Systems for performing medical procedures and medical devices for removing kidney stones.

Abstract

This invention relates to a system for performing medical procedures and a medical device for removing kidney stones. In one aspect, a system for performing medical procedures to remove kidney stones is provided, the system comprising: a first medical instrument configured for percutaneous insertion into a treatment site, the first medical instrument including a first fluid channel and a second fluid channel; a second medical instrument configured to be advanced through a patient lumen into the treatment site, the second medical instrument being deployed with a lithotripter; and a jet control system including a processor, wherein the processor is configured to: provide flushing to the treatment site through the first fluid channel of the first medical instrument; hold the kidney stone against the first medical instrument using at least one of the flushings provided through the first fluid channel; and break up the held kidney stone using the lithotripter deployed by the second medical instrument.

Description

[0001] This application is a divisional application of the application filed on December 6, 2018, with application number 201880079048.2 (international application number PCT / US2018 / 064353) and entitled "Directional Jet Technology". Technical Field

[0002] The systems and methods disclosed herein relate to medical robots, and more specifically to robotic medical systems and methods employing directed jets during surgical procedures for removing objects from a patient's body. Background Technology

[0003] Every year, doctors perform surgeries to remove kidney stones from a patient's urinary tract. Kidney stones can be found in the kidneys and ureters, while bladder stones can be found in the bladder. Such stones may form due to mineral buildup and can cause severe abdominal pain once they grow large enough to obstruct the flow of urine through the ureter or urethra. These stones can be formed from calcium, magnesium, ammonia, uric acid, cysteine, or other compounds.

[0004] To remove urinary stones from the bladder and ureters, physicians typically use a ureteroscope inserted through the urethra into the urinary tract. A ureteroscope usually includes an observation end at its distal end to allow visualization of the urinary tract. The procedure can also utilize a lithotripsy device to capture or break up the stones. During a ureteroscopy, one physician controls the position of the ureteroscope, while another controls the lithotripsy device. To remove large kidney stones from the kidneys, physicians often use the percutaneous nephrolithotomy (PCNL) technique, which involves inserting a nephroscope through the skin to break up and remove the kidney stone. Summary of the Invention

[0005] This disclosure relates to systems and techniques for removing objects from a patient's treatment site, and more specifically to methods and systems employing directed jet techniques during object removal procedures. "Directed jet techniques" can be applied to methods and systems for providing flushing or aspiration (e.g., fluid inflow and outflow) that can improve or facilitate object removal procedures. Directed jet techniques may include setting, controlling, or modulating the characteristics of flushing and / or aspiration to achieve a favorable, beneficial, or desired fluid flow through the treatment site.

[0006] In a first aspect, a method of applying a jet during a medical procedure includes: inserting a first medical instrument into a treatment site, the first medical instrument including a first fluid channel and a second fluid channel; providing flushing to the treatment site through the first fluid channel of the first medical instrument; providing suction from the treatment site through the second fluid channel of the first medical instrument; determining the characteristics of one of the flushing and suction; and selecting the characteristics of the other of the flushing and suction based on the determined characteristics.

[0007] The method may include one or more of the following features in any combination: (a) wherein inserting the first medical instrument into the treatment site includes percutaneously advancing the first medical instrument into the treatment site; (b) wherein inserting the first medical instrument into the treatment site includes advancing the first medical instrument through the patient's lumen into the treatment site; (c) inserting a second medical instrument through the patient's lumen into the treatment site; (d) percutaneously inserting the second medical instrument into the treatment site; (e) wherein the determined characteristic includes at least one of instantaneous flow rate and average flow rate over a period of time; (f) wherein the selected characteristic... (g) Including at least one of instantaneous flow rate and average flow rate over a period of time; wherein the selected characteristic substantially matches the determined characteristic; (h) Determining the characteristics of the treatment site, and when the determined characteristics of the treatment site exceed a threshold, performing at least one of the following operations: reducing flushing into the treatment site, increasing suction from the treatment site, and providing an alarm; (i) wherein the determined characteristics of the treatment site include one of the volume of fluid within the treatment site and the internal pressure of the treatment site; (j) Moving the distal tip of the first medical instrument in a sweeping motion while providing flushing or suction; (k) Its In the above, at least one of the first medical instrument and the second medical instrument is robot-controlled; (1) performing lithotripsy on an object within the treatment site to break the object into fragments; and aspirating the fragments through a second fluid channel of the first medical instrument; (m) wherein the lithotripsy is performed using the second medical instrument; (n) wherein the first medical instrument includes a steerable medical instrument including an articulated distal end; (o) contacting the articulated distal end of the first medical instrument with the object within the treatment site, and providing aspiration through the second fluid channel to hold the object to the articulated distal end; (p) wherein the articulated distal end of the first medical instrument is robot-controlled; The distal end of the connector includes a recess configured to hold the object; (q) performing lithotripsy while holding the object in the recess; (r) moving the first medical instrument to reposition the object within the treatment site; (s) performing lithotripsy on the object within the treatment site to break the object into fragments, and suctioning through a second fluid channel during lithotripsy to remove dust generated by the lithotripsy; (t) wherein the additional first fluid channel includes a fluid orifice that directs fluid away from the second medical instrument; (u) wherein flushing and suction are provided simultaneously; and / or (v) wherein flushing and suction are not provided simultaneously.

[0008] In another aspect, a system for performing a medical procedure may include: a first medical instrument configured to be inserted into a treatment site, the first medical instrument including a first fluid channel and a second fluid channel; a vacuum device connected to one of the first and second fluid channels and configured to apply negative pressure to provide suction from the treatment site; a pump connected to a flushing source and the other of the first and second fluid channels, the pump configured to provide flushing to the treatment site; and a jet control system connected to the vacuum device and the pump, the jet control system including one or more processors configured to: determine the characteristics of one of flushing and suction; and control the characteristics of at least one of the pump or the vacuum device based on the determined characteristics.

[0009] The system may include one or more of the following features in any combination: (a) wherein a first medical instrument is configured to be inserted into a treatment site through a patient's lumen; (b) wherein the first medical instrument is configured to be inserted percutaneously into a treatment site; (c) wherein it further includes a second medical instrument configured to be inserted into a treatment site through a patient's lumen; (d) including a second medical instrument configured to be inserted percutaneously into a treatment site; (e) wherein the first medical instrument further includes a flow rate sensor positioned in a first fluid channel, and wherein the output of the flow rate sensor is connected to a jet control system; (f) wherein the second first medical instrument further includes a flow rate sensor positioned in a second fluid channel, and wherein the output of the flow rate sensor is connected to a jet control system; (g) wherein the first medical instrument also... The first medical instrument includes a pressure sensor configured to measure internal pressure at the treatment site, the output of which is connected to a jet control system, and wherein the one or more processors are further configured to control at least one of a pump or a vacuum device to regulate at least one of aspiration and flushing based on the measured internal pressure at the treatment site; (h) a second medical instrument configured to be inserted into the treatment site, wherein the second medical instrument further includes a pressure sensor configured to measure internal pressure at the treatment site, the output of which is connected to a jet control system, and wherein the one or more processors are further configured to control at least one of a pump or a vacuum device to regulate at least one of aspiration and flushing based on the measured internal pressure at the treatment site; and / or (i) wherein the first medical instrument includes an articulated distal end.

[0010] In another aspect, a medical device may include: an articulated elongated body extending along an axis to a distal end; a first fluid channel extending along the axis and terminating at a first fluid orifice formed in a distal face of the distal end; and at least one additional fluid channel formed through the elongated body and terminating at least one additional fluid outlet orifice formed in a radial surface of the elongated body adjacent to the distal end.

[0011] The medical device may include one or more of the following features in any combination: (a) a recess formed in the distal face; (b) wherein the recess is configured to at least partially receive an object to be removed during a medical procedure; (c) wherein the at least one additional channel circumferentially surrounds the first fluid channel; (d) wherein the at least one additional fluid orifice includes an additional fluid orifice positioned about an axis; (e) wherein the at least one additional channel includes an additional channel positioned radially about the first fluid channel; (f) wherein each of the four additional fluid channels terminates at an additional fluid orifice positioned radially about an axis; and / or (g) at least one drawwire for hinged to an elongated body.

[0012] In another aspect, a non-transitory computer-readable storage medium may include instructions stored thereon that, when executed, cause a processor of the device to perform at least the following operations: determining the characteristics of at least one of flushing entering the treatment site through a first channel of the first medical instrument and suctioning from the treatment site through a second channel of the first medical instrument; and selecting the characteristics of at least one of flushing and suctioning based on the determined characteristics.

[0013] The non-transitory computer-readable storage medium may include one or more of the following features in any combination: (a) wherein the determined characteristic includes at least one of instantaneous flow rate and average flow rate over a period of time; (b) wherein the selected characteristic includes at least one of instantaneous flow rate and average flow rate over a period of time; (c) wherein the selected characteristic substantially matches the determined characteristic; (d) wherein, when executed, the instructions further cause the processor to determine the characteristics of the treatment site, and when the determined characteristics of the treatment site exceed a threshold, perform at least one of the following operations: reduce flushing into the treatment site, increase suction from the treatment site, and provide an alarm; (e) wherein the determined characteristics of the treatment site include instantaneous flow rate and average flow rate over a period of time. (f) wherein, when executed, the instruction further causes the processor to perform lithotripsy on the object within the treatment site using a second medical instrument to break the object into fragments; and to aspirate the fragments through a second fluid channel of the second first medical instrument; (g) wherein, when executed, the instruction further causes the processor to perform lithotripsy on the object within the treatment site using a second medical instrument to break the object into fragments; and to aspirate through a second fluid channel of the second first medical instrument during lithotripsy to remove dust generated by lithotripsy; (h) wherein, when executed, the instruction further causes the processor to simultaneously provide flushing and aspiration; and / or (i) wherein flushing and aspiration are not provided simultaneously.

[0014] In another aspect, a method of applying a jet during the removal of an object from a patient may include: advancing a first medical instrument through a lumen of the patient toward a treatment site containing the object to be removed, the first medical instrument including a first fluid channel for providing flushing through a first orifice located on a remotely articulated distal end, the first orifice being configured to provide flushing in a first fluid flow direction; percutaneously inserting a second medical instrument into the treatment site, the second medical instrument including a second fluid channel for providing suction through a second orifice of the second fluid channel; providing flushing to the treatment site through the first orifice using the first medical instrument; providing suction from the treatment site through the second orifice of the second fluid channel of the second medical instrument; and remotely manipulating the distal end of the first medical instrument such that the first fluid direction is oriented toward the second orifice.

[0015] The method may include one or more of the following features in any combination: (a) determining the position of the second orifice within the treatment site, and wherein manipulating the distal tip includes automatically manipulating the distal tip based on the determined position of the second orifice within the treatment site; (b) wherein the nephroscope includes a second medical instrument and a lithotripter, and wherein the method further includes contacting the lithotripter with the subject, performing lithotripsy to break the subject into fragments, and aspirating the fragments using a suction tube; and / or (c) moving the distal tip of the first medical instrument in a sweeping motion while providing flushing through the first medical instrument.

[0016] Although this disclosure is largely described in relation to examples of the use of ureteroscopy, percutaneous nephrolithotomy (PCNL), and the removal of urinary stones and stone fragments, this disclosure is equally applicable to other surgical / medical procedures relating to the removal of objects from various treatment sites of a patient, including any object that can be safely removed via a patient cavity (e.g., esophagus, ureter, intestine, etc.) or via a percutaneous approach, such as gallbladder stone removal or lung (lung / transthoracic) tumor biopsy.

[0017] In summary, based on this application, the following technical solution is provided.

[0018] A method of applying a jet stream during a medical procedure for removing kidney stones, the method comprising: percutaneously inserting a first medical instrument into a treatment site, the first medical instrument including a first fluid channel and a second fluid channel; advancing a second medical instrument through a patient lumen into the treatment site, the second medical instrument being equipped with a lithotripter; providing flushing to the treatment site through the first fluid channel of the first medical instrument; holding the kidney stone against the first medical instrument using at least one of the flushing provided through the first fluid channel; and breaking up the held kidney stone using the lithotripter deployed by the second medical instrument.

[0019] The method further includes: determining the location of the kidney stone; and navigating the distal end of the first medical instrument toward the determined location of the kidney stone.

[0020] The method further includes aspirating fragments of the kidney stone through the second fluid channel to remove the kidney stone.

[0021] The method further includes providing aspiration from the treatment site through the second fluid channel of the first medical instrument, which further includes: determining one or more characteristics of the flushing provided through the first fluid channel; and providing aspiration from the treatment site through the second fluid channel of the first medical instrument based on the determined one or more characteristics of the flushing.

[0022] In the above method, the one or more characteristics of flushing include the instantaneous flow rate of flushing, the average flow rate of flushing over a time interval, the volume of fluid flushed during the time interval, the instantaneous fluid pressure associated with flushing, and the average fluid pressure associated with flushing.

[0023] The method further includes: determining the orientation of the first medical instrument; and automatically adjusting the orientation of the second medical instrument based on the determined orientation of the first medical instrument.

[0024] The method further includes: determining at least one characteristic of the treatment site; comparing the determined at least one characteristic of the treatment site with a threshold; and, based on the comparison, performing at least one of reducing flushing into the treatment site and increasing suction from the treatment site.

[0025] In the above method, the at least one characteristic of the treatment site is determined based on a plurality of sensors located near the treatment site and at least one of one or more characteristics of rinsing and one or more characteristics of suction. Attached Figure Description

[0026] The disclosed aspects will be described below in conjunction with the accompanying drawings, which are provided for illustrative purposes only and not for limitation, in which the same reference numerals denote the same elements.

[0027] Figure 1 The illustration depicts an embodiment of a trolley-based robotic system arranged for one or more diagnostic and / or therapeutic bronchoscopic procedures.

[0028] Figure 2 Depicting Figure 1 Other aspects of the robotic system.

[0029] Figure 3 The diagram illustrates the setup for ureteroscopy. Figure 1 The implementation method of the robot system.

[0030] Figure 4 The diagram illustrates an arrangement for vascular surgery. Figure 1 The implementation method of the robot system.

[0031] Figure 5 The illustration shows an implementation of a table-based robotic system arranged for bronchoscopy.

[0032] Figure 6 Provided Figure 5 An alternative view of the robotic system.

[0033] Figure 7 The illustration shows an example system configured to house one or more robotic arms.

[0034] Figure 8 The illustration shows an implementation of a table-based robotic system configured for ureteroscopy.

[0035] Figure 9 The illustration shows an implementation of a table-based robotic system configured for laparoscopic surgery.

[0036] Figure 10 The illustration shows a device with pitch or tilt adjustment. Figures 5 to 9 Implementation of a table-based robot system.

[0037] Figure 11 Provided Figures 5 to 10 A detailed illustration of the connection between the platform and the column in a platform-based robotic system.

[0038] Figure 12 An exemplary instrument driver is illustrated.

[0039] Figure 13 An exemplary medical device with a pair of instrument drivers is illustrated.

[0040] Figure 14 The illustration shows an alternative design for the instrument driver and the instrument, wherein the axis of the drive unit is parallel to the axis of the long shaft of the instrument.

