Visualizing pulse field ablation (PFA) tags using signed distance functions

Abstract

Systems and methods for visualization of pulsed field ablation tags are disclosed. In some implementations, a system includes a device including a processor in communication with one or more sensors and a catheter including a plurality of electrodes. In some implementations, the processor is configured to: receive, via the one or more sensors, a location of each of the plurality of electrodes in a three-dimensional environment during a first ablation session; for the first ablation session, calculating a first implicit function representing an energy field of the first ablation session from the received position of each of the plurality of electrodes; and presenting, via a display, a first volumetric representation of the calculated first implicit function.

Description

Technical Field

[0001] The present invention relates to systems and methods for tracking and visualizing invasive medical treatments. More specifically, the present invention relates to systems and methods for visualizing pulsed field ablation (PFA) tags using signed distance functions. Background Art

[0002] During pulsed field ablation (PFA), electrodes of a single-electrode catheter or a multi-electrode catheter (such as the VARIPULSE multi-electrode catheter manufactured by Biosense Webster, Inc. of Irvine, California) are activated to disrupt electrical pathways in the tissue by forming non-conductive ablation lesions. These electrodes may be activated multiple times during the procedure, with each activation sometimes referred to as an ablation session. Due to the number of activations and, for multi-electrode catheters, the number of electrodes, it may be difficult for a physician to understand the effects of one or more ablation sessions. Specifically, while the locations of the activated electrodes of the catheter may be recorded and displayed as a point cloud or multiple labels or markers in three-dimensional space during the procedure, such a display does not indicate the ablation field energy received by the tissue. In addition, the energy from the electric field between the electrodes is not represented. This may be important, particularly in multiple ablation sessions, as energy accumulates in the tissue. In addition, the point cloud representation may not clearly distinguish between different ablation sessions, or clearly indicate that two points or labels were created from the same ablation session. Summary of the invention

[0003] Specific implementations of the systems and methods described herein address these and other problems by representing each ablation session as a combination of adjacent implicit functions. In some implementations, the energy field between adjacent electrodes can be represented by a signed distance function. In many implementations, adjacent implicit functions are smoothly connected, thereby improving the representability of the energy field received by a single catheter ablation session. In some implementations, the implicit functions can be rendered to a display within a three-dimensional environment via volume tracking. In some implementations, shading or color can be used to show the accumulated energy across multiple ablation sessions (e.g., darker areas indicate more accumulated energy, while lighter areas indicate lower accumulated energy, or vice versa).

[0004] According to an exemplary embodiment, a system for visualization of pulsed field ablation tags is provided. In an embodiment, the system includes an apparatus, the apparatus including a processor and a catheter, the processor communicating with one or more sensors, the catheter including a plurality of electrodes. In an embodiment, the processor is configured to: during a first ablation session, receive a position of each of the plurality of electrodes in a three-dimensional environment via the one or more sensors; for the first ablation session, calculate a first implicit function representing an energy field of the first ablation session based on the received position of each of the plurality of electrodes; and present a first volume representation of the calculated first implicit function via a display.

[0005] In some embodiments, the processor is further configured to calculate a first implicit function via a signed distance function based on the position of a pair of adjacent electrodes in the plurality of electrodes during the first ablation session. In another embodiment, the processor is further configured to calculate the implicit function via a plurality of signed distance functions, each signed distance function corresponding to a different pair of adjacent electrodes. In some embodiments, the processor is further configured to calculate, for each of a plurality of voxels of the three-dimensional environment, a distance from the voxel to the position of an electrode in the plurality of electrodes. In another embodiment, the processor is further configured to determine, for each of a plurality of voxels of the three-dimensional environment, whether the corresponding calculated distance is less than a threshold. In yet another embodiment, the processor is further configured to modify, for one or more of the plurality of voxels of the three-dimensional environment, a value associated with the voxel in response to the corresponding calculated distance being less than a threshold. In yet another embodiment, the processor is further configured to modify the value associated with the first voxel in response to the distance from the first voxel to the position of an electrode in the plurality of electrodes being less than a threshold during the first ablation session; and modify the value associated with the first voxel in response to the distance from the first voxel to the position of an electrode in the plurality of electrodes being less than the threshold during the second ablation session. In yet another embodiment, the processor is further configured to present the first volume representation as one or more voxels in a three-dimensional environment, each voxel being shaded based on a value associated with the voxel. In yet another embodiment, the processor is further configured to: during a second ablation session, receive the position of each of the plurality of electrodes via one or more sensors; for the second ablation session, calculate a second implicit function representing the energy field of the second ablation session; and present a second volume representation of the calculated second implicit function and a first volume representation of the calculated first implicit function via a display. In some embodiments, the processor is further configured to: during the first ablation session, classify the position of each of the plurality of electrodes into a plurality of clusters; and for the first ablation session, calculate the first implicit function via a signed distance function between pairs of electrodes within each cluster.

[0006] In another aspect, a method for visualization of pulsed field ablation labels is provided. The method includes receiving, by a processor of an apparatus, a position of each of a plurality of electrodes of a catheter within a three-dimensional environment from one or more sensors during a first ablation session; for the first ablation session, calculating, by the processor, a first implicit function representing an energy field of the first ablation session based on the received position of each of the plurality of electrodes; and presenting, by the processor, via a display, a first volume representation of the calculated first implicit function.

[0007] In some embodiments, the method includes calculating a first implicit function via a signed distance function based on the positions of a pair of adjacent electrodes in a plurality of electrodes during a first ablation session. In another embodiment, the method includes calculating the implicit function via a plurality of signed distance functions, each signed distance function corresponding to a different pair of adjacent electrodes.

[0008] In some embodiments, the method includes, for each voxel in a plurality of voxels of a three-dimensional environment, calculating a distance from the voxel to a location of an electrode in a plurality of electrodes. In another embodiment, the method includes, for each voxel in a plurality of voxels of the three-dimensional environment, determining whether a corresponding calculated distance is less than a threshold. In yet another embodiment, the method includes, for one or more voxels in a plurality of voxels of the three-dimensional environment, modifying a value associated with the voxel in response to the corresponding calculated distance being less than a threshold. In yet another embodiment, the method includes modifying a value associated with the first voxel in response to the distance from the first voxel to the location of an electrode in a plurality of electrodes being less than a threshold during a first ablation session; and modifying a value associated with the first voxel in response to the distance from the first voxel to the location of an electrode in a plurality of electrodes being less than a threshold during a second ablation session. In yet another embodiment, the method includes presenting, by a processor, a first volume representation as one or more voxels in a three-dimensional environment, each voxel being shaded based on a value associated with the voxel. In yet another embodiment, the method includes receiving, via one or more sensors, the position of each of the plurality of electrodes during a second ablation session; for the second ablation session, calculating a second implicit function representing the energy field of the second ablation session; and presenting, via a display, a second volume representation of the calculated second implicit function and a first volume representation of the calculated first implicit function. In another embodiment, the method includes classifying, during a first ablation session, the position of each of the plurality of electrodes into a plurality of clusters; and for the first ablation session, calculating the first implicit function via a signed distance function between pairs of electrodes within each cluster.

[0009] According to one or more embodiments, the above exemplary method embodiments may be implemented as an apparatus, system, and / or computer program product. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] This patent or patent application file contains at least one drawing executed in color. Copies of this patent or patent application publication in color will be provided by the U.S. Patent and Trademark Office upon request and payment of the necessary fee.

[0011] A more detailed understanding may be obtained from the following detailed description provided by way of example in conjunction with the accompanying drawings, in which like reference numerals indicate like elements, and in which:

[0012] Figure 1 An example catheter-based electrophysiological mapping and ablation system is depicted in accordance with one or more embodiments;

[0013] Figure 2 is a block diagram of an example system for remotely monitoring and transmitting patient biometrics according to one or more embodiments;

[0014] Figure 3 is a system diagram of an example of a computing environment in communication with a network according to one or more embodiments;

[0015] FIG. 4A to FIG. 4D is a graphic representation of an example of cardiomyopathy;

[0016] Figure 5A depicts an example of a linear catheter including a plurality of electrodes according to one or more embodiments;

[0017] Figure 5B depicts an example of a balloon catheter having multiple electrodes according to one or more embodiments;

[0018] Figure 5C An example of a loop catheter having multiple electrodes according to one or more embodiments is depicted;

[0019] Fig. 6A is a screenshot of an example of a point cloud generated by multiple ablation sessions according to one or more embodiments;

[0020] Figure 6B is a screenshot of an example of volumetric tracing of multiple implicit functions generated by multiple ablation sessions according to one or more embodiments;

[0021] Figure 6C is an illustration of an example energy field surrounding a plurality of electrodes during an ablation session according to one or more embodiments;

[0022] Fig.6D is a representation according to one or more embodiments Figure 6C Illustration of example signed distance functions of energy fields around multiple electrodes during an ablation session;

[0023] Fig. 6E According to one or more embodiments Figure 6B A screenshot of an example of volume tracking of multiple implicit functions of , wherein a highlighted implicit function corresponds to one of the multiple ablation sessions; and

[0024] Figure 7 is a flow chart of a method of visualizing pulsed field ablation tags according to one or more embodiments. DETAILED DESCRIPTION

[0025] During pulsed field ablation (PFA), electrodes of a single-electrode catheter or a multi-electrode catheter are activated to disrupt electrical pathways in tissue by forming non-conductive ablation lesions. These electrodes may be activated multiple times during the procedure, with each activation sometimes referred to as an ablation session. To provide visual feedback to the physician, some systems track the location of the electrodes during each ablation session and provide visualization of dots or markers (sometimes referred to as tags or ablation tags) in a three-dimensional environment (e.g., representing tissue, blood vessels, or other environments in which the catheter is placed).

