WO2016092461A1 - Positioning electromagnetic field generators for interventional procedures - Google Patents

Positioning electromagnetic field generators for interventional procedures Download PDF

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Publication number
WO2016092461A1
WO2016092461A1 PCT/IB2015/059421 IB2015059421W WO2016092461A1 WO 2016092461 A1 WO2016092461 A1 WO 2016092461A1 IB 2015059421 W IB2015059421 W IB 2015059421W WO 2016092461 A1 WO2016092461 A1 WO 2016092461A1
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WIPO (PCT)
Prior art keywords
strut
joint
electromagnetic field
field generator
ultrasound
Prior art date
Application number
PCT/IB2015/059421
Other languages
French (fr)
Inventor
Shyam Bharat
Original Assignee
Koninklijke Philips N.V.
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Application filed by Koninklijke Philips N.V. filed Critical Koninklijke Philips N.V.
Publication of WO2016092461A1 publication Critical patent/WO2016092461A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/10X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N5/1001X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02Instruments for taking cell samples or for biopsy
    • A61B10/0233Pointed or sharp biopsy instruments
    • A61B10/0241Pointed or sharp biopsy instruments for prostate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/06Devices, other than using radiation, for detecting or locating foreign bodies ; determining position of probes within or on the body of the patient
    • A61B5/061Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/10X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N5/1048Monitoring, verifying, controlling systems and methods
    • A61N5/1049Monitoring, verifying, controlling systems and methods for verifying the position of the patient with respect to the radiation beam
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/10X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N5/1048Monitoring, verifying, controlling systems and methods
    • A61N5/1075Monitoring, verifying, controlling systems and methods for testing, calibrating, or quality assurance of the radiation treatment apparatus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238Type of minimally invasive operation
    • A61B2017/00274Prostate operation, e.g. prostatectomy, turp, bhp treatment
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00547Prostate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046Tracking techniques
    • A61B2034/2051Electromagnetic tracking systems
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046Tracking techniques
    • A61B2034/2059Mechanical position encoders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06Measuring instruments not otherwise provided for
    • A61B2090/067Measuring instruments not otherwise provided for for measuring angles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37Surgical systems with images on a monitor during operation
    • A61B2090/378Surgical systems with images on a monitor during operation using ultrasound
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/10X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N5/1048Monitoring, verifying, controlling systems and methods
    • A61N5/1049Monitoring, verifying, controlling systems and methods for verifying the position of the patient with respect to the radiation beam
    • A61N2005/1051Monitoring, verifying, controlling systems and methods for verifying the position of the patient with respect to the radiation beam using an active marker
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/10X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N5/1048Monitoring, verifying, controlling systems and methods
    • A61N5/1049Monitoring, verifying, controlling systems and methods for verifying the position of the patient with respect to the radiation beam
    • A61N2005/1058Monitoring, verifying, controlling systems and methods for verifying the position of the patient with respect to the radiation beam using ultrasound imaging
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/10X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N5/1048Monitoring, verifying, controlling systems and methods
    • A61N2005/1074Details of the control system, e.g. user interfaces

Definitions

  • the present invention generally relates to a positioning of an electromagnetic field (“EMF") generator during an interventional procedure (e.g., a transrectal biopsy, a transperineal biopsy, a low dose rate brachytherapy and a high dose rate brachytherapy).
  • EMF electromagnetic field
  • the present invention specifically relates a customized mounting arm having degree(s) of freedom for selectively positioning the EMF generator relative to an ultrasound stepper.
  • a EMF generator In brachytherapy procedures involving some form of electromagnetic guidance, a EMF generator needs to be present near an area of the intervention to generate the tracking field for interventional tools. For example, a typical position for the EMF generator in prostate brachytherapy would be above the patient's abdomen whereby the position of the EMF generator leads to minimal interference with the existing clinical setup. As known in the art, the EMF generator is currently held in place using a mounting arm that is attached to a patient table or an ultrasound stepper.
  • EMF electromagnetic-ultrasound
  • the art does not provide any technology for quantifying a location and/or an orientation the EMF generator with respect to the tracking space. Thus, an operator can only visually guide the mounting arm and the EMF generator to a particular location and/or orientation with respect to the tracking space.
  • the present invention provides a mounting arm having a structural configuration for coupling the EMF generator to the ultrasound stepper that facilitates a support, positioning and quantification of an emission position of the EMF generator relative to an ultrasound stepper.
  • One form of the present invention is an intervention system employing an
  • the mounting arm includes strut(s) and joint(s).
  • Each joint is connected to a strut, the EMF generator and/or the ultrasound stepper for positioning and supporting the EMF generator in an emission position relative to the ultrasound stepper (e.g., rotary/lateral joint(s) for rotational/linear motion of the strut(s) to thereby position and support the EMF generator in an angular orientation located above the ultrasound stepper).
  • Each joint includes an encoder for generating parameter data quantitatively indicative of the emission position of the EMF generator relative to the ultrasound stepper (e.g., rotary/linear encoder(s) generating rotational/linear parameter data quantifying the angular orientation/lateral displacement of the strut(s) to each other, to the EMF generator and/or to the ultrasound stepper).
  • an encoder for generating parameter data quantitatively indicative of the emission position of the EMF generator relative to the ultrasound stepper e.g., rotary/linear encoder(s) generating rotational/linear parameter data quantifying the angular orientation/lateral displacement of the strut(s) to each other, to the EMF generator and/or to the ultrasound stepper.
  • EMF generators having a structural configuration known in the art prior to and subsequent to the present invention for controlling an emission of an electromagnetic field, particularly for tracking interventional tool(s) (e.g., ultrasound probe, catheter, needle, etc.) during an interventional procedure (e.g., transrectal and transperineal biopsies and low dose rate and high dose rate brachytherapies).
  • interventional tool(s) e.g., ultrasound probe, catheter, needle, etc.
  • an interventional procedure e.g., transrectal and transperineal biopsies and low dose rate and high dose rate brachytherapies.
  • An example of an EMF generator includes, but is not limited to, an EMF generator commercially available as a component of the Aurora® Electromagnetic Tracking System.
  • the term "ultrasound stepper” broadly encompasses all steppers having a structural configuration known in the art prior to and subsequent to the present invention for facilitating a determination of an angular position and/or a linear position of an ultrasound probe during an interventional procedure.
  • An example of an ultrasound stepper includes, but is not limited to, an ultrasound stepper commercially available as the Multi-Purpose WorkstationTM Stepper.
  • the term “emission position” broadly encompasses a field-of-view orientation of the EMF generator relative to ultrasound stepper established by a linear distance between a location of an EMF generator/mounting arm connection point and a location of an ultrasound stepper/mounting arm connection point
  • the term “operative emission position” broadly encompasses any emission position suitable for the EMF generator to emit an electromagnetic field during an interventional procedure
  • the term “reference emission position” broadly encompasses any designated emission position for referencing the parameter data.
  • the intervention system may further include an EMF position controller to process the parameter data for facilitating various interventional procedures including, but not limited to, electromagnetic-ultrasound ("EM-US”) calibration, quality assurance and EM tracking procedures.
  • EMF position controller to process the parameter data for facilitating various interventional procedures including, but not limited to, electromagnetic-ultrasound ("EM-US”) calibration, quality assurance and EM tracking procedures.
  • EM-US electromagnetic-ultrasound
  • EMF position controller broadly encompasses all structural configurations of an application specific main board or an application specific integrated circuit housed within or linked to a computer or another instruction execution device/system for controlling an application of various inventive principles of the present invention as subsequently described herein.
  • the structural configuration of the EMF position controller may include, but is not limited to, processor(s), computer-usable/computer readable storage medium(s), an operating system, peripheral device controller(s), slot(s) and port(s).
  • Examples of a computer includes, but is not limited to, a server computer, a client computer, a workstation and a tablet.
  • module broadly encompasses an application component of the EMF position controller consisting of an electronic circuit or an executable program (e.g., executable software and/firmware).
