Management of fixation mechanisms

A robotic system with force sensors and actuators addresses the issue of stuck instruments by detecting and managing stuck states, enhancing safety and precision in medical procedures.

KR103041320B1Active Publication Date: 2026-11-03AURIS HEALTH INC
View PDF 6 Cites 0 Cited by

Patent Information

Application Number
KR1020227046080
Authority / Receiving Office
KR · KR
Patent Type
Patents
Current Assignee / Owner
Priority Date
2020-06-01
Filing Date
2021-06-01
Publication Date
2026-11-03
Estimated Expiration
2041-06-01

AI Technical Summary

Technical Problem

The retraction and removal of medical instruments from anatomical cavities can cause damage to biological tissues and instruments due to the risk of instruments becoming stuck, leading to adverse consequences.

Method used

A robotic system with force sensors and actuators detects a stuck state by monitoring force readings during dithering motions and provides warnings or adjusts retraction speed to prevent instrument damage, utilizing robotic arms and control circuits to manage the advancement and retraction of medical devices.

Benefits of technology

Enhances safety by reducing the risk of instrument damage and tissue injury during medical procedures by detecting and managing stuck states, providing enhanced precision and control through robotic assistance.

✦ Generated by Eureka AI based on patent content.

Smart Images

  • Figure 112022141140256-PCT00009_ABST
    Figure 112022141140256-PCT00009_ABST
Patent Text Reader

Abstract

A method for detecting a stuck basket state includes the steps of: retracting an endoscope, in which a basket device is at least partially positioned within a working channel, into the anatomical cavity of a patient; determining that a force reading associated with at least one of the basket device and the endoscope exceeds a predetermined threshold; and determining that the basket device is in a stuck state based at least partially on the determination that the force reading exceeds the predetermined threshold.
Need to check novelty before this filing date? Find Prior Art

Description

Technology Field

[0001] Related application(s)

[0002] This application claims priority to U.S. Provisional Application No. 63 / 033,089, filed June 1, 2020, whose disclosure is incorporated herein by reference in its entirety, and whose title of invention is STUCK INSTRUMENT MANAGEMENT.

[0003] This disclosure relates to the field of medical devices and procedures. Background Technology

[0004] Various medical procedures involve the use of one or more medical instruments within an anatomical cavity. The retraction and / or removal of such instrument(s) from the anatomical cavity may give rise to certain problems that cause damage to biological tissues, instrument component(s), and / or other adverse consequences. Prior art literature

[65535] (Patent Document 0001) US 20170303945 A1 (2017-10-26)(Patent Document 0002) WO 2015134846 A1 (2015-09-11)

[0005] Systems, devices, and methods for facilitating the management and / or determination of a stuck-instrument condition in connection with the execution of a specific medical procedure step, such as instrument retraction, are described herein.

[0006] In some embodiments, the present disclosure relates to a method for detecting a stuck basket condition. The method comprises the steps of: retracting an endoscope, in which a basket device is at least partially positioned within a working channel, into a patient's anatomical cavity; determining that a force reading associated with at least one of the basket device and the endoscope exceeds a predetermined threshold; and determining that the basket device is in a stuck state based at least partially on the determination that the force reading exceeds the predetermined threshold.

[0007] The method may further include a step of axially dithering the basket device, and a step of determining that a force reading associated with at least one of the basket device and the endoscope exceeds a predetermined threshold is performed while dithering the basket device. The method may further include a step of accessing an anatomical cavity with an endoscope through the anatomical structure of a patient's urinary tract, a step of advancing the basket device from the working channel of the endoscope, a step of capturing an object placed within the anatomical cavity with the basket device, a step of determining that at least one of the basket device and the endoscope has entered a hazard zone, and a step of initiating axial dithering of the basket device in response to the step of determining that at least one of the basket device and the endoscope has entered a hazard zone. For example, the step of determining that at least one of the basket device and the endoscope has entered a danger zone is based at least partially on robotic actuator data generated by one or more robotic actuators configured to operate one or more of the endoscope and the basket device. In some embodiments, the step of determining that at least one of the basket device and the endoscope has entered a danger zone is based at least partially on position sensor data associated with one or more of the endoscope and the basket device. In some embodiments, the danger zone includes the ureteropelvic junction of the patient's kidney. Dithering of the basket device may be for the distal end of the endoscope. Dithering of the basket may include dithering the endoscope.

[0008] The method may further include the step of reducing the retraction speed of the endoscope based at least partially on a determined sticking state of the basket device. In some embodiments, the force reading represents an axial force experienced in the proximal portion of the sheath of the basket device. In some embodiments, the force reading represents an axial force on one or more tines of the basket device. In some embodiments, the force reading represents an axial force experienced in the proximal portion of the endoscope. The method may further include the step of presenting a warning in response to a determined sticking state.

[0009] In some embodiments, the present disclosure comprises one or more robotic arms; one or more instrument manipulators coupled to each of the one or more robotic arms; one or more actuators associated with at least one of the one or more instrument manipulators, configured to cause axial movement of at least one of an endoscope, a sheath of a basket device at least partially disposed within the endoscope, and tines of the basket device; one or more sensors associated with the one or more instrument manipulators, configured to generate signals indicating forces experienced by the one or more actuators; and a control circuit communically coupled to the one or more instrument manipulators and the one or more sensors, wherein the basket device is moved forward and backward in a dithering motion, and receives signals from the one or more sensors indicating forces experienced by the one or more actuators while the basket device is moving in the dithering motion, and determines that the force is greater than a predetermined threshold, and that the force is greater than the predetermined threshold The invention relates to a robot system comprising a control circuit configured to execute a response action in response to a decision that it is large.

[0010] The response action may include providing a warning to the user indicating that the basket device is in a stuck state. In some embodiments, the response action includes reducing the retraction speed of the endoscope. In some embodiments, the response action includes stopping the retraction of the endoscope. One or more actuators may include one or more basket sheath actuators. In some embodiments, one or more actuators include one or more basket tine actuators. In some embodiments, one or more actuators include one or more endoscope actuators. One or more sensors may be configured to determine at least one of the insertion and retraction forces associated with the endoscope.

[0011] In some embodiments, the present disclosure relates to a method for detecting a stuck state for a medical device. The method comprises the steps of determining that a force on a component of a medical device is greater than a predetermined force threshold while the medical device is retracting in a dithering motion; starting a timer in response to the determination that the force is greater than the predetermined threshold; determining that the timer has exceeded a predetermined time threshold; and initiating a response action in response to the determination that the timer has exceeded the predetermined time threshold.

[0012] The response action may include generating a warning indicating that the medical device is in a stuck state. The response action may include stopping the retraction of the medical device. The method may further include the step of initiating dithering of one or more components of the medical device in response to a determination that a portion of the medical device is located within a stuck risk zone. For example, the method may further include the step of determining the stuck risk zone based at least partially on the location of the distal end of the sheath where the medical device is at least partially placed.

[0013] In some embodiments, the present disclosure relates to a computing device comprising a robotic system interface and a control circuit that is communicably coupled to the robotic system interface and includes one or more processors and one or more data storage devices. The control circuit may be configured to cause a basket device to be dithered with respect to a working channel of an endoscope in which the basket device is at least partially placed, and to determine that the force experienced by one or more components of the basket device while the basket device is dithered indicates a stuck state of the basket device.

[0014] The determination that the force indicates a stuck state may be based on one or more of the driving behavior of the user operating the endoscope and the size of the object captured by the basket device. In some embodiments, the control circuit is further configured to disable the dithering of the basket in response to a determination that the basket device and the endoscope have retracted within the approach sheath. In some embodiments, the control circuit is further configured to stop the motion of the endoscope in response to a stuck state.

[0015] To summarize the present disclosure, certain aspects, advantages, and novel features have been described. It should be understood that not all such advantages may necessarily be achieved according to any specific embodiment. Accordingly, the disclosed embodiments may be performed in a manner that achieves or optimizes one advantage or a group of advantages as taught herein without necessarily achieving other advantages as taught or suggested herein. Brief explanation of the drawing

[0016] Various embodiments are depicted in the accompanying drawings for exemplary purposes and should not be construed as limiting the scope of the invention in any way. Additionally, various features of different disclosed embodiments may be combined to form additional embodiments that are part of the present disclosure. Throughout the drawings, reference numerals may be reused to indicate correspondences between reference elements. FIG. 1 is a drawing illustrating an embodiment of a medical system comprising one or more basketing components according to one or more embodiments. FIG. 2 is a drawing illustrating a medical system component that can be implemented in the medical system of FIG. 1 according to one or more embodiments. FIG. 3 is a drawing illustrating a ureteroscope including a basketing device within its working channel, positioned in a part of a patient's urinary system according to one or more embodiments. FIGS. 4a to 4d are drawings illustrating basketing systems of various configurations according to one or more embodiments. FIG. 5 is a drawing illustrating various medical devices including a predetermined basketing device component placed in a part of the patient's kidney anatomical structure according to one or more embodiments. FIG. 6a is a drawing illustrating the field of view of an endoscope camera in which a basketing device is observable, according to one or more embodiments. FIG. 6b is a side view of a medical device assembly corresponding to the configuration of a basketing device for an endoscope camera of FIG. 6a according to one or more embodiments. FIG. 7a is a drawing showing the field of view of an endoscope camera in which a fixed-state basketing device according to one or more embodiments can be observed. FIG. 7b is a side view of a medical device assembly corresponding to the configuration of a basketing device for an endoscope camera of FIG. 7a according to one or more embodiments. FIG. 8 is a drawing illustrating a fixation-mechanism image recognition architecture according to one or more embodiments. FIGS. 9-1 and FIGS. 9-2 are flowcharts illustrating a process for managing a fixation-mechanism state according to one or more embodiments. FIGS. 10-1 and FIGS. 10-2 are drawings illustrating certain images corresponding to various blocks, states, and / or operations associated with the process of FIGS. 9-1 and FIGS. 9-2 according to one or more embodiments. FIG. 11 is a flowchart illustrating a process for handling a sticking-mechanism state according to one or more embodiments. FIG. 12 is a flowchart illustrating a process for managing false positive sensor readings on an insertion axis according to one or more embodiments. FIG. 13 is a flowchart illustrating a process for managing false positive sensor readings on an insertion axis according to one or more embodiments. FIG. 14 is a drawing illustrating a false positive correction (remedial action) according to one or more embodiments. FIG. 15 is a flowchart illustrating a process for adjusting a dithering zone / range according to one or more embodiments. FIG. 16 is a drawing illustrating a predetermined image corresponding to various blocks, states, and / or operations associated with the process of FIG. 15 according to one or more embodiments. FIG. 17 is a flowchart illustrating a process for adjusting a dithering zone / range according to one or more embodiments. FIG. 18 is a drawing illustrating a predetermined image corresponding to various blocks, states, and / or operations associated with the process of FIG. 17 according to one or more embodiments. FIG. 19 is a flowchart illustrating a process for managing false positive sensor readings on an open axis according to one or more embodiments. FIG. 20 is a flowchart illustrating a process for managing false positive sensor readings on an open axis according to one or more embodiments. Specific details for implementing the invention

[0017] Headings provided in this specification are for convenience only and do not necessarily affect the scope or meaning of the claimed invention. While certain preferred embodiments and examples are disclosed below, the essence of the invention extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses and variations and equivalents thereof. Accordingly, the scope of claims that may arise from this specification is not limited by any of the specific embodiments described below. For example, in any method or process disclosed in this specification, the operation or operation of the method or process may be performed in any suitable sequence and is not necessarily limited to any specific disclosed sequence. Various operations may be described in sequence as a number of individual operations in a manner that may aid in understanding the specific embodiments; however, the order of description should not be interpreted to mean that these operations depend on the order. Additionally, structures, systems, and / or devices described in this specification may be implemented as integrated components or as separate components. For comparison of various embodiments, certain aspects and advantages of these embodiments are described. Not all such aspects or advantages are necessarily achieved by any specific embodiment. Accordingly, for example, various embodiments may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught in this specification without necessarily achieving other aspects or advantages as may also be taught or suggested in this specification.

[0018] Certain standard anatomical terms of position are used herein to refer to the anatomical structures of animals, namely humans, in relation to preferred embodiments. Certain spatially relative terms, such as “lateral,” “medial,” “upper,” “lower,” “below,” “above,” “vertical,” “horizontal,” “top,” “bottom,” and similar terms are used herein to describe the spatial relationship of one device / element or anatomical structure to another device / element or anatomical structure; however, it is understood that these terms are used herein for ease of description to describe the positional relationships between element(s) / structure(s), as illustrated in the drawings. It should be understood that spatially relative terms are intended to include different orientations of the element(s) / structure(s) in use or operation, in addition to the orientations illustrated in the drawings. For example, an element / structure described as being "above" another element / structure may be described as being located below or next to that other element / structure in relation to the subject patient or an alternative orientation of the element / structure, and vice versa.

[0019] outline

[0020] The present disclosure relates to systems, devices, and methods for managing the retraction and / or advancement of a medical device within a patient's anatomical structure, for example, during the execution of a medical procedure. Although certain aspects of the present disclosure are described in detail herein in the context of renal, urological, and / or nephrological procedures, such as procedures for the removal or treatment of kidney stones, such context is provided for convenience and clarity, and it should be understood that the concepts of attachment-device determination and / or device retraction / advancement disclosed herein are applicable to any suitable medical procedure. However, as mentioned, descriptions of renal / urological anatomical structures and associated medical problems and procedures are provided below to assist in the explanation of the concepts of the invention disclosed herein.

[0021] Kidney stone disease, also known as urolithiasis, is a medical condition involving the formation of solid pieces of material within the urinary tract, referred to as "kidney stones," "urinary stones," "renal stones," "nephrolithiasis," or "nephrolithiasis." Urinary stones can form and / or be found in the kidneys, ureters, and bladder (referred to as "bladder stones"). Such urinary stones can form as a result of mineral concentrations in the urine, and once they reach a size sufficient to obstruct the flow of urine through the ureter or urethra, they can cause significant abdominal pain. Urinary stones can be formed from calcium, magnesium, ammonia, uric acid, cysteine, and / or other compounds or combinations thereof.

[0022] Generally, there are several methods for treating patients with kidney stones, including observation, medical treatment (e.g., drainage therapy), non-invasive treatment (e.g., extracorporeal shock wave lithotripsy (ESWL)), and surgical treatment (e.g., ureteroscopic surgery and percutaneous nephrolithotomy ("PCNL")). In surgical approaches (e.g., ureteroscopic surgery and PCNL), the physician achieves access to the object to be removed (e.g., kidney stone), the object is broken into smaller pieces or fragments, and relatively small stone fragments / particles are mechanically extracted from the kidney.

[0023] To remove urinary stones from the bladder and ureter, a surgeon may insert a ureteroscope into the urinary tract through the urethra. Typically, the ureteroscope includes a scope / camera at its distal end configured to enable visualization of the urinary tract. The ureteroscope may also include a lithotripsy device to capture or break up urinary stones. During the ureteroscopy procedure, one physician / specialist may control the position of the ureteroscope, while another physician / specialist may control the lithotripsy device(s).

[0024] To remove relatively large stones from the kidney, a physician may use a percutaneous nephrolithotomy (“PCNL”) technique, which involves inserting a nephroscope through the skin (i.e. percutaneously) and interposing it in the tissue to provide access to the treatment site to break up and / or remove the stone(s). The percutaneous access device (e.g., nephroscope, sheath, and / or catheter) (and / or direct-entry endoscope) used to provide an access channel to the target anatomical site may include one or more fluid channels to provide fluid flow to the target site and / or to aspirate fluid from the target site (e.g., through passive outflow and / or active suction).

[0025] Robotic devices and / or systems may be employed in connection with various medical procedures, such as kidney stone removal procedures, wherein the robotic tools may enable a physician / urologist to perform endoscopic (e.g., ureteroscopic) targeted access, percutaneous access / treatment, or other modes of medical procedures. Advantageously, aspects of the present disclosure relate to systems, devices, and methods for utilizing robotic devices and systems to detect and manage a fixation-instrument condition. The terms “fixation device,” “fixation basket,” “fixation stone,” “stuck device,” “stuck basket,” and “stuck stone” are used herein in their broad and ordinary senses and may refer to any condition or occurrence in which at least a portion of a medical device or pathology (e.g., a kidney stone or other object to be removed) is at least partially obstructed, blocked, blocked, stuck, adhered, inhibited, or otherwise prevented from continuous movement during their advancement or retraction in some way.