[0026] Due to the number of activations and, for multi-electrode catheters, the number of electrodes, it may be difficult for a physician to understand the effects of one or more ablation sessions. In many implementations, the point cloud may not identify the ablation field energy received by the tissue. In addition, the energy from the electric field between the electrodes is not represented in many implementations. This may be important, particularly in multiple ablation sessions, as energy accumulates in the tissue. Furthermore, the point cloud representation may not clearly distinguish between different ablation sessions, or clearly indicate that two points or labels were created from the same ablation session.

[0027] Disclosed herein are systems and methods for visualization of pulsed field ablation labels or markers. More specifically, the present invention relates to the use of implicit functions to represent energy fields during an ablation session from multiple electrodes. In some embodiments, the implicit function may include a combination or aggregation of signed distance functions between adjacent pairs of electrodes. In many embodiments, a smooth minimum function may be used to determine the energy field between adjacent electrodes during ablation. Determining the energy field may include calculating the intensity or amplitude of the field at different points in some embodiments, or may include estimating or approximating the amplitude of the field in other embodiments. For example, in some embodiments, visualization of the energy field may not require exact values, and approximate values ​​may be sufficient to use, while being faster to compute, consuming fewer resources, etc. The distance from a point in the environment (e.g., represented by a voxel) to one or more electrodes can be used to approximate the energy field in many embodiments.

[0028] For example, in some implementations, an energy field may be determined based on the electrode positions, and an energy threshold may be assigned or determined that may be considered sufficient for ablation. In some implementations, the energy field values ​​may be converted to distances such that the distance at a provided threshold is zero. Distance values ​​may then be assigned to the relevant volumes such that energies below the threshold produce positive distances, while energies above the threshold have negative distances. These distance values ​​may then be easily rendered as volumetric clouds or regions within a three-dimensional environment for viewing.

[0029] In other implementations using approximation, a smooth function (such as a smooth minimum function) that approximates the energy field at a given threshold can be determined. This function can be rendered as a surface, resulting in a similar visualization while significantly reducing processing requirements.

[0030] In many implementations, one or more ablation sessions may be rendered as a volume trace within a three-dimensional environment. The accumulated energy during multiple ablation sessions may be calculated and displayed via shading or color of the volume trace. Although many of the examples discussed herein are of the heart, any anatomical structure, body part, organ, or portion thereof may be a target for ablation and visualization.

[0031] Advantageously, implicit functions require lower processing resources and memory to render while still providing high quality visualization because they use less 3D data for the same or better visual fidelity. For example, each ablation session can be represented by a single aggregated implicit function with smooth boundaries, which requires fewer resources than storing a 3D bitmap or array with exact values ​​for each location or voxel within the environment.

[0032] refer to Figure 1 , which shows an example system (e.g., medical device equipment and / or catheter-based electrophysiological mapping and ablation) shown as system 10, in which one or more features of the subject matter of this article can be implemented according to one or more embodiments. As shown, system 10 includes recorder 11, heart 12, catheter 14, model or anatomical map 20, electrogram 21, spline 22, patient 23, physician 24 (or medical professional or clinician), location pad 25, electrode 26, display device 27, distal end 28, sensor 29, coil 32, patient interface unit (PIU) 30, electrode skin patch 38, ablation energy generator 50 and workstation 55. It should also be noted that each element and / or item of system 10 represents one or more of the element and / or item. Figure 1 The example of the system 10 shown can be modified to implement the embodiments disclosed herein. The embodiments disclosed in the present invention can be similarly applied using other system components and settings. In addition, the system 10 can include additional components, such as elements for sensing electrical activity, wired or wireless connectors, processing and display devices, etc.

[0033] The system 10 includes a plurality of catheters 14 that are inserted percutaneously through the patient's vascular system into a chamber or vascular structure of the heart 12 by a physician 24. Typically, a delivery sheath catheter is inserted into the left atrium or right atrium near a desired location in the heart 12. Multiple catheters may then be inserted into the delivery sheath catheter to reach the desired location. The plurality of catheters 14 may include catheters dedicated to sensing intracardiac electrogram (IEGM) signals, catheters dedicated to ablation, and / or catheters dedicated to both sensing and ablation. An example catheter 14 configured for sensing IEGM is shown herein. The physician 24 brings the distal end 28 of the catheter 14 into contact with the heart wall for sensing a target site in the heart 12. For ablation, the physician 24 would similarly bring the distal end of the ablation catheter to the target site for ablation.

[0034] The catheter 14 is an exemplary catheter that includes one (preferably multiple) electrodes 26 that are optionally distributed on a plurality of splines 22 at a distal tip 28 and configured to sense IEGM signals. In addition, the catheter 14 may also include a sensor 29 that is embedded in or near the distal tip 28 for tracking the location 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.

[0035] The sensor 29 (e.g., a position-based or magnetic sensor) can operate with the position pad 25, which includes a plurality of magnetic coils 32 configured to generate a magnetic field in a predefined working space. The real-time position of the distal tip 28 of the catheter 14 can be tracked based on the magnetic field generated by the position 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.

[0036] The system 10 includes one or more electrode patches 38 positioned in contact with the skin of the patient 23 to establish a position reference for impedance-based tracking of the location pad 25 and the electrodes 26. For impedance-based tracking, current is directed toward the electrodes 26 and sensed at the patches 38 (e.g., electrode skin patches) so that the position of each electrode can be triangulated via the patches 38. Details of impedance-based position 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.

[0037] Recorder 11 displays electrograms 21 captured with electrodes 18 (e.g., surface electrocardiogram (ECG) electrodes) and intracardiac electrograms (IEGMs) captured with electrodes 26 of catheter 14. Recorder 11 may include pacing capabilities for pacing the cardiac rhythm and / or may be electrically connected to a separate pacemaker.

[0038] The system 10 may include an ablation energy generator 50 adapted to conduct ablation energy to one or more of the electrodes 26 at the distal tip 28 of the catheter 14 configured for ablation. The energy generated by the ablation energy generator 50 may include, but is not limited to, radio frequency (RF) energy or pulsed field ablation (PFA) energy (including monopolar or bipolar high voltage DC pulses that may be used to achieve irreversible electroporation (IRE)), or a combination thereof.

[0039] The PIU 30 is an interface configured to establish electrical connectivity between catheters, electrophysiology equipment, a power source, and a workstation 55 for controlling the operation of the system 10. The electrophysiology equipment of the system 10 may include, for example, a plurality of catheters 14, location pads 25, surface ECG electrodes 18, electrode patches 38, an ablation energy generator 50, and a recorder 11. Optionally and preferably, the PIU 30 additionally includes processing capabilities for enabling real-time calculation of the position of the catheters and for performing ECG calculations.

[0040] The workstation 55 includes a memory, a processor unit with a memory or storage device loaded with appropriate operating software, and a user interface capability. The workstation 55 can provide multiple functions, optionally including: (1) three-dimensional (3D) modeling of the endocardial anatomy and rendering the model or anatomical map 20 for display on the display device 27; (2) displaying on the display device 27 an activation sequence (or other data) compiled from the recorded electrograms 21 as representative visual markers or images superimposed on the rendered anatomical map 20; (3) displaying the real-time position and orientation of multiple catheters within the heart chamber; and (5) displaying on the display device 27 a site of interest (such as where ablation energy has been applied). A commercial product embodying elements of the system 10 can be CARTO TM The 3 system was purchased from Biosense Webster, Inc., 31A Technology Drive, Irvine, CA 92618.

[0041] For example, system 10 may be a surgical system (e.g., sold by Biosense Webster). The present invention is part of a surgical system that is configured to obtain biometric data (e.g., anatomical measurements and electrical measurements of a patient's organ such as the heart 12, and as described herein) and to perform cardiac ablation procedures. More specifically, treatment of cardiac conditions such as arrhythmias often requires obtaining 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 arrhythmia is accurately located in a chamber of the heart 12. Such localization can be accomplished via an electrophysiological study during which electrical potentials are spatially resolved using a mapping catheter (e.g., catheter 14) introduced into a chamber of the heart 12. The electrophysiological study (so-called electroanatomical mapping) thus provides 3D mapping data that can be displayed on the display device 27. In many cases, the mapping function and the therapeutic function (e.g., ablation) are provided by a single catheter or a group of catheters, such that the mapping catheter also simultaneously operates as a therapeutic (e.g., ablation) catheter.