  • FIG. 1 illustrates an exemplary embodiment of an intervention system in accordance with the present invention.
  • FIGS. 2-4 illustrate exemplary embodiments of a mounting arm in accordance with the present invention.
  • exemplary embodiments of the present invention will be provided herein directed to a mounting arm coupling an EMF generator to an ultrasound stepper for any interventional procedure (e.g., a brachytherapy procedure).
  • the terms of the art including, but not limited to "intervention”, “calibration”, “quality assurance”, “tracking”, “planning”, “navigation”, “guidance” and “registration” , are to be interpreted as known in the art of the present invention. More particularly, in a multi-modality EM-US brachytherapy system, a calibration procedure and a quality assurance ("QA") procedure are executed prior to the actual brachytherapy procedure.
  • QA quality assurance
  • the calibration procedure is essential in order to correctly visualize the information provided by the EM-US modalities in a common reference coordinate system.
  • the calibration is performed in a water tank or tissue-mimicking phantom, preferably on a patient-table in a designated operating room.
  • a performance accuracy of the EM-US brachytherapy system depends, among other factors, on the positioning of the EMF generator with respect to the intended tracking space whereby each individual EM tracker/sensor will be located during the brachytherapy procedure.
  • an accurate EM-US calibration obtained with the EMF generator at a given position may not be valid at another position of the EMF generator. Therefore, the QA procedure will test the EM-US registration on a tissue-mimicking phantom for different positions of the EMF generator.
  • An inherent EM system performance in terms of noise and position accuracy will also be tested for different positions of the EMF generator.
  • An 'ideal' position of the EMF generator for the brachytherapy procedure will be determined based on these tests.
  • this 'ideal' position of the EMF generator may change from brachytherapy procedure to brachytherapy procedure for various reasons including a varying placement of potentially distorting equipment in the operating room (e.g., an ultrasound scanner, a brachytherapy instrument table, etc.). Therefore, the QA procedure should ideally be performed prior to each patient procedure, or at regular intervals (e.g., weekly).
  • a mounting arm of the present invention precisely reproduces a particular position of the EMF generator in the tracking space for EM sensing of interventional tools.
  • a mounting arm 20 of the present invention couples the EMF generator 10 to the ultrasound stepper 1 1 whereby an emission position of EMF generator 10 relative to ultrasound stepper 1 1 may be quantified, particularly for EM-US calibration, quality assurance and tracking procedures.
  • the emission position of EMF generator 10 relative to ultrasound stepper 1 1 broadly encompasses a field-of-view orientation of EMF generator 10 relative to ultrasound stepper 1 1 established by a linear distance between a location of an EMF generator 10/mounting arm 20 connection point and a location of an ultrasound stepper 1 1 /mounting arm 20 connection point as will be further described herein in connection with the description of FIGS. 2-4.
  • mounting arm 20 employs one or more struts 30, one or more joints 40, and one or more encoders 50 for coupling EMF generator 10 to ultrasound stepper 1 1.
  • Strut(s) 30 and joint(s) 40 broadly encompass structural configurations and material compositions as known in the art for positioning supporting EMF generator 10 in the emission position relative to ultrasound stepper 1 1.
  • Examples of a strut 30 include, but are not limited to, beams, bars, rods, poles, and/or any combination thereof.
  • each strut 30 is connected (i.e., attached/affixed/mounted thereto or integrated with) to a pair of joints 40, or to a joint 40 and EMF generator 20, or to a joint 40 and ultrasound stepper 1 1.
  • Examples of a joint 40 include, but are not limited to, a rotary joint for angularly orienting two structures connected to the rotary joint (e.g., a ball and socket joint, a pivot joint, etc.) and a lateral joint for laterally displacing one structure connected to the lateral joint from another structure connected to the joint.
  • a rotary joint for angularly orienting two structures connected to the rotary joint (e.g., a ball and socket joint, a pivot joint, etc.) and a lateral joint for laterally displacing one structure connected to the lateral joint from another structure connected to the joint.
  • each joint 40 is connected (i.e., attached/affixed/mounted thereto or integrated with) to a pair of struts 30, or to a strut 30 and EMF generator 20, or to a strut 30 and ultrasound stepper 1 1.
  • Each joint 40 includes an encoder 50 operatively connected thereto, and encoder(s) 50 broadly encompass structural configurations as known in the art for generating parameter data quantitatively indicative of the emission position of EMF generator 10 relative to ultrasound stepper 1 1.
  • Examples of an encoder 50 include, but are not limited to:
  • a rotary encoder absolute or incremental, for generating rotational parameter data quantifying an angular orientation of a pair of struts, or of a strut 30 to EMF generator 10, or of a strut 30 to ultrasound stepper;
  • an encoder 50 may include a digital readout as known in the art for displaying the generated parameter data.
  • the reference emission position may be confirmed by including a known "clicking" mechanism (not shown) in strut(s) 30, joint(s) 40, and/or encoder(s) 50 whereby a mounting arm operator may be assured joint(s) 40 are in the reference emission position upon hearing the click.
  • This may be essential for incremental encoders 50 as a reading from an incremental encoder may not be absolutely used to define a reference emission position.
  • FIGS. 2-4 will now be described herein to facilitate further understanding of a mounting arm of the present invention.
  • FIGS. 2-4 collectively illustrate:
  • ultrasound stepper 1 1 connected to a patient table 12 via a mount 13 and supporting an ultrasound probe 14 and a grid 15;
  • connection point between ultrasound stepper 1 1 and the mounting arm also represented by a black dot
  • EMF generator 10 relative to ultrasound stepper 1 1.
  • the reference emission position defines a starting emission position of EMF generator 10 prior to executing a pre-operative or an intra-operative interventional procedure, particularly when employing incremental encoders.
  • the operative emission position defines a potential emission position of EMF generator 10 during an execution of the pre-operative or the intra-operative interventional procedure.
  • a mounting arm 21 includes:
  • Rotary joint 41 includes a digital rotary encoder 51
  • rotary joint 42 includes a digital rotary encoder 52.
  • rotary joints 41 and 42 are rotated to an absolute 0° or an incremental reference of 0° as shown by respective digital rotary encoders 51 and 52 whereby EMF generator 10, strut 31 and strut 32 are aligned with a reference axis RA of the connection of strut 33 to ultrasound stepper 1 1.
  • the reference emission position is defined by the upward orientation of the field-of-view of EMF generator 10 and a linear distance between the connection points represented by the black dots, which are quantified by digital rotary encoders 51 and 52.
  • rotary joint 42 In the operative emission position, rotary joint 42 has been rotated to an absolute ⁇ or an incremental ⁇ as shown by digital rotary encoder 52 that defines an angular orientation between reference axis RA and an intermediate axis IA of strut 32. Further, rotary joint 41 has been rotated to an absolute ⁇ or an incremental ⁇ as shown by digital rotary encoder 51 that defines an angular orientation between intermediate axis IA of strut 32 and a field-of- view axis FA of EMF generator 10.
  • the operative emission position is defined by the angular downward orientation of the field-of-view of EMF generator 10 and a linear distance between the connection points represented by the black dots, which are quantified by digital rotary encoders 51 and 52.
  • a mounting arm 22 includes:
  • Rotary joint 42 includes digital rotary encoder 52, and lateral joint 43 includes a digital linear encoder 53.
  • rotary joint 42 In the reference emission position, rotary joint 42 is rotated to an absolute 0° or an incremental reference of 0° as shown by digital rotary encoder 52 whereby strut 32 is aligned with reference axis RA and whereby EMF generator 10 and strut 31 are perpendicular to reference axis RA. Further, lateral joint 43 is set in a non-extended state that defines a 0" a based distance between struts 31 and 32.
  • the reference emission position is defined by the upward orientation of the field-of-view of EMF generator 10 and a linear distance between the connection points represented by the black dots, which are quantified by digital rotary encoder 51 and digital liner encoder 53.
