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WO2025030175A1 - Commande d'articulation de dispositif allongé flexible basée sur une distance d'insertion d'outil - Google Patents

Commande d'articulation de dispositif allongé flexible basée sur une distance d'insertion d'outil Download PDF

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Publication number
WO2025030175A1
WO2025030175A1 PCT/US2024/040917 US2024040917W WO2025030175A1 WO 2025030175 A1 WO2025030175 A1 WO 2025030175A1 US 2024040917 W US2024040917 W US 2024040917W WO 2025030175 A1 WO2025030175 A1 WO 2025030175A1
Authority
WO
WIPO (PCT)
Prior art keywords
tool
flexible elongate
elongate device
articulable
body portion
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2024/040917
Other languages
English (en)
Inventor
Shibing LIU
Samuel SCHORR
Sang Gyum Kim
Vincent Duindam
Federico Barbagli
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Intuitive Surgical Operations Inc
Original Assignee
Intuitive Surgical Operations Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Intuitive Surgical Operations Inc filed Critical Intuitive Surgical Operations Inc
Publication of WO2025030175A1 publication Critical patent/WO2025030175A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/30Surgical robots
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046Tracking techniques
    • A61B2034/2061Tracking techniques using shape-sensors, e.g. fiber shape sensors with Bragg gratings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/30Surgical robots
    • A61B2034/301Surgical robots for introducing or steering flexible instruments inserted into the body, e.g. catheters or endoscopes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06Measuring instruments not otherwise provided for
    • A61B2090/061Measuring instruments not otherwise provided for for measuring dimensions, e.g. length
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06Measuring instruments not otherwise provided for
    • A61B2090/062Measuring instruments not otherwise provided for penetration depth
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06Measuring instruments not otherwise provided for
    • A61B2090/064Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension
    • A61B2090/065Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension for measuring contact or contact pressure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08Accessories or related features not otherwise provided for
    • A61B2090/0807Indication means

Definitions

  • Disclosed embodiments relate to articulation control of a flexible elongate device.
  • 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.
  • minimally invasive medical instruments including surgical, diagnostic, therapeutic, and/or biopsy instruments
  • 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.
  • a medical system in some examples, includes a flexible elongate device having an articulable body portion and a lumen extending through the articulable body portion.
  • One or more sensors of the medical system are configured to generate sensor data indicating an insertion distance of a distal portion of a tool within the lumen of the flexible elongate device and one or more actuators of the medical system are operably coupled to the flexible elongate device to control articulation of the articulable body portion.
  • a control system is configured to determine the insertion distance of the distal portion of the tool within the lumen of the flexible elongate device based on the sensor data and control operation of the one or more actuators to change an articulation state of the articulable body portion based on the insertion distance.
  • the articulation state can be changed at least two times as the tool is inserted from a proximal end to a distal end of the flexible elongate device.
  • the control system can be configured to control operation of the one or more actuators to transition from an initial articulation state to a relaxed state based on the insertion distance corresponding to a relaxation initiation location.
  • the control system can be configured to control operation of the one or more actuators to transition the articulable body portion from the relaxed state to a returned articulation state based on the insertion distance corresponding to a relaxation end location, where the returned articulation state has at least one articulation property of the initial articulation state.
  • a method of controlling articulation of a flexible elongate device includes determining an insertion distance of a distal portion of a tool within a lumen of a flexible elongate device based on sensor data of one or more sensors, the flexible elongate device having an articulable body portion, the lumen extending through the articulable body portion, and controlling operation of one or more actuators to change an articulation state of the articulable body portion based on the insertion distance.
  • controlling operation of the one or more actuators to change the articulation state of the articulable body portion based on the insertion distance can include controlling operation of the one or more actuators to change the articulation state at least two times as the tool is inserted from a proximal end to a distal end of the flexible elongate device.
  • controlling operation of the one or more actuators to change the articulation state of the articulable body portion can include controlling operation of the one or more actuators to transition from an initial articulation state to a relaxed state based on the insertion distance corresponding to a relaxation initiation location.
  • the method can include controlling operation of the one or more actuators to transition the articulable body portion from the relaxed state to a returned articulation state based on the insertion distance corresponding to a relaxation end location, where the returned articulation state has at least one articulation property of the initial articulation state.
  • a non-transitory computer readable medium has instructions stored thereon that, when executed by a computing device, cause the computing device to determine an insertion distance of a distal portion of a tool within a lumen of a flexible elongate device based on sensor data of one or more sensors, the flexible elongate device having an articulable body portion, the lumen extending through the articulable body portion, and control operation of one or more actuators to change an articulation state of the articulable body portion based on the insertion distance.
  • the instructions when executed, can cause the computing device to control operation of the one or more actuators to change the articulation state at least two times as the tool is inserted from a proximal end to a distal end of the flexible elongate device.
  • the instructions when executed, can cause the computing device to control operation of the one or more actuators to transition from an initial articulation state to a relaxed state based on the insertion distance corresponding to a relaxation initiation location.
  • the instructions when executed, can further cause the computing device to control operation of the one or more actuators to transition the articulable body portion from the relaxed state to a returned articulation state based on the insertion distance corresponding to a relaxation end location, where the returned articulation state has at least one articulation property of the initial articulation state.
  • a medical system in some examples, includes a flexible elongate device having an articulable body portion and a lumen extending through the articulable body portion, one or more sensors, and one or more actuators operably coupled to the flexible elongate device to control articulation of the articulable body portion.
  • a control system of the medical system is configured to determine that a tool inserted into the lumen of the flexible elongate device has reached a relaxation initiation location of the flexible elongate device based on sensor data from the one or more sensors and control operation of the one or more actuators to transition the articulable body portion from an initial articulation state to a relaxed state in response to determining that the tool has reached the relaxation initiation location.
  • control system can be configured to determine that the tool has reached a relaxation end location of the flexible elongate device based on sensor data from the one or more sensors and control operation of the one or more actuators to transition the articulable body portion from the relaxed state to a returned articulation state, the returned articulation state having at least one articulation property of the initial articulation state.
