Device and method for suctioning target elements from biological structures

Abstract

Methods and devices are described generally for the removal of at least one target element from a working area of an organ, a physiological cavity or a physiological pathway. The device comprises a suction sheath that is connected to a suction source for providing suction therethrough to the working area; an irrigation sheath with a tip that is located within or outside of the suction sheath, the irrigation sheath being connectable to a fluid source for providing fluid in the irrigation lumen for irrigation of the working area. The irrigation sheath is moveable and an irrigation sheath position actuator is coupled to the irrigation sheath and configured to extend the distal end of the irrigation sheath to a selectable distance past the distal end of the suction sheath.

Description

TITLE: DEVICE AND METHOD FOR SUCTIONING TARGET ELEMENTS FROM BIOLOGICAL STRUCTURESCROSS-REFERENCE TO RELATED PATENT APPLICATION

[0001] This application claims the benefit of priority of U.S. Provisional Patent Applicant No. 63 / 620,660 filed on January 12, 2024. The complete disclosure of U.S. Provisional Patent Application No. 63 / 620,660 is hereby incorporated by reference.FIELD

[0002] The various embodiments described herein generally relate to a device and method for removing of fragments, such as mineral fragments, from internal organs.BACKGROUND

[0003] Kidney stones are estimated to affect 8.8% of adults between the ages of 20-74. Furthermore, the prevalence of kidney stones is increasing. Emergency room visits in 2010 related to kidney stones, for example, nearly doubled compared to the 1990s, with associated increases in healthcare utilization. Approximately 1.2 million patients visit the emergency room annually for kidney stone related issues, and 20% require admission to the hospital due to health complications. The average emergency room visit cost for a kidney stone patient is estimated to be around $913 USD, and the average hospitalization cost is approximately $5,488 USD. Nearly one in seven patients require an additional emergency room visit, or readmission to hospital, within 30 days of a kidney stone procedure1

[0004] Kidney stones are formed when urine becomes supersaturated with mineral deposits. With larger kidney stones, there is a risk that they can become lodged in the renal system, blocking the flow of urine which can cause pain, blood in the urine, swelling of the kidneys, and even kidney failure2. Kidney stones can be a serious medical finding that requires urgent treatment. Almost 10% of all adults will have a “kidney stone attack” in their lifetime. Passing a kidney stone can cause excruciating pain, described by many as similar to the pain of childbirth. One of the best ways to prevent these attacks is to completely remove kidney stones before they cause pain.

[0005] Ureteroscopy and laser lithotripsy (URSL) is a common surgery where kidney stones are fragmented using laser energy and removed. However, while larger stone fragments are removed, this procedure also creates a significant amount of tiny stone fragments and particles that cannot be effectively removed using conventional devices. Thisis because these tiny stone fragments and particles may be found at various locations in the renal system, including the ureter and in the collecting spaces within the kidney itself called kidney calyces3, especially in the lower regions (called lower pole calyces) because of gravity, and there are no tools that are dexterous that can pick up a large number of small fragments. Studies have shown that residual fragments are seen in 40-60% of patients after USRL4. These stone fragments can be harmful for patients because they can act as a nidus for future stone formation, or as a source of bacterial infection. It is estimated that 20% of patients with residual fragments will require another operation for the same reason5.

[0006] After USRL, one of the best ways to prevent kidney stone attacks is to prevent stones from recurring. This is often best achieved by rendering the patient stone-free at the time of kidney stone surgery. By increasing stone-free rates among patients, the rate of renal colic episodes and emergency room visits will decrease, the need for invasive interventions for advanced kidney stones such as ureteric stenting and re-operation will also decrease and the number of clinic follow-ups required for kidney stone patients will decrease as well as subsequent radiation exposure from repeat CT scans, which are commonly used to image kidney stones. Narcotic use and the incidence of narcotic dependence in kidney stone patients will also decrease by reducing episodes of renal colic from recurrent kidney stones.

[0007] Accordingly, there is a need for a device and method for more effectively removing kidney stone fragments, particles, and other target elements.SUMMARY OF VARIOUS EMBODIMENTS

[0008] In one aspect, in accordance with the teachings herein, there is provided at least one embodiment of a target element removal device for removing at least one target element from a working area of an organ, a physiological cavity or a physiological pathway, wherein the device comprises: a suction sheath having a suction lumen, a proximal end and a distal end, the suction sheath being connectable to a suction source for providing suction through the suction lumen to the working area; and an irrigation sheath having an irrigation lumen, a proximal end and a distal end where the distal end is extended past the distal end of the suction sheath, the irrigation sheath being connectable to a fluid source for providing fluid in the irrigation lumen for irrigation of the working area.

[0009] In at least one embodiment, the irrigation sheath and the suction sheath are fused together.

[0010] In at least one embodiment, the irrigation sheath is located inside, outside or in a wall of the suction sheath.

[0011] In at least one embodiment, the distal end of the irrigation sheath is movable relative to the suction lumen of the suction sheath so that the distal end of the irrigation sheath is extendable with respect to the distal end of the suction sheath; and the device includes an irrigation sheath position actuator that is coupled to the irrigation sheath and configured to extend the distal end of the irrigation sheath to a first selectable distance past the distal end of the suction sheath and optionally retract the distal end of the irrigation sheath with respect to the distal end of the suction sheath by a second selectable distance.

[0012] In at least one embodiment, a distal end portion of the irrigation and / or suction sheath is bendable.

[0013] In at least one embodiment, the suction sheath is pre-bent to maintain an amount of bending when an introducer or scope is removed from the suction sheath.

[0014] In at least one embodiment, the device further comprises a deflection lock to maintain an amount of bending when an introducer or scope is removed from the suction sheath.

[0015] In at least one embodiment, the device further comprises a direction indicator to indicate the amount and direction of bending of the distal end portion of the suction sheath.

[0016] In at least one embodiment, the device further comprises a steering actuator that includes the direction indicator, the deflection lock and a steering mechanism that is coupled to the direction indicator and the distal end portion of the suction sheath for bending the distal end portion of the suction sheath.

[0017] In at least one embodiment, the suction sheath includes a sidewall having an axial longitudinal channel and the irrigation sheath is moveably located in the axial longitudinal channel.

[0018] In at least one embodiment, the device comprises a separate steering actuator and steering mechanism for bending the distal end portion of the irrigation sheath independently of the distal end of portion of the suction sheath.

[0019] In at least one embodiment, the suction sheath is selected from a plurality of suction sheaths having different radii and / or pre-bent with various angles.

[0020] In at least one embodiment, the irrigation sheath is selected from a plurality of irrigation sheaths having different radii.

[0021] In at least one embodiment, a ratio of a suction lumen radius to an irrigation lumen radius is in a range of about 2 to about 14.

[0022] In at least one embodiment, the device further comprises at least one sensor disposed at the proximal or distal end of the suction sheath, the at least one sensor comprising any combination of a temperature sensor, a pressure sensor and at least one flow sensor.

[0023] In at least one embodiment, at least a portion of the device is made using radiopaque material.

[0024] In at least one embodiment, the device has a radiopaque body, radiopaque markers, the irrigation and / or suction sheaths have radiopaque tips, or the irrigation and / or suction sheaths have both radiopaque markers and radiopaque tips.

[0025] In at least one embodiment, the device has multiple irrigation sheaths including the irrigation sheath and additional irrigation sheaths.

[0026] In at least one embodiment, the multiple irrigation sheaths are evenly distributed about a circumference of the suction sheath.

[0027] In at least one embodiment, the multiple irrigation sheaths are configured to provide different streams of irrigation to create a desired flow pattern.

[0028] In at least one embodiment, a length and a location of distal ends of the multiple irrigation sheaths is controlled to irrigate different locations.

[0029] In at least one embodiment, the distal ends of the multiple irrigation sheaths are controlled to be located in different physiological cavities.

[0030] In at least one embodiment, the multiple irrigation sheaths are controlled to irrigate different calyces simultaneously.

[0031] In at least one embodiment, the suction sheath is sized to accommodate a scope, optionally at least one irrigation sheath and optionally the at least one target element at the same time.

[0032] In at least one embodiment, the irrigation sheath has a circular, oval, half-circular, or crescent shaped cross-section.

[0033] In another aspect, in accordance with the teachings herein, there is provided at least one embodiment of a target element removal system for removing at least one target element from a working area of an organ, a physiological cavity or a physiological pathway, wherein the system comprises: a target element removal device having an outer sheath and an inner sheath that is movably disposed within the outer sheath, the target element removal device being defined according to any of the embodiments described herein; and one or both of: (i) a pumping unit that is coupled to an irrigation fluid source to provide irrigation fluid to the inner sheath during use; and (ii) a target element container that is coupled to the outer sheath and to a suction source to apply suction to the outer sheath and receive the at least one target element during use.

[0034] In at least one embodiment, the system further comprises the fluid irrigation source and a suction unit that acts as the suction source.

[0035] In at least one embodiment, the target element container includes a filter, and the pumping unit is configured to provide the suction source and recirculate filtered fluid from the target element container which is provided as the irrigation fluid.

[0036] In at least one embodiment, the irrigation and suction are provided continuously constant, continuously variable or intermittently in an automated or manual manner.

[0037] In at least one embodiment, the irrigation and suction are provided simultaneously constant, simultaneously variable or offset in time in an automated or manual manner.

[0038] In at least one embodiment, the system further comprises a controller that is coupled to the pumping unit and the device for controlling the operation of the pumping unit and the actuators of the device wherein the controller is configured to operate in an automated manner or under manual control of a medical practitioner.

[0039] In at least one embodiment, when the at least one target element is stuck in the suction lumen, any combination of a positive pressure is applied to the suction lumen, an increased amount of suction is applied, an increased irrigation flow rate is used, the irrigation sheath is pulled, pushed or vibrated, a scope, a laser, and a rigid bar is used to dislodge the stuck at least one target element.

[0040] In another aspect, in accordance with the teachings herein, there is provided at least one embodiment of a method for removing at least one target element from a working area of an organ, a physiological cavity or a physiological pathway, wherein the method comprises: positioning a distal end portion of a suction sheath of a target element removal device at the working area, the target element removal device being defined according to any of the embodiments described herein; positioning a tip of an irrigation sheath of the target element removal device past a tip of the suction sheath by a selectable distance; and performing irrigation to the working area through the irrigation sheath to displace the at least one target element and applying suctioning to the working area through the suction sheath to remove the at least one target element.

[0041] In at least one embodiment, the distal tip of the irrigation sheath is extendable with respect to the distal tip of the suction sheath, the device includes an irrigation sheath position actuator that is coupled to the irrigation sheath and the method further comprises extending the distal tip of the irrigation sheath to a first selectable distance past the distal tip of the suction sheath and optionally retracting the distal tip of the irrigation sheath with respect to the distal tip of the suction sheath by a second selectable distance.

[0042] In at least one embodiment, the method is applied to a kidney and the method comprises performing ureteroscopy and laser lithotripsy to break up one or more kidney stones into kidney stone fragments prior to providing irrigation and suctioning via the device.

[0043] In at least one embodiment, the positioning involves using a camera or performing medical imaging to allow for positioning of the distal end portion of the outer sheath at the working area.

[0044] In at least one embodiment, the method comprises monitoring local pressure at the working area and adjusting the amount of suction and / or irrigation to maintain the local pressure in a defined operating range to avoid collapse or rupture of kidney structure surrounding the working area.

[0045] In at least one embodiment, the method comprises monitoring local pressure at the working area and adjusting the amount of pressure in a defined operating range to avoid collapse or rupture of kidney structure surrounding the working area.

[0046] In at least one embodiment, the method comprises monitoring a local temperature at the working area and adjusting the local temperature adjusting an amount of relativesuction and / or irrigation to maintain the local temperature within a defined operating range, to avoid thermal injury of kidney structure surrounding the working area.

[0047] In at least one embodiment, the method comprises providing irrigation and suction are continuously constant, continuously variably or intermittently in an automated or manual manner.

[0048] In at least one embodiment, the method comprises providing irrigation and suction are simultaneously constant, simultaneously variably or offset in time in an automated or manual manner.

[0049] In at least one embodiment, when the at least one target element is stuck in the suction lumen, the method further comprises any combination of applying a positive pressure to the suction lumen, applying an increased amount of suction, applying an increased irrigation flow rate using a scope, using a laser, pulling, pushing or vibration the irrigation sheath, and using a rigid bar to dislodge the stuck at least one target element.

