Ureteroscopic lithotripsy antiretropulsion

Abstract

A lithotripsy device can include a lithotripter configured to deliver lithotripsy energy to tissue located at least partially within a body channel. The lithotripsy device can include a working passage positionable at least partially within the body channel, the working passage at least partially defining a suction opening. The lithotripsy device can include a suction device connectable to the working passage upstream of the suction opening and configured to generate a suction flow to motivate movement of the tissue or portions thereof toward the suction opening. The lithotripsy device can include a controller in communication with the lithotripter and with the suction device, where the controller can be configured to operate the suction device to generate the suction flow at a suction energy configured to offset the lithotripsy energy to reduce or eliminate retropulsion of the tissue when the lithotripsy energy is delivered to the tissue.

Description

URETEROSCOPIC LITHOTRIPSY ANTIRETROPULSIONPRIORITY CLAIM

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application Serial No. 63 / 594,474, filed October 31, 2023 and U.S. Provisional Patent Application Serial No. 63 / 552,233, filed February 12, 2024, the contents of which are incorporated herein by reference.BACKGROUND

[0002] Tissue can form within organs of the human body such as within a kidney. In some cases, the tissue (such as a stone) is unable pass through the organs naturally and surgical intervention is required to remove the tissue. In many cases, the tissue must be broken into smaller pieces for extraction from a body lumen, such as a kidney or urinary tract. A lithotripsy device can be used to break and extract the tissue. Common modalities of lithotripsy include laser lithotripsy, ultrasonic lithotripsy, and mechanical lithotripsy. In each of these modalities, energy can be delivered to the tissue from the lithotripsy device to break the tissue into smaller pieces for removal.BRIEF DESCRIPTION OF THE DRAWINGS

[0003] In the drawings, which are not necessarily drawn to scale, like numerals may describe similar components in different views. Like numerals having 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.

[0004] FIG. 1 illustrates a schematic diagram of an endoscopy system.

[0005] FIG. 2 illustrates a schematic diagram of the imaging and control system ofFIG. 1 showing the imaging and control system connected to the endoscope.

[0006] FIG. 3 illustrates a cross-sectional view of a lithotripsy device.

[0007] FIG. 4 illustrates a cross-sectional view of a lithotripsy device.

[0008] FIG. 5 illustrates a cross-sectional view of a lithotripsy device.

[0009] FIG. 6 illustrates a schematic view of a lithotripsy system.

[0010] FIG. 7 illustrates a graph showing fluid force and suction pressure.

[0011] FIG. 8 illustrates a table showing a calculation.

[0012] FIG. 9 illustrates a schematic view of a lithotripsy control system.

[0013] FIG. 10 illustrates a block diagram illustrating an example of a machine upon which one or more embodiments may be implemented.

[0014] FIG. 11 illustrates a schematic view of a method.DETAILED DESCRIPTION

[0015] Ureteroscopic lithotripsy is considered the first-line treatment for ureteric stones that fail to respond to medical expulsive therapy (MET) or shockwave lithotripsy (SWL). Advances in ureteroscope design and manufacture, as well as stone retrieval devices contribute, to a great extent, in the reported high success rate of ureteroscopic stone extraction. During ureteroscopic lithotripsy, the possibility of stone retropulsion or upward migration can limit success rate. There is a wide variation in retropulsion rate depending upon the kinetic energy of the lithotripter and ureteric stone level, as proximally located stones have a higher rate of stone migration than those that are distally located. A laser pulse, whether for fragmenting or dusting, can impact clinical use by moving the targeted stone away from laser fiber tip, which can be referred to as stone retropulsion. Stone retropulsion during lithotripsy can require the user to chase the stone and can result in longer procedures.

[0016] This disclosure provides solutions to the problem of retropulsion by use of anti -retropulsion systems coupled with (or integrated with) a lithotripsy device. By reducing or eliminating retropulsion during lithotripsy, procedure times can be reduced, which can reduce cost and can improve postoperative patient outcomes. A lithotripsy device or system employing these strategies, can include a working channel or suction channel that can receive a suction stream therethrough, e.g., moving distally to proximally. The device or system can be configured to produce the suction stream to generate a suction force that offsets a force generated by the lithotripter (e.g., laser) on the stone or tissue. The force of the lithotripter can be canceled by the suction force, helping to reduce or eliminate stone or tissue retropulsion.

[0017] For example, a lithotripsy device can include a lithotripter configured to deliver lithotripsy energy to tissue located at least partially within a body channel. The lithotripsy device can include a working passage positionable at least partially within the body channel, the working passage at least partially defining a suction opening. The lithotripsy device can include a suction device connectable to the working passage upstream of the suction opening and configured to generate a suction flow tomotivate movement of the tissue or portions thereof toward the suction opening. The lithotripsy device can include a controller in communication with the lithotripter and with the suction device, where the controller can be configured to operate the suction device to generate the suction flow at a suction energy configured to offset the lithotripsy energy to reduce or eliminate retropulsion of the tissue when the lithotripsy energy is delivered to the tissue.

[0018] The above discussion is intended to provide an overview of subject matter of the present patent application. It is not intended to provide an exclusive or exhaustive explanation of the invention. The description below is included to provide further information about the present patent application.

[0019] FIG. 1 is a schematic diagram of an endoscopy system 10 that can include an imaging and control system 12 and an endoscope 14. The system of FIG. 1 is an illustrative example of an endoscopy system suitable for use with the systems, devices and methods described herein, such as an endoscope with an integrated guide and arm for guiding extension of an auxiliary scope.

[0020] The endoscope 14 can be insertable into an anatomical region for imaging or to provide passage of or attachment to (e.g., via tethering) one or more sampling devices for biopsies, or one or more therapeutic devices for treatment of a disease state associated with the anatomical region. The endoscope 14 can interface with and connect to an imaging and control system 12. The endoscope 14 can also include a ureteroscope, though other types of endoscopes can be used with the features and teachings of the present disclosure. The imaging and control system 12 can include a control unit 16, an output unit 18, an input unit 20, a light source 22, a fluid source 24, and a suction pump 26.

[0021] The imaging and control system 12 can include various ports for coupling with the endoscopy system 10. For example, the control unit 16 can include a data input / output port for receiving data from and communicating data to the endoscope 14. The light source 22 can include an output port for transmitting light to the endoscope 14, such as via a fiber optic link. The fluid source 24 can include a port for transmitting fluid to the endoscope 14. The fluid source 24 can include, for example, a pump and a tank of fluid or can be connected to an external tank, vessel or storage unit. The suction pump 26 can include a port used to draw a vacuum from the endoscope 14 to generate suction, such as for withdrawing fluid from the anatomical region into which the endoscope 14 is inserted. The output unit 18 and the input unit20 can be used by an operator of the endoscopy system 10 to control functions of the endoscopy system 10 and view output of the endoscope 14. The control unit 16 can additionally be used to generate signals or other outputs from treating the anatomical region into which the endoscope 14 is inserted. In some examples, the control unit 16 can generate electrical output, acoustic output, a fluid output and the like for treating the anatomical region with, for example, cauterizing, cutting, freezing and the like.

[0022] The endoscope 14 can include an insertion section 28, a functional section 30 and a handle section 32, which can be coupled to a cable section 34 and a coupler section 36. The coupler section 36 can be connected to the control unit 16 to connect the endoscope 14 to multiple features of the control unit 16, such as the input unit 20, the light source unit 22, the fluid source 24, and the suction pump 26.

[0023] The insertion section 28 can extend distally from the handle section 32 and the cable section 34 can extend proximally from the handle section 32. The insertion section 28 can be elongate and include a bending section, and a distal end to which the functional section 30 can be attached. The bending section can be controllable (e.g., by a control knob 38 on the handle section 32) to maneuver the distal end through tortuous anatomical passageways (e.g., stomach, duodenum, kidney, ureter, etc.). The insertion section 28 can also include one or more working channels (e.g., an internal lumen) that can be elongate and can support insertion of one or more therapeutic tools of the functional section 30, such as a laser fiber 106(of FIG. 4). The working channel can extend between the handle section 32 and the functional section 30. Additional functionalities, such as fluid passages, guide wires, and pull wires can also be provided by the insertion section 28 (e.g., via suction or irrigation passageways, or the like).

[0024] The handle section 32 can include the knob 38 as well as a port 40a. The knob 38 can be connected to a pull wire, or other actuation mechanisms, extending through insertion the section 28. Port 40a, as well as other ports, such as the port 40B (of FIG. 2) can be configured to couple various electrical cables, guide wires, auxiliary scopes, tissue collection devices of the present disclosure, fluid tubes and the like to the handle section 32, such as for coupling with the insertion section 28.

