Restoring the state of systems after a system restart
By allowing medical systems to skip previously completed operations in a second session after a mid-procedure restart, the system addresses the inefficiency of repeated operations, enhancing procedural efficiency and reducing patient recovery time.
Patent Information
- Application Number
- PCT/US2024/049523
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-10-02
- Filing Date
- 2024-10-02
- Publication Date
- 2025-04-10
AI Technical Summary
Medical systems often require restarts during procedures, leading to inefficiencies as previously completed medical instrument operations need to be repeated, wasting time and resources.
The medical system is configured to execute a first session, followed by a mid-procedure restart, and then a second session where completed medical instrument operations from the first session are skipped based on parameter comparisons between the two sessions.
This approach significantly reduces the time and effort required to complete a medical procedure by skipping redundant operations, thereby improving operational efficiency and reducing patient recovery time.
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Figure US2024049523_10042025_PF_FP_ABST
Abstract
Description
RESTORING THE STATE OF SYSTEMS AFTER A SYSTEM RESTARTCROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of priority under 35 U S.C. § 119(e) to U.S. Provisional Patent Application Serial No. 63 / 542,012, filed on October 2, 2023, which is hereby incorporated by reference herein in its entirety.FIELD
[0002] Disclosed embodiments relate to improved robotic and / or medical (including surgical) devices, systems, and methods.BACKGROUND
[0003] Minimally invasive medical techniques are intended to reduce the amount of tissue that is damaged during medical procedures, thereby reducing patient recovery time, discomfort, and harmful side effects. Such minimally invasive techniques may be performed through natural orifices in a patient anatomy or through one or more surgical incisions. Through these natural orifices or incisions, physicians may insert minimally invasive medical instruments (including surgical, diagnostic, therapeutic, and / or biopsy instruments) to reach a target tissue location. One such minimally invasive technique is to use a flexible and / or steerable elongate device, such as a flexible catheter or bronchoscope, that can be inserted into anatomic passageways and navigated toward a region of interest within the patient anatomy.
[0004] Medical systems may be complex and may require potentially time-consuming operations in the performance of procedures, including various setup operations. Occasionally, a restart of a medical system may be necessary or useful, which can result in repeated performance of previously completed operations prior to the restart.SUMMARY
[0005] The following presents a simplified summary of various examples described herein and is not intended to identify key or critical elements or to delineate the scope of the claims.
[0006] In some examples, embodiments of the disclosure relate to a medical system comprising: a manipulator assembly for controlling movements of a medical instrument, and a control system coupled to the manipulator assembly, the control system configured to: execute a first session of the medical system for a procedure, wherein executing the first sessioncomprises completing one or more medical instrument operations for the medical instrument, subsequent to completing the one or more medical instrument operations, executing a midprocedure restart of the medical system, and subsequent to executing the mid-procedure restart the medical system, execute a second session of the medical system for the procedure, wherein executing the second session comprises: skipping the one or more medical instrument operations completed in the first session based on comparing one or more first parameters of the medical system associated with the first session with one or more second parameters of the medical system associated with the second session.
[0007] In some examples, embodiments of the disclosure relate to a non-transitory machine- readable medium comprising a plurality of machine-readable instructions executed by one or more processors associated with a medical system, the plurality of machine-readable instructions causing the one or more processors to perform a method comprising: executing a first session of the medical system for a procedure, wherein executing the first session comprises completing one or more medical instrument operations for a medical instrument; subsequent to completing the one or more medical instrument operations, executing a midprocedure restart of restarting the medical system; and subsequent to executing the midprocedure restart of the medical system, executing a second session of the medical system for the procedure, wherein executing the second session comprises skipping the one or more medical instrument operations completed in the first session based on comparing one or more first parameters of the medical system associated with the first session with one or more parameters of the medical system associated with the second session.
[0008] In some examples, embodiments of the disclosure relate to a method for operating a medical system, comprising: executing a first session of the medical system for a procedure, wherein executing the first session comprises completing one or more medical instrument operations for a medical instrument; subsequent to completing the one or more medical instrument operations, executing a mid-procedure restart of the medical system; and subsequent to executing the mid-procedure restart of the medical system, executing a second session of the medical system for the procedure, wherein executing the second session comprises skipping the one or more medical instrument operations completed in the first session based on comparing one or more first parameters of the medical system associated with the first session with one or more parameters of the medical system associated with the second session.
[0009] It is to be understood that both the foregoing general description and the following detailed description are illustrative and explanatory in nature and are intended to provide an understanding of the present disclosure without limiting the scope of the present disclosure. In that regard, additional aspects, features, and advantages of the present disclosure will be apparent to one skilled in the art from the following detailed description.BRIEF DESCRIPTIONS OF THE DRAWINGS
[0010] FIG. 1 is a simplified diagram of a medical system according to some embodiments.
[0011] FIG. 2A is a simplified diagram of a medical instrument system according to some embodiments.
[0012] FIG. 2B is a simplified diagram of a medical instrument including a medical tool within an elongate device according to some embodiments.
[0013] FIGS. 3 A and 3B are simplified diagrams of side views of a patient coordinate space including a medical instrument mounted on an insertion assembly according to some embodiments.
[0014] FIGs. 4, 5, and 6 are flowcharts of methods according to some embodiments.
[0015] FIG. 7A is an illustration of an engagement operation according to some embodiments.
[0016] FIG. 7B is an illustration of motions and torques associated with an engagement test according to some embodiments.
[0017] Embodiments of the present disclosure and their advantages are best understood by referring to the detailed description that follows. It should be appreciated that like reference numerals are used to identify like elements illustrated in one or more of the figures, wherein showings therein are for purposes of illustrating embodiments of the present disclosure and not for purposes of limiting the same.DETAILED DESCRIPTION
[0018] In the following description, specific details are set forth describing some embodiments consistent with the present disclosure. Numerous specific details are set forth in order to provide a thorough understanding of the embodiments. It will be apparent, however, to one skilled in the art that some embodiments may be practiced without some or all of these specific details. The specific embodiments disclosed herein are meant to be illustrative but notlimiting. One skilled in the art may realize other elements that, although not specifically described here, are within the scope and the spirit of this disclosure. In addition, to avoid unnecessary repetition, one or more features shown and described in association with one embodiment may be incorporated into other embodiments unless specifically described otherwise or if the one or more features would make an embodiment non-functional. In some instances, well known methods, procedures, components, and circuits have not been described in detail so as not to unnecessarily obscure aspects of the embodiments.
[0019] This disclosure describes various instruments and portions of instruments in terms of their state in three-dimensional space. As used herein, the term “position” refers to the location of an object or a portion of an object in a three-dimensional space (e.g., three degrees of translational freedom along Cartesian x-, y-, and z-coordinates). As used herein, the term “orientation” refers to the rotational placement of an object or a portion of an object (e.g., one or more degrees of rotational freedom such as, roll, pitch, and yaw). As used herein, the term “pose” refers to the position of an object or a portion of an object in at least one degree of translational freedom and to the orientation of that object or portion of the object in at least one degree of rotational freedom (e.g., up to six total degrees of freedom). As used herein, the term “shape” refers to a set of poses, positions, and / or orientations measured along an object. As used herein, the term “distal” refers to a position that is closer to a procedural site and the term “proximal” refers to a position that is further from the procedural site. Accordingly, the distal portion or distal end of an instrument is closer to a procedural site than a proximal portion or proximal end of the instrument when the instrument is being used as designed to perform a procedure.
[0020] Embodiments of the disclosure include medical systems and methods for operating such medical systems. A medical system, such as medical systems that use flexible elongate devices (e.g., catheters, bronchoscopes, endoscopes, etc.), but also other medical systems, may occasionally require a restart, e.g., in case of a non-recoverable fault, reasserting recoverable fault, or some other undesirable performance of the medical system.
[0021] A medical system may execute multiple medical instrument operations to perform a medical operation. A medical instrument operation, as used herein, refers to an operation executed by the medical system that involves a medical instrument of the medical system. Typically, these medical instrument operations for a single procedure are performed in a single session (e.g., without restarting the medical system, disconnecting the medical instrument fromthe medical system, etc.). The medical instrument operations may include an engagement operation where (a manipulator assembly that controls movement of the medical instrument are engaged with the medical instrument (e.g., actuator disks of the manipulator assembly engages input disks of the medical instrument), a sensor health operation where data from one or more sensors is verified, a motion tests operation where proper movement and control of the medical instrument is verified, a registration operation where sensor data from the one or more sensors is associated with a reference frame, and a navigation operation where the medical instrument is moved toward a target anatomical feature. Although some or all of these medical instrument operations may be time-consuming, they provide proper and safe operation of the medical system.
[0022] In the event that the medical system is restarted during the medical operation, it may be desirable in a post-restart session to skip one or more of the medical instrument operations successfully completed in a pre-restart session, thereby reducing effort and / or time caused by a mid-procedure restart of the medical system. For example, the skipping of medical instrument operations completed in the pre-restart session may be enabled by using tests that demonstrate correspondence or equivalence in states of the medical system in the pre-restart and post-restart sessions. These tests may be simpler for operators (e.g., requiring reduced operator inputs or actions), faster, less disruptive, safer (e.g., can be safely performed while medical instrument remains within patient anatomy), less resource intensive, or otherwise streamlined relative to the medical instrument operations. In some embodiments, the skipping of the one or more medical instrument operations is enabled by comparing one or more parameters of the medical system in a first session pre-restart with one or more parameters of the medical system in a second session post-restart. In one example, the comparison includes showing an equivalence between the one or more parameters of the medical system post-restart and pre-restart. As such, the second session following the mid-procedure restart may be considerably faster than a workflow where all medical instrument operations are performed in each session for a single procedure. Some or all of the medical instrument operations may be skipped in the second session, depending on when and / or why the mid-procedure restart is performed during a procedure (e.g., how many of the medical instrument operations were successfully completed in the first session and verified as being unnecessary to repeat in the second session).