[0050] In another aspect, in accordance with the teachings herein, there is provided a device for removal of at least one target element and / or delivery of at least one delivery element at a working area of an organ, a physiological cavity or a physiological pathway, wherein the device comprises: a suction sheath having a suction lumen, a proximal end and a distal end, the suction sheath being connectable to a suction source for providing suction through the suction lumen to remove the at least one target from the working area; an irrigation sheath having an irrigation lumen, a proximal end and a distal end and being movably located within the suction lumen of the suction sheath so that the distal end of the irrigation sheath is extendable with respect to the distal end of the outer sheath, the irrigation sheath being connectable to a: (1 ) fluid source for providing fluid in the irrigation lumen for irrigation of the working area when removing the at least one target element at the working area and / or (2) a delivery element source for sending the delivery element to the working area; and an irrigation sheath position actuator that is coupled to the irrigation sheath and configured to extend the distal end of the irrigation sheath to a first selectable distance past the distal end of the suction sheath and optionally retract the inner sheath within the distal end of the outer sheath by a second selectable distance.

[0051] In another aspect, in accordance with the teachings herein, there is provided a use of a device for the removal of at least one target element and / or delivery of at least onedelivery element at a working area of an organ, a physiological cavity or a physiological pathway, wherein the device is defined according to any of the embodiments described herein.

[0052] It will be appreciated that the foregoing summary sets out representative aspects of embodiments to assist skilled readers in understanding the following detailed description. Other features and advantages of the present application will become apparent from the following detailed description taken together with the accompanying drawings. It should be understood, however, that the detailed description and the specific examples, while indicating preferred embodiments of the application, are given by way of illustration only, since various changes and modifications within the spirit and scope of the application will become apparent to those skilled in the art from this detailed description.BRIEF DESCRIPTION OF THE DRAWINGS

[0053] For a better understanding of the various embodiments described herein, and to show more clearly how these various embodiments may be carried into effect, reference will be made, by way of example, to the accompanying drawings which show at least one example embodiment, and which are now described. The drawings are not intended to limit the scope of the teachings described herein.

[0054] FIGS. 1 A-1 C are schematic diagrams illustrating various stages of laser treatment of kidney stones that create kidney stone fragments.

[0055] FIG. 1 D is a schematic diagram illustrating kidney stone reformation from kidney stone fragments.

[0056] FIG. 2A is a schematic diagram of an example embodiment of a target element removal device illustrating device delivery into the working area and device operation for suctioning kidney stone fragments to prevent kidney stone reformation in accordance with the teachings herein.

[0057] FIG. 2B is a schematic diagram showing a magnified view of the device operation by the target element removal device of FIG. 2A illustrating simultaneous irrigation and suctioning in accordance with the teachings herein.

[0058] FIGS. 2C-2D are schematic diagrams showing a distal end of an example embodiment of the target element removal device with the inner sheath in a non-extended position and an extended position at a desired distance relative to the outer sheath.

[0059] FIGS. 2E-2F are schematic diagrams showing a distal end of another alternative embodiment of target element removal device with the inner sheath extended in a first extended position and a different second extended position relative to the outer sheath.

[0060] FIGS. 2G-2I show examples of inner sheaths having different cross-sectional shapes.

[0061] FIGS. 2J-2L show examples of devices with inner sheaths having different cross- sectional shapes and the size of an object that can pass through the outer sheath.

[0062] FIG. 2M shows an example of a device with multiple inner lumens distributed evenly (circumferentially equidistant to one another) within an outer sheath.

[0063] FIG. 2N shows an example flow pattern that may be used with the device of FIG. 2M.

[0064] FIG. 20 includes a series of diagrams showing a distal end of an example embodiment of a target element removal device having a semi-rigid outer sheath which is pre-bent and retains its bend when an introducer or a ureteroscope is removed.

[0065] FIGS. 3A-3C show drawings of another example embodiment of a target element removal device with a flexible distal tip, which can be bent by an internal scope and locked in position with a locking mechanism, a dial that indicates the amount of bending and may alternatively be used as a steering actuator for controlling the amount of bending of the distal end of the device where three example different positions are shown, and an inner sheath position actuator for controlling an amount of extension of the inner sheath past the outer sheath.

[0066] FIG. 3D-3F show perspective, top and exploded views, respectively, of the steering actuator of the target element removal device of FIGS. 3A-3C.

[0067] FIGS. 3G-3H show perspective and top views, respectively, of the inner sheath position actuator of the target element removal device of FIGS. 3A-3C.

[0068] FIGS. 3I-3J show perspective and top views, respectively, of the device of FIGS. 3A-3C with the steering actuator and the inner sheath position actuator at neutral positions.

[0069] FIG. 4A is a schematic diagram of an example embodiment of a system including fluidic components that are used along with in an embodiment of a target element removal device taught herein.

[0070] FIG. 4B is a schematic diagram of another example embodiment of a system including fluidic components that are used along with in an embodiment of a target element removal device taught herein.

[0071] FIG. 5 is a block diagram of another example embodiment of a target element removal system in accordance with the teachings herein.

[0072] FIG. 6 is a flowchart of an example embodiment of a method for removing particulates, such as mineral fragments, using one of the embodiments of the target element removal device described in accordance with the teachings herein.

[0073] Further aspects and features of the example embodiments described herein will appear from the following description taken together with the accompanying drawings.DETAILED DESCRIPTION OF THE EMBODIMENTS

[0074] Various embodiments in accordance with the teachings herein will be described below to provide examples of at least one embodiment of the claimed subject matter. No embodiment described herein limits any claimed subject matter. The claimed subject matter is not limited to devices, systems or methods having all of the features of any one of the devices, systems or methods described below or to features common to multiple or all of the devices, systems or methods described herein. It is possible that there may be a device, system or method described herein that is not an embodiment of any claimed subject matter. Any subject matter that is described herein that is not claimed in this document may be the subject matter of another protective instrument, for example, a continuing patent application, and the applicants, inventors or owners do not intend to abandon, disclaim or dedicate to the public any such subject matter by its disclosure in this document.

[0075] Furthermore, it will be appreciated that for simplicity and clarity of illustration, where considered appropriate, reference numerals may be repeated among the figures to indicate corresponding or analogous elements or steps. In addition, numerous specific details are set forth in order to provide a thorough understanding of the embodiments described herein. However, it will be understood by those of ordinary skill in the art that the embodiments described herein may be practiced without these specific details. In otherinstances, well-known methods, procedures and components have not been described in detail so as not to obscure the embodiments described herein. Also, the description is not to be considered as limiting the scope of the embodiments described herein.

[0076] It should also be noted that the terms “coupled” or “coupling” as used herein can have several different meanings depending on the context in which these terms are used. For example, the terms coupled, or coupling can have a mechanical, electrical or communicative connotation. For example, as used herein, the terms coupled or coupling can indicate that two elements or devices can be directly connected to one another or connected to one another through one or more intermediate elements or devices via an electrical element, an electrical signal, a light signal or a mechanical element depending on the particular context.

[0077] Unless the context requires otherwise, throughout the specification and claims which follow, the word “comprise” and variations thereof, such as, “comprises” and “comprising” are to be construed in an open, inclusive sense, that is, as “including, but not limited to”.

[0078] It should also be noted that, as used herein, the wording “and / or” is intended to represent an inclusive-or. That is, “X and / or Y” is intended to mean X or Y or both X and Y, for example. As a further example, the phrases “X, Y, and / or Z”, “any combination of X, Y, and Z” or “any operable combination of X, Y and Z” is intended to mean X, Y, Z, X and Y, X and Z, Y and Z, or X, Y and Z.

[0079] It should be noted that terms of degree such as "substantially", "about" and "approximately" as used herein mean a reasonable amount of deviation of the modified term such that the end result is not significantly changed. These terms of degree may also be construed as including a deviation of the modified term, such as by 1 %, 2%, 5% or 10%, for example, if this deviation does not negate the meaning of the term it modifies.

[0080] Furthermore, the recitation of numerical ranges by endpoints herein includes all numbers and fractions subsumed within that range (e.g., 1 to 5 includes 1 , 1.5, 2, 2.75, 3, 3.90, 4, and 5). It is also to be understood that all numbers and fractions thereof are presumed to be modified by the term "about" which means a variation of up to a certain amount of the number to which reference is being made if the end result is not significantly changed, such as 1 %, 2%, 5%, or 10%, for example.

[0081] Throughout this specification and the appended claims, infinitive verb forms are often used. Examples include, without limitation: “to detect,” “to provide,” “to transmit,” “to communicate,” “to process,” “to route,” and the like. Unless the specific context requires otherwise, such infinitive verb forms are used in an open, inclusive sense, that is as “to, at least, detect,” to, at least, provide,” “to, at least, transmit,” and so on.

[0082] A portion of the example embodiments of the systems, devices, or methods described in accordance with the teachings herein may be implemented as a combination of hardware or software. For example, a portion of the embodiments described herein may be implemented, at least in part, by using one or more computer programs, executing on one or more programmable devices comprising at least one processing element, and at least one data storage element (including volatile and / or non-volatile memory). These devices may also have at least one input device (e.g., a keyboard, a mouse, a touchscreen, input buttons or sliders, and the like) and at least one output device (e.g., a display screen, a printer, a speaker, and the like) depending on the nature of the device.

[0083] It should also be noted that there may be some elements that are used to implement at least part of the embodiments described herein that may be implemented via software that is written in a high-level procedural language such as object-oriented programming. The program code may be written in C, C++or any other suitable programming language and may comprise modules or classes, as is known to those skilled in object- oriented programming. Alternatively, or in addition thereto, some of these elements implemented via software may be written in assembly language, machine language, or firmware as needed.

[0084] At least some of the software programs used to implement at least one of the embodiments described herein may be stored on a storage media or a device that is readable by a general or special purpose programmable device. The software program code, when read by the programmable device, configures the programmable device to operate in a new, specific and predefined manner in order to perform at least one of the methods described herein.

[0085] Furthermore, at least some of the programs associated with the systems and methods of the embodiments described herein may be capable of being distributed in a computer program product comprising a computer readable medium that bears computerusable instructions, such as program code, for one or more processors. The program code may be preinstalled and embedded during manufacture and / or may be later installed as an update for an already deployed computing system. The medium may be provided in various forms, including non-transitory forms such as, but not limited to, one or more diskettes, compact disks, tapes, chips, and magnetic and electronic storage. In alternative embodiments, the medium may be transitory in nature such as, but not limited to, wire-line transmissions, satellite transmissions, internet transmissions (e.g., downloads), media, digital and analog signals, and the like. The computer useable instructions may also be in various formats, including compiled and non-compiled code.

[0086] Any module, unit, component, server, computer, terminal or device described herein that executes software instructions in accordance with the teachings herein may include or otherwise have access to computer readable media such as storage media, computer storage media, or data storage devices (removable and / or non-removable) such as, for example, magnetic disks, optical disks, or tape. Computer storage media may include volatile and non-volatile, removable and non-removable media implemented in any method or technology for storage of information, such as computer readable instructions, data structures, program modules, or other data. Examples of computer storage media include RAM, ROM, EEPROM, flash memory or other memory technology, CD-ROM, digital versatile disks (DVD) or other optical storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other medium which can be used to store the desired information, and which can be accessed by an application, module, or both. Any such computer storage media may be part of the device or accessible or connectable thereto.

[0087] As noted previously, retrograde ureteroscopic renal surgery for kidney stones often leaves multiple small stone fragments and dust particles as a result of laser fragmentation of the stones. In accordance with the teachings herein, at least one embodiment of a dual lumen device and a method are provided that allow for the dual lumen device to be retrogradely inserted into pathways of an organ, such as the renal collecting system, to irrigate and flush out small mineral fragments (e.g., stones) and dust and apply suction or vacuum to remove and collect the mineral fragments. For example, the dual lumen device(s) and method(s) described herein may be used after a LIRSL procedure to achieve a higher stone free rate post LIRSL procedure.

[0088] In another aspect, the dual sheath device in accordance with the teachings herein, includes an outer sheath having a lumen and an inner sheath having a lumen, where the lumen of the outer sheath may act as an access sheath and allow for a ureteroscope to be inserted through it and used for visual guidance to position the distal end of the outer sheath to a desired location. The lumens of the dual sheath device are flexible enough to allow for navigation into curved pathways such as the lower pole of the renal collecting system, for example, where most mineral fragments tend to accumulate. The dual sheath device may also be attached to an irrigation / aspiration management system (e.g., see FIGS. 4A, 4B and 5) to monitor and maintain an acceptable and safe intra-renal pressure during the irrigation and stone removal process.

