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WO2025238471A1 - Système de navigation chirurgicale à trajet de trajectoire non linéaire - Google Patents

Système de navigation chirurgicale à trajet de trajectoire non linéaire

Info

Publication number
WO2025238471A1
WO2025238471A1 PCT/IB2025/054674 IB2025054674W WO2025238471A1 WO 2025238471 A1 WO2025238471 A1 WO 2025238471A1 IB 2025054674 W IB2025054674 W IB 2025054674W WO 2025238471 A1 WO2025238471 A1 WO 2025238471A1
Authority
WO
WIPO (PCT)
Prior art keywords
ablation device
trajectory
target
computing device
ablation
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/IB2025/054674
Other languages
English (en)
Inventor
Ryan S. SOHLDEN
Kathy E. Mc Cluskey
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.)
Covidien LP
Original Assignee
Covidien LP
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 Covidien LP filed Critical Covidien LP
Publication of WO2025238471A1 publication Critical patent/WO2025238471A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—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
    • 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
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/1815—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using microwaves
    • 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
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577—Ablation
    • 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
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/1815—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using microwaves
    • A61B2018/1869—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using microwaves with an instrument interstitially inserted into the body, e.g. needles
    • 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
    • A61B2034/107—Visualisation of planned trajectories or target regions
    • 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
    • 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
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/90—Identification means for patients or instruments, e.g. tags
    • A61B90/94—Identification means for patients or instruments, e.g. tags coded with symbols, e.g. text
    • A61B90/96—Identification means for patients or instruments, e.g. tags coded with symbols, e.g. text using barcodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/90—Identification means for patients or instruments, e.g. tags
    • A61B90/98—Identification means for patients or instruments, e.g. tags using electromagnetic means, e.g. transponders

Definitions

  • This disclosure relates generally to surgical navigation systems and methods for planning a path for image-guided navigation of an ablation device, such as a microwave ablation antenna, to a target treatment site within a patient. More specifically, this disclosure relates to leveraging a flexural modulus of the ablation antenna to plan a non-linear trajectory path through a patient’s tissue that avoids critical structures and aligns the ablation device with a target (e.g., tumor) within the patient.
  • a target e.g., tumor
  • Electrosurgery involves the application of thermal and/or electrical energy to cut, dissect, ablate, coagulate, cauterize, seal, or otherwise treat biological tissue during a surgical procedure. Electrosurgery is typically performed using a handpiece including a surgical device (e.g., end effector or ablation device) that is adapted to transmit energy to a tissue site during electrosurgical procedures, a remote electrosurgical generator operable to output energy, and a cable assembly operatively connecting the surgical device to the remote generator.
  • a surgical device e.g., end effector or ablation device
  • a remote electrosurgical generator operable to output energy
  • a cable assembly operatively connecting the surgical device to the remote generator.
  • Minimally invasive tumor ablation procedures may be performed using two dimensional (2D) preoperative computed tomography (CT) images and an “ablation zone chart” which typically describes the characteristics of an ablation needle in an experimental, ex-vivo tissue across a range of input parameters (power, time).
  • Energy dose can be correlated to ablation tissue effect (volume, shape) for a specific design.
  • ultrasound guidance Typically, a high level of skill is required to place a surgical device into a target identified under ultrasound.
  • Ultrasound-guided intervention involves the use of real-time ultrasound imaging (transabdominal, intraoperative, etc.) to accurately direct surgical devices to their intended target. This can be performed by percutaneous application and/or intraoperative application.
  • the ultrasound system will include a transducer that images patient tissue and is used to identify the target and to anticipate and/or follow the path of an instrument toward the target.
  • Ultrasound-guided interventions are commonly used today for tumor ablation and surgical resection of organs (liver, lung, kidney, and so forth).
  • a biopsy-like needle may be employed to deliver energy (RF, microwave, cryo, and so forth) with the intent to kill the tumor.
  • the ultrasound-guidance typically offers a two dimensional image plane that is captured from the distal end of a patient-applied transducer.
  • the user needs to visualize and characterize the target, to choose the instrument angle and entry point to reach the target, and to see the surgical device and its motion toward the target.
  • Advancing an ablation device toward a target can be difficult and often takes more than one attempt for a surgeon to reach the final placement. Repositioning can lead to unecessary trauma for the patient’s anatomy and increase risk of spreading cancer cells.
  • Ablation devices today typically include some flex in the shaft of the device making linear placement of the ablation device at the target difficult with resulting deviations along intended target pathways.