[0026] Advancement and retraction of the ureteroscope and / or associated basketing device during ureteroscopic surgery may cause damage to certain anatomical features and / or components of one or more medical instruments used in the procedure. For example, if a kidney stone or other object is extracted or attempted to be extracted, and the stone / object is larger than the size / dimensions of the ureteral access sheath used to access the ureter and / or target anatomical structure in relation to one or more of its dimensions, lacerations or other damage to the ureteral / renal tissue may be caused at or near the location where the stone / object and / or the basket component in which the stone / object is captured come into contact with the tissue, at least partially, for example, due to the size of the stone / object.

[0027] In some examples described herein, the object removal procedure relates to the removal of kidney stones from the kidney. However, the present disclosure is not limited to kidney stone removal and associated devices. For example, the following description is also applicable to other surgical or medical procedures or medical procedures involving 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 and / or endoscopic access, such as gallbladder stone removal, lung (pulmonary / transthoracic) tumor biopsy, or cataract removal. That is, the concept of managing attachment devices disclosed herein is applicable to any device that may become attached during such procedures.

[0028] medical system

[0029] FIG. 1 illustrates an exemplary medical system (100) for performing various medical procedures according to aspects of the present disclosure. The medical system (100) may be used, for example, for endoscopic (e.g., ureteroscopy) procedures. As referenced and described above, certain ureteroscopy procedures include the treatment / removal of kidney stones. In some embodiments, the treatment of kidney stones may benefit from the assistance of certain robotic technology / devices, such as those illustrated in FIG. 1 and described in detail below. Robotic medical solutions may provide relatively higher precision, superior control, and / or superior hand-eye coordination with respect to certain instruments compared to strictly manual procedures. For example, a robot-assisted ureteroscopy approach to the kidney according to some procedures may advantageously enable a urologist to perform both endoscope control and basketing control.

[0030] Although the system (100) of FIG. 1 is presented in the context of a ureteroscopy procedure, it should be understood that the principles disclosed herein may be implemented in any type of endoscopic and / or percutaneous procedure. Additionally, some examples described herein relate to object removal procedures, including the removal of kidney stones from the kidney. However, the present disclosure is not limited to the removal of kidney stones. For example, the following description is also applicable to other surgical or medical procedures involving 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 and / or endoscopic access, such as the removal of gallstones, lung (pulmonary / transthoracic) tumor biopsy, or cataract removal.

[0031] The medical system (100) includes a robotic system (10) (e.g., a mobile robotic cart) configured to engage with and / or control a medical device (40) (e.g., a ureteroscope) to perform a direct-entry procedure on a patient (7). The term “direct-entry” is used herein in its broad and ordinary sense and may refer to any entry of a device through a natural or artificial opening within the patient’s body. For example, referring to FIG. 1, the direct entry of the scope (40) into the patient’s (7) urinary tract may be made through the urethra (65).

[0032] It should be understood that the direct-entry device (40) may be any type of medical device, including an endoscope (e.g., ureteroscope), a catheter (e.g., steerable or non-steerable catheter), a nephroscope, a laparoscope, or other types of medical devices. Embodiments of the present disclosure relating to basketing solutions implemented in connection with a ureteroscopy procedure for the removal of kidney stones through a ureteral access sheath (e.g., ureteral access sheath (90)) are also applicable to solutions for the removal of objects through percutaneous access, e.g., through a percutaneous access sheath. For example, the device(s) may access the kidney percutaneously, e.g., through a percutaneous access sheath, to capture and remove kidney stones; and the device used to capture such stones may be attached to the internal renal anatomical structure and / or the percutaneous access sheath (e.g., at the opening of the percutaneous access sheath). The term “transdermal access” is used herein in its broad and common sense and may refer to the entry of an instrument through the patient’s skin and any other layer of the body, such as through a perforation and / or small incision, necessary to reach the target anatomical location associated with the procedure (e.g., the renal calyx network of the kidney (70)).

[0033] The medical system (100) includes a control system (50) configured to interface with the robot system (10), provide information regarding procedures, and / or perform various other actions. For example, the control system (50) may include one or more display(s) (56) configured to present certain information to assist a doctor (5) and / or other expert(s) or individual(s). The medical system (100) may include a table (15) configured to hold a patient (7). The system (100) may further include an electromagnetic (EM) field generator (18), which may be held by one or more of the robot arms (12) of the robot system (10) or may be a standalone device. Various robot arms are depicted in various locations and coupled to various mechanisms, but such configurations are depicted for convenience and for illustrative purposes, and it should be understood that such robot arms may have different configurations at different points in time and / or during medical procedures. Additionally, robot arms (12) may be coupled to mechanisms different from those depicted in FIG. 1, and in some cases or periods, one or more of the arms may not be coupled to or used with medical mechanisms (e.g., mechanism manipulators / couplings).

[0034] In an exemplary use case, if a patient (7) has a kidney stone (80) located within the kidney (70), a physician may perform a procedure to remove the stone (80) through the urinary tract (63, 60, 65). In some embodiments, the physician (5) may interact with a control system (50) and / or a robotic system (10) to control the robotic system so that the robotic system (10) advances and navigates a medical instrument (40) (e.g., a scope) from the urethra (65), through the bladder (60), upward into the ureter (63), and into the renal pelvis (71) and / or renal pelvic network of the kidney (70) where the stone (80) is located. The physician (5) may further interact with the control system (50) and / or the robot system (10) to induce / control the advancement of the basketing device (30) through the working channel of the instrument (40), wherein the basketing device (30) is configured to facilitate the capture and removal of kidney stones. The control system (50) may provide information associated with the medical instrument (40) and / or other instruments of the system (100), such as real-time endoscopic images captured by it, through the display(s) (56) to assist the physician (5) in navigating / controlling such instrument.

[0035] The anatomical structure of the kidney is described herein for reference in relation to certain medical procedures related to aspects of the concept of the present invention. The kidney (70), schematically illustrated in the typical anatomical position of FIG. 1, generally comprises two bean-shaped organs located on the left and right sides, respectively, within the retroperitoneal space. In an adult, the kidney is generally about 11 cm in height / length. The kidney receives blood from paired renal arteries (69); blood exits the kidney through paired renal veins (67). Each kidney (70) is fluidly connected to a respective ureter (63), which generally comprises a tube that carries urine expelled from the kidney (70) to the bladder (60).

[0036] The kidneys (70) are typically positioned relatively high within the abdominal cavity and are placed in a retroperitoneal position at a slightly oblique angle. Asymmetry within the abdominal cavity, generally due to the position of the liver, causes the right kidney (detailed in FIG. 1) to be typically slightly lower and smaller than the left kidney and positioned slightly more centrally than the left kidney. An adrenal gland (not shown) is located above each kidney. The upper portion of the kidney (70) is partially protected by ribs 11 and 12 (not shown). Each kidney, along with its adrenal gland, is generally surrounded by two layers of fat: perirenal fat located between the renal fascia and the renal capsule, and pararenal fat located above the renal fascia.

[0037] The kidneys (70) participate in the regulation of the volume of various fluid compartments, fluid osmolality, acid-base balance, various electrolyte concentrations, and toxin removal. The kidneys (70) provide a filtration function by secreting certain substances and reabsorbing other substances. Examples of substances secreted in urine are hydrogen, ammonium, potassium, and uric acid. In addition, the kidneys also perform various other functions, such as hormone synthesis.

[0038] The recessed area on the concave edge of the kidney (70) is the renal hilum (81), where the renal artery (69) (not shown in the detail view of the kidney (70)) enters the kidney (70) and the renal vein (67) and ureter (63) (not shown in the detail view) exit. The kidney (70) is surrounded by a renal capsule (74), which is a tough fibrous tissue, and which is itself surrounded by perirenal fat, renal fascia, and pararenal fat. The anterior (front) surface of these tissues is the peritoneum, while the posterior (back) surface is the transversus abdominis fascia.

[0039] The functional material or parenchyma of the kidney (70) is divided into two main structures: the lateral renal cortex (77) and the medial renal medulla (87). These structures take the form of a plurality of generally conical renal lobes, each containing a renal cortex that surrounds a portion of the medulla called a renal pyramid (72). Between the renal pyramids (72), there are projections of the cortex called renal columns (73). The nephron (not shown in detail in FIG. 1), which is the urine-producing functional structure of the kidney, extends across the cortex (77) and the medulla (87). The initial filtration portion of the nephron is the renal corpuscle, which is located within the cortex, followed by the renal tubule, which passes deep from the cortex into the medullary pyramid. The medullary ray, which is part of the renal cortex, is a collection of renal tubules that drain into a single collecting duct.

[0040] The tip / apex or papilla (79) of each renal pyramid empties urine into the respective minor calyx (75); the minor calyx (75) empties into the major calyx (76), the major calyx (76) empties into the renal pelvis (71), which then passes into the ureter (63). A manifold-type set of minor and major calyces may be referred to herein as the “renal calyce network” of the kidney. At the hilar (81), the ureter (63) and the renal vein (67) exit the kidney, and the renal artery (69) enters. Lymphatic tissue containing lymph nodes and hilar fat surround these structures. The hilar fat is adjacent to a fat-filled cavity called the renal sinus. The renal duct collectively includes the renal pelvis (71) and renal calyces (75, 76) and separates these structures from the renal medullary tissue. The funnel-shaped / tubular anatomical structures associated with the renal calyces may be referred to as funnels. That is, the funnels generally lead to the terminal end of the renal calyces where the papilla is exposed within the renal calyces.

[0041] Referring further to the medical system (100), a medical device (40) (e.g., a scope, a direct-entry device, etc.) can be advanced into the kidney (70) through the urinary tract. Specifically, a ureteral access sheath (90) can be placed in an area near the kidney (70) within the urinary tract. The medical device (40) can pass through the ureteral access sheath (90) to achieve access to the internal anatomical structure of the kidney (70) as illustrated. Once at the site of the kidney stone (80) (e.g., within the target renal calyx (75) of the kidney (70) through which the stone (80) is accessible), the medical device (40) can be used to channel / orient a basketing device (30) to the target location. Once the stone (80) is captured within the distal basket portion (35) of the basketing device (30), the ureteral access route used can be used to extract the kidney stone (80) from the patient (7).

[0042] The system (100) may advantageously be configured to implement a certain fixation-instrument detection / determination function as disclosed in detail herein. Such fixation-instrument detection / determination may advantageously provide effective detection / determination of the fixation-instrument state, generation and / or provision of user warnings regarding the fixation-instrument state, and / or in some cases, prevention or reduced risk of the occurrence of a fixation of the medical device during its retraction. A fixation-instrument detection function according to the aspect of the present disclosure may advantageously provide a layer of safety at least partially in relation to a robotic basketing embodiment. For example, robot-assisted fixation-instrument detection as described in detail herein in relation to various embodiments may provide an additional layer of fixation-instrument detection that surpasses the attention and judgment of a surgeon or expert, thereby providing an improved safety state for the patient and / or a reduced risk of device damage. Additionally, compared to a given manual basketing solution, the system / embodiment of the present disclosure, which provides an enhanced stuck basket detection capability based on mechanism actuator force readings, may allow a user to operate the basketing device to safely retract a captured object / stone, wherein such a solution requires only one operator while providing the same or greater amount of protection against damage from a stuck-mechanism state through both vision feedback and force feedback from a robotic system.

[0043] Various scope-type devices disclosed herein, such as the scope (40) of the system (100), may be configured to navigate within human anatomical structures, for example, within natural openings or lumens of human anatomical structures. The terms “scope” and “endoscope” are used herein in their broad and ordinary senses and may refer to any type of elongated medical device configured to be introduced into any type of organ, cavity, lumen, chamber, or space of the body, having image generation, observation, and / or capturing functions. The scope may include, for example, a ureteroscope (for accessing, e.g., the urinary tract), a laparoscope, a nephroscope (for accessing, e.g., the kidney), a bronchoscope (for accessing, e.g., the airway such as the bronchi), a colonoscope (for accessing, e.g., the colon), an arthroscope (for accessing, e.g., the joint), a cystoscope (for accessing, e.g., the bladder), a colonoscope (for accessing, e.g., the colon and / or rectum), a borescope, etc. In some cases, the scope / endoscope may include a rigid or flexible tube and may be dimensioned to pass through an outer sheath, catheter, introducer, or other lumen-type device, or may be used without such a device.

[0044] Referring to FIGS. 1 and 2, which illustrate exemplary embodiments of the control system (50) of FIG. 1 according to one or more embodiments of the present disclosure, the control system (50) may be configured to provide various functions to assist in performing medical procedures. In some embodiments, the control system (50) may be coupled to the robot system (10) and may operate in cooperation with it to perform medical procedures on a patient (7). For example, the control system (50) may communicate with the robot system (10) via a wireless or wired connection (e.g., to control the robot system (10)). Additionally, in some embodiments, the control system (50) may communicate with the robot system (10) to receive position data related to the location of the distal end of the scope (40), the approach sheath (90), or the basketing device (30) from it. Such position data related to the location of the scope (40), the approach sheath (90), or the basketing device (30) may be derived using one or more electromagnetic sensors associated with each component. Additionally, in some embodiments, the control system (50) may communicate with the table (15) to position the table (15) in a specific orientation or otherwise control the table (15). In some embodiments, the control system (50) may communicate with the EM field generator (18) to control the generation of an EM field within an area around the patient (7).

[0045] FIG. 2 further illustrates an exemplary embodiment of the robot system (10) of FIG. 1 according to one or more embodiments of the present disclosure. The robot system (10) may be configured to facilitate at least partially the execution of a medical procedure. The robot system (10) may be arranged in various ways according to a specific procedure. The robot system (10) may include one or more robot arms (12) configured to engage with and / or control, for example, a scope (40) and / or a basketing system (30) to perform one or more aspects of the procedure. As illustrated, each robot arm (12) may include a plurality of arm segments (23) coupled to a joint (24), which may provide multiple degrees of movement / freedom. In the example of FIG. 1, the robotic system (10) is positioned close to the patient's leg, and the robotic arm (12) is operated to engage with and position the scope (40) for access into an access opening, such as the urethra (65) of the patient (7). When the robotic system (10) is properly positioned, the scope (40) can be inserted into the patient (7) by the robot using the robotic arm (12), manually by the physician (5), or a combination thereof. A scope-driver mechanism coupling (11) (i.e., an instrument device manipulator (IDM)) may be attached to the distal part of one of the arms (12b) to facilitate the robotic control / advancement of the scope (32). The other of the arms (12c) may be associated with a mechanism coupling / manipulator (19) configured to facilitate the advancement and operation of the basketing device (30). The scope (40) may include one or more working channels through which additional tools, such as a lithotripter, basketing device, forceps, etc., can be introduced into the treatment area.

[0046] The robot system (10) may be coupled to any component of the medical system (100), such as a control system (50), a table (15), an EM field generator (18), a scope (40), a basketing system (30), and / or any type of transdermal access device (e.g., a needle, a catheter, a nephroscope, etc.). In some embodiments, the robot system (10) is communicably coupled to the control system (50). For example, the robot system (10) may be configured to receive control signals from the control system (50) to perform a specific operation, such as positioning one or more of the robot arms (12) in a specific manner, manipulating the scope (40), manipulating the basketing system (30), etc. In response to this, the robot system (10) may control the components of the robot system (10) using a specific control circuit (211), an actuator (217), and / or other components of the robot system (10) to perform the operation. In some embodiments, the robot system (10) and / or control system (50) is configured to receive images and / or image data from a scope (40) representing the internal anatomical structure of the patient (7), i.e., the urinary system in relation to a specific depiction in FIG. 1, and / or display images based thereon.

[0047] Referring to FIG. 2, the robot system (10) generally comprises an elongated support structure (14) (also referred to as a “column”), a robot system base (25), and a console (13) located on top of the column (14). The column (14) may include one or more arm supports (17) (also referred to as a “carriage”) to support the deployment of one or more robot arms (12) (three are shown in FIG. 2). The arm supports (17) may include individually configurable arm mounts that rotate along a vertical axis to adjust the base of the robot arms (12) for desired positioning relative to the patient.

[0048] The arm support (17) may be configured to translate vertically along the column (14). In some embodiments, the arm support (17) may be connected to the column (14) through a slot (20) located on opposite sides of the column (14) to guide the vertical translation of the arm support (17). The slot (20) includes a vertical translation interface for positioning and maintaining the arm support (17) at various vertical heights relative to the robot system base (25). The vertical translation of the arm support (17) allows the robot system (10) to adjust the reach of the robot arm (12) to accommodate various table heights, patient sizes, and physician preferences. Similarly, an individually configurable arm mount on the arm support (17) may allow the robot arm base (21) of the robot arm (12) to be inclined in various configurations.

