Creating electroanatomical maps of cardiac tissue using far-field signals received at multiple distances from electrodes.

Abstract

To provide a system and method for generating, visualizing, and displaying cardiac signal information present at different depths in cardiac tissue. [Solution] Multiple signal mappings of cardiac tissue are created based on signals derived from different electrode sets of a multi-electrode catheter in the patient's heart. A first set of electrodes is selected, each located within a first distance of the selected electrodes, and a first spatial electrode signal analysis is performed on the electrical activity of the selected electrodes based on the signals from the first set of electrodes. A second set of electrodes is selected, each located within a second distance of the selected electrodes, and a second spatial electrode signal analysis is performed on the electrical activity of the selected electrodes based on the signals from the second set of electrodes. This process is repeated for multiple further locations within the heart and is used to generate at least a first and a second electroanatomical map of the heart.

Description

Technical Field

[0001] (Cross - reference to related applications) This disclosure is directed to several improved techniques for analyzing cardiac signals. It claims priority to U.S. Provisional Patent Application No. 63 / 697,933, titled "Methods For Analyzing Cardiac Signals And Generating Electro - Anatomical Maps Of The Heart", filed on September 23, 2024, which is hereby incorporated by reference in its entirety. The disclosed techniques also relate to concepts discussed in the pending U.S. Patent Application No. 18 / 072,793 (pending), filed on December 1, 2022, titled "Intracardiac Unipolar Far Field Cancelation Using Multiple Electrode Catheters", the U.S. Patent Application No. 18 / 756,903 (pending), filed on June 27, 2024, titled "Intracardiac Unipolar Far Field Cancelation Using Multiple Electrode Catheters And Methods For Creating An Ecg Depth And Radial Lens", the U.S. Patent Application No. 19 / 238,791, filed on June 16, 2025, titled "System and Method for Far - field Voltage Mapping for Scar Severity Estimation", and the U.S. Patent Application No. 18 / 505,956 (pending), filed on November 9, 2023, titled "Catheter With Flexible Polymer As Outer Support Structure". All of these existing applications are hereby incorporated by reference in their entirety and provide background related to the techniques disclosed herein. The improvements disclosed herein can be used in conjunction with the techniques disclosed in the above applications.

[0002] (Field of the Invention) This disclosure relates to generating, visualizing, and displaying information representing cardiac signals. More specifically, a system and method for generating, visualizing, and displaying cardiac signal information present at different depths in cardiac tissue are disclosed. [Background technology]

[0003] Cardiac arrhythmias, such as atrial fibrillation, occur when areas of cardiac tissue conduct electrical signals abnormally. Treatments for arrhythmias include surgically disrupting such signal conduction pathways. By selectively ablating cardiac tissue with the application of energy (e.g., pulsed field or radiofrequency (RF) energy), it may be possible to stop or correct the propagation of unwanted electrical signals from one part of the heart to another. The ablation process can provide a barrier to the unwanted electrical pathways by forming electrically insulating lesions or scar tissue that effectively block the communication of abnormal electrical signals across the tissue.

[0004] In some procedures, ablation can be provided within the cardiovascular system using a catheter with one or more electrodes. The catheter can be inserted into a major vein or artery (e.g., the femoral artery) and then advanced to position the electrodes within the heart or an adjacent cardiovascular structure (e.g., the pulmonary veins). The electrodes can be positioned in contact with cardiac tissue or other vascular tissue and then activated with RF, a pulsed field, or other energy to ablate the contacted tissue. In some cases, the electrodes may be bipolar. In some other cases, a unipolar electrode can be used in conjunction with a grounding pad or with another reference electrode in contact with the patient.

[0005] Examples of ablation catheters include U.S. Patent Publication No. 2013 / 0030426, titled "Integrated Ablation System using Catheter with Multiple Irrigation Lumens," published January 31, 2013 (the disclosure is incorporated herein by reference in its entirety); U.S. Patent Publication No. 2017 / 0312022, titled "Irrigated Balloon Catheter with Flexible Circuit Electrode Assembly," published November 2, 2017 (the disclosure is incorporated herein by reference in its entirety); U.S. Patent Publication No. 2018 / 0071017, titled "Ablation Catheter with a Flexible Printed Circuit Board," published March 15, 2018 (the disclosure is incorporated herein by reference in its entirety); and U.S. Patent Publication No. 2018 / 0056038, titled "Catheter with Bipole Electrode Spacer and Related The information is contained in U.S. Patent No. 10,130,422, entitled "Catheter with Soft Distal Tip for Mapping and Ablating Tubular Region," published on March 1, 2018 (the entire disclosure is incorporated herein by reference), U.S. Patent No. 8,956,353, entitled "Electrode Irrigation Using Micro-Jets," published on February 17, 2015 (the entire disclosure is incorporated herein by reference), and U.S. Patent No. 9,801,585, entitled "Electrocardiogram Noise Reduction," published on October 31, 2017 (the entire disclosure is incorporated herein by reference).

[0006] Some catheter ablation procedures may be performed after identifying the tissue area to be targeted for ablation using electrophysiological (EP) mapping. Such EP mapping may include the use of a sensing microelectrode on a catheter (e.g., the same catheter used to perform the ablation, or a dedicated mapping catheter). Such a sensing microelectrode can monitor electrical signals emanating from conductive endocardial tissue to pinpoint the location of abnormal conductive tissue sites causing arrhythmias. An example of an EP mapping system is described in U.S. Patent No. 5,738,096, title "Cardiac Electromechanics," issued April 14, 1998, the disclosure of which is incorporated herein by reference in its entirety. Examples of EP mapping catheters are described in U.S. Patent No. 9,907,480, titled "Catheter Spine Assembly with Closely-Spaced Bipole Microelectrodes," issued March 6, 2018 (the disclosure is incorporated herein by reference in its entirety); U.S. Patent No. 10,130,422, titled "Catheter with Soft Distal Tip for Mapping and Ablating Tubular Region," issued November 20, 2018 (the disclosure is incorporated herein by reference in its entirety); and U.S. Patent Application Publication No. 2018 / 0056038, titled "Catheter with Bipole Electrode Spacer and Related Methods," published March 1, 2018 (the entire disclosure is incorporated herein by reference).

[0007] In addition to using EP mapping, some catheter ablation procedures may be performed using image-guided surgery (IGS) systems. IGS systems can enable physicians to visually track the position of the catheter within the patient in real time in relation to images of anatomical structures within the patient. Some systems, including the CARTO 3® system by Biosense Webster, Inc. of Irvine, California, can offer a combination of EP mapping and IGS capabilities. Examples of catheters configured for use with IGS systems are disclosed in U.S. Patent No. 9,480,416, title “Signal Transmission Using Catheter Braid Wires,” issued November 1, 2016 (the disclosure of which is incorporated herein by reference in its entirety), and in various other references cited herein.

[0008] Although various catheter systems and methods are described, none are considered to offer the features described herein.

[0009] . [Overview of the Initiative] [Means for solving the problem]

[0010] This disclosure relates to creating multiple signal mappings of cardiac tissue based on signals derived from different electrode sets. In one example, electrical activity is received from multiple electrodes of a multi-electrode catheter in a patient's heart. For a first location in the heart, (i) a first electrode is selected from the multiple electrodes; (ii) a first set of electrodes is selected, each of which is within a first distance from the first electrode, and the first set of electrodes does not include the first electrode; (iii) a first spatial electrode signal analysis of the electrical activity of the first electrode is performed based on the signals from the first set of electrodes; (iv) a second set of electrodes is selected, each of which is within a second distance from the first electrode, and the second distance is greater than the first distance, and the second set of electrodes does not include the first electrode; and (v) a second spatial electrode signal analysis of the electrical activity of the first electrode is performed according to the signals from the second set of electrodes. This process is repeated for multiple further locations in the heart and used to generate at least a first and a second electroanatomical map of the heart. The maps show the electrical activity of cardiac tissue corresponding to a first location and several further locations, the first electroanatomical map shows the electrical activity identified based on the first spatial electrode analysis, and the second electroanatomical map shows the electrical activity identified based on the second spatial electrode signal analysis. Alternatively, the first electroanatomical map shows scar tissue identified based on the first spatial electrode analysis, and the second electroanatomical map shows scar tissue identified based on the second spatial electrode signal analysis.

[0011] In some examples, the first location and several further locations are at a common depth in the cardiac tissue within the heart, and the first and second electroanatomical maps each show a different analysis of electrical signals within that common depth. In some examples, the first and second spatial electrode signal analyses are performed using appropriate artificial intelligence models, such as a previously trained neural network.

[0012] In some examples, the first spatial electrode signal analysis is based at least partially on a first distance, and the second spatial electrode signal analysis is based at least partially on a second distance. In some such examples, the far-field signal is identified based on the first spatial analysis and the second spatial analysis, and the far-field signal is subtracted from the electrical signal from the first electrode. In some examples, the far-field signal is determined from the signals from a first set of electrodes based on the first distance and from the signals from a second set of electrodes based on the second distance.

