Interchangeable probe end for lithotripsy

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 on August 14, 2020, the entire content of which is incorporated herein by reference.

[0002] This document relates to techniques for using lithotripsy to destroy obstructions such as physiological stones or "stones", and more specifically, to techniques for using laser lithotripsy and the like to destroy 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 unit for operating the device or viewing an image. A slender shaft connects the proximal end and the distal end. With some endoscopes, a physician can pass tools through one or more working channels to, for example, excise tissue or remove an object.

[0004] Over the past few decades, several advancements have been made in the field of endoscopes, particularly those related 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 patients and thus must be destroyed and / or removed. Different techniques have been developed to break stones, including ultrasonic or other acoustic lithotripsy, pneumatic lithotripsy, electrohydraulic lithotripsy (EHL), and laser lithotripsy, which can include the destruction of stones using green light, YAG, or holmium lasers.

Summary of the Invention

Problems to be Solved by the Invention

[0005] One approach to lithotripsy involves using a single probe with an immovable probe end for fragmenting and removing calculi. In this approach, a single type of probe end, having a specific size and shape, is used for a variety of calculi, which may be of different hardness and size. Such an approach may limit the operator's flexibility in adjusting the treatment of such calculi based on the probe end type, including their shape and type. [Means for solving the problem]

[0006] This disclosure provides, in particular, a system and method for fragmenting or removing calculi with a device having an end-user-replaceable probe end. Having a wide variety of probe end types and shapes allows for the selection of the probe end best suited to a particular procedure and calculus being processed. Allowing the end-user to select a specific probe end enables more efficient fragmentation or removal of such calculus. For example, a rectangular-cut probe end can more easily fragment softer calculus, while a sharper chisel-cut probe end can more easily fragment harder calculus.

[0007] Interchangeable probe ends can be configured and manufactured based on the individual patient's needs or the needs indicated by a specific stone. For example, a diagnostic tool can be used to identify the type and size of a stone that needs to be fragmented and / or removed, and an end can be suitably formed and manufactured to fragment and / or remove that specific stone. Such interchangeable probe ends can also help extend the lifespan of the reusable probe body, resulting in the operator continuing to use the same probe body and thereby reducing processing costs.

[0008] Replaceable probe ends can help reduce procedure time and allow for the adjustment or optimization of lithotripsy and / or removal procedures. In addition, replaceable probe ends can potentially contribute to lower operating costs by extending the overall operating life of the probe, for example by allowing the end user to replace worn or unnecessary probe ends as needed.

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

[0010] For example, a kit for use with a lithotripsy device may include the probe body of the lithotripsy device and multiple different acoustically transparent probe ends that are selectively user-replaceable, without requiring any other tools.

[0011] For example, a method for crushing a gallstone may include the steps of: selecting or replacing a probe body and probe end, without requiring an additional tool by the end user; and transmitting acoustic energy to the gallstone via the probe body and the selected probe end to at least partially crush the gallstone.

[0012] While the figures are not necessarily proportional to actual size, similar numbers in different drawings may represent similar components. Similar numbers with different letter subscripts may represent different instances of similar components. Overall, the figures illustrate the various embodiments discussed in this document as examples, not limitations. [Brief explanation of the drawing]

[0013] [Figure 1]This is a schematic diagram illustrating a lithotripsy and removal device with a replaceable probe end, as in one example. [Figure 2A] This is a perspective view illustrating a replaceable probe end in one example. [Figure 2B] This is a perspective view illustrating a replaceable probe end in one example. [Figure 3A] This is a schematic diagram illustrating a replaceable probe end in one example. [Figure 3B] This is a schematic diagram illustrating a replaceable probe end in one example. [Figure 3C] This is a schematic diagram illustrating a replaceable probe end in one example. [Figure 4] This is a schematic diagram illustrating a replaceable probe end in one example. [Figure 5] This is a schematic diagram illustrating a replaceable probe end in one example. [Figure 6] This is a schematic diagram illustrating a replaceable probe end in one example. [Figure 7] This flowchart shows an example of how to apply a replaceable probe end. [Modes for carrying out the invention]

[0014] Stone fragmentation and removal may include end-user replaceable probe ends (or end kits) that can be selected or replaced depending on the type or properties (e.g., hardness) of the stone being treated (e.g., kidney stones). End features may include, for example, a fluid inlet or one or more axial grooves. Different ends may have different morphologies or may include or be made of different materials, such as ceramics or composites.

