Internal secondary calculus fragmentation mechanism

Abstract

To provide a device and method for preventing, inhibiting, or repairing clogging in a calculi fracture device, such as in an acoustic probe used for calculi fragmentation and treatment.SOLUTION: The present disclosure includes a calculi fracture device having an acoustic transducer for transferring acoustic energy via a primary fragmentation probe to fracture a calculi mass into calculi fragments, an evacuation tube connecting the probe to a pressure source, and a secondary fragmentation device located in an evacuation pathway extending along the fragmentation probe and the evacuation tube to further break up the calculi fragments to inhibit clogging at a more proximal location in the evacuation pathway. A method for inhibiting clogging of the calculi fracture device can include receiving, from a primary fragmentation device, fragments of a calculi mass along a passage of the evacuation pathway of the calculi fracture device and further breaking up the calculi fragments along the passage of the evacuation pathway at a location that is more proximal to a primary fragmentation location.SELECTED DRAWING: Figure 2

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 065,836, filed August 14, 2020, the contents of which are incorporated herein by reference in their entirety.

[0002] This document relates to techniques for destroying obstructions such as physiological stones or "stones" using lithotripsy, and more particularly to techniques for destroying obstructions using, for example, laser lithotripsy. [Background technology]

[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 that contains an optical or electronic imaging system, and a proximal end with controls, for example, to operate the device or to view its images. An elongated shaft connects the proximal and distal ends. Some endoscopes allow a physician to pass tools down one or more working channels to, for example, remove tissue or retrieve objects.

[0004] Over the past few decades, several advances have been made in the field of endoscopy and especially with regard to the destruction of physiological stones in the bile ducts, urinary tract, kidneys, and gallbladder. Physiological stones in these areas must be destroyed and / or removed because they can block the ducts and cause considerable pain to the patient. Different techniques have been developed to destroy stones, including ultrasound or other acoustic lithotripsy, pneumatic lithotripsy, electrohydraulic lithotripsy (EHL), and laser lithotripsy, which may involve the destruction of stones using green light, YAG, or holmium lasers. Summary of the Invention [Means for solving the problem]

[0005] The present disclosure provides, inter alia, devices and methods for preventing, inhibiting, or repairing clogging in lithotripsy devices, for example in acoustic probes used for stone fragmentation and treatment. The devices and methods herein may include a secondary stone fragmentation mechanism, for example along the discharge path for removing the stone or stone fragments generated by the more distal primary fragmentation mechanism. Such further fragmentation of the stone or stone fragments may help to prevent, inhibit, or repair clogging along the discharge path that may occur without the assistance of such secondary fragmentation. This, in turn, may help to provide the user with more continuous operation of the lithotripsy device while the secondary fragmentation is occurring, without the procedure being hindered by clogging along the discharge path that may otherwise occur.

[0006] In a lithotripsy procedure using, for example, an acoustic transmission probe to break up a stone mass in a patient, the lithotripsy device may become clogged, for example, along the discharge path where suction is applied to remove fragments. The discharge path may extend, for example, from the lithotripsy device tip near the target stone mass, through the device body, and may include a suction or discharge tube connected to the device, along which suction is applied for removal of the fragments. For example, when a stone mass is fragmented, broken or pulverized, the resulting stone fragments may clog the device, for example, at the probe tip, within the probe body, near the ultrasonic transducer, in an attached suction passage, or elsewhere in or along the discharge path, or a combination of one or more of such locations. Such a clog may obstruct or block the discharge path, which may reduce or even stop subsequent discharge during the procedure, making subsequent removal of such additional stone fragments from the patient and device more difficult. In some cases, the operator may even need to stop the procedure when there is a clog, for example to manually clear the clog from the drain of the device, which may require the assistance of additional personnel, such as a technician or nurse. Sometimes the clog can be manually cleared using a cleaning tool, but other times one or more parts of the device must be disassembled to allow access to the clogged portion of the drain to alleviate or reduce or remove the clog. In extreme cases, a back-up device must be used to replace the clogged device. Preferably, the operator will be able to avoid or otherwise address the clog without having to stop the procedure for manual clearing.

[0007] Additional secondary fragmentation mechanisms can function as anti-clogging mechanisms, which may be integrated or otherwise included in the lithotriptor, for example, at one or more locations along the discharge path that may be more proximal to the primary fragmentation mechanism. The secondary fragmentation mechanisms can further break up, break up, or reduce the size of stone fragments to help inhibit, prevent, or interrupt clogging, for example, at one or more joints, pinch points, or other clogging-prone areas along the discharge path within or coupled to the handheld device. Such secondary fragmentation mechanisms can include one or more of an impeller or grinder or other mechanical fragmentation device, or an optical fragmentation device such as a laser, or one or more combinations thereof, along the discharge path within the device, for example, along an associated suction or discharge tube leading proximally from the device. The use of additional secondary fragmentation mechanisms for continuous clogging prevention can help promote continuity of medical treatment and help avoid the need to stop midway through a treatment procedure to prevent clogging of the device.

