Weighted analysis of electrodes on different sides of a multi-electrode catheter

Abstract

To generate, visualize, and display information representing cardiac signals. [Solution] Electrical activity in a patient's heart is detected using a multi-electrode catheter having a first plurality of electrodes on a first side and a second plurality of electrodes on a second side. One of the first plurality of electrodes faces cardiac tissue at a first location, and one of the second plurality of electrodes faces away from cardiac tissue. Signal analysis is performed for the first location based on a first signal received from the electrode facing cardiac tissue and a second signal received from the electrode facing away from cardiac tissue. Signal analysis includes applying weighting to the first signal and at least one of the second signals. This process is repeated for several further locations of cardiac tissue in the heart, and at least one electroanatomical map of the heart is generated based on the signal analysis.

Description

[Technical Field]

[0001] (Cross-reference of related applications) This disclosure covers several improved techniques for analyzing cardiac signals and 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 September 23, 2024, which is incorporated herein by reference in its entirety. The disclosed technology also relates to the concepts discussed in U.S. Patent Application No. 18 / 072,793, filed on 1 December 2022, entitled "Intracardiac Unipolar Far Field Cancelation Using Multiple Electrode Catheters"; U.S. Patent Application No. 18 / 756,903, filed on 27 June 2024, entitled "Intracardiac Unipolar Far Field Cancelation Using Multiple Electrode Catheters And Methods For Creating An Ecg Depth And Radial Lens"; U.S. Patent Application No. 19 / 238,791, filed on 16 June 2025, entitled "System and Method for Far-field Voltage Mapping for Scar Severity Estimation"; and U.S. Patent Application No. 18 / 505,956, filed on 9 November 2023, entitled "Catheter With Flexible Polymer As Outer Support Structure". All of these existing applications are incorporated in their entirety by reference and provide background relevant to the technology disclosed herein. The improvements disclosed herein may be used in conjunction with the technology disclosed in the aforementioned applications.

[0002] (Field of Invention) This disclosure relates to generating, visualizing, and displaying information representing cardiac signals. [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 Application 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); Patent Application 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); Patent Application 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 Patent Application 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. [Overview of the project] [Means for solving the problem]

[0009] This disclosure describes a weighted analysis of electrodes in a multi-electrode catheter. Electrical activity is received from a multi-electrode catheter in the patient's heart. The multi-electrode catheter has a first plurality of electrodes on a first side (e.g., arranged on a first plane) and a second plurality of electrodes on a second side (e.g., arranged on a second plane parallel to the first plane). At least one of the first plurality of electrodes on the first side faces cardiac tissue at a first position, and at least one of the second plurality of electrodes on the second side faces away from cardiac tissue. Electrical activity is received from at least one electrode on the first side and at least one electrode on the second side. A signal analysis of the electrical activity at a first position in cardiac tissue is performed based on a first signal received from at least one electrode on the first side and a second signal received from at least one electrode on the second side. The signal analysis includes applying weighting to at least one of the first signal and the second signal. This process is repeated for multiple further locations of cardiac tissue within the heart, and based on the signal analysis, at least one electroanatomical map of the heart is generated. The map shows the electrical activity at the first location and multiple further locations of cardiac tissue.

[0010] In some examples, the first and second sets of electrodes are bipolar electrodes or ring-shaped electrodes. In some examples, at least one of the first sets of electrodes on the first side is in contact with cardiac tissue at a first position. In some examples, at least one of the second sets of electrodes on the second side is in contact with the blood flowing through the heart. In some examples, the first sets of electrodes on the first side and the second sets of electrodes on the second side are separated by a dielectric layer.

[0011] In some cases, a tissue proximity index (TPI) is determined. The TPI is associated with the proximity of at least one of a first set of electrodes on a first side to cardiac tissue at a first location, and the signal analysis of electrical activity at the first location of cardiac tissue is based at least on the value of the tissue proximity index.

