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WO2025160225A1 - Détection de position d'insertion d'outil - Google Patents

Détection de position d'insertion d'outil

Info

Publication number
WO2025160225A1
WO2025160225A1 PCT/US2025/012679 US2025012679W WO2025160225A1 WO 2025160225 A1 WO2025160225 A1 WO 2025160225A1 US 2025012679 W US2025012679 W US 2025012679W WO 2025160225 A1 WO2025160225 A1 WO 2025160225A1
Authority
WO
WIPO (PCT)
Prior art keywords
sensor
tool
target
medical system
targets
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/US2025/012679
Other languages
English (en)
Inventor
David W. Bailey
Shibing LIU
Jeremy FIDOCK
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 WO2025160225A1 publication Critical patent/WO2025160225A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/30—Surgical robots
    • A61B34/37—Leader-follower robots
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/0233—Pointed or sharp biopsy instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046—Tracking techniques
    • A61B2034/2061—Tracking techniques using shape-sensors, e.g. fiber shape sensors with Bragg gratings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/30—Surgical robots
    • A61B2034/301—Surgical robots for introducing or steering flexible instruments inserted into the body, e.g. catheters or endoscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, 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
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/062—Measuring instruments not otherwise provided for penetration depth
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, 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
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/064—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, 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
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0807—Indication means
    • A61B2090/0811—Indication means for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, 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
    • A61B90/90—Identification means for patients or instruments, e.g. tags
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, 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
    • A61B90/90—Identification means for patients or instruments, e.g. tags
    • A61B90/98—Identification means for patients or instruments, e.g. tags using electromagnetic means, e.g. transponders

Definitions

  • Disclosed embodiments relate to improved robotic and/or medical devices, systems, and methods.
  • 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.
  • An instrument may be inserted through a lumen in the flexible elongate device, e.g., to perform the medical procedure in the region of interest. For various reasons, it may be desirable to know the position (e.g., an insertion depth) of the instrument.
  • a medical system comprises: a position sensing device comprising a first sensor and a second sensor spaced apart from the first sensor along an axis, wherein the first sensor obtains a first periodic signal representing presence of a plurality of targets of a tool detected by the first sensor as the tool moves relative to the first sensor along the axis, wherein the second sensor obtains a second periodic signal representing presence of the plurality of targets detected by the second sensor when the tool moves relative to the second sensor along the axis; and a processing system coupled to the position sensing device, the processing system configured to: determine, using the first and second periodic signals, a position value of the tool along the axis.
  • a medical system comprises: a tool identification sensing device comprising a first sensor and a second sensor spaced apart from the first sensor along an axis, wherein the first sensor obtains a first signal representing presence of a plurality of targets of a tool detected by the first sensor as the tool moves relative to the first sensor along the axis, wherein the second sensor obtains a second signal representing presence of the plurality of targets detected by the second sensor when the tool moves relative to the second sensor along the axis; and a processing system coupled to the tool identification sensing device, the processing system configured to: determine a presence of a first target of the plurality of targets at the second sensor during an insertion of the tool along the axis in an insertion direction defined from the first sensor to the second sensor; determine a first value captured by the first sensor while the first target is determined to be present at the second sensor, the first value indicating a proximity of a second target of the plurality of targets to the first sensor; and depending on the first value, identify a property of the
  • a non-transitory machine-readable medium comprises a plurality of machine-readable instructions executed by one or more processors associated with a medical system, the medical system comprising: a position sensing device comprising a first sensor and a second sensor spaced apart from the first sensor along an axis, and the plurality of machine- readable instructions causing the one or more processors to perform a method comprising: obtaining, from the first sensor, a first periodic signal representing presence of a plurality of targets of a tool detected by the first sensor as the tool moves relative to the first sensor along the axis; obtaining, from the second sensor, a second periodic signal representing presence of the plurality of targets detected by the second sensor when the tool moves relative to the second sensor along the axis; and determining, using the first and second periodic signals, a position value of the tool along the axis.
  • a non-transitory machine-readable medium comprises a plurality of machine-readable instructions executed by one or more processors associated with a medical system, the medical system comprising: a tool identification sensing device comprising a first sensor and a second sensor spaced apart from the first sensor along an axis; and the plurality of machine-readable instructions causing the one or more processors to perform a method comprising: obtaining, from the first sensor, a first signal representing presence of a plurality of targets of a tool detected by the first sensor as the tool moves relative to the first sensor along the axis; obtaining, from the second sensor, a second signal representing presence of the plurality of targets detected by the second sensor when the tool moves relative to the second sensor along the axis; determining a presence of a first target of the plurality of targets at the second sensor during an insertion of the tool along the axis in an insertion direction defined from the first sensor to the second sensor; determining a first value captured by the first sensor while the first target is determined to
  • a medical system comprises: a manipulator assembly for controlling movements of a medical instrument comprising a flexible elongate device with a lumen configured to receive a biopsy needle; and a processing system coupled to the manipulator assembly and configured to: during execution of a biopsy, detect a retraction of the flexible elongate device when the biopsy needle is advanced towards a target tissue of the biopsy, and based on the detection, determine a presence of an exception.
  • 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 a flexible elongate device according to some embodiments.
  • FIG. 2C is a simplified perspective diagram of a manipulator assembly including an instrument and a manipulator arm holding the instrument according to some embodiments.
  • FIGS. 3 A and 3B are simplified diagrams of side views of a patient coordinate space including a medical instrument mounted on an insertion assembly according to some embodiments.
  • FIG. 4 is a simplified perspective diagram of position sensing device according to some embodiments.
  • FIG. 5 is an example of a position sensing according to some embodiments.
  • FIG. 6 shows a detection section of an instrument according to some embodiments.
  • FIG. 7 is a flowchart of a method according to some embodiments.
  • FIG. 8A is a simplified diagram of a biopsy procedure, prior to execution of the biopsy according to some embodiments.
  • FIG. 8B is a simplified diagram of a biopsy procedure, during execution of the biopsy performed with sufficient force applied according to some embodiments.
  • FIG. 8C is a simplified diagram of a biopsy procedure, during execution of the biopsy performed with insufficient force applied according to some embodiments.
  • FIG. 9 is a flowchart of a method according to some embodiments.
