Anti-backlash for ureteroscopy lithotripsy

Abstract

A lithotripsy device can include a lithotripter configured to deliver lithotripsy energy to tissue at least partially positioned within a body passageway. The lithotripsy device can include a working passageway that can be at least partially positioned within the body passageway, the working passageway at least partially defining an aspiration opening. The lithotripsy device can include an aspiration device that can be connected to the working passageway upstream of the aspiration opening and configured to generate an aspiration flow to facilitate movement of the tissue or portions thereof toward the aspiration opening. The lithotripsy device can include a controller in communication with the lithotripter and the aspiration device, where the controller can be configured to operate the aspiration device to generate the aspiration flow with an aspiration energy configured to counteract the lithotripsy energy as the lithotripsy energy is delivered to the tissue, thereby reducing or eliminating recoil of the tissue.

Description

[0001] Priority Statement

[0002] This application claims 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 Technology

[0003] Tissue can form within organs in the human body, such as the kidneys. In some cases, tissue (such as kidney stones) cannot pass through the organ naturally and requires surgical intervention to remove it. In many cases, the tissue must be broken into smaller pieces to be removed from bodily passages such as the kidneys or urethra. Lithotripsy devices are used to break up and remove tissue. Common types of lithotripsy include laser lithotripsy, ultrasonic lithotripsy, and mechanical lithotripsy. In each of these methods, energy is delivered from the lithotripsy device to the tissue to break it into smaller pieces for removal. Attached Figure Description

[0004] In accompanying drawings that are not necessarily drawn to scale, similar reference numerals may describe similar components in different figures. Similar reference numerals with different letter suffixes may indicate different instances of similar components. The accompanying drawings illustrate, by way of example rather than limitation, the various embodiments discussed in this document.

[0005] Figure 1 A schematic diagram of an endoscope system is shown.

[0006] Figure 2 Examples Figure 1 A schematic diagram of the imaging and control system, which shows the imaging and control system connected to the endoscope.

[0007] Figure 3 A cross-sectional view of the stone crushing device is shown.

[0008] Figure 4 A cross-sectional view of the stone crushing device is shown.

[0009] Figure 5 A cross-sectional view of the stone crushing device is shown.

[0010] Figure 6 A schematic diagram of a crushing system is shown.

[0011] Figure 7 A graph illustrating fluid forces and suction pressure is shown.

[0012] Figure 8 An example table showing the calculations is provided.

[0013] Figure 9A schematic diagram of a gravel control system is shown.

[0014] Figure 10 A block diagram illustrating an example of a machine on which one or more implementation methods may be carried out.

[0015] Figure 11 A schematic diagram illustrating the method is provided. Detailed Implementation

[0016] Ureteroscopic lithotripsy is considered a first-line treatment for ureteral stones that have not responded to medical lithotripsy (MET) or shock wave lithotripsy (SWL). Advances in ureteroscope design and manufacturing, as well as stone retrieval devices, have contributed significantly to the reported high success rates of ureteroscopic lithotripsy. During ureteroscopic lithotripsy, the possibility of stone regression or upward migration limits the success rate. Since proximal stones have a higher migration rate than distal stones, the regression rate varies considerably depending on the lithotripter's kinetic energy and the height of the ureteral stone. Laser pulses, whether used for fragmentation or pulverization, can affect clinical use by moving the target stone away from the laser fiber tip, a phenomenon known as stone regression. Stone regression during lithotripsy requires the user to track the stone and can lead to longer procedures.

[0017] This disclosure provides a solution to the problem of regression by using an anti-regression system coupled to (or integrated with) a lithotripsy device. By reducing or eliminating regression during lithotripsy, procedure time can be reduced, which can lower costs and improve postoperative patient outcomes. Lithotripsy devices or systems employing these strategies may include a working channel or suction channel that can receive a suction flow passing through it, e.g., moving from distal to proximal. The device or system may be configured to generate a suction flow to generate a suction force that counteracts the force generated by the lithotripter (e.g., a laser) on the stone or tissue. The force of the lithotripter can be counteracted by the suction force, which helps to reduce or eliminate regression of the stone or tissue.

[0018] For example, a lithotripsy device may include a lithotripter configured to deliver lithotripsy energy to tissue at least partially located within a body channel. The lithotripsy device may include a working passage at least partially positionable within the body channel, the working passage at least partially defining an aspiration opening. The lithotripsy device may include a suction device connectable upstream of the working passage and configured to generate an aspiration flow to facilitate movement of tissue or portions thereof toward the aspiration opening. The lithotripsy device may include a controller communicating with the lithotripter and the aspiration device, wherein the controller may be configured to operate the aspiration device to generate an aspiration flow having a suction energy configured to counteract the lithotripsy energy upon delivery to the tissue to reduce or eliminate tissue retraction.

[0019] The foregoing discussion is intended to provide an overview of the subject matter of this patent application. It is not intended to provide an exclusive or exhaustive interpretation of the invention. The following description is included to provide further information regarding this patent application.

[0020] Figure 1 This is a schematic diagram of an endoscope system 10, which may include an imaging and control system 12 and an endoscope 14. Figure 1 The system described herein is an exemplary example of an endoscope system suitable for the systems, apparatus and methods described herein, such as an endoscope having an integrated guide and arm with an extension for guiding the auxiliary endoscope.

[0021] Endoscope 14 may be inserted into an anatomical region for imaging, or provide access or attachment (e.g., via tether) to one or more sampling devices for biopsy or one or more treatment devices for treating disease conditions associated with the anatomical region. Endoscope 14 may dock and connect to imaging and control system 12. Endoscope 14 may also include a ureteroscope, although other types of endoscopes may also be used with the features and teachings of this disclosure. Imaging and control system 12 may include control unit 16, output unit 18, input unit 20, light source 22, fluid source 24, and suction pump 26.

[0022] The imaging and control system 12 may include various ports for connection to the endoscope system 10. For example, the control unit 16 may include data input / output ports for receiving and transmitting data to the endoscope 14. The light source 22 may include an output port for transmitting light, such as via a fiber optic link, to the endoscope 14. The fluid source 24 may include ports for transmitting fluid to the endoscope 14. The fluid source 24 may include, for example, a pump and a fluid tank, or may be connected to an external tank, container, or storage unit. The suction pump 26 may include ports for evacuating the endoscope 14 to generate suction (such as for extracting fluid from the anatomical region into which the endoscope 14 is inserted). The output unit 18 and the input unit 20 may be used by the operator of the endoscope system 10 to control the functions of the endoscope system 10 and to view the output of the endoscope 14. The control unit 16 may additionally be used to generate signals or other outputs from the anatomical region into which the endoscope 14 is inserted. In some examples, the control unit 16 may generate electrical output, acoustic output, fluid output, etc., for use in treating anatomical areas using methods such as cauterization, cutting, or freezing.

[0023] Endoscope 14 may include an insertion section 28, a function section 30, and a handle section 32, which can be connected to a cable section 34 and a connector section 36. The connector section 36 can be connected to a control unit 16 to connect endoscope 14 to various features of the control unit 16, such as an input unit 20, a light source unit 22, a fluid source 24, and a suction pump 26.

[0024] Insertion segment 28 may extend distally from handle segment 32, and cable segment 34 may extend proximally from handle segment 32. Insertion segment 28 may be elongated and include a curved segment and a distal end to which functional segment 30 may be attached. The curved segment may be controllable (e.g., via a control knob 38 on handle segment 32) to manipulate the distal end through tortuous anatomical passages (e.g., stomach, duodenum, kidney, ureter, etc.). Insertion segment 28 may also include one or more working channels (e.g., lumens) that may be elongated and support one or more therapeutic instruments (such as…) of functional segment 30. Figure 4 The laser fiber 106 is inserted. The working channel can extend between the handle section 32 and the functional section 30. Other functional elements, such as fluid channels, guide wires, and draw wires, can also be provided via the insertion section 28 (e.g., via suction or flushing channels).

[0025] Handle section 32 may include a knob 38 and a port 40a. Knob 38 may be connected to a pull cable or other actuation mechanism extending through insertion section 28. Port 40a and other ports (such as...) Figure 2 Port 40b can be configured to connect various cables, guidewires, auxiliary mirrors, tissue collection devices of this disclosure, fluid tubes, etc., to handle section 32, such as for connection with insertion section 28.

