Stone fragment capture system for lithotripsy systems.

Abstract

The lithotripsy device includes a handpiece, a probe extending therefrom, an excitation source delivering energy to a distal end of the probe, an aspiration passage extending from the probe distal end through the handpiece, and a capture device, the device including a container and a capture element, the container including a storage space, an inlet port connecting to the handpiece at the aspiration passage, and an outlet port, the capture element connected to the container to facilitate capture of stone fragments in the storage space. A method may include fragmenting stones with the lithotripsy device, drawing a vacuum through the device to pull the stone fragments and waste fluid therethrough, drawing a vacuum through the stone capture device connected to the lithotripsy device, depositing the stone fragments in the stone capture device using the capture element, and drawing a vacuum through the device.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 065,958, filed August 14, 2020, the contents of which are incorporated herein by reference in their entirety.

[0002] The present disclosure relates generally to medical devices that can be used to destroy obstructions such as physiological concretions or "stones" using lithotripsy.

[0003] More specifically, the present disclosure relates to systems, devices and methods for capturing stone fragments from a lithotripsy system. [Background technology]

[0004] Medical endoscopes were first developed in the early 1800s and have been used to examine the inside of the body. A typical endoscope includes a distal end containing an optical or electronic imaging system and a proximal end with controls for manipulating tools and devices for viewing images, with a solid or tubular elongated shaft connecting the ends. Some endoscopes allow the physician to pass a tool or treatment through one or more hollow working channels, for example to remove tissue or to obtain an object.

[0005] Over the past few decades, several advances have been made in the field of endoscopy, particularly with regard to the destruction of physiological stones in the bile ducts, urinary tract, kidneys, and gallbladder. Physiological stones in these areas can block the ducts and cause the patient to experience a significant amount of pain. Thus, these stones are typically broken up for surgical removal or biological passage. Different techniques and procedures have been developed to destroy stones, including ultrasound lithotripsy, pneumatic lithotripsy, electrohydraulic lithotripsy (EHL), and laser lithotripsy, which involves the dissolution of stones using green light lasers, YAG lasers, or holmium lasers. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] U.S. Pat. No. 9,974,552 Summary of the Invention [Means for solving the problem]

[0007] The inventors have recognized that, among other things, a problem to be solved when performing a lithotripsy procedure is the recovery of stone fragments from a patient during or after the procedure. Typically, stone fragments are removed from inside the patient via suction applied to the distal end of a lithotripsy device. The suction pulls the stone fragments proximally through a suction tube, typically depositing the fragments in a waste container along with other fluids from the patient, such as biological and irrigation fluids. As such, the stone fragments typically comprise part of a mixture of materials that are located in a single container, thereby making collection of the stone fragments difficult. Collection of the stone fragments may be desirable so that an analysis can be performed. For example, a physician may be able to view the stone fragments in order to prescribe a diet to prevent future stone formation, or the stone fragments may be sent to a laboratory for detailed compositional analysis.

[0008] The present subject matter can provide a solution to this and other problems, for example, by providing a stone fragment capture system that collects stone fragments separately from other collected materials, such as waste fluids. The stone fragment capture system of the present disclosure can collect stone fragments from a flow of material being removed from a patient via suction. The stone fragments can be kept in a container that can hold the fragments pre-separated from the waste fluid for later collection and analysis. In an example, the stone fragments can be stored in a sealed container for shipment to a laboratory without requiring user intervention or repackaging.

[0009] The inventors have also recognized that, among other things, a problem to be solved when performing a lithotripsy procedure is that the lithotripsy device may become clogged with stones or stone fragments. If such a scenario occurs, it may result in an interruption of the procedure so that the device can be disassembled to remove the obstruction. For example, the system may be shut down and the device may be disconnected, disassembled, removed, and reassembled, thereby resulting in frustration and increased length of the procedure and the associated costs of extended procedure times.

[0010] The present subject matter can provide a solution to this and other problems by providing a vacuum port on an attachment for a lithotripsy device that can allow for removal of obstructions in the lithotripsy device without disassembly of the lithotripsy device or without shutting down the lithotripsy system. The vacuum port provides a sealable access port into the lithotripsy device and allows for insertion of instruments to remove obstructions without interrupting the lithotripsy system, thereby reducing downtime and frustration associated with disassembly and reassembly. In an example, the vacuum port attachment can be integrated into a stone fragment capture system.

[0011] In an example, the lithotripsy device may include a hand piece, a lithotripsy probe extending from the hand piece, an excitation source coupled to the hand piece configured to deliver energy to a distal end of the lithotripsy probe, an aspiration passage extending from the distal end of the probe through the hand piece, and a capture device coupled to the hand piece, the capture device may include a container and a capture element, the container including a storage space therein, an entry port configured to connect to the hand piece at the aspiration passage, and an exit port, the capture element connected to the container and configured to facilitate capture of stone fragments in the storage space.

[0012] In another example, a method of harvesting stone fragments from a lithotripsy procedure can include fragmenting the stone with a lithotripsy device, drawing a vacuum through the lithotripsy device to pull the stone fragments and waste fluid through the lithotripsy device, drawing a vacuum through a stone capture device connected to the lithotripsy device, depositing the stone fragments in the stone capture device using a capture element, and continuing to draw the vacuum and depositing the waste fluid in a waste container.

[0013] In an additional example, a capture device for collecting fragments generated during lithotripsy can include a container including a wall defining a storage space within the container, an entry port coupled to the wall and configured to connect to a handpiece at a suction passage, and an exit port coupled to the wall; a capture element connected to the container and configured to facilitate capture of stone fragments in the storage space; and a coupler for connecting the container to a handpiece of a lithotripsy device.

[0014] This Summary is intended to provide an overview of the subject matter of the present patent application. It is not intended to provide an exclusive or comprehensive description of the invention. The Detailed Description is included to provide further information about the present patent application. [Brief description of the drawings]

[0015] [Figure 1] FIG. 1 is an illustrative isometric view of an exemplary lithotripsy system with which the various stone fragment capture devices and systems of the present disclosure may be used. [Diagram 2] FIG. 1 is a perspective view of a lithotripsy system including a handheld probe configured to deliver radiofrequency and ultrasonic energy for stone fragmentation. [Diagram 3] FIG. 1 is a schematic cross-sectional view of a first example of a stone fragment capture system including a valve and a filter for use with a stone fragmentation system, such as the lithotripsy system described herein. [Figure 4A] FIG. 4 is a side view of a valve for use with the stone fragment capture system of FIG. 3 including a biased stop. [Figure 4B] FIG. 4B is a cross-sectional view of the valve of FIG. 4A showing a support strut for a biased stop with a window to allow passage of a stone. [Diagram 5] A schematic cross-sectional view of a second example of a stone fragment capture system including a flapper valve and a flow restrictor valve for use with a stone fragmentation system such as the lithotripsy system described herein. [Figure 6A] FIG. 6 is a schematic perspective view of a flow restriction valve including an adjustable mesh valve suitable for use with the stone fragment capture system of FIG. 5. [Figure 6B] FIG. 6 is a schematic perspective view of a flow restriction valve including an adjustable mesh valve suitable for use with the stone fragment capture system of FIG. 5. [Figure 7A]FIG. 6C is a schematic top view of the adjustable mesh valve of FIGS. 6A and 6B in a large opening configuration. [Figure 7B] FIG. 6C is a schematic top view of the adjustable mesh valve of FIGS. 6A and 6B in an intermediate opening configuration. [Figure 7C] FIG. 6C is a schematic top view of the adjustable mesh valve of FIGS. 6A and 6B in a small opening configuration. [Figure 8A] FIG. 6 is a schematic top view of a flow restriction valve including an iris valve in a closed configuration suitable for use with the stone fragment capture system of FIG. 5. [Figure 8B] FIG. 6 is a schematic top view of a flow restriction valve including an iris valve in an open configuration suitable for use with the stone fragment capture system of FIG. 5. [Figure 9] A schematic cross-sectional view of a third example of a stone fragment capture system including a cartridge and chassis assembly for use with a stone fragmentation system, such as the lithotripsy system described herein. [Figure 10] FIG. 10 is a schematic cross-sectional view of the chassis of FIG. 9 with the cartridge removed. [Figure 11] 10 is a schematic cross-sectional view of a valve of the chassis of FIG. 9 configured to interact with an actuator of the cartridge. FIG. [Figure 12] FIG. 12 is a schematic diagram of a spring valve suitable for use as the valve of FIG. 11. [Figure 13] FIG. 12 is a schematic diagram of a pressure valve suitable for use as the valve of FIG. 11 . [Figure 14] FIG. 12 is a schematic diagram of an electrically operated valve suitable for use as the valve of FIG. 11 . [Figure 15] FIG. 13 is a schematic cross-sectional view of a fourth example stone fragment capture system including a stone capture with a vacuum port for use with a stone fragmentation system such as the lithotripsy system described herein. [Figure 16]FIG. 16 is a schematic top view of the stone trap of FIG. 15 showing the location of the outlet port relative to the inlet port and vacuum port. [Figure 17] 3 is a schematic cross-sectional view of the distal tip of the probe of FIG. 2 showing a flow restriction configured to size-limit the entry of stones into the probe. [Figure 18] 1 is a flow chart illustrating a method for harvesting stone fragments from a lithotripsy procedure using the device and stone fragment capture system of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0016] In the drawings, which are not necessarily drawn to scale, like numerals may describe like components in different figures. Like numerals with different letter suffixes may represent different instances of the like components. The drawings illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in the present document.

