EP4773902A1 - Flux de travail pour robot à aiguille percutanée guidée par ultrasons - Google Patents

Flux de travail pour robot à aiguille percutanée guidée par ultrasons

Info

Publication number
EP4773902A1
EP4773902A1 EP24776415.2A EP24776415A EP4773902A1 EP 4773902 A1 EP4773902 A1 EP 4773902A1 EP 24776415 A EP24776415 A EP 24776415A EP 4773902 A1 EP4773902 A1 EP 4773902A1
Authority
EP
European Patent Office
Prior art keywords
instrument
control system
probe
computer
pathway
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
EP24776415.2A
Other languages
German (de)
English (en)
Inventor
Quirina DE RUITER
Ryan C. Abbott
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 EP4773902A1 publication Critical patent/EP4773902A1/fr
Pending legal-status Critical Current

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
    • 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
    • A61B34/32—Surgical robots operating autonomously
    • 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
    • A61B90/10—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 for stereotaxic surgery, e.g. frame-based stereotaxis
    • A61B90/11—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 for stereotaxic surgery, e.g. frame-based stereotaxis with guides for needles or instruments, e.g. arcuate slides or ball joints
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3403—Needle locating or guiding means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1477—Needle-like probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00184—Moving parts
    • A61B2018/0019—Moving parts vibrating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00184—Moving parts
    • A61B2018/00196—Moving parts reciprocating lengthwise
    • 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
    • A61B2034/2055—Optical 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
    • A61B2034/2059—Mechanical position encoders
    • 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
    • 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
    • A61B2090/065—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension for measuring contact or contact pressure
    • 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
    • A61B2090/364—Correlation of different images or relation of image positions in respect to the body
    • A61B2090/367—Correlation of different images or relation of image positions in respect to the body creating a 3D dataset from 2D images using position information
    • 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
    • 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
    • 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
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/42—Details of probe positioning or probe attachment to the patient
    • A61B8/4209—Details of probe positioning or probe attachment to the patient by using holders, e.g. positioning frames
    • A61B8/4218—Details of probe positioning or probe attachment to the patient by using holders, e.g. positioning frames characterised by articulated arms
    • 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
    • A61B90/50—Supports for surgical instruments, e.g. articulated arms

Definitions

  • Disclosed examples relate to guided robotic control.
  • the disclosed examples relate to systems and methods for analyzing image data and determining insertion paths for medical instruments to reach a treatment region of a subject.
  • 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
  • Various medical instruments may be used to reach the target volume including needles and probes of various lengths, sizes, and flexibilities.
  • some medical instruments may be rigid and only be able to traverse a linear insertion path, while other instruments may be able to bend to reach a treatment volume along one or more curves of an insertion path. Additionally, the path may be altered or changed during insertion due to the movement of the subject, or to compensate for other errors.
  • Image data of the subject is used to plan a pathway towards the region of interest as well as to ensure proper navigation during the procedure.
  • the image data may be analyzed to segment the traversable vessels from other objects in the image, which may harm the patient if ruptured by the invasive medical instrument.
  • Ultrasound imaging is a tool often used for performing imaging to plan insertion pathways for instruments. Ultrasound imaging allows a clinician to visualize organs and tissues in a subject and to identify areas of interest which may include abnormalities or target organs or tissues. These types of imaging techniques have been implemented in planning for performing biopsies, and for drug delivery to a patient.
  • a computer-assisted system may include (i) a repositionable structure, (ii) a probe holder coupled to the repositionable structure, (iii) the probe holder supporting a sensing probe, (iv) an instrument holder coupled to the repositionable structure, the instrument holder supporting an instrument and including an instrument driver configured to control the instrument, and (v) a control system including one or more processors, where in the control system is operably coupled to the repositionable structure, the probe holder, and the instrument holder.
  • the control system is configured to (1) obtain, by the sensing probe, images of a target volume of a subject;, (2) reconstruct a three-dimensional (3D) representation of the target volume from the images of the target volume, (3) segment the 3D representation of the target volume to identify one or more objects, boundaries, or features in the 3D representation, (4) determine an instrument insertion pathway including an insertion site and a treatment site, (5) control the repositionable structure and the instrument holder to advance the instrument along the insertion pathway.
  • 3D three-dimensional
  • a method for performing ultrasound guided robotic percutaneous instrument insertion includes (1) obtaining, by a sensing probe, images of a target volume of a subject, (2) reconstructing, by a control system, a three-dimensional (3D) representation of the target volume from the images of the target volume, (3) segmenting, by the control system, the 3D representation of the target volume to identify one or more objects, boundaries, or features in the 3D representation of the target volume, (4) determining, by the control system, an instrument insertion pathway including an insertion site and a treatment site, (5) controlling, by the control system, a repositionable structure and an instrument holder to advance an instrument along the insertion pathway, wherein the position of the sensing probe is supported by a probe holder that is coupled to the repositionable structure.
  • a non-transitory computer- readable medium storing instructions thereon.
  • the instructions when executed by one or more processors, cause the one or more processors to (1) obtain, by a sensing probe, images of a target volume of a subject, (2) reconstruct, by a control system, a three-dimensional (3D) representation of the target volume from the images of the target volume, (3) segment, by the control system, the 3D representation of the target volume to identify one or more objects, boundaries, or features in the 3D representation of the target volume, (4) determine, by the control system, an instrument insertion pathway including an insertion site and a treatment site, (5) control, by the control system, a repositionable structure and an instrument holder to advance an instrument along the insertion pathway, wherein the position of the sensing probe is supported by a probe holder that is coupled to the repositionable structure.
  • FIG. 1 is a schematic diagram for a robotically-assisted manipulator system according to some examples.
  • FIG. 2 A is a perspective view of a manipulator system according to some examples.
  • FIG. 2B is an alternative perspective view of the manipulator system of FIG. 2A according to some examples.
  • FIG. 2C is an alternative perspective view of the manipulator system of FIG. 2A according to some examples.