  • a method of controlling articulation of a flexible elongate device includes controlling operation of one or more actuators that control articulation of an articulable body portion of a flexible elongate device to hold the articulable body portion at an initial articulation state, determining that a tool inserted into a lumen of the flexible elongate device has reached a relaxation initiation location of the flexible elongate device based on sensor data, and controlling operation of the one or more actuators to transition the articulable body portion from the initial articulation state to a relaxed state in response to determining that the tool has reached the relaxation initiation location.
  • the method can include determining that the tool has reached a relaxation end location of the flexible elongate device and controlling operation of the one or more actuators to transition the articulable body portion from the relaxed state to a returned articulation state, the relumed articulation state having at least one articulation property of the initial articulation state.
  • a non-transitory computer readable medium has instructions stored thereon that, when executed by a computing device, cause the computing device to control operation of one or more actuators that control articulation of an articulable body portion of a flexible elongate device to hold the articulable body portion at an initial articulation state, determine that a tool inserted into a lumen of the flexible elongate device has reached a relaxation initiation location of the flexible elongate device based on sensor data, and control operation of the one or more actuators to transition the articulable body portion from the initial articulation state to a relaxed state in response to determining that the tool has reached the relaxation initiation location.
  • the instructions when executed, can further cause the computing device to determine that the tool has reached a relaxation end location of the flexible elongate device and control operation of the one or more actuators to transition the articulable body portion from the relaxed state to a returned articulation state, the returned articulation state having at least one articulation property of the initial articulation state.
  • FIG. 1 is a simplified diagram of a medical system according to some embodiments.
  • FIG. 2A is a simplified diagram of a medical instrument system according to some embodiments.
  • FIG. 2B is a simplified diagram of a medical instrument including a medical tool within an elongate device according to some embodiments.
  • FIG. 3 is a simplified diagram of an instrument manipulator including a catheter assembly according to some embodiments.
  • FIGS. 4A and 4B are simplified diagrams of side views of a patient coordinate space including a medical instrument mounted on an insertion assembly according to some embodiments.
  • FIGS. 5 A and 5B are simplified diagrams of a medical system according to some embodiments.
  • FIG. 6 is a flowchart illustrating a method for controlling articulation of a flexible elongate device according to some embodiments.
  • FIG. 7 is a flowchart illustrating a method for operating a medical system according to some embodiments.
  • 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).
  • 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).
  • 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).
  • the term “shape” refers to a set of poses, positions, and/or orientations measured along an object.
  • 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.
  • the systems and methods provided herein provide for detection of tool insertion distance within the lumens of flexible elongate devices using one or more types of sensing modalities. Various types of actions can be controlled based on the tool insertion distance.
  • the insertion distance of the tool is used to facilitate tool insertion within the flexible elongate device.
  • the insertion distance of the tool is detected during tool insertion within the lumen of the flexible elongate device and the movement (e.g., articulation or insertion depth) of flexible elongate devices can be controlled as the tool is being inserted.
  • the articulable body portion of the flexible elongate device can be relaxed (e.g., from an initial articulation state, such as a desired state to facilitate performance of a biopsy procedure or other type of procedure using the tool when inserted through the lumen of the flexible elongate device) as a distal portion of the tool enters a flexible region of the flexible elongate device proximal to the articulable body portion to allow the tool to be successfully inserted through the articulable body portion without damaging the flexible elongate device or tool.
  • the articulable body portion may be returned to the prior articulation state, such as to perform the procedure.
  • the articulable body portion can be articulated via operation of one or more actuators, such that the articulation body portion returns to the pose of the articulation state (e.g., can have a corresponding position, pose, shape, bending angle, bending radius, etc.).
  • the articulation body portion returns to the pose of the articulation state (e.g., can have a corresponding position, pose, shape, bending angle, bending radius, etc.).
  • the bending angle is too large or the bending radius is too small and/or too much force is applied by the tool against the lumen wall of the flexible elongate device, the tool may not be able to pass through the articulable body portion, the lumen of the flexible elongate device may be damaged by the tool, or the tool (e.g., a rigid distal portion of the tool) may be damaged.
  • the changing of the bending angle/radius of the articulable body portion can be initiated based on the detected insertion distance of the tool within the lumen.
  • the articulable body portion can be initiated at the correct time during a procedure, controlled more accurately, and may allow tools to be utilized in locations requiring flexible elongate device shapes that otherwise would not accommodate movement of the tool within the lumen.
  • the insertion distance of the tool (e.g., as measured by the distal portion of the tool) within the lumen of the flexible elongate device may be monitored using one or more types of sensors.
  • the flexible elongate device includes a flexible portion and an articulable body portion distal to the flexible portion.
  • the monitoring is used to determine when the distal portion of the tool reaches a relaxation initiation location of the flexible elongate device.
  • the relaxation location may be at or near the proximal end of the articulable body portion, or proximal to the articulable body portion within the flexible portion.
  • one or more actuators controlling articulation of the articulable body portion of the flexible elongate device can then be controlled to transition the articulable body portion from an initial articulation state to a relaxed state.
  • Transition to the relaxed state may include lowering a tension/torque on pull wires and/or switching to passive control), which causes the bending angle of the articulable body portion to decrease, the bending radius of the articulation region to increase, and/or allows the articulable body portion to more easily deflect as the tool is being inserted therethrough.
  • bending requirements on the tool are reduced and any rigid portions of the tool will more easily pass.
  • the tool can continue to he monitored for insertion distance to determine when the distal portion of the tool reaches a relaxation end location of the flexible elongate device.
  • the relaxation end location may be at or near the distal end of the articulable body portion or distal to the articulable body portion.
  • the actuators can then be controlled to return to the initial articulation state, or some other articulation state. Returning to the initial articulation state may include the articulable body portion returning to the bending angle, bending radius, position of the initial articulation state, and/or direction aiming at the target, for example.
  • the insertion distance of the tool can be used to control the system in various other ways.
  • insertion distance may be used to provide notifications to a user that the amount of articulation of the articulable body portion is not suitable for insertion of the tool through the articulable body portion.
  • the indication may include a message that is displayed on a display device of the system. This allows the user to adjust the articulation, such as by relaxing the amount of articulation (e.g., changing bend radius/angle), to facilitate safe passage of the tool.
  • insertion distance may be used to provide a notification that an external imaging device, such as a fluoroscopic imaging device, is not being used.