[0041] Figure 15 A block diagram illustrating a positioning system according to an example embodiment is shown, the positioning system being... Figures 1 to 10 The location of one or more components of a robotic system, such as Figure 13 and Figure 14 The location of the instrument is estimated.

[0042] Figure 16 The illustration shows an example surgical procedure for removing an object from a kidney using a first medical instrument inserted percutaneously into the kidney.

[0043] Figure 17The illustration shows an example surgery using a first medical instrument inserted into the kidney through the patient's lumen, a second medical instrument inserted percutaneously into the kidney, and a directed jet to remove the object from the kidney.

[0044] Figure 18 The illustration shows another example surgical procedure for removing an object from the kidney using a first medical instrument inserted through the patient's lumen into the kidney, a second medical instrument inserted percutaneously into the kidney, and a directed jet.

[0045] Figure 19 The illustration shows another example surgical procedure for removing an object from the kidney using a first medical instrument inserted through the patient's lumen into the kidney, a second medical instrument inserted percutaneously into the kidney, and a directed jet.

[0046] Figure 20 The illustration shows a detailed view of the distal tip of a first medical instrument that provides flushing during an object removal procedure and the distal tip of a second medical instrument that provides suction.

[0047] Figure 21A The illustration shows a detailed view of the distal tip of a first medical instrument that provides flushing during an object removal procedure, and the distal tip of a second medical instrument that provides flushing and aspiration.

[0048] Figure 21B The illustration shows a detailed view of the distal tip of a first medical instrument performing lithotripsy during object removal surgery and the distal tip of a second medical instrument providing flushing and aspiration.

[0049] Figure 22A This is a flowchart illustrating an implementation of a method for directional jetting during object removal surgery.

[0050] Figure 22B This is a flowchart illustrating an implementation of another method for directional jetting during object removal surgery.

[0051] Figure 23 This is a flowchart illustrating an implementation of another method for directional jetting during object removal surgery.

[0052] Figure 24 This is a flowchart illustrating an implementation of a method for holding and repositioning an object using a directional jet during an object removal surgery.

[0053] Figure 25 This is a block diagram illustrating an implementation of a system for directional jets.

[0054] Figure 26A This is a three-dimensional view of the distal end of a medical instrument configured to provide suction and flushing during object removal surgery.

[0055] Figure 26B yes Figure 26A A cross-sectional view of the distal end of a medical instrument, illustrating the flushing and suction channels within the instrument.

[0056] Figure 27 The illustration shows an implementation of a robotic system arranged to perform object removal surgery using directional jets. Detailed Implementation

[0057] 1. Overview

[0058] The aspects of this disclosure can be incorporated into robotic medical systems capable of performing a variety of medical procedures, including minimally invasive procedures such as laparoscopy and non-invasive procedures such as endoscopy. In endoscopic procedures, the system can perform bronchoscopy, ureteroscopy, gastroscopy, etc.

[0059] In addition to performing a wide range of surgeries, this system offers additional benefits such as enhanced imaging and guidance to assist the physician. Furthermore, it provides physicians with the ability to perform surgery from ergonomic positions without awkward arm movements and postures. Moreover, the system allows physicians to perform surgery with improved ease of use, enabling the control of one or more instruments within the system by a single user.

[0060] For illustrative purposes, various embodiments will be described below with reference to the accompanying drawings. It should be understood that many other embodiments of the disclosed concepts are possible, and various advantages can be obtained through the disclosed embodiments. Headings are included herein for reference and to help locate the various sections. These headings are not intended to limit the scope of the concepts described with respect to these headings. These concepts may be applicable throughout the specification.

[0061] A Robot System - Handcart

[0062] Robotic medical systems can be constructed in a variety of ways depending on the specific surgery. Figure 1An embodiment of a trolley-based robotic system 10 is illustrated, arranged for diagnostic and / or therapeutic bronchoscopy procedures. During bronchoscopy, system 10 may include a trolley 11 having one or more robotic arms 12 to deliver medical instruments, such as a steerable endoscope 13—which may be a surgical bronchoscope for bronchoscopy—to a natural orifice entry point (i.e., in this example, the patient's mouth positioned on a table), thereby delivering diagnostic and / or therapeutic instruments. As shown, the trolley 11 may be positioned close to the patient's upper torso to provide access to the entry point. Similarly, the robotic arms 12 may be actuated to position the bronchoscope relative to the entry point. This system can also be used when performing gastrointestinal (GI) procedures via a gastroscopy or a specialized endoscope for GI procedures. Figure 1 The device in the middle. Figure 2 An example implementation of the handcart is described in more detail.

[0063] Continue to refer to Figure 1 Once the trolley 11 is correctly positioned, the robotic arm 12 can mechanically, manually, or in a combination of mechanical and manual methods insert the steerable endoscope 13 into the patient. As shown, the steerable endoscope 13 may include at least two overlapping telescopic portions, such as an inner guide portion and an outer sheath portion, each portion being coupled to separate instrument drivers from a set of instrument drivers 28, each instrument driver being coupled to the distal end of a separate robotic arm. This linear arrangement of the instrument drivers 28, facilitating coaxial alignment of the guide portion and the sheath portion, creates a “virtual track” 29, which can be repositioned in space by manipulating one or more robotic arms 12 to different angles and / or positions. The virtual track described herein is depicted using dashed lines in the accompanying drawings, and therefore the dashed lines do not depict any physical structure of the system. Translation of the instrument drivers 28 along the virtual track 29 causes the inner guide portion to overlap and telescopically extend relative to the outer sheath portion, or causes the endoscope 13 to advance or retract relative to the patient. The angle of the virtual track 29 can be adjusted, translated, and pivoted based on clinical application or physician preference. For example, in bronchoscopy, the angle and position of the virtual track 29 shown represent a compromise between providing the physician with access to the endoscope 13 and minimizing friction caused by bending the endoscope 13 into the patient's mouth.

[0064] After insertion, precise commands from the robotic system can be used to guide the endoscope 13 downwards along the patient's trachea and lungs until the target endpoint or surgical site is reached. To improve navigation through the patient's pulmonary network and / or to achieve the desired target, the endoscope 13 can be manipulated to extend the inner guiding portion relative to the outer sheath portion in a folding telescoping manner, thereby achieving enhanced articulation and a larger bending radius. The use of separate instrument actuators 28 also allows the guiding portion and the sheath portion to be driven independently of each other.

[0065] For example, endoscope 13 can be guided to deliver a biopsy needle to a target, such as a lesion or nodule in a patient's lung. The needle can be deployed downwards along the working channel extending the length of the endoscope to obtain tissue samples for analysis by a pathologist. Depending on the pathological findings, additional tools can be deployed downwards along the working channel of the endoscope for additional biopsies. After the nodule is identified as malignant, endoscope 13 can deliver tools endoscopically to remove potentially cancerous tissue. In some instances, diagnostic and treatment procedures may need to be performed in separate surgeries. In those cases, endoscope 13 can also be used to deliver a reference point to "mark" the location of the target nodule. In other instances, diagnostic and treatment procedures can be performed during the same surgical procedure.

[0066] System 10 may also include a movable tower 30, which can be connected to the trolley 11 via support cables to support the trolley 11's controls, electronics, jetting devices, optics, sensors, and / or power supply. Placing such functionality within the tower 30 allows for easier adjustment and / or repositioning of the smaller form factor of the trolley 11 by the surgeon and his / her staff. Furthermore, the functional allocation between the trolley / tabletop and the supporting tower 30 reduces operating room clutter and facilitates improved clinical workflow. While the trolley 11 can be positioned close to the patient, the tower 30 can be stored in a remote location to avoid obstructing access during surgery.

[0067] In support of the robotic system described above, tower 30 may include one or more components of a computer-based control system, which may store computer program instructions, for example, in a non-transitory computer-readable medium such as a persistent magnetic storage drive or a solid-state drive. The execution of those instructions, whether occurring in tower 30 or cart 11, can control the entire system or one or more subsystems thereof. For example, when executed by the processor of the computer system, the instructions can cause components of the robotic system to actuate associated brackets and arm mounts, actuate the robotic arm, and control medical instruments. For example, in response to receiving a control signal, a motor in the robotic arm's connector can position the arm into a certain posture.

[0068] Tower 30 may also include pumps, flow meters, valve controllers, and / or fluid passages to provide controlled flushing and suction functions to systems that can be deployed through endoscope 13. These components may also be controlled using a computer system of tower 30. In some embodiments, the flushing and suction functions may be delivered directly to endoscope 13 via one or more separate cables.

[0069] Tower 30 may include voltage and surge protectors designed to provide filtered and protected power to trolley 11, thereby avoiding the placement of power transformers and other auxiliary power components in trolley 11, resulting in a smaller and more portable trolley 11.

[0070] Tower 30 may also include support devices for sensors deployed throughout the robotic system 10. For example, tower 30 may include optoelectronic devices for detecting, receiving, and processing data received from optical sensors or cameras throughout the robotic system 10. In conjunction with a control system, such optoelectronic devices can be used to generate real-time images for display on any number of consoles deployed throughout the system, including tower 30. Similarly, tower 30 may also include an electronic subsystem for receiving and processing signals received from deployed electromagnetic (EM) sensors. Tower 30 may also be used to house and position EM field generators detected by EM sensors in or on medical instruments.

[0071] Tower 30 may also include a console 31 in addition to other consoles available in the rest of the system, such as a console mounted on top of the trolley. Console 31 may include a user interface and display, such as a touchscreen, for the physician operator. The consoles in system 10 are generally designed to provide both robot control and preoperative and real-time information for the procedure, such as navigation and positioning information for the endoscope 13. When console 31 is not the only console available to the physician, it can be used by a second operator, such as a nurse, to monitor the patient's health or vital organs and the operation of the system, and can provide procedure-specific data, such as navigation and positioning information.

[0072] Tower 30 can be connected to trolley 11 and endoscope 13 via one or more cables or connectors (not shown). In some embodiments, support functions from tower 30 can be provided to trolley 11 via a single cable, thereby simplifying and tidying up the operating room. In other embodiments, specific functions can be coupled in separate cables and connectors. For example, although power can be supplied to the trolley via a single power cable, support for control devices, optical devices, jet devices, and / or navigation devices can be provided via separate cables.

[0073] Figure 2 Provided Figure 1 The illustration shows a detailed implementation of a trolley-based robotic medical system. The trolley 11 generally includes an elongated support structure 14 (generally referred to as a "post"), a trolley base 15, and a console 16 located at the top of the post 14. The post 14 may include a control panel for mounting one or more robotic arms 12. Figure 2 The deployment is supported by one or more brackets (shown as three in the diagram), such as bracket 17 (alternatively, "arm support"). Bracket 17 may include individually configurable arm mounts that rotate along a vertical axis to adjust the base of the robotic arm 12 for better positioning relative to the patient. Bracket 17 also includes a bracket interface 19 that allows vertical translation of bracket 17 along post 14.

[0074] The bracket interface 19 is connected to the column 14 via a slot, such as slot 20, positioned on the opposite side of the column 14 to guide the vertical translation of the bracket 17. Slot 20 includes a vertical translation interface to position and hold the bracket at various vertical heights relative to the trolley base 15. The vertical translation of the bracket 17 allows the trolley 11 to adjust the range of the robotic arm 12 to accommodate various table heights, patient sizes, and physician preferences. Similarly, individually configurable arm mounts on the bracket 17 allow the robotic arm base 21 of the robotic arm 12 to be angled in various configurations.

[0075] In some embodiments, the slot 20 may be supplemented with a slot cover flush and parallel to the slot surface to prevent dirt and fluid from entering the internal cavity of the column 14 and the vertical translation interface when the bracket 17 is vertically translated. The slot cover can be deployed via a pair of spring reels positioned near the vertical top and bottom of the slot 20. As the bracket 17 is vertically translated up and down, the cover is wound inside the reels until deployed to extend and retract from its wound state. The spring load of the reels provides force to retract the cover into the reels as the bracket 17 translates toward the reels, while also maintaining a tight seal as the bracket 17 translates away from the reels. The cover can be attached to the bracket 17 using, for example, a bracket located in the bracket interface 19, to ensure proper extension and retraction of the cover during the translation of the bracket 17.

[0076] The column 14 may internally include mechanisms such as gears and motors, which are designed to use vertically aligned lead screws to mechanically translate the bracket 17 in response to a control signal generated in response to user input, such as input from the console 16.

[0077] The robotic arm 12 generally includes a robotic arm base 21 and an end effector 22, separated by a series of links 23 connected by a series of couplings 24, each coupling including an independent actuator, each actuator including an independently controllable motor. Each independently controllable coupling represents an independent degree of freedom available to the robotic arm. Each arm in the arm 12 has seven couplings and thus provides seven degrees of freedom. Multiple couplings generate multiple degrees of freedom, thereby allowing "redundant" degrees of freedom. Redundant degrees of freedom allow the robotic arm 12 to position the corresponding end effector 22 in space at specific locations, orientations, and trajectories using different link positions and coupling angles. This allows the system to locate and guide medical instruments from desired points in space, while allowing physicians to move arm couplings to clinically advantageous locations away from the patient to create greater access while avoiding arm collisions.

[0078] The trolley base 15 balances the weight of the posts 14, brackets 17, and arms 12 above the floor. Therefore, the trolley base 15 houses heavier components such as electronics, motors, power supplies, and components that enable the trolley to move and / or remain stationary. For example, the trolley base 15 includes rollable wheel-type casters 25, which allow the trolley to be easily moved around the room before surgery. Once in place, the casters 25 can be secured using wheel locks to keep the trolley 11 in place during surgery.

[0079] The console 16, positioned at the vertical end of column 14, allows both a user interface and a display screen (or a dual-purpose device such as touchscreen 26) to provide both preoperative and intraoperative data to the physician user for receiving user input. Possible preoperative data on touchscreen 26 may include preoperative planning, navigation and imaging data from preoperative computed tomography (CT) scans, and / or information from preoperative patient interviews. Intraoperative data on the display screen may include optical information provided by tools and sensors, coordinate information from sensors, and crucial patient statistics such as respiration, heart rate, and / or pulse. The console 16 can be positioned and tilted to allow the physician to access it from the side of column 14 opposite to bracket 17. From this position, the physician can observe the console 16, robotic arm 12, and patient while operating the console 16 from the rear of cart 11. As shown, the console 16 also includes handles 27 for assisting in manipulating and stabilizing cart 11.

[0080] Figure 3The illustration depicts an embodiment of a system 10 implemented by a robot for ureteroscopy. During the ureteroscopy procedure, a trolley 11 can be positioned to deliver a ureteroscope 32 to the patient's lower abdominal region. The surgical endoscope is designed to pass through the patient's urethra and ureter. During ureteroscopy, it is desirable to align the ureteroscope 32 directly with the patient's urethra to reduce friction and force on the sensitive anatomy in this region. As shown, the trolley 11 can be aligned at the bottom of the table to allow the robotic arm 12 to position the ureteroscope 32 for direct linear access into the patient's urethra. The robotic arm 12 can insert the ureteroscope 32 directly into the patient's lower abdomen along a virtual track 33 through the urethra from the bottom of the table.