  • FIG. 3 is a perspective view of an instrument holder for a manipulator system according to some examples.
  • FIG. 4 is a diagrammatic view of high and low frequency vibration mechanisms for an instrument driver of an instrument holder according to some examples.
  • FIG. 5 is a schematic view of a manipulator system according to some examples.
  • FIG. 6 is an example flow diagram of an example method for performing ultrasound guided robotic percutaneous instrument insertion, according to some examples.
  • FIG. 7 is a diagram illustrating an implementation of performing ultrasound guided robotic percutaneous instrument insertion into a target region, according to some examples.
  • FIG. 8 is a diagram of a target region with multiple insertion pathways for performing ultrasound guided robotic percutaneous instrument insertion, according to some examples.
  • FIG. 9 is an example flow diagram of an example method for performing multi-stage treatment via ultrasound guided robotic percutaneous instrument insertion, according to some examples.
  • position refers to the location of an object or a portion of an object in a three-dimensional space (e.g., three degrees of translational freedom along Cartesian x-, y-, and z-coordinates).
  • orientation refers to the rotational placement of an object or a portion of an object (e.g., one or more degrees of rotational freedom such as, roll, pitch, and yaw).
  • the term “pose” refers to the position of an object or a portion of an object in at least one degree of translational freedom and to the orientation of that object or portion of the object in at least one degree of rotational freedom (e.g., up to six total degrees of freedom).
  • the term “shape” refers to a set of poses, positions, and/or orientations measured along an object.
  • distal refers to a position that is closer to a procedural site and the term “proximal” refers to a position that is further from the procedural site. Accordingly, the distal portion or distal end of an instrument is closer to a procedural site than a proximal portion or proximal end of the instrument when the instrument is being used as designed to perform a procedure.
  • the image data includes 2D and/or 3D images. While the term “pixel” is used herein to refer to a particular point within the image data, the term “pixel” should not be understood to imply that the corresponding image data is a 2D image. In embodiments where the image data is 3D image data, the term “pixel” should be understood to refer to a “voxel” of the 3D image.
  • Systems and methods are provided utilizing a manipulator arm and device holders movable about several degrees of freedom of motion, allowing complex positioning and control.
  • the systems and methods control needle insertion and track movement of the needle along an insertion path, such as with an ultrasound probe.
  • the manipulator arm may have at least four degrees of freedom (e.g., three pivots about vertical axes and a distal pivot about a horizontal axis), while holders for the needle and ultrasound probe may have at least three degrees of freedom (e.g., x-axis, z-axis, pitch, and/or yaw).
  • the systems and methods control movement of the manipulator and an instrument holder according to a remote center around a needle insertion point at the skin level.
  • a control system determines an insertion point at the skin and direction vector for needle insertion and controls movement of the manipulator arm and instrument holder to position an instrument driver to align an insertion axis thereof with the insertion point along the direction vector.
  • the control system can then operate the instrument driver to drive the needle along the insertion axis to the insertion point and control movement of the manipulator arm and instrument holder about the insertion point as a remote center in response to the needle reaching the insertion point at the skin level.
  • An instrument driver for the needle can be configured to impart two degrees of freedom of movement on the needle, including insertion along an insertion axis and rotation about the insertion axis.
  • the systems and methods can further include a stylus that is coupled to and driven by the instrument driver through a lumen of the needle.
  • the instrument driver may also impart two degrees of freedom of movement on the stylus, including insertion along the insertion axis and rotation about the insertion axis.
  • a needle driver for a needle includes both high and low frequency vibration mechanisms coupled to the needle. The high frequency vibration mechanism can be utilized to aid needle insertion through tissue and aid visualization of the needle on ultrasound.
  • the high frequency vibration mechanism includes a stack of piezoelectric members received within a housing coupled to the needle.
  • the low frequency vibration mechanism can be utilized to decrease pain during needle insertion.
  • the low frequency vibration mechanism can be an eccentric motor or linear actuator coupled to the needle.
  • the needle driver can be utilized within the overall system as a component of the instrument holder.
  • the system can also include the manipulator arm and probe holder.
  • the manipulator system can include one or more manipulators that can be operated with the assistance of an electronic controller (e.g., computer) to move and control functions of one or more instruments when coupled to the manipulators.
  • an electronic controller e.g., computer
  • FIG. 1 illustrates an embodiment of a robotically-assisted manipulator system for use with the tools described herein.
  • the manipulator system can be used, for example, in surgical, diagnostic, therapeutic, biopsy, or non-medical procedures, and is generally indicated by the reference numeral 100.
  • a robotically-assisted manipulator system 100 can include one or more manipulator assemblies 102 for operating one or more medical instrument systems 104 in performing various procedures on a patient P positioned on a table T in a medical environment 101.
  • the manipulator assembly 102 can drive catheter or end effector motion, can apply treatment to target tissue, and/or can manipulate control members.
  • the manipulator assembly 102 can be teleoperated, non-teleoperated, or a hybrid teleoperated and nonteleoperated assembly with select degrees of freedom of motion that can be motorized and/or teleoperated and select degrees of freedom of motion that can be non-motorized and/or non- teleoperated.
  • An operator input system 106 which can be inside or outside of the medical environment 101, generally includes one or more control devices for controlling manipulator assembly 102.
  • Manipulator assembly 102 supports medical instrument system 104 and can optionally include a plurality of actuators or motors that drive inputs on medical instrument system 104 in response to commands from a control system 112.
  • the actuators can optionally include drive systems that when coupled to medical instrument system 104 can advance medical instrument system 104 into a naturally or surgically created anatomic orifice.
  • Other drive systems can move the distal end of medical instrument in multiple degrees of freedom, which can 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).
  • the manipulator assembly 102 can support various other systems for irrigation, treatment, or other purposes.
  • Such systems can include fluid systems (including, for example, reservoirs, heating/cooling elements, pumps, and valves), generators, lasers, interrogators, ultrasound gel reservoirs and/or dispensers, and ablation components.