[0025] The imaging and control system 12 can be provided on a mobile platform (e.g., a cart 41) with shelves for housing the light source 22, the suction pump 26, an image processing unit 42 (FIG. 2), etc. Alternatively, several components of imagingand the control system 12 shown in FIGS. 1 and 2 can be provided directly on the endoscope 14 so as to make the endoscope self-contained.

[0026] The functional section 30 can include components for treating and diagnosing anatomy of a patient. The functional section 30 can include an imaging device, an illumination device and a guide. The functional section 30 can also include a working channel, a lithotripsy device, and one or more sensors, as discussed in further detail below, such as for performing one or more lithotripsy procedures.

[0027] FIG. 2 is a schematic diagram of the endoscopy system 10 of FIG. 1 including the imaging and control system 12 and the endoscope 14. FIG. 2 schematically illustrates components of the imaging and the control system 12 coupled to the endoscope 14, which in the illustrated example includes a ureteroscope. The imaging and control system 12 can include the control unit 16, which can include or be coupled to an image processing unit 42, a treatment generator 44 and a drive unit 46, as well as the light source 22, the input unit 20, and the output unit 18. The control unit 16 can include, or can be in communication with, the endoscope 14, a surgical instrument (e.g., a lithotripsy device 100) and system, which can include a device configured to engage tissue and fragment tissue where the tissue can optionally be collected by the device(s). The control unit 16 can be configured to activate a camera to view target tissue distal of a surgical instrument and the endoscopy system. Likewise, the control unit 16 can be configured to activate the light source unit 22 to shine light on the surgical instrument, which can include select components that are configured to reflect light in a particular manner, such as tissue cutters being enhanced with reflective particles.

[0028] The image processing unit 42 and light source 22 can each interface with the endoscope 14 (e.g., at the functional unit 30) by wired or wireless electrical connections. The imaging and control system 12 can accordingly illuminate an anatomical region, collect signals representing the anatomical region, process signals representing the anatomical region, and display images representing the anatomical region on the display unit 18. The imaging and control system 12 can include light the source 22 to illuminate the anatomical region using light of desired spectrum (e.g., broadband white light, narrow-band imaging using preferred electromagnetic wavelengths, and the like). The imaging and control system 12 can connect (e.g., via an endoscope connector) to the endoscope 14 for signal transmission (e.g., lightoutput from light source, video signals from imaging system in the distal end, diagnostic and sensor signals from a diagnostic device, and the like).

[0029] The fluid source 24 (shown in FIG. 1) can be in communication with the control unit 16 and can include one or more sources of air, saline or other fluids, as well as associated fluid pathways (e.g., air channels, irrigation channels, suction channels) and connectors (barb fittings, fluid seals, valves and the like). The fluid source 24 can be utilized as an activation energy for a biasing device or a pressureapplying device of the present disclosure. The imaging and control system 12 can also include the drive unit 46, which can include a motorized drive for advancing a distal section of endoscope 14.

[0030] The coupler section 36 can be connected to the control unit 16 to connect to the endoscope 14 to multiple features of the control unit 16, such as the image processing unit 42 and the treatment generator 44. In examples, the port 40a can be used to insert another instrument or device, such as a daughter scope or auxiliary scope, into the endoscope 14. Such instruments and devices can be independently connected to the control unit 16 via the cable 47. In some examples, the port 40B can be used to connect coupler section 26 to various inputs and outputs, such as video, air, light and electric.

[0031] FIG. 3 illustrates a cross-sectional view of a lithotripsy device or system 100 including a flexible ureteroscope 102, which can be or can include the flexible ureteroscope 102. The lithotripsy device 100 can include a working channel 104 and a laser fiber 106. The working channel 104 can include a suction opening 109 at a distal end or portion of the working channel 104. The working channel 104 can be connected to a suction source (discussed in further detail below) which can be connected to the control unit 16 (of FIG. 2). The working channel 104 can have a size W (e.g., a diameter) between 0.2 millimeters (mm) and 3 mm, such as between .5 mm and 2 mm, such as 1 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, or the like.

[0032] The laser fiber 106 can be located at least partially within the working channel 104 and can extend from a distal tip 105 of the flexible ureteroscope 102 (e.g., of the functional section 30). The laser fiber 106 can extend through the working channel 104 and can be connected to the control unit 16 such that the laser fiber 106 can be configured to receive energy from the control unit 16 for delivery to a stone 50 or tissue. The laser fiber 106 can have a size L (e.g., a diameter) between 50 micronand 1000 micron, such as 50 micron, 100 micron, 150 micron, 200 micron, 250 micron, 300 micron, 350 micron, 400 micron, 450 micron, 500 micron, 550 micron, 600 micron, 650 micron, 700 micron, 750 micron, 800 micron, 850 micron, 900 micron, 950 micron, 1000 micron, or the like.

[0033] In operation, the laser fiber 106 can be activated by the control unit 16 to deliver energy to a stone 50 to fragment the stone 50 within a ureter 52. Before, during, or after fragmentation, the working channel 104 can deliver suction to affect the stone 50 and fragments of the stone 50, such as for removal of the stone fragments from the ureter 52. The working channel 104 can also deliver suction that can be applied to the stone 50 during activation of the laser fiber 106 to limit retropulsion of the stone to help maintain a position of the stone 50 during lithotripsy, which can help limit chasing a stone through a ureter 52. Further details of operation of the lithotripsy device 100 are discussed below.

[0034] Optionally, the flexible ureteroscope 102 can include an extension 111 of the working channel 104. The extension 111 can extend distally beyond a distal tip of the laser fiber 106 such that the suction opening is located distally beyond the distal tip of the laser fiber 106. The extension 111 can be used to draw the stone 50 against the extension 111, such as by applying suction pressure to the stone 50 (as discussed in further detail below).

[0035] Though this application primarily discusses laser lithotripsy, the suction pressure anti -retropulsion techniques (among other techniques) discussed herein can be applied to other lithotripsy technologies such as an ultrasonic lithotripsy, electro- hydraulic lithotriptsy or the like.

[0036] FIG. 4 illustrates a cross-sectional view of the lithotripsy device 100. FIG. 5 illustrates a cross-sectional view of the lithotripsy device 100. FIGS. 4 and 5 are discussed together below. The lithotripsy device 100 can be consistent with FIG. 3 discussed above. FIGS. 4 and 5 show how the lithotripsy device 100 can be used or operated, such as during a lithotripsy procedure.

[0037] FIG. 4 shows how the lithotripsy device 100 can be used without suction applied from the working channel 104, showing the energy pulse P of the laser fiber 106. For example, once a target tissue (e.g., the stone 50) is identified, the laser fiber 106 can be positioned at an appropriate distance, and the laser fiber 106 can be activated to generate a laser energy pulse P. This energy can deliver a force to the stone 50 to fragment the stone 50, but the force can also cause movement of the stone50 in a direction DI, such as from a stone location 50A (FIG. 4) to a stone location 50B (FIG. 4), resulting in stone retropulsion or movement away from the laser fiber 106.

[0038] As shown in FIG. 5, this retropulsion or movement of the stone 50 (as caused by the pulse P from the laser fiber 106) can be compensated for by use of a suction pulse S. That is, in operation, once a target tissue (e.g., the stone 50) is identified, and the laser fiber 106 is positioned at an appropriate distance, a suction pulse S (FIG. 5) can be initiated in coordination with the initial laser energy pulse P. The suction pulse can be generated at the same moment, instant, or time that the laser energy directs the stone 50 in a direction DI (optionally the suction pulse S can be generated before or after the laser energy pulse). The suction pulse(s) can compensate for movement of the stone 50 in the direction DI such as by creating a low-pressure region in or around the laser fiber. This suction or low pressure area can generate a force on the stone 50 in a direction opposite to the direction DI, which can help to pull the stone 50 proximally while the laser pulse applies a force in a distal direction. Such a balance of forces can create a state of equilibrium or near equilibrium to the fluid environment where the target tissue 50 is located and can result in a minimized if not eliminated retropulsion distance of the stone during delivery of the laser energy pulse P, as shown in FIG. 5.

[0039] FIG. 5 also shows that the lithotripsy device 100 can include a sensor module 103 connected to the working channel 104. The sensor module can be or can include one or more of a distance (e.g., proximity) sensor, an imaging module (which can interface with or be part of the imaging and control system 12), a pressure sensor, a temperature sensor, or the like. The sensor module 103 can also be connected to the controller 110 or the control unit 16. The sensor module 103 can be configured to transmit a signal to the controller 110 or the control unit 16 before, during, or after operation of the laser fiber 106 or application of the suction pressure. As discussed in further detail below, the controller 110 or the control unit 16 can use the signal(s) to make one or more determinations for control of the lithotripsy device 100.

