Interchangeable probe tip for calculi fracture

Abstract

To provide, in particular, a system and method for fragmenting or removing calculi using a device having a probe tip interchangeable by an end user.SOLUTION: A device for acoustic calculi fracture can include an acoustically-transmissive elongated probe body extending between a distal portion and a proximal portion and an acoustically-transmissive probe tip that can be selectively user-interchangeable with the probe body. The probe body can have a lumen longitudinally therethrough. A method of fracturing calculi can include: interchanging a probe tip with the probe body by a user without requiring an additional tool; and transmitting acoustic energy via the probe body and the probe tip to a calculus to at least partially fracture the calculus.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 065,845, filed August 14, 2020, the content of which is hereby incorporated by reference in its entirety.

[0002] This document relates to techniques for using lithotripsy to break up obstructions such as physiological stones or "stones", and more particularly to techniques for using laser lithotripsy and the like to break up obstructions.

Background Art

[0003] Medical endoscopes were first developed in the early 1800s and have been used to examine the inside of the body. A typical endoscope has a distal end with an optical or electrical imaging system and a proximal end with a control section for operating the device or viewing an image. A long, slender shaft connects the proximal and distal ends. Some endoscopes allow a physician to pass tools through one or more working channels, for example, to excise tissue or remove an object.

[0004] Over the past several decades, several advancements have been made in the field of endoscopy, particularly with respect to the destruction of physiological stones in the bile duct, urinary tract, kidney, and gallbladder. Physiological stones in these areas can block ducts and cause significant pain to the patient and thus must be broken up and / or removed. Different techniques have been developed to break up stones, including ultrasonic or other acoustic lithotripsy, pneumatic lithotripsy, electrohydraulic lithotripsy (EHL), and laser lithotripsy, which can include the use of green light, YAG, or holmium lasers.

Summary of the Invention

Problems to be Solved by the Invention

[0005] In one approach to lithotripsy, a single probe with a non-removable probe tip can be used for fragmentation and removal of a stone. In this approach, a single type of probe tip having a particular size and shape is used with various stones that may be of different hardnesses and sizes. Such an approach may limit the flexibility for an operator to adjust the treatment of such stones based on their shape and type, among other things, with respect to the probe tip type.

Means for Solving the Problems

[0006] The present disclosure provides, among other things, a system and method for fragmenting or removing a stone with a device having an end-user replaceable probe tip. By having a wide variety of probe tip types and shapes, it is possible to enable the selection of the most suitable probe tip for a particular procedure and the stone to be treated. By allowing an end-user to select a particular probe tip, it is possible to enable more efficient fragmentation or removal of such stones. For example, a softer stone can be more easily fragmented when treated with a rectangular cutting probe tip, while a harder stone can be more easily fragmented when treated with a sharper only cutting probe tip.

[0007] The replaceable probe tip can be configured and manufactured based on the needs of an individual patient or based on the needs indicated by a specific stone. For example, diagnostic tools can be used to identify the type and size of the stone that requires fragmentation and / or removal, and the tip can be suitably formed and manufactured for fragmenting and / or removing that specific stone. Such a replaceable probe tip can also help extend the life of the reusable probe body, so that the operator can continue to use the same probe body, thereby reducing the treatment cost.

[0008] The replaceable probe tip can enable the adjustment or optimization of the calculus fragmentation and / or removal procedure, such as helping to reduce the procedure time. Additionally, the replaceable probe tip can potentially help reduce the operating cost by extending the overall operating life of the probe, such as by enabling the end user to replace a worn or unwanted probe tip as needed.

[0009] In one example, a device for acoustic calculus fragmentation can include an acoustically transmissive elongated probe body extending between a distal portion and a proximal portion. The probe body can include a lumen extending longitudinally through the probe body and one or more acoustically transmissive probe tips that are selectively user-replaceable with the probe body.

[0010] In one example, a kit for use with a calculus fragmentation device can include a plurality of different acoustically transmissive probe tips that are selectively user-replaceable with the probe body of a lithotripsy device without the need for another tool.

[0011] In one example, a method of fragmenting a calculus can include the steps of an end user selecting or replacing a probe body probe tip without the need for an additional tool, and transmitting acoustic energy to the calculus through the probe body and the selected probe tip to at least partially fragment the calculus.

[0012] The figures are not necessarily to scale, and like numerals in different drawings can describe like components. Like numerals with different letter suffixes can represent different instances of like components. The figures generally illustrate, as examples and not as limitations, various embodiments discussed in this document.

Brief Description of the Drawings

[0013]

Figure 1

Figure 2A

Figure 2B

Figure 3A

Figure 3B

Figure 3C

Figure 4

Figure 5

Figure 6

Figure 7

Mode for Carrying Out the Invention

[0014] Lithotripsy and removal can include a replaceable probe tip (or a kit of tips) that can be selected or exchanged by the end user, such as according to the type or nature (e.g., hardness) of the stone to be treated (e.g., kidney stone). The characteristics of the tip can include, for example, a fluid inlet hole or one or more axial grooves. Different tips can have various morphologies, or can include various materials such as ceramics or composites, or can be made of various materials.