  • the external imaging device may be used to verify correct tool positioning during the medical procedure performed by the tool, and tool detection and/or insertion distance may be used to help ensure that the external imaging device is turned on or otherwise operating properly at the appropriate time.
  • the insertion distance of the tool may also be used to detect workflow states of a procedure.
  • the system may detect based on the tool insertion that the navigation operation to navigate the flexible elongate device through anatomical passageways to a target tissue has completed, and that a medical operation (e.g., a biopsy, ablation, electroporation, etc.) has been initiated.
  • a medical operation e.g., a biopsy, ablation, electroporation, etc.
  • Monitoring the tool can be done in many suitable ways, including various sensing modalities at various locations.
  • one or more sensors used to monitor the insertion distance of the tool may be coupled to the manipulator assembly of the medical system (e.g., an anti-buckling guide, a control assembly, etc.), the flexible elongate device (e.g., at a backend of the flexible elongate device), and/or separate from the medical system (e.g., an external imaging device, such as a fluoroscopic imaging device).
  • These sensors can identify the insertion distance of the tool within the flexible elongate device, including when a portion of the tool that corresponds to a distal portion of the tool reaches the relaxation initiation location and relaxation end location.
  • a user may enter an input into the medical system to indicate that the tool has reached the relaxation initiation location or relaxation end location.
  • control parameters of the systems and methods can also be configured according to properties of the type of tool being inserted into the flexible elongate device. For example, a material, stiffness, shape, etc. of the tool being inserted into the flexible elongate device can be utilized to determine the relaxed state, such as a minimum bending radius or maximum bending angle for the tool. Thereafter, the actuators may be controlled to ensure that the articulable body portion is shaped to allow the tool to be successfully inserted therethrough.
  • 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 non-limiting.
  • 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.
  • 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, nonteleoperated, 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.
  • the master assembly 106 allows the operator O to view the procedural site or other graphical or informational displays.
  • the manipulator assembly 102 may be excluded from the medical system 100 and the instrument 104 may be controlled directly by the operator O.
  • the manipulator assembly 102 may be manually controlled by the operator O. Direct operator control may include various handles and operator interfaces for handheld operation of the instrument 104.
  • 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 the manipulator 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.
  • 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.
  • 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.
  • move or otherwise control tools e.g., imaging tools, ablation tools, biopsy tools, electroporation tools, etc.
  • the medical system 100 may include a sensor system 108 with one or more sub-systems 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 end of medical instrument 104 or from some other location; and/or actuator position sensors such as resolvers, encoders, potentiometers, and the like that
  • 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.
  • 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.
  • 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.
  • Display system 110 may also display an image of the procedural site and medical instruments, which may be captured by the visualization system.
  • the medical system 100 provides a perception of telepresence to the operator O.
  • 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.
  • 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 hand controls 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.
  • 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.
  • CT computed tomography
  • MRI magnetic resonance imaging
  • PET positron emission tomography
  • fluoroscopy thermography
  • ultrasound ultrasound
  • OCT optical coherence tomography
  • thermal imaging impedance imaging
  • laser imaging laser imaging
  • nanotube X-ray imaging and/or the like.
  • the virtual images may include two-dimensional, three-dimensional, or higher-dimensional (e.g., including, for example, time based or
  • display system 110 may display a virtual image that is generated based on tracking the location of medical instrument 104.
  • 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.
  • 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.
  • 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 more processors 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.
  • 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.
  • control system 112 may include other types of processing circuitry, such as application- specific integrated circuits (ASICs) and/or field-programmable gate array (FPGAs).
  • ASICs application-specific integrated circuits
  • FPGAs field-programmable gate array
  • the control system 112 may be implemented using hardware, firmware, software, or a combination thereof.
  • 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.
  • 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.
  • PCT Publication WO 2016/191298 published December 1, 2016 and titled “Systems and Methods of Registration for Image Guided Surgery”
  • PCT Publication WO 2016/191298 published December 1, 2016 and titled “Systems and Methods of Registration for Image Guided Surgery”
  • 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.
  • EM electromagnetic
  • 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.
  • 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.
  • 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 FTG. 2A and are example components of the control system 112 of the medical system 100.
  • 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.
  • 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.
  • the flexible body 216 may have an approximately 3 mm outer diameter. Other flexible body outer diameters may be larger or smaller.
  • 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.
  • 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).
  • 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.
  • FBGs Fiber Bragg Gratings
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • a series of position sensors 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.
  • a history of data from 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.
  • 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.
  • 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.
  • 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.
  • the medical tool 226 may be a biopsy tool used to remove sample tissue or a sampling of cells from a target anatomic location.
  • 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.
  • 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 more light emitters that provide illumination to facilitate image capture.
  • the image capture probe may use ultrasound, x-ray, fluoroscopy, CT, MRI, or other types of imaging technology.
  • 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.
  • 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.
  • the elongate device 202 may include integrated imaging capability rather than utilize a removable image capture probe.
  • the imaging device (or fiberoptic bundle) and the light emitters may be located at the distal end 218 of the elongate device 202.
  • the flexible body 216 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.
  • the medical instrument system 200 can perform simultaneous imaging and tool operations.
  • 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.
  • 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.
  • 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 controllab ly bend the distal end 218 as shown, for example, by broken dashed line depictions 219 of the distal end 218 in FIG. 2A.
  • 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.
  • the flexible elongate device 202 may be a steerable catheter.
  • steerable catheters 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.
  • 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.
  • 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 non-steerable with no integrated mechanism for operator control of the bending of distal end 218.
  • one or more channels 221 may be defined by the interior walls of the flexible body 216 of the elongate device 202.
  • 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.
  • 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 system 231 and/or pre-operatively obtained models to provide the physician, clinician, surgeon, or other operator with real-time position information.
  • the real-time position information may be displayed on the display system 110 for use in the control of the medical instrument system 200.
  • 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 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.
  • FIG. 3 shows an example of an instrument manipulator 306, which may be substantially similar to the instrument manipulator 206.
  • the instrument manipulator 306 may include a base 304, an insertion stage 302, and an instrument carriage 308 to which a catheter assembly 310 is coupled.