  • FIG. 10 is an example of a tool identification sensing according to some embodiments.
  • FIG. 11 is an example of a tool identification sensing according to some embodiments.
  • FIG. 12 is a flowchart of a method 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.
  • Embodiments of the disclosure include medical systems and methods for operating such medical systems.
  • Medical systems may be medical systems that use flexible elongate devices (e.g., catheters, bronchoscopes, endoscopes, etc.), but also other medical systems.
  • a medical system may include an instrument or tool e.g., an imaging tool, ablation tool, biopsy tool, electroporation tool, etc.
  • the tool may be inserted into a lumen in a flexible elongate device (such as a catheter, bronchoscope, or endoscope), navigated to a distal end of the flexible elongate device, and positioned proximate to a target site in a region of interest.
  • a flexible elongate device such as a catheter, bronchoscope, or endoscope
  • the flexible elongate device is retracted while the tool is extended to expose the tip of the tool and maintain the position of the tool proximate to the target site.
  • an ablation tool may be navigated through the flexible elongate device to the distal end of the flexible elongate device, or past the distal end of the flexible elongate device, such that the ablation tool is placed proximate to the target site while still within the lumen of the flexible elongate device.
  • the flexible elongate device may then be retracted while the ablation tool is simultaneously extended to expose the distal end of the ablation tool and maintain the position of the ablation tool proximate to the target site.
  • the ablation tool may perform an ablation procedure on tissue at the target site. Retraction of the flexible elongate device during the ablation procedure exposes the energy producing portion of the ablation tool to the tissue and prevents the ablation tool from damaging the flexible elongate device.
  • knowing the position of the tool is necessary or at least beneficial. Knowledge of the position of the tool may be beneficial in many other applications as well. The position of the tool may be determined as subsequently described.
  • the medical system includes a non-contact tool position sensing.
  • Inductive sensing may be used, for example, for the non-contact tool position sensing.
  • the non-contact tool position sensing may rely on a set of ferromagnetic targets (targets) disposed along the tool, and an inductive position sensing device configured to detect the targets.
  • Hall effect sensors may be used to detect magnetic targets.
  • the targets during insertion and retraction of the tool, pass along a set of sensors along an axis.
  • the set of sensors may include a proximal and a distal inductive sensor.
  • the spacing of the targets and the spacing of proximal and distal inductive sensors along the axis are selected such that the signals provided by the proximal and distal inductive sensors form a phase quadrature signal, as the targets are passing along the proximal and distal inductive sensors.
  • the phase quadrature signal may then be used to determine a position value indicative of the position of the tool.
  • the position value derived from the quadrature signal may be referenced to a point in space to determine the position value in the desired reference frame.
  • the referencing may be performed against the position sensing device itself, against any element of the medical system, or against any other point in space. In some embodiments, the referencing is performed to obtain a zero position when a tip or other feature of the tool is flush with the end of the flexible elongate device.
  • the position value is continuously updated over time.
  • a position value that accurately reflects the position of the tool when inserting and/or retracting the tool may be available at any time and in real-time.
  • 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 tools 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 tool, e.g., 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 robot- assisted, non-assisted, or a hybrid robot-assisted and non-assisted assembly with select degrees of freedom of motion that may be motorized and/or robot- assisted and select degrees of freedom of motion that may be non-motorized and/or non-assisted.
  • 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 medical 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 hand-held operation of the medical 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 subsystems for receiving information about the manipulator assembly 102 and/or the medical instrument 104.
  • Such sub-systems may include a position sensor system (e.g., that uses electromagnetic (EM) sensors or other types of sensors that detect position or location); a shape sensor system for determining the position, orientation, speed, velocity, pose, and/or shape of a distal end and/or of one or more segments along a flexible body of the medical instrument 104; a visualization system (e.g., using a color imaging device, an infrared imaging device, an ultrasound imaging device, an x-ray imaging device, a fluoroscopic imaging device, a computed tomography (CT) imaging device, a magnetic resonance imaging (MRI) imaging device, or some other type of imaging device) for capturing images, such as from the distal end of medical instrument 104 or from some other location; and/or actuator position sensors such as resolvers, encoders, potentiometers, and the like that describe
  • 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 nanotube X-ray imaging
  • nanotube X-ray imaging and/or the like.
  • the virtual images may include two-dimensional, three-dimensional, or higherdimensional (e.g., including, for example,
  • 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.
  • the control system 112 may receive feedback from the medical instrument 104, such as force and/or torque feedback. Responsive to the feedback, the control system 112 may transmit signals to the master assembly 106.
  • 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”
  • 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 flexible tool, e.g., 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, position and/or tool identification sensing device 233, and navigation system 232 are also shown in FIG.
  • 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 or lumen 221 through which a flexible tool, e.g., 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 flexible body 216 or mounted externally along the flexible body 216). In some examples, the optical fiber may have a diameter of approximately 200 pm. In other examples, the diameter may be larger or smaller.
  • the optical fiber of the shape sensor 222 may form a fiber optic bend sensor for determining the shape of flexible body 216.
  • Optical fibers including Fiber Bragg Gratings (FBGs) may be used to provide strain measurements in structures in one or more dimensions.
  • 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. 6,380,732 (filed August 11, 1999, and titled “Six-Degree of Freedom Tracking System Having a Passive Transponder on the Object Being Tracked”), which is incorporated by reference herein in its entirety.
  • 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 (not shown), such as EM sensors like the sensors in position sensor system 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 flexible tool 226 within the elongate device 202 according to some embodiments.
  • the flexible body 216 of the elongate device 202 may include the lumen 221 sized and shaped to receive the flexible tool 226.
  • the flexible tool 226 may be used for procedures such as diagnostics, imaging, surgery, biopsy, ablation, illumination, irrigation, suction, electroporation, etc.
  • Flexible tool 226 can be deployed through channel or lumen 221 of flexible body 216 and operated at a procedural site within the anatomy.
  • Flexible tool 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 flexible 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 flexible 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 lumen 221 when the biopsy tool is within the lumen 221.
  • the flexible 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 flexible tool 226 to facilitate simultaneous image capture and tissue intervention, such as within the same lumen 221 or in separate channels.
  • a flexible tool 226 may be advanced from the opening of the lumen 221 to perform the procedure (or some other functionality) and then retracted back into the lumen 221 when the procedure is complete.