[0008] For example, a lithotriptor may include an acoustic transducer for transmitting acoustic energy through a primary fragmentation probe to fragment the stone mass into stone fragments. The device may have an exhaust path extending through the device and an aspiration or exhaust tube, for example for connecting a distal end of the probe to an aspiration or other pressure source. A secondary fragmentation device may be positioned at or along the exhaust path, for example to help further break up the stone fragments, which may help inhibit clogging at more proximal locations along the exhaust path.

[0009] In one example, a method for inhibiting clogging of a lithotriptor may include receiving one or more fragments of a stone mass from a primary fragmentation device along a discharge path of the lithotriptor, the stone fragments being capable of being further broken down along the discharge path, for example at a location proximal to the location of the primary fragmentation device.

[0010] In the drawings, which are not necessarily to scale, like numerals may refer to similar components in different figures. Like numerals with different letter suffixes may represent different instances of similar components. The drawings illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in the present document. [Brief description of the drawings]

[0011] [Figure 1] 1 shows a schematic diagram of an example of a part of a lithotriptor. [Diagram 2] FIG. 1 shows a schematic diagram of an example of part of a rotating blade configuration for secondary fragmentation or anti-clogging in a lithotriptor. [Diagram 3] FIG. 1 shows a schematic diagram of an example of a portion of a dual rotating blade configuration for secondary fragmentation and anti-clogging of a lithotriptor. [Figure 4] FIG. 1 shows a schematic diagram of an example of a portion of an annular rotating blade arrangement for secondary fragmentation, e.g., to prevent clogging of a lithotriptor. [Figure 5A] FIG. 1 shows a schematic diagram of an example of a portion of an auger arrangement for secondary fragmentation, e.g., to prevent clogging of a lithotriptor. [Figure 5B] FIG. 1 shows a schematic diagram of an example of a portion of an auger arrangement for secondary fragmentation, e.g., to prevent clogging of a lithotriptor. [Figure 6A] FIG. 1 shows a schematic diagram of an example of a portion of a burr grinder configuration for secondary fragmentation, e.g., to prevent clogging of a lithotriptor. [Figure 6B] FIG. 1 shows a schematic diagram of an example of a portion of a burr grinder configuration for secondary fragmentation, e.g., to prevent clogging of a lithotriptor. [Figure 7A] FIG. 2 shows a schematic diagram of an example of a portion of a cutting tool configuration for secondary fragmentation, e.g., for a lithotriptor. [Figure 7B] FIG. 2 shows a schematic diagram of an example of a portion of a cutting tool configuration for secondary fragmentation, e.g., for a lithotriptor. [Figure 7C] FIG. 2 shows a schematic diagram of an example of a portion of a cutting tool configuration for secondary fragmentation, e.g., for a lithotriptor. [Figure 8] FIG. 1 shows a schematic diagram of an example of part of a laser fiber configuration for a lithotriptor. [Figure 9] 1 shows a flow chart illustrating an example of a portion of a method for addressing blockages in a lithotriptor. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0012] An example of a system and method for addressing the problem of clogging due to stone mass fragments captured along a discharge path in a lithotriptor can include providing a secondary fragmentation device for further processing stone fragments at one or more locations along the discharge path that are proximal to a distal tip used to provide primary acoustic or other fragmentation of the stone. The discharge path can extend, for example, from the distal tip of the lithotriptor, through the body of the device, and through an aspiration or discharge tube connected to the device. One or more secondary fragmentation locations can be located more proximally along the discharge path, for example, at one or more locations between the ultrasonic transducer and the discharge tube. Illustrative examples of such secondary fragmentation mechanisms can include, for example, propeller-driven blades or other blade configurations, grinders, laser fibers, or one or more other secondary fragmentation modalities. The secondary fragmentation device can be operated, for example, continuously or intermittently (e.g., on a specified schedule or in response to sensed parameters or other triggers, such as an indication of a detected clogging or one or more conditions indicative of a clogging-prone situation) for continued further destruction of stone fragments.

[0013] FIG. 1 shows a schematic diagram of an example of a portion of an acoustically-transmitted stone breaker and removal device 100, which may include a secondary fragmentation device 160. The device 100 may include a hand-held portion, which may include a proximal portion 102, and a distal portion 104. The distal portion may be inserted into an opening in a patient, for example, via an endoscope or other auxiliary instrument. The device 100 may include a probe 110 with a probe body 112 and a secondary fragmentation device 160. The secondary fragmentation device 160 may be positioned at a location along an evacuation path or passageway that is proximal to the distal end of the probe 110. The device 100 may also include or be coupled to one or more of an acoustic transducer 120, a handpiece 125, an evacuation tube 130, and an aspiration or other pressure source 140. The device 100 may be in communication with a generator 150.