[0017] The present disclosure provides examples of devices, systems, and methods that may help address problems associated with fragmenting stones and collecting stone fragments during a lithotripsy procedure. In particular, the present disclosure provides examples of devices, systems, and methods that may be used to harvest stone fragments from the collection process for later analysis. Typically, collection of stone fragments for later analysis can be difficult due to the stone fragments being collected simultaneously with other fluids of the procedure, thereby requiring subsequent processing (e.g., separation and repackaging, etc.). Benefits of the approach described herein include, among others, capturing stone fragments in a container separate from waste fluids, thereby reducing post-processing steps and time. Thus, stone fragments can be pre-separated from waste fluids and stored in a container that can be used to store or ship stone fragments. Moreover, the stone fragment capture devices described herein can include a vacuum port that allows access for unblocking the lithotripsy device without the need for disassembly of the lithotripsy device.

[0018] 1 illustrates an isometric view of an example lithotripsy system 100 that includes a lithotripter 102 having a housing 104 (e.g., a handle, etc.). The lithotripter 102 can include a delivery member 106 deliverable to a treatment site through a working channel WC of an endoscope E. The endoscope E can also include a light source LS and a camera C.

[0019] The delivery member 106 can include a flexible or rigid elongate shaft 108 having a tubular structure. Suitable materials for the delivery member include, but are not limited to, polytetrafluoroethylene ("PTFE"), polyethylene ("PE"), and polyamide. The elongate shaft 108 can include an outer surface 110 and at least one lumen 112 extending therethrough, the lumen suitable for passage of components and materials in communication with the end effectors described herein.

[0020] The delivery member 106 can include an end effector at a distal end, such as a probe 114, that can be delivered to a treatment site. The probe 114 can be configured to deliver energy to fragment mobile stones, such as stones located in the bile duct, urinary tract, kidney, or gallbladder. The probe 114 of the lithotripter 102 can be introduced into the patient, where it is driven by the delivery member 106 through a working channel WC of an endoscope E or similar instrument. The probe 114 can be flexible or rigid.

[0021] The lithotripter 102 can be connected to a signal generator 116. The signal generator 116 can include a power source 118 or can be connectable to an external power source. The signal generator 116 can also include an input 120 for receiving instructions from an operator and a controller 122 having a processing circuit for determining an action based on the operator input and for sending a control signal via an output 124 for communication to the lithotripter 102. The signal generator 116 can create a signal and send the signal to the probe 114 of the lithotripter 102, causing the probe 114 to emit acoustic energy. The acoustic energy can include sound waves, sonic waves, ultrasound, or shock waves, or any combination thereof. The acoustic energy can be delivered to the stone S to degrade, crack, and thereby fracture the stone S. Although the examples herein are described with reference to a combination of ultrasound and shock wave applications, any suitable acoustic energy or combination thereof can be provided to fracture the stone. The terms sonic and ultrasonic may be used interchangeably herein and may include any suitable acoustic energy for stone fragmentation.

[0022] Features of the probe 114 can provide improved fragmentation of the stone S. For example, the probe 114 can include a drill 126 (which need not include a rotating drill bit), such as an ultrasonic drill that emits acoustic energy in a longitudinal direction A1 to drill a hole in the stone. The probe 114 can also include one or more lateral emitters 128 (e.g., lateral ultrasonic transducers, etc.) to deliver acoustic energy inside the hole to fragment the stone from the inside out.

[0023] The drill 126 can be coupled to the elongated shaft 108 and positioned at the distal tip of the probe 114. The drill 126 can include at least a portion extending distally of the elongated shaft 108. In the example of FIG. 1, the drill 126 can be configured to emit ultrasonic energy in a longitudinal direction A1. The drill 126 can cause mechanical modification or destruction of the stone S by creating pulsating shock waves that travel generally along the longitudinal direction A1. The drill 126 can be configured to drill a hole, such as a recess in the stone S or a passage P through the stone S. FIG. 1 shows an example including a drill 126 that has drilled a passage P through the stone S.

[0024] The drill 126 can be an ultrasonic emitter that receives ultrasonic energy from a remotely positioned ultrasonic transducer 136, which will be referred to as the drill transducer 136 for purposes of clarity relative to other emitters and transducers in this disclosure. The drill transducer 136 can be located, for example, within the housing 104 of the lithotripter 102. The drill transducer 136 can transmit ultrasonic energy distally from the housing 104 in a generally longitudinal direction A1. The ultrasonic energy can be transmitted from the drill transducer 136 to the drill 126 via an ultrasonic transmission member 138. The ultrasonic transmission member 138 can be coupled at a proximal end to the drill transducer 136 and at a distal end to the drill 126. The ultrasonic transmission member 138 can be formed from any material capable of transmitting ultrasonic energy from the drill transducer 136 to the drill 126, including, but not limited to, a metal, a metal alloy, a shape memory alloy, a polymer, a ceramic, a fiber, a quartz, or a composite thereof.

[0025] The drill transducer 136 can be electrically coupled to the signal generator 116, such as by a connector 140, and can receive a signal to operate the drill 126. The drill transducer 136 can be activated, for example, by an operator depressing a foot pedal 132 in electrical communication with the signal generator 116, or can be activated by a drill actuator 134 coupled to the housing 104 in electrical communication with the signal generator 116. Additionally or alternatively, the drill transducer 136 can be operated based on input 120 from an operator and / or based on actions determined by the controller 122. Any other suitable actuator for controlling activation of the drill 126 can be provided.

[0026] Although the drill 126 is described as an ultrasonic drill, in some examples, other types of drills may be provided, including, but not limited to, a rotary drill operated by a motor. Like the drill transducer in the example of FIG. 1, the motor may be located remotely of the probe 114, such as in the housing 104, and the motor may be coupled to the drill 126 via a rotary transmission member. In other words, in a variation to the example of FIG. 1, a rotary motor may be provided in place of the drill transducer 136, and a rotary transmission member may be provided in place of the ultrasonic transmission member 138.

[0027] In addition to using ultrasonic emitters for drilling, the probe 114 can include at least one radial or lateral ultrasonic emitter 128 that is configured to direct ultrasonic energy in a radial or lateral direction A2 outwardly and away from the longitudinal direction A1, such as toward an interior surface (passage P) of the stone S. In the example of FIG. 1 , the at least one lateral ultrasonic emitter 128 includes a plurality or array of lateral ultrasonic emitters 128.

[0028] Each of the transverse ultrasound emitters 128 can direct ultrasonic energy in the transverse direction A2, and each of the transverse ultrasound emitters 128 is positioned along a different longitudinal position on the probe 114. In some examples, the transverse ultrasound emitters 128 can be spaced apart along the longitudinal direction A1. The transverse ultrasound emitters 128 can extend transversely or radially around the probe 114. In some examples, the transverse ultrasound emitters 128 can extend around the entire 360-degree circumference of the probe 114, or can extend around the circumference of the probe 114 when the probe has a non-circular cross-section in a direction transverse or perpendicular to the longitudinal direction A1. In other examples, the transverse ultrasound emitters 128 can be positioned only partially around the probe 114.