[0089] The embodiments of the dual sheath device and methods described herein may be used to improve the stone clearance rate and reduce the need for re-treatment of mineral deposits, such as kidney stones, in the same patient. In addition, the embodiments described herein may reduce the need for more invasive approaches such as for removal of lower pole renal stones and larger stone sizes (e.g., to reduce the need for percutaneous stone procedures). This is particularly timely with the advent of new laser technology (such as the thulium laser fiber for example) that has improved the fragmentation of kidney stones. The devices described herein may be used with the new laser technology, offering faster and more efficient stone clearance, leading to an ability to treat larger stones using ureteroscopy and one of the devices described herein, rather than other more invasive surgical modalities, due to the improved ability to clear large volumes of stone fragments intra-operatively.

[0090] The device which is described in several embodiments herein may be referred to as a particulate removal device, or a target element removal device, which may be used in physiological organs, physiological pathways or physiological cavities. Examples of physiological organs include, but are not limited to, the gall bladder, the lungs, the uterus, the pancreas, and the kidney, for example, while examples of physiological pathways include, but are not limited to, nasal passages, the esophagus, the auditory canal, vasculatures, and the biliary tract, for example, while examples of physiological cavities include but are not limited to, sinus cavities, for example. The various embodiments of the particulate removal device employ simultaneous irrigation of a region containing mineral fragments, particulates or other target elements through a smaller inner lumen (which may be referred to as an irrigation lumen), and suction of the target elements (e.g., mineral fragments) through a largerouter lumen (which may be referred to as a suction lumen). The irrigation causes the target elements to move and mix with the irrigation fluid which allows them to be retrieved more effectively by the suction / aspiration provided by the outer lumen. The smaller size of the inner lumen allows for creating more of a vortex / force in the region of the target element deposit to cause more of the target elements to move, including larger size target elements, while the larger size of the outer lumen allows for more of the target elements to be suctioned / removed without getting stuck in the outer lumen.

[0091] It should be noted that while the embodiments of the target element removal device and associated methods described herein are described for use with kidney stone fragment removal this is done for ease of illustration. It should be understood that the devices and methods described may be used to remove other target elements such as but not limited to mineral deposits, for example, in other organs and / or physiological passageways that are accessible by the device. For example, mineral deposits found in various structures can be removed by the device such as, but not limited to, the: lung, gall bladder, bile duct, and / or pancreas, for examples.

[0092] Furthermore, it should be understood that the term “target element” used herein may include, but are not limited to, encompass all solid elements and liquid elements which are targeted for removal, where solid elements include, but are not limited to, stones, other mineral deposits, hardened plaques, foreign bodies, and debris, for example, while liquid elements include, but are not limited to, mucus, sludge, liquids (foreign / unwanted), gel or anything other fluid that may be essentially sucked out of a physiological cavity or passageway.

[0093] It should be understood that a sheath that provides suction may be referred to as a “suction sheath” or “suction channel” and a sheath that provides irrigation may be referred to as an “irrigation sheath” or “irrigation channel”. In various embodiments according to the teachings herein, the suction sheath is typically the outer sheath, and the irrigation sheath is typically the inner sheath. In many of the embodiments described herein the outer sheath is described as providing suction while the inner sheath is described as providing irritation. Also, the suction sheaths may be referred to as having suction lumens and the irrigation sheaths may be referred to as having irrigation lumens. However, there may be embodiments in which the irrigation sheath is located outside or external to the suction sheath in which case the inner sheath / inner lumen provides suction, and the outer sheath / outer lumen providesirrigation. It is also understood that the largest sheath of the sheaths of the device is used to provide suction, and the smaller sheaths of the device are used to provide irrigation. Also, actuators that move a sheath may be referred to as sheath position actuator. Also, an actuator for an irrigation sheath may be referred to as an irrigation sheath position actuator or an inner sheath position actuator when the inner sheath provides irrigation.

[0094] Referring now to FIGS. 1A-1 C, shown therein are schematic diagrams illustrating various stages of laser treatment of kidney stones that create kidney stone fragments. During LIRSL, an access sheath 14, is first introduced into the bladder, through the ureter, and into the kidney 10. An introducer and / or a ureteroscope may be placed within the access sheath 14 to place it at a working space / area (e.g., at the entrance of the renal pelvis in this case). When the ureteroscope is used, it has a camera 16 which may be used by the surgeon to determine when the end of the access sheath 14 is at a region (i.e., working area) of the kidney 10, as well as when the tip of the scope is at the kidney stone 12, which is to be treated and broken up using a laser 18 (see FIG. 1A). When the tip of the ureteroscope is at the right location, the laser 18 is activated which starts to break up the kidney stone 12 into smaller pieces 12f (see FIG. 1 B). However, as the kidney stone 12 is broken up many small stones or mineral fragments 20 are created which may then settle in a kidney calyx 22 (see FIG. 1 C). The danger then is that the mineral fragments can be harmful for patients because they can act as a nidus for formation of a future stone 24, or as a source of bacterial infection (see FIG. 1 D), and the reformed kidney stone is in a region that is hard to reach with the laser 18.

[0095] Referring now to FIGS. 20 and 2D, shown therein are schematic diagrams showing a distal end of an example embodiment of a target element removal device 100 in a non-extended position and an extended position, in accordance with the teachings herein. The device 100 includes an outer sheath 102 having an outer lumen (e.g., channel) 102c, and an inner sheath 104 having an inner lumen (e.g., channel) 104c. The outer sheath 102 terminates at an outer tip 102t having an opening 102o while the inner sheath 104 terminates at an inner tip 104t having an opening 102o. The distal end portions of the outer and inner sheaths 102 and 104 near the tips 104t and 102t, respectively, are flexible. The outer and inner sheaths 102 and 104 may be made using medical-grade plastic or plastic. For example, in some cases, the outer and inner sheaths 102 and 104 may be made using one or moremedical-grade material compositions to achieve a desired rigidity and flexibility. Alternatively, in some cases, medical grade metal may be used for the inner and / or outer sheaths.

[0096] The outer lumen 102c of the outer sheath 102 acts as a suction channel to suck up fluid and particles from a working area, such as mineral particles. The inner lumen 104c of the inner sheath 104 acts as an irrigation channel to direct a flow of liquid to the mineral particles to displace them so that they are easier to suck up by the outer lumen 102c. Accordingly, the outer sheath 102 has a diameter that is larger than the diameter of the inner sheath 104 so that the outer sheath 102 is able to suction larger mineral particles while not being as likely to get clogged while the flow of irrigation fluid from the smaller diameter inner sheath 104 is more likely to create vortexes which increase the likelihood of displacing the mineral particles so that they are more likely to be suctioned.

[0097] Advantageously, in at least one embodiment, the inner sheath 104 is movably disposed within the outer sheath 102 since the inner sheath 104 can be retracted and extended along the longitudinal direction of the outer sheath. For example, the distal end of the inner sheath 104 can be extended to a first selectable distance past the distal end of the outer sheath 102 and then, optionally, the inner sheath 104 can be retractable within the distal end of the outer sheath by a second selectable distance. The first and second distances may be the same or different. FIG. 2C shows that the inner sheath 104 has been positioned so that the tip 104t of the inner sheath 104 is located at approximately the tip 102t of the outer sheath 102 at a distal end portion 106 of the outer sheath 102. However, FIG. 2D shows that the tip 104t of the inner sheath 104 has been extended past the tip 102t of the outer sheath 102 by a distance d. The ability to extend the inner sheath 104 in this manner allows for the inner sheath 104 to be placed closer to the m ineral particle deposit so that the irrigation fluid provided by the inner sheath 104 during operation is more likely to act directly on the mineral particles to displace them. Also, the inner sheath 104 has a smaller diameter compared to the outer sheath 102 so that the inner sheath 104 is able to be placed in smaller spaces to flush out target elements. This is especially advantageous in patients whose calyces have narrow openings and / or distant from the renal pelvis.

[0098] There may be a tradeoff between the relative dimensions of the diameters of the outer sheath 102 and the inner sheath 104 to allow for different-sized mineral particles to be displaced by the irrigation fluid from the inner sheath 104 and suctioned by the outer sheath 102 while also being able to maneuver the sheaths 102 and 104 within tight spaces. Forexample, the Inner Diameter / Outer Diameter (ID / OD) of the outer sheath 102 may be in a range such as, but not limited to: 9 / 11 - 14 / 16 Fr (3 / 3.667 - 4.667 / 5.333mm). As another example, the outer diameter (OD) of the inner sheath 104 may be in a range such as, but not limited to: 1 -4.5 Fr (0.3 mm - 1.5mm). The length of the outer and inner sheaths 102 and 104 may be in a range such as, but not limited to, about 20 to about 55cm, with the length of the inner sheath 104 being longer than the length of the outer sheath 102.

[0099] In at least one embodiment, the diameter of the outer sheath 102 may be predetermined based on the sizes of different ureteroscopes and geometry of the patient’s ureter. It should be understood that the outer sheath 102 may be sized to accommodate a scope, such as the ureteroscope, and optionally the inner sheath 104 at the same time as well as target elements to be suctioned.

[0100] In at least one embodiment, there may be a set of outer sheaths 102 with different curvatures and one of these outer sheaths may be selected based on the shape of the patient’s anatomy and the working area.

[0101] In at least one embodiment, the outer (suction) and inner (irrigation) lumens 102c and 104c can be selected so that the ratio of the diameter of the outer (suction) lumen 102c to the inner (irrigation) lumen 104c can be within a desired range. In various example embodiments, this ratio may range from about 2 to about 14, based on the possible dimensions given for outer and inner sheaths.

[0102] In at least one embodiment, there may be a set of outer sheaths 102 with different diameters and a set of inner sheaths 104 with different diameters and one of the outer sheaths 104 and one of the inner sheaths 102 may be selected based on the patient’s anatomy that is being accessed by the device 100 and the size of the working area and a desired ratio of the diameter of outer sheath 102 to the diameter of the inner sheath 104.

[0103] In addition, in at least one embodiment, the outer sheath 102 may be made with a material composition allowing for a transition between a rigid section and a flexible section. For example, one method of fabrication is the use of medical-grade flexible tubing embedded with thin coils. The increased flexibility in the distal 5-10cm of the outer sheath 102 may be achieved by either adjusting the spacing between the metal coils embedded within the outer sheath 102 (e.g., larger spacing for enhanced flexibility) and / or applying fewer outer layers compared to the remaining length of the outer sheath 102 when fabricating the outer sheath.The rigid section of the outer sheath 102 facilitates multiple entries and exits of tools into the ureter like the ureteroscope, decreases intrarenal pressure during irrigation, and protects the ureter from damage during lithotripsy and the retrieval of stones. Secondly, the flexible section allows a surgeon to access hard-to-reach areas of the kidney where kidney stone fragments accumulate due to gravity.

[0104] In at least one embodiment, at least a portion of the various target element removal devices described herein may be made using radiopaque material. For example, such embodiments of the target element removal devices described herein may have a radiopaque body, radiopaque markers on the inner and / or outer sheaths 104 and 102, inner and / or outer sheaths 104 and 102 with radiopaque tips or inner and / outer sheaths 104 and 1002 with both radiopaque markers and radiopaque tips. For example, radiopaque markers may be located at various intervals along the length of the inner and outer sheaths 104 and 102.

[0105] Referring now to FIGS. 2A-2B, shown therein are a schematic diagram and a magnified diagram of the target element removal device 100 illustrating device delivery into a working area and device operation including simultaneous irrigation and suctioning for removing kidney stone fragments to prevent kidney stone reformation in accordance with the teachings herein. If a surgeon is employing the device 100 right after LIRSL, then the outer sheath 102 can be kept in place while the camera 16 and laser 18 are removed and the inner sheath 104 can be inserted into the outer sheath 102 and extended longitudinally so that the tip 104t of the inner sheath 104 extends past the tip 102t of the outer sheath 102t in the working area. In some cases, it may be possible to keep the camera 16 in place. In other cases, where the device 100 is being used in a standalone manner, a surgeon may insert an introducer or a ureteroscope within the outer sheath 102 (now acting as the access sheath) to position the distal end portion 106 of the outer sheath 102 at the working area. A small camera on the ureteroscope may be used to guide the distal portion 106 of the outer sheath 102 to the opening of a kidney calyx 22 where stone fragments usually accumulate following laser treatment. At this point the introducer or the ureteroscope can be removed and the inner sheath 104 inserted and positioned as described previously. The distance by which the inner sheath 104 extends past the outer sheath 102 may depend on the local geometry of the working area so that irrigation from the inner sheath 104 is causing a vortex / jet to get thedesired action at the working area to displace the mineral fragments for more effective suction thereof.