[0012] In some examples, signal analysis includes (i) determining a first gradient value associated with a first signal received from at least one electrode on a first side; (ii) determining a second gradient value associated with a second signal received from at least one electrode on a second side; and (iii) determining, based on the analysis of the first and second gradient values, whether a first plurality of electrodes on the first side or a second plurality of electrodes on the second side are facing cardiac tissue. In some such examples, determining whether a first plurality of electrodes on the first side or a second plurality of electrodes on the second side are facing cardiac tissue is based on one or more ratios of one of the first gradient values ​​to one of the second gradient values.

[0013] The embodiments herein improve upon existing computer-based electroanatomical mapping systems. In particular, the disclosed signal analysis techniques apply at least one weighting to one or more signals received from electrodes on opposing surfaces of a multi-electrode catheter, improving the capabilities of the computer itself and enabling 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]

[0014] 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] A further example of a multi - electrode catheter design for implementing the technology disclosed herein according to one or more embodiments is shown. [Figure 5A] A further example of a multi - electrode catheter design for implementing the technology disclosed herein is shown, where the unipolar electrodes on the catheter of FIG. 5 are replaced by bipolar split electrodes. [Figure 6A] A further example of a multi - electrode catheter design for implementing the technology disclosed herein according to one or more embodiments is shown. [Figure 6B] A further example of a multi - electrode catheter design for implementing the technology disclosed herein according to one or more embodiments is shown. [Figure 7] A part of the heart tissue to which the disclosed technology according to one or more embodiments is applied is shown. [Figure 8] Techniques for separately identifying electrical activities in different heart tissue layers using a multi - electrode catheter according to one or more embodiments are shown. [Figure 9] It is a flowchart showing a method for generating an electroanatomical map of the heart showing the electrical activity of heart tissue according to one or more embodiments.

Mode for Carrying Out the Invention

[0015] The disclosed technology recognizes that in various use cases, one side of a multi - electrode catheter faces away from the heart tissue and is in a blood pool. The disclosed technology recognizes that signals collected from electrodes (e.g., bipolar or unipolar electrodes) within the blood pool often contain significant far - field information. However, as recognized by the disclosure described below, since the electrodes within the blood pool do not contact the heart tissue, the results of cardiac mapping are enhanced by weighting the signals from the electrodes within the blood pool (e.g., QRS signals) differently, for example, than the signals from the electrodes facing the heart tissue, before processing the signals from the electrodes within the blood pool with the signals from other electrodes.

[0016] Refer to FIG. 1, which shows an exemplary system 10 (e.g., a medical device apparatus and / or catheter - based electrophysiological mapping and ablation) in which one or more features of the subject matter of this specification can be implemented according to one or more embodiments. As shown, system 10 includes a recorder 11, a heart 12, a catheter 14, a model or anatomical map 20, a potential map 21, a spline 22, a patient 23, a physician 24 (or medical professional, healthcare provider, or clinician), a position pad 25, electrodes 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 two or more of that element and / or that item. The example of system 10 shown in FIG. 1 can be modified to implement the embodiments disclosed herein. Embodiments of the present disclosure can also be similarly applied using other system components and configurations. Additionally, system 10 can 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 the cardiac chambers or vascular structures of the heart 12 through the patient's vascular system. Typically, a delivery sheath catheter is inserted into the left or right atrium near a desired location in the heart 12. The plurality of catheters can then be inserted into the delivery sheath catheter to reach the desired location. The plurality of catheters 14 may include a catheter dedicated to sensing intracardiac electrogram (IEGM) signals, a catheter dedicated to ablation, and / or a catheter dedicated to both sensing and ablation. An exemplary catheter 14 configured to sense IEGM is illustrated herein. To sense a target site in the heart 12, the physician 24 brings the distal end 28 of the catheter 14 into contact with the heart wall. For ablation, the physician 24 similarly brings the distal end of the ablation catheter to the target site for ablation.

