Simultaneous pulsed field ablation and mapping

Abstract

An example medical system includes processing circuitry configured to receive information of at least one pulse of pulsed field energy delivered to a location of a heart of a patient. The processing circuitry can receive, from at least one electrode, information of at least one sensed signal of the patient in response to the pulsed field energy. The processing circuitry can determine a morphology match between (a) a template signal of a target morphology and (b) the at least one sensed signal. The processing circuitry can determine a time delay, the time delay based on a time when the at least one pulse is delivered and a time when the at least one sensed signal is generated or sensed. The processing circuitry can generate an output indicating one or more of (a) the morphology match and (b) the time delay.

Description

Docket No.: A0013389W01 / 1289-028W001SIMULTANEOUS PULSED FIELD ABLATION AND MAPPING

[0001] This application claims priority to, and the benefit of, U.S. Provisional Application No. 63 / 706,855, filed October 14, 2024, and entitled, “SIMULTANEOUS PULSED FIELD ABLATION AND SOURCE / EXIT MAPPING,” the entire content of which is incorporated herein by reference.TECHNICAL FIELD

[0002] The disclosure relates to mapping and ablation of cardiac tissue.BACKGROUND

[0003] Cardiac ablation is a procedure that may be employed to treat an irregular heart rhythm (e.g., an arrhythmia). Cardiac ablation may involve alteration of heart tissue to disrupt generation and / or propagation of faulty electrical signals causing the arrhythmia. Ablation devices may include catheters with one or more electrodes. The electrodes may be configured to direct ablation energy to tissue of a patient to cause a lesion in the tissue, for example to block unwanted propagation of electrical signals.SUMMARY

[0004] In general, this disclosure is directed to systems and methods for simultaneously, and / or in sequence but over a relatively short period of time, delivering ablation energy to a heart of a patient as well as mapping the heart of the patient. Mapping can include gathering (e.g., measuring) of sensed signals of the patient, including electrocardiogram (ECG) signals or electrogram (EGM) signals. Similar to pace mapping in which a stimulus delivered to the heart elicits a response in cardiac electrical activity, information of the sensed signals of the patient generated by, and sensed after (e.g., immediately after), delivery of ablation energy can be used to determine whether the ablation energy was delivered to an appropriate location within the heart (e.g., an appropriate location for resolving the arrhythmia) and / or whether the ablation energy was sufficient for resolving an arrhythmia.

[0005] Systems and methods described herein facilitate quantifying and / or generating visualizations of features of EGM signals or ECG signals stimulated by (e.g., caused by) delivery of ablation energy. As compared to performing separate mapping and ablation procedures, the techniques of this disclosure can reduce or eliminate the need for performing additional mappingDocket No.: A0013389W01 / 1289-028W001 after an ablation procedure, as the relevant information regarding an arrhythmia can be obtained in conjunction with delivery of the ablation energy. Moreover, because a clinician can ascertain the effects of a given application of ablation energy delivery over the course of a series of applications of ablation energy delivery, a clinician may be able to more accurately determine the location and / or cause of a given type of arrythmia.

[0006] The information determined according to the techniques of this disclosure can provide a clinician feedback regarding the clinical efficacy of the ablation energy delivered to a particular location of cardiac tissue. An example of such determined information includes a determined match between the morphology of the sensed signal and the morphology of another signal (e.g., a template signal having a morphology corresponding to an arrhythmia). Another example of the determined information includes a time delay information. The time delay information may include a time delay between the ablation energy and the resulting sensed signal of the patient.

[0007] In some examples, the time delay information, which is one example of determined information, may include a change in time delay over a plurality of discrete cardiac activation cycles. For example, the change in time delay over a plurality of discrete cardiac activation cycles may be indicative of a dissociation trend and / or a progressive delay.

[0008] In some cases, such determined information can enable a clinician to more quickly confirm that an arrythmia has been resolved, and with increased confidence, which may reduce the instances and necessity of additional ablation energy delivery and / or the need for repeat ablation procedures. Similarly, such information can potentially reduce the number and / or duration of discrete instances of ablation energy delivered to a patient in order to resolve an arrhythmia. Reducing the number of discrete instances of ablation energy delivered to a particular area of tissue and / or over the course of a procedure can reduce the overall time needed for a mapping and / or ablation procedure, which can facilitate improved clinical outcomes for the patient.