[0106] Once the outer sheath 102 and inner sheath 104 are positioned as desired within the working area, irrigation fluid is pumped into the working area through the inner lumen 104c (e.g., the irrigation lumen of the irrigation sheath) while suction occurs simultaneously through the outer lumen 102c (e.g., the suction lumen of the suction sheath). The sheaths 102 and 104 may be connected to an electrically controlled pump system (e.g., see FIGS. 4A and 4B) outside of the body which maintains efficient aspiration while keeping a safe intrarenal pressure, which may be kept at a constant pressure. This pump arrangement along with the outer and inner sheaths 102 and 104 along with the simultaneous use of irrigation and suctioning generates a flow of fluid that pushes the stone fragments towards the entrance 102o of the outer lumen 102c, where they are subsequently suctioned out of the kidney. Alternatively, in at least one embodiment, passive irrigation may be used which may include using a saline bag hung from a specific height coupled with active suction. Alternatively, in at least one embodiment, active irrigation may be used with passive suction. Alternatively, in at least one embodiment, the device 100 may be operated such that irrigation and suction are performed in a non-simultaneous manner such as, for example, when either or both of irrigation and suction is used in an interm ittent / pulsed nature.

[0107] Referring now to FIGS. 2E-2F, shown therein are schematic diagrams showing a distal end of an alternative embodiment of a target element removal device 150 with the inner sheath 104 extended in a first extended position and a different second extended position relative to an outer sheath 150. The outer sheath 150 includes an outer lumen 152c and ends / finishes at a tip 150t having an opening 150o. However, the outer sheath 150 includes a sidewall 154 having an axial longitudinal channel 154c where the smaller lumen 154 is integral with a sidewall of the outer sheath 150. The inner sheath 104 is sized to be slidably received within the axial longitudinal channel 154c of the sidewall 154. Therefore, the tip 104t of the inner sheath 104 is still extendible with respect to the tip 102t of the outer sheath to different distances (shown as d1 and d2 in FIGS. 2E-2F respectively). The longitudinal axial channel 154c may be formed with the wall of the outer sheath 152 by various means such as, but not limited to, a modified mandrel that has a small cylindrical groove on one side for making the inner layer of the outer sheath 152, followed by a circular outer layer of the outer sheath 152. Advantageously, the inner sheath 104 is protected within the channel 154c ofthe sidewall 154 while other objects are inserted and retracted within the outer lumen 152c of the outer sheath 152 such as an introducer or an ureteroscope. In some cases, the ureteroscope may be used to see if the tip 104 of the inner sheath 104 is positioned in the right location and then the ureteroscope may be removed before the outer lumen 104c of the outer sheath 104 is used to vacuum / suction the mineral fragments.

[0108] In the various embodiments described herein, the inner sheath 104 may have a circular cross-section as generally shown in the figures or alternatively the inner sheath may have a different shaped cross-section such as, but not limited to, oval, half-moon, or crescentshaped cross-sections. Devices in which the inner sheath or multiple inner sheaths have a cross section with a lower profile than a circular cross section reduces the profile of the crosssection of the inner sheath(s) thereby providing more space in the outer sheath to be used for suction thus allowing larger stones, larger particles or larger target elements to be suctioned without clogging the outer lumen 102, which may also in the case of when there are tools in the outer lumen 102 that may or may not be in use. Furthermore, these different cross-sections for the inner sheath may be shaped so that the overall cross-sectional area is the same as a circular cross-section so that the irrigation flow rate does not change appreciably. For example, FIGS. 2G-2I show the progression from a device 160 having an inner sheath having a round circular cross-section, to a device 164 having an inner sheath having a half-circular cross-section to a device 166 having an inner sheath having a crescentshaped cross-section, respectively. In the embodiments of the devices 160 to 164, the different shaped cross sections of the irrigation lumen result in suction lumens having shapes that differ somewhat from a circular cross-section.

[0109] It should be noted that while the embodiments herein generally describe that the inner sheath is movable, there may also be embodiments in which the inner sheaths are fixed in place but have a distal end that ends (is extended) past the distal end of the outer sheath as for devices 160, 162 and 164. In these embodiments, the irrigation sheath is formed in a sidewall of the suction sheath or alternatively may be thought of being one sheath but having a suction lumen and an irrigation lumen. However, the different cross-section shapes for the irrigation sheath / lumen apply to embodiments in which the irrigation sheath / lumen is movable or fixed. Also, it should be noted that FIGS. 2G-2I are not to scale.

[0110] Also, it should be noted that in some embodiments, the inner sheath may actually be located outside of the outer sheath (e.g., see device 164 in FIG. 2I). However, thefunctionality of the sheaths remains the same, e.g., irrigation for the smaller sized sheaths and suction for the larger sized sheaths of a given device. Accordingly, the inner sheath may more generally be referred to as an irrigation sheath and the outer sheath may be referred to as a suction sheath. In at least one embodiment, an example of which is shown in device embodiment 164, the irrigation sheath may be located externally to the suction sheath and also is not movable, but the distal end of the irrigation sheath ends I is located I is extended past the distal end of the suction sheath.

[0111] For embodiments in which the inner sheath (irrigation sheath) is not movable with respect to the outer sheath (e.g., suction sheath), the two sheaths may be fused together such as being made of one extrusion, for example. Such embodiments have an improvement in the working area of the suction sheath since it has more space to accommodate larger stones / particles / target elements as the irrigation sheath is located exterior to the suction sheath. This also reduces costs and complexity considerably for manufacturing.

[0112] In the various embodiments described herein, the extended portion of the irrigation sheath may also be made of material having different material properties compared to the material used to make the rest of the irrigation sheath so that the extended portion may be more flexible.

[0113] FIGS. 2J-2L show an example of the largest stone 176j, 176k, 1761 , that can fit within the suction sheath 172j, 172k, 1721 given that the irrigation sheaths 174j, 174k, 1741 have different cross-sectional shapes for the case where the suction sheath has the same cross-sectional size in each of devices 170j, 170k, 1701 for these examples. The size of the stone 176j, 176k, 1761 that can be passed increases from 2.5 to 2.63 to 2.74 as the irrigation sheath cross-sectional shape is varied from circular, to oval to half-circular. It should be noted that these numbers are approximations where each of the cross-sections of the irrigation sheaths are roughly about the same. However, one can see that how varying from a semicircular cross-section to a crescent shape cross-section for the irrigation sheath allows larger objects to pass through the same suction sheath in cases where the irrigation sheath is located inside the lumen of the suction sheath.

[0114] In at least one embodiment, the target element removal device has multiple inner sheaths including the inner sheath 104 and additional inner sheaths. In such embodiments, there may be 2, 3, 4, 5, 6, 7, 8 or more multiple inner sheaths in total. The multiple innersheaths may be evenly distributed about the inner or outer circumference of the outer sheath 102. For example, in embodiments having three irrigation sheaths, such as for device 180 shown in FIG. 2M having a suction sheath 182, and three irrigation sheaths 184a, 184b, 184c each of the axis of the three irrigation sheaths 182a-18c may be located 60 degrees apart from one another along the inner circumference of the suction sheath 182.

[0115] In embodiments having multiple irrigation sheaths, the multiple irrigation sheaths may be used to provide different streams of irrigation to create various desired flow patterns that may not be possible for embodiments that use a single inner sheath. For example, as shown in FIG. 2N, the three irrigation sheaths 184a-184c of device 180 each provide irrigation streams 184af, 184bf and 184cf, respectively, a looping flow pattern 186 may be created as outer portions of such target element removal devices provide irrigation and the central portion of such devices provide suction. In this example, the first irrigation sheath 184a may be used to provide the irrigation stream 184a to stir up stones, and the additional irrigation sheaths 184b, 184c may provide irrigation flows 184bf, 184cf that are to the side of the irrigation sheath 184a or slightly off axis creating an irrigation shroud, so that stones that are stirred up don't go upstream past the distal end of the suction sheath.

[0116] Alternatively, in embodiments having multiple inner sheaths, the length and location of the distal ends of the multiple inner sheaths can be controlled, according to teachings herein for the single inner lumen embodiments, so that the distal ends of the multiple inner sheaths can be used to irrigate different locations simultaneously or sequentially to reduce the chances of missing some stone fragments, particles or other target elements that should be displaced by irrigation and then removed via suction from the outer sheath. For example, the distal ends of the multiple inner sheaths can be controlled to be located in multiple locations such as multiple calyces (e.g., different calyces) at the same time, e.g., one distal end of an inner sheath per calyx, to flush out these calyces simultaneously or sequentially via irrigation to reduce the chances of failing to suction any fragments, particles or target elements that should be suctioned and to reduce the chances that such fragments, particles or target elements are moved from one calyx to another calyx.

[0117] Referring now to FIG. 20, shown therein are a series of diagrams (a), (b), (c), (d) showing a distal end of an example embodiment of a target element removal device 200 having a semi-rigid outer sheath 202 with a lumen or channel 202c where the outer sheath 202 is pre-bent and retains its bend when an introducer 204 or ureteroscope is removed.This feature may be used in other embodiments described herein. The inner sheath is not seen in these drawings. The pre-bent distal end portion 202e of the outer sheath 202 is not seen in (a) as being bent since the distal end of the introducer 204 having inner channel 204c extends past the end of the outer sheath 202. The outer sheath 202 is flexible and so has a straight end portion due to the introducer 204 having a straight cylindrical shape. However, as the introducer 204 is removed in drawings (b), (c) and (d), the distal end portion 202e of the outer sheath 202 begins to move back to its pre-bent shape at the distal end portion 202e of the outer sheath 202 that had been formed to have this curved shape during the manufacture of the outer sheath 202. This may be implemented several ways such as, but not limited to, changing the material used to fabricate the distal portion of the outer sheath 202 relative to the rest of the outer sheath 302 (e.g., using shape memory material), changing (e.g., increasing) the thickness at the distal portion of the outer sheath 202, adding metal coiling at the inner surfaces of the distal end portion of the outer sheath 202, changing the spacing between these metal coilings, and alternating between flexible and rigid sections for the outer sheath 202 at the distal end portion, for example.

[0118] The pre-bent distal portion of the outer sheath 202 is advantageous since having a pre-bent shape for the distal end portion 202e of the outer sheath 202 allows for increased maneuverability in curved regions of an organ or passageway that the outer sheath 202 is being moved to. For example, in the case of treating kidney stones, the distal end portion 202e of the outer sheath 202 may be curved and oriented such that, during positioning, it is curved towards the lower calyx of the kidney where mineral fragments tend to accumulate. For example, in at least one embodiment, the distal end portion 202e is about 5 to about 10 cm in length relative to the end of the outer sheath 202 and may have a pre-bent portion that is at about, but not limited to, a 90 degree angle, or at about a 120 degree angle or about a 135 degree, for example, when the introducer 204 or an ureteroscope is removed. The curvature of the pre-bent distal portion of the outer sheath 202 may be formed by fabricating the layers of the outer sheath 202 on a bent mandrel, for example. In at least one embodiment, there may be a set of outer sheaths that have pre-bent distal end portions that are pre-bent at various degrees of curvature. Prior to usage, the outer sheath 202 having a pre-bent distal end portion with a curvature that matches the curvature of the anatomy of the organ / physiological pathway may be selected and oriented in the proper manner duringdeployment, such as by using a steering actuator like that shown in FIGS. 3A-3F, 3I and 3J, for example.