[0018] In Figure 1, the catheter 14 is shown to include a plurality of electrodes 26 optionally distributed across a plurality of splines 22 at the distal tip 28 and configured to sense IEGM signals. In some examples, the catheter 14 is a multi-electrode configured to sense cardiac signals. Exemplary multi-electrode catheters for implementing the mapping techniques disclosed herein are shown in Figures 4–6 and discussed in further detail below. The catheter 14 may additionally include a sensor 29 embedded in 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 including three magnetic coils for sensing three-dimensional (3D) position and orientation. The catheter 14 may 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 No. 5,5391,199, No. 5,443,489, No. 5,558,091, No. 6,172,499, No. 6,239,724, No. 6,332,089, No. 6,484,118, No. 6,618,612, No. 6,690,963, No. 6,788,967, and No. 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 patches 38 (e.g., electrode skin patches), thereby allowing the location of each electrode to be triangulated through the patches 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 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 power 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., one 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 may 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 the 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 transmitters and receivers 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 the 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. In one embodiment, the unipolar electrodes are ring 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] In some implementations of the catheter 400, the side of the catheter facing away from cardiac tissue is in a blood pool. The disclosed technology recognizes that signals collected from electrodes in the blood pool (e.g., bipolar or monopolar electrodes) (hereafter referred to as “blood pool electrodes”) often contain significant far-field information. However, since the blood pool electrodes do not come into contact with cardiac tissue, signals from the blood pool electrodes (e.g., QRS signals) should be appropriately weighted before being processed by other electrodes.

[0066] In the example, the weight of each electrode in the blood pool is calculated based on its nearest tissue electrode. In some embodiments, after weighting the QRS signals from the blood pool electrodes, the near-field signal is estimated by subtracting the weighted QRS signal from the blood pool electrodes from the QRS signal from the nearest electrode that is in contact with or close to cardiac tissue (closest to the blood pool electrodes that underwent the previous weighting analysis). In some examples, a tissue proximity index (TPI) is used to determine whether an electrode close to cardiac tissue is close enough to cardiac tissue to collect a useful signal. Electrodes that are in contact with cardiac tissue or have a sufficient TPI are called “tissue electrodes”. In the example above, after weighting the QRS signals from the blood pool electrodes, the near-field signal received by the nearest tissue electrode is determined by subtracting the weighted QRS signal from the blood pool electrodes from the QRS signal from the nearest tissue electrode.

[0067] In some embodiments, the far-field component of the QRS signal from each tissue electrode is estimated by processing weighted signals from the surrounding blood pool and the tissue electrode. The estimated far-field signal of the QRS signal from each tissue electrode is then subtracted from the total QRS signal of the tissue electrode to estimate the near-field signal received by the tissue electrode.

[0068] In certain cases, the weighting coefficient (ω) of the blood pool electrode is determined according to the following formula.

[0069]

number

[0070] Continuing with the specific example, the weighting coefficient (ω) determined for the blood pool electrode is then used to determine the weighted QRS signal of the blood pool electrode.

[0071]

number

[0072]

number

[0073] The weighting techniques disclosed herein are not limited to processing QRS signals but may be used to process any electrical signals collected by electrodes. It should be understood that this disclosure is not limited to performing signal weighting using the specific formulas described above, but rather includes any suitable formulas for weighting signals collected from multi-electrode catheters.

[0074] In some cases, the signal analysis described in relation to Figures 7 and 8 below is performed before applying the weighting formula described above to determine whether one or more electrodes on a given surface of the catheter are in the blood pool.

[0075] Figure 7 shows a portion of cardiac tissue. In the depiction, the cardiac tissue surface 702 (which may be in direct contact with or close to the electrodes during medical procedures) is at the top. Beneath surface 702 are three tissue layers 704, 706, and 708, each of which is located at a different depth from the tissue surface. The disclosed technique provides for the creation of separate electroanatomical maps, each showing electrical activity in one of the tissue layers 704, 706, and 708. For example, a first electroanatomical map of a first tissue layer 704 is derived from electrical signals sensed at a first depth 710 of the cardiac tissue, or sensed over part or all of the first layer 704 between the cardiac tissue surface 702 and the first depth 710; a second electroanatomical map of a second tissue layer 706 is derived from electrical signals sensed at a second depth 712 of the cardiac tissue, or alternatively, sensed over part or all of the second layer 706 between the first depth 710 and the second depth 712; and a third electroanatomical map of a third tissue layer 708 is derived from electrical signals sensed at a third depth 714 of the cardiac tissue, or alternatively, sensed over part or all of the third layer 708 between the second depth 712 and the third depth 714. It will be understood that the techniques disclosed herein can be used to create maps of more than three tissue layers.