[0081] After insertion into the urethra, using control techniques similar to those used in bronchoscopy, the ureteroscope 32 can be navigated to the bladder, ureter, and / or kidney for diagnostic and / or therapeutic applications. For example, the ureteroscope 32 can be guided into the ureter and kidney to break up accumulated kidney stones using a laser or ultrasonic lithotripsy device deployed downwards along the working channel of the ureteroscope 32. After lithotripsy is complete, the resulting stone fragments can be removed using a basket deployed below the ureteroscope 32.

[0082] Figure 4 The illustration depicts an implementation of a similarly arranged robotic system for vascular surgery. In vascular surgery, system 10 can be configured such that a trolley 11 can deliver a medical instrument 34, such as a steerable catheter, to an entry point in the femoral artery in the patient's leg. The femoral artery has both a large diameter for navigation and a relatively less circuitous and tortuous path to the patient's heart, which simplifies navigation. As in ureteroscopy, the trolley 11 can be positioned toward the patient's leg and lower abdomen to allow the robotic arm 12 to provide a virtual track 35 for direct, linear access to the femoral artery entry point in the patient's thigh / hip region. After insertion into the artery, the medical instrument 34 can be guided and inserted via a translational instrument actuator 28. Alternatively, the trolley can be positioned around the patient's upper abdomen to reach alternative vascular entry points, such as the carotid and brachial arteries near the shoulder and wrist.

[0083] B. Robot System - Tabletop

[0084] Various implementations of robotic medical systems can also incorporate patient tables. Incorporating a patient table reduces the number of major pieces of equipment in the operating room by removing trolleys, making the patient more accessible. Figure 5The illustration depicts an embodiment of such a robotic system arranged for bronchoscopy. System 36 includes a support structure or column 37 for supporting a platform 38 (shown as a "table" or "bed") above the floor. Much like in trolley-based systems, the end effector of the robotic arm 39 of system 36 includes an instrument driver 42 designed to manipulate elongated medical instruments, such as manipulators, via or along a virtual track 41 formed by the linear alignment of the instrument driver 42. Figure 5 The bronchoscope 40 is used in the bronchoscopy. In practice, the C-arm used to provide fluoroscopic imaging can be positioned above the patient's upper abdominal region by placing the emitter and detector around the table 38.

[0085] Figure 6 For illustrative purposes, an alternative view of system 36 without a patient and medical instruments is provided. As shown, column 37 may include one or more brackets 43, shown as annular in system 36, from which one or more robotic arms 39 may be positioned to reach the patient. The brackets 43 may translate along a vertical column interface 44 extending along the length of column 37 to provide different vantage points from which the robotic arms 39 may be positioned to reach the patient. One or more brackets 43 may be rotated about column 37 using mechanical motors positioned within column 37 to allow the robotic arms 39 to reach multiple sides of tabletop 38, such as, for example, the two sides of the patient. In embodiments with multiple brackets, the brackets may be individually positioned on the column and may translate and / or rotate independently of the other brackets. While the brackets 43 need not be about column 37 or even circular, the annular shape shown facilitates rotation of the brackets 43 about column 37 while maintaining structural balance. The rotation and translation of the bracket 43 allows the system to align medical instruments such as endoscopes and laparoscopes to different entry points on the patient.

[0086] The arm 39 can be mounted on the bracket via a set of arm mounts 45, which includes a series of engaging members that can be individually rotated and / or extended in a nested telescopic manner to provide additional constructability to the robotic arm 39. Additionally, the arm mounts 45 can be positioned on the bracket 43 such that, when the bracket 43 is properly rotated, the arm mounts 45 can be positioned on the same side of the table 38 (e.g., ...). Figure 6 As shown), positioned on the opposite side of the tabletop 38 (as shown). Figure 9 (as shown in the diagram), or positioned on the adjacent side of the tabletop 38 (not shown).

[0087] Column 37 structurally provides support for the platform 38 and a path for the vertical translation of the bracket. Internally, column 37 may be equipped with a lead screw for guiding the vertical translation of the bracket and a motor for mechanizing the translation of the bracket based on the lead screw. Column 37 can also transmit electrical and control signals to the bracket 43 and the robotic arm 39 mounted on the bracket 43.

[0088] The base of the countertop 46 is connected to the Figure 2 The trolley base 15 in the trolley 11 shown in the diagram serves a similar function, accommodating heavier components to balance the table / bed 38, column 37, bracket 43, and robotic arm 39. The table base 46 may also include rigid casters to provide stability during surgery. The casters, deployed from the bottom of the table base 46, can extend in opposite directions on two sides of the base 46 and can retract when the system 36 needs to be moved.

[0089] Continue to refer to Figure 6 System 36 may also include a tower (not shown) that divides the functionality of system 36 between the table and the tower to reduce the form factor and volume of the table. As in previously disclosed embodiments, the tower may provide various support functions to the table, such as processing power, computing and control capabilities, power supply, jetting devices, and / or optical and sensor processing. The tower can also be moved away from the patient to improve physician accessibility and keep the operating room tidy. Additionally, housing the components in the tower allows for more storage space in the base of the table for potential robotic arms. The tower may also include a console that provides both a user interface for user input such as a keyboard and / or hooks, and a display screen (or touchscreen) for preoperative and intraoperative information such as real-time images, navigation, and tracking information.

[0090] In some implementations, the platform base can be used to store and hold the robotic arm when not in use. Figure 7 The illustration shows a system 47 for storing a robotic arm in an embodiment of a platform-based system. In system 47, a bracket 48 can be vertically translated into a base 49 to store the robotic arm 50, arm mount 51, and bracket 48 within the base 49. A base cover 52 can be translated and retracted to open to deploy the bracket 48, arm mount 51, and arm 50 around a post 53, and when not in use, the base cover 52 closes for storage, thereby protecting the bracket 48, arm mount 51, and arm 50. The base cover 52 can be sealed along the edge of its opening by a membrane 54 to prevent contaminants and fluids from entering when closed.

[0091] Figure 8The illustration depicts an embodiment of a table-based system configured for a robotic ureteroscopy procedure. In ureteroscopy, the table 38 may include a rotating portion 55 for positioning the patient at an angle relative to the column 37 and the table base 46. The rotating portion 55 may rotate or pivot about a pivot point (e.g., positioned below the patient's head) to position the bottom portion of the rotating portion 55 away from the column 37. For example, pivoting the rotating portion 55 allows a C-arm (not shown) to be positioned above the patient's lower abdomen without competing for space with the column (not shown) located below the table 38. By rotating a bracket 35 (not shown) about the column 37, the robotic arm 39 can insert the ureteroscope 56 directly into the patient's groin region along a virtual track 57 to reach the urethra. During ureteroscopy, the rotating portion 55 of the table 38 may also be secured with stirrups 58 to support the position of the patient's legs during the procedure and allow unobstructed access to the patient's groin region.

[0092] In laparoscopic surgery, a minimally invasive instrument (elongated in shape to accommodate one or more incisions) is inserted into the patient's anatomy through one or more small incisions in the abdominal wall. After the patient's abdominal cavity is expanded, the instrument, commonly referred to as a laparoscope, can be guided to perform surgical tasks such as grasping, cutting, ablation, and suturing. Figure 9 The illustration depicts an implementation of a tabletop-based system configured as a robot for laparoscopic surgery. For example... Figure 9 As shown, the bracket 43 of system 36 can be rotated and vertically adjusted to position the pair of robotic arms 39 on opposite sides of the table 38, so that the laparoscope 59 can be positioned to reach his / her abdominal cavity through the smallest incisions on both sides of the patient using the arm mount 45.

[0093] To accommodate laparoscopic surgeries, the robotic table system can also tilt the platform to the desired angle. Figure 10 The illustration shows an implementation of a medical system based on a robot with pitch or tilt adjustment. For example... Figure 10 As shown, system 36 can adapt to the tilt of countertop 38 to position one portion of the countertop at a greater distance from the floor than other portions. Additionally, arm mount 45 can rotate to match the tilt, ensuring that arm 39 maintains the same planar relationship with countertop 38. To accommodate steeper angles, post 37 may also include a collapsible telescopic portion 60 allowing vertical extension of post 37 to prevent countertop 38 from contacting the floor or colliding with base 46.

[0094] Figure 11Detailed illustrations are provided of the connection between the platform 38 and the column 37. The pitch-rotation mechanism 61 can be configured to change the pitch angle of the platform 38 relative to the column 37 with multiple degrees of freedom. The pitch-rotation mechanism 61 is achieved by positioning orthogonal axes 1 and 2 at the column-platform connection, each axis being actuated by separate motors 3 and 4 in response to electronic pitch angle commands. Rotation along one screw 5 achieves tilt adjustment along one axis 1, while rotation along another screw 6 achieves tilt adjustment along another axis 2.

[0095] For example, pitch adjustment is particularly useful in cases involving lower abdominal surgery when attempting to position the table in the Trendelenburg position—that is, positioning the patient's lower abdomen higher than the floor. The Trendelenburg position allows the patient's internal organs to slide towards his / her upper abdomen under gravity, thereby clearing the abdominal cavity to allow minimally invasive instruments to enter and perform lower abdominal surgeries, such as laparoscopic prostatectomy.

[0096] C. Instrument drivers & interfaces

[0097] The end effectors of the system's robotic arm include: (i) an instrument actuator (alternatively referred to as an "instrument drive mechanism" or "instrument device manipulator") incorporating electromechanical devices for actuating medical instruments; and (ii) a movable or detachable medical instrument that may not have any electromechanical components such as motors. This dichotomy may be driven by the need to sterilize medical instruments used in surgical procedures and the inability to adequately sterilize expensive main equipment due to the complex mechanical components and sensitive electronics of medical instruments. Therefore, medical instruments can be designed to be detached, removed, and replaced from the instrument actuator (and thus from the system) for individual sterilization or disposal by a physician or physician staff. In contrast, the instrument actuator does not require replacement or sterilization and can be covered with a curtain for protection.

[0098] Figure 12An example instrument actuator is illustrated. The instrument actuator 62, positioned at the distal end of a robotic arm, includes one or more drive units 63 arranged with parallel shafts to provide controlled torque to a medical instrument via drive shafts 64. Each drive unit 63 includes: a separate drive shaft 64 for interacting with the instrument; a gear head 65 for converting rotation of a motor shaft into desired torque; a motor 66 for generating drive torque; an encoder 67 for measuring the speed of the motor shaft and providing feedback to control circuitry; and control circuitry 68 for receiving control signals and actuating the drive units. Each drive unit 63 is independently controlled and motorized, and the instrument actuator 62 can provide multiple (e.g., ...) to the medical instrument. Figure 12 (Shown as four) independent drive outputs. In operation, the control circuit 68 receives control signals, transmits motor signals to the motor 66, compares the generated motor speed measured by the encoder 67 with the desired speed, and modulates the motor signals to generate the desired torque.

[0099] For surgeries requiring a sterile environment, the robotic system can be coupled with a drive interface positioned between the instrument driver and the medical instrument, such as a sterile adapter connected to a sterile curtain. The primary purpose of the sterile adapter is to transmit angular motion from the drive shaft of the instrument driver to the drive input of the instrument, while maintaining physical isolation between the drive shaft and the drive input, and thus maintaining sterility. Therefore, an example sterile adapter may include a series of rotary inputs and rotary outputs designed to mate with the drive shaft of the instrument driver and the drive input on the instrument. A sterile curtain, made of a thin, flexible material such as transparent or translucent plastic, connected to the sterile adapter, is designed to cover the main equipment, such as the instrument driver, robotic arm, and a trolley (in trolley-based systems) or tabletop (in tabletop-based systems). Using the curtain allows the main equipment to be positioned close to the patient while still within an area that does not require sterilization (i.e., a non-sterile area). On the other side of the sterile curtain, the medical instrument can come into contact with the patient in an area that requires sterilization (i.e., a sterile area).

[0100] D. Medical instruments

[0101] Figure 13An example medical instrument with paired instrument actuators is illustrated. Similar to other instruments designed for use with robotic systems, the medical instrument 70 includes an elongated shaft 71 (or elongated body) and an instrument base 72. The instrument base 72—also referred to as an “instrument handle” because it is intended for manual interaction by a physician—may generally include a rotatable drive input 73, such as a receiver, pulley, or reel, designed to mate with a drive output 74 extending through a drive interface on an instrument actuator 75 located at the distal end of a robotic arm 76. When physically connected, latched, and / or coupled, the mating drive input 73 of the instrument base 72 may share a rotational axis with the drive output 74 in the instrument actuator 75 to allow torque to be transmitted from the drive output 74 to the drive input 73. In some embodiments, the drive output 74 may include a spline designed to mate with a receiver on the drive input 73.

[0102] The elongated shaft 71 is designed for delivery through anatomical openings or lumens, such as in endoscopy, or through minimally invasive incisions, such as in laparoscopy. The elongated shaft 66 can be flexible (e.g., with endoscope-like properties) or rigid (e.g., with laparoscopy-like properties) or a customized combination of both. When designed for laparoscopy, the distal end of the rigid elongated shaft can be connected to an end effector and surgical instruments such as graspers or scissors. The end effector includes an engaged wrist formed by a U-shaped clamp with a rotation axis. The end effector and surgical instruments can be actuated based on forces from tendons as the drive input rotates in response to torque received from the drive output 74 of the instrument driver 75. When designed for endoscopy, the distal end of the flexible elongated shaft can include a steerable or controllable bending segment that can be hinged and bent based on torque received from the drive output 74 of the instrument driver 75.

[0103] Torque from the instrument actuator 75 is transmitted downward along the elongated shaft 71 using ribs within the shaft 71. These individual ribs, such as draw cables, can be individually anchored to individual drive inputs 73 within the instrument handle 72. The ribs are guided downward from the handle 72 along one or more pull lumen within the elongated shaft 71 and anchored at the distal portion of the shaft 71. In laparoscopy, these ribs can be coupled to an end effector mounted distally, such as a wrist, gripper, or scissors. In such an arrangement, torque applied to the drive input 73 will transmit tension to the ribs, causing the end effector to actuate in some way. In laparoscopy, the ribs can cause the coupling to rotate about the axis, thereby causing the end effector to move in one direction or the other. Alternatively, the ribs can be connected at the distal end of the elongated shaft 71 to one or more jaws of a gripper, where tension from the ribs causes the gripper to close.

[0104] During endoscopic examination, ribs can be attached to curved or articulated sections that are positioned along an elongated axis 71 (e.g., at the distal end) via adhesives, control rings, or other mechanical fasteners. When fixedly attached to the distal end of the curved section, torque applied to the drive input 73 is transmitted downward along the rib, causing the softer curved section (sometimes referred to as the articulated section or articulated region) to bend or articulate. Along the non-curved sections, it may be advantageous to have individual tension lumen spirals or coils guiding individual ribs along the wall of the endoscope axis (or inside the wall of the endoscope axis) to balance the radial forces caused by tension in the ribs. The angle of the spirals and / or the spacing between the spirals can be varied or designed for a particular purpose, wherein tighter spirals exhibit less axial compression under load, while a smaller amount of spirals results in greater axial compression under load but also exhibits limited bending. On the other hand, the pulling lumen can be guided parallel to the longitudinal axis of the elongated shaft 71 to allow controlled hinges in desired curved or hinged sections.