[0042] Figure 2 is a block diagram of an example system 100 for remotely monitoring and transmitting patient biometrics (i.e., patient data). Figure 2 In the example shown, system 100 includes a patient biometric monitoring and processing device 102 associated with a 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.

[0043] According to one embodiment, the patient biometric monitoring and processing device 102 may be a device that is internal to the patient's body (e.g., subcutaneously implantable), such as Figure 1 The patient biometric monitoring and processing device 102 may be inserted into the patient's body via any suitable means, including oral injection, surgical insertion via a vein or artery, endoscopic procedure, or laparoscopic procedure.

[0044] According to one embodiment, the patient biometric monitoring and processing device 102 may be a device external to the patient's body, such as Figure 1 The patient biometric monitoring and processing device 102 may include an attachable patch (e.g., which attaches to the patient's skin) as described in more detail below. The monitoring and processing device 102 may also include a catheter with one or more electrodes, a probe, a blood pressure cuff, a weight scale, a bracelet or smart watch biometric tracker, a glucose monitor, a continuous positive airway pressure (CPAP) machine, or virtually any device that can provide input related to the patient's health or biometrics.

[0045] According to one embodiment, the patient biometric monitoring and processing device 102 may include both components internal to the patient and components external to the patient.

[0046] Figure 2 1 shows a single patient biometric monitoring and processing device 102. However, the exemplary system may include multiple patient biometric monitoring and processing devices. The patient biometric monitoring and processing device may communicate with one or more other patient biometric monitoring and processing devices. Additionally or alternatively, the patient biometric monitoring and processing device may communicate with the network 110.

[0047] One or more patient biometric monitoring and processing devices 102 may collect patient biometric data (e.g., electrical signals, blood pressure, temperature, blood sugar level, or other biometric data) and receive at least a portion of the patient biometric data representing the collected patient biometric and additional information associated with the collected patient biometric from one or more other monitoring and processing devices 102. The additional information may be, for example, diagnostic information and / or additional information obtained from an additional device such as a wearable device. Each patient biometric monitoring and processing device 102 may process data including its own collected patient biometrics as well as data received from one or more other patient biometric monitoring and processing devices 102.

[0048] Biometric data (e.g., patient biometrics, patient data, or patient biometric data) may include one or more of local activation time (LAT), electrical activity, topology, bipolar mapping, reference activity, ventricular activity, dominant frequency, impedance, and the like. The LAT may be a time point corresponding to a threshold activity of local activation calculated based on a normalized initial starting point. The electrical activity may be any applicable electrical signal that may be measured based on one or more thresholds and may be sensed and / or enhanced based on a signal-to-noise ratio and / or other filters. The topology may correspond to a physical structure of a body part or a portion of a body part, and may correspond to changes in the physical structure relative to different portions of a body part or relative to different body parts. The dominant frequency may be a frequency or frequency range that is prevalent at a portion of a body part, and may be different in different portions of the same body part. For example, the dominant frequency of the PV of a heart may be different from the dominant frequency of the right atrium of the same heart. Impedance may be a resistance measurement at a given area of ​​a body part.

[0049] 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, audio 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 various diseases, such as cardiovascular diseases (e.g., arrhythmias, cardiomyopathy, and coronary artery disease) and autoimmune diseases (e.g., type I and type II diabetes). It should be noted that BS ECG data may include data and signals collected from electrodes on the surface of the patient, IC ECG data may include data and signals collected from electrodes inside the patient, and ablation data may include data and signals collected from tissue that has been ablated. In addition, BS ECG data, IC ECG data, and ablation data, along with catheter electrode positioning data, may be derived from one or more procedure records.

[0050] exist Figure 2 In the embodiment of the present invention, the network 110 is an example of a short-range network, such as a local area network (LAN) or a personal area network (PAN). Information can be sent between the patient biometric monitoring and processing device 102 and the local computing device 106 via the network 110 using any of a variety of short-range wireless communication protocols, such as Bluetooth, Wi-Fi, Zigbee, Z-Wave, near field communication (NFC), ultraband, Zigbee, or infrared (IR).

[0051] The network 120 may be a wired network, a wireless network, or include one or more wired and wireless networks. For example, the network 120 may be a long-range network (e.g., a wide area network (WAN), the Internet, or a cellular network). Information may be sent via the network 120 using any of a variety of long-range wireless communication protocols (e.g., TCP / IP, HTTP, 3G, 4G / LTE, or 5G / New Radio).

[0052] The patient biometric 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 monitoring and processing device 102 may continuously or periodically monitor, store, process, and transmit any number of various patient biometrics via the network 110. Examples of patient biometrics include electrical signals (e.g., ECG signals and brain biometrics), blood pressure data, blood glucose data, and temperature data. Patient biometrics may be monitored and transmitted to treat any number of various diseases, such as cardiovascular diseases (e.g., arrhythmias, cardiomyopathy, and coronary artery disease) and autoimmune diseases (e.g., type I and type II diabetes).

[0053] The patient biometric sensor 112 may include, for example, one or more sensors configured to sense a type of biometric patient biometric. For example, the patient biometric sensor 112 may include electrodes configured to collect electrical signals (e.g., heart signals, brain signals, or other bioelectrical signals), a temperature sensor, a blood pressure sensor, a blood glucose sensor, a blood oxygen sensor, a pH sensor, an accelerometer, and a microphone.

[0054] As described in more detail below, the patient biometric monitoring and processing device 102 may be an ECG monitor for monitoring ECG signals of a heart (e.g., heart 12). The patient biometric sensor 112 of the ECG monitor may include one or more electrodes for collecting ECG signals. The ECG signals may be used to treat various cardiovascular diseases.

[0055] In another example, the patient biometric monitoring and processing device 102 can be a continuous glucose monitor (CGM) for continuously monitoring the patient's blood glucose level to treat various diseases, such as type I and type II diabetes. The CGM can include electrodes disposed subcutaneously that can monitor blood glucose levels from the patient's interstitial fluid. The CGM can be, for example, a component of a closed-loop system in which blood glucose data is sent to an insulin pump for calculating insulin delivery without user intervention.

[0056] The transceiver 122 may include a separate transmitter and receiver. Alternatively, the transceiver 122 may include a transmitter and receiver integrated into a single device.

[0057] The processor 114 may be configured to store patient data, such as patient biometric data collected by the patient biometric sensor 112, in the memory 118, and to transmit the patient data across 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 described in more detail below.

[0058] According to an embodiment, the patient biometric monitoring and processing device 102 includes a UI sensor 116, which can be, for example, a piezoelectric sensor or a capacitive sensor configured to receive user input (such as a tap or touch). For example, in response to the patient 104 tapping or contacting the surface of the patient biometric monitoring and processing device 102, the UI sensor 116 can be controlled to achieve capacitive coupling. Gesture recognition can be achieved via any of a variety of capacitance types, such as resistive capacitance, surface capacitance, projected capacitance, surface acoustic wave, piezoelectric, and infrared touch. The capacitive sensor can be set at a small area or over the length of the surface so that a tap or touch of the surface activates the monitoring device.

[0059] As described in more detail below, the processor 114 can be configured to selectively respond to different tap patterns (e.g., single or double taps) of the capacitive sensor (which can be the UI sensor 116) so that different tasks of the patch (e.g., collection, storage, or transmission of data) can be activated based on the detected pattern. In some embodiments, when a gesture is detected, audible feedback can be given to the user from the patient biometric monitoring and processing device 102.

[0060] The local computing device 106 of the system 100 communicates with the patient biometric monitoring and processing apparatus 102 and may be configured to act as a gateway to the remote computing system 108 via the second network 120. For example, the local computing device 106 may be, for example, a smart phone, a smart watch, a 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, for example, modem and / or router capabilities, a desktop or laptop computer using an executable program to transfer information between the patient biometric monitoring and processing apparatus 102 and the remote computing system 108 via a radio module of the PC, or a USB dongle. Patient biometrics may be transferred between the local computing device 106 and the patient biometric monitoring and processing apparatus 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 the acquired patient electrical signals and information associated with the acquired patient electrical signals, as described in more detail below.

[0061] In some embodiments, the remote computing system 108 may be configured to receive at least one of the monitored patient biometric and information associated with the monitored patient via the network 120 as a remote network. 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 transmitted between the local computing device 106 and the remote computing system 108 via a wireless technology standard such as any of the wireless technologies described above. As described in more detail below, the remote computing system 108 may be configured to provide (e.g., visually display and / or audibly provide) at least one of the patient biometric and the related information to a healthcare professional (e.g., a physician).

[0062] Figure 3 1 is a system diagram of an example of a computing environment 200 in communication with a network 120. In some cases, computing environment 200 is incorporated 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.

[0063] like Figure 3 As shown, computing environment 200 includes a remote computing system 108 (hereinafter computer system), which is one example of a computing system on which embodiments described herein may be implemented.

