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WO1999049407A1 - Systemes et procedes interactifs de commande de l'utilisation d'instruments diagnostiques ou therapeutiques dans des regions internes du corps - Google Patents

Systemes et procedes interactifs de commande de l'utilisation d'instruments diagnostiques ou therapeutiques dans des regions internes du corps Download PDF

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Publication number
WO1999049407A1
WO1999049407A1 PCT/US1999/006512 US9906512W WO9949407A1 WO 1999049407 A1 WO1999049407 A1 WO 1999049407A1 US 9906512 W US9906512 W US 9906512W WO 9949407 A1 WO9949407 A1 WO 9949407A1
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WO
WIPO (PCT)
Prior art keywords
display
interface
image
function
interface according
Prior art date
Application number
PCT/US1999/006512
Other languages
English (en)
Inventor
Dorin Panescu
David Mcgee
James G. Whayne
Robert R. Burnside
David K. Swanson
Daniel A. Dupree
Tuan Nguyen
Original Assignee
Boston Scientific Corporation
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
Priority claimed from US09/048,643 external-priority patent/US6192266B1/en
Priority claimed from US09/048,629 external-priority patent/US6106460A/en
Application filed by Boston Scientific Corporation filed Critical Boston Scientific Corporation
Priority to AU34535/99A priority Critical patent/AU3453599A/en
Publication of WO1999049407A1 publication Critical patent/WO1999049407A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
    • A61B5/283—Invasive
    • A61B5/287—Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6852—Catheters
    • A61B5/6858—Catheters with a distal basket, e.g. expandable basket
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; Determining position of diagnostic devices within or on the body of the patient
    • A61B5/065—Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
    • A61B5/068—Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe using impedance sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/74—Details of notification to user or communication with user or patient; User input means
    • A61B5/742—Details of notification to user or communication with user or patient; User input means using visual displays
    • A61B5/7435—Displaying user selection data, e.g. icons in a graphical user interface
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/74—Details of notification to user or communication with user or patient; User input means
    • A61B5/7475—User input or interface means, e.g. keyboard, pointing device, joystick
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/30—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H30/00—ICT specially adapted for the handling or processing of medical images
    • G16H30/40—ICT specially adapted for the handling or processing of medical images for processing medical images, e.g. editing
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/50—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for simulation or modelling of medical disorders
    • 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
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart 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
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
    • 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
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00898—Alarms or notifications created in response to an abnormal condition
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02—Operational features
    • A61B2560/0266—Operational features for monitoring or limiting apparatus function
    • A61B2560/0276—Determining malfunction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/04—Arrangements of multiple sensors of the same type
    • A61B2562/043—Arrangements of multiple sensors of the same type in a linear array
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; Determining position of diagnostic devices within or on the body of the patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/346—Analysis of electrocardiograms
    • A61B5/349—Detecting specific parameters of the electrocardiograph cycle
    • A61B5/363—Detecting tachycardia or bradycardia

Definitions

  • This invention relates generally to systems for diagnosing and treating medical conditions using instruments deployed within a living body.
  • Multiple electrode arrays are used to diagnose or treat a variety of medical conditions. For example, physicians use arrays of multiple electrodes to examine the propagation of electrical impulses in heart tissue to locate aberrant conductive pathways. The techniques used to analyze these pathways, commonly called “mapping,” identify regions in the heart tissue, called foci, which can be ablated to treat the arrhythmia. When used for this purpose, the multiple electrode arrays are typically located in electrical contact with either epicardial or endocardial tissue.
  • the multiple electrodes are coupled to an external cardiac stimulator, which applies electrical pacing signals through one or more electrodes at given frequencies, durations, or amplitudes to myocardial tissue, a process called "pacing.”
  • the multiple electrodes on the array are also typically coupled to signal processing equipment, called “recorders,” which display the morphologies of the electrocardiograms or electrograms recorded during pacing.
  • recorders signal processing equipment
  • another roving electrode is deployed in association with the multiple electrode array, to pace the heart at various endocardial locations, a technique called “pace mapping.”
  • an electrode coupled to a source of, e.g., radio frequency energy is deployed.
  • the physician In conducting these diagnostic or therapeutic procedures, the physician must compare all paced electrocardiograms or electrograms to those previously recorded during an induced arrhythmia episode. The physician also must know the position of all deployed electrodes in order to interpret the data in a meaningful way. The physician also needs to be able to accurately maneuver and position the roving or ablation electrode, when used. For these reasons, these procedures required a considerable degree of skill and experience on the part of the attending medical personnel.
  • One aspect of the invention provides an interface for association with a structure which, in use, is deployed in an interior body region of a patient.
  • the structure includes an operative element coupled to a controller, which establishes an operating condition for the operative element to perform a diagnostic or therapeutic procedure in the interior body region.
  • the interface comprises a display screened an interface manager coupled to controller and the display screen.
  • the interface manager includes a first function to generate a first display comprising an image of the structure at least partially while the operative element performs the procedure.
  • the interface manager also includes a second function to generate a second display comprising one or more data fields reflecting the operating condition of the controller.
  • the interface manager further includes a third function to enable selection of the first display or the second display for viewing on the display screen.
  • systems and methods provide an interface for association with an electrode structure which, in use, is deployed in contact with heart tissue to perform a diagnostic or therapeutic procedure.
  • the interface comprises a display screen, and an interface manager coupled to the display screen.
  • the interface manager includes a first function to generate a real image of the electrode structure acquired by an imaging device.
  • the interface manager includes a second function to generate an idealized image of the electrode structure based at least in part upon the real image.
  • the interface manger includes a third function to display a view image comprising a third function to display a view image comprising either the real image, or the idealized image, or both on the display screen.
  • Fig. 1 is a schematic view of a system, which couples several individually controlled diagnostic or therapeutic instruments to a main processing unit through an instrument interface and which includes a graphical user interface (GUI);
  • GUI graphical user interface
  • Fig. 2 is a schematic view of the representative instruments, including a multiple electrode basket, a roving electrode, and a roving imaging device, which are coupled to individual controllers via the instrument interface;
  • Fig. 3 is a schematic view of the instrument interface
  • Fig. 4 is a depiction of the start-up screen of the GUI
  • Fig. 5 is a depiction of the record protocols-configuration screen of the GUI
  • Fig. 6 is a depiction of the record protocols-sequence screen of the GUI
  • Fig. 7 is a depiction of the pace protocols-configuration screen of the GUI
  • Fig. 8 is a depiction of the pace protocols-sequence screen of the GUI
  • Fig. 9 is a depiction of the virtual image navigation screen of the GUI.
  • Fig. 10 is an enlarged view of the idealized image of the multiple electrode basket displayed by the virtual image navigation screen of the GUI;
  • Fig. 11 is a depiction of the virtual image navigation screen of the GUI, with the Binary Map dialog box displayed;
  • Fig.12 is a depiction of the binary map dialog box with the Create Map control button selected
  • Fig.13 is a depiction of the virtual image navigation screen of the GUI, with the Anatomic Features dialog boxes displayed; - 4 -
  • Fig. 14 is a schematic view showing the creation of proximity-indicating output for display by the virtual image navigation screen of the GUI;
  • Fig. 15 is an enlarged view of an idealized image displayed by the virtual image navigation screen of the GUI, with the Sensitivity Adj dialog box displayed for adjusting sensitivity of the proximity-indicating output;
  • Fig. 16 is an enlarged view of an idealized image displayed by the virtual image navigation screen of the GUI, showing the interpolation of proximity-indicating output;
  • Fig. 17 is aschematic view showing the creation of location out based upon spacial variations in electrical potentials, for display by the virtual image navigation screen of the GUI;
  • Fig. 18 is a schematic view showing the creation of location output based upon differential waveform analysis, for display by the virtual image navigation screen of the GUI;
  • Fig. 19 is a depiction of the virtual image navigation screen of the GUI, with the Markers dialog box displayed;
  • Fig. 20 is a depiction of the virtual image navigation screen of the GUI, with the Find Site dialog box displayed;
  • Fig. 21 is a depiction of the real image navigation screen of the GUI
  • Fig. 22 is a depiction of the real image navigation screen of the GUI, with the compare image function enabled
  • Fig. 23 is a schematic showing an implementation of the analyze image function
  • Fig. 24 is a depiction of the test screen of the GUI
  • Fig. 25 is a depiction of the print screen of the GUI
  • Fig. 26 is a depiction of the service screen of the GUI
  • Fig. 27 is a depiction of the virtual image navigation screen of the GUI, with the Event Log control button function toggled on to display the Event Log;
  • Fig. 28 is a depiction of the virtual image navigation screen of the GUI, with the Patient Data Base function enabled and the Patient Data dialog box opened for data input at the outset of a new study
  • Fig. 29 is a depiction of the virtual image navigation screen of the GUI, with the Patient Data Base function enabled and the Select Image dialog box opened for data input;
  • Fig. 30 is a depiction of the print screen of the GUI, with the Patient Data Base control button selected to open the Patient Records dialog box;
  • Fig. 31 is a depiction of the print screen of the GUI, with the Patient Data Base control button selected and the Directory dialog box opened;
  • Fig. 32 is a depiction of the print screen of the GUI, with the Patient Data Base control button selected and the Find/Sort dialog box opened.
  • the invention may be embodied in several forms without departing from its spirit or essential characteristics.
  • Fig. I shows a system 10 for diagnosing, treating or otherwise administering health care to a patient.
  • the system 10 includes various diagnostic or therapeutic instruments.
  • Fig. 1 shows three instruments 12, 14, and 16.
  • the instrument 12 comprises an a ⁇ ay of multiple electrodes 18.
  • the instruments 14 and 16 each comprises an operative element usable for some diagnostic or therapeutic purpose.
  • one of the operative elements 14 or 16 can comprise a device for imaging body tissue, such as an ultrasound transducer or an array of ultrasound transducers, or an optic fiber element, or a CT or MRI scanner.
  • one of the operative elements 14 or 16 can comprise a device to deliver a drug or therapeutic material to body tissue.
  • one of the operative elements 14 or 16 can comprise a device, e.g., an electrode, for sensing a physiological characteristic in tissue, such as electrical activity in heart tissue, or for transmitting energy to stimulate or ablate tissue.
  • the operative elements 14 and 16 When deployed in the body, the operative elements 14 and 16 can be readily moved relative to the multiple electrode array 12. For this reason, the instruments 14 and 16 will also each sometimes be called a "roving instrument.”
  • the system 10 includes one or more instrument controllers (designated 20,
  • controllers 20, 22, and 24 condition an associated instrument 12, 14, and 16 to perform its desired diagnostic or therapeutic functions.
  • the system 10 includes an instrument manager or interface 26.
  • the interface 26 couples the instrument controllers 20, 22, and 24 to their respective instruments 12, 14, and 16, establishing electrical flow paths, which process the various diagnostic or therapeutic data and signals in an organized and efficient fashion.
  • the interface 26 serves as a master switching unit, which governs the connections linking the instrument controllers 20, 22, and 24 to the individual instruments 12, 14, and 16.
  • the interface 26 can comprise an integrated module, or an assembly of discrete components. Further details of a representative embodiment for the interface 26 will described later.
  • the system 10 also includes a main processing unit (MPU) 28.
  • the MPU 28 comprises a PentiumTM type microprocessor, although other types of conventional microprocessors can be used.
  • the MPU 28 includes an input/output (1/0) device 30, which controls and monitors signal and data flow to and from the MPU 30.