[0040] FIG. 6 illustrates a schematic view of the lithotripsy system 100 that can include a suction control system 107. The suction control system 107 can include a valve system 108, a regulator 118, and an air pump 120. The suction control system 107 can be in communication with the controller 110 such that one or more of the valve system 108, the regulator 118, and the air pump 120 can be operated by thecontroller 110 or can receive one or more signals therefrom. Optionally, the valve system 108 can be manually user-operable, e.g., through a switch, button, or the like.

[0041] The suction control system 107 can be connected to a suction cannister 122 and a suction pump 124, such as via a tube set 112, which can include one or more lines, hoses, or the like. The suction pump 124 can be a fluid pump (such as an air or gas pump) configured to generate a suction flow or suction pressure to be applied to or through the working channel 104 (e.g., via the suction control system 107). The suction pump 124 110 can be a can be a positive displacement pump, a centrifugal pump, an axial pump, or the like. The suction pump 124 can be connected to the suction cannister 122, which can be connected to the valve system 108 (e.g., via the regulator 118). The suction cannister 122 can be an accumulator or cannister (e.g., a tank, bladder, or the like) configured to store a negative pressure to allow the valve system 108 to deliver a relatively high suction pressure instantly (or quickly) for a duration of time instead of waiting for the suction pump 124 to build pressure when or after suction pressure is called for by a user (e.g., via the controller 110).

[0042] The valve system 108 of the suction control system 107 can be configured to turn on or off suction. The valve system 108 can include one or more valves, such as a one-way, two-way, or three way valve. For example, the valve system 108 can be configured to connect the tubeset 114 to the air pump 120 or the regulator 118 for connection to the suction pump 124. The valve system 108 can optionally include an actuator connected to the controller 110, allowing the controller 110 to operate the valve system 108. The air pump 120 can be a pump, such as a positive displacement air pump configured to pump air from the tubeset 114 and the flexible ureteroscope 102 to a drain 126 or similar device, as discussed in further details below. The regulator 118 can be a pressure regulator configured to control a maximum (or minimum) pressure delivered by the suction pump 124 to the valve system 108. The regulator 118 can be connected to the controller 110 such as to allow the controller 110 to control a maximum or minimum pressure. The suction control system 107 can also include one or more high pressure or low pressure switches connected that can be optionally connected to the controller 110 to allow the controller 110 to disable the suction pump 124 when the pressure is above or below a limit. Optionally, the pressure switches can be connected to other electronic components of the lithotripsy device 100 to automatically disable the suction pump 124 when the pressure is above or below a limit. The suction pressure delivered to the stone via the working channel104 can be between 1,000 Pascals (Pa) and 100,000 Pa, such as 1,000 Pa, 2,000 Pa, 3,000 Pa, 4,000 Pa, 5,000 Pa, 6,000 Pa, 7,000 Pa, 8,000 Pa, 9,000 Pa, 10,000 Pa, or the like.

[0043] The drain 126 can be connected to the suction control system 107 by a first check valve 128 that can be configured to allow one way flow between the suction control system 107 towards the drain 126. The drain 126 can be configured to receive air and fluids from the valve system 108 or other portions of the suction control system 107, such as when the valve system 108 allows for flow from the air pump 120 to the drain 126. That is, the first check valve 128 can limit or prevent flow from traveling from the drain to the suction control system 107 or another part of the system 100.

[0044] The valve system 108 can also be connected to the Y-type or T-type connection 116 to connect to the flexible ureteroscope 102, such as via a check valve 130. The check valve 130 can allow one way suction (e.g., from the suction pump 124 and stored suction pressure from the suction cannister 122) from the flexible ureteroscope 102, such as when the valve system 108 allows for flow from the suction pump 124 to the flexible ureteroscope 102. That is, the second check valve 130 can limit or prevent flow from traveling to the flexible ureteroscope 102 from the valve system 108 or the suction control system 107. The cannister 136 can contain excess fluid from the suction pulse operation momentarily and can be directed towards the drain through the one way check valve 128 once the valve 108 returns to its original or off position. Backflow towards the tubing 114 can be prevented by one way check valve 130. FIG. 6 also shows, schematically, how the laser fiber 106 can connect to the flexible ureteroscope 102, such as via an adapter 132, which can be a Touhy Borst adapter, and optionally through a biopsy port 134.

[0045] The lithotripsy system 100 can also include a controller 110 (e.g., a read only VO controller) that can be configured to adjust timing parameters of suction pulses. Optionally, pressure (and other) settings can be set during manufacturing using a programmable controller. The controller 110 can optionally be a programable controller, such as a single or multi-board computer, a direct digital controller (DDC), a programable logic controller (PLC), or the like. In other examples the controller 110 can be any computing device, such as a handheld computer, for example, a smart phone, a tablet, a laptop, a desktop computer, or any other computing device including a processor, memory, and communication capabilities. The controller 110can be a sub-system of a laser console (e.g., laser controller), the control unit 16, or can be a separate reusable system. The controller 110 can optionally be all of or a portion of the control unit 16 or can be connected to the control unit 16.

[0046] Optionally, the lithotripsy device 100 can include an actuator 135 connected to the laser fiber 106. The actuator 135 can be any type of actuator, such as a pneumatic, mechanical, or electrical actuator configured to move the laser fiber 106 within the working channel 104 and with respect to the working channel 104. The actuator 135 can be connected to the controller 110 such that the controller 110 (or the control unit 16) can operate the actuator 135 to advance or retract the laser fiber 106.

[0047] In operation of some examples, the controller 110 can be used to control suction flow from the suction pump 124 to the flexible ureteroscope 102, such as to create suction pressure to offset a lithotripsy force from the laser fiber 106, as discussed above. Before the laser fiber 106 is activated, the suction pump 124 can be operated to create a suction (or negative pressure) in the suction cannister 122, which can be made possible, in part, by the valve system 108 being in a closed position (disconnecting the suction pump 124 from the working channel 104 of the flexible ureteroscope 102). When the laser fiber 106 is activated, the valve system 108 can connect the flexible ureteroscope 102 to the suction pump 124 to allow the suction pressure to be applied to the flexible ureteroscope 102 (e.g., via the working channel 104) to offset the lithotripsy force from the laser fiber 106. When the laser fiber 106 is disabled, the valve system 108 can close the connection between the imaging and control system 12 and the flexible ureteroscope 102, eliminating the suction pressure from the flexible ureteroscope 102.

[0048] Following delivery of suction pressure, the controller 110 can activate the air pump 120 to allow air to flow from the air pump 120 to the drain 126 to clear fluids or debris from the valve system 108 and optionally from a suction accumulator 136. The suction accumulator 136 can be connectable to the working passage between the suction opening and the control valve 108 and the suction accumulator 136 can be configured to receive and store liquids or solids entering the working passage after the suction force is generated or when the suction for is delivered. In this way, the lithotripsy device 100 can be used to offset retropulsion and to clear the line between lithotripsy events (e.g., activation events of the laser fiber 106).

[0049] FIG. 7 shows a graph illustrating a force applied to the stone as generated by the lithotripsy pulse P (shown in FIG. 4) on top of the x-axis and shows a suctionforce applied to the stone as generated by the pump (e.g., the suction pump 124), such as the suction pressure S (shown in FIG. 5) below the x-axis. FIG. 7 shows, graphically, that the forces should be equal and opposite to limit retropulsion.

[0050] FIG. 8 illustrates a table showing a calculation where a force applied to the tissue (e.g., from the laser fiber 106 to the stone 50) is calculated. Pulse energy (Joules) and pulse frequency can be used to determine peak power and square output power (Watts) delivered from the laser fiber 106 to the stone 50. A weight of the stone 50 can be used (e.g., in grams) and to determine a retropulsion distance (e.g., a maximum and a minimum) in millimeters (mm) such as based on the power delivered and the stone weight or mass. The retropulsion distance can be used to determine an acceleration of the stone 50 (mm / second or mm / s), which can be used, along with the weight of the stone 50, to determine the force applied to the stone. Once the force applied to the stone 50 is determined, a required (or desired) pressure applied by suction can be determined to counteract the force applied by the laser fiber 106 to the stone 50. These calculations can be determined by the controller 110 or the control unit 16, as discussed in further detail below.

[0051] FIG. 9 shows a schematic diagram of an exemplary computer-based clinical decision support system (CDSS) 902 that can be configured to make one or more determinations with regard to delivery of a vacuum pressure via the working channel 104 based on, for example, the stone 50. The CDSS 902 can include an input interface 904 through which one or more characteristics of the stone 50 or a procedure, which can be specific to a patient or procedure, can be provided as input features to an artificial intelligence (Al) model 906 a processor 908 which performs an inference operation where one or more characteristics of the stone 50 or a procedure can be applied to the Al model to generate one or more determinations with regard to delivery of a vacuum pressure via the working channel 104, and a user interface (UI) through which one or more determinations with regard to delivery of a vacuum pressure via the working channel 104 can be communicated to a user, e.g., a clinician.