[0049] A robot arm (12) may generally comprise a robot arm base (21) and an end effector (22) separated by a series of linking arm segments (23) connected by a series of joints (24), and each joint may comprise one or more independent actuators (217). Each actuator may comprise an independently controllable motor. Each independently controllable joint (24) may provide or represent independent degrees of freedom available to the robot arm. In some embodiments, each of the arms (12) has seven joints and thus provides seven degrees of freedom, including "redundant" degrees of freedom. The redundant degrees of freedom allow the robot arm (12) to position each of its end effectors (22) in a specific position, orientation, and trajectory in space using different linkage positions and joint angles. This allows the system to position and orient the medical device from a desired point in space, while simultaneously allowing the physician to move the arm joint to a clinically advantageous position away from the patient to create a superior approach while avoiding arm collisions.

[0050] The robot system base (25) balances the weight of the column (14), arm support (17), and arm (12) on the floor. Accordingly, the robot system base (25) can accommodate certain relatively heavier components, such as electronic devices, motors, and power supplies, as well as optionally components that immobilize or enable the robot system. For example, the robot system base (25) may include a wheel-shaped caster (28) that allows the robot system to move easily around the operating room before the procedure. After reaching the appropriate position, the caster (28) may be immobilized using a wheel lock to keep the robot system (10) in place during the procedure.

[0051] Positioned at the upper end of the column (14), the console (13) may provide both a user interface for receiving user input and a display screen (16) for providing both preoperative data and intraoperative data to the physician / user (or a dual-purpose device such as a touchscreen, for example). Potential preoperative data on the console / display (16) or display (56) may include preoperative planning, navigation and mapping data derived from preoperative computerized tomography (CT) scans, and / or records from preoperative patient interviews. Intraoperative data on the display may include optical information provided from tools, sensor and coordinate information from sensors, as well as vital patient statistics such as respiration, heart rate, and / or pulse. The console (13) may be positioned and tilted to allow the physician to access the console from the side of the column (14) opposite the arm support (17). From this position, the doctor can observe the console (13), the robot arm (12), and the patient while operating the console (13) from behind the robot system (10). As illustrated, the console (13) may also include a handle (27) to assist in operating and stabilizing the robot system (10).

[0052] Each end effector (213) of the robot arms (12) may be configured to include or be coupled to a mechanism device manipulator (IDM) that can be attached using a mechanism changer interface (MCI). In some embodiments, the IDM may be removed and replaced with a different type of IDM, for example, an IDM of type 1 (11) may operate an endoscope, while an IDM of type 2 (19) may operate a basketing device. Another type of IDM may be configured to maintain an electromagnetic field generator (18). The MCI may provide a power and control interface. For example, the interface may include a connector for transmitting pneumatic, power, electrical signals, and / or optical signals from the robot arm (12) to the IDM. The IDM (213) may be configured to operate a medical device (e.g., surgical tool / instrument) such as a scope (40) using a technique including, for example, direct drive, harmonic drive, gear drive, belt and pulley, magnetic drive, etc. In some embodiments, the medical device manipulator (213) may be attached to each of the robot arms (212), wherein the robot arm (212) is configured to insert or retract each combined medical device into or out of the treatment site.

[0053] As referenced above, the system (100) may include a control circuit (211) of the robot system (10) and a control circuit (251) of the control system (50), and may include a specific control circuit configured to perform a specific function described herein. That is, the control circuit of the system (100) may be part of the robot system (10), the control system (50), or a combination thereof. Accordingly, any reference to the control circuit in this specification may refer to a circuit implemented in the robot system, the control system, or any other component of the medical system, such as the medical system (100) illustrated in FIG. 1. The term “control circuit” is used herein in its broad and common sense and may refer to any set of any device that manipulates a signal (analog and / or digital) based on hard coding of a circuit and / or operation instruction, a processor, a processing circuit, a processing module / unit, a chip, a die (e.g., a semiconductor die including one or more active and / or passive components and / or connection circuits), a microprocessor, a micro-controller, a digital signal processor, a microcomputer, a central processing unit, a field programmable gate array, a programmable logic device, a state machine (e.g., a hardware state machine), a logic circuit, an analog circuit, a digital circuit, and / or any set of any device that manipulates a signal (analog and / or digital) based on hard coding of circuit and / or operation instructions. A control circuit referenced herein may further include one or more circuit boards (e.g., a printed circuit board), conductive traces and vias, and / or mounting pads, connectors, and / or components. A control circuit referenced herein may further include a single memory device, multiple memory devices, and / or one or more storage devices that may be implemented as embedded circuits of the device. Such a data storage may include read-only memory, random access memory, volatile memory, non-volatile memory, static memory, dynamic memory, flash memory, cache memory, data storage register, and / or any device for storing digital information.In an embodiment where the control circuit comprises a hardware and / or software state machine, an analog circuit, a digital circuit, and / or a logic circuit, it should be noted that the data storage device(s) / register(s) storing any associated operation instruction may be embedded in the circuit comprising the state machine, the analog circuit, the digital circuit, and / or the logic circuit, or may be located outside the circuit.

[0054] The control circuit (211, 251) may include a computer-readable medium configured to store and / or store hard-coded and / or operation instructions corresponding to at least some of the steps and / or functions illustrated in one or more of the drawings and / or described herein. In some cases, such a computer-readable medium may be included in the article of manufacture. The control circuit (211 / 251) may be maintained / placed locally in whole or at least partially located remotely (e.g., coupled indirectly communicable via a local area network and / or a wide area network). Any of the control circuit (211, 251) may be configured to perform any aspect(s) of the various processes disclosed herein, including the process illustrated in FIG. 9 and FIG. 11, as described below.

[0055] In relation to the robot system (10), at least a portion of the control circuit (211) may be integrated with the base (25), column (14), and / or console (13) of the robot system (10), and / or other systems communicably coupled to the robot system (10). In relation to the control system (50), at least a portion of the control circuit (251) may be integrated with the console base (51) and / or display unit (56) of the control system (50). It should be understood that any description in this specification of the function control circuit or associated function may be understood as being implemented in the robot system (10), the control system (50), or any combination thereof, and / or at least partially in one or more other local or remote systems / devices.

[0056] Referring further to FIG. 2, the control system (50) may include various I / O components (258) configured to assist a physician (5) or another person in performing a medical procedure. For example, the input / output (I / O) components (258) may be configured to allow user input to control / navigate the scope (40) and / or basketing system within the patient (7). In some embodiments, for example, the physician (5) may provide input to the control system (50) and / or the robotic system (10), wherein, in response to such input, a control signal may be transmitted to the robotic system (10) to operate the scope (40) and / or the catheter basketing system (30). The control system (50) may include one or more display devices (56) for providing various information regarding the procedure. For example, the display(s) (56) may provide information regarding the scope (40) and / or the basketing system (30). For example, the control system (50) may receive a real-time image captured by the scope (40) and display the real-time image through the display(s) (56). Additionally or alternatively, the control system (50) may receive signals (e.g., analog, digital, electrical, acoustic / sound wave, pneumatic, tactile, hydrostatic, etc.) from a medical monitor and / or sensor associated with the patient (7), and the display(s) (56) may present information regarding the health or environment of the patient (7). Such information may include information displayed through the medical monitor, such as information regarding heart rate (e.g., ECG, HRV, etc.), blood pressure / blood flow rate, muscle bio-signals (e.g., EMG), body temperature, blood oxygen saturation (e.g., SpO2), CO2, brain waves (e.g., EEG), environment and / or local or core body temperature, etc.

[0057] To facilitate the function of the control system (50), the control system may include various components (sometimes referred to as “subsystems”). For example, the control system (50) may include a control electronic device / circuit (251), as well as one or more power supply units / supply interfaces (259), pneumatic devices, light sources, actuators, data storage devices, and / or communication interfaces (254). In some embodiments, the control system (50) is movable, but in other embodiments, the control system (50) is substantially a stationary system. Although various functions and components are discussed as being implemented by the control system (50), any of such functions and / or components may be integrated into and / or performed by other systems and / or devices, such as, for example, a robot system (10), a basketing system (30), a table (15), etc.

[0058] Referring further to FIG. 1, the medical system (100) may provide various advantages, such as providing guidance to assist a physician in performing a procedure (e.g., instrument tracking, instrument alignment information, etc.), enabling the physician to perform the procedure from an ergonomic position without the need for difficult arm motions and / or positions, enabling one physician to perform the procedure with one or more medical instruments, avoiding radiation exposure (e.g., associated with fluoroscopic techniques), enabling the procedure to be performed in a single surgical setup, and providing continuous suction to remove objects more efficiently (e.g., to remove kidney stones). For example, the medical system (100) may provide guidance information to assist a physician in using various medical instruments to access target anatomical features while minimizing bleeding and / or damage to anatomical structures (e.g., major organs, blood vessels, etc.). Additionally, the medical system (100) may provide non-radiation-based navigation and / or positioning techniques to reduce physician and patient exposure to radiation and / or reduce the amount of equipment in the operating room. Additionally, the medical system (100) may provide functions distributed between a control system (50) and a robotic system (10) that can move independently. Such distribution and / or mobility of functions may enable the control system (50) and / or robotic system (10) to be positioned at a location optimal for a specific medical procedure, which may maximize the work area around the patient (7) and / or provide an optimized position for the physician (5) to perform the procedure.

[0059] Various components of the system (100) may be combined to communicate with one another through a network that may include wireless and / or wired networks. Exemplary networks include one or more personal area networks (PAN), local area networks (LAN), wide area networks (WAN), internet area networks (IAN), cellular networks, the internet, personal area networks (PAN), and human area networks (BAN). For example, various communication interfaces of the system of FIG. 2 may be configured to communicate with one or more devices / sensors / systems, for instance, through wireless and / or wired network connections. In some embodiments, various communication interfaces may implement wireless technologies such as Bluetooth, Wi-Fi, and near-field communication (NFC). Additionally, in some embodiments, various components of the system (100) may be connected for data communication, fluid exchange, power exchange, etc., through one or more support cables, tubes, etc.

[0060] The control system (50), basketing system (30), and / or robot system (10) may include a predetermined user control unit (e.g., control unit (55)) that may include any type of user input (and / or output) device or device interface, such as one or more buttons, keys, joysticks, handheld controllers (e.g., video-game-type controllers), computer mice, trackpads, trackballs, control pads, and / or sensors that capture hand gestures and finger gestures (e.g., motion sensors or cameras), touchscreens, and / or interfaces / connectors accordingly. Such user control units are communicateably and / or physically coupled to each control circuit.

[0061] In some embodiments, a user may manually operate the robot arm (12) of the robot system (10) without using an electronic user control unit. For example, during a setup in a surgical operating room, the user may move the robot arm (12) and / or any other medical device to provide a desired approach to a patient. The robot system (10) may rely on force feedback and inertia control from the user to determine the appropriate configuration of the robot arm (12) and the associated device.

[0062] The basketing system (30) includes various hardware and control components. For example, as illustrated in FIG. 2, the processing system (30) may include a basket (35) formed by one or more wire ties (36). For example, the basketing system (30) may include four wire ties positioned within a basketing sheath (37) along its length, wherein the ties protrude from the distal end of the sheath (37) to form a basket shape (35). The ties (36) further extend from the proximal end of the sheath (37). The ties (36) may be configured to slide within the basketing sheath (37) to receive a certain amount of frictional resistance. The ties (36) and the sheath (37) may be coupled to respective actuators (75) of the basket cartridge component (32). The relationship between the actuator (75) of the basket cartridge (32), the tin (36), and the sheath (37) is described in detail later in relation to FIGS. 4a through 4e. The basket cartridge (32) may be physically and / or communically coupled to the handle part / component (31) of the basketing system (30). The handle component (31) may be configured to be used to assist basketing control manually or via robot control.

[0063] The basketing system (30) may be powered via a power interface (39) and / or controlled via a control interface (38), and each or both of these may interface with a robot arm / component of the robot system (10). The basketing system (30) may additionally include one or more sensors (72), such as pressure and / or other force-reading sensors, which may be configured to generate a signal indicating the force experienced at one or more of the actuator (75) and / or other couplings of the basketing system (30). Such sensor readings may be used to determine the state of a stuck basket, as described in detail herein. In some embodiments, the sensor(s) (72) include one or more sensors configured to directly measure the force at or near the basket portion (35) of the other (36). For example, a force sensor on the tip of the basket (35) and / or on the tip of the approach sheath through which the basketing device (30) approaches the target anatomical structure can be used to directly detect the force on the basket (35) caused by the basket (35) adhering to the anatomical structure or to the opening at the end of the approach sheath.

[0064] Basketing control

[0065] FIG. 3 illustrates a ureteroscope (40) placed in a portion of a patient's urinary system according to one or more embodiments of the present disclosure. As referenced above, ureteroscopy procedures may be performed to investigate and / or treat abnormalities within the human ureter. For example, ureteroscopy procedures may be performed to treat and / or remove kidney stones. Such procedures may be performed at least partially manually and / or may be performed at least partially using robotic technology, such as the robotic system (10) illustrated in FIG. 1. For example, the use of a robotic device and / or system for a given endoscopic procedure may provide relatively superior precision, control, and / or coordination compared to a strictly manual procedure. In some embodiments, the scope (40) includes a working channel (44) for deploying a basketing device (30) (e.g., basket component (35)) into a surgical area at the distal end of the scope.

[0066] The approach sheath (90), through which the scope (40) passes to access the target anatomical structure, may advantageously have a diameter sufficient for the scope (40) to be pulled through it in addition to the object captured within the basket (35) when the size of the object / stone is not too large. The approach sheath (90) may be advanced through the ureter (63) to a location near the renal pelvis (71) and / or the ureteropelvic junction (71). The distal end of the approach sheath (90) may be parked at a location on the ureter (63) and / or renal pelvis (71), where such parking location may be at least partially anatomically structure-dependent. That is, the approach sheath (90) may be positioned as far into the renal anatomical structure as possible, as allowed by the urinary tract path, which may be somewhat tortuous in a certain part thereof. Generally, the approach sheath (90) may not be articulated to the extent that the scope (40) can be articulated, and therefore it may not be practical to navigate / drive the approach sheath (90) into extension.

[0067] The scope (40) may be articulated, for example, with respect to at least the distal part of the scope, and thus the scope may be steered within the human anatomical structure. In some embodiments, the scope (40) is configured to be articulated with five degrees of freedom, for example, including XYZ coordinate movement as well as pitch and yaw. In some embodiments, the scope (40) is articulated with six degrees of freedom, including XYZ coordinate movement as well as pitch, yaw, and roll. The position sensor(s) of the scope (40) (e.g., electromagnetic sensors) may likewise have similar degrees of freedom with respect to the position information they generate / provide.

[0068] For a robot embodiment, the robot arm of the robot system may be configured / configurable to manipulate the scope (40) using an elongated moving member. The elongated moving member may include one or more pull wires (e.g., pull or push wires), cables, fibers, and / or flexible shafts. For example, the robot arm may be configured to actuate a plurality of pull wires (not shown) coupled to the scope (40) to deflect the tip (42) of the scope (40). The pull wires may include any suitable or preferred material, such as metallic and non-metallic materials such as stainless steel, Kevlar, tungsten, carbon fiber, etc. In some embodiments, the scope (40) is configured to exhibit nonlinear behavior in response to a force applied by the elongated moving member. Nonlinear behavior can be based on the rigidity and compressibility of the scope, as well as variations in slack or rigidity between different slender moving members.

[0069] A scope (e.g., endoscope / ureteroscope) (40) may include a tubular and flexible medical device configured to be inserted into a patient's anatomical structure to capture an image of the anatomical structure. In some embodiments, the scope (40) may include an optical assembly, such as an imaging device (48) such as an optical camera, and may receive wires and / or optical fibers for transmitting signals to / from the distal end (42) of the scope (40). The scope (40) may further include a light source (49), such as an LED or a fiber optic light source / lens.

[0070] A camera / imaging device (48) may be used to capture images of internal anatomical spaces, such as the internal renal calyx of a kidney (70). The scope (40) may be further configured to accommodate an optical fiber for transmitting light from a proximal light source, such as a light-emitting diode, to the distal end (42) of the scope. The distal end (42) of the scope (40) may include a port for a light source to illuminate the anatomical space when using the camera / imaging device. In some embodiments, the scope (40) is configured to be controlled by a robotic system similar to the robotic system (10) shown in FIGS. 1 and 2 in one or more aspects. The imaging device (48) may include an optical fiber, a fiber array, and / or a lens. The optical component moves with the tip of the scope (40), so that the movement of the tip of the scope creates a change in the image captured by the imaging device(s) (48).