[0064] The remote computing system 108 may perform various functions via the processor 220, which may include one or more processors. The functions may include analyzing monitored patient biometrics and associated information, and providing (e.g., via the display 266) alerts, additional information, or instructions based on physician-determined or algorithm-driven thresholds and parameters. As described in more detail below, the remote computing system 108 may be used to provide (e.g., via the display 266) a patient information dashboard to a healthcare provider (e.g., a physician) such that such information may enable the healthcare provider to identify and prioritize patients with more critical needs than others.

[0065] like Figure 3 As shown, the computer system 210 may include a communication mechanism such as a bus 221 or other communication mechanism for transmitting information within the computer system 210. The computer system 210 also includes one or more processors 220 coupled to the bus 221 for processing information. The processor 220 may include one or more CPUs, GPUs, or any other processors known in the art.

[0066] The computer system 210 also includes a system memory 230 coupled to the bus 221 for storing information and instructions to be executed by the processor 220. The system memory 230 may include computer-readable storage media in the form of volatile and / or non-volatile memory, such as a read-only system memory (ROM) 231 and / or a random access memory (RAM) 232. The system memory RAM 232 may include other dynamic storage devices (e.g., dynamic RAM, static RAM, and synchronous DRAM). The system memory ROM 231 may include other static storage devices (e.g., programmable ROM, erasable PROM, and electrically erasable PROM). In addition, the system memory 230 may be used to store temporary variables or other intermediate information during the execution of instructions by the processor 220. The basic input / output system 233 (BIOS) may include routines for transferring information between elements within the computer system 210 (such as during the boot process), which may be stored in the system memory ROM 231. The RAM 232 may contain data and / or program modules that are immediately accessible to and / or currently operated by the processor 220. System memory 230 may additionally include, for example, operating system 234 , application programs 235 , other program modules 236 , and program data 237 .

[0067] The illustrated computer system 210 also includes a disk controller 240 that is coupled to the bus 221 to control one or more storage devices for storing information and instructions, such as a hard disk 241 and a removable media drive 242 (e.g., a floppy disk drive, an optical drive, a tape drive, and / or a solid-state drive). Storage devices may be added to the computer system 210 using an appropriate device interface (e.g., small computer system interface (SCSI), integrated device electronics (IDE), universal serial bus (USB), or FireWire).

[0068] The computer system 210 may also include a display controller 265 coupled to the bus 221 to control a monitor or display 266, such as a cathode ray tube (CRT) or a liquid crystal display (LCD), to display 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 the processor 220. The pointing device 261 may be, for example, a mouse, a trackball, or a pointing stick for communicating directional information and command selections to the processor 220 and for controlling cursor movement on the display 266. The display 266 may provide a touch screen interface that may allow input to supplement or replace the communication of directional information and command selections by the pointing device 261 and / or the keyboard 262.

[0069] In response to processor 220 executing one or more sequences of one or more instructions contained in a memory (such as system memory 230), computer system 210 may perform a portion or each of the functions and methods described herein. Such instructions may be read into system memory 230 from another computer-readable medium (such as hard disk 241 or removable media drive 242). Hard disk 241 may contain one or more data repositories and data files used by the embodiments described herein. Data repository contents and data files may be encrypted to increase security. Processor 220 may also be employed in a multi-processing arrangement to execute one or more sequences of instructions contained in system memory 230. In an alternative embodiment, hard-wired circuitry may be used in place of or in combination with software instructions. Therefore, embodiments are not limited to any particular combination of hardware circuitry and software.

[0070] As described above, the computer system 210 may include at least one computer-readable medium or memory for storing instructions programmed according to the embodiments described herein and for containing data structures, tables, records, or other data described herein. The term computer-readable medium as used herein refers to any non-transient tangible medium that participates in providing instructions to the processor 220 for execution. Computer-readable media can take many forms, including but not limited to non-volatile media, volatile media, and transmission media. Non-limiting examples of non-volatile media include optical disks, solid-state drives, magnetic disks, and magneto-optical disks, such as hard disks 241 or removable media drives 242. Non-limiting examples of volatile media include dynamic memory, such as system memory 230. Non-limiting examples of transmission media include coaxial cables, copper wires, and optical fibers, including wires that constitute bus 221. Transmission media can also take the form of sound waves or light waves, such as those generated during radio wave and infrared data communications.

[0071] The computing environment 200 may also include a computer system 210 that operates in a networked environment using logical connections to the local computing device 106 and one or more other devices, such as personal computers (laptops or desktops), mobile devices (e.g., patient mobile devices), servers, routers, network PCs, peer devices, or other public network nodes, and typically includes many or all of the elements described above with respect to the computer system 210. When used in a networked environment, the computer system 210 may include a modem 272 for establishing communications 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 appropriate mechanism.

[0072] like Figure 2 and Figure 3 As shown, network 120 can be any network or system 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 capable of facilitating communication between computer system 210 and other computers (e.g., local computing device 106).

[0073] Arrhythmias, specifically atrial fibrillation, have always been common and dangerous medical conditions, especially in the elderly population. For patients with normal sinus rhythm, the heart, which is composed of atria, ventricles, and excitatory conduction tissue, beats in a synchronized, patterned manner under the action of electrical stimulation. For patients with arrhythmias, abnormal areas of cardiac tissue do not follow the synchronized beating cycle associated with normal conduction tissue as patients with normal sinus rhythm do. Instead, abnormal areas of cardiac tissue conduct abnormally to adjacent tissues, disrupting the cardiac cycle into an asynchronous rhythm. It was previously known that such abnormal conduction occurs in various regions of the heart, such as in the sinoatrial (SA) node region, in the conduction pathways along the atrioventricular (AV) node and the bundle of His, or in the myocardial tissue that forms the walls of the ventricular and atrial heart chambers.

[0074] Arrhythmias, including atrial arrhythmias, may be of the multi-wavelet reentrant type, characterized by multiple asynchronous loops of electrical impulses dispersed around the atrial chambers and generally self-propagating. Alternatively, or in addition to the multi-wavelet reentrant type, arrhythmias may also have a focal origin, such as when an isolated area of ​​tissue within the atrium beats autonomously in a rapid, repetitive manner. Ventricular tachycardia (V-tach or VT) is a tachycardia or rapid heart rhythm originating from one of the ventricles. This is a potentially life-threatening arrhythmia as it can lead to ventricular fibrillation and sudden death.

[0075] Atrial fibrillation, a type of arrhythmia, occurs when the normal electrical impulses produced by the sinus node are overwhelmed by chaotic electrical impulses originating in the atria and pulmonary veins, which cause irregular impulses to be transmitted to the ventricles. Irregular heartbeats result and can last from minutes to weeks, or even years. Atrial fibrillation (AF) is usually a chronic condition that slightly increases the risk of death, usually from stroke. The risk increases with age. About 8% of people over the age of 80 have some degree of AF. Atrial fibrillation is usually asymptomatic and generally not life-threatening on its own, but it can cause palpitations, weakness, fainting, chest pain, and congestive heart failure. The risk of stroke increases during AF because blood can pool and form clots in the poorly contracting atria and left atrial appendage. The first line of treatment for AF is medication that can slow the heart rate or restore the heart rhythm to normal. In addition, people with AF are often given anticoagulants to prevent them from being at risk for stroke. The use of such anticoagulants comes with its own risk of internal bleeding. For some patients, drug therapy is not enough and their AF is considered medically refractory, meaning it cannot be cured with standard medical interventions. Synchronized electrical cardioversion can also be used to restore AF to a normal rhythm. Alternatively, AF patients are treated with catheter ablation.

[0076] Therapies based on catheter ablation can include mapping the electrical properties of cardiac tissue (particularly the endocardium and cardiac volumes), and selectively ablating cardiac tissue by applying energy. Cardiac mapping, such as creating a map of electrical potentials propagating along the cardiac tissue (voltage map) or a map of arrival times to various tissue localization points (local activation time (LAT) map), can be used to detect localized cardiac tissue dysfunction. Ablation, such as those based on cardiac mapping, can stop or modify the propagation of unwanted electrical signals from one part of the heart to another.

[0077] The ablation process destroys unwanted electrical pathways by forming non-conducting lesions. A variety of energy delivery modalities have been disclosed for forming lesions, and include the use of microwaves, lasers, and more commonly radiofrequency energy to form conduction blocks along the walls of cardiac tissue. In a two-step procedure of mapping followed by ablation, electrical activity at various points in the heart is sensed and measured, typically by inserting a catheter containing one or more electrical sensors (or electrodes) into the heart and acquiring data at multiple points. This data is then used to select a target area of ​​the endocardium to be ablated.

[0078] Cardiac ablation and other cardiac electrophysiology procedures are becoming increasingly complex as clinicians treat increasingly challenging conditions such as atrial fibrillation and ventricular tachycardia. Treatment of complex arrhythmias currently relies on the use of three-dimensional (3D) mapping systems in order to reconstruct the anatomy of the ventricle of interest.

