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WO2025064464A1 - Outil médical à fenêtre de signal et procédés d'utilisation - Google Patents

Outil médical à fenêtre de signal et procédés d'utilisation Download PDF

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Publication number
WO2025064464A1
WO2025064464A1 PCT/US2024/047152 US2024047152W WO2025064464A1 WO 2025064464 A1 WO2025064464 A1 WO 2025064464A1 US 2024047152 W US2024047152 W US 2024047152W WO 2025064464 A1 WO2025064464 A1 WO 2025064464A1
Authority
WO
WIPO (PCT)
Prior art keywords
tool
medical
window
signal
examples
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2024/047152
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English (en)
Inventor
Hans F. Valencia
Alain Sadaka
Randall L. Schlesinger
Serena H. Wong
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Intuitive Surgical Operations Inc
Original Assignee
Intuitive Surgical Operations Inc
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Filing date
Publication date
Application filed by Intuitive Surgical Operations Inc filed Critical Intuitive Surgical Operations Inc
Publication of WO2025064464A1 publication Critical patent/WO2025064464A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/005—Flexible endoscopes
    • A61B1/0051—Flexible endoscopes with controlled bending of insertion part
    • A61B1/0055—Constructional details of insertion parts, e.g. vertebral elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/005—Flexible endoscopes
    • A61B1/009—Flexible endoscopes with bending or curvature detection of the insertion part
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/267—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for the respiratory tract, e.g. laryngoscopes, bronchoscopes
    • A61B1/2676—Bronchoscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; Determining position of diagnostic devices within or on the body of the patient
    • A61B5/061—Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body
    • A61B5/062—Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body using magnetic field
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Clinical applications
    • A61B8/0833—Clinical applications involving detecting or locating foreign bodies or organic structures
    • A61B8/0841—Clinical applications involving detecting or locating foreign bodies or organic structures for locating instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/12—Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00809—Lung operations
    • 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
    • A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
    • A61B2034/101—Computer-aided simulation of surgical operations
    • A61B2034/105—Modelling of the patient, e.g. for ligaments or bones
    • 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
    • A61B2034/2051—Electromagnetic tracking systems
    • 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
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046—Tracking techniques
    • A61B2034/2063—Acoustic tracking systems, e.g. using ultrasound
    • 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
    • A61B2034/2072—Reference field transducer attached to an instrument or patient
    • 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
    • A61B90/30—Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
    • A61B2090/306—Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure using optical fibres
    • 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
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37—Surgical systems with images on a monitor during operation
    • A61B2090/378—Surgical systems with images on a monitor during operation using ultrasound

Definitions

  • the present disclosure is related to systems and methods for localizing a medical tool that includes a signal window.
  • 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, an operator may insert a minimally invasive medical instrument (including surgical, diagnostic, therapeutic, and/or biopsy instruments) to reach a target tissue location.
  • a minimally invasive medical instrument including surgical, diagnostic, therapeutic, and/or biopsy instruments
  • One such minimally invasive technique is to use a flexible elongate device, such as a flexible catheter, bronchoscope, or endoscope, that can be inserted into anatomic passageways and navigated toward a region of interest within the patient anatomy.
  • Various medical tools may be extended from the flexible elongate device. Improved systems and methods are needed for localizing the medical tools relative to the flexible elongate device and anatomic regions in which the medical tool is extended.
  • a system may comprise a flexible elongate device including one or more signal transmitters and a tool configured to extend from a distal end of the flexible elongate device.
  • the tool may comprise a body portion defining a window and a localization sensor coupled to the body portion. At least a portion of the localization sensor is exposed by the window to receive a signal from the one or more signal transmitters through the window.
  • the system may also comprise a control system configured to determine a location of the tool based on the signal received by the localization sensor from the one or more signal transmitters.
  • a medical tool may comprise a body portion with an acoustic window defined in the body portion and an optical fiber localization sensor extending into the acoustic window.
  • the acoustic window is configured to allow through passage of an ultrasound signal and wherein the body portion around the acoustic window is configured to absorb the ultrasound signal.
  • a method may comprise localizing a tool relative to one or more ultrasound transducers supported by an instrument to which the tool is movably coupled and localizing the one or more ultrasound transducers relative to a reference frame. Based on the localization of the tool to the one or more ultrasound transducers, the tool may be localized relative to the reference frame.
  • FIG. 1 illustrates an example of a flexible elongate device in a patient anatomy near a target tissue, according to some examples.
  • FIG. 2 illustrates a flexible elongate device extended within an anatomic passage, according to some examples.
  • FIG. 3A illustrates an end view of a flexible elongate device, according to some examples.
  • FIG. 3B illustrates an end view of a flexible elongate device, according to some examples.
  • FIG. 3C illustrates a side view of a flexible elongate device, according to some examples.
  • FIG. 4A illustrates a top view of a medical tool including a window, according to some examples.
  • FIG. 4B illustrates a side view of a medical tool including an elongated implement, according to some examples.
  • FIG. 5 is a flowchart illustrating a method for localizing a medical tool, according to some examples.
  • FIG. 6 is a flowchart illustrating a method for localizing a medical tool relative to a signal transmitter, according to some examples.
  • FIG. 7 A illustrates a top view of a medical tool including a window, according to some examples.
  • FIG. 7B illustrates a top view of a medical tool including a window, according to some examples.
  • FIG. 7C illustrates a top view of a medical tool including a window, according to some examples.
  • FIG. 7D illustrates a side view of a medical tool including a window, according to some examples.
  • FIG. 8A illustrates a side view of a medical tool including a window, according to some examples.
  • FIG. 8B illustrates an opposite side view of the medical tool of FIG. 8A.
  • FIG. 9 A illustrates a top view of a medical tool, according to some examples.
  • FIG. 9B, 9C, and 9D illustrate cross-sectional views of the medical tool of FIG. 9A.
  • FIG. 10A illustrates a top view of a medical tool, according to some examples.
  • FIG. 10B, 10C, and 10D illustrate cross-sectional views of the medical tool of FIG. 10A.
  • FIG. 11 is a simplified diagram of a medical system, according to some examples.
  • FIG. 12A is a simplified diagram of a medical instrument system, according to some examples.
  • FIG. 12B is a simplified diagram of a medical instrument including a medical tool within a flexible elongate device, according to some examples.
  • a medical tool location may be tracked and localized relative to signal transmitters that may also be used for other sensing or imaging modalities.
  • the signal transmitters may be registered to a reference frame (e.g., an anatomical reference frame) and thus the medical tool, by virtue of being localized relative to the signal transmitters, may also be localized relative to the reference frame.
  • a reference frame e.g., an anatomical reference frame
  • the medical tool by virtue of being localized relative to the signal transmitters, may also be localized relative to the reference frame.