[0076] FIG. 8 shows a technique for separately identifying electrical activity in different tissue layers 704, 706, 708 using a multi - electrode catheter having monopolar electrodes (labeled e1, e2, and e3) such as the catheter 500 described above. Although not shown, the techniques described in relation to FIG. 8 can also be applied using the catheter 400, and the monopolar electrodes are positioned on different faces of the catheter. Generally, the techniques disclosed herein utilize differences in electrode surface area and / or the spacing of electrodes from each other in the x - y plane (i.e., the plane parallel to the face of the multi - electrode catheter) or along the z - axis (perpendicular to the face of the multi - electrode catheter) to estimate or detect voltages at different tissue depths. Returning to FIG. 8, in the figure, electrode e1 and electrode e2 are separated by a distance (L1), and electrode e2 and electrode e3 are separated by a distance (L2). For simplicity, the calculations described below assume that L1 = L2, although it will be understood that the electrodes need not be equally spaced. In the following calculations, the far - field voltages at electrodes e1, e2, and e3 are, respectively, V1 ff , V2 ff and V3 ff . For simplicity, the far - field effect from layer 1 (Vff layer 1) is assumed to be V1 ff - V2 ff , and the far - field effect from the combined layers 1 and 2 is assumed to be V1 ff - V3 ff . In more advanced implementations, the far - field voltages collected at e1, e2, and e3 can be processed, weighted, and / or filtered to remove or adjust specific signal components before performing the calculations using this technique. To determine the far - field effect from only layer 2 (Vff layer 2), the following equation is used.

[0077]

Equation

[0078] Similarly, to separate the far - field effect from only layer 3 (V ff層3 ), the following equation is used.

[0079]

number

[0080] In some examples, the far-field signal is estimated by applying the technique described in U.S. Patent Application Publication No. 2023 / 0181087 to each of one or more electrodes and / or different layers of cardiac tissue. For example, the near-field signal at each of the different tissue depths below the surface position is determined by subtracting the far-field signal component associated with each layer (Vff layer n calculated using the above formula) from the signal received by the electrode directly adjacent to the tissue surface at the position of interest. In some examples, near-field activity is estimated first for the layer directly adjacent to the electrode, which is a shallow layer, and the voltage values ​​for deeper layers are generated by subtracting the far-field signal component associated with each layer (Vff layer n calculated using the above formula) from the signal detected for the shallow layer.

[0081] In one example, the technique described above in relation to Figure 8 is applied to each electrode on one surface (the first surface) of the catheter 400 by treating each individual electrode on the first surface of the catheter 400 as a unipolar electrode in order to determine V1 to V3 for each electrode on the first surface. The same technique is applied to each electrode on the opposing surface (the second surface) by treating each individual electrode on the second surface of the catheter as a unipolar electrode in order to determine V1 to V3 for each electrode on the second surface. Next, for each electrode on the first surface of the catheter, a first gradient value is determined that represents the rate at which the voltage changes as the distance from the electrode changes, and for each electrode on the second surface of the catheter, a second gradient value is determined that represents the rate at which the voltage changes as the distance from the electrode changes. In some examples, it is assumed that signals from electrodes in contact with or facing cardiac tissue have a higher frequency than signals coming from electrodes in the blood pool, and the gradient value (indicating frequency) is associated with the higher frequency signal and used to identify which surface of the catheter has electrodes in the blood pool. In alternative embodiments, it is assumed that the impedance profile of signals from electrodes in contact with or facing cardiac tissue will differ from the impedance profile of signals coming from electrodes in the blood pool, and the impedance values ​​are used to identify which side of the catheter has electrodes in the blood pool. In one example, one or more ratios of a first gradient value and a second gradient value are analyzed to determine the side of the catheter in the blood pool. In some cases, the signal