[0015] For an end-user operator who acoustically fragments and removes stones, it is desirable to reduce the fragmentation time. This can be helped by using an acoustic fragmentation signal of a larger amplitude, but such a large amplitude can increase probe wear or lead to premature probe failure. The operator may desire to reduce the fragmentation time without probe failure and for the lithotripsy device to take an overall shorter time to complete the procedure before it is once inserted into the patient and the puncture site is closed. Additionally, after such a procedure, it may be desirable that there are no remaining fragments.

[0016] The end-user can be enabled to select and use a probe tip type that can be adapted to the stone being treated, for example, by a probe tip that can be removably coupled to the probe body of the lithotripsy device, such as the lumen of the probe body. This can enable more efficient fragmentation of the stone, which can in turn help to better fragment the target stone, which can then help to reduce the size of the resulting particles that are discharged through the probe. For example, a distal probe tip of a ceramic or composite type can be fixed and aligned by the end-user to the probe body such that the discharge path passes through the end and through the probe. This can enable efficient destruction of the stone and discharge of the stone fragments. The specific probe tip may be easily removable by the end-user and interchangeable with another probe tip of a different type or other properties, etc., when desired by the end-user, such as based on the stone type or some other reason.

[0017] FIG. 1 illustrates a schematic view of an example of a portion of an acoustically transmissive lithotripsy and removal probe assembly 100 having an end-user replaceable probe tip 114. The probe assembly 100 can include a proximal portion 102 and a distal portion 104. The probe assembly 100 can include a probe 110 having a probe body 112 and a probe tip 114 that is end-user attachable or end-user removable. The probe assembly 100 can also include or be coupled to one or more of an acoustic transducer 120, a handpiece 125, a discharge path 130, and a pressure source 140. The probe assembly 100 can communicate with a generator 150.

[0018] The probe assembly 100 can include a lithotripsy device for the treatment of stones, such as by fragmentation. The probe assembly 100 can perform a lithotripsy treatment by using ultrasonic or other acoustic energy, using low-frequency solenoid-driven ballistics shock, or any combination thereof, to fragment a stone or otherwise treat a physiological target. The probe assembly 100 can include a two-frequency or other multi-frequency device, such as being able to enable pulsed operation of both sound waves and ultrasonic waves for the destruction of stones.

[0019] Probe 110 can be sized and shaped to enable insertion into a patient, such as through an incision, for treating a calculus or the like. Probe 110 can include an acoustically transmissive probe for transmitting acoustic energy from a generator or an acoustic transducer to a target calculus for fragmentation. Probe 110 can include a proximal portion 102 closer to the operator using the device and a distal portion 104 closer to the treatment site. Probe 110 can have a length of from about 350 mm to about 600 mm, depending, for example, on the specific probe type and the probe distal end that can be attached or detached by the end user. Probe 110 can have a diameter of from about 0.90 mm to about 3.80 mm, depending, for example, on the specific probe type and the probe distal end that can be attached or detached by the end user.

[0020] Probe 110 can include a probe body 112 extending between the proximal portion 102 and the distal portion 104, having, for example, a lumen 113 also extending between the proximal portion 102 and the distal portion 104. The probe body 112 can be sized and shaped for insertion into a patient to reach a calculus for fragmentation or the like. The probe body 112 can include a metallic material or a composite metallic material or can be made of a metallic material or a composite metallic material. The probe body 112 can include one or more couplers or other attachment mechanisms for coupling to the probe tip 114. The probe body 112 can enable an operator to manipulate the probe tip 114 to be positioned and operated on or near a target calculus.

[0021] The probe tip 114 can be selected by the end user and attached to the probe body 112. The probe tip 114 can be sized, shaped, and positioned to break, fragment, or pulverize one or more target stones. The probe tip 114 can be attached to the probe body 112. In some cases, the probe tip 114 can include a lumen 116. When the probe tip 114 is attached to the probe body 112 by the end user, the lumen 116 of the probe tip 114 can be aligned with and extend from the lumen 113 of the probe body 112, such as for providing a continuous irrigation and / or drainage path. The probe tip 114 can have a desired morphology or other properties, such as only a cutting tip, a rectangular tip, an end with a large or small distal or peripheral surface area, various topographies, various morphologies, or made of various materials, depending on the particular procedure being performed or the particular target on which the procedure is being performed.

[0022] The acoustic transducer 120 may be operable to provide acoustic energy to a target stone via an acoustically transmissive probe 110. The acoustic transducer 120 can provide ultrasonic energy, sonic energy, or some combination thereof, for example, to break a target stone by fragmentation or pulverization. In some cases, the acoustic transducer 120 can be configured to pulse-impact between various energy levels or energy types. This can include, for example, applying ultrasonic energy with intermittent low-frequency acoustic energy pulses or with an energy delivery of an intermittent ballistic mechanism. The acoustic transducer 120 can provide acoustic energy of various waveforms or frequencies depending on a particular operation. For example, the acoustic transducer 120 can operate to select, adjust, or optimize a waveform in one or more portions of a procedure. The acoustic transducer 120 can acoustically couple to an acoustically transmissive probe body 112, for example, to provide acoustic energy to a probe tip 114 that can be disposed near or in contact with the target stone down the length of the probe body 112. In one example, the acoustic transducer 120 can have a diameter of about 4 to about 6 cm, a length of about 15 to about 25 cm, and a weight of about 0.4 to about 1.0 kg, depending on the particular transducer used.