  • the instrument manipulator 306 provides for insertion and retraction of the catheter assembly 310, with respect to the patient anatomy, by moving the instrument carriage 308 and insertion stage 302 in a telescoping manner relative to the base 304.
  • the instrument manipulator 306, thus, provides an insertion degree of freedom for the insertion and retraction of the flexible catheter 310a.
  • the insertion may advance the flexible catheter 310a into the patient anatomy, whereas the retraction may withdraw the flexible catheter 310a from the patient anatomy.
  • the base 304 includes a shaft portion 304a and a main portion 304b. As described in detail below, the shaft portion 304a removably couples to a device connector or swivel connector 318 which receives the flexible catheter 310a.
  • the insertion stage 302 is coupled to the main portion 304b of the base 304 and translates along the main portion 304b.
  • the instrument carriage 308 is coupled to and translates along the insertion stage 302.
  • the catheter assembly 310 may include a flexible catheter 310a and a control assembly 310b.
  • the instrument carriage 308 couples to the control assembly 310b at an instrument interface 314 of the instrument carriage 308.
  • the instrument manipulator 306 also couples to a probe assembly 316 which includes a probe 316b and a probe connector 316a.
  • the probe assembly 316 may insert into a working lumen of the flexible catheter 310a through the connector 312 on the control assembly 310b and may run through the flexible catheter 310a.
  • the probe 316b may include, for example, a viewing scope assembly that provides images of a surgical site.
  • the instrument carriage 308 may include electronic and optical components providing probe 316b with endoscopic capabilities.
  • the probe assembly 316 may be detached from the instrument manipulator 306 and flexible catheter control assembly 310b, and removed from the catheter assembly 310.
  • Alternative instruments such as biopsy needles, ablation tools, and other flexible instruments may be coupled to the instrument manipulator 306 and/or the catheter assembly 310, through the flexible catheter 310a working lumen.
  • the device connector or swivel connector 318 may include a manipulator interface which may be removably coupled to the base 304.
  • the flexible catheter 310a runs through a catheter guide 322, which is a selectively collapsible and extendable device that supports the length of the flexible catheter 310a during movement of the instrument carriage 308.
  • the flexible catheter 310a without guidance may buckle in regions with no lateral support, e.g., in the space between the instrument interface 314 and the device connector 318.
  • the catheter guide 322 may be an anti-buckling guide by providing lateral support to the flexible catheter 310a.
  • FIGS. 4A and 4B are simplified diagrams of side views of a patient coordinate space including a medical instrument mounted on an insertion assembly according to some embodiments.
  • a surgical environment 400 may include a patient P positioned on the patient table T.
  • Patient P may be stationary within the surgical environment 400 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.
  • a medical instrument 404 is used to perform a medical procedure which may include, for example, surgery, biopsy, ablation, illumination, irrigation, suction, or electroporation.
  • the medical instrument 404 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 404 may be, for example, the medical instrument 104.
  • the medical instrument 404 may include an elongate device 410 (e.g., a catheter) coupled to an instrument body 412.
  • Elongate device 410 includes one or more channels sized and shaped to receive a medical tool.
  • Elongate device 410 may also include one or more sensors (e.g., components of the sensor system 108).
  • a shape sensor 414 may be fixed at a proximal point 416 on the instrument body 412.
  • the proximal point 416 of the shape sensor 414 may be movable with the instrument body 412, and the location of the proximal point 416 with respect to a desired reference frame may be known (e.g., via a tracking sensor or other tracking device).
  • the shape sensor 414 may measure a shape from the proximal point 416 to another point, such as a distal end 418 of the elongate device 410.
  • the shape sensor 414 may be aligned with the elongate device 410 (e.g., provided within an interior channel or mounted externally).
  • the shape sensor 414 may optical fibers used to generate shape information for the elongate device 410.
  • position sensors e.g., EM sensors
  • a series of position sensors may be positioned along the flexible elongate device 410 and used for shape sensing.
  • Position sensors may be used alternatively to the shape sensor 414 or with the shape sensor 414, such as to improve the accuracy of shape sensing or to verify shape information.
  • Elongate device 410 may house cables, linkages, or other steering controls that extend between the instrument body 412 and the distal end 418 to controllably bend the distal end 418. In some examples, at least four cables are used to provide independent up-down steering to control a pitch of distal end 418 and left-right steering to control a yaw of distal end 418.
  • the instrument body 412 may include drive inputs that removably couple to and receive power from drive elements, such as actuators, of a manipulator assembly.
  • the instrument body 412 may be coupled to an instrument carriage 406.
  • the instrument carriage 406 may be mounted to an insertion stage 408 that is fixed within the surgical environment 400.
  • the insertion stage 408 may be movable but have a known location (e.g., via a tracking sensor or other tracking device) within surgical environment 400.
  • Instrument carriage 406 may be a component of a manipulator assembly (e.g., manipulator assembly 102) that couples to the medical instrument 404 to control insertion motion (e.g., motion along an insertion axis A) and/or motion of the distal end 418 of the elongate device 410 in multiple directions, such as yaw, pitch, and/or roll.
  • the instrument carriage 406 or insertion stage 408 may include actuators, such as servomotors, that control motion of instrument carriage 406 along the insertion stage 408.
  • a sensor device 420 which may be a component of the sensor system 108, may provide information about the position of the instrument body 412 as it moves relative to the insertion stage 408 along the insertion axis A.
  • the sensor device 420 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 406, thus indicating the motion of the instrument body 412.
  • the insertion stage 408 has a linear track as shown in FIGS. 4A and 4B.
  • the insertion stage 408 may have curved track or have a combination of curved and linear track sections.
  • FIG. 4A shows the instrument body 412 and the instrument carriage 406 in a retracted position along the insertion stage 408.
  • the proximal point 416 is at a position L0 on the insertion axis A.
  • the location of the proximal point 416 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 406 along the insertion stage 408.
  • the distal end 418 of the elongate device 410 may be positioned just inside an entry orifice of patient P.
  • the instrument body 412 and the instrument carriage 406 have advanced along the linear track of insertion stage 408, and the distal end 418 of the elongate device 410 has advanced into patient P.
  • the proximal point 416 is at a position LI on the insertion axis A.