[0026] Imaging and control system 12 may be mounted on a mobile platform (e.g., trolley 41) having a means of accommodating light source 22, suction pump 26, and image processing unit 42. Figure 2 Shelves, etc. Alternatively, choose another location. Figure 1 and Figure 2 Several components of the imaging and control system 12 shown can be directly mounted on the endoscope 14 to make the endoscope self-contained.

[0027] Functional section 30 may include components for treating and diagnosing the patient's anatomy. Functional section 30 may include imaging devices, illumination devices, and guides. Functional section 30 may also include a working channel, a lithotripsy device, and one or more sensors, such as those discussed in more detail below, for performing one or more lithotripsy procedures.

[0028] Figure 2 yes Figure 1A schematic diagram of an endoscope system 10, which includes an imaging and control system 12 and an endoscope 14. Figure 2 Components of an imaging and control system 12 coupled to an endoscope 14, which in the illustrated example includes a ureteroscope, are schematically illustrated. The imaging and control system 12 may include a control unit 16, which may include or be coupled to an image processing unit 42, a treatment generator 44, and a drive unit 46, as well as a light source 22, an input unit 20, and an output unit 18. The control unit 16 may include or communicate with the endoscope 14, surgical instruments (e.g., a lithotripter 100), and systems, including means configured to engage and break up tissue, wherein the tissue can be selectively collected by the means. The control unit 16 may be configured to activate a camera to view target tissue distal to the surgical instruments and the endoscope system. Similarly, the control unit 16 may be configured to activate a light source unit 22 to illuminate surgical instruments, which may include selected components configured to reflect light in a particular manner, such as a tissue cutter enhanced with reflective particles.

[0029] Image processing unit 42 and light source 22 can each interface with endoscope 14 (e.g., at functional unit 30) via wired or wireless connections. Imaging and control system 12 can thus illuminate the anatomical region, collect signals representing the anatomical region, process signals representing the anatomical region, and display an image representing the anatomical region on display unit 18. Imaging and control system 12 may include light source 22 to illuminate the anatomical region using light of a desired spectrum (e.g., broadband white light, narrowband imaging using preferred electromagnetic wavelengths, etc.). Imaging and control system 12 can be connected to endoscope 14 (e.g., via endoscope connector) for signal transmission (e.g., light output from the light source, video signals from a remote imaging system, diagnostic and sensor signals from diagnostic devices, etc.).

[0030] ( Figure 1 The fluid source 24 (shown) is communicative to the control unit 16 and may include one or more of an air source, a saline source, or other fluid sources, as well as associated fluid channels (e.g., air channels, flushing channels, suction channels) and connectors (barbed fittings, fluid seals, valves, etc.). The fluid source 24 may be used as activation energy for the biasing or pressure application devices of this disclosure. The imaging and control system 12 may also include a drive unit 46, which may include an electric actuator for advancing a distal segment of the endoscope 14.

[0031] The connector section 36 can be connected to the control unit 16 to connect the endoscope 14 to various features of the control unit 16, such as the image processing unit 42 and the treatment generator 44. In an example, port 40a can be used to insert another instrument or device, such as a sub-scope or auxiliary scope, into the endoscope 14. Such instruments and devices can be independently connected to the control unit 16 via cable 47. In some examples, port 40b can be used to connect the connector section 26 to various inputs and outputs such as video, air, light, and electricity.

[0032] Figure 3 A cross-sectional view of a lithotripsy device or system 100 including a flexible ureteroscope 102 is illustrated. The lithotripsy device or system may be or include the flexible ureteroscope 102. The lithotripsy device 100 may include a working channel 104 and a laser fiber 106. The working channel 104 may include a suction opening 109 at its distal end or in part. The working channel 104 may be connected to a suction source (discussed in more detail below), which may be connected to (…). Figure 2 The control unit 16. The working channel 104 may have a size W (e.g., diameter) between 0.2 mm and 3 mm (e.g., between 0.5 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, etc.).

[0033] The laser fiber 106 may be at least partially located within the working channel 104 and may extend from the distal end 105 of the flexible ureteroscope 102 (e.g., functional segment 30). The laser fiber 106 may extend through the working channel 104 and may 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 the stone 50 or tissue. The size L (e.g., diameter) of the laser fiber 106 may be between 50 micrometers and 1000 micrometers, such as 50 micrometers, 100 micrometers, 150 micrometers, 200 micrometers, 250 micrometers, 300 micrometers, 350 micrometers, 400 micrometers, 450 micrometers, 500 micrometers, 550 micrometers, 600 micrometers, 650 micrometers, 700 micrometers, 750 micrometers, 800 micrometers, 850 micrometers, 900 micrometers, 950 micrometers, 1000 micrometers, etc.

[0034] During operation, the laser fiber 106 can be activated by the control unit 16 to deliver energy to the stone 50 to break it up within the ureter 52. Before, during, or after breaking up the stone, the working channel 104 can deliver suction to act on the stone 50 and its fragments, such as to remove stone fragments from the ureter 52. The working channel 104 can also deliver suction applicable to the stone 50 during activation of the laser fiber 106 to limit stone retraction, helping to maintain the position of the stone 50 during lithotripsy, which helps limit its movement through the ureter 52 for tracking. Further operational details of the lithotripsy device 100 are discussed below.

[0035] Optionally, the flexible ureteroscope 102 may include an extension 111 of the working channel 104. The extension 111 may extend distally beyond the distal end of the laser fiber 106, such that the aspiration opening is located distally beyond the distal end of the laser fiber 106. The extension 111 may be used to aspirate the stone 50 toward the extension 111, for example, by applying aspiration pressure to the stone 50 (discussed in more detail below).

[0036] Although this application primarily discusses laser lithotripsy, the suction pressure anti-reverse technique (and other techniques) discussed herein can be applied to other lithotripsy techniques, such as ultrasonic lithotripsy and electro-hydraulic lithotripsy.

[0037] Figure 4 A cross-sectional view of the stone crushing device 100 is shown. Figure 5 A cross-sectional view of the crushing device 100 is shown. Let's discuss it together. Figure 4 and Figure 5 The crushing device 100 can be used in conjunction with the one discussed above. Figure 3 Consistent. Figure 4 and Figure 5 The lithotripsy device 100 is shown in how it can be used or operated, such as during lithotripsy surgery.

[0038] Figure 4 The diagram illustrates how the lithotripsy device 100 can be used without suction being applied from the working channel 104, showing the energy pulse P of the laser fiber 106. For example, once the target tissue (e.g., stone 50) is identified, the laser fiber 106 can be positioned at an appropriate distance and activated to generate a laser energy pulse P. This energy can deliver a force to the stone 50 to break it, but the force can also cause the stone 50 to move in direction D1, such as from stone location 50A ( Figure 4 Move to the stone location 50B ( Figure 4 This causes the stones to retract or move away from the laser fiber 106.

[0039] like Figure 5As shown, this retraction or movement of the stone 50 (caused by the pulse P from the laser fiber 106) can be compensated for by using the suction pulse S. That is, in operation, once the target tissue (e.g., stone 50) is identified and the laser fiber 106 is positioned at the appropriate distance, the suction pulse S can be initiated in coordination with the initial laser energy pulse P. Figure 5 The suction pulse can be generated at the same moment, instantaneously, or over time as the laser energy is directed towards the stone 50 along direction D1 (optionally, the suction pulse S can be generated before or after the laser energy pulse). The suction pulse can compensate for the movement of the stone 50 along direction D1 (e.g., by generating a low-pressure region within or around the laser fiber). This suction or low-pressure region can generate a force on the stone 50 in the opposite direction to direction D1, which can help pull the stone 50 proximally when the laser pulse applies force in the distal direction. Such a force balance can create a balanced or near-balanced state in the fluid environment where the target tissue 50 is located, and can minimize (if not eliminate) the retraction distance of the stone during the delivery of the laser energy pulse P. Figure 5 As shown.

[0040] Figure 5 The rock-crushing device 100 is also shown to include a sensor module 103 connected to the working channel 104. The sensor module may be or may include one or more of a distance (e.g., proximity) sensor, an imaging module (which may interface with or be part of the imaging and control system 12), a pressure sensor, a temperature sensor, etc. The sensor module 103 may also be connected to a controller 110 or a control unit 16. The sensor module 103 may be configured to transmit signals to the controller 110 or control unit 16 before, during, or after the operation of the laser fiber 106 or the application of suction pressure. As discussed in more detail below, the controller 110 or control unit 16 may use the signals to make one or more determinations for controlling the rock-crushing device 100.