  • some of the signal transmitters described herein are ultrasound signal transmitters that may also be used for image generation, it is contemplated that the systems and methods described herein may be applied using other types of signal transmitters.
  • FIG. 1 illustrates a medical instrument system 100 extending within branched anatomic passageways or airways 102 of an anatomical structure 104.
  • the anatomic structure 104 may be a lung and the passageways 102 may include the trachea 106, primary bronchi 108, secondary bronchi 110, and tertiary bronchi 112.
  • the anatomic structure 104 has an anatomical frame of reference (XA, YA, ZA).
  • a distal end portion 118 of the medical instrument system 100 may be advanced into an anatomic opening (e.g., a patient mouth) and through the anatomic passageways 102 to perform a medical procedure, such as a biopsy, ablation, electroporation, or other type of diagnostic or therapeutic procedure, at or near a target tissue 113.
  • a medical instrument system 150 e.g., the elongated medical instrument system 100
  • the flexible elongate device 152 may be or may be integrated into a robotically-controlled system and/or a manually-controlled system that controls articulation and insertion/retraction of the flexible elongate device 152.
  • a medical instrument system that is bendable and steerable in multiple degrees of freedom is described below in FIGS. 12A and 12B (e.g., system 700).
  • the flexible elongate device 152 may include a visualization system 154 and an imaging localization system 156.
  • the visualization system 154 may include an (c.g., visible light) optical imaging system 158 positioned at a distal end portion of the flexible elongate device 152.
  • the visualization system 154 may also or alternatively include an imaging device 161 that generates images based on transmitting signals and receiving the signals reflected off the environment (also referred to as a “signal-based imaging device”), such as an ultrasound or photoacoustic imaging device.
  • the imaging device 161 may be located at a distal end portion 163 of the flexible elongate device 152 or in one or more other locations of the flexible elongate device 152.
  • the imaging device 161 may generate image data for a field of view 159.
  • the optical imaging system 158 may generate image data for a different field of view.
  • An ultrasound imaging device may include transducer arrays that may be comprised of a plurality of transducers of any size or shape, as described in greater detail below.
  • contact between the flexible elongate device 152 and a wall 157 of the anatomic passageway 102 may be required or may improve the quality of the imaging data.
  • the imaging device 161 includes an ultrasound transducer
  • contact between the flexible elongate device 152 and the wall 157 may eliminate air gaps and promote the effective transmission of the ultrasound signal and the generation of a clear’ image.
  • the imaging localization system 156 may include, for example, an optical fiber shape sensor, an electromagnetic (EM) sensor, or plurality of EM sensors positioned at a known location relative to the visualization system 154 to track the position and orientation of all or parts of the visualization system 154.
  • the imaging localization system 156 may be used to track the configuration, including position and/or orientation, of the distal end portion 163 of the flexible elongate device 152, including the imaging device 161, in multiple (e.g., six) degrees of freedom. If the imaging device 161, or components of the imaging device 161, are located at other portions of the flexible elongate device 152, the imaging localization system 156 may be used to track the configuration of the other portions.
  • the localization data from the imaging localization system 156 may be used to determine the configuration of the image data from the imaging device 161 in three-dimensional space.
  • an optical fiber forms a shape sensor for determining the shape of the flexible elongate device 152.
  • the optical fiber or a portion of the optical fiber may be fixed at the distal end portion 163 of the flexible elongate device 152 or at a known location relative to the imaging device 161 to provide localization data, including position and/or orientation data, for the imaging device 161.
  • the position and orientation of the imaging device 161 may be determined by the measured shape of the sensor.
  • a proximal end of the shape sensor may be fixed or known relative to a robot-assisted medical system. In other examples, if the flexible elongate device is manually manipulated, the proximal end of the shape sensor may be fixed to the patient body or another fixed or tracked location near’ the patient.
  • a shape sensor such as an optical fiber bend sensor, may include Fiber Bragg Gratings (FBGs) that may be used to provide strain measurements in structures in one or more dimensions.
  • FBGs Fiber Bragg Gratings
  • Various systems and methods for monitoring the shape and relative position of an optical fiber in three dimensions are described in U.S. Patent Application No. 11/180,389 (filed July 13, 2005) (disclosing “Fiber optic position and shape sensing device and method relating thereto”); U.S. Patent Application No. 12/047,056 (filed on Jul. 16, 2004) (disclosing “Fiber-optic shape and relative position sensing”); and U.S. Patent No. 6,389,187 (filed on Jun.
  • Optical Fiber Bend Sensor in some embodiments may employ other suitable strain sensing techniques, such as Rayleigh scattering, Raman scattering, Brillouin scattering, and Fluorescence scattering.
  • the shape of the flexible elongate device 152 may be determined using other techniques. For example, a history of the distal end pose of flexible elongate device 152 can be used to reconstruct the shape of the flexible elongate device 152 over the interval of time.
  • a shape sensor may comprise a plurality of position sensors (such as electromagnetic position sensors) which collectively provide shape data regarding a shape of at least a portion of the flexible elongate device 152.
  • a shape sensor as that term is used herein may provide any number of data points in any number of degrees of freedom including three or six degrees of freedom at a series of points monitored by the shape sensor along the length of the flexible elongate device 152.
  • the flexible elongate device 152 may include a steering system 160, including control wires, cables, or other control apparatus to bend or steer a distal end portion of the flexible elongate device 152, which may include the visualization system 154.
  • the flexible elongate device 152 may also include a channel or passage 164 through which a tool 166 may be extended to emerge from a port 155 of the flexible elongate device 152 to engage the target tissue 113.
  • the port 155 is shown in FIG. 2 as being a distal port defined at the distal end of the flexible elongate device 152. In other examples, the port 155 may be in other places.
  • FIG. 3 A illustrates an end view of a flexible elongate device 152A which may be the same or substantially similar to flexible elongate device 152 with differences as described.
  • the imaging device 161 includes one or more signal transmitters 180.
  • the signal transmitters 180 may be parts of transceivers that transmit and receive signals or may be transmitters that transmit but do not receive signals.
  • the signal transmitters 180 may include, for example, a forward-facing linear array of ultrasound transducer elements.
  • the signal transmitters 180 may include a primary linear array of transducer elements 183 and at least one auxiliary transducer element 185 spaced away from the primary linear array. Whereas the linear array may track the position of a localization sensor 167 in a single plane, adding a spaced apart auxiliary transducer element may provide three-dimensional position information via triangulation of the localization sensor 167.
  • the auxiliary transducer may be spaced apart and located on the flexible elongate device 152, and in some examples, the auxiliary transducer may be spaced apart on another device, which may be located inside or outside of the patient anatomy.