  • Robotically-assisted manipulator system 100 also includes a display system 110 for displaying an image or representation of the surgical site and medical instrument system 104 generated by an imaging system 109 which can include an imaging system, such as an ultrasound imaging system.
  • Display system 110 and operator input system 106 can be oriented so an operator O can control medical instrument system 104 and operator input system 106 with the perception of telepresence.
  • a graphical user interface can be displayable on the display system 110 and/or a display system of an independent planning workstation.
  • the ultrasound imaging system components of the imaging system 109 can be integrally or removably coupled to medical instrument system 104.
  • a separate imaging device such as an endoscope, 3D video, or infrared camera, attached to a separate manipulator assembly can be used with medical instrument system 104 to image the surgical site.
  • the ultrasound imaging system 109 can be implemented as hardware, firmware, software, or a combination thereof which interact with or are otherwise executed by one or more computer processors, which can include the processors of the control system 112.
  • Robotically-assisted manipulator system 100 can also include a sensor system 108.
  • the sensor system 108 can include a position/location sensor system (e.g., an actuator encoder or an electromagnetic (EM) sensor system) and/or a shape sensor system (e.g., an optical fiber shape sensor) for determining the position, orientation, speed, velocity, pose, and/or shape of the medical instrument system 104.
  • the sensor system 108 can also include temperature, pressure, force, or contact sensors or the like.
  • Robotically-assisted manipulator system 100 can also include the control system 112.
  • Control system 112 includes at least one memory 116 and at least one computer processor 114 for effecting control between medical instrument system 104, operator input system 106, sensor system 108, and display system 110.
  • Control system 112 also includes programmed instructions (e.g., a non-transitory machine-readable medium storing the instructions) to implement a procedure using the robotically-assisted manipulator system including for navigation, steering, imaging, engagement feature deployment or retraction, applying treatment to target tissue (e.g., via the application of energy), or the like.
  • Control system 112 can optionally further include a virtual visualization system to provide navigation assistance to operator O when controlling medical instrument system 104 during an image-guided surgical procedure.
  • Virtual navigation using the virtual visualization system can be based upon reference to an acquired pre-operative or intra-operative dataset of anatomic passageways.
  • the virtual visualization system processes images of the surgical site imaged using imaging technology such as computerized tomography (CT), magnetic resonance imaging (MRI), fluoroscopy, thermography, ultrasound, optical coherence tomography (OCT), thermal imaging, impedance imaging, laser imaging, nanotube X-ray imaging, and/or the like.
  • CT computerized tomography
  • MRI magnetic resonance imaging
  • fluoroscopy thermography
  • ultrasound ultrasound
  • OCT optical coherence tomography
  • thermal imaging impedance imaging
  • laser imaging laser imaging
  • nanotube X-ray imaging and/or the like.
  • the control system 112 can use a pre-operative image to locate the target tissue (using vision imaging techniques and/or by receiving user input) and create a pre-operative plan, including a determined first location for performing treatment.
  • the pre-operative plan can include, for example, a planned size to expand an expandable device, a treatment duration, a treatment temperature, and/or multiple deployment locations.
  • Other configurations of teleoperated manipulator systems are also contemplated, such as systems configured for multi-port or single-port procedures.
  • the embodiments described herein can be used with a da Vinci® Surgical System, such as the da Vinci X®, Xi®, or SP® Surgical Systems, all commercialized by Intuitive Surgical, Inc., of Sunnyvale, California.
  • the embodiments described herein can be used in combination with real time CT guidance (on a CT table), real-time Cone beam CT and X-ray image guidance (in an interventional angiography room), with an X-ray table and or surgical operating table.
  • FIGS. 2A-2C illustrate an example embodiment of a manipulator system 200 that can be used as part of the manipulator system 100.
  • the manipulator system 200 includes a repositionable structure 202 that includes a plurality of links 204 and a plurality of joints 206.
  • the system 200 further includes an instrument holder 208 configured to receive an instrument 210 (e.g., a needle, cannula, etc.) and a probe holder 212 configured to receive a sensing probe 214 (e.g., an ultrasound probe) having a field of view.
  • the instrument holder 208 and the probe holder 212 arc coupled to one or more of the links 204.
  • the rcpositionablc structure 202 has a number of mechanical degrees of freedom of motion through which the instrument holder 208 and the probe holder 212 can be positioned and controlled to scan a patient with the sensing probe 214 and insert the instrument 210 into the patient.
  • the instrument holder 208 has at least three degrees of freedom of motion and the probe holder 212 has at least three degrees of freedom of motion.
  • the repositionable structure 202 has at least four mechanical degrees of freedom of motion.
  • a control system 216 (FIG. 5) of the manipulator system 200 is operably coupled to the repositionable structure 202, the instrument holder 208, and the probe holder 212 to control operation of the instrument holder 208 and movement of the repositionable structure 202, the instrument holder 208, and the probe holder 212.
  • the control system 216 can correspond to the control system 112 described above.
  • the control system 216 is configured to move the instrument 210 along an insertion path and move the sensing probe 214 to keep the instrument 210 within the field of view of the sensing probe 214 as the instrument 210 moves along the insertion path.
  • the repositionable structure 202 is configured such that movement of the repositionable structure 202 moves both the instrument holder 208 and the probe holder 212. As shown, both the instrument holder 208 and the probe holder 212 are coupled to a distal link 204a of the repositionable structure 202, such that when any of the links 204 and joints 206 move, the repositionable structure 202 moves both the instrument 210 and the sensing probe 214 through the instrument holder 208 and the probe holder 212.
  • control system 216 is configured to operate the instrument holder 208 to move the instrument 210 along the insertion path at least by moving the repositionable structure 202 according to a first set of movements and moving the instrument holder 208 according to a second set of movements.
  • the control system 216 is also configured to move the sensing probe 214 to keep the instrument 210 within the field of view of the sensing probe 214 as the instrument 210 moves along the insertion path at least by moving the repositionable structure 202 according to the first set of movements and moving the probe holder 212 according to a third set of movements.