  • the 1/0 device 30 can comprise, e.g., one or more parallel port links and one or more conventional serial RS-232C port links or EthernetTM communication links.
  • the 1/0 device 30 is coupled to a data storage module or hard drive 32, as well as to the instrument interface 26 and a printer 34.
  • the system 10 also includes an operator interface module 36, which is coupled to the 1/0 device 30.
  • the graphics display monitor 38 includes a graphics display monitor 38, a key board input 40, and a pointing input device 42, such as a mouse or trackball.
  • the graphics display monitor 38 can also provide for touch screen input.
  • the system 10 includes an operating system 44 for the MPU 28.
  • the operating system 44 resides as process software on the hard drive 32, which is down loaded to the MPU 28 during system initialization and startup.
  • the operating system 44 can comprise a Microsoft WINDOWS® 3.1, WINDOWS 95® or NT operating system.
  • the operating system 44 can reside as process software in EPROM's in the MPU 28.
  • the operating system 44 executes through the operator interface 36 a graphical user interface, or GUI 46, the details of which will be described later.
  • the GUI 46 is configured to operate on a WINDOWS® compatible laptop or desktop computer.
  • the GUI 46 can be realized, e.g., as a "C" language program implemented using the MS WINDOWSTM application and the standard WINDOWS 32 API controls, e.g., as provided by the WINDOWSTM Development Kit, along with conventional graphics software disclosed in public literature.
  • the MPU 28, hard drive 32, and the components of the operator interface 36 can be implemented in a conventional lap top or desktop computer, which serves as a host for the operating system 44 and GUI 46.
  • Other computer system forms can, of course, be used, e.g., using a server to host the operating system 44 and GUI 46 for a network of workstations, each of which comprises an operator interface 36.
  • the operating system 44 administers the activation of a library 48 of control applications, which are designated, for purpose of illustration, as Al to A7 in Fig. 1.
  • control applications Al to
  • A7 all reside in storage 54 as process software on the hard drive 32 and are down loaded and run based upon operator input through the GUI 46.
  • all or some of the control applications Al to A7 can reside as process software in EPROM's in the MPU 28, which can likewise be called and run through the GUI 46.
  • Each control application Al to A7 prescribes procedures for carrying out given functional tasks using the system 10 in a predetermined way.
  • the library 48 includes one or more clinical procedure applications, which are designated Al and A2 in Fig. 1.
  • Each procedure application Al and A2 contains the steps to carry out a prescribed clinical procedure using the system 10.
  • each procedure application Al and A2 When run by the operating system 44, each procedure application Al and A2 generates prescribed command signals, which the 1/0 device 30 distributes via the instrument interface 26 to condition the instrument controllers 20, 22, and 24 to perform a desired task using the instruments 12, 14, and 16.
  • the 1/0 device 26 also receives data from the instrument controllers 20, 22, and 24 via the instrument interface 26 for processing by procedure application Al or A2 being run.
  • the GUI 46 presents to the operator, in a graphical format, various outputs generated by the procedure application Al or A2 run by the operating system 44 and allows the user to alter or modify specified processing parameters in real time. Further details of specific representative procedure applications Al and A2 will be described in greater detail later.
  • the library 48 also includes one or more specialized navigation applications A3 and A4.
  • the navigation applications A3 and A4 when run by the operating system 44, allow the operator to visualize on the GUI 46 the orientation of the multiple electrode array 12 and roving instruments 14 and 16 when deployed in an interior body region.
  • the navigation applications A3 and A4 thereby assist the operator in manipulating and positioning these instruments to achieve the diagnostic or therapeutic results desired.
  • one navigation application A3 constructs an ideal or virtual image of the deployed array 12 and the roving instruments 14, and 16, while the other navigation application A4 displays an actual, real-time image of these instruments 12, 14, and 16.
  • One or both of the navigation applications A3 and A4 can also display in graphical form on the GUI 44 information to aid the operator in interpreting data acquired by the multiple electrode array 12 and roving instruments 14 and 16 when deployed in an interior body region.
  • the library 48 also includes one or more utility applications A5 to A7.
  • the utility applications A5 to A7 carry out, e.g., system testing, system servicing, printing, and other system support functions - 9 -
  • the operating system 44 also includes one or more speciality functions (designated FI and F2 in Fig. 1), which run in the background during execution of the various applications Al to A7.
  • one function FI can serve to establish and maintain an event log 50, stored in the hard drive 32, which keeps time track of specified important system events as they occur during the course of a procedure.
  • Another function F2 can serve to enable the operator, using the GUI 44, to down load patient specific information generated by the various applications Al to A7 to the hard drive 32 as data base items, for storage, processing, and retrieval, thereby making possible the establishment and maintenance of a patient data base 52 for the system 10.
  • the system 10 is well adapted for use inside body lumens, chambers or cavities for either diagnostic or therapeutic purposes. For this reason, the system 10 will be described in the context of its use within a living body.
  • the system 10 particularly lends itself to catheter-based procedures, where access to the interior body region is obtained, for example, through the vascular system or alimentary canal. Nevertheless, the system 10 can also be used in association with systemsand methods that are not necessarily catheter-based, e.g., laser delivery devices, atherectomy devices, transmyocardial revascularization (TMR),percutaneous myocardial revascularization (PMR), or handheld surgical tools.
  • catheter-based e.g., laser delivery devices, atherectomy devices, transmyocardial revascularization (TMR),percutaneous myocardial revascularization (PMR), or handheld surgical tools.
  • the system 10 can be used during the diagnosis and treatment of a ⁇ hythmia conditions within the heart, such asventricular tachycardia or atrial fibrillation.
  • the system 10 also can be used during the diagnosis or treatment of intravascular ailments, in association, for example, with angioplasty or atherectomy techniques.
  • the system 10 also can be used during the diagnosis or treatment of ailments in the gastrointestinal tract, the prostrate, brain,gall bladder, uterus, and other regions of the body.
  • representative components of the system 10 will be described in the context of the diagnosis and treatment of abnormal cardiac conditions.
  • instruments 14 and 16 are deployable within or near a heart chamber, typically in one of the ventricles.
  • the structure of the a ⁇ ay of multiple electrodes 18 carried by the first instrument 12 can vary.
  • the instrument 12 comprises a composite, three dimensional basket structure 58 that is carried at the distal end of a catheter tube 56 for introduction into the targeted heart chamber.
  • the basket structure includes eight spaced apart spline elements (alphabetically designated A to H in Fig. 2) assembled together by a distal hub 60 and a proximal base 62.
  • Each spline A to H in turn, carries eight electrodes 18, which are numerically designated on each spline from the most proximal to the most distal electrode as 1 to 8 in Fig. 2.
  • the basket structure 58 thus supports a total of sixty- four electrodes 18, which Fig.
  • spline and electrode order e.g., (A,8), which identifies the most distal electrode on spline A.
  • spline and electrode order e.g., (A,8)
  • a greater or lesser number of spline elements and/or electrodes 18 can be present.
  • Each spline element A to H preferably comprises a flexible body made from resilient, inert wire or plastic.
  • Elastic memory material such as nickel titanium (commercially available as NITINOLTM material) can be used.
  • Resilient injection molded plastic or stainless steel can also be used.
  • Each spline element A to H is preferably preformed with a convex bias, creating a normally open threedimensional basket structure.
  • the basket structure 58 is deployed in the heart by advancement through a conventional guide sheath (not shown) snaked through the vasculature.
  • the guide sheath compresses and collapses the structure 58. Retraction of the guide sheath allows the structure 58 to spring open into the three-dimensional shape shown in
  • Each of the electrodes 18 is electrically connected to an individual conductor in a multiple conductor cable 64 (see Fig. 1 also).
  • the cable 64 terminates in one or more connectors, through which electrical connection can be made to the individual - 11 -
  • the connectors are coupled to the instrument interface 26.
  • the instrument 12 need not be configured as a basket 58.
  • the array can take the form of an elongated electrode array, which can be straight, curved, or formed into a loop.
  • a three-dimensional structure can be formed carrying dual outer and inner arrays of electrodes.
  • Various other configurations for multiple electrode a ⁇ ays are shown in copending U.S. Patent Application Serial No. 08/938,721, filed September 26, 1997, and entitled "Systems and Methods for Generating Images of Structures Deployed Within Interior Body Regions.”
  • the first roving instrument 14 is also carried at the distal end of a catheter tube 66 for deployment and manipulation in the body.
  • the instrument 14 comprises an electrode 68 intended, in use, to sense electrical activity in heart tissue, as well as to transmit energy to stimulate or ablate tissue.
  • the electrode 68 is electrically connected by a cable 70 to the instrument interface 26.
  • the second roving instrument 16 comprises an imaging device 72.
  • the imaging device 72 operates using a selected visualizing technique, e.g., fluoroscopy, ultrasound, CT, or MRI, to create a real-time image of a body region.
  • a cable 76 conveys signals from the imaging device 72 to the instrument interface 26.
  • the instrument controller 20 comprises at least one external cardiac stimulator.
  • the cardiac stimulator 20 hosts a selection of diagnostic procedures, which generates electrical pulses of various duration, number, and cycles. The pulses stimulate or pace myocardial tissue, so that resultant electrical activity can be mapped.
  • a stimulator 20 of the type is of the type currently used in electrophysiology labs and can be commercially purchased,e.g., from Medtronic or Bloom, and.
  • the system 10 can include additional stimulators, if desired. When multiple stimulators are present, the interface 26 can quickly switch between different pulse frequencies, durations, or amplitudes during pacing. - 12 -
  • the instrument controller 22 comprises an electrogram recorder of the type that is commercially available from, e.g., Prucka,
  • the electrogram recorder 22 functions to record, store, process, analyze, and display signals acquired by the electrodes on the basket structure 558 and as well as the roving electrode 68 during pacing.
  • the instrument controller 24 comprises an appropriate controller for the imaging device 72.
  • the controller 24 generates a video output from the signals generated by the device 72.
  • the format of the video output can vary, e.g., it can comprise composite video, video-modulate RF signal, or RGB/RGBI including applicable TV standards (i.e. NTSC, PAL or SECAM).
  • a generator for transmitting radio frequency ablation energy can also be coupled to the roving electrode 68, through the instrument interface 26 (as shown in solid lines in Fig. 2), or through its own instrument interface 26' (shown in phantom lines in Fig. 2) coupled to the MPU 28.
  • the instrument interface 26 is centered around an application specific integrated circuit (ASIC) 80 of the type shown and described in U.S. Application Serial No. 08/770,971 entitled, "Unified
  • the interface 26 can comprise an assembly of separate components and not an integrated circuit.
  • the ASIC 80 comprises a cross point switch matrix 82.
  • the matrix 82 includes a block of primary analog input pins 84 through which low level external signals from the recorder 22 and real image processor 24 can be received.
  • a block of additional analog input pins 86 are provided, through which high level external signals, such as those produced by the stimulator 20 or generator 78, can be received.
  • the matrix 82 includes a block of analog output pins 88.
  • the matrix 82 enables any of the input pins 84/86 to be connected to any of the output pins 88. This operation permits, for example, various subsets of the electrodes 18 on the basket structure 58 to be connected to various subsets of input - 13 -
  • any of the high level input pins 86 can be coupled to any of the primary input pins 84. This permits pacing pulses generated by the stimulator 20 to be applied through any of the electrodes 18 on the basket structure 58 or through the roving electrode 68. Alternatively, high level pacing pulse signals can be switched backward from any of the output pins 88 to any of the input pins 84, to permit "retrograde" pacing from the electrogram recorder 22, if it has pacing output capabilities.