[0015] For end-user operators performing acoustic fragmentation and removal of lithotripsy, reducing fragmentation time is desirable. This can be helped by using larger amplitude acoustic fragmentation signals, but such large amplitudes may lead to increased probe wear or premature probe failure. Operators may want to reduce fragmentation time without probe failure and for the overall procedure to be completed in a shorter time before the lithotripsy device is inserted into the patient and the puncture site is closed. In addition, it may be desirable that there are no remaining fragments after such a procedure.

[0016] More efficient fragmentation of calculus can be enabled by allowing the end user to select and use a probe end type that can be adapted to the calculus being treated, for example, by allowing the end user to select and use a probe end that can be detachably coupled to the probe body of the lithotripsy device, for example, a probe end that can be detachably coupled to the lumen of the probe body. This can help to better fragment the target calculus, which in turn can help to reduce the size of the resulting particles expelled through the probe. For example, a ceramic or composite type distal probe end can be fixed and positioned by the end user on the probe body so that the expulsion path passes through the end and through the probe. This can enable efficient calculus fracture and expulsion of calculus fragments. A particular probe end may be easily detachable and interchangeable with another probe end of a different type or other properties, depending on the type of calculus or any other reason the end user desires.

[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 detachable. 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 implement a lithotripsy treatment by using ultrasonic or other acoustic energy, by using low-frequency solenoid-driven ballistics shock, or by using any combination thereof, for example, 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 on, for example, the specific probe type and the probe distal end that can be attached or detached by the end user using it. Probe 110 can have a diameter of from about 0.90 mm to about 3.80 mm, depending on, for example, the specific probe type and the probe distal end that can be attached or detached by the end user using it.

[0020] Probe 110 can include a probe body 112 extending between the proximal portion 102 and the distal portion 104 and having, for example, a lumen 113 also extending therebetween. 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 the target calculus.

[0021] The probe end 114 can be selected by the end user and attached to the probe body 112. The probe end 114 can be sized, shaped, and positioned to break, fragment, or crush one or more target stones. The probe end 114 can be attached to the probe body 112. In some cases, the probe end 114 can include a lumen 116. Once the probe end 114 is attached to the probe body 112 by the end user, the lumen 116 of the probe end 114 can be aligned with and extend from the lumen 113 of the probe body 112, for example, to provide a continuous irrigation and / or drainage passage. Depending on the specific procedure to be performed or the specific target to which the procedure is performed, the probe end 114 can have a desired morphology or other properties, such as a cut end, a rectangular end, an end with a large or small distal or peripheral area, various topography, various morphologies, or various materials.

[0022] The acoustic transducer 120 may be operable to deliver acoustic energy to the target calculus via an acoustically transparent probe 110. The acoustic transducer 120 can deliver ultrasonic energy, sound wave energy, or any combination thereof to break up the target calculus, such as by fragmentation or pulverization. In some cases, the acoustic transducer 120 can be configured to deliver pulsed impacts between various energy levels or energy types. This could include, for example, applying ultrasonic energy in intermittent low-frequency acoustic energy pulses or in an intermittent ballistic energy dosing mechanism. Depending on the specific operation, the acoustic transducer 120 can deliver acoustic energy of various waveforms or frequencies. For example, the acoustic transducer 120 can operate to select, adjust, or optimize a waveform in one or more parts of a procedure. The acoustic transducer 120 can be acoustically coupled to an acoustically transparent probe body 112, for example, to provide acoustic energy to a probe end 114 that can be positioned near or in contact with the target calculus by extending down the length of the probe body 112. In one example, the acoustic transducer 120 may have a diameter of about 4 to 6 cm, a length of about 15 to 25 cm, and a weight of about 0.4 to 1.0 kg, depending on the specific transducer used.

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

[0024] The discharge path 130 can be fluidly connected to the lumen of the probe 110 to bring irrigation, suction, or both to the probe assembly 100. The discharge path 130 can extend outward from the handpiece 125 toward a pressure source 140 or other pressure source. The pressure source 140 can provide a discharge pressure that descends the length of the discharge path 130 so as to draw fragments of the crushed stone away from the lumen of the probe 110 and down the discharge path 130. The discharge path 130 can be additionally irrigated as desired.