  • the flexible 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.
  • Some embodiments include a position sensing device 233 that may be used to determine the position of the flexible tool 226.
  • a position value for the tool 226 may be continuously provided even while inserting or retracting of the of the tool 226 in the lumen 221, and/or in presence of insertion or retraction of the elongate device 202.
  • the position sensing device 233 is described below in reference to FIG. 4.
  • the elongate device 202 may include integrated imaging capability rather than utilize a removable image capture probe.
  • the imaging device (or fiber-optic bundle) and the light emitters may be located at the distal end 218 of the elongate device 202.
  • the flexible body 215 may include one or more dedicated channels that carry the cable(s) and/or optical fiber(s) between the distal end 218 and the visualization system 231.
  • 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 elongate 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 controllably 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 drive unit 204 may further include brakes.
  • One brake may be paired with one actuator. In configurations that pair an actuator with a gear reducer, the brake may be located on the actuator side, which enables even a relatively small brake to produce a significant braking force.
  • the elongate device 202 and/or medical tool 226 may include gripping features, manual actuators, or other components for manually controlling the motion of the elongate device 202 and/or medical tool 226.
  • the elongate device 202 may be steerable or, alternatively, the elongate device 202 may be nonsteerable with no integrated mechanism for operator control of the bending of distal end 218.
  • one or more channels 221 (which may also be referred to as lumens), through which medical tools 226 can be deployed and used at a target anatomical location, may be defined by the interior walls of the flexible body 216 of the elongate device 202.
  • the medical instrument system 200 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.
  • a flexible bronchial instrument such as a bronchoscope or bronchial catheter
  • 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. 2C shows the manipulator assembly 102 including an instrument manipulator 206 coupled to a support structure 298 in accordance with some embodiments of the disclosure.
  • the links of the support structure 298 may include one or more non- servo-controlled links (e.g., which may be manually positioned and locked into place) and/or one or more servocontrolled links (e.g., powered links that may be controlled in response to commands from a control system).
  • the support structure 298 provides adjustments to position the instrument manipulator 206 at an optimal position and orientation and/or position the flexible elongate device 202 relative to the patient anatomy or other medical devices.
  • the support structure 298 may provide for a rotation Ei about the axis E, the extension/retraction E2 along the axis E, the rotation Di about the axis D, and the rotation Ci about the axis C, and the rotation Bi, about the axis B, to position the instrument manipulator 206 in a desired position relative to a table (not shown), medical devices (not shown), and/or the patient (not shown).
  • optimal location and orientation can include alignment of the instrument manipulator 206 with respect to the patient anatomy, for example, for optimal positioning of the flexible elongate device (202) to minimize friction of the flexible elongate device (202) positioned within the patient anatomy (e.g. anatomical openings, patient vasculature, patient endoluminal passageways, etc.) or within medical devices coupled to patient anatomy (e.g., cannulas, trocars, endotracheal tubes (ETT), laryngeal esophageal masks (LMA), etc.).
  • patient anatomy e.g. anatomical openings, patient vasculature, patient endoluminal passageways, etc.
  • medical devices coupled to patient anatomy e.g., cannulas, trocars, endotracheal tubes (ETT), laryngeal esophageal masks (LMA), etc.
  • optimal location and orientation of the instrument manipulator 206 may additionally or alternatively include optimizing the operator ergonomics by providing sufficient operator workspace and/or ergonomic access to the flexible elongate device 202 when utilizing various medical tools such as needles, graspers, scalpels, grippers, ablation probes, visualization probes, and/or the like, with the flexible elongate device 202.
  • the instrument manipulator 206 may be further configured to provide teleoperational, robotic control, or other form of controlled translation or manual translation Ai along axis A to provide for insertion and retraction of the flexible elongate device 202 with respect to the patient anatomy.
  • a swivel connector 236 receives the flexible elongate device 202 and provides mechanical guidance at the interface to a working lumen near at an orifice.
  • the orifice may be the patient’s mouth, and the swivel connector may be positioned near the mouth to provide mechanical guidance of the flexible elongate device during insertion and retraction of the flexible elongate device.
  • the flexible elongate device 202 runs through an elongate device guide 238, which is a selectively collapsible and extendable device that supports the length of the flexible elongate device during movement Ai.
  • the flexible elongate device 202 without guidance may buckle in regions with no lateral support, e.g., in the space between the drive unit 204 and the swivel connector 236.
  • the elongate device guide 238 may be an anti-buckling guide by providing lateral support to the flexible elongate device 202.
  • Various systems and methods related to elongate device guides are described in PCT/US2017/041160 (filed Jul. 7, 2017) (disclosing “Guide Apparatus for Delivery of an Elongate Device and Methods of Use”), which is incorporated by reference herein in its entirety.
  • the position sensing device 233 can be coupled to the flexible elongate device 202, such as embedded within the flexible elongate device 202, or coupled to another portion of the manipulator assembly 102 through which the tool 226 is inserted, such as the proximal portion of the flexible elongate device at the drive unit 204, the elongate device guide 238, the swivel connector 236, etc.
  • FIGS. 3 A and 3B are simplified diagrams of side views of a patient coordinate space including a medical instrument mounted on an insertion assembly according to some embodiments.
  • a surgical environment 300 may include a patient P positioned on the patient table T.
  • Patient P may be stationary within the surgical environment 300 in the sense that gross patient movement is limited by sedation, restraint, and/or other means. Cyclic anatomic motion, including respiration and cardiac motion, of patient P may continue.
  • a medical instrument 304 is used to perform a medical procedure which may include, for example, surgery, biopsy, ablation, illumination, irrigation, suction, or electroporation.
  • the medical instrument 304 may also be used to perform other types of procedures, such as a registration procedure to associate the position, orientation, and/or pose data captured by the sensor system 108 to a desired (e.g., anatomical or system) reference frame.
  • the medical instrument 304 may be, for example, the medical instrument 104.
  • the medical instrument 304 may include an elongate device 310 (e.g., a catheter) coupled to an instrument body 312.
  • Elongate device 310 includes one or more channels sized and shaped to receive a medical tool.
  • Elongate device 310 may also include one or more sensors (e.g., components of the sensor system 108).