  • the repositionable structure 202 includes a support assembly 218 including a base 220 and a support column 222.
  • An arm 224 is connected to the support column 222.
  • the arm 224 and, in some examples, the support column 222, can be used as the manipulator assembly 102.
  • the arm 224 includes the links 204 and joints 206.
  • the arm 224 can include shoulder 206a, elbow 206b, and wrist 206c joints that are pivotable about vertical axes.
  • the arm 224 can further includes a distal joint 206d that is pivotable about a horizontal axis.
  • the arm 224 has four mechanical degrees of freedom of motion, but additional or fewer links 204 and joints 206 can be utilized to provide a desired number of mechanical degrees of freedom of motion.
  • a drive 226 can be disposed between the support column 222 and the arm 224.
  • the drive 226 can be operated to move the arm 224 along a Z axis (e.g., height) of the support column 222 for an additional degree of freedom of motion for the repositionable structure 202.
  • the probe holder 212 includes a drive 228 operable to move the sensing probe 214 along an X axis, a drive 230 to move the sensing probe 214 along a Z axis, and a joint 232 to pivot the sensing probe 214 about a pitch axis.
  • This configuration gives the probe holder 212 three degrees of freedom of motion.
  • a pressure sensor 234 can be operably coupled to the probe holder 212 so that the control system 216 can maintain a desired pressure on the patient with the sensing probe 214 using data from the pressure sensor 234.
  • the pressure sensor 234 can be part of the sensing probe 214, part of the probe holder 212, or a separate sensor coupled to the probe holder 212, etc.
  • the instrument holder 208 includes a drive 236 operable to move the instrument holder 208 along an X axis, a joint 238 to pivot the instrument holder 208 about a yaw axis, and a joint 240 to pivot the instrument holder 208 about a pitch axis.
  • the instrument holder 208 can include an instrument driver 242 that includes an insertion drive 244 to move the instrument 210 along an insertion axis X and, in some examples, a rotation drive 246 to rotate the instrument 210 about the insertion axis X. This configuration gives the instrument holder 208 four or five degrees of freedom of motion.
  • a pressure sensor 248 can be operably coupled to the instrument driver 242 so that the control system 216 can monitor a pressure at the tip of the instrument 210 (e.g., during piercing of the patient’s skin and/or during insertion) to adjust for tissue pressure and collect insertion data. This can be helpful for when the instrument 210 transitions from soft tissue to hard tissue (e.g., a tumor nodule) and from hard tissue to soft tissue.
  • the pressure sensor 248 can be a load cell, for example.
  • the instrument holder 208 can include one or more vibration mechanisms to aid in instrument insertion.
  • the instrument holder 208 can include a high frequency vibration mechanism 250 coupled to the instrument 210. Vibrating the instrument 210 at a high frequency can help visualizing the instrument 210 with the sensing probe 214 (e.g., under ultrasound). High frequency vibration can also reduce an insertion force needed for instrument insertion and drag induced tissue distortion.
  • the instrument holder 208 can include a low frequency vibration mechanism 252 coupled to the instrument 210. Vibrating the instrument 210 at a low frequency can reduce patient pain during instrument insertion by numbing the local area around the insertion path. Vibration of the instrument can also assist with increased visualization of the instrument 210 in ultrasound imaging.
  • Some instruments 210, such as needles, may be coated with a microbubble or other element that increases the visualization and detection of the instrument 210 in an ultrasound image.
  • vibration of the instrument 210 combined with rotation of the instrument 210 via the rotation drive 246 can help the instrument 210 penetrate a free floating/moving object (e.g., a lymph node or similar structure not fixed inside tissue) rather than undesirably pushing the object away as can happen with conventional systems.
  • the frequency range for the high frequency vibration mechanism 250 can be about 27 kHz to about 44 kHz, which can be advantageous for visibility under ultrasound vision, between about 20 kHz to about 50 kHz, which can be advantageous to reduce insertion forces, or about 34 kHz; and the frequency range for the low frequency vibration mechanism 252 can be about 75 Hz to about 250 Hz, which can be advantageous for pain reduction, or about 166 Hz.
  • the vibration mechanisms 250, 252 can be part of the instrument holder 208, coupled to the instrument holder 208, or be a separate component directly coupled to the instrument 210 separate from the instrument holder 208.
  • the instrument 210 can define a lumen that extends longitudinally through a length of the instrument 210. With this configuration, in some examples, the instrument 210 can be utilized to deliver fluid at a treatment location. Additionally or alternatively, the system 200 can include a second instrument 262 (e.g., a stylus) that is inserted through the lumen of the instrument 210. The second instrument 262 can be utilized for any desired reason. In some examples, the second instrument 262 can have a solid cross-section and complementary bevel to provide a solid overall tip between the first and second instruments 210, 262, the second instrument 262 can be a biopsy stylus or needle, the second instrument 262 can be an anchor stylus, and so forth.
  • a second instrument 262 e.g., a stylus
  • the second instrument 262 can also be a mini camera, an endoscope, an OCT, optical imaging laser and so forth.
  • the instrument driver 242 can further include an insertion drive 264 to move the second instrument 262 along the insertion axis X within the lumen of the first instrument 210 and, in some examples, a rotation drive 266 to rotate the second instrument 262 about the insertion axis X.
  • This configuration gives the instrument holder 208 an additional one or two degrees of freedom of motion.
  • the insertion drives 244, 264 can be rack and pinion drives that utilize a common rack.
  • a high frequency vibration mechanism 268 can be coupled to the second instrument 210 to provide similar benefits as described above.
  • the high frequency vibration mechanism 268 can be coupled to a proximal mount 270 of the second instrument 262.
  • the high frequency vibration mechanism 268 can be any suitable mechanism, including a plurality of piezoelectric members as described above, an ultrasonic transducer, and so forth.