[0023] The handpiece 125 can be shaped and sized to enable an end-user operator to grip and manipulate the probe assembly 100. In one example, the handpiece 125 can house all or a portion of the acoustic transducer 120. The handpiece 125 can include one or more buttons or other user interface means, such as to enable the operator to control the probe assembly 100. For example, the handpiece 125 can include a dial for variable suction control that communicates with the pressure source 140. In one example, the handpiece can include one or more buttons for applying ultrasound, sound waves, or other energy from the acoustic transducer 120 to a target stone for fragmentation. In some examples, the system can include, additionally or alternatively, a foot pedal or other auxiliary actuator, such as for controlling the activation of the acoustic transducer 120.

[0024] The discharge path 130 can be fluidly connected to the lumen of the probe 110 to effect irrigation, suction, or both, etc. to the probe assembly 100. The discharge path 130 can extend outwardly from the handpiece 125 toward the pressure source 140 or other pressure source. The pressure source 140 can provide a discharge pressure that drops along the length of the discharge path 130 to draw fragmented stone pieces away from the lumen of the probe 110 and down the discharge path 130. The discharge path 130 can additionally be irrigated as desired.

[0025] The generator 150 may be in electrical communication with the probe assembly 100 to provide electrical energy to the probe assembly 100 during use, for example. The generator 150 can provide electrical energy for powering the acoustic transducer 120 to generate ultrasonic or other acoustic or ballistic energy, such as for fragmenting a target calculus. In one example, the generator 150 can provide AC electrical energy of about 90 to about 264 volts (peak-to-peak). The electrical energy signal provided by the generator 150 can be varied (e.g., amplitude, frequency, pulse width, modulation, etc.) depending on the particular procedure being performed and the desired parameters.

[0026] Figures 2A-2B illustrate an example of a perspective view of a portion of the probe assembly 100 having a user-exchangeable probe tip 114. The probe assembly 100 can include a proximal portion 102 and a distal portion 104. The probe assembly 100 can include a probe body 112 having a lumen 113. The probe assembly 100 can also include a probe tip 114 having an attachment mechanism 222, a lumen 116, one or more optional lateral openings 226, and one or more optional axial grooves 228. The probe assembly 100 can be used with an acoustic transducer and a generator, such as those discussed above with reference to FIG. 1, for fragmenting one or more target calculi.

[0027] The probe assembly 100 can have the probe tip 114 attached to the probe body 112 for delivery to the operator, or the probe tip 114 can be unattached to the probe body 112 and instead one or more probe tips 114 can be provided separately (e.g., as an accessory or in a kit containing various probe tips 114) for delivery to the operator, who can then (as an end user) select the desired probe tip 114 and attach it to the probe body 112 as desired. In some cases, a number of various probe tips 114 can be included for use with a single probe body 112. The number of probe tips 114 can be configured differently, such that the end user operator can switch the particular probe tip 114 in or out, depending on the particular procedure being performed, for example, or being dedicated to a particular target or part of a procedure.

[0028] The probe body 112 can be shaped and sized such that an end user can removably connect to the probe tip 114 and function with the probe tip 114. The probe body 112 can extend from a proximal portion 102 to a distal portion 104. At the proximal portion 102, a handpiece and an acoustic transducer can be provided for use by the operator. At the distal portion 104, the probe body 112 can be attachable by the end user to the probe tip 114.

[0029] The probe body 112 can be coupled to an acoustic energy source, such as the transducer discussed with reference to FIG. 1, to provide acoustic energy through the probe body to activate the probe tip 114 for acoustically fragmenting a target calculus. The probe body 112 can include a lumen 113 therethrough in the longitudinal direction, such as to allow fragments of the calculus to be aspirated or discharged through the probe body for collection or disposal in a suction or discharge tube or pathway, etc.

[0030] The probe tip 114 may be user - attachable and removable to the probe body 112, such that the end - user operator of the probe assembly 100 can, depending on the procedure being performed and the type of target stone, optionally select or exchange various probe tips 114 as desired. The user - exchangeable probe tip 114 may be acoustically transmissive to enable acoustic fragmentation, fragmentation, or pulverization of the target stone. The acoustic impedance of the probe tip 114 can be matched to the acoustic impedance of the probe body 112 such that acoustic energy of a desired frequency is transmitted across the boundary, joint, or coupling between these two components without significant attenuation of the acoustic energy due to acoustic impedance mismatch between these two components. The probe tip 114 may be user - exchangeable without the need for separate tools such as those described herein, such that the probe tip 114 can be exchanged by the end - user operator before or even during the procedure, rather than during the manufacturing period of the probe assembly 100.

[0031] The probe tip 114 can include or be made of ceramic, or composite materials such as zirconia, alumina, or compounds, and optionally doped with one or more of diamond, cubic zirconia, carbon nanotubes, tungsten, or combinations thereof. Lightweight materials such as ceramic can help avoid any significant increase in the weight of the probe assembly 100 when the probe tip 114 is attached. This can result in an overall smaller mass that needs to be adjusted or optimized for the transducer or probe body 112 to effectively transfer acoustic energy to the target stone. The material of the probe tip 114 may be acoustically transmissive at ultrasonic or acoustic frequencies used for treatment.