[0025] The generator 150 may communicate with the probe assembly 100 to provide electrical energy to the probe assembly 100 during its service life. The generator 150 can also provide electrical energy to power the acoustic transducer 120 to generate ultrasonic or other acoustic or ballistic energy, such as for fragmenting a target lithotripsy. In one example, the generator 150 can provide AC electrical energy of approximately 90 to approximately 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 specific processing to be performed and the desired parameters.

[0026] Figures 2A and 2B illustrate example perspective views of parts of a probe assembly 100 having a user-replaceable probe end 114. The probe assembly 100 may include a proximal section 102 and a distal section 104. The probe assembly 100 may include a probe body 112 having a lumen 113. The probe assembly 100 may also include a probe end 114 having a mounting mechanism 222, a lumen 116, one or more optional transverse openings 226, and one or more optional axial grooves 228. The probe assembly 100 can be used with acoustic transducers and generators, such as those discussed above with reference to Figure 1, for fragmentation of one or more target stones.

[0027] The probe assembly 100 can be delivered to an operator with the probe ends 114 attached to the probe body 112, or the probe ends 114 may not be attached to the probe body 112, and instead, one or more probe ends 114 may be provided separately (for example, as an auxiliary accessory or in a kit containing various probe ends 114) and delivered to the operator, who can then (as an end user) select the desired probe end 114 and attach it to the probe body 112 as desired. In some cases, a number of different probe ends 114 may be included for use with a single probe body 112. The number of probe ends 114 can be configured differently, and as a result, the end-user operator can switch specific probe ends 114 in and out, depending on the specific procedure being performed, or even dedicated to a specific target or part of the procedure.

[0028] The probe body 112 can be shaped and sized to function at the probe end 114 and be removably connected to it by the end user. The probe body 112 can extend from a proximal end 102 to a distal end 104. At the proximal end 102, a handpiece and acoustic transducer may be provided for operator use. At the distal end 104, the probe body 112 may be attachable to the probe end 114 by the end user.

[0029] The probe body 112 can be coupled to an acoustic energy source, such as a transducer discussed with reference to Figure 1, to activate the probe end 114 by providing acoustic energy through the probe body in order to acoustically fragment the target stone. The probe body 112 may include a lumen 113 running longitudinally through it to allow fragments of the stone to be collected or discharged through the probe body 112 into an aspiration or discharge tube or pathway for collection or disposal.

[0030] The probe end 114 may be user-attachable and detachable to the probe body 112, so that the end-user operator of the probe assembly 100 can select or replace various probe ends 114 as desired, depending on the procedure being performed and the type of target stone. The user-replaceable probe end 114 may be acoustically transparent to allow acoustic fragmentation, pulverization, or pulverization of the target stone. The acoustic impedance of the probe end 114 can be matched to the acoustic impedance of the probe body 112 so that acoustic energy of a desired frequency is transmitted across the boundary, joint, or coupling between the two components without significant attenuation of acoustic energy due to acoustic impedance mismatch between the two components. The probe end 114 may be user-replaceable without requiring separate tools such as those described herein, so that the probe end 114 can be replaced by the end-user operator before or even during a procedure, rather than during the manufacturing period of the probe assembly 100.

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

[0032] The probe end 114 may be any number of interchangeable probe ends of various morphologies. For example, the probe end 114 can be selected from a variety of interchangeable probe ends that allow for varying the contact pressure depending on the target stone type. For example, a probe end with a broad end can be used for softer stones, and a probe end with a sharp end can be used for harder stones. For example, a rectangular probe end with a larger surface area in contact with the stone can be used for softer stones. In contrast, a serrated, segmented, or cup-end type probe end with a smaller surface area that is more targeted to contact the stone can be used to break up harder stones. In some cases, a two-purpose probe end with an oblique end or an angled end (such as about 45 degrees) can be used for a probe end that has both needle-like properties for targeting harder stones and grinding-type properties for targeting softer stones.