[0119] Referring now to FIGS. 3A-3C, 3I and 3J, shown therein are drawings of another example embodiment of a target element removal device 300 with a flexible distal tip, which can be bent by an internal ureteroscope and locked in position with a locking mechanism, and a dial that indicates the amount of bending. Alternatively, the dial may be used as part of a steering actuator 306 for controlling the amount of bending of the distal end of the device 300 where three example different positions are shown. The device 300 also includes an inner sheath position actuator 308 for controlling the amount of extension of an inner (irrigation) sheath past the outer (suction) sheath. As with the previous embodiments, the device 300 includes an outer sheath 302, an inner sheath 304 where a distal end portion 302e of the outer sheath 302 is bendable and a tip of the inner sheath 304 is extendable past the tip of the outer sheath 302. However, the amount and direction of the bending of the distal end portion 302e of the outer sheath 302 is controllable either passively by using an internal ureteroscope within the outer sheath 302 during guidance of the outer sheath 302 to the working area or an active means can be used via moving a dial of the steering actuator 306 and the amount of extension of the inner sheath 304 relative to the end of the outer sheath 302 is controllable by the inner sheath position actuator 308. In addition, the outer sheath 302 has a suction port 302v having an opening 302co that is connectable with a suction source via tubing.

[0120] The steering actuator 306 has a housing 306h, a dial 306d that is rotatably mounted to the housing 306h and a locking slider 306I that slidably locks within a slot 306s that is on the upper surface that extends along the proximal region of the housing 306h. The dial 306d may be referred to as a direction indicator, deflection dial or a steering dial. The dial 306d has an indicator 306i indicating the orientation and amount of bending of the distal end portion 302e of the outer sheath 302. The locking slider 306I is slidably received within the slot 306s and provides a friction fit when positioned adjacent to the dial 306d and acts as a deflection lock so that the dial 306d is locked in position either after a ureteroscope or introducer is used to bend the distal end portion 302e of the sheath 302 or after the dial 306d is turned by a user. Accordingly, the locking slider 306I acts as a locking mechanism. For example, in FIG. 3A, the dial 306d is turned to the left as is the distal end portion 302e of the outer sheath 302, while in FIGS. 3B, 3I and 3 J , the dial 306d is in a neutral position pointingalong the shaft of the outer sheath 302 and the distal end portion 302e of the outer sheath 302 is straight, and in FIG. 3C, the dial 306d is turned to the right as is the distal end portion 302e of the outer sheath 302, while in FIG. 3B. During active steering, the amount / level of bending / deflection of the distal end portion 302e of the outer sheath 302 may be controlled by the amount of rotation of the dial 306d with more of a rotation providing more of a bend in the distal end portion 302e of the outer sheath 302. During passive steering, the dial 306d is rotated due to the positioning of the distal end portion 302e of the outer sheath 302 by an internal ureteroscope or introducer. Advantageously, in either the passive or active steering cases, the locking mechanism locks the dial 306d in place and the indicator 306i provides an indication to the user of the approximate position of the distal end 302e of the sheath. An additional advantage of the dial 306d is the reduced use of fluoroscopy to confirm the location of the distal end portion 302e of the outer sheath 302, which reduces the patient’s and operator’s exposure to radiation.

[0121] The inner sheath position actuator 308 comprises a housing 308h having a groove 308g on an upper surface thereof, a slider 308s that is linearly moveable along the extent of the groove 308g and a port 308p at a proximal end where a port 304p of the inner sheath 304 is held in place. A user may use the slider 308s to extend and retract a distal end portion of the inner sheath 304 past an end of the outer sheath 302 as described previously. The slider 308s may also be locked in place due to the internal structure of the actuator 308 (for example a rack and pinion or rachet structure may be used). In FIGS. 3A-3C, the slider 308s is positioned as distally far as possible so that the end of the inner sheath 304 extends as far away from the end of the outer sheath 302 that is possible. In FIGS. 3I and 3J, the slider 308s is positioned as proximal as possible so that the end of the inner sheath 304 do not extend past the end of the outer sheath 302.

[0122] Referring now to FIGS. 3D-3F show perspective, top and exploded views, respectively, of the steering actuator 306 of the target element removal device of FIGS. 3A- 3C, where certain internal structures are shown with hidden lines. The housing 306h has a rounded trapezoidal distal end portion, a central ring structure 306r, a proximal portion that is rectangular shaped with a slot 306c that has a T-shaped profile and a channel 306c that runs longitudinally along a central axis of housing 306h where the channel 306c is positioned in a lower half of the housing 306h. The locking slider 306I has an I-beam shaped profile with lower and upper flanges 306fl1 and 306fl2 connected with a web 306w therebetween andhaving a locking pin 306lp at a distal portion which points to the distal end of the housing 306h when assembled. The dial 306d has an upper portion that is disc-shaped and a lower portion that is also disc-shaped with a smaller radius compared to the upper portion with two posts at about the 3 and 6 o-clock positions and having teeth 306t that are disposed at least along a circumferential proximal portion thereof (although in this example, the teeth 306t are positioned along a majority of the circumference of the lower portion of the dial 306d) although in an alternative embodiment the teeth may be disposed along about half of the dial that is proximal to the actuator 308. This portion of the dial 306d may also be referred to as a gear. There are also steering wires 306sw that each have one distal end that is connected to equidistant locations at the distal end portion of the outer sheath 302 and internal to the outer sheath 302 (e.g., crimping may be used to make these connections). There may be other locations where the steering wires 306sw may be slidably maintained (e.g., using loops) along the internal surface of the outer sheath 302 so that they do not get in the way of any objects that are passed through the central portion of the lumen 302c of the outer sheath 302. The steering wires 306sw also have proximal ends that are each attached to an aperture 306a of one the posts 306p. Accordingly, when the dial 306d is turned to one side, either by passive or steering described previously, the steering wire 306sw on that side is retracted (e.g., pulled) while the steering wire 306sw on the other side is extended which causes the distal end portion 302e of the outer sheath 302 to bend along the same side the dial 306d is rotated. The outer sheath 302 also has a port 302p on a proximal end thereof. The rotated position of the dial 306d may be locked in place by the post 306p of the sliding lock 3061 thereby maintaining the deflection of the tip of the outer sheath 302.

[0123] During assembly, the proximal end of the outer sheath 302 does not have the port 302p and is passed through the channel 306c at the distal end of the housing 306h and the channel 306c at the proximal end of the housing 306. The proximal end of the outer sheath 302 then extends past the proximal end of the housing 306h and the port 302p is attached. The port 302p will slidingly engage a portion of the inner sheath actuator 308 to attach the steering actuator 306 with the sliding actuator 308 and also hold the proximal end portion of the outer sheath 302 in place in the steering and sliding actuators 306 and 308. The left and right steering wires 306sw are then attached to the left and right posts 306p via the apertures 306a and the dial 306d is then placed on top of the ring portion 306h of the housing. The upper portion of the dial 306d has a circumferential lip that sits on the upper surface of thering portion 306p. The sliding lock 306I is then slid along the slot 306s until the locking pin 306lp engages one of the teeth 306t of the dial 306d when the distal end 302e of the outer sheath 302 is in a neutral position (e.g., as shown in FIG. 3B. The sliding lock 306I makes a friction fit so that it is positioned at the proximal-most portion of the dial 306d.

[0124] Referring now to FIGS. 3G-3H, shown therein are perspective and top views, respectively, of the inner sheath position actuator 308 of the target element removal device 300 of FIGS. 3A-3C with the internal structure being shown with hidden lines. The housing 308h of the actuator 308 has a mainly rectangular shape and includes a channel 308c that runs along a lower portion of the longitudinal extent of the housing 308h and is aligned with the channel 306c of the housing 306h of the steering actuator 306. The proximal end of the housing 306h has an open end with a collar 308p. The channel 308c has a diameter for slidably receiving the inner sheath 304. The collar 308p has an aperture through which the inner sheath 304 is slid. The proximal end of the inner sheath 304 has a port 304p that engages the collar 308p. The port 304p of the inner sheath 304 has an aperture and is shaped to be connected to an irrigation line (tubing) to receive an irrigation fluid during use, examples of which are shown in FIGS. 4A and 4B. The slider 308s has an upper portion that slides along an upper surface of the housing 308h, a lower portion that engages the outer sheath 304 and a web (not shown) that connects the lower and upper portions of the slider 308s and also slidably engages the groove 308g. The distal end of the groove 308g acts as a limit to limit the distal position of the slider 308s. The main locking mechanism for the slider 308s is a friction fit with the groove 308g. In at least one alternative embodiment, a rack and pinion structure may be used to hold the slider 308s in place after it is moved. The housing 308h also includes a slot 308sl at a distal portion thereof for engaging the steering actuator 306 and the outer sheath 302. Additionally, in at least one embodiment, along the longitudinal direction of the housing 308h, there may be graduations / markings to indicate the amount by which the inner sheath 304, e.g., the irrigation sheath, extends beyond the outer sheath 302, e.g., the suction sheath.

[0125] During assembly, the distal end of the inner sheath 304 is passed through the collar 308p so that the distal end of the port 304p engages and is adjacent to the proximal side of the collar 308p. The lower portion of the slider 308s may then be vertically moved through the groove 308g into the housing 306g to engage around the outer surface of the inner sheath 302. The distal end of the inner sheath 304 is then slid through the port 302p ofthe outer sheath until the port 302p slidably engages the slot 308sl at the distal end of the housing 308h of the actuator 308 to connect the actuators 306 and 308 in an abutting fashion. Furthermore, the portion of sheath 304 enclosed in the housing 308h has a slack or a small loop, such that sliding of the slider 308s does not disengage the connection of the inner sheath 304 to the collar 308p. An irrigation line can then be connected to the port 304p of the inner sheath 304 and a suction line can be connected to the suction port 302v of the outer sheath 302.

[0126] It should be noted that the steering wires 306sw are one example of a steering mechanism that is coupled to the direction indicator and the distal end portion of the outer sheath for causing the distal end portion of the outer sheath 302 to bend or curve in a desired direction. In other embodiments, the steering mechanism may be implemented in different ways. For example, the steering mechanism may be a pneumatic, hydraulic or electric mechanism rather than a mechanical mechanism (e.g., the steering wires 306sw). For example, a pneumatic mechanism may include thin air channels that travel the length of the sheath, attached to small pistons, or air bladders / balloons at the distal end portion of the sheath, that when inflate flex the sheath in the contralateral direction. In another example, hydraulic mechanisms may be implemented in a similar manner as a pneumatic mechanism, but liquid is used instead of gas to achieve steering of the end portion of the sheath. In another example, an electric mechanism may be implemented by using small conductive wires that run axially along different sides of the sheath that are electrically coupled to actuatable artificial muscle fibers located at different sides of certain sections of the sheath where steering / bending are desired. A current can then be transmitted via one of the wires to the artificial muscle fibers on one side of the sheath thereby creating pulling on those sections causing the distal end portion of the sheath to curve. It should be noted that these various steering mechanisms may be controlled electronically and / or controlled manually.

[0127] In at least one embodiment described herein, the inner sheath may also be flexible / bendable and steerable. For example, the inner sheath may have the same flexibility as the outer sheath. In another example embodiment, the inner sheath be made of metal tubing allowing the wall thickness to be thinner. In another example embodiment, the device may have a separate steering actuator and separate steering mechanism for the inner sheath so that it may be steered / bent somewhat independently of the outer sheath. This may be advantageous in applications where the inner sheath may have to bend in a different waythan the outer sheath to access different locations. For example, the lower calyxes of the kidney may be quite challenging to access, since the scope may have to bend almost 180 degrees in the renal pelvis to gain access to these calyxes, and also the calyxes might not be in the same plane, e.g., the planes may differ by about 60 degrees, so it is beneficial for both the outer sheath and the inner sheath to be steerable resulting in a very flexible device. In such embodiments, the inner sheath may have a similar steering actuator and steering mechanism as was described previously for the outer sheath.

[0128] Referring now to FIG. 4A, shown therein is a schematic diagram of an example embodiment of a target element removal system 400 including fluidic components that are used along with an embodiment of a target element removal device taught herein. For illustrative purposes, only the device 300 is shown. The system 400 includes a pumping unit 402, a target element container 404, an irrigation line 406, a suction line 408 and a return line 410. The pumping unit 402 includes an irrigation port 402ip and a suction port 402vp. The target element container 404 has an input port 404ip and an output port 404op. One end of the irrigation line 406 is coupled to the irrigation port 402ip of the pumping unit 402 and another end of the irrigation line 406 is coupled to the port 304p of the inner sheath 304. One end of the suction line 408 is coupled to the suction port 302v of the outer sheath 302 and another end of the suction line 408 is coupled to the input port 404ip of the target element container 404. One end of the return line 410 is coupled to the output port 404op of the target element container 404 and the other end of the return line 410 is coupled to the input port 402vp of the pumping unit 402.