[0023] A more detailed discussion of the medical system, the medical instrument operations, and methods enabling the skipping of the one or more of the medical instrument operations, including resulting benefits, is provided below in reference to the figures.
[0024] Turning to the figures, FIG. 1 is a simplified diagram of a medical system 100 according to some embodiments. The medical system 100 may be suitable for use in, for example, surgical, diagnostic (e.g., biopsy), or therapeutic (e.g., ablation, electroporation, etc.) procedures. While some embodiments are provided herein with respect to such procedures, any reference to medical or surgical instruments and medical or surgical methods is nonlimiting. The systems, instruments, and methods described herein may be used for animals, human cadavers, animal cadavers, portions of human or animal anatomy, non-surgical diagnosis, as well as for industrial systems, general or special purpose robotic systems, general or special purpose teleoperational systems, or robotic medical systems.
[0025] As shown in FIG. 1, medical system 100 may include a manipulator assembly 102 that controls the operation of a medical instrument 104 in performing various procedures on a patient P. Medical instrument 104 may extend into an internal site within the body of patient P via an opening in the body of patient P. The manipulator assembly 102 may be teleoperated, non-teleoperated, or a hybrid teleoperated and non-teleoperated assembly with one or more degrees of freedom of motion that may be motorized and / or one or more degrees of freedom of motion that may be non-motorized (e.g., manually operated). The manipulator assembly 102 may be mounted to and / or positioned near a patient table T. A master assembly 106 allows an operator O (e.g., a surgeon, a clinician, a physician, or other user) to control the manipulator assembly 102. In some examples, the master assembly 106 allows the operator O to view the procedural site or other graphical or informational displays. In some examples, the manipulator assembly 102 may be excluded from the medical system 100 and the instrument 104 may be controlled directly by the operator O. In some examples, the manipulator assembly 102 may be manually controlled by the operator O. Direct operator control may include various handles and operator interfaces for hand-held operation of the instrument 104.
[0026] The master assembly 106 may be located at a surgeon’s console which is in proximity to (e.g., in the same room as) a patient table T on which patient P is located, such as at the side of the patient table T. In some examples, the master assembly 106 is remote from the patient table T, such as in in a different room or a different building from the patient table T. The master assembly 106 may include one or more control devices for controlling themanipulator assembly 102. The control devices may include any number of a variety of input devices, such as joysticks, trackballs, scroll wheels, directional pads, buttons, data gloves, trigger-guns, hand-operated controllers, voice recognition devices, motion or presence sensors, and / or the like.
[0027] The manipulator assembly 102 supports the medical instrument 104 and may include a kinematic structure of links that provide a set-up structure. The links may include one or more non- servo-controlled links (e.g., one or more links that may be manually positioned and locked in place) and / or one or more servo-controlled links (e.g., one or more links that may be controlled in response to commands, such as from a control system 112). The manipulator assembly 102 may include a plurality of actuators (e.g., motors) that drive inputs on the medical instrument 104 in response to commands, such as from the control system 112. The actuators may include drive systems that move the medical instrument 104 in various ways when coupled to the medical instrument 104. For example, one or more actuators may advance medical instrument 104 into a naturally or surgically created anatomic orifice. Actuators may control articulation of the medical instrument 104, such as by moving the distal end (or any other portion) of medical instrument 104 in multiple degrees of freedom. These degrees of freedom may include three degrees of linear motion (e.g., linear motion along the X, Y, Z Cartesian axes) and in three degrees of rotational motion (e.g., rotation about the X, Y, Z Cartesian axes). One or more actuators may control rotation of the medical instrument about a longitudinal axis. Actuators can also be used to move an articulable end effector of medical instrument 104, such as for grasping tissue in the jaws of a biopsy device and / or the like, or may be used to move or otherwise control tools (e.g., imaging tools, ablation tools, biopsy tools, electroporation tools, etc.) that are inserted within the medical instrument 104.
[0028] The medical system 100 may include a sensor system 108 with one or more subsystems for receiving information about the manipulator assembly 102 and / or the medical instrument 104. Such sub-systems may include a position sensor system (e.g., that uses electromagnetic (EM) sensors or other types of sensors that detect position or location); a shape sensor system for determining the position, orientation, speed, velocity, pose, and / or shape of a distal end and / or of one or more segments along a flexible body of the medical instrument 104; a visualization system (e.g., using a color imaging device, an infrared imaging device, an ultrasound imaging device, an x-ray imaging device, a fluoroscopic imaging device, a computed tomography (CT) imaging device, a magnetic resonance imaging (MRI) imaging device, or some other type of imaging device) for capturing images, such as from the distal endof medical instrument 104 or from some other location; and / or actuator position sensors such as resolvers, encoders, potentiometers, and the like that describe the rotation and / or orientation of the actuators controlling the medical instrument 104.
[0029] The medical system 100 may include a display system 110 for displaying an image or representation of the procedural site and the medical instrument 104. Display system 110 and master assembly 106 may be oriented so physician O can control medical instrument 104 and master assembly 106 with the perception of telepresence.
[0030] In some embodiments, the medical instrument 104 may include a visualization system, which may include an image capture assembly that records a concurrent or real-time image of a procedural site and provides the image to the operator O through one or more displays of display system 110. The image capture assembly may include various types of imaging devices. The concurrent image may be, for example, a two-dimensional image or a three-dimensional image captured by an endoscope positioned within the anatomical procedural site. In some examples, the visualization system may include endoscopic components that may be integrally or removably coupled to medical instrument 104. Additionally or alternatively, a separate endoscope, attached to a separate manipulator assembly, may be used with medical instrument 104 to image the procedural site. The visualization system may be implemented as hardware, firmware, software or a combination thereof which interact with or are otherwise executed by one or more computer processors, such as of the control system 112.
[0031] Display system 110 may also display an image of the procedural site and medical instruments, which may be captured by the visualization system. In some examples, the medical system 100 provides a perception of telepresence to the operator O. For example, images captured by an imaging device at a distal portion of the medical instrument 104 may be presented by the display system 110 to provide the perception of being at the distal portion of the medical instrument 104 to the operator O. The input to the master assembly 106 provided by the operator O may move the distal portion of the medical instrument 104 in a manner that corresponds with the nature of the input (e.g., distal tip turns right when a trackball is rolled to the right) and results in corresponding change to the perspective of the images captured by the imaging device at the distal portion of the medical instrument 104. As such, the perception of telepresence for the operator O is maintained as the medical instrument 104 is moved using the master assembly 106. The operator O can manipulate the medical instrument 104 and handcontrols of the master assembly 106 as if viewing the workspace in substantially true presence, simulating the experience of an operator that is physically manipulating the medical instrument 104 from within the patient anatomy.
[0032] In some examples, the display system 110 may present virtual images of a procedural site that are created using image data recorded pre-operatively (e.g., prior to the procedure performed by the medical instrument system 200) or intra-operatively (e.g., concurrent with the procedure performed by the medical instrument system 200), such as image data created using computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), fluoroscopy, thermography, ultrasound, optical coherence tomography (OCT), thermal imaging, impedance imaging, laser imaging, nanotube X-ray imaging, and / or the like. The virtual images may include two-dimensional, three-dimensional, or higherdimensional (e.g., including, for example, time based or velocity-based information) images. In some examples, one or more models are created from pre-operative or intra-operative image data sets and the virtual images are generated using the one or more models.
[0033] In some examples, for purposes of image guided medical procedures, display system 110 may display a virtual image that is generated based on tracking the location of medical instrument 104. For example, the tracked location of the medical instrument 104 may be registered (e.g., dynamically referenced) with the model generated using the pre-operative or intra-operative images, with different portions of the model correspond with different locations of the patient anatomy. As the medical instrument 104 moves through the patient anatomy, the registration is used to determine portions of the model corresponding with the location and / or perspective of the medical instrument 104 and virtual images are generated using the determined portions of the model. This may be done to present the operator O with virtual images of the internal procedural site from viewpoints of medical instrument 104 that correspond with the tracked locations of the medical instrument 104.
[0034] The medical system 100 may also include the control system 112, which may include processing circuitry that implements the some or all of the methods or functionality discussed herein. The control system 112 may include at least one memory and at least one processor for controlling the operations of the manipulator assembly 102, the medical instrument 104, the master assembly 106, the sensor system 108, and / or the display system 110. Control system 112 may include instructions (e.g., a non-transitory machine-readable medium storing the instructions) that when executed by the at least one processor, configures the one or moreprocessors to implement some or all of the methods or functionality discussed herein. While the control system 112 is shown as a single block in FIG. 1, the control system 112 may include two or more separate data processing circuits with one portion of the processing being performed at the manipulator assembly 102, another portion of the processing being performed at the master assembly 106, and / or the like. In some examples, the control system 112 may include other types of processing circuitry, such as application-specific integrated circuits (ASICs) and / or field-programmable gate array (FPGAs). The control system 112 may be implemented using hardware, firmware, software, or a combination thereof.