[0105] In endoscopic procedures, the elongated shaft 71 houses numerous components used to assist in robotic surgery. The shaft may include a working channel for deploying surgical instruments at its distal end, rinsing and / or aspirating the surgical area. The shaft 71 may also house wires and / or optical fibers for transmitting signals to / from optical components at its distal end, which may include an optical camera. The shaft 71 may also house optical fibers to transmit light from a proximal-positioned light source, such as a light-emitting diode, to the distal end of the shaft.

[0106] At the distal end of the instrument 70, the distal tip may also include an opening for a working channel for delivering tools used for diagnosis and / or treatment, and for rinsing and aspirating the surgical site. The distal tip may also include a port for a camera, such as a fiberoptic endoscope or digital camera for capturing images of the internal anatomical space. Relatedly, the distal tip may also include a port for a light source used to illuminate the anatomical space when the camera is in use.

[0107] exist Figure 13 In the example, the drive shaft axis, and therefore the drive input axis, is orthogonal to the axis of the elongated shaft. However, this arrangement complicates the rolling capability of the elongated shaft 71. Rolling the elongated shaft 71 along its axis while keeping the drive input 73 stationary as the ribs extend away from the drive input 73 and into the tension lumen within the elongated shaft 71 can lead to undesirable tangling of the ribs. This tangling can interfere with any control algorithms intended to predict the movement of the flexible elongated shaft during endoscopic procedures.

[0108] Figure 14 An alternative design for an instrument actuator and instrument is illustrated, wherein the axis of the drive unit is parallel to the axis of the instrument's elongated shaft. As shown, a circular instrument actuator 80 comprises four drive units, wherein the drive outputs 81 of the four drive units are aligned in parallel at the end of a robot arm 82. The drive units and their respective drive outputs 81 are housed in a rotating assembly 83 of the instrument actuator 80, which is driven by one of the drive units within the assembly 83. In response to torque provided by the rotating drive unit, the rotating assembly 83 rotates along a circular bearing that connects the rotating assembly 83 to a non-rotating portion 84 of the instrument actuator. Electrical and control signals can be communicated from the non-rotating portion 84 of the instrument actuator 80 to the rotating assembly 83 via electrical contacts, which can be maintained by rotation of a brushed slip ring connector (not shown). In other embodiments, the rotating assembly 83 may respond to separate drive units that are integrated into the non-rotating portion 84 and are therefore not parallel to the other drive units. The rotating mechanism 83 allows the instrument driver 80 to rotate the drive unit and its corresponding drive output 81 as a single unit about the instrument driver axis 85.

[0109] Similar to previously disclosed embodiments, instrument 86 may include an elongated shaft portion 88 and an instrument base 87 (shown for discussion purposes as having a transparent outer shell), the instrument base 87 including a plurality of drive inputs 89 (e.g., receivers, pulleys, and drums), the plurality of drive inputs 89 configured to receive drive outputs 81 in instrument driver 80. Unlike previously disclosed embodiments, the instrument shaft 88 extends from the center of the instrument base 87, and the axis of the instrument base 87 is generally parallel to the axis of the drive inputs 89, rather than as in... Figure 13 Orthogonal in the design.

[0110] When coupled to the rotating assembly 83 of the instrument driver 80, the medical instrument 86, including the instrument base 87 and the instrument shaft 88, rotates together with the rotating assembly 83 about the instrument driver axis 85. Since the instrument shaft 88 is positioned at the center of the instrument base 87, it is coaxial with the instrument driver axis 85 when attached. Therefore, rotation of the rotating assembly 83 causes the instrument shaft 88 to rotate about its own longitudinal axis. Furthermore, since the instrument base 87 rotates together with the instrument shaft 88, any ribs connected to the drive input 89 in the instrument base 87 will not become entangled during rotation. Therefore, the parallelism of the axes of the drive output 81, the drive input 89, and the instrument shaft 88 allows the shaft to rotate without causing any control ribs to become entangled.

[0111] E. Navigation and Control

[0112] Traditional endoscopy may involve the use of fluorescence imaging (e.g., delivery via a C-arm) and other forms of radiation-based imaging to provide endoscopic guidance to the operating physician. In contrast, the robotic system envisioned in this disclosure can provide radiation-free navigation and positioning, reducing physician radiation exposure and the number of devices required in the operating room. As used herein, the term "positioning" can refer to determining and / or monitoring the location of an object in a reference coordinate system. Techniques such as preoperative mapping, computer vision, real-time EM tracking, and robot command data can be used alone or in combination to achieve a radiation-free operating environment. In other cases, where radiation-based imaging is still used, preoperative mapping, computer vision, real-time EM tracking, and robot command data can be used alone or in combination to improve upon information obtained solely through radiation-based imaging.

[0113] Figure 15This is a block diagram illustrating a positioning system 90 according to an exemplary embodiment, which estimates the positions of one or more components of a robotic system, such as instruments. The positioning system 90 may be a group of one or more computer devices configured to execute one or more instructions. The computer devices may be embodied in a processor (or multiple processors) and computer-readable storage from one or more of the components discussed above. By way of example and not limitation, the computer device may be located in... Figure 1 The tower 30 shown is located in Figures 1 to 4 The handcart shown is located in Figures 5 to 10 The bed shown is of medium size.

[0114] like Figure 15 As shown, the positioning system 90 may include a positioning module 95 that processes input data 91 to 94 to generate positioning data 96 for the distal end of a medical instrument. The positioning data 96 may be data or logic representing the position and / or orientation of the distal end of the instrument relative to a reference frame. This reference frame may be relative to the patient's anatomy or relative to a known object such as an EM field generator (see the discussion of EM field generators below).

[0115] The various input data are now described in more detail 91 to 94. Preoperative mapping can be accomplished using the collection of low-dose CT scans. Preoperative CT scans, for example, as “slices” of cross-sectional views of the patient’s internal anatomy, are reconstructed into three-dimensional images, which are visualized. When analyzed in an aggregated manner, image-based models of the anatomical cavities, spaces, and structures of the patient’s anatomy, such as the patient’s lung network, can be generated. Techniques such as centerline geometry can be determined and simulated from CT images to develop a three-dimensional volume of the patient’s anatomy, referred to as model data 91 (also referred to as “preoperative model data” when generated using only preoperative CT scans). The use of centerline geometry is discussed in U.S. Patent Application No. 14 / 523,760, the entire contents of which are incorporated herein by reference. Network topology models can also be derived from CT images and are particularly suitable for bronchoscopy.

[0116] In some implementations, the instrument may be equipped with a camera to provide visual data 92. The positioning module 95 can process the visual data to enable one or more vision-based position tracking. For example, preoperative model data can be combined with visual data 92 to enable computer vision-based tracking of medical instruments (e.g., an endoscope or instrument moving through the working channel of an endoscope). For example, using preoperative model data 91, the robotic system can generate a prospective library of endoscope images from the model based on the expected path of the endoscope, with each image associated with a position within the model. During surgery, the robotic system can refer to this library to aid in positioning by comparing real-time images captured at a camera (e.g., a camera at the distal end of the endoscope) with those images in the library.

[0117] Other computer vision-based tracking techniques use feature tracking to determine camera motion, and thus, endoscope motion. Some features of the positioning module 95 can identify circular geometries corresponding to anatomical lumens in the preoperative model data 91, and track changes in those geometries to determine which anatomical lumen to select, as well as track the relative rotation and / or translational motion of the camera. The use of topological mapping can also enhance vision-based algorithms or techniques.

[0118] Another computer vision-based technique, optical flow, can analyze the displacement and translation of image pixels in a video sequence within visual data 92 to infer camera motion. Examples of optical flow techniques can include motion detection, object segmentation calculation, brightness, motion compensation coding, stereo parallax measurement, etc. By comparing multiple frames in multiple iterations, the motion and position of the camera (and therefore the endoscope) can be determined.

[0119] The positioning module 95 can use real-time EM tracking to generate the real-time position of the endoscope in a global coordinate system that can be registered with the patient's anatomy as represented by a preoperative model. In EM tracking, an EM sensor (or tracker) measures changes in the EM field generated by one or more stationary EM field generators positioned at known locations, including EM sensors (or trackers) with one or more sensor coils embedded in one or more locations and orientations of the medical instrument (e.g., an endoscopic tool). The positional information detected by the EM sensor is stored as EM data 93. The EM field generator (or transmitter) can be positioned close to the patient to generate a low-intensity magnetic field detectable by the embedded sensor. The magnetic field induces a small current in the sensor coil of the EM sensor, which can be analyzed to determine the distance and angle between the EM sensor and the EM field generator. These distances and orientations can be "registered" with the patient's anatomy (e.g., a preoperative model) during surgery to determine a geometric transformation that aligns a single position in the coordinate system with its position in the preoperative model of the patient's anatomy. Once registered, embedded EM trackers in one or more locations of the medical instrument (e.g., the distal tip of an endoscope) can provide a real-time display of the medical instrument’s progress through the patient’s anatomy.

[0120] Robot commands and kinematic data 94 can also be used by the positioning module 95 to provide positioning data 96 for the robot system. Device pitch and yaw generated by articulation commands can be determined during preoperative calibration. During surgery, these calibration measurements can be combined with known insertion depth information to estimate the instrument's position. Alternatively, these calculations can be combined with EM, vision, and / or topology models for analysis to estimate the medical instrument's position within the network.

[0121] like Figure 15 As shown, the positioning module 95 can use many other types of input data. For example, although not in Figure 15 As shown, an instrument using shape sensing fibers can provide shape data, which the positioning module 95 can use to determine the position and shape of the instrument.

[0122] The localization module 95 can use the input data 91 to 94 in combination. In some cases, such a combination may use a probabilistic method, where the localization module 95 assigns confidence weights to the position determined by each of the input data 91 to 94. Therefore, in cases where the EM data may be unreliable (e.g., where EM interference may be present), the confidence of the position determined by the EM data 93 may be reduced, and the localization module 95 may rely more heavily on the visual data 92 and / or robot commands and kinematic data 94.

[0123] As discussed above, the robotic systems discussed in this paper can be designed to combine one or more of the above technologies. Computer-based control systems for tower, bed, and / or trolley-based robotic systems can, for example, store computer program instructions in non-transitory computer-readable storage media such as permanent magnetic storage drives or solid-state drives. When executed, these computer program instructions enable the system to receive and analyze sensor data and user commands, generate control signals throughout the system, and display navigation and positioning data such as the instrument's position in a global coordinate system and anatomical diagrams.

[0124] 2. Directional jet technology

[0125] Various embodiments of this disclosure relate to systems and techniques for removing objects from a patient's treatment site, and more particularly to methods and systems for using directed jets during object removal surgery.

[0126] During object removal surgery, jets (e.g., flushing (inflow) and / or aspiration (outflow) of a fluid such as saline solution) can be applied to the treatment site. For example, during percutaneous nephrolithotomy (PCNL), jets can be used to clear the field of vision of stone dust and small fragments caused by ruptured kidney stones. However, as discussed in more detail below, the conventional methods of using jets during object removal surgery can also cause complications. For example, flushing can generate an electric current within the treatment site that moves the object to be removed away from the medical instruments used during the procedure.

[0127] As used herein, the term "directional jet technique" applies to the methods, techniques, and systems described in this disclosure that improve upon conventional jet techniques to facilitate object removal surgery and / or address or mitigate one or more problems associated with conventional object removal surgery. Typically, directional jet techniques involve controlling various characteristics (e.g., rate, direction, pressure, location, etc.) of the flushing and / or aspiration flows, and / or separating one inflow point (or multiple inflow points) of the flushing from one outflow point (or multiple outflow points) of the aspiration to facilitate object removal surgery. In some examples, directional jet techniques involve providing flushing and aspiration via a single medical instrument (e.g., a percutaneously inserted medical instrument), and may also involve controlling the characteristics of the flushing and aspiration to facilitate object removal. In some examples, directional jet techniques involve controlling the flow direction from the inflow point to the outflow point to, for example, hold or stabilize the object during surgery. These and other characteristics of directional jet techniques, as well as various methods and systems for implementing directional jets during object removal surgery, will become apparent from the following detailed description of several examples. The following examples are intended to illustrate the principles of this disclosure and should not be construed as limiting this disclosure.

[0128] In several examples described herein, object removal procedures involve the removal of kidney stones from the kidney. However, this disclosure is not limited to the removal of kidney stones. For example, the following description also applies to other surgical or medical procedures or medical treatments related to the removal of objects from a patient, including any object that can be removed from a treatment site or patient cavity (e.g., esophagus, ureter, intestine, eye, etc.) via percutaneous access devices and / or endoscopic access devices, such as gallbladder stone removal, lung (lung / transthoracic) tumor biopsy, or cataract removal.

[0129] A. Background discussion on object removal

[0130] As mentioned above, object removal is a common surgical procedure or medical operation. To better understand the features and advantages of the methods and systems for object removal using directional jets described in this article, this section first introduces background information relevant to certain object removal surgeries. A procedure for removing kidney stones from a kidney is described with the aid of an example.

[0131] Several methods exist for treating patients with kidney stones, including observation, pharmacological treatment (such as expulsion therapy), non-invasive treatment (such as extracorporeal shock wave lithotripsy (ESWL)), and surgical treatment (such as ureteroscopy and PCNL). In both surgical methods (ureteroscopy and PCNL), the physician can access the affected structure (i.e., can access the object to be removed; for example, can access the stone), energy is delivered to the stone to break it into smaller pieces or fragments, and the small stone fragments / granules are mechanically extracted from the kidney.

[0132] One component of PCNL is the use of jets (flushing and suction). During PCNL, jets can be used to remove stone dust, small fragments, and blood clots from the treatment site, as well as to provide a field of view for medical instruments.

[0133] Figure 16An exemplary procedure for removing an object 101 from a kidney 103 using a medical instrument 100 that is percutaneously inserted into the kidney 103 is illustrated. The illustrated example may represent a PCNL procedure. The object 101 can be any object intended for removal, such as a kidney stone. In the illustrated example, the medical instrument 100 includes a laparoscope or nephroscope 105. The nephroscope 105 can be percutaneously inserted into the kidney 103 through an access sleeve 107. The nephroscope 105 may include a working channel 108 through which various instruments can be inserted. As illustrated, a lithotripter 109 (such as an ultrasonic lithotripter) can be inserted through the working channel 108 of the nephroscope 105. The nephroscope 105 may also include optics configured to allow the surgeon to visualize the treatment site. A field of view 117 of the optics is illustrated.

[0134] Typically, the medical instrument 100 is navigated within the kidney 103 by twisting it toward the object 101. The surgeon's goal is to bring the distal end 121 of the lithotripter 109 into contact with the object 101 to break it into smaller fragments that can then be removed.

[0135] As Figure 16 As illustrated by the arrows, flushing (e.g., flushing with saline solution) can be applied to the treatment site (e.g., kidney 103) via medical instrument 100. In this example, flushing passes through nephroscope 105, exiting through distal tip 113 into kidney 103. Fluiding can be used to remove stone dust and small fragments from field of view 117 to allow the surgeon to visualize the treatment site, and to dilate kidney 103 to allow access to object 101. In the illustrated example, aspiration is also applied to the treatment site via medical instrument 100. As shown, fluid can be removed from kidney 103 through channels in inlet sheath 107 and lithotripter 109. In some instances, flushing is (actively) pumped via lithotripter 109, while residual flushing via inlet sheath 107 is passive (e.g., passively flowing through inlet sheath 107). In some examples, jetting is applied throughout the procedure.