[0013] In some examples, the first electrode is located at a first location within the heart, the signal is emitted from the first location along a first direction, and the first set of electrodes and the second set of electrodes are aligned at an angle perpendicular to the first direction. In some examples, the first set of electrodes and the second set of electrodes are located on separate planes and separated by a dielectric layer. In some examples, the multi-electrode catheter comprises at least one pair of electrodes spaced apart from each other by a distance smaller than the dimensions of a pair of electrodes.

[0014] The embodiments herein improve upon existing computer-based electroanatomical mapping systems. In particular, by decomposing signals from electrodes selected at various distances in real time into near-field and far-field components, the disclosed systems improve the capabilities of the computer itself and enable more accurate and insightful maps than those that can be produced using conventional systems or manual human analysis. Such improvements are rooted in the technology and address problems inherent in electrophysiological signal processing, including the cancellation of far-field interference and improved local activation detection. [Brief explanation of the drawing]

[0015] A more detailed understanding can be obtained from the following explanation, which is given as an example in conjunction with the attached drawings, where similar reference numbers in the drawings indicate similar elements. [Figure 1] This document illustrates one or more exemplary catheter-based electrophysiological mapping and ablation systems according to their respective embodiments. [Figure 2]This is a block diagram of an exemplary system for remotely monitoring and communicating patient biometric data, according to one or more embodiments. [Figure 3] This is a system diagram of an example computing environment that communicates with a network, according to one or more embodiments. [Figure 4] An example of a multi-electrode catheter design for implementing the technology disclosed herein, according to one or more embodiments, is shown. [Figure 5] Further examples of multi-electrode catheter designs for implementing the technologies disclosed herein are shown in one or more embodiments. [Figure 5A] Figure 5 shows a further example of a multi-electrode catheter design for implementing the technology disclosed herein, in which the unipolar electrode on the catheter is replaced with a bipolar split electrode. [Figure 6A] Further examples of multi-electrode catheter designs for implementing the technologies disclosed herein are shown in one or more embodiments. [Figure 6B] Further examples of multi-electrode catheter designs for implementing the technologies disclosed herein are shown in one or more embodiments. [Figure 7] A multi-electrode catheter, according to one or more embodiments, depicting bipolar split electrodes arranged within or along a circle surrounding selected electrodes, and used to implement the techniques disclosed herein. [Figure 8] A multi-electrode catheter that depicts bipolar split electrodes, according to one or more embodiments, at an angle perpendicular to, or aligned with, the direction of signal propagation from selected electrodes. [Figure 9] This is a signal diagram illustrating an exemplary application of the disclosed technique for a unipolar electrode on a multi-electrode catheter. [Figure 10A] One or more embodiments of the disclosed technology are shown, illustrating electroanatomical maps generated using the disclosed techniques. [Figure 10B] Further electroanatomical maps generated using the disclosed techniques are shown in one or more embodiments. [Figure 11]An exemplary method for training and applying a machine learning algorithm to decompose near-field and far-field components from a measured signal according to one or more embodiments is shown. [Figure 12] A flowchart showing a method for generating an electroanatomical map of a heart indicative of electrical activity of heart tissue or scar tissue based on the spatial electrode analysis technique disclosed herein according to one or more embodiments.

Best Mode for Carrying Out the Invention

[0016] The techniques disclosed below are applied to different locations within the heart as the catheter moves through the patient's heart during the procedure to generate an improved electroanatomical map of the heart. In one example, a first electroanatomical map and a second electroanatomical map of the heart are generated, the first electroanatomical map showing electrical activity identified based on a first spatial electrode analysis, and the second electroanatomical map showing electrical activity identified based on a second spatial electrode signal analysis. Alternatively, the first electroanatomical map shows scar tissue (e.g., areas of low conductivity) identified based on a first spatial electrode analysis, and the second electroanatomical map shows scar tissue (e.g., areas of low conductivity) identified based on a second spatial electrode signal analysis. Refer to Figure 1, which shows an exemplary system (e.g., a medical device and / or catheter-based electrophysiological mapping and ablation) shown as System 10, in which one or more features of the subject matter of this specification can be implemented according to one or more embodiments. System 10, as illustrated, includes a recorder 11, a heart 12, a catheter 14, a model or anatomical map 20, an electrograph 21, a spline 22, a patient 23, a physician 24 (or a medical professional, healthcare provider, or clinician), a positioning pad 25, an electrode 26, a display device 27, a distal tip 28, a sensor 29, a coil 32, a patient interface unit (PIU) 30, an electrode skin patch 38, an ablation energy generator 50, and a workstation 55. It should be further noted that each element and / or item of System 10 represents one or more of its elements and / or items. The embodiment disclosed herein can be carried out by modifying the example of System 10 shown in Figure 1. Embodiments of this disclosure can also be applied similarly using other system components and settings. Additionally, System 10 may include additional components such as elements for sensing electrical activity, wired or wireless connectors, processing devices, and display devices.

[0017] System 10 includes a plurality of catheters 14 that are percutaneously inserted by a physician 24 into a cardiac chamber or vascular structure of a patient through the patient's vasculature. Typically, a delivery sheath catheter is inserted into the left atrium or right atrium near a desired location within the heart 12. Thereafter, the plurality of catheters can be inserted into the delivery sheath catheter to reach the desired location. The plurality of catheters 14 can include catheters dedicated to sensing intracardiac electrogram (IEGM) signals, catheters dedicated to ablation, and / or catheters dedicated to both sensing and ablation. Exemplary catheters 14 configured to sense IEGM are illustrated herein. The physician 24 contacts the distal tip 28 of the catheter 14 with the heart wall to sense a target site of the heart 12. For ablation, the physician 24 similarly delivers the distal end of the ablation catheter to the target site for ablation.

[0018] In FIG. 1, catheter 14 is shown as including a plurality of electrodes 26 that are optionally distributed across a plurality of splines 22 at the distal tip 28 and configured to sense IEGM signals. In some examples, catheter 14 is a multi-electrode catheter configured to sense cardiac signals. Exemplary multi-electrode catheters for implementing the mapping techniques disclosed herein are shown in FIGS. 4-7 and discussed in further detail below. Catheter 14 can additionally include a sensor 29 embedded within or near the distal tip 28 to track the position and orientation of the distal tip 28. Optionally and preferably, the position sensor 29 is a magnetic-based position sensor that includes three magnetic coils for sensing three-dimensional (3D) position and orientation. Catheter 14 can be a pulsed-field ablation (PFA) catheter.

[0019] A sensor 29 (e.g., a position-based or magnetic-based position sensor) may work in conjunction with a place pad 25 which includes a plurality of magnetic coils 32 configured to generate a magnetic field within a given working volume. The real-time position of the distal tip 28 of the catheter 14 may be tracked based on the magnetic field generated by the place pad 25 and sensed by the sensor 29. Details of magnetic-based position sensing technology are described in U.S. Patents 5,5391,199, 5,443,489, 5,558,091, 6,172,499, 6,239,724, 6,332,089, 6,484,118, 6,618,612, 6,690,963, 6,788,967, and 6,892,091.

[0020] System 10 includes one or more electrode patches 38 positioned on the patient 23 for skin contact to establish location reference of the location pad 25 and impedance-based tracking of the electrodes 26. For impedance-based tracking, a current is directed to the electrodes 26 and sensed in the patch 38 (e.g., an electrode skin patch), thereby allowing the location of each electrode to be triangulated through the patch 38. Details of impedance-based location tracking techniques are described in U.S. Patents 7,536,218, 7,756,576, 7,848,787, 7,869,865, and 8,456,182, which are incorporated herein by reference.

[0021] The recorder 11 displays the electrocardiogram 21 captured by the electrode 18 (e.g., an electrocardiogram (ECG) electrode) and the intracardiac electrocardiogram (IEGM) captured by the electrode 26 of the catheter 14. The recorder 11 may include pacing capabilities for pacing the heart rhythm and / or may be electrically connected to a standalone pacer.

[0022] System 10 may include an ablation energy generator 50 adapted to deliver ablation energy to one or more electrodes 26 located at the distal tip 28 of a catheter 14 configured for ablation. The energy produced by the ablation energy generator 50 may include, but is not limited to, radio frequency (RF) energy or pulsed-field ablation (PFA) energy, or a combination thereof, including unipolar or bipolar high-voltage DC pulses that may be used to induce irreversible electroporation (IRE).

[0023] The PIU 30 is an interface configured to establish electrical communication between the catheter, the electrophysiological equipment, the power supply, and the workstation 55 that controls the operation of the system 10. The electrophysiological equipment of the system 10 may include, for example, multiple catheters 14, a location pad 25, a body surface ECG electrode 18, an electrode patch 38, an ablation energy generator 50, and a recorder 11. Optionally, and preferably, the PIU 30 additionally includes processing capabilities for implementing real-time calculation of the catheter location and performing ECG calculations.