[0029] The lateral ultrasonic emitter 128 can be positioned proximal to the drill 126. A benefit of this arrangement is that the lateral ultrasonic emitter 128 can follow the drill 126 such that after the drill 126 prepares the passage P in the stone S, the lateral ultrasonic emitter 128 can be advanced through the passage P. When activated, such as by a lateral emitter actuator 142 in electrical communication with the lateral ultrasonic emitter 128 via an electrical element 144, such as a wire, the lateral ultrasonic emitter 128 can be configured to emit ultrasonic energy into the passage P and into the interior of the stone S to fracture the stone S from inside the stone S.

[0030] Similar to the drill transducer 136, the lateral ultrasonic emitter 128 can include ultrasonic or other acoustic transducers. An electro-acoustic transducer is a component that can convert an electrical signal into a change in a physical quantity, such as sound waves or pressure. The ultrasonic transducer can include a linear piezoelectric stack with a piezoelectric element positioned between two metal plates. In an additional example, a magnetoresistive stack can be used. Such a piezoelectric element can convert electrical energy (e.g., electrical current) into mechanical energy (e.g., sound waves, sonic waves, ultrasonic waves, shock waves). The piezoelectric element can include a crystal, such as quartz, which has physical properties that result in the crystal experiencing mechanical stress when exposed to an electric field that causes the crystal to change size or shape. The piezoelectric element alternately expands and contracts in response to an alternating electric field, such as may be provided by the signal generator 116. This expansion and contraction can generate sound waves that can be delivered to the stone S to fracture the stone S.

[0031] To help position the stone S relatively stationary relative to the working channel WC of the endoscope E while drilling a hole, and relatively stationary relative to the probe 114 (except for longitudinal A1 movement of the probe 114 through the stone), suction, as indicated by suction arrow 130, can be applied through the working channel WC. The suction 130 can cause the stone S to become "caught" by pulling the stone S toward the working channel WC, and thus, toward the drill 126 of the probe 114 for drilling. Upon fracturing the stone S, the stone fragments can be sucked into the working channel WC.

[0032] Some lithotripsy systems described herein may include a fluid input 166 for receiving fluid from a fluid reservoir FS and for delivering fluid to a treatment site. For example, irrigation or flushing fluids may be transmitted through the endoscope E or elongated shaft 108. A typical stone fragment retrieval system involves simply collecting a mixture of solids and liquids taken from a patient during the performance of a procedure. For example, suction 130 may be applied to the distal end of the endoscope E or elongated shaft 108, and a vacuum may be drawn therethrough to deposit material, such as stone fragments and waste fluids, into a waste container. In an example, a tube 150 may be connected to the housing 104 and fluidly couple a lumen extending through the working channel WC of the endoscope E with a collection container 152. The tube 150 may additionally be connected to a suction device 154 or pump to draw a vacuum through the working channel WC (indicated by suction arrow 130).

[0033] 2 is a perspective view of a lithotripsy system 200 including a handheld probe 202 configured to deliver radio frequency and ultrasonic energy for stone fragmentation. In an example, the lithotripsy system 200 can include a vibrating lithotripter as described in U.S. Patent No. 9,974,552, entitled "Vibrating Lithotripter" by St. George et al., which is assigned to Gyrus ACMI, Inc., the contents of which are incorporated herein in their entirety.

[0034] The handheld probe 202 can include a handpiece or handle 204 and a shaft 206. The handheld probe 202 can be connected to a generator 208, such as via a cable 210. A collection tube 212 can be connected to a storage container, such as a fluid reservoir FS (FIG. 1), to collect fluids and other biological materials collected via the shaft 206. The shaft 206 can extend from a proximal end 214 to a distal end 216 and can include an internal lumen (e.g., lumen 532, FIG. 17). The handle 204 can further include buttons 218A and 218B for controlling activation energy and a knob 220 for controlling the suction level.

[0035] The handle 204 can include any device suitable for facilitating manipulation and operation of the shaft 206. The handle 204 can be positioned at the proximal end 214 of the shaft 206 or at another suitable location along the shaft 206. In examples, the handle 204 can include a pistol grip, a knob, a handlebar grip, or the like. In addition to or in the alternative to the buttons 218A and 218B and the knob 220, the handle 204 can include one or more of buttons, triggers, levers, knobs, dials, and the like for control of energy activation, aspiration, irrigation, and the like.

[0036] In various examples, the distal end 216 of the shaft 206, or another suitable location along the shaft 16, can include a surgical device, which can include components or devices for interacting with a patient, such as those configured to cut and cauterize tissue and / or create a desired tissue effect in a patient. In examples, the surgical tools can include forceps, cutting tools, ablation electrodes, cryogenic needles or applicators, ultrasonic probe tips, and the like, as well as combinations thereof. As such, the handheld probe 202 can be provided with linkages, such as mechanical linkages for actuating the forceps or cutting tools, electrical linkages for activating the ablation electrodes, acoustic linkages, and liquid conduits (e.g., for delivery of cryogenic argon gas), as well as combinations thereof. In examples, the surgical device can be included on a device used with the handheld probe 202. In additional examples, the handheld probe 202 can include or be combined with a device for viewing the patient (e.g., optical devices including endoscopes (e.g., endoscope E above) and fiberscopes, etc.).

[0037] The generator 208 can include a source of energy for the handheld probe 202. For example, the generator 208 can be configured to provide electricity to perform ablation and cauterization functions and / or provide ultrasonic energy to provide cutting, coagulation, fragmentation, or other types of surgical functions. In an example, the generator 208 can provide ultrasonic energy while intermittent ballistic shock wave energy is provided via an oscillating free mass in the handle 204.

[0038] The shaft 206 can include an elongated member configured to deliver energy into the patient to fragment the stone. The shaft 206 can be rigid and formed from a metal or plastic material. In an example, the shaft 206 can be sized to perform a lithotripsy procedure in conjunction with an endoscope. As such, the shaft 206 can be inserted into an incision in the patient's epidermis, through a body cavity of the patient, and into an organ. Thus, to facilitate a minimally invasive surgical procedure, it is desirable for the diameter or cross-sectional shape of the shaft 206 to be as small as possible. However, the shaft 206 can also incorporate a lumen (e.g., lumen 532 of FIG. 17) to allow removal of stone fragments created by the fragmentation energy, e.g., via suction. As such, the size of the shaft 206 and the lumen extending therethrough must be balanced to allow for minimal invasiveness and sufficient removal of the stone fragments. For example, a lumen that is too small can increase the time it takes to adequately fragment the stone into small pieces.

[0039] The lithotripsy 100 of FIG. 1 and the lithotripsy system 200 of FIG. 2 are examples of lithotripsy systems that can be used with the stone fragment capture devices, systems, and methods described herein. For example, the stone fragment capture device can be connected to the housing 104 and the tube 150 to collect stone fragments harvested by the lithotripter 102 and facilitate the clearance of obstructions that may form within the lithotripter 102. Similarly, the stone fragment capture device of the present disclosure can be connected to the handle 204 and the tube 212. Although the present application is described with reference to a lithotripsy system used for stone harvesting, other types of surgical and endoscopic devices can also be used with the stone fragment capture systems and methods disclosed herein. For example, any surgical device that can be configured for insertion into a patient, including harvesting biological material with waste fluids via suction, such as forceps intended to remove endometrial tissue from the uterus, can benefit from the present disclosure. Examples of surgical devices that can be used with the present disclosure can utilize various energy sources (e.g., laser energy, ultrasonic energy, etc.) to crack, fragment, and / or collect particles (e.g., stones and other solid or rigid bodies), and can also effect ejection of such particles after they have been broken down, such as by using a vacuum to draw solids, liquids, and mixtures into a designated collection receptacle.

[0040] 3 is a schematic cross-sectional view of a stone fragment capture system 250 for use with the stone fragmentation system 252 of FIG. 2. The stone fragmentation system 252 can be used with the lithotripsy system 100 of FIG. 1, which can deliver fragmentation energy radially along the probe 114, as well as with the stone lithotripsy system 200 of FIG. 2, which can deliver fragmentation energy longitudinally along the shaft 206. The stone fragment capture system 250 can include a valve 254 and a filter 256, which can be coupled to a container 258. The container 258 can include a housing 260, a cap 262, an inlet port 264, an outlet port 266, and a baffle 267.

[0041] The stone fragmentation system 252 can include any of the lithotripsy systems described herein or another surgical system configured to generate suction therethrough. The stone fragmentation system 252 can include a handle 268 and a stem 270. In an example, the handle 268 can include a knob 272, similar to the knob 220 of FIG. 2, to control functions of the stone fragmentation system 252, such as the suction level. A passageway 274 can be configured to extend from the handle 268, such as from a shaft or probe extending distally therefrom, through the knob 272 positioned at a proximal end and the stem 270.