[0136] The applied jet can establish, as during surgery, a flow rate of 100 μL / 200 μL / 3 ... Figure 16The fluid flow is illustrated by the arrows. Initially, fluid can flow outward from the distal tip 113 of the nephroscope 105 toward the subject 101. Flushing into the sheath 107 and the lithotripter 109 can cause the fluid flow to return toward the medical instrument 100. As illustrated, in the region of the subject 101, the flow is directed toward and away from the distal end of the medical instrument 100. In some instances, the net effect of this flow may be the formation of numerous small and unpredictable eddies 119 around the subject 101 and the distal end of the medical instrument 100. This may cause the subject 101 to be pushed away from the medical instrument 100. This may prevent the surgeon from bringing the lithotripter 109 into contact with the subject 101 and / or dispersing fragments generated by the lithotripter 109 during stone fragmentation. These difficulties may arise when only flushing is actively managed and aspiration is passive, thus preventing high-level jet control during the procedure. Another potential danger is that the kidney 103 may become overfilled.

[0137] As another example, during ureteroscopic lithotripsy, a ureteroscope is inserted through the ureter into the kidney, and a stone retrieval basket and lithotripter are used to reposition and break down the kidney stones. For example, the lithotripter can be deployed through the ureteroscope and used to break the stone into fragments. Several problems can occur during lithotripsy of kidney stones. For example, the lithotripter (which applies energy to break the stone) may cause the stone to move around unpredictably within the kidney. Furthermore, as mentioned above, lithotripsy produces stone dust, which can obstruct vision within the treatment site. After the stone has broken up, the lithotripter can be removed, and a basket device can be deployed through the ureteroscope to retrieve the stone fragments. This process is both cumbersome and time-consuming. After attempting to remove all stone fragments through the basket, small stone debris may remain.

[0138] The procedures discussed above for removing kidney stones (PCNL and ureteroscopy) can present certain challenges or complications. For example, PCNL uses a jet that generates an electric current within the kidney, which can move the object and fragments away from the medical instrument, complicating the removal process. Ureteroscopy uses a lithotripter accessed through a ureteroscope to break up kidney stones; however, there may not be a mechanism in place to stabilize the stone during lithotripsy. Often, the energy used to break up the stone can cause it to bounce off the lithotripter, complicating removal. Furthermore, stone dust is generated during lithotripsy, obstructing the view of the treatment site. Another challenge with these procedures is that the surrounding anatomy outside the kidney can make it difficult for the physician to access the treatment site. For example, the surrounding anatomy outside the kidney may limit the location of percutaneous access.

[0139] B. Overview of Object Removal Using Directed Jet Techniques

[0140] The methods and systems described herein can be used to alleviate or resolve one or more problems in PCNL and ureteroscopy (described above) through the use of directed jet techniques. In some embodiments, directed jet can be applied such that flushing (inflow) enters the treatment site through a first channel of a first medical device (e.g., a percutaneously inserted medical instrument), and aspiration (outflow) exits the treatment site through a second channel of the first medical instrument. In some embodiments, both flushing and aspiration can be active. In some embodiments, flushing and aspiration can be managed to produce desired flow characteristics. In some embodiments, a second medical instrument that does not provide flushing or aspiration may also be used during the procedure, for example, to break up the object being removed. In some embodiments, directed jet can be applied such that flushing (inflow) enters the treatment site through a first medical device (e.g., a catheter or endoscope), while aspiration (outflow) exits the treatment site through a second medical instrument (e.g., a catheter or endoscope). This can create a controlled flow from the first instrument toward the second instrument. The controlled flow can facilitate object removal. A first medical instrument can be inserted antegradely into the treatment site along the object to be removed, while a second medical instrument can be inserted retrogradely into the treatment site along the object. The first medical instrument can be inserted through a patient's lumen or percutaneously. The second medical instrument can be inserted through a patient's lumen or percutaneously. In some embodiments, the first medical instrument is inserted into the treatment site (e.g., the kidney) through a patient's lumen (e.g., the ureter) while the second medical instrument is inserted percutaneously into the treatment site, or the first medical instrument is inserted percutaneously into the treatment site while the second medical instrument is inserted into the treatment site (e.g., the kidney) through a patient's lumen (e.g., the ureter).

[0141] One or both of the first and second medical instruments can be as described above. Figures 1 to 15 The described robot-controlled medical instrument. Therefore, in some embodiments, the methods and systems described below can be employed in a robotic manner.

[0142] In some instances, directional jetting techniques may include separating one or more points of inflow (flushing) from one or more points of outflow (aspiration). For example, the inflow can be directed toward the outflow point by deflecting the distal end of a first medical instrument toward a second medical instrument. This can be achieved by referring to the above... Figures 1 to 15The described systems and instruments are performed robotically and / or automatically. In some embodiments, the inflow (flushing) point does not need to be directional (i.e., pointing in a specific direction), provided that the first medical instrument is configured to achieve a sufficiently high inflow rate without causing turbulence. This allows the treatment site (e.g., the kidney) to fill with fluid without displacing the stone. In some embodiments, the outflow (aspiration) point can be a single point or a concentrated point. The outflow point can be configured to provide a high flow rate at a high velocity, such that fragments are drawn toward the outflow point.

[0143] In some implementations, the flushing and aspiration rates can be adjusted to improve stone displacement or stability or to intentionally create turbulence so that the flush reaches all corners of the treatment site. For example, gentle alternating cycles of flushing and aspiration can produce a similar irrigation effect, preferably pulling large stone fragments away from the renal calyces and toward the aspiration site. Alternatively, brief, pulsating inflows and outflows can be used to create turbulence and ensure that smaller, lighter stone fragments do not settle at the bottom of the treatment site but remain floating in the flushing fluid and are eventually aspirated through the outflow.

[0144] Figure 17 The illustration depicts an example surgical procedure for removing object 101 from kidney 103 using a first medical instrument 200 inserted through patient lumen 202 into kidney 103, a second medical instrument 204 inserted percutaneously into kidney, and a directed jet. Figure 17 In the illustrated example, the first medical instrument 200 includes an endoscope, such as a ureteroscope. The patient lumen 202 may include a ureter. The first medical instrument 200 may include a channel for supplying flushing. This channel may be connected to a flushing source and a pump (see [link to illustration]). Figure 25 The first medical instrument 200 may be articulated. The first medical instrument 200 may be robot-controlled.

[0145] As illustrated, the second medical instrument 204 may include a nephroscope 105. The nephroscope 105 may be a rigid nephroscope. The nephroscope 105 can be percutaneously inserted into the kidney 103 through an access sleeve 107. The nephroscope 105 may include a working channel 108 through which various tools can be inserted or used as a channel for aspiration or flushing. In some embodiments, other channels within the nephroscope may be used for aspiration and flushing. As illustrated, a lithotripter 109 (e.g., an ultrasonic lithotripter) can be inserted through the working channel 108 of the nephroscope 105. The nephroscope 105 may also include optics configured to allow the surgeon to visualize the treatment site. A field of view 117 of the optics is illustrated.

[0146] exist Figure 17The flow of fluid is illustrated with arrows. As shown, flushing is provided via the first medical instrument 200 and aspiration via the second medical instrument 204. In the illustrated embodiment, flushing is provided via the lithotripter 109, but alternatively (or additionally), flushing may be provided via the nephroscope 105 and / or the access sheath 107. As shown, the inflow (flushing) point and the outflow (aspiration) point are separate, and a general flow direction is established from the first medical instrument 200 to the second medical instrument 204.

[0147] As mentioned above, the second medical instrument 204 may include optical devices (e.g., a camera) for visualizing the treatment site (having a field of view 117). Because the flow is directed continuously away from the first instrument 200 and toward the second instrument 204, the field of view 117 of the optical devices can remain clear, thereby allowing for improved visualization of the treatment site. Furthermore, because the flow is directed toward the second medical instrument 204, which includes the lithotripter 109, the object 101 and fragments can be propelled toward the second medical instrument 204, thereby advantageously facilitating contact with the lithotripter 109.

[0148] This directional jet design allows debris, dust, thrombi, and fragments to flow naturally toward the second medical device 204 and into the stone extraction or destruction device (lithotomizer 109). In cases where the physician needs to track fragments, he or she may need to manipulate the device to a less extent than during other procedures, due to the tendency of the fragments to flow toward rather than away from the second medical device 204.

[0149] Furthermore, this allows for the use of a much larger diameter lithotripter 109 when flushing is provided through the nephroscope 105 and / or into the sheath 107, since flushing and / or suction through the lithotripter 109 is no longer necessary.

[0150] In another example, the second instrument 204 may be a hinged catheter that is inserted into the treatment site (e.g., the kidney) via a percutaneous access device (see [link to original text]). Figure 18 , Figure 19 , Figure 26A and Figure 26BThe catheter can be configured to navigate within the kidney. For example, the catheter can be configured to insert and retract into the treatment site and / or hinge (e.g., bend). In some embodiments, the catheter may include drawstrings for controlling the hinge. In some embodiments, four drawstrings are oriented in four orthogonal directions to enable the hinge of the catheter. Other methods for permitting catheter hinges are also possible. The catheter may include, for example, a suction lumen (or channel). The suction lumen may be connected to a pump. The pump may be an external pump. The pump can generate negative pressure that allows flow from the treatment site into the catheter. The suction function can be switched (e.g., turned on and off) and adjusted by the user or the system. In some embodiments, the suction lumen can be used for flushing.

[0151] During object removal surgery using directional jet lithotripsy, a urinary catheter can serve several functions. For example, it can stabilize stones during lithotripsy. If the stone is larger than the catheter's aspiration lumen, it can be held at the distal end of the aspiration lumen, thus stabilizing the stone while breaking it down into dust and smaller fragments. The aspiration flow can hold the stone to the distal end. This provides the user with fewer moving targets for lithotripsy.

[0152] A urinary catheter can improve visibility at the treatment site. It can remove stone fragments from the kidney. This can provide the user with improved visibility (e.g., continuous, adequate visibility) from an imaging device inserted into the treatment site (e.g., an imaging device on a medical instrument inserted into the treatment site).

[0153] A catheter can remove stone fragments and debris. A fluid flow carries fluid and debris into the catheter. Debris can be cleared as it is formed (i.e., when the stone breaks up). Removing debris via a catheter can replace removing it via a ureteroscopic basket, which can be time-consuming due to the difficulty of sealing the basket around the stone and the need to remove and reinsert the ureteroscope during each fragment removal. Removing debris via a catheter can result in a more efficient removal procedure. Such a procedure can be completed faster because, for example, the fragments are removed as the stone breaks up. Removing stone debris via a catheter also reduces the risk of tissue damage from stone fragments (such as tissue damage during stone removal via a ureter).

[0154] A urinary catheter can be used to reposition kidney stones. For example, a catheter can be configured to navigate within the kidney toward a stone or fragments of a stone. By aspiration, the stone or fragments can be held at the distal tip of the catheter and moved to another location within the kidney. This feature can remove or reduce the need for a basket device to reposition or move the stone. A catheter can also be configured to advance into the ureter to retrieve stones or fragments that have migrated into the ureter. This allows the physician to perform the procedure without a ureteral protection device, which is sometimes used during certain procedures.

[0155] A urinary catheter can be used in several ways during surgery. For example, the catheter can be moved throughout the procedure. It can be navigated around the treatment site to target a specific stone / fragment to restrain it during lithotripsy and to aspirate dust / debris. As another example, the catheter may initially be stationary during surgery and the stone can be repositioned into the catheter using a first medical instrument (e.g., a ureteroscope). The stone may rupture at the catheter site. Later during the procedure, the catheter can be navigated across the treatment site to pick up any remaining debris. As yet another example, the catheter may only be inserted when needed, such as during escalation of the procedure (e.g., percutaneously).

[0156] Figure 18 The illustration depicts an example surgical procedure for removing object 101 from kidney 103 using a first medical instrument 200 inserted into kidney 103 through patient lumen 202, a second medical instrument 204 inserted percutaneously (e.g., through an intubation sheath 107) into kidney 103, such as a steerable catheter, and directional jetting. Flushing can be provided through the first medical instrument 200, and aspiration can be provided through the second medical instrument 204. In this example, the inflow (flushing) point and outflow (aspiration) point are separate, and a general flow direction is established from the first medical instrument 200 toward the second medical instrument 204. Arrows indicate the direction of fluid flow.

[0157] like Figure 18 As illustrated, the first medical instrument 200 may be articulated. That is, the shape or orientation of the first medical instrument 200 can be controlled. In some embodiments, as described above, the articulation is robot-controlled. As illustrated, the first medical instrument 200 may be articulated such that the flushing flow toward the second medical instrument 204 is oriented or guided. This can help establish a fluid flow from the first medical instrument 200 toward the second medical instrument 204.

[0158] The second medical device 204 (e.g., a steerable catheter) can also be articulated. That is, the shape or orientation of the second medical device 204 can be controlled. In some embodiments, as described above, the articulation is robot-controlled. As illustrated, the second medical device 204 may include an articulated distal tip 206. The second medical device 204 (or its distal tip 206) can be articulated such that the distal tip 206 is oriented or guided toward the first medical device 200 and / or the object 101. This can help establish a fluid flow from the first medical device 200 toward the second medical device 204 for pulling the object 101 toward the second medical device 204.

[0159] Figure 19 The illustration depicts another example surgical procedure for removing object 101 from kidney 103 using a first medical instrument 200 inserted into kidney 103 through patient lumen 202, a second medical instrument 204 (e.g., a steerable catheter) inserted percutaneously (e.g., through an access sheath 107) into kidney 103, and directional jetting. In the illustrated example, the first medical instrument 200 includes a lithotripter 109. Fluid flow from the first medical instrument 200 to the second medical instrument 204 can be used to retain object 101 and / or fragments onto the distal tip 206 of the second medical instrument 204. This can stabilize object 101 and / or fragments during lithotripsy using the lithotripter 109 of the first medical instrument 200. The distal tip 206 of the second medical instrument 204 may include a recess (or other holding device) on its distal tip to stabilize and hold object 101 and / or fragments. See, for example, the description below. Figure 26A and Figure 26B .

[0160] Figure 20 Detailed views are provided of the distal tip 203 of the first medical instrument 200 (providing flushing) and the distal tip 206 of the second medical instrument 204 (providing aspiration during object removal surgery). Arrows illustrate the flow direction from the first medical instrument 200 to the second medical instrument 204. As shown, flushing passes through a first fluid channel 205 in the first medical instrument 200 and exits at the distal tip 203. Aspiration is provided through the distal tip 206 and the second fluid channel 207. As shown, the flow guides the object 101 toward the distal tip 206 of the second medical instrument 204.

[0161] In some examples, the catheter may also have the ability to flush fluid into the kidney (in addition to the aspiration described above). For example, the flushing channel of the catheter may begin at the proximal end of the catheter and may include an annular space between the catheter axis and the aspiration lumen. The distal end of the catheter may include a flushing opening. For example, the catheter may include circumferential orifices (e.g., four orifices) from which flushing fluid exits. Flushing may be turned on / off by the user or the system. Flushing may be connected to a jet system that has the ability to balance or otherwise modify the flushing / aspiration levels as described herein.