  • the rotation and/or orientation of the actuators measured by the sensor device 420 indicating movement of the instrument carriage 406 along the insertion stage 408 and/or one or more position sensors associated with instrument carriage 406 and/or the insertion stage 408 may be used to determine the position LI of the proximal point 416 relative to the position LO.
  • the position LI may further be used as an indicator of the distance or insertion depth to which the distal end 418 of the elongate device 410 is inserted into the passageway(s) of the anatomy of patient P.
  • FIG. 5 is a simplified diagram of a medical system 500 including a flexible elongate device 502.
  • the medical system 500 may correspond to the medical instrument system 200 and/or the flexible elongate device 502 may correspond to the elongate device 202.
  • the flexible elongate device 502 can include a flexible body and a lumen 504 that extends through the flexible body.
  • the lumen 504 may provide a delivery channel for a medical tool 506.
  • the medical tool 506 can be any suitable tool, including, for example, a vision probe, a biopsy tool (e.g., a needle, brush, cryoprobe, or forceps), an ablation tool, an electroporation tool, an ultrasound device (e.g., endobronchial ultrasound (EBUS) probe), a chemical delivery tool, and/or other biopsy or treatment tools, to be inserted through the flexible body of the flexible elongate device 502.
  • a vision probe e.g., a biopsy tool (e.g., a needle, brush, cryoprobe, or forceps)
  • an ablation tool e.g., an electroporation tool
  • an ultrasound device e.g., endobronchial ultrasound (EBUS) probe
  • chemical delivery tool e.g.,
  • the flexible body of the flexible elongate device 502 can include an articulable body portion 508, which may be in a distal section 510 of the body including a distal tip 512 thereof.
  • the system 500 includes one or more actuators 514 that control articulation of the articulable body portion 508 via manipulation of one or more control elements 516, such as pull wires, tendons, push rods, and/or the like, connected to a control structure 518 (e.g., control ring) of the articulable body portion 508.
  • control elements 516 such as pull wires, tendons, push rods, and/or the like
  • Operation of the actuator 514 causes the respective control element 516 to pull back to cause the articulable body portion 508 to bend in the direction of the control element 516 or release allowing the articulable body portion 508 to return to a straighter configuration.
  • desired articulation of the articulable body portion 508 is determined based on data from a shape sensor 519 (e.g., fiber shape sensor) of the flexible elongate device 502 that extends at least along the articulable body portion 508.
  • a shape sensor 519 e.g., fiber shape sensor
  • the system 500 can include an instrument carriage 515 (e.g., instrument carriage 308).
  • the instrument carriage 515 is moved in a telescoping manner by an instrument manipulator (not shown) to provide for insertion and retraction of the flexible elongate device 502 with respect to the patient anatomy.
  • the instrument carriage 515 can include a force sensor 517 that is configured to provide data regarding tool force.
  • the force sensor 517 can provide sensor data indicating that a needle of the tool 506 is being jabbed into tissue or that the tool 506 is being inserted through the flexible elongate device 502.
  • the system 500 includes a control system 520 that is operably coupled to the actuator(s) 514 to thereby control manipulation of positioning of the articulable body portion 508 of the flexible elongate device 502.
  • the system 500 further includes one or more sensors 522 coupled or disposed adjacent to the flexible elongate device 502 that provide sensor data indicating an insertion distance of the tool 506 (e.g., a distal portion 506a of the tool 506) within the lumen 504 of the flexible elongate device 502.
  • the control system 520 can utilize the sensor data to determine an insertion distance of the tool 506 and/or that the tool 506 has reached a predetermined location of the flexible elongate device 502.
  • the tool 506 can have a stiffness greater than the flexible elongate device 502 and/or a distal portion 506a that is or includes a rigid portion, such that the tool 506 may not be able to navigate the lumen 504 through the articulable body portion 508 if the articulable body portion 508 has a shape with a sufficiently large bending angle and/or small bending radius.
  • control system 520 can control articulation of the flexible elongate device 502 as the tool 506 is being inserted into the lumen 504 of the flexible elongate device 502 to allow the tool 506 to be successfully inserted through articulable body portion 508.
  • the control system 520 can control operation of the actuators 514 to change one or more articulation states of the articulable body portion 508 based on a distance that the tool 506 is inserted into the lumen 504 of the flexible elongate device 502.
  • the control system 520 can be configured to change the articulation state at least two times as the tool 506 is inserted from a proximal end 524 to the distal end 510 of the flexible elongate device 502.
  • the articulation states can include a relaxed articulation state that allows the tool 506 to be successfully inserted through the articulable body portion 508 and an initial articulation state (e.g., the articulation that the articulable body portion 508 was in prior to the tool 506 being inserted into the lumen 504 of the flexible elongate device 502 or prior to the tool 506 reaching the articulable body portion 508 of the flexible elongate device 502).
  • the articulation states can also include a returned articulation state where articulation of the articulable body portion 508 is controlled to at least partially return towards the initial articulation state.
  • the returned articulation state may be the same as the initial articulation state or may be different.
  • the returned articulation state may have one or more of the articulation properties of the initial articulation state.
  • the returned articulation state and the initial articulation state may one or more articulation properties including bending angle, bending radius, position, pose, and/or pointing direction (e.g., direction aiming at the target).
  • the returned articulation state could be different from the initial articulation so long as the shared articulation property of the states results in the tool being able to reach the target when extended from the lumen of the flexible elongate device.
  • the tip of the flexible elongate device may have the same pointing direction, but other articulation properties may different.
  • the bending angle in the returned articulation state may be smaller than the bending angle in the initial articulation state and/or the bending radius in the returned state may be larger than the bending radius in the initial articulation state.
  • Differences in the initial and returned articulation states may allow for optimization of the returned articulation state.
  • the flexible elongate device may not be able to return to the exact initial articulation state, such as may be caused by stiffness changes resulting from the insertion of the tool within the articulable body portion 508.
  • the returned articulation state may have more optimized articulation properties to facilitate movement and/or operation of the tool.
  • the control system 520 determines when the tool 506 (e.g., the distal portion 506a) reaches or enters a flexible region 526 (FIG. 5B) of the flexible elongate device 502 based on sensor data.
