Medical devices, program instructions, and computer-readable media for the diagnosis and location determination of cardiac arrhythmias.

Abstract

To provide medical apparatus and methods for diagnostic and site determination of cardiac arrhythmias within a heart of a subject.SOLUTION: A computing device receives, records and processes electrocardiogram (ECG) signals in the form of bipolar and unipolar ECGs associated with respective cardiac tissue locations corresponding to catheter distal end sensors on locations. Unipolar ECGs that include signals from a plurality of successive heartbeats corresponding to locations within an area of study are analyzed to identify Fractionated Unipolar ECG Signal Complexes (FUESCs) of unipolar ECGs by defining complexes of the unipolar ECGs that correspond to respective bipolar activity windows. Identified arrhythmia sites for treatment include a predetermined number of unipolar ECGs that have a predetermined number of FUESCs. Atrial arrhythmia sites for treatment by ablation can be identified with respect to FUESCs of unipolar ECGs that include signals from at least 10 successive heartbeats of an atrial tissue study area.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] (Cross-reference of related applications) This application claims the benefits of U.S. Provisional Patent Application No. 63 / 189,957, filed on 18 May 2021, which is incorporated as if fully described by reference.

[0002] (Field of invention) This invention relates to the diagnosis and treatment of cardiac arrhythmias. More specifically, it relates to obtaining information indicating local electrical activity within the ventricles, and to the identification and treatment of arrhythmogenic regions. [Background technology]

[0003] Cardiac arrhythmias, such as atrial fibrillation, are a group of conditions in which the heart rate is too fast, too slow, or has an irregular rhythm. Arrhythmias are the cause of approximately 300,000 deaths worldwide each year. For some patients with severe arrhythmias, catheter ablation may be recommended because drug therapy has been unsuccessful, and it has been shown to reduce symptoms and improve the patient's quality of life.

[0004] An electrical map of a patient's heart can serve as a basis for determining therapeutic actions, such as tissue ablation, to modify the propagation of cardiac electrical activity and restore a normal heart rhythm. Electrical properties of cardiac tissue, such as local activation time, can be measured as a function of their precise location within the heart. Data can be acquired using one or more catheters with electrical and location sensors at their distal tips, which are advanced into the heart. Electrical activity at a particular point within the heart is typically measured by advancing a catheter with an electrical sensor at or near its distal tip to that point in the heart, bringing the tissue into contact with the sensor, and collecting data at that point. Multi-electrode catheters have been developed to simultaneously measure electrical activity at multiple points within the cardiac chambers. Data can be accumulated at 100 or more sites to generate a detailed cardiac map.

[0005] Over the past decade, several mapping studies in human atrial fibrillation have made important observations. Atrial electrograms during persistent atrial fibrillation exhibit three distinct patterns: single potential, dual potential, and complex fractionated atrial electrogram (CFAE), based on individual deviations per heartbeat separated by isoelectric intervals or low-amplitude baselines. CFAE regions represent the atrial fibrillation matrix and can be target sites for therapies such as ablation. Ablation of regions with persistent CFAEs can eliminate or further render atrial fibrillation non-inductive. [Overview of the project] [Problems that the invention aims to solve]

[0006] It would be advantageous to have an improved fractionation detection system for faster and more reliable identification of target ablation sites. Currently, voltage and substrate maps are insufficient to identify channels or isthmus sites corresponding to atrial flutter. Isthmus sites, such as the Cabotrichus spid isthmus, may be targets for ablation for the treatment of atrial flutter. It would be advantageous to have a system that can provide automated identification of fractionated signals. It would also be advantageous for the system to determine which of the fractionated signals is associated with channels or isthmus sites corresponding to atrial flutter. [Means for solving the problem]

[0007] A medical device and method are provided for the diagnosis and location determination of cardiac arrhythmias within a target heart. A computing device receives, records, and processes electrocardiogram (ECG) signals in the form of bipolar and unipolar ECGs associated with each cardiac tissue location, based on the sensing location of the distal end sensor of a catheter. Fractionated unipolar ECG signal complexes (FUESCs) are identified from among the unipolar ECGs by analyzing the recorded unipolar ECGs, which include signals from multiple consecutive heartbeats corresponding to locations within the cardiac tissue investigation area, and defining a complex of unipolar ECGs corresponding to each bipolar activity window. A cardiac arrhythmia site identified for ablation therapy includes a predetermined number of unipolar ECGs having a predetermined number of FUESCs.

[0008] Atrial arrhythmia sites for ablation therapy can be identified with respect to FUESCs of a unipolar ECG from an atrial tissue investigation area containing signals from at least 10 consecutive heartbeats.

[0009] In one example, a medical device for diagnosing and locating cardiac arrhythmias within a target heart has a catheter component comprising at least one catheter having multiple selectively locatable distal-end sensors configured to sense electrocardiogram (ECG) signals within the target heart, coupled to a computing device having a processor and associated memory. The computing device is configured to receive, record, and process electrocardiogram (ECG) signals in the form of bipolar and unipolar ECGs associated with the location of each cardiac tissue, based on the sensing location of each distal-end sensor.

[0010] The processor is configured to identify a fractionated monopolar ECG signal complex (FUESC) from among the received monopolar ECGs with respect to a cardiac tissue examination area where monopolar ECGs containing signals from multiple consecutive heartbeats corresponding to locations within the cardiac tissue examination area are recorded. The FUESC determines the bipolar activity window from a bipolar ECG including a first monopolar ECG and a second monopolar ECG, defines a set of complexes of the first monopolar ECG, each corresponding to its respective bipolar activity window, determines multiple complex level parameters for the complexes of the first monopolar ECG with respect to multiple consecutive bipolar activity windows, calculates multiple complex level ratings based on at least one of the multiple complex level parameters, and uses multiple parameters, including at least one of the multiple complex level parameters and at least one of the multiple complex level ratings, to measure the quality of annotations on the complexes of the first monopolar ECG. FUESC is identified by calculating an annotation (QoA), determining an evidence annotation measure (EVI) for the first unipolar ECG complex using at least one of several complex level parameters and at least one of several complex level ratings, and calculating a final score for the first unipolar ECG complex based on the complex's QoA and EVI, such that the first unipolar ECG complex is determined to be FUESC, provided that the final score is at least a predetermined threshold.

[0011] In this example, the processor is configured to determine cardiac arrhythmia sites for ablation therapy as cardiac tissue sites, each including a location corresponding to a predetermined number of unipolar ECGs containing a predetermined number of FUESCs.

[0012] The exemplary apparatus may also include a display coupled with a computing device, along with a processor configured to output visualizations of cardiac tissue examination areas of the target heart to the display. Such an output display is ●The relative location of the distal end sensor to the cardiac tissue examination area, along with the selected sensed ECG received by at least one of the distal end sensors, ● Visual indicators of cardiac tissue identified as a site of cardiac arrhythmia for ablation therapy, ● Based on selected criteria, this may include color coding of cardiac tissue.

[0013] The processor may be configured to determine a bipolar active window by determining a first active window and a second active window, and then fusing the first active window and the second active window under the condition that they overlap by 20 percent or more.

[0014] An exemplary device can determine the site of cardiac arrhythmia for ablation therapy when the unipolar ECG includes signals from at least 10 consecutive heartbeats and the cardiac tissue investigation area is the atrial tissue of at least a portion of the atrioventricular region of the heart under investigation. In such a case, the multiple complex level parameters within the bipolar activity window configured to be determined by the processor may be selected from the group consisting of complex discernibility (CDE), complex morphological stability (CMS), complex timing stability (CTS), bipolar activity window start (CS), bipolar activity window end (CE), and bipolar activity window duration (CD), minimum / maximum amplitude ratio (CAR), minimum / maximum slope ratio (CVR), number of slopes (CN), maximum slope amplitude (CA), and maximum slope (CV), and the processor is configured to determine the site of atrial arrhythmia for ablation therapy as an atrial tissue site, including the respective locations corresponding to at least three unipolar ECGs containing at least three consecutive FUESCs.

[0015] The processor may be configured to calculate multiple composite level ratings using parameters selected from the group consisting of the number of slopes (CN), maximum amplitude (CA), maximum slope (CV), relative amplitude range (AREST), relative slope range (VREST), absolute amplitude range (ASCALE), and absolute slope range (VSCALE), and / or to calculate QoA based on at least two parameters from the group consisting of ASCALE, VSCALE, AREST, VREST, CAR, CVR, unipolar / bipolar slope overlap (UBO), CMS, CTS, and CDE. The processor may also be configured to determine the potential type of the composite of the first unipolar potential map as any of a single potential, a dual potential, a fractionated potential, or a highly fractionated potential, and to calculate QoA for the composite of the first unipolar ECG based on the following formula:

[0016] [Number] where N is the number of parameters, P i is the i-th value of the N parameters listed above, and w p,i is the weight value of the i-th parameter corresponding to the potential type p.

[0017] The processor may also be configured to calculate the final score for the composite of the first unipolar ECG as a percentage of the sum of EVI + M, where EVI is determined as a percentage based on the amplitude scale, composite width, and classification of the amplitude ratio, the number of slopes of the first unipolar ECG, and the table entry corresponding to the potential type, and M is calculated as a percentage value based on the following formula:

[0018] [Number]

[0019] An exemplary method for diagnosing and locating cardiac arrhythmias within a target heart includes receiving, recording, and processing electrocardiogram (ECG) signals in the form of bipolar and unipolar ECGs associated with each cardiac tissue location, based on the sensing location of each distal end sensor of a catheter. A fractionated unipolar ECG signal complex (FUESC) from the received unipolar ECGs is identified with respect to a cardiac tissue investigation area where unipolar ECGs containing signals from multiple consecutive heartbeats corresponding to locations within the cardiac tissue investigation area are recorded.