  • the various instruments 12, 14, and 16 are coupled to the ASIC 80 through appropriate isolation circuitry (not shown), which isolates the ASIC 80 from potentially damaging signals, currents and voltages.
  • the ASIC 80 includes embedded on-chip software that comprises a switch manager 90.
  • the switch manager 90 configures the cross point switch matrix 82 to establish desired electrical connections among the various instruments 12, 14, and 16 and controllers 20, 22, and 24, to carry out various operating modes for the system 10.
  • the number and type of operating modes controlled by the switch manager 90 in large part parallel the number and type of applications Al to A7 and functions FI and F2 available for execution by the operating system 44.
  • the switch manager 90 enters a procedure mode.
  • the manager 90 configures the multiple electrodes 18 on the basket structure 58 and the roving electrode 68 for recording or pacing based upon the command signals generated by the MPU 28.
  • the procedure mode carried out by the switch manager 90 is not necessarily constrained by the data channel limitations of the associated instrument controllers. For example, if the procedure application Al or A2 calls for signal acquisition or pacing from sixty-four (64) electrodes, and the data acquisition capabilities of the electrogram recorder 22 happens to be only twenty-four (24)channels 116, the switch manager 90 configures the sixty-four (64) electrodes into four subsets of sixteen (16) electrodes, switching among the subsets to achieve the desired data - 14 -
  • the interface 26 displays a visual PACE output, e.g., through a LED 92 on an exterior panel 114, which is activated when the stimulator 20 is, coupled by the manager 90 to one or more instrument electrodes.
  • the manager 90 is commanded by the MPU 28 to enable the navigation mode.
  • the manager 90 periodically communicates to the MPU 28 the electrically sensed position of the roving electrode 68 for display in the GUI 46, using an embedded navigation routine 94, which will be described in greater detail later.
  • the position reporting frequency is at least once per heart chamber cycle (i.e., once every 150 ms or greater).
  • the manager 90 inputs signals from the imaging device 72 to the processor 24, and outputs processed video signals to the MPU 28 for display on the GUT 46.
  • the interface displays visual NAVIGATION DISABLED and NAVIGATIONENABLED outputs, e.g., through LEDs 96 and 98 on the exterior panel 114.
  • the NAVIGATION ENABLED LED 98 is activated when either navigation application A3 or A4 is executed and the navigation mode is enabled. Conversely, the NAVIGATION DISABLED LED 96 is activated when neither navigation application A3 or A4 are executed.
  • the multiple electrode instrument 12 carries an electrical identification code 100, which uniquely identifies the physical property and configuration of the electrodes on the basket structure 58.
  • the switch manager 90 includes an embedded ID routine 102, which electrically senses the code 100 and inputs configuration data according to the code 100 for use in the navigation routine 94.
  • the code 100 can be variously implemented, e.g., in an integrated circuit, which expresses the code 100 in digital form, or as separate electrical elements, such as several resistors having different resistance values which express the digits of the code 100.
  • application A5 constitutes a prescribed testing utility.
  • the testing application A5 is executed on the MPU 28, the switch - 15 -
  • the interface displays a visual TEST output, e.g., through a LED 104 on the exterior panel 114, which is activated when the testing application A5 is executed.
  • the embedded on-chip switch manager 90 also runs a self-test routine 106 immediately after power-on or hardware reset. In the self-test mode, the manager 90 verifies the overall functionality of the interface 26. The embedded on-chip switch manager 90 also continuously self-checks the interface's functionality, e.g., through a conventional watchdog routine 108, which interrupts improper software execution. When a failure is detected (or when the self-test mode fails), the manager 90 switches to a safe mode, where command execution is inhibited and the navigation mode is disabled. The interface 26 displays a visual WARNING output, e.g., through a LED 110 on the exterior panel 114, which is activated when the safe mode is entered. The interface remains in the safe mode until the user presses a reset button 112 on the exterior of the interface 26 to continue. D. The Operator Interface and GUI
  • the graphics display device 38 of the operator interface 36 supports SVGA or comparable display of graphic information by the GUI 46.
  • the MPU 28 preferable has a SPECfp92 benchmark of at least 25 to support rapid update of graphical information on the GUI 46. 1. Start-Up
  • the operating system 44 Upon boot-up of the MPU 28, the operating system 44 implements the GUI 46.
  • the GUI 46 displays an appropriate start-up logo and title image, followed by the START-UP screen 118, as shown in Fig. 4.
  • the START-UP screen 118 includes a column of icon push button controls 120 to 134, which are labeled for each of the main operating modes or functions available to the MPU 28 for execution. - 16 -
  • the illustrated embodiment provides these executable modes: RECORDING PROTOCOLS (executing Application Al); PACING PROTOCOLS (executing Application A2); VIRTUAL IMAGE NAVIGATION (executing Application A3); REAL IMAGE NAVIGATION (executing Application A4); TEST (executing Application A5); PRINT (executing Application A6); and SERVICE (executing ApplicationA7).
  • Selected a button control 120 to 134 using the pointing device 42 or keyboard 40 causes the operating system 44 to down load and implement the associated application on the MPU 28.
  • the additional icon push button control 134 labeled EVENT LOG is present on the start up scree 118.
  • This control 134 when selected, toggles on and off the display of an event log, which the Event Log Function FI of the operating system 44 continuously executes in the background.
  • the Event Log Function FI records specified major events that occur during the course of a given procedure. More details about the Event Log Function FI and the EVENT LOG toggle button 134 will be provided later.
  • each of these push button controls 120 to 134 are displayed by the GUI 46 throughout a given operating session, regardless of what application is being executed.
  • the push buttons 120 and 132 for the executable modes are displayed in one color (e.g., grey) when not selected and a different color (e.g., green) when selected.
  • the label of the toggle push button 134 changes when selected.
  • the operating system 44 itself is not available for general use by the operator, outside of the confines of the GUI 46. Access to the operating system 44 is restricted only to authorized service personnel, through executing the password protected SERVICE application A7, which will be described later.
  • GUI 46 Further details of the GUI 46 will be now described by selecting and executing the applications Al to A7, as well as describing the execution of the functions FI and F2.
  • the selection of the RECORDING PROTOCOLS push button 120 executes the recording protocols application (Al).
  • the recording protocols application Al operates to define or configure electrode subgroups among the available electrodes
  • the recording protocols application Al when executed by the MPU 28, displays a first sub-window 136, as shown in Fig. 5. As can be seen in Fig. 5, all main mode and function push buttons 120 to 134 remain displayed on the right side of the window 136. The selected push button 120 changes color when selected, while the other non-selected push buttons 122 to 134 remain displayed in their original state.
  • the first sub- window 136 allow the operator to define a Recording
  • the recording configuration window 136 displays an INPUT CHANNEL column field 144, a CATHETER TYPE column field 146, and an ELECTRODE column field 148. Information in these fields 144, 146, and 148 together define a currently valid Catheter Configuration, which is assigned by default or by the operator an identifier in a RECORD CONFIGURATION field 150.
  • the recording configuration window 136 also displays an OUTPUT CHANNEL field 170, which assigns an output channel number to each electrode, which also becomes a component of the valid Catheter Configuration 150.
  • a catheter configuration can be saved as a file on the hard drive, for processing, editing, and retrieval, various file management push button controls (CREATE 152, OPEN 154, SAVE 156, DELETE 158, and APPLY 160) are provided for this purpose.
  • the INPUT CHANNEL field 144 identifies the input channels 116 of the recorder 22.
  • the OUTPUT CHANNEL field 170 identifies the output channel assigned to each electrode. By default, the rows are indexed by INPUT CHANNEL - 18 -
  • the operator can index in channel output order, by selecting the SORT BY OUTPUT control button 162.
  • the SORT BY OUTPUT control button label toggles to SORT BY INPUT.
  • the operator can always select indexing the display either between recorder input channel or electrode output channel.
  • the operator can scroll using the control buttons 164, up and down the INPUT CHANNEL field 144 in conventional fashion. In the illustrated embodiment, the scrolling occurs in steps of sixteen, and information is updated across all fields 144, 146, and 148 while scrolling.
  • the recording protocols application Al accepts a STATUS field input 166, which indicates an non-operational state of the channel (e.g., shorted or open). No input in the STATUS field 166 (i.e., a blank field) indicates a good operational channel.
  • the STATUS field 166 receives input from the test application A5, or from self- tests conducted by the switch manager 90, as already described.
  • the INPUT CHANNEL field 144 can be edited by the operator, to associate available electrodes 18 or 68 with available recorder input channels 116, as desired.
  • the operator can configure the INPUT CHANNELS into electrode subgroups, so a recorder 22 having a lesser number of input channels than the number of electrodes can nevertheless be used to record and process signals obtained by the multiple electrode basket 58.
  • a recorder 22 having a lesser number of input channels than the number of electrodes can nevertheless be used to record and process signals obtained by the multiple electrode basket 58.
  • electrodes Al to D8 define the first electrode subgroup
  • El to H8 define the next electrode group.
  • the OUTPUT CHANNEL field 170 can likewise be edited using a drop down menu control 168 or by input from the keyboard 40.
  • the OUTPUT CHANNEL field 170 can likewise be edited using a drop down menu control 168 or by input from the keyboard 40.
  • CHANNEL field 170 accepts a numeric value from between 1 to 72.
  • the CATHETER TYPE field 146 contains an key word identifier, which indicates the type of instrument carrying the electrodes 18 or 68, e.g., whether it is a multiple electrode basket structure 58 (which is designated "Constellation” in Fig. 5, which in shorthand identifies a CONSTELLATION® Catheter sold by EP
  • a roving electrode 68 for example, in shorthand, "Roving"
  • the CATHETER TYPE column field 146 is editable, either by predefined default drop down menu control 168 or by input from the keyboard 40. Thereby, the operator can, in a single record configuration, associate with the recorder input channels, several different types of electrode carrying instruments, e.g., a multiple electrode basket 58 and a roving electrode 68, and others.
  • the ELECTRODE field 148 identifies each electrode 18 on the instrument by the assigned numeric, alphabetic or alpha-numeric code. As already explained, for the basket 58, the electrodes 18 are identified Al, B4, C6, etc., with the splines alphabetically identified (A, B, C, D, etc.), and the electrodes on each spline numerically identified from the distal to the proximal end of the spline (1, 2, 3, etc.).
  • Instruments with a single electrode or linear or curvilinear arrays of electrodes can numerically identify electrodes in order from distal to proximal end of the instrument.
  • the ELECTRODE column field 148 is editable, either by predefined default drop down menu controls 168 or by input from the keyboard 40.
  • the record sequence window 142 (see Fig. 6) is displayed by selecting the Sequence tab 140.
  • the window 142 lists the recording sequences and the order in which they are applied to the recorder 22 via the instrument interface 26.
  • the window 142 displays a CONFIGURATION column field 172, a SEQUENCE TYPE column field 174, DURATION column field 176, a #PULSES column field 178, and a #CYCLES column field 180.
  • Each row of information in these fields 174 to 180 together define a recording protocol.
  • the numeric order in which the protocols are - 20 -
  • the window 142 allows for a maximum of fourteen rows, that is, fourteen different recording protocols for each recording sequence.
  • Each recording protocol (row) in a given recording sequence is assigned a file name 182, either by default or by the operator for storage in the hard drive, with a ".rec" file identifier.
  • the hard drive 32 can carry pre-determined recording protocols as rec files, so that the operator need not be concerned about inputting the specifics of the recording sequence.