  • a shape sensor 314 may be fixed at a proximal point 316 on the instrument body 312.
  • the proximal point 316 of the shape sensor 314 may be movable with the instrument body 312, and the location of the proximal point 316 with respect to a desired reference frame may be known (e.g., via a tracking sensor or other tracking device).
  • the shape sensor 314 may measure a shape from the proximal point 316 to another point, such as a distal end 318 of the elongate device 310.
  • the shape sensor 314 may be aligned with the elongate device 310 (e.g., provided within an interior channel or mounted externally).
  • the shape sensor 314 may optical fibers used to generate shape information for the elongate device 310.
  • position sensors e.g., EM sensors
  • a series of position sensors may be positioned along the flexible elongate device 310 and used for shape sensing.
  • Position sensors may be used alternatively to the shape sensor 314 or with the shape sensor 314, such as to improve the accuracy of shape sensing or to verify shape information.
  • Elongate device 310 may house cables, linkages, or other steering controls that extend between the instrument body 312 and the distal end 318 to controllably bend the distal end 318.
  • at least four cables are used to provide independent up-down steering to control a pitch of distal end 318 and left-right steering to control a yaw of distal end 318.
  • the instrument body 312 may include drive inputs that removably couple to and receive power from drive elements, such as actuators, of a manipulator assembly.
  • the instrument body 312 may be coupled to an instrument carriage 306.
  • the instrument carriage 306 may be mounted to an insertion stage 308 that is fixed within the surgical environment 300.
  • the insertion stage 308 may be movable but have a known location (e.g., via a tracking sensor or other tracking device) within surgical environment 300.
  • Instrument carriage 306 may be a component of a manipulator assembly (e.g., manipulator assembly 102) that couples to the medical instrument 304 to control insertion motion (e.g., motion along an insertion axis A) and/or motion of the distal end 318 of the elongate device 310 in multiple directions, such as yaw, pitch, and/or roll.
  • the instrument carriage 306 or insertion stage 308 may include actuators, such as servomotors, that control motion of instrument carriage 306 along the insertion stage 308.
  • the instrument carriage 306 or insertion stage 308 may further include brakes.
  • One brake may be paired with one actuator.
  • an actuator may be provided for driving the medical instrument along the insertion axis of the manipulator assembly, and a brake may be provided for inhibiting movement of the medical instrument along the insertion axis.
  • a sensor device 320 which may be a component of the sensor system 108, may provide information about the position of the instrument body 312 as it moves relative to the insertion stage 308 along the insertion axis A.
  • the sensor device 320 may include one or more resolvers, encoders, potentiometers, and/or other sensors that measure the rotation and/or orientation of the actuators controlling the motion of the instrument carriage 306, thus indicating the motion of the instrument body 312.
  • the insertion stage 308 has a linear track as shown in FIGS. 3 A and 3B.
  • the insertion stage 308 may have curved track or have a combination of curved and linear track sections.
  • FIG. 3A shows the instrument body 312 and the instrument carriage 306 in a retracted position along the insertion stage 308.
  • the proximal point 316 is at a position L0 on the insertion axis A.
  • the location of the proximal point 316 may be set to a zero value and/or other reference value to provide a base reference (e.g., corresponding to the origin of a desired reference frame) to describe the position of the instrument carriage 306 along the insertion stage 308.
  • the distal end 318 of the elongate device 310 may be positioned just inside an entry orifice of patient P.
  • the instrument body 312 and the instrument carriage 306 have advanced along the linear track of insertion stage 308, and the distal end 318 of the elongate device 310 has advanced into patient P.
  • the proximal point 316 is at a position LI on the insertion axis A.
  • FIG. 4 is a simplified perspective diagram of position sensing device in accordance with embodiments of the disclosure.
  • the position sensing 400 device is disposed on component of the manipulator assembly 102.
  • the position sensing device may be disposed on the elongate device guide 238 (e.g., on a proximal side near the drive unit 204) or may be part of the swivel connector 236.
  • the position sensing device 400 may be placed elsewhere, without departing from the disclosure.
  • the position sensing device 400 is a component of the flexible elongate device 410. In such a configuration, the position sensing device may be located at a proximal end 412 of the flexible elongate device 410.
  • the position sensing device 400 includes a first sensor 402 and a second sensor 404.
  • the first sensor 402 and the second sensor 404 may be aligned on an axis 498.
  • the first sensor 402 may be a proximal sensor and the second sensor 404 on the axis may be a distal sensor.
  • the axis 498 may be an insertion axis of the flexible elongate device 410.
  • the tool 426 may be inserted in an insertion direction and/or may be retracted in a retraction direction. In some embodiments, insertion and retraction may be relative to a patient anatomy, e.g., as illustrated in FIGs. 3A and 3B.
  • the proximal and distal sensors 402, 404 are inductive sensors (e.g., an inductor or inductive coil) that detect a change in inductance caused by ferromagnetic properties of a material of the tool 426, thereby enabling determination of the position of the tool (426) relative to the position sensing device 400.
  • the use of the proximal and distal sensors 402, 404 to obtain a position value representing the position (e.g., insertion depth) of the tool 426, possible configurations of the position sensing device, and possible configurations of the tool 426 are described below in reference to FIGs. 5 and 6.
  • Embodiments of the disclosure may include additional sensors, e.g., to provide redundancy.
  • proximal and distal sensors 402, 404 may be Hall effect sensors that detect a change in the surrounding magnetic field, caused by magnets disposed on the tool 426.
  • a Hall effect sensor includes a magnet analogous to, for example, a gear tooth sensor, thereby enabling detection of ferromagnetic targets. If a Hall effect sensor without magnet is used, the targets may be magnetic.
  • FIG. 5 is an illustration of a position sensing performed according to some embodiments. The position sensing 500 is performed to detect a current position of the tool 526.
  • the current position of the tool 526 may be reflected by a position value obtained based on signals obtained from the first sensor 502 and the second sensor 504.
  • the tool position in accordance with some embodiments, may be detected while the tool is stationary and/or while the tool is moving. In FIG. 5, the determining of a position value is illustrated in presence of a movement 590 of the tool 526.
  • the first and the second sensors 502, 504 are inductive sensors that respond to presence of absence of targets along the tool 526.