[0024] The workstation 55 includes memory, a processor unit having memory or storage device loaded with appropriate operating software, and user interface functions. The workstation 55 may optionally provide several functions, including: (1) modeling the endocardial anatomical structure in three dimensions (3D) and rendering the model or anatomical map 20 for display on a display device 27; (2) displaying activation sequences (or other data) compiled from recorded electrophoresis 21 on the display device 27 as representative visual indicators or images superimposed on the rendered anatomical map 20; (3) displaying the real-time position and orientation of multiple catheters within the cardiac chambers; and (5) displaying sites of interest on the display device 27, such as the locations where ablation energy has been applied. One commercially available product embodying the elements of system 10 is available as the CARTO® 3 system from Biosense Webster, Inc. (31A Technology Drive, Irvine, CA 92618).

[0025] For example, system 10 can be part of a surgical system (e.g., the CARTO® system sold by Biosense Webster) configured to acquire biometric data (e.g., anatomical and electrical measurements of a patient's organs, such as the heart 12, as described herein) and perform cardiac ablation procedures. More specifically, in the treatment of cardiac conditions such as cardiac arrhythmias, it is often required to obtain detailed mapping of cardiac tissue, chambers, veins, arteries, and / or electrical pathways. For example, a prerequisite for successfully performing catheter ablation (as described herein) is that the cause of the cardiac arrhythmia is precisely located in the chambers of the heart 12. Such localization can be performed by electrophysiological examination, during which spatially resolved potentials are detected by a mapping catheter (e.g., catheter 14) introduced into the chambers of the heart 12. Thus, this electrophysiological examination, so-called electroanatomical mapping, provides 3D mapping data that can be displayed on a display device 27. In many cases, mapping and therapeutic functions (e.g., ablation) are provided by a single catheter or a group of catheters, and as a result, the mapping catheter also functions as a therapeutic (e.g., ablation) catheter.

[0026] Figure 2 is a block diagram of an exemplary system 100 for remotely monitoring and communicating patient biometrics (i.e., patient data). In the example illustrated in Figure 2, system 100 includes a patient biometric monitoring and processing unit 102 associated with patient 104, a local computing device 106, a remote computing system 108, a first network 110, a patient biometric sensor 112, a processor 114, a user input (UI) sensor 116, a memory 118, a second network 120, and a transmitter-receiver (i.e., transceiver) 122.

[0027] According to one embodiment, the patient biometric measurement and monitoring device 102 may be a device located inside the patient's body (e.g., subcutaneously implantable), such as the catheter 14 in Figure 1. The patient biometric measurement and monitoring device 102 may be inserted into the patient via any applicable method, including oral injection, surgical insertion via vein or artery, endoscopic procedure, or laparoscopic procedure.

[0028] According to one embodiment, the patient biometric monitoring and processing device 102 may be an external device to the patient, such as the electrode patch 38 in Figure 1. For example, as will be described in more detail below, the patient biometric monitoring and processing device 102 may include an attachable patch (e.g., attached to the patient's skin). The monitoring and processing device 102 may also include a catheter, probe, blood pressure cuff, scale, bracelet or smartwatch biometric tracker having one or more electrodes, a glucose monitor, a continuous positive airway pressure (CPAP) machine, or substantially any device capable of providing input regarding the patient's health or biometric indicators.

[0029] According to one embodiment, the patient biometric measurement monitoring and processing device 102 may include both components located inside the patient and components located outside the patient.

[0030] A single patient biometric monitoring and processing unit 102 is shown in Figure 2. However, the exemplary system may include multiple patient biometric monitoring and processing units. A patient biometric monitoring and processing unit may communicate with one or more other patient biometric monitoring and processing units. Additionally or alternatively, a patient biometric monitoring and processing unit may communicate with a network 110.

[0031] One or more patient biometric monitoring and processing devices 102 can acquire patient biometric data (e.g., electrical signals, blood pressure, body temperature, blood glucose levels, or other biometric data) and can receive at least a portion of the patient biometric data representing the acquired patient biometric values, as well as additional information associated with the patient biometric values ​​acquired from one or more other patient biometric monitoring and processing devices 102. The additional information may be, for example, diagnostic information and / or additional information obtained from additional devices such as wearable devices. Each patient biometric monitoring and processing device 102 can process data including its own acquired patient biometric values ​​and data received from one or more other patient biometric monitoring and processing devices 102.

[0032] Biometric data (e.g., patient biometrics, patient data, or patient biometric data) may include one or more of the following: local activation time (LAT), electrical activity, topology, bipolar mapping, baseline activity, ventricular activity, dominant frequency, impedance, etc. LAT may be the time of threshold activity corresponding to local activation, calculated based on a normalized initial start point. Electrical activity may be any applicable electrical signal that can be measured based on one or more thresholds and can be sensed and / or augmented based on the signal-to-noise ratio and / or other filters. Topology may correspond to the physical structure of a body part or a part of a body part, and may correspond to variations in the physical structure of different parts of a body part or different parts of a body part. Dominant frequency may be a frequency or range of frequencies commonly found in a part of a body part and may differ in different parts of the same body part. For example, the dominant frequency of the PV in a heart may differ from the dominant frequency of the right atrium of the same heart. Impedance may be a resistance measurement in a given region of a body part.

[0033] Examples of biometric data include, but are not limited to, patient identification data, intracardiac electrocardiogram (IC ECG) data, bipolar intracardiac reference signals, anatomical and electrical measurements, trajectory information, body surface (BS) ECG data, historical data, brain biometrics, blood pressure data, ultrasound signals, radio signals, voice signals, two-dimensional or three-dimensional image data, blood glucose data, and temperature data. Biometric data can generally be used to monitor, diagnose, and treat any number of different diseases, such as cardiovascular diseases (e.g., arrhythmias, cardiomyopathy, and coronary artery disease) and autoimmune diseases (e.g., type 1 and type 2 diabetes). Note that BS ECG data may include data and signals collected from electrodes on the patient's surface, IC ECG data may include data and signals collected from electrodes inside the patient's body, and ablation data may include data and signals collected from the tissue being ablated. Furthermore, BS ECG data, IC ECG data, and ablation data can be derived from one or more procedure records, along with catheter electrode position data.

[0034] In Figure 2, network 110 is an example of a short-range network (e.g., a local area network (LAN) or a personal area network (PAN)). Information can be transmitted between the patient vital signs monitoring and processing device 102 and the local computing device 106 via network 110 using one of various short-range wireless communication protocols such as Bluetooth, Wi-Fi, Zigbee, Z-Wave, near-field communication (NFC), ultra-wideband wireless, Zigbee, or infrared (IR).

[0035] Network 120 may be a wired network, a wireless network, or may include one or more wired and wireless networks. For example, network 120 may be a long-range network (e.g., a wide area network (WAN), the Internet, or a cellular network). Information may be transmitted over network 120 using any one of various long-range wireless communication protocols (e.g., TCP / IP, HTTP, 3G, 4G / LTE, or 5G / New Radio).

[0036] The patient biometric measurement monitoring and processing device 102 may include a patient biometric sensor 112, a processor 114, a UI sensor 116, a memory 118, and a transceiver 122. The patient biometric measurement monitoring and processing device 102 may continuously or periodically monitor, store, process, and communicate any number of different patient biometric measurements via the network 110. Examples of patient biometric measurements include electrical signals (e.g., ECG signals and brain biometric measurements), blood pressure data, blood glucose data, and body temperature data. Patient biometric measurements may be monitored and communicated for therapeutic purposes across any number of different diseases, such as cardiovascular diseases (e.g., arrhythmias, cardiomyopathy, and coronary artery disease), and autoimmune diseases (e.g., type 1 and type 2 diabetes).

[0037] The patient biometric sensor 112 may include, for example, one or more sensors configured to sense the type of biometric value of a biometric patient. For example, the patient biometric sensor 112 may include electrodes configured to acquire electrical signals (e.g., cardiac signals, brain signals, or other bioelectrical signals), a body temperature sensor, a blood pressure sensor, a blood glucose sensor, a blood oxygen sensor, a pH sensor, an accelerometer, or a microphone.

[0038] As will be described in more detail below, the patient biometric monitoring and processing device 102 may be an ECG monitor for monitoring the ECG signal of the heart (e.g., heart 12). The patient biometric sensor 112 of the ECG monitor may include one or more electrodes for acquiring the ECG signal. The ECG signal can be used for the treatment of various cardiovascular diseases.