  • control system 216 can be configured to control the movement and operation of the components of the system 100. These include the support assembly drive 226, the joints 206 of the arm 224, the drives and joints 228, 230, 232 of the prob holder 212, the drives and joints 236, 238, 240, 244, 246, 264, 266, and the vibration mechanisms 250, 252, 268, if included.
  • control system 216 can be configured to control the movement of the repositionable structure 202 (e.g., drive 226 and joints 206) and the instrument holder 208 (e.g., drives 236 and joints 238, 240) to selectively move and operate about a remote center during a procedure.
  • the remote center can correspond to an insertion point at the skin of the instrument 210 into a patient along the insertion path. This configuration allows the system 100 to move as needed during a procedure to insert the instrument 210 along the insertion path while minimizing or avoiding damage at the insertion point at the skin level.
  • the control system 216 can be configured to control movement of the repositionable structure 202 and instrument holder 208 about the remote center to deflect the insertion path, such as by rotating the instrument 210 with the rotation drive 246.
  • control system 216 can be configured to control movement of the repositionable structure 202 and the instrument holder 208 about the remote center corresponding to the instrument insertion point, at the skin, into the patient. Movement about the remote center imposes a set of constraints on at least one of: one or more of the degrees of freedom of motion of the repositionable structure 202 or one or more degrees of freedom of motion of the instrument holder 208.
  • control system 216 can be configured to control movement of the repositionable structure 202 and the probe holder 212 to perform an initial scan of a target region within the patient with the sensing probe 214.
  • the initial scan can be utilized to determine the insertion path.
  • control system 216 can utilize the initial scan to determine the instrument insertion point and a direction vector for instrument insertion.
  • the initial scan can be performed without imposing the set of constraints on the set of degrees of freedom of motion of the repositionable structure 202 or of the instrument holder 208 that are imposed while movement is performed around the remote center. Accordingly, the remote center functionality of the system 100 can be turned off for the initial scan.
  • the sensing probe 214 should be in physical contact with the patient with a range of pressures between the sensing probe 214 and the patient to transfer the ultrasound imaging energy.
  • the system 100 may utilize the various degrees of freedom to maintain a pressure as measured by the pressure sensor 234 coupled to the instrument driver 242.
  • an ultrasound gel may be used to improve the contact between the sensing probe 214 and the patient to assist in providing the imaging energy to the patient.
  • the remote center functionality can be activated in response to the instrument 210 reaching the insertion point, after which the control system 216 controls movement of the repositionable structure 202 and instrument holder 208 about the remote center. Reaching the insertion point at the skin can be determined based data from the pressure sensor 234, a length of the instrument 210 that has been driven forward by the insertion drive 244, and so forth. Further, control of movement about the remote center can be maintained until the instrument 210 is withdrawn from the patient.
  • the control system 216 can be configured to move the sensing probe 214 to maintain a tip of the instrument 210 within the ultrasound 2D slice at all times during insertion.
  • the system 100 can be configured to insert multiple instruments 210 into a patient by decoupling an inserted instrument and loading a subsequent instrument 210.
  • the instrument driver 242 can include one or more slots 272 allowing the instrument 210 to be offloaded from the instrument driver 242.
  • the instrument driver 242 can include a releasable collet allowing the instrument to be decoupled therefrom.
  • the housing 256 can also include a slot 274 or releasable connector for the radial coupling.
  • the system obtains one or more images of the target volume 700.
  • the sensing probe 214 is positioned relative to, or against, the subject 702 to obtain images of the target volume 700.
  • the image data may be pre-operative image data or intraoperative image data.
  • the image data is 3D image data, such as computed tomography (CT) image data, cone-beam CT (CBCT) image data, positron emission tomography (PET) image data, ultrasound image data, or magnetic resonance imaging (MRI) image data.
  • CT computed tomography
  • CBCT cone-beam CT
  • PET positron emission tomography
  • ultrasound image data or magnetic resonance imaging (MRI) image data.
  • MRI magnetic resonance imaging
  • the sensing probe 214 may include one or more of an ultrasound probe, photoacoustic probe, microscope, optical imaging probe, video camera, infrared camera, handheld x-ray system, electronic palpation device, impulse-radar detector, focused ultrasound probe, gamma probe, perfusion imager, optical coherence tomography device.
  • the sensing probe 214 includes an ultrasound probe with a ficld-of-vicw (FOV) 715 for capturing images of objects, such as a target 705, in the FOV 715.
  • FOV ficld-of-vicw
  • the system reconstructs a 3D representation of the target volume 700.
  • the 3D representation of the target volume 700 includes a plurality of voxels and may have voxels in free space not including tissue, voxels that include tissue of the subject 702, and voxels that may include a portion of both free space outside of the subject 702, and tissue of the subject 702.
  • the system 100 constructs the 3D representation using both the FOV of the ultrasound probe, and information and data pertaining to the position and orientation of the sensing probe 214 relative to other FOVs of the ultrasound probe, or relative to other image FOVs and scans.
  • the method further includes, at block 606, segmenting the 3D representation to identify one or more objects, boundaries, or features in the 3D representation of the target volume.
  • segmenting the 3D representation may further include the processor, or the control system 216, identifying a treatment site 712 of the subject 702.
  • the control system 216 determines an instrument insertion pathway.
  • the control system 216 determines an insertion site 710 for insertion of an instrument into the subject 702, and further identifies the treatment site 712 either during the segmenting, or from further processing of the 3D representation.
  • the treatment site 712 is a location inside of the subject 702 in which the instrument 210, or at least a portion of the instrument 210 such as a tip of a needle or distal end of the instrument, is to reach to provide a treatment.
  • the treatment may include providing a drug to the treatment site, providing a therapy to the treatment site, performing a biopsy at the treatment site, blood drawing, delivery of electronic leads, microrobots, or microsensors, delivering energy, providing gene therapy, providing a picc line, providing a dialysis fistula, delivery of hydrogel, delivery of an implant, placement of needle electrodes, extracting tissue, delivering tissue, measuring tissue, and/or destroying tissue.