[0042] The container 258 can be coupled to the handle 268 and the tube 276. The housing 260 can be positioned such that the inlet port 264 couples to the stem 270. The stem 270 can include a barb 278 that can be configured to facilitate attachment of the container 258 to the handle 268. For example, the barb 278 can be a resilient rim extending around the stem 270 that can have a diameter slightly larger than the inner diameter of the stem inlet port 264. The inlet port 264 can include a cylindrically shaped tube extending from a floor 280 of the housing 260. The tube forming the inlet port 264 can be tapered to slow the movement of the fragments 284 entering the container 258. The floor 280 can include an annular disk connecting the inlet port 264 to the housing 260. Similarly, the outlet port 266 can include a cylindrically shaped tube extending from the cap 262. The cap 262 can include an end plate 282, which can include an annular disk connecting the outlet port 266 to the cap 262. The cap 262 can be coupled to the housing 260 via any suitable means, such as, for example, a threaded or snap-fit ​​connection. In an example, the tube 276 can be integral with the outlet port 266, as shown. In another example, the tube 276 can be coupled to the outlet port 266 via a barbed connection similar to barb 278. Although the example shown shows the container 258 directly coupled to the stem 270 of the handle 268, the container 258 can additionally be coupled to the handle 268 via a length of tubing, which can be coupled, for example, around the stem 270 and inserted into the inlet port 264.

[0043] The container 258 can be positioned between the handle 268 and the tube 276 to capture the stone fragments 284 leaving the passageway 274. The inlet port 264 can be configured to align with the outlet port 266 along the axis A3. However, in other examples, the outlet port 266 can be offset from the axis A3, as discussed below with reference to FIGS. 15 and 16. The stone fragments 284 can flow through the passageway 274 from the handle 268 to the stem 270. The stone fragments 284 can be dispersed into the interior of the container 258, such as by using a capture element including, for example, one or more of the inlet port 264, the baffle 267, and the tube including the filter 256. For example, the stone fragments 284 can fall to the floor 280 via gravity. In an example, the housing 260 can extend beyond the tip 286 of the inlet port 264 to provide clearance for the stone fragments 284 to enter the container 258. In an example, the end plate 282 can be positioned a predetermined distance away from the tip 286 to allow the momentum of the stone fragments 284 to dissipate. Additionally, a baffle 267 can be positioned opposite the tip 286 to deflect the fragments 284 into the housing 260. The baffle 267 can include a body of various shapes that extends radially inward from the wall of the housing 260 or axially outward from the inlet port 264 to block the outlet port 266 from direct impact of the fragments 284. The baffle 267 can dampen the momentum of the fragments 284 and promote the movement of the fragments 284 out of the suction path, e.g., the path of the flowing liquid, between the inlet port 264 and the outlet port 266.

[0044] The filter 256 can be positioned within the container 258 to prevent the escape of the stone fragments 284 from the container 258. In the illustrated example, the filter 256 is positioned within the exit port 266. However, the filter 256 can be positioned anywhere within the container 258 to prevent the free ingress of material into the exit port 266. In the example, the filter 256 is attached to the cap 262 to facilitate access of the stone fragments 284 within the container 258 when the cap 262 is removed. However, the filter 256 can be configured to be removable from the housing 260 on its own, independent of the cap 262. The filter 256 can be sized to allow liquid and tissue or small pieces of stone fragments and other debris to pass through the container 258, but it prevents larger pieces of material from being retained within the container 258. The capture elements described herein, the filters 256 and other filter or orifice elements described herein (e.g., flow restrictor valve 360 ​​of Figures 8A and 8B) can be sized to retain pieces of material or stone fragments that are suitable for further analysis, such as by visual inspection for color and texture analysis.

[0045] The valve 254 can be positioned proximate the tip 286 of the stem 270 and can be used to intermittently close the stem 270 to prevent escape of the stone fragments 284 out of the container 258. For example, the valve 254 can close to prevent the stone fragments 284 from leaving the container 258 at the inlet port 264 when the container 258 is removed from the inlet port 264 and when the tube 276 is removed from the cap 262. The valve 254 can include any suitable device for allowing flow into the housing 260 when the container 258 is attached to the stem 270 and for preventing the stone fragments from leaving the housing 260 when the container 258 is removed from the handle 268. The valve 254 can be configured to be mechanically opened by engagement with the stem 270 or by the action of a vacuum being drawn through the container 258. As discussed with reference to FIGS. 4A and 4B, the valve 254 can include a biased stop.

[0046] FIG. 4A is a side perspective view of a first example of a valve 254 for use with the stone fragment capture system 250 of FIG. 3. In the illustrated example, the valve 254 can include a stop 290, a resilient element 292, a backstop 294, struts 296A-296H, and a support ring 298. FIG. 4B is a cross-sectional view of the valve 254 of FIG. 4A taken at section 4B-4B to show the support struts 296A-296H. FIGS. 4A and 4B will be discussed simultaneously. The struts 296A-296H can be connected at a first end to the ring 298 and at a second end to the backstop 294. The support ring 298 can be positioned around the stem 270 and position the backstop 294 against the opening of the inlet port 264 that connects to the passageway 274. The support ring 298 can be coupled to the inlet port 264 using any suitable means, such as adhesives, fasteners, or threaded fastenings. The struts 296A-296H can be used to guide the stop 290 into and out of engagement with the tip 286. The stop 290 can include a circular or rectangular shape, or any suitable shape for closing the inlet port 264. The stop 290 can include a bore or notch for sliding along the struts 296A-296H, or can simply be guided between the struts 296A-296H. When the stone fragmentation system 252 is not operating, the elastic element 292 can push the backstop 294 and press the stop 290 against the inlet port 264. As such, escape and ingress of material into the container 258 can be prevented or inhibited. When the stone fragmentation system 252 is operating, a vacuum is pulled from the tube 276, allowing the stop 290 to be pulled away from the tip 286. As such, stone fragments 284 are allowed to flow out of the inlet port 264, between the struts 296A-296H, and into the container 258.

[0047] 5 is a schematic cross-sectional view of a stone fragment capture system 300 for use with the stone fragmentation system 252. The stone fragment capture system 300 can include a valve 304 and a filter 306, which can be coupled to a container 308. The container 308 can include a housing 310, a cap 312, an inlet portion 314, and an outlet portion 316.

[0048] The stone fragment capture system 300 can be used with stone fragmentation systems described herein, such as, for example, stone fragmentation system 252, and with other lithotripsy or other surgical systems configured to generate suction therethrough. For example, the inlet portion 314 can be connected to the stem 270 such that the passageway 274 can connect to the interior of the housing 310.

[0049] The container 308 can be coupled to the handle 268 (FIG. 3) and the tube 276 (FIG. 3). The housing 310 can be positioned such that the inlet portion 314 couples to the stem 270. The inlet portion 314 can include a cylindrically shaped opening extending through a floor 330 of the housing 310. The inlet portion 314 can include a resilient material having an opening slightly smaller than the diameter of the stem 270 such that a sealed fit can be achieved therebetween. The floor 330 can include an annular disk or polygonal plate connecting the inlet portion 314 to the housing 310. Similarly, the outlet portion 316 can include a cylindrically shaped tube extending from the cap 312. The cap 312 can include an end plate 332, which can include an annular disk connecting the outlet portion 316 to the cap 312. The cap 312 can be coupled to the housing 310 via any suitable means, such as, for example, a threaded or snap-fit ​​connection. In an example, the tube 276 can be integral with the outlet portion 316. In other examples, the tube 276 (FIG. 3) can be coupled to the outlet portion 316 via a barbed connection similar to barb 278 (FIG. 3). Although the illustrated example shows the container 308 directly coupled to the stem 270 of the handle 268, the container 308 can additionally be coupled to the handle 268 via a length of tubing, which can be coupled, for example, around the stem 270 and inserted into the inlet portion 314.