[0039] In another example, the patient biometric monitoring and processing device 102 may be a continuous glucose monitor (CGM) for continuously monitoring a patient's blood glucose levels to treat various diseases such as type 1 and type 2 diabetes. The CGM may include subcutaneously placed electrodes that can monitor blood glucose levels from the patient's interstitial fluid. The CGM may be a component of a closed-loop system in which blood glucose data is sent to an insulin pump for, for example, calculated insulin delivery without user intervention.

[0040] The transceiver 122 may include separate transmitters and receivers. Alternatively, the transceiver 122 may include a transmitter and receiver integrated into a single device.

[0041] The processor 114 may be configured to store patient data, such as patient biometric data acquired by the patient biometric sensor 112, in the memory 118 and to communicate the patient data over the network 110 via the transmitter of the transceiver 122. Data from one or more other patient biometric monitoring and processing devices 102 may also be received by the receiver of the transceiver 122, as will be described in more detail below.

[0042] According to one embodiment, the patient biometric monitoring and processing device 102 includes a UI sensor 116, which may be a piezoelectric or capacitive sensor configured to receive user input such as a tap or touch. For example, the UI sensor 116 may be controlled to perform capacitive coupling in response to a patient 104 tapping or touching the surface of the patient biometric monitoring and processing device 102. Gesture recognition may be performed via any one of various capacitive types, such as resistive capacitive, surface capacitive, projected capacitive, surface acoustic wave, piezoelectric, and infrared touch. The capacitive sensor may be positioned over a small area or length on the surface so that a tap or touch on the surface activates the monitoring device.

[0043] As will be described in more detail below, the processor 114 may be configured to selectively respond to different tapping patterns (e.g., single tap or double tap) of a capacitive sensor, which may be a UI sensor 116, and as a result, different tasks of the patch (e.g., data acquisition, storage, or transmission) may be triggered based on the detected pattern. In some embodiments, when a gesture is detected, audible feedback may be provided to the user from the patient biometric monitoring and processing device 102.

[0044] The local computing device 106 of system 100 may be configured to communicate with the patient biometrics monitoring and processing device 102 and to function as a gateway to the remote computing system 108 via the second network 120. The local computing device 106 may be, for example, a smartphone, smartwatch, tablet, or other portable smart device configured to communicate with other devices via the network 120. Alternatively, the local computing device 106 may be a fixed or standalone device, such as a fixed base station including modem and / or router capabilities, a desktop or laptop computer using an executable program to communicate information between the patient biometrics monitoring and processing device 102 and the remote computing system 108 via a wireless module of a PC, or a USB dongle. Patient biometrics may be communicated between the local computing device 106 and the patient biometrics monitoring and processing device 102 via a short-range wireless network 110, such as a local area network (LAN) (e.g., a personal area network (PAN)), using short-range wireless technology standards (e.g., Bluetooth, Wi-Fi, ZigBee, Z-wave, and other short-range wireless standards). In some embodiments, the local computing device 106 may also be configured to display acquired patient electrical signals and information associated with those signals, as will be described in more detail below.

[0045] In some embodiments, the remote computing system 108 may be configured to receive at least one of monitored patient biometrics and information associated with the monitored patient via a long-range network, which is a network 120. For example, if the local computing device 106 is a mobile phone, the network 120 may be a wireless cellular network, and information may be communicated between the local computing device 106 and the remote computing system 108 via a wireless technology standard, such as one of the wireless technologies described above. As will be described in more detail below, the remote computing system 108 may be configured to provide (e.g., visually and / or audibly) at least one of the patient's biometrics and associated information to a medical professional (e.g., a physician).

[0046] Figure 3 is a system diagram of an example computing environment 200 communicating with network 120. In some examples, the computing environment 200 is integrated into a public cloud computing platform (such as Amazon Web Services or Microsoft Azure), a hybrid cloud computing platform (such as HP Enterprise OneSphere), or a private cloud computing platform.

[0047] As shown in Figure 3, the computing environment 200 includes a remote computing system 108 (hereinafter referred to as the computer system), which is one example of a computing system in which embodiments described herein may be implemented.

[0048] The remote computing system 108 can perform a variety of functions via a processor 220 which may include one or more processors. These functions may include analyzing the biometric measurements and associated information of a monitored patient, and providing warnings, additional information, or instructions (e.g., via a display 266) according to thresholds and parameters determined by a physician or algorithmically driven. As will be described in more detail below, the remote computing system 108 can be used to provide a patient information dashboard (e.g., via a display 266) to a healthcare professional (e.g., a physician), which may enable the healthcare professional to identify and prioritize patients with more critical needs than other patients.

[0049] As shown in Figure 3, the computer system 210 may include a communication mechanism such as a bus 221, or other communication mechanisms for communicating information within the computer system 210. The computer system 210 further includes one or more processors 220 coupled to the bus 221 for processing information. The processors 220 may include one or more CPUs, GPUs, or any other processors known in the art.

[0050] The computer system 210 also includes system memory 230 coupled to bus 221 for storing information and instructions executed by processor 220. System memory 230 may include computer-readable storage media in the form of volatile and / or non-volatile memory, such as read-only memory (ROM) 231 and / or random access memory (RAM) 232. System memory RAM 232 may include other dynamic storage devices (e.g., dynamic RAM, static RAM, and synchronous DRAM). System memory ROM 231 may include other static storage devices (e.g., programmable ROM, erasable PROM, and electrically erasable PROM). In addition, system memory 230 may be used to store temporary variables or other intermediate information during instruction execution by processor 220. A basic input / output system (BIOS) 233 may include routines for transferring information that can be stored in system memory ROM 231 between elements within the computer system 210, such as at startup. RAM 232 may include data and / or program modules that are immediately accessible to the processor 220 and / or currently being manipulated by the processor 220. System memory 230 may additionally include, for example, an operating system 234, application programs 235, other program modules 236, and program data 237.

[0051] The illustrated computer system 210 also includes a disk controller 240 coupled to a bus 221 for controlling one or more storage devices for storing information and instructions, such as a magnetic hard disk 241 and a removable media drive 242 (e.g., a floppy disk drive, a compact disk drive, a tape drive, and / or a solid-state drive). Storage devices may be added to the computer system 210 using a suitable device interface (e.g., small computer system interface, SCSI, integrated device electronics, IDE, Universal Serial Bus, USB, or FireWire).

[0052] The computer system 210 may also include a display controller 265 coupled to a bus 221 for controlling a monitor or display 266, such as a cathode ray tube (CRT) or liquid crystal display (LCD), for displaying information to a computer user. The illustrated computer system 210 includes a user input interface 260 and one or more input devices, such as a keyboard 262 and a pointing device 261, for interacting with a computer user and providing information to a processor 220. The pointing device 261 may be, for example, a mouse, trackball, or pointing stick for communicating instruction information and command selections to the processor 220 and controlling cursor movement on the display 266. The display 266 may provide a touchscreen interface, which may allow input that complements or replaces the communication of instruction information and command selections by the pointing device 261 and / or the keyboard 262.

[0053] The computer system 210 may perform some or all of the functions and methods described herein in response to a processor 220 that executes one or more sequences of one or more instructions contained in memory, such as system memory 230. Such instructions may be read into system memory 230 from another computer-readable medium, such as a hard disk 241 or a removable media drive 242. The hard disk 241 may include one or more data stores and data files used by embodiments described herein. The data store contents and data files may be encrypted to improve security. The processor 220 may also be employed in multiple processing configurations to execute one or more sequences of instructions contained in system memory 230. In alternative embodiments, hardwired circuitry may be used instead of or in combination with software instructions. Thus, embodiments are not limited to any particular combination of hardware circuitry and software.

[0054] As described above, the computer system 210 may include at least one computer-readable medium or memory for holding instructions programmed according to the embodiments described herein and for containing data structures, tables, records, or other data described herein. As used herein, the term computer-readable medium refers to any non-temporary tangible medium involved in providing instructions to the processor 220 for execution. Computer-readable mediums can take many forms, including but not limited to non-volatile media, volatile media, and transmission media. Non-limited examples of non-volatile media include optical disks, solid-state drives, magnetic disks, and magneto-optical disks, such as the hard disk 241 or removable media drive 242. Non-limited examples of volatile media include dynamic memory, such as the system memory 230. Non-limited examples of transmission media include coaxial cables, copper wires, and optical fibers, such as the wires that make up the bus 221. Transmission media can also take the form of acoustic waves or light waves, such as those generated during radio and infrared data communications.

[0055] The computing environment 200 may further include a computer system 210 operating in a networked environment using logical connections to a local computing device 106 and to one or more other devices such as a personal computer (laptop or desktop), a mobile device (e.g., a patient mobile device), a server, a router, a network PC, a peer device, or other common network node, and typically includes many or all of the elements described above with respect to the computer system 210. When used in a network environment, the computer system 210 may include a modem 272 for establishing communication over a network 120 such as the Internet. The modem 272 may be connected to the system bus 221 via a network interface 270 or via another suitable mechanism.