  • the sensor data can indicate a particular or target structure corresponding to the tool 506 reaching the flexible region 526 and/or can indicate a length of the tool 506 corresponding to an insertion depth where the tool 506 reaches the flexible region 526.
  • the proximal start of the flexible region 526 can be defined by a relaxation initiation location 526a and the sensor data can indicate when the tool 506 has reached the relaxation initiation location 526a.
  • control system 520 controls operation of the actuators 514 to transition the initial articulation state to a relaxed state, relaxing articulation of the articulable body portion 508 of the flexible elongate device 502 as the distal portion 506a of the tool 506 enters the flexible region 526 of the flexible elongate device 502.
  • the control system 520 can next determine when the tool 506 (e.g., the distal portion 506a) exits or reaches an end of the flexible region 526 of the flexible elongate device 502 based on sensor data.
  • the sensor data can indicate a particular or second target structure corresponding to the tool 506 reaching the end of the flexible region 526 and/or can indicate a length of the tool 506 corresponding to an insertion depth where the tool 506 reaches the end of the flexible region 526.
  • the distal end of the flexible region 526 can be defined by a relaxation end location 526b and the sensor data can indicate when the tool 506 has reached the relaxation end location 526b.
  • control system 520 Upon determining that the tool 506 has reached the relaxation end location 526b of the flexible region 526, the control system 520 controls operation of the actuators 514 to at least partially transition the relaxed state to the returned articulation state.
  • the flexible region 526 of the flexible elongate device 502 can be any suitable portion of the flexible elongate device 502.
  • the relaxation initiation location 526a and relaxation end location 526b can correspond to any suitable location along the flexible elongate device 502.
  • the relaxation initiation location 526a is proximal to the articulable body portion 508 or at a proximal end of the articulable body portion 508.
  • the relaxation end location 526b can be at a distal end of the articulable body portion 508 or distal of the articulable body portion 508. These locations would allow the tool 506 to be successfully inserted through the articulable body portion 508 without damaging the flexible elongate device 502.
  • the initial articulation state of the articulable body portion 508 can include a larger bending angle for the articulable body portion 508 and/or a smaller bending radius for the articulable body portion 508 than the relaxed state. As will be understood, the initial articulation state will likely depend on the particular procedure being performed and the patient anatomy.
  • the sensor(s) 522 can be disposed in any location suitable in the system 500 to obtain sensor data for the control system 520 to determine the insertion depth/location of the tool 506 within the lumen 504 of the flexible elongate device 502.
  • one or more of the sensor(s) 522 can be mounted or otherwise coupled to a manipulator assembly 528 (e.g., manipulator assembly 102) that includes the actuators 514, an anti-buckling guide 530 (e.g., antibuckling guide 322) for the flexible elongate device 502, a swivel connector 532 (e.g., swivel connector 318) for the flexible elongate device 502, a control assembly 534 (e.g., control assembly 310b) configured to support and position the flexible elongate device 502, the proximal end 524 of the flexible elongate device 502, and so forth.
  • the sensors 522 can be disposed along a tool insertion path into the lumen 504 of the flexible elong
  • the sensor(s) 522 can include any type or combination of types of sensors to provide suitable sensor data to the control system 520.
  • the sensor(s) 522 can include at least one of an inductance sensor or a capacitive sensor.
  • the sensor data includes inductance data regarding the structure of the tool 506 or flexible elongate device 502.
  • the control system 520 can compare the inductance data with stored inductance data to identify target structure along the length of the tool 506/flexible elongate device 502 corresponding to the tool 506 reaching the relaxation initiation location 526a.
  • the control system 520 can compare the inductance data with stored inductance data to identify a second target structure along the length of the tool 506/flexible elongate device 502 corresponding to the tool 506 reaching the relaxation end location 526b.
  • the sensor data includes capacitance data regarding the structure of the tool 506 or flexible elongate device 502.
  • the control system 520 can compare the capacitance data with stored capacitance data to identify a target structure along the length of the tool 506/flexible elongate device 502 corresponding to the tool 506 reaching the relaxation initiation location 526a.
  • the control system 520 can compare the capacitance data with stored capacitance data to identify a second target structure along the length of the tool 506/flexible elongate device 502 corresponding to the tool 506 reaching the relaxation end location 526b.
  • the sensors 522 can include an imaging device configured to generate images of the tool 506 within the lumen 504 of the flexible elongate device 502.
  • the imaging device can be a fluoroscopic imaging device.
  • the control system 520 can determine tool insertion depth (e.g., relaxation initiation location 526a and/or relaxation end location 526b) utilizing fluoroscopy.
  • fluoroscopy can also be utilized to determine a number of jabs into tissue performed with a needle of the tool 506.
  • control system 520 can check if the fluoroscopic imaging device is currently operating in response to receiving sensor data from one or more of the other sensors 517, 519, 522 indicating that the tool 506 is being inserted into the lumen 504 of the flexible elongate device.
  • the control system 520 can also check if the fluoroscopic imaging device is currently operation in response to detecting that the needle of the tool 506 is being jabbed into tissue based on sensor data from the force sensor 517 of the instrument carriage 515.
  • control system 520 can be configured to automatically turn the fluoroscopic imaging device on in response to the indication that the tool 506 is being inserted into the lumen 504 of the flexible elongate device 502 and/or that the needle of the tool 506 is being jabbed into tissue.
  • Checking that the fluoroscopic imaging device is currently operating can include utilizing frame grabbers or the like.
  • one or more of the sensors 522 can be disposed within or otherwise coupled to the tool 506 to measure data associated with the flexible elongate device 502.
  • the control system 520 can compare the sensor data from the sensor 522 coupled to the tool 506 with stored data to identify target structure along the length of the flexible elongate device 502 corresponding to the relaxation initiation location 526a.
  • the control system 520 can compare the sensor data with stored data to identify a second target structure along the length of the flexible elongate device 502 corresponding to the relaxation end location 526b.
  • the relaxed state can be at least partially dependent on a tool type of the tool 506 inserted into the lumen 504 of the flexible elongate device 502.
  • the tool type can identify a stiffness of the tool 506 and/or any rigid lengths, and a corresponding bending angle/bending radius needed for the tool 506 to be inserted through a bent portion of the lumen 504.
