EP2032028A2 - Cartographie cardiaque sans contact, englobant un cathéter mobile et une intégration multibattement - Google Patents

Cartographie cardiaque sans contact, englobant un cathéter mobile et une intégration multibattement

Info

Publication number
EP2032028A2
EP2032028A2 EP07798369A EP07798369A EP2032028A2 EP 2032028 A2 EP2032028 A2 EP 2032028A2 EP 07798369 A EP07798369 A EP 07798369A EP 07798369 A EP07798369 A EP 07798369A EP 2032028 A2 EP2032028 A2 EP 2032028A2
Authority
EP
European Patent Office
Prior art keywords
catheter
endocardium surface
electrodes
physiological information
heart
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP07798369A
Other languages
German (de)
English (en)
Other versions
EP2032028A4 (fr
Inventor
Doron Harlev
Leon Amariglio
Pavel Greenfield
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Boston Scientific Scimed Inc
Original Assignee
Rhythmia Medical Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US11/451,908 external-priority patent/US7505810B2/en
Priority claimed from US11/451,898 external-priority patent/US7515954B2/en
Priority claimed from US11/451,871 external-priority patent/US7729752B2/en
Application filed by Rhythmia Medical Inc filed Critical Rhythmia Medical Inc
Priority to EP13194523.0A priority Critical patent/EP2712546A1/fr
Priority to EP13194525.5A priority patent/EP2745773A3/fr
Publication of EP2032028A2 publication Critical patent/EP2032028A2/fr
Publication of EP2032028A4 publication Critical patent/EP2032028A4/fr
Withdrawn legal-status Critical Current

Links

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
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7235—Details of waveform analysis
    • A61B5/7246—Details of waveform analysis using correlation, e.g. template matching or determination of similarity
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7235—Details of waveform analysis
    • A61B5/7253—Details of waveform analysis characterised by using transforms

Definitions

  • This invention relates to the determination and representation of physiological information relating to a heart surface using a non-contact catheter
  • Cardiac arrhythmias are a leading cause of stroke, heart disease and sudden death
  • the physiological mechanism of arrhythmia involves an abnormality m the electrical conduction of the heart
  • treatment options for patients with arrhythmia which include medication, implantable devices, and minimally invasive procedures
  • Minimally invasive procedures such as catheter ablation, have evolved in recent years to become an established treatment for patients with a variety of supraventricular and ventricular arrhythmias
  • a typical minimally invasive procedure involves mapping of the heart tissue in order to identify the site of origin of the arrhythmia followed by a targeted ablation of the site
  • Other minimally invasive procedures involve the delivery of biological agents such as cells or genes as a form of therapy to the identified site of origin of the arrhythmia The procedure takes place in an electrophysiology laboratory and takes several hours, most of which is spent mapping the electrical conduction in the heart
  • Conventional 3D mapping techniques include contact mapping and non-contact mapping
  • contact mapping techniques one or more catheters are advanced into the heart Physiological signals resulting from the electrical activity of the heart are acquired with one or more electrodes located at the catheter distal tip after determining that the tip is in stable and steady contact with the endocardium surface of a particular heart chamber Location and electrical activity is usually measured sequentially on a pomt-by- point basis at about 50 to 200 points on
  • contact-based mapping techniques tend to be time consuming since the catheter, and thus its electrodes, have to be moved to a relatively large number of locations in the heart cavity to acquire sufficient data to construct the electro-anatomical depiction of the heart. Additionally, moving the catheter to different locations so that the catheter's electrode(s) touch the endocardium is a cumbersome process that is technically challenging. Further complicating the contact-based mapping methodology is the occurrence of unstable arrhythmias condition. Particularly, ventricular tachyarrhythmias may compromise the heart's ability to circulate blood effectively.
  • non-contact-based mapping systems a multiple electrodes catheter is percutaneously placed in the heart chamber of interest. Once in the chamber, the catheter is deployed to assume a 3D shape. Using the signals detected by the non- contact electrodes and information on chamber anatomy and relative electrode location, the system provides physiological information regarding the endocardium of the heart chamber.
  • non-contact mapping techniques can simultaneously acquire signals using the multiple electrodes catheter and thus enable faster reconstruction of the electrical activity on the endocardial surface, because the catheter's multiple electrodes are not in contact with the endocardium surface some loss of accuracy of the reconstructed map, which is proportional to the distance from the endocardium, occurs due to the degradation of the signals acquired by the multiple electrodes.
  • a non-contact cardiac mapping method includes: (i) inserting a catheter into a heart cavity having an endocardium surface, the catheter including multiple, spatially distributed electrodes; (ii) measuring signals at the catheter electrodes in response to electrical activity in the heart cavity with the catheter spaced from the endocardium surface; and (iii) determining physiological information at multiple locations of the endocardium surface based on the measured signals and positions of the electrodes with respect to the endocardium surface.
  • Embodiments may further include one or more of the following features:
  • the method may further include moving the catheter to each of multiple, different positions in the heart cavity for which the catheter is spaced from the endocardium surface, and, for each of the different catheter positions, determining the positions of the catheter electrodes with respect to the endocardium surface and measuring signals at the catheter electrodes in response to electrical activity in the heart cavity.
  • the determination of the physiological information at the multiple locations of the endocardium surface is based further on the positions of the catheter electrodes and the measured signals at the different catheter positions.
  • the number of catheter positions at which the signals are measured and used to determine the physiological information at the multiple locations of the endocardium surface may be more than three. In some embodiments the number of catheter positions at which the signals are measured is more than five, and in some other embodiments the number of catheter positions at which the signals are measured is more than ten.
  • the catheter is moved over a range larger than about one third of the diameter of the heart cavity to measure the signals used to determine the physiological information at the multiple locations of the endocardium surface.
  • the signals may be measured for at least one electrical heart cycle for each catheter position.
  • the determination of the physiological information at the multiple locations of the endocardium surface may include synchronizing the signals measured at the different catheter positions with one another according to an electrical heart beat cycle.
  • the measured signals may be synchronized based on physiological data including, for example, ECG and/or intercardiac electrograms
  • the determination of the physiological information at the multiple locations of the endocardium surface may further include processing the synchronized signals as though they were obtained at one time from all of the positions sampled by the catheter electrodes for the different positions of the catheter in the heart cavity
  • the determination of the physiological information at the multiple locations of the endocardium surface may further include applying a transformation function to the synchronized signals
  • the transformation function relates signals measured from at least some of the different positions of the catheter in the heart cavity to the physiological information at the multiple locations of the endocardium surface
  • the determination of the physiological information at the multiple locations of the endocardium surface may further include determining the transformation function by calculating a forward transformation for relating the physiological information at the multiple locations of the endocardium surface to the signals measured for the different positions of the catheter in the heart cavity and inverting the forward transformation
  • Inverting the forward transformation may include reformulating an underdetermined mat ⁇ x inversion by regulanzation
  • Inverting may include a least squares minimization
  • the determination of the physiological information at the multiple locations of the endocardium surface may include determining multiple estimates of the physiological information for each of at least some of the locations on the endocardium based on the measured signals corresponding to at least some of the different catheter positions
  • the method may include processing the multiple estimates to improve an accuracy of the physiological information
  • the processing of the multiple estimates may also include averaging the estimates
  • Averaging may be a weighted averaging
  • the signals may be measured during multiple electrical heart beat cycles, and the physiological information may be determined, at least in part, by combining information derived from the signals for different heart beat cycles
  • the combining may include integrating information derived from the signals for common phases of the electrical heart beat cycles
  • the integrated information may include integrated electric potentials on the endocardium surface for common phases of the multiple electrical heart cycle
  • the information derived from the signals for different heart beat cycles may include, for example, a maximum voltage amplitude for each of the different heart beat cycles at different ones of the endocardium surface locations
  • the combining may include averaging together the maximum voltage amplitudes for the different heart beat cycles
  • the averaging may be a weighted averaging
  • the method may further include generating a representation of the endocardium surface of a patient's heart cavity prior to inserting the catheter into the heart cavity, and registering the representation of the endocardium surface with a first coordinate system used to determine the positions of the catheter electrodes relative to the endocardium surface after the catheter is inserted into the heart cavity
  • the determination of the physiological information at the multiple locations of the endocardium surface may be based on the positions of the catheter electrodes, the measured signals
  • Generating the representation of the endocardium surface may include segmenting a volumetric representation of the heart cavity
  • the volumetric representation may be obtained from, for example, a coherence tomography (CT) image, a magnetic resonance imaging (MRI) image and/or an ultrasound image
  • CT coherence tomography
  • MRI magnetic resonance imaging
  • the volumetric representation may be segmented into a substantially closed surface representation of the endocardium surface
  • Generating the representation of the endocardium surface may include partitioning the representation into a plurality of surface elements based on, for example, Attorney Docket No 20240 002WO1 Client Reference RMD-INVD-IA- PCT a numerical calculation technique applied to facilitate computing of the physiological information at the endocardium surface and/or characteristics of the endocardium surface
  • the representation partitioned into a plurality of elements may mclude, for example, a surface mesh comprising triangles, a volumetric mesh comp ⁇ sing tetrahedra and/or a regular Carte
  • the method may further include contacting the catheter to the endocardium surface at multiple locations to establish multiple points of the endocardium surface in the first coordinate system
  • the method may also include determining the position of the catheter when it contacts the endocardium surface at the multiple locations using, for example, electric fields, magnetic fields, fluoroscopy, and/or ultrasound to determine the position of the catheter in the first coordinate system
  • Registering may include translating and orienting the surface representation in the first coordinate system to fit the established points of the endocardium surface in the first coordinate system
  • the determining of the physiological information may include, p ⁇ or to inserting the catheter into the heart cavity, processing information relatmg to characteristics of the endocardium surface
  • each transformation function may be associated with a different position within the heart cavity
  • each transformation function may be associated with a different position and orientation of the catheter within the heart cavity In some embodiments, each transformation function may be associated with the respective positions of the catheter electrodes within the heart cavity
  • Determining of the physiological information may further include, p ⁇ or to inserting the catheter into the heart cavity, processing information relatmg to the characteristics of the catheter.