[0082] In general, the weighting techniques disclosed may be used to better estimate near-field and far-field signals collected using a catheter having at least several electrodes in a blood pool. Such weighting techniques may be used in combination with either of the techniques described above to (i) create multiple signal mappings of cardiac tissue based on signals derived from different sets of electrodes, as disclosed in U.S. Patent Application No. 19 / 334,535, titled "Creating Multiple Layers Of Electro-Anatomical Mappings of Cardiac Tissue At Different Depths Using Multi-Polar Signals," and / or (ii) create electroanatomical mappings of cardiac tissue at different depths, as disclosed in U.S. Patent Application No. 19 / 334,525, titled "Creating Electro-Anatomical Mappings of Cardiac Tissue at Different Depths" (which is incorporated herein by reference in its entirety), filed on the same date as this specification.

[0083] Figure 9 shows a flowchart of method 900 for applying the weighting technique disclosed herein by detecting electrical activity from a multi-electrode catheter in the heart, the multi-electrode catheter having a first plurality of electrodes on a first side and a second plurality of electrodes on a second side. The first plurality of electrodes and the second plurality of electrodes may consist of bipolar electrodes or ring electrodes. At least one of the first plurality of electrodes on the first side faces cardiac tissue at a first position, and at least one of the second plurality of electrodes on the second side faces away from cardiac tissue. In step 902, electrical activity is received from at least one electrode on the first side and at least one electrode on the second side. In this step, a first signal corresponding to the electrical activity at a first position is sensed from at least one electrode on the first side, and a second signal corresponding to the electrical activity is sensed from at least one electrode on the second side. In step 904, a weighting value is determined for at least one of the first signal and the second signal. For example, in this step, weighting coefficients for the second signal are calculated and used to derive a weighted version of the second signal. In step 906, a signal analysis of the electrical activity at a first location of cardiac tissue is performed based on the application of different weights to the first and second signals. For example, the first signal may have a weight of 1, while the second signal is weighted based on the results of step 904. This process is repeated for several further locations of cardiac tissue in the heart until all locations of interest have been processed. In step 908, at least one electroanatomical map of the heart is generated based on the signal analysis. The map shows the electrical activity at the first location and several further locations of cardiac tissue. Alternatively, the map shows scar tissue (e.g., areas of low conductivity) identified based on the signal analysis.

[0084] 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 may 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.

[0085] 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 they may operate or execute a combination of dedicated hardware and computer instructions.

[0086] 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.

[0087] 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.

[0088] 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.

[0089] 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.

[0090] [Implementation Method] (1) A method, (a) Receiving electrical activity from a multi-electrode catheter in the patient's heart, wherein the multi-electrode catheter has a first plurality of electrodes on a first side and a second plurality of electrodes on a second side, At least one of the first plurality of electrodes on the first side is close to cardiac tissue at the first position, and at least one of the second plurality of electrodes on the second side faces away from the cardiac tissue in the heart. The electrical activity is received from at least one electrode on the first side and at least one electrode on the second side, and the electrical activity is received from the multi-electrode catheter. (b) Performing a signal analysis of the electrical activity at the first location of cardiac tissue based on a first signal received from the at least one electrode on the first side and a second signal received from the at least one electrode on the second side, wherein the signal analysis includes applying weighting to at least one of the first signal and the second signal. (c) Repeat steps (a) to (b) for several further locations of cardiac tissue in the heart, (e) A method comprising generating, based on the signal analysis, at least one electroanatomical map of the heart showing electrical activity or scar tissue at the first location and the plurality of further locations of the cardiac tissue. (2) The method according to Embodiment 1, wherein the first plurality of electrodes and the second plurality of electrodes are bipolar electrodes or ring-shaped electrodes. (3) The method according to Embodiment 1, wherein at least one of the first plurality of electrodes on the first side is in contact with cardiac tissue at the first position. (4) The method according to Embodiment 1, wherein at least one of the second plurality of electrodes on the second side is in contact with the blood flowing through the heart. (5) The method according to Embodiment 1, wherein the first plurality of electrodes on the first side and the second plurality of electrodes on the second side are separated by a dielectric layer.