[0035] In some examples, the control system 112 may receive feedback from the medical instrument 104, such as force and / or torque feedback. Responsive to the feedback, the control system 112 may transmit signals to the master assembly 106. In some examples, the control system 112 may transmit signals instructing one or more actuators of the manipulator assembly 102 to move the medical instrument 104. In some examples, the control system 112 may transmit informational displays regarding the feedback to the display system 110 for presentation or perform other types of actions based on the feedback.
[0036] The control system 112 may include a virtual visualization system to provide navigation assistance to operator O when controlling the medical instrument 104 during an image-guided medical procedure. Virtual navigation using the virtual visualization system may be based upon an acquired pre-operative or intra-operative dataset of anatomic passageways of the patient P. The control system 112 or a separate computing device may convert the recorded images, using programmed instructions alone or in combination with operator inputs, into a model of the patient anatomy. The model may include a segmented two- dimensional or three-dimensional composite representation of a partial or an entire anatomic organ or anatomic region. An image data set may be associated with the composite representation. The virtual visualization system may obtain sensor data from the sensor system 108 that is used to compute an (e.g., approximate) location of the medical instrument 104 with respect to the anatomy of patient P. The sensor system 108 may be used to register and display the medical instrument 104 together with the pre-operatively or intra-operatively recorded images. For example, PCT Publication WO 2016 / 191298 (published December 1, 2016 and titled “Systems and Methods of Registration for Image Guided Surgery”), which is incorporated by reference herein in its entirety, discloses example systems.
[0037] During a virtual navigation procedure, the sensor system 108 may be used to compute the (e.g., approximate) location of the medical instrument 104 with respect to the anatomy of patient P. The location can be used to produce both macro-level (e.g., external) tracking images of the anatomy of patient P and virtual internal images of the anatomy of patient P. The system may include one or more electromagnetic (EM) sensors, fiber optic sensors, and / or other sensors to register and display a medical instrument together with pre- operatively recorded medical images. For example, U.S. Patent No. 8,900,131 (filed May 13, 2011 and titled “Medical System Providing Dynamic Registration of a Model of an Anatomic Structure for Image-Guided Surgery”), which is incorporated by reference herein in its entirety, discloses example systems.
[0038] Medical system 100 may further include operations and support systems (not shown) such as illumination systems, steering control systems, irrigation systems, and / or suction systems. In some embodiments, the medical system 100 may include more than one manipulator assembly and / or more than one master assembly. The exact number of manipulator assemblies may depend on the medical procedure and space constraints within the procedural room, among other factors. Multiple master assemblies may be co-located or they may be positioned in separate locations. Multiple master assemblies may allow more than one operator to control one or more manipulator assemblies in various combinations.
[0039] FIG. 2A is a simplified diagram of a medical instrument system 200 according to some embodiments. The medical instrument system 200 includes a flexible elongate device 202 (also referred to as elongate device 202), a drive unit 204, and a medical tool 226 that collectively is an example of a medical instrument 104 of a medical system 100. The medical system 100 may be a teleoperated system, a non-teleoperated system, or a hybrid teleoperated and non-teleoperated system, as explained with reference to FIG. 1. A visualization system 231, tracking system 230, and navigation system 232 are also shown in FIG. 2A and are example components of the control system 112 of the medical system 100. In some examples, the medical instrument system 200 may be used for non-teleoperational exploratory procedures or in procedures involving traditional manually operated medical instruments, such as endoscopy. The medical instrument system 200 may be used to gather (e.g., measure) a set of data points corresponding to locations within anatomic passageways of a patient, such as patient P.
[0040] The elongate device 202 is coupled to the drive unit 204. The elongate device 202 includes a channel 221 through which the medical tool 226 may be inserted. The elongate device 202 navigates within patient anatomy to deliver the medical tool 226 to a procedural site. The elongate device 202 includes a flexible body 216 having a proximal end 217 and a distal end 218. In some examples, the flexible body 216 may have an approximately 3 mm outer diameter. Other flexible body outer diameters may be larger or smaller.
[0041] Medical instrument system 200 may include the tracking system 230 for determining the position, orientation, speed, velocity, pose, and / or shape of the flexible body 216 at the distal end 218 and / or of one or more segments 224 along flexible body 216, as will be described in further detail below. The tracking system 230 may include one or more sensors and / or imaging devices. The flexible body 216, such as the length between the distal end 218 and the proximal end 217, may include multiple segments 224. The tracking system 230 may be implemented using hardware, firmware, software, or a combination thereof. In some examples, the tracking system 230 is part of control system 112 shown in FIG. 1.
[0042] Tracking system 230 may track the distal end 218 and / or one or more of the segments 224 of the flexible body 216 using a shape sensor 222. The shape sensor 222 may include an optical fiber aligned with the flexible body 216 (e.g., provided within an interior channel of the flexibly body 216 or mounted externally along the flexible body 216). In some examples, the optical fiber may have a diameter of approximately 200 pm. In other examples, the diameter may be larger or smaller. The optical fiber of the shape sensor 222 may form a fiber optic bend sensor for determining the shape of flexible body 216. Optical fibers including Fiber Bragg Gratings (FBGs) may be used to provide strain measurements in structures in one or more dimensions. Various systems and methods for monitoring the shape and relative position of an optical fiber in three dimensions, which may be applicable in some embodiments, are described in U.S. Patent Application Publication No. 2006 / 0013523 (filed July 13, 2005 and titled “Fiber optic position and shape sensing device and method relating thereto”); U.S. Patent No. 7,772,541 (filed on March 12, 2008 and titled “Fiber Optic Position and / or Shape Sensing Based on Rayleigh Scatter”); and U.S. Patent No. 8,773,650 (filed on Sept. 2, 2010 and titled “Optical Position and / or Shape Sensing”), which are all incorporated by reference herein in their entireties. Sensors in some embodiments may employ other suitable strain sensing techniques, such as Rayleigh scattering, Raman scattering, Brillouin scattering, and Fluorescence scattering.
[0043] In some examples, the shape of the flexible body 216 may be determined using other techniques. For example, a history of the position and / or pose of the distal end 218 of the flexible body 216 can be used to reconstruct the shape of flexible body 216 over an interval of time (e.g., as the flexible body 216 is advanced or retracted within a patient anatomy). In some examples, the tracking system 230 may alternatively and / or additionally track the distal end 218 of the flexible body 216 using a position sensor system 220. Position sensor system 220 may be a component of an EM sensor system with the position sensor system 220 including one or more position sensors. Although the position sensor system 220 is shown as being near the distal end 218 of the flexible body 216 to track the distal end 218, the number and location of the position sensors of the position sensor system 220 may vary to track different regions along the flexible body 216. In one example, the position sensors include conductive coils that may be subjected to an externally generated electromagnetic field. Each coil of position sensor system 220 may produce an induced electrical signal having characteristics that depend on the position and orientation of the coil relative to the externally generated electromagnetic field. The position sensor system 220 may measure one or more position coordinates and / or one or more orientation angles associated with one or more portions of flexible body 216. In some examples, the position sensor system 220 may be configured and positioned to measure six degrees of freedom, e.g., three position coordinates X, Y, Z and three orientation angles indicating pitch, yaw, and roll of a base point. In some examples, the position sensor system 220 may be configured and positioned to measure five degrees of freedom, e.g., three position coordinates X, Y, Z and two orientation angles indicating pitch and yaw of a base point. Further description of a position sensor system, which may be applicable in some embodiments, is provided in U.S. Patent No. 6,380,732 (filed August 11, 1999 and titled “Six-Degree of Freedom Tracking System Having a Passive Transponder on the Object Being Tracked”), which is incorporated by reference herein in its entirety.
[0044] In some embodiments, the tracking system 230 may alternately and / or additionally rely on a collection of pose, position, and / or orientation data stored for a point of an elongate device 202 and / or medical tool 226 captured during one or more cycles of alternating motion, such as breathing. This stored data may be used to develop shape information about the flexible body 216. In some examples, a series of position sensors (not shown), such as EM sensors like the sensors in position sensor 220 or some other type of position sensors may be positioned along the flexible body 216 and used for shape sensing. In some examples, a history of datafrom one or more of these position sensors taken during a procedure may be used to represent the shape of elongate device 202, particularly if an anatomic passageway is generally static.
[0045] FIG. 2B is a simplified diagram of the medical tool 226 within the elongate device 202 according to some embodiments. The flexible body 216 of the elongate device 202 may include the channel 221 sized and shaped to receive the medical tool 226. In some embodiments, the medical tool 226 may be used for procedures such as diagnostics, imaging, surgery, biopsy, ablation, illumination, irrigation, suction, electroporation, etc. Medical tool 226 can be deployed through channel 221 of flexible body 216 and operated at a procedural site within the anatomy. Medical instrument 226 may be, for example, an image capture probe, a biopsy tool (e.g., a needle, grasper, brush, etc.), an ablation tool (e.g., a laser ablation tool, radio frequency (RF) ablation tool, cryoablation tool, thermal ablation tool, heated liquid ablation tool, etc.), an electroporation tool, and / or another surgical, diagnostic, or therapeutic tool. In some examples, the medical tool 226 may include an end effector having a single working member such as a scalpel, a blunt blade, an optical fiber, an electrode, and / or the like. Other end types of end effectors may include, for example, forceps, graspers, scissors, staplers, clip appliers, and / or the like. Other end effectors may further include electrically activated end effectors such as electrosurgical electrodes, transducers, sensors, and / or the like.