  • the characteristics of the endocardium surface may be derived from a pre- acquired representation of the endocardium surface Attorney Docket No 20240 002WO 1 Client Reference RMD INVD IA PCT
  • the processing prior to inserting the catheter into the heart cavity may be performed to expedite the determination of the physiological information at the multiple locations of the endocardium surface from the measured signals
  • the transformation functions may be inverse transformation functions, where the partial computation of the one or more inverse transformation functions may include at least partially computing one or more forward transformation functions for determining the signals measured at the catheter electrodes from the physiological information at the multiple locations of the endocardium surface, each forward transformation function being associated with the position of one or more catheter electrodes within the heart cavity Each forward transformation function may further be associated with an orientation of the catheter within the heart cavity
  • the catheter may be hollow
  • At least partially computing the one or more forward transformations may include processing information relating to the shape of the endocardium surface
  • At least partially computing the one or more forward transformations may include processing information relating to the distribution of the electrodes on the catheter
  • At least partially computing the one or more forward transformations may include fully computing the one or more forward transformations based on the information relating to at least the shape of the endocardium surface
  • Determining the physiological information from the measured signals may include inverting the forward transformation function associated with the position of the catheter used to measure the signals and applying the inverted forward transformation function to the measured signals
  • Inverting the forward transformation may include reformulating an underdetermined matrix inversion by regula ⁇ zation
  • Inverting may further include performing a least squares minimization
  • the inversion may further include a Tikhonov regula ⁇ zation
  • the one or more transformation functions can be expressed as one or more matrices
  • the method may further include computmg values indicative of a degree of spatial resolution of the determined physiological information for at least some of the locations of the endocardium surface Attorney Docket No 20240-002WO1 Client Reference RMD-INVD-IA- PCT
  • the computed values may be derived, at least m part, from a transformation function relating the physiological information at the multiple locations of the endocardium surface to the signals measured by the catheter electrodes
  • the method may further mclude displaying at least a portion of the endocardium surface to include at least some of the computed resolution values
  • the method may further include overlaying on a display device at least some of the physiological information determined at the multiple surface locations
  • the method may further include displaying at least a portion of the endocardium surface to include a selected subset of the physiological information determined at the multiple surface locations, where the subset is selected based on at least some of the computed resolution values
  • the determined physiological information may include electrical potential values at the multiple locations of endocardium surface at different phases of the heart beat cycle
  • the method further may include determining frequency dependent features of converting the electrical potential values into a frequency representation of electrical activity at multiple locations of the endocardium surface during the heart beat cycle
  • the method may further include displaying at least a portion of the endocardium surface to include information about the frequency representation at corresponding locations of the endocardium surface
  • the information about the frequency representation may include information indicative of a dominant frequency in the frequency representation
  • the method may further mclude using the determined physiological information to guide treatment of the heart cavity
  • the treatment may include ablation of one or more selected regions of the heart
  • the treatment may include cell therapy, gene therapy, or application of other biological agents
  • the method may further mcludes repeating the measurement of catheter electrode signals and the determination of the physiological information after the treatment, and displaying a difference map including information about how the determined physiological information changed in response to the treatment Attorney Docket No 20240 002WO 1 Client Reference RMD INVD IA PCT
  • the determined physiological information may include isopotential lines or bands corresponding to sets of contiguous locations of the multiple locations of endocardium surface having electrical potential values that are equal or within a selected range
  • the method may further include displaying at least a portion of the endocardium surface to include at least some of the isopotential lmes Displaying may include presenting the isopotential lines for each of different phases of the heart beat cycle
  • the determined physiological information may include electrical potential values at the multiple locations of endocardium surface at different phases of the heart beat cycle, and the method may further include displaying at least a portion of the endocardium surface to include information about the electric potential values
  • Displaying information about the electric potential values may mclude, for example, the maximum electrical potential during the heart beat cycle for different locations of the endocardium surface and/or the root mean square of the electrical potentials during the heart beat cycle for different locations of the endocardium surface
  • the determined physiological information may include an activation time for each of different locations of the endocardium surface
  • the method may further include displaying at least a portion of the endocardium surface to include representations indicative of the activations times
  • the activation times within a common activation time range are displayed with a common color or visual indication
  • the number of locations on the endocardium surface where physiological information is determined maybe more than 10 times more than the number of electrodes on the catheter
  • the catheter may be spaced from the endocardium surface by more than about 3 mm when measu ⁇ ng the signals
  • the method may further include displaying at least a portion of the endocardium surface to include at least some of the physiological information determined at the multiple surface locations
  • the signals measured may be electrical signals
  • the signals measured may be electric potential signals
  • the physiological information may be electrical information
  • the physiological information may include electrical potentials at the multiple locations of the endocardium Attorney Docket No 20240 002WO1 Client Reference RMD-INVD IA PCT surface at each of one or more phases of the heart cycle, and any information de ⁇ vable there from, such as isopotential maps, maximum or RMS voltage maps, activation time maps, and frequency maps
  • Determining the position of the catheter electrodes may include measuring information about, for example, a position and/or o ⁇ entation of the catheter within the heart cavity
  • Determining the position of the catheter electrodes may be based further on information about the distribution of the electrodes on the catheter
  • Measuring information about, for example, a position and/or o ⁇ entation of the catheter within the heart cavity may include measuring the position of one or more catheter electrodes within the heart cavity
  • Determining the position of the catheter electrodes may mclude directly measuring the position of each catheter electrode withm the heart cavity
  • a system in another aspect, mcludes a catheter configured to be inserted into a heart cavity having an endocardium surface, the catheter including multiple, spatially distributed electrodes, the multiple electrodes configured to measure signals in response to electrical activity in the heart cavity with the catheter spaced from the endocardium surface
  • the system also includes a processing unit configured to determine physiological information at multiple locations of the endocardium surface based on the measured signals and positions of the electrodes with respect to the endocardium surface
  • the system may further include a sensor device configured to mteract with the processing unit to determine the positions of the catheter electrodes with respect to the endocardium surface
  • a sensor device configured to mteract with the processing unit to determine the positions of the catheter electrodes with respect to the endocardium surface
  • the processing unit can be configured (e g , programmed) to carry out one of more of the processing/determining type method steps desc ⁇ bed above
  • a computer program product residing on a machine-readable medium for sto ⁇ ng computer instructions that, when executed, cause a processor-based machine to receive from multiple, spatially distributed electrodes of a Attorney Docket No 20240-002WOI Client Reference RMD-INVD-IA - PCT catheter, after the catheter has been inserted into a heart cavity having an endocardium surface, signals measured by the electrodes in response to electrical activity in the heart cavity, with the catheter spaced from the endocardium surface
  • the computer instructions also cause the processor-based machine to determine physiological information at multiple locations of the endocardium surface based on the measured signals and positions of the electrodes with respect to the endocardium surface
  • embodiments of the computer program product may include any feature corresponding to any of the features as set forth above for the method
  • FIG 1 is a schematic diagram of an exemplary non-contact mapping system
  • FIG 2 is a flow diagram of an exemplary non-contact mapping procedure
  • FIG 3 is an exemplary illustration of a representation of the endocardium surface
  • FIG 4 is an exemplary illustration of a meshed boundary representation of an endocardium surface of a left atrium
  • FIG 5 is an illustration of an exemplary voltage map generated using a linear color map matching scheme
  • FIG 6 is a flowchart of an exemplary embodiment of a catheter registration procedure
  • FlG 7 is a flowchart of an exemplary embodiment of a procedure for reconstructing physiological information from signals acquired by the multiple electrodes of a catheter
  • FIG 8 is a flowchart of an exemplary embodiment of a procedure to generate a resolution map
  • FIG 9 is a diagram showing a time and frequency representations of an exemplary electrogram Attorney Docket No 20240-002WO1 Client Reference RMD-INVD-IA- PCT
  • FIG 10 is a flowchart of an exemplary embodiment of a procedure to generate an activation time map
  • FIG 11 is a flowchart of an embodiment of an exemplary embodiment of a procedure to generate a voltage map
  • FIG 12 is a schematic diagram showing signal phase alignment
  • FIG 13 is a flowchart of an exemplary embodiment of a procedure for generating a frequency map
  • the non-contact mappmg system uses a movable multi-electrode catheter that is displaced to multiple locations within the heart chamber, thereby improving the resolution and accuracy of data that can be acquired by a single catheter Transformation functions are computed p ⁇ or to the commencement of signal measurement and acquisition of raw data to expedite the reconstruction process to assemble the physiological information provided to a user
  • FIG 1 shows a schematic diagram of an exemplary embodiment of a non-contact system 100
  • the non-contact system 100 includes a moveable catheter 110 having multiple spatially distributed electrodes During the signal acquisition stage of the non- contact mapping procedure the catheter 110 is displaced to multiple locations within the heart chamber into which catheter 110 is inserted
  • the distal end of the catheter 110 is fitted with multiple electrodes spread somewhat uniformly over the catheter
  • the electrodes may be mounted on the catheter 110 following a 3D olive shape
  • the electrodes are mounted on a device capable of deploying the electrodes into the desired shape while inside the heart, and retracting the electrodes when the catheter is removed from the heart
  • electrodes may be mounted on a balloon, or shape memory material such as Nitinol Attorney Docket No 20240 002WO1 Client Reference RMD-INVD-I A - PCT
  • the catheter's multiple electrodes acquire signals resulting from the electrical activity in the heart cavity in a non-contact manner
  • the catheter is spaced from the endocardium surface Consequently, reconstructing and presenting to a user (such as a doctor and/or technician) physiological data pertaining to the heart's electrical activity may be based on information acquired at multiple locations, thereby providing a more accurate and faithful reconstruction of physiological behavior of the endocardium surface
  • the acquisition of signals at multiple catheter locations in the heart chamber enables the catheter to effectively act as a "mega- catheter" whose effective number of electrodes and electrode span is proportional to the product of the number of locations in which signal acquisition is performed and the number of electrodes the catheter has
  • the catheter 110 is moved to more than three locations (for example, more than 5, 10, or even 50 locations) within the heart chamber Further, the spatial range over which the catheter is moved may be larger than one third (1/3) of the diameter of the heart cavity (for example, larger than 35%, 40%, 50% or even 60% of the diameter of the heart cavity) Additionally, as will be desc ⁇ bed in further details below, in some embodiments the reconstructed physiological information is computed based on signals measured over several heart beats, either at a single catheter location within the heart chamber or over several locations In circumstances where the reconstructed physiological information is based on multiple measurements over several heart beats, the measurements are synchronized with one another so that the measurement are performed at approximately the same phase of the heart cycle The signal measurements over multiple beats can be synchronized based on features detected from physiological data such as surface ECG or intracardiac electrograms
  • Non-contact mapping system 100 further includes the processmg unit 120 which performs several of the operations pertaining to the non-contact mapping procedure, including the reconstruction procedure to determine the physiological information at the endocardium surface
  • the reconstruction of physiological information (e g , electrical potentials) at the endocardium surface includes Attorney Docket No 20240 002WO 1 Client Reference RMD INVD-I A - PCT the computations of transform functions corresponding to the solution of the partial differential equations that define the relationship between acquired signals measured by the catheter's multiple electrodes and the physiological behavior (e g , the electrical potential behavior) of the endocardium surface
  • the "forward" transform or transformation as the mathematical operation that provides the signals measured by the catheter electrodes based on the electrical activity at different locations of the endocardium surface Because there are typically many more endocardium surface locations than catheter electrodes this forward transformation is generally well-defined