  • rotary joint 42 In the operative emission position, rotary joint 42 has been rotated to an absolute ⁇ or an incremental ⁇ as shown by digital rotary encoder 52 that defines an angular orientation between reference axis RA and an intermediate axis IA of strut 32. Further, lateral joint 43 has been linearly extended along field-of-view axis FA of EMF generator 10 to an absolute d" or an incremental d" as shown by digital rotary encoder 51 that defines a d" lateral displacement of strut 31 from strut 32.
  • the operative emission position is defined by the angular downward orientation of the field-of-view of EMF generator 10 and a linear distance between the connection points represented by the black dots, which are quantified by digital rotary encoder 51 and digital linear encoder 53.
  • lateral joint 43 may be linearly extended along intermediate axis IA of strut 32 to an absolute d" or an incremental d" as shown by digital linear encoder 53 that defines a d" lateral displacement of strut 32 from strut 31.
  • a mounting arm 23 includes:
  • rotary joint 41 includes digital rotary encoder 51
  • rotary joint 42 includes digital rotary encoder 52.
  • rotary joints 41 and 42 are rotated to an absolute 0° or an incremental reference of 0° as shown by respective digital rotary encoders 51 and 52 whereby EMF generator 10 and strut 34 are aligned with a reference axis RA of the connection of rotary joint 42 to ultrasound stepper 11.
  • the reference emission position is defined by the upward orientation of the field-of-view of EMF generator 10 and a linear distance between the connection points represented by the black dots, which are quantified by digital rotary encoders 51 and 52.
  • rotary joint 42 In the operative emission position, rotary joint 42 has been rotated to an absolute ⁇ or an incremental ⁇ as shown by digital rotary encoder 52 that defines an angular orientation between reference axis RA and an intermediate axis IA of strut 34. Further, rotary joint 41 has been rotated to an absolute ⁇ or an incremental ⁇ as shown by digital rotary encoder 51 that defines an angular orientation between intermediate axis IA of strut 32 and a field-of- view axis FA of EMF generator 10.
  • the operative emission position is defined by the angular downward orientation of the field-of-view of EMF generator 10 and a linear distance between the connection points represented by the black dots, which are quantified by digital rotary encoders 51 and 52.
  • FIGS. 2-4 those having ordinary skill in the art will appreciate additional embodiments of a mounting arm within the scope of the present invention.
  • intervention system further employs an intervention machine 60 for monitoring an emission position of EMF generator 10 during various interventional procedures including, but not limited to, EM-US calibration, quality assurance and EM tracking procedures.
  • intervention machine 60 employs a monitor 61, an interface platform 62, a workstation 63 and an EMF position controller 64 installed within workstation 63.
  • EMF position controller 64 includes and/or is accessible by an operating system (not shown) as known in the art for controlling various graphical user interfaces, data and images on monitor 61 as directed by a workstation operator (e.g., a doctor, technician, etc.) via a keyboard, buttons, dials, joysticks, etc. of interface platform 62, and for storing/reading data as programmed and/or directed by the workstation operator of interface platform 62.
  • an operating system not shown
  • Workstation 63 may be connected/coupled to encoders(s) 50 as known in the art to input encoder output data to be processed by EMF position controller 64 and/or EMF position controller 64 may provide user interfaces to input encoder output data for monitoring the emission position of EMF generator 10 as needed by interventional procedure module(s) 65 utilizing EM generator 10 (e.g., transrectal and transperineal biopsies and low dose rate and high dose rate brachytherapies).
  • module(s) 65 implement various aspects, preoperative or intraoperative, of an interventional procedure including, but not limited to a preoperative planning, a pre-operative calibration, a pre-operative quality insurance, an intraoperative navigation and an intra-operative guidance.
  • EMF position controller 64 executes a pre-op EMF position module 66 structurally configured for inputting reference emission position data EPRF and/or operative emission position data EPopto output registration emission position data EPRG.
  • Reference emission position data EPRF indicates a reference emission position of EM generator 10 for facilitating a use of encoder(s) 50, particularly incremental encoder(s) 50.
  • the reference emission position of EM generator 10 will typically be an emission position of EM generator 10 inoperative for purposes of the interventional procedure (e.g., registration, calibration, navigation, etc.).
  • the reference emission position of EM generator 10 as shown is inoperative for purposes of an interventional procedure (e.g., registration, calibration, navigation, etc.).
  • reference emission position data EPRF will include data output of 0° of rotary encoders 51 and 52 as an indication of the reference emission position of EM generator 10.
  • the reference emission position may be confirmed by including a known "clicking" mechanism (not shown) in strut(s) 30, joint(s) 40, and/or encoder(s) 50 whereby a mounting arm operator may be assured joint(s) 40 are in the reference emission position upon hearing the click.
  • This may be essential for incremental encoders 50 as a reading from an incremental encoder may not be absolutely used to define a reference emission position.
  • Operative emission position data EPOP indicates potential operative emission positions for purposes of the interventional procedure (e.g., registration, calibration, navigation, etc.).
  • the operative emission position of EM generator 10 as shown is operative for purposes of an interventional procedure.
  • operative emission position data EPOP will include respective data output ⁇ and ⁇ of rotary encoders 41 and 42 of 0° as an indication of the operative emission position of EM generator 10.
  • module 66 In practice, the data flow of module 66 involves:
  • GUI 68 of each operative emission position of EMF generator 10 as being ideal for an intra-operative phase of the interventional procedure.
  • reference emission position data EPRF I ' S initially recorded and stored.
  • Mounting arm 21 is thereafter manipulated to position and support EMF generator in various operative emission positions and calibrated/quality tested as needed.
  • the operative emission position is designated as a registration emission position of EMF generator 10 ideal for the intra-operative phase of the intra-operative procedure.
  • EMF position controller 64 executes an intra-op EMF position module 67 structurally configured for inputting registration emission position data EPRG and operative emission position data EPOP to output a fit error FE.
  • registration emission position data EPRG indicates the operative emission position of EMF generator 10 as shown as being the 'ideal' registration emission position.
  • current operative emission position data EPOP is continually inputted from encoder(s) 50 or is intermittently inputted via an intra-operative graphical user interface 69 by a workstation operator reading digital readout(s) of encoder(s) 50.
  • Module 67 computes fit error FE as any differential between 'ideal' registration emission position data EPRG and current operative emission position data EPOP, and displays fit error FE and any additional feedback via intra-operative GUI 69.
  • a fit error FE of zero represent a positioning and support of EMF generator 10 in the 'ideal' registration emission position.
  • each phase of the interventional procedure may involve a designation of a single registration emission position and/or multiple registration emission positions.
  • EMF generator 1 1 is positioned/supported by mounting arm 20 in a workable tracking space location 'A' with a particular field-of-view orientation recorded via encoder(s) 50.
  • EMF generator 1 1 is repositioned and supported via mounting arm 20 in the same tracking space location 'A' and field-of-view orientation as indicated by encoder(s) 50.
  • EMF generator 1 1 is positioned/supported by mounting arm 20 in multiple workable tracking space locations (e.g., ' ⁇ ', ' ⁇ ', 'C, 'D'), each location with a particular field-of-view orientation recorded via encoder(s) 50. Calibration of the system is performed at each location. During the clinical intervention, EMF generator 1 1 is repositioned and supported via mounting arm 20 at one of the calibrated locations (e.g., ' A') and
  • the selected calibrated location is based on clinical convenience including, but not limited to, a size of the patient, desired access points for the clinical intervention, and locations of other equipment utilized for clinical intervention.
  • EMF generator 11 is positioned/supported by mounting arm 20 in multiple 'ideal' tracking space locations (e.g., ' ⁇ ', ' ⁇ ', 'C, 'D'), each location with a particular field- of-view orientation recorded via encoder(s) 50.
  • the 'ideal' locations are determined based on various potential distortion factors including, but not limited to, equipment surrounding the clinical setup. Following this Q&A step, the aforementioned pre-operative calibration and clinical intervention may be performed.