  • the treatment site 712 may include an organ, a tissue, a tumor, a cancer, a blood vessel, a live tumor, the epidermis, a ligament, muscles, sinuses, the brain, pain sources or areas, nerves, lymph vessels, or a portion or subsection of any thereof.
  • the control system 216 may determine two or more potential insertion pathways and select a determined insertion pathway from the two or more candidate pathways. For example, as illustrated in FIG. 8, the control system may determine a first insertion pathway 720a with a first insertion site 710a, a second insertion pathway 720b with a second insertion site 710b, and a third insertion pathway 720c with a third insertion site 710c. Each of the first, second and third insertion pathways 720a-720c provide a path to the treatment site 712.
  • the control system 216 may select the determined insertion pathway based on a pathway length into the subject 702, or a number of voxels that the pathway traverses in the 3D representation.
  • one insertion pathway may include a voxel with free space, a voxel with both free space and tissue, and three voxels with tissue to reach the treatment site 712.
  • Another second pathway may include no voxels with free space, and four voxels with tissue to reach the treatment site 712.
  • the determined pathway may be determined as the second pathway with a total of four voxels because of the reduced distance of the overall insertion pathway.
  • the determined insertion pathway may be determined as the first pathway with a total of five voxel with only three voxels in the tissue of the subject 702, which may be chosen to reduce the distance of the insertion pathway inside of the subject.
  • the determined pathway may be determined by a number of voxels with free space in the 3D representation, or the determined insertion pathway may be determined by a number of voxels in free space versus a number of voxels with tissue.
  • the determined insertion pathway and insertion site may be determined based on the position of organs and tissue, and further may be determined to avoid identified objects such as to avoid a bone, blood vessel, organ, tissue region, etc. While illustrated as linear insertion pathways in FIG. 8, the insertion pathway may include one or more curves or arcs (further described with reference to FIG. 7), and the determined pathway may be determined based on an amount of curvature or direction of curvature of the insertion pathway.
  • the control system 216 may determine the determined pathway based on an instrument type of the instrument (e.g., a needle, an endoscope, an implant, a catheter, a picc line, a stylus) or a needle type for inside which the instrument is inserted.
  • an instrument type of the instrument e.g., a needle, an endoscope, an implant, a catheter, a picc line, a stylus
  • a user may further provide user preferences that the determined pathway may further be determined from. For example, a user may select a determined insertion pathway from the plurality of candidate insertion pathways. A user may provide specific tissues, organs, or regions inside of the patient to avoid during insertion of the instrument. Similarly, the user may define one or more restricted regions of the 3D representation to exclude any insertion pathway from traversing the restricted regions.
  • the user preferences may include a maximum or minimum distance for an insertion pathway into the subject 702, a maximum or minimum curvature of the insertion pathway, a preference for a straight path, a user identified determined insertion site or region for one or more insertion sites, a restriction of an insertion site or restricted region that forbids insertion sites, and/or a user defined treatment site 712.
  • the control system may further determine a restricted region in the 3D representation.
  • the restricted region indicates a region of the 3D representation, and further, of the subject 702, that is not to be traversed by either the determined insertion pathway and/or the two or more candidate insertion pathways.
  • the restricted region is a 3D volume and the control system 216 may determine the a candidate insertion pathways as paths that do not intersect or traverse any of the volume of the restricted region.
  • the processor may determine the restricted region automatically from the one or more objects, boundaries, or features of the 3D representation.
  • each potential insertion pathway 720a-720c may each have an independent respective insertion site 710a-710c.
  • two or more of the candidate insertion pathways 720a-720c may have a same insertion site.
  • a fourth curved insertion pathway 720d may have a same insertion site 710a as the first insertion pathway 720a.
  • a single insertion site 710a may be used for more than one insertion pathway.
  • an insertion pathway 720 may include one or more curves or arcs.
  • the instrument 210 may be inserted into the subject 702 at a first position 730a.
  • the distal end of the instrument may be imaged by the sensing probe 214 while the instrument 210 is being inserted into the patient to monitor a position of the instrument 210 along the insertion path 720.
  • the instrument 210 may be repositioned to a second position 730b having an angle relative to the first position 730 to cause the instrument to curve along a first arc 721a.
  • the instrument 210 may be repositioned again to a third position 730c with an angle relative to the first and second positions 730a and 730b to cause the instrument 210 to bend along a second arc 721b to reach the treatment site 712.
  • an insertion path may include one or more curves or arcs to reach a treatment site, avoid restricted regions, avoid objects, reduce a number of traversed voxels, etc.
  • the sensing probe 214 may continuously image the FOV 715 to observe the position of a distal end of the instrument to provide feedback for controlling the position of the instrument to achieve a certain insertion pathway depth and/or pathway curves.
  • the method 600 may optionally include, at block 610, obtaining preoperative imaging data and merging the preoperative imaging data and the 3D volume representation to provide a combined image of the target volume 700.
  • the preoperative image data may include one or more of CT scan data, MRI scan data, cone beam CT data, and/or ultrasound data.
  • the combined image of the target volume may allow for some tissues, voids, and structures to be imaged, or allow for better imaging of a region of a patient.
  • ultrasound imaging does not pass through regions of air, such as in the lungs.
  • Ultrasound imaging can image the airlung surface, and combined with a CT scan, the combined image shows that surface of the lung along with the mostly filled air cavity of the lung structure.
  • a bone may obscure an ultrasound image from imaging a portion of an organ behind the bone, combined with an MRI scan, the resultant image allows for imaging of the organs that were obscured by the bone structure.
  • a preoperative MRI or CT scan may provide a higher image quality and potentially can show additional features or targets that may be hard to image using ultrasound imaging.
  • a preoperative imaging set may have a larger field of view and could be analyzed by an operator to preselect a target, such as a tumor target.
  • Matching pre-operative FOV imaging data with an ultrasound image data set can guide the positioning and orientation of an ultrasound probe or sensor towards targets that may hard to reach.
  • Data or image fusion can be performed using rigid registration or non-rigid registration (e.g. vessel based registration).