[0014] The device 100 may include a lithotripsy device, for example for the treatment of stones by fragmentation. The device 100 may provide lithotripsy treatment, for example using ultrasound or other acoustic energy, using low frequency solenoid driven ballistic impacts, or any combination thereof, to fragment stones or otherwise treat physiological targets. The device 100 may include a dual or other multi-frequency device, such as may allow for both sonic and ultrasonic pulsing for the destruction of stones.

[0015] The probe 110 can be sized and shaped to allow for at least partial insertion, e.g., into a patient, e.g., through an incision, e.g., to treat a stone. The probe 110 can include an acoustic transmission probe for transmitting acoustic energy from a generator or acoustic transducer to a target stone for fragmentation. The probe 110 can include a proximal portion 102 closer to an operator using the device and a distal portion 104 closer to the treatment site. The probe 110 can have a length of, e.g., about 250 mm to about 600 mm, depending on the particular probe type and distal probe tip used. The probe 110 can have a diameter of, e.g., about 0.90 mm to about 3.80 mm, depending on the particular probe type and probe tip used.

[0016] The probe 110 may include a probe body 112 extending between the proximal portion 102 and the distal portion 104, e.g., with a lumen also extending between the proximal portion 102 and the distal portion 104. The probe body 112 may be sized and shaped for insertion into a patient, e.g., to reach a stone for fragmentation. The probe body 112 may include or be made of a ceramic, metal, or composite material. The probe body 112 may include one or more couplers or other attachment mechanisms for coupling with a probe tip 114. The probe body 112 may enable an operator to manipulate the placement and actuation of the probe tip 114 on or near a target stone.

[0017] The probe tip 114 can be attached to the probe body 112. The probe tip 114 can be sized, shaped, and configured to break, fragment, or fragment 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 an end user, the lumen 116 of the probe tip 114 can align with and extend from the lumen 113 of the probe body 112, for example, to provide a continuous irrigation and / or drainage path. The probe tip 114 can have desired morphology or other characteristics, such as a turned tip, a squared tip, a tip with a large or small distally facing surface area, varying surface textures, different morphologies, or be of different materials, depending on the particular procedure to be performed or the particular target on which the procedure is to be performed.

[0018] The acoustic transducer 120 can be operable to provide acoustic energy to the target stone via the acoustic transmission probe 110. The acoustic transducer 120 can provide ultrasonic energy, sonic energy, or some combination thereof to, for example, destroy the target stone, for example, by fragmentation or pulverization. In some cases, the acoustic transducer 120 can be configured for impact pulsing between various energy levels or types. This can include, for example, applying ultrasonic energy with intermittent low-frequency acoustic energy pulses or with intermittent ballistic mechanical energy doses. The acoustic transducer 120 can provide acoustic energy with varying waveforms or frequencies depending on the particular operation. For example, the acoustic transducer 120 can be operated to select, adjust, or optimize waveforms for one or more portions of the procedure. The acoustic transducer 120 can be acoustically coupled to the acoustic transmission probe body 112 to, for example, provide acoustic energy down the length of the probe body 112 to the probe tip 114, which can be positioned near or in contact with the target stone. In one example, the acoustic transducer 120 has 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. It is possible.

[0019] The handpiece 125 can be shaped and sized to allow an end user operator to grasp and manipulate the device 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 another user interface means that allows, for example, an operator to control the device 100. For example, the handpiece 125 can include a dial for variable suction control in communication with the pressure source 140. In one example, the handpiece can include one or more buttons for applying ultrasonic, sonic, or other energy from the acoustic transducer 120 to target stones for fragmentation. In some examples, the system can additionally or instead include a foot pedal or other auxiliary actuator, for example to control the actuation of the acoustic transducer 120.

[0020] The exhaust tube 130 may be fluidly connected to the lumen 113 of the probe 110 to provide, for example, irrigation, suction, or both to the device 100. The exhaust tube 130 may extend outwardly from the handpiece 125 toward a pressure source 140 or other pressure source. The pressure source 140 may provide an exhaust pressure down the length of the exhaust tube 130 to draw fragments of the broken stone down the exhaust tube 130 and away from the lumen 113 of the probe 110. The exhaust tube 130 may additionally be irrigated as desired. The exhaust tube 130 may be part of a larger exhaust channel 170 through which stone fragments are removed.

[0021] The generator 150 can be in electrical communication with the device 100, for example to provide electrical energy to the device 100 during use. The generator 150 can provide electrical energy to power the acoustic transducer 120 to generate ultrasonic or other acoustic or ballistic energy, for example to fragment a target stone. 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 modified (e.g., amplitude, frequency, pulse width, modulation, etc.) as may depend on the particular treatment to be performed and the desired parameters.