  • FIGS. 1-4 from the description of the exemplary embodiments of a mounting arm and intervention workstation of the present invention, those having ordinary skill in the art will appreciate numerous benefits of the present invention including, but not limited to, a facilitation of a precise and accurate positioning and support of a EMF generator in any EM-guided interventional procedure.
  • FIGS. 1-4 may be implemented in various combinations of electronic components/circuitry, hardware, executable software and executable firmware, particularly as application modules of a EMF position controller as described herein, and provide functions which may be combined in a single element or multiple elements.
  • the functions of the various features, elements, components, etc. shown/illustrated/depicted in the FIGS. 1-4 can be provided through the use of dedicated hardware as well as hardware capable of executing software in association with appropriate software.
  • processor When provided by a processor, the functions can be provided by a single dedicated processor, by a single shared processor, or by a plurality of individual processors, some of which can be shared and/or multiplexed.
  • explicit use of the term "processor” should not be construed to refer exclusively to hardware capable of executing software, and can implicitly include, without limitation, digital signal processor ("DSP") hardware, memory (e.g., read only memory (“ROM”) for storing software, random access memory (“RAM”), non-volatile storage, etc.) and virtually any means and/or machine (including hardware, software, firmware, circuitry, combinations thereof, etc.) which is capable of (and/or configurable) to perform and/or control a process.
  • DSP digital signal processor
  • any flow charts, flow diagrams and the like can represent various processes which can be substantially represented in computer readable storage media and so executed by a computer, processor or other device with processing capabilities, whether or not such computer or processor is explicitly shown.
  • exemplary embodiments of the present invention can take the form of a computer program product or application module accessible from a computer-usable and/or computer-readable storage medium providing program code and/or instructions for use by or in connection with, e.g., a computer or any instruction execution system.
  • a computer-usable or computer readable storage medium can be any apparatus that can, e.g., include, store, communicate, propagate or transport the program for use by or in connection with the instruction execution system, apparatus or device.
  • Such exemplary medium can be, e.g., an electronic, magnetic, optical, electromagnetic, infrared or semiconductor system (or apparatus or device) or a propagation medium.
  • Examples of a computer-readable medium include, e.g., a semiconductor or solid state memory, magnetic tape, a removable computer diskette, a random access memory (RAM), a read-only memory (ROM), flash (drive), a rigid magnetic disk and an optical disk.
  • Current examples of optical disks include compact disk - read only memory (CD-ROM), compact disk - read/write (CD- R/W) and DVD.

Abstract

An intervention system employing an electromagnetic field ("EMF") generator (10), an ultrasound stepper (11), and a mounting arm (20) coupling EMF field generator (10) to ultrasound stepper (11). For this coupling, mounting arm (20) includes strut(s) (30) and joint(s) (40). Each joint (40) is connected to a strut (30), EMF generator (10) and/or ultrasound stepper (11) for positioning and supporting EMF generator (10) in an emission position relative to ultrasound stepper (11) (e.g., (e.g., rotary/lateral joint(s) for rotational/linear motion of the strut(s) positioning and supporting the EMF generator in an angular orientation located above the ultrasound stepper). Each joint (40) includes an encoder (50) for generating parameter data quantitatively indicative of the emission position of EMF generator (10) relative to ultrasound stepper (11) (e.g., rotary/linear encoder(s) generating rotational/linear parameter data quantifying the angular orientation/lateral displacement of the strut(s) to each other, to the EMF generator and/or to the ultrasound stepper).

Description

POSITIONING ELECTROMAGNETIC FIELD GENERATORS
FOR INTERVENTIONAL PROCEDURES
The present invention generally relates to a positioning of an electromagnetic field ("EMF") generator during an interventional procedure (e.g., a transrectal biopsy, a transperineal biopsy, a low dose rate brachytherapy and a high dose rate brachytherapy). The present invention specifically relates a customized mounting arm having degree(s) of freedom for selectively positioning the EMF generator relative to an ultrasound stepper.
In brachytherapy procedures involving some form of electromagnetic guidance, a EMF generator needs to be present near an area of the intervention to generate the tracking field for interventional tools. For example, a typical position for the EMF generator in prostate brachytherapy would be above the patient's abdomen whereby the position of the EMF generator leads to minimal interference with the existing clinical setup. As known in the art, the EMF generator is currently held in place using a mounting arm that is attached to a patient table or an ultrasound stepper.
Due to inherent limitations in EMF technology, the position of the EMF generator with respect to the tracking space of interventional tools is critical and impacts accuracy of the measurements. For example, in multi-modal electromagnetic-ultrasound ("EM-US") systems, if the position of the EMF generator during the tracking procedure is not the same as its position during a pre-procedural system calibration, the EM-US registration accuracy may be sub-optimal, which may negatively impact the treatment. Currently, the art does not provide any technology for quantifying a location and/or an orientation the EMF generator with respect to the tracking space. Thus, an operator can only visually guide the mounting arm and the EMF generator to a particular location and/or orientation with respect to the tracking space.
To assist an operator in guiding the mounting arm and the EMF generator, the present invention provides a mounting arm having a structural configuration for coupling the EMF generator to the ultrasound stepper that facilitates a support, positioning and quantification of an emission position of the EMF generator relative to an ultrasound stepper.
One form of the present invention is an intervention system employing an
electromagnetic field ("EMF") generator, an ultrasound stepper, and a mounting arm coupling the EMF field generator to the ultrasound stepper. For this coupling, the mounting arm includes strut(s) and joint(s). Each joint is connected to a strut, the EMF generator and/or the ultrasound stepper for positioning and supporting the EMF generator in an emission position relative to the ultrasound stepper (e.g., rotary/lateral joint(s) for rotational/linear motion of the strut(s) to thereby position and support the EMF generator in an angular orientation located above the ultrasound stepper).
Each joint includes an encoder for generating parameter data quantitatively indicative of the emission position of the EMF generator relative to the ultrasound stepper (e.g., rotary/linear encoder(s) generating rotational/linear parameter data quantifying the angular orientation/lateral displacement of the strut(s) to each other, to the EMF generator and/or to the ultrasound stepper).
For purposes of the present invention, the term "EMF generator" broadly
encompasses all EMF generators having a structural configuration known in the art prior to and subsequent to the present invention for controlling an emission of an electromagnetic field, particularly for tracking interventional tool(s) (e.g., ultrasound probe, catheter, needle, etc.) during an interventional procedure (e.g., transrectal and transperineal biopsies and low dose rate and high dose rate brachytherapies). An example of an EMF generator includes, but is not limited to, an EMF generator commercially available as a component of the Aurora® Electromagnetic Tracking System.
For purposes of the present invention, the term "ultrasound stepper" broadly encompasses all steppers having a structural configuration known in the art prior to and subsequent to the present invention for facilitating a determination of an angular position and/or a linear position of an ultrasound probe during an interventional procedure. An example of an ultrasound stepper includes, but is not limited to, an ultrasound stepper commercially available as the Multi-Purpose Workstation™ Stepper.
For purposes of the present invention, the term "emission position" broadly encompasses a field-of-view orientation of the EMF generator relative to ultrasound stepper established by a linear distance between a location of an EMF generator/mounting arm connection point and a location of an ultrasound stepper/mounting arm connection point, the term "operative emission position" broadly encompasses any emission position suitable for the EMF generator to emit an electromagnetic field during an interventional procedure, and the term "reference emission position" broadly encompasses any designated emission position for referencing the parameter data.
The intervention system may further include an EMF position controller to process the parameter data for facilitating various interventional procedures including, but not limited to, electromagnetic-ultrasound ("EM-US") calibration, quality assurance and EM tracking procedures.