  • the ultrasound scan can provide the updated real time information. For one example, when performing an ablation procedure, a preoperative scan can be combined with a postoperative 3D ultrasound volume to identify if a tumor has been fully ablated.
  • the control system 216 may adapt the determined instrument insertion pathway based on the combined image of the target volume.
  • the preoperative data may further provide insight into tissue densities, objects, features, or boundaries that the original 3D representation may not have captured. Therefore, the instrument insertion path may be updated or otherwise adapted based on information gleaned from the combined image of two different images and/or 3D representations of the target region 700.
  • the method 600 may further include receiving pressure data from the pressure sensor 248 coupled to the instrument driver 242, with the pressure data indicative of a pressure exerted on the instrument.
  • the control system 216 may then determine a current instrument position or trajectory based on the received pressure data. For example, the control system 216 may determine that the instrument has reached a border between different types of tissue, or the surface of an organ based on a change in the pressure data, and may further determine the position of the instrument along the insertion pathway. Additionally, the control system 216 may determine, from the pressure data, that the position of the instrument is not along the desired insertion pathway and the insertion trajectory may be updated to compensate for the current position of the instrument. The pressure data, along with a current position or trajectory of the instrument, may be used to update the insertion trajectory, or to adjust control of the instrument to compensate for any deviation from a desired insertion trajectory.
  • the system 100 can continuously perform the ultrasound scans to image and analyze the motion of the patient due to breathing by imaging the distance and positions between the target, and needle tip or instrument 210 to correct the path or trajectory of the instrument 210 based on the patients breathing.
  • the system 100 may determine motions of the patient from functions such as breathing, heartbeat, digestion, or another biological motion or function. Additionally, the breathing of the patient may be measured by placing a sensor on the body of the patient, extracted from an ECG, determined during an evaluation and having the patient take a deep breath or provide a breathing pattern sample, from the pressure sensor 234 coupled to the sensing probe 214, or by another means. Further, the system may only move the instrument 210 or a needle during certain breathing or motion phases, such as only during exhalation.
  • the method 600 includes controlling the repositionable structure 202 and the instrument holder 208 to advance the instrument 210 along the determined or identified insertion pathway.
  • the instrument 210 is advanced until it reaches the treatment site 712 and treatment is administered.
  • the instrument is then extracted out of the subject 702 along the insertion pathway.
  • the stylus may alone be retracted back through the instrument 210, such as a needle, while the needle remains inside of the patient, creating a channel in the needle to deliver additional therapies.
  • the instrument 210 may further be rotated or vibrated to advance the instrument 210 along the insertion pathway to assist with reduction of induced pain, reduction of required insertion force, to cross from one tissue to another, or to insert the instrument 210 into denser tissues, harder tissues or objects, rolling or movable objects or targets (e.g., a lymph node), etc.
  • the pressure sensor 234 coupled to the instrument holder 208 may be used to provide a close-feedback loop and the needle insertion pathway or trajectory may be updated or further determined from derived forces from the pressure sensor feedback loop.
  • the probe holder 212 may further be controlled to reposition the probe to perform one or more update scans or image sweeps of the target region 700 during the insertion of the instrument 210.
  • the method 600 may further include controlling at least one of the repositionable structure 202 and the probe holder 212 to keep the position of the instrument 210 within the FOV 715 of the sensing probe 214. Together the repositionable structure 202 and probe holder 212 control a position and orientation of the sensing probe 214, and as such, the sensing probe 214 may be moved and reoriented during insertion of the instrument 210 to actively image the position of the instrument 210 as the instrument 210 moves along the insertion pathway.
  • the method 600 may include moving the repositionable structure 202 according to a first set of movements which cause the movement of both the probe holder 212 and instrument holder 208 simultaneously.
  • the sensing probe 214 may then obtain images of the instrument 210 (e.g., a portion of the instrument, a distal end of the instrument, or another part of the instrument) to track and provide feedback pertaining to the position and trajectory of the instrument 210 during advancement of the instrument 210 along the insertion pathway.
  • the sensing probe 214 may be repositioned actively along with the insertion of the instrument 210 with the sensing probe 214 obtaining real-time images to track the position and/or trajectory of the instrument 210.
  • the method 600 may include moving the probe holder 212 and the instrument holder 212 in tandem such that a distal end of the instrument 210 is maintained in the FOV 715 of the sensing probe 214 during movement of the instrument 210.
  • the control system may move the sensing probe 214 and the instrument 210 synchronously to maintain the distal end of the instrument 210 within a 2D imaging plane of the sensing probe 214.
  • the distal end is maintained within the 2D imaging plane as the distal end inserts from an insertion site towards the treatment site or retracts from the treatment site towards the insertion site.
  • movement of the repositionable structure 202 and the probe holder 208 may be controlled to maintain a 2D plane imaging depth while also maintaining a given exerted pressure of the sensing probe 214 against the subject 702 or against a target during scanning of the target volume 700.
  • the update image sweep may be periodically performed based on a predefined parameter or setting.
  • the update image sweep may be performed in response to the advancement of the instrument by a predefined distance along the insertion pathway.
  • the predefined distance may be on the order of millimeters, less than 1 cm, about 2 cm, about 3 cm, between 3cm and 5 cm, 10 cm, or greater than 10 cm.
  • the updated probe sweep may be performed based on a given time interval (e.g., every half second, every second, every 5 seconds, every 10 seconds, every 30 seconds, etc.).
  • the update image sweep may be performed based on pressure data received from the pressure sensor 248.
  • the pressure data may include one or more unexpected pressure values indicating that the instrument may not be at a position along the desired insertion pathway, or that the instrument has encountered a restricted region, tissue, or organ.
  • the repositionable structure 202 and the instrument driver 242 may stop the insertion of the instrument 210 to perform the update image sweep to update the insertion pathway (and/or validate a current insertion pathway) based on the updated 3D representation.
  • the method 600 may further include, at block 616, repositioning the repositionable structure and moving the sensing probe to a new position to image a different part of the target volume 700, a different orientation of the target volume 700, a different angle or view of the target 705, or a different region of the subject 702.