[0033] The probe end 114 can be fixed and attached to the probe body 112 by an end-user operator through one or more couplers or mounting parts that can achieve mating or other engagement between them. For example, the coupler on the probe end 114 may include one or more tool-free mounting parts and / or interlocks that are user-operable relative to the probe body 112 for engagement, attachment, and / or locking, and for release or removal therefrom. The mounting mechanism 222 may include screws or other protrusions, grooves or shapes that engage with a corresponding complementary mechanism on the probe body 112, for example, to help lock the probe end 114 to the probe body 112 or otherwise mechanically secure it. In one example, the mounting mechanism 222 may include a screw on the inner diameter of the probe body 112 and a corresponding screw mechanism on the probe end 114. In another example, the mounting mechanism 222 may include a right-rotating slot in the probe body 112 corresponding to a hub post on the probe end 114, such as a post that clicks into the slot with a quarter turn. In some cases, the outer diameter of the probe 110 can be crimped to allow for a better diameter fit. In one example, the mounting mechanism 222 may include an inward-facing coil 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 coil shape. Additional relief sections may allow for an improved diameter fit. In some cases, an inward-facing spring hook can be used. In another example, the mounting mechanism 222 may include an outward-facing coil shape and a corresponding inner groove. In some cases, an external spring hook can be used. In some cases, the mounting mechanism 222 may include adhesive, either additionally or as an alternative.

[0034] For example, the probe body 112 may include a lumen 113 into which a reduced-outer-diameter interference fit mounting mechanism 222 for the probe end 114 can be inserted. The interference fit mounting mechanism 222 for the probe end 114 is positioned so that the matching outer diameter portion of the probe end 114 is aligned with the mating end of the distal end of the probe body 112, and the probe end 114 is inserted into the lumen of the probe body 112 so as to ensure a secure engagement. The interference fit allows for attachment and retention without locking.

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

[0036] In one example, the mounting mechanism 222 may be a snap-fit. The snap-fit ​​may include pressing one or more interlocking components, such as projections, grooves, or other geometric shapes on the probe end 114, into a corresponding mechanism on the probe body 112. Depending on the shape and size of the probe body 112 and the probe end 114, such a snap-fit ​​may include a cantilever, twist, annular, or combination snap-fit. The snap-fit ​​can be used for both mounting and interlocking the probe body 112 and the probe end 114.

[0037] In one example, the mounting 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 end 114. In another example, the screw may be on the outside of the probe body 112. The screw allows the probe end 114 to be attached to and secured to the probe body 112.

[0038] The probe end 114 may include a longitudinal lumen 116 that aligns with the lumen 113 of the probe body 112 when the probe end 114 is fixed to the probe body 112, for example, to allow fragmented calculus portions to be removed through aspiration or drainage pathways defined by the lumens 113, 116, and an optional separate drainage pathway.

[0039] The probe end 114 may include one or more lateral openings 226, such as an opening into the lumen 113 from a lateral region near the outside of the probe end 114. The lateral openings 226 can allow fluid to flow into the lumen 116 of the probe end 114, for example, to help flush out fragments of a calculus in the lumen 116. The lateral openings 226 can help facilitate, increase, or maximize fluid flow in one or both of the lumen 113, 116, for example, to help transport calculus fragments when the distal end opening of the probe end 114 into the lumen 116 is partially or completely blocked. The location of the lateral openings 226 on the replaceable probe end 114 can help suppress or prevent stress buildup and fracture points that may occur if the lateral openings 226 are located in the probe body 112. The probe body 112 is subjected to vibration during its operating period and may be intended to be more durable and reusable than the probe end 114, which can be discarded or replaced by the end user as described herein.

[0040] The probe end 114 may 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 end 114 can help facilitate fluid flow within the lumen 116, for example, when the opening of the probe end 114 is partially blocked. The axial grooves 228 can allow for additional fluid flow when the lumen 113 of the probe body 112 and the lumen 116 of the probe end 114 are closed. The axial grooves 228 may extend along the probe end 114, or, if desired, further into and along the probe body 112.

[0041] End-user operators, such as surgeons, can select a specific probe end 114 (from a kit of multiple probe ends 114 available) that is best suited to a particular procedure or a particular stone or group of stones to be treated. For example, a particular probe end 114 can be selected based on the material of one or both of the probe end or the probe body, based on the morphology of the probe end, based on the acoustic impedance of the probe end, based on the desired acoustic energy range for the procedure, the surface area of ​​the probe end itself, other dimensions of the probe end, or one or more combinations of these parameters.