[0091] (6) The method according to Embodiment 1, further comprising determining a tissue proximity index associated with the proximity of at least one of the first plurality of electrodes on the first side to the cardiac tissue at the first location, wherein the signal analysis of electrical activity at the first location of the cardiac tissue is based at least on the value of the tissue proximity index. (7) The signal analysis is Determining a first gradient value associated with the first signal received from the at least one electrode on the first side, Determining a second gradient value associated with the second signal received from the at least one electrode on the second side, The method according to Embodiment 1, further comprising determining, based on an analysis of the first gradient value and the second gradient value, whether the first plurality of electrodes on the first side or the second plurality of electrodes on the second side are facing the cardiac tissue. (8) The method according to Embodiment 7, wherein determining whether the first plurality of electrodes on the first side or the second plurality of electrodes on the second side are facing the cardiac tissue is based on one or more ratios of one of the first gradient values ​​to one of the second gradient values. (9) A system, One or more processors that communicate with multiple electrodes of a multi-electrode catheter, The system comprises a display and a memory that communicates with one or more processors, and the one or more processors communicate with each of a plurality of locations in the patient's heart. Receiving electrical activity from a multi-electrode catheter in the heart, wherein the multi-electrode catheter has a first plurality of electrodes on a first side and a second plurality of electrodes on a second side. At least one of the first plurality of electrodes on the first side is in close proximity to cardiac tissue at a certain position, and at least one of the second plurality of electrodes on the second side faces away from the cardiac tissue in the heart. The electrical activity is received from at least one electrode on the first side and at least one electrode on the second side, and the electrical activity is received from the multi-electrode catheter. Performing a signal analysis of electrical activity at the location of cardiac tissue based on a first signal received from the at least one electrode on the first side and a second signal received from the at least one electrode on the second side, wherein the signal analysis includes applying weighting to at least one of the first signal and the second signal. A system collectively configured to perform the following: generate at least one electroanatomical map of the heart showing electrical activity or scar tissue at each of the plurality of locations within the heart, based on the signal analysis. (10) The system according to embodiment 9, wherein the first plurality of electrodes and the second plurality of electrodes are bipolar electrodes or ring-shaped electrodes.

[0092] (11) The system according to Embodiment 9, wherein at least one of the first plurality of electrodes on the first side is in contact with cardiac tissue at a first position. (12) The system according to Embodiment 9, wherein at least one of the second plurality of electrodes on the second side is in contact with the blood flowing through the heart. (13) The system according to Embodiment 9, wherein the first plurality of electrodes on the first side and the second plurality of electrodes on the second side are separated by a dielectric layer. (14) The system according to Embodiment 9, further comprising determining a tissue proximity index associated with the proximity of at least one of the first plurality of electrodes on the first side to the cardiac tissue at a first location, wherein the signal analysis of electrical activity at the first location of the cardiac tissue is based at least on the value of the tissue proximity index. (15) The signal analysis is Determining a first gradient value associated with the first signal received from the at least one electrode on the first side, Determining a second gradient value associated with the second signal received from the at least one electrode on the second side, The system according to Embodiment 9, further comprising determining, based on an analysis of the first gradient value and the second gradient value, whether the first plurality of electrodes on the first side or the second plurality of electrodes on the second side are facing the cardiac tissue.