  • distal refers to the portion that is being described which is farther from an operator (whether a surgeon or a surgical robot), while the term “proximal” refers to the portion that is being described which is closer to the operator.
  • Terms including “generally,” “about,” “substantially,” and the like, as utilized herein, are meant to encompass variations, e.g., manufacturing tolerances, material tolerances, use and environmental tolerances, measurement variations, design variations, and/or other tolerances and variations, up to and including plus or minus 10 percent. Further, to the extent consistent, any or all of the aspects detailed herein may be used in conjunction with any or all of the other aspects detailed herein.
  • a system including an ablation device including a plurality of electromagnetic (EM) sensors.
  • the system may also include a tracking system configured to sense a position of the plurality of EM sensors.
  • the system may further include a computing device including a processor and a memory storing instructions which, when executed by the processor, cause the computing device to determine a trajectory of the ablation device based on the change in an axial distance between at least two of the plurality of EM sensors and to display the ablation device and a target within a patient, and the trajectory in relation to an ultrasound image plane of ultrasound image data generated by an ultrasound imager.
  • the ablation device includes a handle housing, an elongated shaft extending distally from the handle housing, a distal radiating portion disposed at a distal portion of the elongated shaft, and a distal tip portion disposed at a distal end of the distal radiating portion for piercing tissue.
  • the plurality of EM sensors are disposed on an elongated shaft of the ablation device at a known axial distance from each other.
  • the plurality of EM sensors are disposed between a distal end of the handle housing and a proximal end of the distal radiating portion.
  • the ablation device includes a microwave antenna.
  • the instructions when executed by the processor, further cause the computing device to overlay a safe zone on the ultrasound image data that delineates an area within the patient where the ablation device is bendable to align the trajectory with the target without a bend tolerance of the ablation device being exceeded.
  • the instructions when executed by the processor, further cause the computing device to overlay an unreachable zone on the ultrasound image data that delineates an area within the patient where the trajectory is not able to be aligned with the target without exceeding a bend tolerance of the ablation device.
  • the instructions when executed by the processor, further cause the computing device to generate at least one of an audible alert or a visual alert in response to a bend tolerance of the ablation device being exceeded.
  • the instructions when executed by the processor, further cause the computing device to display the trajectory in a first color indicating that the trajectory is aligned with the target without exceeding a bend tolerance of the ablation device, and in a second color indicating that the trajectory is unable to be aligned with the target without exceeding the bend tolerance of the ablation device.
  • a system including a tracking system configured to sense a position of a plurality of sensors disposed on an ablation device.
  • the system may also include a computing device including a processor and a memory storing instructions which, when executed by the processor, cause the computing device to determine a trajectory of the ablation device based on a change in an axial distance between at least two of the plurality of sensors.
  • the computing device may also display the ablation device and the trajectory relative to a target within a patient.
  • the system also includes an ultrasound imager configured to generate ultrasound image data and the instructions, when executed by the processor, further cause the computing device to display the ablation device, a target within a patient, and the trajectory in relation to an ultrasound image plane of the ultrasound image data.
  • the instructions when executed by the processor, further cause the computing device to overlay a safe zone on the ultrasound image data that delineates an area within the patient where the ablation device is bendable to align the trajectory with the target without a bend tolerance of the ablation device being exceeded.
  • the instructions when executed by the processor, further cause the computing device to overlay an unreachable zone on the ultrasound image data that delineates an area within the patient where the trajectory is not able to be aligned with the target without exceeding a bend tolerance of the ablation device.
  • the sensors are disposed on an elongated shaft of the ablation device at a known axial distance from each other.
  • the ablation device includes a handle housing, an elongated shaft extending distally from the handle housing, a distal radiating portion disposed at a distal portion of the elongated shaft, and a distal tip portion disposed at a distal end of the distal radiating portion for piercing tissue.
  • the plurality of sensors are disposed between a distal end of the handle housing and a proximal end of the distal radiating portion.
  • the ablation device includes a microwave antenna.
  • the instructions when executed by the processor, further cause the computing device to generate at least one of an audible alert or a visual alert in response to a bend tolerance of the ablation device being exceeded.
  • the instructions when executed by the processor, further cause the computing device to display the trajectory in a first color indicating that the trajectory is aligned with the target without exceeding a bend tolerance of the ablation device, and in a second color indicating that the trajectory is unable to be aligned with the target without exceeding the bend tolerance of the ablation device.