[0020] FUESC is ● Determine the bipolar activity window from a bipolar ECG including a first unipolar ECG and a second unipolar ECG, and define a series of complexes of the first unipolar ECG, each corresponding to its respective bipolar activity window. ● Determining multiple complex-level parameters for the first unipolar ECG complex related to multiple consecutive bipolar activity windows, ●Calculate multiple complex level ratings based on at least one of multiple complex level parameters, ● Calculate the quality measure (QoA) of annotations for the first unipolar ECG complex using multiple parameters, including at least one of multiple complex level parameters and at least one of multiple complex level ratings. ● Determining the Evidence Annotation Measure (EVI) for a first unipolar ECG complex using at least one of multiple complex level parameters and at least one of multiple complex level ratings, ●The complex of the first unipolar ECG can be identified by calculating a final score for the complex of the first unipolar ECG based on the QoA and EVI of each complex, provided that the final score is at least a predetermined threshold, such that the complex of the first unipolar ECG is determined to be FUESC.

[0021] Cardiac tissue sites, including each location corresponding to a predetermined number of unipolar ECGs containing a predetermined number of FUESCs, are determined to be cardiac arrhythmia sites for ablation therapy.

[0022] This method may include displaying a visualization of the cardiac tissue examination area of ​​the target heart, including the relative location of the distal sensor to the cardiac tissue examination area, along with a selected sensed ECG received by at least one of the distal sensor, a visual target of cardiac tissue determined to be a cardiac arrhythmia site for ablation treatment, and / or coloring of the cardiac tissue based on selected criteria.

[0023] This method may include determining the bipolar activity window by determining a first activity window and a second activity window, and fusing the first activity window and the second activity window under conditions of overlapping by 20 percent or more.

[0024] This method may be performed with respect to a unipolar ECG including signals from at least 10 consecutive heartbeats and a cardiac tissue investigation area which is the atrial tissue of at least a portion of the atrioventricular region of the target heart. In such a case, the multiple complex level parameters within the bipolar activity window to be determined may be selected from the group consisting of complex recognition (CDE), complex morphological stability (CMS), complex timing stability (CTS), bipolar activity window start (CS), bipolar activity window end (CE), and bipolar activity window duration (CD), minimum / maximum amplitude ratio (CAR), minimum / maximum slope ratio (CVR), number of slopes (CN), maximum slope amplitude (CA), and maximum slope (CV). The atrial arrhythmia site for ablation treatment may then be determined as an atrial tissue site including the respective locations corresponding to at least three unipolar ECGs containing at least three consecutive FUESCs.

[0025] This method may be used when calculating multiple composite level ratings using parameters selected from the group consisting of number of slopes (CN), maximum amplitude (CA), maximum slope (CV), relative amplitude range (AREST), relative slope range (VREST), absolute amplitude range (ASCALE), and absolute slope range (VSCALE), and when calculating QoA based on at least two parameters from the group consisting of ASCALE, VSCALE, AREST, VREST, CAR, CVR, unipolar / bipolar slope overlap (UBO), CMS, CTS, and CDE.

[0026] This method can further determine the potential type of the composite of the first unipolar ECG as either a single potential, a dual potential, a fractionated potential, or a highly fractionated potential, and then calculate the QoA for the composite of the first unipolar ECG based on the following formula:

[0027]

number

[0028] This method can also calculate the final score for the first unipolar ECG complex as a percentage of the sum of EVI + M, where EVI is determined as a percentage based on the classification of amplitude scale, complex width, and amplitude ratio, the number of slopes and potential types of the first unipolar ECG, and M is calculated as a percentage value based on the following formula:

[0029]

number

[0030] To perform FUESC identification, a tangible, non-temporary, computer-readable medium may be provided. An example of a tangible, non-temporary, computer-readable medium is that, when read by a processor, the processor will... ● Processing electrocardiogram (ECG) signals in the form of bipolar and unipolar ECGs associated with the location of each cardiac tissue, based on the sensing location of each distal end sensor of the catheter. ● Identifying a fractionated unipolar ECG signal complex (FUESC) from a recorded unipolar ECG, relating to a unipolar ECG of a cardiac tissue examination area that includes signals from multiple consecutive heartbeats corresponding to a location within the cardiac tissue examination area, wherein the identification of the FUESC is ○ Determine the bipolar activity window from a bipolar ECG including a first unipolar ECG and a second unipolar ECG, and define a series of complexes of the first unipolar ECG, each corresponding to its respective bipolar activity window. ○ Determining multiple complex-level parameters for the first unipolar ECG complex related to multiple consecutive bipolar activity windows. ○Calculate multiple complex level ratings based on at least one of multiple complex level parameters. ○ Calculate the quality measure (QoA) of annotations for a first unipolar ECG complex using multiple parameters, including at least one of multiple complex level parameters and at least one of multiple complex level ratings. ○ Determining the Evidence Annotation Measure (EVI) for a first unipolar ECG complex using at least one of multiple complex level parameters and at least one of multiple complex level ratings, and ○Identification is performed by calculating the final score for the first unipolar ECG complex based on the QoA and EVI of each complex, such that the complex of the first unipolar ECG is determined to be FUESC, provided that the final score is at least a predetermined threshold. ● A tangible, non-temporary, computer-readable medium that stores program instructions that enable the determination of cardiac arrhythmia sites for ablation treatment, including cardiac tissue sites, each corresponding to a predetermined number of unipolar ECGs, each containing a predetermined number of FUESCs.

[0031] A tangible, non-temporary computer-readable medium is, in particular, used by a processor. ● Regarding a unipolar ECG that includes signals from at least 10 consecutive heartbeats and a cardiac tissue investigation area which is at least a portion of the atrial tissue of the atrioventricular region of the target heart, the identification of FUESC from the recorded unipolar ECG, ● Determining multiple complex level parameters within a bipolar activity window, selected from the group consisting of complex recognition (CDE), complex morphological stability (CMS), complex timing stability (CTS), bipolar activity window start (CS), bipolar activity window end (CE), and bipolar activity window duration (CD), minimum / maximum amplitude ratio (CAR), minimum / maximum slope ratio (CVR), number of slopes (CN), maximum slope amplitude (CA), and maximum slope (CV), ● Calculating multiple composite level ratings using parameters selected from the group consisting of the number of slopes (CN), maximum amplitude (CA), maximum slope (CV), relative amplitude range (AREST), relative slope range (VREST), absolute amplitude range (ASCALE), and absolute slope range (VSCALE). ●Calculate QoA based on at least two parameters from the group consisting of ASCALE, VSCALE, AREST, VREST, CAR, CVR, Unipolar / Bipolar Slope Overlap (UBO), CMS, CTS, and CDE. ● The potential type of the composite of the first monopolar potential diagram is determined to be either a single potential, a dual potential, a fractionated potential, or a highly fractionated potential. ● The atrial arrhythmia site can be determined for ablation treatment as an atrial tissue site that includes at least three locations corresponding to unipolar ECGs, each containing at least three consecutive FUESCs. [Brief explanation of the drawing]

[0032] The aforementioned and other features and advantages of the present invention will become apparent from the following more specific description of preferred embodiments of the invention, as illustrated in the accompanying drawings. [Figure 1] This is an illustrative diagram of an apparatus for performing procedures on a living heart using a cardiac catheter having multiple branches, according to an exemplary embodiment. [Figure 2] This is a detailed view of one of the catheter branches shown in Figure 1, according to an exemplary embodiment. [Figure 3] This is an example of three-dimensional cardiac mapping. [Figure 4] This is a diagram of an exemplary basket ventricular mapping catheter. [Figure 5] This is a diagram of an example spline catheter. [Figure 6A] This is a flowchart of a process for determining the bipolar activity window according to an exemplary embodiment. [Figure 6B] This is a flowchart of a pre-filtering process according to an exemplary embodiment. [Figure 6C] Let's illustrate with an example of the bipolar potential diagram during the pre-filtering process shown in Figure 6B. [Figure 6D] This is a flowchart illustrating a denotch filter according to an exemplary embodiment. [Figure 7] This figure illustrates a process for determining the activity window of a bipolar potential diagram according to an exemplary embodiment. [Figure 8] This figure illustrates a process for determining the bipolar activity window according to an exemplary embodiment. [Figure 9] This flowchart illustrates a process for overlapping two bipolar activity windows to determine a bipolar activity window, according to an exemplary embodiment. [Figure 10] As can be seen with respect to Figure 9, this is an example of a visual representation of the process for overlapping two bipolar activity windows. [Figure 11] This figure illustrates a slope cardiogram (SCG) according to an exemplary embodiment. [Figure 12A] This is a graph of the duration of a negative slope versus the amplitude of a negative slope, according to an exemplary embodiment. [Figure 12B] This is a graph of negative slope values ​​versus negative slope amplitude according to an exemplary embodiment. [Figure 13] This is an example of a unipolar potential diagram where the descending slope is specified as either primary, secondary, or far-field. [Figure 14] This is an example of a monopolar potential diagram with a determined bipolar activity window. [Figure 15] This is an example of a unipolar potential diagram illustrating the calculation of the signal-to-noise ratio (SNR). [Figure 16] This is an example of a unipolar potential diagram annotated with the determined complex level parameters. [Figure 17A] This is an example of a slope electrocardiogram in which the downstroke cross-correlation between the complex of all bipolar active window signals in the same unipolar potential diagram was analyzed. [Figure 17B] This is a cross-correlation matrix illustrating the correlations between all possible complex pairs in the exemplary unipolar potential diagram in Figure 17A. [Figure 17C] This graph illustrates the complex morphological stability (CMS) score in an exemplary embodiment. [Figure 18] This is an example of a unipolar potential diagram where the time intervals of the bipolar potential diagrams are calculated and compared with each other. [Figure 19] This is an example of a unipolar potential diagram illustrating the calculation of the Complex Degree Evaluator (CDE). [Figure 20] This is a flowchart illustrating fraction detection and analysis according to an exemplary embodiment. [Figure 21] This figure illustrates parameters and weights for measuring the quality of annotations (QoA) according to an exemplary embodiment. [Figure 22]This is a classification table of Evidence Annotation Measures (EVIs) showing the likelihood of a bipolar activity window having detected activation for each slope number and potential type. [Figure 23] This graph illustrates combined evidence annotation measurements and quality factor percentages for single potential, dual potential, fractionated potential (3 deflections), and highly fractionated potential (>3 deflections) according to exemplary embodiments. [Modes for carrying out the invention]

[0033] The following detailed description should be read in reference to the drawings, where similar elements in different drawings are numbered identically. The drawings are not necessarily to scale and depict selected embodiments, and are not intended to limit the scope of the invention. The detailed description illustrates the principles of the invention as examples, not as limitations. This description describes several embodiments, adaptations, modifications, substitutions, and uses of the invention, including those that are currently considered to be the best modes for carrying out the invention, and which will clearly enable those skilled in the art to manufacture and use the invention.