[0052] In some embodiments, the input interface 904 can be a direct data link between the CDSS 902 and one or more medical devices that generate at least some of the input features. For example, the input interface 904 may transmit images of the stone 50 or one or more flow or pressure readings directly to the CDSS during a therapeutic or diagnostic medical procedure. Additionally, or alternatively, the input interface 904 can be a classical user interface that facilitates interaction between auser and the CDSS 902. For example, the input interface 904 can facilitate a user interface through which the user can manually enter one or more criteria, such as a desired pulse energy or duration. Additionally, or alternatively, the input interface 904 can provide the CDSS 902 with access to an electronic patient record from which one or more input features may be extracted. In any of these cases, the input interface 904 is configured to collect one or more of the following input features in association with a specific patient on or before a time at which the CDSS 902 is used to determine a size of the stone, a mass of the stone, a force applied to the stone, a distance of the stone from a tip of the laser fiber 106, a required vacuum pressure, or other determinations. For example, one or more images of a stone can be received, such as from a camera of the lithotripsy device 100 or the endoscopy system 10. The one or more images or portions thereof can be transmitted to the input interface 904 of the CDSS 902.

[0053] Based on one or more of the above input features, the processor 908 can perform an inference operation using the Al model to generate one or more of the determinations. For example, input interface 904 may deliver the images or pressure readings into an input layer of the Al model that can propagates these input features through the Al model to an output layer. The Al model can provide a computer system the ability to perform tasks, without explicitly being programmed, by making inferences based on patterns found in the analysis of data. Al model can explore the study and construction of algorithms (e.g., machine-learning algorithms) that can learn from existing data and make predictions about new data. Such algorithms can operate by building an Al model from example training data in order to make data- driven predictions or decisions expressed as outputs or assessments.

[0054] Two common modes for machine learning (ML) are supervised ML and unsupervised ML. Supervised ML uses prior knowledge (e.g., examples that correlate inputs to outputs or outcomes) to learn the relationships between the inputs and the outputs. The goal of supervised ML is to learn a function that, given some training data, best approximates the relationship between the training inputs and outputs so that the ML model can implement the same relationships when given inputs to generate the corresponding outputs. Unsupervised ML is the training of an ML algorithm using information that is neither classified nor labeled, and allowing the algorithm to act on that information without guidance. Unsupervised ML is useful in exploratory analysis because it can automatically identify structure in data.

[0055] Common tasks for supervised ML are classification problems and regression problems. Classification problems, also referred to as categorization problems, aim at classifying items into one of several category values (for example, is this object an apple or an orange?). Regression algorithms aim at quantifying some items (for example, by providing a score to the value of some input). Some examples of commonly used supervised-ML algorithms are Logistic Regression (LR), Naive- Bayes, Random Forest (RF), neural networks (NN), deep neural networks (DNN), matrix factorization, and Support Vector Machines (SVM). Some common tasks for unsupervised ML include clustering, representation learning, and density estimation. Some examples of commonly used unsupervised-ML algorithms are K-means clustering, principal component analysis, and autoencoders.

[0056] Another type of ML is federated learning (also known as collaborative learning) that trains an algorithm across multiple decentralized devices holding local data, without exchanging the data. This approach stands in contrast to traditional centralized machine-learning techniques where all the local datasets are uploaded to one server, as well as to more classical decentralized approaches which often assume that local data samples are identically distributed. Federated learning enables multiple actors to build a common, robust machine learning model without sharing data, thus allowing to address critical issues such as data privacy, data security, data access rights and access to heterogeneous data.

[0057] In some examples, the Al model can be trained continuously or periodically prior to performance of the inference operation by the processor 908. Then, during the inference operation, the patient specific input features provided to the Al model may be propagated from an input layer, through one or more hidden layers, and ultimately to an output layer that corresponds to the one or more of the determinations. For example, one or more images collected from the lithotripsy device 100 or the 10 can be inputted to the input interface 904. Alternatively, images of other stones or tissues can be inputted into the input interface 904 from a database 910 along with one or more characteristics of the stones or tissues that are known, which can allow the Al model to provide training based on the associated images and characteristics.

[0058] During or subsequent to the inference operation, the one or more of the determinations can be communicated to the user via the user interface (UI) or automatically cause the suction pump 124 to perform a desired action. For example,when a determination of a suction force is generated or created by the model 906 and output by the processor 908, the required suction force can be used to adjust, for example, the regulator 118 such that the suction pressure S delivered through the working channel 104 to the stone 50 properly offsets the laser pulse P delivered to the stone 50 during fragmentation, helping to limit retropulsion of the stone.

[0059] For example, the Al model can use input, such as one or more images received from the lithotripsy device 100 via the input interface 904 to determine a size, shape, weight, composition, or mass of the stone or tissue 50 within a ureter. The Al model can also use input received indicative of a laser pulse energy, laser pulse frequency, laser pulse duration, or laser pulse power that is to be delivered to the stone during one or more laser pulses. Optionally, the Al model can determine an ideal or recommended laser pulse characteristic such as energy, laser pulse frequency, laser pulse duration, or laser pulse power that should be delivered to the stone from the laser fiber 106 to achieve fragmentation of the stone based on the determined size, shape, weight, composition, or mass of the stone 50.

[0060] Whether the Al model determines the laser pulse characteristic or receives such information (e.g., from the controller 110 or the control unit 16), the Al model can use the determined or received laser pulse characteristic to determine a force that will be delivered to the stone or tissue 50 and the Al model can determine a retropulsion force of the stone 50. The Al model can also use such information, along with a determined weight, size, composition, or mass of the stone 50 to determine a force that will be applied to the stone 50. As it is desired to apply an equal and opposite force using the suction pressure (e.g., from the suction pump 124), using the determined force applied to the stone from the laser pulse, the Al model can determine a required suction force to be applied to the stone. The Al model can then use the physical characteristics of the stone 50 to determine a required suction pressure to deliver the determined suction force to reduce or eliminate retropulsion of the stone during delivery of the laser pulse.

[0061] Based on all of this information, the Al model can also determine an ideal duration for firing the laser pulse (and therefore for applying suction pressure). The Al model can also determine an optimal or acceptable interval between laser pulses (and therefore interval between applying suction pressure). In determining such a suction interval or duration, the Al model can consider, among other variables, the type of the suction pump 124, an amount of time required to fill the suction cannister122, and a pressure reading at the regulator 118 (such as if the regulator 118 includes a pressure transducer in communication with the controller 110 or the control unit 16).

[0062] In some examples, such as where the flexible ureteroscope 102 includes the extension 111 on the working channel 104, the controller 110 or the control unit 16 can operate the suction pump 124 prior to activating the lithotripter (e.g., the laser fiber 106) to draw the stone 50 against the extension, which can provide a known distance between the laser fiber 106 and the stone 50. Before or after the stone is engaged by the extension 111, the Al model can determine a size, shape, mass, weight, composition, or the like of the stone 50, such as using images received from the controller 110 or the control unit 16. Once the stone is against the extension 111, a distance between the stone 50 and the laser fiber 106 can be fixed or known, which can reduce a number of variables considered by the Al model for determining output power. Also, the controller 110 or the control unit 16 can operate the suction pump 124 to maintain sufficient suction to hold the stone 50 against the extension 111 during the lithotripsy.

[0063] In some examples, where the lithotripsy device 100 includes the actuator 135 connected to the laser fiber 106 (discussed above), the Al model can determine a size, shape, mass, weight, composition, or the like of the stone 50 and can determine an ideal or desired distance from the laser fiber 106 to the stone 50 along with an amount of energy (or other characteristic of output) of the lithotripter based on the distance of the laser fiber 106 from the stone 50 and based on the character! stic(s) of the stone 50 determined by the Al model. The Al model can transmit the determined distance (e.g., to the controller 110 or the control unit 16), which can be used to operate the actuator 135 to position the laser fiber 106 at the determined distance from the stone 50. Also, the output characteristics of the laser fiber 106 can be transmitted to the lithotripsy device 100 or the control unit 16 to be delivered by the laser fiber 106 along with an appropriate suction pressure (and optionally duration, etc.) to be produced by the suction pump 124 and the valve system 108 to help allow the lithotripsy device 100 to efficiently and effectively fragment or otherwise break up the stone 50 while reducing stone retropulsion. Optionally, when the lithotripsy device 100 includes the extension 111 and the actuator 135, the Al model can determine whether to advance or retract the laser fiber 106 based on known distance between the laser fiber 106 and the stone 50 after the suction pump 124 is used to pull the stone 50 against the extension 111.