  • an ablation device including a handle housing, an elongated shaft extending distally from the handle housing, and a distal radiating portion disposed at a distal portion of the elongated shaft.
  • the ablation device may also include a plurality of sensors between the handle housing and the distal radiating portion. The ablation device may bend to cause a change in an axial distance between at least two of the plurality of sensors.
  • FIG. 1 shows a schematic diagram of a surgical planning and procedure system in accordance with aspects of the present disclosure
  • FIG. 2 shows a schematic diagram of a computing device that forms part of the surgical planning and procedure system of FIG. 1 ;
  • FIG. 3 shows a side view of an ablation device for use with the surgical planning and procedure system of FIG. 1;
  • FIGS. 4A-4D are illustrations of an example graphical user interface that may be used during a procedure phase of an ablation procedure in accordance with aspects of this disclosure
  • FIGS. 5A and 5B are illustrations of an example graphical user interface that may be used during a procedure phase of an ablation procedure in accordance with aspects of this disclosure.
  • FIG. 6 is a schematic illustration of an exemplary robotic surgical system configured for use with the surgical plume evacuation system of FIG. 1.
  • the present disclosure relates to a system for planning and performing a surgical ablation procedure.
  • the system presents a clinician with a streamlined method of treatment planning from the initial target identification and selection, target sizing, treatment zone sizing, entry point and route selection to create a pathway to the target, and a treatment plan review.
  • the treatment plan may then be used as a guide during the performance of the ablation procedure, where the system is configured to track the position of surgical tools inside the patient and give the clinician a real-time view of the position of the tools in relation to the target and the pre-planned pathway toward the target.
  • the system also presents a clinician with the capability to compare and contrast pre-operative and post-operative CT image data to assess the outcome of a surgical treatment procedure that has been performed.
  • Ablation treatment is generally divided into two phases: (1) a planning phase and (2) a procedure phase.
  • the planning phase of ablation treatment is more fully described in commonly-owned U.S. Patent No. 11,227,427.
  • An ablation planning and procedure system may be a unitary system configured to perform both the planning phase and the procedure phase, or the system may include separate devices and software programs for the various phases.
  • An example of the latter may be a system wherein a first computing device with one or more specialized software programs is used during the planning phase, and a second computing device with one or more specialized software programs may import data from the first computing device to be used during the procedure phase.
  • a surgical navigation and treatment system 10 which includes a computing device 100, a display 110, a table 120, an ablation device 130, an ultrasound imager 140, an ultrasound workstation 150, and an electrosurgical energy source 160 (e.g., a microwave generator).
  • Computing device 100 may be, for example, a laptop computer, desktop computer, tablet computer, or other similar device.
  • Computing device 100 may be configured to control an electrosurgical generator, a peristaltic pump, a power supply, and/or any other accessories and peripheral devices relating to, or forming part of, system 10.
  • Display 110 is configured to output instructions, images, and messages relating to the performance of an ablation procedure.
  • Table 120 may be, for example, an operating table or other table suitable for use during a surgical procedure, which includes an electromagnetic (EM) field generator 121.
  • EM field generator 121 is used to generate an EM field during the ablation procedure and forms part of an EM tracking system which is used to track the positions of surgical instruments within the body of a patient.
  • EM field generator 121 may include various components, such as a specially designed pad to be placed under, or integrated into, an operating table or patient bed.
  • EM field generator 121 may be a flat structure on which a patient lays or may be a side-mount device mounted to table 120 or to a suitable surgical boom or stand for positioning of EM field generator 121 alongside a patient laying on table 120.
  • Ablation device 130 includes a plurality of EM tracking sensors (e.g., sensor coils), referenced generally as 135, embedded within or attached to an elongated shaft 134 of ablation device 130 (see FIG. 3).
  • the EM tracking system is configured to track the location of EM tracking sensors 135.
  • Ablation device 130 is a surgical instrument (e.g., a microwave ablation antenna, an RF ablation device, etc.) which is used to ablate tissue. While the present disclosure describes the use of system 10 in a surgical environment, it is also envisioned that some or all of the components of system 10 may be used in alternative settings, for example, an imaging laboratory and/or an office setting.
  • Ultrasound imager 140 such as an ultrasound wand, may be used to image the patient's body during the ablation procedure to generate ultrasound imaging data for visualizing the location of the surgical instruments, such as ablation device 130, inside the patient's body via display 110 and/or display 206.
  • Ultrasound imager 140 may have an EM tracking sensor (not shown) embedded within or attached to the ultrasound wand, for example, a clip-on sensor or a sticker sensor.