[0079] For example, cardiologists rely on software such as Biosense Webster, Inc. (Diamond Bar, Calif.) The 3D Mapping System's Complex Fractionated Atrial Electrogram (CFAE) module analyzes intracardiac EGM signals and identifies ablation sites for the treatment of a wide range of cardiac conditions, including atypical atrial flutter and ventricular tachycardia.

[0080] 3D maps provide multiple pieces of information about the electrophysiological properties of the tissue, representing the anatomical and functional substrates of these challenging arrhythmias.

[0081] Cardiomyopathies of varying etiologies (hypoxic, dilated (DCM), hypertrophic cardiomyopathy (HCM), arrhythmogenic right ventricular dysplasia (ARVD), left ventricular noncompaction (LVNC), etc.) have an identifiable matrix characterized by areas of unhealthy tissue surrounded by functional cardiomyocytes.

[0082] FIG. 4A to FIG. 4D Examples of cardiomyopathies with different etiologies are shown. As a first example, Figure 4A and Figure 4BAn exemplary rendering of a heart 400 with post-ischemic ventricular tachycardia (VT) is shown, characterized by an endo-epicardial low or intermediate voltage region 402 where signal conduction is slowed. This shows that measuring any prolonged electrical potential within or around dense scar regions can help identify potential isthmuses that sustain VT. Figure 4A Post-ischemic VT is shown to be characterized by endo-epicardial low or intermediate voltage areas where signal conduction is slowed. This shows that measuring any prolonged electrical potential within or around dense scar areas can help identify potential isthmuses that sustain VT. Figure 4A The bipolar signal amplitude (Bi) variations in various sectors of the heart 400 are shown. Figure 4A A Bi range of 0.5 mV to 1.5 mV is shown. Figure 4B The Shortex Composite Interval (SCI) variations in various sectors of the heart are shown. For example, the SCI ranges from 15.0 ms to 171.00 ms, with the SCI range of interest being between 80 ms and 170 ms.

[0083] Figure 4C and Figure 4D An exemplary rendering of a heart 410 experiencing left ventricular noncompaction cardiomyopathy is shown. More specifically, Figure 4C shows an epicardial voltage map, and Figure 4D A potential duration map (PDM) is shown. Figure 4C and Figure 4D In FIG. 4 , the three black circles in 412 are marked as abnormally prolonged potentials, such as potentials above 200 milliseconds.

[0084] Abnormal tissue is usually characterized by low-voltage EGMs. However, initial clinical experience in endocardial-epicardial mapping indicates that low-voltage areas are not always present as the only arrhythmogenic mechanism in such patients. In fact, areas of low or medium voltage can exhibit EGM fragmentation and prolonged activity during sinus rhythm, which corresponds to the key isthmus identified during sustained and organized ventricular arrhythmias, for example, only for non-tolerant ventricular tachycardia. In addition, in many cases, EGM fragmentation and prolonged activity are observed in areas that show normal or near-normal voltage amplitudes (>1mV-1.5mV). Although the latter areas can be evaluated based on voltage amplitude, they cannot be considered normal based on the intracardiac signal and therefore represent the true arrhythmogenic substrate. 3D mapping is able to localize the arrhythmogenic substrate on the endocardial and / or epicardial layers of the right / left ventricle, which can vary in distribution depending on the extension of the primary disease.

[0085] The substrate associated with these cardiac disorders is associated with the presence of fragmented and elongated EGMs in the endocardial and / or epicardial layers of the ventricular chambers (right and left). 3D mapping systems, such as 3. Ability to locate potential arrhythmogenic substrates of cardiomyopathy in terms of abnormal EGM detection.

[0086] Electrode catheters have been commonly used in medical practice for many years. They are used to stimulate and map electrical activity in the heart, and to ablate sites of abnormal electrical activity. When used, the electrode catheter is inserted into a major vein or artery, such as the femoral artery, and then guided into the heart chamber of interest. A typical ablation procedure involves inserting a catheter having at least one electrode at its distal end into a heart chamber. A reference electrode, which is usually taped to the patient's skin, is provided, or a second catheter disposed in or near the heart can be used to provide the reference electrode. RF (radio frequency) current is applied to the tip electrode of the ablation catheter, and the current flows to the reference electrode through the surrounding medium (i.e., blood and tissue). The distribution of the current depends on the amount of contact between the electrode surface and the tissue compared to the blood, which has a higher conductivity than the tissue. Due to the resistance of the tissue, heating of the tissue occurs. The tissue is heated sufficiently to cause cell destruction in the heart tissue, resulting in the formation of non-conductive ablation lesions in the heart tissue. In this process, heating of the electrode also occurs due to conduction from the heated tissue to the electrode itself. If the electrode temperature becomes high enough, perhaps above 60°C, a thin transparent coating of dehydrated blood proteins may form on the surface of the electrode. If the temperature continues to rise, this dehydrated layer may become increasingly thicker, causing blood coagulation on the electrode surface. Because the dehydrated biomaterial has a higher electrical resistance than the endocardial tissue, the impedance to the flow of electrical energy into the tissue also increases. If the impedance increases sufficiently, impedance rise occurs, and the catheter must be removed from the body and the tip electrode cleaned.

[0087] The treatment of cardiac disorders (such as arrhythmias) generally requires obtaining detailed mapping of cardiac tissue, chambers, veins, arteries and / or electrical pathways. For example, a prerequisite for the successful performance of catheter ablation is that the cause of the arrhythmia is accurately located in the heart chamber. Such localization can be accomplished via an electrophysiological study, during which electrical potentials are spatially resolved using a mapping catheter introduced into the heart chamber. This electrophysiological study (so-called electroanatomical mapping) therefore provides 3D mapping data that can be displayed on a monitor. In many cases, the mapping function and the therapeutic function (e.g., ablation) are provided by a single catheter or a group of catheters, so that the mapping catheter also operates simultaneously as a therapeutic (e.g., ablation) catheter.

[0088] Mapping of cardiac regions, such as cardiac regions, tissues, veins, arteries, and / or electrical pathways, can result in identification of problem areas, such as scar tissue, sources of arrhythmias (e.g., electrical rotors), healthy areas, and the like. The cardiac region can be mapped such that a visual rendering of the mapped cardiac region is provided using a display, as further disclosed herein. In addition, cardiac mapping can include mapping based on one or more modalities, such as, but not limited to, local activation time (LAT), electrical activity, topology, bipolar mapping, dominant frequency, or impedance. Data corresponding to multiple modalities can be captured using a catheter inserted into the patient, and data corresponding to multiple modalities can be provided for rendering simultaneously or non-simultaneously based on corresponding settings and / or preferences of a medical professional.

[0089] Cardiac mapping can be implemented using one or more techniques. As an example of a first technique, cardiac mapping can be implemented by sensing the electrical properties of cardiac tissue (e.g., local activation time) according to precise locations within the heart. The corresponding data can be collected using one or more catheters that are advanced into the heart using catheters having electrical sensors and position sensors in their distal ends. For example, the position and electrical activity can initially be measured at about 10 to about 20 points on the inner surface of the heart. These data points are generally sufficient to generate a preliminary reconstruction or mapping map of satisfactory quality of the heart surface. The preliminary map can be combined with data taken from additional points to produce a more comprehensive map of the heart's electrical activity. In a clinical setting, it is not uncommon to accumulate data at 100 or more sites to generate a detailed and comprehensive map of the electrical activity of the heart chambers. The generated detailed map can then be used as a basis for deciding on a course of therapeutic action, such as tissue ablation, to change the propagation of the heart's electrical activity and restore normal heart rhythm.

[0090] A catheter containing a position sensor can be used to determine the trajectory of points on the surface of the heart. These trajectories can be used to infer motion characteristics, such as the contractility of the tissue. When trajectory information is sampled at a sufficient number of points in the heart, a map depicting such motion characteristics can be constructed.

[0091] Electrical activity in the heart is typically measured by advancing a catheter containing an electrical sensor at or near its distal tip to a point in the heart, contacting the tissue with the sensor, and collecting data at that point. One disadvantage of mapping a cardiac chamber using a catheter containing only a single distal tip electrode is the time required to collect data point by point at the necessary number of points required for a detailed map of the chamber as a whole. Therefore, multi-electrode catheters have been developed to measure electrical activity at multiple points in a cardiac chamber simultaneously.

[0092] A multi-electrode catheter may be implemented using any suitable shape, such as a linear catheter having multiple electrodes, a balloon catheter including electrodes dispersed on multiple ridges that shape the balloon, a lasso or loop catheter having multiple electrodes, or any other suitable shape. Figure 5A An example of a linear catheter 502 including a plurality of electrodes 504, 505, and 506 that can be used to map a cardiac region is shown. The linear catheter 502 can be fully or partially elastic such that it can twist, bend, and / or otherwise change its shape based on received signals and / or based on the application of external forces (e.g., cardiac tissue) on the linear catheter 502.