[0064] In some examples, a relationship between (i) the applied energy or power of the lithotripter delivered to the stone or tissue and (ii) the force applied on the target stone / tissue resulting from application of the lithotripter or the distance between the stone or tissue and the lithotripter tip can be empirically established prior to or during the medical procedure. For example, the distance between the target from the tip of the laser fiber 106 can be determined (e.g., by the controller 110) based on the signal from the sensor module 103 or any suitable approaches. Based on the determined distance, the controller may estimate the applying force on the target stone / tissue. In addition, information of the applied energy / power may be obtained from, for example, settings of the lithotripter. This relationship may be stored in a database in memory accessible to the controller 110. Additionally, or alternatively, such a relationship can be computationally established using a computationally model, such as a trained Al model using previously acquired data.

[0065] During the lithotripsy procedure, the controller 110 may access the database to retrieve the stored relationship; based on the relationship and the setting of the lithotripter, the controller 110 can estimate the force applied on the target stone / tissue resulting from application of the lithotripter, and based thereon determine or adjust the setting(s) of the pump so as to offset (or at least reduce) the retropulsion force resulting from application of the lithotripter energy. In one embodiment, the applied energy / power (obtained from, e.g., the lithotripter setting(s)) can be an input to the trained Al model, which can then predict and output the estimated pump setting corresponding thereto. The controller may subsequently operate the pump based on the setting to create suction for eliminating (or at least reducing the retropulsion force of the target stone / tissue).

[0066] In one example, a relationship between (i) the applied energy or power (or the force generated therefrom) of the lithotripter, (ii) the characteristic (e.g., size or weight) of the target tissue or stone, and (iii) the force applied on the target stone / tissue resulting from application of the lithotripter or the distance between the tissue and the lithotripter can be empirically or computationally established prior to or during the medical procedure. For example, as described above, the applied energy or power of the lithotripter may be obtained from the setting of the lithotripter, and the distance between the stone and the lithotripter can be known or established based on known measurements (e.g., signals detected by the sensor module 103) or any suitable data. In addition, the characteristic (e.g., size, density, or weight) of the stone / tissuemay be estimated using any suitable means (e.g., a scale, a CT image or an endoscopic image of the stone / tissue). Again, this relationship may be stored in a database of memory accessible to the controller. In another example, this relationship can be determined using a computational model, such as an Al model trained using previously acquired data as described above.

[0067] During the lithotripsy procedure, the controller 110 may access the database to retrieve the stored relationship; based on the retrieved relationship, the setting of the lithotripter and the characteristic of the target (acquired based on, for example, a CT image or an endoscopic image of the target), the controller 110 may estimate the force applied on the target stone / tissue resulting from application of the lithotripter. Subsequently, the controller may determine or adjust the setting(s) of the pump based on the applying force on the target so as to offset (or at least reduce) the retropulsion force. In one embodiment, the applied energy / power of the lithotripter is an input to the trained Al model, which can then predict and output the estimated pump setting corresponding thereto. Again, the controller may then operate the pump based on the predicted setting to create suction, thereby eliminating (or at least reducing the retropulsion force of the target stone / tissue).

[0068] FIG. 10 illustrates a block diagram of an example machine 1000 upon which any one or more of the techniques (e.g., methodologies) discussed herein may perform. Examples, as described herein, may include, or may operate by, logic or a number of components, or mechanisms in the machine 1000. Circuitry (e.g., processing circuitry) is a collection of circuits implemented in tangible entities of the machine 1000 that include hardware (e.g., simple circuits, gates, logic, etc.). Circuitry membership may be flexible over time. Circuitries include members that may, alone or in combination, perform specified operations when operating. In an example, hardware of the circuitry may be immutably designed to carry out a specific operation (e.g., hardwired). In an example, the hardware of the circuitry may include variably connected physical components (e.g., execution units, transistors, simple circuits, etc.) including a machine readable medium physically modified (e.g., magnetically, electrically, moveable placement of invariant massed particles, etc.) to encode instructions of the specific operation. In connecting the physical components, the underlying electrical properties of a hardware constituent are changed, for example, from an insulator to a conductor or vice versa. The instructions enable embedded hardware (e.g., the execution units or a loading mechanism) to create members of thecircuitry in hardware via the variable connections to carry out portions of the specific operation when in operation. Accordingly, in an example, the machine readable medium elements are part of the circuitry or are communicatively coupled to the other components of the circuitry when the device is operating. In an example, any of the physical components may be used in more than one member of more than one circuitry. For example, under operation, execution units may be used in a first circuit of a first circuitry at one point in time and reused by a second circuit in the first circuitry, or by a third circuit in a second circuitry at a different time. Additional examples of these components with respect to the machine 1000 follow.

[0069] In alternative embodiments, the machine 1000 may operate as a standalone device or may be connected (e.g., networked) to other machines. In a networked deployment, the machine 1000 may operate in the capacity of a server machine, a client machine, or both in server-client network environments. In an example, the machine 1000 may act as a peer machine in peer-to-peer (P2P) (or other distributed) network environment. The machine 1000 may be a personal computer (PC), a tablet PC, a set-top box (STB), a personal digital assistant (PDA), a mobile telephone, a web appliance, a network router, switch or bridge, or any machine capable of executing instructions (sequential or otherwise) that specify actions to be taken by that machine. Further, while only a single machine is illustrated, the term “machine” shall also be taken to include any collection of machines that individually or jointly execute a set (or multiple sets) of instructions to perform any one or more of the methodologies discussed herein, such as cloud computing, software as a service (SaaS), other computer cluster configurations.

[0070] The machine (e.g., computer system) 1000 may include a hardware processor 1002 (e.g., a central processing unit (CPU), a graphics processing unit (GPU), a hardware processor core, or any combination thereof), a main memory 1004, a static memory (e.g., memory or storage for firmware, microcode, a basic-input- output (BIOS), unified extensible firmware interface (UEFI), etc.) 1006, and mass storage 1008 (e.g., hard drive, tape drive, flash storage, or other block devices) some or all of which may communicate with each other via an interlink (e.g., bus) 1030. The machine 1000 may further include a display unit 1010, an alphanumeric input device 1012 (e.g., a keyboard), and a user interface (UI) navigation device 1014 (e.g., a mouse). In an example, the display unit 1010, input device 1012 and UI navigation device 1014 may be a touch screen display. The machine 1000 may additionallyinclude a storage device (e.g., drive unit) 1008, a signal generation device 1018 (e.g., a speaker), a network interface device 1020, and one or more sensors 1016, such as a global positioning system (GPS) sensor, compass, accelerometer, or other sensor. The machine 1000 may include an output controller 1028, such as a serial (e.g., universal serial bus (USB), parallel, or other wired or wireless (e.g., infrared (IR), near field communication (NFC), etc.) connection to communicate or control one or more peripheral devices (e.g., a printer, card reader, etc.).

[0071] Registers of the processor 1002, the main memory 1004, the static memory 1006, or the mass storage 1008 may be, or include, a machine readable medium 1022 on which is stored one or more sets of data structures or instructions 1024 (e.g., software) embodying or utilized by any one or more of the techniques or functions described herein. The instructions 1024 may also reside, completely or at least partially, within any of registers of the processor 1002, the main memory 1004, the static memory 1006, or the mass storage 1008 during execution thereof by the machine 1000. In an example, one or any combination of the hardware processor 1002, the main memory 1004, the static memory 1006, or the mass storage 1008 may constitute the machine readable media 1022. While the machine readable medium 1022 is illustrated as a single medium, the term "machine readable medium" may include a single medium or multiple media (e.g., a centralized or distributed database, or associated caches and servers) configured to store the one or more instructions 1024.

[0072] The term “machine readable medium” may include any medium that is capable of storing, encoding, or carrying instructions for execution by the machine 1000 and that cause the machine 1000 to perform any one or more of the techniques of the present disclosure, or that is capable of storing, encoding or carrying data structures used by or associated with such instructions. Non-limiting machine readable medium examples may include solid-state memories, optical media, magnetic media, and signals (e.g., radio frequency signals, other photon based signals, sound signals, etc.). In an example, a non-transitory machine readable medium comprises a machine readable medium with a plurality of particles having invariant (e.g., rest) mass, and thus are compositions of matter. Accordingly, non-transitory machine-readable media are machine readable media that do not include transitory propagating signals. Specific examples of non-transitory machine readable media may include: non-volatile memory, such as semiconductor memory devices (e.g.,Electrically Programmable Read-Only Memory (EPROM), Electrically Erasable Programmable Read-Only Memory (EEPROM)) and flash memory devices; magnetic disks, such as internal hard disks and removable disks; magneto-optical disks; and CD-ROM and DVD-ROM disks.