[0032] The probe tip 114 can be any number of interchangeable probe tips of various morphologies. For example, the probe tip 114 can be selected from various interchangeable probe tips that allow changing the contact pressure according to the target stone type. For example, a probe tip with a wide end can be used for softer stones, and a probe tip with a sharp end can be used for harder stones. For example, a probe tip with a rectangular end having a larger surface area in contact with the stone can be used for softer stones. In contrast, a probe tip with a narrow, smaller surface area, only cut, serrated, segmented, or cup-end type for contacting the stone can be used to break harder stones as the target. In some cases, a two-purpose probe tip having an oblique end or an end with an angle (such as about 45 degrees) can be used for a probe tip having both the needle-like characteristics for harder stones and the grinding-type characteristics for softer stones.

[0033] The probe tip 114 can be fixed and attached to the probe body 112 by an end - user operator through one or more couplers or mounting parts, etc., that can achieve fitting or other engagement therebetween. For example, the coupler on the probe tip 114 can include one or more tool - less mounting parts and / or interlocks that are user - operable with respect to the probe body 112 for engagement, attachment, and / or locking there, and for release or removal therefrom. The attachment mechanism 222 can include threads or other protrusions or grooves or shapes that engage with a corresponding complementary mechanism of the probe body 112 to help lock the probe tip 114 to the probe body 112 or otherwise mechanically fix it. In one example, the attachment mechanism 222 can include threads on the inner diameter of the probe body 112 and a corresponding thread mechanism on the probe tip 114. In another example, the attachment mechanism 222 can include a right - hand rotation slot in the probe body 112 corresponding to a hub post on the probe tip 114, such as a post that clicks into a slot with a quarter - turn. In some cases, the outer diameter of the probe 110 can be clamped to allow for a better - diameter fit. In one example, the attachment mechanism 222 can include an inward - facing scroll shape on the distal end of the probe 110. In this case, a relief groove may be present in the device to interact with the scroll shape. Additional relief segments can be able to improve the diameter fit. In some cases, inward - facing spring - like hooks can be used. In another example, the attachment mechanism 222 can include an outward - facing scroll shape and a corresponding inner groove. In some cases, external spring - like hooks can be used. In some cases, the attachment mechanism 222 can include adhesive in addition or as an alternative.

[0034] For example, the probe body 112 can include a lumen 113 into which an interference fit mounting mechanism 222 with a reduced outer diameter at the probe tip 114 can be inserted. The interference fit mounting mechanism 222 at the probe tip 114 can be inserted such that the mating outer diameter portion of the probe tip 114 is placed against the distal end of the probe body 112 and the probe tip 114 engages firmly with the probe body 112 when the interference fit mounting mechanism 222 is inserted into the lumen of the probe body 112. The interference fit can enable attachment and retention without locking.

[0035] In one example, the attachment mechanism 222 can be a locking mechanism that enables attachment, engagement, and locking of the probe tip 114 to the probe body 112. Such a locking engagement can include a quarter-turn interlock or a similar retention system where the probe tip 114 is inserted into the probe body 112 by an end user and then rotated a quarter turn or some other specified amount to lock the probe tip 114 within the probe body.

[0036] In one example, the attachment mechanism 222 can be a snap fit. A snap fit can include pressing one or more interlocking components, such as protrusions, grooves, or other geometries on the probe tip 114, into corresponding mechanisms on the probe body 112. Such snap fits can include cantilever, torsion, annular, or combined snap fits depending on the shape and size of the probe body 112 and the probe tip 114. The snap fit can be used for both attaching and interlocking the probe body 112 and the probe tip 114.

[0037] In one example, the attachment mechanism 222 may be a screw-type mechanism. For example, the screw may be on the inner wall of the lumen 113 of the probe body 112, and the corresponding screw may be on the outer wall of the probe tip 114. In other examples, the screw may be on the outside of the probe body 112. The screw can enable the probe tip 114 to be attached to and fixed to the probe body 112.

[0038] The probe tip 114 can include a longitudinal lumen 116 that is aligned with the lumen 113 of the probe body 112 when the probe tip 114 is fixed to the probe body 112, such that fragmented stone portions can be removed through the suction or discharge path defined by the lumens 113, 116, and an optional separate discharge path.

[0039] The probe tip 114 can include one or more lateral openings 226, such as an opening from a lateral region near the outside of the probe tip 114 into the lumen 113. The lateral openings 226 can allow the inflow of fluid into the lumen 116 of the probe tip 114, such as to assist in flowing fragments of the stone in the lumen 116. The lateral openings 226 can assist in promoting, increasing, or maximizing the fluid flow in one or both of the lumens 113, 116, such as to assist in transferring fragments of the stone when the distal end opening of the probe tip 114 into the lumen 116 is partially or completely blocked. The location of the lateral openings 226 on the replaceable probe tip 114 can assist in deterring or preventing stress risers and fracture points that may occur if the lateral openings 226 were located in the probe body 112. The probe body 112 is intended to be more durable and reusable than the probe tip 114, which can be discarded or replaced by the end user, as described herein, and is subject to vibrations during operation.