[0071] In some embodiments, a medical device (e.g., a scope) (40) includes a sensor configured to generate sensor position data and / or transmit it to another device and to generate detectable distortion or signature within an electromagnetic field. The sensor position data may indicate the position and / or orientation of the medical device (40) (e.g., its distal end (42)) and / or may be used to determine / estimate the position / or orientation of the medical device. For example, the sensor (sometimes referred to as a "position sensor") may include an electromagnetic (EM) sensor having a coil of conductive material or other forms / exemplars of an antenna. In some embodiments, the scope (40) includes an electromagnetic sensor potted to the distal end (42) of the scope (40). The electromagnetic sensor (not shown) may include a wire or other conductive element end configured to induce current in the presence of an electromagnetic field. Additionally, the medical device / scope (40) and / or basketing device (30) may include other types of sensors such as shape-sensing fibers, accelerometer(s), gyroscope(s), satellite-based positioning sensor(s) (e.g., GPS (global positioning system) sensors), radio-frequency transceiver(s), etc. In some embodiments, sensors on the medical device may provide sensor data to a control system, which is then used to determine the position and / or orientation of the medical device. Position data derived using one or more position sensors associated with the scope (40) or basketing device (30) may be used to determine when the scope and / or basket (35) is within or near the fixed device danger zone, as described in detail herein.

[0072] The scope (40) and / or basketing device (30) may be controlled in any suitable or desirable manner, based on manual operation of the handle component(s), electronic user input, or automatically. For example, image (311) illustrates an exemplary robotic control configuration for controlling the scope (40) and / or basketing device (30), while image (312) illustrates an exemplary manual control configuration. In some embodiments, the scope (40) and / or basketing device (30) may be controlled using an ambidextrous controller (55), as illustrated in FIG. 1. Although the controller (55) is illustrated as a hand-held controller, user input may be received using any type of I / O device, such as a touchscreen / pad, mouse, keyboard, microphone, etc.

[0073] FIGS. 4a through 4d illustrate basketing control systems of various configurations according to one or more embodiments. In relation to various embodiments of the present disclosure, basketing may be performed using one or more robotic mechanism device manipulators (IDMs), such as a scope-driver IDM (11) and a basketing IDM (19), at least partially as illustrated in FIGS. 4a through 4d. The IDMs (11, 19) may be coupled to one or more robot arms of a robotic system. Control signals for controlling various actuators associated with the IDMs (11, 19) may be provided using a control interface between the IDM and each robot arm coupled thereto.

[0074] In some embodiments, the basketing IDM (19) may include a handle component (31) and a basketing cartridge component (32). The handle component (31) may be coupled to the scope (40) at the proximal end of the scope and may include a channel through which a basketing device sheath (37) can enter the scope (40), wherein the basketing sheath (37) may be at least partially placed within the working channel (44) of the scope (40) (along with a basketing tin placed therein) as described above in relation to FIG. 3. The scope (40) and the basketing device (30) may generally be in a relatively fixed position at the handle component (31), wherein the relative position between the scope (40) and the basket (30) may be changed through the operation of one or more of the actuators (33, 34) of the basketing cartridge (32). The operation of the basketing sheath actuator (33) can cause the insertion and retraction of the basketing device (30) into the scope (40).

[0075] In some embodiments that are partial implementations of the scope and / or basket retraction process, the basketing device (30) may be dithered with respect to the scope (40) for various purposes including improving the sensitivity of the stick-mechanism detection and / or preventing the stick-mechanism. The dithering motion of the basketing device (30), as described in detail below in relation to the various stick-mechanism detection solutions disclosed herein, may be implemented at least partially by sliding the basketing sheath actuator (33) back and forth (e.g., distally and proximally) in a vibrating manner so that the basket (35) moves back and forth with respect to the distally end of the scope (40).

[0076] The scope (40) can be advanced from the distal end of the approach sheath (90) by driving one or more actuators (38) associated with the scope-driver IDM (11). For example, such actuators (38) may include wheel-type actuators, etc. The actuators (38) may be used to advance and retract the scope (40). During a kidney stone removal procedure, the actuators (38) may be used to retract the scope (40) after the successful capture of the kidney stone (80) in the basket (35), as illustrated in FIG. 4e. In some embodiments, the approach sheath (90) is coupled to the scope-driver IDM (11) in a fixed manner using a sheath coupling component (91).

[0077] The basketing cartridge (32) may include a plurality of actuators (33, 34). For example, the actuators (33, 34) may include sliding, carriage-type actuators. Specifically, the cartridge (32) may include a first actuator (33) fixed to a sheath component (37) of the basketing device (30), as well as a second actuator (34) fixed to a wire / tine (36) of the basketing device (30), wherein the tine (36) may pass through the basketing sheath (37) at least partially and / or otherwise be placed within it. In some embodiments, the basket (35) is formed by the tine (36) at its distal portion that protrudes outside the distal end of the basketing sheath (37).

[0078] By sliding the sheath actuator (33), the basketing device (30) can be extended from the distal end of the scope (40). For example, as shown in FIG. 4b, the actuator (30) can be slid forward to create a corresponding forward advance of the basketing device (30) and the basket (35). The basket actuator (34) can be used to create an outward bowing / extension of the basket portion (35) of the tine by opening the basket (35) by pulling the tine proximally, thereby causing the distal end (39) of the basket (35) to be pulled toward the distal opening of the sheath (37). When the tin (35) is in the extended / open position shown in FIG. 4b, the basket (35) is placed around the stone / object (80) so that the stone / object (80) can be captured within the basket tin (35).

[0079] As illustrated in FIG. 4c, the basket (35) can be retracted around the stone (80) to capture the stone within it. For example, the basket tine actuator (34) can be advanced by a certain amount relative to the sheath actuator (33) to push the basket tine further out of the sheath (37) from its distal end, thereby extending the basket (35) and bringing the tine closer to the axis of the basketing device (30). The sheath actuator (33) can be pulled proximal to bring the basketing device (30) closer again to the distal end of the scope (40). For example, it may be desirable for the basket (35) to be positioned proximal to / adjacent to the distal end of the scope (40) during the retraction of the scope and the basketing device (30).

[0080] In some embodiments, the basket (35) may be further cinched / contracted around the stone (80) by further pulling the tines (36) proximally, thereby further pulling the tines (35) into the sheath (37) and reducing the length of the tines protruding distally from the distal end of the basketing sheath (37). FIG. 4d illustrates a basket (35) with a reduced size resulting from moving the actuator (34) proximally relative to the actuator (33).

[0081] Once the stone (80) is captured and the basket (35) is in a desired position near the distal end of the scope (40), the actuator(s) (38) can be engaged to retract the scope (40) through the opening (93) of the approach sheath (90) and additionally through the approach sheath (90), as shown in FIG. 4e. In some embodiments, the basketing device (30) can be retracted together with the scope (40) as the scope (40) is pulled proximally. For example, frictional force between the basketing sheath (37) and the working channel (44) of the scope (40) can cause the basketing device (30) to accompany the scope (40), for example, when the scope is retracted / moved.

[0082] One or more force sensors may be associated with one or more of the actuator and / or coupling interfaces of the basketing system illustrated in FIGS. 40a through 40e. For example, a force sensor (e.g., a pressure sensor) may be associated with one or more of the basket tine actuator (34), basket sheath actuator (33), scope-driver actuator(s) (38), and / or approach sheath coupling (91). For example, in some embodiments, a force present in and / or detected in the basket tine actuator (34) may indicate a stuck-mechanism state, wherein the basket tine (35) is caught on / caught or pulled distally on the actuator (34) during the retraction of the scope (40). In some embodiments, a force reading in the basketing sheath actuator (33) may indicate a stuck-mechanism state. For example, when the basket tine (35) is pulled against the distal opening of the basket sheath (37) and / or along one or more of its parts, such force / friction may be present at least partially in the sheath actuator (33). Accordingly, embodiments of the present disclosure may include evaluating / analyzing sensor readings associated with the basketing sheath actuator (33) to determine / identify a stuck-mechanism state. Generally, movement of the sheath actuator (33) causes the basketing sheath (37) and the tine (36) to move simultaneously.

[0083] In some embodiments, a sensor associated with the scope-driver actuator (38) may provide a signal indicating a stuck-mechanism state. For example, if the basket (35) is stuck on an anatomical structure or in the opening of the approach sheath (90), the retraction of the scope may be inhibited due to friction between the basketing device (30) and the working channel (44) of the scope (40). For example, in some embodiments, the basketing device (30) may be clamped or otherwise fixed to one or more parts of the scope (40), for example, at or near a part of the handle component (31). Thus, the force associated with the stuck basket may be perceived and / or read at the actuator (38) coupled to the scope (40). In some embodiments, the force experienced by the approach sheath (90), which may be at least partially perceived / detected at the sheath coupling (91), may provide an indication of the stuck-mechanism state. It should be understood that any embodiment disclosed in this specification may be implemented to determine a stuck-mechanism state based on sensor readings associated with a basket tin actuator (34), a basket sheath actuator (33), a scope driver actuator(s) (38), and / or a sheath coupling (91), or any combination thereof.

[0084] In some embodiments, the basket portion (35) of the tine (36) of the basketing device (30) may be associated with one or more force sensors, for example, at the distal end (39) of the basket (35). Such sensors may provide a signal with reduced friction loss compared to the signal experienced or generated at a more proximal component / location associated with another actuator / coupling of the basketing system. Thus, embodiments of the present disclosure implementing a force sensor associated with the distal basket portion (35) of the basketing device (30) may provide relatively sensitive readings indicating a stuck-mechanism state. In some embodiments, one or more force sensors may be placed at the base of the basket (35) at or near the distal opening of the basketing sheath (37). Such sensor(s) may provide readings that can serve as a basis for determining a stuck-mechanism according to embodiments of the present disclosure.

[0085] FIG. 5 illustrates various medical devices comprising a predetermined basketing device component positioned in a portion of the patient's renal anatomical structure according to one or more embodiments. In particular, FIG. 5 illustrates a scope (40) and a basketing device (30) at various positions associated with a stone / object capture and removal procedure according to an aspect of the present disclosure.

[0086] As referenced above, attempting to extract a relatively large stone may cause lacerations or other damage to the ureter and / or other anatomical feature(s). With reference to the drawing in FIG. 5, if the stone (80) is too large to be fitted into the access sheath (90) (e.g., ureteral access sheath) and the basket (35c) gets caught on the distal end or other part of the access sheath (90), the extraction force on the scope (40) and / or basket device (30) may cause the access sheath (90) to move, potentially causing wear on the inner wall of the ureter (63). Additionally, if an attempt is made to pull the basket (35) within the access sheath (90) in a situation where the basket does not fit neatly inside due to the size of the stone (80) trapped in the basket (35), the basket tin (35) may be damaged or broken.

[0087] In situations where a targeted stone / object (80) is too large for various reasons to retract neatly through the ureteropelvic junction (78) and into the approach sheath (90), embodiments of the present disclosure may provide an effective solution for detecting a sticking-instrument condition, or danger or instrument sticking / cracking. As an exemplary use case, when a targeted stone / object is broken (e.g., using a laser as part of a lithotripsy procedure), it may not be possible for the surgeon to confidently determine the exact size or diameter of the stone and / or whether the stone / fragment is small enough to pass through the ureter and / or the ureteral approach sheath. According to some manual procedures, the surgeon may attempt to irradiate the stone / object with a laser to produce a stone fragment small enough to be neatly fitted through the ureteropelvic junction (78) and the approach sheath (90) based on personal experience regarding such procedures. Nevertheless, such a surgeon may encounter a sticking-instrument condition over time during the procedure. In the case of a manual procedure, when faced with a fixation-instrument condition, a physician holding a ureteroscope and monitoring real-time scope camera images may be able to identify / perceive on the camera that the stone / basket is seen further away from the scope camera view than expected, which may be due to the basket / stone being fixed on a specific anatomical structure and / or the opening of the approach sheath (90). Additionally, if basket control is also operated manually, the fixation-instrument / stone condition may be perceived tactilely on the control mechanism in the form of a force opposing the retraction of the scope and / or basket.

[0088] As referenced above, the size of the stone (80) for one or more of its dimensions may cause the stone (80) to adhere to the patient's anatomical structure and / or to the opening of the access sheath (90) into which the object (80) captured within the basket is pulled. However, according to the given solution, it may not be possible for the location and / or system to determine the exact size of the stone (80). Therefore, the risk of instrument adhesion / snagging may not be completely avoided in some cases. Additionally, regarding robot-assisted ureteroscopy procedures, while a camera view from the endoscope camera may be available for monitoring by a physician / expert, if the scope and / or basket device is controlled by a robot rather than held by a human surgical personnel, force feedback may not be perceived by the human user. Therefore, detection / determination of a stuck mechanism / absence state may be more difficult in certain aspects in relation to robot-implemented scope-driven and / or basketing procedures.

[0089] If the stone (80) and / or basket (35) is adhered to the patient's anatomical structure, further retraction of the basket (35) from the position of adhesion may cause tissue laceration (e.g., ureteral laceration). Additionally, if the basket (35c) is adhered to the opening of the access sheath (90), further retraction of the basket (35c) and / or scope (40c) may cause movement / removal of the access sheath (90) from its parking position and / or damage to the basket (35).

[0090] Embodiments of the present disclosure provide a stick-mechanism detection based on force readings associated with couplings and / or actuators associated with one or more components of the approach sheath (90), scope (40), and / or basketing device (30). For example, once an object (80) is captured by the basket (35), as the scope (40) is retracted, force readings on one or more components of the mechanism can be analyzed to determine whether such force exceeds a predetermined threshold indicating a stick-mechanism state. In some embodiments, the sensitivity of such stick-mechanism determination can be improved by implementing basket dithering according to the embodiments of the present disclosure.

[0091] Basket dithering may be implemented when the scope (40) and / or basket (35) enter a danger zone (99), where the danger zone (99) may be an area with a relatively high risk of instrument sticking / snagging. For example, the sticking-instrument danger zone (99) may generally cover an area at or near the ureteropelvic junction (78) and / or an area immediately before (i.e., distal) the opening of the approach sheath (90), which may generally be associated with a higher risk of snagging at the urinary anatomical structure and the opening of the approach sheath (90), respectively. For example, the narrowing of the urinary tract as the anatomical structure moves from the renal pelvis (71) into the ureter (63) represents a narrowing of the channel / cavity that may cause instrument jamming if the basket (35) and / or the stone / object (80) trapped inside it has a width / diameter or other dimensions greater than the specified dimensions of the anatomical passage. Additionally, the opening of the access sheath (90) is generally narrower than the anatomical structure through which the basket (35) retracts to lead to the access sheath (90). Thus, the access sheath (90) represents a relatively narrow passage where the basket (35) and / or the stone / object (80) trapped inside it may become stuck when its dimensions are larger than the diameter of the access sheath opening. Accordingly, the danger zone (99) advantageously includes one or both of the narrowed area of ​​the ureteropelvic junction (78) and the area immediately anterior to the opening (93) of the approach sheath (90). In some embodiments, the area of ​​the danger zone (99) may be determined at least partially based on the location of the opening / distal end of the approach sheath (90), so that the danger zone (99) occupies an area of ​​a predetermined distance anterior to the approach sheath (90).

[0092] Basket dithering may be implemented to amplify the difference in force signals between the stuck-mechanism state and the non-stuck state. For example, slightly advancing and retracting the basket while the scope and basket are retracting may help ensure that the stuck-mechanism sensor readings are clearly identifiable. For example, the use of basket dithering may reduce noise and / or improve sensitivity for force readings on various mechanisms, as described in detail herein. For example, by implementing basket dithering, the influence of static friction may be reduced or eliminated when the basket (35) is advanced and retracted by a certain distance in a vibrating manner. Generally, static friction may exist when the basket (35) is in a relatively stationary position and in contact with the walls of an anatomical structure. When the basket (35) moves in a vibrating manner, the friction experienced on the mechanism may be primarily in the form of kinetic friction, which is typically associated with a smaller coefficient of friction compared to static friction. Therefore, when basket dithering is employed, the signal-to-noise ratio of the force applied to various mechanism components may be relatively higher compared to a solution in which the scope (40) and / or basket (35) is retracted without basket dithering.

[0093] As the basket is retracted into and through the danger zone (99), force feedback readings on actuator(s) associated with one or more components of the basketing system (30), scope (40), and / or sheath (90) can be analyzed to determine when such force increases in a manner consistent with the stuck-mechanism state and / or the associated danger. When such a determination is made, for example, when the force reading rises above a given threshold level, the retraction speed of the scope (40) and / or basket (30) may be automatically reduced to guide the user / operator to continue the operation and / or retraction of the scope with greater caution.