[0056] Network 120, as shown in Figures 2 and 3, may be any network or system generally known in the art, including the Internet, an intranet, a local area network (LAN), a wide area network (WAN), a metropolitan area network (MAN), a direct connection or a series of connections, a cellular telephone network, or any other network or medium that can facilitate communication between computer system 210 and other computers (e.g., local computing device 106).

[0057] Catheter ablation-based therapies may include mapping the electrical properties of cardiac tissue, particularly the endocardium and cardiac volume, and selectively ablating cardiac tissue by applying energy. Cardiac mapping can create, for example, a map of the potentials of wave propagation along cardiac tissue (voltage map), or a map of the time it takes to reach points where various tissues are located (local excitation time (LAT) map), which can be used to detect localized dysfunction in cardiac tissue. Ablation, such as cardiac mapping-based ablation, can stop or modify the propagation of unwanted electrical signals from one part of the heart to another.

[0058] Ablation is a method that destroys unwanted electrical pathways by forming non-conductive damaged areas. Cardiac ablation may rely on the use of a three-dimensional (3D) mapping system, such as the CARTO® 3 3D mapping system manufactured by Biosense Webster, Inc. (Diamond Bar, Calif.). The 3D map can provide a variety of information, including the visualization (e.g., on a display or monitor) of tags representing the positions of electrodes in a multi-electrode catheter for the ablation session.

[0059] The techniques described herein are not limited to any particular multi-electrode catheter configuration, but the techniques may be understood in relation to the multi-electrode catheter designs 400 and 500 described below.

[0060] Figure 4 shows an example of an end effector 400 for a catheter. The end effector 400 may include a flexible circuit layer 410 extending along the longitudinal axis LL from a proximal portion 413 to a distal portion 414, a framework 420 coupled to the flexible circuit layer 410 and extending along the longitudinal axis LL from a proximal portion 413 to a distal portion 414, generally parallel to the flexible circuit layer 410, and a flexible polymer layer 430 enclosing both the framework 420 and the flexible circuit layer 410. The flexible circuit layer 410 may include a first surface 411 and a second surface 412 opposite to the first surface 411. The flexible circuit layer 410 defines a planar configuration 418 extending through the longitudinal axis LL, with the framework 420 positioned inside the flexible circuit layer 410.

[0061] In some examples, the end effector 400 may include one or more first electrodes 440a attached to a first surface 411 of the flexible circuit layer 410, and one or more second electrodes 440b attached to a second surface 412 of the flexible circuit layer 410. The first electrodes 440a may be axially aligned with the second electrodes 440b to define a pair of opposing electrodes 440. In some examples, the pair of opposing electrodes 440 may be aligned substantially parallel to the longitudinal axis LL. In other examples, the pair of opposing electrodes 440 may be aligned substantially lateral to the longitudinal axis LL. Further details of the end effector 400 are described in U.S. Patent Application No. 18 / 505,956, titled “Catheter With Flexible Polymer As Outer Support Structure,” filed November 9, 2023, which is incorporated herein by reference in its entirety.

[0062] Figure 5 shows further examples of multi-electrode catheter designs 500 for implementing the technology disclosed herein, according to one or more embodiments. The catheter 500 may be a catheter having a plurality of electrodes 534, such as at least 20 electrodes. As shown, the plurality of electrodes may include just 48 electrodes located across a plurality of spines 537 or distributed across a plurality of spines 537. Using such a large number of electrodes 534 scattered over a wide area by the spines 537 makes it possible to capture a large amount of electrical activity over a wide area at once. According to one or more embodiments, the plurality of spines 537 may be moved through the sheath in a condensed state and expanded when they enter the body of the patient 23 in Figure 1. Electrical activity at any focal point in the heart 12 can typically be measured by advancing the catheter 500, bringing the catheter 500 into contact with cardiac tissue, and acquiring data related to the electrical activity at that point.

[0063] As shown in the figure, the catheter 500 is formed from an array of unipolar electrodes. The electrodes are considered unipolar because the voltage can be measured at each electrode, for example, against a common electrode positioned on the surface of the patient's body, or against a reference electrode on the catheter. In an alternative design, the unipolar electrodes on the catheter 500 may be replaced with bipolar electrodes 570, as shown in Figure 5A. In yet another alternative design, the unipolar electrodes on the catheter 500 may be selectively paired to form bipolar electrodes in real time, as described in U.S. Patent Application No. 17 / 341,315, titled “Bipolar Electrode Pair Selection,” incorporated herein by reference.

[0064] As described above, the catheter 400 includes two coplanar electrode arrays, one array on each side (or face) of the catheter. In one embodiment, the electrodes on each face of the catheter 400 are arranged in pairs and are referred to as bipolar electrodes because the voltage is measured between each bipolar pair. In some configurations, a dielectric layer 604 separates the faces of the catheter 400, as shown in Figures 6A and 6B. In this configuration, the bipolar electrode pairs on each face of the catheter 400 are replaced by electrode pairs or used to model electrode pairs, with the electrodes of each pair located on either side of the dielectric layer separating the faces of the catheter. An example of such an electrode pair (consisting of electrodes 602 and 606) is shown in Figure 6A, in which case the electrodes of the pair are located on either side of the dielectric layer 604 separating the faces of the catheter. A further example of one such electrode pair (consisting of electrodes 602 and 606) is shown in Figure 6B. In the example shown in Figure 6B, the dielectric layers 604a and 604b are positioned adjacent to electrodes 602 and 606, respectively, and other components of the catheter 610 (e.g., one or more catheter substrates, electrical traces, polymers, or other materials) are positioned between the dielectric layers 604a and 604b. In the electrode configurations shown in Figures 6A and 6B, the dielectric materials 608a and 608b are optionally positioned along the side walls of electrodes 602 and 606.

[0065] Referring now to Figure 7, a further multi-electrode catheter 700 is shown having multiple bipolar split electrodes 702. Each bipolar split electrode 702 consists of two electrodes that are close together and spaced apart. Although one side of the multi-catheter 700 is shown having multiple bipolar split electrodes 702, in some embodiments the multi-catheter 700 has multiple bipolar split electrodes 702 on both the shown side and the opposite side (not shown). In the example in Figure 7, one bipolar split electrode 704 on the catheter 700 is close to (or even in contact with) cardiac tissue, while the other bipolar split electrodes on the catheter are spaced apart from the bipolar split electrode 704 that is close to or in contact with cardiac tissue. In this example, the bipolar split electrode 704 (the electrode selected in this example) is close to (or in contact with) cardiac tissue at a first location within the heart. A bipolar split electrode along or within the smallest ring 706 around the selected bipolar split electrode 704 is within a first distance of the selected electrode, a bipolar split electrode in the central ring 708 is within a second (further) distance of the selected electrode, and a bipolar split electrode in the outermost ring 710 is within a third (even further) distance of the selected electrode.

[0066] Referring further to Figure 7, in one example, the disclosed technology uses a bipolar segmented electrode positioned along or within a plurality of circles, or another group of electrodes spatially positioned around a selected bipolar segmented electrode 704, to identify and then subtract a far-field signal component from the signal received by the selected electrode 704. For example, a first spatial electrode signal analysis of the electrical activity sensed by the selected electrode 704 is performed based on signals from a set of electrodes positioned along or within a circle 706 and within a first distance (e.g., the radius of the ring 706) of the selected electrode; a second spatial electrode signal analysis of the electrical activity sensed by the selected electrode 704 is performed based on signals from a set of electrodes positioned along or within a circle 708 and within a second distance (e.g., the radius of the ring 708) of the selected electrode; and in some cases, a third spatial electrode signal analysis of the electrical activity sensed by the selected electrode 704 is performed based on signals from a set of electrodes positioned along or within a circle 710 and within a third distance (e.g., the radius of the ring 710) of the selected electrode. The amplitude (or other characteristics) of far-field signals received by various electrodes are expected to vary depending on the distance of each of the various electrodes from the selected electrode. In some examples, for each distance around the selected electrode 704, the far-field component of the signal received by the selected electrode 704 is determined using the technique disclosed in U.S. Patent Application Publication No. 2023 / 0181087 (which is incorporated herein by reference in its entirety), and the signal can be processed by performing signal analysis on each of the signals received by the selected electrode 704 and the signals received from electrodes located along or within a circle and at a given distance from the selected electrode 704. The disclosed technique utilizes the different characteristics of far-field signals received at multiple distances from the selected electrode to scale, subtract, or modify the contribution of the far-field component to the electricity attributable to the selected electrode, thereby more accurately estimating and processing the far-field signal of the signal collected by the selected electrode in a desired manner.Based on the different characteristics of the far-field signals received at multiple distances from the selected electrode 704, the estimated far-field signal determined for the selected electrode 704 is subtracted from the voltage detected by the selected electrode 704 in order to estimate the near-field signal received by the selected electrode 704. The above technique is hereafter referred to as the “multi-pole” technique in this disclosure. These techniques can be repeated for all bipolar segmented electrodes of the catheter until all electrodes have been processed.