[0162] Figure 21A Detailed views are provided of the distal tip of a first medical instrument 200 that provides irrigation during object removal surgery and the distal tip 206 of a second medical instrument 204 that provides both irrigation and aspiration (see also the description below). Figure 26A and Figure 26B The arrows illustrate the flow direction from the first medical device 200 to the second medical device 204. As shown, in this example, the flush passes through the first fluid channel 205 in the first medical device 200 and exits at the distal tip 203. Similar to... Figure 20 Aspiration is provided through the distal tip 206 and the second fluid channel 207 of the second medical device 204. However, the second medical device 204 also includes an additional fluid channel 209 for supplying flushing. The additional fluid channel 209 may circumferentially surround the second fluid channel 207. In the illustrated embodiment, the additional fluid channel 209 terminates at a fluid outlet 211 near the distal tip 206 of the second medical device 204. In some embodiments, the fluid outlet 211 may direct flushing away from the second medical device 204 away from the distal tip 206. In some embodiments, the fluid outlet 211 may radially direct flushing away from the distal tip 206. As shown, the flow may direct object 101 toward the distal tip 206 of the second medical device 204.

[0163] In some implementations, flushing and aspiration can be provided by a single medical instrument, while another medical instrument can be used to perform other aspects of the procedure. For example, Figure 21B Detailed views are provided of the distal end of a first medical instrument 200 that performs lithotripsy using a lithotripter 216 during object removal surgery, and the distal end 206 of a second medical instrument 204 that provides both irrigation and aspiration. The second medical instrument 204 may resemble the following reference. Figure 26A and Figure 26B The instrument 700 is described. As shown, in this example, only the second instrument 204 is used to provide the jet. Both flushing and suction are provided through the second instrument 204.

[0164] Directional jet lithotripsy can offer one or more of the following advantages. During ureteroscopic lithotripsy, kidney stones may move around the kidney and migrate within it. Energy from the lithotripter may exacerbate this movement. Directional jet lithotripsy, with or without a catheter providing both suction and flushing, can use suction to limit these unwanted stone movements. For example, the fluid flow can hold the stone to the distal end of the instrument.

[0165] In addition, small dust particles are generated during lithotripsy, which may obstruct the view through the ureteroscope. In some ureteroscopic lithotripsy procedures, the view may become so blurred that the procedure must be stopped. Directional jets, with or without a catheter that provides both suction and flushing, can offer the advantage of removing dust particles (or other substances) from the treatment site, thus providing the user with consistently good visibility.

[0166] Furthermore, basket loading can be time-consuming because it is difficult to capture stone fragments in the basket and then remove the entire ureteroscope from the patient for each fragment removal. Directional jetting offers the advantage of rapidly removing stone fragments as they form.

[0167] Finally, during some ureteroscopic lithotripsy procedures, if kidney stones need to be repositioned, a basket retrieval device is typically used. This can be time-consuming because the stone needs to be positioned in the basket, and because the lithotripter needs to be replaced with the basket retrieval device. Directional jet lithotripsy offers the advantages of navigating the catheter through the kidney and holding it to the stone using aspiration, and then repositioning the stone to another location in the kidney by moving the aspiration catheter.

[0168] C. Example methods for directional jet technology

[0169] Figure 22A This is a flowchart illustrating an implementation of a method 300 for managing a directed jet during a medical procedure, such as an object removal surgery. In some examples, the object removal surgery is for removing kidney stones from the kidney. Method 300 can also be implemented in other types of medical procedures and other treatment sites. In some implementations, method 300 is used in robotic medical systems, such as those described above. Figures 1 to 15 Implementation in any of the systems described.

[0170] Method 300 begins at box 302. At box 302, a first medical instrument is inserted into the treatment site. The first medical instrument can be inserted through the patient's lumen. In an example of kidney stone removal, the patient's lumen may be a ureter. In some examples, the first medical instrument may be inserted percutaneously into the treatment site. The first medical instrument may be an endoscope, nephroscope, catheter, or other type of medical instrument. The first medical instrument may be articulated. In some examples, the first medical instrument is not articulated. In some embodiments, the first medical instrument may include one or more working channels configured to receive various tools (e.g., lithotripters, basket retrieval devices, forceps, etc.) passing through them. The first medical instrument may include at least one first fluid channel. The first fluid channel may be configured to provide a jet to the treatment site during the medical procedure.

[0171] At frame 304, a second medical instrument is inserted into the treatment site. The second medical instrument can be inserted through the patient's lumen. In the example of kidney stone removal, the patient's lumen can be a ureter. In some examples, the second medical instrument can be inserted percutaneously into the treatment site. The second medical instrument can be an endoscope, nephroscope, catheter, or other type of medical instrument. The second medical instrument can be articulated. In some examples, the second medical instrument is not articulated. The second medical instrument may include one or more working channels configured to receive various tools (e.g., lithotripters, basket retrieval devices, forceps, etc.) passing through them. The second medical instrument may include at least one second fluid channel. The second fluid channel may be configured to supply fluid to the treatment site during the medical procedure.

[0172] In some instances, the order of boxes 302 and 304 can be reversed. In some instances, boxes 302 and 304 can be executed simultaneously.

[0173] In some instances, the first and second medical devices are inserted into the treatment site via different access methods. For example, the first medical device may be inserted through a patient lumen while the second medical device may be inserted percutaneously, or the first medical device may be inserted percutaneously while the second medical device may be inserted through a patient lumen. As another example, the first medical device may be inserted into the treatment site through a first patient lumen, and the second medical device may be inserted into the treatment site through a second patient lumen, different from the first patient lumen. As yet another example, the first medical device may be inserted through a first percutaneous route, while the second medical device may be inserted through a second percutaneous route, different from the first percutaneous route. In some examples, the first and second medical devices are inserted through the same patient lumen or through the same percutaneous route.

[0174] In some instances, a first medical device and a second medical device are inserted into a treatment site such that the distal ends of the first and second medical devices are separated within the treatment site. For example, the distal end of the first medical device may be positioned antegrade to the object to be removed, while the distal end of the second medical device may be positioned retrogradely to the object to be removed. As another example, the distal end of the medical device may be positioned retrogradely to the object to be removed, while the distal end of the second medical device may be positioned antegrade to the object to be removed. In some instances, the first and second medical devices are positioned such that the object is positioned between the distal ends of the first and second medical devices.

[0175] In some instances, the distal end of the first medical device may be oriented (e.g., guided or pointed) toward the distal end of the second medical device. Alternatively or additionally, the distal end of the second medical device may be oriented toward the distal end of the first medical device. In some examples, "pointing" may refer to the approximate axis or direction of fluid flow into or out of a first or second fluid channel of the first or second medical device. In some embodiments, the distal ends of the first and second medical devices may include position sensors. The position sensor may be an EM sensor. The EM sensor may be configured to provide positional information and / or orientation information regarding the distal ends of the first and second medical devices. Other types of position and orientation sensors may be used. The output of the position sensor may be used to orient the first and second medical devices. In some embodiments, the first and second medical devices may be oriented visually or by other methods.

[0176] In some instances, the distal end of the first medical instrument may contact the object to be removed. Alternatively or additionally, the distal end of the second medical instrument may contact the object to be removed. In some embodiments, neither instrument contacts the object to be removed.

[0177] At box 306, flushing is provided via a first medical instrument. For example, flushing may be provided via a first fluid channel of the first medical instrument. The first fluid channel may be connected to a flushing source via a pump. The flushing source may provide a liquid flushing agent (e.g., saline solution) for flushing the treatment site. The pump may be configured to move the flushing agent through the fluid channel and into the treatment site. In one example, the pump is a peristaltic pump. The pump may be configured to set a specific flow rate through the first medical instrument. In another example, the pump may be a vacuum source configured to apply negative pressure, which draws the flushing agent from the flushing source, through the first medical instrument, and into the treatment site. The flow rate may be changed by adjusting the vacuum pressure.

[0178] At box 308, aspiration is provided via a second medical device. For example, aspiration can be provided via a second fluid channel of the second medical device. The second fluid channel can be connected to a collection container via a vacuum device. The vacuum device can be configured to apply a negative pressure that draws fluid (e.g., an irrigation solution) from the treatment site through the second medical device and into the collection container. The flow rate can be varied by adjusting the vacuum pressure. In another example, the vacuum device can be replaced by a pump, such as a peristaltic pump. The pump can be used to move fluid (e.g., an irrigation solution) from the treatment site through the second medical device and into the collection container. The pump or vacuum device can be configured to set a specific flow rate through the second medical device.

[0179] In some instances, the order of boxes 306 and 308 may be reversed. In some instances, boxes 306 and 308 may be performed simultaneously. In some instances, boxes 306 and 308 may be performed alternately to provide, for example, flushing followed by suction in a series of repetitive steps.

[0180] At box 310, method 300 determines a characteristic of either flushing or aspiration. This characteristic may be the instantaneous flow rate of flushing or aspiration. This characteristic may be the average flow rate of flushing or aspiration over a time interval. This time interval may be, for example, 1.0 second, 2.5 seconds, 5 seconds, 10 seconds, 15 seconds, or longer, as well as intervals higher and lower than the listed values. This characteristic may be the volume of fluid flushed or aspirated during a time interval, such as any of the time intervals listed above. This characteristic may be the instantaneous fluid pressure associated with flushing or aspiration. This characteristic may be the average fluid pressure associated with flushing or aspiration over a time interval, such as any of the time intervals listed above. Fluid pressure may be, for example, the fluid pressure within a first fluid channel, the fluid pressure within a second fluid channel, or the fluid pressure within the treatment site itself.

[0181] In some instances, one or more sensors are used to determine the characteristics. The sensors may be positioned, for example, in a first fluid channel, on a first medical instrument, in a second fluid channel, on a second medical instrument, or additionally within the treatment site. The sensors may be flow rate sensors, pressure sensors, or other sensors used to determine the flushing or aspiration characteristics. In some embodiments, the sensors may measure intrarenal pressure. In some instances, the characteristic is determined by a pump or vacuum source supplying flushing or aspiration. For example, the characteristic may be determined based on a flow rate set by the pump or a vacuum pressure applied by the vacuum source. In some instances, the characteristic is calculated based on one or more known or measured parameters. For example, the characteristic may include the amount of flushing fluid within the treatment site calculated based on the amount of flushing fluid pumped into the treatment site.

[0182] At box 312, method 300 selects (e.g., sets or adjusts) the characteristic of one of rinsing or suction based on the characteristics determined at box 310. For example, if the characteristics of suction are determined at box 310, the characteristics of rinsing are selected at box 312 based on the determined characteristics. If the characteristics of rinsing are determined at box 310, the characteristics of suction are selected at box 312 based on the determined characteristics.

[0183] The selected characteristic can be any of the characteristics described in the defined characteristics of reference box 310 above. For example, the selected characteristic can be instantaneous flow rate or average flow rate, fluid volume, pressure, etc.

[0184] In some instances, the selected characteristic may correspond to the determined characteristic. For example, if the instantaneous flow rate of flushing is determined, the flow rate of aspiration is selected. This is not necessarily the case in all instances. For example, the flushing volume may be determined, and the instantaneous flow rate or pressure associated with aspiration may be adjusted. In some instances, the selected characteristic is chosen to match the determined characteristic. For example, if the flushing flow rate is determined to be x mL / sec, the aspiration flow rate may be chosen to match it—that is, the aspiration flow rate may be selected as x mL / sec such that the flushing flow rate and the aspiration flow rate match. This is not necessarily the case in all implementations. For example, if the flushing flow rate is determined to be x mL / sec, the aspiration flow rate may be selected based on the determined flow rate without needing to match it exactly—that is, the aspiration flow rate may be selected as y mL / sec such that the flushing flow rate and the aspiration flow rate do not match exactly. In some implementations, the determined characteristic and the selected characteristic are related but not perfectly matched. For example, the aspiration flow rate may be greater than, less than, or equal to the flushing flow rate.

[0185] Through boxes 310 and 312, one of aspiration or flushing can be adjusted based on the other. Therefore, method 300 provides a means for balancing (e.g., momentarily or over a period of time) aspiration and flushing. Method 300 also provides mechanisms for regulating the condition of the treatment site. For example, by balancing flushing and aspiration, the internal fluid volume or pressure of the treatment site can be regulated or maintained. Method 300 also provides mechanisms for regulating the condition of fluid flow. For example, by balancing flushing and aspiration, the flow rate between a first medical instrument and a second medical instrument can be regulated or maintained. Other fluid flow characteristics can be regulated or generated by using method 300, for example, pulsed aspiration and / or flushing.

[0186] Because the fluid flow through the treatment site generated by method 300 is typically from the first medical instrument toward the second medical instrument, method 300 is able to achieve many of the advantages and benefits of the aforementioned directional jet. For example, method 300 can be used to maintain a clear field of view, to draw stones (or stone fragments) toward the second medical instrument for aspiration, to hold stones (or stone fragments) in place during lithotripsy, and / or to allow movement or repositioning of stones (or stone fragments) by holding the stones to the distal end of the second medical instrument.

[0187] Method 300 may include Figure 22A Additional steps or blocks not shown in the diagram. For example, method 300 may include determining characteristics of the treatment site. Characteristics of the treatment site may be, for example, the volume of fluid within the treatment site or the pressure within the treatment site. The determined characteristics of the treatment site may be determined by a sensor or may be calculated based on one or more characteristics of flushing and / or aspiration. In some embodiments, the determined characteristics of the treatment site are the internal pressure of the treatment site, which may be determined based on flushing and aspiration pressure and / or flushing and aspiration flow rate.

[0188] In some instances, the characteristics of the identified treatment site can be compared to a threshold. When it is determined that the identified characteristic meets or exceeds a threshold, the method may include at least one of the following actions: reducing flushing into the treatment site, increasing suction from the treatment site, and providing an alarm. For example, if it is determined that the internal pressure of the treatment site is too high, flushing may be reduced and / or suction increased to lower the pressure within the treatment site. An alarm may also be provided to a physician.

[0189] Method 300 may further include the following step: moving the distal tip of the first medical instrument and / or the distal tip of the second medical instrument in a sweeping motion while providing flushing or aspiration. That is, the distal tip of the first medical instrument and / or the distal tip of the second medical instrument may be moved in a shaking motion.

[0190] Method 300 may further include performing lithotripsy on an object within the treatment site to break the object into fragments. The lithotripsy may be performed using a lithotripter inserted through a first or second medical instrument. Method 300 may also include aspirating fragments of the object through a second fluid channel of the second medical instrument. In some instances, the second medical instrument navigates around the treatment site to collect fragments. In some instances, a fluid flow from the first medical instrument toward the second medical instrument carries the fragments to the second medical instrument for aspiration.

[0191] As previously described, the second medical instrument may be a steerable medical instrument including an articulated distal end. Method 300 may include contacting the distal end with an object within the treatment site. Contacting the distal end may include articulating or navigating the distal end to the object. Contacting the distal end with the object may include drawing the object to the distal end using a fluid flow. Method 300 may also include providing suction through a second fluid channel to hold the object to the distal end of the second medical instrument. The distal end may include a recess configured to hold the object. Method 300 may also include performing lithotripsy while holding the object to the distal end of the second medical instrument. Method 300 may also include moving the second medical instrument while holding the object to the distal end to reposition the object within the treatment site.