[0093] Figure 5B An example of a balloon catheter 512 is shown, which includes a plurality of splines (e.g., Figure 5B ), including splines 514, 516, 517, and multiple electrodes on each spline, including electrodes 521, 522, 523, 524, 525 and 526 as shown. The balloon catheter 512 can be designed so that when it is deployed in the patient's body, its electrodes can remain in close contact with the endocardial surface. For example, the balloon catheter can be inserted into an inner cavity (such as a pulmonary vein (PV)). The balloon catheter can be inserted into the PV in a deflated state so that the balloon catheter does not occupy its maximum volume when inserted into the PV. The balloon catheter can be expanded inside the PV so that the electrodes on the balloon catheter are in contact with the entire circular segment of the PV. Such contact with the entire circular portion of the PV or any other inner cavity can achieve effective mapping and / or ablation.

[0094] Figure 5C An example of a loop catheter 530 (also referred to as a lasso catheter) is shown that includes a plurality of electrodes 532, 534, and 536 that can be used to map a cardiac region. The loop catheter 530 can be fully or partially elastic so that it can twist, bend, and / or otherwise change its shape based on received signals and / or based on the application of external forces (e.g., cardiac tissue) on the loop catheter 530.

[0095] According to one example, a multi-electrode catheter may be advanced into a chamber of the heart. An anteroposterior fluorogram (AP) and a lateral fluorogram may be obtained to establish the position and orientation of each electrode. An electrogram relative to a time reference (such as, starting from the P wave in the sinus rhythm from the surface ECG) may be recorded by each of the electrodes in contact with the surface of the heart. As further disclosed herein, the system may distinguish between those electrodes that record electrical activity and those electrodes that do not record electrical activity due to not being in close proximity to the endocardial wall. After recording the initial electrogram, the catheter may be repositioned, and the fluorogram and electrogram may be recorded again. The electrical mapping map may then be constructed according to iterations of the above process.

[0096] According to one example, cardiac mapping can be generated based on the detection of intracardiac potential fields. Non-contact technology that simultaneously collects a large amount of cardiac electrical information can be implemented. For example, a catheter having a distal end portion may be provided with a series of sensor electrodes distributed on its surface and connected to an insulated electrical conductor for connection to a signal sensing and processing device. The size and shape of the end portion may be such that the electrodes are substantially spaced apart from the wall of the heart chamber. The intracardiac potential field may be detected during a single heartbeat. According to one example, the sensor electrodes may be distributed on a series of circumferences located in planes spaced apart from each other. These planes may be perpendicular to the long axis of the end portion of the catheter. At least two additional electrodes may be provided adjacently at the end of the long axis of the end. As a more specific example, the catheter may include four circumferences, wherein eight electrodes are equiangularly spaced apart on each circumference. Therefore, in this specific implementation, the catheter may include at least 34 electrodes (32 circumferential electrodes and 2 end electrodes).

[0097] According to another example, an electrophysiological cardiac mapping system and technique based on a non-contact and non-expanding multi-electrode catheter can be implemented. An electrogram can be obtained using a catheter having a plurality of electrodes (e.g., between 42 and 122 electrodes). According to this specific implementation, knowledge of the relative geometry of the probe and the endocardium can be obtained, such as by an independent imaging modality (such as transesophageal echocardiography). After independent imaging, the non-contact electrodes can be used to measure the cardiac surface potential and construct a map therefrom. The technique may include the following steps (after the independent imaging step): (a) measuring the potential using a plurality of electrodes disposed on a probe positioned in the heart; (b) determining a geometric relationship between the probe surface and the endocardial surface; (c) generating a coefficient matrix representing the geometric relationship between the probe surface and the endocardial surface; and (d) determining the endocardial potential based on the electrode potential and the coefficient matrix.

[0098] According to another example, techniques and apparatus for mapping the potential distribution of a cardiac chamber may be implemented. An intracardiac multi-electrode mapping catheter assembly may be inserted into the patient's heart. The mapping catheter assembly may include a multi-electrode array with an integral reference electrode, or preferably, a matching reference catheter. The electrodes may be deployed in a substantially spherical array. The electrode array may be spatially referenced to a point on the endocardial surface by a reference electrode or by a reference catheter in contact with the endocardial surface. A preferred electrode array catheter may carry a plurality of separate electrode sites (e.g., at least 24). In addition, the exemplary technique may be implemented by knowing the location of each of the electrode sites on the array and knowing the geometry of the heart. These locations are preferably determined by the technique of impedance plethysmography.

[0099] According to another example, a cardiac mapping catheter assembly may include an electrode array defining a plurality of electrode sites. The mapping catheter assembly may also include an inner cavity to receive a reference catheter having a distal end electrode assembly that can be used to detect a heart wall. The mapping catheter may include a braid of insulated wires (e.g., having 24 to 64 wires in the braid), and each wire may be used to form an electrode site. The catheter may be easily positioned in the heart for collecting electrical activity information from a first set of non-contact electrode sites and / or a second set of contact electrode sites.

[0100] According to another example, another catheter for mapping electrophysiological activity within the heart can be implemented. The catheter body may include a distal tip adapted to deliver stimulation pulses for cardiac pacing or an ablation electrode for ablating tissue in contact with the tip. The catheter may also include at least one pair of orthogonal electrodes to generate a difference signal indicative of local cardiac electrical activity adjacent to the orthogonal electrodes.

[0101] According to another example, a process for measuring electrophysiological data in a heart chamber may be implemented. The method may include, in part, positioning a set of active electrodes and passive electrodes into the heart, providing current to the active electrodes to generate an electric field in the heart chamber, and measuring the electric field at the passive electrode sites. The passive electrodes are contained in an array positioned on an inflatable balloon of a balloon catheter. In a preferred embodiment, the array is said to have from 60 to 64 electrodes.

[0102] According to another example, cardiac mapping can be implemented using one or more ultrasound transducers. The ultrasound transducer can be inserted into the patient's heart, and multiple ultrasound slices (e.g., two-dimensional or three-dimensional slices) can be collected at various positions and orientations within the heart. The position and orientation of a given ultrasound transducer can be known, and the collected ultrasound slices can be stored so that they can be displayed at a later time. One or more ultrasound slices corresponding to the position of a probe (e.g., a treatment catheter) can be displayed after a period of time, and the probe can be overlaid on one or more ultrasound slices.

[0103] According to other examples, the body patch and / or body surface electrodes may be positioned on or near the patient's body. A catheter having one or more electrodes may be positioned within the patient's body (e.g., within the patient's heart), and the position of the catheter may be determined by the system based on signals transmitted and received between the one or more electrodes of the catheter and the body patch and / or body surface electrodes. In addition, the catheter electrodes may sense biometric data (e.g., LAT values) from within the patient's body (e.g., within the heart). The biometric data may be associated with the determined position of the catheter so that a rendering of a body part (e.g., heart) of the patient may be displayed, and the biometric data overlaid on the shape of the body part may be displayed, as determined by the position of the catheter.

[0104] As discussed above, some systems may illustrate or display the results of ablation sessions via a point cloud of markers or labels representing the location of each electrode during ablation across multiple sessions. Fig. 6A is a screenshot 600 of an example of such a point cloud generated by multiple ablation sessions according to one or more embodiments. Each label 602 (which may be variously referred to as a point, location, electrode location, marker, ablation label, or any other similar term) is represented by Fig. 6A In a specific implementation using a point cloud as shown in the example, it may be difficult for a physician to understand the effects of one or more ablation sessions. For example, there is no clear indication of the ablation field energy received by the tissue. The energy from the electric field between the electrodes is not represented. There is no indication of the accumulation of energy on the tissue due to repeated ablations. And there is no indication of which tags were created during the same ablation session.

[0105] In contrast, Figure 6B 610 is a screenshot of an example of a volume trace 612 of multiple implicit functions generated by multiple ablation sessions according to one or more embodiments. The implicit function may include a signed distance function or other smooth function based on the position of adjacent electrodes during the ablation session, thereby generating a multi-lobed region or tube shape. In many implementations, the surface of the region may represent areas that received the same or similar amount of energy during the ablation session. In some implementations, this may be determined via a signed distance function or any other similar smooth function.

[0106] For example, briefly refer to Figure 6C , which shows an example of an energy field 622 surrounding a plurality of electrodes 620 during an ablation session according to one or more embodiments. The energy field 622 is shown as concentric circles and represents an energy gradient or equal or approximately equal amounts of energy provided during ablation at a given distance. The energy at any particular distance from the electrode may be based on the inverse square law; this Figure 6C , where the lines become thinner the further from each electrode 620. It will be appreciated that the illustration is for illustrative purposes only and that the thickness of the lines is not to scale or proportional to any particular energy level; it will also be appreciated that, although only a few concentric circles are shown, the ablation energy may extend farther than shown.