[0067] The techniques described above can be applied to different locations within the heart as the catheter moves through the patient's heart during the procedure to generate an improved electroanatomical map of the heart. In one example, a first electroanatomical map and a second electroanatomical map of the heart are generated, the first showing electrical activity identified based on the first spatial electrode analysis, and the second showing electrical activity identified based on the second spatial electrode signal analysis. Alternatively, the first electroanatomical map may show scar tissue (e.g., areas of low conductivity) identified based on the first spatial electrode analysis, and the second electroanatomical map may show scar tissue (e.g., areas of low conductivity) identified based on the second spatial electrode signal analysis.

[0068] In some examples, the above techniques acquire signals by placing multiple catheter electrodes inside the heart to collect signals, while in other examples, the catheters are placed on the epicard or on the heart but outside of it.

[0069] While the above example was based on the use of bipolar split electrodes spaced apart within a plurality of concentric rings around a selected electrode, the techniques disclosed herein may be applied using other individual electrodes or groups of electrodes spaced at different distances from the selected electrode. For example, consider the case shown in Figure 8, where the selected bipolar split electrode 802 is close to (or in contact with) cardiac tissue at a first location within the heart, and the signal originates from the first location in the propagation direction indicated by arrow 804. In such a case, the first set of bipolar electrodes 806 is spaced at a first distance or within that range from the selected electrode 802, and the second set of bipolar split electrodes 808 is spaced at a second distance or within that range from the selected electrode. As shown, the first set of electrodes 806 is aligned at an angle perpendicular to the propagation direction indicated by arrow 804, or with respect to that angle. Similarly, the second set of electrodes 808 is aligned at an angle perpendicular to the propagation direction indicated by arrow 804, or with respect to that angle.

[0070] In examples where this technique is applied using a catheter 400 (having two arrays of bipolar electrodes on the same plane, with one array on each side (or face) of the catheter), a first set of electrodes and a second set of electrodes, spaced by a first and second distance, respectively, from the selected electrode, are arranged on separate planes and separated, for example, by a dielectric layer. In some examples, these techniques are applied using a multi-electrode catheter having bipolar electrodes spaced apart from each other by a distance smaller than the dimensions of each electrode in a pair.

[0071] The techniques described above are particularly applicable to unipolar and bipolar signals, which are combinations of near-field and far-field signals. During cardiac ablation procedures, it may be desirable to separate near-field and far-field signals. The techniques described above can be applied to decompose a signal into near-field and far-field components, enabling the identification of near-field activity only, far-field activity only, or varying proportions of each. In some examples, machine learning algorithms are trained and applied to decompose near-field and far-field signals using the techniques described above.

[0072] The signal diagrams described below illustrate an example of the application of the above technique to six unipolar electrodes (identified as B1-B6) on a multi-electrode catheter such as catheter 500. The diagrams show six signal pairs 902, 904, 906, 908, 910, and 912, where the box region of each signal pair represents the region of interest. Each pair of signals 902, 904, 906, 908, 910, and 912 includes a gray signal corresponding to a signal collected from a specific selected electrode (e.g., B1) and a white signal representing signals collected from one or more electrodes (or sets of electrodes) along such electrode (e.g., B1) or spaced within a given distance from such electrode (e.g., B1). According to the technique described herein, for a particular electrode (e.g., B1), there may be other signals (not shown) corresponding to signals collected from one or more other electrodes (or other sets of electrodes) along such electrode (e.g., B1) or spaced within different distances from such electrode (e.g., B1).

[0073] As described above, the disclosed technique can be applied to decompose the signals collected at each electrode (e.g., B1-B6) into near-field and far-field components for the purpose of identifying only near-field activity at each electrode, only far-field activity at each electrode, or different proportions at each electrode. Figures 10A and 10B are two electroanatomical maps generated using such a technique, each map reflecting different proportions of near-field and far-field signals captured by each electrode (e.g., B1-B6).

[0074] In certain embodiments, the electroanatomical mapping system generates maps that show at least electrical activity, with each map reflecting varying degrees of far-field signal contribution. For example, the system may provide a continuum of maps and / or optional mapping modes in which (1) the electrophoresis defining points in the map primarily reflects local electrical activity with minimal far-field signal interference (e.g., by reducing or subtracting the far-field component), (2) the electrophoresis defining points in the map is a near-field-far-field map in which the far-field component is moderately reduced or subtracted, and (3) the electrophoresis contains a relatively larger number of far-field signal components, or the degree to which the far-field and near-field signals vary defines points. This variability in signal processing and mapping processes can potentially provide physicians with important insights into underlying arrhythmias, revealing aspects of power source or propagation that may not be discernible from near-field activity alone. By visualizing the electrical behavior across different levels of far-field contributions, physicians can better distinguish arrhythmia sources, thereby improving diagnostic accuracy and treatment outcomes. To allow for even finer-grained variability in far-field signal contributions, more than three additional maps can be provided as desired, depending on the number and configuration of electrodes.

[0075] Electroanatomical mapping systems can provide an intuitive way to select from various map options through their user interface (UI) and user experience (UX) design. One possible approach is to allow the operator to select from a predetermined menu presenting options such as “near-field,” “near-field-far-field,” and “far-field” maps. Another approach can leverage dynamic scrolling features, as well as zooming in or out using a mouse, trackpad, or other gestures. By scrolling, the user can transition between maps and progressively adjust the contribution of far-field signals. For example, scrolling upwards can reveal maps with gradually decreasing far-field interference, moving towards near-field activity, while scrolling downwards can increase the far-field contribution. These selectable options provide flexibility and ease of use, enabling the operator to quickly navigate or “animate” between maps to enable improved diagnostics.

[0076] The disclosed technology can be used to generate a real-time map using signals collected over time in a single snapshot. Alternatively, signals can be collected and processed over a longer time window before the data is displayed.

[0077] In some embodiments, a machine learning algorithm is trained to decompose near-field and far-field signals using the techniques described above. Figure 11 shows an exemplary method 1100 for training a machine learning algorithm (steps 1102-1106) and applying the machine learning algorithm (step 1110) to decompose the near-field and far-field components from the signal measured in step 1108. In one example of step 1102, training data including far-field ventricular measurements is acquired using a multi-catheter electrode and a body surface ECG. In some examples, the training dataset may include separated far-field signals obtained by positioning the catheter in a location not in contact with the myocardium or in the vicinity of the myocardium, for example, identified by a tissue proximity index (TPI) value. The signals in the training dataset may also include ECG values ​​at a given 3D location (for each electrode). Surface ECG signals can also be used as part of the training signal. Surface ECG signals are essentially considered far-field signals. In step 1104, training data including a synthetic local-field signal is added to the training data acquired in step 1102. For example, previously identified near-field signals may be modified by varying their amplitude and / or adding random noise to generate a synthetic local-field signal for use in step 1104. In some examples, ground truth data for far-field signals is obtained by performing multiple cryothermal exfoliations characterized by freezing the myocardial layer from depth toward the mapping plane (e.g., so that the far-field contribution in the frozen layer is suppressed). This ground truth data can be used to train machine learning algorithms, which include training a neural network to identify near-field and far-field components of signals generated at different depths from the tissue surface. This disclosure encompasses any suitable methods or sources for collecting or creating relevant data for training machine learning algorithms.Neural network training is performed in step 1106 using the far-field signal resulting from capture using a body surface ECG and the residual near-field signal remaining after the far-field signal is subtracted from the signal captured by the multi-electrode catheter. Training takes patient measurements obtained using multi-catheter electrodes and body surface ECG as input (step 1108) and yields a far-field reduction model 1110 that decomposes the measurement signals from the catheter electrodes into far-field and near-field components.

[0078] Unlike general data processing, the disclosed neural network is trained using electrophysiology-specific data, including synthetic and / or clinical signals, thereby improving computer capabilities in this field. The result is improved diagnostic accuracy and real-time mapping performance that cannot be achieved by human review or general-purpose computer routines.