  • the other device may be a different flexible elongate device (e.g., a catheter, endoscope, bronchoscope, etc.), a medical tool, an ultrasound device, an imaging device (e.g., an endoscope, a fluoroscopic imaging device, a cone beam computed tomography (CBCT) device, a tomosynthesis device, etc.), a robotic arm, or some other type of device with an auxiliary transducer element.
  • a different flexible elongate device e.g., a catheter, endoscope, bronchoscope, etc.
  • a medical tool e.g., an ultrasound device, an imaging device (e.g., an endoscope, a fluoroscopic imaging device, a cone beam computed tomography (CBCT) device, a tomosynthesis device, etc.), a robotic arm, or some other type of device with an auxiliary transducer element.
  • an imaging device e.g., an endoscope, a fluoroscopic imaging device,
  • FIG. 3B illustrates an end view of a flexible elongate device 152B which may be the same or substantially similar to flexible elongate device 152 with differences as described.
  • the imaging device 161 includes one or more signal transmitters 182.
  • the signal transmitters 182 may include be just transmitters or may be components of transceivers.
  • the signal transmitters 182 may include, for example, a forward-facing annular array of ultrasound transducer elements.
  • An annular a may provide tracking of the localization sensor 167 in thrcc- dimensions via triangulation of the localization sensor 167.
  • FIG. 3C illustrates a side view of a flexible elongate device 152C which may be the same or substantially similar to flexible elongate device 152 with differences as described.
  • the imaging device 161 includes one or more signal transmitters 187.
  • the signal transmitters 187 may include be just transmitters or may be components of transceivers.
  • the signal transmitters 187 may include, for example, a side-facing of ultrasound transducer element or plurality of side-facing ultrasound transducer elements. Side-facing transducer elements may provide tracking of the localization sensor 167 in three-dimensions via triangulation of the localization sensor 167.
  • the localization sensor 194 may include an optical fiber that carries signals (e.g., acoustic signals) received from the transmitters between proximal and distal end portions of the medical tool 190.
  • a window 196 may be formed at a distal end portion of the tool body 192.
  • the window 196 may be an acoustic window that transmits signals, such as acoustic signals from an ultrasound transmitter while the surrounding tool body 192 may at least partially or fully absorb signals such as the acoustic signals.
  • the window 196 may be an aperture through a wall of the tool body 192.
  • the window 196 may be a region in the wall of the tool body 192 that is formed from or filled by a different material than the material forming the wall, such as a material that is more capable of passing signals without attenuation or absorption than the material of the wall.
  • thermoplastics such as a polyether block amide may be used to fill the window.
  • the localization sensor 194, such as at a distal end, may be exposed by the window 196 to receive signals generated by signal transmitters from multiple directions, such as signal transmitters carried by the flexible elongate device and/or other devices.
  • the localization sensor is not limited to being an optical fiber, and can be any type of sensor that is capable of sensing acoustic signals, including an ultrasound receiver (e.g., either as separate receiver or as part of a transceiver), piezoelectric device, microphone, etc.
  • ultrasound receiver e.g., either as separate receiver or as part of a transceiver
  • piezoelectric device e.g., either as separate receiver or as part of a transceiver
  • microphone e.g., a microphone, etc.
  • window shapes, localization sensors, and tool configurations are described below.
  • FIG. 4B illustrates a top view of a portion of a distal portion of a medical tool 270 (e.g., the medical tool 166) that may be extendable from, rotatable within, bendable relative to, or otherwise movable with respect to a flexible elongate device (e.g., flexible elongate device 152).
  • the medical tool 270 may also be used with other types of medical instruments, including rigid elongate devices, robotic arms, etc.
  • the medical tool 270 may include a tool member 272 through which a channel 271 extends.
  • the medical tool 270 may also include an elongated implement 273 including a tool body 277 sized to extend within the channel 271 and, optionally, through an opening at the distal end of the channel 271 to an area distal of the tool member 272.
  • the tool member 272 may be a needle and the elongated implement may be a stylet.
  • a localization sensor 274 (e.g., localization sensor 167) may extend within the tool body 277.
  • the localization sensor 274 may include an optical fiber that carries signals (e.g., acoustic signals) received from the transmitters between proximal and distal end portions of the medical tool 270.
  • a window 16 may be formed at a distal end portion of the tool body 277.
  • the window 276 may be an acoustic window that transmits signals, such as acoustic signals from an ultrasound transmitter while the surrounding tool body 277 may at least partially or fully absorb signals such as the acoustic signals.
  • the window 276 may be an aperture through a wall of the tool body 277.
  • the window 276 may be a region in the wall of the tool body 277 that is formed from or filled by a different material than the material forming the wall, such as a material that is more capable of passing signals without attenuation or absorption than the material of the wall.
  • thermoplastics such as a polyether block amide may be used to fill the window.
  • the localization sensor 274 may be exposed by the window 276 to receive signals generated by signal transmitters from multiple directions, such as signal transmitters earned by the flexible elongate device and/or other devices.
  • the localization sensor is not limited to being an optical fiber, and can be any type of sensor that is capable of sensing acoustic signals, including an ultrasound receiver (e.g., either as separate receiver or as pail of a transceiver), piezoelectric device, microphone, etc.
  • ultrasound receiver e.g., either as separate receiver or as pail of a transceiver
  • piezoelectric device e.g., either as separate receiver or as pail of a transceiver
  • a medical tool may be delivered within the imaging field view of view of an ultrasound imaging instrument for direct visualization of the tool into the target tissue.
  • the position and/or orientation of the tool may be outside of the imaging field of view, but real time visualization of the tool with respect to the imaged target tissue may still be useful.
  • the tool may be localized with respect to the frame of reference of the imaged tissue, and the current and/or prior positions of the tool with respect to the imaged tissue may be marked or displayed.
  • FIG. 5 is a flowchart illustrating a method 200 for localizing a medical tool.
  • the method 200 is illustrated as a set of operations or processes that may be performed in the same or in a different order than the order shown.
  • One or more of the illustrated processes may be omitted in some examples of the method.
  • one or more processes that are not expressly illustrated in FIG. 5 may be included before, after, in between, or as part of the illustrated processes.
  • one or more of the processes of method 200 may be implemented, at least in pail, by a control system executing code stored on non-transitory, tangible, machine- readable media that when run by one or more processors (e.g., the processors of a control system 612) may cause the one or more processors to perform one or more of the processes.
  • a control system executing code stored on non-transitory, tangible, machine- readable media that when run by one or more processors (e.g., the processors of a control system 612) may cause the one or more processors to perform one or more of the processes.
  • a tool e.g. the medical tool 166
  • a device e.g. the flexible elongate device 152 to which the tool is movably coupled.