[0094] In some embodiments, the basket (35) includes one or more electromagnetic sensors, wherein such sensors may provide a sensor signal and / or otherwise indicate the location of the basket (35), and such location information may serve as a basis for determining when the basket (35) is in or near the danger zone (99). Additionally, location information determined using the electromagnetic sensor(s) associated with the basket (35) may be used to trigger the initiation of dithering for sticking-mechanism detection.

[0095] To provide effective detection of a stuck-device condition and to reduce the incidence of false positives regarding stuck-device detection that may cause annoyance or confusion to the user, the stuck-device risk zone (99) may be configured to cover an area determined to be particularly vulnerable to stuck-device risk. For example, the risk zone (99) may be configured based on the location of the access sheath (90), wherein the risk zone (99) covers a predetermined distance in front of and / or around the distal opening of the access sheath (90). Dithering of the basket (30c) around the approach sheath (90) can advantageously improve the sensitivity of detecting the fixation basket (35c) at the entrance / opening of the approach sheath (90), whereas dithering of the basket (35b) further away from the approach sheath (90) can improve the sensitivity of detecting the fixation-basket condition at or near the relatively narrow opening of the ureteropelvic junction (78).

[0096] In some cases, the exact position of the scope (40) and / or approach sheath (90) is unknown. For example, the estimation of the scope and / or sheath position may be based on one or more of the following: robot arm / mechanism position(s); knowledge / data indicating the scope length, sheath length, and / or other known data; the scope being longer / farther than expected, and the feed roller arm holding the UAS may add uncertainty; determined position data based on data generated using one or more position sensors; camera image analysis, etc. However, such measurements may not be associated with sufficiently strict tolerances in some cases. Generally, it may be desirable to consider the entire relevant tolerance chain to ensure that the fixation mechanism determination feature disclosed herein is implemented in a zone / area including the distal end of the approach sheath (90), thereby ensuring that such feature is implemented until the basket is safely within the approach sheath.

[0097] In some embodiments, image processing may be implemented to identify that the scope (40) is within the approach sheath (90) before interrupting a predetermined sticking mechanism detection mechanism(s). For example, the interruption of one or more of the sticking mechanism determination mechanisms disclosed herein may be triggered by visual identification of one or more features associated at least partially with the inner and / or distal end of the approach sheath (e.g., by pseudo / expert analysis or digital image processing).

[0098] In situations where the approach sheath position tolerance leads to a range of areas where the distal end of the approach sheath may be located, it may be desirable to operate according to a relatively extended risk zone to ensure that the approach sheath is located at least partially within it. Accordingly, although the illustrated risk zone (99) is depicted as ending at or near the actual location of the opening (93) of the approach sheath (90), it should be understood that in some embodiments, the zone in which the predetermined disclosed fixation mechanism determining mechanism disclosed herein is executed may extend further into the ureter (63) than depicted in FIG. 5 and / or cover an area overlapping with the distal end of the approach sheath (90). In some embodiments, the risk zone (99) in which the predetermined fixation mechanism determining mechanism(s) are executed includes an area corresponding to the range of the scope (40). That is, the risk zone (99) may extend into the extension (70) as far as the scope (40) and / or basket (30) can reach and / or reach.

[0099] As described in detail in this specification, force readings that can be used as inputs to determine the state of a stuck mechanism may include force readings representing forces present in one or more of the following: a scope drive (i.e., insertion and / or retraction) actuator(s) / pulley(s), approach sheath coupling(s), basket sheath insertion / retraction actuator(s), basket tine insertion / retraction actuator(s), and / or one or more robot arms or other robot components (e.g., insertion / retraction rail-type systems). For example, referring again to FIGS. 4a through 4e, the force on the distal drive feed roller / pulley (38) may be decomposed to determine the state of the stuck mechanism. Although force sensors are described throughout this disclosure, it should be understood that such sensors may be any type of sensor configured to generate and / or provide signal(s) representing the force experienced on an actuator, coupling, and / or other mechanical component of a mechanical and / or robotic system / device, including direct torque sensors, current sensors, etc.

[0100] In any disclosed embodiment, the fixation mechanism state may be determined based on sensor readings indicating a force on any type of insertion and / or retraction mechanism(s), whether such mechanism(s) drive the insertion and / or retraction of an access sheath, endoscope, basketing sheath, basketing tine, or other component of the surgical system. For example, sensor data on which the determination of the fixation mechanism state may be based may be generated and / or provided by sensor(s) associated with a rail-based mechanism drive system. Such sensor data may advantageously indicate a tug force on one or more components of the system. In some embodiments, such insertion / retraction mechanics may be implemented as a virtual or actual rail system, wherein such a system is configured to generate linear (i.e., rail-type) motion of one or more components of the surgical system. The insertion / retraction force detected using such a sensor may serve as the basis for determining the fixation mechanism state.

[0101] Vision-based Stabilization-Organization Decision

[0102] In some embodiments, an endoscope camera image may provide a basis for fixation-mechanism determination. Such vision-based fixation-mechanism determination function may be implemented by a control circuit of a medical system using a predetermined image-processing technique. FIG. 6a illustrates a field of view (701) of an endoscope camera in which a basketing device (35) is observable, according to one or more embodiments of the present disclosure. FIG. 6b illustrates a side view of a medical device assembly corresponding to the configuration of the basketing device (35) to an endoscope camera (48) used to capture the image (701) of FIG. 6a, according to one or more embodiments. In the image (701), the basket (35) and the stone (80) are relatively large in the field of view due to the proximity of the basket (35) to the scope camera (48).

[0103] FIG. 7a illustrates a field of view (702) of an endoscope camera (48) in which a fixed basketing device (35) according to one or more embodiments of the present disclosure is observable therein. FIG. 7b illustrates a side view of a medical device assembly of FIG. 6b corresponding to the configuration of the basketing device (35) for the endoscope camera (48) shown in FIG. 7a according to one or more embodiments. Compared to the image of the basket (35) and the stone (80) in the image (701) of FIG. 6a, the image of the basket (35) and the stone (80) in the image (702) of FIG. 7a is smaller in size and positioned higher in the image frame (702). Such a change in image size and / or position may be caused by the fixed basket (35) as the scope (40) is retracted and may provide an indication of it. Accordingly, an image processing mechanism configured to identify substantial changes in image size and / or position regarding basket tine and / or captured object(s) can be implemented to determine the fixation-mechanism state.

[0104] Unlike solutions in which the basketing system actuator force is used exclusively to detect / determine the stick-mechanism state, some embodiments of the present disclosure include implementing vision analysis / processing to determine the stick-mechanism state. For example, an image captured by an endoscope camera may provide information regarding the stick-mechanism state. For example, a scope image may be processed to determine and / or estimate the distance between the distal end / tip of the scope (40), which may generally be associated with the scope's camera (48) and the camera view window (701, 702) presented to the user accordingly, and the basket (35) or a part thereof or the absence (80).

[0105] The endoscopic image (701) associated with FIG. 6a may represent an image captured by the endoscope (40), wherein the basket (35) is not fixed and thus can be observed relatively close to the camera (48) of the endoscope (40) in the field of view (701). As shown in FIG. 6b, which can generally be considered to correspond to the image (701) captured by the scope camera (48) shown in FIG. 6a, the stone (80) is at a relatively close distance to the distal end of the scope (40). d 1 It can be in ).

[0106] The image (702) of FIG. 7a is at a greater distance from the end of the scope (40) d 2 Diagnoses a stone (80) in ) at such a larger distance ( d 2 ) may be the result of the basket (35) and / or stone (80) being attached to a certain anatomical structure or device, and thus the retraction of the scope (40) causes the basketing device (30) to be pulled out of the working channel (44) of the scope (40). Accordingly, in the image (702), the stone (80) and basket (35) are shown in a relatively smaller size, indicating the location of the stone (80) and basket (35) further away from the scope camera (48) due to the increased distance of the stone (80) and basket (35) from the scope camera (48).

[0107] In some embodiments, the control circuit of a medical device or system may be configured to determine the shape and / or size associated with a visible stone and / or basket feature in a camera view, wherein such shape and / or distance information may be used to determine the change in distance of the stone and / or basket to the camera of the endoscope and / or determine its absolute distance. Thus, a determination that the basket and / or stone is smaller in a subsequent image compared to a previously captured image may indicate the presence of a sticking-mechanism state. A predetermined corrective action may be implemented in response to such a determination, as described in detail herein.

[0108] In some embodiments, an electromagnetic sensor or other position sensor associated with the basket (35) and / or the basketing device (30) may be used to determine the position of the basket (35) relative to the position of the scope (40), which may be indicated by a position sensor(s) associated with the distal end of the scope (40). Such position information may be used to determine the distance between the basket (35) and the scope (40), wherein such distance may indicate a stuck-mechanism state.

[0109] In some embodiments, the basket tines may have at least partially stress-dependent color-type characteristics. For example, such tines may be configured to exhibit a change in the visual characteristics of the basket, such as that observable in the field of view of the endoscope camera, in the presence of a stress load induced by a sticking-basket state. That is, the displayed camera image presented to the user may have coloring characteristics that indicate the stress the basket undergoes and, accordingly, the sticking-mechanism state. In some embodiments, optical fibers may be used to provide shape-sensing capabilities. For example, the basket may be equipped with a relatively thin optical fiber having a grading that can be interrogated, for example, by stimulating a pulse train of light, wherein the control circuit of the system is configured to interpret such readings and make a sticking-mechanism determination at least partially based thereon.

[0110] FIG. 8 illustrates a fixation-mechanism architecture (800) according to one or more embodiments. The architecture (800) provides a framework (e.g., a feature-identification and / or force-sensor-analysis framework) for identifying one or more robotic actuator / coupling forces associated with one or more mechanism, anatomical, and / or stone / object features and / or one or more components of a robotic surgical system within an endoscopic camera image in order to dynamically determine / identify a fixation-mechanism state based on its specifics according to one or more embodiments of the present disclosure. The framework (800) may be implemented in a predetermined control circuit comprising one or more processors, data storage devices, connection features, substrates, passive and / or active hardware circuit devices, chips / dies, etc. For example, the framework (800) may be implemented at least partially in the control circuit (251) and / or control circuit (211) described above and illustrated in FIG. 2. The framework (800) may employ machine learning capabilities to perform automatic fixation-instrument state determination / detection, for example, on ureteroscope images of internal renal anatomical structures, wherein the images include certain instrument components and / or renal stones or other objects. Additionally or alternatively, the framework (800) may employ machine learning capabilities to perform automatic fixation-instrument state determination / detection, for example, on robotic endoscopes and / or basketing actuator forces, as described in detail herein.

[0111] The framework (800) may be configured to operate on a predetermined image-type data structure, such as image data representing at least a portion of a treatment site associated with one or more medical procedures and / or instrument components used in such procedures(s). In some embodiments, the framework (800) may be configured to operate on robot actuator force profile data as described herein. Such input data / data structure may be operated in some way by a predetermined transformation circuit (820) associated with the image-processing portion of the framework (800). The transformation circuit (820) may include any suitable or desirable transformation and / or classification architecture, such as any suitable or desirable artificial neural network architecture.

[0112] The transformation circuit (820) may be trained according to known images and / or actuator / coupling force profiles (812). For example, image data may include, as input / output pairs, representations of medical device components (e.g., baskets) and / or kidney stones or other objects and target labels (832) corresponding to each image (812), wherein the transformation / classification framework (820) is configured to adjust one or more parameters or associated weights to correlate known input and output image data. Additionally or alternatively, data (812) may include a robotic actuator / coupling force reading profile and a transformation / classification framework (820) that may be provided as inputs to the transformation / classification framework (820), wherein the transformation circuit is configured to correlate the known force profile with known fixed device output labels. For example, the transformation circuit (820) (e.g., a convolutional neural network) may be trained using a labeled dataset and / or machine learning. In some implementations, the machine learning framework may be configured to perform learning / training in any suitable or desirable manner.

[0113] Known target labels (832) may be generated at least partially by manually labeling images and / or force profiles as being associated with or not associated with a sticky mechanism state. For example, manual labeling may be determined and / or applied by a relevant medical professional to label whether, for example, a basket component / structure is present in the image and / or whether the representation of the basket component / structure and / or force profile indicates a sticky mechanism state. Known input / output pairs may represent parameters of the conversion circuit (820), which may be dynamically updateable in some embodiments.

[0114] A known stick-mechanism label (832) can identify the boundaries and / or internal regions of a target mechanism feature present therein, or indicate whether a related image corresponds to a stick-mechanism state. In some embodiments, the framework (800) may be configured to generate a real-time target label (835) in a binary manner indicating whether a specific image and / or force profile of real-time data (815) indicates a stick-mechanism state.

[0115] The framework (800) may be further configured to generate a real-time target label (835) associated with a real-time scope image (815) using a trained version of the conversion circuit (820). For example, during the retraction of a medical instrument (e.g., basket and / or scope) during a medical procedure, a real-time scope image showing the medical instrument may be processed using the conversion circuit (820) to generate a real-time target label (835) that identifies the presence of a sticky-instrument state in the real-time image. For example, in some embodiments, a ureteroscope image may be processed by the conversion circuit (820) to identify a sticky basket. User notification of this may be provided in response to the real-time sticky-instrument label determination (835).

[0116] The transformation framework (820) may include an artificial neural network such as a convolutional neural network. For example, the framework (820) may implement a deep learning architecture that is performed on an input image and assigns learnable weights to various modalities / objects in the image to distinguish them from one another, and / or is biased thereon. The filters / features of the framework (820) may be hand-engineered or learned through machine learning.

[0117] The framework (820) may include a plurality of neurons (825) (e.g., a layer of neurons as illustrated in FIG. 8) corresponding to an overlapping region of the input image that covers a visual region of the input image. The framework (820) may further operate to flatten the input image or part(s) thereof in some way. The framework (820) may be configured to capture spatial and / or temporal dependencies in the input image (815) through the application of a predetermined filter. Such a filter may be executed in various convolution operations to achieve desired output data. Such convolution operations may be used to extract features such as edges, contours, etc. The framework (820) may include any number of convolution layers, wherein more layers may provide identification of higher-level features. The framework (820) may further include one or more pooling layers configured to reduce the spatial size of convolved features, which may be useful for extracting rotation and / or position-invariant features, such as in certain anatomical features. Once prepared through flattening, pooling, and / or other processes, the image data may be processed by a multi-level perceptron and / or feed-forward neural network. Additionally, backpropagation may be applied to each iteration of training. The framework may be capable of distinguishing dominant and certain low-level features in the input image and classifying them using any suitable or preferred technique. In some embodiments, the neural network architecture includes any of the following known convolutional neural network architectures: LeNet, AlexNet, VGGNet, GoogLeNet, ResNet, or ZFNet.

[0118] The framework (800) can be trained with a sufficient amount of driving data, such as endoscopic image data, where a truth table can be generated based on known labels of the stuck-mechanism state and the non-stuck-mechanism state. During operation, real-time images (815) and / or other driving information can be used as inputs to the system (820) to provide real-time stuck-mechanism predictions / results as outputs (835).

[0119] Stubbornness-Absence Status Management Process

[0120] FIGS. 9-1 and 9-2 illustrate flowcharts illustrating a process (900) for managing a fixation-mechanism state according to one or more embodiments. FIGS. 10-1 and 10-2 illustrate certain images corresponding to various blocks, states, and / or actions associated with the process (900) of FIGS. 9-1 and 9-2 according to one or more embodiments. In executing the process (900) of FIG. 9, the user may provide certain controls through a control system coupled to a robotic basketing system (e.g., a robotic system coupled with one or more mechanism device manipulators (IDMs) to control a basketing device and / or scope). Such a control system may provide real-time endoscope camera images and / or other information related to the procedure. In some embodiments, one or more aspects of the process (900) may be implemented by control circuits of a control system coupled to a robotic basketing system and / or control circuits associated with the robotic basketing system. Various force sensor readings related to various operation stages of the process (900) may be provided by a robot system and may be configured to determine torque / force readings on one or more actuators of the robot basketing system.

[0121] In block (901), the process (900) involves capturing a stone with a basket (35) within the patient's anatomical cavity. For example, the stone (80) may be captured in an area of ​​the renal anatomical structure beyond the ureteropelvic junction (78), as shown in image (1001) of FIG. 10-1. In block (902), the process (900) involves retracting the scope (40) and / or basket (35) into the fixation-instrument risk zone (99), as shown in image (1003) of FIG. 10-1.