[0073] The instructions 1024 may be further transmitted or received over a communications network 1026 using a transmission medium via the network interface device 1020 utilizing any one of a number of transfer protocols (e.g., frame relay, internet protocol (IP), transmission control protocol (TCP), user datagram protocol (UDP), hypertext transfer protocol (HTTP), etc.). Example communication networks may include a local area network (LAN), a wide area network (WAN), a packet data network (e.g., the Internet), mobile telephone networks (e.g., cellular networks), Plain Old Telephone (POTS) networks, and wireless data networks (e.g., Institute of Electrical and Electronics Engineers (IEEE) 802.11 family of standards known as WiFi®, IEEE 802.16 family of standards known as WiMax®), IEEE 802.15.4 family of standards, peer-to-peer (P2P) networks, among others. In an example, the network interface device 1020 may include one or more physical jacks (e.g., Ethernet, coaxial, or phonejacks) or one or more antennas to connect to the communications network 1026. In an example, the network interface device 1020 may include a plurality of antennas to wirelessly communicate using at least one of single-input multiple-output (SIMO), multiple-input multiple-output (MIMO), or multiple-input single-output (MISO) techniques. The term “transmission medium” shall be taken to include any intangible medium that is capable of storing, encoding or carrying instructions for execution by the machine 1000, and includes digital or analog communications signals or other intangible medium to facilitate communication of such software. A transmission medium is a machine readable medium.

[0074] FIG. 11 illustrates a schematic view of a method 1100, in accordance with at least one example of this disclosure. The method 1100 can be a method of operating a lithotripsy system. More specific examples of the method 1100 are discussed below. The steps or operations of the method 1100 are illustrated in a particular order for convenience and clarity; many of the discussed operations can be performed in a different sequence or in parallel without materially impacting other operations. The method 1100 as discussed includes operations performed by multiple different actors, devices, or systems. It is understood that subsets of the operationsdiscussed in the method 1100 can be attributable to a single actor, device, or system could be considered a separate standalone process or method.

[0075] The method 1100 for performing a medical procedure (e.g., lithotripsy) can begin at step 1102, where a scope defining a working channel can be positioned at least partially within a body channel, where the working channel can extend along a longitudinal axis of the scope, and where the working channel can define a suction opening of the working channel at a distal tip of the scope. For example, the scope 102 defining the working channel 104 can be positioned at least partially within a body channel, where the working channel 104 can extend along a longitudinal axis of the scope, and where the working channel 104 can define a suction opening 109 of the working channel at a distal tip 105 of the scope.

[0076] At step 1104, a lithotripter can be inserted through the working channel. For example, a lithotripsy device 100 can be inserted through the working channel 104. At step 1106, a suction device can be connected to the working channel upstream of the suction opening. For example, the suction device air pump 120 can be connected to the working channel 104 upstream of the suction opening 109.

[0077] At step 1108, lithotripsy energy can be delivered from the lithotripter to tissue located at least partially within the body channel. For example, lithotripsy energy can be delivered from the lithotripter 100 to tissue 50 located at least partially within the body channel. At step 1110, a lithotripsy force or energy applied (or to be applied) to the tissue can be determined based on operation of the lithotripter.

[0078] At step 1112, a force applied on the target stone / tissue resulting from application of the lithotripter or a distance signal can be generated based on a distance between the tissue and the lithotripter upon activation of the lithotripter can be determined as described above. For example, a distance signal can be generated by the sensor module 103 based on a distance between the stone 50 and the lithotripter lithotripsy device 100 and a distance can be determined based on the distance signal by the controller 110. In one example, the relationship between the applied energy or power of the lithotripter and the force applied on the target stone / tissue is retrieved. Based on the relationship and the energy or power of the lithotripter to be applied to the target stone / tissue, a force on the target stone / tissue resulting from the application of the lithotripsy energy / power can be determined. The step 1112 can also include determining the force applied to the target stone / tissue resulting from operation of the lithotripter.

[0079] At step 1114, an image stream can be generated using an image sensor, such as the sensor module 103, which can be or can include an image sensor. Then, a characteristic of the tissue can be determined based on the imaging stream or signal, such as by the controller 110. For example, the controller 110 can use the image stream to determine a characteristic of the stone / tissue such as one or more of a size of the tissue (e.g., the stone 50), a weight of the tissue, a shape of the tissue, or a composition of the tissue. Then, the controller 110 can operate one or more of the lithotripter 100, the lithotripter actuator 135, and the suction device 124 based on the image stream or based on the determined size of the tissue, shape of the tissue, or composition of the tissue. Optionally, the applying force on the target stone / tissue estimated in step 1112 may be further based on the characteristic of the target.

[0080] At step 1116, a lithotripter actuator can be operated to treat the stone / tissue. At step 1118, a suction force to be generated can be determined based on one or more of the stone characteristic, the distance between the lithotripter and the stone, the lithotripsy force or force to be generated, or the like as described above. The suction force can be determined based on one or more signals such as the sensor module 103 and can be determined by the controller 110, or the Al model, or another control device.

[0081] In addition, at step 1120 the suction device can be operated (e.g., simultaneously) to deliver a suction pressure to generate a suction force on the tissue based on the lithotripsy force applied to the stone / tissue or the characteristic of the stone or tissue based on the relationships established in step 1112, step 1114, or step 1118 so as to motivate movement of the tissue or portions thereof toward the suction opening at a suction energy configured to offset the lithotripsy energy to reduce or eliminate retropulsion of the tissue when the lithotripsy energy is delivered to the tissue.

[0082] In some examples, a control valve can be operated to generate a suction force when the lithotripter delivers the lithotripsy energy, the control valve connectable to the working channel and the suction device. In some examples, liquids or solids entering the working channel can be stored or received after the suction force is generated in a suction accumulator connectable to the working channel between the suction opening and the control valve. In some examples, the liquids or solids can be cleared from the suction accumulator to a drain using an air pump connectable to the control valve and the suction accumulator.NOTES AND EXAMPLES

[0083] The following, non-limiting examples, detail certain aspects of the present subject matter to solve the challenges and provide the benefits discussed herein, among others.

[0084] Example l is a lithotripsy device comprising: a lithotripter configured to deliver lithotripsy energy to tissue located at least partially within a body channel; a working passage positionable at least partially within the body channel, the working passage at least partially defining a suction opening; a suction device connected to the working passage upstream of the suction opening and configured to generate a suction flow to motivate movement of the tissue or portions thereof toward the suction opening; and a controller in communication with the lithotripter and with the suction device, the controller configured to operate the suction device to generate the suction flow at a suction energy configured to offset the lithotripsy energy to reduce or eliminate retropulsion of the tissue when the lithotripsy energy is delivered to the tissue.

[0085] In Example 2, the subject matter of Example 1 optionally includes wherein the lithotripter comprises a laser emitter operable to deliver light energy to the tissue.

[0086] In Example 3, the subject matter of any one or more of Examples 1-2 optionally include wherein the lithotripter is an ultrasonic lithotripter.

[0087] In Example 4, the subject matter of any one or more of Examples 1-3 optionally include wherein the controller is configured to determine a lithotripsy force applied to the tissue based on operation of the lithotripter, and wherein the controller is configured to operate the suction device to deliver a suction pressure to generate a suction force on the tissue based on the lithotripsy force applied to the tissue.

[0088] In Example 5, the subject matter of Example 4 optionally includes a control valve connected to the working passage and the suction device, the control valve in communication with the controller, and the controller configured to operate the control valve to generate the suction force when the lithotripter delivers the lithotripsy energy.

[0089] Example 6 is a lithotripsy system comprising one or more components discussed above.

[0090] Example 7 is a method of operating a lithotripsy system comprising one or more steps discussed above.

[0091] Example 8 is a lithotripsy device comprising: a lithotripter configured to deliver lithotripsy energy to tissue located at least partially within a body channel; a working passage positionable at least partially within the body channel, the working passage at least partially defining a suction opening; a suction device connectable to the working passage upstream of the suction opening and configured to generate a suction flow to motivate movement of the tissue or portions thereof toward the suction opening; and a controller in communication with the lithotripter and with the suction device, the controller configured to operate the suction device to generate the suction flow at a suction energy configured to offset the lithotripsy energy to reduce or eliminate retropulsion of the tissue when the lithotripsy energy is delivered to the tissue.

[0092] In Example 9, the subject matter of Example 8 optionally includes wherein the lithotripter comprises a laser emitter operable to deliver light energy to the tissue.

[0093] In Example 10, the subject matter of any one or more of Examples 8-9 optionally include wherein the lithotripter is an ultrasonic lithotripter.

[0094] In Example 11, the subject matter of any one or more of Examples 8-10 optionally include wherein the controller is configured to operate the suction device to generate the suction flow simultaneously with the lithotripsy energy.

[0095] In Example 12, the subject matter of any one or more of Examples 8-11 optionally include wherein the controller is configured to determine a lithotripsy force applied to the tissue based on operation of the lithotripter, and wherein the controller is configured to operate the suction device to deliver a suction pressure to generate a suction force on the tissue based on the lithotripsy force applied to the tissue.