  • a localization sensor e.g. the localization sensor 167) near the tip of a medical tool may detect signals from the signal transmitter and use the detected signals to triangulate the location of the localization sensor, and thus the tip of the tool, relative to the signal transmitter.
  • the tool may include a localization sensor that includes an ultrasound transducer, and the signal transmitter may be an ultrasound transducer array positioned at a known location on a flexible elongate device.
  • Ultrasound signals in the form of acoustic waves, may be emitted from the ultrasound transducer array and received at the ultrasound transducer coupled to the tool.
  • the ultrasound transducer may register receipt of the ultrasound signals.
  • Information from the ultrasound transducer may be used to triangulate the location of the optical sensor (and/or a portion of the medical tool having a known configuration relative to the optical sensor) relative to the ultrasound transducer array.
  • FIG. 6 is a flowchart illustrating a method 250 for localizing a medical tool relative tool relative to a signal transmitter.
  • the method 250 is an example of a technique that may be used to perform the process 202.
  • the localization sensor may include an ultrasound transducer that is an optical sensor
  • the signal transmitter may include an ultrasound transducer array.
  • ultrasound signals may be emitted from one or more elements of ultrasound transducer array. Each of the elements of the transducer array may have a known position and orientation relative to the other elements of the transducer array.
  • light may be sent to the optical fiber coupled to the medical tool.
  • a laser light source may be coupled to an optical fiber to send a light signal along the optical fiber to the optical sensor.
  • the optical sensor may include an optical interferometer, an optical resonator, or optical fiber-based sensors.
  • the ultrasound signal is received at the optical sensor.
  • the optical sensor may be exposed within a window of the tool and acoustic signals may propagate through the window to be received by the optical sensor.
  • modifications of light caused by ultrasound signals at the optical sensor are evaluated. For example, in the presence of the acoustic signals received at the optical sensor, the light sent to the optical sensor may undergo a wavelength or spectral shift.
  • the optical sensor may send optical data indicating the detection of the acoustic signal to an optoelectronic device for processing.
  • a distance between the optical sensor and activated elements of the transducer array may be determined. For example, based on the time of travel of the ultrasound signal and a known speed of the ultrasound signal, a plurality of distances between the optical sensor and the activated elements of the transducer array may be determined.
  • the optical sensor may be localized relative to the transducer array. For example, the location of the optical sensor relative to the transducer array may be triangulated based on the determined plurality of distances and the known configuration of the transducer array. [0047] With further reference to FIG.
  • the signal transmitter may be localized relative to a reference frame.
  • a signal transmitter may be localized relative to an image reference frame.
  • the image reference frame may be for an ultrasound image (2D or 3D) generated by an ultrasound signal transmitter.
  • the image reference frame may be an anatomical image (2D or 3D) for an anatomical model (e.g., a preoperative or intra-operative CT model).
  • Localizing the signal transmitter to the image reference frame may include tracking a three-dimensional location of the signal transmitter using the imaging localization system 156.
  • the location of the signal transmitter may be fixed relative to a shape sensor of the imaging localization system that extends within the flexible elongate device 152.
  • the frame of reference of the flexible elongate device 152 (and thus the frame of reference of the signal transmitters of the imaging device 161 that are part of the flexible elongate device), as measured by the imaging localization system 156 may be registered to the image reference frame.
  • Registration of the image and device reference frames may include rotating, translating, or otherwise manipulating by rigid or non-rigid transforms points associated with one or both of the reference frames.
  • registration between image and device reference frames may be achieved, for example, by using a point-based iterative closest point (ICP) technique as described in U.S. Pat. App. Pub. Nos. 2018/0240237 and 2018/0235709, incorporated herein by reference in their entireties, or another point cloud registration technique.
  • ICP point-based iterative closest point
  • the tool may be localized relative to the reference frame. More specifically, based on the localization of the tool to the signal transmitter and based on the localization of the signal transmitter to the reference frame, the location of the tool may be referenced to the reference frame. For example, with the location of the localization sensor 167 at a distal portion of the tool 166 known relative the ultrasound transducer of the imaging device 161, as described in process 202 and with the location of the ultrasound transducer known relative to an image reference frame as described in process 204, the location of the localization sensor 167 may be transformed into a location in the image reference frame. With the tool localized relative to an image reference frame, the locations of clinical actions, annotations, imaging, or other actions that occur in the tool reference frame may be registered to the image reference frame.
  • an anatomical model in the reference frame may be marked at a location of an intervention with the tool.
  • a pre-operative anatomical model may be annotated to indicate a location of a clinical intervention, the location of an anatomical condition, or another action or observation of the tool.
  • virtual markers may be added by a user to areas that have been biopsied or treated to enhance the user’s sense of location within the patient anatomy. Virtual markers, along with displayed model, may be virtually rotated to provide the user with an understanding of the location of the markers relative to the three-dimensional anatomy, a target tissue, or a lesion.
  • the model may be annotated with tissue boundary markers such as lymph node boundaries. In some examples, the model may be annotated with tool trajectories. In some examples, the process 208 may be omitted.
  • an integrated image of the tool with the anatomical model in the reference frame may be displayed. For example, a pre-operative anatomical 2D image or 3D model (e.g., a CT model) may be displayed, and an image or graphical representation of the tool may be overlayed or otherwise displayed in relation to the displayed model. In some examples, the process 210 may be omitted.
  • an integrated image of the tool with an image generated by the signal transmitter may be displayed.
  • an ultrasound image generated by data from the ultrasound transducer carried by the flexible elongate device 152 may be displayed, and an image or graphical representation of the tool 166 may be overlayed or otherwise displayed in relation to the displayed model.
  • the process 212 may be omitted.
  • a tool may be manufactured and configured to promote the performance of the tool for a medical procedure and to allow its location to be tracked using the localization sensor.
  • the tool may be used to perform a biopsy and may include a needle, forceps, brush, or other tissue sampling or collection device.
  • a tool may include an ablation tool including a heated or cryo-probe, an electroporation tool, a forceps, a medication delivery device, a fiducial delivery device, or another type of diagnostic or therapeutic device.
  • FIG. 7A illustrates a top view of a distal portion of a medical tool 300 (e.g. the medical tool 166) that may be extendable from, rotatable within, bendable relative to, or otherwise movable with respect to a flexible elongate device (e.g. flexible elongate device 152).
  • the medical tool 300 may also be used with other types of medical instruments, including rigid elongate devices, robotic arms, etc.
  • the medical tool 300 may include a tool body 302 and a localization sensor 304.
  • the tool body 302 may be formed of a rigid material that may generally resist bending.
  • the medical tool 300 may be a biopsy needle including a tapered or pointed, tissue penetrating tip 303.