[0042] These types of probe end selection parameters can correlate with the procedure performed and, either or both, the type or other characteristics of the stone being fragmented. For example, harder stones can be fragmented more effectively with a cut end shape, which can allow for more specific directivity or area of ​​cutting or fragmentation. Softer stones can be fragmented more effectively with a rectangular end shape or an end shape with a larger surface area. The probe end 114 can help achieve acoustic impedance matching, for example, with respect to the probe body 112 and the acoustic transducer, with respect to the target stone, or both. This can help achieve more effective transfer 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 end 114 from the kit or from a set of available probe ends 114 at or near the characteristic resonant frequency of the target stone.

[0043] Figures 3A to 3C illustrate schematic diagrams of a probe assembly 100 comprising a replaceable probe end 114 having one or more tongs 326. The probe assembly 100 may have a proximal section 102 and a distal section 104. The probe assembly 100 may include a probe body 112 and a probe end 114. The probe body 112 may include a lumen 113. The probe end 114 may have an inner diameter 324 defining a lumen 116 along which the tongs 326 can be positioned. The probe end 114 may additionally include one or more transverse openings 226. The probe end 114 can be detached from the probe body 112 and mounted so as to align the lumen 113 and the lumen 116.

[0044] In one approach, the probe end may have an inner diameter or similar dimension along the lumen wall, where both the inner diameter and lumen wall shape remain constant throughout the length of the probe end. In another approach, the inner diameter 324 of the lumen may gradually increase, such as from the distal end-open probe end 114 toward the probe body 112, as shown for the probe end 114, and the lumen 116 may be defined to have a longitudinally tapered inner diameter. In this approach, the longitudinally tapered inner diameter 324 can help allow for better movement of stone fragments through the lumen 116 toward the lumen 113 of the probe body from the probe end 114.

[0045] The probe end 114 may have a smaller end hole laterally at its distal portion 104 compared to other probe ends, including a comparison with one or more other probe ends that may be included together in the kit or set. The smaller hole in the probe end 114 can be drawn out from the larger size at the more proximal location at various angles and in various shapes.

[0046] One or more tongs 326 may extend outward from the probe end 114. During the operating period, the tongs 326 may be lowered onto the probe 110 and allowed to capture and move fragments of the stone into it, thereby allowing the fragments of the stone to move toward the lumen 113 of the probe body 112 and toward the discharge or discharge pathway. Depending on the type of stone being processed and the size and type of fragments expected, the tongs 326 may include multiple tongs as desired at various angles. The tongs 326 may extend distally outward from the probe end 114 to create a larger space, allowing the stone or fragments of the stone to move into the tongs 326. The tongs 326 may be straight or angled inward at various angles. A lateral opening 226 opened in the probe end 114 may allow for the suction and removal of the stone fragments.

[0047] Figure 4 illustrates a schematic diagram of an end-user replaceable probe end in the probe assembly 100. The probe assembly 100 may have a proximal section 102 and a distal section 104. The probe assembly 100 may include a probe body 112 and a probe end 114 having sections 422, 424, and 426. In the probe assembly 100, the distal section 104 can accommodate the probe end 114, and the probe end 114 may be length-adjustable at the end of the probe body 112.

[0048] For example, the probe end 114 may include three or more ring-shaped portions 422, 424, 426. The operator can adjust the number of portions 422, 424, 426 that extend distally to the probe body 112 for use. The probe end 114 may be slidable longitudinally with respect to the probe body 112 between the proximal and distal portions 102. The probe end portions 422, 424, 426 may be slidable relative to each other, depending on the desired probe end shape, size, and length for processing the target stone. The probe end portions 422, 424, 426 can be nested within each other. They can be connected to each other, for example, by interference fits, snap fits, screws, quarter-turn interlocks, or other mechanisms that allow the ends 422, 424, 426 to move laterally outward from each other.

[0049] During use, the first portion 422 can be used to fragment the target stone. The first portion 422 can extend laterally distally 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 wishes 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 is extended, it remains attached to the first portion 422, effectively lengthening the probe assembly 100. Similarly, if the operator no longer wishes to use the second portion 424, the third portion 426 can be pushed out from within the second portion 424. Throughout this process, portions 422, 424, and 426 may remain attached to the assembly 100. Parts 422, 424, and 426 are not removed during the operating period.