[0096] In Example 13, the subject matter of Example 12 optionally includes a control valve connectable to the working passage and the suction device, the control valve in communication with the controller, and the controller configured to operate the control valve to generate the suction force when the lithotripter delivers the lithotripsy energy.

[0097] In Example 14, the subject matter of any one or more of Examples 12-13 optionally include a control valve connectable to the working passage and the suction device, the control valve operable by a user to control the suction force.

[0098] In Example 15, the subject matter of any one or more of Examples 12-14 optionally include a control valve connectable to the working passage and the suction device, the control valve operable to control the suction force; a suction accumulatorconnectable to the working passage between the suction opening and the control valve, the suction accumulator configured to receive and store liquids or solids entering the working passage after the suction force is generated; and an air pump connectable to the control valve and the suction accumulator, the air pump operable to clear the liquids or solids from the suction accumulator to a drain.

[0099] In Example 16, the subject matter of any one or more of Examples 8-15 optionally include wherein the working passage extends distally beyond a distal tip of the lithotripter such that the suction opening is located distally beyond the distal tip of the lithotripter.

[0100] In Example 17, the subject matter of any one or more of Examples 8-16 optionally include a lithotripter actuator connected to the lithotripter, the lithotripter actuator in communication with the controller, and the controller figured to operate the lithotripter actuator to move the lithotripter proximally or distally based on a location of the tissue relative to a distal tip of the lithotripter.

[0101] In Example 18, the subject matter of Example 17 optionally includes a distance sensor in communication with the controller and configured to generate a signal based on a distance between the tissue and the lithotripter, the controller figured to operate the lithotripter actuator to move the lithotripter based on the signal.

[0102] In Example 19, the subject matter of any one or more of Examples 17-18 optionally include an image sensor in communication with the controller and configured to generate a signal based on an image stream produce by the image sensor, the controller figured to operate one or more of the lithotripter, the lithotripter actuator, and the suction device based on the signal.

[0103] In Example 20, the subject matter of Example 19 optionally includes wherein the controller is configured to determine one or more of a size of the tissue, a shape of the tissue, or a composition of the tissue based on the image stream.

[0104] In Example 21, the subject matter of Example 20 optionally includes wherein the controller is configured to operate one or more of the lithotripter, the lithotripter actuator, and the suction device based on the determined size of the tissue, shape of the tissue, or composition of the tissue.

[0105] Example 22 is a lithotripsy system comprising: a scope defining a working passage positionable at least partially within a body channel, the working passage extending along a longitudinal axis of the scope, and the working channel defining an opening of the working channel at a distal tip of the scope; a lithotripter insertablethrough the working passage, the lithotripter configured to deliver lithotripsy energy to tissue located at least partially within the body channel; a suction device connectable to the working passage upstream of the suction opening and configured to generate a suction flow to motivate movement of the tissue or portions thereof toward the suction opening; and a controller in communication with the lithotripter and with the suction device, the controller configured to operate the suction device to generate the suction flow at a suction energy configured to offset the lithotripsy energy to reduce or eliminate retropulsion of the tissue when the lithotripsy energy is delivered to the tissue.

[0106] In Example 23, the subject matter of Example 22 optionally includes wherein the controller is configured to determine a lithotripsy force applied to the tissue based on operation of the lithotripter, and wherein the controller is configured to operate the suction device to deliver a suction pressure to generate a suction force on the tissue based on the lithotripsy force applied to the tissue.

[0107] In Example 24, the subject matter of Example 23 optionally includes a control valve connectable to the working passage and the suction device, the control valve in communication with the controller, and the controller configured to operate the control valve to generate the suction force when the lithotripter delivers the lithotripsy energy.

[0108] In Example 25, the subject matter of Example 24 optionally includes a control valve connectable to the working passage and the suction device, the control valve operable by a user to control the suction force.

[0109] In Example 26, the subject matter of Example 25 optionally includes a control valve connectable to the working passage and the suction device, the control valve operable to control the suction force; a suction accumulator connectable to the working passage between the suction opening and the control valve, the suction accumulator configured to receive and store liquids or solids entering the working passage after the suction force is generated; and an air pump connectable to the control valve and the suction accumulator, the air pump operable to clear the liquids or solids from the suction accumulator to a drain.

[0110] In Example 27, the subject matter of any one or more of Examples 25-26 optionally include a lithotripter actuator connected to the lithotripter, the lithotripter actuator in communication with the controller, and the controller figured to operate the lithotripter actuator to move the lithotripter proximally or distally based on alocation of the tissue relative to a distal tip of the lithotripter; a distance sensor in communication with the controller and configured to generate a signal based on a distance between the tissue and the lithotripter, the controller figured to operate the lithotripter actuator to move the lithotripter based on the signal; and an image sensor in communication with the controller and configured to generate a signal based on an image stream produce by the image sensor, the controller figured to operate one or more of the lithotripter, the lithotripter actuator, and the suction device based on the signal.

[0111] Example 28 is a method of operating a lithotripsy system, the method comprising: positioning a scope defining a working channel at least partially within a body channel, the working channel extending along a longitudinal axis of the scope, and the working channel defining a suction opening of the working channel at a distal tip of the scope; inserting a lithotripter through the working channel; connecting a suction device to the working channel upstream of the suction opening; delivering lithotripsy energy from the lithotripter to tissue located at least partially within the body channel; and generating a suction flow to motivate movement of the tissue or portions thereof toward the suction opening at a suction energy configured to offset the lithotripsy energy to reduce or eliminate retropulsion of the tissue when the lithotripsy energy is delivered to the tissue.

[0112] In Example 29, the subject matter of Example 28 optionally includes determining a lithotripsy force applied to the tissue based on operation of the lithotripter.

[0113] In Example 30, the subject matter of Example 29 optionally includes operating the suction device to deliver a suction pressure to generate a suction force on the tissue based on the lithotripsy force applied to the tissue.

[0114] In Example 31, the subject matter of any one or more of Examples 28-30 optionally include operating a control valve to generate a suction force when the lithotripter delivers the lithotripsy energy, the control valve connectable to the working channel and the suction device.

[0115] In Example 32, the subject matter of Example 31 optionally includes receiving and storing liquids or solids entering the working channel after the suction force is generated in a suction accumulator connectable to the working channel between the suction opening and the control valve.

[0116] In Example 33, the subject matter of Example 32 optionally includes clearing the liquids or solids from the suction accumulator to a drain using an air pump connectable to the control valve and the suction accumulator.

[0117] In Example 34, the subject matter of any one or more of Examples 28-33 optionally include operating a lithotripter actuator to move the lithotripter proximally or distally based on a location of the tissue relative to a distal tip of the lithotripter.

[0118] In Example 35, the subject matter of Example 34 optionally includes generating a distance signal based on a distance between the tissue and the lithotripter; and operating the lithotripter actuator to move the lithotripter based on the distance signal.

[0119] In Example 36, the subject matter of any one or more of Examples 34-35 optionally include generating an image stream using an image sensor; and operating one or more of the lithotripter, the lithotripter actuator, and the suction device based on the image stream.

[0120] In Example 37, the subject matter of Example 36 optionally includes determining one or more of a size of the tissue, a shape of the tissue, or a composition of the tissue based on the image stream.

[0121] In Example 38, the subject matter of Example 37 optionally includes operating one or more of the lithotripter, the lithotripter actuator, and the suction device based on the determined size of the tissue, shape of the tissue, or composition of the tissue.

[0122] Example 39 is a method of operating a lithotripsy system, the method comprising: determining a lithotripsy force applied or to be applied to a target based on operation of the lithotripter; determining an operation setting of a suction device for generating a suction force on the target so as to offset the lithotripsy force applied on the target resulting from activation of a lithotripter.

[0123] In Example 40, the subject matter of Example 39 optionally includes acquiring an image of the tissue using an image sensor; determining a characteristic of the target based on the acquired image; and determining the operation setting of the suction device based on the characteristic of the target.

[0124] In Example 41, the subject matter of Example 40 optionally includes wherein the characteristic of the target comprises at least one of a size of the target, a weight of the target, a shape of the target, or a composition of the target.

[0125] In Example 42, the subject matter of Example 41 optionally includes wherein the lithotripsy force is determined based on an operation setting of the lithotripter.

[0126] In Example 43, the subject matter of any one or more of Examples 39-42 optionally include operating a lithotripter actuator to move the lithotripter proximally or distally based on a location of the tissue relative to a distal tip of the lithotripter.

[0127] In Example 44, the subject matter of Example 43 optionally includes generating a distance signal based on a distance between the target and the lithotripter; and operating the lithotripter actuator to move the lithotripter based on the distance signal.