[0046] The medical tool 226 may be a biopsy tool used to remove sample tissue or a sampling of cells from a target anatomic location. In some examples, the biopsy tool is a flexible needle. The biopsy tool may further include a sheath that can surround the flexible needle to protect the needle and interior surface of the channel 221 when the biopsy tool is within the channel 221. The medical tool 226 may be an image capture probe that includes a distal portion with a stereoscopic or monoscopic camera that may be placed at or near the distal end 218 of flexible body 216 for capturing images (e.g., still or video images). The captured images may be processed by the visualization system 231 for display and / or provided to the tracking system 230 to support tracking of the distal end 218 of the flexible body 216 and / or one or more of the segments 224 of the flexible body 216. The image capture probe may include a cable for transmitting the captured image data that is coupled to an imaging device at the distal portion of the image capture probe. In some examples, the image capture probe may include a fiber-optic bundle, such as a fiberscope, that couples to a more proximal imaging device of the visualization system 231. The image capture probe may be single- spectral or multi-spectral, for example, capturing image data in one or more of the visible, near-infrared, infrared, and / or ultraviolet spectrums. The image capture probe may also include one or morelight emitters that provide illumination to facilitate image capture. In some examples, the image capture probe may use ultrasound, x-ray, fluoroscopy, CT, MRI, or other types of imaging technology.
[0047] In some examples, the image capture probe is inserted within the flexible body 216 of the elongate device 202 to facilitate visual navigation of the elongate device 202 to a procedural site and then is replaced within the flexible body 216 with another type of medical tool 226 that performs the procedure. In some examples, the image capture probe may be within the flexible body 216 of the elongate device 202 along with another type of medical tool 226 to facilitate simultaneous image capture and tissue intervention, such as within the same channel 221 or in separate channels. A medical tool 226 may be advanced from the opening of the channel 221 to perform the procedure (or some other functionality) and then retracted back into the channel 221 when the procedure is complete. The medical tool 226 may be removed from the proximal end 217 of the flexible body 216 or from another optional instrument port (not shown) along flexible body 216.
[0048] In some examples, the elongate device 202 may include integrated imaging capability rather than utilize a removable image capture probe. For example, the imaging device (or fiber-optic bundle) and the light emitters may be located at the distal end 218 of the elongate device 202. The flexible body 215 may include one or more dedicated channels that carry the cable(s) and / or optical fiber(s) between the distal end 218 and the visualization system 231. Here, the medical instrument system 200 can perform simultaneous imaging and tool operations.
[0049] In some examples, the medical tool 226 is capable of controllable articulation. The medical tool 226 may house cables (which may also be referred to as pull wires), linkages, or other actuation controls (not shown) that extend between its proximal and distal ends to controllably bend the distal end of medical tool 226, such as discussed herein for the flexible elongate device 202. The medical tool 226 may be coupled to a drive unit 204 and the manipulator assembly 102. In these examples, the elongate device 202 may be excluded from the medical instrument system 200 or may be a flexible device that does not have controllable articulation. Steerable instruments or tools, applicable in some embodiments, are further described in detail in U.S. Patent No. 7,316,681 (filed on Oct. 4, 2005 and titled “Articulated Surgical Instrument for Performing Minimally Invasive Surgery with Enhanced Dexterity and Sensitivity”) and U.S. Patent No. 9,259,274 (filed Sept. 30, 2008 and titled “Passive Preloadand Capstan Drive for Surgical Instruments”), which are incorporated by reference herein in their entireties.
[0050] The flexible body 216 of the elongate device 202 may also or alternatively house cables, linkages, or other steering controls (not shown) that extend between the drive unit 204 and the distal end 218 to controllably bend the distal end 218 as shown, for example, by broken dashed line depictions 219 of the distal end 218 in FIG. 2A. In some examples, at least four cables are used to provide independent up-down steering to control a pitch of the distal end 218 and left-right steering to control a yaw of the distal end 281. In these examples, the flexible elongate device 202 may be a steerable catheter. Examples of steerable catheters, applicable in some embodiments, are described in detail in PCT Publication WO 2019 / 018736 (published Jan. 24, 2019 and titled “Flexible Elongate Device Systems and Methods”), which is incorporated by reference herein in its entirety.
[0051] In embodiments where the elongate device 202 and / or medical tool 226 are actuated by a teleoperational assembly (e.g., the manipulator assembly 102), the drive unit 204 may include drive inputs that removably couple to and receive power from drive elements, such as actuators, of the teleoperational assembly. In some examples, the elongate device 202 and / or medical tool 226 may include gripping features, manual actuators, or other components for manually controlling the motion of the elongate device 202 and / or medical tool 226. The elongate device 202 may be steerable or, alternatively, the elongate device 202 may be nonsteerable with no integrated mechanism for operator control of the bending of distal end 218. In some examples, one or more channels 221 (which may also be referred to as lumens), through which medical tools 226 can be deployed and used at a target anatomical location, may be defined by the interior walls of the flexible body 216 of the elongate device 202.
[0052] In some examples, the medical instrument system 200 (e.g., the elongate device 202 or medical tool 226) may include a flexible bronchial instrument, such as a bronchoscope or bronchial catheter, for use in examination, diagnosis, biopsy, and / or treatment of a lung. The medical instrument system 200 may also be suited for navigation and treatment of other tissues, via natural or surgically created connected passageways, in any of a variety of anatomic systems, including the colon, the intestines, the kidneys and kidney calices, the brain, the heart, the circulatory system including vasculature, and / or the like.
[0053] The information from the tracking system 230 may be sent to the navigation system 232, where the information may be combined with information from the visualization system231 and / or pre-operatively obtained models to provide the physician, clinician, surgeon, or other operator with real-time position information. In some examples, the real-time position information may be displayed on the display system 110 for use in the control of the medical instrument system 200. In some examples, the navigation system 232 may utilize the position information as feedback for positioning medical instrument system 200. Various systems for using fiber optic sensors to register and display a surgical instrument with surgical images, applicable in some embodiments, are provided in U.S. Patent No. 8,900,131 (filed May 13, 2011 and titled “Medical System Providing Dynamic Registration of a Model of an Anatomic Structure for Image-Guided Surgery”), which is incorporated by reference herein in its entirety.
[0054] FIGS. 3 A and 3B are simplified diagrams of side views of a patient coordinate space including a medical instrument mounted on an insertion assembly according to some embodiments. As shown in FIGS. 3 A and 3B, a surgical environment 300 may include a patient P positioned on the patient table T. Patient P may be stationary within the surgical environment 300 in the sense that gross patient movement is limited by sedation, restraint, and / or other means. Cyclic anatomic motion, including respiration and cardiac motion, of patient P may continue. Within surgical environment 300, a medical instrument 304 is used to perform a medical procedure which may include, for example, surgery, biopsy, ablation, illumination, irrigation, suction, or electroporation. The medical instrument 304 may also be used to perform other types of procedures, such as a registration procedure to associate the position, orientation, and / or pose data captured by the sensor system 108 to a desired (e.g., anatomical or system) reference frame. The medical instrument 304 may be, for example, the medical instrument 104. In some examples, the medical instrument 304 may include an elongate device 310 (e.g., a catheter) coupled to an instrument body 312. Elongate device 310 includes one or more channels sized and shaped to receive a medical tool.
[0055] Elongate device 310 may also include one or more sensors (e.g., components of the sensor system 108). In some examples, a shape sensor 314 may be fixed at a proximal point 316 on the instrument body 312. The proximal point 316 of the shape sensor 314 may be movable with the instrument body 312, and the location of the proximal point 316 with respect to a desired reference frame may be known (e.g., via a tracking sensor or other tracking device). The shape sensor 314 may measure a shape from the proximal point 316 to another point, such as a distal end 318 of the elongate device 310. The shape sensor 314 may be aligned with the elongate device 310 (e.g., provided within an interior channel or mounted externally). In someexamples, the shape sensor 314 may optical fibers used to generate shape information for the elongate device 310.
[0056] In some examples, position sensors (e.g., EM sensors) may be incorporated into the medical instrument 304. A series of position sensors may be positioned along the flexible elongate device 310 and used for shape sensing. Position sensors may be used alternatively to the shape sensor 314 or with the shape sensor 314, such as to improve the accuracy of shape sensing or to verify shape information.
[0057] Elongate device 310 may house cables, linkages, or other steering controls that extend between the instrument body 312 and the distal end 318 to controllably bend the distal end 318. In some examples, at least four cables are used to provide independent up-down steering to control a pitch of distal end 318 and left-right steering to control a yaw of distal end 318. The instrument body 312 may include drive inputs that removably couple to and receive power from drive elements, such as actuators, of a manipulator assembly.
[0058] The instrument body 312 may be coupled to an instrument carriage 306. The instrument carriage 306 may be mounted to an insertion stage 308 that is fixed within the surgical environment 300. Alternatively, the insertion stage 308 may be movable but have a known location (e.g., via a tracking sensor or other tracking device) within surgical environment 300. Instrument carriage 306 may be a component of a manipulator assembly (e.g., manipulator assembly 102) that couples to the medical instrument 304 to control insertion motion (e.g., motion along an insertion axis A) and / or motion of the distal end 318 of the elongate device 310 in multiple directions, such as yaw, pitch, and / or roll. The instrument carriage 306 or insertion stage 308 may include actuators, such as servomotors, that control motion of instrument carriage 306 along the insertion stage 308.