[0050] Parts 422, 424, and 426 may be actuated 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 roller wheels, such wheels can be coupled to parts 422, 424, and 426, and actuated with a finger or thumb, the parts 422, 424, and 426 can be moved slidably along the assembly 100, distally toward the distal part 104 toward the desired new part. In some cases, parts 422, 424, and 426 can be actuated through a mechanical mechanism, such as one or more springs integrated into the probe body 112. In this case, the springs can be compressed or released to push or pull parts 422, 424, and 426 along the axis of the probe 110. In some cases, this mechanism may be a hydraulic, electromagnetic, or pneumatic piston actuator for moving parts 422, 424, and 426 in and out of the probe body 112.

[0051] Figure 5 shows a schematic diagram of an example of a replaceable probe end portion in a probe assembly 100. The probe assembly 100 may have a proximal portion 102 and a distal portion 104. The probe assembly 100 may include a probe end 114 having a sheath 516 and an end portion 518. Here, the sheath 516 can act as a sheath surrounding the end portion 518. The end portion 518 of the probe end 114 may be movable laterally along the sheath 516, so that the end user can adjust the distal position of the end portion 518 of the probe end 114 in or out of the sheath 516. In the probe assembly 100, the distal portion 104 can accommodate the sheath 516, thereby making the length of the end portion of the sheath 516 adjustable. The sheath 516 may be positioned within one or more additional portions of the probe, such as the probe body 112, and may be attachable to one or more additional portions by the end user. The probe end 114 can be coupled to the probe body 112, allowing the end 518 to slide along the sheath 516, so that the operator can move the end 518 distally along the sheath 516 while the probe body 112 remains constant. The operator can adjust the position of the end 518 relative to the sheath 516 as required for a specific operation. The end 518 of the probe end 114 can make contact with the target stone. The end user can move the end 518 of the probe end 114 relative to the sheath 516 using a switch, dial, or other trigger mechanically coupled to the probe end 114. The mechanical trigger can be integrated into the handpiece 125 for easy access, enabling coupling and lateral movement of the probe end 114.

[0052] Figure 6 illustrates a schematic diagram of a replaceable probe end in probe assembly 100, similar to the probe assembly discussed above with reference to Figure 5. The probe assembly 100 may have a proximal section 102 and a distal section 104. The probe assembly 100 may include a probe end 114 having a probe delivery sheath 610, an internal rotating tube 615, and a probe ring 620 with a threaded portion 622. In probe assembly 100, the distal section 104 can accommodate the internal rotating tube 615, the probe ring 620, and the threaded portion 622. In the probe end 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 may be slidable within the probe delivery sheath 610. The probe ring 620 may include a threaded portion 622 distal to the probe delivery sheath 610, which is connected by an internal rotating tube 615, thereby enabling the attachment of the probe end 114 to the probe body 112. In this method, the probe end 114 can be replaced by an assembly, which can enable distal and proximal joining and positioning of the probe end 114.

[0054] Figure 7 illustrates a flowchart illustrating a method 700 for processing gallstones. Method 700 may include steps 710 and 720. The process may optionally include a step of selecting a probe end from a set of available probe ends or from a kit containing various probe ends. In this case, the kit may include probe ends of various surface morphologies or materials, or other deformation forms, as discussed above. The kit may include probe ends that are labeled for operator use, such as for hard gallstones, soft gallstones, large gallstones, small gallstones, and other parameters that correlate with the type of gallstone being processed, such as hard gallstones, soft gallstones, large gallstones, small gallstones, and other parameters.

[0055] Step 710 may include a step of replacing the probe body with the probe end. The probe end can be replaced with the probe body by a user, such as a surgeon or other operator, during or before the procedure. The probe end can be replaced without requiring additional tools or manufacturing techniques.

[0056] Step 720 may include a step of transmitting acoustic energy to the calculus via the probe body and probe end in order to at least partially fragment the calculus. The energy supplied to the calculus via the probe end can fragment, pulverize, or otherwise break up the target calculus.

[0057] Method 700 can enable the customization of probe ends, such as specially manufacturing the probe ends based on the specific patient needs and procedures to be performed. For example, a diagnostic tool can be used to identify the size and type of stone that needs to be removed, and 3D printing or high-speed machining can be used to manufacture the corresponding desired probe.

[0058] For example, the probe end can be selected in step 710 based on one or more parameters of the target stone, such as the size of the stone, the density of the stone, the type of stone, or one or more combinations thereof. In some cases, more than one probe may be used during the procedure, and as a result, the probe end replacement may include a step of replacing the probe end with an alternative probe end during the medical procedure based on the parameters of the stone.