[0129] The system 400 employs a recirculating fluid design in which a single motor may be used to control a pump in the pumping unit 402 to provide both irrigation and suction, helping to balance output and input flow rates (i.e., balance irrigation and suction rates), which aids in keeping the intra-renal pressure at a low safe level. Several factors contribute to variability in intra-renal pressure during operation, such as the use of a ureteric access sheath (e.g., the outer sheath 302), the irrigation rate, and the method of irrigation (e.g., gravity-induced, manual syringe pump, etc.). Typically, pressure ranges of about 5 to about 10 cmbhO are deemed safe, with a threshold of about 40 cmbhO. Exceeding this threshold may potentially lead to infectious and hemorrhagic complications, and in cases of very high pressure, forniceal rupture. The pumping unit 402 includes a filtration device to capture / filter any mineral fragments and other target elements and to clean the fluid before it is sent backto patient and used as irrigation fluid. The pump may be a peristaltic pump, a diaphragm pump or another suitable type of pump that preferably has an integrated flow rate indicator and a dial / button to change the irrigation and suction / aspiration rates. Since the system 400 does not have an external irrigation source, it is primed prior to operation, with the target element container 404 serving as an irrigation reservoir. The target element container 404 may be a bottle that has a size depending on the size of the anatomy with which the system 400 is used. For example, the target element container 404 may have a volume of about 50 ml to about 1500 ml. Saline fluid may be used as the irrigation fluid. The outlet port 404op of the target element container 404 may include a filter that will capture mineral particles and / or other target elements, or a mesh divider may be positioned between a top and bottom of the target element container 404 such that stone or mineral fragments and / or other target elements from the inlet port 404ip are collected on top of the mesh as they fall downward due to gravity after passing through the inlet port 404ip.

[0130] Referring now to FIG. 4B, shown therein is a schematic diagram of another example embodiment of a target element removal system 450 including fluidic components that are used along with in an embodiment of a target element removal device taught herein. For illustrative purposes only the device 300 is shown. The system 450 includes a pumping unit 452 having ports 452ip and 452vp, the waste container 404 having ports 406ip and 406op, as well as the irrigation line 406 and the suction line 408, which are coupled as explained for system 400. However, the system 450 does not use a recirculating fluid design and so includes an irrigation fluid source 454, a suction unit 456, a source fluid line 458 and a suction unit line 460. The irrigation fluid source 454 may contain saline. In at least one embodiment, the suction unit 456 may be provided by a wall vacuum / suction unit. The fluid source line 458 has a first end that is coupled to the irrigation fluid source 454 and a second end that is coupled to the 452vp of the pumping unit 452. The suction unit line 460 has a first end that is coupled to port 406op of the target element container 404 and a second end 456 that is coupled to the suction unit 456.

[0131] In this case, separate pumps are used for irrigation and suctioning / aspiration. In this case, greater care must be taken to balance output and input flow rates (i.e., balance irrigation and suction / vacuum / aspiration rates), which aids in keeping the intrarenal pressure at a low safe level as described previously.

[0132] During use of either system 400 or 450, a user, such as a surgeon or other medical practitioner, operates the pumping unit 402 (or pumping unit 452 and suction unit 456) to control the rate of irrigation / aspiration via a user interface (e.g., dials). The user also manually operates the steering actuator 306 and the inner sheath actuator 308 to position the distal end 302e of the device 300 at the working area prior to operating the pumping unit 402 / pumping unit 452 and suction unit 456. In an alternative embodiment, a controller, such as but not limited to controller 502 which is described with reference to FIG. 5, may be used to electronically control the operation of the system 400. The controller may be configured to operate automatically through software program instructions, or it may be operated under manual control of a medical practitioner, such as a surgeon, for example. In such cases, the device 300 may include stepper motors that can be used to move the actuators 306 and / or 308 as desired as well as operate the pump of the pumping unit to use a desired irrigation and suction rates. One skilled in the art may consider the use of a DC motor, a servo motor, a linear actuator, a linear pneumatic actuator, among others. In such cases, the controller 502 may be provided with operation parameters as well as safety metrics for certain operating parameters (e.g., pressure) and fluid characteristics (e.g., temperature).

[0133] Referring now to FIG. 5, shown therein is a block diagram of another example embodiment of a target element removal system 500 in accordance with the teachings herein. The system 500 includes the controller 502 and the target element removal device 300 having the steering actuator 306 and the inner sheath position actuator 308. The device 300 is used for illustrative purposes only and another device embodiment may alternatively be used. The controller 502 includes a processing unit 504, a device interface 506, I / O hardware 508, a display device 510, a communication unit 512, a power supply unit 514, and a memory unit 516. The memory unit 516 includes random access memory (“RAM”) and nonvolatile storage for storing data files and software code for various programs such as those used to provide an operating system 518, programs 520 as well as software modules such as a control application 522, an I / O module 524, and also files 526 which may include one or more databases 132 that collectively are used perform various functions related to removal of target elements such as, but not limited to, mineral fragments or other target elements from a patient, displaying results and / or storing results. Various components of the controller 502 may be connected by a communication bus (not shown) to facilitate communication therebetween and a power bus (not shown) to receive power from the power supply unit 514.The controller 502 may be implemented as part of a desktop computer, a laptop, a mobile device, a tablet, and the like. In other embodiments, the controller 502 may have a different configuration and / or include other components or not include all of the components shown in FIG. 5 while still providing the functions discussed herein.

[0134] For illustrative purposes only, the system 500 is shown including the components of the system 450 including the pumping unit 452, the suction unit 456, the waste container 404, the tubing 530 (includes all of the lines described in FIG. 4B), and the irrigation fluid source 454. In other embodiments, other setups may be used for these components such as in the recirculating embodiment of FIG. 4A. Also, included are sensors 532 which may be used for sensing the positions of the actuators 506 and 508.

[0135] In at least one embodiment, the sensors 532 may also include a temperature sensor at a distal end portion of the outer sheath 302 and within the outer sheath 302 to measure the temperature of the irrigation fluid in the working area to operate the device 300 safely and avoid any damage to the organs or passageways including / near the working area.

[0136] In at least one embodiment, the sensors 532 may also include a pressure sensor located at a distal end of the outer sheath 302 to measure the local pressure at the working area which can be monitored to operate the device 300 safely and avoid any damage to the organs or passageways including / near the working area.

[0137] In at least one embodiment, the sensors 532 may also include flow rate sensors that are located at a proximal end portion of the device 300 to ensure that the flow rates for the irrigation fluid and the suction at the device are what is intended for safe operation.

[0138] In at least one embodiment, the sensors 532 may include any combination of the position, temperature, pressure and flow rate sensors. However, the temperature and / or pressure sensors may be positioned distally or proximally relative to the distal end 302e of the device 300.

[0139] In at least one embodiment, the local pressure at the working area may be monitored and the amount of suction and / or irrigation may be adjusted to maintain the local pressure in a defined operating range to avoid collapse or rupture of kidney structure surrounding the working area.

[0140] In at least one embodiment, the local pressure at the working area may be monitored and the amount of pressure may be adjusted within a defined operating range to avoid collapse or rupture of kidney structure surrounding the working area.

[0141] In at least one embodiment, the local temperature at the working area may be monitored and the local temperature may be adjusted by adjusting an appropriate amount of relative suction and / or irrigation to maintain the local temperature within a defined operating range, to avoid thermal injury to the kidney structure (or other organ / tissue) surrounding the working area.

[0142] It should be noted that there may be instances when the at least one target element is stuck in the suction lumen. In such cases, in at least one embodiment, any combination of a positive pressure is applied to the suction lumen, an increased amount of suction is applied, an increased irrigation flow rate is used, a scope is used (e.g., pushed), a laser (e.g. on a scope is turned on), an irrigation sheath is pulled, pushed or vibrated, and a rigid bar is used to dislodge the stuck at least one target element.

[0143] The processing unit 504 controls the operation of the controller 502 and can include any suitable processor that can provide sufficient processing power depending on the configuration, purposes and requirements of the controller 502 as is known by those skilled in the art. For example, the processing unit 504 may include a high-performance general processor. In alternative embodiments, the processing unit 504 may include more than one processor with each processor being configured to perform different dedicated tasks. In alternative embodiments, specialized hardware can be used to provide some of the functions provided by the processing unit 504. The processing unit 504 is configured to perform at least some of the functions described for method 600.

[0144] The device interface 506 may include any interface and hardware that allows the controller 502 to send and receive signals with other devices external to the controller 502 such as sensors, as well as other electronic devices including computers, mobile devices, tablets, servers and the like. For example, the device interface 506 can include at least one communication port including any combination of at least one serial port, at least one parallel port and at least one USB port that provides USB connectivity, a networking interface device, an analog to digital converter (ADC) or a digital to analog converter (DAC). The device interface 506 can also include at least one of an Internet, a Local Area Network (LAN), anEthernet, a Firewire, a modem or a digital subscriber line connection. In some embodiments, various combinations of these elements may be incorporated within the device interface 506.

[0145] For example, the one or more sensor(s) 532 can include a thermal sensor for measuring temperature values which can be received via an ADC and analyzed by the processing unit 504. Likewise, digital actuator control signals may be generated which might need to be converted to analog signals via a DAC in the device interface 506 that can be received by a stepper motor to moving the intended actuator 306 or 308. As another example, the processing unit 504 can generate a digital pump control signal that may be sent as a digital signal via the device interface 506 to the pump(s) 452 / 456.

[0146] The I / O hardware 508 enables a user to provide input via one or more input devices, which may include, but is not limited to, a mouse, a keyboard, a trackpad, a thumbwheel, a trackball, voice recognition, a touchscreen, one or more push buttons, and / or a scroll wheel, for example, depending on the implementation of the controller 502. The I / O hardware 508 also outputs information to one or more output devices, which may include, for example, the display device 510, a printer and / or a speaker. In some cases, the display device 510 may be used to provide one or more GUIs through an Application Programming Interface. A user may then interact with the one or more GUIs via the I / O hardware 508 for configuring the controller 502 to operate in a certain fashion and / or providing input data. For example, the user may input data for system parameters that are used for proper operation of hardware and software that is used for performing mineral fragment or other target element removal, such as calibration data and operating parameters.

[0147] The display device 510 can be any suitable display that provides visual information depending on the implementation of the controller 502. For instance, the display device 510 can be a flat screen monitor, a touch screen and the like if the controller 502 is a desktop computer. In other cases, the display device 510 can be a display suitable for a laptop, tablet or handheld device such as an LCD-based display and the like. The display device 510 can provide notifications and display operating parameters to the user of the controller 502.

[0148] The communication unit 512 can be a radio that communicates utilizing CDMA, GSM, GPRS or Bluetooth protocol according to standards such as IEEE 802.11 a, 802.11 b, 802.11 g, or 802.11 n. The communication unit 512 can be used by the electronic device 102 to communicate with other devices or computers. The communication unit 114 can be a radiothat communicates utilizing CDMA, GSM, GPRS or Bluetooth protocol according to standards such as IEEE 802.11 a, 802.11 b, 802.11g, or 802.11 n. The communication unit 512 can provide the processing unit 104 with a way of communicating wirelessly with various devices that may be remote from the system 500. In some embodiments, the communication unit 512 may be optional.

[0149] The power supply unit 514 can be any suitable power source or power conversion hardware that provides power to the various components of the controller 502. The power supply unit 514 may be a power adaptor or a rechargeable battery pack depending on the implementation of the controller 502 as is known by those skilled in the art. In some cases, the power supply unit 514 may include a surge protector that is connected to a mains power line and a power converter that is connected to the surge protector (both not shown). The surge protector protects the power supply unit 514 from any voltage or current spikes in the main power line and the power converter converts the power to a lower level that is suitable for use by the various elements of the controller 502. In other embodiments, the power supply unit 514 may include other components for providing power or backup power as is known by those skilled in the art.

[0150] The memory unit 516 includes volatile and non-volatile storage such as ROM, one or more hard drives, one or more flash drives and / or some other suitable data storage elements. The non-volatile storage may be used to store software instructions, including computer-executable instructions, for implementing the operating system 518, the programs 520 and other software modules, as well as storing any data used by these software modules. The operating system 518 and the programs 520 include software instructions for providing basic operations and functions of the processing unit 504. The data may be stored in the files 526, such as for data relating to patients that are being treated by the system 500. The data files 526 can be used to store data for the operation of the system 500 such as, but not limited to, device settings, parameter settings, and calibration data, for example. The control application 522 includes software instructions for providing various functions related to the target element removal device as described herein. A processor of the processing unit 504 is configured to perform these functions when the processor executes the software instructions of the control application 522. The I / O (input / output) module 524 includes software instructions that, when executed by the processor, can configure the processor to store data in the files 296 and / or retrieve data from the files 296.