[0040] The probe tip 114 can additionally include one or more grooves or channels, such as one or more axial grooves 228. The axial grooves 228 within the lumen 116 of the probe tip 114 can help facilitate fluid flow within the lumen 116, such as when the opening of the probe tip 114 is partially blocked. The axial grooves 228 can additionally allow for fluid flow when the lumen 113 of the probe body 112 and the lumen 116 of the probe tip 114 are closed. The axial grooves 228 can extend along the probe tip 114 or, optionally, further into and along the probe body 112.

[0041] An end-user operator, such as a surgeon, can select a particular probe tip 114 (from a kit of multiple available probe tips 114, for example) that is most suitable for a particular procedure or a particular stone or group of stones to be treated. For example, a particular probe tip 114 can be selected based on the material of one or both of the probe tip or the probe body, based on the morphology of the probe tip, based on the acoustic impedance of the probe tip, based on the desired range of acoustic energy for the procedure, the surface area of the probe tip itself, other dimensions of the probe tip, or one or more combinations of those parameters.

[0042] These types of probe tip selection parameters can correlate with one or both of the procedure being performed and the type or other characteristics of the stone being fragmented. For example, harder stones can only be fragmented more effectively with a cutting edge profile that can allow for more specific directionality or regions of cutting or fragmentation. Softer stones can be fragmented more effectively with a rectangular edge profile or an edge profile having a larger surface area. The probe tip 114 can help achieve acoustic impedance matching, for example, for the probe body 112 and the acoustic transducer, for the target stone, or for both. This can help achieve more effective transmission of acoustic energy from the probe body 112 to the target stone, and such additional flexibility can help deliver acoustic energy to the target stone in a desired manner, such as by appropriately selecting a particular probe tip 114 from a kit or a set of available probe tips 114 at or near the characteristic resonance frequency of the target stone's characteristics.

[0043] Figures 3A - 3C illustrate schematic views of a probe assembly 100 comprising an interchangeable probe tip 114 having one or more tongs 326. The probe assembly 100 can have a proximal portion 102 and a distal portion 104. The probe assembly 100 can include a probe body 112 and a probe tip 114. The probe body 112 can include a lumen 113. The probe tip 114 can have an inner diameter 324 that defines a lumen 116 along which the tongs 326 can be placed. The probe tip 114 can additionally include one or more lateral openings 226. The probe tip 114 can be removable from the probe body 112 and can be attached such that the lumen 113 and the lumen 116 are aligned.

[0044] In one approach, the probe tip can have an inner diameter or a similar dimension across the lumen wall, where both the inner diameter and the lumen wall shape do not change throughout the length of the probe tip. In another approach, as shown for probe tip 114, etc., the inner diameter 324 of the lumen can gradually increase, such as from the distal end opening probe tip 114 towards the probe body 112, etc., and the lumen 116 can be defined to have a longitudinally tapered inner diameter. In this approach, the longitudinally tapered inner diameter 324 can help to enable better movement of stone fragments through the lumen 116 and towards the lumen 113 of the probe body from the probe tip 114.

[0045] The probe tip 114 can have a laterally smaller end hole at the distal portion 104 in a comparison with one or more other probe tips that may be included together in a kit or set. The smaller hole of the probe tip 114 can be drawn from a larger size at a more proximal location at various angles and profiles.

[0046] One or more tongs 326 can extend outwardly from the probe tip 114. The tongs 326 can be lowered onto and into the probe 110 during operation to enable extraction, such as capturing and moving fragments of the stone therein, such that the fragments of the stone move towards the lumen 113 of the probe body 112 and towards the discharge or the discharge path. The tongs 326 can include a plurality of tongs at various angles as desired depending on the type of stone being treated and the expected size and type of the fragments. The tongs 326 can extend distally outwardly from the probe tip 114 to create a larger space to enable movement of the stone or a fragment of the stone into the tongs 326. The tongs 326 can be straight or angled inwardly at various angles. A lateral opening 226 opened in the probe tip 114 can enable aspiration and removal of fragments of the stone.

[0047] FIG. 4 illustrates a schematic view of an end-user replaceable probe tip in the probe assembly 100. The probe assembly 100 can have a proximal portion 102 and a distal portion 104. The probe assembly 100 can include a probe body 112 and a probe tip 114 having portions 422, 424, 426. In the probe assembly 100, the distal portion 104 can house the probe tip 114, and the probe tip 114 can be length-adjustable at the end of the probe body 112.

[0048] For example, the probe tip 114 can include three or more ring-shaped portions 422, 424, 426. The operator can adjust the number of portions 422, 424, 426 that extend distally relative to the probe body 112 for use. The probe tip 114 can be slidable longitudinally between the proximal portion 102 and the distal portion 104 relative to the probe body 112. The probe tip portions 422, 424, 426 can be slidable relative to each other according to the desired probe tip shape, size, and length for treatment of a target calculus. The probe tip portions 422, 424, 426 can be nested within each other. They can be connected to each other, for example, by an interference fit, a snap fit, a screw, a quarter-turn interlock, or other mechanisms that allow the ends 422, 424, 426 to move laterally outward relative to each other.