  • the file name 182 appears in the CONFIGURATION field 172.
  • the recording sequence which lists the order of the protocols, is also assigned a file name 184 for storage in the hard drive 32, either by default or by the operator. This file name 184 appears in the editable Record Sequence field.
  • Various file management push button controls (CREATE 186, OPEN 188, SAVE 190, DELETE 192, ADD ROW 194, REMOVE 196, and APPLY 198) are provided for establishing, retrieving, saving, removing, or otherwise editing recording files retaining the protocols and recording sequences configurations.
  • the SEQUENCE TYPE field 174 constitutes a control button, which toggles between Automatic mode and Manual mode.
  • Automatic mode the recording application Al applies the protocol row to the interface box without requiring operator intervention, following the timing specified either in the DURATION field 176 or #PULSES field 178, as will be described later.
  • Manual mode the recording application Al requires operator intervention before applying the protocol. In the illustrated embodiment, the operator intervenes by selecting the NEXT control button 200 in the sequence window 142.
  • the number inserted by the operator in the DURATION field 176 specifies the number of seconds for which the specified protocol is to be applied to the instrument interface 26.
  • the number inserted by the operator in the #PULSES field 178 specifies the number of pacing pulses for which the specified protocol is to be applied to the instrument interface 26. The longer of the time period specified in the DURATION field 176 and #PULSES - 2 1 -
  • #CYCLES field 180 controls the timing of the protocol applied to the instrument interface 26.
  • the number inserted by the operator in the #CYCLES field 180 specifies the number of cycles for which either the duration field value or pacing pulse field value controls the application of the protocol to the instrument interface 26.
  • the operator can, respectively, establish a new record configuration, retrieve an existing record as a file from the hard drive 32, save a new or edited record as a file to the hard drive 32, or delete a record file from the hard drive 32.
  • the operator adds a new row of editable fields, in which the operator can add a new recording protocol for the recording sequence, which is assigned the next sequential row number.
  • the REMOVE control bottom 196 the operator can remove any highlighted protocol row.
  • the recording application Al commands the instrument interface 26 to be configured to carry out the recording sequence specified in the record sequence window 142.
  • the recording application Al starts applying the sequencing row by row to the instrument interface 26 in row order.
  • the recording application Al displays a highlight 202 around the sequence row that is being currently applied to the instrument interface 26.
  • the recording application Al interrupts the sequencing.
  • the control button label toggles to RESUME, which permits, when selected, the resumption of the sequencing, toggling the label back to PAUSE.
  • the RESET control button 206 the recording application Al begins sequencing at the first listed row, regardless of the current status of the sequence.
  • the RESET control button 206 is active for selection only when the sequencing is paused or otherwise not being applied. Furthermore, changes to any editable field in the window 142 are accepted only when the sequencing is paused or not being applied.
  • the selection of the PACING PROTOCOLS push button 122 executes the recording protocols application A2.
  • the pacing protocols application A2 operates to define or configure the connectivity among the one or more pacing stimulators 20 and the electrodes connected via the instrument interface 26.
  • the pacing protocols application A2 when executed by the MPU 28, displays a first sub-window 208, as shown in Fig. 7.
  • the main mode or function push buttons 120 to 134 still remain in view on the right side of the window 208 in their original first color, except the selected push button control 122, which changes color when selected.
  • the first sub-window 208 allow the operator to define a Pacing
  • the configuration window 208 displays an INPUT CHANNEL column field 216, a TERMINAL TYPE column field 218, an ELECTRODE column field 220, and a TERMINAL column field 222.
  • TERMINAL TYPE field 218, and the ELECTRODE field 220 corresponds to the information inputted by the operator on the current recording configuration window 136 (Fig. 5) in the INPUT CHANNEL field 144, CATHETER TYPE field 146, and ELECTRODE field 48, respectively.
  • the recording configuration name in current recording configuration window 136 (Fig. 5) (i.e., "constell") also appears in the
  • the pacing protocols application For each INPUT CHANNEL 216, the pacing protocols application also displays a
  • STATUS field input 226, which corresponds with the information in the STATUS field 166 in the current recording configuration window 136 (Fig. 5).
  • the only editable field in the pacing configuration window 208 is the TERMINAL column field 222.
  • the editable TERMINAL field 222 allows for selection of known electrode terminals by a drop down menu control 230.
  • the drop down menu 230 contains the selections: "None”, “1", “1+”, “2-”, and "2+”.
  • the pacing application A2 replaces a previously entered value of the TERMINAL field 222 in a different row with "None" whenever the operator selects the same terminal value in another row from the drop down menu 230.
  • the CREATE 232 and OPEN 234 control buttons are not active on the pacing configuration sheet, as a pacing configuration can be established or retrieved only in conjunction with the establishment or retrieval of a recording configuration, through the recording applications Al.
  • a DISCONNECT STIMULATOR control button 242 appears in the window 208, preferably in red or another distinguishing color.
  • the DISCONNECT STIMULATOR button 242 allows the operator to immediately interrupt transmission of the pacing inputs to the hardware interface 26.
  • the DISCONNECT STIMULATOR control button 242, once implemented, continues to be displayed throughout the remainder of the operating session, regardless of what application is implemented, unless selected to interrupt pacing.
  • the pacing sequence window 214 lists the pacing protocols and the order in which they are applied to the stimulator 20 via the instrument interface 26. - 24 -
  • the window 214 displays a CONFIGURATION column field 244, a SEQUENCE TYPE field column 246, a DURATION column field 248, a #PULSES column field 250, and a #CYCLES column field 252.
  • Each row of information in these fields 244 to 252 together define a pacing protocol.
  • the numeric order in which the protocols are listed comprises a pacing sequence.
  • the window 214 allows for a maximum of fourteen rows, that is, fourteen different pacing protocols for each pacing sequence.
  • Each pacing protocol (row) in a given pacing sequence is assigned a file name 254, either by default or by the operator for storage in the hard drive 32, with a ".pac" file identifier.
  • the hard drive 32 can carry pre-determined pacing protocols as pac files, so that the operator need not be concern about inputting the specifics of the pacing sequence.
  • the file name 254 appears in the CONFIGURATION field 244.
  • the pacing sequence, listing the order of the protocols is also assigned a file name 256 for storage in the hard drive 32, which is the same name assigned to the current recording sequence (i.e., "test"), which appears in the Pacing Sequence field 258.
  • the SEQUENCE TYPE field 246 constitutes a control button, which toggles between Automatic mode and Manual mode.
  • Automatic mode the pacing application A2 applies the protocol row to the instrument interface 26 without requiring operator intervention, following the timing specified either in the DURATION field 248 or #PULSES field 250, as will be described later.
  • Manual mode the pacing application requires operator intervention before applying the protocol. In the illustrated embodiment, the operator intervenes by selecting the NEXT control button 260 in the sequence window 214.
  • the DURATION field 248, the #PULSES field 250, and the #CYCLES field 252 are each editable by keyboard entry. The number inserted by the operator in the
  • DURATION field 248 specifies the number of seconds for which the specified protocol is to be applied to the interface 26.
  • the number inserted by the operator in the #PULSES field 250 specifies the number of pacing pulses for which the specified protocol is to be applied to the interface 26. The longer of the time period specified in the DURATION field 248 and #PULSES field 250 controls the timing of the protocol applied to the interface 26.
  • the number inserted by the operator in the #CYCLES field specifies the number of cycles for which either the duration field - 25 -
  • pacing pulse field value controls the application of the protocol to the interface 26.
  • the operator can, respectively, establish a new record configuration, retrieve an existing record as a file from the hard drive 32, save a new or edited record as a file to the hard drive 32, or delete a record file from the hard drive 32.
  • the operator By selecting the ADD ROW control button 270, the operator adds a new row of editable fields, in which the operator can add a new recording protocol of the recording sequence, which is assigned the next sequential row number.
  • the REMOVE control button 272 the operator can remove any highlighted protocol row.
  • the pacing application A2 commands the instrument interface 26 to be configured to carry out the pacing sequence specified in the pacing sequence window 214.
  • the pacing application A2 starts applying the sequencing row by row to the instrument interface 26 in the order specified.
  • the pacing application A2 applies a highlight 276 about the sequence row in the window 214 that is being currently applied to the instrument interface 26.
  • STIMULATOR control button 242 appears, preferably in red or another distinguishing color, to allow the operator to immediately interrupt transmission of the pacing inputs to the instrument interface.
  • the DISCONNECT STIMULATOR control button 242 once implemented, continues to be displayed throughout the remainder of the operating session, regardless of what application is implemented, unless selected.
  • the PAUSE control button 278 By selecting the PAUSE control button 278, the pacing application A2 temporarily interrupts the pacing sequence.
  • the control button label toggles to RESUME, which permits, when selected, the resumption of the sequencing, toggling the label back to PAUSE.
  • the recording application begins sequencing at the first listed row, regardless of the current pacing status.
  • RESET control button 280 is active for selection only when the sequencing is - 26 -
  • the navigation application A3 when executed by the MPU 28, displays a virtual navigation window 282, as shown in Fig. 9.
  • the main application control push buttons 120 to 134 still remain in view on the right side of the navigation window 282 in their original first color, except the selected VIRTUAL IMAGE NAVIGATION push button control 124, which changes color when selected.
  • the virtual image navigation application A3 generates in the window 282 an idealized graphical image 284, which models the geometry of the particular multiple electrode instrument 12 deployed in the body region.
  • the instrument 12 is the three-dimensional basket 58 shown in Fig. 2, and the image 284 reflects this geometry modeled as a wire-frame image.
  • the physician is able to visualize the location of each electrode and spline on the basket 58, as well as view the location of the roving electrode 68 relative to the basket image 284.
  • the navigation application A3 provides split screen images (designated 284L and 284R) in a left panel 10286 and a right panel 288.
  • the electrical identification code 100 of the basket 58 also identifies the geometry and layout of electrodes on the basket 58.
  • the navigation application A3 calls upon a library of idealized graphical images in hard drive storage 54, which reflect the different geometries identified by the code 100. Based upon the code 100, the navigation application A3 generates an idealized graphical image that corresponds to the geometry of the particular one in use.
  • the toolbar
  • Basket Size push button 342 which, when selected, opens a dialog box from which the operator can select one basket size from a listing of basket sizes.
  • the model wire-frame image displays splines A to H in a selected first color, except for spline A, which is preferably displayed in a different color for reference and orientation purpose.
  • the toggle Show Splines control button 340 By selecting the toggle Show Splines control button 340, the left and right images 284L and 284R display alphabetical spline labels A through H.
  • the control button 340 toggles between Show Splines and Hide Splines, which removes the alphabetic labels.
  • the X-axis of the image 284L is aligned by default along the major head-to-foot axis of the patient, the Y-axis is aligned along the shoulder-to-shoulder axis of the patient, and the Z-axis is aligned along the front to-back axis of the patient.
  • the color of the splines A to H is preferably displayed in different hues or shades to indicate their three-dimensional orientation along the Z-axis of this coordinate system, e.g., a bright shade when the spline appears in the foreground (when the Z value > 0)and a dark shade when the spline appears in the background (when the Z value ⁇ 0).
  • the idealized electrodes N can be represented by small rectangles or nodes.
  • a pop-up window 292 displays the location of a selected electrode N by spline electrode designation (Al, B2, etc., as explained above).
  • the pop-up window 292 displays a menu 294, which highlights the pacing terminal type of the electrode (1+, 1-, 2+, 2-). If the pointing device 42 selects the roving electrode 68, the pop-up window 292 will identify it as "Roving.”