  • ultrasound imager 140 may be positioned in relation to ablation device 130 such that ablation device 130 is at an angle to the ultrasound image plane, thereby enabling the clinician to visualize the spatial relationship of ablation device 130 with the ultrasound image plane and with objects being imaged. Further, the EM tracking system may also track the location of ultrasound imager 140. In some embodiments, one or more ultrasound sensors 140 may be placed inside the body of the patient. EM tracking system may then track the location of such ultrasound sensors 140 and ablation device 130 inside the body of the patient.
  • Ablation device 130 is used to ablate a lesion or tumor (hereinafter referred to as a “target”) by using electromagnetic radiation (e.g., microwave energy, RF energy, etc.) to heat tissue in order to denature or kill cancerous cells.
  • electromagnetic radiation e.g., microwave energy, RF energy, etc.
  • the location of ablation device 130 within the body of the patient may be tracked during the surgical procedure.
  • An example approach of tracking the location of ablation device 130 is by using the EM tracking system, which tracks the location of ablation device 130 by tracking EM tracking sensors 135 (see FIG. 3) attached to ablation device 130.
  • EM tracking sensors such as printed EM sensors and/or coil sensors.
  • Computing device 100 may include memory 202, processor 204, display 206, network interface 208, input device 210, and/or output module 212.
  • Memory 202 includes any non-transitory computer-readable storage media for storing data and/or software that is executable by processor 204 and which controls the operation of computing device 100.
  • memory 202 may include one or more solid-state storage devices such as flash memory chips.
  • memory 202 may include one or more mass storage devices connected to the processor 204 through a mass storage controller (not shown) and a communications bus (not shown).
  • mass storage controller not shown
  • communications bus not shown
  • computer readable storage media includes non-transitory, volatile and non-volatile, removable and nonremovable media implemented in any method or technology for storage of information such as computer-readable instructions, data structures, program modules or other data.
  • computer-readable storage media includes RAM, ROM, EPROM, EEPROM, flash memory or other solid state memory technology, CD-ROM, DVD, Blu-Ray or other optical storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other medium which can be used to store the desired information, and which can be accessed by computing device 100.
  • Memory 202 may store application 216 and/or CT data 214. Application 216 may, when executed by processor 204, cause display 206 to present user interface 218.
  • Processor 204 may be a general purpose processor, a specialized graphics processing unit (GPU) configured to perform specific graphics processing tasks while freeing up the general purpose processor to perform other tasks, and/or any number or combination of such processors.
  • GPU graphics processing unit
  • Display 206 may be touch sensitive and/or voice activated, enabling display 206 to serve as both an input and output device.
  • a keyboard not shown
  • mouse not shown
  • other data input devices may be employed.
  • Network interface 208 may be configured to connect to a network such as a local area network (LAN) consisting of a wired network and/or a wireless network, a wide area network (WAN), a wireless mobile network, a Bluetooth network, and/or the internet.
  • LAN local area network
  • WAN wide area network
  • computing device 100 may receive computed tomographic (CT) image data of a patient from a server, for example, a hospital server, internet server, or other similar servers, for use during surgical ablation planning.
  • CT image data may also be provided to computing device 100 via a removable memory 202.
  • Computing device 100 may receive updates to its software, for example, application 216, via network interface 208.
  • Computing device 100 may also display notifications on display 206 that a software update is available.
  • Input device 210 may be any device by means of which a user may interact with computing device 100, such as, for example, a mouse, keyboard, foot pedal, touch screen, and/or voice interface.
  • Output module 212 may include any connectivity port or bus, such as, for example, parallel ports, serial ports, universal serial busses (USB), or any other similar connectivity port known to those skilled in the art.
  • Application 216 may be one or more software programs stored in memory 202 and executed by processor 204 of computing device 100.
  • Application 216 may be installed directly on computing device 100, or may be installed on another computer, for example a central server, and opened on computing device 100 via network interface 208.
  • Application 216 may run natively on computing device 100, as a web-based application, or any other format known to those skilled in the art.
  • application 216 will be a single software program having all of the features and functionality described in the present disclosure.
  • application 216 may be two or more distinct software programs providing various parts of these features and functionality.
  • Application 216 communicates with a user interface 218 which generates a user interface for presenting visual interactive features to a clinician, for example, on display 206 and for receiving clinician input, for example, via a user input device.
  • user interface 218 may generate a graphical user interface (GUI) and output the GUI to display 206 for viewing by a clinician.