[0049] In use, the first portion 422 can be used for crushing a target stone. The first portion 422 can extend laterally in a distal direction from the probe body 112. The second portion 424 and the third portion 426 may be nested within the first portion 422 at the start of operation. If the first portion 422 is damaged during operation or if the operator desires to reach further with the assembly 100, the second portion 424 can be pushed out from within the first portion 422 for use. When the second portion 424 extends, the second portion 424 remains attached to the first portion 422 and can effectively lengthen the probe assembly 100. Similarly, if the operator no longer desires to use the second portion 424, the third portion 426 can be pushed out from within the second portion 424. Throughout this process, the portions 422, 424, and 426 may remain attached to the assembly 100. The portions 422, 424, and 426 are not removed during operation.

[0050] The portions 422, 424, 426 may be actuatable by one or more triggers on the handpiece of the assembly, such as one or more buttons, levers, or roller wheels. In the case of a roller wheel, such a wheel can be coupled to the portions 422, 424, 426 and, by actuation with a finger or thumb, the portions 422, 424, 426 can be slidably moved along the assembly 100, such as in a distal direction, towards the distal portion 104 where a new portion is desired. In some cases, the portions 422, 424, 426 can be actuated through a mechanical mechanism such as one or more springs integrated within the probe body 112. In this case, the spring can be compressed or released to push or pull the portions 422, 424, and 426 along the axis of the probe 110. In some cases, the mechanism may be a hydraulic, electromagnetic, or pneumatic piston actuator for moving the portions 422, 424, 426 in and out of the probe body 112.

[0051] FIG. 5 illustrates a schematic view of an example of a portion of an exchangeable probe tip in the probe assembly 100. The probe assembly 100 can have a proximal portion 102 and a distal portion 104. The probe assembly 100 can include a probe tip 114 having a sheath portion 516 and an end portion 518. Here, the sheath portion 516 can act as a sheath surrounding the end portion 518. The end portion 518 of the probe tip 114 can be movable laterally along the sheath portion 516, such that the end user can adjust the distal position of the end portion 518 of the probe tip 114 inside and outside of the sheath portion 516. In the probe assembly 100, the distal portion 104 can receive the sheath portion 516, whereby the length can be adjusted at the end of the sheath portion 516. The sheath portion 516 can be positioned within one or more additional portions of the probe, such as the probe body 112, and may be attachable by the end user to the one or more additional portions. The probe tip 114 can be coupled to the probe body 112 and can allow slidable movement of the end portion 518 along the sheath portion 516, such that the operator can move the end portion 518 distally along the sheath portion 516 while the probe body 112 remains stationary. The operator can adjust the position of the end portion 518 relative to the sheath portion 516 as required for a particular operation. The end portion 518 of the probe tip 114 can contact the target calculus. The end user can move the end portion 518 of the probe tip 114 relative to the sheath portion 516 with a switch, dial, or other trigger that is mechanically coupled to the probe tip 114. The mechanical trigger can be integrated within the handpiece 125 for easy access and can allow for the coupling and lateral movement of the probe tip 114.

[0052] FIG. 6 illustrates a schematic view of an exchangeable probe tip in the probe assembly 100, similar to the probe assembly discussed above with reference to FIG. 5. The probe assembly 100 can have a proximal portion 102 and a distal portion 104. The probe assembly 100 can include a probe tip 114 having a probe delivery sheath 610, an internal rotating tube 615, and a probe ring 620 having a threaded portion 622. In the probe assembly 100, the distal portion 104 can accommodate the internal rotating tube 615, the probe ring 620, and the threaded portion 622. At the probe tip 114, the internal rotating tube 615, the probe ring 620, and the threaded portion 622 are movable laterally relative to the probe delivery sheath 610.

[0053] The probe ring 620 can be slidable within the probe delivery sheath 610. The probe ring 620 can include a threaded portion 622 connected by the internal rotating tube 615 at the distal end of the probe delivery sheath 610, thereby enabling attachment of the probe tip 114 to the probe body 112. In this way, the probe tip 114 can be exchanged as an assembly, and the assembly can enable distal and proximal joining and positioning of the probe tip 114.

[0054] FIG. 7 illustrates a flowchart showing a method 700 for treating a stone. The method 700 can include steps 710 and 720. The process can optionally include a step of selecting a probe tip from a set of available probe tips or from a kit including various probe tips. In this case, the kit can include, for example, probe tips with various surface morphologies or materials, or other deformable forms of probe tips as discussed above. The kit can include, for example, probe tips labeled for operator use, such as hard stones, soft stones, large stones, small stones, and labeling for other parameters correlated with the type of mass of the stone to be treated.

[0055] Step 710 can include the step of exchanging the probe body and the probe tip. The probe tip can be exchanged with the probe body by a user, such as a surgeon or other operator, during or prior to the procedure. The probe tip can be exchanged without the need for additional tools or manufacturing techniques.

[0056] Step 720 can include the step of transmitting acoustic energy to the calculus through the probe body and the probe tip to at least partially fragment the calculus. The energy provided to the calculus through the probe tip can fragment, powderize, or otherwise break up the target calculus.

[0057] Method 700 can enable the customization of the probe tip, such as manufacturing the probe tip specifically for a particular patient's needs and the procedure being performed. For example, diagnostic tools can be used to identify the size and type of stone that needs to be removed, and 3D printing or high-speed machining can produce the desired probe.