[0059] A sensor device 320, which may be a component of the sensor system 108, may provide information about the position of the instrument body 312 as it moves relative to the insertion stage 308 along the insertion axis A. The sensor device 320 may include one or more resolvers, encoders, potentiometers, and / or other sensors that measure the rotation and / or orientation of the actuators controlling the motion of the instrument carriage 306, thus indicating the motion of the instrument body 312. In some embodiments, the insertion stage 308 has a linear track as shown in FIGS. 3 A and 3B. In some embodiments, the insertion stage 308 may have curved track or have a combination of curved and linear track sections.
[0060] FIG. 3A shows the instrument body 312 and the instrument carriage 306 in a retracted position along the insertion stage 308. In this retracted position, the proximal point 316 is at a position L0 on the insertion axis A. The location of the proximal point 316 may be set to a zero value and / or other reference value to provide a base reference (e.g., corresponding to the origin of a desired reference frame) to describe the position of the instrument carriage 306 along the insertion stage 308. In the retracted position, the distal end 318 of the elongate device 310 may be positioned just inside an entry orifice of patient P. Also in the retracted position, the data captured by the sensor device 320 may be set to a zero value and / or other reference value (e.g., 1=0). In FIG. 3B, the instrument body 312 and the instrument carriage 306 have advanced along the linear track of insertion stage 308, and the distal end 318 of the elongate device 310 has advanced into patient P. In this advanced position, the proximal point 316 is at a position LI on the insertion axis A. In some examples, the rotation and / or orientation of the actuators measured by the sensor device 320 indicating movement of the instrument carriage 306 along the insertion stage 308 and / or one or more position sensors associated with instrument carriage 306 and / or the insertion stage 308 may be used to determine the position LI of the proximal point 316 relative to the position L0. In some examples, the position LI may further be used as an indicator of the distance or insertion depth to which the distal end 318 of the elongate device 310 is inserted into the passageway(s) of the anatomy of patient P.
[0061] FIGs. 4, 5, and 6 show flowcharts of methods for restoring the state of a system after a system restart, in accordance with embodiments of the disclosure. The methods may be implemented using instructions stored on a non-transitory medium that may be executed by a computing system, e.g., the computing system 120.
[0062] While the various blocks in FIGs. 4, 5, and 6 are presented and described sequentially, some or all of the blocks may be executed in different orders, may be combined or omitted, and some or all of the blocks may be executed in parallel. Furthermore, the blocks may be performed actively or passively.
[0063] Turning to FIG. 4, in block 410, a first session of a medical system is executed, in accordance with some embodiments. The first session is pre-restart and may include one or more medical instrument operations of a procedure. The procedure may include medical instrument operations that are executed in preparation of performing a medical operation such as, for example, a biopsy. The procedure may also include the medical operation. Some other examples of medical operations may include ablation, electroporation, surgical operations, etc.A description of the first session including the medical instrument operations that may be performed during the first session is provided below in reference to FIG. 5.
[0064] In one or more embodiments, an event 498 occurs during or after the operations of block 410. Based on the occurrence of the event 498, the procedure is not completed in the first session (e.g., the medical operation is not performed directly after block 410). The event 498 may be any event that makes a restart of the medical system either necessary or advisable. The event 498 may be, for example, a failed execution of a medical instrument operation of block 410, any type of non-recoverable error, a recoverable error, a decision to restart the medical system by the operator of the medical system, or any other reason.
[0065] In block 420, a mid-procedure restart of the medical system is executed, in accordance with embodiments of the disclosure. The mid-procedure restart may involve a power-cycling of the medical system, of parts of the medical system, or alternatively the clearing of parameters, resetting a state, restarting an operating system or similar application, etc. The mid-procedure restart may be initiated by the user of the medical system, e.g., by pressing a physical button, a virtual button of a touch screen interface, or using any other input. In another example, the mid-procedure restart may be executed automatically. In some embodiments, the mid-procedure restart involves obtaining, from the user, an input that determines whether the previous procedure, executed during the first session, is to be continued or, alternatively, whether a different procedure is to be performed, after the mid-procedure restart. Depending on the selection, the patient plan and / or other parameterizations used for the previous procedure or a different patient plan and / or other parameterizations are to be loaded for the procedure to be performed after the mid-procedure restart. The user may provide the user input via a user interface.
[0066] In block 430, a second session of the medical system is executed, in accordance with embodiments of the disclosure. The second session is post-restart and may skip one or more medical instrument operations of the procedure that were completed in the first session. Execution of the medical instrument operations in block 410 may be time-consuming and / or tedious. By skipping one of more of the medical instrument operations in block 430, the operations of block 430 may be completed considerably faster than the operations of block 410. Accordingly, the medical system may be ready for performing the medical operation within limited time after the mid-procedure restart of block 420. A detailed description of the operations of block 430, including the skipping of one or more of the medical instrumentoperations and the operations performed to enable the skipping of the one or more medical instrument operations is provided below in reference to FIG. 6. After completion of the medical instrument operations, the medical system may perform the medical operation in the second session.
[0067] Although two sessions are shown in FIG. 4, a procedure may include one or more sessions. For a procedure, the medical instrument operations that were completed in any prior session may be skipped in the current session to facilitate more efficient performance of the procedure. Furthermore, multiple mid-procedure restarts may be performed in necessary or beneficial, based on the described operations, without departing from the disclosure.
[0068] Turning to FIG. 5, operations that may be performed during a procedure (other than the medical operation) are shown. These operations may be performed during the execution of the first session of the medical system. Depending on the timing of the event 498, not all operations as shown in FIG. 5 may be executed in the first session. For example, assuming that a second test operation depends on the results of a first test operation, the second test operation may not be performed if the event 498 prevents completion of the first test operation.
[0069] In block 510, the medical system is powered on. The power on may be initiated by a user of the medical system. The power on may initialize the medical system in preparation for execution of the subsequently described medical instrument operations. The power on may involve, for example, a boot operation of a computing system associated with the medical system.
[0070] In block 520, medical instrument operations are performed. A number of different medical instrument operations are subsequently described. The disclosure is not limited to these medical instrument operations. For example, one or more of the medical instrument operations as described may not be performed, other medical instrument operations may be performed, etc.
[0071] In block 522, an engagement operation is performed. In one or more embodiments, the medical instrument is engaged with the manipulator assembly to enable the manipulator assembly to control movements of the medical instrument, as previously discussed in reference to FIGs. 1, 2A, 2B, 3A, and 3B. In one or more embodiments, mechanical energy (e.g., in the form of forces or torques) is transmitted from the drive unit to the medical instrument via a coupling interface between the drive unit and the medical instrument. The coupling interface may include input disks of the medical instrument and corresponding actuator disks of themanipulator assembly. Other mechanical techniques for engaging the medical instrument and manipulator assembly to allow the motion of the manipulator assembly to cause motion of the medical instrument may also be used. After the medical instrument has been mechanically disposed on the manipulator assembly, an engagement of the actuator disks with the input disks may be performed. Once engaged, the actuator disks and input disks can transmit mechanical energy from the drive unit to the medical instrument. In some embodiments, a mechanism that detects engagement through capacitive coupling may be present. With successful engagement, a capacitor may be charged. When the medical instrument is removed or disengaged, the capacitor may be discharged. Alternatively, a magnetic latching mechanism may be used for the detection of engagement / disengagement. An example of an engagement of an actuator disk and an input disk and an operation performed to achieve engagement is provided below in reference to FIG. 7A. In some embodiments, the medical device includes an elongate device, and the engagement involves engaging of the elongate device (e.g., a catheter) to enable controllable articulation of the elongate device by the drive unit as previously described.
[0072] In block 524, a sensor health operation is performed. As previously described in reference to FIGs. 1, 2A, 2B, 3A, and 3B, the medical system may include one or more sensors for measuring movement of the medical instrument, e.g., a shape sensor. The sensor health operation may be based on sensor health data received from the sensor. The sensor health data may include, for example, calibration data, Signal to Noise Ratios (SNR) levels, connection reflection strength, and redundant core comparisons. The sensor health operation may include verifying the acceptability of the sensor health data, such as verifying that the sensor health data has acceptable values and / or within acceptable ranges of values. In one or more embodiments, the obtained sensor health data are stored for further use during the second session of the medical system if the medical system passes the sensor health operation. In some embodiments, a fingerprint may be generated for the sensor health data. The fingerprint may be generated and stored in response to successful completion of the sensor health operation (e.g., instead of the sensor health data itself). The fingerprint provides a representation of the sensor health data that is smaller in size than the sensor health data and may be stored across multiple sessions in a non-volatile memory of the medical system or some other type of data storage device that may be accessed across different sessions. Different sensor health data may result in different fingerprints. Various types of digital fingerprinting techniques may be used, such as an SHA-256 or some other type of hash function
[0073] In block 526, a motion test operation is performed. The motion test operation may be performed to confirm that the medical instrument moves as expected, in response to movement of the actuators of the drive unit. The motion test operation may include a comparison of movement of the medical instrument measured by the sensor with predicted movement of the medical instrument generated based on measured movement of the actuator. More specifically, movement of the medical instrument may be measured, for example, by the shape sensor and / or other sensor, and movement of the actuators may be measured, for example, by encoders. A model that may consider kinematics and / or dynamics of the medical system can be used to predict the movement of the medical instrument based on the measurements from the encoders. A comparison of the predicted and the measured movement of the medical instrument may then be performed. If the expected and measured motion of the medical instrument corresponds (e.g., the discrepancy of the comparison is below a specified threshold), the motion test operation is deemed successful. In the example of the medical instrument that includes a flexible elongate device, the movement of the medical instrument may include an articulation change of the flexible elongate device. In one example, the flexible elongate device is driven to perform small movements in two perpendicular axes during the motion test operation.