  • GUI graphical user interface
  • Computing device 100 is linked to display 110, thus enabling computing device 100 to control the output on display 110 along with the output on display 206.
  • Computing device 100 may control display 110 to display output which is the same as or similar to the output displayed on display 206.
  • the output on display 206 may be mirrored on display 100.
  • computing device 100 may control display 110 to display different output from that displayed on display 206.
  • display 110 may be controlled to display guidance images and information during an ablation procedure, while display 206 is controlled to display other output, such as configuration or status information.
  • the term “clinician” refers to any medical professional (i.e., doctor, surgeon, nurse, or the like) or other user of the treatment planning system 10 involved in planning, performing, monitoring and/or supervising a medical procedure involving the use of the embodiments described herein.
  • ablation device 130 is shown and generally includes a handle housing 132 and an elongated shaft 134 extending from a distal end of handle housing 132.
  • Handle housing 132 may be configured as a handle to facilitate grasping and manipulation by a surgeon or may be configured to mount to an arm 1002, 1003 of a surgical robotic system 1000 for use in robotic surgery (see FIG. 6).
  • ablation device 130 may be a microwave ablation antenna configured to deliver microwave energy to tissue via a distal radiating portion 136 disposed at a distal portion of elongated shaft 134.
  • a tapered distal tip portion 138 is disposed distal to distal radiating portion 136 at a distal end of elongated shaft 134 and is configured to pierce tissue to facilitate passage of elongated shaft 134 through tissue toward a target within the patient.
  • Distal tip portion 138 may be made of or include a material that is visible under ultrasound imaging and/or CT imaging such as, for example, ceramic.
  • EM tracking sensor 135 work in conjunction with the EM tracking system to enable tracking and navigation of the EM sensors 135, and thus elongated shaft 134 of ablation device 130, within the magnetic field generated by EM field generator 121.
  • the EM tracking system receives location and/or orientation data corresponding to EM tracking sensors 135 that enables EM tracking sensors 135 to be tracked during navigation toward a target site within the patient.
  • each of EM tracking sensors 135 includes coils of wire formed by wrapping wire around a core.
  • EM tracking sensors 135 are made of or include a copper material and are visible to the clinician under various imaging modalities (e.g., ultrasound, CT, etc.).
  • computing device 100 may include computational models (e.g., a CAD model) of various types and sizes of ablation devices from which a user may select ablation device 130.
  • computing device 100 may automatically identify ablation device 130 when it is connected to electrosurgical energy source 160 and/or to computing device 100 (e.g., via a coded resistor, data stored on a ROM housed within ablation device 130, bar code, RFID, etc.).
  • the stiffness and bending capability (or flexural modulus) of elongated shaft 134 of ablation device 130 is characterized according to the material properties of elongated shaft 134 and may be stored in memory 202 of computing device 100.
  • Bending of elongated shaft 134 may be simulated using finite-element analysis of elongated shaft 134 and patient tissue to generate a model of ablation device 130. From there, computing device 100 may simulate several locations to determine viable path options and determine whether any possible path options allow ablation device 130 to be maneuvered to a target while avoiding critical structures within the patient (e.g., vessels). Additionally, the clinician may choose an orientation for ablation device 130 and input it into computing device 100 to determine a specific path and allow computing device 100 to determine whether that path is a viable option. [0055] EM tracking sensors 135 are positioned along elongated shaft 134 at a known axial distance and location relative to each other.
  • EM tracking sensors 135 may be evenly spaced apart along elongated shaft 134 such that the axial distance is the same between any two adjacent EM tracking sensors 135.
  • the axial distances between EM tracking sensors 135 may vary.
  • the axial distance between a first pair of adjacent EM tracking sensors 135 may be different than an axial distance between a second pair of adjacent EM tracking sensors 135.
  • EM tracking sensors 135 may be positioned closer together along a portion of elongated shaft 134 where there is more flexibility and/or where higher stress is experienced (e.g., a distal portion of elongated shaft 134) and positioned further apart from each other along a portion of elongated shaft 134 where there is less flexibility and/or where relatively less stress is experienced (e.g., a proximal portion of elongated shaft 134 closer to handle housing 132).
  • the portion of elongated shaft 134 where EM tracking sensor 135 are positioned relatively further apart may include less EM tracking sensor 135 relative to the portion of elongated shaft 134 where EM tracking sensors 135 are positioned relatively closer together.
  • an axial distance between EM tracking sensors 135 may be uniform, varied, or any combination of uniform and varied.