[0041] Figure 6 A schematic diagram of a crushing system 100, which may include a suction control system 107, is illustrated. The suction control system 107 may include a valve system 108, a regulator 118, and an air pump 120. The suction control system 107 may communicate with a controller 110 such that one or more of the valve system 108, the regulator 118, and the air pump 120 may be operated by or receive one or more signals from the controller 110. Optionally, the valve system 108 may be manually operated by a user (e.g., via a switch, button, etc.).

[0042] The suction control system 107 may be connected (e.g., via pipe assembly 112) to the suction tank 122 and the suction pump 124. Pipe assembly 112 may include one or more lines, hoses, etc. The suction pump 124 may be a fluid pump (e.g., an air pump or a 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 may be a positive displacement pump, a centrifugal pump, an axial flow pump, etc. The suction pump 124 may be connected to the suction tank 122, which may be connected to the valve system 108 (e.g., via regulator 118). The suction tank 122 may be an accumulator or tank (e.g., a tank body, an air bladder, etc.) configured to store negative pressure to allow the valve system 108 to provide relatively high suction pressure for a period of time immediately (or quickly) when or after the suction pressure is invoked by a user (e.g., via controller 110) without waiting for the suction pump 124 to build up pressure.

[0043] The valve system 108 of the suction control system 107 can be configured to open or close suction. The valve system 108 may include one or more valves such as a check valve, a two-way valve, or a three-way valve. For example, the valve system 108 may be configured to connect tubing 114 to an air pump 120 or a regulator 118 to a suction pump 124. The valve system 108 may optionally include an actuator connected to a controller 110, allowing the controller 110 to operate the valve system 108. The air pump 120 may be a pump such as a positive displacement air pump, configured to pump air from tubing 114 and the flexible ureteroscope 102 to an outlet 126 or similar device, as discussed in further detail below. The regulator 118 may be a pressure regulator configured to control the maximum (or minimum) pressure delivered from the suction pump 124 to the valve system 108. The regulator 118 may be connected to the controller 110, allowing the controller 110 to control the maximum or minimum pressure. The suction control system 107 may also include one or more high-pressure or low-pressure switches, which are 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, pressure switches may 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 channel 104 may be between 1000 Pascals (Pa) and 100000 Pa, such as 1000 Pa, 2000 Pa, 3000 Pa, 4000 Pa, 5000 Pa, 6000 Pa, 7000 Pa, 8000 Pa, 9000 Pa, 10000 Pa, etc.

[0044] The outlet 126 can be connected to the suction control system 107 via a first check valve 128, which can be configured to allow unidirectional flow from the suction control system 107 toward the outlet 126. The outlet 126 can be configured (e.g., when the valve system 108 allows air to flow from the air pump 120 to the outlet 126) to receive air and fluid from the valve system 108 or other parts of the suction control system 107. In other words, the first check valve 128 can restrict or prevent fluid flow from the outlet to the suction control system 107 or other parts of the system 100.

[0045] Valve system 108 may also be connected to Y- or T-connectors 116 for connection to flexible ureteroscope 102, such as via check valve 130. Check valve 130 allows unidirectional aspiration from flexible ureteroscope 102 (e.g., from aspiration pump 124 and from aspiration pressure stored in aspiration canister 122), such as when valve system 108 allows flow from aspiration pump 124 to flexible ureteroscope 102. That is, a second check valve 130 restricts or prevents fluid from flowing from valve system 108 or aspiration control system 107 to flexible ureteroscope 102. Canister 136 may temporarily contain excess fluid from aspiration pulse operation and, once valve 108 returns to its original or closed position, can be directed to the outlet via check valve 128. Backflow toward tubing assembly 114 can be prevented via check valve 130. Figure 6 The laser fiber 106 is also schematically shown to be connected to the flexible ureteroscope 102 via, for example, adapter 132 (which may be a Touhy Borst adapter) and optionally via biopsy port 134.

[0046] The crushing system 100 may also include a controller 110 (e.g., a read-only I / O controller) configured to adjust timing parameters of the suction pulses. Optionally, pressure (and other) settings may be set during manufacturing using a programmable controller. The controller 110 may optionally be a programmable controller such as a single-board or multi-board computer, a direct digital controller (DDC), a programmable logic controller (PLC), etc. In other examples, the controller 110 may be any computing device, such as a handheld computer, like a smartphone, tablet, laptop, desktop computer, or any other computing device including a processor, memory, and communication capabilities. The controller 110 may be a subsystem of a laser control console (e.g., a laser controller), control unit 16, or may be a separate, reusable system. The controller 110 may optionally be all or part of control unit 16, or may be connected to control unit 16.

[0047] Optionally, the rock-breaking device 100 may include an actuator 135 connected to the laser fiber 106. The actuator 135 may be any type of actuator, such as a pneumatic actuator, mechanical actuator, or electric actuator, configured to move the laser fiber 106 within and relative to the working channel 104. The actuator 135 may be connected to a controller 110, enabling the controller 110 (or control unit 16) to operate the actuator 135 to advance or retract the laser fiber 106.

[0048] In some example operations, as discussed above, controller 110 can be used to control the suction flow from suction pump 124 to flexible ureteroscope 102, such as to generate suction pressure to counteract the lithotripsy force from laser fiber 106. Before laser fiber 106 is activated, suction pump 124 can be operated to generate suction (or negative pressure) in suction canister 122, which can be achieved in part by valve system 108 being in the closed position (disconnecting suction pump 124 from the working channel 104 of flexible ureteroscope 102). When laser fiber 106 is activated, valve system 108 can connect flexible ureteroscope 102 to suction pump 124 to allow suction pressure to be applied to flexible ureteroscope 102 (e.g., via working channel 104) to counteract the lithotripsy force from laser fiber 106. When the laser fiber 106 is disabled, the valve system 108 can shut off the connection between the imaging and control system 12 and the flexible ureteroscope 102, which eliminates the suction pressure from the flexible ureteroscope 102.

[0049] After the suction pressure is applied, the controller 110 can activate the air pump 120 to allow air to flow from the air pump 120 to the outlet 126 to purge fluid or debris from the valve system 108 and optionally from the suction accumulator 136. The suction accumulator 136 can be connected to the working passage between the suction inlet and the control valve 108, and the suction accumulator 136 can be configured to receive and store liquid or solid entering the working passage after the suction force is generated or during the suction process. In this way, the stone crushing device 100 can be used to counteract backlash and clear the pipeline between stone crushing events (e.g., activation events of the laser fiber 106).

[0050] Figure 7 A graph is shown that illustrates the impact of the gravel pulse P (e.g., above the x-axis) on the x-axis. Figure 4 The force applied to the stone (as shown) and the suction force applied to the stone generated by the pump (e.g., suction pump 124) below the x-axis (such as suction pressure S) are also shown. Figure 5 As shown). Figure 7 The diagram illustrates that these forces should be equal in magnitude and opposite in order to limit the backlash.

[0051] Figure 8A table illustrating the calculations is provided, showing the force applied to tissue (e.g., from laser fiber 106 to stone 50). Pulse energy (joules) and pulse frequency can be used to determine the peak and squared output power (watts) delivered from laser fiber 106 to stone 50. The weight of stone 50 (e.g., in grams) can be used and, for example, based on the delivered power and the weight or mass of stone, to determine the retraction distance (e.g., maximum and minimum) (in millimeters (mm)). The retraction distance can be used to determine the acceleration of stone 50 (mm / s or mm / s), which, together with the weight of stone 50, can be used to determine the force applied to stone. Once the force applied to stone 50 is determined, the required (or desired) pressure applied by suction to counteract the force applied to stone 50 by laser fiber 106 can be determined. These calculations can be determined by controller 110 or control unit 16, as discussed in further detail below.

[0052] Figure 9 A schematic diagram of an exemplary computer-based clinical decision support system (CDSS) 902 is shown, which can be configured to make one or more determinations regarding the delivery of vacuum pressure via working channel 104 based on, for example, stone 50. CDSS 902 may include: an input interface 904 through which patient-specific procedures, surgical procedures, or stone 50, or one or more features, can be provided as input features to an artificial intelligence (AI) model 906; a processor 908 that performs inference operations in which one or more features of the surgical procedure or stone 50 can be applied to the AI ​​model to generate one or more determinations regarding the delivery of vacuum pressure via working channel 104; and a user interface (UI) through which one or more determinations regarding the delivery of vacuum pressure via working channel 104 can be conveyed to a user, such as a clinician.