  • Each of the targets 528 may include or may be made of an electrically conductive material, e.g., a ferromagnetic material such as chromium-nickel-aluminum steel, 17-7.
  • a signal obtained from a sensor is higher in presence of a target 528 than in absence of a target.
  • the targets 528 pass the first and second sensors 502, 504, thereby generating first and second periodic signals 532, 534.
  • the periodicity of the signals may depend on the speed of the movement, the geometric configuration of the first and second sensors 502, 504, and a geometric configuration of the targets 528 of the tool 526.
  • the geometric configurations are such that sinusoidal signals are generated at the first and second sensors 502, 504 as the targets 528 pass the first and second sensors 502, 504.
  • the spacing of the first and second sensors Di and the geometry and spacing of the targets D2 i.e.
  • pitch are selected such that the first and second periodic signals are sinusoidal signals that have a 90° degree phase shift (i.e., one of the first and second periodic signals can be represented by a sine, the other of the first and second signals can be represented by a cosine), thereby forming a quadrature signal.
  • the tool 526 is moved in a direction from left to right.
  • FIG. 6 shows a detection section 600 of a tool, which may be used for a position sensing as previously described in reference to FIG. 5.
  • FIG. 6 includes a front view (left panel), a top view (right panel, top), and a side view (right panel, bottom).
  • the target section 600 includes multiple targets T, separated by gaps Gi, G2.
  • Each of the targets T may have a cylindrical shape with a circular base visible in the front view.
  • the diameter d of the targets T may be governed by the cross-section of a lumen for the tool.
  • Each target further has a length IT, visible in the top view and the side view. The selection of IT is discussed below.
  • the tool is flexible, allowing, for example, a flexing along the axis of the tool, while being relatively stiff in a longitudinal direction. While sections of the tool occupied by a target T may be stiff, sections occupied by gaps Gi, G2 may provide mechanical flexibility to enable a flexing.
  • Each of the gaps Gi, G2 may include a section that connects to targets T adjacent to the gap.
  • the section has a width w that may correspond to the diameter d of the targets T.
  • the section further has a thickness t. t is significantly less than w to enable flexing in one degree of freedom while providing longitudinal stiffness. As illustrated in FIG.
  • gaps of type GI and type G2 are alternatingly present in the detection section 600, with t and w offset by 90°, thereby enabling a flexing of the detection section of the tool in all directions, over the length of the detection section, while maintaining stiffness in the longitudinal direction.
  • first and second periodic signals are obtained as previously described, when the detection section 600 is moved relative to the first and second sensors.
  • the spacing Di of the first and second sensors 502, 504 and the spacing D2 of the targets 528 is selected to obtain a 90° phase offset between the first and second periodic signals 532, 534.
  • D2 may be chosen based on Di, which then enables selection of suitable IT and 1G.
  • IT and 1G and potentially additional parameters are optimized to obtain first and second periodic signals 532, 534 that are sinusoidal.
  • the first and second periodic signals 532, 534 may be considered phase quadrature signals, which enable a direct derivation of a phase angle. Deviations from a pure sinusoidal signal and/or from the 90° phase offset may result in reduced accuracy of the phase angle.
  • IT and 1G are optimized.
  • 1G ⁇ IT is used, i.e., a ratio of target length vs gap length exceeds 50%.
  • the overall amount of ferromagnetic metal is increased.
  • an increase in the amount of ferromagnetic metal results in a higher inductance signal (i.e., an increased amplitude of the sinusoidal signal), thereby increasing the achievable signal to noise ratio.
  • the amplitude of the first and second periodic signals 532, 534 may be maximized by selection of an appropriate ferromagnetic material for the targets, and/or by minimizing a gap between the first and second sensors and the targets.
  • FIG. 6 shows an immediate transition between targets T and gaps Gi, G2, to further optimize the sinusoidal shape of the first and second periodic signals 532, 534, a gradual, e.g., tapered, transition between the targets and the gaps may be implemented.
  • 1G and IT and potentially additional design parameters may be simulatively or empirically determined.
  • the overall length of the detection section 600 may be selected based on the amount of movement of the tool to be measured. While the detection section 600 includes seven targets, separated by six gaps, a detection section may include any number of targets. With more targets being available for detection, the position of the tool may be tracked for larger movements. While a detection using inductive sensors has been described, alternatively, other detection methods may be used.
  • the first and second sensors may be Hall effect sensors. In this case, the targets would be magnets. Alternatively, the Hall effect sensors may be equipped with magnets, thereby enabling detection of ferromagnetic targets.
  • signals obtained from these sensors may be used for additional purposes. For example, based on signals obtained from the first and second sensors, a presence or absence of a tool may be detected, and/or the tool may be identified, e.g., as described below in reference to FIGs. 10, 11, and 12.
  • FIG. 7 shows a flowchart of a method 700 for non-contact tool position sensing, in accordance with embodiments of the disclosure.
  • the method 700 may be used to determine the position of a tool, e.g., a tool as described or any other tool, along an axis.
  • the method 700 may be executed in a loop to determine changes of the position over time to track movement of the tool.
  • method 700 may be used to determine position values of the tool as the tool moves in both the insertion and retraction directions over time, e.g., to capture jabbing movements performed with a biopsy tool during a biopsy.
  • the execution of the method 700 in a loop may be performed at a frequency sufficiently high to ensure that even faster movements are accurately captured.
  • the method may be implemented using instructions stored on a non-transitory medium that may be executed by a computing system, e.g., the computing system 120.
  • a first periodic signal is obtained using a first sensor and a second periodic signal is obtained using a second sensor.
  • the first and second periodic signals may be obtained using inductive sensors or Hall effect sensors, as previously described.
  • block 720 a position value of the tool along the axis is determined, using the first and second periodic signal.
  • the execution of block 720 may involve several operations (blocks 725-730) that are subsequently described.
  • a phase quadrature signal is determined based on the first and the second periodic signals.
  • the phase quadrature signal is determined after completed execution of blocks 726 and 727.
  • a test is performed to determine whether the first or the second periodic signals are absent.
  • the test is performed to ensure that the detection section of the tool is present at both the first and the second sensors.
  • a quadrature signal can be determined only if the tool is inserted to an extent that results in an overlap of the detection section of the tool with both the first and the second sensors.