  • the localization sensor 304 may be an optical sensor system including an optical fiber cable 308 and a sensor head 310 coupled to a distal end of the optical fiber cable 308.
  • the optical fiber cable 308 may include, for example, one or more multi-mode optical fibers. In some examples the optical fiber cable 308 may have a relatively small diameter such as approximately 80 microns or smaller.
  • the sensor head 310 may include, for example, one or more sensing elements such as a pressure sensor that may include an interferometer such as a Fabry- Perot interferometer. In some examples, the sensor head may include one or more optical resonators such as a whispering gallery mode resonator.
  • a sensor head may be a distal portion of the optical fiber cable 308 that may itself serve as the sensing element.
  • the sensor head 310 may be located at a known distance DI from the tip 303 of the tool body 302. Thus, localizing the localization sensor may allow the location of the tip at the known distance DI to also be known.
  • the optical sensor system may also include a light source 305, such as a laser light source, that may be coupled to or otherwise in optical communication with a proximal end portion of the optical fiber cable 308.
  • the optical sensor system may also include an optoelectronic device 307, such as a photodetector, that converts light received from the optical fiber cable 308 into electrical signals. Light from the light source 305 may be carried to the sensor head 310, and light may be returned from the sensor head 310 to the optoelectronic device 307 for processing.
  • a window 306 may be formed at a distal end portion of the tool body 302, and the distal end of the optical fiber cable 308 and/or the sensor head 310 may be exposed within the window 306.
  • the window 306 may be generally aligned with the tip 303 of the tool body 302.
  • the window 306 may extend through a wall 309 of the tool body 302 and may be formed by electrical discharge machining (EDM), laser cutting, or other techniques.
  • the window 306 may include a relatively straight distal edge 312 and distal comers 314.
  • a passage 311 may be formed in the wall 309 to accommodate the optical fiber cable 308.
  • the passage 311 may be a groove formed, for example, by electrical discharge machining (EDM).
  • the passage 311 may be a slot through the wall 309 along all or a portion of its length.
  • the optical fiber cable 308 may be fully or partially surrounded within the passage 311 by an acoustic potting material 316.
  • acoustic potting material may extend within the window 306 to fill all or a portion of the window to eliminate air gaps that may form around the localization sensor 304 during use.
  • FIG. 7B illustrates a top view of a distal portion of a medical tool 320 (e.g. the medical tool 166) that may be extendable from, rotatable within, bendable relative to, or otherwise movable with respect to a flexible elongate device (e.g. flexible elongate device 152).
  • the medical tool 320 may also be used with other types of medical instruments, including rigid elongate devices, robotic arms, etc.
  • the medical tool 320 may be similar to the medical tool 300, with differences as described.
  • a window 326 may be formed at a distal end portion of the tool body 302, and the distal end of the optical fiber cable 308 and/or the sensor head 310 may be exposed within the window 326.
  • FIG. 7C illustrates a top view of a distal portion of a medical tool 340 (e.g. the medical tool 166) that may be extendable from, rotatable within, bendable relative to, or otherwise movable with respect to a flexible elongate device (e.g. flexible elongate device 152).
  • the medical tool 340 may also be used with other types of medical instruments, including rigid elongate devices, robotic arms, etc.
  • the medical tool 340 may be similar to the medical tool 300, with differences as described.
  • a window 346 may be formed at a distal end portion of the tool body 302, and the distal end of the optical fiber cable 308 and/or the sensor head 310 may be exposed within the window 346.
  • FIG. 9A illustrates a top view of a medical tool 400 (e.g. the medical tool 166) that may be extendable from, rotatable within, bendable relative to, or otherwise movable with respect to a flexible elongate device (e.g. flexible elongate device 152).
  • the medical tool 400 may also be used with other types of medical instruments, including rigid elongate devices, robotic arms, etc.
  • Cross sectional views of the medical tool 400 are illustrated at FIGS. 9B-9D.
  • the medical tool 400 may include a tool body 402 and a localization sensor 404.
  • the tool body 402 may be the same or substantially similar to any of the tool bodies disclosed herein.
  • An inner support member 416 may extend within the flexible portion 408 to prevent migration of the optical fiber cable 412 into a central passage 420 of the flexible portion 408. The inner support member may also prevent the central passage 420 from collapsing and resist kinking of the flexible portion.
  • the inner support member 416 may include a laser cut hypotube that includes a plurality of slits or a single helical slit.
  • the hypotube may be attached to an inner surface 418 of the flexible portion 408 by spot welding or by tack laser welding.
  • the inner support member 416 may include a continuous tube formed of a flexible material such as nitinol.
  • FIG. 10A illustrates a top view of a medical tool 500 (e.g. the medical tool 166) that may be extendable from, rotatable within, bendable relative to, or otherwise movable with respect to a flexible elongate device (e.g. flexible elongate device 152).
  • the medical tool 500 may also be used with other types of medical instruments, including rigid elongate devices, robotic arms, etc.
  • Cross sectional views of the medical tool 500 are illustrated at FIGS. 10B-10D.
  • the medical tool 500 may include a tool body 502 and a localization sensor 504.
  • the tool body 502 may be the same or substantially similar to any of the tool bodies disclosed herein.
  • the localization sensor 504 may be the same or substantially similar to any of the localization sensors described herein.
  • An inner support member 516 may extend within the flexible portion 508 to prevent migration of the optical fiber cable 512 into a central passage 520 of the flexible portion 508. The inner support member 516 may also prevent the central passage 520 from collapsing and resist kinking of the flexible portion.
  • the inner support member 516 may include a flexible polymer tube affixed to an inner surface 518 of the flexible portion 508 by an adhesive.
  • the flexible inner support member 516 may include a combination of polymer and metal materials, such as a braided metal wire structure encased in a polymer tube that is affixed by an adhesive. An encased metal braid may provide a seal, preventing ingress of fluid or debris.
  • a flexible sleeve 523 may extend along the flexible portion 508 to prevent ingress of fluid or debris.
  • FIG. 10 is a simplified diagram of a medical system 600 according to some embodiments.
  • the medical system 600 may be suitable for use in, for example, surgical, diagnostic (e.g., biopsy), or therapeutic (e.g., ablation, electroporation, etc.) procedures. While some embodiments are provided herein with respect to such procedures, any reference to medical or surgical instruments and medical or surgical methods is non-limiting.
  • the systems, instruments, and methods described herein may be used for animals, human cadavers, animal cadavers, portions of human or animal anatomy, non-surgical diagnosis, as well as for industrial systems, general or special purpose robotic systems, general or special purpose robot-assisted medical systems.