[0050] The container 308 can be positioned between the handle 268 and the tube 276 to capture the stone fragments 334 leaving the passageway 274. The inlet 314 can be configured to align with the outlet 316 along the axis A4. However, in other examples, the outlet 316 can be offset from the axis A4, as discussed below with reference to FIGS. 15 and 16. The stone fragments 334 can flow through the passageway 274 from the handle 268 to the stem 270. The stone fragments 334 can be dispersed into the interior of the container 308. For example, the stone fragments 334 can fall to the floor 330 via gravity. In an example, the housing 310 can extend beyond the tip 336 of the stem 270 to provide clearance for the stone fragments 334 to enter the container 308. In an example, the end plate 332 can be positioned a predetermined distance away from the tip 336 to allow the momentum of the stone fragments 334 to dissipate. Container 308 may be provided with a capture element as described with reference to FIG. 3, such as an elongated tube extending from inlet portion 314 and a baffle similar to baffle 267.

[0051] The valve 304 can be positioned proximate the tip 336 of the stem 270 and can be used to intermittently close the stem 270 to prevent escape of the stone fragments 334 out of the container 308. The valve 304 can include any suitable device for allowing flow into the housing 310 when the container 308 is attached to the stem 270 and for preventing the stone fragments from leaving the housing 310 when the container 308 is removed from the handle 268. In the illustrated embodiment, the valve 304 can include a flapper valve having a stop 338, a resilient element 340, and a sidewall 342. The sidewall 342 can include a cylindrical body or a tube having another cross-sectional shape for surrounding the stem 270. The stop 338 can be pivotally connected to the sidewall 342 at a coupling 344, which can include a pinned coupling. As such, the stop 338 can rotate about the coupling 344 between engaging the sidewall 342 and being positioned approximately parallel to the central axis of the stem 270. The resilient element 340 can bias the stop 338 to a closed position engaged with the sidewall 342. The resilient element 340 can include a spring, such as a butterfly spring, that can push against the sidewall 342 and the stop 338 simultaneously. The valve 304 can be configured to be opened upon the flow of material through the container 308, for example, when a vacuum is pulled from the outlet 316.

[0052] 6A-7C, the filter 306 can be positioned within the container 308 to prevent escape of stone fragments 334 from the container 308. The filter 306 can include a flow restriction valve that can be adjusted to vary the size of the stone fragments 334 that can be permitted to flow through the stone fragment capture system 300. For example, the filter 306 can include opposing mesh layers 346A and 346B, whose relative positions can be varied to adjust the radial gap size between the meshes.

[0053] 6A and 6B are schematic perspective views of a filter 306 including a flow restriction valve suitable for use with the stone fragment capture system 500 of FIG. 5 and with other systems described herein. Filter 306 can include opposing mesh layers 346A and 346B. The mesh in each of layers 346A and 346B can be oriented parallel to one another. For example, layer 346A can include mesh strands 348A-348D and layer 346B can include strands 350A-350D. Although layers 346A and 346B are described as each having four strands of parallel mesh, they can include any suitable number of strands for filtering or inhibiting the flow of biological material. Strands 348A-348D can be attached to frame 352 and strands 350A-350D can be attached to frame 354. Frames 352 and 354 can be connected by struts 356 such that frames 352 and 354 are rotatable relative to one another. One of frames 352 and 354 can be coupled to handle 358. As shown in FIG. 6A, strands 348A-348D and strands 350A-350D are parallel to one another in a horizontal position (with respect to the orientation of FIG. 6A). In FIG. 6B, frame 352 is rotated by handle 358 in a counterclockwise direction relative to frame 354 such that strands 350A-350D are in a vertical position (with respect to the orientation of FIG. 6B) perpendicular to strands 348A-348D.

[0054] 7A-7C include schematic top views of mesh layers 346A and 346B of filter 306 in aligned, transverse, and vertical alignment, respectively. Thus, the radial spacing between the strands (e.g., relative to a central axis of frame 354) is such that strands 348A-348D and strands 350A-350D are arranged in large, medium, and small spacing configurations.

[0055] In Figure 7A, strands 348A-348D and strands 350A-350D are parallel to one another in a vertical position (with respect to the orientation of Figure 7A). As such, spacing S1, measured radially from the center of frame 354, is at its maximum. In Figure 7B, strands 348A-348D are rotated approximately 45 degrees clockwise relative to Figure 7A. As such, spacing S2, measured radially from the center of frame 354, is less than S1.

[0056] In Figure 7C, strands 348A-348D are rotated approximately 90 degrees clockwise relative to Figure 7A, so that spacing S3, measured radially from the center of frame 354, is less than S2 and is at its minimum.

[0057] Mesh layers 346A and 346B can be manually adjusted by a user of stone fragment capture system 500 to control the size of stone fragments desired to be captured by container 308. For example, mesh layers 346A and 346B can be adjusted to the position of FIG. 7A to collect larger fragments, which may be useful, for example, if only a few fragments are desired for laboratory analysis. However, mesh layers 346A and 346B can be adjusted to the position of FIG. 7C to collect only small fragments, which may be useful, for example, if a large volume of fragments is desired for visual inspection.

[0058] 8A and 8B are schematic top views of a flow restriction valve 360 ​​suitable for use with the stone fragment capture system 300 of FIG. 5. The flow restriction valve 360 ​​can include an iris valve with shims 362A-G. FIG. 8A shows the shims 362A-G in a closed configuration, and FIG. 8B shows the shims 362A-G in an open configuration. The shims 362A-G can be constrained by a frame 364. A lever 366 is connected to the frame 364 and can move the shims 362A-G between an open position and a closed position. As shown in FIG. 8A, the shims 362A-G can be positioned such that the orifice 368 is small. Thus, the flow restriction valve 360 ​​can be configured to minimize the amount of biological material that will pass through the container 308, thereby reducing the size of the stone fragments that will be retained in the container 308. As shown in FIG. 8B, the shims 362A-G can be positioned such that the orifice 368 is large. Thus, the flow restriction valve 360 ​​can be configured to maximize the amount of biological material that will pass through the container 308, thereby increasing the size of the stone fragments that will be retained in the container 308. Thus, for example, an operator of the stone fragment capture system 500 of FIG. 5 can adjust the flow restriction valve 360 ​​to the desired size of the stone fragments that will be retained by the container 308. The shims 362A-G can be configured to operate as will be recognized by those skilled in the art, such as by being pinned at their outer diameter ends proximate the frame 364 and connected to an outer diameter actuation mechanism that simultaneously rotates each of the shims 362A-G at the pinned connection. In an example, the flow restriction valve 360 ​​can be constructed similar to an iris shutter similar to those used in cameras that are scaled up in size and robustness for use in pressurized environments as a flow control orifice.

[0059] 9 is a schematic cross-sectional view of a stone fragment capture system 400 for use with the stone fragmentation system 252 and with other systems described herein. The stone fragment capture system 400 can include a chassis 402 and a cartridge 403. The chassis 402 can include a stem 404A, a stem 404B, a barb 406A, a barb 406B, a first valve 408A, and a second valve 408B. The cartridge 403 can include a housing 410 and a filter 412.

[0060] The stone fragment capture system 400 can be coupled to tubes 414A and 414B. The stem 404A can be configured to align with the stem 404B along the axis A5. However, in other examples, the stem 404B can be offset from the axis A5, as discussed below with reference to FIGS. 15 and 16. The tube 414A can be connected to a fragmentation tool, such as the handle 252. The tube 414B can be connected to a waste collection container and a vacuum generator (e.g., a pump, etc.).

[0061] The stone fragmentation capture system 300 can be used with the stone fragmentation systems described herein (such as, for example, the stone fragmentation system 252) and other lithotripsy systems. For example, the inlet portion 314 can be connected to the stem 270 such that the passageway 274 can connect to the interior of the housing 310.

[0062] The stone fragment capture system 300 can be configured such that the chassis 402 can remain connected to the tubes 414A and 414B, with one or more cartridges 403 being sequentially coupled to the chassis 402. Additionally, each cartridge 403 can include a self-sealing system such that, upon removal from the chassis 402, each cartridge 403 is ready to be transported or shipped to a different location for storage and analysis. For example, the valves 408A and 408B can be configured to open and close upon insertion and removal of the cartridge 403 into the chassis 402, as discussed with reference to FIGS. 11-14.

[0063] The chassis 402 and cartridge 403 can be configured for use with different systems or for collecting stone fragments of different sizes. For example, the chassis 402 can include stems 404A and 404B having different sizes, such that tubes 414A and 414B of different sizes can be connected thereto. Also, the cartridge 403 can be configured to have different grades of filters 412. The filters 412 can additionally include the filters 306 of FIG. 5 or the flow restriction valves 360 of FIG. 8A and FIG. 8B. As such, the stone fragment capture system 300 can be configured to allow stone fragments of different sizes to pass therethrough.