[0022] The device 100 may additionally include a secondary fragmentation device 160, which may be positioned in or along the discharge path 170, for example, anywhere proximal to the distal end of the probe tip 114 that may provide primary fragmentation of the target stone. The discharge path 170 may include the discharge tube 130, the lumen 113 of the probe body 112, and the lumen 116 of the probe tip 114. The secondary fragmentation device 160 may be an integrated device with the stone breaker and removal device 100, for example, to further fragment stone mass in the path to inhibit, prevent, or interrupt clogging. Illustrative examples of such secondary fragmentation devices, which may aid in cutting stone fragments or breaking up stone fragments, are shown and described below with reference to FIGS. 2-8. In either case, the resulting reduced size stone fragments are less likely to clog any more proximal portions of the discharge path 170, for example, at one or more clogging prone areas, for example, at joints or kinks in the path. Thus, the use of the secondary fragmentation device 160 can help reduce or prevent clogging in the device 100.

[0023] 2 shows a schematic diagram of a rotating blade secondary fragmentation device 160 to help address or avoid clogging of a stone breaker device, such as the device 100 above. The secondary fragmentation device 160 can be positioned along the discharge path 170, such as in the discharge tube 130. The secondary fragmentation device 160 can include a cutting instrument 210 with a blade 212 having a slot 214, a retaining feature 215, and a propeller 216, for example. The secondary fragmentation device 160 can assist in further fragmenting the stone fragments 250 into smaller stone fragments 255 as the fragments move away from the distal end of the probe 110 treating the target stone mass and towards an outlet for disposal.

[0024] The cutting instrument 210 can be mounted within the discharge pathway 170, for example, in the discharge tube 130. In some cases, the secondary fragmentation device 160 can be disposed in the lumen 113 of the probe body 112, the lumen 116 of the probe tip 114, or both. The cutting instrument 210 can include a rotating blade 212 operable to cut, crush, or otherwise break up the incoming stone fragments 250 into smaller fragments 255. The blade 212 can include one or more slots 214 with angled sharp edges to enable cutting of the incoming stone fragments 250 as the blade 212 rotates relative to the discharge tube 130.

[0025] The cutting tool 210 can have a retaining feature 215 around the inner circumference of the exhaust tube 130 in which the rotating blade 212 can seat. The retaining feature 215 can be, for example, a fixed bearing disposed in the passageway. In some examples, the retaining feature 215 can be a recessed groove in which the rotating blade 212 seats. In some examples, the retaining feature can include a circumferential protrusion in the passageway in which the rotating blade 212 seats. In some cases, the retaining feature 215 can enable reduced friction. The retaining feature 215 can enable the rotating blade 212 to rotate relative to the retaining feature 215. The retaining feature 215 can be secured to the inner surface of the exhaust tube 130.

[0026] A turbine or other propeller 216 can provide propulsion to the rotating blades 212 for cutting the stone fragments 250. The propeller 216 can be located downstream or upstream of the blades 212, and can be mechanically coupled to the blades 212, for example, near a central portion of the blades 212. In some cases, the propeller 216 or other propulsion component can be rotated by irrigation or other fluid flow from the probe 110 through the exhaust tube 130. The cutting instrument 210 can be continuously actuated by the propeller 216, or can be actuated in a pulsed or scheduled manner, for example, by varying the suction and / or irrigation to regulate the flow and thereby regulate the rotation of the rotating blades 212 or another cutting instrument 210. Alternatively, instead of being actuated by fluid flow, the rotating blades 212 or other rotary cutting instrument can be electromechanically actuated, for example, by configuring it as a motor rotor, with a motor stator located adjacent to the motor rotor, but outside the exhaust path. The rotating blades 212 can be continuously actuated during the procedure or can be moved to a position that can be blocked. The device may be controllably electromechanically or otherwise actuated in response to a trigger condition, such as a sensed indication of increased activity.

[0027] 3 shows a schematic diagram of an example of a portion of a dual rotating blade secondary fragmentation device 160 for preventing clogging of a stone breaker such as the device 100 discussed above. The secondary fragmentation device 160 can include a first blade 310 and a second blade 320. The blades 310 and 320 can be disposed in the discharge tube 130 of the discharge path 170 such that the incoming stone fragments 250 pass through and are cut by the blades 310, 320 as they move in the direction of fluid flow in the discharge tube 130. In some cases, the secondary fragmentation device 160 can be disposed in other parts of the discharge path 170, such as in the lumen 113 of the probe body 112 or in the lumen 116 of the probe tip 114.