  • the processing unit 120 can compute, generally p ⁇ or to the insertion of the catheter into the heart chamber and/or before signal acquisition by the catheter's electrodes has commenced, transformation functions that can be used in realtime to facilitate the reconstruction process More specifically, the transformation functions that are applied to the raw data can be represented in terms of individual transformation components
  • the individual transformation components include, for example, transformation components corresponding to chamber anatomy, and/or the geometry of the catheter
  • the processing unit 120 computes transformation functions pertaining to the chamber's geometry and/or the catheter's geometry, and those components are combined during the reconstruction process with other transformation functions to form the overall inverse transform function Since the overall inverse transform that is applied to the raw data depends on the particular location of the catheter 110 (for example, position and/or o ⁇ entation) in the Attorney Docket No 20240 002WO1 Client Reference RM D-INVD- 1 A PCT heart
  • the mapping procedure can be performed expeditiously by computing in real-time those transformation components that could not be computed ahead of the signal acquisition stage, and combining those components with the approp ⁇ ate pre- processed transformation components to obtain the overall transformation function(s) That overall transformation function is applied to the acquired raw data to perform the inverse reconstruction operation
  • the processing unit 120 In addition to computing the pre-processed partial transformation functions, the processing unit 120 also performs a catheter registration procedure
  • the location of the catheter 110 inserted into the heart chamber can be determined using a conventional sensing and tracking system (not shown) that provide the 3D spatial coordinates of the catheter and/or its multiple electrodes with respect to the catheter's coordinate system as established by the sensing and tracking system
  • a conventional sensing and tracking system not shown
  • the processing unit 120 determines a coordinate system transformation function that transforms the 3D spatial coordinates of the catheter's locations into coordinates expressed in terms of the endocardium surface's coordinate system, or vice-versa
  • the processing unit 120 also performs postprocessing operations on the reconstructed physiological information to extract and display useful features of the information to the operator of the system 100 and/or other persons (e g , a physician) Attorney Docket No 20240 002WO1 Client Reference RMD INVD-IA PCT
  • the non-contact mapping system 100 includes the image acquisition and preparation module 130
  • the acquisition and preparation module 130 receives volumetric images (e g , CT, MRI or ultrasound images taken by a scanner apparatus) of the torso, and processes them, using a procedure referred to as segmentation, to obtain a representation of the endocardium surface Mapping of the data acquired by the multiple electrodes of catheter 110 is performed with reference to the representation of the endocardium surface
  • the boundary and or chamber volume representation is partitioned mto elements whose characteristics are determined in accordance with, among other things, the types of numerical calculation techniques that are used to perform the mapping, as well as the overall geometry and characteristics of the endocardium surface as determined during the segmentation process from the acquired volumetric images
  • the signals acquired by the multiple electrodes of catheter 110 are passed to the processing unit 120 via the signal conditioning module 140
  • the signal conditioning module 140 receives the signals communicated from the catheter 110 and performs signal enhancement operations on the signals before they are forwarded to the processing unit 120
  • Signal conditioning hardware is required to amplify, filter and continuously sample intracardiac potential measured by each electrode
  • the intracardiac signals typically have a maximum amplitude of 6OmV, with a mean of a few millivolts
  • the signals are bandpass filtered in a frequency range (e g , 0 5-500Hz) and sampled with analog to digital converters (e g , with 15-bit resolution at IkHz)
  • the signal can be filtered to remove the frequency corresponding to the power supply (e g , 60 Hz)
  • Other types of signal processing operations such as spectral equalization, automatic gam control, etc may also take place
  • the resultant processed signals are forwarded by the module 140 to the processing unit 120 for further processing
  • the signal conditioning module 140 is implemented by use of integrated components on a dedicated p ⁇ nted circuit board In other embodiments, some of the signal conditioning tasks may be implemented on a CPU, FPGA or DSP after Attorney Docket No 20240 002WO 1 Client Reference RMD INVD IA PCT sampling To accommodate safety regulations, the signal conditioning module is isolated from high voltage power supplies
  • the processing unit 120, image acquisition and preparation module 130 shown in FIG 1 is a processor-based device that includes a computer and/or other types of processor-based devices suitable for multiple applications Such devices can include volatile and non-volatile memory elements, and peripheral devices to enable input/output functionality Such peripheral devices include, for example, a CD-ROM d ⁇ ve and/or floppy d ⁇ ve, or a network connection, for downloading related content to the connected system Such peripheral devices may also be used for downloading software containing computer instructions to enable general operation of the respective unit/module, and for downloading software implemented programs to perform operations in the manner that will be described in more detailed below with respect to the various systems and devices shown in FIQ 1 Alternatively, the various units/modules may be implemented on a single processor-based platform capable of performing the functions of these units/modules Additionally or alternatively, one or more of the procedures performed by the processing unit 120 and/or image acquisition module 130 and/or signal conditioning module 140 may be implemented using processing hardware such as digital signal processors (DSP), field programmable gate arrays (
  • the non-contact mapping system 100 also includes pe ⁇ pheral devices such as printer ISO and/or display device 170, both of which are interconnected to the processing unit 120 Additionally, the non-contact mapping system 100 includes storage device 160 that is used to store data acquired by the va ⁇ ous interconnected modules, including the volumetric images, raw data measured by electrodes and the resultant endocardium representation computed there from, the partially computed transformations used to expedite the mapping procedures, the reconstructed physiological information corresponding to the endocardium surface, etc
  • FIG 2 is a flow diagram providing a top-level depiction of the va ⁇ ous procedures performed by the system 100 in the course of performing the non-contact mapping Attorney Docket No 20240 002WO1 Client Reference RMD-INVD-IA PCT procedure 200 As shown, the system 100 initially acquires at 202 volumetric cardiac representations of a patient's heart Such volumetric representations may include high- resolution CT, MRI and/or ultrasonic slice images providing data regarding the geometry and characteristic of the patient's heart The
  • the non-contact mapping procedure pre- computes at 206 transformation functions that thereafter can be quickly retrieved during the reconstruction of physiological information, thereby expediting the computation of the reconstruction transformations in real-time
  • the pre-processed transformation functions are represented and stored in the form of look-up tables, in the form of matrices, functional representations, or the like
  • Individual transformation functions correspond to one or more of the multiple locations within the heart chamber to which electrodes and/or the moveable catheter 110 may be moved du ⁇ ng the non-contact Attorney Docket No 20240 002WO 1 Client Reference RMD INVD-IA- PCT mapping procedure
  • Other pre-computed transformations may correspond to the various heart shapes with respect to which the physiological information is determined
  • the pre- computed transformation functions may either be stored on a local storage module forming part of the processing unit 120, or may be alternatively stored on storage device 160
  • the catheter 110 is inserted into the heart chamber to be studied at 208
  • the catheter 110 is typically inserted into the heart chamber via a suitable blood vessel leading to the heart chamber
  • the electrodes of the catheter 110 are bundled into a compact configuration that enables the catheter 110 to be delivered to the heart chamber with mimmal obstruction
  • the electrodes of the catheter are deployed into a specified electrode arrangement relative to the catheter 110
  • the moveable catheter 110 is displaced to multiple locations within the heart chamber, whereupon the catheter's electrodes acquire and record signals (e g , electrical signals) resulting from the electrical activity of the heart
  • the system 100 applies reconstruction transformations on the signals acquired by the multiple electrodes of the catheter 110 Because the transformations applied to the acquired signals depends, among other things, on the location of the catheter relative to the endocardium surface, the mapping procedure first establishes the location of the catheter 110 with respect to the endocardium surface's coordinate system
  • the non-contact mapping system 100 determines at 208 the 3D location of the catheter in a 3D coordinate system that corresponds to a sensing and tracking system used to locate the physical location of the catheter 110
  • the location of the electrodes relative to the catheter 110 is fixed and known, and thus the only information that needs to be determined is the location and orientation of the catheter 110 m the 3D space established by the sensmg and tracking system
  • a sensor that is affixed to the catheter 110 may be used to determine the location and orientation of the catheter hi other embodiments the location and orientation of the various electrodes relative to the catheter may vary, and accordingly in Attorney Docket No 20240 002WO 1 Client Reference RMD-INVD-IA PCT such embodiments sensors attached proximate to the various electrodes may be used to facilitate the determination of the location of the catheter and/or its electrodes or by using a scheme that localizes electrode location using electrical impedance
  • the sensing and tracking system employed to determine the 3D location of the catheter could be based, for example, on electromagnetic radiation tracking
  • electromagnetic fields are generated outside the patient body
  • a collection of miniaturized coils oriented to detect orthogonal magnetic fields forming a sensor are placed inside the catheter to detect the generated magnetic fields
  • a processing unit determines the location and orientation of the sensor based on amplitude and phase information m the signal detected by the multiple coils
  • the sensing and tracking system may be based on ultrasound, impedance or fluoroscopy tracking In impedance and fluoroscopy tracking it is possible to locate the electrode location without necessitating dedicated sensors In the case of impedance, electrical potential generated by electric field generators are detected by the existing electrodes In case of fluoroscopy, electrode location may be detected by an image processing scheme that identifies and tracks the electrodes and/or opaque markers located on the catheter
  • the 3D coordinates of the catheter 110 at various locations on the endocardium surface are determined.
  • an operator moves the catheter 110 mside the heart chamber until it determines that the catheter, or one or more of its electrodes, touches the endocardium surface
  • the 3D spatial coordinates of the catheter (and/or its electrodes) at that point on the endocardium surface is determined
  • the operator then moves the catheter 110 to additional points on the endocardium surface, and the 3D coordinates of the catheter 110 relative to the sensing and tracking system employed, at those additional points on the endocardium surface are determined
  • the two coordinate system have to be aligned
  • a coordinate system transformation is computed at 212 that best matches the 3D locations of the catheter 110 at the endocardium surface, as determined at 210, to points on the endocardium surface that was determined at 204
  • the alignment procedure determines the optimal transformation that would cause the endocardium points expressed in the catheter's 3D coordinate system to be congruent with the endocardium surface representation that was determined from the volumetric data Optimization techniques, such as least-square error computation procedures and/or other mathematical regression and curve-fitting techniques, are used to align the catheter's 3D coordinate
  • the catheter registration procedure to align the endocardium surface's coordinate system with the coordinate system used to determine the 3D location of the catheter 110 yields a six (6) parameter transformation that includes three (3) displacement parameters (XOJ ⁇ O) and three rotation parameters (#>, ⁇ o, ⁇ o) These transformation parameters are subsequently applied to 3D spatial coordinates obtained by the sensing and tracking system used to determine the catheter's spatial coordinates to obtain the catheter's locations in terms of the endocardium surface's coordinate system
  • generating a representation of the endocardium surface based on the pre-acquired volumetric data separately from determining the location of the catheter Attorney Docket No 20240 002 WOl Client Reference RMD-INVD-I A - PCT relative to the endocardium surface provides an accurate representation of the endocardium surface not attainable by sequential contact mapping
  • the catheter 110 is moved, at 214, to a first location within the heart chamber in which the first set of measurement by the catheter's multiple electrodes is performed
  • Control of the catheter's movement and location within the heart chamber is performed manually by the operator manipulating the catheter 110
  • the movement of the catheter 110 within the heart chamber may be automated by use of techniques such as magnetic (see, e g , Stereotaxis, Inc of St Louis, MO) or robotic (see, e g , Hansen Robotics, Inc ) navigation Catheter manipulation may be used to cause the catheter to follow a pre-determined displacement route to collect data at locations that may be considered to be of higher interest than others
  • the catheter 110 may be moved at specified displacement intervals m an area of the heart chamber that is known have abnormal cardiac activity
  • the 3D location of the catheter 110 is then determined using one of the techniques discussed previously 110 and/or to its multiple electrodes, thereby providing the catheter's spatial location in the catheter's coordinate system
  • the multiple electrodes of the catheter 110 acquire at 216 signals resulting from the heart's electrical activities
  • the signals are electrical signals (e g , potential, current, magnetic, etc )
  • the non-contact mapping system 100 generates at 218 reconstruction transformation functions to be applied on the acquired signals to reconstruct the physiological information at the endocardium surface
  • the generated reconstruction transformation functions are based, among other things, on the pre-computed reconstruction transformation functions that were determined at 206, and the catheter's location relative to the endocardium surface
  • a corresponding set of reconstructed physiological information is computed Attorney Docket No 20240-002WO1 Client Reference RMD-INVD-I A - PCT
  • a composite resultant set of physiological information can be generated by selecting from multiple sets of reconstructed physiological information portions of the reconstructed information.