  • the EM tracking system detects the change in location of EM tracking sensors 135 relative to each other to measure and quantify the bend of elongated shaft 134 in three-dimensional (3D) space, which computing device 100 uses to calculate a trajectory curve corresponding to the bend of elongated shaft 134.
  • Computing device 100 causes the trajectory curve to be overlay ed on an ultrasound image generated by ultrasound workstation 150 and displayed on display 110 and/or display 206 such that the clinician can visualize a trajectory of ablation device 130 relative to an identified target in the ultrasound image.
  • trajectory curve may alternatively or additionally be overlaid on a CT image and displayed on display 110 and/or display 206.
  • GUI 300 generated by user interface 218, which may be presented by computing device 100 on display 206 and/or display 110.
  • GUI 300 includes a graphical representation of ablation device 130 being navigated relative to a target “T” (e.g., tumor) within a patient under ultrasound imaging generated by ultrasound imager 140.
  • target “T” e.g., tumor
  • ablation device 130 is illustrated in use for a percutaneous ablation procedure during which elongated shaft 134 of ablation device 130 is inserted through skin and in between ribs of the patient to treat target “T” within the patient.
  • GUI 300 includes a graphical representation of a trajectory 310 of ablation device 130, showing the trajectory at which ablation device 130 is being navigated inside the patient’s body.
  • trajectory 310 may correspond to the length of ablation device 130 or, more specifically, to the length of elongated shaft 134.
  • the width of trajectory 310 may correspond to the width of elongated shaft 134.
  • GUI 300 may depict ablation device 130 and trajectory 310 as outlines, such that the ultrasound image (e.g., displayed on an ultrasound image plane) is not obscured by ablation device 130 and trajectory 310.
  • GUI 300 may further depict ablation device 130 and trajectory 310 in relation to an ultrasound image plane such that portions of elongated shaft 134 and trajectory 310 that are behind the ultrasound image plane are depicted as shadowed (e.g. dimmed or greyed-out).
  • portions of elongated shaft 134 and trajectory 310 that are in front of the ultrasound image plane may be shown having normal brightness and not shadowed or dimmed.
  • FIG. 4 A shows an initial advancement of ablation device 130 along trajectory 310 to place ablation device 130 relative to target “T” under ultrasound imaging generated by ultrasound imager 140.
  • trajectory 310 is linear and advancement of ablation device 130 along trajectory 310 has resulted in elongated shaft 134 not being sufficiently aligned with target “T” or with a center of target “T”.
  • This initial attempt at placement of ablation device 130 along a linear trajectory path may have been the result of the clinician attempting to avoid a critical structure (e.g., vessel) within the patient or may have simply been an error in the clinician’s planned approach. Either way, this initial placement may not be ideal since the resulting ablation zone margin may expand beyond target “T” and damage surrounding healthy tissue.
  • the clinician is able to visualize this initial placement via display 110 and/or display 206 and, if the clinician wishes to refine the placement of ablation device 130 relative to target “T”, the clinician retracts ablation device 130, as illustrated in FIG. 4B, before making another attempt at placement of ablation device 130 in sufficient alignment with target “T” or with a center of target “T”.
  • Retraction of ablation device 130 in this scenario involves retracting ablation device 130 from target “T” while maintaining elongated shaft 134 within the patient such that ablation device 130 is not fully retracted and removed from within the patient.
  • the clinician causes elongated shaft 134 to flex or bend, as shown in FIG.
  • the EM tracking system detects a change in the known axial distance between at least two of EM tracking sensors 135 and computing device 100 calculates a curve for trajectory 310 based on the detected bending of elongated shaft 134.
  • Computing device 100 uses the calculated curve to create an arc in trajectory 310 for display on GUI 300, as depicted in FIG. 4C.
  • the clinician may, in real time, adjust the bend in ablation device 130 to cause the displayed arc in trajectory 310 to correspondingly change so that the clinician can align trajectory 310 with target “T” or with the center of target “T”.
  • ablation device 130 would typically be fully retracted from the patient following ablation of one target and repositioned to align with a subsequent target (not shown).
  • ablation device 130 may be retracted from target “T” while maintaining elongated shaft 134 within the patient and, once retracted a sufficient distance, the clincician bends ablation device 130 to cause the arc in trajectory 310 to correspondingly change so that the clinician can align the now- curved trajectory 310 with a subsequent target.