[0053] In some implementations, input interface 904 may be a direct data link between CDSS 902 and one or more medical devices that generate at least some input features. For example, during a treatment or diagnostic medical procedure, input interface 904 may directly transmit an image of stone 50 or one or more readings of flow or pressure to CDSS. Additionally or alternatively, input interface 904 may be a classic user interface facilitating interaction between a user and CDSS 902. For example, input interface 904 may provide a user interface through which a user can manually input one or more criteria, such as desired pulse energy or duration. Additionally or alternatively, input interface 904 may provide CDSS 902 with access to an electronic medical record from which one or more input features can be extracted. In any of these cases, input interface 904 is configured to collect one or more of the following input features associated with a particular patient when or before CDSS 902 is used to determine the size of the stone, the mass of the stone, the force applied to the stone, the distance between the stone and the end of laser fiber 106, the required vacuum pressure, or other determinations. For example, one or more images of stones (such as those from a camera in the lithotripsy device 100 or the endoscope system 10) can be received. One or more images, or portions thereof, can be transmitted to the input interface 904 of the CDSS 902.

[0054] Based on one or more of the above input features, processor 908 can use an AI model to perform inference operations to generate one or more determinations. For example, input interface 904 can input images or pressure readings into the input layer of the AI ​​model, which can then propagate these input features through the AI ​​model to the output layer. The AI ​​model can provide a computer system with the ability to perform tasks by making inferences based on patterns discovered in the analysis of data, without explicit programming. The AI ​​model can explore the research and construction of algorithms (e.g., machine learning algorithms) that can learn from existing data and predict new data. Such algorithms can operate by building AI models based on example training data to make data-driven predictions or decisions represented as outputs or evaluations.

[0055] Two common paradigms for machine learning (ML) are supervised ML and unsupervised ML. Supervised ML uses prior knowledge (e.g., examples that correlate inputs with outputs or outcomes) to learn the relationship between inputs and outputs. The goal of supervised ML is to learn a function that, given some training data, best approximates the relationship between inputs and outputs, so that the ML model can achieve the same relationship to generate the corresponding output given the input. Unsupervised ML, on the other hand, trains the ML algorithm using information that is neither classified nor labeled, allowing the algorithm to operate on that information without guidance. Unsupervised ML is useful in exploratory analytics because it can automatically identify structures in the data.

[0056] Common tasks in supervised ML include classification and regression problems. Classification problems, also known as categorization problems, aim to classify items into one of several category values ​​(e.g., is this object an apple or an orange?). Regression algorithms aim to quantify some items (e.g., by assigning scores to values ​​of a given input). Examples of some commonly used supervised ML algorithms include logistic regression (LR), Naive Bayes, random forests (RF), neural networks (NN), deep neural networks (DNN), matrix factorization, and support vector machines (SVM). Some common tasks in unsupervised ML include clustering, representation learning, and density estimation. Examples of some commonly used unsupervised ML algorithms include K-means clustering, principal component analysis, and autoencoders.

[0057] Another type of machine learning is federated learning (also known as collaborative learning), which trains an algorithm across multiple decentralized devices holding local data without exchanging data. This approach contrasts with traditional centralized machine learning techniques, where all local datasets are uploaded to a single server, and with more classic decentralized methods, which typically assume that local data samples are of the same distribution. Federated learning enables multiple participants to build a shared, robust machine learning model without sharing data, thus allowing for the resolution of critical issues such as data privacy, data security, data access rights, and access to heterogeneous data.

[0058] In some examples, the AI ​​model may be trained continuously or periodically before the processor 908 performs inference operations. Then, during the inference operation, patient-specific input features provided to the AI ​​model can propagate from the input layer through one or more hidden layers, ultimately reaching the output layer corresponding to one or more determinations. For example, one or more images collected from the lithotripsy device 100 or the endoscope system 10 can be input to the input interface 904. Alternatively, images of other stones or tissues can be input to the input interface 904 from the database 910 along with one or more features of known stones or tissues, which allows the AI ​​model to provide training based on associated images and features.

[0059] During or after the inference operation, one or more determinations can be transmitted to the user via the user interface (UI) or automatically cause the suction pump 124 to perform the desired action. For example, when the determination of the suction force is generated or created by the model 906 and output by the processor 908, the required suction force can be adjusted, such as by the regulator 118, so that the suction pressure S delivered to the stone 50 through the working channel 104 properly counteracts the laser pulse P delivered to the stone 50 during fragmentation, which helps limit the stone's retreat.

[0060] For example, the AI ​​model can use inputs such as one or more images received from the lithotripsy device 100 via input interface 904 to determine the size, shape, weight, composition, or mass of a stone or tissue 50 within the ureter. The AI ​​model can also use received inputs indicating the laser pulse energy, laser pulse frequency, laser pulse duration, or laser pulse power to be delivered to the stone during one or more laser pulses. Optionally, the AI ​​model can determine, based on the determined size, shape, weight, composition, or mass of the stone 50, ideal or recommended laser pulse characteristics, such as energy, laser pulse frequency, laser pulse duration, or laser pulse power, that should be delivered from the laser fiber 106 to the stone to achieve stone fragmentation.

[0061] Whether the AI ​​model determines the characteristics of the laser pulse or receives such information (e.g., from controller 110 or control unit 16), the AI ​​model can use the determined or received laser pulse characteristics to determine the force to be delivered to the stone or tissue 50, and the AI ​​model can determine the retraction force of the stone 50. The AI ​​model can also use such information, along with the determined weight, size, composition, or mass of the stone 50, to determine the force to be applied to the stone 50. Since it is desired to apply forces of equal magnitude and opposite direction using suction pressure (e.g., from suction pump 124), the AI ​​model can use the determined force applied to the stone from the laser pulse to determine the required suction force to be applied to the stone. The AI ​​model can then use the physical properties of the stone 50 to determine the required suction pressure to deliver the determined suction force to reduce or eliminate stone retraction during the delivery of the laser pulse.

[0062] Based on all this information, the AI ​​model can also determine the ideal duration for emitting laser pulses (and thus for applying suction pressure). The AI ​​model can also determine the optimal or acceptable interval between laser pulses (and thus the interval between applying suction pressure). In determining such suction intervals or durations, the AI ​​model may take into account, among other variables, the type of suction pump 124, the amount of time required to fill suction tank 122, and the pressure reading at regulator 118 (e.g., if regulator 118 includes a pressure transducer communicating with controller 110 or control unit 16).

[0063] In some examples, such as when the flexible ureteroscope 102 includes an extension 111 on the working channel 104, the controller 110 or control unit 16 can operate the suction pump 124 to draw the stone 50 toward the extension before activating the lithotripter (e.g., laser fiber 106), which provides a known distance between the laser fiber 106 and the stone 50. Before or after the stone is drawn into the extension 111, the AI ​​model can determine the size, shape, mass, weight, composition, etc., of the stone 50, such as using images received from the controller 110 or control unit 16. Once the stone is against the extension 111, the distance between the stone 50 and the laser fiber 106 can be fixed or known, which reduces the number of variables considered by the AI ​​model to determine the output power. Furthermore, the controller 110 or control unit 16 can operate the suction pump 124 to maintain sufficient suction during lithotripsy to keep the stone 50 against the extension 111.

[0064] In some examples, when the lithotripsy device 100 includes an actuator 135 connected to the laser fiber 106 (as described above), the AI ​​model can determine the size, shape, mass, weight, composition, etc. of the stone 50, and can determine the ideal or desired distance between the laser fiber 106 and the stone 50, as well as the energy (or other output characteristics) of the lithotripter, based on the distance between the laser fiber 106 and the stone 50 and the characteristics of the stone 50 determined by the AI ​​model. The AI ​​model can transmit the determined distance to (e.g., a controller 110 or 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. Furthermore, the output characteristics of the laser fiber 106 to be delivered by the laser fiber 106, and the appropriate suction pressure (and optionally, duration, etc.) to be generated by the suction pump 124 and valve system 108, can be transmitted to the lithotripsy device 100 or control unit 16 to help allow the lithotripsy device 100 to efficiently and effectively break down or otherwise decompose the stone 50 while minimizing stone retraction. Optionally, when the lithotripsy device 100 includes an extension 111 and an actuator 135, after the suction pump 124 is used to pull the stone 50 toward the extension 111, the AI ​​model can determine whether to advance or retract the laser fiber 106 based on the known distance between the laser fiber 106 and the stone 50.