  • selecting which portions of reconstructed information to use can be based on resolution maps that are indicative of the quality of the reconstructed information for a particular portion or set of the reconstructed physiological information
  • Other criteria and technique for selecting suitable portions of data to reconstruct a composite set of physiological information may be used
  • one (or more) composite reconstruction transformation function is computed that is applied collectively to the raw data acquired at multiple locations to generate a resultant composite set of reconstructed physiological information based on a substantial part of the data acquired
  • a transformation function represents a "mega transformation function" that corresponds to the "mega catheter” referred to above, whose effective number of electrodes and electrode span is related to the number of locations to which the catheter was moved within the heart chamber Under those circumstances the generation of the composite reconstruction transformation function is deferred until data is collected from the catheter's multiple locations
  • the "mega transformation function" and "mega catheter” may be updated on an ongoing basis to take into account a given relevant measurement window
  • This window may be a fixed number of measurements Attorney Docket No 20240-002WO1 Client Reference RMD-INVD-I A - PCT such that the arrival of new measurements displaces measurements that were obtained before the time window. This yields a constantly updating moving average.
  • signals are measured throughout a heart beat cycle (for example, a measurement can be made at each catheter electrode at each of multiple, different phases of a single beat heart cycle).
  • the reconstructed set of physiological information is computed based on measurements taken over one or more heart beats.
  • the catheter is moved to a particular location, and acquires multiple sets of raw data over several heart beats.
  • the acquired data is averaged, and the reconstruction process is applied to the averaged values.
  • B heart beats i.e., B measurements
  • an improvement in the signal-to-noise ratio proportional to -/# is obtained.
  • the timing of the measurement operation is generally synchronized to ensure that measured data is acquired at approximately the same phase of the heart cycle.
  • the non-contact mapping system performs at 222 post-processing operations on the reconstructed physiological information to extract clinically useful data.
  • the non- contact mapping system 100 produces a composite reconstructed set of physiological information. Post processing operation are performed, under those circumstances, on the composite set of reconstructed physiological information.
  • the post processing operations are performed individually on one or more sets of reconstructed physiological information.
  • the post processing may involve nothing further then selecting a format for outputting (e.g., displaying) the reconstructed potentials to a user.
  • the post-processing may involve significant further mathematical manipulation of the reconstructed potentials to provide additional types of physiological information.
  • the reconstructed physiological information and/or sets of post-processed data are then displayed at 224
  • the information is displayed on a 3D graphical rendering of the representation of the endocardium surface generated at 204
  • Some of the post-processing operations performed on the reconstructed set(s) of physiological information include the generation of a resolution map
  • Such a resolution map indicates the spatial resolution of physiological information at points on the endocardium surface, thereby providing a measure of the reliability and accuracy of the information at various points on the endocardium surface
  • the resolution map may also be used to form a composite set of reconstructed physiological information by associating with individual sets of acquired raw data and/or individual sets of reconstructed physiological information corresponding resolution maps
  • a resultant composite set is then formed by selecting portions of acquired raw data (or reconstructed information) whose reliability or accuracy, as indicated by the resolution map corresponding to the set from which the data is selected, is sufficiently high
  • Resolution maps may be used with any form of post-process
  • Another type of post-processing operation that may be performed includes the generation of isopotential maps Particularly, where the reconstructed physiological information pertains to electrical potentials, the reconstructed potentials may be color coded and superimposed on the 3D endocardial representation Isopotential maps are the reconstructed potentials computed for every sampled set of data over a single or multiple heart beats
  • Timing maps provide information on the time- dependent behavior of the heart's electrical activity
  • the activation map indicates at what point in time particular points on the endocardium surface experience a change in their electrical activity
  • the activation map could identify the Attorney Docket No 20240 002WO1 Client Reference RMD-INVD- 1 A - PCT point in time at which particular cells on the endocardium surface experienced depolarization
  • Another type of timing map may be an iso-duration map where the amount of time certain tissue has been active for is detected
  • Timing maps may be computed from the reconstructed potentials over a single or multiple heart beats
  • Timing maps may be determined and displayed for one or more points on the endocardium surface representation
  • Voltage maps can be used to display characteristics of voltage amplitude in a given area The voltage maps may be computed from the reconstructed potentials over a single or multiple heart beats Useful voltage map information that may be determined and displayed for one or more points on the endocardium surface representation includes the maximum amplitude, or root mean square potential values
  • Another type of post-processing operation is the generation of a difference map
  • the difference map provides information regarding the effectiveness of the clinical procedure (e g , ablation) performed on the patient to ameliorate the symptoms of arrhythmias
  • the difference map compares the electrical behavior of the heart, as reflected from two or more voltage maps generated before and after the performance of the particular clinical procedure
  • a further type of post processing operation is the generation of frequency maps
  • Frequency mapping and more generally spectral analysis, are used to identify on the endocardium surface localized sites of high-frequency activity during fibrillation
  • Frequency maps are computed by acquiring multiple sets of reconstructed information over a particular time interval which includes a single or multiple heart beats The acquired raw data is then used to obtain the frequency representation of that data Specific information (e g , dominant frequency components) from the frequency representation is subsequently identified, and that identified information may be displayed
  • volumetric data can be obtained in advance of the performance of the signal acquisition and/or the reconstruction procedure, or it can be obtained substantially concomitantly with the performance of either of these procedures
  • volumetric data represented as image slices, can be acquired before the catheter 110 is inserted into the heart chamber that is to be mapped
  • Acquisition of the volumetric data is performed using conventional scanning apparatus, such as CT, ultrasound, or MIU scanners, that provide acquired volumetric images to the image acquisition and preparation module 130
  • conventional scanning apparatus such as CT, ultrasound, or MIU scanners
  • the acquired image is usually stored and transferred in industry standard, e g , DICOM format
  • the volumetric images may be acquired under a customized protocol
  • contrast agents may be injected into the body during image acquisition The injection is tuned such that the contrast agent is present in the endocardium during the acquisition time
  • a boundary representation of Attorney Docket No 20240-002WO1 Client Reference RMD-INVD- 1 A - PCT the endocardium surface is generated based on the volumetric data using a procedure known as segmentation.
  • the segmentation algorithm detects the blood to endocardium boundary using the difference in corresponding contrast enhanced by the injected contrast agent.
  • the segmentation may be performed utilizing one of a number of algorithms.
  • One such algorithm is seeded region growing.
  • the basic approach of the algorithm is to start from a seed region (typically one or more volume pixels, denoted voxels) that are considered to be inside the object to be segmented.
  • the voxels neighboring this region are evaluated to determine if they should also be considered part of the object. If so, they are added to the region and the process continues as long as new pixels are added to the region.
  • the evaluation criteria for inclusion as part of the region may be based, for example, on algorithm based on statistical properties of the region.
  • the algorithm computes the mean and standard deviation of intensity values for all the voxels currently included in the region.
  • a user-provided factor is used to multiply the standard deviation and define a range around the mean (for example 3x). Neighbor voxels whose intensity values fall inside the range are accepted and included in the region. When no more neighbor voxels are found that satisfy the criterion, the algorithm is considered to have finished its first iteration. At that point, the mean and standard deviation of the intensity levels are recomputed using all the voxels currently included in the region. This mean and standard deviation defines a new intensity range that is used to visit current region neighbors and evaluate whether their intensity falls inside the range. This iterative process is repeated until no more voxels are added or the maximum number of iterations is reached.
  • a number of segmentation techniques may be used to perform segmentation.
  • a number of commercially available and open source segmentation tools may be used to perform boundary detection. For example, these include Cardiac ++ by GE Healthcare systems, Amira by Mercury Computer Systems, and the open source National Library of Medicine Insight Segmentation and Registration Toolkit (ITK).
  • FIG. 3 provides an exemplary illustration of a resultant boundary representation of the endocardium surface produced from the acquired high resolution volumetric data after the performance of segmentation.
  • representative volumetric Attorney Docket No 20240-002WO1 Client Reference RMD INVD-IA- PCT data compnsing four image slices of the heart cavity are processed using a segmentation technique to generate the 3D boundary representation of the endocardium surface
  • the anatomical geometry of the endocardium representation is partitioned into a discrete number of surface elements to facilitate the performance of the numerical computations that have to be undertaken during the reconstruction process.
  • the number of surface elements, as well as their geometry, controls the maximum attainable resolution of the eventual reconstructed physiological information
  • the partitioning of the segmented endocardium surface representation depends, among other things, on the numerical computation method used to solve the relevant partial differential equations (PDE's) that define the relationship between the physiological information at the endocardium surface and the measured signals
  • PDE's partial differential equations
  • FD finite differences
  • FEM finite element Method
  • BEM boundary element method
  • an advantage of the BEM method is that implementation of the BEM method to perform the computation needed to solve the PDE's in the course of the reconstruction process results in the generation of a non- varying mesh that does not change for different catheter positions
  • the endocardium surface representation obtained is partitioned by using the Strang-Persson approach.