For purposes of the present invention, the term "EMF position controller" broadly encompasses all structural configurations of an application specific main board or an application specific integrated circuit housed within or linked to a computer or another instruction execution device/system for controlling an application of various inventive principles of the present invention as subsequently described herein. The structural configuration of the EMF position controller may include, but is not limited to, processor(s), computer-usable/computer readable storage medium(s), an operating system, peripheral device controller(s), slot(s) and port(s). Examples of a computer includes, but is not limited to, a server computer, a client computer, a workstation and a tablet.
For purposes of the present invention, the term "module" broadly encompasses an application component of the EMF position controller consisting of an electronic circuit or an executable program (e.g., executable software and/firmware).
The foregoing form and other forms of the present invention as well as various features and advantages of the present invention will become further apparent from the following detailed description of various embodiments of the present invention read in conjunction with the accompanying drawings. The detailed description and drawings are merely illustrative of the present invention rather than limiting, the scope of the present invention being defined by the appended claims and equivalents thereof.
FIG. 1 illustrates an exemplary embodiment of an intervention system in accordance with the present invention.
FIGS. 2-4 illustrate exemplary embodiments of a mounting arm in accordance with the present invention.
To facilitate an understanding of the present invention, exemplary embodiments of the present invention will be provided herein directed to a mounting arm coupling an EMF generator to an ultrasound stepper for any interventional procedure (e.g., a brachytherapy procedure).
For purposes of the present invention, the terms of the art including, but not limited to "intervention", "calibration", "quality assurance", "tracking", "planning", "navigation", "guidance" and "registration" , are to be interpreted as known in the art of the present invention. More particularly, in a multi-modality EM-US brachytherapy system, a calibration procedure and a quality assurance ("QA") procedure are executed prior to the actual brachytherapy procedure.
The calibration procedure is essential in order to correctly visualize the information provided by the EM-US modalities in a common reference coordinate system. Typically, the calibration is performed in a water tank or tissue-mimicking phantom, preferably on a patient-table in a designated operating room.
A performance accuracy of the EM-US brachytherapy system depends, among other factors, on the positioning of the EMF generator with respect to the intended tracking space whereby each individual EM tracker/sensor will be located during the brachytherapy procedure. However, an accurate EM-US calibration obtained with the EMF generator at a given position may not be valid at another position of the EMF generator. Therefore, the QA procedure will test the EM-US registration on a tissue-mimicking phantom for different positions of the EMF generator. An inherent EM system performance in terms of noise and position accuracy will also be tested for different positions of the EMF generator.
An 'ideal' position of the EMF generator for the brachytherapy procedure will be determined based on these tests. However, this 'ideal' position of the EMF generator may change from brachytherapy procedure to brachytherapy procedure for various reasons including a varying placement of potentially distorting equipment in the operating room (e.g., an ultrasound scanner, a brachytherapy instrument table, etc.). Therefore, the QA procedure should ideally be performed prior to each patient procedure, or at regular intervals (e.g., weekly).
For the above reasons, the ability to position the EMF generator at a given position with respect to the tracking space during the brachytherapy procedure is critical. Unlike mounting arms known in the art, a mounting arm of the present invention precisely reproduces a particular position of the EMF generator in the tracking space for EM sensing of interventional tools.
Referring to FIG. 1 , a mounting arm 20 of the present invention couples the EMF generator 10 to the ultrasound stepper 1 1 whereby an emission position of EMF generator 10 relative to ultrasound stepper 1 1 may be quantified, particularly for EM-US calibration, quality assurance and tracking procedures. The emission position of EMF generator 10 relative to ultrasound stepper 1 1 broadly encompasses a field-of-view orientation of EMF generator 10 relative to ultrasound stepper 1 1 established by a linear distance between a location of an EMF generator 10/mounting arm 20 connection point and a location of an ultrasound stepper 1 1 /mounting arm 20 connection point as will be further described herein in connection with the description of FIGS. 2-4.
Still referring to FIG. 1, mounting arm 20 employs one or more struts 30, one or more joints 40, and one or more encoders 50 for coupling EMF generator 10 to ultrasound stepper 1 1.
Strut(s) 30 and joint(s) 40 broadly encompass structural configurations and material compositions as known in the art for positioning supporting EMF generator 10 in the emission position relative to ultrasound stepper 1 1.
Examples of a strut 30 include, but are not limited to, beams, bars, rods, poles, and/or any combination thereof.
In practice, each strut 30 is connected (i.e., attached/affixed/mounted thereto or integrated with) to a pair of joints 40, or to a joint 40 and EMF generator 20, or to a joint 40 and ultrasound stepper 1 1.
Examples of a joint 40 include, but are not limited to, a rotary joint for angularly orienting two structures connected to the rotary joint (e.g., a ball and socket joint, a pivot joint, etc.) and a lateral joint for laterally displacing one structure connected to the lateral joint from another structure connected to the joint.
In practice, each joint 40 is connected (i.e., attached/affixed/mounted thereto or integrated with) to a pair of struts 30, or to a strut 30 and EMF generator 20, or to a strut 30 and ultrasound stepper 1 1.
Each joint 40 includes an encoder 50 operatively connected thereto, and encoder(s) 50 broadly encompass structural configurations as known in the art for generating parameter data quantitatively indicative of the emission position of EMF generator 10 relative to ultrasound stepper 1 1.
Examples of an encoder 50 include, but are not limited to:
(1) a rotary encoder, absolute or incremental, for generating rotational parameter data quantifying an angular orientation of a pair of struts, or of a strut 30 to EMF generator 10, or of a strut 30 to ultrasound stepper; and
(2) a linear encoder, absolute or incremental, for generating linear
parameter data quantifying a lateral displacement between a pair of struts, or between a strut 30 to EMF generator 10, or between a strut 30 to ultrasound stepper. In practice, an encoder 50 may include a digital readout as known in the art for displaying the generated parameter data.
Also in practice, the reference emission position may be confirmed by including a known "clicking" mechanism (not shown) in strut(s) 30, joint(s) 40, and/or encoder(s) 50 whereby a mounting arm operator may be assured joint(s) 40 are in the reference emission position upon hearing the click. This may be essential for incremental encoders 50 as a reading from an incremental encoder may not be absolutely used to define a reference emission position.
FIGS. 2-4 will now be described herein to facilitate further understanding of a mounting arm of the present invention. FIGS. 2-4 collectively illustrate:
(1) ultrasound stepper 1 1 connected to a patient table 12 via a mount 13 and supporting an ultrasound probe 14 and a grid 15;
(2) a mounting arm of the present invention coupling EMF generator 10 to ultrasound stepper 1 1 ;
(3) a connection point between EMF generator 10 and the mounting arm represented by a black dot;
(4) a connection point between ultrasound stepper 1 1 and the mounting arm also represented by a black dot; and
(5) a reference emission position and an operative emission position of
EMF generator 10 relative to ultrasound stepper 1 1.
The reference emission position defines a starting emission position of EMF generator 10 prior to executing a pre-operative or an intra-operative interventional procedure, particularly when employing incremental encoders.
The operative emission position defines a potential emission position of EMF generator 10 during an execution of the pre-operative or the intra-operative interventional procedure.
Referring to FIG. 2, a mounting arm 21 includes:
(1) a strut 31 connected to EMF generator 10 in a fixed orientation as
represented by the black dot;
(2) a rotary joint 41 connected to strut 31 and a strut 32;
(3) a rotary joint 42 connected to strut 32 and a strut 33; and (4) strut 33 connected to ultrasound stepper 1 1 in a fixed orientation as represented by the black dot.
Rotary joint 41 includes a digital rotary encoder 51, and rotary joint 42 includes a digital rotary encoder 52.
In the reference emission position, rotary joints 41 and 42 are rotated to an absolute 0° or an incremental reference of 0° as shown by respective digital rotary encoders 51 and 52 whereby EMF generator 10, strut 31 and strut 32 are aligned with a reference axis RA of the connection of strut 33 to ultrasound stepper 1 1. The reference emission position is defined by the upward orientation of the field-of-view of EMF generator 10 and a linear distance between the connection points represented by the black dots, which are quantified by digital rotary encoders 51 and 52.