[0065] In some examples, the relationship between (i) the applied energy or power delivered to the lithotripter to the stone or tissue and (ii) the force applied to the target stone / tissue due to the application of the lithotripter, or the distance between the stone or tissue and the lithotripter tip, can be empirically established before or during the medical procedure. For example, the distance between the target and the tip of the laser fiber 106 can be determined (e.g., by the controller 110) based on signals from the sensor module 103 or any suitable method. Based on the determined distance, the controller can estimate the force applied to the target stone / tissue. Furthermore, information on the applied energy / power can be obtained, for example, from the lithotripter settings. This relationship can be stored in a database in memory accessible to the controller 110. Additionally or alternatively, this relationship can be established computationally using a computational model, such as an AI model trained using previously acquired data.

[0066] During lithotripsy, controller 110 can access a database to retrieve stored relationships; based on these relationships and the lithotripter settings, controller 110 can estimate the force exerted on the target stone / tissue due to the application of the lithotripter, and determine or adjust the pump settings accordingly to counteract (or at least reduce) the backlash force caused by the application of lithotripter energy. In one implementation, the applied energy / power (obtained from, for example, the lithotripter settings) can be input to a trained AI model, which can then predict and output a corresponding estimated pump setting. The controller can then operate the pump based on the settings to create suction to eliminate (or at least reduce) the backlash force on the target stone / tissue.

[0067] In one example, the relationship between (i) the energy or power applied by the lithotripter (or the force generated therefrom), (ii) the characteristics of the target tissue or stone (e.g., size or weight), and (iii) the force applied to the target stone / tissue due to the application of the lithotripter or the distance between the tissue and the lithotripter can be established empirically or computationally before or during the medical procedure. For example, as mentioned above, the energy or power applied by the lithotripter can be obtained from the settings of the lithotripter, and the distance between the stone and the lithotripter can be known or determined based on known measurements (e.g., signals detected by sensor module 103) or any suitable data. Furthermore, the characteristics of the stone / tissue (e.g., size, density, or weight) can be estimated using any suitable method (e.g., scales, CT images of the stone / tissue, or endoscopic images). Additionally, this relationship can 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 AI model trained using previously acquired data), as mentioned above.

[0068] During lithotripsy, controller 110 can access a database to retrieve stored relationships; based on the retrieved relationships, lithotripter settings, and target characteristics (obtained from, for example, CT or endoscopic images of the target), controller 110 can estimate the force exerted on the target stone / tissue due to the application of the lithotripter. The controller can then determine or adjust pump settings based on the force exerted on the target to counteract (or at least reduce) the backlash force. In one embodiment, the energy / power applied by the lithotripter is input to a trained AI model, which can then predict and output a corresponding estimated pump setting. Furthermore, the controller can then operate the pump based on the predicted settings to generate suction, thereby eliminating (or at least reducing) the backlash force on the target stone / tissue.

[0069] Figure 10 A block diagram of an example machine 1000 is illustrated, on which any one or more techniques (e.g., methods) discussed herein may be implemented. As described herein, the example may include logic, multiple components, or mechanisms in or operable by logic, multiple components, or mechanisms in the machine 1000. A circuit (e.g., a processing circuit) is a collection of circuits implemented in the tangible entity of the machine 1000, which includes hardware (e.g., simple circuits, gates, logic, etc.). Circuit membership may change over time. A circuit includes members that can perform a specific operation individually or in combination during operation. In the example, the hardware of the circuit may be immutably designed to perform a specific operation (e.g., hardwired). In the example, the hardware of the circuit may include variablely connected physical components (e.g., execution units, transistors, simple circuits, etc.) including machine-readable media that encode instructions for a specific operation through physical modifications (e.g., magnetism, electrical properties, movable placement of massless particles, etc.). When connecting physical components, the underlying electrical properties of the hardware composition change, for example, from an insulator to a conductor or vice versa. Instructions enable embedded hardware (e.g., execution units or loading mechanisms) to create circuit members in the hardware via variable connections to perform a portion of a specific operation during operation. Thus, in the example, when the device is operating, the machine-readable medium element is part of the circuit or communicatively coupled to other components of the circuit. In the example, any physical component can be used in more than one member of more than one circuit. For example, during operation, the execution unit may be used in a first circuit of a first circuit system at one point in time and may be multiplexed at different times by a second circuit in the first circuit system or a third circuit in the second circuit system. Other examples of these components of machine 1000 are as follows.

[0070] In an alternative implementation, machine 1000 may operate as a standalone device or be connected (e.g., networked) to other machines. In a network deployment, machine 1000 may act as a server machine, a client machine, or both in a server-client network environment. In the example, machine 1000 may act as a peer-to-peer (P2P) (or other distributed) network environment. Machine 1000 may be a personal computer (PC), tablet PC, set-top box (STB), personal digital assistant (PDA), mobile phone, web device, network router, switch, or bridge, or any machine capable of executing instructions (sequentially or otherwise) specifying actions to be taken by the machine. Furthermore, although only a single machine is illustrated, the term "machine" should also be considered to include any collection of machines that individually or collectively execute a set (or more) of instructions to perform any of the methods discussed herein, such as cloud computing, Software as a Service (SaaS), and other computer cluster configurations.

[0071] Machine (e.g., computer system) 1000 may include hardware processor 1002 (e.g., central processing unit (CPU), graphics processing unit (GPU), hardware processor core, or any combination thereof), main memory 1004, static memory (e.g., memory or storage device for firmware, microcode, basic input-output system (BIOS), unified extensible firmware interface (UEFI), etc.) 1006, and mass storage device 1008 (e.g., hard disk drive, tape drive, flash memory device, or other block device), some or all of which may communicate with each other via interconnect (e.g., bus) 1030. Machine 1000 may also include display unit 1010, alphanumeric input device 1012 (e.g., keyboard), and user interface (UI) navigation device 1014 (e.g., mouse). In this example, display unit 1010, input device 1012, and UI navigation device 1014 may be a touchscreen display. Machine 1000 may additionally include a storage device (e.g., a 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, a compass, an accelerometer, or other sensors. 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 with or control one or more peripheral devices (e.g., a printer, a card reader, etc.).

[0072] The registers of processor 1002, main memory 1004, static memory 1006, or mass storage device 1008 may be or include machine-readable medium 1022 on which one or more sets of data structures or instructions 1024 (e.g., software) are stored, which implement or are used for any or more of the techniques or functions described herein. During execution of instructions 1024 by machine 1000, instructions 1024 may also reside wholly or at least partially within any register of processor 1002, main memory 1004, static memory 1006, or mass storage device 1008. In the example, one or any combination of hardware processor 1002, main memory 1004, static memory 1006, or mass storage device 1008 may constitute machine-readable medium 1022. Although machine-readable medium 1022 is shown 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 one or more instructions 1024.

[0073] The term "machine-readable medium" can include any medium capable of storing, encoding, or carrying instructions executable by machine 1000 and causing machine 1000 to perform any one or more of the techniques disclosed herein, or any medium capable of storing, encoding, or carrying data structures used by or associated with such instructions. Examples of non-limiting machine-readable media can include solid-state memory, optical media, magnetic media, and signals (e.g., radio frequency signals, other photon-based signals, sound signals, etc.). In the examples, non-transitory machine-readable media include machine-readable media having a plurality of particles with invariant (e.g., rest) mass, and thus being a component of matter. Therefore, a non-transitory machine-readable medium is a machine-readable medium that does not include transiently propagating signals. Specific examples of non-transitory machine-readable media can include: non-volatile memories 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 discs.

[0074] Instruction 1024 can also be used to send or receive data on the communication network 1026 via a transmission medium using the network interface device 1020, using any of a variety of transmission 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 local area networks (LANs), wide area networks (WANs), packet data networks (e.g., the Internet), mobile phone networks (e.g., cellular networks), conventional telephone (POTS) networks, and wireless data networks (e.g., the IEEE 802.11 series of standards known as Wi-Fi®, the IEEE 802.16 series of standards known as WiMax®, the IEEE 802.15.4 series of standards, peer-to-peer (P2P) networks, etc.). In the example, the network interface device 1020 may include one or more physical jacks (e.g., Ethernet, coaxial, or telephone jacks) or one or more antennas for connection to the communication network 1026. In the example, network interface device 1020 may include multiple antennas to perform wireless communication using at least one of single-input multiple-output (SIMO), multiple-input multiple-output (MIMO), or multiple-input single-output (MISO) technologies. The term "transmission medium" should be considered to include any intangible medium capable of storing, encoding, or carrying instructions executable by machine 1000, and includes digital or analog communication signals or other intangible media to facilitate communication of such software. The transmission medium is a machine-readable medium.