  • the approach is based on a mechanical analogy of a stable equilibrium truss consisting of weights and springs
  • the method assumes that the boundary is supplied as a signed distance function
  • a signed distance function refers to a three dimensional grid of data that contains the values of the function phi that represents the signed distance ( ⁇ 0 if inside, >0 if outside) from a given point to the boundary
  • the signed distance function may be readily obtained following the segmentation process described above Attorney Docket No 20240-002WOI Client Reference RMD INVD IA PCT
  • all opemngs on the representation are typically closed
  • the opening in the geometry of the endocardium representation can be closed with surface sections providing the shortest distances between any given point along the perimeters of the openings on the endocardium surface representation
  • geometries satisfying different criteria for the sections used to patch the openings in the endocardium surface representation may be used
  • the sections that have been added to the representation where opening previously existed are partitioned to surface elements Attorney Docket No 20240 002 WOl Client Reference RMD INVD-IA- PCT having the same geometry as the surface elements used in endocardium surface representation
  • the surface sections now cove ⁇ ng the openings also include triangle-shaped surface elements Subsequently, the solutions of the PDE'
  • the surface elements should be of high quality
  • the quality of a t ⁇ angle-shaped surface element is a measure of how close it is to being equilateral
  • a simple measure of the triangle quality is the "radius ratio"
  • the radius ratio is defined as the ratio of the radius of the circumscribed circle and that of the inscnbed circle The smaller the value, the higher the quality of the triangle
  • the quality of the entire mesh can be measured as the average quality of the individual surface elements
  • some numerical computation techniques, such as FEM are known to be sensitive to the quality of the worst triangle
  • FIG 4 is an exemplary illustration of a resultant meshed boundary representation of an endocardium surface of a left at ⁇ um generated by performing the procedure described herein As shown, the boundary representation of the left at ⁇ um includes a mesh of triangular surface elements
  • physiological data obtained during the acquisition of the volumetric data may be used to enable the matching of volumetric images to the specific phase of the heart's mechanical cycle
  • reconstructed physiological information obtained by performing of the non-contact mappmg procedure could be presented on endocardium surface representation that most closely matches the mechanical phase of the heart during which the raw data resulting from the heart's electrical activity was acquired
  • separate representations of the endocardium surface can be generated for different phases of the heart's cycle usmg the boundary construction procedure
  • Raw data acquired during a particular phase would then be reconstructed with respect to the representation of the endocardium surface corresponding to that phase
  • the reconstruction transformations and catheter registration procedure are performed with respect to that particular representation of the endocardium surface
  • the reconstructed physiological information is Attorney Docket No 20240-002WO1 Client Reference RMD-INVD-I A - PCT subsequently displayed using the corresponding endocardium surface representation.
  • the raw data is
  • the reconstructed sets of physiological information are the solutions to elliptic partial differential equations (PDE's) that arise from Laplace's equation.
  • PDE elliptic partial differential equations
  • a multi-variable function is defined on the closed domain that satisfies two properties: the bulk equation inside the domain (in the present case, e.g., blood) and the boundary conditions (in the present case, e.g., the endocardium and catheter).
  • components of the transformation functions are computed prior to the acquisition of raw data and/or Attorney Docket No 20240-002WO1 Client Reference RMD INVD IA PCT reconstruction of physiological information from that raw data Subsequently, these pre- computed transformation function components are used to expedite the computation of the full transformation functions In circumstances where full reconstruction functions had been computed for particular locations of the catheter and/or electrodes 110, the computation of the forward transformation functions in real-time is avoided
  • the pre-computed transformation functions can be used with any type of numerical computation methods used to solve the PDE's to obtain the reconstructed physiological information solutions
  • the following example illustrates how pre- computed transformation functions can be determined and used in conjunction with boundary element method (BEM) for solving the corresponding PDE's
  • BEM boundary element method
  • the BEM method is based on Green's second identity, as provided below
  • variable V represents the electrostatic potential, which has the property that its Laplacian vanishes
  • U 7 with the distance r measured from a given origin 0
  • variable S 1 is defined as the surface of the heart
  • variable S c is defined as the surface of the catheter
  • the overall surface S with respect to which equation (4) is to be solved, is defined as the union of the heart's surface and the catheter's surface, or S - S e u S c Both surfaces are assumed closed and sufficiently smooth
  • V 1 and correspondingly
  • f are defined as the potential and its normal derivative on the surface of the heart
  • V c and %- are likewise defined as the potential and its normal derivative on the surface of the catheter
  • V e is subject to Dinchlet boundary conditions on SV and zero Neumann boundary conditions on S 0 in the case where the catheter displaces a significant amount of blood Accordingly, V 1 and V c can be determined using the following pair of equations
  • e 2 ⁇ is - [r dn ' dn 2 ⁇ k I c dn i BK ,, a ⁇ V i d ⁇ c 2 ⁇ is - W dn ' dn ) 2 ⁇ h I ' dn (8)
  • the operators, or matrices, applied to V e form the so-called forward transformation, denoted A, that relates the potentials at the endocardium surface, resulting from the electrical activity of the heart, to the potential measured at the multiple electrodes of the catheter 110
  • A forward transformation
  • the matrix S c ⁇ c depends only on the geometry of the catheter and can therefore Attorney Docket No 20240-002WOI Client Reference RMD INVD-I A - PCT be pre-computed If the catheter can assume different shapes and configurations, separate S c ⁇ c matrices corresponding to each such shape/configuration are computed
  • the matrices 5 M( , O e ⁇ e and G ⁇ depend on the geometry of the heart and can be pre- computed if the shape of the heart is obtained before the procedure hi some embodiments O e ⁇ € is the largest matrix since the heart is represented by a mesh with significantly more elements than the catheter For example, the heart is typically represented by 3000 triangles while the catheter is typically represented by 500 Therefore, O e ⁇ e is a 3000 x 3000 matrix, and thus its inversion would be costly (especially in terms of time) if the inversion had to be performed in
  • the matrices corresponding to the independent geometry of the endocardium surface and/or the catheter are computed in advance of the signal acquisitions and/or reconstruction stages of the non-contact mapping
  • These pre-computed matnces are stored in a memory device, such as storage device 116 for later retrieval
  • the forward transform matnx is generated by retrieving, for example, the pre-computed S Me , O e ⁇ e , and matrices, and using them in the course of computing the full forward transform matnx hi these embodiments where at least some of the pre-computed components associated with the forward transform are available, the forward transform matnx has effectively been partially pre-computed
  • the other matnces depend on the configuration of the endocardium and the catheter 110 relative to each other (e g , the relative distance between the catheter and specific locations on the endocardium surface)
  • the relative positions and configuration of the endocardium surface relative to the catheter are typically known only when the catheter is inserted into the heart chamber and the data acquisition process has begun, to further expedite the reconstruction procedure, in some embodiments, the following matnx may be pre-computed for a large number of possible catheter locations.
  • Equation (16) can be independently computed and stored at storage device 160 (or elsewhere) for subsequent retrieval During the performance of the mapping procedure, the catheter's position relative to the endocardium surface is determined and rather than computing the matrix of Equation (16) from scratch, the location is used to access a look-up table to retrieve the approp ⁇ ate pre- computed matrix corresponding to the determined location
  • the extent of blood displacement in the heart chamber is much less significant than for balloon-shaped catheters Accordingly, one can approximate the presence of the catheter as having no effect on the electrostatic potentials inside the heart cavity, and essentially the integrations over the catheter surface in Equations (7) and (8), and the equations derived there from, can be ignored As a result, the catheter orientation is no longer required to calculate the forward transform matrix A, the only knowledge that is required regarding the catheter is the positions of the various catheter electrodes
  • V. ' U 2 ⁇ *.J ⁇ lr * dnL-V.' * d ⁇ n or, in the matrix form
  • pre-computed matrices generated for select locations of the catheter may be used to estimate the matrices for other locations of the catheter 110 with respect to which corresponding forward matrices were not pre-computed Perturbation analysis can be used to do this
  • a satisfactory inverse operator has been constructed for a certain relative configuration of the endocardium and the catheter
  • the electrophysiologist moves the catheter by a small amount
  • a boundary perturbation technique can be used for reconstructing the potential on the endocardium by utilizing the measurements on the displaced catheter, the known amount of displacement, and the inverse operator constructed for the original position
  • the matrix for the new location can be determine by using the pre- computed matrices for nearby locations, or components therein, as bases in a perturbative solution (e g , a linear superposition of the basis functions or matrices) for determining the matrix for the new location
  • a perturbative solution e g , a linear superposition of the basis functions or matrices
  • pre-computed transformation matrices may be generated for separate representations of the endocardium surface in circumstances where different representations for different phases of the heart's cycle are used
  • corresponding pre-computed matrices are generated that are based on the individual geometry of these endocardium surface representations
  • the matrices which depend on the geometry of the catheter e g , -S c ⁇ :
  • the matrices corresponding respectively to the chosen catheter and to the particular endocardium surface geometry are retrieved from storage device 160 and used to complete the computation of the full forward matrix corresponding to the particular location at which raw data was acquired
  • an important aspect of the non-contact mapping procedure is the determination of the catheter's position relative to the endocardium surface representation
  • the relative position of the catheter with respect to the endocardium surface representation is required, among other reasons, to compute the reconstruction transformation functions to compute the physiological information at the endocardium surface
  • FIG 6 is a flowchart of an exemplary embodiment of a catheter registration procedure 600 for determining a transformation function that aligns the catheter's coordinate system with the coordinate system of the endocardium surface representation, and thus enables expressing the position of the catheter's location in terms of the endocardium surface's coordinates system
  • the following will desc ⁇ be two methods for performing catheter registration The first method relates to a point cloud to surface registration while the second method employs the identification of fiduciary anatomical markers
  • FIG 6 describes a point cloud to surface registration
  • a catheter is first inserted into the heart chamber and is moved to a location where the catheter and/or at least one of its electrodes touch the endocardium surface (at 610)
  • an operator moves the catheter 110 inside the heart chamber until it determines that the catheter, or one or more of its electrodes, touches the endocardium surface
  • the operator may be guided by visual aides such as a real-time ultrasound system providing a visual image of the catheter inside the heart chamber, a camera coupled to a fibreoptic strand connected to the catheter, fluoroscopy, impedance measurements, the size and shape of intracardiac electrograms, pressure sensors fitted on the tip of the catheter etc
  • the operator may determine that the catheter is touching the endocardium surface when it encounters the higher mechanical resistance exerted by the endocardium walls, thereby alerting the operator that the catheter is at the endocardium surface
  • the 3D spatial coordinates of the catheter (and/or its electrodes) is determined at 620.
  • the spatial coordinates maybe established using one of several conventional sensing and tracking systems.
  • Such conventional sensing and tracking systems include systems that determine the location of the tracked object (in this case the catheter and/or its electrodes) using magnetic fields, electric fields, fluoroscopy, and ultrasound signals. These systems localize the catheter in the 3D space of the localization system.
  • 6,690,936 entitled “System for determining the location and orientation of an invasive medical instrument”
  • 5,713,946 entitled “Apparatus and method for intrabody mapping”
  • 5,694,945 entitled “Apparatus and method for intrabody mapping”
  • 5,568,809 entitled “Apparatus and method for intrabody mapping”
  • 5,833,608 entitled “Magnetic determination of position and orientation”
  • 5,752,513 entitled “Method and apparatus for determining position of object”
  • 6,427,314 entitled “Magnetic determination of position and orientation”
  • U.S. Patent Application Publication entitled “Method and apparatus for catheter navigation and location and mapping in the heart.”
  • the location of the electrodes relative to the catheter 110 is fixed and known, and thus the only information that needs to be determined is the location and orientation of the catheter 110 in the 3D space established by the localization system.