[0034] Figure 1 is a schematic illustrative diagram of an exemplary medical device 10 for performing a procedure on a living heart 12 according to an embodiment. The device 10 includes one or more catheters, such as a catheter 14 and a control console 24.

[0035] The catheter 14 may be used for any suitable therapeutic and / or diagnostic purpose, such as anatomical mapping of the cavities of the target heart 12. The catheter 14 may be a multi-electrode catheter having an elongated body with a plurality of branches 37, each having mapping and position-sensing functions. The catheter 14 may further include a handle 20, which has a control unit that allows an operator 16, typically a physician, to maneuver, position, and orient the distal end 18 and branches 37 of the catheter 14 as needed. A catheter with five branches described in U.S. Patent No. 6,961,602 is suitable for use as catheter 14. This catheter is available from Biosense Webster as the Pentaray® catheter or probe.

[0036] In some embodiments, the exemplary catheter 14 includes an elongated body having a proximal end, a distal end 18, and at least one lumen extending longitudinally through it, and a mapping assembly attached to the distal end of the catheter body, including at least two branches 37. Each branch 37 has a proximal end attached to the distal end of the catheter body and a free distal end. Each branch 37 includes a support arm having shape memory, a non-conductive cover surrounding the support arm, at least one position sensor 41 (Figure 2) attached to the distal end of the branch 37, one or more electrodes attached to the distal end of the branch 37 and electrically insulated from the support arm, and one or more electrode lead wires extending into the non-conductive cover, each electrode wire being attached to the corresponding electrode. In some embodiments, additional position sensors (not shown) may be positioned on the shaft of the catheter 14 proximal to the branch 37.

[0037] The catheter 14 may be percutaneously inserted by an operator 16 into a lumen or vascular structure of the heart 12 through the patient's vascular system. The operator 16 may bring the distal tip 18 of the catheter into contact with the heart wall at a desired mapping site. The distal end 18 of the catheter 14 may then collect measurements that are stored and processed by a computer or other computing device 22, which includes a processor and associated data storage memory. The collected measurements may be referred to as “points.” Each point includes a three-dimensional coordinate on the tissue of the lumen and respective measurements of several physiological properties measured at this coordinate. The sensing data may also take the form of a unipolar or bipolar electrocardiogram (ECG) containing signals from multiple consecutive heartbeats corresponding to a location within the cardiac tissue investigation area. The data storage of the computing device may include and / or be associated with a remote recording device (not shown).

[0038] Additionally or alternatively, ablation energy and electrical signals may be transmitted to the heart 12 via a cable to the console 24 through one or more optional ablation electrodes located at or near the distal tip 18. Pacing signals and other control signals may be transmitted from the console 24 to the heart 12 via a cable 38 and one or more ablation electrodes.

[0039] The connection 35 may connect the console 24 to the body surface electrodes 30 and other components of the positioning subsystem. A temperature sensor 43 (Figure 2), such as a thermocouple or thermistor, may be mounted on or near the distal tip 18.

[0040] The console 24 may include one or more ablation generators 25. The catheter 14 may be adapted to conduct ablation energy to the heart using any known ablation technique, including but not limited to radiofrequency energy, ultrasonic energy, and laser-generated light energy. Such methods are disclosed in U.S. Patents 6,814,733, 6,997,924, and 7,156,816 by the same applicant, which are incorporated herein by reference.

[0041] The computing device 22 may be an element of the positioning system 26 of the device 10 that measures the coordinates of the location and orientation of the catheter 14.

[0042] In some embodiments, the positioning system 26 may include a magnetic position tracking device that generates a magnetic field within a predetermined nearby working volume and determines the position and orientation of the catheter 14 by sensing these magnetic fields with the catheter using a magnetic field generating coil 28, and may also include impedance measurements, for example, as taught in U.S. Patent No. 7,756,576, incorporated herein by reference. The positioning system 26 may be enhanced by position measurements using impedance measurements as described in U.S. Patent No. 7,536,218, incorporated herein by reference.

[0043] As described above, the catheter 14 is connected to a console 24, which allows the operator 16 to observe and adjust the function of the catheter 14. The console 24 includes a computing device 22. The processor 22 may be coupled to a display 29. In some embodiments, the display 29 may have a graphical user interface (GUI) 29. A signal processing circuit may receive, amplify, filter, and digitize signals from the catheter 14, including signals generated by the above-mentioned sensors and a plurality of position-sensing electrodes (not shown) placed on the catheter 14. The digitized signals may be received and used by the console 24 and the positioning system 26 to calculate the position and orientation of the catheter 14 and to analyze the electrical signals from the electrodes.

[0044] The exemplary computing device 22 is preferably configured to output to a display a selected desired visualization of the target heart 12, along with the relative locations of the distal ends of one or more catheters deployed therein, and color representations of various features of the cardiac tissue, allowing a physician to see feature differences within different parts of the cardiac tissue. Such visualizations may include graphic representations, such as electrocardiogram (ECG) signals, as illustrated in Figure 3 (colors omitted).

[0045] In some embodiments, the computing device 22 may be a computer and may also be programmed with software to perform the functions described herein. For example, in some embodiments, the computing device 22 is a programmed digital computing device including a central processing unit (CPU), a graphics processing unit (GPU), random-access memory (RAM), a non-volatile secondary storage device such as a hard drive or CD-ROM drive, a network interface, and / or peripherals. As is known in the Art, program code and / or data, including a software program, are loaded into RAM for execution and processing by the CPU and / or GPU, and results are generated for display, output, transmission, or storage. The software code may be downloaded to a computer in electronic form via a network, or provided and / or stored on a non-temporary tangible medium such as magnetic memory, optical memory, or electronic memory.

[0046] One commercially available product embodying numerous elements such as device 10 is available as the CARTO®3 system, which is available from Biosense Webster, Inc., 3333 Diamond Canyon Road, Diamond Bar, California 91765. Existing such systems provide physicians with selective three-dimensional visualization of the patient's heart, in which the relative locations of the distal ends of one or more catheters are deployed, as well as color representation of various features of cardiac tissue. An example of such mapping performed using the CARTO®3 system is illustrated and discussed in Three-Dimensional Mapping of Cardiac Arrhythmias—What Do the Colors Really Mean?, Munoz et al., Circulation: Arrhythmia and Electrophysiology, 2010, Volume 3, Issue 6:e6-e11, originally published on December 1, 2010, at https: / / doi.org / 10.1161 / CIRCEP.110.960161, which is incorporated herein by reference as if it were fully described.

[0047] Figure 2 is a detail view of one of the branches 37 at the distal end 18 of the exemplary catheter 14 shown in Figure 1, illustrating an electrode configuration according to an embodiment. This exemplary electrode configuration may comprise a tip electrode 39, two ring electrodes 41, and a temperature sensor 43. The tip electrode 39 may be configured for both sensing and ablation. The temperature sensor 43 may be used when the catheter 14 is in ablation mode. The two ring electrodes 41 may be configured as sensing electrodes for detecting electrophysiological signals in the heart. However, as will be understood by those skilled in the art, the sensing and ablation electrodes may vary in number, configuration, and distribution in many combinations. One or more cables 45 can transmit signals between the electrodes, sensors, and console 24. Because multiple electrodes are distributed across several branches 37, it is possible to collect signals simultaneously from multiple locations.

[0048] In the current system, catheters such as the catheter 14 described above are moved within the ventricle or adjacent blood vessels, and the location of the catheter 14 is continuously recorded. The computing device 22 can receive the coordinates of each of multiple locations within the ventricle. For example, as described above with respect to Figure 1, the CPU can receive coordinates from a positioning routine, which verifies the position of the distal end of the catheter 14 as it moves within the lumen. Each coordinate may be referred to as a "point," and a collection of coordinates may be referred to as a "point cloud." A point cloud may contain hundreds, thousands, or tens of thousands of points, along with gaps where no points exist.

[0049] Software programming code embodying aspects of the present invention is typically maintained in a permanent storage device such as a computer-readable medium. In a client-server environment, such software programming code can be stored on a client or server. Software programming code can be embodied in any of the various known media for use in data processing systems. This includes, but is not limited to, magnetic and optical storage devices such as disk drives, magnetic tapes, compact discs (CDs), and digital video discs (DVDs), and computer instruction signals embodied in a transmission medium, with or without a carrier wave to which the signals are modulated. For example, the transmission medium may include a communication network such as the Internet. In addition, while the present invention can be embodied in computer software, the functions necessary to carry out the present invention can alternatively be embodied in part or in whole using hardware components such as application-specific integrated circuits or other hardware, or some combination of hardware components and software.

[0050] Figure 3 shows a first diagram of a three-dimensional cardiac mapping 300a and a second diagram of a three-dimensional cardiac mapping 300b according to an embodiment (colors omitted). The three-dimensional cardiac mappings 300a and 300b include low-voltage regions 301, which are shaded. In the color coding of the cardiac mapping, different colors can be used to indicate different voltage levels relative to the displayed cardiac image, and a gradient scale 303 can be displayed for the convenience of the operator. In an example of atrioventricular mapping, regions with voltage measurements of 0.1 mV or less are displayed in red to indicate low-voltage regions, and regions with voltage measurements of 0.5 mV or more are displayed in pink to indicate high-voltage regions, which have voltages between the low-voltage threshold and the high-voltage threshold displayed in the color on the gradient scale corresponding to that voltage.