[0075] Figure 11 A schematic diagram illustrating method 1100 according to at least one example of this disclosure is shown. Method 1100 may be a method of operating a crushing system. More specific examples of method 1100 are discussed below. For convenience and clarity, the steps or operations of method 1100 are illustrated in a particular order; many of the operations discussed may be performed in different orders or in parallel without materially affecting other operations. As discussed, method 1100 includes operations performed by multiple different actors, devices, or systems. It should be understood that a subset of operations discussed in method 1100 may be attributed to a single actor, device, or system and may be considered as a separate, independent process or method.

[0076] Method 1100 for performing a medical procedure (e.g., lithotripsy) may begin at step 1102, in which an endoscope defining a working channel may be at least partially positioned within a body channel, wherein the working channel may extend along the longitudinal axis of the endoscope, and wherein the working channel may define a suction opening of the working channel at a distal end of the endoscope. For example, an endoscope 102 defining a working channel 104 may be at least partially positioned within a body channel, wherein the working channel 104 may extend along the longitudinal axis of the endoscope, and wherein the working channel 104 may define a suction opening 109 of the working channel at a distal end 105 of the endoscope.

[0077] In step 1104, the crusher can be inserted through the working channel. For example, the crushing device 100 can be inserted through the working channel 104. In step 1106, the 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.

[0078] In step 1108, lithotripsy energy can be delivered from the lithotripter to tissue at least partially located within a body channel. For example, lithotripsy energy can be delivered from lithotripter 100 to tissue 50 at least partially located within a body channel. In step 1110, the lithotripsy force or energy to be applied (or applied) to the tissue can be determined based on the operation of the lithotripter.

[0079] In step 1112, the force applied to the target stone / tissue due to the application of the lithotripter can be determined based on the distance between the tissue and the lithotripter upon activation of the lithotripter, or a distance signal can be generated, as described above. For example, the distance signal can be generated by sensor module 103 based on the distance between stone 50 and the lithotripter (lithotripsy device 100), and the distance can be determined by controller 110 based on the distance signal. In one example, the relationship between the energy or power applied by the lithotripter and the force applied to the target stone / tissue is retrieved. Based on this relationship and the energy or power of the lithotripter to be applied to the target stone / tissue, the force applied to the target stone / tissue due to the applied lithotripsy energy / power can be determined. Step 1112 may also include determining the force applied to the target stone / tissue due to the operation of the lithotripter.

[0080] In step 1114, an image stream may be generated using an image sensor (such as sensor module 103, which may be or may include an image sensor). The characteristics of the tissue may then be determined based on the imaging stream or a signal (such as that provided by controller 110). For example, controller 110 may use the image stream to determine characteristics of the stone / tissue, such as one or more of the size, weight, shape, or composition of the tissue (e.g., stone 50). Controller 110 may then operate one or more of the lithotripter 100, lithotripter actuator 135, and suction device 124 based on the image stream or based on the determined size, shape, or composition of the tissue. Optionally, the force applied to the target stone / tissue estimated in step 1112 may be further based on the characteristics of the target.

[0081] In step 1116, the lithotripter actuator can be operated to treat the stone / tissue. In step 1118, the suction force to be generated can be determined based on one or more of the following: stone characteristics described above, the distance between the lithotripter and the stone, lithotripsy force, or the force to be generated. The suction force can be determined based on one or more signals such as sensor module 103, and can be determined by controller 110, AI model, or another control device.

[0082] Furthermore, in step 1120, the suction device is operable (e.g., simultaneously operated) to deliver suction pressure based on the lithotripsy force applied to the stone / tissue or based on the characteristics of the stone or tissue determined by the relationship established in steps 1112, 1114, or 1118, thereby generating suction force on the tissue so as to cause the tissue or a portion thereof to move toward the suction opening with suction energy configured to counteract the lithotripsy energy, thereby reducing or eliminating tissue retraction when delivering lithotripsy energy to the tissue.

[0083] In some examples, when the crusher delivers crushing energy, a control valve can be operated to generate suction force; the control valve can be connected to the working channel and the suction device. In some examples, liquid or solid entering the working channel after the suction force is generated can be stored or received in a suction accumulator connected to the working channel between the suction inlet and the control valve. In some examples, an air pump connected to the control valve and the suction accumulator can be used to purge liquid or solid from the suction accumulator to the discharge port.

[0084] Notes and Examples

[0085] The following non-limiting examples detail some aspects of this topic to address challenges and provide the benefits discussed herein, as well as others.

[0086] Example 1 is a lithotripsy device comprising: a lithotripter configured to deliver lithotripsy energy to tissue at least partially located within a body channel; a working passage at least partially positioned 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 facilitate movement of tissue or a portion thereof toward the suction opening; and a controller communicating with the lithotripter and the suction device, the controller being configured to operate the suction device to generate a suction flow with suction energy configured to counteract the lithotripsy energy, thereby reducing or eliminating tissue retraction when the lithotripsy energy is delivered to the tissue.

[0087] In Example 2, the subject of Example 1 may optionally include, wherein the lithotripter includes a laser emitter operable to deliver light energy to tissue.

[0088] In Example 3, any one or more of the subjects in Examples 1-2 may optionally include, wherein the lithotripter is an ultrasonic lithotripter.

[0089] In Example 4, the subject matter of any one or more of Examples 1-3 may optionally include, wherein the controller is configured to determine the lithotripsy force applied to the tissue based on the operation of the lithotripter, and wherein the controller is configured to operate the suction device to generate a suction force on the tissue by delivering a suction pressure based on the lithotripsy force applied to the tissue.

[0090] In Example 5, the subject matter of Example 4 may optionally include: a control valve connected to the working passage and the suction device, the control valve communicating with a controller, and the controller being configured to operate the control valve to generate suction force when the crusher delivers crushing energy.

[0091] Example 6 is a crushing system that includes one or more of the components described above.

[0092] Example 7 is a method of operating a crushing system, which includes one or more of the steps described above.

[0093] Example 8 is a lithotripsy device comprising: a lithotripter configured to deliver lithotripsy energy to tissue at least partially located within a body channel; a working passage at least partially positioned 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 facilitate movement of tissue or a portion thereof toward the suction opening; and a controller communicating with the lithotripter and the suction device, the controller being configured to operate the suction device to generate a suction flow with a suction energy configured to counteract the lithotripsy energy when lithotripsy energy is delivered to the tissue, thereby reducing or eliminating tissue retraction.

[0094] In Example 9, the subject of Example 8 may optionally include, wherein the lithotripter includes a laser emitter operable to deliver light energy to tissue.

[0095] In Example 10, any one or more of the subjects in Examples 8-9 may optionally include, wherein the lithotripter is an ultrasonic lithotripter.

[0096] In Example 11, any one or more of the subjects in Examples 8-10 may optionally include a controller configured to operate the suction device simultaneously with the crushed stone energy to generate a suction flow.

[0097] In Example 12, the subject matter of any one or more of Examples 8-11 may optionally include, wherein the controller is configured to determine the lithotripsy force applied to the tissue based on the operation of the lithotripter, and wherein the controller is configured to operate the suction device to generate a suction force on the tissue by delivering a suction pressure based on the lithotripsy force applied to the tissue.

[0098] In Example 13, the subject matter of Example 12 may optionally include: a control valve that can be connected to the working passage and the suction device, the control valve communicating with a controller, and the controller being configured to operate the control valve to generate a suction force when the crusher delivers crushing energy.

[0099] In Example 14, any one or more of the subjects in Examples 12-13 may optionally include: a control valve that can be connected to the working passage and the suction device, the control valve being operable by a user to control the suction force.

[0100] In Example 15, the subject matter of any or more of Examples 12-14 may optionally include: a control valve that can be connected to a working passage and a suction device, the control valve being operable to control the suction force; a suction accumulator that can be connected to the working passage between a suction opening and the control valve, the suction accumulator being configured to receive and store liquid or solid entering the working passage after the suction force is generated; and an air pump that can be connected to the control valve and the suction accumulator, the air pump being operable to purge liquid or solid from the suction accumulator to a discharge outlet.

[0101] In Example 16, any one or more of the subjects in Examples 8-15 may optionally include a working passage extending distally beyond the distal end of the crusher, such that the suction opening is located distally beyond the distal end of the crusher.

[0102] In Example 17, any one or more of the subjects in Examples 8-16 may optionally include a crusher actuator connected to a crusher, the crusher actuator communicating with a controller, and the controller being configured to operate the crusher actuator to move the crusher proximally or distally based on the position of the tissue relative to the distal end of the crusher.