[0064] In an example, valves 408A and 408B can be attached to cartridge 403 and configured to open upon insertion of cartridge 403 into chassis 402 by engagement of valves 408A and 408B with an actuator attached to chassis 402.

[0065] In an example, valves 408A and 408B can be mounted to chassis 402 and configured to open upon insertion of cartridge 403 into chassis 402 by engagement of valves 408A and 408B with an actuator mounted to cartridge 402, as shown in FIG. 12.

[0066] 10 is a schematic cross-sectional view of the chassis 402 of FIG. 9 with the cartridge 403 removed. The chassis 402 can be configured as a body to easily receive the cartridge 403 to allow flow through the cartridge 403 when the cartridge 403 is seated in the chassis 402, and to allow flow around the space for the cartridge 403 when the cartridge 403 is removed from the chassis 402. The chassis 402 can include a shell 432 having a socket 434, an internal passage 435, and valves 408A and 408B. The cartridge 403 can include actuators 436A and 436B. In an example, the chassis 402 can include a half-cylinder.

[0067] When the cartridge 403 is not positioned in the socket 434, the valves 408A and 408B can be configured to direct flow from the stem 404A, through the valve 408A, through the internal passage 435, through the valve 408B, and into the stem 404B. When the cartridge 403 is positioned in the socket 434, the valves 408A and 408B can be configured to direct flow from the stem 404A, through the valve 408A, through the cartridge 403, through the valve 408B, and into the stem 404B.

[0068] FIG. 11 is a schematic cross-sectional view of a valve 408B of the chassis 402 configured to interact with an actuator 436B of the cartridge 403. The valve 408B can include a flap 438 and a hinge 440. As shown in FIGS. 12-14, the flap 438 can be biased toward the shell 432. The cartridge 403 can be fitted into a socket 434 of the chassis 402 such that the actuator 436B presses against the valve 408B. The actuator 436B can overcome the biasing force applied to the flap 438 by the biasing device. Thus, flow can be permitted from within the cartridge 403 through the valve 408B. When the flap 438 is closed, fluid can freely flow from the internal passage 435 to the stem 404B. When the flap 438 is open, it can close the interior passageway 435, allowing fluid to flow freely from the cartridge 403 to the stem 404B.

[0069] 12, 13, and 14 include schematic diagrams of a spring valve 440, a pressure valve 442, and an electrically operated valve 444 suitable for use as the valve 408B of FIG.

[0070] 12, the spring valve 440 can include a flap 438 connected to the shell 432 at a hinge 440, with the flap 438 biased by a spring 446. The spring 446 can be configured to press the flap 438 against the chassis 402 to close off flow through the cartridge 403 and allow flow through the interior passageway 435. An actuator 436B can be configured to engage the flap 438 to press the flap 438 away from the chassis 402.

[0071] 13, the pressure valve 442 can include a rod 448A, a dashpot 450, and a rod 448B. The rod 448A can be attached to the flap 438 at a hinge 452A, and the rod 448B can be attached to the shell 432 at a hinge 452B. The dashpot 450 can be configured to press the flap 438 against the chassis 402 to close off flow through the cartridge 403 and allow flow through the internal passageway 435. The actuator 436B can be configured to engage the flap 438 to press the flap 438 away from the chassis 402.

[0072] 14, the motorized valve 444 can include a motor 454, which can be connected to the flap 438 via a linkage 456. In an additional example, the motor 454 can act as the hinge 440 and can be directly coupled to the flap 438. The motor 454 can be configured to press the flap 438 against the chassis 402 to close off flow through the cartridge 403 and allow flow through the interior passageway 435. The actuator 436B can be configured to engage the flap 438 to press the flap 438 away from the chassis 402.

[0073] FIG. 15 is a schematic cross-sectional view of a stone fragment capture system 500 for use with the stone fragmentation system 252 and with other systems described herein. The stone fragmentation system 252 can include any of the lithotripsy systems described herein and can include a handle 204 and a shaft 206. The stone fragment capture system 500 can include a stone capture device 502 with a vacuum port 504. The stone capture device 502 can include a housing 506 including an upper component 508A and a lower component 508B, and a coupler 510. FIG. 16 is a schematic top view of the stone capture device 502 of FIG. 15 showing the position of the tube connector 512 relative to the coupler 510. FIG. 15 and FIG. 16 are discussed simultaneously.

[0074] The stone fragment capture system 500 can include a system for capturing stone fragments, which simultaneously allows access to the interior of the handle 204 and shaft 206 via a vacuum port 504. The vacuum port 504 can include a sealable port, which can be opened to allow for the insertion of an instrument into the handle 204 through the stone capture device 502. In an example, the sealable port can include a threaded port with a cap. In an additional example, the sealable port can include a self-sealing access point, such as an iris point access system including multiple deflectable tabs that can abut or overlap each other in an undeflected state to seal the access point, but that can be bent or deflected away from each other to allow for access into the access point.

[0075] The vacuum port 504 and coupler 510 can be aligned along the axis A6 of the handheld probe 202, with the shaft 206 and handle 204 extending along the axis A6. As such, if an obstruction in the handle 204 or shaft 206 occurs (e.g., from a stuck stone fragment, etc.), the probe can be inserted into the vacuum port 504 all the way toward the distal tip 216 (FIG. 17) of the shaft 206 to push or otherwise dislodge the stone fragment or other obstruction.

[0076] The stone capture device 500 can function similarly to the container 258 of FIG. 3, the container 308 of FIG. 5, or any of the other stone fragment capture systems described or contemplated herein. However, as shown in FIG. 16, the tube connector 512 can be positioned off axis A7 from axis A6, allowing the vacuum port 504 to be axially aligned with the coupler 510. The vacuum port 504 can be integrated into the container 258 of FIG. 3 and the container 308 of FIG. 5 by offsetting the outlet port 266 and the outlet portion 316 from the inlet port 264 and the inlet portion 314, respectively. For example, referring to FIG. 3, the outlet port 266 can be offset from axis A3 on the end plate 282 closer to the side wall of the cap 262, allowing the entry port (such as, for example, the vacuum port 504) to be positioned in alignment with the inlet port 264. In such cases, valve 254 may be omitted or may be configured as a two-way valve, allowing flow in both directions when activated (e.g., pulled open by vacuum to allow flow out, or pushed open by a probe to allow clearance of an obstruction). Similarly, chassis 402 of FIG. 10 may be modified accordingly to include a vacuum port.

[0077] The upper and lower components 508A, 508B can be releasably coupled to one another to allow access to the stone fragments captured therein. For example, the upper and lower components 508A, 508B can be threadedly connected or connected by a snap-fit ​​feature. Additionally, a sealing member (e.g., an O-ring seal, etc.) can be provided between the upper and lower components 508A, 508B.

[0078] 17 is a schematic cross-sectional view of the distal end 216 of the shaft 206 of FIG. 2 showing a flow restriction 530 positioned in a lumen 532 configured to size-restrict the entry of stones into the shaft 206. The flow restriction 530 can include a constriction of the lumen 532 with a ring-like or annular feature. The flow restriction 530 can define a maximum stone size that can be allowed through the shaft 206, which can be a stone size smaller than the narrowest passage through the shaft 206 and handle 204, thereby reducing the possibility of an obstruction forming in the hand-held probe 202. In an example, the inner diameter of the flow restriction 530 can be larger than the largest size stone fragment desired to be collected in the stone fragment capture device of the present disclosure.

[0079] 18 is a line diagram illustrating a method 600 for harvesting stone fragments from a lithotripsy procedure using the device and stone fragment capture system of the present disclosure. Method 600 illustrates various exemplary steps of the stone fragment recovery process. Other steps as described herein may be included and some steps may be omitted. Additionally, the illustrated steps may be performed in a different order.

[0080] In step 602, stones in a patient can be fragmented using a surgical device (e.g., one of the lithotripsy devices disclosed herein, such as the lithotripter 102 and handheld probe 202).

[0081] In step 604, a valve (eg, an inlet valve (eg, valve 254, valve 304), etc.) of the stone fragment capture device can be opened, such as by drawing a vacuum through the medical device used in step 602.

[0082] In step 606, the stone fragments being pulled by the vacuum being pulled through the stone fragment capture device may collide with a capture element (e.g., a tapered tube (e.g., inlet port 264), a filter (e.g., filter 256, filter 306), a valve (e.g., valve 254, valve 304), an orifice (e.g., flow restriction valve 360), or a baffle (e.g., baffle 267) in the stone fragment capture device).