[0107] Fig.6D is a representation according to one or more embodiments Figure 6C624 . For example, the boundaries shown by function 624 represent threshold distances from the left and middle electrodes, and the boundaries shown by function 624' represent threshold distances from the middle and right electrodes, where the boundaries correspond to the energy levels received at that distance from the electrodes. Thus, in many embodiments, the boundaries may also represent points around the electrodes that acquire similar or identical amounts of energy. Thus, these functions may be combined into aggregate implicit functions to represent areas that accumulate the same energy during each ablation session. Although in Figure 6C and Fig.6D Although shown as a two-dimensional representation in FIG, in many specific implementations, a three-dimensional environment can be utilized and a three-dimensional surface can be identified based on an implicit function. Figure 6C and Fig.6D , but in some implementations, the electrodes may be inactive (e.g., disabled, not in contact with tissue, etc.) during the ablation session. In some implementations, such inactive electrodes may be skipped during the calculation of the implicit function.

[0108] The distance to the boundary 624, 624' (e.g., a threshold distance) can be dynamically configurable, set by a manufacturer or administrator, or otherwise varied. For example, a higher threshold will result in thicker sections between adjacent electrodes, while a lower threshold may result in narrower sections or even discontinuities. Changing the threshold may be useful to illustrate different accumulated energy levels in one or more ablation sessions.

[0109] As discussed above, each of the plurality of ablation sessions may be represented by an implicit function. Thus, in many implementations, the volume renderings of these sessions may be distinguished from the other sessions. For example, Fig. 6E According to one or more embodiments Figure 6B Screen shot 630 of an example of volume tracking of multiple implicit functions of FIG. 6A , wherein a highlighted implicit function 632 (shown with a highlighted border) corresponds to one ablation session of a plurality of ablation sessions.

[0110] In some embodiments, in order to render the volume represented by each implicit function, the system may subdivide the three-dimensional environment area into multiple voxels. In some embodiments, each voxel may be associated with the nearest electrode position or the active electrode position during the ablation session. The system may calculate the implicit function and determine for each voxel whether the voxel is on the boundary of the volume surface (or in some embodiments within the boundary). For example, in some embodiments, the system may determine whether the distance from the voxel to the nearest neighboring electrode is within a threshold. If so, the value of the voxel representing the unit of accumulated energy may be incremented, modified, or adjusted according to the aggregation function. When the volume surface is rendered for a subsequent ablation session, the value associated with the voxel may be similarly incremented or adjusted. In various embodiments, energy accumulation across sessions may be used by any arbitrary function, such as the square or root of the sum of the sessions on the voxel. For example, the aggregation function may include increasing the value representing the accumulated energy of the voxel based on the distance to the electrode (or multiple electrodes). In some embodiments, the aggregation function may be based on the ablation time during the ablation session. Thus, higher values ​​for voxels are associated with locations where energy was accumulated during multiple ablation sessions or where more total energy was accumulated. Fig. 6E As shown in the example screenshots of , such voxels may be shaded or colored differently (e.g., darker in the embodiment shown, but other shades or colors are possible in other embodiments). In some implementations, transparency (alone or in addition to texture and / or color) can be used to represent accumulated energy, such that voxels with higher received energy can be more opaque than voxels with less received energy. These various implementations provide intuitive and effective visualization of accumulated energy across multiple ablation sessions. Combinations of the functionality discussed above and / or other functionality can be used in various embodiments and can provide smooth changes in color and / or texture of a surface. Thus, as used herein, shading can be used to refer to any of a variety of visual effects, including streaking, stippling, shading, cross-hatching, transparency, specularity, reflectivity, color, or any other type of visual modifier that can provide an indication of energy accumulation. Now turning to Figure 7 , a method 700 (e.g., performed by one or more processors of a computing device) of visualizing pulsed field ablation labels according to one or more exemplary embodiments is shown. The method 700 addresses the need for a physician to understand the effects of one or more ablation sessions in an easy and intuitive visual manner, and provides high-quality, efficient visualization, reducing the required processing resources relative to high-density arrays or bitmaps.

[0111] The method begins at box 702, where one or more processors of the device may receive the position of one or more electrodes of the catheter from one or more sensors during the ablation session. The position can be represented in any suitable format, such as by x, y and z coordinates, spherical coordinates, an index to a voxel in an array, or any other such format. The catheter can be of any type and form, such as a linear catheter, a balloon catheter, or a loop catheter discussed above, and may include one electrode or more than one electrode. In various specific implementations, the sensor may include an RF sensor, a magnetic sensor, an inductive sensor, or a combination of sensors of any other type and form. Receiving the position of the electrode may include filtering noise or other motion (e.g., due to the patient inhaling), identifying periods of time when the electrode or catheter tip does not move or has zero velocity, etc.

[0112] At block 703, in some implementations, one or more processors may subdivide the electrodes and / or regions into a plurality of clusters, and at block 704, a cluster may be selected for processing. Doing so may reduce the processing requirements for each cluster, for example, because electrodes further away may have the least effect. In some implementations, each cluster may include a subset of the plurality of electrodes. In some implementations, each cluster may include a subset of the voxels of the three-dimensional environment. In many implementations, the clusters may be processed in parallel because they are independent; therefore, in some implementations, block 704 may be performed in parallel for different clusters by different processors, servers, devices, or other computing devices. In other implementations, blocks 703 to 704 may be skipped.

[0113] At box 705, in some implementations, an ablation session may be selected from a plurality of sessions, and at box 706, in some implementations, one or more processors may select a pair of electrodes from a plurality of electrodes, or select a pair of receiving locations (such as an adjacent pair of locations). In some implementations, the electrodes (or locations) may be selected in response to the associated locations of the electrodes (or locations) being in the same cluster. In other implementations, the electrodes (or locations) may be selected in response to the associated locations of the electrodes (or locations) received from the same ablation session. In some implementations, each electrode may be associated with a semi-unique identifier or a unique identifier. Points or voxels in a region may be associated with identifiers of electrodes that provided energy to the points or voxels at an amplitude or energy level above a threshold during the ablation session.

[0114] At block 708, in some implementations, one or more processors may calculate an implicit function based on the position of the selected pair of electrodes. In some implementations, the implicit function may include a smoothing function. In some implementations, the implicit function may include a signed distance function. In some implementations, the function may be further based on a predetermined threshold.

[0115] In some implementations, if there are additional electrodes, blocks 706 to 708 may be repeated iteratively. For example, in some implementations, the system may calculate a function of a first electrode or position and a second electrode or position, then may select a third electrode position and calculate a function of a combination of the first electrode or position and the second electrode or position (e.g., a previously calculated function) and the newly selected electrode or position, thus iteratively constructing an aggregate function of all three electrodes or positions. In other implementations, blocks 706 to 708 may be repeated continuously using paired electrodes or positions (e.g., calculating a distance function of a first electrode or position and a second electrode or position, then calculating a distance function of a second electrode or position and a third electrode or position, etc.). In such implementations, the system may avoid calculating twice the energy contributed by the second electrode to any particular voxel. For example, as discussed above, in some implementations, the value associated with each voxel in the cluster may be incremented in response to the position of the voxel being within or on the boundary of the signed distance function of the first electrode or position and the second electrode or position. In some such implementations, any voxel whose associated value was incremented may not have its value incremented again when determining the effect of the second electrode or location and the newly selected third electrode or location. In other words, in such implementations, during the calculation of the effect of any ablation session, the value associated with the voxel may be incremented only once, regardless of how many adjacent electrode effects are applied. In other implementations, such as when constructing an aggregation function as discussed above, the value associated with the voxel may be incremented multiple times.

[0116] In many implementations, blocks 705 to 708 may be repeated for additional ablation sessions. Although shown as being repeated before block 710, in some implementations, blocks 705 to 710 may be repeated (e.g., a loop may occur after the first instance of block 710, and block 710 may be repeated for each additional session). Similarly, in many implementations, blocks 704 to 708 may be repeated for additional clusters of electrode locations within an environment. In many implementations, blocks 704 to 708 may be performed in parallel for different clusters by separate processors, servicing programs, or devices.

[0117] At box 710, a volumetric representation of the calculated implicit function (or functions for multiple ablation sessions) may be rendered. As discussed above, in many embodiments, the system may determine a value associated with each voxel in a cluster or three-dimensional environment that increments in response to the voxel being within a signed distance function of a pair of adjacent electrodes or corresponding locations (or on its boundary in various embodiments). In some embodiments, a unique or semi-unique identifier of one or more electrodes associated with the corresponding boundary may be stored with the voxel or associated with the voxel; in various embodiments, this may be in addition to or in lieu of an energy value or other counter. For example, in response to determining that a voxel is within a boundary (or on the boundary) based on a signed distance function or other smoothing function, an identifier of the associated electrode may be stored in association with the voxel, such that during the ablation session, the voxel includes a set of electrode identifiers and their locations associated therewith. This enables the system to calculate the distance to the boundary with high visual fidelity at runtime without the need to store additional data about the boundary surface. In some implementations, the system may shade, color, make visible, or otherwise highlight or show each voxel with an incremental value to display the volume representation. In other implementations, the representation may be rendered via ray tracing using the boundaries of an implicit function as a reflective surface. Other implementations of rendering may be utilized as desired. The volume representation may be rendered to a display such as a monitor, a stereoscopic display (e.g., a virtual reality or augmented reality display or glasses), a volumetric display, a holographic display, a pseudo three-dimensional display (e.g., a two-dimensional display with head tracking and rendering of a pseudo three-dimensional environment), or any other suitable display.