  • An absence of the tool at the first/second sensor may be detected based on a corresponding sensor reading being below a pre-specified threshold.
  • the threshold may be selected such that a sensor reading below the threshold may be indicative of an empty lumen, whereas a sensor reading above the threshold may be indicative of a target or a gap of the detection section of the tool being at the sensor.
  • the execution of the method may proceed with the remaining operations of the method 700 only if the first and second periodic signals are present. Otherwise, the phase quadrature signal is suppressed.
  • an amplitude offset is removed from the first and second periodic signals.
  • the amplitude offset may be removed, for example, by determining a mean of the first signal/second signal over, for example one or two full cycles, followed by a subtraction of the mean. For periodic signals with little to no variation between cycles (approximating an ideal sine waveform), a maximum and a minimum of the first/second periodic signal may be determined, to obtain a center value (between the maximum and the minimum) from the first/second periodic signal. In this case, the offset may be removed by subtracting the center value.
  • the amplitude offset may be determined separately for the first and second periodic signals. Alternatively, if the first and second periodic signals are known to have similar offset characteristics, the offset may be determined for only one of the two signals, and may then be applied to both signals.
  • the determining of the amplitude offset in block 727 may be performed once, e.g., during an initial execution of the method 700, whereas the application of the offset to the signals may be continuously performed to obtain offset-compensated first and second periodic signals for the subsequently performed operations.
  • a position value is generated from the phase quadrature signal.
  • the position value may represent a linear distance.
  • the position value may be obtained as described in reference to FIG. 5.
  • the position value reflects the position of the tool along the insertion axis of the tool.
  • the position value may be determined relative to different reference points.
  • the position value may represent the position of the tool relative to the flexible elongate device along the insertion axis.
  • the position value may also represent the position of a distal end of the tool at a distal end of the elongate device or distal to the distal end of the elongate device.
  • a position may be represented relative to any feature, depending on the chosen reference point.
  • the position value is used to represent and exposure of a needle or other end effector beyond the distal end of the flexible elongate device.
  • the method 700 is described in context of an insertion axis of a tool, the method is equally applicable to tracking other positions and movements.
  • the method 700 may also be used to track movement of the flexible elongate device along the insertion axis of the flexible elongate device.
  • Medical systems in accordance with embodiments of the disclosure may be used for procedures that involve penetrating tissue.
  • One such example is a biopsy procedure in which a biopsy needle is used to obtain cells from the tissue.
  • the biopsy needle is a tool inserted into the lumen of the flexible elongate device, as previously described.
  • the flexible elongate device may be steered towards the target site. Once near the target site, the needle may be advanced towards and into the tissue using a jabbing movement, where a sample may be taken, followed by a retraction of the biopsy needle.
  • FIGs. 8A-8C different outcomes resulting from execution of biopsies are described in reference to FIGs. 8A-8C.
  • FIG. 8A shows a simplified diagram of a biopsy procedure 800, prior to execution of the biopsy according to some embodiments.
  • a biopsy needle 802 protrudes from a flexible elongate device 802 (e.g., a catheter), in proximity to tissue 898.
  • the biopsy needle may be advanced in a jabbing motion.
  • the jabbing motion may be manually executed, e.g., by a surgeon.
  • the execution of the jabbing motion may be inconsistent.
  • the jabbing motion may be performed with more or less force, faster or slower, etc.
  • the jabbing motion may be driven by an actuator which may be controlled using a feedback loop.
  • a successful biopsy may depend on proper execution of the jabbing motion, and outcomes may be different depending on the execution, as subsequently discussed in reference to FIGs. 8B and 8C.
  • FIG. 8B shows a simplified diagram of a biopsy procedure 830, during execution of a biopsy performed using a jabbing motion with sufficient force and/or momentum, according to some embodiments.
  • the biopsy needle 802 comes into contact with the tissue 898 at a relatively high velocity, the biopsy needle 802 penetrates the tissue 898 as need to collect a sample.
  • the biopsy needle advances relative to the catheter 804, with the distal end of the catheter 804 remaining stationary or mostly stationary.
  • FIG. 8C shows a simplified diagram of a biopsy procedure 860, during execution of a biopsy performed with insufficient force or momentum, according to some embodiments.
  • the biopsy procedure 860 may have been performed with a more gradual rather than a jabbing motion.
  • the biopsy needle 802 advances relative to the catheter 804, but the biopsy needle fails to penetrate the tissue 898.
  • the biopsy needle may cause some dimpling of the tissue 898, but as a result of failing to penetrate the tissue, the relative motion of the biopsy needle 802 vs the catheter 804 results in a pushing back (retraction) of the catheter at the distal end as indicated by arrow 894.
  • the retraction of the catheter at the distal end may be possible for example, as a result of buckling of the catheter within the anatomy, as a result of the catheter being pushed out of the anatomy, etc.
  • FIGs. 8A-8C illustrate the importance of proper execution of a biopsy procedure using a jabbing motion.
  • a method for detecting a potentially improperly executed biopsy is subsequently discussed in reference to FIG. 9. The method may be used to detect a failed biopsy resulting from an improperly executed jabbing motion. The failed biopsy may be detected immediately without inspection of the biopsy needle for the presence of a biopsy sample. A user may then be notified in real-time or near-real-time to enable the user to repeat the biopsy.
  • FIG. 9 shows a flowchart of a method 900 for monitoring procedures performed using a medical system in accordance with some embodiments.
  • the method 900 may be used to determine that a biopsy (or other) procedure may have failed, based on a detected push-back or retraction of the flexible elongate device, e.g., as described in reference to FIGs. 8A-8C. While these figures illustrate biopsy procedures, the method 900 is applicable to any procedure for which a retraction of the flexible elongate device can occur as a result of a jabbing motion executed with insufficient force or momentum.
  • the method may be implemented using instructions stored on a non-transitory medium that may be executed by a computing system, e.g., the computing system 120.
  • the various blocks in FIG. 9 are presented and described sequentially, some or all of the blocks may be executed in different orders, may be combined or omitted, and some or all of the blocks may be executed in parallel. Furthermore, the blocks may be performed actively or passively.
  • the flexible elongate device is monitored for a retraction during a biopsy or other procedure that involves a jabbing motion of a tool.
  • the execution of biopsy or other procedure may be determined using various different methods.