  • trajectory 310 may be shown in a particular color (e.g., green) indicating that alignment with target “T” is achievable without having to bend elongated shaft 134 beyond its bend tolerance (e.g., flexural modulus) such that elongated shaft 134 will not undergo stress to such a degree that the material quality of elongated shaft 134 will be compromised.
  • trajectory 310 may be displayed in a particular color (e.g., red) indicating that alignment with target “T” is not achievable because target “T” is beyond the bend tolerance of elongated shaft 134.
  • GUI 300 shows ablation device 130 being advanced along trajectory 310 within the patient under ultrasound imaging generated by ultrasound imager 140.
  • a safe zone “SZ” that delineates an area within the patient where trajectory 310 can be aligned with a target “Tl” within safe zone “SZ” without a bend tolerance of elongated shaft 134 being exceeded to possibly stress elongated shaft to the point of compromising the material quality of elongated shaft 134.
  • unreachable zones “UZ” that delineate areas within the patient where trajectory 310 is unable to align with a target “T2” within unreachable zone “UZ” without exceeding the bend tolerance of elongated shaft 134.
  • FIG. 5 A shows elongated shaft 134 bent and being advanced along trajectory 310 within safe zone “SZ” where trajectory 310 is aligned with target “Tl”. Also shown is target “T2” located within unreachable zone “UZ”. In this scenario, ablation device 130 can be navigated within safe zone “SZ” to reach target “Tl” or multiple other targets within safe zone “SZ” without being damaged from bending elongated shaft 134 beyond its bend tolerance.
  • GUI 300 may display safe zone “SZ” shaded in a particular color (e.g., green) and/or display an outline of the outer periphery of safe zone “SZ” to help the clinician clearly identify safe zone “SZ” and its boundaries during navigation of ablation device 130.
  • a particular color e.g., green
  • FIG. 5B shows elongated shaft 134 bent and being advanced along trajectory 310 in attempt to reach target “T2” within unreachable zone “UZ”.
  • trajectory 310 cannot be aligned with target “T2” without bending elongated shaft 134 beyond its bend tolerance, which may result in stress and/or damage to elongated shaft 134.
  • distal radiating portion 136 of ablation device 130 cannot reach target “T2” based on the approach of ablation device 130 illustrated in FIG. 5B.
  • computing device 100 may cause an alert to be displayed on GUI 300 in response to elongated shaft 134 being bent beyond its bend tolerance and/or being flexed beyond the boundary of safe zone “SZ” and into unreachable zone “UZ”.
  • the alert may be, for example, a visual alert (e.g., a flashing warning) generated on display 110 and/or display 206, an audible alert (e.g., auditory tone), or a combination visual/audible alert.
  • FIG. 6 a robotic surgical system 1000 configured for use in accordance with this disclosure is shown. Aspects and features of robotic surgical system 1000 not germane to the understanding of this disclosure are omitted to avoid obscuring the aspects and features of this disclosure in unnecessary detail.
  • Robotic surgical system 1000 generally includes a plurality of robot arms 1002, 1003; a control device 1004; and an operating console 1005 coupled with control device 1004.
  • Operating console 1005 may include a display device 1006, which may be set up in particular to display three-dimensional images; and manual input devices 1007, 1008, by means of which a clinician, e.g., a surgeon, may be able to telemanipulate robot arms 1002, 1003 in a first operating mode.
  • Robotic surgical system 1000 may be configured for use on a patient 1013 lying on a patient table 1012 to be treated in a minimally invasive manner.
  • Robotic surgical system 1000 may further include a database 1014, in particular coupled to control device 1004, in which are stored, for example, pre-operative data from patient 1013 and/or anatomical atlases.
  • Each of the robot arms 1002, 1003 may include a plurality of members, which are connected through joints, and a mounted device which may be, for example, a surgical tool “ST.”
  • the surgical tools “ST” may include, for example, ablation device 130 (FIG. 3).
  • Ablation device 130 may, in turn, be connected to electrosurgical energy source 160 (FIG. 1), which is mounted on the robot arm 1002, 1003, disposed on a surgical cart (not shown) associated with robotic surgical system 1000, or otherwise positioned as part of or separate from robotic surgical system 1000 to provide any of the above-detailed navigation and ablation functionalities for use with robotic surgical system 1000.
  • Robot arms 1002, 1003 may be driven by electric drives, e.g., motors, connected to control device 1004.
  • the motors may be rotational drive motors configured to provide rotational inputs to accomplish a desired task or tasks.