[0083] In step 608, the stone fragments may be diverted from the main flow of fluid through the stone fragment capturing device and deposited in a container (eg, container 258, container 308) of the stone fragment capturing device.

[0084] In step 610, an obstruction (if any) can be removed from the surgical device, such as by extending a probe through a vacuum port (e.g., vacuum port 504) into the stone fragment capturing device, through the stone fragment capturing device, and into the shaft of the surgical device to remove the obstruction.

[0085] In step 612, the biological material flowing through the stone fragment capture device may impinge on a filter (e.g., filter 256, filter 306) within the stone fragment capture device, thereby allowing only liquid and sufficiently small solids to pass through it.

[0086] In step 614, the size of the filtering capacity of the filter can be adjusted (eg, by rotating handle 358 or handle 366) to control the size of the debris retained in the stone fragment capture device.

[0087] In step 616, a valve of the stone fragment capture device (eg, an outlet valve (eg, flow restriction valve 360, valve 408B), etc.) may be closed to retain the stone fragments accumulated therein.

[0088] In step 618, the cartridge (eg, cartridge 403) of the stone fragment capturing device holding the stone fragments can be removed from the chassis (eg, chassis 402) that secures the stone fragment capturing device to the surgical device.

[0089] In step 620, the cartridge or other container holding the stone fragments can be opened (e.g., by removing cap 262 or cap 312 or by separating components 508A and 508B) so that the stone fragments can be accessed, e.g., for analysis.

[0090] Various notes and examples For purposes of this disclosure, "proximal" refers to the end of the system that is closer to the device operator during use and "distal" refers to the end of the system that is distal or further from the device operator during use.

[0091] 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. Moreover, the inventors also contemplate examples that use any combination or permutation of those elements shown or described (or one or more aspects thereof) with respect to a particular example (or one or more aspects thereof) or any other example (or one or more aspects thereof) shown or described herein.

[0092] In this document, the terms "a" or "an" are used to include one or more, as is common in patent documents, independent of any other instances or usages of "at least one" or "one or more." In this document, the term "or" is used to refer to an open-ended "or," such that "A or B" includes "A but not B," "B but not A," and "A and B," unless otherwise indicated. In this document, the terms "including" and "in which" are used as the plain English equivalents of the respective terms "comprising" and "wherein." Also, in the following claims, the terms "including" and "comprising" are open-ended, i.e., a system, device, article, composition, formulation, or process that includes elements in addition to the elements recited after such term in a claim is still deemed to fall within the scope of that claim. Moreover, 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 their objects.

[0093] The above description is intended to be illustrative and not restrictive. For example, the examples described above (or one or more aspects thereof) can be used in combination with each other. Other embodiments can be used, for example, by those of ordinary skill in the art upon reviewing 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, the subject matter of the invention may lie in less than 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.

[0094] Example 1 is a lithotripsy device comprising: a hand piece; a lithotripsy probe extending from the hand piece; an excitation source coupled to the hand piece configured to deliver energy to a distal end of the lithotripsy probe; an aspiration passage extending from the distal end of the probe through the hand piece; and a capture device coupled to the hand piece, the capture device comprising: a container; and a capture element, the container including a wall defining a storage space within the container; an entry port configured to couple to the hand piece at the aspiration passage; and an exit port, the capture element connected to the container and configured to facilitate capture of stone fragments in the storage space.

[0095] In Example 2, the subject matter of Example 1 includes where the capture element includes a filter, the filter being disposed within the container and extending across the exit port.

[0096] In Example 3, the subject matter of Example 2 includes that the container includes a first portion having an entry port and a second portion having an exit port, the first and second portions being separable to provide access to the storage space.

[0097] In Example 4, the subject matter of Example 3 includes wherein the filter is coupled to the second portion.

[0098] In Example 5, the subject matter of Examples 2-4 includes that the filter is adjustable.

[0099] In Example 6, the subject matter of Examples 2-5 includes wherein the filter includes an iris valve.

[0100] In Example 7, the subject matter of Examples 2-6 includes where the filter includes first and second mesh screens, the first mesh screen being rotatably adjustable relative to the second mesh screen.

[0101] In Example 8, the subject matter of Examples 1-7 includes where the capture element includes a baffle disposed between the inlet port and the exit port.

[0102] In Example 9, the subject matter of Examples 1-8 includes where the capture element includes an elongated tube extending from the entry port.

[0103] In Example 10, the subject matter of Examples 1-9 includes further including a first sealing element disposed in the entry port.

[0104] In Example 11, the subject matter of Example 10 includes where the first sealing element includes a flapper valve or a slide valve.

[0105] In Example 12, the subject matter of Example 11 includes where the first sealing element is biased to a closed position.

[0106] In Example 13, the subject matter of Examples 10-12 includes a second sealing element positioned at the outlet of the container.

[0107] In Example 14, the subject matter of Example 13 includes a chassis, the container is removable from the chassis, and the second sealing element is positioned at the exit port.

[0108] In Example 15, the subject matter of Example 14 includes wherein the chassis includes a seat for receiving a container; and a bypass suction passage that bypasses the seat.

[0109] In Example 16, the subject matter of Examples 13-15 includes where the second sealing element includes a vacuum port.

[0110] In Example 17, the subject matter of Example 16 includes that the vacuum port is axially aligned with an aspiration passageway extending from the distal end of the probe through the handpiece.

[0111] In Example 18, the subject matter of Examples 16-17 includes that the vacuum port is axially aligned with the container's entry port and the container's exit port is offset from the vacuum port and the entry port.

[0112] In Example 19, the subject matter of Examples 17-18 includes where the vacuum port includes a self-sealing valve.

[0113] In Example 20, the subject matter of Examples 1-19 includes tubing connecting the inlet port with a handpiece.

[0114] Example 21 is a method of harvesting stone fragments from a lithotripsy procedure, the method including the steps of: fragmenting the stone with a lithotripsy device; drawing a vacuum through the lithotripsy device to pull the stone fragments and waste fluid through the lithotripsy device; drawing a vacuum through a stone capture device connected to the lithotripsy device; depositing the stone fragments in the stone capture device using a capture element; and continuing to draw the vacuum and depositing the waste fluid in a waste container.

[0115] In Example 22, the subject matter of Example 21 includes guiding the stone into a capture element of a stone capturing device and depositing the stone fragments in the stone capturing device.

[0116] In Example 23, the subject matter of Example 22 includes where the capture element includes a baffle.

[0117] In Example 24, the subject matter of Examples 21-23 includes filtering stone fragments from the waste fluid in a stone capture device.

[0118] In Example 25, the subject matter of Example 24 includes adjusting the filtering capacity of the filter.

[0119] In Example 26, the subject matter of Examples 21-25 includes the step of opening a valve with the stone capturing device to permit stone fragments and waste fluid into the stone capturing device.

[0120] In Example 27, the subject matter of Examples 21-26 includes adjusting an orifice size of the stone capturing device to control the escape of stone fragments from the stone capturing device.

[0121] In Example 28, the subject matter of Examples 21-27 includes the step of opening the stone capturing device to access the deposited stone fragments.

[0122] In Example 29, the subject matter of Examples 21-28 includes removing the stone capturing device from a chassis that couples the stone capturing device to a lithotripsy device.

[0123] In Example 30, the subject matter of Examples 21-29 includes inserting a probe into the lithotripsy device through a vacuum port on the stone capture device to remove an obstruction in the lithotripsy device.

[0124] Example 31 is a capture device for collecting fragments generated during lithotripsy, the capture device including a container including a wall defining a storage space within the container; an entry port coupled to the wall and configured to couple to a handpiece at a suction passage; and an exit port coupled to the wall; a capture element connected to the container and configured to facilitate capture of stone fragments in the storage space; and a coupler for connecting the container to a handpiece of a lithotripsy device.

[0125] In Example 32, the subject matter of Example 31 includes wherein the coupler element includes a barbed hose coupler.

[0126] In Example 33, the subject matter of Examples 31-32 includes where the coupler element includes a resilient opening extending through the wall.

[0127] In Example 34, the subject matter of Examples 31-33 includes wherein the exit port includes a barbed hose coupler.

[0128] In Example 35, the subject matter of Examples 31-34 includes where the capture element includes an adjustable filter.

[0129] In Example 36, the subject matter of Examples 31-35 includes where the capture element includes an adjustable orifice.