  • the left and right panels 286 and 288 make it possible to simultaneously display the images 284L and 284R from different idealized orientations.
  • the navigation application A3 generates an Operational Screen Toolbar 296, which provides the physician with a variety of options to customize the idealized image 284L and 294R in each panel 286 and 288.
  • the physician is able to set up the desired images 284L and 284R in the left and right panels 286 and 288.
  • the Toolbar 296 includes an array of Left View Control Buttons 298 for the image 284L displayed in the left panel 286.
  • the left panel 286 shows the image 284L from preset right or left anterior angles or preset right or left posterior oblique angles.
  • the Left View Control Buttons 298 allow the physician to choose among the preset orientations for the left image 284L, such as Left 45° or 30° (labeled respectively LA045 and LA030 in Fig. 9), Right 45s? or 309 (labeled respectively RA045 and RA030 in Fig. 9), or Anterior/Posterior (labeled AP in Fig. 9).
  • An Edit Control field 316 displays the currently selected preset orientation.
  • the Toolbar 296 also includes three sets of Orientation Control Buttons
  • buttons 304 (X,Y,Z) when selected, cause the left image 284L to rotate about an idealized coordinate system located at center of the image 284L. Selection of the button 304 (X) rotates the image 284L in either a left-to-right or right to-left direction. Selection of the button 304(Y) rotates the image 284L in either a top-to-bottom or bottom-to-top direction. Selection of the button 304(Z)rotates the image in either a clockwise or counterclockwise direction. Alternatively, or in combination with the Orientation Control buttons 304 (XN,Z) the navigation application A3 can provide for rotation of the left image 284L by conventional "dragging" of the pointing device 42.
  • the Orientation Angles for the present left image 284L are displayed in the fields 306 (X), 306 (Y), and 306 (Z), respectively, on the Toolbar 296.
  • the Toolbar 296 includes a RESET 312 button, which, when selected, inputs predefined default values as Orientation Angles in the fields 306 (X), 306 (Y), and 306(Z), and the left image 284L is redrawn accordingly.
  • the Edit Control field 316 includes a control button 318, which activates a drop down menu.
  • the drop down menu lists the prescribed preset orientations (LA045, LA030, RA045, RA030, and AP) for selection.
  • the drop down menu also permits the physician to include on the listing a title identifying a custom orientation set up using the Orientation Control buttons 304 (XN,Z). The physician is thereby able to set up and use custom orientations, along with the preset orientations.
  • the image 284R displayed in the right panel 288 is displayed from a selected orthogonal side angle relative to the left image 284L.
  • the orientation of the right image 284R is adjusted to reflect the adjustments in the orientation of the left image 284L.
  • An array of Right View Control Buttons 300 allows the physician to select among preset orthogonal views for the right image 284R, e.g., as labeled in Fig. 9, Superior, Inferior, Left 90, and Right 90.
  • the preset Superior view is offset relative to the left image 284L 90 degrees about the Y-axis and 180 about the X-axis.
  • the preset Inferior view is offset relative to the left image 284L minus 90 degrees about the Y-axis.
  • the preset Left 90 view is offset relative to the left image 284L 90 degrees about the X-axis.
  • the preset Right 90 view is offset relative to the left image 284L minus 90 degrees about the X-axis.
  • a field 332 displays the name (e.g., Superior) of the selected preset view of the right image 284R.
  • the navigation application A3 displays orientation arrows 302 in the left panel 286 to assist the operator in establishing the relationship between the left and right panel images 284L and 284R.
  • the orientation arrows 302 point at the left image 284L along the horizontal or vertical axis of the line of sight along which the right image 284R is viewed for display in the right panel 288.
  • the right panel 288 is also labeled Anterior (front) and Posterior (rear) to further help the physician orient the right image 284R.
  • Other graphical clues such as a bitmap human figure or small coordinate axes may be displayed to aid orientation.
  • the Toolbar 296 includes Fluor Angle Control buttons 320 and associated Fluoro Angle field 322.
  • the buttons 320 rotate both the current left and right images 284L and 284R about the X-axis.
  • the Fluoro Angle field 322 changes accordingly from zero to plus or minus 90 degrees.
  • the Zoom Left push button 344 and the Zoom Right push button 346 when selected, allow the operator to call up a full-screen image of, respectively, the left image 284L or the right image 284R. All functions of the toolbar 296 remain function for the selected zoom image. - 3 0 -
  • the Toolbar 296 (see Fig. 9) includes control buttons, which integrate for viewing in the display panels 286 and 288 functions performed by the record protocols application Al and the pacing protocols application A2, previously described.
  • the SHOW PACE push button 290 when selected, opens in the right panel 286 a modified version of the Pacing Configuration window 208 (shown in full form in Fig. 7).
  • the modified version displayed upon selection of the SHOW PACE button 290 includes the Pace Configuration field 224, the scroll bar 228, the Input Channel Field 216, the Terminal field 222, along with the SAVE 236, DELETE 238, and APPLY 240 control buttons.
  • the NEXT REC push button 308 on the Toolbar 296 has the same function as the Next control button 200 on the Record Sequence window 142 (see Fig. 6), by advancing the record sequence to the next row when the current row is designated Manual in the Type field 174 of the Record Sequence window 142. Similarly, the
  • NEXT PACE push button 338 on the Toolbar 296 has the same function as the Next control button 260 on the Pace Sequence window 214 (see Fig. 8), by advancing the pace sequence to the next row when the current row is designated Manual in the
  • the toolbar 296 also includes a Binary Map push button 348. When selected
  • the Binary Map push button 348 opens a push button selection menu
  • Selection of the CREATE MAP button 350 opens a sub menu 362 on the toolbar 296, which lists the default selections for the binary maps, along with a CLOSE button 370.
  • the sub menu 362 lists as map selections early activation, fractionation, good pace map, concealed entrainment, and user defined.
  • the application A3 executes the desired mapping function based upon input from the record and pace applications Al and A2.
  • the application A3 annotates the images 284L and 284R with graphical symbols, called Binary Map - 31 -
  • Designators 364. identify by shaped and colored symbols the recording electrodes, the pacing electrodes, the roving electrode 68, and regions of electrical activity that the selected map function seeks out. Selecting the MAP LEGENDS button 360 (see Fig. 12) opens a sub menu 366, which lists the Binary Map Designators 364 by type, shape, and color. Using the pointing device 42, the operator is able to select among the individual electrodes on the displayed images 284L and 284R, to designate (e.g., by clicking) which electrode is to serve as a pacing electrode or as a recording electrode. The operator is thereby able to control the pacing and recording activities using the images 284L and 284R on the display panels 286 and 288.
  • the type of electrical activity highlighted by the Designators depends upon the type of binary map selected. For example:
  • the early activation map identifies and marks with the appropriate Binary Map Designator the electrodes where early depolarization of the heart tissue has occurred (early depolarization is often an indicator of abnormal heart tissue adjacent the electrode).
  • the fractionation map identifies and marks with the appropriate Binary Map
  • the good pace map identifies and marks with the appropriate Binary Map Designator the electrodes with a high pace mapping matching index.
  • This index reflects how many of the morphologies of 12-lead surface electrocardiograms (ECG) acquired during non-induced a ⁇ hythmia match the morphologies of the same signals acquired during paced induced a ⁇ hythmia from the particular electrode. If by pacing from a particular electrode, a high number of the 12-lead ECG morphologies are similar during non induced and pace-induced a ⁇ hythmia then it is likely that the particular electrode 18 resides close to an arrhythmogenic focus.
  • the concealed entrainment map identifies and marks with the appropriate
  • abnormal cardiac tissue often is located electrodes exhibiting concealed entrainment
  • the user defined map function enables the operator to place a operator-specified Binary Map Designator on the displayed image 284L or 284R.
  • the operator may position the graphical symbol pointing and clicking the pointing device 42 on to selected electrode or spline region displayed on an image 284L or 284R.
  • the operator can thus locate areas of cardiac tissue exhibiting certain preselected characteristics.
  • the application A3 opens a dialog box listing all existing binary maps that have been created.
  • the operator can quickly select and switch among any existing binary map.
  • the ability to chose among different mapping functions are of importance in identifying potential ablation sites. Frequently, abnormal cardiac tissue, which can be effectively treated through ablation, often exhibits more than one abnormal characteristic. Such sites frequently appear on two or more of the early activation, fractionation and concealed entrainment maps. If the same electrode or groups of electrodes appear on two or more of the early activation, fractionation, good pace map and concealed entrainment maps, a likely site for ablation is particularly well indicated.
  • the operator deletes the selected Designator 364.
  • the application A3 dismisses the selection menu 362, deselects all Designators 364, and returns control to the main menu 368.
  • the toolbar 296 also includes a Features push button 372. When selected
  • the Features push button 372 opens a push button selection menu 374, with buttons for selecting Atrial Anatomic Features 376 or Ventricular Anatomic - 33 -
  • the selection box 380 includes an anatomic features field 382 (listing e.g., the aortic valve, the inferior vena cava, the superior vena cava, etc.), along with control buttons labeled CLEAR ALL 384, REMOVE 386, and CLOSE 388.
  • the application A3 maintains an editable text file, from which the features 382 in the field 382 are inputted.
  • the operator selects a feature from the field 382F drags the selected feature to an image 284L or 284R, and drops the selected feature at the appropriate location on the image 284L or 284R. Having the relative locations of such anatomical structures displayed relative to the images 284L and 284R helps the physician in guiding the roving electrode 68, and in mapping and treating the target myocardial tissue.
  • the anatomic marker scan be deleted as a group by clicking on the CLEAR ALL button 384, or can be selectively deleted by clicking the REMOVE button 386. Selection of the CLOSE button 388 dismisses the features selection boxes 374 and 380 and returns control to the navigation window 282 (shown in Fig. 9).
  • the navigation application A3 makes possible the establishment and processing of images files by providing Management Control Buttons, labeled OPEN 310 and SAVE 314, on the Toolbar 296 (see Fig. 9).
  • the left image 284L is saved as an image file on the hard drive 32.
  • the image file is also saved as a record in the patient data base 52, the details of which will be described later.
  • the navigation application A3 reads the cu ⁇ ent values in the Orientation Angle fields 306(X), 306(Y), and 306(Z)(which can comprise a custom orientation) and computes the data necessary to recreate the saved orientation and the other prescribed preset orientations (LA045, LA030, RA045, RA030, and AP) for the left image 284L.
  • the navigation application A3 displays a dialog box asking the physician to designate which one of the preset or custom views constitutes the primary selected view.
  • the OPEN control button 310 allows the physician to retrieve an existing image record as a file from the hard drive 32 for further viewing and editing.
  • the navigation application A3 allows the physician to uniquely associate the image 284L/R with a file record, so that the physician can quickly recall, process, edit, or switch among any previously saved image. a. Navigation Data
  • the navigation application A3 also displays in the left and right panels 286 and 288 an idealized image 324 of the roving electrode 68, showing its location relative to the idealized images 284L and 284R.
  • the roving electrode image 324 can appear as a square, with consideration for a Z-axis shadowing effect, as previously described for the splines.
  • the toggle ROVING SITE button control 414 the display of the roving electrode image 324 can show a cu ⁇ ent real-time position for the image 324 (as Fig. 9 depicts), or in a track view showing the path of movement for the image 324 over a period of time.
  • an electrical field F is established inside the body region S between an electrode 18 carried by the basket 58 an indifferent electrode 326, coupled to an electrical reference 328.