[0058] For example, the probe tip can be selected in step 710 based on one or more parameters of the target calculus, such as the size of the stone, the density of the stone, the type of the stone, or a combination of one or more of them. In some cases, more than one probe can be used during the procedure, and as a result, the exchange of the probe tip can include the step of exchanging an alternative probe tip during the medical procedure based on the parameters of the calculus.

[0059] Various considerations and examples Each of these non-limiting examples can stand alone or can be combined with one or more of the other examples in various orders or combinations.

[0060] Example 1 can include a device for acoustic lithotripsy. The device can include an acoustically transparent elongated probe body extending between a distal portion and a proximal portion, the probe body having a lumen therethrough in a longitudinal direction, and an acoustically transparent probe tip that is selectively user-exchangeable with the probe body.

[0061] Example 2 can include Example 1, and the acoustically transparent probe tip is selectively user-exchangeable with the probe body without requiring a separate tool.

[0062] Example 3 can include any one of Examples 1-2, and further includes an acoustic energy source operable to provide acoustic energy through the probe body such that the probe tip is actuated for acoustic fragmentation of one or more stones through the probe tip.

[0063] Example 4 can include any one of Examples 1-3, and the probe tip includes a tool-free interlock operable by a user with respect to the probe body for exchanging the probe tip with the probe body.

[0064] Example 5 can include any one of Examples 1-4, and the probe tip includes a ceramic or composite ceramic material.

[0065] Example 6 can include any one of Examples 1-5, and the probe tip includes a longitudinal lumen configured to be aligned with the lumen of the probe body.

[0066] Example 7 can include any one of Examples 1-6, and the probe tip includes a lateral opening from the longitudinal lumen to a circumferential lateral region outside the probe tip.

[0067] Example 8 can include any one of Examples 1-7, and the lateral opening is configured to allow fluid to flow into the lumen of the probe body through at least a portion of the longitudinal lumen of the probe tip.

[0068] Example 9 can include any one of Examples 1-8, and the probe tip further includes one or more axial grooves.

[0069] Example 10 can include any one of Examples 1-9, and the distance between the distal end of the probe tip and the distal end of the probe body is at least one of user-adjustable or user-selectable by user replacement of the probe tip.

[0070] Example 11 can include any one of Examples 1-10, the distance between the distal end of the probe tip and the distal end of the probe body is user-adjustable, and the probe body is slidable relative to the probe body along the longitudinal axis of the probe body.

[0071] Example 12 can include a kit for a lithotripsy device that includes a plurality of various acoustically transmissive probe tips that are selectively user-replaceable with the probe body of the lithotripsy device without the need for a separate tool.

[0072] Example 13 can include Example 12, and at least one of the probe tips further includes a locking mechanism for fixing the probe tip to the probe body.

[0073] Example 14 can include any one of Examples 12-13, and further includes an acoustic energy source attached to the probe body for providing acoustic energy through the probe body.

[0074] Example 15 can include any one of Examples 12-14, and various probe tips differ in at least one of the following characteristics: material, end morphology, acoustic impedance, end surface area, or end dimensions, or a combination of one or more thereof.

[0075] Example 16 can include any one of Examples 12-15, and the probe tip is attachable to the probe body with one or more attachment mechanisms.

[0076] Example 17 can include a method of crushing a calculus, including a step of a user replacing a probe tip with a probe body, and a step of transmitting acoustic energy to the calculus through the probe body and the probe tip to at least partially crush the calculus.

[0077] Example 18 can include Example 17 and further includes a step of selecting a probe tip based on one or more parameters of the calculus.

[0078] Example 19 can include any of Examples 17 - 18, where the one or more parameters include the size of the stone, the density of the stone, the type of the stone, or a combination of one or more of them.

[0079] Example 20 can include any of Examples 17 - 19 and further includes a step of replacing the probe tip with an alternative probe tip during a medical procedure based on the parameters of the calculus.

[0080] Example 21 can include any of Examples 17 - 20, where the step of a user replacing a probe tip with a probe body includes a step of replacing the probe tip without the need for additional tools.

[0081] Each of these non - limiting examples can be self - standing and can be combined with one or more of the other examples in various orders or combinations.

[0082] The detailed description above includes references to the accompanying drawings that form a part of the detailed description. The drawings show, for purposes of illustration, specific embodiments in which the invention can be practiced. These embodiments are also referred to herein as "examples." Such examples can include elements in addition to those shown or described. However, the inventor also contemplates examples in which only those elements shown or described are provided. Further, the inventor contemplates examples that use combinations or permutations of those elements (or one or more aspects thereof) shown or described with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof).

[0083] In the event of any conflict in usage between this document and any document incorporated by reference, the usage in this document prevails.

[0084] In this document, the terms "a" or "an" are used to include one or more, independent of any other instance or use of the terms "at least one" or "one or more", as is common in patent documents. In this document, the term "or" is used to denote a non-exclusive logical disjunction, and thus "A or B" includes, unless otherwise specified, "A but not B", "B but not A", and "A and B". In this document, the terms "including" and "in which" are used as the plain English equivalents of the respective terms "comprising" and "wherein". Also, in the following claims, the terms "including" and "comprising" are open-ended, i.e., a system, device, article, composition, formulation, or process that includes elements in addition to those listed after such terms in the claims is still considered to fall within the scope of that claim. Further, in the following claims, terms such as "first", "second", and "third" are used merely as labels and are not intended to impose numerical requirements on their objects.