  • Different tool types would require a varying range of relaxation relative to a given initial articulation state to be successfully inserted through the articulable body portion 508.
  • the tool type can be input to the system 500 by a user and/or can be determined by the control system 520 based on analysis of sensor data from one or more of the sensors 522.
  • inductance data can be used to identify particular structure of a tool type for identification purposes. Thereafter, the control system 520 can determine the amount of relaxation relative to the initial articulation state needed to allow the tool 506 to be inserted therethrough and control the operation of the actuators 514 to transition the articulable body portion 508 from the initial articulation state to the relaxed state corresponding to the tool type. In further examples, feedforward terms (e.g., spine stiffness) for the control system 520 may also be adjusted based on the tool type of the tool 506. [0101] The control system 520 can also be configured to disable transitioning to the relaxed state in response to a predetermined criteria or condition being met.
  • feedforward terms e.g., spine stiffness
  • control system 520 can determine that the bending angle of the articulable body portion 508 of the flexible elongate device 502 in the initial articulation state is below a threshold bending angle. If the articulable body portion 508 does not have an overly bent shape, the articulation state change can be unnecessary to allow the tool 506 to be inserted through the articulable body portion 508, such that disabling the articulation relaxation functionality may shorten an overall procedure time. In another example, the control system 520 can determine that the articulable body portion 508 of the flexible elongate device 502 is disposed in a location within a patient where movement could be detrimental.
  • the articulation relaxation functionality may be disabled prior to a procedure based on an intended path or target location, or a user can instruct the control system 520 to disable the articulation relaxation functionality based on an analysis of the articulable body portion 508 location.
  • the control system 520 determines a tool type of the tool 506 as discussed above, the control system 520 can determine that the tool 506 is sufficiently flexible (e.g., overall stiffness and/or any rigid portions) to pass through the lumen 504 of the flexible elongate device 502 at the initial articulation state based on the tool type.
  • the medical system 500 can further include a control panel 536 that is operably coupled to the control system 520 and configured to allow a user to intervene in or direct the operation of the articulation relaxation functionality.
  • the control panel 536 can include an input and an output to direct the operation of the system 500, as well as be informed or queried as to the operation of the system 500.
  • the control panel 536 can include any number of suitable user inputs/outputs.
  • the control panel 536 can include a touchscreen or other display, a scroll ball, buttons, switches, a microphone for voice command, speakers, and so forth.
  • control panel 536 can allow a user to disable the articulation relaxation functionality (e.g., transitioning from the initial articulation state to the relaxation state and/or transitioning from the relaxation state to the returned articulation state) before or during transitioning. This allows a user to terminate or abort the articulation relaxation functionality at any stage.
  • motion of the articulable body portion 508 is stopped and control of the actuators 514 is switched to a normal following mode at the guidance of a user.
  • a notification may also be shown on the control panel 536 that the articulation relaxation functionality is aborted.
  • control panel 536 can be used to direct the control system 520 to control operation of the actuators 514 to transition the articulable body portion 508 from the initial articulation state to the relaxed state and/or from the relaxed state to the returned articulation state.
  • the user can direct the control system 520 to operate independent of the flexible body portion 526 (e.g., the relaxation initiation location 526a and/or the relaxation end location 526b).
  • the control panel 536 can provide an indication to the control system 520 that the tool 506 inserted into the lumen 504 of the flexible elongate device 502 has reached the relaxation initiation location 526a and/or the relaxation end location 526b of the flexible elongate device 502.
  • control panel 536 can be utilized to request authorization prior to changing an articulation state of the articulable body portion 508 of the flexible elongate device 502.
  • the control system 520 can query the user whether transitioning from the initial articulation state to the relaxed state is desired. The user can utilize the user input 536 to authorize or deny the transition.
  • the control system 520 can query the user whether transitioning from the relaxed state to the return articulation state is desired.
  • the user can utilize the user input 536 to authorize or deny the transition. Determining that the tool 506 has been fully inserted can include identifying target structure of the tool 506/flexible elongate device 502 as described herein, by user input, and so forth.
  • the control panel 536 can also be utilized to notify a user when the above-described predetermined criteria or condition for disabling transitioning to the relaxed state arc met and/or when the transitioning is disabled.
  • the control system 536 can notify a user via the control panel 536 that the bending angle of the articulable body portion 508 of the flexible elongate device 502 in the initial articulation state is below a threshold bending angle, that the articulable body portion 508 of the flexible elongate device 502 is disposed in a location within a patient where movement could be detrimental, and/or that the tool 506 is sufficiently flexible to pass through the lumen 504 of the flexible elongate device 502 at the initial articulation state based on a tool type of the tool 506.
  • the control panel 536 can also be utilized to notify a user when the control system 520 determines that the tool 506 is being inserted based on sensor data from the sensors 517, 519, 522 and the fluoroscopic imaging device is not currently operating and/or when the control system 520 determines that the needle of the tool 506 is being jabbed into tissue based on the sensor data of the force sensor 517 and the fluoroscopic imaging device is not currently operating.
  • a model may define a relationship between sensor data and a position of the tool 506 within the flexible elongate device 502.
  • the sensor data can include one or more of: shape data, position data, bending angle data, encoder data, and so forth. Accordingly, the sensor data can be provided by the shape sensor 519 and/or the other sensors 522.
  • the sensors 522 can take any suitable form, including, for example, a position sensor (e.g., an electro-magnetic sensor), and/or an imaging sensor (e.g., camera, ultrasound, fluoroscope, etc.).
  • a position sensor e.g., an electro-magnetic sensor
  • an imaging sensor e.g., camera, ultrasound, fluoroscope, etc.
  • the sensors 522 include one or more actuator encoders for the actuator(s) 514.
  • the actuator encoders are configured to generate encoder data regarding operational states (e.g., motor position, speed, etc.) of the actuator(s) 514.
  • the sensor(s) 522 may also include a current sensor configured to measure a current through a motor of the actuator(s) 514, which is then converted to motor torque, and/or a torque sensor coupled to an output of a gearbox of or coupled to the actuator(s) 514.
  • the model may define the relationship between movement of the flexible elongate device 502 (e.g., position data, shape data, bending angle data), movement of the actuator(s) 514 (e.g., encoder data, torque data) and a position of the tool 506 within the flexible elongate device 502.