  • Control device 1004, e.g., a computer may be configured to activate the motors, in particular by means of a computer program, in such a way that robot arms 1002, 1003, and, thus, their mounted surgical tools “ST” execute a desired movement and/or function according to a corresponding input from manual input devices 1007, 1008, respectively.
  • Control device 1004 may also be configured in such a way that it regulates the movement of robot arms 1002, 1003 and/or of the motors.
  • Control device 1004 may control one or more of the motors based on rotation, e.g., controlling to rotational position using a rotational position encoder (or Hall effect sensors or other suitable rotational position detectors) associated with the motor to determine a degree of rotation output from the motor and, thus, the degree of rotational input provided.
  • control device 1004 may control one or more of the motors based on torque, current, or in any other suitable manner.
  • metal material included in EM tracking sensors 135 may distort the EM field generated by EM field generator 121 and/or distort deflection measurements.
  • a calibration of system 10 may be needed to account for metal materials on ablation device 130 (e.g., EM tracking sensors 135) along with monitoring of EM interference.
  • system 10 may include a pre-calibrated setting that accounts for use of system 10 with robotic surgical system 1000 or a calibration of system 10 may be performed prior to a procedure.
  • handle housing 132 of ablation device 130 may, in aspects of the present disclosure, include a plurality of coils (e.g., three coils in three different fixed locations) that are orthogonal to each other and configured to detect distortion.
  • distortion in the EM field causes measurements between each of the plurality of coils to change, which triggers system 10 to generate an alert and/or indication that the location and/or orientation data corresponding to EM tracking sensors 135 provided to the EM tracking system is inaccurate.

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Abstract

Un système comprend un dispositif d'ablation comprenant une pluralité de capteurs de suivi. Le système comprend également un dispositif informatique comprenant un processeur et une mémoire stockant des instructions qui, lorsqu'elles sont exécutées par le processeur, amènent le dispositif informatique à déterminer une trajectoire du dispositif d'ablation sur la base d'un changement d'une distance axiale entre au moins deux capteurs de la pluralité de capteurs EM et à afficher le dispositif d'ablation et une cible à l'intérieur d'un patient, et la trajectoire par rapport à un plan d'image ultrasonore de données d'image ultrasonore générées par un imageur ultrasonore.
PCT/IB2025/054674 2024-05-16 2025-05-05 Système de navigation chirurgicale à trajet de trajectoire non linéaire Pending WO2025238471A1 (fr)

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Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060229594A1 (en) * 2000-01-19 2006-10-12 Medtronic, Inc. Method for guiding a medical device
US20130158538A1 (en) * 2009-12-11 2013-06-20 Biosense Webster (Israel), Ltd. Pre-formed curved ablation catheter
US20140024909A1 (en) * 2011-02-24 2014-01-23 MRI Interventions, Inc. Mri-guided catheters
US20160367168A1 (en) * 2015-06-19 2016-12-22 St. Jude Medical, Cardiology Division, Inc. Electromagnetic dynamic registration for device navigation
US11227427B2 (en) 2014-08-11 2022-01-18 Covidien Lp Treatment procedure planning system and method
US20220079671A1 (en) * 2020-09-14 2022-03-17 Covidien Lp System and methods for insertion depth tracking
CN114209417A (zh) * 2021-12-13 2022-03-22 四川锦江电子科技有限公司 可视化深度消融导管
US20230157783A1 (en) * 2020-02-21 2023-05-25 Intuitive Surgical Operations, Inc. Systems and methods for delivering targeted therapy

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060229594A1 (en) * 2000-01-19 2006-10-12 Medtronic, Inc. Method for guiding a medical device
US20130158538A1 (en) * 2009-12-11 2013-06-20 Biosense Webster (Israel), Ltd. Pre-formed curved ablation catheter
US20140024909A1 (en) * 2011-02-24 2014-01-23 MRI Interventions, Inc. Mri-guided catheters
US11227427B2 (en) 2014-08-11 2022-01-18 Covidien Lp Treatment procedure planning system and method
US20160367168A1 (en) * 2015-06-19 2016-12-22 St. Jude Medical, Cardiology Division, Inc. Electromagnetic dynamic registration for device navigation
US20230157783A1 (en) * 2020-02-21 2023-05-25 Intuitive Surgical Operations, Inc. Systems and methods for delivering targeted therapy
US20220079671A1 (en) * 2020-09-14 2022-03-17 Covidien Lp System and methods for insertion depth tracking
CN114209417A (zh) * 2021-12-13 2022-03-22 四川锦江电子科技有限公司 可视化深度消融导管

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