[0103] In Example 18, the subject of Example 17 optionally includes a distance sensor that communicates with the controller and is configured to generate a signal based on the distance between the tissue and the crusher, the controller being configured to operate a crusher actuator to move the crusher based on the signal.

[0104] In Example 19, any one or more of the subjects in Examples 17-18 may optionally include an image sensor that communicates with a controller and is configured to generate a signal based on an image stream produced by the image sensor, the controller being configured to operate one or more of a crusher, a crusher actuator, and a suction device based on the signal.

[0105] In Example 20, the subject of Example 19 may optionally include, wherein the controller is configured to determine one or more of the size, shape, or composition of an organization based on an image stream.

[0106] In Example 21, the subject of Example 20 may optionally include a controller configured to operate one or more of a crusher, a crusher actuator, and a suction device based on the size, shape, or composition of a determined tissue.

[0107] Example 22 is a lithotripsy system comprising: an endoscope defining a working passage at least partially locating within a body passage, the working passage extending along the longitudinal axis of the endoscope and defining an opening of the working passage at a distal end of the endoscope; a lithotripter inserted through the working passage, the lithotripter configured to deliver lithotripsy energy to tissue at least partially located within the body passage; a suction device connectable to the working passage upstream of the suction opening and configured to generate a suction flow to facilitate movement of tissue or a portion thereof toward the suction opening; and a controller communicating with the lithotripter and the suction device, the controller configured to operate the suction device to generate a suction flow with a suction energy configured to counteract the lithotripsy energy while delivering lithotripsy energy to the tissue, thereby reducing or eliminating tissue retraction.

[0108] In Example 23, the subject matter of Example 22 may optionally include, wherein the controller is configured to determine the lithotripsy force applied to the tissue based on the operation of the lithotripter, and the controller is configured to operate the suction device to deliver suction pressure to generate suction force on the tissue based on the lithotripsy force applied to the tissue.

[0109] In Example 24, the subject matter of Example 23 may optionally include a control valve that can be connected to the working passage and the suction device, the control valve communicating with a controller, and the controller being configured to operate the control valve to generate a suction force when the crusher delivers crushing energy.

[0110] In Example 25, the subject matter of Example 24 may optionally include a control valve that can be connected to the working passage and the suction device, and the control valve can be operated by the user to control the suction force.

[0111] In Example 26, the subject matter of Example 25 optionally includes a control valve that can be connected to the working passage and the suction device, the control valve being operable to control the suction force; a suction accumulator that can be connected to the working passage between the suction opening and the control valve, the suction accumulator being configured to receive and store liquid or solid entering the working passage after the suction force is generated; and an air pump that can be connected to the control valve and the suction accumulator, the air pump being operable to purge liquid or solid from the suction accumulator to the discharge port.

[0112] In Example 27, the subject matter of any one or more of Examples 25-26 may optionally include: a crusher actuator connected to a crusher, the crusher actuator communicating with a controller, and the controller being configured to operate the crusher actuator to move the crusher proximally or distally based on the position of the tissue relative to the distal end of the crusher; a distance sensor communicating with the controller and configured to generate a signal based on the distance between the tissue and the crusher, the controller being configured to operate the crusher actuator based on the signal to move the crusher; and an image sensor communicating with the controller and configured to generate a signal based on an image stream generated by the image sensor, the controller being configured to operate one or more of the crusher, the crusher actuator, and the suction device based on the signal.

[0113] 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 the longitudinal axis of the scope and defining a suction opening of the working channel at a distal end 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 at least partially located within the body channel; and generating a suction flow with suction energy configured to counteract the lithotripsy energy as the lithotripsy energy is delivered to the tissue, which promotes movement of the tissue or a portion thereof toward the suction opening, thereby reducing or eliminating tissue retraction.

[0114] In Example 29, the subject of Example 28 may optionally include: determining the lithotripsy force applied to the tissue based on the operation of the lithotripter.

[0115] In Example 30, the subject matter of Example 29 may optionally include: operating a suction device to deliver suction pressure to generate suction force on the tissue based on the lithotripsy force applied to the tissue.

[0116] In Example 31, the subject matter of any one or more of Examples 28-30 may optionally include: when the crusher delivers crushing energy, operating a control valve to generate a suction force, the control valve being connected to the working channel and the suction device.

[0117] In Example 32, the subject matter of Example 31 may optionally include: a suction accumulator that receives and stores liquid or solid that enters the working channel after the generation of suction force in the working channel. The working channel can be connected to the suction opening and the control valve.

[0118] In Example 33, the subject matter of Example 32 may optionally include: using an air pump that can be connected to a control valve and a suction accumulator to remove liquid or solid from the suction accumulator to the discharge port.

[0119] In Example 34, the subject matter of any one or more of Examples 28-33 may optionally include: operating a crusher actuator to move the crusher proximally or distally based on the position of the tissue relative to the distal end of the crusher.

[0120] In Example 35, the subject matter of Example 34 may optionally include: generating a distance signal based on the distance between the tissue and the crusher; and operating a crusher actuator based on the distance signal to move the crusher.

[0121] In Example 36, the subject matter of any one or more of Examples 34-35 may optionally include: generating an image stream using an image sensor; and operating one or more of a crusher, a crusher actuator, and a suction device based on the image stream.

[0122] In Example 37, the subject of Example 36 may optionally include: determining one or more of the size, shape, or components of an organization based on an image stream.

[0123] In Example 38, the subject matter of Example 37 may optionally include: operating one or more of a lithotripter, a lithotripter actuator, and a suction device based on the determined size, shape, or composition of the tissue.

[0124] Example 39 is a method of operating a crushing system, the method comprising: determining a crushing force to be applied to or to be applied to a target based on the operation of the crusher; determining an operating setting of a suction device for generating a suction force on the target to counteract the crushing force applied to the target due to activation of the crusher.

[0125] In Example 40, the subject of Example 39 may optionally include: acquiring images of tissue using an image sensor; determining the characteristics of the target based on the acquired images; and determining the operational settings of the aspiration device based on the characteristics of the target.

[0126] In Example 41, the subject matter of Example 40 may optionally include: the characteristics of the target include at least one of the target's size, the target's weight, the target's shape, or the target's composition.

[0127] In Example 42, the subject of Example 41 may optionally include the fact that the crushing force is determined based on the operating settings of the crusher.

[0128] In Example 43, the subject matter of any one or more of Examples 39-42 may optionally include: operating a crusher actuator to move the crusher proximally or distally based on the position of the tissue relative to the distal end of the crusher.

[0129] In Example 44, the subject of Example 43 may optionally include: generating a distance signal based on the distance between the target and the crusher; and operating a crusher actuator based on the distance signal to move the crusher.

[0130] In Example 45, the subject matter of any one or more of Examples 39-44 may optionally include: when the crusher delivers crushing energy, operating a control valve to generate a suction force, the control valve being connected to the working channel and the suction device.

[0131] In Example 46, the subject matter of Example 45 may optionally include: a suction accumulator that receives and stores liquid or solid that enters the working channel after the generation of suction force in the working channel. The working channel can be connected to the suction opening and the control valve.

[0132] In Example 47, the subject matter of Example 46 may optionally include: using an air pump that can be connected to a control valve and a suction accumulator to remove liquid or solid from the suction accumulator to the discharge port.

[0133] In Example 48, any one or any combination of the apparatus or methods in Examples 1-47 may optionally be configured such that all the listed elements or options are available for use or selection.

[0134] The above detailed description includes reference to the accompanying drawings, which form a part of the detailed description. The drawings illustrate specific embodiments in which the invention can be practiced by way of illustration. These embodiments are also referred to herein as “examples.” Such examples may include elements other than those shown or described. However, the inventors also contemplate examples in which only those elements shown or described are provided. Furthermore, the inventors contemplate examples using any combination or arrangement of those elements (or one or more aspects thereof) shown or described relative to a particular example (or one or more aspects thereof) or relative to other examples (or one or more aspects thereof) shown or described herein.

[0135] In the event of any inconsistency in usage between this document and any document incorporated by reference, the usage in this document shall prevail. In this document, the terms “comprising” and “wherein” are used as common English equivalents of the corresponding terms “comprising” and “characterized in.” Furthermore, in the appended claims, the terms “comprising” and “comprising” are open-ended, meaning that any system, apparatus, article, composition, formulation, or process that includes elements other than those listed after such terms in a claim is still considered to fall within the scope of that claim.