[0059] Various notes and examples Each of these non-restrictive examples can stand on its own or can be combined with one or more of the other examples in various orders or combinations.

[0060] Example 1 may include a device for acoustic lithotripsy. The device may include an acoustically transparent, elongated probe body extending between a distal and proximal portion, having a lumen through which the probe body passes in the longitudinal direction, and an acoustically transparent probe end that is selectively user-replaceable on the probe body.

[0061] Example 2 may include Example 1, in which the acoustically transparent probe end is selectively user-replaceable on the probe body without requiring a separate tool.

[0062] Example 3 may include any of Examples 1-2 and further comprises an acoustic energy source that can operate to provide acoustic energy through the probe body so that the probe end is activated for acoustic fragmentation of one or more stones via the probe end.

[0063] Example 4 may include any of Examples 1-3, and the probe end includes a user-operable, tool-free interlock relative to the probe body for exchanging the probe end at the probe body.

[0064] Example 5 may include any of Examples 1-4, and the probe end may be made of ceramic or composite ceramic material.

[0065] Example 6 may include any of Examples 1 to 5 and includes a longitudinal lumen in which the probe end is configured to align with the lumen of the probe body.

[0066] Example 7 may include any of Examples 1-6, wherein the probe end has a transverse opening from the longitudinal lumen to a lateral region surrounding the outside of the probe end.

[0067] Example 8 may include any of Examples 1 to 7, wherein 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 end.

[0068] Example 9 may include any of Examples 1 to 8, and the probe end further comprises one or more axial grooves.

[0069] Example 10 may include any of Examples 1 to 9, wherein the distance between the distal end of the probe end and the distal end of the probe body is user-adjustable or user-selectable by user replacement of the probe end.

[0070] Example 11 may include any of Examples 1 to 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 relative to the probe body along its longitudinal axis.

[0071] Example 12 may include a kit for a lithotripsy device that features a variety of acoustically transparent probe ends that are selectively user-replaceable on the probe body of the lithotripsy device without requiring a separate tool.

[0072] Example 13 may include Example 12, wherein at least one of the probe ends further comprises a locking mechanism for securing the probe end to the probe body.

[0073] Example 14 may include any of Examples 12-13 and further comprises an acoustic energy source attached to the probe body to provide acoustic energy through the probe body.

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

[0075] Example 16 may include any of Examples 12 to 15, wherein the probe end can be attached to the probe body by one or more mounting mechanisms.

[0076] Example 17 may include a method for fragmenting a calculus, comprising the steps of: a user replacing the probe end with the probe body; and transmitting acoustic energy to the calculus via the probe body and the probe end in order to fragment the calculus at least partially.

[0077] Example 18 may include Example 17 and further includes the step of selecting a probe end based on one or more parameters of the stone.

[0078] Example 19 may include any of Examples 17-18, where one or more parameters include stone size, stone density, stone type, or one or more combinations thereof.

[0079] Example 20 may include any of Examples 17-19 and further include a step of exchanging the probe end with an alternative probe end during the medical procedure based on the parameters of the gallstone.

[0080] Example 21 may include any of Examples 17-20, and the step of the user replacing the probe end on the probe body may include a step of replacing the probe end without requiring any additional tools.

[0081] Each of these non-restrictive examples can stand on its own and can be combined with one or more of the other examples in various orders or combinations.

[0082] The above detailed description includes references to accompanying drawings that form part of the detailed description. The drawings illustrate specific embodiments by which the present invention can be carried out for illustrative purposes. These embodiments are also referred to herein as “examples.” Such examples may include elements in addition to those shown or described. However, the inventors also intend examples in which only those elements shown or described are provided. Furthermore, the inventors also intend examples that use combinations or permutations of those elements shown or described (or one or more embodiments thereof) with respect to a particular example (or one or more embodiments thereof) or to other examples (or one or more embodiments thereof).

[0083] In the event of any inconsistency in usage between this document and any document incorporated by reference, the usage in this document shall prevail.