In the operative emission position, rotary joint 42 has been rotated to an absolute Θ or an incremental Θ as shown by digital rotary encoder 52 that defines an angular orientation between reference axis RA and an intermediate axis IA of strut 32. Further, rotary joint 41 has been rotated to an absolute Ψ or an incremental Ψ as shown by digital rotary encoder 51 that defines an angular orientation between intermediate axis IA of strut 32 and a field-of- view axis FA of EMF generator 10. The operative emission position is defined by the angular downward orientation of the field-of-view of EMF generator 10 and a linear distance between the connection points represented by the black dots, which are quantified by digital rotary encoders 51 and 52.
Referring to FIG. 3, a mounting arm 22 includes:
(1) strut 31 connected to EMF generator 10 in a fixed orientation as
represented by the black dot;
(2) a lateral joint 43 connected to strut 31 and strut 32;
(3) rotary joint 42 connected to strut 32 and strut 33; and
(4) strut 33 connected to ultrasound stepper 1 1 in a fixed orientation as represented by the black dot.
Rotary joint 42 includes digital rotary encoder 52, and lateral joint 43 includes a digital linear encoder 53.
In the reference emission position, rotary joint 42 is rotated to an absolute 0° or an incremental reference of 0° as shown by digital rotary encoder 52 whereby strut 32 is aligned with reference axis RA and whereby EMF generator 10 and strut 31 are perpendicular to reference axis RA. Further, lateral joint 43 is set in a non-extended state that defines a 0" a based distance between struts 31 and 32. The reference emission position is defined by the upward orientation of the field-of-view of EMF generator 10 and a linear distance between the connection points represented by the black dots, which are quantified by digital rotary encoder 51 and digital liner encoder 53.
In the operative emission position, rotary joint 42 has been rotated to an absolute Θ or an incremental Θ as shown by digital rotary encoder 52 that defines an angular orientation between reference axis RA and an intermediate axis IA of strut 32. Further, lateral joint 43 has been linearly extended along field-of-view axis FA of EMF generator 10 to an absolute d" or an incremental d" as shown by digital rotary encoder 51 that defines a d" lateral displacement of strut 31 from strut 32. The operative emission position is defined by the angular downward orientation of the field-of-view of EMF generator 10 and a linear distance between the connection points represented by the black dots, which are quantified by digital rotary encoder 51 and digital linear encoder 53.
In practice (not shown), concurrently or alternatively depending upon the structural configuration, lateral joint 43 may be linearly extended along intermediate axis IA of strut 32 to an absolute d" or an incremental d" as shown by digital linear encoder 53 that defines a d" lateral displacement of strut 32 from strut 31.
Referring to FIG. 4, a mounting arm 23 includes:
(1) rotary joint 41 connected to EMF generator 10 and a strut 34; and
(2) rotary joint 42 connected to strut 34 and ultrasound stepper 1 1.
As previously described herein, rotary joint 41 includes digital rotary encoder 51, and rotary joint 42 includes digital rotary encoder 52.
In the reference emission position, rotary joints 41 and 42 are rotated to an absolute 0° or an incremental reference of 0° as shown by respective digital rotary encoders 51 and 52 whereby EMF generator 10 and strut 34 are aligned with a reference axis RA of the connection of rotary joint 42 to ultrasound stepper 11. The reference emission position is defined by the upward orientation of the field-of-view of EMF generator 10 and a linear distance between the connection points represented by the black dots, which are quantified by digital rotary encoders 51 and 52. In the operative emission position, rotary joint 42 has been rotated to an absolute Θ or an incremental Θ as shown by digital rotary encoder 52 that defines an angular orientation between reference axis RA and an intermediate axis IA of strut 34. Further, rotary joint 41 has been rotated to an absolute Ψ or an incremental Ψ as shown by digital rotary encoder 51 that defines an angular orientation between intermediate axis IA of strut 32 and a field-of- view axis FA of EMF generator 10. The operative emission position is defined by the angular downward orientation of the field-of-view of EMF generator 10 and a linear distance between the connection points represented by the black dots, which are quantified by digital rotary encoders 51 and 52.
Referring to FIGS. 2-4, those having ordinary skill in the art will appreciate additional embodiments of a mounting arm within the scope of the present invention.
Referring back to FIG. 1, the intervention system further employs an intervention machine 60 for monitoring an emission position of EMF generator 10 during various interventional procedures including, but not limited to, EM-US calibration, quality assurance and EM tracking procedures. To this end, intervention machine 60 employs a monitor 61, an interface platform 62, a workstation 63 and an EMF position controller 64 installed within workstation 63.
EMF position controller 64 includes and/or is accessible by an operating system (not shown) as known in the art for controlling various graphical user interfaces, data and images on monitor 61 as directed by a workstation operator (e.g., a doctor, technician, etc.) via a keyboard, buttons, dials, joysticks, etc. of interface platform 62, and for storing/reading data as programmed and/or directed by the workstation operator of interface platform 62.
Workstation 63 may be connected/coupled to encoders(s) 50 as known in the art to input encoder output data to be processed by EMF position controller 64 and/or EMF position controller 64 may provide user interfaces to input encoder output data for monitoring the emission position of EMF generator 10 as needed by interventional procedure module(s) 65 utilizing EM generator 10 (e.g., transrectal and transperineal biopsies and low dose rate and high dose rate brachytherapies). In practice, module(s) 65 implement various aspects, preoperative or intraoperative, of an interventional procedure including, but not limited to a preoperative planning, a pre-operative calibration, a pre-operative quality insurance, an intraoperative navigation and an intra-operative guidance.
For the pre-operative phase of an interventional procedure, EMF position controller 64 executes a pre-op EMF position module 66 structurally configured for inputting reference emission position data EPRF and/or operative emission position data EPopto output registration emission position data EPRG.
Reference emission position data EPRF indicates a reference emission position of EM generator 10 for facilitating a use of encoder(s) 50, particularly incremental encoder(s) 50. In practice, the reference emission position of EM generator 10 will typically be an emission position of EM generator 10 inoperative for purposes of the interventional procedure (e.g., registration, calibration, navigation, etc.). For example, referring to FIG. 2, the reference emission position of EM generator 10 as shown is inoperative for purposes of an
interventional procedure. For this example, reference emission position data EPRF will include data output of 0° of rotary encoders 51 and 52 as an indication of the reference emission position of EM generator 10.
As previously stated herein, in practice, the reference emission position may be confirmed by including a known "clicking" mechanism (not shown) in strut(s) 30, joint(s) 40, and/or encoder(s) 50 whereby a mounting arm operator may be assured joint(s) 40 are in the reference emission position upon hearing the click. This may be essential for incremental encoders 50 as a reading from an incremental encoder may not be absolutely used to define a reference emission position.
Operative emission position data EPOP indicates potential operative emission positions for purposes of the interventional procedure (e.g., registration, calibration, navigation, etc.). For example, referring to FIG. 2, the operative emission position of EM generator 10 as shown is operative for purposes of an interventional procedure. For this example, operative emission position data EPOP will include respective data output Ψ and Θ of rotary encoders 41 and 42 of 0° as an indication of the operative emission position of EM generator 10.
In practice, the data flow of module 66 involves:
(1) with mounting arm 20 positioning/supporting EMF generator 10 in a reference emission position, a recording/storage of reference emission position data EPRF as inputted from encoder(s) 50 or via a pre-operative graphical user interface ("GUI") 68 by a workstation operator reading digital readout(s) of encoder(s) 50;
(2) with mounting arm 20 being manipulated to position and support EMF generator 10 among various operative emission positions, a recording/storage of operative emission position data EPOP as inputted from encoder(s) 50 or via pre-operative GUI 68 by a workstation operator reading digital readout(s) of encoder(s) 50; and
(3) an output of registration emission position data EPRG inclusive of a designation by a module 65 or by a workstation operator via pre-operative
GUI 68 of each operative emission position of EMF generator 10 as being ideal for an intra-operative phase of the interventional procedure.