[0009] In some examples a method includes receiving, by processing circuitry, information of at least one pulse of pulsed field energy delivered to a location of a heart of a patient; receiving, by the processing circuitry and from at least one electrode, information of at least one sensed signal of the patient in response to delivery of the pulsed field energy, wherein the at least one sensed signal of the patient includes one or more of an electrocardiogram (ECG) signal and an electrogram (EGM) signal of the patient; determining, by the processing circuitry, one or more of: a morphology match between (a) a template signal of a target morphology and (b) the at least one sensed signal of the patient, and time delay information, the time delay information including a time delay based on a time when the at least one pulse is delivered and a time when the at leastDocket No.: A0013389W01 / 1289-028W001 one sensed signal is generated or sensed; and generating, via a user interface, an output indicating one or more of (a) the morphology match and (b) the time delay information.

[0010] In some examples, a system includes at least one electrode; and processing circuitry configured to: receive information of at least one pulse of pulsed field energy delivered to a location of a heart of a patient; receive, from the at least one electrode, information of at least one sensed signal of the patient in response to delivery of the pulsed field energy, wherein the at least one sensed signal of the patient includes one or more of an electrocardiogram (ECG) signal and an electrogram (EGM) signal of the patient; determine one or more of: a morphology match between (a) a template signal of a target morphology and (b) the at least one sensed signal of the patient, and time delay information, the time delay information including a time delay based on a time when the at least one pulse is delivered and a time when the at least one sensed signal is generated or sensed; and generate, via a user interface, an output indicating one or more of (a) the morphology match and (b) the time delay.

[0011] In some examples, a method includes navigating a catheter with an elongated body and a plurality of electrodes at a distal portion of the elongated body to a target site within a heart of a patient; delivering pulsed field energy to the target site using one or more of the plurality of electrodes; gathering one or more of a stimulated electrocardiogram (ECG) or stimulated electrogram (EGM) from one or more electrodes; quantifying a morphology match between the one or more stimulated ECG or EGM and a template signal; and providing feedback based on the morphology match.

[0012] This summary is intended to provide an overview of the subject matter described in this disclosure. It is not intended to provide an exclusive or exhaustive explanation of the methods and systems described in detail within the accompanying drawings and description below.BRIEF DESCRIPTION OF DRAWINGS

[0013] FIG. 1 A is a partially conceptual diagram illustrating an example system for delivering ablation energy and / or recording signals from a heart of a patient.

[0014] FIG. IB is a conceptual diagram illustrating a distal portion of an example catheter configured to deliver ablation energy and / or measure signals.

[0015] FIG. 2A is a conceptual diagram illustrating an example user interface for facilitating delivery of ablation energy and generating feedback regarding measured signals.

[0016] FIG. 2B is a conceptual diagram illustrating an example user interface for facilitating delivery of ablation energy and generating feedback regarding measured signals.Docket No.: A0013389W01 / 1289-028W001

[0017] FIG. 3 is an illustration of an electrocardiogram (ECG) waveform and a pulsed field ablation (PF A) energy waveform on respective voltage versus time plots.

[0018] FIG. 4 is a flow diagram illustrating an example technique for determining, and generating an output indicative of, a morphology match and / or a time delay between signals.

[0019] FIG. 5 is a flow diagram illustrating an example technique for quantifying and providing feedback regarding a morphology match between signals.DETAILED DESCRIPTION

[0020] Medical procedures aimed at resolving a cardiac arrythmia of a patient can involve discrete (e.g., separated in time) mapping and ablation steps. In some cases, mapping can include delivery of a pacing stimulus (e.g., from the ablation catheter, and / or from another pacing device) that elicits (e.g., generates) a response in cardiac activity. Such a response is measured via sensed signals of the patient, including electrocardiogram (ECG) signals or electrogram (EGM) signals. The sensed signals of the patient generated and sensed after (e.g., immediately after) pacing can be compared to a target arrhythmia, e.g., to determine whether the pacing stimulus was delivered at an appropriate ablation location within the heart (e.g., for resolving the arrhythmia). Delivery of pacing stimulus and sensing the resulting ECG signals and / or EGM signals from the pacing stimulus is sometimes referred to as “pace mapping.”