[0192] In addition to providing flushing via the first medical instrument at frame 306 and providing aspiration via the second medical instrument 308, method 300 may also include providing flushing via the second medical instrument. In addition to the second fluid channel for providing aspiration, the second medical instrument may also include one or more additional fluid channels for providing flushing. See, for example, [link to relevant documentation]. Figure 26A and Figure 26B The device.

[0193] Figure 22B This is a flowchart illustrating an implementation of another method 350 for managing a directed jet during a medical procedure, such as an object removal surgery. In some examples, the object removal surgery is for removing kidney stones from the kidney. Method 350 can also be implemented in other types of medical procedures and other treatment sites. In some implementations, method 350 is used in robotic medical systems, such as those described above. Figures 1 to 15 Implementation in any of the systems described.

[0194] In method 350, both flushing and aspiration are performed, for example, as described above (see reference). Figure 21B The described single medical device is provided. This medical device may be similar to the following reference. Figure 26A and Figure 26B The medical instrument 700 is described.

[0195] Method 350 begins at box 350. At box 352, a first medical instrument is inserted into the treatment site. The first medical instrument can be inserted through the patient's lumen. In an example of kidney stone removal, the patient's lumen may be a ureter. In some examples, the first medical instrument may be inserted percutaneously into the treatment site. The first medical instrument may be an endoscope, nephroscope, catheter, or other type of medical instrument. The first medical instrument may be articulated. In some examples, the first medical instrument is not articulated. In some embodiments, the first medical instrument may include one or more working channels configured to receive various tools (e.g., lithotripters, basket retrieval devices, forceps, etc.) passing through them. The first medical instrument may include at least one first fluid channel and at least one second fluid channel. The first and second fluid channels may be configured to provide a jet to the treatment site during the medical procedure. In some instances, the distal end of the first medical instrument may contact the object to be removed.

[0196] At box 354, flushing is provided via a first medical instrument. For example, flushing can be provided via a first fluid channel of the first medical instrument. As described above, the first fluid channel can be connected to a flushing source.

[0197] At box 356, aspiration is provided via a first medical instrument. For example, aspiration can be provided via a second fluid channel of the first medical instrument. As described above, the second fluid channel can be connected to a collection container via a vacuum device. In some instances, the order of boxes 354 and 356 can be reversed. In some instances, boxes 354 and 356 can be performed simultaneously. In some instances, boxes 354 and 356 can be performed alternately such that, for example, flushing is provided in a series of repetitive steps, followed by aspiration.

[0198] At box 358, method 350 determines the characteristics of either rinsing or suction as described above. At box 360, method 350 selects (e.g., sets or adjusts) the characteristics of the other of rinsing or suction based on the characteristics of rinsing or suction determined at box 358.

[0199] Method 350 illustrates that, in some examples, directional jets can be delivered via a single medical instrument, such as Figure 26A and Figure 26B The instruments shown are provided. In some embodiments, the second medical instrument may also be used during the procedure to perform other tasks, as described above. For example, the second instrument may be a ureteroscope through which a lithotripter can be deployed to break up the object to be removed.

[0200] Figure 23A flowchart illustrating an implementation of another method 400 for directional jetting during a medical procedure, such as object removal surgery, is provided. In some examples, object removal surgery is a procedure for removing kidney stones from a kidney. Method 400 can also be implemented in other types of medical procedures and other treatment sites. In some implementations, method 400 is implemented in a robotic medical system, such as those described above. Figures 1 to 15 Implemented in any system described in the system. In some instances, method 400 can be used with... Figure 22A Method 300 and / or Figure 22B Method 350 is executed together.

[0201] Method 400 begins at box 402. At box 402, a first medical instrument is positioned in the treatment site. The first medical instrument can be inserted through the patient's lumen. In an example of kidney stone removal, the patient's lumen may be a ureter. In some examples, the first medical instrument may be inserted percutaneously into the treatment site. The first medical instrument may be an endoscope, nephroscope, catheter, or other type of medical instrument. The first medical instrument may be articulated. In some examples, the first medical instrument is not articulated. In some embodiments, the first medical instrument may include one or more working channels configured to receive various tools (e.g., lithotripters, basket devices, forceps, etc.) passing through it. The first medical instrument may include at least one first fluid channel. The first fluid channel may be configured to provide a jet to the treatment site during the medical procedure.

[0202] At frame 404, a second medical instrument is positioned in the treatment site. The second medical instrument can be inserted through the patient's lumen. In the example of kidney stone removal, the patient's lumen may be a ureter. In some examples, the second medical instrument may be percutaneously inserted into the treatment site. The second medical instrument may be an endoscope, nephroscope, catheter, or other type of medical instrument. The second medical instrument may be articulated. In some examples, the second medical instrument is not articulated. The second medical instrument may include one or more working channels configured to receive various tools (e.g., lithotripters, basket retrieval devices, forceps, etc.) passing through them. The second medical instrument may include at least one second fluid channel. The second fluid channel may be configured to provide a jet to the treatment site during the medical procedure.

[0203] In some instances, the order of boxes 402 and 404 can be reversed. In some instances, boxes 402 and 404 can be executed simultaneously.

[0204] In some instances, the first and second medical devices are positioned at the treatment site via different access methods. For example, the first medical device may be inserted through a patient lumen while the second medical device may be inserted percutaneously, or the first medical device may be inserted percutaneously while the second medical device may be inserted through a patient lumen. As another example, the first medical device may be inserted into the treatment site through a first patient lumen, while the second medical device may be inserted into the treatment site through a second patient lumen, different from the first patient lumen. As yet another example, the first medical device may be inserted through a first percutaneous route, while the second medical device may be inserted through a second percutaneous route, different from the first percutaneous route. In some examples, the first and second medical devices are inserted through the same patient lumen or through the same percutaneous route.

[0205] In some instances, the first and second medical devices are positioned within a treatment site such that the distal ends of the first and second medical devices are separated within the treatment site. For example, the distal end of the first medical device may be antegrade to the positioning of the object to be removed, while the distal end of the second medical device may be retrograde to the positioning of the object to be removed. As another example, the distal end of the first medical device may be retrograde to the positioning of the object to be removed, while the distal end of the second medical device may be antegrade to the positioning of the object to be removed. In some instances, the first and second medical devices are positioned such that the object is positioned between the distal ends of the first and second medical devices.

[0206] At block 406, flushing is provided through a first orifice of the first medical instrument in a first fluid flow direction. In some embodiments, the first fluid flow direction may be perpendicular to the first orifice. The first fluid flow direction may be the general flow direction of the fluid exiting the first fluid orifice. At block 408, suction is provided through a second orifice of the second medical instrument. In some instances, the order of blocks 406 and 408 may be reversed. In some instances, blocks 406 and 408 may be performed simultaneously.

[0207] At box 410, the first medical instrument and / or the second medical instrument are manipulated such that a first flow direction is oriented toward a second orifice of the second medical instrument. Manipulating the first medical instrument and / or the second medical instrument may include remote manipulation and / or robotic manipulation of the first medical instrument and / or the second medical instrument. Manipulating the first medical instrument and / or the second medical instrument may include moving the first medical instrument and / or the second medical instrument such that a first fluid flow direction is oriented toward or towards the second fluid orifice.

[0208] According to method 400, directing the fluid flow from the first medical instrument toward the second medical instrument can provide one or more of the benefits mentioned above.

[0209] Method 400 may include one or more additional steps. For example, method 400 may include determining the position and / or orientation of the distal end of a first medical instrument and / or the distal end of a second medical instrument. The first and / or second medical instruments may include a position sensor at their distal ends. The position sensor may be an EM sensor. The EM sensor may be configured to provide position information and orientation information regarding the distal ends of the first and second medical instruments. For example, other types of position and orientation sensors, such as shape-sensing fibers, may be used. The output of the position sensor may be used to orient the first and second medical instruments.

[0210] In some embodiments of method 400, block 410 occurs automatically. For example, the positions and orientations of the distal ends of the first and second medical instruments can be determined, and the first and second medical instruments can be manipulated automatically. For example, the orientation of the first medical instrument can be automatically manipulated to track the position of the second medical instrument. That is, as the second medical instrument moves, the orientation of the first medical instrument is automatically adjusted such that the first fluid flow direction remains directed toward or towards the second medical instrument. This can help ensure that the fluid flow remains oriented in the correct direction.

[0211] Figure 24 This is a flowchart illustrating an implementation of a method 500 for holding and repositioning an object using a directional jet during a medical procedure, such as an object removal surgery. In some examples, the object removal surgery is for removing kidney stones from a kidney. Method 500 can also be implemented in other types of medical procedures and other treatment sites. In some implementations, method 500 is used in robotic medical systems, such as those described above. Figures 1 to 15 Implemented in any system described in the system. In some instances, method 500 can be used with... Figure 22A Method 300 Figure 22B Method 350 and Figure 23 Method 400 is executed together. In some instances, method 500 can be used. Figure 26A and Figure 26B The medical equipment was adopted.

[0212] Method 500 begins at box 502. At box 502, a first medical instrument is positioned in the treatment site. For example, the first medical instrument may be inserted through a patient's lumen. In an example of kidney stone removal, the patient's lumen may be a ureter. In some examples, the first medical instrument may be percutaneously inserted into the treatment site. The first medical instrument may be an endoscope, nephroscope, catheter, or other type of medical instrument. The first medical instrument may be articulated. In some examples, the first medical instrument is not articulated. In some embodiments, the first medical instrument may include one or more working channels configured to receive various tools (e.g., lithotripters, basket retrieval devices, forceps, etc.) passing through them. The first medical instrument may include at least one first fluid channel. The first fluid channel may be configured to provide a jet to or from the treatment site during the medical procedure.

[0213] At box 504, the distal end of the first medical instrument is brought into contact with the object to be removed. Bringing the distal end into contact with the object may include hinged or navigating the distal end to the object. In some instances, the hinged or navigated first medical instrument is robotically achieved, for example, by manipulating the first medical instrument via an instrument manipulator or robotic arm to which the first medical instrument is attached. In some instances, the hinge or navigation is controlled by a physician controlling a robotic system. In some instances, the hinge or navigation is determined automatically by the robotic system. For example, the robotic system may determine the positions of the object and the first medical instrument and navigate the first medical instrument to the object. Bringing the distal end into contact with the object may include drawing the object to the distal end using a fluid flow, for example, by suction through the first medical instrument and / or flushing provided by a second medical instrument.

[0214] At box 506, suction is provided by a first medical instrument to hold the object to the distal end of the first medical instrument. A vacuum device connected to the first medical instrument may be provided to the suction. The vacuum device may be configured to apply a negative pressure that draws fluid from the treatment site through the first medical instrument. In another example, the vacuum device may be replaced by a pump, such as a peristaltic pump. The pump may be used to move fluid from the treatment site through the first medical instrument. When fluid is aspirated through the first medical instrument, the fluid flow can hold the object to the distal end of the first medical instrument. In some instances, the first medical instrument may include a recess (or other receiving or holding device) at its distal end to help secure the object. See, for example, [link to relevant documentation]. Figure 26A and Figure 26B .

[0215] At box 508, the first medical instrument is moved within the treatment site to reposition the object. During movement, suction can be maintained to hold the object to its distal end. The movement can be performed robotically. The movement can be automatic (e.g., following pre-programmed actions or moving to a pre-programmed location) or based on physician input or control. In some instances, the first medical instrument is used to move the object within the treatment site to a location more suitable for lithotripsy. For example, the object can be moved to a location where fragments can be more easily collected or where there is more workspace. As another example, the object can be moved away from sensitive areas of the patient's anatomy. In some implementations, box 508 can be omitted. That is, in some implementations, repositioning the object within the treatment site is not required.

[0216] At frame 510, lithotripsy is performed on the subject using a second medical instrument while flushing is being provided. Alternatively, lithotripsy can be performed while the subject is held at the distal end of a first medical instrument. The fluid flow from the second medical instrument to the first medical instrument can be used to hold the subject during lithotripsy and to guide debris and dust into the first fluid instrument for suction and removal. The fluid flow also maintains a clear field of vision, which assists the physician in performing the procedure.

[0217] Method 500 may include one or more additional steps. For example, method 500 may include providing flushing via a first medical instrument. The first medical instrument may include one or more additional fluid channels for providing flushing (in addition to a first fluid channel for providing aspiration). The additional fluid channels may be, for example, as described below. Figure 26A and Figure 26B The arrangement shown in the device. The outflow of the flush can be directed away (e.g., radially away) from the distal end of the first medical instrument.

[0218] D. Example systems and apparatus for directed jet technology

[0219] Figure 25 This is a block diagram illustrating an implementation of a system 600 for using directional jetting during medical procedures, such as object removal surgery. In some instances, system 600 can be used to implement the methods 300, 400, and 500 described above. Furthermore, system 600 can form the above-mentioned reference... Figures 1 to 15 Any part of the robot system described.

[0220] As illustrated, system 600 includes a first medical instrument 616, a second medical instrument 620, a pump 608 connected to the first medical instrument 616, a vacuum device 612 connected to the second medical instrument 620, and a directional jet module or jet control system 602 connected to the pump 608 and the vacuum device 612. The directional jet control system 602 may be configured to control the pump 608 and the vacuum device 612 to provide directional jets (e.g., flushing and aspiration) to the treatment site via the first medical instrument 616 and the second medical instrument 620.

[0221] The first medical instrument 616 may be configured to be inserted into the treatment site via a patient lumen. Alternatively, the first medical instrument 616 may be configured to be inserted percutaneously into the treatment site. The first medical instrument 616 may be an endoscope (e.g., a ureteroscope), a catheter (e.g., a steerable or non-steerable catheter), a nephroscope, or other types of medical instruments as described herein. The first medical instrument 616 may include a first fluid channel for providing a jet (flushing or aspiration). In the illustrated embodiment, the first medical instrument is attached to a pump 608 for providing flushing. The pump 608 is attached to a flushing source 610 that provides a flushing agent (e.g., a saline solution) to be pumped through the first medical instrument and into the treatment site. In some examples, the pump 608 is a peristaltic pump. In some embodiments, the pump 608 may be replaced by a vacuum device that applies a vacuum pressure to draw the flushing agent from the flushing source 610 and extract it through the first medical instrument 616.

[0222] A first medical device 616 can be connected to a first instrument manipulator 624. The first instrument manipulator 624 can be robotically controlled to manipulate the first medical device 616. For example, the first medical device 616 can be articulated or steerable, and the first instrument manipulator 624 can be used to articulate or steer the first medical device. Furthermore, the first medical device manipulator 624 can be attached to a robotic arm configured to insert or retract the first medical device 616 into or from a treatment site. An example of an instrument manipulator is described above. Figures 1 to 15 As described. The first medical device 616 may include one or more working channels through which additional tools, such as lithotripters, basket retrieval devices, forceps, etc., can be introduced into the treatment site.