[0074] In some embodiments, a controller configuration is used by the medical system to control the medical instrument, both for the motion test and for subsequent medical instrument operations (e.g., if the motion test is successfully completed). The controller configuration may include parameters that are read by the medical system from a memory of the medical instrument. The controller configuration may be stored for further use during the second session of the medical system if the medical system successfully completes the motion test operation. The controller configuration may include controller parameters such as PID parameters for the control of the actuators, gains, thresholds, current limits, etc. Any other types of parameters of the medical system may be included without departing from the disclosure. In some embodiments, a fingerprint may be generated for the controller configuration. The fingerprint may be generated and stored in response to successful completion of the motion test operation (e.g., instead of the controller configuration itself). The fingerprint provides a representation of the controller configuration that is smaller in size than the controller configuration and may be stored across multiple sessions in a non-volatile memory of the medical system or some other type of data storage device that may be accessed across different sessions. Different controller configurations may result in differentfingerprints. Various types of digital fingerprinting techniques may be used, such as SHA- 256 or some other type of hash function.
[0075] In block 528, a registration operation is performed. The registration operation is performed to associate sensor data regarding the medical instrument with a reference frame, such as an anatomical reference frame. For example, the raw sensor data captured sensors are in a sensor reference frame and the registration operation correlates the sensor reference frame with an anatomical reference frame. The reference frame, when an anatomical reference frame, may be defined with respect to a model of the anatomy generated using pre-operative or intraoperative images, e.g., based on CT images. Upon completion of the registration operation, the measured or otherwise determined pose of the medical instrument is known relative to the anatomy represented by the model. The registration operation may include driving the medical instrument through multiple passageways of patient anatomy to capture points in space that are representative of the shape of the anatomy, and then correlating the captured points in space with the shape represented by the model. The correlation between sensor data and the reference frame created in the registration operation may be stored, such as in a non-volatile memory of the medical system or some other type of data storage device that may be accessed across different sessions. In some embodiments, the registration data are stored in a file on a hard drive, e.g., in the form of a transformation matrix.
[0076] In block 530, a navigation operation is performed. The navigation operation may move the medical instrument toward a target anatomical feature for performing the medical operation. As the medical instrument moves through the patient anatomy, sensor data is captured and the registration is used with the sensor data to determine the location of the medical instrument within the anatomy.
[0077] After completion of the operations of block 530, the medical instrument may have a known pose relative to the anatomy, and the medical instrument may be at the target anatomical feature, ready to perform the medical procedure. However, as previously discussed, an event may prevent completion of some or all medical instrument operations of the block 520 of the method of FIG. 5. Accordingly, the execution of the operations associated with blocks 522- 530 may be interrupted at any stage.
[0078] Turning to FIG. 6, processes performed during the execution of the second session of the medical system for the procedure are shown. One or more medical instrument operations completed in the first session (pre-reboot) may be skipped in the second session (post-reboot).
[0079] In block 610, one or more first parameters of the medical system associated with the first session may be compared with one or more second parameters of the medical system associated with the second session. In some embodiments, comparing the one or more first parameters with the one or more second parameters includes determining that the one or more first parameters are equivalent to the one or more second parameters. Accordingly, medical instrument operations for which equivalence is successfully established do not need to be repeated in the second session. Further, medical instrument operations that have not been completed in the first session may be performed in the second session in order to complete the preparation of the medical system to perform the medical operation.
[0080] In block 612, an engagement test is performed to confirm that the medical instrument is engaged with the manipulator assembly and / or has remained engaged between first and second sessions. In the engagement test, comparing the one or more first parameters with the one or more second parameters may include determining that a correlation between motion of the input disks and the actuator disks caused by the engagement operation in the first session remains in the second session. This correlation can occur when the input disks and the actuator disks engaged in the first session remain engaged in the second session, including during the mid-procedure restart.
[0081] In some embodiments, the engagement test includes ensuring that the actuator disks of the manipulator assembly are capable of imparting motion to the input disks of the medical instrument without performing a full engagement operation. For example, each input disk of the medical instrument independently engages each actuator disk of the manipulator assembly. When the input disks are separated from the actuator disks (e.g., as may be caused by detachment of the instrument from the manipulator assembly), the input disks may rotate freely and independently. This can result in the apertures / holes in the input disks being misaligned with the protrusions in the actuator disks when the instrument is reattached with the manipulator assembly, which would require the engagement operation to ensure engagement of all input disks with corresponding actuator disks. Accordingly, even when reattaching the medical instrument to the manipulator assembly, some or all of the input disks and the actuator disks may remain disengaged until an engagement operation (e.g., as described in block 522 of FIG. 5) is performed. Therefore, a disengagement of the medical instrument from the manipulator assembly results in the correlation between motion of the input disks and the actuator disks caused by the engagement operation to not remain in the second session, andthus such disengagement is detectable by performing the engagement test. The execution of the engagement test is described below in reference to FIG. 7B.
[0082] In some embodiments, when a mechanism that detects engagement through capacitive coupling is present, the engagement test may involve measuring the voltage across the capacitor. If a voltage is present, it may be assumed that the medical instrument has remained engaged through the mid-procedure restart. A similar test may be performed with other mechanism such as a latching magnetic mechanism.
[0083] If the engagement test is performed successfully, the engagement operation may be skipped in the second session, and the execution of the method of FIG. 6 may proceed with the next block. The engagement test may take less time than the engagement operation and may articulate the medical instrument to a lesser degree than the engagement operation, which can be beneficial when the medical instrument remains in the anatomy during the engagement test. For example, the lower torque and / or magnitude of disk rotation (and corresponding medical instrument articulation) used in the engagement test may be safe when performed while the medical instrument is inside of the anatomy. The engagement operation is typically performed outside of the anatomy, with the higher torque and / or magnitude of disk rotation used in the engagement operation allowed to potentially unsafe when performed while the medical instrument is inside of the anatomy.
[0084] In block 614, a sensor health test is performed to confirm that the sensor of the medical instrument is functioning. In the sensor health test, comparing the one or more first parameters with the one or more second parameters includes comparing the first sensor health data, used and stored during the first session with second sensor health data received from the sensor in the second session. The sensor heath test is deemed successful if the second sensor health data match the first sensor health data or are otherwise sufficiently similar to the first sensor health data.
[0085] In some embodiments, the second sensor health data received from the sensor in the second session includes, for example, SNR levels, a connection reflection strength, redundant core comparisons, etc.
[0086] A second fingerprint may be generated from the second sensor health data received from the sensor in the second session, and the comparison of the second sensor health data received from the sensor in the second session with the first sensor health data received from the sensor in the first session may involve comparing the first fingerprint representing the firstsensor health data received from the sensor in the first session with the second fingerprint representing the second sensor health data received from the sensor in the second session. The same techniques may be used to generate fingerprints in different sessions to provide a consistent basis of comparisons.
[0087] If the sensor health operation is performed successfully, the sensor health operation may be skipped in the second session and the execution of the method of FIG. 6 may proceed with the next block. For example, the sensor health data in the second session does not need to be verified as having acceptable values and / or within acceptable ranges of values if this sensor health data corresponds with the sensor health data that was successfully verified in the first session.
[0088] In block 616, the controller configuration of the medical system is confirmed. In the second session, the second controller configuration may be loaded in the same way as the first controller configuration in the first session. For the confirmation of the second controller configuration, comparing the one or more first parameters with the one or more second parameters includes comparing a first controller configuration of the medical system used to control the medical instrument in the first session to the second controller configuration of the medical system used to control the medical instrument in the second session. The confirmation of the controller configuration is deemed successful if the second controller configuration matches the first controller configuration or is otherwise sufficiently similar to the first controller configuration.
[0089] The comparison may be performed by comparing a first fingerprint representing the first controller configuration to a second fingerprint representing the second controller configuration. The second fingerprint may be generated based on the second controller configuration, e.g., during the execution of block 616 or before, at any time after loading the second controller configuration.
[0090] If the confirmation of the controller configuration is performed successfully, the execution of the method of FIG. 6 may proceed with the next block.
[0091] In some embodiments, a motion test operation (e.g., as described in block 526 of FIG. 5 may be skipped during the second session based on the successful completion of the sensor health operation and the successful confirmation of the controller configuration.
[0092] In block 618, a confirmation of the registration may be performed. The confirmation of the registration may be achieved using a registration test. In one example of a registration test, the user may inspect the current registration and may confirm the registration if the registration appears to be correct. The user may rely on visual input from the medical instrument to confirm the registration. The visual input may be provided by, for example, a camera of the medical instrument or a vision probe that is temporarily inserted into the medical instrument. In one example, a camera view generated by an image sensor (e.g., vision probe or integrated sensor with flexible elongate device) may be compared with a virtual camera view that is generated based on the registration, anatomical model, and sensor data. The virtual camera view includes a virtual image of the anatomical model from the perspective of the medical instrument at the registered position. If the camera view and virtual camera view correspond, such as for multiple frames captured while the medical instrument is driven within the anatomy, the registration may be confirmed. The confirmation of the registration may be provided by the user (e.g., using a graphical user interface that presents both the camera view and virtual camera view) or programmatically using image processing techniques to compare the camera and virtual camera views. Alternatively, if the user disagrees with the registration or the registration is otherwise deemed invalid, a new registration operation may be performed in the second session, (e.g., as described in block 528 of FIG. 5). The registration may also be performed if no registration is available from the first session.