  • the control system 520 utilizes the model and the sensor data to determine a current position of the tool 506.
  • the control system 520 updates the model to determine a new position of the tool 506 within the flexible elongate device 502.
  • FIG. 6 illustrates a method 600 for controlling articulation of a flexible elongate device in a medical system (e.g., the flexible elongate device 502 and medical system 500) according to some embodiments.
  • the method 600 is illustrated as a set of operations or processes 602 through 624. Not all of the illustrated processes may be performed in all embodiments of the method 600. Additionally, one or more processes that arc not expressly illustrated in FIG. 6 may be included before, after, in between, or as part of the processes 602 through 624. Processes may also be performed in different orders.
  • one or more of the processes 602 through 624 may be implemented, at least in part, in the form of executable code stored on non-transitory, tangible, machine-readable media that when run by one or more processors (e.g., the processors of a controller) may cause the one or more processors to perform one or more of the processes.
  • the processes 602 through 624 may be performed by a controller.
  • process 602 operation of one or more actuators (e.g., actuators 514) that control articulation of an articulable body portion of a flexible elongate device (e.g., articulable body portion 508) are controlled to hold the articulable body portion at an initial articulation state.
  • sensor data is measured with one or more sensors (e.g., sensors 522).
  • the sensor data is utilized to determine that a tool (e.g., tool 506) inserted into a lumen (e.g., lumen 504) of the flexible elongate device has reached a relaxation initiation location (e.g., relaxation initiation location 526a) of the flexible elongate device.
  • a user is queried for authorization to transition the articulable body portion from the initial articulation state to a relaxed state.
  • operation of the one or more actuators is controlled to transition the articulable body portion from the initial articulation state to the relaxed state in response to determining that the tool has reached the relaxation initiation location.
  • the relaxed state can be at least partially dependent on a tool type of the tool.
  • sensor data is utilized to determine that the tool has reached a relaxation end location (e.g., relaxation end location 526b) of the flexible elongate device.
  • a user is queried for authorization to transition the articulable body portion from the relaxed state to a returned articulation state.
  • operation of the one or more actuators is controlled to transition the articulable body portion from the relaxed state to the returned articulation state.
  • reception of a signal from a user input is utilized to determine that the tool inserted into the lumen of the flexible elongate device has reached the relaxation initiation location of the flexible elongate device after process 602.
  • operation of the one or more actuators is controlled to transition the articulable body portion from the initial articulation state to the relaxed state in response to determining that the tool has reached the relaxation initiation location.
  • the relaxed state can be at least partially dependent on the tool type of the tool.
  • a signal from the user input is utilized to determine that the tool inserted into the lumen of the flexible elongate device has reached the relaxation end location of the flexible elongate device.
  • operation of the one or more actuators is controlled to transition the articulable body portion from the relaxed state to the returned articulation state.
  • FIG. 7 illustrates a method 700 for operating a medical system (e.g., the medical system 500) according to some embodiments.
  • the method 700 is illustrated as a set of operations or processes 702 and 704. Not all of the illustrated processes may be performed in all embodiments of the method 700. Additionally, one or more processes that are not expressly illustrated in FIG. 7 may be included before, after, in between, or as part of the processes 702 and 704. Processes may also be performed in different orders.
  • one or more of the processes 702 and 704 may be implemented, at least in part, in the form of executable code stored on non-transitory, tangible, machine -readable media that when run by one or more processors (e.g., the processors of a controller) may cause the one or more processors to perform one or more of the processes.
  • the processes 702 and 704 may be performed by a controller.
  • an insertion distance of a tool (e.g., tool 506) within a lumen of a flexible elongate device (e.g., flexible elongate device 502 and lumen 504) is determined based on sensor data (e.g., from sensors 522).
  • sensor data e.g., from sensors 522
  • at least one component of the medical system is controlled based on the insertion distance.
  • the component can include one or more of: one or more actuators (e.g., actuators 514) that control articulation of an articulable body portion of a flexible elongate device (e.g., articulable body portion 508), a user notification device (e.g., control panel 536) to notify a user of a status of the system and/or query a user for instructions as described herein, and/or a generator of the system for electroporation/ablation tools inserted within the lumen of the flexible elongate device.
  • actuators e.g., actuators 514
  • a user notification device e.g., control panel 5366
  • a generator of the system for electroporation/ablation tools inserted within the lumen of the flexible elongate device.
  • control system 112, 520 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.
  • 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).
  • 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).

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  • Surgery (AREA)
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  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Robotics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Heart & Thoracic Surgery (AREA)
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Abstract

Des systèmes et des procédés médicaux comprennent un dispositif allongé flexible présentant une partie corps articulable et un actionneur destiné à commander l'articulation de la partie corps articulable du dispositif allongé flexible. Un système de commande détermine une distance d'insertion ou un emplacement d'un outil inséré dans le dispositif allongé flexible et commande le fonctionnement de l'actionneur pour modifier un état d'articulation de la partie de corps articulable.
PCT/US2024/040917 2023-08-03 2024-08-05 Commande d'articulation de dispositif allongé flexible basée sur une distance d'insertion d'outil Pending WO2025030175A1 (fr)

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US20200078104A1 (en) * 2016-06-30 2020-03-12 Intuitive Surgical Operations, Inc Systems and methods of steerable elongate device
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US7316681B2 (en) 1996-05-20 2008-01-08 Intuitive Surgical, Inc Articulated surgical instrument for performing minimally invasive surgery with enhanced dexterity and sensitivity
US6380732B1 (en) 1997-02-13 2002-04-30 Super Dimension Ltd. Six-degree of freedom tracking system having a passive transponder on the object being tracked
US20060013523A1 (en) 2004-07-16 2006-01-19 Luna Innovations Incorporated Fiber optic position and shape sensing device and method relating thereto
US7772541B2 (en) 2004-07-16 2010-08-10 Luna Innnovations Incorporated Fiber optic position and/or shape sensing based on rayleigh scatter
US9259274B2 (en) 2008-09-30 2016-02-16 Intuitive Surgical Operations, Inc. Passive preload and capstan drive for surgical instruments
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