[0028] The blades 310, 320 can be similar to the rotating blades 212 discussed above in that the blades 310, 320 can be shaped and sized to reside in the drain tube 130 and rotate within the drain tube 130 to effect cutting of the incoming stone fragments 250. In some cases, the blades 310, 320 can be located in another portion of the drainage path, for example, in the lumen 113 or 116. The blades 310, 320 can be flush or spaced apart relative to each other within the drain tube 130. The blades 310, 320 can be spaced apart to allow for further fragmentation of the stone fragments 250 into smaller fragments 255 without jamming between the two blades 310, 320.

[0029] The blades 310, 320 can rotate in the same direction or counter-rotate in opposite directions to inhibit or prevent further blockage between the blades 310, 320, for example. If the blades 310, 320 counter-rotate in opposite directions, the blades moving rapidly in opposite directions can help to break up or further fragment the stone fragments 250 without creating further blockage between the blades 310, 320. In some cases, additional blades, such as three, four, or more blades, can be placed in the drain pipe, along the drain pipe 130, or elsewhere along the drain path 170. The blades 310, 320 can be mechanically, electrically, or fluidically actuated as desired, for example, with adjacent blades counter-rotating in opposite directions to create backflow, if desired. For example, the blades 310, 320 can be coupled to a mechanical component in the drain path 170 that runs up to the blades 310, 320 but is coupled to an actuator external to the drain path 170, for example, at the handpiece 125 for user actuation. For example, the blades 310, 320 can be coupled to wires for electrical actuation, which run along the discharge path 170 and can be coupled to manual or automated mechanisms for actuation by a user or a system. In some cases, a propulsion mechanism, such as a mechanical or physical gear or propeller, can be used to actuate the blades 310, 320, in which case an actuator can be connected to the blades 310, 320 in the path. In some cases, an external actuator, such as an external magnetic actuator, can be used. In this case, one or more magnetic disks or other magnets can be externally aligned with the blades 310, 320, and the material and movement of the magnetic disks can be correlated to enable magnetic propulsion of the blades 310 and 320 during operation.

[0030] The blades 310, 320 can be configured to rotate continuously during operation of the device 100, can be on a set rotation schedule, such as a pulsatile schedule, or can be manually actuated as desired. The rotation speed of the blades 310, 320 can be varied depending on the characteristics of the stone fragments 250 entering the discharge path 170 towards the secondary fragmentation device 160. The blades 310, 320 can be rotated continuously, for example, to help reduce the size of the incoming stone fragments, and can vary their rotation speed according to user preferences or an operating schedule. Other types of secondary fragmentation devices can be started and stopped automatically, on a schedule, or in response to indications of clogging, for example by an operator seeing a decrease in suction.

[0031] 4 shows a schematic diagram of an annular rotating blade secondary fragmentation device 160 to address potential clogging of a stone breaker such as device 100. In the secondary fragmentation device 160, a grinding ring 410 disposed in the discharge pipe 130 can reduce the size of the incoming stone fragments 250. The grinding ring 410 can include a grate 412 around the ring 410 and one or more impellers 414 fixed to the ring 410. The grinding ring 410 can, for example, skive the incoming fragments.

[0032] The grinding ring 410 can be actuated to rotate within the exhaust tube 130. In some cases, the grinding ring 410 can be located in another portion of the exhaust path 170, such as in the lumen 113. The grinding ring 410 can be actuated by a mechanical or electrical actuator, or by a fluid flow within the exhaust path 170. The grinding ring 410 can be manually actuated, continuously actuated, or automatically actuated, for example, on a set pulse schedule.

[0033] As the grinding ring 410 rotates, the grates 412 and impeller 414 around the circumference of the ring 410 move rapidly to shear off the incoming stone fragments 250. The grates 412 can be sized, shaped, or positioned to accommodate the expected size or hardness of the incoming stone fragments 250. The grates 412 can include sharp edges so that the impeller 414 presses the incoming fragments against the grates 412, allowing for a reduction in the size of the fragments. The grates 412 can be of similar or different sizes, for example, in a pattern or gradient around the ring 410. The grates 412 can be equally or unevenly spaced around the grinding ring 410 as desired depending on the type of stone fragments being treated. In some cases, the grates 412 are stationary and the impeller 414 can move.

[0034] Similarly, the impellers 414 may be larger or smaller depending on the expected size of the stone fragments 250 entering the discharge tube 130. The impellers 414, like the blades, may be shaped as triangles, diamonds, or other suitable shapes. The impellers 414 may be equally or unevenly spaced around the ring 410. The impellers 414 may each have at least one portion or edge that is sharp enough to further break the incoming stone fragments 250 into smaller fragments 255.

[0035] 5A-5B show schematic diagrams of an auger secondary fragmentation device 160 for addressing blockages in a stone breaker such as device 100. The secondary fragmentation device 160 can include a rotating blade 510 and an auger bit 520 having a first end 522 and a second end 524. The device 160 can act as an auger.