[0079] Figure 12 is a flowchart illustrating a method 1200 for generating an electroanatomical map of the heart showing the electrical activity of cardiac or scar tissue based on spatial electrode analysis techniques disclosed herein, according to one or more embodiments. In step 1202, electrical activity is received from multiple electrodes of a multi-electrode catheter in the patient's heart. In step 1204, electrodes are selected from the multiple electrodes to be in contact with or near a first location in the cardiac tissue. In step 1206, a first set of electrodes is selected, each of which is at or within a first distance from the first electrode, and the first set of electrodes does not include the first electrode. In step 1208, a first spatial electrode signal analysis of the electrical activity of the first electrode is performed based on the signals from the first set of electrodes. In step 1210, a second set of electrodes is selected, each within a second distance from the first electrode, where the second distance is greater than the first distance, and the second set of electrodes does not include the first electrode. In step 1212, a second spatial electrode signal analysis of the electrical activity of the first electrode is performed according to the signals from a second set of electrodes. This process is repeated for several further locations within the heart until all locations of interest have been processed. In step 1214, at least a first electroanatomical map and a second electroanatomical map of the heart are generated using the results of the first and second spatial analyses at each of the first and subsequent locations. The maps show the electrical activity of cardiac tissue corresponding to the first and subsequent locations, with the first electroanatomical map showing the electrical activity identified based on the first spatial electrode analysis, and the second electroanatomical map showing the electrical activity identified based on the second spatial electrode signal analysis. Alternatively, the first electroanatomical map shows scar tissue identified based on the first spatial electrode analysis, and the second electroanatomical map shows scar tissue identified based on the second spatial electrode signal analysis.

[0080] While features and elements have been described above in specific combinations, those skilled in the art will understand that each feature or element can be used alone or in combination with other features and elements. In addition, the methods described herein can be implemented in computer programs, software, or firmware embedded in computer-readable media for execution on a computer or processor. Examples of computer-readable media include electronic signals (transmitted via wired or wireless connections) and computer-readable storage media. Examples of computer-readable storage media include, but are not limited to, read-only memory (ROM), random access memory (RAM), registers, cache memory, semiconductor memory devices, magnetic media such as internal hard disks and removable disks, magneto-optical media, and optical media such as CD-ROM disks and digital versatile disks (DVDs). A software-related processor can be used to implement radio frequency transceivers for use in WTRUs, UEs, terminals, base stations, RNCs, or any host computer.

[0081] The flowcharts and block diagrams in the figures illustrate the structure, functionality, and operation of possible implementations of systems, methods, and computer program products according to various embodiments of the present invention. In this regard, each block in the flowchart or block diagram may represent a module, segment, or portion of an instruction containing one or more executable instructions for implementing the indicated logical function. In some alternative implementations, the functions shown in the blocks may be performed in an order other than that shown in the figures. For example, two consecutively shown blocks may actually be executed substantially simultaneously, or they may, depending on the relevant functionality, be executed in reverse order. It should also be noted that each block in the block diagrams and / or flowchart illustrations, and combinations of blocks in the block diagrams and / or flowchart illustrations, may be implemented by a dedicated hardware-based system that performs the specified function or operation, or by operating or executing a combination of dedicated hardware and computer instructions.

[0082] Although the features and elements have been described above in specific combinations, those skilled in the art will understand that each feature or element can be used individually or in combination with other features and elements. In addition, the methods described herein may be implemented in computer programs, software, or firmware incorporated into a computer-readable medium for execution on a computer or processor. The computer-readable medium as used herein should not be interpreted as being a transient signal in itself, such as radio waves or other freely propagating electromagnetic waves, electromagnetic waves propagating through waveguides or other transmission media (e.g., optical pulses passing through fiber optic cables), or electrical signals transmitted through wires.

[0083] Examples of computer-readable media include electrical signals (transmitted via wired or wireless connections) and computer-readable storage media. Examples of computer-readable storage media include, but are not limited to, registers, cache memory, semiconductor memory devices, magnetic media such as internal hard disks and removable disks, magneto-optical media, optical media such as compact disks (CDs) and digital multi-purpose discs (DVDs), random access memory (RAM), read-only memory (ROM), erasable programmable read-only memory (EPROM or flash memory), static random access memory (SRAM), and memory sticks. A processor can be used with software to implement a radio frequency transceiver for use in a terminal, base station, or any host computer.

[0084] The terms used herein are intended solely to describe specific embodiments and are not intended to be limiting. Where used herein, unless otherwise specified in the context, the singular forms "a," "an," and "the" also include the plural forms. It should be further understood that the terms "comprise" and / or "comprising," as used herein, indicate the presence of a described feature, integer, step, operation, element, and / or component, but do not exclude the presence or addition of another feature, integer, step, operation, element, component, and / or group thereof.

[0085] The descriptions of the various embodiments in this specification are illustrative and not intended to be exhaustive or limitful to the embodiments disclosed. Many modifications and variations will be apparent to those skilled in the art without departing from the scope and spirit of the embodiments described. The terms used herein have been selected to best describe the principles, practical applications, or technical improvements of the embodiments compared to the art available on the market, or to enable those skilled in the art to understand the embodiments disclosed herein.

[0086] [Implementation Method] (1) A method, (a) Receiving electrical activity from multiple electrodes of a multi-electrode catheter, (b) With respect to the first location within the heart, (i) Selecting a first electrode from the plurality of electrodes, (ii) Selecting a first set of electrodes that are each located within a first distance from the first electrode, wherein the first set of electrodes does not include the first electrode. (iii) Performing a first spatial electrode signal analysis of the electrical activity of the first electrode according to the signals from the first set of electrodes, (iv) Selecting a second set of electrodes, each located within a second distance from the first electrode, wherein the second distance is greater than the first distance, and the second set of electrodes does not include the first electrode. (v) Perform a second spatial electrode signal analysis of the electrical activity of the first electrode according to the signals from the second set of electrodes, (c) Repeat step (b) for several further locations within the heart, (d) A method comprising generating a first electroanatomical map of the heart showing electrical activity of cardiac tissue corresponding to at least the first location and the plurality of further locations, and a second electroanatomical map of the heart showing electrical activity of cardiac tissue corresponding to the first location and the plurality of further locations, wherein the first electroanatomical map shows electrical activity or scar tissue identified based on the first spatial electrode signal analysis, and the second electroanatomical map shows electrical activity or scar tissue identified based on the second spatial electrode signal analysis. (2) The method according to Embodiment 1, wherein the first spatial electrode signal analysis and the second spatial signal analysis are performed using a previously trained neural network. (3) The method according to Embodiment 1, wherein the first set of electrodes and the second set of electrodes are separated by a dielectric layer. (4) The method according to Embodiment 1, wherein the first set of electrodes and the second set of electrodes are arranged on different planes. (5) The method according to Embodiment 1, wherein the first spatial electrode signal analysis is at least partially based on the first distance, and the second spatial electrode signal analysis is at least partially based on the second distance.

[0087] (6) The method of Embodiment 5, wherein a far-field signal is identified based on the first spatial analysis and the second spatial analysis, the far-field signal is subtracted from an electrical signal from the first electrode, and the far-field signal is determined from the signals from a first set of electrodes based on the first distance and from the signals from a second set of electrodes based on the second distance. (7) The method according to Embodiment 1, wherein the first electrode is located at the first location in the heart. (8) The method according to Embodiment 7, wherein a signal is emitted from the first location along the first direction, and the first set of electrodes and the second set of electrodes are aligned at an angle perpendicular to the first direction. (9) The method according to Embodiment 1, wherein the multi-electrode catheter comprises at least one pair of electrodes, and the at least one pair of electrodes are spaced apart from each other by a distance smaller than the dimensions of the pair of electrodes. (10) The method according to Embodiment 1, wherein the multi-electrode catheter is positioned on the endocardial tissue inside the heart or on the epicardial tissue outside the heart.

[0088] (11) A system, One or more processors that communicate with multiple electrodes of a multi-electrode catheter, The display and The system comprises the display and memory that communicates with one or more processors, and the one or more processors communicate with multiple locations of cardiac tissue in the heart. Receiving the electrical activity of the patient's heart from multiple electrodes of a multi-electrode catheter, By selecting an electrode from the aforementioned plurality of electrodes, the selected electrode is identified. Selecting a first set of electrodes, each located within a first distance from the selected electrode, wherein the first set of electrodes does not include the selected electrode. Performing a first spatial electrode signal analysis of the electrical activity of the selected electrodes according to the signals from the first set of electrodes, Selecting a second set of electrodes located within a second distance from the selected electrode, wherein the second distance is greater than the first distance, and the second set of electrodes does not include the selected electrode. The system is collectively configured to perform a second spatial electrode signal analysis of the electrical activity of the selected electrodes according to the signals from the second set of electrodes, The system further comprises one or more processors further collectively configured to generate at least a first electroanatomical map of the heart showing the electrical activity of cardiac tissue corresponding to each of the plurality of locations, and a second electroanatomical map of the heart showing the electrical activity of cardiac tissue corresponding to each of the plurality of further locations, wherein the first electroanatomical map shows electrical activity or scar tissue identified based on the first spatial electrode signal analysis, and the second electroanatomical map shows electrical activity or scar tissue identified based on the second spatial electrode signal analysis. (12) The system according to embodiment 11, wherein the first spatial electrode signal analysis and the second spatial signal analysis are performed using a previously trained neural network. (13) The system according to embodiment 11, wherein the first set of electrodes and the second set of electrodes are separated by a dielectric layer. (14) The system according to embodiment 11, wherein the first set of electrodes and the second set of electrodes are arranged on different planes. (15) The system according to Embodiment 11, wherein the first spatial electrode signal analysis is at least partially based on the first distance, and the second spatial electrode signal analysis is at least partially based on the second distance.