[0051] Typically, low-voltage areas in cardiac mapping are associated with diseased or affected tissue. Currently, operators, such as physicians, lack the ability to accurately assess such low-voltage areas. In many cases, operators are unaware of what is happening in the low-voltage areas. Identifying the fractional signals within the low-voltage areas would be advantageous in determining what is occurring within the area and whether ablation should be performed in that area.

[0052] For example, systems, devices, and methods are disclosed for faster and more reliable identification of target ablation sites by automated identification of fractionated signals associated with low-voltage areas. As described in detail below, the monopolar potential diagrams of monopolar electrode pairs associated with selected cardiac tissue regions are analyzed and scored to determine whether they represent fractionated signals. The selected region of investigation may be, for example, the entire atrioventricular region or a region encompassing a low-voltage area within the atrioventricular region.

[0053] Herein, we refer to Figure 4, which shows a basket ventricular mapping catheter 40 according to one embodiment. The basket ventricular mapping catheter 40 can be used as the catheter 14 described above. The catheter 40 is similar in design to the basket catheter described in U.S. Patent No. 6,748,255 to Fuimaono et al., which has been assigned to the assignee of the present invention and is incorporated herein by reference. The catheter 40 has a plurality of ribs, each rib having a plurality of electrodes. In one embodiment, the catheter 40 has 64 unipolar electrodes, which may consist of up to 7 bipolar pairs per rib. For example, rib 42 has unipolar electrodes M1 to M8 having bipolar configurations B1 to B7. In this example, the distance between electrodes may be 4 mm.

[0054] Here, we refer to Figure 5, which shows an example of a spline catheter 46 that can be used as the catheter 14 described above. The catheter 46 has multiple distal branchings, each branch having several electrodes. The exemplary catheter 14 in Figure 4 has 20 monopolar electrodes, which can be configured as either two or three bipolar pairs per branch. For example, branch 47 has a first pair of monopolar electrodes 48, 50 and a second pair of monopolar electrodes 52, 54 (M1-M4). The difference between each pair of monopolar electrodes is calculated in blocks 56, 58. The outputs (B1, B2) of blocks 56, 58 can be correlated to each other to form a hybrid bipolar electrode configuration, an arrangement referred to herein as a “dual bipolar configuration”. In this example, the inter-electrode distance may be 4-4-4 or 2-6-6 mm.

[0055] Figure 6A is a flowchart illustrating a process for determining the bipolar activation window 600 according to an embodiment. In 602, a prefilter is applied to two unipolar potential diagrams 601a and 601b. Unipolar potential diagrams 601a and 601b are typically generated from a pair of adjacent electrodes. When performing an atrioventricular investigation, the prefilter may be configured to remove the ventricular far field (VFF) effect. Far field reduction can be achieved using the teachings of patent application 14 / 166,982 by the same applicant, entitled Hybrid Bipolar / Unipolar Detection of Activation Wavefront, which are incorporated herein by reference.

[0056] In 603, the outputs of pre-filter blocks 602a and 602b are subtracted to determine the bipolar potential diagram 604. In 605, one or more pre-filters are applied to the bipolar potential diagram 604. In 606, a denotch filter may be applied to the first bipolar feature signal 635a and the second bipolar feature signal 635b. In 607, a time interval containing a window of interest (hereinafter referred to as the "bipolar activity window") may be determined for the first bipolar feature diagram 635a and the second bipolar feature diagram 635b. Different methods may be used to determine the bipolar activity window, as will be discussed in more detail with respect to Figures 7 and 8.

[0057] Figure 6B illustrates flowcharts 630a and 630b of the pre-filter process 605 according to an embodiment. In 631a and 631b, sums can be calculated. In 632a and 632b, a median filter can be applied to the bipolar potentiometer 602a. The median filtered signal can be determined and used to correct the potentiometer signal so that baseline activity is removed from the potentiometer signal. In 633a and 633b, the outputs of 621a and 631b are converted to absolute values. In 634a, a first moving average filter can be applied to the output of 631a. The moving average filter can generate a smoothed output signal, referred to as a feature signal, by taking a fixed number of input samples at once and averaging them. As the length of the filter increases, the smoothness of the output signal increases, and sharp modulations in the data are increasingly smoothed.

[0058] In 634b, a second moving average filter may be applied to the output of 633b. In some embodiments, the first moving average filter may be 40ms and the second moving average filter may be 10ms. The output of process 630a may be the first bipolar feature 635a, and the output of process 630b may be the second bipolar feature 635b.

[0059] Figure 6C illustrates an example of a bipolar potential diagram during the pre-filtering process described in Figure 6B. Graph 651 illustrates the measured bipolar potential diagram. Graph 652 illustrates the bipolar potential diagram after baseline correction using the median (632a, 632b in Figure 6B). Graph 653 illustrates the bipolar potential diagram after conversion to absolute values ​​(633a, 633b in Figure 6B). Graph 654 illustrates the obtained first bipolar feature 635a and second bipolar feature 635b after the moving average filter has been applied (634a, 634b in Figure 6B).

[0060] Figure 6D is a flowchart of the out-notch filter 640 according to an embodiment used in 606 of Figure 6A. At 641, a positive / negative swing combination with the minimum positive swing (swingpMin) or negative swing (swingpMin) is determined. At 642, if swingpMin is less than a predetermined threshold (swingnThr) or swingnMin is less than a predetermined threshold (swingnThr), the process proceeds to 643. If swingpMin is greater than or equal to swingnThr or swingnMin is greater than or equal to swingnThr, the process moves to 644 and the process terminates. At 643, the previous swing is compared with the next swing. If the previous negative swing is less than the next negative swing, or if the previous positive swing is less than the next positive swing, the trough is removed at 645 or the peak is removed at 646, respectively.

[0061] Figure 7 illustrates an exemplary process for determining the activation window of a bipolar feature 700 according to an embodiment. Process 700 can be used on a relatively unfiltered bipolar feature signal. For example, process 700 can be used on a first bipolar feature signal 635a to which a 10 ms moving average filter has been applied. Starting at external points 701 and 702 and moving toward peak 703, this slope can be calculated to determine whether the potential diagram is relatively flat (i.e., the slope is below a certain threshold). Each point indicating when the potential diagram is no longer relatively flat can be determined (points 704 and 705). These points 704 and 705 can be designated as the start and end of the activation window, respectively. The start and end times of the activation windows 704 and 705 can define the first bipolar feature window.

[0062] Figure 8 illustrates an exemplary process for determining the activation window of a bipolar feature 800 according to an embodiment. Process 800 may be used for a relatively more filtered bipolar feature. For example, process 800 may be used on a bipolar feature 635b to which a 40 ms moving average filter has been applied. Starting at peak 803 and moving downward, the current average 801 and the next average 802 are calculated. If the current average 801 is greater than the next average 802, indicating that the potential diagram is still descending, the process continues to descend the potential diagram until the current average 801 is less than or equal to the next average 802, indicated as points 804 and 805 in Figure 800. Points 804 and 805 may be designated as the start and end of the activation window, respectively. The start and end times of the activation windows 804 and 805 may define a second bipolar feature window.

[0063] Figure 9 is a flowchart illustrating the merging of previously determined activity windows of a bipolar feature 900 to determine a bipolar activity window, according to an embodiment. The start and end times of the first bipolar feature window 901a (e.g., 704 and 705 in Figure 7) and the start and end times of the second bipolar feature window 901b (e.g., 804 and 805 in Figure 8) are used to calculate the overlap in 902. If the overlap between such windows is 20 percent or more, the first bipolar feature window 901a and the second bipolar feature window 902b are merged.

[0064] Figure 10 is an illustrative visual representation of the process for overlapping two bipolar activity windows, as discussed with respect to Figure 9. Figure 10 includes a first bipolar feature potential diagram 1000 with a specified activity window, a second bipolar feature 1010 with a specified activity window, and a combined potential diagram 1020 with a fused bipolar activity window. In the example illustrated in Figure 10, the first bipolar feature window 1001 of the first potential diagram 1000 and the second bipolar feature activity window 1011 of the second potential diagram were determined to have an overlap greater than the fusion threshold. Therefore, the first activity window 1001 and the second activity window 1011 can be combined to create a fused bipolar activity window 1021 in the combined bipolar potential diagram 1020.

[0065] After the bipolar activity window is defined, the unipolar signals within the window can be analyzed according to the method described below.

[0066] Figure 11 illustrates an exemplary slope electrocardiogram (SCG) 1100. The corresponding electrocardiogram 1101 is also illustrated. The SCG 1100 shows the downward (negative) slope amplitude and duration. In the example illustrated in Figure 11, the negative slope is defined as a rectangle. The width of rectangle 1110 represents the slope amplitude, and the length of rectangle 1111 represents the slope duration. The duration and amplitude of a negative slope can be used to determine whether a particular slope is a primary slope, a secondary slope, a far-field, or noise. Similarly, the slope value and amplitude of a negative slope can be used to determine whether a particular slope is a primary slope, a secondary slope, a far-field, or noise.

[0067] Figure 12A is a graph 1210 of the duration 1211 of a negative slope versus the amplitude 1212 of a negative slope according to an embodiment. Depending on where the points representing the duration and amplitude of the negative slope decrease on the graph, it can be determined whether the negative slope is a primary slope 1213, a secondary slope 1214, a fairfield 1215, or noise 1216. For example, in the embodiment illustrated in Figure 12A, if the amplitude of the negative slope is less than 0.15 mV, the negative slope is identified as noise regardless of its duration. If the amplitude of the negative slope is greater than 0.3 mV and its duration is greater than 35 ms, the negative slope may be identified as a far field. If the negative slope is identified as noise or a far field, it may not be counted as a slope in further analysis, which will be discussed in more detail below. If the amplitude of the negative slope is greater than 0.3 mV and its duration is less than 35 ms, it may be identified as a primary slope. If the negative slope amplitude is less than 0.3 mV and its duration is less than 35 ms, it can be identified as a secondary slope. However, the thresholds provided above are merely examples, and other thresholds may be used.