[0036] The secondary fragmentation device 160 can be disposed in the discharge tube 130 or in the lumen 113 or 116 on the discharge path 170 of the device 100. The rotating blade 510 can be similar to any of the rotating blades discussed above. The auger bit 520 can have a diameter that decreases across the plane of the bit from the first end 522 to the second end 524. The auger bit 520 can be mechanically coupled or fixed to the rotating blade 510. The auger bit 520 is disposed distal to the blade 510 and rotates the blade 510 when actuated. The auger bit 520 can be mechanically, electrically, or fluidically actuated as desired.

[0037] The auger bit 520 can be configured to rotate continuously during operation of the device 100, can be on a set rotation schedule, or can be manually actuated as desired. The auger bit 520 can additionally help to expel fragments of stone fragments 250 through the drain tube 130 as it rotates, creating a funnel effect, for example. The auger bit 520 can be disposed about an axis parallel to or coaxial with the longitudinal axis of the drain tube 130.

[0038] 6A-6B show schematic diagrams of a grinder secondary fragmentation device 160, such as a burr grinder, for addressing clogging of a stone breaker device such as device 100. Here, the burr grinder device 160 can be disposed in the discharge path 170 between the acoustic transducer 120 and the discharge tube 130. In some examples, the secondary fragmentation device 160 can be disposed elsewhere along the discharge path 170, such as in the discharge tube 130 or in the lumen 113 of the probe body 112 or the lumen 116 of the probe tip 114.

[0039] The burr grinder device 160 can include an outer portion 610 and an inner portion 620. The inner portion 620 can fit into the outer portion 610 with a small gap between which the stone fragments 250 can enter and be crushed. The two portions 610, 620 can include rough surfaces and can rotate in opposite directions so that smaller stone fragments 250 enter the burr grinder. In some cases, one portion of the grinder can remain stationary while the other portion rotates. The burr grinder can be mechanically, electrically, or hydraulically actuated as desired. In some cases, other types of grinders can be used.

[0040] 7A-7C show schematic diagrams of a cutting tool secondary fragmentation device 160 for a stone breaker such as the device 100. The cutting tool secondary fragmentation device 160 can be located in the discharge tube 130 or in another lumen of the device 100 along the discharge path 170. This secondary fragmentation device 160 can be located along a fixed node of the standing wave generated in the device, since the node has a tendency to become clogged or to reduce flow. The cutting tool secondary fragmentation device 160 can include a cutting feature 710 with various cutting surfaces 712 rigidly fixed in the fluid path of the discharge tube 130. The cutting feature 710, shown in FIG. 7B, can have a cross shape or other bars or patterns fixed to the discharge tube 130 to allow fluid flow through one or more fluid flow regions.

[0041] Various cutting surfaces 712, shown in FIG. 7C, can face outward to receive one or more stone fragments. When actuated, the cutting feature 710 vibrates and can be driven by the same acoustic energy as the device 100. The vibration of the cutting feature 710 can drive the cutting of stone fragments flowing through the drain tube 130 and the cutting feature 710. In some examples, different shaped instruments can be used in the channel 170. For example, one or more disks or static vibrating blades can be placed in the channel, and the cutting surface can be positioned such that the incoming stone fragments are sliced ​​as the disks vibrate with the acoustic energy of the device. Various instruments can be mounted in the channel 170 to vibrate back and forth or side to side depending on how the instrument is mounted and which direction the cutting surface is facing, which in turn helps reduce the size of the incoming stone fragments.

[0042] Figure 8 shows a schematic diagram of a laser fiber secondary fragmentation device 160 for use with a lithotriptor such as device 100. In Figure 8, a stand-alone laser fiber can be used to further fragment the stone fragments. In some cases, the laser fiber can be integrated with any of the secondary fragmentation devices discussed above with reference to Figures 2-7C.

[0043] 8, a laser source 810 can be connected to a laser fiber 820 that extends into the drainage path through an access port 830. The laser fiber 820 can be positioned to run along the transverse axis of the drainage path 170, for example, within the lumen of the drainage tube 130 or the probe 110. The laser fiber 820 can be sized, shaped, and positioned to direct a laser at the incoming stone fragments to reduce their size.

[0044] 9 shows a flow chart illustrating a method 900 for inhibiting clogging of a lithotriptor. The method 900 may include, in step 910, receiving fragments of a stone mass from a primary fragmentation device along a path of a discharge path of the lithotriptor, and, in step 920, further breaking up the stone fragments at a location along the path of the discharge path more proximal to the location of the primary fragmentation.