  • the biopsy or other procedure may be detected based on the medical system operating in a particular operation mode (e.g., a biopsy operation mode) of a workflow.
  • the user of the medical system may specify that a biopsy is being performed.
  • the biopsy may be detected based on a presence of a biopsy needle in the lumen of the flexible elongate device.
  • the presence of the biopsy needle may be detected as previously described.
  • the biopsy (or other procedure) may also be detected based on a motion of the tool relative to the flexible elongate device in a direction exposing the biopsy needle at the distal end of the flexible elongate device.
  • the motion of the tool may be determined using real-time or near-real time imaging, such as fluoroscopy imaging.
  • fluoroscopy imaging the biopsy needle (or other tool) and whether it penetrates the tissue may be directly visible, and the user may directly observe needle and catheter movements.
  • the retraction of the flexible elongate device may also be detected using various different methods.
  • the method 700 of FIG. 7 may be used if it is applied to tracking the position of the flexible elongate device.
  • the retraction of the flexible elongate device may be detected using real-time or near-real time imaging, such as fluoroscopy imaging.
  • the retraction of the flexible elongate device may be detected, using a shape sensor of the flexible elongate device (e.g., shape sensor 413, shown in FIGs. 3A and 3B).
  • the retraction of the flexible elongate device may further be detected using a position sensor system (e.g., position sensor system 220, shown in FIG. 2A).
  • the various methods for detecting movement of the tool and/or the flexible elongate device may be used alone or in combination.
  • fluoroscopy imaging alone may be sufficient for monitoring movement of both the tool and the flexible elongate device, whereas other methods may require separate sensing for the detection of tool movement and flexible elongate device movement.
  • a test is performed to determine whether a retraction of the flexible elongate device is present. The retraction may be detected if it exceeds a specified threshold. If the specified threshold is exceeded, the method may proceed with the execution of block 930. If the threshold is not exceeded, the method may proceed with the execution of block 910 to continue the monitoring. [0120] In block 930, a presence of an exception is determined. The presence of the exception may be detected based a retraction of the flexible elongate device detected in block 920. Other methods may further be used to determine that an exception is presence. For example, a force sensor may be used to measure the force during execution of the jabbing motion. The exception may also be determined based on the combination of the force measurement and the test for retraction, performed in block 920.
  • an exception mitigating action is taken.
  • the exception mitigating action may include notifying the user of the medical system.
  • the notification or message may state that a retraction of the flexible elongate device has been detected.
  • the notification may state that the procedure (e.g., the biopsy) may not have been executed correctly.
  • the notification may state that the procedure has failed.
  • the notification may further instruct the user to repeat the procedure with more force or momentum. More specifically, the notification may instruct the user to perform the biopsy using a proper jabbing motion, executed dynamically with sufficient force/momentum. If a measurement of the force during the execution of the jabbing motion is available, force information may be displayed. In addition, a force level required for proper execution of the procedure may be displayed.
  • FIG. 10 is an illustration of a tool identification sensing performed according to some embodiments.
  • the tool identification sensing 1000 may be used to identify the tool that is being inserted. Automatically determining, by the computer-assisted system, the type of tool that is being inserted can be beneficial for various reasons. For example, different tools may have different degrees of freedom, different tools may be operated using different control parameters, different tools may be integrated differently into a procedure workflow, etc.
  • the tool identification sensing 1000 relies on the first and second sensors 502, 504, previously introduced in reference to FIG. 5.
  • the first and second sensors 502, 504 may be part of a tool identification sensing device, which may be the position sensing device as previously described.
  • the tool 526, in FIG. 5B includes additional targets with different, tool-specific separations between these targets, thereby enabling distinction of these tools based on the sensor signal obtained as these tools are being inserted with the targets passing the first and second sensors 502, 504.
  • two additional targets 528, labeled “A” and “B”, are shown.
  • the targets 528, labeled “1”, “2”, and “3” correspond to the identically- spaced targets in a sequence of targets as previously introduced in reference to FIG. 5, with target 1 marking the beginning of the identically-spaced targets.
  • the additional targets may be placed at a distal end of the tool 526 such that they pass the first and second sensors 502, 504, before the other targets during an insertion of the tool.
  • the additional targets enable a tool identification during the insertion of the tool, as subsequently described. While FIG. 10 illustrates the tool identification sensing 1000 in a configuration that also includes targets for a position sensing 500, the tool identification sensing 1000 may alternatively be implemented in absence of a position sensing 500.
  • varying the separation of the additional targets “A” and “B” and the separation between targets “B” and “1” along axis 598 enables an encoding of up to four different tools. Assume that, as the tool 526 is inserted (insertion motion 592), when the second sensor 504 reports a “high” signal in presence of target A, the signal obtained from the first sensor 502 is evaluated. Depending on the spacing of target B and target A, the first sensor 502 may report a value that could be “high” (when the spacing between targets A and B is approximately Di, as shown in the upper panel of FIG. 5B), or “low”, for other spacings that do not accommodate a simultaneous alignment of target A with the second sensor 504 and target B with the first sensor 502.
  • the second sensor 504 reports a “high” signal in presence of target B
  • the signal obtained from the first sensor 502 is evaluated again.
  • the first sensor 502 may report a value that could be “high” (when the spacing between targets B and 1 is approximately Di), or “low” (for other spacings that do not accommodate a simultaneous alignment of target B with the second sensor 504 and target 1 with the first sensor 502, as shown in the lower panel of FIG. 5B).
  • an example 1100 is provided based on the signals of the first sensor 502 and the second sensor 504.
  • the signals of the first and second sensors are inductance values, plotted as the tool is being inserted as shown in the example of FIG. 10.
  • target A approaches the first sensor, resulting in an increase of the induction sensed by the first sensor.
  • target A passes the first sensor, resulting in a decrease of the induction sensed by the fist sensor.
  • target A approaches the second sensor, while simultaneously target B approaches the first sensor.
  • the signals of both first and second sensors simultaneously increase and peak approximately simultaneously as identified in the plot (the second sensor signal reaching a value of 1.77 pH while the first sensor signal simultaneously reaches a peak value of 2.38pH).
  • These values correspond to the scenario shown as the first identification operation in FIG. 10.