[0151] In at least one embodiment, the control application 522 includes program code for allowing a user, such as a surgeon, to set operational parameters such as the irrigation flow rate and the suction flow rate and when to activate the pump(s) to provide the irrigation and suction. Also, in embodiments where the actuators 306 and / or 308 have motors that drive them, wherein the motors can be one or more of a stepper motor, a DC motor, a servo motor, a linear actuator, or a pneumatic actuator, the processor, while executing the control application 522, can prompt the user (e.g., for manual control) to provide control inputs to set the amount by which the tip of the inner sheath 304 would extend past the outer sheath 302 during using and if there should be any bending for the end portion of the outer sheath 304 and if so by how much. Once these control inputs are received by the processor, corresponding control signals can be sent to the motors associated with the actuators 306 and / or 308. The control application 522 may include program code to provide the processor with the ability to toggle cooling of irrigation on / off, and / or execute an alarm sound when either the pressure, flow, and / or temperature metrics are abnormal or unsafe, or if a blockage has been detected, or any combination thereof.

[0152] Accordingly, in at least one embodiment, the control application 522 may also include software code to implement a GUI engine, or may include a function call to a GUI engine (not shown) that includes software instructions that, when executed by the processor(s) of the processing unit 504, configure the processor(s) to generate various GUIs that are then output on the display device 510, or another visual output device, to allow the user to perform the various functions described herein including providing operational parameters.

[0153] For ease of understanding, certain aspects of the methods described herein are described as being performed by processor(s) of the processing unit 504 when executing software instructions of the control application 522, for example. It should be noted, however, that these methods are not limited in that respect, and the various aspects of the methods described herein may be performed by other hardware and / or software components that provide the same functionality for removal and / or placement of target elements.

[0154] Referring now to FIG. 6, shown therein is a flowchart of an example embodiment of a method 600 for removing target elements such as, but not limited to, mineral fragments, for example, in accordance with the teachings herein. For ease of illustration the device 300 will be referred to in describing method 600 but it should be noted that other embodiments ofthe target element removal devices described herein can be used with method 300. Also, while method 600 will describe the manual operation of the device 300, it is possible to perform method 600 with another device embodiment including a processor such as that provided by the controller 502, for example. Also, while method 600 is described in the context of treating kidney stones, steps 606 to 618 may be performed on other organs or passages within a physiological body.

[0155] At step 602, the outer (suction) sheath 302 of the device 300 is positioned so that the distal end portion 302e of the outer sheath 302 is near the working area. The outer sheath 302 may be positioned using an introducer or a ureteroscope as explained earlier. The port 302p is large enough to accommodate both the introducer and the ureteroscope. In addition, in at least one embodiment, there may be a friction-fit funnel-like component that comes attached to 302p, to resemble a funnel in a conventional ureteric sheath. This will be removed before attaching the actuator 308. Step 602 may involve selecting an outer sheath 302 with a certain radius and length given the radial size and length of the passageway that leads to the working area so that outer sheath 302 can fit within the passageway and optionally a portion of the working area. In an alternative embodiment, when device 300 is not used, the inner sheath 304 can also be inserted at the same time as the outer sheath 302 (e.g., by using device 150).

[0156] The method 600 then proceeds to step 604 where a suitable laser device for treating a kidney stone is activated to perform laser lithotripsy to break the kidney stone into small, tiny mineral fragments. It should be noted that step 604 is optional but will be performed when Ureteroscopy and laser lithotripsy (LIRSL) is to be performed on the patient. If this is not the case, then step 604 is not performed and the method 600 proceeds from step 602 to step 606.

[0157] At step 606, the ureteroscope may be used to navigate to the calyx of interest that contains mineral fragments. The outer sheath 302 is then advanced distally in such a way that the flexible tip 302e takes the curvature of the scope that it encloses. The shape of the outer sheath 302 is then locked, using the steering actuator 306. This actuator may also be used to make the distal end 302e of the outer sheath 302 curve towards the working space. The placement of the tip 302t of the outer sheath 302 is in the entrance of the calyx or the inside of the calyx, geometry permitting. In an alternative embodiment involving a pre-bentsheath 200, same workflow will be followed as sheath 302 but locking mechanism may not be necessary.

[0158] The method 600 then proceeds to step 608 to determine whether the distal end portion 302e of the outer sheath 302 is in the right location at the working space. This may be determined by using a small camera that is snaked within the outer sheath 302, e.g., if a ureteroscope is used to place the outer sheath 302 then the camera of the ureteroscope may be used. Alternatively, this may be done by performing medical imaging if the camera is not used. For example, the medical imaging may be fluoroscopy. However, the direction of the positioning may also be ascertained by viewing the orientation of the indicator 306i on the dial 306d.

[0159] At step 610 based on the aforementioned visual or medical imaging and possibly the indicator 306i on the dial 306d (when used), the user can determine if the distal end 302e of the device 300 is located properly with respect to the working area. For best results, the tip 302t of the outer sheath 302 may be placed as close as possible to the entrance of the calyx containing the mineral fragments, so that the irrigation sheath 304 may be inserted deep into the calyx so as to generate a stream of turbulent flow that pushes mineral fragments out of the calyx so that they are more easily suctioned by the outer sheath 302. If the determination at step 610 is true, then the method 600 proceeds to step 612. If the determination at step 610 is false and the positioning is not correct, then the method 600 returns to step 606 where the distal end 302e of the outer sheath 302 of the device 300 is repositioned and steps 606 to 610 are performed again until the position of the distal end 302e of the outer sheath 302 is correct.

[0160] When the positioning of the outer sheath 302 is determined to be correct at step 610, the method 600 moves to step 612. The inner (irrigation) sheath position actuator 307 may be used to extend the 304t tip of the inner sheath past the tip 302t of the outer sheath 302 so that it is in close proximity to the mineral fragment deposits. In an alternative embodiment, the inner (inner) sheath may already be located within the outer sheath as explained earlier such as for the device 150 (e.g., see FIGS. 2E-2F) and the actuators 306 and 308 then connected to the outer and inner sheaths 152 and 104 so that bending of the distal end of the outer sheath 152 and extension of the inner sheath 104 may be performed. For example, the actuator 308 may include markings indicating the actual amount of extension of the inner sheath tip relative to the outer sheath tip and during the visual reviewduring the positioning of the distal end of the outer sheath, a desired amount of extension to place the tip of the inner sheath into the calyx containing the mineral fragments may be determined. The actual amount of extension may then be set to be the desired amount of extension is selectable using the actuator 308. In an alternative embodiment, the irrigation sheath may not be moveable and extends past the suction sheath (e.g., FIGS. 2G-2I).

[0161] At step 614, the method 600 involves performing irrigation via the inner sheath 302 and suctioning via the outer sheath 304. The irrigation flow rate is set to be approximately the same as the amount of suction. The irrigation and suction flow rates may be set based on the amount of force needed to displace the mineral fragments for suctioning. Such irrigation and suction rates may be set based on the result of the device’s performance test and / or clinical trials; however, the irrigation and suction rates may be indicated as recommended ranges, and the operator will have the ability to fine-tune the flows as necessary. The irrigation and suctioning may be continuous and done simultaneously. Alternatively, in at least one embodiment the irrigation and suctioning can be intermittent and simultaneous, continuously or variably, in an automated or manual manner (e.g., under automated control by a controller or under manual control of a medical practitioner (e.g., surgeon) who is using the device during a procedure). The term continuously means that the irrigation and suction can be provided at constant rates / amounts. The term variably means that the irrigation and suction can be provided at a rate / amount that varies over time. For example, a first amount / rate of irrigation and / or suction may be used to displace and / or suction small particles / target elements and a second amount / rate of irrigation and / or suction may be used to displace and suction / vacuum larger particles / target elements where the first rate is lower than the second rate. In at least one embodiment, the first rate may be applied before the second rate. Alternatively, in at last one embodiment the irrigation and suctioning may be intermittent and / or offset, continuously or variably, in an automated or manual manner such that they are not done simultaneously. For example, irrigation may be performed for a time period t1 , and suctioning may be done after a delay t2 after time period t1 . For example, this may be done when "the irrigation cycle” is used to place a target element at a physiological location which is then allowed to dwell at the location rather than being suctioned up right away. For example, the target element may be a medication or an imaging dye, or hot / cold irrigation may be used.

[0162] At step 616, the method 600 involves visually inspecting the working area to determine if there are still debris (e.g., mineral fragments and / or other target elements) that are to be removed. This inspection may be done by inserting a camera and positioning it at the tip 302t of the outer sheath 302 or using medical imaging. If there is still debris that is to be removed, the method 600 moves to step 606 (e.g., the outer sheath may have to be repositioned for better removal of the debris), and steps 606 to 616 are repeated. Otherwise, if there is no further debris to remove the method 600 moves to step 618. It is preferable that as much of the debris be removed as possible since when more of the debris is removed, it will take a longer amount of time before the next kidney stone attack occurs. In addition, the suctioning process may uncover larger debris (e.g., larger stone fragments) that were previously obscured by the debris that was just suctioned away. In such cases, these larger fragments that are now uncovered may be scooped out using a basket, or the laser may be used to break up these fragments and the fragment removal procedure is performed again.

[0163] At step 618, the method 600 ends and post procedures may be done in a regular fashion and the device 300 is removed when a standard access sheath is typically removed.

[0164] The device 100 was tested using a 3D-printed kidney model which demonstrated that the device 100 was effective and time-efficient. For example, when positioned into the kidney calyx of the kidney model, the device 100 was found to completely aspirate 1 gram of stone fragments with diameters between 0.2-0.4 mm in just 10 seconds. The test results provide an indication that the device 100, and various alternative embodiments thereof described herein, may be used to improve the quality of life of kidney stone patients, allowing them to live freely without fear of impending kidney stone attacks. Since the device 100, and various alternative embodiments thereof described herein focus on prevention, it is believed that use of the device 100 will save our healthcare system millions of dollars by preventing additional treatment and investigations associated with recurrent kidney stones. However, the devices described herein may be used in other organs and also passageways where mineral fragments and / or other target elements deposit and agglomerate or other regions where debris may need to be removed such as neuro-surgery, for example.

[0165] While the devices described in accordance with the teachings herein are typically used for the removal of target elements, it should be noted that these devices may be used to place at least one delivery element within an organ, physiological cavity or physiological passageway by providing a target element source that is connected to the inner lumen andusing positive pressure in the inner lumen to place the target element at the desired working area. The target element source may be a vial, syringe or container that contains the targe element. For example, in such use cases, the delivery element may be, but is not limited, to a liquid, gel, medication, or imaging dye, for example, and it is desired to place one of these liquids / solids into another desired physiological cavity or passageway for a medical purpose such as, but not limited to imaging and / or treatment, for instance. For example, the delivery element may be a contrasting agent that may be used for better visibility of certain physiological structures during fluoroscopy. In another example, the delivery element may comprise agglutinating factors that are to be placed within a target physiological structure to clump microscopic fragments together and the clumped fragments may then be removed. In another example, the inner sheath may be used to perform highly-local injection of the delivery element which may be more effective than using conventional means since the inner sheath may be extended and allow for placement in physiological structures having small and complex geometries.

[0166] Accordingly, in an alternative embodiment, one of the devices described herein may be used for the removal of at least one target element and / or for delivery of at least one delivery element at a working area of an organ, a physiological cavity or a physiological pathway. The device comprises an outer (suction) sheath having an outer (suction) lumen, a proximal end and a distal end, the outer sheath being connectable to a suction source for providing suction through the outer lumen to remove the at least one target from the working area; an inner (irrigation) sheath having an inner (irrigation) lumen, a proximal end and a distal end and being movably located within the outer lumen of the outer sheath so that the distal end of the inner sheath is extendable with respect to the distal end of the outer sheath, the inner sheath being connectable to a: (1 ) fluid source for providing fluid in the inner lumen for irrigation of the working area when removing the at least one target element at the working area and / or (2) a delivery element source for sending the delivery element to the working area; and an inner (irrigation) sheath position actuator that is coupled to the inner sheath and configured to extend the distal end of the inner sheath to a first selectable distance past the distal end of the outer sheath and optionally retract the inner sheath within the distal end of the outer sheath by a second selectable distance. Alternatively, in at least one embodiment, the irrigation sheath is not moveable with respect to the suction sheath but has an end that extends past the end of the suction sheath. In such embodiments, the irrigation sheathposition actuator is not used, and the irrigation sheath may be fused with the suction sheath and may be positioned outside or inside the suction sheath or within a wall of the suction sheath.