[0045] Further breaking up the stone fragments in step 920 can include a variety of methods, including applying laser energy to the stone fragments or applying mechanical forces to the stone fragments by cutting or crushing the stone fragments. Breaking up the stone fragments can be done continuously, pulsatile, or in response to an indication of a blockage. Breaking up the stone fragments can be accomplished using, for example, any of the secondary fragmentation devices discussed above with reference to Figures 2-8.

[0046] Each of these non-limiting examples is valid on its own or can be combined in various permutations or combinations with one or more of the other examples.

[0047] Example 1 may include a lithotriptor including an acoustic transducer for transmitting acoustic energy through a primary fragmentation probe to fragment the stone mass into stone fragments, a drainage tube connecting the probe to a pressure source, the drainage tube having an exhaust path extending through the primary fragmentation probe and the drainage tube, and a secondary fragmentation device disposed in the exhaust path to further break up the stone fragments and inhibit clogging at a more proximal location in the exhaust path.

[0048] Example 2 can include example 1, wherein the secondary fragmentation device includes a rotary cutting instrument disposed in the discharge path.

[0049] Example 3 can include any of Examples 1-2, further including a motive force mechanically coupled to the rotary cutting instrument to induce rotation of the rotary cutting instrument in response to flow through the exhaust passage.

[0050] Example 4 can include any of Examples 1-3, wherein the cutting instrument includes a retention feature fixed to the discharge passage and a rotating cutting instrument that allows rotation of the cutting instrument relative to a fixed bearing.

[0051] Example 5 can include any of Examples 1-4, wherein the rotary cutting instrument includes at least two rotary cutting instruments disposed along the discharge path.

[0052] Example 6 can include any of examples 1-5, wherein the rotary cutting instrument includes two or more counter-rotary cutting instruments.

[0053] Example 7 can include any of Examples 1-6, wherein the axis of rotation of the rotary cutting instrument is parallel to or coaxial with the longitudinal axis of the discharge channel.

[0054] Example 8 can include any of examples 1-7, wherein the drainage tube is coupled to the acoustic transducer to enable passage of acoustic energy from the primary fragmentation probe to the stone.

[0055] Example 9 can include any of Examples 1-8, further including an auger disposed in the discharge path and distal to the secondary fragmentation device.

[0056] Example 10 can include any of Examples 1-9, wherein the auger includes an auger bit disposed about an axis parallel to or coaxial with the longitudinal axis of the discharge path.

[0057] Example 11 can include any of Examples 1-10, wherein the secondary fragmentation device includes a grinder.

[0058] Example 12 can include any of Examples 1-11, wherein the grinder includes a rotary grinder having a circumferential piece with a plurality of cutting implements thereon.

[0059] Example 13 can include any of Examples 1-12, wherein the secondary fragmentation device includes a laser fiber.

[0060] Example 14 may include a method of inhibiting clogging of a lithotriptor, the method including receiving fragments of a stone mass from a primary fragmentation device along a path of a discharge path of the lithotriptor, and further fragmenting the stone fragments at a location along the path of the discharge path proximal to the location of the primary fragmentation.

[0061] Example 15 can include example 14, wherein further breaking up the stone fragments includes applying laser energy to the stone fragments.

[0062] Example 16 can include any of Examples 1-15, wherein further breaking up the stone fragments includes applying a mechanical force to the stone fragments.

[0063] Example 17 can include any of Examples 1-16, wherein applying the mechanical force includes breaking the stone fragments.

[0064] Example 18 can include any of Examples 1-17, wherein applying the mechanical force includes crushing the stone fragments.

[0065] Example 19 can include any of examples 1-18, wherein the step of further breaking up the stone fragments occurs continuously.

[0066] Example 20 can include any of Examples 1-19, wherein the step of further breaking up the stone fragments is performed pulsatilely.

[0067] Example 21 can include any of Examples 1-20, wherein the step of further breaking up the stone fragments is initiated in response to a condition indicative of a blockage.

[0068] Each of these non-limiting examples is valid on its own or can be combined in various permutations or combinations with one or more of the other examples.

[0069] The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention may be practiced. 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 contemplate examples in which only those elements shown or described are provided. The inventors also contemplate examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof) or with respect to other examples (or one or more aspects thereof) shown or described herein.

[0070] In the event of a conflict in usage between this document and any document so incorporated by reference, the usage in this document will control.

[0071] The terms "a" or "an" are used herein to include one or more than one, as is common in patent documents, independent of any other instances or usages of "at least one" or "one or more." The term "or" is used herein to refer to non-exclusiveness, or "A or B" to include "A but not B," "B but not A," and "A and B," unless otherwise indicated. The terms "including" and "in which" are used herein 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, formula, or process that includes some elements in addition to those recited after such terms in a claim will still be considered to fall within the scope of that claim. Also, in the following claims, the terms "first," "second," and "third," etc. are used merely as labels and are not intended to impose numerical requirements on these items.