  • the electrode 68 carried by the roving instrument 14 senses voltage amplitudes in the field F.
  • the magnitude of a given sensed voltage amplitude V SENSE vary according to location of the roving electrode 68 in the electric field F, and, in particular, to the distance between the transmitting basket electrode 18 and the roving electrode 68.
  • the sensed voltage amplitude V SENSE is compared to a threshold value VTHRE S H- VT HRESH is selected based 25 upon empirical data to reflect a voltage amplitude that occurs, given the electrical conditions established, when a selected close-to-far transitional distance (e.g., 5 mm) exists between transmitting and sensing electrodes. If the sensed voltage amplitude V SENSE is equal to or greater than the threshold value V THRESH , the roving electrode 68 is deemed to be in a "close - 35 -
  • the roving electrode 68 is deemed to be in a "far condition" to the basket electrode 18.
  • the navigation application A3 can implement this methodology by initialized the electrode nodes N on the GUI 46 at a designated color or shade.
  • the initialized color or shade for a given node N constitutes a default visual signal to the physician, that the roving electrode 68 is at the "far condition" relative to the associated basket electrode 18.
  • the switch manager 90 of the ASIC 80 periodically runs an algorithm from the embedded program 94, which assesses V SENSE for the roving electrode 68 relative to each electrode 18 on the basket 58.
  • the manager 90 communicates the V values associated with each basket electrode 18 to the navigation application A3 executed by the MPU 28.
  • the navigation application A3 compares each V SENSE to a selected V THRESH -
  • the navigation application A3 switches "ON" a given node N on the GUI 46, e.g., by changing the designated color, shape, or shade or 20 by flashing the node N, whenever the comparison indicates that the roving electrode 68 is in a "Close Condition" relative to the electrode 18 to which the node N co ⁇ esponds.
  • the physician is able to select open a pop-up Sensitivity Adjustment Window 330.
  • the Window 330 allows the physician to alter the spacial sensitivity for the proximity-indicating output, i.e, by changing the threshold value V THRESH used by the navigation application A3.
  • navigation application A3 interpolates the proximity-indicating outputs to switches "ON" a phantom node PN
  • FIG. 16 also shows, if more two nodes, e.g., N5, N6, N9,and N10 are ordered to be switched "ON” simultaneously, the navigation application A3 interpolates by switching "ON" a phantom node PN (5, 6, 9, 10) at the geometric center of the three or more electrode nodes N5, N6, N9, N10.
  • the algorithm of the program 94 embedded with the ASIC 80 can direct the switch manager 90 to generate an electrical field F from either the roving electrode 68 or at least one of the basket electrodes 30 (called the "transmitting electrode”).
  • the electric field F will be characterized, in part, by the physical dimensions and spacing among basket electrodes 18.
  • the program 94 also directs the switch manager 90 to condition either the roving electrode 68 or at least one of the basket electrodes 18 to sense electrical potentials in the electric field, which will change based upon the position of the roving electrode 68 relative to basket electrodes 18.
  • the sensed electrical potentials are communicated by the switch manager 90 to the navigation application A3.
  • the navigation application A3 includes an embedded navigation algorithm 454, which analyzes the spatial variations in the electrical potentials sensed within the field, in terms of, e.g., variations in phase, or variations in amplitude, or both, or variations in impedances between the transmitting and sensing electrodes. Knowing these spacial variations in the electrical field, and knowing the physical dimensions and spacing among basket electrodes 18 (which the identification code 100 of the basket 58 provides, or which can otherwise be embedded as empirically derived mathematical coefficients and weighing factors in the navigation algorithm 454), the navigation algorithm 454 generates a location output 334. The location output 334 locates the roving electrode 68 within the space defined by the basket 58, in terms of its position relative to the position of the multiple basket electrodes 18. The navigation application A3 updates the display by the GUI 46 of the moving electrode image 324 based upon the location output 334.
  • the algorithm of the program 94 embedded with the ASIC 80 can direct the switch manager 90 to generate an electric wave form output W from either the roving electrode 68 or at least one of the basket electrodes 30.
  • the shape of the electric wave form output W within the basket 58 will be characterized, in part, by the physical dimensions and spacing among basket electrodes 18.
  • the program 94 also directs the switch manager 90 to condition the roving electrode 68 to periodically sense a local electric waveform.
  • the manager 90 communicates the sensed local wave form to the navigation application A3.
  • the navigation application A3 includes a navigation algorithm 454, which conducts a differential comparison of the waveform output and the sensed local waveform. Knowing the results of the differential waveform comparison, and knowing the physical dimensions and spacing among basket electrodes 18 (which the identification code 100 can provide or which can be otherwise embedded as empirically derived mathematical coefficients and weighing factors in the navigation algorithm 454), the navigation algorithm 454 generates a location output 336.
  • the location output 336 expresses the position of the roving electrode 68 relative to the basket electrodes 18.
  • the navigation application A3 updates the display the moving electrode image 324 on the GUI 46 based upon the location output 336.
  • the toolbar 296 of the navigation window an INS MARKER control button 390 and a FIND SITE control button 392.
  • control buttons 390 or 392 make it possible to annotate the displayed images 284L and 284R.
  • the INS MARKER control button 390 when selected, allows the operator to annotate either image 284L or 284R by adding an identifier or marker and an associated text comment to selected locations of the image 284L/R.
  • the INS MARKER button 390 opens a Markers Control Menu 394.
  • the Markers Control Menu 394 includes push button controls labeled ADD MARKERS 396, MOVE MARKERS 398, DEL MARKERS 400, and CLOSE 402.
  • the application A3 When the ADD MARKERS button 396 is selected, the application A3 enables the operator to operate the pointing device 42 to select a spot on either image 284L or 284R and, by clicking, drop a shaped bitmap marker 404 (shown in Fig. 19) on the image.
  • the marker 404 includes an associated number, which the application A3 assigns in numeric order as markers 404 are created. Once inserted in one image 204L or R, a co ⁇ esponding marker 404 is automatically inserted in the other image.
  • Fig. 19 shows, when the marker 404 is dropped into position on the image, the application A3 opens a pop up comments window 406.
  • the window 406 includes an automatic time stamp 410 and an editable comments field 408. The operator enters the desired comment into the comment window 406 using the keyboard 40.
  • the markers 404 and comment windows 406 can be placed near electrodes nodes on either the foreground or background of the image 284L/R.
  • the markers 404 and windows 406 mark selected locations that are significant or of interest, such as mapping sites, ablation sites, etc. The physician is thereby better able to remain coordinated and oriented with the displayed image and, therefore, better able to interpret data recovered by the basket 58.
  • the application A3 removes a selected marker 404 and associated comment window 406 when the DEL MARKER button 400 is selected.
  • the MOVE MARKERS button 398 when selected, allow the operator to drag and then drop a selected marker 404 and associated comment window 406 to a different location on the image 284L/R. - 39 -
  • Selecting the CLOSE button 402 dismisses the marker control menu 394.
  • the marker(s) 404 and comment window(s) 406 remain on the image 284L/R.
  • Selecting the SAVE button 314 on the toolbar 296, as previously described, saves the image 284L/R together with all current markers 404 and comment windows 406.
  • Information resident on the entire graphical display, including model image 284L/R, markers 404, and associated comment windows 408 are saved as a data file records for storage, retrieval, or manipulation.
  • Selecting the FIND SITE button 392 opens a dialog box 410 (see Fig. 20), into which the operator enters an electrode coordinate (Al, B6, 30 etc.).
  • the navigation application A3 draws a flashing circle 412 about the corresponding electrode node on both images 284L/R. The flashing circle 412 remains on the image until another action is taken by the operator.
  • the selection of the REAL IMAGE NAVIGATION push button control 126 runs the real image navigation application A4.
  • the application A4 when executed by the MPU 28, displays a sub-window 416, as shown in Fig. 21, which displays in real-time the image 418 acquired by the imaging device 72.
  • the main application control push buttons 120 to 134 still remain in view on the right side of the screen in their original first color, except the selected REAL IMAGE NAVIGATION push button control 126, which changes color when selected.
  • the application allows the operator to process the image 418 in various ways to achieve different results. a. Image Comparison
  • the sub-window 416 of the application A4 displays the image 416 acquired by the fluoroscope or other imaging device 72. This image 416 may be used in association with the virtual image navigation application A3 to help visualize the actual orientation of the basket 58 and roving electrode 68 in the body region.
  • the sub-window 416 includes a COMPARE control button 420. When selected, the visualize application switches to a new sub-window 422 (see Fig. 22, which displays in a left panel 424 the left panel image 284L of the virtual navigation - 40 -
  • sub-window 282 (generated by the application A3 previously discussed) along with a right panel 426,in which the real-time image 418 is displayed.
  • the orientation control buttons 304 (XN,Z) and 320 and associated numeric orientation angle fields 306 (XN, Z) and 322 present on the virtual image navigation screen 282 are also displayed in the compare window 422. This presentation allows the physician to compare the fluoroscopic or other independent image and manipulate the GUI image 284L to more closely match the view of the real-time image 418.
  • the images 284L and R displayed on the virtual image navigation screen 282 (see Fig. 9) are updates to reflect changes in orientation made using the compare screen 422.
  • the applications A3 and A4 permit point-and-drag control by the pointing device 42, to change the shape of the idealized image 284L on either navigation screen 282 or 422, to more closely match the shape of the image 418 as seen in the real-time image panel 426, or using an independent real time imaging system.
  • the shape of the idealized image 284L can be formed by dragging the pointing device 42, for example, to appear in a range of configurations from spherical to a more elongated ellipsoid (when the image 284L depicts a three-dimensional basket 58, as shown in Fig.
  • the compare windows 422 includes a SAVE control button 428.
  • the SAVE button 428 saves the shape characteristic formed by the physician in the compare window 422, along with other image information, as already discussed.
  • the sub-window 416 of the application A4 also includes specialized file management control buttons, labeled CREATE 430, OPEN 432, SAVE 434, DELETE 436, and EDIT 438.
  • the application A4 freezes the real-time image 416 (or a prescribed sequence of video images 416) so that it can - 41 -
  • the grabbed image or video image sequences, with annotations can be saved to the hard drive as a data base record file, preferably as part of the patient data base 52,which will be described in greater detail later.
  • a data base record file preferably as part of the patient data base 52,which will be described in greater detail later.
  • the sub-window 416 of the application A4 also includes an ANALYZE IMAGE control button 440.
  • the application A4 executes an embedded graphic analysis function 442.
  • the function 442 electronically process the video input signals 458 to mathematically generate digital three-dimensional basket coordinates 450 and three-dimensional roving electrode coordinates 452.
  • the digital coordinates 450 and 452 are communicated to the navigation processing algorithm 454 of the application A3 to help construct the idealized image 284L/R displayed on the navigation screen 282.
  • the basket electrodes 18 and splines and the roving electrode 68 are visualized from two different angles using a biplane fluoroscopy unit 444.
  • the unit 444 includes one fluoro arm 446, which captures a real AP (anterior-posterior) video image, and a second fluoro arm 448, - 42 -
  • the imbedded navigation algorithm 94 in the interface 26 receives from the basket electrodes 18 and the roving electrode 68 electrical positionindicating signals.
  • the interface 26 conveys these as electrical signal inputs 456 to the navigation processing algorithm 454 executed by the application A3.
  • the navigational outputs 334/336 of this algorithm 454 are displayed in graphical form on the image 284L/R.