[0084] In this text, the terms “a” or “an” are used to include one or more, independently of any other instance or use of the terms “at least one” or “one or more,” as is common in patent documents. In this text, the term “or” is used to refer to a non-exclusive OR, and therefore “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise specified. In this text, the terms “including” and “in which” are used as plain English equivalents of the terms “comprising” and “wherein.” Furthermore, in the following claims, the terms “including” and “comprising” are open-ended, meaning that any system, device, article, composition, preparation, or process that includes elements in addition to those listed after such terms in the claim is still considered to fall within the scope of that claim. Furthermore, 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 those objects.

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

[0086] The above description is intended to be descriptive, not limiting. For example, the above examples (or one or more of their embodiments) can be used in combination with one another. Those skilled in the art can use other embodiments by considering the above description. The abstract is provided so that readers can quickly confirm the nature of this technical disclosure. The abstract is submitted with the understanding that it is not used to interpret or limit the scope or meaning of the claims. Furthermore, in the above detailed description, various features can be grouped together to simplify the disclosure. This should not be interpreted as meaning that any feature disclosed without being claimed is intended to be essential to any claim. Rather, the subject matter of the invention may be in fewer features than all of the particular disclosed embodiments. Accordingly, the following claims are incorporated herein as examples or embodiments within the detailed description, and each claim is intended to stand alone as a distinct embodiment, and such embodiments are intended to be combined with one another in various combinations or permutations. The scope of the invention should be determined by referring to the entire scope of the appended claims and the equivalents to which such claims are granted. [Explanation of symbols]

[0087] 100 probe assemblies 102 Proximal part 104 Distal part 110 probes 112 Probe body 113 Lumen 114 Probe end 116 Lumen 120 Acoustic Transducers 125 Handpieces 130 Emission Routes 140 Pressure source 150 generators 222 Mounting mechanism 226 Horizontal opening 228 Axial groove 324 Inner diameter 326 Tongs 422 Part 1 424 Part 2 426 Third part 516 Scabbard part 518 End 610 Probe delivery sheath 615 Internal Rotating Tube 620 Probe Ring 622 Threaded part

Claims

1. A system for acoustically crushing kidney stones, An acoustically transparent, elongated probe body extending between a distal and proximal portion, having a lumen extending longitudinally through the probe body and defining the longitudinal axis of the probe body, A probe end that is selectively replaceable by the end user relative to the probe body, and is acoustically transparent, and is slidable relative to the probe body along the longitudinal axis of the probe body, A system equipped with these features.

2. The system according to claim 1, wherein the probe end is selectively replaceable by the end user relative to the probe body without requiring a separate tool.

3. Further comprising an acoustic energy source attached to the probe body, configured to provide acoustic energy through the probe body, The aforementioned acoustic energy source is a multi-frequency device that enables pulsed operation of sound waves and ultrasound. The system according to claim 1, wherein the acoustic energy source is operable to provide acoustic energy through the probe body so that the probe end is activated to acoustically fragment one or more stones.

4. The system according to claim 1, wherein the probe end includes a tool-free interlock that can be operated by an end user relative to the probe body for replacing the probe end relative to the probe body.

5. The system according to claim 1, wherein the probe end comprises a ceramic or composite ceramic material.

6. The system according to claim 1, further comprising a longitudinal lumen configured such that the probe end is aligned with the lumen of the probe body.

7. The system according to claim 6, wherein the probe end has a lateral opening from the longitudinal lumen to a lateral region surrounding the outside of the probe end.

8. The system according to claim 7, wherein 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 end.

9. The system according to claim 1, wherein the probe end further comprises one or more axial grooves.

10. The system according to claim 1, wherein the distance between the distal end of the probe end and the distal end of the probe body is adjustable by the end user or selectable by the end user by replacing the probe end.

11. The system according to claim 10, wherein the distance between the distal end of the probe end and the distal end of the probe body is adjustable by the end user.

12. Further comprising a plurality of different probe ends, wherein the plurality of different probe ends include probe ends, and each probe end of the plurality of different probe ends is The probe body is selectively replaceable by the end user. It is acoustically transparent, and The system according to claim 1, wherein the probe body is slidable relative to the probe body along the longitudinal axis of the probe body.

13. The system according to claim 12, wherein the first probe end of the plurality of different probe ends is provided with a locking mechanism configured to fix the first probe end to the probe body.

14. The system according to claim 12, wherein each probe end of the plurality of different probe ends is different from the other probe ends of the plurality of different probe ends by having at least one of a different material, a different end morphology, a different acoustic impedance, a different end surface area, or a different end dimension.

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