[0068] Figure 12B is a graph 1220 of negative slope values ​​1221 versus negative slope amplitudes 1222 according to an embodiment. Depending on where the points representing the negative slope values ​​and amplitudes decrease on the graph, it can be determined whether the negative slope is a primary slope 1223, a secondary slope 1224, a fairfield 1225, or noise 1226. For example, in the embodiment illustrated in Figure 12B, if the amplitude of the negative slope is less than 0.15 mV, the negative slope is identified as noise regardless of its slope value. If the amplitude of the negative slope is greater than 0.15 mV and its slope value is greater than 0.2 mV / ms, the negative slope may be identified as a far field. If the negative slope is identified as noise or a far field, it may not be counted as a slope in further analysis, which will be discussed in more detail below. A negative slope can be identified as a primary slope if its amplitude is greater than 0.3 mV and its slope value is less than 0.2 mV / ms. A negative slope can be identified as a secondary slope if its amplitude is greater than or equal to 0.3 mV but less than 0.015 mV and its slope value is less than 0.2 mV / ms. However, the thresholds provided above are merely examples, and other thresholds may be used.

[0069] Figure 13 is an exemplary unipolar potential diagram 1300 having a downward slope designated as either primary, secondary, or far-field. The type of downward slope can be determined using the method described above. Primary downward slopes 1301, secondary downward slopes 1302, and far-field downward slopes are designated by dashed lines of their respective types, as shown in the keys of the diagram.

[0070] In some embodiments, artifact slopes can be removed from the unipolar potential diagram. In some embodiments, small downward notches related to noise can be removed. Small downward notches related to noise can be defined in some embodiments as slopes with an amplitude of less than 0.02 mV. Additionally or alternatively, slow downward slopes related to far-field potentials can be removed. In some embodiments, slow downward slopes related to far-field potentials can be defined as slopes with an amplitude of less than 0.03 mV / ms and a duration greater than 25 ms. Additionally or alternatively, small upward slopes embedded in large downward slopes can be removed. Upward slopes within large downward slopes with an amplitude of less than 0.05 mV and a duration of less than 5 ms can be defined in some embodiments as small upward slopes embedded in large downward slopes. However, the thresholds provided above are merely examples, and other thresholds may be used.

[0071] Significant unipolar slopes within a bipolar activity window can be detected. In some embodiments, downward slopes with peaks or troughs within a bipolar activity window are eligible for detection. Downward slopes may need to meet certain criteria defined as significant unipolar slopes. For example, a significant slope may be defined as a bipolar activity window exceeding 100 ms with an amplitude greater than 0.05 mV, a duration of less than 50 ms, a slope greater than 0.005 mV / ms, and an overlap of more than 30%.

[0072] Figure 14 shows an exemplary monopolar potential diagram 1400 with a determined bipolar activity window. The number of complexes in monopolar potential diagram 1400 within the bipolar activity window that satisfy specific criteria for amplitude and inter-peak spacing is determined. In some bipolar activity windows, multiple activations are present within the window. In the example illustrated in Figure 14, the bipolar activity window is shaded with an amount of shading corresponding to the number of downward slopes within the window. For example, in Figure 14, the complexes within bipolar activity window 1401 contain three slopes. The number of slopes within the bipolar activity window is used in fractionation analysis, as will be described in more detail below.

[0073] Figure 15 is an exemplary monopolar potentiometer 1500 illustrating the calculation of the signal-to-noise ratio (SNR). The monopolar complex 1501 within the bipolar active window of the monopolar potentiometer 1500 is considered the signal, while the portion of the potentiometer outside the bipolar active window is designated as noise 1502. The root-mean-square (RMS) amplitude is calculated for each portion of the potentiometer designated as signal and noise. The SNR can then be calculated as a measure of signal power. The SNR can be used in fractional analysis, as described in more detail below.

[0074] Figure 16 shows an exemplary complex 1600 unipolar potentiometer annotated with determined complex level parameters. In the example illustrated in Figure 16, the unipolar potentiometer complex 1600 is annotated with the complex start (CS) 1610 (start of the bipolar activity window), the complex end (CE) 1611 (end of the bipolar activity window), and the complex duration (CD) 1612. The number of slopes (CN) 1620 and the amplitude (CA) and slope value (CV) of each slope can be determined. These parameters can be used to calculate the complex amplitude ratio (CAR) and the complex slope ratio (CSR). For example, CAR can be calculated using Equation 1 below, where min(CA) is the minimum amplitude and max(CA) is the maximum amplitude. Similarly, CSR can be calculated using Equation 2 below, where min(CV) is the minimum slope value and max(CV) is the maximum slope value of the slope within the activity window. Fractional analysis can take complex-level parameters into account, as will be discussed in more detail below.

[0075]

number

[0076] Referring to Figure 17A, an exemplary slope electrocardiogram is analyzed for the downward slope cross-correlation between all complexes C1-C11 within the same monopolar potential diagram 1700. The correlation between the i-th complex 1701 and the j-th complex 1702 is C ij It may be written as C ij The value of C is between 1 and 0. ij If the value of is 1, it indicates that the two complexes are identical, and C ijA value of 0 indicates no correlation between the two complexes. A correlation value greater than 0 with respect to another complex provides an indicator that the signal is not simply noise. The correlation may be determined using the morphology of the two complexes. In other embodiments, the correlation is determined using the timing of the slopes within the complexes. The timing of the slopes is not affected by factors such as respiration and blood flow that may affect the morphology of the complexes.

[0077] Figure 17B is a cross-correlation matrix 1710 that graphically illustrates the correlations between complexes between all possible pairs of the 11 complex pairs C1-C11 in the exemplary unipolar potential diagram 1700 of Figure 17A. In Figure 17B, the higher the correlation value between pairs, the darker the box representing the pair is shaded. For example, the boxes representing pairs with correlation values ​​of 0.85-1 are shaded the darkest. As can be seen in the correlation matrix 1710, the complexes in the exemplary unipolar potential diagram 1700 are highly correlated.

[0078] In embodiments where correlation is determined using morphology, complex morphological stability (CMS) can be calculated. CMS can be calculated using the following equation 3, where XTC is the threshold correlation value. In one example, the threshold correlation value is 0.8, and if half of the complex exhibits high correlation, the CMS score is 100, as illustrated in Figure 17C.

[0079]

number

[0080] Furthermore, a local activation time (LAT) with a significant unipolar slope can be calculated. The LAT of the electrical activity at a desired position can be defined with respect to the electrical activity that satisfies a predetermined condition. For example, the predetermined condition may include the occurrence time of the maximum rapid deflection of the potential map at that location, and the LAT is assumed to be the time from the reference case until the maximum rapid deflection of the potential map at that location next appears. If there is no distinct maximum rapid deflection, an intermediate amplitude or an intermediate time point can be used as the LAT.

[0081] The LAT may be positive or negative. Methods for determining the occurrence time of the maximum rapid deflection of the potential map, as well as other definitions and conditions for determining the LAT, are well known to those skilled in the art, and all such methods, definitions, and conditions are assumed to be included within the scope of the present invention.

[0082] FIG. 18 is an example of a unipolar potential map 1800 in which the time intervals (shown shaded) of the unipolar complex within the bipolar activation window are calculated and compared with each other according to an embodiment. For example, the time interval (I n ) 1801 between the LATs of consecutive unipolar potential map complexes within each bipolar activation window is calculated and can be compared with the next time interval (I n+1 ) 1802 following the time interval 1801. The average time interval (I n ) 1803 of the time intervals of the unipolar potential maps over a predetermined number of intervals including the time interval (I n+1 ) 1801 and the time interval (I mean ) 1802 can also be calculated to determine the complex timing stability (CTS) value.

[0083] For example, when Equation 4 is satisfied, the CTS value is 0. When Equation 5a is satisfied, the CTS value can be calculated using Equation 5b.

[0084]

Equation

[0085] Fractional analysis can take CTS values ​​into account, as will be discussed in more detail below.

[0086] Figure 19 shows an example of a unipolar potentiometer 1900 illustrating the calculation of the complex recognition estimate (CDE). The portion of the unipolar potentiometer 1900 indicated in upper parentheses within the bipolar activity window is a complex, such as complex 1901, and the portion of the potentiometer outside the bipolar activity window is designated in lower parentheses as isoelectric intervals. Isoelectric interval Iso11902 can be compared to the next isoelectric interval Iso21903. If the isoelectric points 1902 and 1903 around complex 1901 are highly equivalent to the signal of complex 1901, the CDE of complex 1901 is low and undesirable. The CDE uses the root mean square (RMS) amplitude of the potentiometer portion for each equation 6. Fractionation analysis can take CDE values ​​into account, as will be discussed in more detail below. CDE=100 * RMS(complex signal) / RMS(complex + Iso1 + Iso2 signal) Equation 6

[0087] The processor of the computing device 22 may be configured to use the received and / or location signal to calculate the measured change in the location of the catheter 14 during signal acquisition. The measurement calculation may take respiratory motion into account when measuring the change in the location of the catheter 14 sensor. Positional stability refers to the measurement of the change in the location of the distal end of the catheter 14 during signal acquisition. In some embodiments, fractional analysis may require that the variation in the catheter's location over a defined time window be less than or equal to a predefined maximum distance. This variation may be measured with respect to a standard deviation centered on the mean position over the defined time window.