  • the signals of both first and second sensors drop simultaneously and increase again as target 1 approaches the first sensor while target B approaches the second sensor (the second sensor signal reaching a value of 1.86 pH while the first sensor signal simultaneously reaches a peak value of 2.41 pH).
  • these values do not correspond to the second identification operation in FIG. 10, where target 1 is not aligned with the first sensor when target B is aligned with the second sensor.
  • the measurements obtained in example 1100 are based on an alignment of target 1 with the first sensor when target B is aligned with the second sensor.
  • the distinction between presence or absence of a target at a sensor may be made based on sensor detection thresholds. If the corresponding sensor signal exceeds the sensor detection threshold, a determination is made that a target is present. If the corresponding sensor signal fails to exceed the sensor detection threshold, a determination is made that no target is present.
  • Example first and second sensor detection thresholds applied to the first and second sensor signals, respectively, are illustrated in example 1100.
  • thresholds may be used to perform such a classification. For example, by classifying a sensor signal using two thresholds, a distinction may be made between “high”, “intermediate, and “low”. Assume that, based on the example 1100, that whenever the first sensor signal is determined to be “high”, i.e., in presence of a target, the second sensor signal is evaluated against two thresholds as either “high”, “intermediate, or “low”. In this case, When performed twice (targets A, B, and 1), nine distinct outcomes are possible, thereby enabling the distinction of nine different tools.
  • additional tools may be represented by adding additional targets, for example, by adding a target C.
  • additional targets for example, by adding a target C.
  • Using a binary threshold up to eight tools may be distinguished in this manner. Even more tools may be represented when using a second threshold to distinguish between a “high”, “intermediate, and “low” sensor signal, in combination with additional targets.
  • the signal of the second sensor 504 may be evaluated when a “high” signal is detected at the first sensor 502.
  • FIG. 12 shows a flowchart of a method 1200 for non-contact tool identification, in accordance with embodiments of the disclosure.
  • the method 1200 may be used to identify a tool, e.g., a tool as described or any other tool, during the insertion of the tool along an axis.
  • the method 1200 may be performed in isolation or in combination with any of the previously described methods.
  • the method of FIG. 12 is performed to identify a tool, followed by execution of one or more of the methods for tool insertion position sensing.
  • the method may be implemented using instructions stored on a non-transitory medium that may be executed by a computing system, e.g., the computing system 120.
  • the method may be implemented based on a configuration as shown in FIG. 10, the configuration including first and second sensors configured to detect the presence or absence of targets at the sensors.
  • the method may be performed during an ongoing tool insertion as previously described.
  • a presence of a target at the second sensor is determined.
  • the target for which a presence is detected at the second sensor may be target A.
  • the detection may be performed by applying a specified sensor detection threshold to the sensor signal provided by the second sensor. If the sensor signal exceeds the sensor detection threshold, it is determined that the target is present. If the sensor signal is below the sensor detection threshold, it is determined that no target is present.
  • a value captured by the first sensor is determined.
  • the target for which a value of the sensor signal is determined at the first sensor may be target B.
  • the determining of the value may further involve applying at least one specified sensor detection threshold to the value of the sensor signal. If one threshold is used, the result may be a classification of the value as either “high” or “low”. If multiple thresholds are used, a classification with a finer granularity may be performed. For example, with two thresholds a value may be classified as being “high”, “low”, or “intermediate” (i.e., with the target being present near the sensor, but without being fully aligned with the sensor).
  • the sensor detection thresholds used in operations 1202 and 1206 may be independently set, e.g., based on sensor sensitivity. A calibration may be performed to identify proper threshold values.
  • a property of the tool that is being inserted is identified. More specifically, for example, the property may be identified as a first property in presence of a “high” value (e.g., caused by the presence of target B at the first sensor), and the property may be identified as a second property in presence of a “low” value (when no target is close to the first sensor).
  • the identification may be performed, for example, using a lookup table that stores the combination of states for presence of absence of a target detected at the first sensor and associates this combination of states with a specific property.
  • a property may be a tool ID (allowing the distinction of different tools), a tool type, a tool parameter, a manufacturer, etc.
  • operations 1202-1206 may be repeated before identifying the tool.
  • the repetition enables the sequential evaluation of multiple targets during an ongoing tool insertion. For example, now referring to FIGs. 10 and 11, during a first execution, the presence of target B at the first sensor is evaluated while target A is aligned with the second sensor. Next, in a second execution, the presence of target 1 is evaluated while target B is aligned with the second sensor.
  • control system 112 may be implemented in software for execution on one or more processors of a computer system.
  • the software may include code that when executed by the one or more processors, configures the one or more processors to perform various functionalities as discussed herein.
  • the code may be stored in a non-transitory computer readable storage medium (e.g., a memory, magnetic storage, optical storage, solid-state storage, etc.).
  • the computer readable storage medium may be part of a computer readable storage device, such as an electronic circuit, a semiconductor device, a semiconductor memory device, a read only memory (ROM), a flash memory, an erasable programmable read only memory (EPROM), a floppy diskette, a CD-ROM, an optical disk, a hard disk, or other storage device.
  • the code may be downloaded via computer networks such as the Internet, Intranet, etc. for storage on the computer readable storage medium.
  • the code may be executed by any of a wide variety of centralized or distributed data processing architectures.
  • the programmed instructions of the code may be implemented as a number of separate programs or subroutines, or they may be integrated into a number of other aspects of the systems described herein.
  • 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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Abstract

Un système médical comprend un dispositif de détection de position qui comprend un premier capteur et un second capteur espacé du premier capteur le long d'un axe. Le premier capteur obtient un premier signal périodique représentant la présence d'une multitude de cibles d'un outil détecté par le premier capteur lorsque l'outil se déplace par rapport au premier capteur le long de l'axe, et le second capteur obtient un second signal périodique représentant la présence de la multitude de cibles détectées par le second capteur lorsque l'outil se déplace par rapport au second capteur le long de l'axe. Le système médical comprend en outre un système de traitement couplé au dispositif de détection de position, le système de traitement étant configuré pour déterminer, à l'aide des premier et second signaux périodiques, une valeur de position de l'outil le long de l'axe.
PCT/US2025/012679 2024-01-23 2025-01-23 Détection de position d'insertion d'outil Pending WO2025160225A1 (fr)

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