[0130] In Example 37, the subject matter of Examples 31-36 includes where the capture element includes an elongated tube extending from the entry port.

[0131] In Example 38, the subject matter of Examples 31-37 includes where the capture element includes a baffle.

[0132] In Example 39, the subject matter of Examples 31-38 includes a first sealing element disposed in the entry port.

[0133] In Example 40, the subject matter of Examples 31-39 includes a second sealing element positioned at the outlet of the container.

[0134] In Example 41, the subject matter of Example 40 includes a chassis, the container is removable from the chassis, and the second sealing element is positioned at the exit port.

[0135] In Example 42, the subject matter of Examples 40-41 includes where the second sealing element includes a vacuum port axially aligned with the entry port, the vacuum port including a self-sealing valve.

[0136] Example 43 is at least one machine-readable medium including instructions that, when executed by a processing circuit, cause the processing circuit to perform operations to implement any of Examples 1-42.

[0137] Example 44 is an apparatus including means for implementing any of Examples 1-42.

[0138] Example 45 is a system for implementing any of Examples 1-42.

[0139] Example 46 is a method for implementing any of Examples 1-42.

[0140] Each of these non-limiting examples can stand alone or can be combined in various permutations or combinations with one or more of the other examples. [Explanation of symbols]

[0141] 100 Lithotripsy System 102 Lithotripter 104 Housing 106 Delivery member 108 Long and thin shaft 110 Outer surface 112 lumens 114 Probe 116 Signal Generator 118 Power supply 120 Input 122 Controller 124 Output 126 Drill 128 lateral emitters 130 Suction Arrow 132 Foot Pedal 134 Drill actuator 136 Ultrasonic transducer, drill transducer 138 Ultrasonic transmission components 140 Connector 142 Lateral Emitter Actuator 144 Electrical elements, wires 150 tubes 152 Collection Container 154 Suction Devices 166 Fluid Input 200 Lithotripsy System 202 Handheld Probe 204 Handle 206 Shaft 208 Generator 210 Cable 212 Collection tube 214 Proximal end 216 Distal end 218A Button 218B Button 220 Nobu 250 Stone Fragment Capture System 252 Stone Fragmentation System 254 Valve 256 Filters 258 Container 260 Housing 262 Cap 264 Inlet Port 266 Exit Port 267 Baffle 268 Handle 270 Stem 272 Nobu 274 Passage 276 Tube 278 Barb 280 Floor 282 End Plate 284 Stone Fragment 286 Tip 290 Stop 292 Elastic Elements 294 Backstop 296A~296H Strut 298 Support Ring 300 Stone Fragment Capture System 304 Valve 306 Filters 308 Container 310 Housing 312 Cap 314 Entrance 316 Exit section 330 Floor 332 End Plate 336 Tip 338 Stop 340 Elastic Element 342 Side wall 344 Coupling 346A Mesh layer 346B Mesh layer 348A~348D Strand 350A~350D Strand 352 frames 354 Frames 356 Strut 358 Handle 360 Flow Restrictor Valve 362A~362G SIM 364 frames 366 Lever 400 Stone Fragment Capture System 402 Chassis 403 Cartridge 404A Stem 404B stem 406A Barb 406B Barb 408A First Valve 408B Second Valve 410 Housing 412 Filters 414A Tube 414B Tube 432 Shell 434 Socket 435 Internal passage 436A Actuator 436B Actuator 438 Flap 440 Hinge, spring valve 446 Spring 442 Pressure Valve 444 Electric valve 448A Rod 448B Rod 450 dashpot 452A Hinge 452B Hinge 454 Motor 456 Linkage 500 Stone Fragment Capture System 502 Stone Capture Device 504 Vacuum Port 506 Housing 508A Upper Components 508B Lower Components 510 Coupler 512 Tube Connector 530 Flow Restrictor 532 lumens A1 Longitudinal direction A2 horizontal direction A3 axis A4 axis A5 axis A6 axis A7 axis C Camera E Endoscope FS Fluid Reservoir LS light source P aisle S Stone S1 interval S2 interval S3 interval WC Working Channel

Claims

1. 1. A lithotripsy device comprising: A handpiece; a lithotripsy probe extending from the handpiece; an excitation source coupled to the handpiece configured to deliver energy to a distal end of the lithotripsy probe; an aspiration passageway extending from the distal end of the lithotripsy probe through the handpiece; a capture device coupled to the handpiece; Including, The capture device comprises: A container; Capture element and Including, The container comprises: a wall defining a storage space within the container; an entry port configured to couple to the handpiece at the aspiration passage; an exit port connected to the wall; Including, the capture element is connected to the container and configured to facilitate capture of stone fragments in the storage space; The lithotripsy device comprises: A first sealing element; and A second sealing element; and Chassis and Further comprising: the container is removable from the chassis; the first sealing element is positioned on the chassis such that, when the chassis receives the container, the entry port of the container is located at a location corresponding to the first sealing element; the second sealing element is positioned on the chassis such that, when the chassis receives the container, the exit port of the container is located at a location corresponding to the second sealing element; The chassis includes: a seat for receiving said container; a bypass suction passage that bypasses the seat; 4. A lithotripsy device, comprising:

2. The lithotripsy device of claim 1 , wherein the capture element includes a filter, the filter being disposed within the container and extending across the exit port.

3. 3. The lithotripsy device of claim 2, wherein the container includes a first portion having the entry port and a second portion having the exit port, the first and second portions being separable to allow access to the storage space.

4. The lithotripsy device of claim 3 , wherein the filter is coupled to the second portion.

5. The lithotripsy device of claim 2 , wherein the filter is adjustable.

6. The lithotripsy device of claim 2 , wherein the filter comprises an iris valve.

7. 3. The lithotripsy device of claim 2, wherein the filter comprises first and second mesh screens, the first mesh screen being rotatably adjustable relative to the second mesh screen.

8. The lithotripsy device of claim 1 , wherein the capture element comprises a baffle disposed between the entry port and the exit port.

9. The lithotripsy device of claim 1 , wherein the capture element comprises an elongated tube extending from the entry port.

10. The lithotripsy device of claim 1 , wherein the first sealing element comprises a flapper valve or a slide valve.

11. The lithotripsy device of claim 10 , wherein the first sealing element is biased to a closed position.

12. The lithotripsy device of claim 1 , wherein the second sealing element comprises a vacuum port.

13. 13. The lithotripsy device of claim 12, wherein the vacuum port is axially aligned with the aspiration passageway extending from the distal end of the lithotripsy probe through the handpiece.

14. 13. The lithotripsy device of claim 12, wherein the vacuum port is axially aligned with the entry port of the container and the exit port of the container is offset from the vacuum port and the entry port.

15. The lithotripsy device of claim 13 , wherein the vacuum port includes a self-sealing valve.

16. 10. The lithotripsy device of claim 1, further comprising a tube connecting the entry port with the handpiece.

17. 1. A capture device for collecting fragments generated during lysotripsy, said capture device comprising: A container comprising: a wall defining a storage space within said container; an access port coupled to the wall and configured to connect to a handpiece of a lithotripsy device at an aspiration passage; and An exit port connected to the wall a container including: a capture element connected to the container and configured to facilitate capture of stone fragments in the storage space; a first coupler for connecting the container to a second coupler of a handpiece of a lithotripsy device; A first sealing element; A second sealing element; Chassis and; Including, the container is removable from the chassis; the first sealing element is positioned on the chassis such that, when the chassis receives the container, the entry port of the container is located at a location corresponding to the first sealing element; A capture device, wherein the second sealing element is positioned on the chassis such that when the chassis receives the container, the exit port of the container is located at a location corresponding to the second sealing element.

18. The capture device of claim 17 , wherein the second coupler comprises a barbed hose coupler.

19. The capture device of claim 17 , wherein the first coupler includes a resilient opening extending through the wall.

20. The capture device of claim 17 , wherein the first coupler includes an elongated tube extending from the entry port.

21. The capture device of claim 17 , wherein the capture element comprises a tunable filter.

22. The capture device of claim 17 , wherein the capture element includes an adjustable orifice.

23. The capture device of claim 17 , wherein the capture element comprises an elongated tube extending from the entry port.

24. The capture device of claim 17 , wherein the capture element comprises a baffle.

25. 20. The capture device of claim 17, wherein the second sealing element includes a vacuum port axially aligned with the entry port, the vacuum port including a self-sealing valve.

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