[0088] The Tissue Proximity Indicator (TPI) value can indicate whether the catheter is in proximity to the tissue of interest when the signal is recorded. The TPI can be positive or negative and may indicate whether the catheter is in proximity to the tissue, not in proximity to the tissue, or whether it is unclear. Generally, for accuracy, signals taken when the catheter is in contact with or close to the tissue are preferred. Furthermore, if the distal end of the catheter 14 is in contact with the tissue, the signal may indicate tissue characteristics. Fraction analysis may or may not take the TPI value of the signal into account. For example, if the TPI indicates that it was not recorded within a certain proximity range, the analysis may not use that signal in the fraction analysis.

[0089] Furthermore, slope ensemble statistics can be calculated for each potential type from the slope characteristics per complex. For example, if a single potential exists within the bipolar activity window of a unipolar potential diagram, the amplitude and slope can be determined. If a dual potential, a fractionated potential (three deflections), or a highly fractionated potential (long and more than three deflections) exists within the bipolar activity window, the average amplitude and slope can be determined. In some complexes, there may be slopes that do not satisfy the minimum amplitude or other characteristics within the complex so that they are not counted when determining the potential type. For example, a complex with three slopes where one slope is not a predetermined minimum amplitude can be considered to have a dual potential.

[0090] The ensemble statistics of slope amplitude and value can be sorted from minimum to maximum to create scaled AREST and VREST. The ratings of the maximum amplitude AREST (CA) and slope VREST (CV) can be determined for each complex in the sorted list by calculating the index > REST(AREST, VREST) ​​for each potential type divided by the number of entries in the list.

[0091] Slope amplitude and slope value can be rated based on a dedicated potential scale. The amplitude score can be determined for each ASCALE (CA) and VSCALE (CV) complex within the dedicated scale by calculating an index by dividing by the number of entries in the list for each potential type.

[0092] Figure 20 is a flowchart of an exemplary fractionation analysis 2000. Analysis 2000 performs annotation quality (QoA) and evidence value (EVI) measurements. QoA is the level of confidence provided for each annotation. QoA may be provided for each complex type based on the complex parameters in the recording. EVI is the annotation evidence (bipolar activity window) provided for each complex. In this example, evidence annotation values ​​are provided for each complex type based on the slope parameters in the complex.

[0093] In 2010, one or more signal level parameters of the unipolar potential diagram are determined. These one or more signal level parameters may include, but are not limited to, SNR estimates. SNR estimates may be calculated according to the method described above.

[0094] In 2020, the bipolar activity window of the bipolar potential diagram is determined. The bipolar activity window can be determined using the method described above.

[0095] In 2030, one or more complex-level parameters are determined based on the bipolar activity window. As illustrated in Figure 20, one or more complex parameters may include complex recognition (CDE), complex morphological stability (CMS), complex timing stability (CTS), bipolar activity window start (CS), bipolar activity window end (CE), and bipolar activity window duration (CD), minimum / maximum amplitude ratio (CAR), minimum / maximum slope ratio (CVR), number of slopes (CN), maximum slope amplitude (CA), and maximum slope (CV). Unipolar / bipolar slope overlap (UBO) parameters may also be determined. Complex-level parameters may be determined using the methods described above.

[0096] In 2040, the number of slopes (CN), maximum amplitude (CA), and maximum slope (CV) may be used to determine one or more composite level range rating statistics. One or more composite level range rating statistics may include, but are not limited to, the relative slope amplitude range (AREST) ​​and the slope value range (VREST). The relative slope amplitude range (AREST) ​​and the slope value range (VREST) ​​may be determined using the methods described above. Additionally or alternatively, in 2050, the absolute slope amplitude range (ASCALE) and the slope value range (VSCALE) for AREST and VREST can be determined. In the embodiment illustrated in Figure 20, exemplary potential-specific scales for slope amplitude and slope value for single potentials, dual potentials, and fractionated potentials are shown with highly fractionated potentials included in the list of fractionated potentials. Exemplary dedicated scales are also provided in Table 1 below.

[0097] [Table 1]

[0098] In 2060, the complex level rating score can be determined. The complex level rating score can be determined using the method described above. For example, in some embodiments, the ratings of the maximum amplitude AREST (CA) and slope SREST (CV) can be determined for each complex in a sorted list by obtaining the index > REST(AREST, VREST) ​​for each potential type divided by the number of entries in the list.

[0099] In 2070, the QoA is then determined based on one or more composite level parameters and / or composite level ratings in 2060, as will be discussed in more detail with respect to Figure 21. In 2080, the evidence annotation measure EVI is determined using evidence table 2081, as will be discussed in more detail with respect to Figure 22.

[0100] Figure 21 is an illustration of parameters 2101 and weights 2102 for QoA measurement according to an embodiment. In some embodiments, the QoA measurement may be a weighted sum of two or more of the following parameters: (1) ASCALE 2101a, (2) VSCALE 2101b, (3) AREST 2101c, (4) VREST 2101d, (5) Complex Amplitude Ratio (CAR) 2101e, (6) Complex Slope Ratio (CVR) 2101f, (7) Unipolar / Bipolar Slope Overlap (UBO) 2101g, (8) Complex Morphological Stability (CMS) 2101h, (9) Complex Timing Stability (CTS) 2101i, and (10) Complex Recognition Estimate (CDE) 2101j. However, this parameter list is not exhaustive, and other parameters may be used in the QoA measurement.

[0101] The weights used in QoA measurements can be defined for each potential type. For example, the weights can be defined depending on whether the potential type is single 2110, dual 2120, or fractionated 2130. In this example, fractionated values ​​are also used for highly fractionated types.

[0102] In one example, QoA measurement is calculated as a percentage using the following equation 7, with the above 10 parameters (N=10). However, more or fewer parameters can be used in QoA measurement.

[0103]

number

[0104] Figure 22 shows an exemplary evidence table 2200 as a percentage value of evidence annotation measurement EVI according to an embodiment. The evidence table may include multiple classifications 2110 based on one or more ECG complex parameters. In the example illustrated in Figure 22, the classification 2110 is based on the signal's ECG complex amplitude scale, complex width, and amplitude ratio. For example, a complex with an amplitude scale of 20 or less, a complex width greater than 60, and an amplitude ratio greater than 10 may be classified as group 19 (2110a). The evidence score may then be coded in the table based on the classification, the number of slopes (one 2120a, two 2120b, three 2120c, or three or more 2120d), and the potential type (i.e., single 2130a, dual 2130b, fraction 2130c, or advanced fraction (fraction +) 2130d). For example, if a complex classified as group 19 has more than three gradients and is identified as a highly fractionated potential, the complex has an evidence score of 90 (2140) (if identified as a fractionated potential, the complex has an evidence score of 80).

[0105] The final score of the composite can be determined using QoA and EVI measurements. In one example, the modulation coefficient M is first calculated based on QoA and EVI. In this example, the modulation coefficient (M) is determined using Equation 8.

[0106]

number

[0107] Next, as demonstrated in Equation 9, the final score S is calculated as the sum of the evidence score EVI and the modulation coefficient M. S=EVI+M Equation 9

[0108] Figure 23 is a graph 2300 illustrating combined evidence annotation measurements (EVI) and modulation coefficients M for single potentials 2310, dual potentials 2320, fractionated potentials (three deflections) 2330, and highly fractionated potentials (long and more than three deflections) 2340 according to the embodiment. As shown in Figure 23, the final score can be expressed as a percentage, with 100 percent being the highest possible score. The final score can be used to determine whether the complex is a fractionated complex.

[0109] A monopolar electromorphism with a predetermined number of consecutive complexes having a final score of 90% or higher can be identified as a fractionated signal. For example, a monopolar electromorphism complex with an EVI value of 90% and a QoA value of at least 50% from the table in Figure 22, and a monopolar electromorphism complex with an EVI value of 80% and a QoA value of at least 75% from the table in Figure 22, satisfy this final score of 90% or higher.

[0110] The detection of fractionated potentials, in combination with LAT, is relevant to creating a view of wave propagation during arrhythmias such as atrial flutter. Fractionated potentials can result from the slow propagation of activation waves (structural fractionation), which can travel across areas of diseased tissue that exhibit irregular (e.g., zigzag) types of activation delays compared to simple, rapid propagation in healthy tissue.

[0111] In addition, double and fractionated potentials can arise as a result of multiple dissociation waves separated by the functional lines of the block, which also give rise to the complex activation pattern and associated fractionated potentials (functional fractions). Since the latter generally do not last very long, sustained fractions (e.g., at least several beats) draw attention to the structural properties of the fractions.

[0112] Therefore, by detecting sustained fractionated potentials in combination with local activation time (LAT) derived from single and dual potentials, it becomes possible to create activation maps that include the boundaries of potential ablation sites specified by the fractionated potentials.

[0113] Cardiac tissue regions that correlate highly with the fractionated signals can be determined by the device 10 as atrial proarrhythmic sites for treatment via catheter ablation. For example, a monopolar electrograph representing an area of ​​investigation, such as the entire left atrium, is obtained from the catheter 47 and can be scored by the computing device 22 based on the above. The monopolar electrograph scored as a fractionated signal is evaluated to determine whether there are atrial tissue regions represented by at least several (e.g., ≥3) replicated fractionated monopolar electrographs. A combination of atrial tissue regions having a predetermined number of monopolar electrographs that satisfy such criteria, for example, at least three, is determined by the processor of the computing device 22 to be atrial proarrhythmic sites for electroablation treatment. The investigation region using the determined atrial proarrhythmic sites can then be displayed on the display 29 to assist the operator 16 in performing the ablation treatment.

[0114] To reduce computational complexity, more focused investigations may be conducted. For example, instead of evaluating a unipolar electrophysiogram representing the entire ventricle, a unipolar electrophysiogram representing the cardiac region surrounding or within a low-voltage area can be obtained and scored to determine the presence of cardiac tissue regions within the cardiac investigation area that meet the above criteria for being a proarrhythmic site for electroablation therapy.