[0093] (16) The system according to Embodiment 15, wherein determining whether the first plurality of electrodes on the first side or the second plurality of electrodes on the second side are facing the cardiac tissue is based on one or more ratios of one of the first gradient values ​​to one of the second gradient values. (17) A computer-readable storage medium that allows a computer to access multiple locations of cardiac tissue in a patient's heart. Receiving electrical activity from a multi-electrode catheter in the heart, wherein the multi-electrode catheter has a first plurality of electrodes on a first side and a second plurality of electrodes on a second side. At least one of the first plurality of electrodes on the first side is in close proximity to cardiac tissue at a certain position, and at least one of the second plurality of electrodes on the second side faces away from the cardiac tissue in the heart. The electrical activity is received from at least one electrode on the first side and at least one electrode on the second side, and the electrical activity is received from the multi-electrode catheter. Performing a signal analysis of electrical activity at the location of cardiac tissue based on a first signal received from the at least one electrode on the first side and a second signal received from the at least one electrode on the second side, wherein the signal analysis includes applying weighting to at least one of the first signal and the second signal. A computer-readable storage medium comprising program code for causing the system to generate at least one electroanatomical map of the heart showing electrical activity or scar tissue at each of the plurality of locations within the heart, based on the signal analysis. (18) The computer-readable storage medium according to Embodiment 17, wherein the first plurality of electrodes and the second plurality of electrodes are bipolar electrodes or ring-shaped electrodes. (19) The computer-readable storage medium according to Embodiment 17, wherein at least one of the first plurality of electrodes on the first side is in contact with cardiac tissue at a first position. (20) The computer-readable storage medium according to Embodiment 17, wherein at least one of the second plurality of electrodes on the second side is in contact with the blood flowing through the heart.

Claims

1. It is a system, One or more processors that communicate with multiple electrodes of a multi-electrode catheter, The system comprises a display and a memory that communicates with one or more processors, and the one or more processors communicate with each of a plurality of locations in the patient's heart. Receiving electrical activity from a multi-electrode catheter in the heart, wherein the multi-electrode catheter has a first plurality of electrodes on a first side and a second plurality of electrodes on a second side. At least one of the first plurality of electrodes on the first side is in close proximity to cardiac tissue at a certain position, and at least one of the second plurality of electrodes on the second side faces away from the cardiac tissue in the heart. The electrical activity is received from at least one electrode on the first side and at least one electrode on the second side, and the electrical activity is received from the multi-electrode catheter. Performing a signal analysis of electrical activity at the location of cardiac tissue based on a first signal received from the at least one electrode on the first side and a second signal received from the at least one electrode on the second side, wherein the signal analysis includes applying weighting to at least one of the first signal and the second signal. A system collectively configured to perform the following: generate at least one electroanatomical map of the heart showing electrical activity or scar tissue at each of the plurality of locations within the heart, based on the signal analysis.

2. The system according to claim 1, wherein the first plurality of electrodes and the second plurality of electrodes are bipolar electrodes or ring-shaped electrodes.

3. The system according to claim 1, wherein at least one of the first plurality of electrodes on the first side is in contact with cardiac tissue at a first position.

4. The system according to claim 1, wherein at least one of the second plurality of electrodes on the second side is in contact with the blood flowing through the heart.

5. The system according to claim 1, wherein the first plurality of electrodes on the first side and the second plurality of electrodes on the second side are separated by a dielectric layer.

6. The system according to claim 1, further comprising determining a tissue proximity index associated with the proximity of at least one of the first plurality of electrodes on the first side to the cardiac tissue at a first location, wherein the signal analysis of electrical activity at the first location of the cardiac tissue is based at least on the value of the tissue proximity index.

7. The aforementioned signal analysis, Determining a first gradient value associated with the first signal received from the at least one electrode on the first side, Determining a second gradient value associated with the second signal received from the at least one electrode on the second side, The system according to claim 1, further comprising determining, based on an analysis of the first gradient value and the second gradient value, whether the first plurality of electrodes on the first side or the second plurality of electrodes on the second side are facing the cardiac tissue.

8. The system according to claim 7, wherein determining whether the first plurality of electrodes on the first side or the second plurality of electrodes on the second side are facing the cardiac tissue is based on one or more ratios of one of the first gradient values ​​to one of the second gradient values.