Generally for example, referring to FIG. 2, reference emission position data EPRF I'S initially recorded and stored. Mounting arm 21 is thereafter manipulated to position and support EMF generator in various operative emission positions and calibrated/quality tested as needed. For each calibrated/quality operative emission position, such as the one shown in FIG. 2, the operative emission position is designated as a registration emission position of EMF generator 10 ideal for the intra-operative phase of the intra-operative procedure.
For the intra-operative phase of an interventional procedure, EMF position controller 64 executes an intra-op EMF position module 67 structurally configured for inputting registration emission position data EPRG and operative emission position data EPOP to output a fit error FE.
Generally for example, referring to FIG. 2, registration emission position data EPRG indicates the operative emission position of EMF generator 10 as shown as being the 'ideal' registration emission position. As mounting arm 20 is being manipulated to position and support EMF generator 10 from the reference emission position to the 'ideal" registration emission position, current operative emission position data EPOP is continually inputted from encoder(s) 50 or is intermittently inputted via an intra-operative graphical user interface 69 by a workstation operator reading digital readout(s) of encoder(s) 50. Module 67 computes fit error FE as any differential between 'ideal' registration emission position data EPRG and current operative emission position data EPOP, and displays fit error FE and any additional feedback via intra-operative GUI 69. A fit error FE of zero represent a positioning and support of EMF generator 10 in the 'ideal' registration emission position.
More specifically, each phase of the interventional procedure may involve a designation of a single registration emission position and/or multiple registration emission positions.
Single Registration Emission Position. In a pre-operative calibration, EMF generator 1 1 is positioned/supported by mounting arm 20 in a workable tracking space location 'A' with a particular field-of-view orientation recorded via encoder(s) 50. During the clinical intervention, EMF generator 1 1 is repositioned and supported via mounting arm 20 in the same tracking space location 'A' and field-of-view orientation as indicated by encoder(s) 50.
Multiple Registration Emission Positions (Calibration). In a pre-operative calibration, EMF generator 1 1 is positioned/supported by mounting arm 20 in multiple workable tracking space locations (e.g., 'Α', 'Β', 'C, 'D'), each location with a particular field-of-view orientation recorded via encoder(s) 50. Calibration of the system is performed at each location. During the clinical intervention, EMF generator 1 1 is repositioned and supported via mounting arm 20 at one of the calibrated locations (e.g., ' A') and
corresponding field-of-view orientation as indicated by encoder(s) 50. The selected calibrated location is based on clinical convenience including, but not limited to, a size of the patient, desired access points for the clinical intervention, and locations of other equipment utilized for clinical intervention.
Multiple Registration Emission Position (Quality Assurance). In a pre-operative quality assurance, EMF generator 11 is positioned/supported by mounting arm 20 in multiple 'ideal' tracking space locations (e.g., 'Α', 'Β', 'C, 'D'), each location with a particular field- of-view orientation recorded via encoder(s) 50. The 'ideal' locations are determined based on various potential distortion factors including, but not limited to, equipment surrounding the clinical setup. Following this Q&A step, the aforementioned pre-operative calibration and clinical intervention may be performed.
Referring to FIGS. 1-4, from the description of the exemplary embodiments of a mounting arm and intervention workstation of the present invention, those having ordinary skill in the art will appreciate numerous benefits of the present invention including, but not limited to, a facilitation of a precise and accurate positioning and support of a EMF generator in any EM-guided interventional procedure.
Furthermore, as one having ordinary skill in the art will appreciate in view of the teachings provided herein, features, elements, components, etc. described in the present disclosure/specification and/or depicted in the FIGS. 1-4 may be implemented in various combinations of electronic components/circuitry, hardware, executable software and executable firmware, particularly as application modules of a EMF position controller as described herein, and provide functions which may be combined in a single element or multiple elements. For example, the functions of the various features, elements, components, etc. shown/illustrated/depicted in the FIGS. 1-4 can be provided through the use of dedicated hardware as well as hardware capable of executing software in association with appropriate software. When provided by a processor, the functions can be provided by a single dedicated processor, by a single shared processor, or by a plurality of individual processors, some of which can be shared and/or multiplexed. Moreover, explicit use of the term "processor" should not be construed to refer exclusively to hardware capable of executing software, and can implicitly include, without limitation, digital signal processor ("DSP") hardware, memory (e.g., read only memory ("ROM") for storing software, random access memory ("RAM"), non-volatile storage, etc.) and virtually any means and/or machine (including hardware, software, firmware, circuitry, combinations thereof, etc.) which is capable of (and/or configurable) to perform and/or control a process.
Moreover, all statements herein reciting principles, aspects, and embodiments of the invention, as well as specific examples thereof, are intended to encompass both structural and functional equivalents thereof. Additionally, it is intended that such equivalents include both currently known equivalents as well as equivalents developed in the future (e.g., any elements developed that can perform the same or substantially similar function, regardless of structure). Thus, for example, it will be appreciated by one having ordinary skill in the art in view of the teachings provided herein that any block diagrams presented herein can represent conceptual views of illustrative system components and/or circuitry embodying the principles of the invention. Similarly, one having ordinary skill in the art should appreciate in view of the teachings provided herein that any flow charts, flow diagrams and the like can represent various processes which can be substantially represented in computer readable storage media and so executed by a computer, processor or other device with processing capabilities, whether or not such computer or processor is explicitly shown.
Furthermore, exemplary embodiments of the present invention can take the form of a computer program product or application module accessible from a computer-usable and/or computer-readable storage medium providing program code and/or instructions for use by or in connection with, e.g., a computer or any instruction execution system. In accordance with the present disclosure, a computer-usable or computer readable storage medium can be any apparatus that can, e.g., include, store, communicate, propagate or transport the program for use by or in connection with the instruction execution system, apparatus or device. Such exemplary medium can be, e.g., an electronic, magnetic, optical, electromagnetic, infrared or semiconductor system (or apparatus or device) or a propagation medium. Examples of a computer-readable medium include, e.g., a semiconductor or solid state memory, magnetic tape, a removable computer diskette, a random access memory (RAM), a read-only memory (ROM), flash (drive), a rigid magnetic disk and an optical disk. Current examples of optical disks include compact disk - read only memory (CD-ROM), compact disk - read/write (CD- R/W) and DVD. Further, it should be understood that any new computer-readable medium which may hereafter be developed should also be considered as computer-readable medium as may be used or referred to in accordance with exemplary embodiments of the present invention and disclosure.
Having described preferred and exemplary embodiments of novel and inventive system and method for positioning and supporting an EMF generator, (which embodiments are intended to be illustrative and not limiting), it is noted that modifications and variations can be made by persons having ordinary skill in the art in light of the teachings provided herein, including the FIGS. 1-4. It is therefore to be understood that changes can be made in/to the preferred and exemplary embodiments of the present disclosure which are within the scope of the embodiments disclosed herein.
Moreover, it is contemplated that corresponding and/or related systems incorporating and/or implementing the device or such as may be used/implemented in a device in accordance with the present disclosure are also contemplated and considered to be within the scope of the present invention. Further, corresponding and/or related method for
manufacturing and/or using a device and/or system in accordance with the present disclosure are also contemplated and considered to be within the scope of the present invention.

Claims

Claims
1. An intervention system, comprising:
an electromagnetic field generator (10) operable to emit an electromagnetic field; an ultrasound stepper (1 1); and
a mounting arm (20) coupling the electromagnetic field generator (10) to the ultrasound stepper (1 1), wherein the mounting arm (20) includes
at least one strut (30) and least one joint (40),
wherein each joint (40) is connected to at least one of a strut (30), the electromagnetic field generator (10) and the ultrasound stepper (1 1) for positioning and supporting the electromagnetic field generator (10) in an emission position relative to the ultrasound stepper (1 1), and
wherein each joint (40) includes an encoder (50) for generating parameter data quantitatively indicative of the emission position of the electromagnetic field generator (10) relative to the ultrasound stepper (1 1).