[0115] The methods described herein may also include algorithms that can be used by skilled software engineers to generate the step-by-step computer code necessary for the implementation of the overall method in a computer system (e.g., a general-purpose computer or a dedicated computer such as a Carto system). The corresponding potentiometers, calculations, and results may be displayed on a display such as a graphical user interface.

[0116] It should be understood that many modifications are possible based on the disclosures herein. While features and elements are described above in specific combinations, each feature or element can be used alone without other features and elements, or in various combinations with or without other features and elements.

[0117] [Implementation Method] (1) A medical device for diagnosing and determining the location of cardiac arrhythmias within the target heart, A catheter component comprising at least one catheter having multiple selectively locatable distal-end sensors coupled to a computing device, The sensor is configured to detect (ECG) signals within the target heart, The computing device has a processor and associated memory, The computing device is configured to receive, record, and process electrocardiogram (ECG) signals in the form of bipolar and unipolar ECGs associated with the location of each cardiac tissue, based on the sensing location of each distal end sensor. With respect to the cardiac tissue examination area where a unipolar ECG is recorded, including signals from multiple consecutive heartbeats corresponding to locations within the cardiac tissue examination area, the processor selects a fractionated unipolar ECG signal complex (FUESC) from the unipolar ECG. The bipolar activity window is determined from a bipolar ECG including a first unipolar ECG and a second unipolar ECG, and a set of complexes of the first unipolar ECG corresponding to each bipolar activity window is defined. Determining multiple complex-level parameters relating to the complex of the first unipolar ECG with respect to multiple consecutive bipolar activity windows, Calculating multiple complex level ratings based on at least one of the aforementioned multiple complex level parameters, Calculating the quality measure (QoA) of the annotation for the complex of the first unipolar ECG using a plurality of parameters, including at least one of the plurality of complex level parameters and at least one of the plurality of complex level ratings, Determining the Evidence Annotation Measure (EVI) with respect to the complex of the first unipolar ECG using at least one of the plurality of complex level parameters and at least one of the plurality of complex level ratings, The system is configured to identify a complex of the first unipolar ECG by calculating a final score for that complex of the first unipolar ECG based on the QoA and EVI of each complex, provided that the final score is at least a predetermined threshold, such that the complex of the first unipolar ECG is determined to be FUESC. A medical device wherein the processor is configured to determine cardiac arrhythmia sites for ablation therapy as cardiac tissue sites, each including a location corresponding to a predetermined number of unipolar ECGs, each including a predetermined number of FUESCs. (2) Further comprising a display coupled with the computing device, The processor outputs to the display, The selected sensed ECG received by at least one of the distal end sensors, along with the relative location of the distal end sensor to the cardiac tissue examination area, Visual indicators of cardiac tissue identified as a site of cardiac arrhythmia for ablation therapy, The apparatus according to Embodiment 1, configured to output a visualization of the cardiac tissue examination area of ​​the target heart, which includes one or more of the following: coloring of the cardiac tissue based on selected criteria. (3) The apparatus according to Embodiment 1, wherein the processor is configured to determine the bipolar active window by determining a first active window and a second active window, and by fusing the first active window and the second active window under the condition that they overlap by 20 percent or more. (4) The unipolar ECG includes signals from at least 10 consecutive heartbeats, The cardiac tissue investigation area is at least a portion of the atrial tissue of the atrium of the target heart, The processor is configured to determine the plurality of complex level parameters within the bipolar activity window, which are selected from the group consisting of complex recognition (CDE), complex morphological stability (CMS), complex timing stability (CTS), bipolar activity window start (CS), bipolar activity window end (CE), and bipolar activity window duration (CD), minimum / maximum amplitude ratio (CAR), minimum / maximum slope ratio (CVR), number of slopes (CN), maximum slope amplitude (CA), and maximum slope (CV). The apparatus according to Embodiment 1, wherein the processor is configured to determine atrial arrhythmia sites for ablation therapy as atrial tissue sites, each including a location corresponding to at least three unipolar ECGs, each including at least three consecutive FUESCs. (5) The apparatus according to Embodiment 4, wherein the processor is configured to calculate the plurality of composite level ratings using parameters selected from the group consisting of the number of slopes (CN), maximum amplitude (CA), maximum slope (CV), relative amplitude range (AREST), relative slope range (VREST), absolute amplitude range (ASCALE), and absolute slope range (VSCALE).

[0118] (6) The apparatus according to Embodiment 5, wherein the processor is configured to calculate the QoA based on at least two parameters from the group consisting of ASCALE, VSCALE, AREST, VREST, CAR, CVR, unipolar / bipolar slope overlap (UBO), CMS, CTS, and CDE. (7) The apparatus according to Embodiment 6, wherein the processor is configured to determine the potential type of the composite of the first unipolar potential diagram as either a single potential, a dual potential, a fractionated potential, or a highly fractionated potential. (8) The processor is configured to calculate the QoA for the composite of the first unipolar ECG based on the following formula:

[0119]

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[0120]

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[0121] (11) The location of the distal end sensor relative to the cardiac tissue examination area, along with the selected sensed ECG received by at least one of the distal end sensors, Visual indicators of cardiac tissue identified as a site of cardiac arrhythmia for ablation therapy, The method according to Embodiment 10, further comprising displaying a visualization of the cardiac tissue examination area of ​​the target heart, which includes coloring of the cardiac tissue based on selected criteria, and one or more of the following: (12) The method according to Embodiment 10, wherein determining the bipolar activity window includes determining a first activity window and a second activity window, and fusing the first activity window and the second activity window under the condition that they overlap by 20 percent or more. (13) With respect to a unipolar ECG, which includes signals from at least 10 consecutive heartbeats and a cardiac tissue investigation area which is at least a portion of the atrium of the atrium ventricle of the heart in question, The multiple complex level parameters within the bipolar activity window to be determined are selected from the group consisting of complex recognition (CDE), complex morphological stability (CMS), complex timing stability (CTS), bipolar activity window start (CS), bipolar activity window end (CE), and bipolar activity window duration (CD), minimum / maximum amplitude ratio (CAR), minimum / maximum slope ratio (CVR), number of slopes (CN), maximum slope amplitude (CA), and maximum slope (CV). The method according to Embodiment 10, wherein the atrial arrhythmia site for ablation therapy is determined to be an atrial tissue site including at least three locations corresponding to unipolar ECGs, each containing at least three consecutive FUESCs. (14) The method according to Embodiment 13, wherein the plurality of composite level ratings are calculated using parameters selected from the group consisting of the number of slopes (CN), maximum amplitude (CA), maximum slope (CV), relative amplitude range (AREST), relative slope range (VREST), absolute amplitude range (ASCALE), and absolute slope range (VSCALE). (15) The method according to Embodiment 14, wherein the QoA is calculated based on at least two parameters from the group consisting of ASCALE, VSCALE, AREST, VREST, CAR, CVR, unipolar / bipolar slope overlap (UBO), CMS, CTS, and CDE.

[0122] (16) The method according to Embodiment 15, wherein the potential type of the composite in the first monopolar potential diagram is determined to be a single potential, a double potential, a fractionated potential, or a highly fractionated potential. (17) The QoA for the composite of the first unipolar ECG is calculated based on the following formula:

[0123]

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[0124]

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Claims

1. A medical device for diagnosing and determining the location of cardiac arrhythmias within the target heart, A catheter component comprising at least one catheter having multiple selectively locatable distal-end sensors coupled to a computing device, The sensor is configured to detect (ECG) signals within the target heart, The computing device has a processor and associated memory, The computing device is configured to receive, record, and process electrocardiogram (ECG) signals in the form of bipolar and unipolar ECGs associated with the location of each cardiac tissue, based on the sensing location of each distal end sensor. With respect to the cardiac tissue examination area where a unipolar ECG is recorded, including signals from multiple consecutive heartbeats corresponding to locations within the cardiac tissue examination area, the processor selects a fractionated unipolar ECG signal complex (FUESC) from the unipolar ECG. The bipolar activity window is determined from a bipolar ECG including a first unipolar ECG and a second unipolar ECG, and a series of complexes of the first unipolar ECG corresponding to each bipolar activity window is defined. Determining multiple complex-level parameters relating to the complex of the first unipolar ECG with respect to multiple consecutive bipolar activity windows, Calculating multiple complex level ratings based on at least one of the aforementioned multiple complex level parameters, Calculating the quality measure (QoA) of annotations relating to the complex of the first unipolar ECG using a plurality of parameters, including at least one of the plurality of complex level parameters and at least one of the plurality of complex level ratings, Determining the evidence annotation measurement (EVI) with respect to the complex of the first unipolar ECG using at least one of the plurality of complex level parameters and at least one of the plurality of complex level ratings, The system is configured to identify a complex of the first unipolar ECG by calculating a final score for that complex based on the QoA and EVI of each complex, provided that the final score is at least a predetermined threshold, such that the complex of the first unipolar ECG is determined to be a FUESC. A medical device wherein the processor is configured to determine cardiac arrhythmia sites for ablation therapy as cardiac tissue sites, each including a location corresponding to a predetermined number of unipolar ECGs, each including a predetermined number of FUESCs.

2. The computer device further comprises a display coupled to the aforementioned computing device. The processor outputs to the display, The selected sensed ECG received by at least one of the distal end sensors, along with the relative location of the distal end sensor to the cardiac tissue examination area, Visual indicators of cardiac tissue identified as a site of cardiac arrhythmia for ablation therapy, The apparatus according to claim 1, configured to output a visualization of the cardiac tissue examination area of ​​the target heart, which includes one or more of the following: coloring of the cardiac tissue based on selected criteria.

3. The apparatus according to claim 1, wherein the processor is configured to determine the bipolar active window by determining a first active window and a second active window, and by fusing the first active window and the second active window under the condition that they overlap by 20 percent or more.