  • medical system 600 may include a manipulator assembly 602 that controls the operation of a medical instrument 604 (e.g., medical instrument system 100, 150) in performing various procedures on a patient P.
  • Medical instrument 604 may extend into an internal site within the body of patient P via an opening in the body of patient P.
  • the manipulator assembly 602 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 602 may be mounted to and/or positioned near a patient table T.
  • a master assembly 606 allows an operator O (e.g., a surgeon, a clinician, a physician, or other user) to control the manipulator assembly 602.
  • the master assembly 606 allows the operator O to view the procedural site or other graphical or informational displays.
  • the manipulator assembly 602 may be excluded from the medical system 600 and the instrument 604 may be controlled directly by the operator O.
  • the manipulator assembly 602 may be manually controlled by the operator O. Direct operator control may include various handles and operator interfaces for hand-held operation of the instrument 604.
  • the master assembly 606 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 606 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 606 may include one or more control devices for controlling the manipulator assembly 602.
  • 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 602 supports the medical instrument 604 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 612).
  • the manipulator assembly 602 may include a plurality of actuators (e.g., motors) that drive inputs on the medical instrument 604 in response to commands, such as from the control system 612.
  • the actuators may include drive systems that move the medical instrument 604 in various ways when coupled to the medical instrument 604.
  • one or more actuators may advance medical instrument 604 into a naturally or surgically created anatomic orifice.
  • Actuators may control articulation of the medical instrument 604, such as by moving the distal end (or any other portion) of medical instrument 604 in multiple degrees of freedom.
  • 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 604, 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 604.
  • medical instrument 604 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 604.
  • the medical system 600 may include a sensor system 608 with one or more sub-systems for receiving information about the manipulator assembly 602 and/or the medical instrument 604.
  • 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 604; a visualization system 709 (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 604 or from some other location; and/or actuator position sensors such as resolvers, encoders, potentiometers, and the like
  • the medical system 600 may include a display system 610 for displaying an image or representation of the procedural site and the medical instrument 604.
  • Display system 610 and master assembly 606 may be oriented so physician O can control medical instrument 604 and master assembly 606 with the perception of telepresence.
  • the medical instrument 604 may include a visualization system 609, 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 610.
  • 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 604. Additionally or alternatively, a separate endoscope, attached to a separate manipulator assembly, may be used with medical instrument 604 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 612.
  • Display system 610 may also display an image of the procedural site and medical instruments, which may be captured by the visualization system.
  • the medical system 600 provides a perception of telepresence to the operator O.
  • images captured by an imaging device at a distal portion of the medical instrument 604 may be presented by the display system 610 to provide the perception of being at the distal portion of the medical instrument 604 to the operator O.
  • the display system 610 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 100, 150) or intra-operatively (e.g., concurrent with the procedure performed by the medical instrument system 100, 150), 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
  • OCT optical coherence tomography
  • thermal imaging impedance imaging
  • laser imaging laser imaging
  • nanotube X-ray imaging and/or the like.
  • the virtual images may include two-dimensional, three-dimensional, or higher-dimensional (e.g., including, for example, time based or velocity-based information) images.
  • one or more models are created from pre-operative or intra-operative image data sets and the virtual images are generated using the one or more models.
  • display system 610 may display a virtual image that is generated based on tracking the location of medical instrument 604.
  • the tracked location of the medical instrument 604 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 604 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 604 that correspond with the tracked locations of the medical instrument 604.
  • the medical system 600 may also include the control system 612, which may include processing circuitry that implements the some or all of the methods or functionality discussed herein.
  • the control system 612 may include at least one memory 616 and at least one processor 714 for controlling the operations of the manipulator assembly 602, the medical instrument 604, the master assembly 606, the sensor system 608, and/or the display system 610.
  • Control system 612 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 612 is shown as a single block in FIG.
  • control system 612 may include two or more separate data processing circuits with one portion of the processing being performed at the manipulator assembly 602, another portion of the processing being performed at the master assembly 606, and/or the like.
  • control system 612 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 612 may be implemented using hardware, firmware, software, or a combination thereof.
  • control system 612 may receive feedback from the medical instrument 604, such as force and/or torque feedback. Responsive to the feedback, the control system 612 may transmit signals to the master assembly 606. In some examples, the control system 612 may transmit signals instructing one or more actuators of the manipulator assembly 602 to move the medical instrument 604. In some examples, the control system 612 may transmit informational displays regarding the feedback to the display system 610 for presentation or perform other types of actions based on the feedback. [0074] The control system 612 may include a virtual visualization system to provide navigation assistance to operator O when controlling the medical instrument 604 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 612 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 608 that is used to compute an (e.g., approximate) location of the medical instrument 604 with respect to the anatomy of patient P.
  • the sensor system 608 may be used to register and display the medical instrument 604 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 608 may be used to compute the (e.g., approximate) location of the medical instrument 604 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 600 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 600 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. 12A is a simplified diagram of a medical instrument system 700 according to some embodiments.
  • the medical instrument system 700 includes a flexible elongate device 702 (e.g. flexible elongate device 152), a drive unit 704, and a medical tool 826 that collectively is an example of a medical instrument 604 of a medical system 600.
  • the medical system 600 may be a robot-assisted system, a non-robot-assisted system, or a hybrid robot-assisted and non-assisted system, as explained with reference to FIG. 11.
  • a visualization system 731, tracking system 730, and navigation system 732 are also shown in FIG. 12A and are example components of the control system 612 of the medical system 600.
  • the medical instrument system 700 may be used for non-robot-assisted exploratory procedures or in procedures involving traditional manually operated medical instruments, such as endoscopy.
  • the medical instrument system 700 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 702 is coupled to the drive unit 704.
  • the elongate device 702 includes a channel 721 through which the medical tool 726 may be inserted.
  • the elongate device 702 navigates within patient anatomy to deliver the medical tool 726 to a procedural site.
  • the elongate device 702 includes a flexible body 716 having a proximal end 717 and a distal end 718.
  • the flexible body 716 may have an approximately 3 mm outer diameter. Other flexible body outer diameters may be larger or smaller.
  • Medical instrument system 700 may include the tracking system 730 for determining the position, orientation, speed, velocity, pose, and/or shape of the flexible body 716 at the distal end 718 and/or of one or more segments 724 along flexible body 716, as will be described in further detail below.
  • the tracking system 730 may include one or more sensors and/or imaging devices.
  • the flexible body 716 such as the length between the distal end 718 and the proximal end 717, may include multiple segments 724.
  • the tracking system 730 may be implemented using hardware, firmware, software, or a combination thereof. In some examples, the tracking system 730 is part of control system 612 shown in FIG. 1.