[0085] Examples of the methods described herein may be machines or may be at least partially computer-implemented. Some examples can include a computer-readable medium or a machine-readable medium encoded with executable instructions operable to cause an electronic device to perform a method as described in the above examples. Implementations of such methods can include code such as microcode, assembly language code, high-level language code, and the like. Such code can include computer-readable instructions for performing various methods. The code can form part of a computer program product. Further, in one example, the code can be tangibly stored on one or more volatile, non-transitory, or non-volatile, tangible computer-readable media, such as during execution or at other times. Examples of such tangible computer-readable media include, but are not limited to, hard disks, removable magnetic disks, removable optical disks (e.g., compact disks and digital video disks), magnetic cassettes, memory cards or sticks, random access memory (RAM), read-only memory (ROM), and the like.

[0086] The above description is intended to be illustrative and not restrictive. For example, the above examples (or one or more aspects thereof) can be used in combination with each other. Upon reviewing the above description, those skilled in the art and the like can use other embodiments. The abstract is provided so that readers can quickly ascertain the nature of the present technical disclosure. The abstract is presented with the understanding that it is not used to interpret or limit the scope or meaning of the claims. Also, in the above detailed description, various features can be grouped together to simplify the present disclosure. By doing so, features disclosed without being claimed should not be construed as being essential to any of the claims. Rather, the subject matter of the present invention may lie in fewer features than all of the specific disclosed embodiments. Accordingly, the following claims are hereby incorporated by way of example or embodiment into the detailed description herein, and each claim stands on its own as a separate embodiment, and such embodiments are intended to be combinable with each other in various combinations or permutations. The scope of the present invention should be determined with reference to the appended claims and the full scope of equivalents to which such claims are entitled.

Description of Reference Numerals

[0087] 100 Probe assembly 102 Proximal portion 104 Distal portion 110 Probe 112 Probe body 113 Lumen 114 Probe tip 116 Lumen 120 Acoustic transducer 125 Handpiece 130 Drainage path 140 Pressure source 150 Generator 222 Mounting mechanism 226 Lateral opening 228 Axial groove 324 Inner diameter 326 Tongue 422 First portion 424 Second part 426 Third part 516 Sheath portion 518 End portion 610 Probe delivery sheath 615 Inner rotating tube 620 Probe ring 622 Threaded portion

Claims

**Claim 1** An acoustically transparent, elongated probe body extending between a distal portion and a proximal portion, the probe body having a lumen therethrough in the longitudinal direction, and An acoustically transparent probe tip that is selectively user-exchangeable with the probe body A device for acoustic lithotripsy comprising. **Claim 2** The device according to claim 1, wherein the acoustically transparent probe tip is selectively user-exchangeable with the probe body without the need for a separate tool. **Claim 3** The device according to claim 1, further comprising an acoustic energy source operable to provide acoustic energy through the probe body such that the probe tip is actuated for acoustic lithotripsy of one or more stones through the probe tip. **Claim 4** The device according to claim 1, wherein the probe tip includes a tool-free interlock operable by a user with respect to the probe body for exchanging the probe tip with the probe body. **Claim 5** The device according to claim 1, wherein the probe tip includes a ceramic or composite ceramic material. **Claim 6** The device according to claim 1, wherein the probe tip includes a longitudinal lumen configured to align with the lumen of the probe body. **Claim 7** The device according to claim 6, wherein the probe tip includes a lateral opening from the longitudinal lumen to a circumferential lateral region outside the probe tip. **Claim 8** The device according to claim 7, wherein the lateral opening is configured to permit inflow of fluid from at least a portion of the longitudinal lumen of the probe tip into the lumen of the probe body. **Claim 9** The device according to claim 1, wherein the probe tip further includes one or more axial grooves. **Claim 10** The device according to claim 1, wherein the distance between the distal end of the probe tip and the distal end of the probe body is at least one of user-adjustable or user-selectable by user-exchange of the probe tip. **Claim 11** The device according to claim 10, wherein the distance between the distal end of the probe tip and the distal end of the probe body is user-adjustable and the probe body is slidable with respect to the probe body along the longitudinal axis of the probe body. **Claim 12** A kit for a lithotripsy device comprising a plurality of various acoustically transmissive probe tips that are selectively user-exchangeable on the probe body of the lithotripsy device without the need for separate tools. A kit for a lithotripsy device comprising a plurality of various acoustically transmissive probe tips that are selectively user-exchangeable on the probe body of the lithotripsy device without the need for separate tools. Claim 13 The kit according to claim 12, wherein at least one of the probe tips further comprises a locking mechanism for fixing the probe tip to the probe body. Claim 14 The kit according to claim 12, further comprising an acoustic energy source attached to the probe body for providing acoustic energy through the probe body. Claim 15 The various probe tips have the following characteristics, namely, material, end morphology, acoustic impedance, end surface area, or end dimensions, or one or more combinations thereof The kit according to claim 12, which differ by at least one of these.

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