[0122] The determination that the basket (35) has entered the fixation-instrument danger zone (99) may be based at least partially on one or more basket-positioning mechanisms that can be used to position the basket (35) within the anatomical structure and / or at a given stage of the procedure. The danger zone (99) may include, for example, an area immediately distal / anterior to the opening (93) of the ureteropelvic junction (78) and / or the approach sheath (90). The determination that the basket (35) is in the danger zone (99) may be achieved in any suitable or preferred manner. In some embodiments, the position of the basket (35) may be indicated by a command from a scope (40) and / or a robotic system controlling the basket (35). For example, additional known information regarding the position of the scope (40) relative to the distal end (93) of the sheath (90) may provide information indicating the position of the basket (35) and / or the distal end of the scope (40). The position of the basket (35) may be determined using any suitable or preferred positioning mechanism. In some embodiments, basket dithering and / or basket positioning may be triggered upon entry of the basket (35) and / or scope (40) into the ureteropelvic junction (78) and / or danger zone (99). In some embodiments, the positioning of the basket (35) and / or basket dithering may be automatically triggered in response to the determination of successful capture of the stone (80).

[0123] In block (904), the process (900) includes enabling dithering of the basket (35), as illustrated in the image (1005) of FIG. 10-1. Such dithering operation can advantageously improve the sensitivity of the associated force sensor readings associated with one or more actuators / couplings of the robotic mechanism used to control the scope (40) and / or the basket device (30). Dithering may be implemented according to any embodiment disclosed herein. For example, dithering may include relatively slow motion of the basket (35) advancing and retracting relative to the scope (40). The dithering distance may advantageously be relatively short to reduce the impact of dithering on user control / experience. The implemented dithering speed may be set to a speed slower than the normal driving speed of the scope (40). In addition, the dithering distance can be set as part of the total basket movement range / distance to avoid interfering with or confusing the surgeon / specialist during basket retraction.

[0124] Although the flowchart of FIG. 9 describes retracting the basket (35) into the danger zone (99), in some embodiments, basket dithering and / or other sticking-mechanism detection functions may be automatically triggered when a stone (80) is captured by the basket (35) and / or such functions may be deactivated when the basket (35) safely enters the access sheath (90). In some embodiments, sticking-basket determination based on force readings from sensor(s) associated with robot-controlled actuator(s) or coupling(s) may be implemented without implementing basket dithering. That is, any embodiment disclosed herein for sticking-mechanism determination may be performed / implemented with or without basket dithering.

[0125] In some embodiments, certain preventive measures / functions may be implemented to prevent a stuck-mechanism condition. For example, some embodiments provide a mechanism configured such that when a stuck-mechanism force is detected, the robot system simulates manual basketing adjustment or causes the basket to slip / advance forward in a similar manner. In this way, the stuck-mechanism force, which may cause physiological and / or mechanism damage, may be set to be greater than such slip force, and after the stuck-mechanism condition is detected, the user may manually resolve the stuck-mechanism condition and reposition the basket to a non-slip position.

[0126] In block (906), the process (900) includes retracting the distal end of the basket (35) and / or the scope (40) through the ureteropelvic junction / ureteral transition area / small opening. For example, the retraction associated with the operation of block (906) may be performed while the basket (35) is dithering, as illustrated in image (1005), which may provide the desired sensor sensitivity for estimating the fixation mechanism. If the force detected by one or more actuators associated with the basketing device (30) and / or the endoscope (40) indicates a fixation-mechanism state, the process (900) may proceed to block (910), where a predetermined fixation-mechanism correction operation may be implemented.

[0127] Seizure-mechanism detection may be based on one or more torque / force readings on one or more axes / actuators associated with the robotic basketing system, such as torque / force experienced by a basket-insertion driver / actuator (e.g., engaged with a basketing sheath). In some embodiments, the determination that a seizure-mechanism state exists may be based on the determination that the basket insertion axis force experienced by one or more actuators associated with the basket sheath and / or basket tin is greater than a predetermined threshold for a threshold amount of time. For example, in some embodiments, when the first force and / or time threshold is satisfied, a correction action includes decelerating the scope retraction speed to allow sufficient time for the seizure-mechanism detection function to be implemented and / or to reduce the force generated by the seizure basket to reduce the magnitude and / or risk of damage caused by it. In some embodiments, if, after the retraction speed is decelerated, the basket force continues to increase beyond another predetermined threshold level, such as a fault threshold level, the retraction of the scope may be stopped to prevent damage and allow for correction of the stuck-mechanism condition.

[0128] In an embodiment in which a correction action associated with the block (910) includes stopping / stopping the retraction of the scope in response to a determined stick-mechanism state, such action may serve to prevent or reduce the risk of user error, such as that which may occur when a physician / professional does not pay proper attention to the endoscopic image and / or the tactile sensation of the mechanism when retracting the scope (40) and / or basket (30).

[0129] When the stuck-mechanism state is not determined, the process (900) proceeds to block (908), where the distal end of the basket (35) and / or scope (40) is retracted into the access sheath (90) through its distal opening (93). When the stuck-mechanism state is detected in relation to the retraction into the sheath (90), the process (900) may proceed to block (910), where the correction action associated with the stuck-mechanism state may be implemented in any suitable or desirable manner.

[0130] The calibration operation associated with block (910) may allow the user to resolve a stuck-mechanism defect, readjust the basket / absence position, and continue retraction in some cases that allow for recovery. After the calibration operation of block (910), the process (900) may continue to any of the subsequent steps of the process and / or the process may end at block (916). After a successful calibration operation associated with block (910), additional force readings exceeding the relevant threshold level may re-trigger the calibration operation at block (910) and / or cause it to return to it.

[0131] In block (912), the process (900) includes disabling basket dithering. For example, the disabling of such dithering may be triggered by a determination that the distal end of the basket (35) and / or scope (40) has entered the access sheath (90). In block (914), the process (900) includes retracting the basket through the access sheath (90). Such retraction through the access sheath (90) may be performed at an accelerated speed in some embodiments. That is, once inside the access sheath (90), the retraction speed may be increased to reduce procedure time and / or for other purposes related to convenience and / or efficiency. Once the basket has been retracted through the access sheath (90), the process (900) may be terminated in block (916).

[0132] FIG. 11 is a flowchart illustrating a process (600) for handling a fixation-mechanism state according to one or more embodiments. In block (602), the process (600) comprises retracting a basket having an object (e.g., a stone) trapped inside it toward a ureteral access sheath. For example, the basket may be retracted into an endoscope, where the basket is placed within the working channel of the endoscope.

[0133] In block (604), the process (600) includes determining whether the basket is in a stuck-mechanism state based on force readings from sensor(s) associated with the robot scope- and / or basketing-control actuator(s). For example, the determination in the determination block (604) may include determining that a force reading from one or more actuators of the basketing system is greater than a predetermined stuck-mechanism detection threshold. In some embodiments, the determination in block (604) may be performed while the basket is operating in dithering motion, which may provide a relatively greater sensitivity for stuck-mechanism detection / determination as described in detail herein.

[0134] The determination of whether the force experienced by one or more actuator(s) of the basketing and / or robotic system indicates a sticky-mechanism state may be supplemented by and / or notified by certain other information / data related to the procedure and / or user. For example, information regarding the patient's specific anatomical structure, the operator's driving behavior, and / or the size of the stone may be used as input to determine whether the current state indicates a sticky-mechanism state in relation to the determination block (604). In some embodiments, the control circuit configured to determine the sticky-mechanism state may be at least partially adaptive and configured to adjust input parameters associated with such determination to predict the likelihood of a sticky-mechanism state and further improve the accuracy of sticky-mechanism detection.

[0135] If the force reading(s) analyzed in relation to block (604) indicate a stuck-mechanism state, a timer may be initiated in block (605). The timer may run for a period during which the force reading(s) exceed a relevant threshold. That is, the period associated with block (605) may correspond to the period during which the force reading(s) associated with one or more actuators of the robot basketing system remain above a stuck-mechanism threshold level.

[0136] As determined in the determination block (607), if the time during which the force(s) applied to the relevant actuator(s) are maintained above a predetermined threshold is greater than the fault threshold, the process (600) may proceed to block (608). For example, if the amount of time, as indicated by the stick-mechanism timer, where the force on the basket and / or scope exceeds the stick-mechanism threshold, is greater than the fault threshold, a minor fault may occur, whereby the operator is not permitted to further retract the basket / scope until the stick-mechanism condition is resolved in block (608).

[0137] If the period during which the force on the actuator(s) is greater than the sticking mechanism threshold is not long enough to trigger a fault condition associated with block (608), but is greater than a predetermined warning threshold, the process (600) proceeds to block (610), where a warning or other notification indicating a sticking mechanism condition and / or its danger may be generated or provided to the user. Such a warning may urge the operator / user to adjust the basket and / or proceed with the retraction of the basket with caution.

[0138] In addition to providing user alerts, in some embodiments, the process (600) includes reducing the retraction speed of the scope and / or basketing device in response to one or more of the following decisions: that a stick-mechanism state exists in block (604); that the timer period is greater than a warning threshold in block (609); and / or that the timer period is greater than a fault threshold in block (607). Reducing the retraction speed may help prevent force spikes without sufficient time to stop retraction and prevent physiological and / or instrument damage. In some embodiments, the stick-mechanism timer may be reset whenever the detected force falls below a pre-limited stick-mechanism force threshold to filter out noise data and reduce the risk that a single spike in basket force will trigger a false alarm. In block (612), the process (600) includes retracting the basket and scope into the approach system.

[0139] If the fixation-instrument status is satisfied in either box (607 or 609), or if the fixation-instrument status is not determined in block (604), the process (600) may proceed to block (606), where the fixation-instrument timer is stopped if it is currently running. In the determination block (611), the process (600) includes determining whether the distal end of the basket and / or endoscope is within the fixation-instrument danger zone. If so, the process (600) includes activating basket dithering in block (613) in accordance with the aspect of the present disclosure. If the distal end of the basket and / or endoscope is not yet within the fixation-instrument danger zone, the process (600) may return to block (602), where the retraction of the basket / scope toward the ureteral access sheath continues.

[0140] False positives

[0141] FIG. 12 is a flowchart illustrating a process (1200) for managing false positive sensor readings on the insertion axis of a basketing device according to one or more embodiments. In block (1202), the process (1200) includes capturing a stone with a basketing device within the patient's kidney. For example, a stone fragment among a plurality of stone fragments may be captured. The stone may be captured by operating the opening axis of the basketing device, which controls the opening and closing of the basket tine / wire by extending and / or retracting the tine / wire from the sheath of the basketing device. Capturing the stone may further include operating the insertion axis of the basketing device, which may cause the operation of the basket sheath to cause the insertion and / or retraction of the basket to an endoscope in which the basketing device is placed (e.g., within the working channel of a scope).

[0142] In the subprocess block (1204), the process (1200) comprises retracting the scope and basket while dithering the basket with respect to the distal end of the scope, as described in detail in this specification. Such dithering may be implemented within the attachment mechanism risk zone, whereby the dithering process is implemented for the detection of attachment stones as described in detail throughout this disclosure. During the retraction of the scope, which may include retracting the scope and basket proximally from within the approach sheath (e.g., ureteral approach sheath) used to access the target anatomical structure and / or from a predetermined distance distal / lateral to the distal end / opening of the approach sheath, the basket insertion axis may be dithered back and forth to provide improved sensitivity for the detection of attachment mechanisms, as described in detail. Generally, the dithering distance / range of the motion can be set to a relatively small distance, so that it may not be perceived by the user while still generating dynamic movement about the basket insertion axis to provide improved sticking mechanism detection sensitivity.

[0143] In block (1206), it is determined whether an elevated force is detected on the insertion axis associated with the basketing device. For example, one or more force sensors associated with the sheath of the basketing device may indicate an elevated force that may potentially indicate a stuck absence. The insertion axis may be associated with a slider / actuator of the handle / cartridge associated with the basketing device, wherein the slider actuator is configured to control the insertion and retraction of the basket and / or its sheath relative to the scope when the basket is placed within the working channel of the scope.

[0144] As described in detail above, a robotic manipulator (e.g., an intangible device manipulator (IDM), an end effector, etc.) may be used as an input source for detecting a stuck mechanism. For example, a stuck mechanism detection function according to an aspect of the present disclosure may be implemented to detect an insertion axis force peak / level that may occur when an actual stuck mechanism state is present, so that the user may be notified of a potential stuck mechanism state before damage or injury to the mechanism and / or anatomical structure occurs. The detection of an elevated force associated with block (1206) may relate to a force on the insertion axis rising sufficiently high to reach a threshold level, at which point scope deceleration may be implemented in some cases as a stuck mechanism correction action; and the scope retraction speed may be reduced to avoid an insertion axis force rising too quickly to cause a fault and trigger a stuck mechanism correction action. If no increased force is detected on the insertion axis in the block (1206), the process (1200) proceeds to the block (1216), where the captured stone is collected, for example, at the proximal end of the access sheath used to access the target anatomical structure.

[0145] If an increased force is detected on the insertion axis in block (1206), the process (1200) proceeds to a determination block (1208), where it is determined whether a soft stop position (e.g., a soft stop position providing a buffer distance from a possible hard stop position) has been previously set for the insertion axis (e.g., a soft stop position regarding the movement of the insertion axis slider / actuator). For example, the soft stop position may serve as a software limit for the motion (e.g., proximal and / or retraction motion) of the basket slider / actuator configured to control the insertion axis (e.g., basket sheath insertion / retraction). Thus, if a soft stop position is set, the dithering and / or other motion (e.g., retraction) of the insertion axis of the basketing device may be artificially limited at a location other than a physical hard stop position. In some embodiments, detection of an increased force on the insertion axis triggers the recording / setting of a hard stop insertion axis actuator position for future reference as a position associated with a potential physical hard stop.

[0146] If a soft stop position is previously set, the process (1200) proceeds to block (1210), where a sticking mechanism correction action is implemented. That is, if an increased force is detected on the insertion axis after the soft stop position has previously been set, it can be determined that the increased force on the insertion axis represents an actual sticking mechanism state and thus the correction action is guaranteed. The sticking mechanism correction action may include slowing down the scope retraction to avoid the insertion axis force rising too quickly to allow the system to cause a fault. If the insertion axis force continues to rise while the slow scope retraction is implemented, a sticking mechanism warning / fault may be generated to notify the user of a potential sticking mechanism state and to trigger the cessation / stopping of the scope retraction. The sticking mechanism correction action may include requesting a confirmation response from the user / doctor regarding the sticking mechanism state and / or its resolution.

[0147] If a soft stop position has not been previously set / recorded, a certain action may be implemented to determine whether the elevated force detected on the insertion axis in block (1206) actually indicates a false positive state caused by contact with a physical hard stop by the insertion axis actuator, rather than the result of a stuck mechanism state. For example, the slider / actuator may reach the physical limit of the track on which it slides / operates (e.g., posterior / proximal limit). The basketing device / system may include a proximal basketing cartridge / handle comprising one or more actuators, such as an insertion axis actuator and / or an opening axis actuator (which controls the movement of the basket tin within the basket sheath, described in more detail later in connection with FIGS. 19 and 20). When the basketing cartridge / handle is coupled or engaged with a robot manipulator (e.g., end effector), the position of the actuator may be unknown, arbitrary, or offset, so that they may or may not be within the proximity range of a hard stop position within their respective tracks during various stages of the process (1200). Thus, when an elevated insertion axis force is detected and a soft stop position has not been previously set, the process (1200) proceeds to block (1212), where the insertion axis and / or basket may be deflected forward relative to the scope by a predetermined certain distance / amount. That is, the basket may be advanced forward by a certain amount (e.g., nominal amount) to offset the basket and the associated actuator from the position where the elevated insertion axis force was detected. Forward deflection of the insertion axis can move the insertion axis actuator further away from the actual hard stop boundary when an increased force is induced by contact with a hard stop on the insertion axis, and consequently, the basket protrudes relatively further from the distal end of the scope.

[0148] In addition to advancing / deflecting the basket forward relative to the distal end of the scope, the process (1200) may include, in block (1214), setting a soft stop position associated with the position of the insertion axis / basket at the time when an elevated force on the insertion axis is detected. For example, the soft stop position may be at a determined / suspected hard stop position, or the recorded soft stop position may advantageously be located at a buffer distance (i.e., a soft stop buffer) away from the determined / suspected hard stop position. That is, the set / recorded soft stop position may be a position that is distal (i.e., additionally inserted) relative to the position of the basket at the time / point when the elevated force is detected. The soft stop position may thus be set to a position that provides a buffer between the potential hard stop position where the elevated force is detected and the soft stop position. Setting a soft stop can prevent the insertion axis actuator from moving to a position where the increased insertion axis force is detected, and this can be associated with a physical hard stop of the insertion axis actuator / slider.