  • the image analysis function 442 When enabled by selection of the ANALYZE IMAGE control button 440, the image analysis function 442, the analysis function 442 mathematically computes, based up the video input signals 458, three-dimensional digital basket coordinates 450.
  • the digital coordinates 450 are inputted to the navigation processing algorithm 454 of the application A3.
  • the application A3 generates a basket image output 466 that takes the real image basket coordinates 450 into account, thereby providing an idealized image 284L/R that more closely co ⁇ esponds to the real image 418.
  • Fig. 23 also shows, when enabled, the analysis function 442 also generates, based upon the real image of the roving electrode 68, three dimensional roving digital coordinates 452.
  • the application A3 includes a comparator 464, which compares the three-dimensional digital roving coordinates 452 to the location output(e.g.,334 or 336) generated by the navigation algorithm 454, as previously described (see Fig. 17 or Fig.18).
  • the e ⁇ or output of the comparator 464 is communicated to an iterative calibration loop 460, which adjusts empirically initialized mathematical coefficients and weighing factors assigned to the navigation algorithm 454 to minimize comparison e ⁇ ors.
  • the analysis function 442 thereby provides a self-calibration feature for navigation algorithm 454 of the application A3.
  • the calibrated output 462 is used to construct the display of navigational information on the navigation screen 282. 8. Test Application (A5)
  • the selection of the TEST push button control 128 runs the test application A5.
  • the test application A5 when executed by the MPU 28, displays the test - 43 -
  • the test application A5 when executed, conditions the switch manager 90 to apply voltage among the various electrodes 18 and recorder input channels 116 (see Fig.3) to verify the ability to operate according to the configuration specified in the Record Configuration window 136 (shown in Fig. 5).
  • the test application A5 executes a short/open channel test at each input channel pair specified by the operator on the test sub-window 468.
  • the test application A5 displays the results of the test.
  • the test application A5 also allows the operator to set the local system time.
  • the test sub-window 468 includes a SHORT/OPEN TEST push button control 470, alMV TEST push button control 472, and a 5MV TEST push button control 474.
  • the sub-window also includes a RESULTS data fields 476, 478, 480 aligned with each test push button control 470, 472, and 474.
  • the sub-window 468 also includes an editable SET TIME data field 482 in HH:MM:SS format.
  • a START push button control 484 (to start a selected test), a STOP push button control 486 (to stop a selected test), and a CLOSE push button control 488 (to terminal all selected tests and close the test sub-window 468) are also displayed on the test sub-window 468.
  • the detection of shorted and open electrodes can be performed either "exhaustively" or by specifying particular pairs of inputs and outputs.
  • all possible combinations of input and output pins are tested. Although effective in finding all potential malfunctions, such latest takes considerable time.
  • the test can be conducted only between specified pairs of inputs and outputs. Operating speed is considerably increased using such a test protocol.
  • the test application A5 configures the switch manager 90 to detect open or shorted electrodes.
  • the ASIC 80 includes a constant - 44 -
  • a detector 492 on the ASIC 80 senses the occu ⁇ ence of the high voltage.
  • the detector 492 can also check whether the phase angle is greater than a predetermined limit (e.g., 45°). If prescribed criteria are met, the switch manager 90 returns an Open Electrode signal to the test application A5.
  • the test application generates an Open Electrode message in the associated RESULTS data field 476.
  • the test application A5 also updates the STATUS field 166 in the recording configuration windowl36 (see Fig. 5) and the STATUS field 226 in the pacing configuration window 208 (see Fig. 7) indicate an opened electrode condition.
  • a low voltage condition below a specified low voltage threshold results when the constant cu ⁇ ent source 490 is coupled to a shorted electrode.
  • the detector 492 senses the low voltage condition. The detector 492 can also check whether the phase angle meets various criteria. If prescribed criteria are met, the switch manager 90 returns a Shorted Electrode signal to the test application A5.
  • the test application generates a Shorted Electrode message in the associated RESULTS 20 datafield 476.
  • the test application A5 also updates the STATUS field 166 in the recording configuration window 136 (see Fig. 5) and the STATUS field 226 in the pacing configuration window 208(see Fig. 7) indicate a shorted electrode condition.
  • test application A5 The absence of an Open Electrode signal and a Shorted Electrode signal is interpreted by the test application A5 as an operational electrode.
  • the test application A5 generates a operational electrode message in the associated
  • the test application A5 configures the switch manager 90 to output a low (1 mV) electrical level for a set period of time to the electrodes.
  • the test application A5 configures the switch manager 90 to output a high (5 mV) electrical level for a set period of time to the electrodes.
  • the ASIC 80 includes a high voltage source 494 and a low voltage source 496 (see Fig. 3), which are coupled 20 to the outputs when so commanded by the test application A5.
  • the voltages thus applied are sensed at the associated electrodes. The absence of the sensed voltages, or the sensing of different voltage values, indicates a faulty condition in the hardware interface 26.
  • the test application A5 generates a an appropriate message in the associated RESULTS data fields 478 or 480.
  • the selection of the PRINT push button control 130 runs the print application A6.
  • the print application A6 when executed by the MPU 28, displays the pint sub-window 498, as shown in Fig. 25.
  • the main control push buttons 120 to 134 continue to remain in view on the right side of the print window 498 in their original first color, except the selected PRINT push button control 130, which changes color when selected.
  • the print window 498 provides an array of push button controls, which permits the operator to select, by keyboard entry or pointing device 42, one or more screen displays to be printed on the printer.
  • the illustrated embodiment offers the buttons labeled for the following print selections: Record Configuration information 500, Record Sequence information 502, Pace Configuration information 504, Pace Sequence information 506, the Left Navigational Image 508, the Right Navigational Image 510; the Real Image Freeze 512; all or selected data base items of the Patient Data Base 514(as will be described later).
  • the print application A6 compiles and formats the selected information for output to the printer 34.
  • the print application A6 also appends pre-designated patient information from the data base to the printout.
  • the print application A6 displays status information in a PRINT STATUS field 524.
  • a CANCEL PRINT button control 526 allows the operator to cancel the cu ⁇ ent printing operation.
  • the CLOSE control button 528 dismisses the print window 498 and returns control to the application being executed at the time the PRINT button 130 was selected. 10.
  • Service Application A7
  • the selection of the SERVICE push button control 132 runs the service application A7.
  • the service application A7 when executed by the MPU 28, displays the service sub-window 516, as shown in Fig. 26.
  • the main control push buttons 120 to 134 remain in view on the right side of the window 516 in their original first color, except the selected SERVICE push button control
  • the service window 516 displays a dialog box 518, which contains input fields for the operator to enter a SERVICE IDENTIFICATION 520 and a PASSWORD 530.
  • the service application A7 accepts the inputs in the fields 520 and 530 and compares them to known identification and password codes embedded in the application A7. When the inputs match the known codes, the service application A7 terminates the GUI 46 and returns control of the MPU 28 to the underlying operating system 44.
  • the service application A7 provides access to the underlying operating system 44 and associated host computer functions only to authorized service personnel.
  • Selection of the CANCEL button 534 dismisses the service window 516 and returns control to the application being executed at the time the SERVICE button 132 was selected.
  • the Event Log Function The operating system includes an Event Log Function FI (see Fig. 1) , which retains in system memory a record of specified critical events as they occur during the course of a given procedure, or example, in the illustrated embodiment, critical -47 -
  • the Event Log Function FI records the specified events by time (read from the operating system 44) in the event log 50 (see Fig. 1).
  • the event log data base 50 indexes the recorded events according to patient information, the coordinates of the roving instrument, the recording configuration name, the pacing electrodes, and comments (which identify the nature of the event).
  • the selection of the EVENT LOG control button 134 toggles display of the contents of event log for the current session on and off.
  • a pop-up window 536 is displayed on the navigation screen 282(see Fig. 27).
  • the pop-up window 282 has data field entries, provided from the event log data base 50, which are a ⁇ anged under headers for Time 538, Roving Instrument Coordinates 540, Recording configuration Name 542, Pacing Electrodes 544, and Comments 546. When active, the operator can input additional information in the Comment field 546.
  • the control button 134 is selected off, the pop-up window is not displayed, although the Event Log Function FI still continues to record events in the event log data file 50.
  • the operating system 44 includes a Patient Data Base function F2.
  • the function F2 makes it possible, during the course of a given procedure, to store, retrieve, and manipulate patient-specific and related procedure-specific information in a patient data base 52 resident on the hard drive 32.
  • the Patient Data Base function F2 creates data base items incorporating patient-specific and related procedure specific information, comprising, e.g., patient name and other identifying information, together with navigation images 284L/R generated by the navigation application A3; the threshold sensitivity set using the Sensitivity Adjustment window 330 in the navigation application A3 (see -48 -
  • Fig. 15 catheter configuration and recording configuration and sequences generated by the recording protocols application Al; pacing configuration and sequences generated by the pacing protocols application A2; physician's comments and annotations inserted by use of the Markers Control Menu 394 in the navigation application A3 (see Fig. 19); anatomic features positions inserted using the Features button 372 in the navigation application A3 (see Figs. 9 and 13); mapping information generated through use of the binary map selection menu 368 by the navigation application A3 (see Figs. 11 and 12); contents of the Event Log 50; and fluoroscopyl ultrasound,or other medical images generated by the real image application A4 (see Fig. 21).
  • the Patient Data Base function F2 compiles patient-specific and procedure-specific information as disk files saved to the hard disk 32.
  • the disk files in the data base 52 are organized in study subdirectories based upon the patient's name.
  • the data base items can also be manipulated by the operator, e.g., selected data base files can be accessed or opened upon command for editing, deletion, searching, listing, sorting, compiling, and printing.
  • the Patient Data Base function F2 can be implemented in various ways.
  • the Patient Data Base function F2 opens a Patient Data Window 548(see Fig. 28) at the time that the Toolbar 296 (previously described) is first generated by the navigation application A3 in the course of a given procedure, as this event occurs at the beginning of a given study.
  • the Patient Data Window 548 when opened, requires the physician to enter data about the particular patient and procedure, to thereby establish a new patient/study subdirectory in the data base 52, before the new study is allowed to proceed.
  • Selecting the Cancel button 616 dismisses the Data Window 548 without establishing a new patient/study subdirectory, returning the operator to the navigation window 282 for the current study.
  • the physician enters the name of the patient and a - 4 9 -
  • the Patient field 550 includes a drop down menu control 572, listing existing patient names from which the operator can select.
  • the function F2 detects existing subdirectories for the same name and creates an addition study subdirectory, or otherwise a new patient directory is established and the new study subdirectory created.
  • the function F2 assigns a name to the new study in a Study Name field 554, with an associated time marker 556.
  • the patient three digit numeric sequence serves as a study name extension.
  • the physician can enter in the Text field 558 of the Data Window 548 additional Information or comments regarding the patient, such as the patient's ID number, age, etc., which the physician wants to save as part of the patient/study record.
  • the physician can also enter diagnostic information, e.g., heart tissue pacing data; or therapeutic information, e.g., heart tissue ablation data; or identify the attending physician or staff personnel.
  • the Data Window 548 includes an Open Button 562, which recalls the most recent study record for the patient, and inserts information in the Text field 558 of the existing record into the Text field 558 of the new study record.
  • the function F2 automatically saves the patient/study information to the newly created subdirectory.
  • the function F2 opens an image selection dialog box 564 (see Fig.29).
  • the dialog box 564 prompts the physician to set the idealized image viewing angles.