  • the control system 216 identifies the position of the target volume 700 relative to the new position of the sensing probe 214.
  • the control system 216 may store in memory previous spatial coordinates and compare the previous spatial coordinates to new repositioned spatial coordinates to determine the position of the target volume 7090 relative to the new position of the sensing probe 214.
  • the control system 216 may map the relative position of the target volume 700 based on known positions of the sensing probe 214, or by a repositioning vector between the old position and the repositioned position and orientation of the sensing probe 214. In examples, to identify the position of the target volume relative to the new position of the sensing probe, the control system 216 may receive a user input identifying the location of the target volume 700 such as via a user interface or by providing spatial coordinates of the target volume or of the new position of the sensing probe.
  • probe holder 212 repositions the sensing probe 214 such that at least a portion of the target volume 700 is within the FOV 715 of the sensing probe 214.
  • the sensing probe obtains one or more images of the target volume 700 from the new position and orientation of the sensing probe 214.
  • the sensing probe 214 may be controlled to perform a sweep over the FOV 215 of the sensing probe 214 to obtain a plurality of images of the target volume.
  • the control system 216 may then reconstruct a new 3D reconstruction of the target volume based on the plurality of images from performing the sweep of the sensing probe 214.
  • the method 600 may further include controlling the repositionable structure 202 and the instrument holder 208 to extract the instrument 210 along the instrument insertion pathway.
  • the controller may control the repositionable structure 202 and the probe holder 212 to maintain the distal end of the instrument 210 in the FOV of the sensing probe 214.
  • the controller may control the repositionable structure 202 and the instrument holder 208 to insert the second instrument into the subject along the instrument insertion pathway.
  • the second instrument may be inserted to further provide treatment to the treatment site 712 of the target 705, or to observe the treatment site 712, or to extract tissue or part of the target 705.
  • FIG. 9 is an example flow diagram of an example method 900 for performing ultrasound guided robotic percutaneous instrument insertion for performing a multi-stage treatment, according to some examples.
  • the method 900 includes obtaining a plurality of images of the target volume 700 having a target 705 for providing multi-stage treatment.
  • the sensing probe 214 obtains the plurality of images and, at block 904, reconstructs a 3D representation of the target volume 700.
  • the control system 216 segments the 3D representation to identify objects, boundaries and features in the 3D representation.
  • the control system 216 determines one or more instrument insertion pathways from the 3D representation and the identified objects, boundaries, and/or features.
  • the repositionable structure 202 and the instrument holder 208 insert the first instrument along a first stage insertion pathway.
  • the first instrument provides a first stage treatment to the treatment site 712.
  • the first stage treatment may provide a multistage treatment to a target region or target or a patient.
  • a multistage treatment may include a first stage treatment including using an ultrasound probe at a needle tip to image a target or target region, and then replacing the ultrasound probe with a medication delivery catheter.
  • multiple electrodes need to be placed around a tumor volume to treat the full tumor which also requires multiple stages of delivering electrodes.
  • Yet another multistage treatment could include placing a catheter tube at a target, and then deliver pain medication through the catheter.
  • the repositionable structure 202 and the instrument holder 208 extract the first instrument along the first stage insertion pathway.
  • the first instrument is then replaced with a second instrument, or a second instrument having a second instrument is used to insert the second instrument into the subject 702.
  • multiple needles may be inserted into a patient to provide one or more treatments.
  • a first needle may be inserted into a tumor to provide energy to the tumor.
  • the needle can be left inserted into the tumor and decoupled from the system 100.
  • the system 100 may then be loaded with a second needle.
  • the second needle may then be inserted into the patient or the tumor adjacent to the first needle according to a treatment planning. This is particularly useful when delivering an energy based therapy where a single needle is used on an ellipsoid volume to treat the volume that is less than the tumor volume wherein multiple needles need to be delivered to cover the full tumor which can be as much as ten needles in current technologies.
  • the method 900 may further include inserting a third instrument to provide additional treatment stages during the multi-stage treatment.
  • the third instrument may be inserted along either then first insertion pathway 720a, second insertion pathway 720b, or along a third insertion pathway that is different than the first and second insertion pathways 720a and 720b.
  • a first treatment may include providing active anesthesia to the treatment site, while the second treatment performs a biopsy at the treatment site 712 or nearby on the target 705.
  • first stage and second stage may utilize a same insertion site with different insertion pathways to a same treatment site, or to two different treatment sites.
  • first and second instruments are a same instrument that may be used to perform multiple stages of the treatment such as to provide two doses of a drug, or to perform two biopsies. Further, the same instrument may be used for the first and second stages with different insertion sites to provide treatment to different areas of the target 705, or to provide treatment to different sides or from different angles of the treatment site 712.
  • 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.

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Abstract

Sont décrits des systèmes et des procédés d'insertion d'instrument percutané robotique guidé par ultrasons dans un sujet. Le procédé peut consister (i) à obtenir des images d'un volume cible d'un sujet, les images étant obtenues par une sonde de détection positionnée physiquement par un support de sonde qui est couplé à une structure repositionnable; (ii) reconstruire une représentation tridimensionnelle (3D) du volume cible à partir des images du volume cible; (iii) segmenter la représentation 3D du volume cible pour identifier un ou plusieurs objets, limites ou caractéristiques dans la représentation 3D du volume cible; (iv) déterminer un trajet d'insertion d'instrument comprenant un site d'insertion et un site de traitement; et (v) commander la structure repositionnable et un porte-instrument pour faire avancer un instrument le long du trajet d'insertion.
EP24776415.2A 2023-09-06 2024-09-05 Flux de travail pour robot à aiguille percutanée guidée par ultrasons Pending EP4773902A1 (fr)

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PCT/US2024/045229 WO2025054219A1 (fr) 2023-09-06 2024-09-05 Flux de travail pour robot à aiguille percutanée guidée par ultrasons

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