[0136] In this document, as is common in patent documents, the terms “a” or “an” are used to include one or more, independent of any other instances or uses of “at least one” or “one or more.” In this document, the term “or” is used to refer to a non-exclusive “or,” such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise stated. In the appended claims, the terms “comprising” and “wherein” are used as common English equivalents to the corresponding terms “comprising” and “characterized by.” Furthermore, in the appended claims, the terms “comprising” and “comprising” are open-ended, meaning that any system, apparatus, article, composition, formulation, or process that includes elements other than those listed following such terms in the claim is still considered to fall within the scope of that claim. Additionally, in the appended claims, the terms “first,” “second,” and “third,” etc., are used only as designations and are not intended to impose a quantitative requirement on their contents.

[0137] The above description is intended to be illustrative and not restrictive. For example, the above examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments may be used by those skilled in the art after reading the above description. The abstract is provided to allow the reader to quickly determine 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. Furthermore, in the above detailed description, various features may be grouped together to simplify this disclosure. This should not be construed as an intention to make unclaimed features essential to any claim. Rather, the inventive subject matter may be present in all features of fewer than a particular disclosed embodiment. Therefore, the appended claims are hereby incorporated into the detailed description as examples or embodiments, and each claim stands independently as a separate example, and it is contemplated that such embodiments may be combined with each other in various combinations or substitutions. The scope of the invention should be determined with reference to the appended claims and the full scope of the equivalents conferred by those claims.

Claims

1. A stone crushing device, the stone crushing device comprising: A lithotripter configured to deliver lithotripsy energy to tissue located at least partially within a body channel; A working passage, which can be at least partially located within the body channel, and which at least partially defines a suction opening; A suction device, which can be connected to the working passage upstream of the suction opening and is configured to generate a suction flow to facilitate movement of the tissue or a portion of the tissue toward the suction opening; as well as A controller, which communicates with the lithotripter and the suction device, is configured to operate the suction device to generate the suction flow with suction energy configured to counteract the lithotripter energy when the lithotripter energy is delivered to the tissue, thereby reducing or eliminating the tissue's retraction.

2. The stone crushing device according to claim 1, wherein, The lithotripter includes a laser emitter operable to deliver light energy to the tissue.

3. The stone crushing device according to claim 1, wherein, The crusher is an ultrasonic crusher or an electric hydraulic crusher.

4. The stone crushing device according to any one of claims 1 to 3, wherein, The controller is configured to operate the suction device to generate the suction flow simultaneously with the crushed stone energy.

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

6. The stone crushing device according to claim 5, wherein the stone crushing device comprises: A control valve is connected to the working passage and the suction device, the control valve communicates with the controller, and the controller is configured to operate the control valve to generate the suction force when the crusher delivers the crushing energy.

7. The stone crushing device according to claim 5, wherein the stone crushing device comprises: A control valve is connected to the working passage and the suction device, and the control valve can be operated by a user to control the suction force.

8. The stone crushing device according to claim 5, wherein the stone crushing device comprises: A control valve, which can be connected to the working passage and the suction device, and is operable to control the suction force; A suction accumulator, which can be connected to the working passage between the suction opening and the control valve, is configured to receive and store liquid or solid that enters the working passage after the suction force is generated. as well as An air pump is connected to the control valve and the suction accumulator, and the air pump is operable to remove the liquid or the solid from the suction accumulator to the outlet.

9. The stone crushing device according to any one of claims 1 to 8, wherein, The working passage extends distally beyond the distal end of the crusher, such that the suction opening is located distally beyond the distal end of the crusher.

10. The stone crushing device according to any one of claims 1 to 9, wherein the stone crushing device comprises: A crusher actuator is connected to the crusher, the crusher actuator communicates with the controller, and the controller is configured to operate the crusher actuator based on the position of the tissue relative to the distal end of the crusher to move the crusher proximally or distally.

11. The stone crushing device according to claim 10, wherein the stone crushing device comprises: A distance sensor, which communicates with the controller and is configured to generate a signal based on the distance between the tissue and the crusher, the controller being configured to operate the crusher actuator based on the signal to move the crusher.

12. The stone crushing device according to claim 10, wherein the stone crushing device comprises: An image sensor, which communicates with the controller and is configured to generate a signal based on an image stream produced by the image sensor, wherein the controller is configured to operate one or more of the crusher, the crusher actuator, and the suction device based on the signal.

13. The stone crushing device according to claim 12, wherein, The controller is configured to determine one or more of the tissue's size, shape, or components based on the image stream.

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

15. A stone crushing system, the stone crushing system comprising: A mirror, the mirror defining a working channel that can be at least partially positioned within a body passage, the working channel extending along the longitudinal axis of the mirror, and the working channel defining a suction opening at the distal end of the mirror; A lithotripter, insertable through the working channel, the lithotripter being configured to deliver lithotripsy energy to tissue at least partially located within the body channel; A suction device, which can be connected to the working channel upstream of the suction opening and is configured to generate a suction flow to facilitate movement of the tissue or a portion of the tissue toward the suction opening; as well as A controller, which communicates with the lithotripter and the suction device, is configured to operate the suction device to generate the suction flow with suction energy configured to counteract the lithotripter energy when the lithotripter energy is delivered to the tissue, thereby reducing or eliminating the tissue's retraction.

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

17. The stone crushing system according to claim 16, wherein the stone crushing system comprises: A control valve is connected to the working channel and the suction device, the control valve communicates with the controller, and the controller is configured to operate the control valve to generate the suction force when the crusher delivers the crushing energy.

18. The stone crushing system according to claim 17, wherein the stone crushing system comprises: A control valve is provided, which can be connected to the working channel and the suction device, and can be operated by a user to control the suction force.

19. The stone crushing system according to claim 18, wherein the stone crushing system comprises: A control valve, which can be connected to the working channel and the suction device, and is operable to control the suction force; A suction accumulator, which can be connected to the working channel between the suction opening and the control valve, the suction accumulator being configured to receive and store liquid or solid that enters the working channel after the suction force is generated; as well as An air pump is connected to the control valve and the suction accumulator, and the air pump is operable to remove the liquid or the solid from the suction accumulator to the outlet.

20. The stone crushing system according to claim 18, wherein the stone crushing system comprises: A crusher actuator is connected to the crusher, the crusher actuator communicates with the controller, and the controller is configured to operate the crusher actuator based on the position of the tissue relative to the distal end of the crusher to move the crusher proximally or distally. A distance sensor, which communicates with the controller and is configured to generate a signal based on the distance between the tissue and the crusher, the controller being configured to operate the crusher actuator based on the signal to move the crusher; as well as An image sensor, which communicates with the controller and is configured to generate a signal based on an image stream produced by the image sensor, wherein the controller is configured to operate one or more of the crusher, the crusher actuator, and the suction device based on the signal.

21. A method of operating a crushing system, the method comprising the following steps: The crushing force applied to or to the target is determined based on the operation of the crusher; The operating settings of the suction device are determined, the suction device being used to generate a suction force on the target, thereby counteracting the crushing force applied to the target due to the activation of the crusher.

22. The method according to claim 21, further comprising the step of: Use an image sensor to acquire images of the tissue; The characteristics of the target are determined based on the acquired images; as well as The operating settings of the suction device are determined based on the characteristics of the target.

23. The method according to claim 22, wherein, The characteristics of the target include at least one of the target's size, the target's weight, the target's shape, or the target's composition.

24. The method according to claim 23, wherein, The crushing force is determined based on the operating settings of the crusher.

25. The method according to any one of claims 21 to 24, the method comprising the following steps: Based on the position of the tissue relative to the distal end of the crusher, the crusher actuator is operated to move the crusher proximally or distally.

26. The method according to claim 25, wherein the method comprises the following steps: A distance signal is generated based on the distance between the target and the crusher; as well as The crusher actuator is operated based on the distance signal to move the crusher.

27. The method according to any one of claims 21 to 26, the method comprising the following steps: When the crusher delivers crushing energy, a control valve is operated to generate a suction force. The control valve can be connected to the working channel and the suction device.

28. The method of claim 27, wherein the method comprises the following steps: The liquid or solid that enters the working channel after the suction force is generated will be received and stored in a suction accumulator that can be connected to the working channel between the suction opening and the control valve.

29. The method according to claim 28, wherein the method comprises the following steps: An air pump that can be connected to the control valve and the suction accumulator is used to remove the liquid or solid from the suction accumulator to the outlet.

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