  • the location of the various electrodes relative to the catheter may vary, and accordingly in such embodiments electrodes may be tracked individually relative to the endocardium, or relative to a location on the catheter with known position relative to the endocardium. Electrode tracking may employ any of the above mentioned tracking methods such that instead of tracking only one known point on the catheter, each electrode is individually tracked.
  • the procedure depicted at 610-620 is repeated. Particularly, the operator moves the catheter 110 to the next point on the endocardium surface, and the 3D coordinates of the catheter 110 relative to the localization system are determined.
  • the registration transformation, to is computed at 640.
  • the computed geometric transformation is the one that best matches the 3D locations of the catheter 110, as determined at 610-630, to the endocardium surface representation.
  • computation of the registration transformation to is performed by minimizing the following expression: min ⁇ X 2 (I ? )
  • the surface S representing the segmented boundary of the endocardium surface and nearby vessels.
  • the vector p which corresponds to the 3D spatial coordinates measured for the roving catheter using the localization system, and the operator T[to](p.) which is the transformation operator performed on the points p,.
  • the resultant vector to is represented as a six parameter transformation [xo,yo, zo, 3), ⁇ a, ⁇ b] that is applied to catheter locations to express those locations in terms of the endocardium surface coordinate system.
  • determination of the transformation vector to may be achieved using the fiduciary anatomical markers technique
  • this technique a number of fiduciary markers are identified in both the endocardial boundary and the localization system respective coordinate systems Once identified, the transformation that yields the minimum mean square error between the two point sets is chosen
  • anatomical landmarks that are easy to identify m both modalities (Mitral annulus, coronary sinus, etc ) are used as the fiduciary markers These landmarks may be easily identified in the pre-acquired endocardial boundary Once a given landmark is identified, the catheter may be advanced to the landmark guided, for example, by fluoroscopy Once in contact, a reading from the catheter localization system is taken to establish the catheter's position in terms of localization system's coordinate system
  • a variation of the above technique may be to place surface markers on the patient that are easy to identify in both the pre-acquired and real-time localization modalities
  • the registration process yields a transformation vector that includes three (3) displacement parameters (X O ⁇ ) and three rotation parameters (ft, ⁇ a, ⁇ o)
  • This transformation can then be applied to 3D spatial coordinates obtained by the localization system to obtain the roving catheter's location m terms of the endocardium surface representation's coordinate system
  • the mapped locations of the catheter's 110 are subsequently used to compute the reconstruction transformation, and/or perform all other computations that require the catheter's location in terms of the endocardium surface's coordinate system
  • the heart may experience mechanical change during the activation wavefront propagation
  • several geometrical transformation vectors such as t 0 , corresponding to multiple heart shapes may be computed
  • the system may detect physiological data such as ECG, intracardiac electrograms and stroke volume using impedance plethysmography and use this data to select the cardiac phase, approp ⁇ ate endocardial boundary representation and the corresponding geometric transformation k
  • the transformation to establishes the geometric mapping with a respect to a representative point on the catheter 110 e g , the tip of the electrode that touched the endocardium surface when the catheter was moved around, the central point on the body of the catheter, etc
  • the coordinates of any point on the catheter and/or its electrode in terms of the endocardium surface representation's coordinate system can be determined
  • V 2 P 0
  • Laplace's equation needs to be solved numerically Numerical methods such as boundary element method (BEM), finite element method (FEM), finite volume method, etc may be used to solve Laplace's equation
  • Numerical methods such as boundary element method (BEM), finite element method (FEM), finite volume method, etc may be used to solve Laplace's equation
  • spherical harmonics may be used to solve Laplace's equation
  • Each numerical method represents the geometry in a discrete way, but each method uses its own representation
  • the potentials on the endocardial surface and on the catheter are represented by finite-dimensional vectors Since Laplace's equations are linear, these vectors are related by a matrix A, known as the forward matrix
  • V c is a vector containing the potentials measured by the electrodes on the catheter and V e is a vector containing the real endocardial potentials
  • the matrix A has dimensions of m x «, where m is the number of electrodes on the catheter and n is the number of degrees of freedom in the endocardial potential, usually the number of surface elements used to represent the surface S e Typically m ⁇ n
  • the effective number of electrodes m can be increased, thereby reducing the disparity between m and n and thus improving the accuracy of the computations
  • Equation (20) provides a transformation relationship from the endocardial to the catheter potentials This relationship, which is generally referred to as the forward problem, is well posed and can be solved with great precision
  • V 1 a vector representing the estimated endocardial potentials, has to be determined given V c Since mat ⁇ x A is generally rectangular, underdetermined, and rank deficient to within IEEE double precision, solving this equation is difficult, if not impossible
  • the first step towards calculating V 1 is to reformulate Equation (20) as a least squares problem in which the expression ⁇ ' - A ⁇ V ' f (21) also referred to as the objective function is minimized over all possible V 1
  • the mat ⁇ x A is either determined in real-time, or, as described above, a pre-computed mat ⁇ x A corresponding to the particular geometry of the catheter 110 (including the position and o ⁇ entation of the catheter) is retrieved from storage device 160
  • the storage device does not store full-forward transformation matrices A corresponding, for example, to the particular position(s) and/or onentauon(s) of the catheter 110
  • the computation of the matrix A can nevertheless be expedited by retrieving from storage device 160 partially pre-computed functions or function components, and completing the computation of the matrix A as desc ⁇ bed with reference to Equation (16) If A were over-determined (i e , its rank exceeding the dimension of V c ), and typically it is not, then V t
  • Equation (22) cannot usually be applied in practice.
  • One difficulty relating to performing a least-square error procedure is that because the matrix A attenuates the physiological signal, the inverse operation needs to amplify the signal.
  • the level of attenuation in the forward and amplification in the inverse depends on the size and the location of the catheter and the nature of the electrical potential on the endocardium.
  • V e In practice, significant components of V e are attenuated on the order of 1000 or greater. As a result, small errors in V c will produce large errors in V 1 . Thus the inverse problem is ill-posed.
  • a regularization technique can be used for dealing with the ill-posed nature of the inverse problem.
  • the regularization technique involves making additional assumptions about the behavior of the endocardial signal. These assumptions may relate to the spatial or temporal characteristics of the physiological information at the endocardium surface.
  • Tikhonov regularization technique One technique that can be used is the zeroth (0 th ) order Tikhonov regularization technique. The technique is predicated on the assumption that the essential part of the signal is contained among the right singular values of A that correspond to the lowest singular values. An alternative geometric interpretation is that Tikhonov regularization limits the amplitude of spatial variation of the reconstructed signal.
  • the zeroth order Tikhonov regularization limits the amplitude of spatial variation of the reconstructed signal.
  • the regularization parameter t controls the amount of spatial smoothing applied to reconstructed potentials V e .
  • the regularization parameter t provides a trade off Attorney Docket No. 20240-002WO1 Client Reference RMD-INVD-IA- PCT between spatial resolution and sensitivity to noise. As t decreases, the reconstruction resolution is improved, but noise and the instability of the solution increases.
  • / may be chosen such that it is three (3) times the root mean square value of noise detected by the electrodes. Other methods such L-curve may be used to find an optimal regularization parameter.
  • Tikhonov regularization In addition to addressing the ill-posedness of the inversion problem, Tikhonov regularization also solves the problem of the under-determination of A.
  • FIG. 7 is a flowchart of an exemplary procedure 700 for reconstructing physiological information from signals acquired by the multiple electrodes of the catheter 110.
  • the catheter 110 is moved to one of multiple locations within the heart chamber at 710.
  • an operator controls the movement of the catheter and decides its next location, while in other embodiments the catheter's movement is fully or partially automated.
  • the position of the catheter 110 in relation to the endocardium surface representation is determined at 720.
  • the localization system tracking the location of the catheter 110 determines the 3D spatial coordinates of the catheter 110 relative to the localization system. The localization system thus provides the position and orientation of the catheter 110 in terms of the localization system coordinate system.
  • the previously determined geometric coordinate transformation vector to is then applied to the position of the catheter 110, as expressed in terms of the localization system's coordinate system, and transforms that position to a resultant catheter position expressed in term of the endocardium surface's coordinate system.
  • the catheter's multiple electrodes then acquire the raw data signals that resulted from the electrical activity of the heart and send the signals to the processing unit 120 at 730.
  • the acquired signals are electrical and/or magnetic signals resulting from the electrical activity of the heart.
  • the catheter's multiple electrodes acquire multiple sets of signal in each heart beat over several heart beats.
  • signal acquisition is performed in several locations in the heart chamber.
  • the multiple sets of signals are processed (e.g., by performing an averaging or a weighted averaging operation) to generate a resultant set of raw data on which the reconstruction procedure will subsequently be performed.
  • a forward transform A is then constructed for the composite raw data set that includes data from multiple catheter locations, and the reconstruction set of physiological data, corresponding to the composite set, is then determined.
  • a synchronization mechanism may be used to enable the system 100 to acquire signals at substantially the same cycle of heart's electrical activity.
  • the synchronization could be based on physiological data (e.g., ECG measurements, intracardiac electrogram measurement, operator pacing) collected by the synchronization mechanism. Accordingly, the reconstruction of physiological information from a composite set obtained in the above-described manner results in processing the synchronized raw data signals as though they were obtained at one time from all the positions sampled by the catheter's electrodes for the different positions of the catheter in the heart chamber.
  • physiological data e.g., ECG measurements, intracardiac electrogram measurement, operator pacing
  • the forward reconstruction transform A is determined at 740.
  • the forward transform A depends on the position and/or orientation of the catheter 110 relative to the endocardium surface representation.
  • determining the matrix A includes computing the values of the forward matrix in accordance with the expression
  • folly computed forward matrices each corresponding to a particular position of the catheter, can be retrieved from storage device 160
  • the position of the catheter 110 and/or its electrodes is used to access a look-up table that maintains the various pre-computed forward transforms Having determined the forward transform, the reconstructed set of physiological information (e g , electrical potentials) at the endocardium surface representation is determined at 750
  • a regularized inversion procedure as desc ⁇ bed above is used to estimate the values of the reconstructed physiological information set based on the set of raw data that was acquired (be it a set of data acquired from a single measurement by the multiple electrodes or some resultant set derived from multiple measurements) and the forward transform A that was determined at 750 (for example, as desc ⁇ bed above with respect to Equation (21))
  • the physiological information can be overlaid on the endocardium surface representation using, for example, conventional graphic display techniques (e g , graphical rendering) Post-processmg operations may be additionally applied to the set of reconstructed physiological information
  • the physiological information can be displayed, for example, using a color code whereby a color is assigned to ranges of values A certain value corresponding to a particular surface element is mapped to a corresponding color which is then used to fill the area on the graphical representation of the endocardium associated with the surface element with that color
  • Other ways to represent the values of the physiological information can be used
  • the Tikhonov regula ⁇ zation technique can be used, whereby the regula ⁇ zation parameter t is chosen, in some embodiments, to be three times the root mean square of noise
  • the Tikhonov regula ⁇ zation technique helps to reduce the computation error due to noise, the technique adversely affects the spatial resolution of the reconstructed information
  • the Attorney Docket No. 20240-002WO1 Client Reference RMD-INVD-IA - PCT larger the regularization parameter, the more spatially smooth (and hence low resolution) the reconstruction becomes.