  • Tracking system 730 may track the distal end 718 and/or one or more of the segments fiber aligned with the flexible body 716 (e.g., provided within an interior channel of the flexibly body 716 or mounted externally along the flexible body 716).
  • 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 722 may form a fiber optic bend sensor for determining the shape of flexible body 716.
  • 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
  • Patent Application Publication No. 2006/0013523 (filed July 13, 2005 and titled “Fiber optic position and shape sensing device and method relating thereto”); U.S. Patent No. 7,772,541 (filed on March 12, 2008 and titled “Fiber Optic Position and/or Shape Sensing Based on Rayleigh Scatter”); and U.S. Patent No. 8,773,650 (filed on Sept. 2, 2010 and titled “Optical Position and/or Shape Sensing”), which are all incorporated by reference herein in their entireties. Sensors in some embodiments may employ other suitable strain sensing techniques, such as Rayleigh scattering, Raman scattering, Brillouin scattering, and Fluorescence scattering.
  • suitable strain sensing techniques such as Rayleigh scattering, Raman scattering, Brillouin scattering, and Fluorescence scattering.
  • the shape of the flexible body 716 may be determined using other techniques. For example, a history of the position and/or pose of the distal end 718 of the flexible body 716 can be used to reconstruct the shape of flexible body 716 over an interval of time (e.g., as the flexible body 716 is advanced or retracted within a patient anatomy).
  • the tracking system 730 may alternatively and/or additionally track the distal end 718 of the flexible body 716 using a position sensor system 720.
  • Position sensor system 720 may be a component of an EM sensor system with the position sensor system 720 including one or more position sensors.
  • the position sensor system 720 is shown as being near the distal end 718 of the flexible body 716 to track the distal end 718, the number and location of the position sensors of the position sensor system 720 may vary to track different regions along the flexible body 716.
  • the position sensors include conductive coils that may be subjected to an externally generated electromagnetic field. Each coil of position sensor system 720 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 720 may measure one or more position coordinates and/or one or more orientation angles associated with one or more portions of flexible body 716.
  • the position sensor system 720 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 720 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 730 may alternately and/or additionally rely on a collection of pose, position, and/or orientation data stored for a point of an elongate device 702 and/or medical tool 726 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 716.
  • a series of position sensors such as EM sensors like the sensors in position sensor 720 or some other type of position sensors may be positioned along the flexible body 716 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 702, particularly if an anatomic passageway is generally static.
  • FIG. 12B is a simplified diagram of the medical tool 726 within the elongate device 702 according to some embodiments.
  • the flexible body 716 of the elongate device 702 may include the channel 721 sized and shaped to receive the medical tool 726.
  • the medical tool 726 may be used for procedures such as diagnostics, imaging, surgery, biopsy, ablation, illumination, irrigation, suction, electroporation, etc.
  • Medical tool 726 can be deployed through channel 721 of flexible body 716 and operated at a procedural site within the anatomy.
  • Medical tool 726 may be, for example, an image capture probe, a biopsy tool (e.g., a needle, grasper, brush, etc.), an ablation tool (e.g., a laser ablation tool, radio frequency (RF) ablation tool, cryoablation tool, thermal ablation tool, heated liquid ablation tool, etc.), an electroporation tool, and/or another surgical, diagnostic, or therapeutic tool.
  • the medical tool 726 may include an end effector having a single working member such as a scalpel, a blunt blade, an optical fiber, an electrode, and/or the like.
  • Other end types of end effectors may include, for example, forceps, graspers, scissors, staplers, clip appliers, and/or the like.
  • Other end effectors may further include electrically activated end effectors such as electrosurgical electrodes, transducers, sensors, and/or the like.
  • the medical tool 726 may be a biopsy tool used to remove sample tissue or a sampling of cells from a target anatomic location.
  • the biopsy tool is a flexible needle.
  • the biopsy tool may further include a sheath that can surround the flexible needle to protect the needle and interior surface of the channel 721 when the biopsy tool is within the channel 721.
  • the medical tool 726 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 718 of flexible body 716 for capturing images (e.g., still or video images).
  • the captured images may be processed by the visualization system 731 for display and/or provided to the tracking system 730 to support tracking of the distal end 718 of the flexible body 716 and/or one or more of the segments 724 of the flexible body 716.
  • 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 731.
  • 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 716 of the elongate device 702 to facilitate visual navigation of the elongate device 702 to a procedural site and then is replaced within the flexible body 716 with another type of medical tool 726 that performs the procedure.
  • the image capture probe may be within the flexible body 716 of the elongate device 702 along with another type of medical tool 726 to facilitate simultaneous image capture and tissue intervention, such as within the same channel 721 or in separate channels.
  • a medical tool 726 may be advanced from the opening of the channel 721 to perform the procedure (or some other functionality) and then retracted back into the channel 721 when the procedure is complete.
  • the medical tool 726 may be removed from the proximal end 717 of the flexible body 716 or from another optional instrument port (not shown) along flexible body 716.
  • the elongate device 702 may include integrated imaging capability rather than utilize a removable image capture probe.
  • the imaging device (or fiberoptic bundle) and the light emitters may be located at the distal end 718 of the elongate device 702.
  • the flexible body 715 may include one or more dedicated channels that carry the cable(s) and/or optical fiber(s) between the distal end 718 and the visualization system 731.
  • the medical instrument system 700 can perform simultaneous imaging and tool operations.
  • the medical tool 726 is capable of controllable articulation.
  • the medical tool 726 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 726, such as discussed herein for the flexible elongate device 702.
  • the medical tool 726 may be coupled to a drive unit 704 and the manipulator assembly 602.
  • the elongate device 702 may be excluded from the medical instrument system 700 or may be a flexible device that does not have controllable articulation. Steerable instruments or tools, applicable in some embodiments, are further described in detail in U.S. Patent No.
  • the flexible body 716 of the elongate device 702 may also or alternatively house cables, linkages, or other steering controls (not shown) that extend between the drive unit 704 and the distal end 718 to controllably bend the distal end 718 as shown, for example, by broken dashed line depictions 719 of the distal end 718 in FIG. 12A.
  • at least four cables are used to provide independent up-down steering to control a pitch of the distal end 718 and left-right steering to control a yaw of the distal end 718.
  • the flexible elongate device 702 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 704 may include drive inputs that removably couple to and receive power from drive elements, such as actuators, of the robot-assisted assembly.
  • the elongate device 702 and/or medical tool 726 may include gripping features, manual actuators, or other components for manually controlling the motion of the elongate device 702 and/or medical tool 726.
  • the elongate device 702 may be steerable or, alternatively, the elongate device 702 may be non-steerable with no integrated mechanism for operator control of the bending of distal end 718.