[0167] While the applicant's teachings described herein are in conjunction with various embodiments for illustrative purposes, it is not intended that the applicant's teachings be limited to such embodiments as the embodiments described herein are intended to be examples. On the contrary, the applicant's teachings described and illustrated herein encompass various alternatives, modifications, and equivalents, without departing from the embodiments described herein, the general scope of which is defined in the appended claims.REFERENCES1. Khan, S.R., Pearle, M. S., Robertson, W. G., Gambaro, G., Canales, B. K., Doizi, S., Traxer, 0., & Tiselius, H.G. (2016). Kidney stones. Nature Reviews. Disease Primers, 2(1 ), 16008-16008. https: / / doi.Org / 10.1038 / nrdp.2016.8. 2. Iremashvili, V., Li, S., Penniston, K., Best, S., Hedican, S., & Nakada, S. (2019). Role ofResidual Fragments on the Risk of Repeat Surgery After Flexible Ureteroscopy and Laser Lithotripsy: Single Center Study. The Journal of Urology, 201 (2), 358-363. https: / / doi.Org / 10.1016 / j.juro.2018.09.053.3. Rebuck, D.A., Macejko, A., Bhalani, V., Ramos, P., & Nadler, R. B. (2011 ). The Natural History of Renal Stone Fragments Following Ureteroscopy. Urology (Ridgewood, N.J.),77(3), 564-568. https: / / doi.Org / 10.1016 / j.urology.2010.06.056.4. Raheem, O.A., Khandwala, Y. S., Sur, R. L., Ghani, K. R., & Denstedt, J. D. (2017). Burden of Urolithiasis: Trends in Prevalence, Treatments, and Costs. European Urology Focus, 3(1 ), 18-26. https: / / doi.Org / 10.1016 / j.euf.2O17.04.001 . 5. Moe, 0. (2006). Kidney stones: pathophysiology and medical management. The Lancet(British Edition), 367(9507), 333-344. https: / / doi.org / 10.1016 / S0140-6736(06)68071 -9.

Claims

CLAIMS:1 . A target element removal device for removing at least one target element from a working area of an organ, a physiological cavity or a physiological pathway, wherein the device comprises: a suction sheath having a suction lumen, a proximal end and a distal end, the suction sheath being connectable to a suction source for providing suction through the suction lumen to the working area; and an irrigation sheath having an irrigation lumen, a proximal end and a distal end where the distal end is extended past the distal end of the suction sheath, the irrigation sheath being connectable to a fluid source for providing fluid in the irrigation lumen for irrigation of the working area.

2. The device of claim 1 , wherein the irrigation sheath and the suction sheath are fused together.

3. The device of claim 1 or claim 2, wherein the irrigation sheath is located inside, outside or in a wall of the suction sheath.

4. The device of claim 1 or 3, wherein the distal end of the irrigation sheath is movable relative to the suction lumen of the suction sheath so that the distal end of the irrigation sheath is extendable with respect to the distal end of the suction sheath; and the device includes an irrigation sheath position actuator that is coupled to the irrigation sheath and configured to extend the distal end of the irrigation sheath to a first selectable distance past the distal end of the suction sheath and optionally retract the distal end of the irrigation sheath with respect to the distal end of the suction sheath by a second selectable distance.

5. The device of any one of claims 1 to 4, wherein a distal end portion of the suction and / or irrigation sheath is bendable.

6. The device of claim 5, wherein the suction sheath is pre-bent to maintain an amount of bending when an introducer or scope is removed from the suction sheath.

7. The device of claim 5 or claim 6, wherein the device further comprises a deflection lock to maintain an amount of bending when an introducer or scope is removed from the suction sheath.

8. The device of claim 5 or 6, wherein the device further comprises a direction indicator to indicate the amount and direction of bending of the distal end portion of the suction sheath.

9. The device of claim 8, wherein the device comprises a steering actuator that includes the direction indicator, the deflection lock and a steering mechanism that is coupled to the direction indicator and the distal end portion of the suction sheath for bending the distal end portion of the suction sheath.

10. The device of any one of claims 4 to 9, wherein the suction sheath includes a sidewall having an axial longitudinal channel and the irrigation sheath is moveably located in the axial longitudinal channel.

11. The device of any one of claims 1 to 10, wherein the device comprises a separate steering actuator and steering mechanism for bending the distal end portion of the irrigation sheath independently of the distal end of portion of the suction sheath.

12. The device of any one of claims 1 to 11 , wherein the suction sheath is selected from a plurality of suction sheaths having different radii and / or pre-bent with various angles.

13. The device of any one of claims 1 to 12, wherein the irrigation sheath is selected from a plurality of irrigation sheaths having different radii.

14. The device of any one of claims 1 to 13, wherein a ratio of a suction lumen radius to an irrigation lumen radius is in a range of about 2 to about 14.

15. The device of any one of claims 1 to 14, further comprising at least one sensor disposed at the proximal or distal end of the suction sheath, the at least one sensor comprising any combination of a temperature sensor, a pressure sensor and at least one flow sensor.

16. The device of any one of claims 1 to 15, wherein at least a portion of the device is made using radiopaque material.

17. The device of claim 16, wherein the device has a radiopaque body, radiopaque markers, the irrigation and / or suction sheaths have radiopaque tips, or the irrigation and / or suction sheaths have both radiopaque markers and radiopaque tips.

18. The device of any one of claims 1 to 17, wherein the device has additional irrigation sheaths providing multiple irrigation sheaths.

19. The device of claim 18, wherein the multiple irrigation sheaths are evenly distributed about a circumference of the suction sheath.

20. The device of claim 18 or claim 19, wherein the multiple irrigation sheaths are configured to provide different streams of irrigation to create a desired flow pattern.

21. The device of any one of claims 18 to 20, wherein a length and a location of distal ends of the multiple irrigation sheaths are controlled to irrigate different locations.

22. The device of claim 21 , wherein the distal ends of the multiple irrigation sheaths are controlled to be located in different physiological cavities.

23. The device of claim 22, wherein the multiple irrigation sheaths are controlled to irrigate different calyces simultaneously.

24. The device of any one of claims 1 to 23, wherein the suction sheath is sized to accommodate a scope, optionally at least one irrigation sheath, and optionally the at least one target element at the same time.

25. The device of any one of claims 1 to 24, wherein the irrigation sheath has a circular, oval, half-circular, or crescent shaped cross-section.

26. A target element removal system for removing at least one target element from a working area of an organ, a physiological cavity or a physiological pathway, wherein the system comprises: a target element removal device having a suction sheath and at least one irrigation sheath, the target element removal device being defined according to any one of claims 1 to 25; and one or both of:(i) a pumping unit that is coupled to an irrigation fluid source to provide irrigation fluid to the at least one irrigation sheath during use; and(ii) a target element container that is coupled to the suction sheath and to a suction source to apply suction to the suction sheath and receive the at least one target element during use.

27. The system of claim 26, further comprising the fluid irrigation source and a suction unit that acts as the suction source.

28. The system of claim 26, wherein the target element container includes a filter, and the pumping unit is configured to provide the suction source and recirculate filtered fluid from the target element container which is provided as the irrigation fluid.

29. The system of any one of claims 26 to 28, wherein the irrigation and suction are provided continuously constant, continuously variably or intermittently in an automated or manual manner.

30. The system of any one of claims 26 to 28, wherein the irrigation and suction are provided simultaneously constant, simultaneously variably or offset in time in an automated or manual manner.

31. The system of any one of claims 26 to 30, further comprising a controller that is coupled to the pumping unit and the device for controlling the operation of the pumping unit and the actuators of the device wherein the controller is configured to operate in an automated manner or under manual control of a medical practitioner.

32. The system of any one of claims 26 to 31 , wherein when the at least one target element is stuck in the suction lumen, any combination of a positive pressure is applied to the suction lumen, an increased amount of suction is applied, an increased irrigation flow rate is used, a scope, a laser, the irrigation sheath is pulled, pushed or vibrated, and a rigid bar is used to dislodge the stuck at least one target element.

33. A method for removing at least one target element from a working area of an organ, a physiological cavity or a physiological pathway, wherein the method comprises: positioning a distal end portion of a suction sheath of a target element removal device at the working area, the target element removal device being defined according to any one of claims 1 to 25; andpositioning a distal tip of an irrigation sheath of the target element removal device past a distal tip of the suction sheath by a selectable distance; and performing irrigation to the working area through the irrigation sheath to displace at least one target element and applying suctioning to the working area through the suction sheath to remove the at least one target element.

34. The method of claim 33, wherein the distal tip of the irrigation sheath is movable relative to the tip of the suction sheath, the device includes an irrigation sheath position actuator that is coupled to the irrigation sheath and the method further comprises extending the distal tip of the irrigation sheath to a first selectable distance past the distal tip of the suction sheath and optionally retracting the distal end of the irrigation sheath with respect to the distal tip of the suction sheath by a second selectable distance.

35. The method of claim 33 or claim 34, wherein the method is applied to a kidney and the method comprises performing ureteroscopy and laser lithotripsy to break up one or more kidney stones into kidney stone fragments prior to providing irrigation and suctioning via the device.

36. The method of any one of claims 33 to 35, wherein the positioning involves using a camera or performing medical imaging to allow for positioning of the distal end portion of the outer sheath at the working area.

37. The method of any one of claims 33 to 36, wherein the method comprises monitoring local pressure at the working area and adjusting the amount of suction and / or irrigation to maintain the local pressure in a defined operating range to avoid collapse or rupture of kidney structure surrounding the working area.

38. The method of any one of claims 33 to 36, wherein the method comprises monitoring local pressure at the working area and adjusting the amount of pressure in a defined operating range to avoid collapse or rupture of kidney structure surrounding the working area.

39. The method of any one of claims 33 to 36, wherein the method comprises monitoring a local temperature at the working area and adjusting the local temperature adjusting an amount of relative suction and / or irrigation to maintain the local temperature within a defined operating range, to avoid thermal injury of kidney structure surrounding the working area.

40. The method of any one of claims 33 to 39, wherein the method comprises providing irrigation and suction continuously constant or continuously variable or intermittently in an automated or manual manner.41 . The method of any one of claims 33 to 39, wherein the method comprises providing irrigation and suction simultaneously constant or simultaneously variable or offset in time in an automated or manual manner.

42. The method of any one of claims 33 to 41 , wherein when the at least one target element is stuck in the suction lumen, the method further comprises any combination of a applying a positive pressure to the suction lumen, applying an increased amount of suction, applying an increased irrigation flow rate, using a scope, using a laser, pulling, pushing or vibration the irrigation sheath, and using a rigid bar to dislodge the stuck at least one target element.

43. A device for the removal of at least one target element and / or delivery of at least one delivery element at a working area of an organ, a physiological cavity or a physiological pathway, wherein the device comprises: a suction sheath having a suction lumen, a proximal end and a distal end, the suction sheath being connectable to a suction source for providing suction through the suction lumen to remove the at least one target from the working area; an irrigation sheath having an irrigation lumen, a proximal end and a distal end and being movably located within the suction lumen of the suction sheath so that the distal end of the irrigation sheath is extendable with respect to the distal end of the outer sheath, the irrigation sheath being connectable to a: (1 ) fluid source for providing fluid in the irrigation lumen for irrigation of the working area when removing the at least one target element at the working area and / or (2) a delivery element source for sending the delivery element to the working area; and an irrigation sheath position actuator that is coupled to the irrigation sheath and configured to extend the distal end of the irrigation sheath to a first selectable distance past the distal end of the suction sheath and optionally retract the inner sheath within the distal end of the outer sheath by a second selectable distance.

44. Use of a device for the removal of at least one target element and / or delivery of at least one delivery element at a working area of an organ, a physiological cavity or a physiological pathway, wherein the device is defined according to any one of claims 1 to 25 or 43.

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