  • the signals detected by catheter electrodes should be shielded to reduce interference and conditioned by a low noise input stage.
  • the signal to noise ratio can be improved by a factor of -JB where B is the number of measurements in the presence of a periodic signal and independent and identically distributed noise.
  • V c (t) is defined as the measurements made on the catheter at instant t. If the signals are sampled at increments of ⁇ t (e.g. ImS), then for a heart beat having a period P (e.g. 75OmS for 80 beats per minute) the measured signals can be expressed as V c (s-At+P ⁇ ,) or F c (s,6) where s is the phase number in the cycle, and P f , is the time stamp at which the fiducial marker associated with beat b was detected.
  • the parameter s can thus be regarded as a specific phase in the cardiac cycle.
  • a specific fiducial marker needs to be identified within each heart beat. This can be done by relying on reference signals such as body surface ECG or intracardiac signals such as those collected in the coronary sinus. A specific implementation of this is described further below in the next section.
  • B measurements of signals are available for the phase s of the heart cycle.
  • the B measurements at the same phase can be averaged according to:
  • the resultant set of signals corresponds to data averaged over B measurements, assuming independently and identically distributed noise sources an improvement in signal to noise proportional to V-? is obtained.
  • the resultant averaged set of signal values are now used to perform the reconstruction of the physiological Attorney Docket No. 20240-002WO1 Client Reference RMD-INVD-I A - PCT information, and accordingly the reconstruction resolution can be increased by using the averaged data and reducing the value of the Tikhonov regularization parameter t by a factor of -JB .
  • Additional improvement in reconstruction accuracy can be obtained by moving the catheter. Since catheter movement is slow relative to the heart rate, when moving the catheter raw signals are acquired at multiple locations over multiple beats. Catheter movement and the use of multiple beats have several advantages. One advantage is that use of multiple beats improves the signal-to-noise ratio. Another advantage is that the movement of the catheter allows improved resolution in areas that the catheter was moved closer to, and effectively provides signal measurements from more electrode locations (thereby effectively providing more electrodes).
  • the forward transform matrix A does not remain constant.
  • each catheter location where raw data is acquired would be associated with a corresponding forward transformation A b .
  • a new measurement vector V c can be assembled that contains all electrode measurements conducted at the same (or substantially the same) phase s.
  • the vector V ⁇ s can be expressed as:
  • a composite forward transform A is defined such that:
  • V e (s) V c (s) (27)
  • the values of V e (s) i e , the reconstructed set of physiological information corresponding to a particular phase s) can be determined by performing the inverse procedure previously discussed For example, a regularized inversion of A may take place as discussed above
  • VMV max(V e (s)) - min(V c (s)) (28)
  • VMV -
  • the following describes a method of aligning the K signals Vi(t)-V ⁇ (t), as shown in FIG 12
  • all signals are amplified, filtered and sampled
  • a synchronization signal is concurrently acquired in an identical manner
  • the synchronization signal can be acquired from surface ECG, or an intracardiac signal in a fixed location such as that detected by a coronary smus catheter
  • the Fiducial Point Detector detects the time markers at which particular event occur
  • the FPD may detect the R wave m surface ECG or activation time of an intracardiac electrogram
  • the detection is performed in a manner similar to alignment methods for averaging of high resolution ECG See, for example, Jane Raimon,"Alignment methods for averaging of high resolution cardiac signals", IEEE Transactions in Biomedical Engineering. VoI 38 No 6 (June 1991), Brooks, Dana, "Improved alignment method for noisy high-resolution ECG and Holter records using multiscale cross-correlation", IEEE Transactions in Biomedical Engineering.
  • Fiducial points are detected when the cross-correlation between the template and synchronization signal reach a maximum
  • the template signal itself may be a relatively clean signal that was acquired from the synchronization signal previously, or an average of a number of these signals
  • the template signal may be selected visually by the user or Attorney Docket No 20240 002WO 1 Client Reference RMD-INVD-I A - PCT automatically by a computer algorithm which uses a p ⁇ o ⁇ knowledge about the statistics of the signal
  • the synchronization signal may come from the pacing apparatus In this case, no cross- correlation is necessary and the FPM will just pass the time markers associated with the synchronization signal
  • the FDM outputs the time markers Pi PB at which the fiducial points were detected These time markers are then used to align the acquired signals After the acquired signals are aligned, they are expressed as V ⁇ (s,b), where s is the phase number in a particular beat b
  • a number of post-processing and visualization techniques may be used to display the reconstructed physiological information m a clinically meaningful manner
  • Some of the post-processing operations include the following
  • the potential is greatly attenuated on its way from the endocardial surface to catheter electrodes
  • the potential may be attenuated so much, that by the time it reaches the catheter its values are lower than the noise floor Due to this attenuation, potentials (or other types of physiological information) on the endocardium surface representation in areas that are closer to the catheter may be reconstructed with greater accuracy and spatial resolution than potentials in areas farther away from the catheter
  • potentials or other types of physiological information
  • a heuristic approach that is designed to measure how much of the signal remains above noise by the tune it reaches to the catheter is used to compute resolution maps
  • signals expe ⁇ ence attenuation which depends, among other things, on the spatial frequency of signal That is, the higher the spatial frequency, the greater the level of attenuation
  • the singular value decomposition of the forward transform A suggests an approach for determining the attenuation levels of the forward transformation.
  • the right and left singular vectors R, and L are unique orthonormal bases that map one to another under A and are related through the vector ⁇ , which represents an attenuation of one basis, relative to the other.
  • an endocardial signal V e is deemed to be reconstructible if the singular value components that remain above noise after being transformed by A add up to at least 60% of the total signal energy.
  • the resolution at a particular point i on the endocardium is said to be Res, if a bell-shaped signal centered at that point and having a "standard deviation" of Res, is reconstructible.
  • A is a matrix of size mxn where the number of rows m corresponds to the number of catheter electrodes and the number of columns n is the number of elements on the mesh describing the shape of the endocardium surface.
  • the values in column ; ' in A can represent the voltage measurements on all electrodes had there been a potential of IV on the i a element on the mesh and a potential of OV everywhere else.
  • each squared entry in the column corresponds to the energy received by one of the catheter electrodes (j in the above equation represents the 7* electrode of the catheter).
  • the average amount of energy that makes it from a particular element / on the heart's surface to the catheter's electrodes is a good indicator of the reconstruction resolution. Areas on the heart surface whose voltage is attenuated greatly by the time they reach the catheter are reconstructed with poor resolution while areas whose voltage arrives less attenuated are reconstructed more accurately.
  • FIG. 8 is a flowchart of an exemplary embodiment of a procedure 800 to generate a resolution map. As shown, a forward transform A, corresponding to a particular catheter location is first obtained at 810 using, for example, either of the techniques described above.
  • the resolution map may be displayed at 830 to the physician to aid in determining the accuracy and reliability of the reconstructed physiological information, hi preferred embodiments the resolution map is overlaid (i.e., superimposed) with the reconstructed physiological signal on the endocardial representation by one of the following techniques: 1. Grid Lines - The resolution values can be represented on the endocardial representation by controlling the grid line density appearing on the endocardial representation.
  • the grid lines on the endocardial Attorney Docket No 20240 002 WOl Client Reference RMD-INVD-I A ⁇ PCT representation will appear dense while in areas of low resolution they will appear coarse
  • the resolution can be displayed by superimposing dots on the endocardial representation
  • resolution is displayed by controlling dot density, instead of g ⁇ d line density, such that dot density in high resolution areas will be higher than in areas of low resolution
  • the resolution values can also be represented on the endocardial surface by controlling the transparency of the displayed areas Thus, areas of high resolution will appear opaque while areas of low resolution will appear increasingly transparent 3 Brightness - The resolution values can also be represented by controlling the brightness of the displayed areas on the endocardium surface representation Thus, areas of high resolution will appear bright while those of low resolution will appear increasingly dark
  • a thresholding scheme may be used instead of assigning overlaying the resolution value.
  • a minimum resolution threshold (for example 1 cm) may be defined Areas where the resolution is better than the threshold will be displayed (e g opaque, bright, etc ) with corresponding physiological information while areas of low resolution will be masked (e g transparent, dark, etc )
  • the resolution may be displayed on an mdependent endocardial representation, alongside an additional endocardial representation depicting the physiological information
  • the physician may use this resolution map to determine the reliability with which data is reconstructed on the endocardium surface representation If an inadequate resolution is available at a point of interest, the physician may advance the catheter towards the point of interest to improve reconstruction resolution
  • generated resolution maps are used to construct a composite set of reconstructed physiological information
  • a corresponding resolution map for each of those available reconstructed sets, is generated using, for example, one of the techniques Attorney Docket No 20240-002WO1 Client Reference RMD-INVD-IA PCT described above
  • a resultant composite set of reconstructed physiological information is generated by selecting, for a particular surface element at the endocardium surface representation, a reconstructed value from that set of reconstruction physiological information whose corresponding resolution map value is the best or most optimal or by performing a weighted average as desc ⁇ bed above B Isopotential Representation
  • the reconstructed potentials provide a snapshot of potential distribution on (he endocardium surface at a given instant Such potential values may be color coded and superimposed on the endocardial representation for display For clarity, contoured isopotential lines may also be added showing lines of interpolated equal potential
  • the propagation of potentials may also be calculated using multiple time instances and displayed in a similar manner As a result color data and/or isopotential lmes will be displayed as an animation depicting the temporal behavior of potential distribution C Timing Map
  • Timing maps display information pertaining to the timing of particular events relative to the occurrence of other easily detectable reference events This information may include temporal features such as the onset of depolarization (activation), repolarization and activation duration Reference events may include the R wave on an ECG or activation time in a specific intracardiac electrogram (e g electrode at coronary sinus)
  • activation time map (lsochrone)
  • the activation time of each point on the endocardium is determined and its value color coded and displayed on the endocardial surface
  • an isochrones map identifies the time instances at which particular locations on the endocardium surface experienced a depolarization of their potentials
  • the electrical activity during a heart beat cycle (or more) can thus be displayed on a single isochrones contour map showing lines of interpolated equal activation times
  • the construction of the isochrones map requires the detection of activation instants from reconstructed potentials
  • FIG. 10 is a flowchart of an exemplary embodiment of a procedure 1000 to generate an activation time map. As shown, multiple reconstructed sets of potential values relating to the endocardium surface are provided at 1010.
  • the activation time (i.e., the time at which the potential was depolarized) at that surface element is determined at 1020 based on the values of reconstructed sets.
  • the activation time is determined by identifying the reconstructed set at which the rate of potential change was the highest.