9. A computer-readable storage medium that allows a computer to access information about multiple locations of cardiac tissue in a patient's heart. Receiving electrical activity from a multi-electrode catheter in the heart, wherein the multi-electrode catheter has a first plurality of electrodes on a first side and a second plurality of electrodes on a second side. At least one of the first plurality of electrodes on the first side is in close proximity to cardiac tissue at a certain position, and at least one of the second plurality of electrodes on the second side faces away from the cardiac tissue in the heart. The electrical activity is received from at least one electrode on the first side and at least one electrode on the second side, and the electrical activity is received from the multi-electrode catheter. Performing a signal analysis of electrical activity at the location of cardiac tissue based on a first signal received from the at least one electrode on the first side and a second signal received from the at least one electrode on the second side, wherein the signal analysis includes applying weighting to at least one of the first signal and the second signal. A computer-readable storage medium comprising program code for causing the system to generate at least one electroanatomical map of the heart showing electrical activity or scar tissue at each of the plurality of locations within the heart, based on the signal analysis.

10. The computer-readable storage medium according to claim 9, wherein the first plurality of electrodes and the second plurality of electrodes are bipolar electrodes or ring-shaped electrodes.

11. The computer-readable storage medium according to claim 9, wherein at least one of the first plurality of electrodes on the first side is in contact with cardiac tissue at a first position.

12. The computer-readable storage medium according to claim 9, wherein at least one of the second plurality of electrodes on the second side is in contact with the blood flowing through the heart.

13. It is a method, (a) Receiving electrical activity from a multi-electrode catheter in the patient's heart, wherein the multi-electrode catheter has a first plurality of electrodes on a first side and a second plurality of electrodes on a second side, At least one of the first plurality of electrodes on the first side is close to cardiac tissue at the first position, and at least one of the second plurality of electrodes on the second side faces away from the cardiac tissue in the heart. The electrical activity is received from at least one electrode on the first side and at least one electrode on the second side, and the electrical activity is received from the multi-electrode catheter. (b) Performing a signal analysis of the electrical activity at the first location of cardiac tissue based on a first signal received from the at least one electrode on the first side and a second signal received from the at least one electrode on the second side, wherein the signal analysis includes applying weighting to at least one of the first signal and the second signal. (c) Repeating steps (a) to (b) for multiple further locations of cardiac tissue in the heart, (e) A method comprising generating, based on the signal analysis, at least one electroanatomical map of the heart showing electrical activity or scar tissue at the first location and the plurality of further locations of the cardiac tissue.

14. The method according to claim 13, wherein the first plurality of electrodes and the second plurality of electrodes are bipolar electrodes or ring-shaped electrodes.

15. The method according to claim 13, wherein at least one of the first plurality of electrodes on the first side is in contact with cardiac tissue at the first position.

16. The method according to claim 13, wherein at least one of the second plurality of electrodes on the second side is in contact with the blood flowing through the heart.

17. The method according to claim 13, wherein the first plurality of electrodes on the first side and the second plurality of electrodes on the second side are separated by a dielectric layer.

18. The method according to claim 13, further comprising determining a tissue proximity index associated with the proximity of at least one of the first plurality of electrodes on the first side to the cardiac tissue at a first location, wherein the signal analysis of electrical activity at the first location of the cardiac tissue is based at least on the value of the tissue proximity index.

19. The aforementioned signal analysis, Determining a first gradient value associated with the first signal received from the at least one electrode on the first side, Determining a second gradient value associated with the second signal received from the at least one electrode on the second side, The method according to claim 13, further comprising determining, based on an analysis of the first gradient value and the second gradient value, whether the first plurality of electrodes on the first side or the second plurality of electrodes on the second side are facing the cardiac tissue.

20. The method according to claim 19, wherein determining whether the first plurality of electrodes on the first side or the second plurality of electrodes on the second side are facing the cardiac tissue is based on one or more ratios of one of the first gradient values ​​to one of the second gradient values.

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