[0021] Information from pace mapping can aid a clinician in determining the appropriateness of a particular location in the heart for delivering ablation energy. In some examples, a sufficient match between the morphology of the sensed signal and the morphology of another signal (e.g., a signal having a morphology corresponding to an arrhythmia) may indicate an appropriate ablation site. As another example, the time delay between the pacing stimulus and the measured sensed signal (e.g., ECG signal and / or EGM signal) may provide information about the relationship between the pacing site and the target arrhythmia (e.g., including an exit of a critical isthmus of the target arrhythmia).

[0022] Pulsed field (PF) ablation (PF A) involves delivery of high-amplitude short-duration electrical energy pulses, also referred to herein as PFA energy. In some cases, PFA energy pulses can capture (e.g., stimulate) cardiac tissue, which can have an effect similar to pacing (e.g., and may induce a cardiac arrhythmia). Because the delivery of PFA energy can have some of the same effects as pacing (e.g., cause capture of cardiac tissue, which can result in measurable cardiac activity as measured via ECG and / or EGM signals), delivery of PFA energy can be used in a similar manner as pacing is used in pace mapping. For example, the time delay of relevant portions of sensed signals (e.g., ECG signals or EGM signals) and / or a determined morphology of such sensed signals after delivery of PFA energy may provide information about theDocket No.: A0013389W01 / 1289-028W001 appropriateness of the ablation site. Furthermore, changes in the sensed signal (e.g., the time delay of relevant portions of the ECG and / or EGM signal or changes in morphology) after subsequent PF ablation pulse train deliveries may provide information about the immediate effects of the ablation, e.g., modification of the arrhythmogenic substrate. Such changes to the sensed signals may occur whether the PFA energy causes reversible electroporation (i.e., temporary suppression of electrical activation), irreversible electroporation (i.e., permanent loss of electrical activation), or a combination of reversible and irreversible electroporation in the affected tissues.

[0023] Aspects of this disclosure relate to systems and methods for delivering ablation energy as well as performing electroanatomical mapping. In examples, an electroanatomical mapping and ablation system is configured to determine, quantify, and / or generate visualizations of the morphology match between the sensed signals of the patient (e.g., ECG signals and / or EGM signals) after a given instance of PF energy (e.g., a pulse train) and a targeted arrhythmia. A medical professional or the example systems described in this disclosure can use such a morphology match as feedback regarding the appropriateness of the ablation site and / or the immediate effects of the ablation. In additional examples, an electroanatomical mapping and ablation system is configured to determine, quantify, and / or generate visualizations of a time delay between the PF ablation delivery and measured cardiac activation (e.g., at least a portion of the ECG signals and / or EGM signals) after a given PF ablation pulse train or a change in the time delay over a plurality of discrete cardiac activations cycles, which may provide feedback regarding the immediate effects of the ablation.

[0024] Aspects of this disclosure relate to quantifying and / or generating visualizations of features of EGM signals or ECG signals stimulated by (e.g., caused by) PFA energy delivery. Because signal features of EGM signals and / or ECG signals corresponding to ventricular activity can be relatively easier to sense and process, at least compared to signal features corresponding to atrial activity, the techniques of this disclosure may facilitate mapping and ablation procedures related to ventricular arrhythmias. Example ventricular arrhythmias include premature ventricular contraction (PVC) and ventricular tachycardia (VT). As compared to performing separate electroanatomical mapping (e.g., pace mapping) and ablation procedures, the techniques of this disclosure can reduce or eliminate the need for performing additional mapping after an ablation procedure, as the relevant information regarding an arrhythmia (e.g., ventricular arrhythmia) can be obtained in conjunction with delivery of PF ablation energy. Moreover, because a clinician can ascertain the effects of a given application of PF energy delivery over the course of a series of applications of PF energy delivery, a clinician may be able to more accurately determine the location of the source and / or cause of a given type of arrythmia.Docket No.: A0013389W01 / 1289-028W001