[0093] In some embodiments, the registration test may include a streamlined registration operation that includes driving the medical instrument through multiple passageways of patient anatomy to capture points in space that are representative of the shape of the anatomy, and then correlating the captured points in space with the shape represented by the model. However, the amount of driving and / or points captured in the registration test may be smaller than the registration operation.
[0094] In block 620, a navigation operation may be performed (e.g., as described in block 530 of FIG. 5). In some embodiments, such as when the mid-procedure restart is executed during the navigation operation in the first session, the position of the medical instrument relative to the anatomy at the time of the restart may be used as the basis for resuming the navigation operation in the second session. The navigation operation may not be necessary if it has been completed during the first session.
[0095] After completion of the processes of the method of FIG. 6 as necessary, the medical instrument is verified as operating correctly, the pose of the medical instrument relative to the anatomy is exactly known, the medical instrument has been navigated to the target location, and the medical operation may be performed as indicated by block 630. Completing the one or more medical instrument operations as described in FIG 5 takes more time than performing the comparison of the one or more first parameters with the one or more second parameters as described in FIG. 6. Accordingly, when a restart of the medical system is executed, time and effort may be reduced by performing the method of FIG. 6, in comparison to repeating the method of FIG. 5.
[0096] While FIG. 6 describes multiple processes that may be performed, it is possible that some of these processes can be skipped, for example based on the type of an error that caused the mid-procedure restart. In this case, if it is known that a medical instrument operation is not affected by the error, then it may not be necessary to repeat or confirm the medical instrument operation in the second session. As such, one or more confirmation processes may also be skipped based on the type of error that caused the mid-procedure restart. Consider the following two examples. In a first example, if the error is caused by an issue with the medical instrument, it may be necessary to perform the confirmation processes as described in FIG. 6. However, in a second example, if the error is caused by another issue such as a memory error that is not related to the medical instrument, at least some of the confirmation processes of FIG. 6 may be skipped. Furthermore, if an error that caused a non-recoverable fault was due to a failure of the instrument and / or other recoverable item, the recovery of that item is selectively skipped and instead initialized using the nominal procedure. Other items that are unrelated to the error may be recovered. For example, if the system has detected a broken catheter pull wire, it may emit a non-recoverable fault. Upon reboot of the system, the catheter would not be recovered (because of the broken pull wire), but all other aspects such as the catheter guide installation, vision probe installation, registration, biopsy markers etc. may be recovered.
[0097] FIG. 7A is an illustration of an engagement operation according to some embodiments. The left panel of FIG. 7A shows a state prior to the engagement operation (not engaged), whereas the right panel of FIG. 7A shows a state after the engagement operation (engaged). In the state prior to the engagement operation, there is an orientational offset between the actuator disk 702 of the manipulator assembly and the input disk 706 of the medical instrument. Accordingly, the protrusion 704 of the actuator disk 702 is prevented from entering the aperture / hole 708 of the input disk. During the engagement, an actuator associatedwith the actuator disk 702 rotates the actuator disk. When the actuator disk 702 reaches orientational alignment with the input disk 706, the protrusion 704 enters the aperture 708. In this state, engagement has occurred, and mechanical energy can be transmitted between the actuator disk 702 and the input disk 706. While the example shows an engagement between apertures and protrusions, other mechanical elements that are capable of engaging may be used, without departing from the disclosure.
[0098] FIG. 7B is an illustration of motions and torques associated with an engagement test according to some embodiments. The left panels of FIG. 7B shows motions and torques associated with an engagement test when the actuator disk 702 and the input disk 706 are not engaged, whereas the right panel of FIG. 7B shows motions and torques associated with an engagement test when the actuator disk 702 and the input disk 706 are engaged. Axes of the corresponding plots in the left and right panels are scaled identically. When performing the engagement test, a small movement of the input disk is initially performed to determine whether the actuator disk 702 and the input disk 706 are engaged.
[0099] As shown in the left panel, when the actuator disk 702 and the input disk 706 are not engaged, the actuator driving the actuator disk 702 may cover a significant angular range without any noticeable increase in torque, because the actuator disk 702 is rotated freely relative to the input disk 706.
[0100] As shown in the right panel, when the actuator disk 702 and the input disk 706 are engaged, the actuator driving the actuator disk 702 may cause a noticeable increase in torque even for small movements of the actuator disk, because the actuator disk 702 is transmitting mechanical energy to the input disk 706, thereby driving the medical instrument (e.g., articulating the medical instrument).
[0101] Accordingly, engagement of the actuator disk 702 and the input disk 706 may be detected based on the near-immediate presence of a torque in response to even a small movement of the actuator disk 702. In contrast, a non-engagement of the actuator disk 702 and the input disk 706 may be detected based on an absence of a significant torque in response to even a larger movement of the actuator disk 702.
[0102] In some embodiments, in the engagement test, the input disks are rotated with a reduced torque, in comparison to the rotation of the input disks performed with more torque applied for an engagement operation. Accordingly, the engagement test may be performed while the medical instrument is within the patient anatomy, whereas the engagement operationmay not be performed while the medical instrument is within the patient anatomy. Further, while the engagement test may result in a very limited articulation of the medical instrument, thereby being suitable for execution while the medical instrument is within the patient anatomy, an engagement operation may result in significant articulation of the medical instrument (potentially to the maximally possible articulation, i.e., a hard-stop)
[0103] Embodiments of the disclosure have various benefits. Some embodiments leverage tests performed pre-restart to provide automated behind-the-scene tests that are transparent to the user after the restart of the medical system. A reinstallation of the medical instrument may not be necessary, the medical instrument may not need to be removed from the anatomy, and the repetition of tests of the medical instrument may be unnecessary. Some embodiments enable the user to proceed with the previously performed registration after confirmation by the user, instead of requiring repetition of the registration. Some embodiments enable the user to proceed from near the target after the restart, instead of requiring the user to repeat the navigation to the target.
[0104] One or more components of the embodiments discussed in this disclosure, such as control system 112, may be implemented in software for execution on one or more processors of a computer system. The software may include code that when executed by the one or more processors, configures the one or more processors to perform various functionalities as discussed herein. The code may be stored in a non-transitory computer readable storage medium (e.g., a memory, magnetic storage, optical storage, solid-state storage, etc.). The computer readable storage medium may be part of a computer readable storage device, such as an electronic circuit, a semiconductor device, a semiconductor memory device, a read only memory (ROM), a flash memory, an erasable programmable read only memory (EPROM); a floppy diskette, a CD-ROM, an optical disk, a hard disk, or other storage device. The code may be downloaded via computer networks such as the Internet, Intranet, etc. for storage on the computer readable storage medium. The code may be executed by any of a wide variety of centralized or distributed data processing architectures. The programmed instructions of the code may be implemented as a number of separate programs or subroutines, or they may be integrated into a number of other aspects of the systems described herein. The components of the computing systems discussed herein may be connected using wired and / or wireless connections. In some examples, the wireless connections may use wireless communication protocols such as Bluetooth, near-field communication (NFC), Infrared Data Association(IrDA), home radio frequency (HomeRF), IEEE 802.11, Digital Enhanced Cordless Telecommunications (DECT), and wireless medical telemetry service (WMTS).
[0105] Various general-purpose computer systems may be used to perform one or more processes, methods, or functionalities described herein. Additionally or alternatively, various specialized computer systems may be used to perform one or more processes, methods, or functionalities described herein. In addition, a variety of programming languages may be used to implement one or more of the processes, methods, or functionalities described herein.
[0106] While certain embodiments and examples have been described above and shown in the accompanying drawings, it is to be understood that such embodiments and examples are merely illustrative and are not limited to the specific constructions and arrangements shown and described, since various other alternatives, modifications, and equivalents will be appreciated by those with ordinary skill in the art.
Claims
CLAIMSWhat is claimed is:
1. A medical system comprising: a manipulator assembly for controlling movements of a medical instrument, and a control system coupled to the manipulator assembly, the control system configured to: execute a first session of the medical system for a procedure, wherein executing the first session comprises completing one or more medical instrument operations for the medical instrument, subsequent to completing the one or more medical instrument operations, executing a mid-procedure restart of the medical system, and subsequent to executing the mid-procedure restart the medical system, execute a second session of the medical system for the procedure, wherein executing the second session comprises: skipping the one or more medical instrument operations completed in the first session based on comparing one or more first parameters of the medical system associated with the first session with one or more second parameters of the medical system associated with the second session.
2. The medical system of claim 1, wherein completing the one or more medical instrument operations takes more time than comparing the one or more first parameters with the one or more second parameters.
3. The medical system of claim 1, wherein comparing the one or more first parameters with the one or more second parameters comprises determining that the one or more first parameters is equivalent to the one or more second parameters.
4. The medical system of claim 1, wherein the one or more medical instrument operations comprise an engagement operation to engage the medical instrument with the manipulator assembly such that the manipulator assembly controls the movements of the medical instrument.