  • one or more channels 721 (which may also be referred to as lumens), through which medical tools 726 can be deployed and used at a target anatomical location, may be defined by the interior walls of the flexible body 716 of the elongate device 702.
  • the medical instrument system 700 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 700 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 730 may be sent to the navigation system 732, where the information may be combined with information from the visualization system 731 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 610 for use in the control of the medical instrument system 700.
  • the navigation system 732 may utilize the position information as feedback for positioning medical instrument system 700.
  • 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.
  • the systems and methods described herein may be suited for imaging, via natural or surgically created connected passageways, in any of a variety of anatomic systems, including the lung, colon, the intestines, the stomach, the liver, the kidneys and kidney calices, the brain, the heart, the circulatory system including vasculature, and/or the like. While some examples are provided herein with respect to medical procedures, any reference to medical or surgical instruments and medical or surgical methods is non-limiting. For example, the instruments, systems, and methods described herein may be used for non-medieal purposes including industrial uses, general robotic uses, and sensing or manipulating non-tissue work pieces.
  • example applications involve cosmetic improvements, imaging of human or animal anatomy, gathering data from human or animal anatomy, and training medical or non-medical personnel. Additional example applications include use for procedures on tissue removed from human or animal anatomies (without return to a human or animal anatomy) and performing procedures on human or animal cadavers. Further, these techniques can also be used for surgical and nonsurgical medical treatment or diagnosis procedures.
  • control system e.g., control system 612
  • processors e.g., the processors 614 of control system 612
  • control system 612 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 pail 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).
  • the term “position” refers to the location of an object or a portion of an object in a three-dimensional space (e.g., three degrees of translational freedom along Cartesian x-, y-, and z-coordinates).
  • the term “orientation” refers to the rotational placement of an object or a portion of an object (three degrees of rotational freedom - e.g., 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 (up to six total degrees of freedom).
  • the term “shape” refers to a set of poses, positions, 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.
  • 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.

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Abstract

Système pouvant comprendre un dispositif allongé souple comprenant un ou plusieurs émetteurs de signal et un outil conçu pour s'étendre à partir d'une extrémité distale du dispositif allongé souple. L'outil peut comprendre une partie corps délimitant une fenêtre et un capteur de localisation accouplé à la partie corps. Au moins une partie du capteur de localisation est exposée par la fenêtre pour recevoir un signal provenant du ou des émetteurs de signal à travers la fenêtre. Le système peut également comprendre un système de commande conçu pour déterminer un emplacement de l'outil sur la base du signal reçu par le capteur de localisation en provenance du ou des émetteurs de signal.
PCT/US2024/047152 2023-09-21 2024-09-18 Outil médical à fenêtre de signal et procédés d'utilisation Pending WO2025064464A1 (fr)

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US7772541B2 (en) 2004-07-16 2010-08-10 Luna Innnovations Incorporated Fiber optic position and/or shape sensing based on rayleigh scatter
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US8900131B2 (en) 2011-05-13 2014-12-02 Intuitive Surgical Operations, Inc. Medical system providing dynamic registration of a model of an anatomical structure for image-guided surgery
US20160038119A1 (en) * 2013-04-26 2016-02-11 Ucl Business Plc A method and apparatus for determining the location of a medical instrument with respect to ultrasound imaging, and a medical instrument to facilitate such determination
US9259274B2 (en) 2008-09-30 2016-02-16 Intuitive Surgical Operations, Inc. Passive preload and capstan drive for surgical instruments
WO2016191298A1 (fr) 2015-05-22 2016-12-01 Intuitive Surgical Operations, Inc. Systèmes et procédés d'alignement pour chirurgie guidée par image
US20180235709A1 (en) 2015-08-14 2018-08-23 Intuitive Surgical Operations, Inc. Systems and Methods of Registration for Image-Guided Surgery
US20180240237A1 (en) 2015-08-14 2018-08-23 Intuitive Surgical Operations, Inc. Systems and Methods of Registration for Image-Guided Surgery
WO2019018736A2 (fr) 2017-07-21 2019-01-24 Intuitive Surgical Operations, Inc. Systèmes et procédés de dispositif allongé flexible

Patent Citations (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4705604A (en) 1984-07-06 1987-11-10 Solvay & Cie. (Societe Anonyme) Process for extracting poly-beta-hydroxybutyrates by means of a solvent from an aqueous suspension of microorganisms
US7316681B2 (en) 1996-05-20 2008-01-08 Intuitive Surgical, Inc Articulated surgical instrument for performing minimally invasive surgery with enhanced dexterity and sensitivity
US6380732B1 (en) 1997-02-13 2002-04-30 Super Dimension Ltd. Six-degree of freedom tracking system having a passive transponder on the object being tracked
US6389187B1 (en) 1997-06-20 2002-05-14 Qinetiq Limited Optical fiber bend sensor
US20060013523A1 (en) 2004-07-16 2006-01-19 Luna Innovations Incorporated Fiber optic position and shape sensing device and method relating thereto
US7772541B2 (en) 2004-07-16 2010-08-10 Luna Innnovations Incorporated Fiber optic position and/or shape sensing based on rayleigh scatter
US20070167769A1 (en) * 2005-12-28 2007-07-19 Olympus Medical Systems Corp. Ultrasonic diagnosis apparatus
US20080119727A1 (en) * 2006-10-02 2008-05-22 Hansen Medical, Inc. Systems and methods for three-dimensional ultrasound mapping
US9259274B2 (en) 2008-09-30 2016-02-16 Intuitive Surgical Operations, Inc. Passive preload and capstan drive for surgical instruments
US8773650B2 (en) 2009-09-18 2014-07-08 Intuitive Surgical Operations, Inc. Optical position and/or shape sensing
US8900131B2 (en) 2011-05-13 2014-12-02 Intuitive Surgical Operations, Inc. Medical system providing dynamic registration of a model of an anatomical structure for image-guided surgery
US20160038119A1 (en) * 2013-04-26 2016-02-11 Ucl Business Plc A method and apparatus for determining the location of a medical instrument with respect to ultrasound imaging, and a medical instrument to facilitate such determination
WO2016191298A1 (fr) 2015-05-22 2016-12-01 Intuitive Surgical Operations, Inc. Systèmes et procédés d'alignement pour chirurgie guidée par image
US20180235709A1 (en) 2015-08-14 2018-08-23 Intuitive Surgical Operations, Inc. Systems and Methods of Registration for Image-Guided Surgery
US20180240237A1 (en) 2015-08-14 2018-08-23 Intuitive Surgical Operations, Inc. Systems and Methods of Registration for Image-Guided Surgery
WO2019018736A2 (fr) 2017-07-21 2019-01-24 Intuitive Surgical Operations, Inc. Systèmes et procédés de dispositif allongé flexible

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