[0149] In addition to setting a soft stop position and / or as a result of setting a soft stop position, the process (1200) may further include moving the dithering range of motion forward for implementation when dithering the basket to an area distal to the soft stop position, as a means of determining whether the increased force on the insertion axis originated from the hard stop of the insertion axis actuator / slider and thus potentially does not indicate an actual stuck mechanism state. The modified dithering area may be limited at one end (e.g., proximal end) by the recorded soft stop position and / or the identified hard stop position.

[0150] After forward deflection of the basket, setting of the soft stop position, and / or forward movement of the dithering zone, the process (1200) may return to the sub-process (1204), where the basket and scope are retracted while implementing basket dithering, or the process (1200) may proceed to the fixation mechanism correction operation(s) in the block (1210). Although the flowchart of FIG. 12 describes the sub-process (1204) as including basket dithering, it should be understood that the process (1200) may be implemented without implementing basket dithering and / or moving the dithering zone. The process (1200) may continue from the sub-process (1204), where, since a soft stop position was previously set, if an increased force is subsequently detected on the insertion axis in block (1206), the process (1200) will proceed to the correction operation(s) in block (1210), where such increased force can be interpreted as an indication of the actual stuck mechanism state. If no additional increased force is detected after the insertion axis / basket is deflected forward, the previously detected increased force may be determined to be associated with the actual hard stop state for the insertion axis actuator. In some embodiments, the hard stop position for the insertion axis may be recorded / maintained in some way for at least the duration of the engagement of the basketing cartridge / handle with the robot manipulator (e.g., end effector) until its disengagement.

[0151] After collecting the captured stones in block (1216), it may be determined in block (1218) whether there are any additional stones and / or stone fragments to be collected. If so, the process may proceed to block (1220), where any previously set soft stop location may be erased / reset and / or the dithering zone may be returned / reset to the default range / zone. The scope and basket are reinserted into the target anatomical structure in block (1222), and then additional stones / fragments are captured in block (1202).

[0152] FIG. 13 is a flowchart illustrating a process (1300) for managing false positive sensor readings on the insertion axis of a basketing device according to one or more embodiments. In block (1302), the process (1300) includes capturing a stone with a basketing device within the patient's kidney. For example, a stone fragment among a plurality of stone fragments may be captured. The stone may be captured by operating the opening axis of the basketing device, which controls the opening and closing of the basket tine / wire by extending and / or retracting the tine / wire from the sheath of the basketing device. Capturing the stone may further include operating the insertion axis of the basketing device, which may cause the operation of the basket sheath to cause the insertion and / or retraction of the basket to an endoscope in which the basketing device is placed (e.g., within the working channel of a scope).

[0153] Referring further to FIG. 13, blocks (1305, 1307) of the process (1300) may be implemented to reset the dithering zone of the basketing device in relation to the dithering operation of the insertion axis of the basketing device when the user moves the basket outside (or within) the originally set dithering zone. In the determination block (1305), it is determined whether the user has inserted or retracted the basket from the default position. For example, the determination in block (1305) may include determining whether the user has operated the insertion axis of the basketing device, for example, by operating the insertion axis actuator / slider manually or by a robot. For example, when the scope is retracted, the basket may generally be dithered within a predetermined dithering zone / range. If the user inserts or retracts the basket for some reason independently of the basket's dithering motion and subsequently continues to retract the scope, it may be desirable to modify the range of the dithering zone.

[0154] When the basket is inserted or retracted by the user, the process (1300) may proceed to block (1307), where the dithering zone for the basket may be modified / configured to compensate for the insertion or retraction of the basket implemented by the user. For example, if the user inserts the basket by a certain amount, the dithering zone may be moved forward by a corresponding amount; similar modifications may be implemented for the case of retraction.

[0155] In the subprocess block (1304), the process (1300) comprises retracting the scope and basket while dithering the basket with respect to the distal end of the scope, as described in detail in this specification. Such dithering may be implemented within the attachment mechanism risk zone, whereby the dithering process is implemented for the detection of attachment stones as described in detail throughout this disclosure. During the retraction of the scope, which may include retracting the scope and basket together from the inner side of the access sheath (e.g., ureteral access sheath) used to access the target anatomical structure and / or from a certain distance proximal to the distal end / outer side of the access sheath / opening, the basket insertion axis may be dithered back and forth to provide improved sensitivity for the detection of attachment mechanisms, as described in detail. Generally, the dithering distance / range of the motion can be set to a relatively small distance so that it may not be perceived by the user while still generating dynamic movement about the basket insertion axis to provide improved sticking mechanism detection sensitivity. Although the flowchart of FIG. 13 describes the subprocess (1304) as including basket dithering, it should be understood that the process (1300) can be implemented without implementing basket dithering and / or moving the dithering zone.

[0156] In block (1306), it is determined whether an elevated force is detected on the insertion axis associated with the basketing device. For example, one or more force sensors associated with the sheath of the basketing device may indicate an elevated force that may potentially indicate a stuck absence. The insertion axis may be associated with a slider / actuator of the handle / cartridge associated with the basketing device, wherein the slider actuator is configured to control the insertion and retraction of the basket and / or its sheath relative to the scope when the basket is placed within the working channel of the scope.

[0157] As described in detail above, a robotic manipulator (e.g., an intangible device manipulator (IDM), an end effector, etc.) may be used as an input source for detecting a stuck mechanism. For example, a stuck mechanism detection function according to an aspect of the present disclosure may be implemented to detect an insertion axis force peak / level that may occur when an actual stuck mechanism state exists, so that the user may be notified of a potential stuck mechanism state before damage or injury to the mechanism and / or anatomical structure occurs. The elevated force detection associated with block (1306) may relate to a force on the insertion axis rising sufficiently high to reach a threshold level, at which point scope deceleration may be implemented in some cases as a stuck mechanism correction action; and the scope retraction speed may be reduced to avoid an insertion axis force rising too quickly to cause a fault and trigger a stuck mechanism correction action. If no increased force is detected on the insertion axis in the block (1306), the process (1300) proceeds to the block (1316), where the captured stone is collected, for example, at the proximal end of the access sheath used to access the target anatomical structure.

[0158] If an increased force is detected on the insertion axis in block (1306), the process (1300) proceeds to the determination block (1308), where it is determined whether a hard stop position has previously been set / recorded for the insertion axis (e.g., a hard stop position regarding the movement of the insertion axis slider / actuator). The referenced hard stop position may be an actual confirmed physical hard stop limit, or another position limit identified as a potential hard stop limit.

[0159] If a hard stop position has been previously set, the process (1300) proceeds to block (1310), where a sticking mechanism correction action is implemented. That is, if an increased force is detected on the insertion axis after the hard stop position has been previously recorded, it can be determined that the increased force on the insertion axis represents an actual sticking mechanism state and thus a correction action is guaranteed. The sticking mechanism correction action may include slowing down the scope retraction to avoid the insertion axis force rising too quickly to allow the system to cause a fault. If the insertion axis force continues to rise while slow scope retraction is implemented, a sticking mechanism warning / fault may be generated to notify the user of a potential sticking mechanism state and to trigger a stop / interruption of the scope retraction. The sticking mechanism correction action may include requesting a confirmation response from the user / doctor regarding the sticking mechanism state and / or its resolution.

[0160] If a hard stop limit / position has not been previously set / recorded, a certain action may be implemented to account for the possibility that the elevated force detected on the insertion axis in block (1306) is not actually the result of a stuck mechanism state, but rather indicates a false positive state possibly caused by contact with a physical hard stop by the insertion axis actuator. For example, the slider / actuator may reach the physical limit of the track on which it slides / operates (e.g., a posterior / proximal limit). The basketing device / system may include a proximal basketing cartridge / handle comprising one or more actuators, such as an insertion axis actuator and / or an opening axis actuator (for controlling the movement of the basket tin within the basket sheath, described in more detail later in connection with FIGS. 19 and 20). When the basketing cartridge / handle is coupled or engaged with a robot manipulator (e.g., end effector), the position of the actuator may be unknown, arbitrary, or offset, so that they may or may not be within the proximity range of a hard stop position within their respective tracks during various stages of the process (1300). Thus, when an elevated insertion axis force is detected and a potential hard stop limit position has not been previously set, the process (1300) proceeds to block (1312), where the insertion axis and / or basket may be deflected forward relative to the scope by a predetermined certain distance / amount. That is, the basket may be advanced forward by a certain amount to offset the basket and the associated actuator from the position where the elevated insertion axis force was detected (i.e., the potential hard stop limit). Forward deflection of the insertion axis can move the insertion axis actuator further away from the actual hard stop boundary when an increased force is induced by contact with a hard stop on the insertion axis, and consequently, the basket protrudes relatively further from the distal end of the scope.Forward deflection of the basket can provide the basket with a buffer (or a larger buffer) from a physical hard stop proximal to the insertion axis.

[0161] In addition to advancing / deflecting the basket forward relative to the distal end of the scope, the process (1300) may include recording a potential hard stop position associated with the position of the insertion axis / basket at the time when an elevated force on the insertion axis is detected in block (1314). The process (1300) may further include moving the dithering zone / range of motion forward for implementation when dithering the basket to an area further distal by a certain distance. Such distance may be a buffer distance from the recorded hard stop position, so that the proximal limit of the dithering zone / range is a soft stop position separated by a buffer distance from the hard stop position. After recording the potential hard stop position, if it is subsequently determined that the insertion axis can be driven past such limit without a physical hard stop, the recorded hard stop position may be modified accordingly.

[0162] After forward deflection of the basket, recording of the hard stop position, and / or forward movement of the dithering zone, the process (1300) may proceed to the calibration operation(s) associated with the block (1310), and ultimately to allow further retraction of the scope in relation to the block (1304). The process (1300) may continue from the subprocess (1304), where, since the hard stop position was previously recorded, if an elevated force is subsequently detected on the insertion axis in the block (1306), the process (1300) will proceed to the calibration operation(s) in the block (1310), where such elevated force can be interpreted as an indication of the actual stuck mechanism state. If no additional elevated force is detected after forward deflection of the insertion axis / basket, the process (1300) may proceed safely to the collection. In block (1310), the system may generate a fault, and then the user may acknowledge the fault to verify whether an actual stuck mechanism state exists (block (1311)). Once the fault is acknowledged, the user may be allowed to drive the scope again (e.g., return to block (1302 or 1304)).

[0163] After collecting the captured stones from block (1316), it can be determined whether there are any additional stones and / or stone fragments remaining to be collected from block (1318). If so, the process can proceed to block (1322), where the scope and basket are reinserted into the target anatomical structure, and then additional stones / fragments are captured from block (1302).

[0164] FIG. 14 is a diagram illustrating a hard stop force detection calibration operation according to one or more embodiments. The diagram in FIG. 14 includes a time axis moving from the top to the bottom of the page—where time proceeds in that direction—and an insertion axis extending from left to right and increasing to indicate the relative distance of the basket to the distal end of the scope. The zigzag movement of the line (1401) represents a dithering motion of the basket relative to the scope by the operation of the insertion axis actuator / slider, as described in detail herein. The dithering motion of the basket may be within a predetermined dithering zone / range (1405) of motion during a first time window (1409).

[0165] At a point (1402) indicating a specific point in time while dithering the basket and / or the corresponding basket insertion position (1403), an elevated force is detected on the insertion axis, which may be caused by an actual stuck mechanism state or may be a false positive reading caused by an insertion axis actuator / slider reaching a physical hard stop position. For example, the slider / actuator may reach the rear / physical limit of the track on which it is sliding / operating. In response, the position where the elevated force on the insertion axis is detected may be stored, set, and / or otherwise recorded as a hard stop position.

[0166] In response to the detected increased force on the insertion axis, the basket is at the exemplified distance ( D 1It may be deflected forward by a distance equal to and / or related to ), wherein such forward deflection of the basket is represented by at least a portion of the line segment (1407) and / or line segment (1408). A soft stop insertion axis position (1404) may be set and / or enforced / implemented, wherein such a soft stop basket insertion position (1404) may be equal to the hard stop position (1403) or, as illustrated, a distance ( D 1 It can be forward-biased by ). Additionally, the dithering zone / range of motion for dithering the basket can be forward-biased to a modified zone / range (1406), wherein the modified dithering zone / range (1406) can be determined and / or positioned so that the nearest insertion position during the associated dithering motion does not cross the soft stop boundary (1404).

[0167] FIG. 15 illustrates a flowchart illustrating a process (1500) for adjusting a dithering zone / range according to one or more embodiments of the present disclosure, such as one that may be implemented in relation to the aforementioned processes (1200, 1300). FIG. 16 illustrates a predetermined image corresponding to various blocks, states, and / or actions associated with the process (1500) of FIG. 15 according to one or more embodiments. In FIG. 16, the illustrated unidirectional arrow may indicate a basket motion, such as motion with respect to a scope (103).

[0168] Process (1500) provides adjustment of the dithering zone when, for example, during scope retraction, the dithering motion of the basket causes the basket insertion axis to reach a distal hard stop. For example, block (1502) includes the user retracting the scope while dithering the basket; the user may or may not perceive the dithering of the basket, as it can be automatically implemented as a response system process. Image (1602) illustrates the distal end of the basket sheath (102) and / or the basket tin (101) dithering in the dithering zone. One or more parts of the basket (101) distal to the distal end of the basket sheath (102) and / or the basket (102) are referred to as basket (104) below; such reference may refer to any such component / part.

[0169] In block (1504), the process (1500) includes detecting a hard stop when inserting the basket forward in relation to the dithering motion. For example, it can be understood that the elevated insertion axis force reading generated upon basket insertion is possibly or certainly the result of actuator hard stop contact; the actual stuck absence state may generally not generate a relatively high force during basket insertion. In block (1505), the process (1500) includes recording the insertion axis position (105) associated with the hard stop.

[0170] In block (1506), the process (1500) includes adjusting the dither zone proximally. In some embodiments, such dither zone adjustment may include a buffer between the distal end (106) of the adjusted dither zone and the hard stop position (105). For example, in relation to adjusting the dither zone, the insertion axis may be driven backward by a certain distance to relieve tension on the driver of the insertion axis actuator (e.g., a robot manipulator / end effector driver coupled in drive engagement with the input of the basketing device cartridge / handle). distance ( D 2 ) can be considered as a soft stop buffer, which indicates the distance the basket (104) is driven backward to release tension on the device and prevent continuous bumping into the physical limits of the device / system.

[0171] FIG. 17 illustrates a flowchart illustrating a process (1700) for adjusting a dithering zone / range according to one or more embodiments of the present disclosure, such as one that may be implemented in relation to the aforementioned processes (1200, 1300). FIG. 18 illustrates a predetermined image corresponding to various blocks, states, and / or actions associated with the process (1700) of FIG. 17 according to one or more embodiments. In FIG. 18, the illustrated unidirectional arrow may indicate a basket motion, such as a motion with respect to a scope (103).

[0172] Process (1700) provides adjustment of the dithering zone when, for example, during scope retraction, the dithering motion of the basket causes the basket insertion axis to reach a proximal hard stop. For example, block (1702) includes the user retracting the scope while dithering the basket; the user may or may not perceive the dithering of the basket, as it can be automatically implemented as a response system process. Image (1802) illustrates the distal end of the basket sheath (102) and / or the basket tin (101) dithering in the dithering zone. One or more parts of the basket (101) distal to the distal end of the basket sheath (102) and / or the basket (102) are referred to as basket (104) below; such reference may refer to any such component / part.

[0173] In block (1704), the process (1700) includes changing the dithering direction from forward insertion to backward retraction as a result of the basket (104) reaching the distal boundary of the dithering zone. In block (1706), the process (1700) includes detecting a hard stop when retracting the basket backward in relation to the dithering motion. In block (1705), the process (1700) includes recording the insertion axis position (107) associated with the hard stop.

[0174] In block (1706), the process (1700) includes adjusting the dither zone distally. In some embodiments, such dither zone adjustment may include a buffer between the proximal end (108) of the adjusted dither zone and the hard stop position (107). For example, in relation to adjusting the dither zone, the insertion axis may be driven forward by a certain distance to relieve tension on the driver of the insertion axis actuator (e.g., a robot manipulator / end effector driver coupled in drive engagement with the input of the basketing device cartridge / handle). distance ( D 3) can be considered as a soft stop buffer, which indicates the distance the basket (104) is driven forward to release tension on the device and prevent continuous bumping into the physical limits of the device / system.

[0175] FIG. 19 is a flowchart illustrating a process (1900) for managing false positive sensor readings on an open axis according to one or more embodiments. As referenced above, the state of the fixation mechanism may cause a relatively high force to be transmitted to the basket open axis, and thus, for any embodiment of the present disclosure, it may be advantageous to monitor the force on the open axis in relation to the management of the fixation mechanism. For example, the actuation of a basket slider / actuator configured to actuate a basket tine against a basket sheath may be implemented for stone capture. As previously mentioned, such actuation may be considered as an "open axis" actuation, wherein the force and the associated actuation may be considered as the "open axis" of the basketing system.