5. The medical system of claim 4, wherein:the engagement operation engages input disks of the medical instrument with actuator disks of the manipulator assembly; and comparing the one or more first parameters with the one or more second parameters comprises determining a correlation between motion of the input disks and the actuator disks caused by the engagement operation in the first session remains in the second session.
6. The medical system of claim 5, wherein: comparing the one or more first parameters with the one or more second parameters comprises executing an engagement test; and the actuator disks apply more torque in the engagement operation than the engagement test.
7. The medical system of claim 1, further comprising: a sensor for measuring movements of the medical instrument, and wherein the one or more medical instrument operations comprise a sensor health operation, the sensor health operation comprising verifying acceptability of first sensor health data received from the sensor.
8. The medical system of claim 7, wherein comparing the one or more first parameters with the one or more second parameters comprises comparing the first sensor health data received from the sensor in the first session with second sensor health data received from the sensor in the second session.
9. The medical system of claim 7, wherein comparing the one or more first parameters with the one or more second parameters comprises comparing a first fingerprint representing the first sensor health data received from the sensor in the first session with a second fingerprint representing second sensor health data received from the sensor in the second session.
10. The medical system of claim 7, wherein the sensor comprises a shape sensor.
11. The medical system of claim 1, wherein comparing the one or more first parameters with the one or more second parameters comprises comparing a first controller configuration of the medical system used to control the medical instrument in the first session to a second controller configuration of the medical system used to control the medical instrument in the second session.
12. The medical system of claim 1, wherein comparing the one or more first parameters with the one or more second parameters comprises comparing a first fingerprint representing a first controller configuration of the medical system used to control the medical instrument in the first session to a second fingerprint representing a second controller configuration of the medical system used to control the medical instrument in the second session.
13. The medical system of claim 1, wherein the one or more medical instrument operations comprise a motion test operation for the medical instrument.
14. The medical system of claim 13, further comprising: an actuator for controlling movements of the medical instrument; and a sensor for measuring the movements of the medical instrument, and wherein the motion test operation comprises comparing movement of the medical instrument measured by the sensor with predicted movement of the medical instrument generated based on measured movement of the actuator.
15. The medical system of claim 14, wherein the medical instrument comprises a flexible elongate device, the sensor comprises a shape sensor, and the movement of the medical instrument comprises an articulation change of the flexible elongate device.
16. The medical system of claim 1, wherein the one or more medical instrument operations comprise a registration operation to associate sensor data regarding the medical instrument with a reference frame.
17. The medical system of claim 1, wherein the one or more medical instrument operations comprise a navigation operation to move the medical instrument toward a target anatomical feature.
18. The medical system of claim 1, wherein: executing the first session comprises, in response to completing the one or more medical instrument operations: generating a first fingerprint representing the one or more first parameters, storing the first fingerprint for retrieval after executing the mid-procedure restart of the medical system, andcomparing that the one or more first parameters with the one or more second parameters comprises comparing a second fingerprint representing the one or more second parameters with the first fingerprint.
19. The medical system of claim 1, wherein the one or more medical instrument operations comprise: an engagement operation to engage the medical instrument with the manipulator assembly, a sensor health operation for a sensor that measures movements of the medical instrument, and a motion test operation for the medical instrument.
20. The medical system of claim 1, wherein executing the second session comprises completing a medical instrument operation that was not completed in the first session subsequent to skipping the one or more medical instrument operations completed in the first session.
21. The medical system of claim 1, wherein executing the first session further comprises completing a medical instrument operation to which a type of an error that caused the mid-procedure restart of the medical system is not related, and wherein executing the second session further comprises skipping the medical instrument operation to which the type of the error is not related, without comparing the one or more first parameters of the medical system associated with the first session with the one or more parameters of the medical system associated with the second session.
22. A non-transitory machine-readable medium comprising a plurality of machine-readable instructions executed by one or more processors associated with a medical system, the plurality of machine-readable instructions causing the one or more processors to perform a method comprising: executing a first session of the medical system for a procedure, wherein executing the first session comprises completing one or more medical instrument operations for a medical instrument; subsequent to completing the one or more medical instrument operations, executing a mid-procedure restart of restarting the medical system; and subsequent to executing the mid-procedure restart of the medical system, executing a second session of the medical system for the procedure, wherein executing the second session comprises skipping the one or more medical instrument operations completed in the first session based on comparing one or more first parameters of the medical system associated with the first session with one or more parameters of the medical system associated with the second session.
23. The non-transitory machine-readable medium of claim 22, wherein completing the one or more medical instrument operations takes more time than comparing the one or more first parameters with the one or more second parameters.
24. The non-transitory machine-readable medium of claim 22, wherein comparing the one or more first parameters with the one or more second parameters comprises determining that the one or more first parameters is equivalent to the one or more second parameters.
25. The non-transitory machine-readable medium of claim 22, wherein the one or more medical instrument operations comprise an engagement operation to engage the medical instrument with a manipulator assembly of the medical system such that the manipulator assembly controls movements of the medical instrument.
26. The non-transitory machine-readable medium of claim 25, wherein: the engagement operation engages input disks of the medical instrument with actuator disks of the manipulator assembly; and comparing the one or more first parameters with the one or more second parameters comprises determining that a correlation between motion of the input disks andthe actuator disks caused by the engagement operation in the first session remains in the second session.
27. The non-transitory machine-readable medium of claim 26, wherein: comparing the one or more first parameters with the one or more second parameters comprises executing an engagement test, and the actuator disks apply more torque in the engagement operation than the engagement test.
28. The non-transitory machine-readable medium of claim 22, wherein the medical system comprises a sensor for measuring movements of the medical instrument, and wherein the one or more medical instrument operations comprise a sensor health operation, the sensor health operation comprising verifying acceptability of first sensor health data received from the sensor.
29. The non-transitory machine-readable medium of claim 28, wherein comparing the one or more first parameters with the one or more second parameters comprises comparing the first sensor health data received from the sensor in the first session with second sensor health data received from the sensor in the second session.
30. The non-transitory machine-readable medium of claim 28, wherein comparing the one or more first parameters with the one or more second parameters comprises comparing a first fingerprint representing the first sensor health data received from the sensor in the first session with a second fingerprint representing second sensor health data received from the sensor in the second session.
31. The non-transitory machine-readable medium of claim 22, wherein comparing the one or more first parameters with the one or more second parameters comprises comparing a first controller configuration of the medical system used to control the medical instrument in the first session to a second controller configuration of the medical system used to control the medical instrument in the second session.
32. The non-transitory machine-readable medium of claim 22, wherein comparing the one or more first parameters with the one or more second parameters comprises comparing a first fingerprint representing a first controller configuration of the medical system used tocontrol the medical instrument in the first session to a second fingerprint representing a second controller configuration of the medical system used to control the medical instrument in the second session.
33. The non-transitory machine-readable medium of claim 22, wherein the one or more medical instrument operations comprise a motion test operation for the medical instrument.
34. The non-transitory machine-readable medium of claim 33, wherein the medical system comprises: an actuator for controlling movements of the medical instrument, and a sensor for measuring the movements of the medical instrument, and wherein the motion test operation comprises comparing movement of the medical instrument measured by the sensor with predicted movement of the medical instrument generated based on measured movement of the actuator.
35. The non-transitory machine-readable medium of claim 22, wherein the one or more medical instrument operations comprise a registration operation to associate sensor data regarding the medical instrument with a reference frame.
36. The non-transitory machine-readable medium of claim 22, wherein the one or more medical instrument operations comprise a navigation operation to move the medical instrument toward a target anatomical feature.
37. The non-transitory machine-readable medium of claim 22, wherein: executing the first session comprises, in response to completing the one or more medical instrument operations: generating a first fingerprint representing the one or more first parameters, storing the first fingerprint for retrieval after executing the mid-procedure restart of the medical system, and comparing that the one or more first parameters with the one or more second parameters comprises comparing a second fingerprint representing the one or more second parameters with the first fingerprint.
38. The non-transitory machine-readable medium of claim 22, wherein the one or more medical instrument operations comprise:an engagement operation to engage the medical instrument with a manipulator assembly of the medical system, a sensor health operation for a sensor that measures movements of the medical instrument, and a motion test operation for the medical instrument.
39. The non-transitory machine-readable medium of claim 22, wherein executing the second session comprises completing a medical instrument operation that was not completed in the first session subsequent to skipping the one or more medical instrument operations completed in the first session.
40. The non-transitory machine-readable medium of claim 22, wherein executing the first session further comprises completing a medical instrument operation to which a type of an error that caused the mid-procedure restart of the medical system is not related, and wherein executing the second session further comprises skipping the medical instrument operation to which the type of the error is not related, without comparing the one or more first parameters of the medical system associated with the first session with the one or more parameters of the medical system associated with the second session.
1. A method for operating a medical system, comprising: executing a first session of the medical system for a procedure, wherein executing the first session comprises completing one or more medical instrument operations for a medical instrument; subsequent to completing the one or more medical instrument operations, executing a mid-procedure restart of the medical system; and subsequent to executing the mid-procedure restart of the medical system, executing a second session of the medical system for the procedure, wherein executing the second session comprises skipping the one or more medical instrument operations completed in the first session based on comparing one or more first parameters of the medical system associated with the first session with one or more parameters of the medical system associated with the second session.
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