2. The intervention system of claim 1, wherein each encoder (50) includes a digital readout to display the parameter data.
3. The intervention system of claim 1,
wherein the at least one strut (30) includes a first strut (30) and a second strut (30); wherein the at least one joint (40) includes a rotary joint (40) connecting the first strut (30) and the second strut (30) for angularly orienting the first strut (30) and the second strut (30); and
wherein the rotary joint (40) includes a rotary encoder (50) for generating rotational parameter data quantifying an angular orientation of the first strut (30) and the second strut (30).
4. The intervention system of claim 1,
wherein the at least one strut (30) includes a first strut (30) and a second strut (30); wherein the at least one joint (40) includes a lateral joint (40) connecting the first strut (30) and the second strut (30) for laterally orienting the first strut (30) and the second strut (30); and
wherein the lateral joint (40) includes a linear encoder (50) for generating linear parameter data quantifying a lateral displacement of the first strut (30) and the second strut (30).
5. The intervention system of claim 1,
wherein the at least one strut (30) includes a first strut (30);
wherein the at least one joint (40) includes a rotary joint (40) connecting the first strut (30) and the electromagnetic field generator (10) for angularly orienting the first strut (30) and the electromagnetic field generator (10); and
wherein the rotary joint (40) includes a rotary encoder (50) for generating rotational parameter data quantifying an angular orientation of the first strut (30) and the
electromagnetic field generator (10).
6. The intervention system of claim 1,
wherein the at least one strut (30) includes a first strut (30);
wherein the at least one joint (40) includes a lateral joint (40) connecting the first strut (30) and the electromagnetic field generator (10) for laterally orienting the first strut (30) and the electromagnetic field generator (10); and
wherein the lateral joint (40) includes a linear encoder (50) for generating linear parameter data quantifying a lateral displacement of the first strut (30) and the
electromagnetic field generator (10).
7. The intervention system of claim 1,
wherein the at least one strut (30) includes a first strut (30);
wherein the at least one joint (40) includes a rotary joint (40) connecting the first strut (30) and the ultrasound stepper (1 1) for angularly orienting the first strut (30) and the ultrasound stepper (1 1); and
wherein the rotary joint (40) includes a rotary encoder (50) for generating rotational parameter data quantifying an angular orientation of the first strut (30) and the ultrasound stepper (1 1).
8. The intervention system of claim 1,
wherein the at least one strut (30) includes a first strut (30);
wherein the at least one joint (40) includes a lateral joint (40) connecting the first strut (30) and the ultrasound stepper (1 1) for laterally orienting the first strut (30) and the ultrasound stepper (1 1); and
wherein the lateral joint (40) includes a linear encoder (50) for generating linear parameter data quantifying a lateral displacement of the first strut (30) and the ultrasound stepper (1 1).
9. The intervention system of claim 1, further comprising:
an electromagnetic field position controller operable to determine a registration emission position of the electromagnetic field generator (10) relative to the ultrasound stepper (1 1) corresponding to a registration between an ultrasound probe and the electromagnetic field generator (10).
10. The intervention system of claim 9,
wherein the electromagnetic field position controller is further to determine a fit error between the registration emission position and a current operative emission position of the electromagnetic field generator (10) relative to the ultrasound stepper (1 1) corresponding to an interventional procedure.
1 1. A mounting arm (20) for coupling an electromagnetic field generator (10) to an ultrasound stepper (1 1), the mounting arm (20) comprising:
at least one strut (30) and least one joint (40),
wherein each joint (40) is connected to at least one of a strut (30), the electromagnetic field generator (10) and the ultrasound stepper (1 1) for positioning and supporting the electromagnetic field generator (10) in an emission position relative to the ultrasound stepper (1 1), and
wherein each joint (40) includes an encoder (50) for generating parameter data quantitatively indicative of the emission position of the electromagnetic field generator (10) relative to the ultrasound stepper (1 1).
12. The mounting arm (20) of claim 1 1, wherein each encoder (50) includes a digital readout to display the parameter data.
13. The mounting arm (20) of claim 1 1,
wherein the at least one strut (30) includes a first strut (30) and a second strut (30); wherein the at least one joint (40) includes a rotary joint (40) connecting the first strut (30) and the second strut (30) for angularly orienting the first strut (30) and the second strut (30); and
wherein the rotary joint (40) includes a rotary encoder (50) for generating rotational parameter data quantifying an angular orientation of the first strut (30) and the second strut (30).
14. The mounting arm (20) of claim 1 1,
wherein the at least one strut (30) includes a first strut (30) and a second strut (30); wherein the at least one joint (40) includes a lateral joint (40) connecting the first strut (30) and the second strut (30) for laterally orienting the first strut (30) and the second strut (30); and
wherein the lateral joint (40) includes a linear encoder (50) for generating linear parameter data quantifying a lateral displacement of the first strut (30) and the second strut (30).
15. The mounting arm (20) of claim 1 1,
wherein the at least one strut (30) includes a first strut (30);
wherein the at least one joint (40) includes a rotary joint (40) connecting the first strut (30) and the electromagnetic field generator (10) for angularly orienting the first strut (30) and the electromagnetic field generator (10); and
wherein the rotary joint (40) includes a rotary encoder (50) for generating rotational parameter data quantifying an angular orientation of the first strut (30) and the
electromagnetic field generator (10).
16. The mounting arm (20) of claim 1 1,
wherein the at least one strut (30) includes a first strut (30);
wherein the at least one joint (40) includes a lateral joint (40) connecting the first strut (30) and the electromagnetic field generator (10) for laterally orienting the first strut (30) and the electromagnetic field generator (10); and
wherein the lateral joint (40) includes a linear encoder (50) for generating linear parameter data quantifying a lateral displacement of the first strut (30) and the
electromagnetic field generator (10).
17. The mounting arm (20) of claim 1 1,
wherein the at least one strut (30) includes a first strut (30);
wherein the at least one joint (40) includes a rotary joint (40) connecting the first strut (30) and the ultrasound stepper (1 1) for angularly orienting the first strut (30) and the ultrasound stepper (1 1); and
wherein the rotary joint (40) includes a rotary encoder (50) for generating rotational parameter data quantifying an angular orientation of the first strut (30) and the ultrasound stepper (1 1).
18. The mounting arm (20) of claim 1 1,
wherein the at least one strut (30) includes a first strut (30);
wherein the at least one joint (40) includes a lateral joint (40) connecting the first strut (30) and the ultrasound stepper (1 1) for laterally orienting the first strut (30) and the ultrasound stepper (1 1); and
wherein the lateral joint (40) includes a linear encoder (50) for generating linear parameter data quantifying a lateral displacement of the first strut (30) and the ultrasound stepper (1 1).
19. An intervention method, comprising:
providing a mounting arm (20) coupling an electromagnetic field generator (10) to an ultrasound stepper (1 1), wherein the mounting arm (20) positions and supports the electromagnetic field generator (10) in an emission position relative to the ultrasound stepper (1 1); and providing at least one encoder (50) operative with the mounting arm(20),
wherein the at least one encoder (50) generates parameter data quantitatively indicative of the emission position of the electromagnetic field generator (10) relative to the ultrasound stepper (1 1).
20. The intervention method of claim 19, further comprising:
providing an electromagnetic field position controller determining a fit error between a registration emission position and a current operative emission position of the
electromagnetic field generator (10) relative to the ultrasound stepper (1 1), wherein the registration emission position corresponds to a registration between an ultrasound probe and the electromagnetic field generator (10), and
wherein the current operative emission position corresponds to an interventional procedure.
PCT/IB2015/059421 2014-12-09 2015-12-07 Positioning electromagnetic field generators for interventional procedures WO2016092461A1 (en)

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