[0176] In block (1902), the process (1900) comprises capturing a stone or stone fragment with a basketing device deployed from the working channel of the endoscope (referred to herein for convenience as "scope"). For example, capturing the stone with a basket may involve operating the opening axis of the basketing device to pull one or more wire ties or other basket components into (or out of) the basketing sheath and / or around the captured stone. Closing of the basket ties around the scope may be implemented at least partially by operating a basket slider / actuator proximally (or otherwise), wherein such an actuator may be associated with a basketing cartridge that is associated with a proximal part of the basketing device / system and driven by a robotic manipulator. In some cases, when closing the basket tines around a stone / fragment, the tines are wedged against the sides of the basket sheath in a way that reduces the amount of force detected on the open axis. However, in some cases, the tines may not close sufficiently tightly around the trapped stone fragment, so the sensitivity to force readings on the open axis becomes greater; and the state of the fixation mechanism may be perceived on the open axis in some such cases.

[0177] In block (1904), the process (1900) involves retracting the scope and basket together proximally toward and / or into the distal opening of the approach sheath through which the scope and basket approach the target anatomical chamber / location. The determination block (1906) relates to whether an elevated force is detected on the open axis of the basketing system during retraction relative to block (1904). For example, the basketing device / system may include one or more force sensors associated with the open axis and may be configured to generate a signal indicating a force experienced on the open axis, such as a force pulling the basket tine.

[0178] If no increased force is detected on the open axis, the process (1900) may proceed to complete the retraction of the scope and basket and collect the missing stones / fragments in relation to the action(s) associated with block (1912). If additional missing stones / fragments remain to be collected, as indicated in the determination block (1919), the process may include re-inserting the scope and basket through the access sheath into the target anatomical chamber (e.g., the renal calyces of the kidney), as indicated in block (1918), and returning to a sub-process (1902) involving the additional capture of one or more additional missing stones / fragments by the basket.

[0179] If an increased force is detected on the open axis during the retraction of the scope and basket as determined in block (1906), the process may continue to block (1908), where it may be determined whether the open axis is currently in a forward-biased position. For example, forward bias of the open axis (e.g., basket tin) may have been previously implemented in relation to the increased force previously detected on the open axis.

[0180] As determined in block (1908), if the open axis has not previously been forward deflected, the process (1900) may proceed to a predetermined action intended to identify and / or manage the possibility associated with a false positive state that does not represent an actual stuck mechanism state, such as the result of an increased force detected on the open axis, which may be the result of an open axis actuator / slider contacting a hard stop during the retraction of the scope and basket. For example, such action may include forward deflecting the open axis by acting the open axis actuator / slider forward / distal by a predetermined distance, e.g., 1 to 5 mm, 5 to 10 mm, or more than that, as illustrated in block (1910). Forward deflecting the open axis may be considered and / or implemented as establishing a soft stop position associated with the forward-deflected position of the open axis and driving to such position.

[0181] After forward-deflecting the open approach, the process (1900) may return to the retraction (1904) and / or absence-capture (1902) action of the process (1900). If an elevated force is detected on the open axis during absence capture and / or scope / basket retraction after forward deflection of the open axis in block (1910), the path from the determination block (1908) may proceed to the block (1916) related to the correction of the stuck mechanism. For example, if an elevated force is detected on the open axis after a preventive forward deflection of the open axis actuator has been implemented, the elevated force may be determined to represent an actual stuck mechanism state, and thus the process (1900) may proceed to implement an action associated with the correction action for the stuck mechanism state as described in detail herein.

[0182] FIG. 20 is a flowchart illustrating a process (2000) for managing false positive sensor readings on an open axis according to one or more embodiments. As referenced above, the state of the fixation mechanism may cause a relatively high force to be transmitted to the basket open axis, and thus, for any embodiment of the present disclosure, it may be advantageous to monitor the force on the open axis in relation to the management of the fixation mechanism. For example, the actuation of a basket slider / actuator configured to actuate a basket tine against a basket sheath may be implemented for stone capture. As previously described, such actuation may be considered as an "open axis" actuation, wherein the force and the associated actuation may be considered as the "open axis" of the basketing system.

[0183] In block (2002), the process (2000) comprises capturing a stone or stone fragment with a basketing device deployed from the working channel of the endoscope (referred to herein for convenience as "scope"). For example, capturing the stone with a basket may involve operating the opening axis of the basketing device to pull one or more wire ties or other basket components into (or out of) the basketing sheath and / or around the captured stone. Closing of the basket ties around the scope may be implemented at least partially by operating a basket slider / actuator proximally (or otherwise), wherein such an actuator may be associated with a basketing cartridge that is associated with a proximal part of the basketing device / system and driven by a robotic manipulator. In some cases, when closing the basket tines around a stone / fragment, the tines are wedged against the sides of the basket sheath in a manner that reduces the amount of force detected on the open axis. However, in some cases, the tines may not close sufficiently tightly around the trapped stone fragment, so the sensitivity to force readings on the open axis becomes greater; and the state of the fixation mechanism may be perceived on the open axis in some such cases.

[0184] In block (2004), the process (2000) comprises retracting the scope and basket together proximally toward and / or into the distal opening of the approach sheath through which the scope and basket approach the target anatomical chamber / location. The determination block (2006) relates to whether an elevated force (e.g., a force exceeding a predetermined threshold) is detected on the open axis of the basketing system during retraction in relation to block (2004). For example, the basketing device / system may include one or more force sensors associated with the open axis and may be configured to generate a signal indicating a force experienced on the open axis, such as a force pulling the basket tine.

[0185] If no increased force is detected on the open axis, the process (2000) may proceed to complete the retraction of the scope and basket and collect the stones / fragments in relation to the action(s) associated with block (2012). If additional stones / fragments remain to be collected, as indicated in the determination block (2019), the process (2000) may include re-inserting the scope and basket through the access sheath into the target anatomical chamber (e.g., the renal calyces of the kidney), as indicated in block (2018), and returning to a sub-process (2002) involving the additional capture of one or more additional stones / fragments by the basket.

[0186] If an increased force is detected on the open axis during the retraction of the scope and basket as determined in block (2006), the process may continue to block (2010), which may include driving the open axis forward by a predetermined soft stop buffer distance by, for example, acting the open axis actuator / slider forward / distal by a predetermined distance (e.g., 1 to 5 mm, 5 to 10 mm, or more). The forward driving / deflection of the open axis may be implemented to provide a slight gap from the possible hard stop boundary / limit associated with the increased force detected in block (2006).

[0187] Even if it may not be known whether the increased force is due to a stuck mechanism state or simply a hard stop collision / contact, the process (2000) may nevertheless proceed to a similar stuck-mechanism-related calibration action as associated with block (2016). Forward drive of the open axis may be considered as part of the stuck mechanism calibration action associated with block (2016). Possibly, among other things, the calibration action associated with block (2016) may include notifying the user of a potential stuck mechanism state. The user may then check camera view(s) and / or other parameter(s) to determine whether an actual stuck mechanism state exists. If so, the user may operate the basket, scope, and / or other mechanism(s) to resolve the stuck mechanism state. Once the user acknowledges that the stuck mechanism state (block (2011)) is resolved, if present, the system may allow further drive of the scope (e.g., retraction). For example, the process (2000) may proceed to any of the blocks (2002, 2004, 2012, 2019) or terminate in some way.

[0188] If false positive processing as shown in FIGS. 12, FIGS. 20 and / or FIGS. 20 is not implemented, the increased insertion and / or opening axis forces triggered by a physical hard stop state with respect to each actuator(s) / slider(s) cause recurring failures resulting from the false assumption that such increased forces are due to a stuck mechanism state. Accordingly, the process illustrated in FIGS. 12 through 20 can enable the management of a stuck mechanism according to an embodiment of the present disclosure without the risk of fatal or problematic hard stop interference / derailment.

[0189] Additional Examples

[0190] According to the embodiments, a certain operation, event, or function of any of the processes or algorithms described herein may be performed in a different sequence, added, merged, or completely omitted. Accordingly, in certain embodiments, not all described operations or events are required for the execution of a process.

[0191] Unless specifically stated otherwise or otherwise understood within the context in which they are used, conditional language used herein, such as, among others, “may,” “will be,” “may be,” “may be,” “e.g.,” etc., is intended in its ordinary sense and is generally intended to convey that while a certain embodiment includes a certain feature, element, and / or step, another embodiment does not include a certain feature, element, and / or step. Accordingly, such conditional language is generally not intended to imply that one or more embodiments necessarily include logic for determining, with or without drafter input or prompt, whether a feature, element, and / or step is included in or will be performed in any particular embodiment, or that these feature, element, and / or step are present in any manner required for one or more embodiments. Terms such as "comprising," "equipping," and "having" are synonyms and are used in their ordinary senses and in an inclusive, open manner, and do not exclude additional elements, features, actions, operations, etc. Additionally, the term "or" is used in its inclusive sense (and not in its exclusive sense), so that when used, for example, to link a list of elements, the term "or" implies one, some, or all of the elements within the list. Unless specifically stated otherwise, conjunctions such as the phrase "at least one of X, Y, and Z" are understood in the same context as they are generally used to convey that an item, term, element, etc., may be X, Y, or Z. Accordingly, such conjunctions are generally not intended to imply that a given embodiment requires at least one of X, at least one of Y, and at least one of Z for each to exist.

[0192] In the above description of the embodiments, it should be recognized that various features are sometimes grouped together in a single embodiment, drawing, or description to simplify the disclosure and aid in understanding one or more of the various aspects of the invention. However, this method of the disclosure should not be interpreted as reflecting an intention that any claim requires more features than explicitly cited in such claim. Furthermore, any component, feature, or step exemplified and / or described in a particular embodiment of this specification may be applied to or used in conjunction with any other embodiment(s). Also, a component, feature, step, or group of components, features, or steps is not required or essential to each embodiment. Accordingly, the scope of the invention disclosed in this specification and claimed below is not intended to be limited by the specific embodiments described above, but is to be determined solely by a reasonable reading of the claims below.

[0193] It should be understood that specific ordinal terms (e.g., "first" or "second") may be provided for ease of reference and do not necessarily imply physical characteristics or order. Accordingly, as used herein, ordinal terms used to modify elements such as structures, components, actions, etc. (e.g., "first," "second," "third," etc.) do not necessarily indicate the priority or order of such elements relative to any other elements, but rather distinguish such elements from other elements that generally have similar or identical names (but for the use of ordinal terms). Furthermore, as used herein, indefinite articles (“a” and “an”) may indicate “one or more” rather than “one.” Additionally, actions performed “based on” a state or event may also be performed based on one or more other states or events not explicitly mentioned.

[0194] Unless otherwise defined, all terms used herein (including technical and scientific terms) have the same meaning as generally understood by those skilled in the art to which the exemplary embodiments belong. It should also be understood that terms such as those defined in commonly used dictionaries should be interpreted as having a meaning consistent with their meaning in the context of the relevant technology, and should not be interpreted in an idealized or overly formal sense unless explicitly defined so in this specification.

[0195] Spatially relative terms "outer," "inner," "upper," "lower," "below," "upper," "vertical," "horizontal," and similar terms may be used herein for ease of description to describe the relationship between one element or component and another element or component as illustrated in the drawings. It should be understood that spatially relative terms are intended to include different orientations of the device in use or operation in addition to the orientations illustrated in the drawings. For example, if the device illustrated in the drawings is inverted, a device located "below" or "under" another device may be placed "above" another device. Thus, the exemplary term "below" may include both lower and upper positions. The device may also be oriented in different directions, and thus spatially relative terms may be interpreted differently depending on the orientation.

[0196] Unless otherwise explicitly stated, comparative and / or quantitative terms such as "less," "more," "greater," etc., are intended to include the concept of equality. For example, "less" can mean not only "less" in the strictest mathematical sense, but also "less than or equal to."

Claims

Claim 1 A method for detecting a stuck instrument condition, comprising: retracting a first instrument having a second instrument that is at least partially disposed within the working channel of the first instrument; dithering at least one of the first instrument or the second instrument in a vibrating manner during the step of retracting the first instrument; determining that a force reading associated with at least one of the first instrument or the second instrument exceeds a threshold during the step of dithering the first instrument or the second instrument; and determining that the second instrument is in a stuck state based at least partially on the determination that the force reading exceeds the threshold. Claim 2 A method according to claim 1, further comprising: a step of determining that at least one of the first apparatus or the second apparatus has entered a hazard zone; and a step of initiating the dithering in response to the step of determining that at least one of the first apparatus or the second apparatus has entered the hazard zone. Claim 3 A method according to paragraph 2, wherein the step of determining that at least one of the first mechanism or the second mechanism has entered the danger zone is based at least partially on robotic actuator data generated by one or more robotic actuators configured to operate one or more of the first mechanism or the second mechanism, or position sensor data associated with the first mechanism or the second mechanism. Claim 4 The method of claim 1 further comprises the step of detecting a hard stop force reading associated with at least one of an opening axis or an insertion axis associated with the second mechanism; and the step of driving the at least one of the opening axis or the insertion axis forward by a predetermined distance in response to the hard stop force reading. Claim 5 A robotic system comprising: one or more robotic arms; one or more instrument manipulators coupled to each of the one or more robotic arms; one or more actuators associated with at least one of the one or more instrument manipulators, said one or more actuators configured to cause axial movement of at least one of an endoscope, a sheath of a basket device at least partially disposed within the endoscope, or tines of said basket device; and one or more sensors associated with the one or more instrument manipulators, said one or more sensors configured to generate signals indicating the force experienced by said one or more actuators. A robot system comprising a control circuit configured to communicately coupled to the one or more mechanism manipulators and the one or more sensors, wherein the control circuit causes the basket device to advance and retract in a dithering motion; receives signals from the one or more sensors indicating the force experienced by the one or more actuators while the basket device is moving in the dithering motion; determines that the force is greater than a predetermined threshold; and executes a response action in response to the determination that the force is greater than the predetermined threshold. Claim 6 A robot system according to claim 5, wherein the response action includes providing a warning to the user indicating that the basket device is in a stuck state, or reducing or stopping the retraction speed of the endoscope. Claim 7 A robot system according to claim 5, wherein the one or more actuators comprise one or more basket sheath actuators, one or more basket tine actuators, or one or more endoscope actuators. Claim 8 A robot system according to claim 5, wherein the control circuit detects a hard stop force reading associated with at least one of an opening axis or an insertion axis associated with the basket device; and further configured to drive the at least one of the opening axis or the insertion axis forward using at least one of the one or more actuators in response to the hard stop force reading. Claim 9 A method for detecting a stuck state of a mechanism, comprising: determining that a force on a component of the mechanism is greater than a predetermined force threshold while the mechanism is retracting in a dithering motion; starting a timer in response to the determination that the force is greater than the predetermined force threshold; determining that the timer has exceeded a predetermined time threshold; and initiating a response operation in response to the determination that the timer has exceeded the predetermined time threshold. Claim 10 A computing device comprising: a robotic system interface; and a control circuit coupled to the robotic system interface for communication and comprising one or more processors and one or more data storage devices, wherein the control circuit is configured to cause a basket device to be dithered with respect to a working channel of an endoscope in which the basket device is at least partially placed; to determine that, while the basket device is dithered, a force experienced by one or more components of the basket device exceeds a threshold; and to determine that the basket device is in a stuck state based on the determination that the force exceeds the threshold. Claim 11 A computing device according to claim 10, wherein the determination that the force indicates the fixation state is based on one or more of the driving behavior of the user driving the endoscope and the size of the object captured by the basket device. Claim 12 A computing device according to claim 10, wherein the control circuit is further configured to disable the dithering of the basket device in response to a determination that the basket device and the endoscope have retracted within the approach sheath. Claim 13 A computing device according to claim 10, wherein the control circuit is further configured to stop the motion of the endoscope in response to the fixation state. Claim 14 delete Claim 15 delete Claim 16 delete Claim 17 delete Claim 18 delete Claim 19 delete Claim 20 delete Claim 21 delete Claim 22 delete Claim 23 delete Claim 24 delete Claim 25 delete Claim 26 delete Claim 27 delete Claim 28 delete Claim 29 delete Claim 30 delete

Citation Information

Patent Citations

  • Systems and devices for measuring distal force of work instruments

    JP2009527344A

  • Method of sensing forces on a working instrument

    US20070197939A1

  • Apparatus for measuring distal forces on a working instrument

    US20070233044A1

  • Retraction force sensing basket

    US20170303945A1

  • Surgical apparatus with force sensor for extraction of substances within the body

    WO2015134846A1