[0089] (16) The system according to Embodiment 15, wherein a far-field signal is identified based on the first spatial analysis and the second spatial analysis, the far-field signal is subtracted from an electrical signal from the first electrode, and the far-field signal is determined from the signals from a first set of electrodes based on a first distance and from a second set of electrodes based on a second first distance. (17) The system according to embodiment 11, wherein the first electrode is located at a first location within the heart. (18) The system according to embodiment 17, wherein a signal is emitted from the first location along the first direction, and the first set of electrodes and the second set of electrodes are aligned at an angle perpendicular to the first direction. (19) The system according to embodiment 11, wherein the multi-electrode catheter comprises at least one pair of electrodes, and the at least one pair of electrodes are spaced apart from each other by a distance smaller than the dimensions of the pair of electrodes. (20) A computer-readable storage medium that allows a computer to access information about multiple locations in cardiac tissue in the heart. Receiving the electrical activity of the patient's heart from multiple electrodes of a multi-electrode catheter, By selecting an electrode from the aforementioned plurality of electrodes, the selected electrode is identified. Selecting a first set of electrodes, each located within a first distance from the selected electrode, wherein the first set of electrodes does not include the selected electrode. Performing a first spatial electrode signal analysis of the electrical activity of the selected electrodes according to the signals from the first set of electrodes, Selecting a second set of electrodes, each located within a second distance from the selected electrode, wherein the second distance is greater than the first distance, and the second set of electrodes does not include the selected electrode. The program code includes a program that performs a second spatial electrode signal analysis of the electrical activity of the selected electrode according to the signals from the second set of electrodes, The computer-readable storage medium further includes program code for causing a computer to generate at least a first electroanatomical map and a second electroanatomical map of the heart showing the electrical activity of the cardiac tissue corresponding to the plurality of locations, wherein the first electroanatomical map shows electrical activity or scar tissue identified based on the first spatial electrode analysis, and the second electroanatomical map shows electrical activity or scar tissue identified based on the second spatial electrode signal analysis.

Claims

1. It is a system, One or more processors that communicate with multiple electrodes of a multi-electrode catheter, The display and The system comprises the display and a memory that communicates with one or more processors, and the one or more processors communicate with multiple locations of cardiac tissue in the heart. Receiving the electrical activity of the patient's heart from multiple electrodes of a multi-electrode catheter, By selecting an electrode from the aforementioned plurality of electrodes, the selected electrode is identified. Selecting a first set of electrodes, each located within a first distance from the selected electrode, wherein the first set of electrodes does not include the selected electrode. Performing a first spatial electrode signal analysis of the electrical activity of the selected electrodes according to the signals from the first set of electrodes, Selecting a second set of electrodes located within a second distance from the selected electrode, wherein the second distance is greater than the first distance, and the second set of electrodes does not include the selected electrode. The system is collectively configured to perform a second spatial electrode signal analysis of the electrical activity of the selected electrodes according to the signals from the second set of electrodes, The system further comprises one or more processors further collectively configured to generate at least a first electroanatomical map of the heart showing the electrical activity of cardiac tissue corresponding to each of the plurality of locations, and a second electroanatomical map of the heart showing the electrical activity of cardiac tissue corresponding to each of the plurality of further locations, wherein the first electroanatomical map shows electrical activity or scar tissue identified based on the first spatial electrode signal analysis, and the second electroanatomical map shows electrical activity or scar tissue identified based on the second spatial electrode signal analysis.

2. The system according to claim 1, wherein the first spatial electrode signal analysis and the second spatial signal analysis are performed using a previously trained neural network.

3. The system according to claim 1, wherein the first set of electrodes and the second set of electrodes are separated by a dielectric layer.

4. The system according to claim 1, wherein the first set of electrodes and the second set of electrodes are arranged on different planes.

5. The system according to claim 1, wherein the first spatial electrode signal analysis is at least partially based on the first distance, and the second spatial electrode signal analysis is at least partially based on the second distance.

6. The system according to claim 5, wherein a far-field signal is identified based on the first spatial analysis and the second spatial analysis, the far-field signal is subtracted from an electrical signal from the first electrode, and the far-field signal is determined from the signals from a first set of electrodes based on a first distance and from a second set of electrodes based on a second first distance.

7. The system according to claim 1, wherein the first electrode is located at a first location within the heart.

8. The system according to claim 7, wherein a signal is emitted from a first location along a first direction, and the first set of electrodes and the second set of electrodes are aligned at an angle perpendicular to the first direction.

9. The system according to claim 1, wherein the multi-electrode catheter comprises at least one pair of electrodes, and the at least one pair of electrodes are spaced apart from each other by a distance smaller than the dimensions of the pair of electrodes.

10. A computer-readable storage medium that allows a computer to access information about multiple locations in cardiac tissue within the heart. Receiving the electrical activity of the patient's heart from multiple electrodes of a multi-electrode catheter, By selecting an electrode from the aforementioned plurality of electrodes, the selected electrode is identified. Selecting a first set of electrodes, each located within a first distance from the selected electrode, wherein the first set of electrodes does not include the selected electrode. Performing a first spatial electrode signal analysis of the electrical activity of the selected electrodes according to the signals from the first set of electrodes, Selecting a second set of electrodes, each located within a second distance from the selected electrode, wherein the second distance is greater than the first distance, and the second set of electrodes does not include the selected electrode. The program code includes a program that performs a second spatial electrode signal analysis of the electrical activity of the selected electrode according to the signals from the second set of electrodes, The computer-readable storage medium further includes program code for causing a computer to generate at least a first electroanatomical map and a second electroanatomical map of the heart showing the electrical activity of the cardiac tissue corresponding to the plurality of locations, wherein the first electroanatomical map shows electrical activity or scar tissue identified based on the first spatial electrode analysis, and the second electroanatomical map shows electrical activity or scar tissue identified based on the second spatial electrode signal analysis.

11. It is a method, (a) Receiving electrical activity from the patient's heart through multiple electrodes of a multi-electrode catheter, (b) With respect to the first location within the heart, (i) Selecting a first electrode from the plurality of electrodes, (ii) Selecting a first set of electrodes that are each located within a first distance from the first electrode, wherein the first set of electrodes does not include the first electrode. (iii) Performing a first spatial electrode signal analysis of the electrical activity of the first electrode according to the signals from the first set of electrodes, (iv) Selecting a second set of electrodes that are each located within a second distance from the first electrode, wherein the second distance is greater than the first distance, and the second set of electrodes does not include the first electrode. (v) Perform a second spatial electrode signal analysis of the electrical activity of the first electrode according to the signals from the second set of electrodes, (c) Repeat step (b) for several further locations within the heart, (d) A method comprising generating a first electroanatomical map of the heart showing electrical activity of cardiac tissue corresponding to at least the first location and the plurality of further locations, and a second electroanatomical map of the heart showing electrical activity of cardiac tissue corresponding to the first location and the plurality of further locations, wherein the first electroanatomical map shows electrical activity or scar tissue identified based on the first spatial electrode signal analysis, and the second electroanatomical map shows electrical activity or scar tissue identified based on the second spatial electrode signal analysis.

12. The method according to claim 11, wherein the first spatial electrode signal analysis and the second spatial signal analysis are performed using a previously trained neural network.

13. The method according to claim 11, wherein the first set of electrodes and the second set of electrodes are separated by a dielectric layer.

14. The method according to claim 11, wherein the first set of electrodes and the second set of electrodes are arranged on different planes.

15. The method according to claim 11, wherein the first spatial electrode signal analysis is at least partially based on the first distance, and the second spatial electrode signal analysis is at least partially based on the second distance.

16. The method according to claim 15, wherein a far-field signal is identified based on the first spatial analysis and the second spatial analysis, the far-field signal is subtracted from an electrical signal from the first electrode, and the far-field signal is determined from the signals from a first set of electrodes based on the first distance and from the signals from a second set of electrodes based on the second distance.

17. The method according to claim 11, wherein the first electrode is located at the first location within the heart.

18. The method according to claim 17, wherein a signal is emitted from a first location along a first direction, and the first set of electrodes and the second set of electrodes are aligned at an angle perpendicular to the first direction.

19. The method according to claim 11, wherein the multi-electrode catheter comprises at least one pair of electrodes, and the at least one pair of electrodes are spaced apart from each other by a distance smaller than the dimensions of the pair of electrodes.

20. The method according to claim 11, wherein the multi-electrode catheter is positioned on the endocardial tissue inside the heart or on the epicardial tissue outside the heart.

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