherein the spinner head comprises an annular body coupled to the shaft.

79. The device of claim 78, wherein the annular body tapers between its opposite ends.

80. The device of claim 78, wherein a first end of the annular body has a smaller diameter than a second end of the annular body.

81. The device of claim 78, wherein a distal end of the annular body defining the inlet is larger than a proximal end of the annular body coupled to the shaft.

82. The device of claim 71, wherein the spinner head comprises one or more slits spaced apart from the inlet such that fluid drawn into the inlet is released through the one or more slits to generate a recirculating flow pattern through the spinner head to generate the localized suction adjacent the inlet.

83. The device of claim 71, wherein the spinner head comprises a plurality of slits on the spinner head located between adjacent fins on the spinner head, the slits spaced apart from the inlet such that fluid drawn into the inlet is released through the slits togenerate a recirculating flow pattern through the spinner head to generate the localized suction adjacent the inlet.

84. The device of claim 82, further comprising a filter covering the one or more slits to prevent debris within the interior of the spinner head from escaping out the one or more slits.

85. The device of claim 71, wherein the flexible shaft comprises a lumen extending between the proximal and distal ends.

86. The device of claim 85, further comprising an imaging element slidably received within the lumen.

87. The device of claim 86, wherein the imaging element comprises a camera carried on an elongate member sized for introduction into the lumen.

88. The device of claim 85, further comprising a laser fiber slidably received within the lumen.

89. A method for removing renal calculi or other debris, comprising: introducing a spinner device into a body lumen to position an inlet of a spinner head of the spinner device adjacent a target object; and rotating the spinner device to generate localized suction adjacent the inlet to capture the target object within an interior of the spinner head.

90. The method of claim 89, wherein the target object comprises an entire kidney stone, a fragment of a kidney stone, or dust from a kidney stone.

91. The method of claim 89, wherein the body lumen comprises a kidney, a bladder, or a ureter.

92. The method of claim 89, further comprising imaging the spinner device using a camera introduced into the body lumen.

93. The method of claim 92, where the spinner device is introduced through a tubular member and wherein the camera is mounted on a distal end of the tubular member.

94. The method of any one of claims 89-93, wherein the spinner device is provided on a distal end of a flexible shaft for introducing the spinner device into the body lumen.

95. The method of claim 94, further comprising introducing an imaging element through a lumen of the flexible shaft for imaging within the body lumen.

96. The method of claim 94, further comprising: introducing a laser fiber through a lumen of the flexible shaft; and delivering laser light through the laser fiber to break kidney stones or other debris within the body lumen into fragments, and wherein the spinner device is rotated to capture the fragments.

97. The method of claim 94, further comprising: applying vacuum to the lumen of the flexible shaft to draw kidney stones or other debris within the body lumen towards the spinner device, and wherein the spinner device is rotated to capture the kidney stones or other debris.

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