[0223] The second medical instrument 620 may be configured to be inserted into the treatment site via a percutaneous approach. Alternatively, the second medical instrument 620 may be configured to be inserted into the treatment site via a patient lumen. The second medical instrument 620 may be an endoscope (e.g., a ureteroscope), a catheter (e.g., a steerable or non-steerable catheter), a nephroscope, or other types of medical instruments as described herein. The second medical instrument 620 may include a second fluid channel for providing a jet (flushing or aspiration). In the illustrated embodiment, the second medical instrument is attached to a vacuum device 612 for providing aspiration. The vacuum device 612 may be configured to apply negative pressure to draw fluid from the treatment site. The vacuum device 612 is connected to a collection container into which the aspirated fluid is collected. In some examples, the vacuum device 612 may be replaced by a pump that pumps liquid from the treatment site through the second medical instrument 620 and into the collection container 614.

[0224] The second medical device 620 can be connected to a second instrument manipulator 626. The second instrument manipulator 626 can be robotically controlled to manipulate the second medical device 620. For example, the second medical device 620 can be articulated or steerable, and the second instrument manipulator 626 can be configured to articulate or steer the second medical device 620. Furthermore, the second medical device manipulator 626 can be attached to a robotic arm configured to insert or retract the second medical device 620 into or from a treatment site. The second medical device 620 may include one or more working channels through which additional tools, such as lithotripters, basket removal devices, forceps, etc., can be introduced into the treatment site.

[0225] In some embodiments, the jet is provided by only one of the first medical instrument 616 or the second medical instrument 620, wherein the instrument provides both flushing and aspiration. The instrument providing the jet can be inserted percutaneously into the patient. In some embodiments, the instrument may be similar to Figure 26A and Figure 26B The instrument shown in the figure. The other of the first medical instrument 616 or the second medical instrument 620 may not provide a jet and may be used for other functions, such as breaking the object to be removed.

[0226] The jet control system 602 may include a processor 604 and a memory 606. The memory 606 may include instructions configuring the processor 604 to determine characteristics of either flushing or aspiration, and to control characteristics of at least one of a pump or vacuum device based on the determined characteristics. The determined characteristics may be, for example, the instantaneous flow rate of flushing or aspiration. This characteristic may be the average flow rate of flushing or aspiration over a time interval. The time interval may be, for example, 1.0 second, 2.5 seconds, 5 seconds, 10 seconds, 15 seconds, or longer, as well as intervals higher and lower than the listed values. This characteristic may be the volume of fluid flushed or aspirated during a time interval, such as any of the time intervals listed above. This characteristic may be the instantaneous fluid pressure associated with flushing or aspiration. This characteristic may be the average fluid pressure associated with flushing or aspiration over a time interval, such as any of the time intervals listed above. The fluid pressure may be, for example, the fluid pressure in a first fluid channel, the fluid pressure in a second fluid channel, or the fluid pressure within the treatment site itself.

[0227] In some instances, one or more sensors, such as sensors 618 and 622 located on the first medical instrument 616 and the second medical instrument 620, respectively, are used to determine the characteristics. Sensor 618 may be positioned, for example, in a first fluid channel of the first medical instrument 616 or on the first medical instrument 616 itself. Sensor 622 may be positioned in a second fluid channel of the second medical instrument 620 or on the second medical instrument 620 itself. In some embodiments, one or both of the first medical instrument 616 and the second medical instrument 620 include multiple sensors 616 and 622. Sensors 618 and 622 may be flow rate sensors, pressure sensors, or other sensors used to determine the characteristics of flushing or aspiration. Outputs from sensors 616 and 622 may be connected to processor 604, allowing processor 604 to use the outputs of sensors 618 and 622 to determine the characteristics. In some instances, the characteristics are determined by a pump 608 or a vacuum device supplying flushing or aspiration. For example, the characteristics may be determined based on a flow rate set by pump 608 or a vacuum pressure applied by vacuum device 612. In some instances, the characteristics are calculated based on one or more known or measured parameters. For example, a characteristic may include the volume of flushing fluid within the treatment site, calculated based on the amount of flushing fluid pumped into and / or aspirated from the treatment site.

[0228] In some embodiments, sensors 618 and 622 include position sensors configured to provide position information about the first medical instrument 616 and the second medical instrument 620. The position sensors can provide three degrees of freedom (e.g., x, y, and z coordinates) or six degrees of freedom (e.g., x, y, and z coordinates plus pitch, roll, and yaw angles). Position sensors 618 and 622 can be, for example, EM sensors, shape-sensing fibers, or other types of position sensors including accelerometers, gyroscopes, etc.

[0229] In some embodiments, the memory 606 includes instructions to further configure the processor 604 to calculate the position of the first position sensor to determine the position of the first medical instrument 616, calculate the position of the second position sensor to determine the position of the second medical instrument 620, and manipulate the first medical instrument 616 or the second medical instrument 620 such that the outflow port of the first medical instrument 616 is oriented toward the inflow port of the second medical instrument 620.

[0230] One or both of the first medical device 616 and the second medical device 620 can be configured to provide both flushing and aspiration. For example, as Figure 25 As illustrated, the second medical device 620 can be connected to a vacuum device 612 for providing suction, and can also (via dashed lines) be connected to a pump 608 for providing flushing. In this embodiment, the second medical device 620 may include additional fluid channels for providing flushing. The following... Figure 26A and Figure 26B An example of a medical device 700 is shown, which includes a first fluid channel for providing aspiration or flushing and an additional fluid channel for providing the other of aspiration or flushing.

[0231] Figure 26A and Figure 26B These are perspective and cross-sectional views of the distal end of a medical instrument 700 configured to provide suction and flushing during object removal surgery. The medical instrument 700 can be used as either the first or second medical instrument described above. The medical instrument 700 can be inserted percutaneously or through a patient lumen into the treatment site.

[0232] Reference Figure 26A and Figure 26BThe medical device 700 may include an elongated body 702 terminating at a distal end 704. In the illustrated embodiment, a recess 706 or concave portion is formed in the distal face of the distal end. The recess 706 provides a space therein to receive an object to be removed during surgery. In some embodiments, suction and / or flushing retain the object in the recess 706. During lithotripsy, the object can be held in the recess 706 to stabilize and secure it. As the object is broken up by lithotripsy, fragments and dust can be suctioned out by the medical device 700.

[0233] Medical device 700 may include fluid channel 708 (see Figure 26B The fluid channel 708 may terminate at a distal end having a fluid orifice 710. The fluid channel 708 may be used for suction or flushing. In one example, the fluid channel 708 is used for suction, and the fluid drawn into the fluid channel 708 may be used to hold an object within the recess 706.

[0234] The medical device 700 may also include one or more additional channels 712 surrounding the fluid channel 708 (see Figure 26B These additional channels 712 can be configured to provide either aspiration or flushing, compared to the fluid channel 708. The additional channels 712 may terminate at an orifice 714 near the distal end 704 of the medical instrument. The orifice 714 may be positioned in the radial surface of the medical instrument 700 to direct the flow through the orifice radially, for example, as... Figure 21A and Figure 21B As shown in the diagram. In some embodiments, the medical device 700 includes four orifices 714. In some embodiments, the orifices 714 guide fluid in a direction orthogonal or substantially orthogonal to the longitudinal axis of the medical device 700. In some embodiments, the orifices 714 guide fluid in a direction non-orthogonal or at an angle relative to the longitudinal axis of the medical device 700.

[0235] The medical instrument 700 may be articulated. For example, the medical instrument may include a draw cable (or other mechanism) for controlling the shape or orientation of the medical instrument 700.

[0236] Figure 27 An embodiment of a robotic system 800 is illustrated, which is arranged to perform object removal surgery using a directional jet. The robotic system 800 can be similar to the one described above. Figures 1 to 15The described robotic system. In the illustrated embodiment, the robotic system includes multiple robotic arms 805. The robotic arms 805 can be configured to manipulate instruments and tools used during surgery. As illustrated, system 800 includes three robotic arms 805a, 805b, and 805c. Other numbers of robotic arms 805 may be used in other embodiments.

[0237] Robotic arms 805a and 805b can be attached to a first instrument 801. The first instrument 801 may include an outer sheath having a working channel and an internal catheter positioned within the outer sheath. In some embodiments, robotic arm 805a controls the outer sheath, and robotic arm 805b controls the internal sheath. The first instrument 801 can be inserted into a patient's body through a patient lumen. As illustrated, robotic arms 805a and 805b can insert the first instrument 801 through the urethra into the patient's lower abdomen. In some embodiments, insertion is performed along a virtual trajectory as described above. After insertion into the urethra, using the control techniques described above, the first instrument 801 can be navigated to a treatment site (e.g., the bladder, ureter, and / or kidney) for diagnostic and / or therapeutic applications.

[0238] Robotic arm 805c can be attached to second instrument 802. In some embodiments, second instrument 802 may include an outer sheath having a working channel and an internal catheter positioned within the outer sheath. In some embodiments, multiple robotic arms may be used to manipulate second instrument 802. In the illustrated embodiment, second instrument 802 is percutaneously (i.e., laparoscopically) inserted into the treatment site.

[0239] like Figure 27 As shown, with the first instrument 801 and the second instrument 802 positioned by the robotic arm 805, the system 800 can be configured to achieve the directional jet as described above. For example, the first instrument 801 and the second instrument 802 can be used to provide flushing and suction to the treatment site as described above.

[0240] Figure 27 An example of a robotic system 800 configured for directional jetting is provided. Other systems including other numbers or types of robotic arms, other numbers or types of medical instruments, and / or other methods for inserting and controlling instruments are also possible.

[0241] 3. Implementation System and Terminology

[0242] The embodiments disclosed herein provide systems, methods, and apparatus for removing objects from a patient's treatment site, and specifically relate to methods and systems for employing directed jetting during object removal procedures. Directed jetting techniques may include controlling various characteristics (e.g., rate, direction, pressure, etc.) of the fluid flow through the treatment site for flushing and / or aspiration, and / or separating the inflow point of flushing from the outflow point of aspiration to facilitate object removal procedures. In some examples, directed jetting techniques involve controlling the flow direction from the inflow point to the outflow point to hold or stabilize the object during the procedure.

[0243] It should be noted that the terms “connected,” “being connected,” “being connected,” or other variations of the word “connected,” as used herein, can indicate indirect or direct connection. For example, if a first component is “connected” to a second component, the first component can be indirectly connected to the second component through another component, or directly connected to the second component.

[0244] The phrases and features of specific computer implementation processes / functions described herein, as used herein, may be stored as one or more instructions on a processor-readable or computer-readable medium. The term "computer-readable medium" refers to any available medium that can be accessed by a computer or processor. By way of example and not limitation, such media may include random access memory (RAM), read-only memory (ROM), electrically erasable programmable read-only memory (EEPROM), flash memory, optical disc read-only memory (CD-ROM) or other optical disc storage devices, magnetic disk storage devices or other magnetic storage devices, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer. It should be noted that computer-readable media may be tangible and non-transitory. As used herein, the term "code" may refer to software, instructions, code, or data that can be executed by a computing device or processor.

[0245] The methods disclosed herein include one or more steps or actions for implementing the described methods. The steps and / or actions of the method may be interchanged without departing from the scope of the claims. In other words, the order and / or use of specific steps and / or actions may be modified without departing from the scope of the claims unless proper operation of the described methods requires a specific order of steps or actions.

[0246] As used herein, the term "multiple" means two or more. For example, multiple components means two or more components. The term "determine" encompasses a variety of actions, and therefore, "determine" can include calculation, operation, processing, derivation, research, lookup (e.g., searching in a table, database, or other data structure), determination, etc. Furthermore, "determine" can include receiving (e.g., receiving information), accessing (e.g., accessing data in memory), etc. Additionally, "determine" can include parsing, selecting, choosing, establishing, etc.

[0247] Unless otherwise explicitly stated, the phrase “based on” does not mean “based on only”. In other words, the phrase “based on” describes both “based on only” and “based on at least”.

[0248] The prior description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the invention. Various modifications to these embodiments will be apparent to those skilled in the art, and the general principles defined herein can be applied to other embodiments without departing from the scope of the invention. For example, it will be understood that those skilled in the art will be able to employ many corresponding alternatives and equivalent structural details, such as equivalent ways of fastening, mounting, connecting, or engaging tool components, equivalent mechanisms for generating specific actuating movements, and equivalent mechanisms for transmitting electrical energy. Therefore, the invention is not intended to be limited to the embodiments shown herein, but should be given the broadest scope consistent with the principles and novel features disclosed herein.

Claims

1. A system for performing a medical procedure to remove kidney stones, the system comprising: A first medical device, configured to be percutaneously inserted into a treatment site, the first medical device including a first fluid channel and a second fluid channel; A second medical device, configured to be advanced through a patient's lumen to the treatment site, the second medical device being equipped with a lithotripter; and The jet control system includes a processor configured to: The first fluid channel of the first medical instrument provides flushing to the treatment area; The kidney stone is held against the first medical instrument by flushing through the first fluid channel; as well as The held kidney stones are broken up using the lithotripter deployed by the second medical instrument.

2. The system of claim 1, wherein, The processor is also configured to: Determine the location of the kidney stone; and Navigate the distal end of the first medical instrument toward the determined location of the kidney stone.

3. The system according to claim 1, wherein, The processor is also configured to aspirate fragments of the broken kidney stone through the second fluid channel to remove the kidney stone.

4. The system according to claim 1, wherein, The processor is also configured to: Aspiration is provided from the treatment site through the second fluid channel of the first medical instrument; Determine at least one characteristic of the flushing provided through the first fluid channel; and Based on the determined at least one characteristic of the flushing, aspiration is provided from the treatment site through the second fluid channel of the first medical instrument.

5. The system according to claim 4, wherein, The at least one characteristic of flushing includes the instantaneous flow rate of flushing, the average flow rate of flushing over a time interval, the volume of fluid flushed during the time interval, the instantaneous fluid pressure associated with flushing, or the average fluid pressure associated with flushing.

6. The system according to claim 1, wherein, The processor is also configured to: Determine the orientation of the first medical instrument; and The orientation of the second medical instrument is adjusted based on the determined orientation of the first medical instrument.

7. The system according to claim 4, wherein, The processor is also configured to: Determine at least one characteristic of the treatment site; Compare at least one characteristic of the treatment site with a threshold; and Based on the comparison, at least one of reducing flushing into the treatment site and increasing suction from the treatment site is performed.

8. The system according to claim 7, wherein, The at least one characteristic of the treatment site is determined based on a plurality of sensors located near the treatment site and at least one of one or more characteristics of flushing and one or more characteristics of suction.

9. A medical device for removing kidney stones, the medical device comprising: A hinged elongated body extending along an axis to a distal end; A first fluid channel extending along the axis to provide flushing to the treatment site, wherein the first fluid channel terminates at a first fluid orifice formed in the distal face of the distal end; and At least one additional fluid channel, formed through the articulated elongated body, provides suction from the treatment site, wherein the at least one additional fluid channel terminates at at least one additional fluid outlet orifice formed in a radial surface of the articulated elongated body adjacent to the distal end. The medical device further includes a recess formed in the distal face of the distal end, wherein the recess is configured to at least partially receive and retain the kidney stone to be removed during a medical procedure.

10. The medical device according to claim 9, wherein, The at least one additional fluid channel surrounds the first fluid channel in a ring.

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