  • Selecting the Reset button 568 starts the new study with default idealized image views in the left and right panels 286 and 288(which is the same function as the Reset View button 312 on the Toolbar 296, as shown in Fig. 9) -
  • the physician can proceed to customize the default left and right panel images 284L/R, as previously described.
  • selecting the Existing view button 570 in the image selection box 564 starts the new study with the same markers, binary maps, features, comments, sensitivity threshold, and views active in the immediately preceding study. This option allows the physician to quickly switch among different diagnostic or therapeutic protocols (each constituting a "study") on the same patient - 50 -
  • the new study commences, with the selected image views displayed in the navigation window 282.
  • the physician can call upon all the features of the applications Al to A7 and function FI as already described. For example, the physician can set up binary maps, in the manner previously described (see Fig. 11 and 12), or mark anatomic features (see Fig. 13). The physician can set up markers 404 and comment windows 406 in association with the selected image views, as Fig. 19 shows.
  • the physician can include further information identifying the procedure, diagnostic information, therapeutic information, or otherwise annotate the image 284L/R.
  • the entire graphical display, including the idealized image 284L/R, markers 406, and associated comment windows 406 are saved as a data file in the patient/study subdirectory, uniquely associated with the particular study and particular patient for storage, retrieval, or manipulation, b.
  • Manipulating Patient Data Base Information In the illustrated embodiment, selection of the Patient Data Base button 514 in the print window 498 (Fig. 25) opens a patient record dialog box 574 (see Fig. 30).
  • the dialog box 574 includes a Patient Name field 576 and a Study field 578, in which the operator can specify a particular subdirectory.
  • the fields 576 and 578 each includes a menu control button 580, which, when selected, opens a drop down menu listing patient names and studies residing in the data base 32. Selection of the open button 582 opens a directory box 584 (see Fig. 31), which list the files 618 contained in the specified subdirectory. The highlighted file can be opened for viewing (by selecting the View button 586); or printed (by selecting the Print button 588); or saved (by selecting the Save button 606).
  • a Find/Sort box 592 provides access to special functions that compile, search, manipulated, or filter the records in the patient data base 52 in conventional ways, e.g., by use of a SEARCH DATA BASE - 51 -
  • control button 594 (which allows key- word or file searching), a LIST DATA BASE control button 596 (which lists data base files in established directory and subdirectory order), and a SORT DATA BASE 598 control button (which allows files be arranged, e.g., chronologically, by file type,etc).
  • the results of the requested function are displayed for viewing in a Results field 598, which can be opened for viewing (by selecting the
  • a communications link 610 allows patient record information to be transmitted from the hard drive 32 to a central data storage station 612.
  • a network 614 of local or remote systemslO, 10 (A), 10 (B), and 10 (C) can be linked to the central data storage station 612, by an Internet-type network, or by an intranet-type network.
  • the network 614, all linked to the central data storage station 612 allows patient-specific data base records for many patients at one or more treatment facilities to be maintained at a single location for storage, retrieval, or manipulation.
  • the patient record dialog box also includes an IMPORT control button 608.
  • the button 608 allows patient/study data base files residing on the station 612 to be up loaded into the patient data base 32 resident on the system 10.
  • the various save functions in the directory box 584 (see Fig.31) or the Find/Sort box 592 (see Fig. 32) can specify down loading patient/study data base files from the MPU 28 to the central data storage station 612.

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Abstract

Selon un premier aspect, l'invention concerne une interface associée à une structure qui, lors de son utilisation, est déployée dans une région corporelle interne d'un patient. Cette structure comprend un élément opérationnel couplé à un dispositif de commande, qui établit un état de fonctionnement afin que l'élément opérationnel exécute un acte diagnostique ou thérapeutique dans la région corporelle interne. L'interface produit un premier affichage comprenant une image de la structure au moins partiellement lorsque l'élément opérationnel exécute l'acte. L'interface produit également un second affichage comprenant un ou plusieurs champs de données reflétant l'état de fonctionnement du dispositif de commande. L'interface permet de sélectionner lequel du premier ou du second affichage sera visualisé à l'écran. Selon un second aspect, l'invention concerne une interface, destinée à être associée à une structure d'électrode déployée au contact des tissus cardiaques, qui produit une image réelle de la structure d'électrode obtenue par un dispositif d'imagerie. L'interface produit également une image idéale de la structure d'électrode basée en partie sur l'image réelle. L'interface permet d'afficher sur un écran d'affichage soit l'image réelle, soit l'image idéale, voire les deux.
PCT/US1999/006512 1998-03-26 1999-03-24 Systemes et procedes interactifs de commande de l'utilisation d'instruments diagnostiques ou therapeutiques dans des regions internes du corps WO1999049407A1 (fr)

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AU34535/99A AU3453599A (en) 1998-03-26 1999-03-24 Interactive systems and methods for controlling the use of diagnostic or therapeutic instruments in interior body regions

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US09/048,643 US6192266B1 (en) 1998-03-26 1998-03-26 Systems and methods for controlling the use of diagnostic or therapeutic instruments in interior body regions using real and idealized images
US09/048,629 US6106460A (en) 1998-03-26 1998-03-26 Interface for controlling the display of images of diagnostic or therapeutic instruments in interior body regions and related data
US09/048,629 1998-03-26
US09/048,643 1998-03-26

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PCT/US1999/006472 WO1999048415A2 (fr) 1998-03-26 1999-03-26 Systemes et procedes interactifs de commande de l'utilisation d'instruments diagnostiques ou therapeutiques dans des regions internes du corps

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EP1585429A2 (fr) * 2002-07-22 2005-10-19 Stereotaxis, Inc. Interface utilisateur pour la commande a distance de dispositifs medicaux
EP2337491A1 (fr) * 2008-09-10 2011-06-29 C.R.Bard, Inc. Appareil et procédés d'affichage relatifs au placement intravasculaire d'un cathéter
EP2286714A3 (fr) * 2001-09-25 2012-03-14 Olympus Corporation Détection de la direction d'insertion d'un endoscope
US8388541B2 (en) 2007-11-26 2013-03-05 C. R. Bard, Inc. Integrated system for intravascular placement of a catheter
US8388546B2 (en) 2006-10-23 2013-03-05 Bard Access Systems, Inc. Method of locating the tip of a central venous catheter
WO2013046090A1 (fr) * 2011-09-26 2013-04-04 Koninklijke Philips Electronics N.V. Système et procédé d'imagerie médicale
US8437833B2 (en) 2008-10-07 2013-05-07 Bard Access Systems, Inc. Percutaneous magnetic gastrostomy
US8478382B2 (en) 2008-02-11 2013-07-02 C. R. Bard, Inc. Systems and methods for positioning a catheter
US8512256B2 (en) 2006-10-23 2013-08-20 Bard Access Systems, Inc. Method of locating the tip of a central venous catheter
USD699359S1 (en) 2011-08-09 2014-02-11 C. R. Bard, Inc. Ultrasound probe head
US8781555B2 (en) 2007-11-26 2014-07-15 C. R. Bard, Inc. System for placement of a catheter including a signal-generating stylet
US8784336B2 (en) 2005-08-24 2014-07-22 C. R. Bard, Inc. Stylet apparatuses and methods of manufacture
US8801693B2 (en) 2010-10-29 2014-08-12 C. R. Bard, Inc. Bioimpedance-assisted placement of a medical device
US8849382B2 (en) 2007-11-26 2014-09-30 C. R. Bard, Inc. Apparatus and display methods relating to intravascular placement of a catheter
US9125578B2 (en) 2009-06-12 2015-09-08 Bard Access Systems, Inc. Apparatus and method for catheter navigation and tip location
US9211107B2 (en) 2011-11-07 2015-12-15 C. R. Bard, Inc. Ruggedized ultrasound hydrogel insert
EP2265175A4 (fr) * 2008-04-17 2016-03-09 Bard Inc C R Systèmes et procédés pour rompre un champ stérile pour placement intravasculaire d'un cathéter
US9339206B2 (en) 2009-06-12 2016-05-17 Bard Access Systems, Inc. Adaptor for endovascular electrocardiography
US9445734B2 (en) 2009-06-12 2016-09-20 Bard Access Systems, Inc. Devices and methods for endovascular electrography
US9456766B2 (en) 2007-11-26 2016-10-04 C. R. Bard, Inc. Apparatus for use with needle insertion guidance system
US9492097B2 (en) 2007-11-26 2016-11-15 C. R. Bard, Inc. Needle length determination and calibration for insertion guidance system
US9521961B2 (en) 2007-11-26 2016-12-20 C. R. Bard, Inc. Systems and methods for guiding a medical instrument
US9532724B2 (en) 2009-06-12 2017-01-03 Bard Access Systems, Inc. Apparatus and method for catheter navigation using endovascular energy mapping
US9554716B2 (en) 2007-11-26 2017-01-31 C. R. Bard, Inc. Insertion guidance system for needles and medical components
US9636031B2 (en) 2007-11-26 2017-05-02 C.R. Bard, Inc. Stylets for use with apparatus for intravascular placement of a catheter
US9839372B2 (en) 2014-02-06 2017-12-12 C. R. Bard, Inc. Systems and methods for guidance and placement of an intravascular device
US9901714B2 (en) 2008-08-22 2018-02-27 C. R. Bard, Inc. Catheter assembly including ECG sensor and magnetic assemblies
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US10524691B2 (en) 2007-11-26 2020-01-07 C. R. Bard, Inc. Needle assembly including an aligned magnetic element
US10639008B2 (en) 2009-10-08 2020-05-05 C. R. Bard, Inc. Support and cover structures for an ultrasound probe head
US10751509B2 (en) 2007-11-26 2020-08-25 C. R. Bard, Inc. Iconic representations for guidance of an indwelling medical device
US10820885B2 (en) 2012-06-15 2020-11-03 C. R. Bard, Inc. Apparatus and methods for detection of a removable cap on an ultrasound probe
US10893905B2 (en) 2017-09-12 2021-01-19 Farapulse, Inc. Systems, apparatuses, and methods for ventricular focal ablation
US10973584B2 (en) 2015-01-19 2021-04-13 Bard Access Systems, Inc. Device and method for vascular access
US10992079B2 (en) 2018-10-16 2021-04-27 Bard Access Systems, Inc. Safety-equipped connection systems and methods thereof for establishing electrical connections
US11000207B2 (en) 2016-01-29 2021-05-11 C. R. Bard, Inc. Multiple coil system for tracking a medical device
US11020179B2 (en) 2016-01-05 2021-06-01 Farapulse, Inc. Systems, devices, and methods for focal ablation
US11103213B2 (en) 2009-10-08 2021-08-31 C. R. Bard, Inc. Spacers for use with an ultrasound probe

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EP2286714A3 (fr) * 2001-09-25 2012-03-14 Olympus Corporation Détection de la direction d'insertion d'un endoscope
EP1585429A4 (fr) * 2002-07-22 2011-05-11 Stereotaxis Inc Interface utilisateur pour la commande a distance de dispositifs medicaux
EP1585429A2 (fr) * 2002-07-22 2005-10-19 Stereotaxis, Inc. Interface utilisateur pour la commande a distance de dispositifs medicaux
US8784336B2 (en) 2005-08-24 2014-07-22 C. R. Bard, Inc. Stylet apparatuses and methods of manufacture
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US9901714B2 (en) 2008-08-22 2018-02-27 C. R. Bard, Inc. Catheter assembly including ECG sensor and magnetic assemblies
US11027101B2 (en) 2008-08-22 2021-06-08 C. R. Bard, Inc. Catheter assembly including ECG sensor and magnetic assemblies
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