  • the activation time is determined by identifying the first reconstructed set at which there was a potential change, as compared to the preceding reconstructed set, exceeding some predetermined threshold.
  • activation time is determined using cross-correlation with a template beat in the manner described above. Other ways for establishing the activation time instance can be used.
  • the identified reconstructed set is associated with a particular time instance, which is recorded in the activation time map. It will be appreciated that the entries of the activation time map may have initially been set to a value that is indicative of no associated activation time (e.g., a value of 0 or a negative value).
  • the derived activation time map is displayed at 1030.
  • isochrones maps are helpful in depicting activation propagation in a single image, they can be limited in that they discard information related to potential waveforms, amplitude and areas where multiple activations per beat are present.
  • Additional processing may be conducted to highlight properties of the activation propagation. For example, areas that have not been activated or that experienced more than one activation in a given heart beat may be highlighted for further investigation.
  • activation time maps may be generated for other types of physiological information.
  • FIG 11 is a flowchart of an embodiment of an exemplary embodiment of a procedure 1100 to generate a voltage map
  • the reconstructed set(s) may correspond to reconstructed potentials computed from a single measurement performed by the multiple electrodes of the catheter 110, or alternatively may correspond to several measurements taken over several heart beats, or may more generally correspond to multiple measurements taken at multiple locations m the heart chamber over several heart beats and/or at different phases of the heart cycle
  • the reconstructed sets provided are then processed to determine, for each surface element of the endocardium surface representation, a metric value that is representative of the corresponding values from the reconstructed sets (at 1120)
  • the metric value is the maximum amplitude potential value identified from the respective values (provided by the available reconstructed sets) associated with a surface element
  • the metric value is computed as the root mean square of the various respective values from the reconstructed sets
  • Other representative values of the potential at various locations of the endocardium surface may be computed.
  • the metric values of the voltage map are converted to corresponding color map values (at 1130)
  • the voltage map containing the color values computed at 1130 is subsequently displayed at 1140 on the endocardium surface representation
  • FIG 5 is an illustration of an exemplary voltage map generated using a linear color map matching scheme As shown, areas of differing electrical activity in the endocardium surface are readily discernable
  • Another useful color conversion scheme for the voltage map procedure 1100 is a logarithmic color conversion scheme E Difference Map
  • Another type of post-processing operation that is based on voltage maps is the generation of a difference map
  • the difference map provides information regarding the effectiveness of the clinical procedure, such as an ablation procedure, performed on a patient to ameliorate the symptoms of arrhythmias
  • the difference map compares the electrical behavior of the heart, as reflected from two or more voltage maps generated before and after the performance of the particular clinical procedure
  • the clinical procedure for example, an ablation procedure
  • the ablation procedure is performed at the areas of the heart that are determined, aided by the information provided by the first voltage map, to require treatment
  • a second voltage map is generated The values of the first ablation map are subtracted from the corresponding values of the second voltage map If there is no significant difference between any the respective voltage map entries corresponding to a particular endocardium surface locations where the ablation procedure was performed, this may be indicative that the ablation procedure performed at those locations had little clinical effect
  • maps analogous to the voltage maps desc ⁇ bed above may be generated for other types of physiological information
  • the difference map could show differences in measured potential at a specific phase in the heart cycle
  • spectral analysis frequency data is color coded and displayed on the 3D anatomical endocardium surface representation
  • the data displayed is the dominant frequency at which activation takes place in a given location
  • FIG 9 is a diagram showing a time and frequency representations of an electrogram
  • the image on the left depicts the electrogram potential as a function of time in fibrillating tissue
  • the image on the right depicts a Fast Fourier Transform (FFT) of the same signal
  • FFT Fast Fourier Transform
  • the dominant frequency (DF) of the signal is 9 6 Hz
  • the DF can be calculated by applying an FFT on the time-dependent signal, determining the frequency at which maximum amplitude is present The DF is then color coded and displayed on corresponding chamber anatomy
  • FIG 13 is a flowchart of an exemplary embodiment of a procedure 1300 for generating a frequency map
  • multiple reconstructed sets of physiological information at the endocardium surface are provided at 1310
  • the reconstructed sets correspond to a temporal sequence of measurements performed by the catheter 110
  • a frequency transform procedure such as a Fast Fourier Transform
  • the frequency transform procedure is performed individually for the values of the reconstructed sets corresponding to individual surface elements of the endocardium surface representation
  • a representative value, for example a dominant frequency, obtained from the resultant frequency representation of the time behavior for a particular surface element is recorded in the frequency map entry corresponding to that particular surface element
  • the temporal data with respect to which the frequency transform is performed could correspond to multiple surface elements
  • the frequency representation values are converted to corresponding color map values to enable the resultant values to be more easily observed when displayed (at 1330)
  • the color frequency map, containing the color values computed at 1330, is subsequently displayed at 1340 on the endocardium surface representation
  • the source of the arrhythmia may be identified by electro- anatomically characterizing the underlying tissue during sinus rhythm, spontaneous or induced arrhythmia, or during pacmg
  • Electro-anatomical characterization includes a number of spatio-temporal features of the conduction For example, these include activation time mapping to identify early activation sites that are indicative of exit sites and unwanted automatic cell firing, maximum voltage to identify low voltage areas that are indicative of infracted regions, as well as repolarization time and spectral behavior
  • Therapy may include ablation of tissue accomplished by the delivery of RF energy, microwave energy, cooling, ultrasound, chemical agents, radiation or laser Alternatively, therapy may also be accomplished by the introduction and targeted delivery of biological agents such as cells capable of performing myocardial repair, or genes capable of changing physiological behavior
  • electro-anatomical mapping primarily involves the identification of areas with low potentials that are indicative of infarction as well as areas that exhibit reduced mechanical motion
  • therapy may involve the targeted delivery of introduction of cells or genes capable of performing myocardial repair and regeneration
  • myocardial repair Recent advances in the area of stem cell biology have provided scientists with potential tools to develop novel strategies for myocardial regeneration
  • Such biological therapies also affect the electrical properties of the tissue which can be mapped using electro-anatomical mapping
  • electro-anatomical mapping may be used to validate therapy effectiveness For example, this may be accomplished during the same procedure to validate conduction block in areas where ablation energy was delivered or to validate the regenerated mechanical motion following biological implantation Alternatively, or in addition, a scheduled follow up may be performed several months after the procedure to validate long term therapy effectiveness
  • the methods and systems described herein are not limited to a particular hardware or software configuration, and may find applicability in many computing or processing environments
  • the methods and systems can be implemented in hardware, or a combination of hardware and software, and/or can be implemented from commercially available modules applications and devices
  • the methods and systems can be implemented in one or more computer programs, where a computer program can be understood to include one or more processor executable Attorney Docket No 20240-002WO1 Client Reference RMD-INVD-I A - PCT instructions
  • the computer program(s) can execute on one or more programmable processors, and can be stored on one or more storage medium readable by the processor (including volatile and non-volatile memory and/or storage elements), one or more input devices, and/or one or more output devices
  • the processor thus can access one or more input devices to obtain mput data, and can access one or more output devices to communicate output data
  • the input and/or output devices can include one or more of the following Random Access
  • the computer program(s) can be implemented using one or more high level procedural or object-oriented programming languages to communicate with a computer system, however, the program(s) can be implemented in assembly or machine language, if desired
  • the language can be compiled or interpreted
  • the device(s) or computer systems that integrate with the processors) can include, for example, a personal computers), workstation (e g , Sun, HP), personal digital assistant (PDA), handheld device such as cellular telephone, laptop, handheld, or another device capable of being integrated with a processor(s) that can operate as provided herein Accordingly, the devices provided herein are not exhaustive and are provided for illustration and not limitation
  • references to "a microprocessor” and “a processor”, or “the microprocessor” and “the processor,” can be understood to include one or more microprocessors that can communicate in a stand-alone and/or a distributed environment(s), and can thus be configured to communicate via wired or wireless communications with other processors, where such one or more processor can be configured to operate on one or more processor-controlled devices that can be similar or different devices
  • references to memory can include one or more processor- readable and accessible memory elements and/or components that can be internal to the processor-controlled device, external to the processor-controlled device, and can be accessed via a wired or wireless network using a variety of communications protocols, Attorney Docket No 20240-002WO1 Client Reference RMD INVD-IA- PCT and unless otherwise specified, can be arranged to include a combination of external and internal memory devices, where such memory can be contiguous and/or partitioned based on the application Accordingly, references to a database can be understood to include one or more memory associations, where

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Abstract

L'invention concerne un procédé de cartographie cardiaque sans contact consistant : (i) à introduire un cathéter dans une cavité cardiaque possédant une surface endocarde, le cathéter englobant de multiples électrodes réparties spatialement; (ii) à mesurer des signaux au niveau des électrodes de cathéter en réaction à l'activité électrique dans la cavité cardiaque avec le cathéter espacé de la surface endocarde; et (iii) à déterminer des informations physiologiques en de multiples emplacements de la surface endocarde en fonction des signaux mesurés et des positions des électrodes par rapport à la surface endocarde. L'invention concerne également des systèmes et programmes informatiques associés.
EP07798369A 2006-06-13 2007-06-11 Cartographie cardiaque sans contact, englobant un cathéter mobile et une intégration multibattement Withdrawn EP2032028A4 (fr)

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EP13194523.0A EP2712546A1 (fr) 2006-06-13 2007-06-11 Cartographie cardiaque sans contact, englobant un cathéter mobile et une intégration multibattement
EP13194525.5A EP2745773A3 (fr) 2006-06-13 2007-06-11 Cartographie cardiaque sans contact, comprenant un cathéter mobile et une intégration multi-battements

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US11/451,908 US7505810B2 (en) 2006-06-13 2006-06-13 Non-contact cardiac mapping, including preprocessing
US11/451,898 US7515954B2 (en) 2006-06-13 2006-06-13 Non-contact cardiac mapping, including moving catheter and multi-beat integration
US11/451,871 US7729752B2 (en) 2006-06-13 2006-06-13 Non-contact cardiac mapping, including resolution map
PCT/US2007/070854 WO2007146864A2 (fr) 2006-06-13 2007-06-11 Cartographie cardiaque sans contact, englobant un cathéter mobile et une intégration multibattement

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EP13194523.0A Division EP2712546A1 (fr) 2006-06-13 2007-06-11 Cartographie cardiaque sans contact, englobant un cathéter mobile et une intégration multibattement

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CA2654759A1 (fr) 2007-12-21
JP2013006070A (ja) 2013-01-10
EP2032028A4 (fr) 2010-09-01
WO2007146864A2 (fr) 2007-12-21
EP2745773A3 (fr) 2014-07-02
WO2007146864A3 (fr) 2008-12-04
JP5281570B2 (ja) 2013-09-04
JP2015163195A (ja) 2015-09-10
EP2712546A1 (fr) 2014-04-02
EP2745773A2 (fr) 2014-06-25
JP2009539566A (ja) 2009-11-19

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