[0072] Examples of the methods described herein may be at least partially machine or computer implemented. Some examples may include computer readable or machine readable media encoded with instructions operable to configure an electronic device to perform the methods as described in the examples above. Such method implementations may include code, such as microcode, assembly language code, higher level language code, and the like. 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, for example during execution or at other times, on one or more volatile, non-transitory, or non-volatile tangible computer readable media. Examples of these tangible computer readable media may 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.

[0073] The above description is intended to be illustrative, not restrictive. For example, the above examples (or one or more aspects thereof) can be used in combination with each other. Other embodiments can be used, for example, by one of ordinary skill in the art having reviewed the above description. The Abstract is provided to enable the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above detailed description, various features may be grouped together to streamline the disclosure. This should not be construed as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter never lies in all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the detailed description as an example or embodiment, with each claim standing on its own as a separate embodiment, and it is contemplated that such embodiments can be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled. [Explanation of symbols]

[0074] 100 Acoustic lithotripsy and removal device 102 Proximal part 104 Distal part 110 Acoustic Transmission Probe 112 Probe body 113 Lumen 114 Probe tip 116 Lumen 120 Acoustic Transducer 125 Handpiece 130 Discharge pipe 140 Pressure Source 150 Generator 160 Secondary fragmentation device 170 Emission Route 210 Cutting instruments 212 Blade 214 Slots 215 Retention Features 216 Propeller 250 Incoming stone fragments Stone fragments smaller than 255 310 First Blade 320 Second Blade 410 Crushing Ring 412 Great 414 Impeller 510 Rotating Blade 520 Orgabit 522 First End 524 Second End 610 Outer part 620 Inner part 710 Cutting Feature 712 Cut surface 810 Laser Source 820 Laser Fiber 830 Access Port

Claims

1. an acoustic transducer for transmitting acoustic energy through the primary fragmentation probe to fragment the stone mass into stone fragments; an exhaust tube connecting the probe to a pressure source, the exhaust tube having an exhaust path extending through the primary fragmentation probe and the exhaust tube; a secondary fragmentation device disposed in the drainage passage to further break up the stone fragments and inhibit blockage at more proximal locations in the drainage passage; Including, The secondary fragmentation device includes a laser fiber Lithotripsy device.

2. The secondary fragmentation device includes a laser fiber having a portion extending longitudinally through the exhaust path.

2. The calculus breaking device according to claim 1.

3. The portion of the laser fiber that extends longitudinally through the exhaust passage includes a distal end of the laser fiber that is located within the exhaust passage.

3. The calculus breaking device according to claim 2.

4. the distal end of the laser fiber located within the discharge path is directed toward a more distal end of the lithotriptor; 4. The calculus breaking device according to claim 3.

5. The portion of the laser fiber extending longitudinally through the exhaust passage is received within the exhaust passage at a side access port. A calculus breaking device according to any one of claims 2 to 4.

6. the side access port into the exhaust pathway is proximal to the distal end of the laser fiber when the portion of the laser fiber extends longitudinally through the exhaust pathway through the side access port; 6. A calculus breaking device according to claim 5.

7. The lateral access port defines a coaxial port access that forms an oblique angle with a coaxial longitudinal axis along the exhaust path.

6. A calculus breaking device according to claim 5.

8. The oblique angle is an acute angle.

8. The calculus breaking device according to claim 7.

9. the lateral access port is located proximal to the neck of the exhaust pathway and branches outwardly to provide a distal region of the exhaust pathway, the distal region including a larger inner diameter than a portion of the exhaust pathway in which the distal end of the laser fiber is located when the laser fiber is inserted through the lateral access port; 6. A calculus breaking device according to claim 5.

10. The discharge path further includes a rotary cutting tool.

2. The calculus breaking device according to claim 1.

11. and a motive force mechanically coupled to the rotary cutting instrument to induce rotation of the rotary cutting instrument in response to flow through the exhaust passage. The calculus breaking device according to claim 10.

12. the cutting instrument includes a retention feature secured to the discharge path and a rotational cutting instrument that allows rotation of the cutting instrument relative to the retention feature; The calculus breaking device according to claim 10.

13. the rotary cutting instruments include at least two rotary cutting instruments disposed along the discharge path; The calculus breaking device according to claim 10.

14. The rotary cutting instrument includes two or more counter-rotating cutting instruments. The lithotriptor according to claim 13.

15. The axis of rotation of the rotary cutting tool is parallel to or coaxial with the longitudinal axis of the discharge channel; The calculus breaking device according to claim 10.

16. the drain tube is coupled to the acoustic transducer to enable passage of acoustic energy from the primary fragmentation probe to the stone.

2. The calculus breaking device according to claim 1.

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