4. The unipolar ECG includes signals from at least 10 consecutive heartbeats, The cardiac tissue investigation area is at least a portion of the atrial tissue of the atrium of the target heart, The processor is configured to determine the plurality of complex level parameters within the bipolar activity window, which are selected from the group consisting of complex recognition (CDE), complex morphological stability (CMS), complex timing stability (CTS), bipolar activity window start (CS), bipolar activity window end (CE), and bipolar activity window duration (CD), minimum / maximum amplitude ratio (CAR), minimum / maximum slope ratio (CVR), number of slopes (CN), maximum slope amplitude (CA), and maximum slope (CV). The apparatus according to claim 1, wherein the processor is configured to determine atrial arrhythmia sites for ablation therapy as atrial tissue sites, each including a location corresponding to at least three unipolar ECGs, each including at least three consecutive FUESCs.

5. The apparatus according to claim 4, wherein the processor is configured to calculate the plurality of composite level ratings using parameters selected from the group consisting of the number of slopes (CN), maximum amplitude (CA), maximum slope (CV), relative amplitude range (AREST), relative slope range (VREST), absolute amplitude range (ASCALE), and absolute slope range (VSCALE).

6. The apparatus according to claim 5, wherein the processor is configured to calculate the QoA based on at least two parameters from the group consisting of ASCALE, VSCALE, AREST, VREST, CAR, CVR, unipolar / bipolar slope overlap (UBO), CMS, CTS, and CDE.

7. The apparatus according to claim 6, wherein the processor is configured to determine the potential type of the composite of the first unipolar ECG as one of a single potential, a dual potential, a fractionated potential, or a highly fractionated potential.

8. The processor is configured to calculate the QoA for the composite of the first unipolar ECG based on the following formula: [Math 1] In the formula, N is the number of parameters, and P ｉ w is the i-th value of the N parameters listed above, ｐ，ｉ The apparatus according to claim 7, wherein is the weight value of the i-th parameter corresponding to the potential type p.

9. The apparatus according to claim 7, wherein the processor is configured to calculate the final score for the composite of the first unipolar ECG as a percentage of the sum of EVI + M, where EVI is determined as a percentage based on the classification of amplitude scale, composite width, and amplitude ratio, the number of slopes of the first unipolar ECG, and a table entry corresponding to the potential type, and M is calculated as a percentage value based on the following formula. [Math 2]

10. A program instruction for diagnosing and determining the location of cardiac arrhythmias within the target heart, When the aforementioned program instruction is read by the processor, the processor: Based on the sensing locations of each distal end sensor of the catheter, the system receives, records, and processes electrocardiogram (ECG) signals in the form of bipolar and unipolar ECGs associated with the respective locations of cardiac tissue. With respect to the cardiac tissue examination area in which a unipolar ECG is recorded, including signals from multiple consecutive heartbeats corresponding to locations within the cardiac tissue examination area, a fractionated unipolar ECG signal complex (FUESC) is selected from the unipolar ECG. Determining the bipolar activity window from a bipolar ECG including a first unipolar ECG and a second unipolar ECG, and defining a series of complexes of the first unipolar ECG corresponding to each bipolar activity window, Determining multiple complex-level parameters relating to the complex of the first unipolar ECG with respect to multiple consecutive bipolar activity windows, Calculating multiple complex level ratings based on at least one of the aforementioned multiple complex level parameters, Calculating a quality measure (QoA) of annotations relating to the complex of the first unipolar ECG using a plurality of parameters, including at least one of the plurality of complex level parameters and at least one of the plurality of complex level ratings. Determining the evidence annotation measurement (EVI) with respect to the complex of the first unipolar ECG using at least one of the plurality of complex level parameters and at least one of the plurality of complex level ratings, and Identification is performed by calculating the final score for the first unipolar ECG complex based on the QoA and EVI of each complex, such that the complex of the first unipolar ECG is determined to be a FUESC, provided that the final score is at least a predetermined threshold. A program instruction to determine cardiac arrhythmia sites for ablation therapy, including cardiac tissue sites that correspond to a predetermined number of unipolar ECGs, each containing a predetermined number of FUESCs.

11. The selected sensed ECG received by at least one of the distal end sensors, along with the relative location of the distal end sensor to the cardiac tissue examination area, Visual indicators of cardiac tissue identified as a site of cardiac arrhythmia for ablation therapy, The program instruction according to claim 10, which causes the processor to further display a visualization of the cardiac tissue examination area of ​​the target heart, including one or more of the following: coloring of the cardiac tissue based on selected criteria.

12. The program instruction according to claim 10, wherein determining the bipolar activity window includes determining a first activity window and a second activity window, and merging the first activity window and the second activity window under the condition that they overlap by 20 percent or more.

13. The procedure is performed with respect to a unipolar ECG, which includes signals from at least 10 consecutive heartbeats and a cardiac tissue investigation area that is at least a portion of the atrial tissue of the atria and ventricles of the target heart. The plurality of complex level parameters within the bipolar activity window to be determined are selected from the group consisting of complex recognition (CDE), complex morphological stability (CMS), complex timing stability (CTS), bipolar activity window start (CS), bipolar activity window end (CE), and bipolar activity window duration (CD), minimum / maximum amplitude ratio (CAR), minimum / maximum slope ratio (CVR), number of slopes (CN), maximum slope amplitude (CA), and maximum slope (CV). The program instruction according to claim 10, wherein the atrial arrhythmia site for ablation therapy is determined to be an atrial tissue site including at least three locations corresponding to unipolar ECGs, each including at least three consecutive FUESCs.

14. The program instruction according to claim 13, wherein the plurality of composite level ratings are calculated using parameters selected from the group consisting of the number of slopes (CN), maximum amplitude (CA), maximum slope (CV), relative amplitude range (AREST), relative slope range (VREST), absolute amplitude range (ASCALE), and absolute slope range (VSCALE).

15. The program instruction according to claim 14, wherein the QoA is calculated based on at least two parameters from the group consisting of ASCALE, VSCALE, AREST, VREST, CAR, CVR, unipolar / bipolar slope overlap (UBO), CMS, CTS, and CDE.

16. The program instruction according to claim 15, wherein the potential type of the composite of the first unipolar ECG is determined to be a single potential, a dual potential, a fractionated potential, or a highly fractionated potential.

17. The QoA for the composite of the first unipolar ECG is calculated based on the following formula: [Math 3] In the formula, N is the number of parameters, and P ｉ w is the i-th value of the N parameters listed above, ｐ，ｉ The program instruction according to claim 16, wherein is the weight value of the i-th parameter corresponding to the potential type p.

18. The program instruction according to claim 17, wherein the processor is configured to calculate the final score for the composite of the first unipolar ECG as a percentage of the sum of EVI + M, where EVI is determined as a percentage based on the classification of amplitude scale, composite width, and amplitude ratio, the number of slopes of the first unipolar ECG, and a table entry corresponding to the potential type, and M is calculated as a percentage value based on the following formula. [Math 4]

19. A tangible, non-temporary computer-readable medium, which, when read by a processor, provides to the processor: Based on the sensing location of each distal end sensor of the catheter, the ECG signals in the form of bipolar and unipolar electrocardiograms (ECGs) associated with the location of each cardiac tissue, With respect to a unipolar ECG of a cardiac tissue investigation area, which includes signals from multiple consecutive heartbeats corresponding to locations within the cardiac tissue investigation area, a fractionated unipolar ECG signal complex (FUESC) is selected from the unipolar ECG. Determining the bipolar activity window from a bipolar ECG including a first unipolar ECG and a second unipolar ECG, and defining a series of complexes of the first unipolar ECG corresponding to each bipolar activity window, Determining multiple complex-level parameters relating to the complex of the first unipolar ECG with respect to multiple consecutive bipolar activity windows, Calculating multiple complex level ratings based on at least one of the aforementioned multiple complex level parameters, Calculating a quality measure (QoA) of annotations relating to the complex of the first unipolar ECG using a plurality of parameters, including at least one of the plurality of complex level parameters and at least one of the plurality of complex level ratings. Determining the evidence annotation measurement (EVI) with respect to the complex of the first unipolar ECG using at least one of the plurality of complex level parameters and at least one of the plurality of complex level ratings, and Identification is performed by calculating the final score for the first unipolar ECG complex based on the QoA and EVI of each complex, such that the complex of the first unipolar ECG is determined to be a FUESC, provided that the final score is at least a predetermined threshold. A tangible, non-temporary, computer-readable medium containing program instructions for determining cardiac arrhythmia sites for ablation therapy, as cardiac tissue sites including locations corresponding to a predetermined number of unipolar ECGs, each containing a predetermined number of FUESCs.

20. When the aforementioned program instruction is read by the processor, the processor: Identifying a FUESC from a recorded unipolar ECG, which includes signals from at least 10 consecutive heartbeats and a cardiac tissue investigation area that is at least a portion of the atrial tissue of the atria and ventricles of the target heart; Determining the multiple complex level parameters within the bipolar activity window, selected from the group consisting of complex recognition (CDE), complex morphological stability (CMS), complex timing stability (CTS), bipolar activity window start (CS), bipolar activity window end (CE), and bipolar activity window duration (CD), minimum / maximum amplitude ratio (CAR), minimum / maximum slope ratio (CVR), number of slopes (CN), maximum slope amplitude (CA), and maximum slope (CV), The calculation of the multiple composite level ratings is performed using parameters selected from the group consisting of the number of slopes (CN), maximum amplitude (CA), maximum slope (CV), relative amplitude range (AREST), relative slope range (VREST), absolute amplitude range (ASCALE), and absolute slope range (VSCALE). The QoA is calculated based on at least two parameters from the group consisting of ASCALE, VSCALE, AREST, VREST, CAR, CVR, Unipolar / Bipolar Slope Overlap (UBO), CMS, CTS, and CDE. The potential type of the composite of the first unipolar ECG is determined to be one of the following: single potential, dual potential, fractionated potential, or highly fractionated potential. A tangible, non-temporary, computer-readable medium according to claim 19, which determines an atrial arrhythmia site for ablation therapy as an atrial tissue site including at least three locations corresponding to at least three unipolar ECGs, each including at least three consecutive FUESCs.

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