[0118] Thus, embodiments of the systems and methods discussed herein provide an intuitive and easily understood visualization of the effects of one or more ablation sessions on tissue by using implicit functions, particularly signed distance functions, calculated based on the positions of adjacent electrodes of a catheter during ablation, which embodiments reduce processing or resource consumption relative to array-based implementations.

[0119] Although the features and elements are described above in detail, it will be appreciated by those skilled in the art that each feature or element may be used alone or in any combination with other features and elements. In addition, the methods described herein may be implemented in a computer program, software, or firmware incorporated in a computer-readable medium for execution by a computer or processor. Examples of computer-readable media include electronic signals (transmitted via a wired or wireless connection) 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 processor associated with software may be used to implement a radio frequency transceiver used in a WTRU, UE, terminal, base station, RNC, or any host computer.

[0120] The flow charts and block diagrams in the accompanying drawings illustrate the possible specific implementation architecture, functions and operations of the system, method and computer program product according to various embodiments of the present invention. In this regard, each box in the flow chart or block diagram may represent a module, fragment or part of an instruction, which includes one or more executable instructions for implementing a specified logical function. In some alternative implementations, the function indicated in the box may not occur in the order indicated in the accompanying drawings. For example, depending on the function involved, the two boxes shown in succession may actually be executed substantially simultaneously, or the box may sometimes be executed in the opposite order. It should also be noted that each box in the block diagram and / or the flow chart diagram and the combination of the boxes in the block diagram and / or the flow chart diagram can be implemented by a system based on dedicated hardware that performs a specified function or action or by a combination of dedicated hardware and computer instructions.

[0121] Although the features and elements are described above in detail, it will be appreciated by those skilled in the art that each feature or element may be used alone or in any combination with other features and elements. In addition, the methods described herein may be implemented in a computer program, software, or firmware incorporated in a computer-readable medium for execution by a computer or processor. As used herein, a computer-readable medium should not be understood as a transient signal per se, such as a radio wave or other freely propagating electromagnetic wave, an electromagnetic wave propagating through a waveguide or other transmission medium (e.g., a light pulse passing through a fiber optic cable), or an electrical signal transmitted by wire.

[0122] Examples of computer-readable media include electronic signals (transmitted via a wired or wireless connection) and computer-readable storage media. Examples of computer-readable storage media include, but are not limited to, registers, cache memories, 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 versatile disks (DVDs), random access memories (RAMs), read-only memories (ROMs), erasable programmable read-only memories (EPROMs or flash memories), static random access memories (SRAMs), and memory sticks. A processor associated with software can be used to implement a radio frequency transceiver used in a terminal, a base station, or any host computer.

[0123] The terms used herein are only for the purpose of describing specific embodiments and are not intended to be limiting. As used herein, unless the context clearly indicates otherwise, the singular forms "a", "a", and "the / said" include plural references. It should also be understood that the terms "comprise" and / or "comprising" when used in this specification specify the presence of the features, integers, steps, operations, elements and / or parts, but do not exclude the presence or addition of one or more other features, integers, steps, operations, elements and / or groups thereof.

[0124] The description of various embodiments herein is presented for the purpose of illustration, but is not intended to be exhaustive or limited to the disclosed embodiments. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and essence of the described embodiments. The terminology used herein is selected to best explain the principles of the embodiments, practical applications or technical improvements over technologies available on the market, or to enable other persons of ordinary skill in the art to understand the embodiments disclosed herein.

Claims

1. A system for visualization of pulsed field ablation labels, the system comprising: an apparatus comprising a processor and a catheter, the processor communicating with one or more sensors, the catheter comprising a plurality of electrodes; and Wherein, the processor is configured to: receiving, via the one or more sensors, a position of each of the plurality of electrodes within a three-dimensional environment during a first ablation session, for the first ablation session, calculating a first implicit function representing an energy field for the first ablation session based on the received position of each electrode of the plurality of electrodes, and A first volume representation of the calculated first implicit function is presented via a display.

2. The system according to claim 1, wherein: The processor is further configured to calculate the first implicit function with a signed distance function based on positions of a pair of adjacent electrodes of the plurality of electrodes during the first ablation session.

3. The system according to claim 2, wherein: The processor is further configured to calculate the implicit function by means of a plurality of signed distance functions, each signed distance function corresponding to a different pair of adjacent electrodes.

4. The system according to claim 1, wherein: Each electrode of the plurality of electrodes is associated with a unique identifier; and wherein the processor is further configured to determine, for each voxel of a plurality of voxels of the three-dimensional environment, one or more identifiers of electrodes that provided energy to a location corresponding to the voxel during the first ablation session.

5. The system according to claim 1, wherein: The processor is further configured to calculate, for each voxel of a plurality of voxels of the three-dimensional environment, a distance from the voxel to a location of an electrode of the plurality of electrodes.

6. The system according to claim 5, wherein: The processor is further configured to determine, for each voxel of the plurality of voxels of the three-dimensional environment, whether a corresponding calculated distance is less than a threshold.

7. The system according to claim 6, wherein: The processor is further configured to, for one or more voxels of the plurality of voxels of the three-dimensional environment, modify a value associated with the voxel in response to the corresponding calculated distance being less than the threshold.

8. The system according to claim 6, wherein: The processor is further configured to modify a value associated with the first voxel in response to the distance from the first voxel to the location of an electrode of the plurality of electrodes being less than the threshold during the first ablation session; and modifying the value associated with the first voxel in response to the distance from the first voxel to the location of an electrode of the plurality of electrodes being less than the threshold during a second ablation session.

9. The system according to claim 6, wherein: The processor is further configured to render the first volume representation as one or more voxels in the three-dimensional environment, each voxel being shaded based on the value associated with the voxel.

10. The system according to claim 9, wherein: The processor is further configured to: receiving, via the one or more sensors, a position of each of the plurality of electrodes during a second ablation session; for the second ablation session, calculating a second implicit function representing an energy field of the second ablation session; as well as A second volume representation of the calculated second implicit function is presented via the display together with the first volume representation of the calculated first implicit function.

11. The system according to claim 1, wherein: The processor is further configured to: during the first ablation session, classifying the location of each electrode of the plurality of electrodes into a plurality of clusters; as well as For the first ablation session, the first implicit function is calculated with the aid of a signed distance function between pairs of electrodes within each cluster.

12. A method for visualization of pulsed field ablation labels, the method comprising: During a first ablation session, receiving, by a processor of the device from one or more sensors, a position of each of a plurality of electrodes of the catheter within a three-dimensional environment; for the first ablation session, calculating, by the processor, a first implicit function representing an energy field of the first ablation session based on the received position of each electrode of the plurality of electrodes; as well as A first volume representation of the calculated first implicit function is presented, by the processor, via a display.

13. The method of claim 12, further comprising calculating the first implicit function by means of a signed distance function based on positions of a pair of adjacent electrodes of the plurality of electrodes during the first ablation session.

14. The method of claim 13, further comprising calculating the implicit function with the aid of a plurality of signed distance functions, each signed distance function corresponding to a different pair of adjacent electrodes.

15. The method according to claim 12, wherein: Each electrode of the plurality of electrodes is associated with a unique identifier; and the method further comprises, for each voxel of a plurality of voxels of the three-dimensional environment, determining one or more identifiers of electrodes that provided energy to a location corresponding to the voxel during the first ablation session. 16 . The method of claim 12 , further comprising calculating, for each voxel of a plurality of voxels of the three-dimensional environment, a distance from the voxel to a location of an electrode of the plurality of electrodes. 17 . The method of claim 16 , further comprising, for each voxel of the plurality of voxels of the three-dimensional environment, determining whether a corresponding calculated distance is less than a threshold. 18 . The method of claim 17 , further comprising, for one or more voxels of the plurality of voxels of the three-dimensional environment, modifying a value associated with the voxel in response to the corresponding calculated distance being less than the threshold.

19. The method of claim 17, further comprising modifying the value associated with the first voxel in response to the distance from the first voxel to the position of the electrode among the plurality of electrodes being less than the threshold during the first ablation session; and modifying the value associated with the first voxel in response to the distance from the first voxel to the position of the electrode among the plurality of electrodes being less than the threshold during the second ablation session.

20. The method of claim 17, further comprising rendering, by the processor, the first volume representation as one or more voxels in the three-dimensional environment, each voxel being shaded based on the value associated with the voxel.

21. The method according to claim 20, further comprising: receiving, via the one or more sensors, a position of each of the plurality of electrodes during a second ablation session; for the second ablation session, calculating a second implicit function representing an energy field of the second ablation session; as well as A second volume representation of the calculated second implicit function is presented via the display together with the first volume representation of the calculated first implicit function.

22. The method according to claim 12, further comprising: during the first ablation session, classifying the location of each electrode of the plurality of electrodes into a plurality of clusters; as well as For the first ablation session, the first implicit function is calculated with the aid of a signed distance function between pairs of electrodes within each cluster.

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