[0128] In Example 45, the subject matter of any one or more of Examples 39-44 optionally include operating a control valve to generate a suction force when the lithotripter delivers the lithotripsy energy, the control valve connectable to the working channel and the suction device.

[0129] In Example 46, the subject matter of Example 45 optionally includes receiving and storing liquids or solids entering the working channel after the suction force is generated in a suction accumulator connectable to the working channel between the suction opening and the control valve.

[0130] In Example 47, the subject matter of Example 46 optionally includes clearing the liquids or solids from the suction accumulator to a drain using an air pump connectable to the control valve and the suction accumulator.

[0131] In Example 48, the apparatuses or method of any one or any combination of Examples 1 - 47 can optionally be configured such that all elements or options recited are available to use or select from.

[0132] 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 can be practiced. These embodiments are also referred to herein as “examples.” Such examples can include elements in addition to those shown or described. However, the present inventors also contemplate examples in which only those elements shown or described are provided. Moreover, the present 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.

[0133] In the event of inconsistent usages between this document and any documents so incorporated by reference, the usage in this document controls. 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, that is, a system, device, article, composition, formulation, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim.

[0134] In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, 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 a nonexclusive 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, that is, a system, device, article, composition, formulation, or process that includes elements in addition to those listed after such a term in a claim are 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.

[0135] The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments can be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to allow 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 interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description as examples or embodiments, 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 theinvention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

Claims

CLAIMS:

1. A lithotripsy device comprising: a lithotripter configured to deliver lithotripsy energy to tissue located at least partially within a body channel; a working passage positionable at least partially within the body channel, the working passage at least partially defining a suction opening; a suction device connectable to the working passage upstream of the suction opening and configured to generate a suction flow to motivate movement of the tissue or portions thereof toward the suction opening; and a controller in communication with the lithotripter and with the suction device, the controller configured to operate the suction device to generate the suction flow at a suction energy configured to offset the lithotripsy energy to reduce or eliminate retropulsion of the tissue when the lithotripsy energy is delivered to the tissue.

2. The lithotripsy device of claim 1, wherein the lithotripter comprises a laser emitter operable to deliver light energy to the tissue.

3. The lithotripsy device of claim 1, wherein the lithotripter is an ultrasonic lithotripter or an electro-hydraulic lithotripter.

4. The lithotripsy device of any of claims 1-3, wherein the controller is configured to operate the suction device to generate the suction flow simultaneously with the lithotripsy energy.

5. The lithotripsy device of any of claims 1-4, wherein the controller is configured to determine a lithotripsy force applied to the tissue based on operation of the lithotripter, and wherein the controller is configured to operate the suction device to deliver a suction pressure to generate a suction force on the tissue based on the lithotripsy force applied to the tissue.

6. The lithotripsy device of claim 5, comprising: a control valve connectable to the working passage and the suction device, the control valve in communication with the controller, and the controller configured tooperate the control valve to generate the suction force when the lithotripter delivers the lithotripsy energy.

7. The lithotripsy device of claim 5, comprising: a control valve connectable to the working passage and the suction device, the control valve operable by a user to control the suction force.

8. The lithotripsy device of claim 5, comprising: a control valve connectable to the working passage and the suction device, the control valve operable to control the suction force; a suction accumulator connectable to the working passage between the suction opening and the control valve, the suction accumulator configured to receive and store liquids or solids entering the working passage after the suction force is generated; and an air pump connectable to the control valve and the suction accumulator, the air pump operable to clear the liquids or solids from the suction accumulator to a drain.

9. The lithotripsy device of any of claims 1-8, wherein the working passage extends distally beyond a distal tip of the lithotripter such that the suction opening is located distally beyond the distal tip of the lithotripter.

10. The lithotripsy device of any of claims 1-9, comprising: a lithotripter actuator connected to the lithotripter, the lithotripter actuator in communication with the controller, and the controller figured to operate the lithotripter actuator to move the lithotripter proximally or distally based on a location of the tissue relative to a distal tip of the lithotripter.

11. The lithotripsy device of claim 10, comprising: a distance sensor in communication with the controller and configured to generate a signal based on a distance between the tissue and the lithotripter, the controller figured to operate the lithotripter actuator to move the lithotripter based on the signal.

12. The lithotripsy device of claim 10, comprising: an image sensor in communication with the controller and configured to generate a signal based on an image stream produce by the image sensor, the controller figured to operate one or more of the lithotripter, the lithotripter actuator, and the suction device based on the signal.

13. The lithotripsy device of claim 12, wherein the controller is configured to determine one or more of a size of the tissue, a shape of the tissue, or a composition of the tissue based on the image stream.

14. The lithotripsy device of claim 13, wherein the controller is configured to operate one or more of the lithotripter, the lithotripter actuator, and the suction device based on the determined size of the tissue, shape of the tissue, or composition of the tissue.

15. A lithotripsy system comprising: a scope defining a working channel positionable at least partially within a body channel, the working channel extending along a longitudinal axis of the scope, and the working channel defining a suction opening of the working channel at a distal tip of the scope; a lithotripter insertable through the working channel, the lithotripter configured to deliver lithotripsy energy to tissue located at least partially within the body channel; a suction device connectable to the working channel upstream of the suction opening and configured to generate a suction flow to motivate movement of the tissue or portions thereof toward the suction opening; and a controller in communication with the lithotripter and with the suction device, the controller configured to operate the suction device to generate the suction flow at a suction energy configured to offset the lithotripsy energy to reduce or eliminate retropulsion of the tissue when the lithotripsy energy is delivered to the tissue.

16. The lithotripsy system of claim 15, wherein the controller is configured to determine a lithotripsy force applied to the tissue based on operation of the lithotripter, and wherein the controller is configured to operate the suction device to deliver a suction pressure to generate a suction force on the tissue based on the lithotripsy force applied to the tissue.

17. The lithotripsy system of claim 16, comprising: a control valve connectable to the working channel and the suction device, the control valve in communication with the controller, and the controller configured to operate the control valve to generate the suction force when the lithotripter delivers the lithotripsy energy.

18. The lithotripsy system of claim 17, comprising: a control valve connectable to the working channel and the suction device, the control valve operable by a user to control the suction force.

19. The lithotripsy system of claim 18, comprising: a control valve connectable to the working channel and the suction device, the control valve operable to control the suction force; a suction accumulator connectable to the working channel between the suction opening and the control valve, the suction accumulator configured to receive and store liquids or solids entering the working channel after the suction force is generated; and an air pump connectable to the control valve and the suction accumulator, the air pump operable to clear the liquids or solids from the suction accumulator to a drain.

20. The lithotripsy system of claim 18, comprising: a lithotripter actuator connected to the lithotripter, the lithotripter actuator in communication with the controller, and the controller figured to operate the lithotripter actuator to move the lithotripter proximally or distally based on a location of the tissue relative to a distal tip of the lithotripter; a distance sensor in communication with the controller and configured to generate a signal based on a distance between the tissue and the lithotripter, the controllerfigured to operate the lithotripter actuator to move the lithotripter based on the signal; and an image sensor in communication with the controller and configured to generate a signal based on an image stream produce by the image sensor, the controller figured to operate one or more of the lithotripter, the lithotripter actuator, and the suction device based on the signal.

21. A method of operating a lithotripsy system, the method comprising: determining a lithotripsy force applied or to be applied to a target based on operation of the lithotripter; determining an operation setting of a suction device for generating a suction force on the target so as to offset the lithotripsy force applied on the target resulting from activation of a lithotripter.

22. The method of claim 21, further comprising: acquiring an image of the tissue using an image sensor; determining a characteristic of the target based on the acquired image; and determining the operation setting of the suction device based on the characteristic of the target.

23. The method of claim 22, wherein the characteristic of the target comprises at least one of a size of the target, a weight of the target, a shape of the target, or a composition of the target.

24. The method of claim 23, wherein the lithotripsy force is determined based on an operation setting of the lithotripter.

25. The method of any of claims 21-24, comprising: operating a lithotripter actuator to move the lithotripter proximally or distally based on a location of the tissue relative to a distal tip of the lithotripter.

26. The method of claim 25, comprising:generating a distance signal based on a distance between the target and the lithotripter; and operating the lithotripter actuator to move the lithotripter based on the distance signal.

27. The method of any of claims 21-26, comprising: operating a control valve to generate a suction force when the lithotripter delivers the lithotripsy energy, the control valve connectable to the working channel and the suction device.

28. The method of claim 27, comprising: receiving and storing liquids or solids entering the working channel after the suction force is generated in a suction accumulator connectable to the working channel between the suction opening and the control valve.

29. The method of claim 28, comprising: clearing the liquids or solids from the suction accumulator to a drain using an air pump connectable to the control valve and the suction accumulator.

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