[0025] As discussed throughout this disclosure, the information generated according to the techniques of this disclosure can provide a clinician feedback regarding the clinical efficacy of the PF ablation to a particular area of cardiac tissue. In some cases, such information can enable a clinician to more quickly confirm that an arrythmia has been resolved, and with increased confidence, which may reduce the instances and necessity of additional instances of PF energy delivery and / or the need for repeat ablation procedures. Similarly, such information can potentially reduce the number and / or duration of discrete instances of ablation energy delivered to a patient in order to resolve an arrhythmia. Reducing the number of discrete instances of ablation energy delivered to a particular area of tissue and / or over the course of a procedure can reduce the overall time needed for a mapping and / or ablation procedure, which can facilitate improved clinical outcomes for the patient.

[0026] While aspects of this disclosure are discussed with respect to ventricular arrhythmias, the systems and techniques of this disclosure are not so limited. For example, the techniques of this disclosure may be applicable to atrial arrhythmias and / or other cardiac conditions.

[0027] FIG. 1 A is a conceptual diagram illustrating a system 100, which includes a catheter 110 and an interface unit 150. FIG. IB is a conceptual diagram illustrating a distal portion 116 of catheter 110. Catheter 110 may be configured to deliver ablation energy (e.g., PF A, radiofrequency ablation, and / or the like), to a heart 103 of a patient 101. In some examples, catheter 110 is configured to sense and / or measure signals from heart 103 of patient 101, and / or perform other functions related to a cardiac mapping procedure.

[0028] In some examples, at least a portion of catheter 110 (e.g., distal portion 116) is configured to be introduced into one or more chambers of heart 103, e.g., for delivering ablation energy and / or measuring signals from heart 103. In some examples, at least a portion of catheter 110 (e.g., distal portion 116) is configured to be delivered to a plurality of locations (e.g., target sites) within heart 103. For example, distal portion 116 of catheter may be configured to be navigated to multiple, discrete locations in contact with tissue with heart 103 and deliver ablation energy to, and / or received sensed signals from, each of the multiple locations. In this way, catheter 110 may be configured to deliver targeted ablation energy to, and / or sense signals (e.g., local electrograms) from, multiple locations within heart 103.

[0029] Additionally or alternatively, system 100 includes one or more catheters, delivery devices, and / or the like, for accessing, treating, ablating, mapping, and / or characterizing other anatomical features and structures (e.g., besides heart 103) of patient 101. In some examples, system 100 includes one or more catheters, delivery devices, and / or the like configured for epicardial access (e.g., for performing ablation and / or sensing of signals from an epicardial location). Epicardial locations can include a space between heart 103 and the pericardium. InDocket No.: A0013389W01 / 1289-028W001 some examples, epicardial locations are accessed via a subxiphoid access point (e.g., with a catheter / sheath passing under a sternum of patient 101 and into the pericardial space of patient 101). Other locations of patient 101, e.g., for accessing, treating, ablating, mapping, and / or characterizing, include the coronary sinus, other coronary vessels, and / or the like.

[0030] Catheter 110, and / or distal portion 116, can define any suitable shape, size, and / or configuration. In some examples, distal portion 116 of catheter 110 (e.g., ablation electrode 122) defines a diameter of less than or equal to about 20 mm. Such a size of distal portion 116 of catheter 110 (e.g., ablation electrode 122) can enable catheter 110 to deliver targeted ablation energy to, and / or sense signals (e.g., local electrograms) from, multiple locations within heart 103. Catheter 110, and or distal portion 116, can be considered a focal, a small-tip focal, and / or a wide-area focal ablation and / or mapping catheter.

[0031] In the example of FIG. 1 A, catheter 110 includes a proximal portion 118 located proximally of distal portion 116. In some examples, proximal portion 118 of catheter 110 includes a handle, which may be configured to couple (e.g., via one or more cables) to interface unit 150. Proximal portion 118 of catheter 110 may be configured to remain extracorporeal to patient 101, e.g., while distal portion is within patient 101. Catheter 110 can include an elongated body, such as a shaft 112, which may be configured to be introduced into heart 103 of patient 101. Shaft 112 of catheter 110 can carry one or more therapy delivery elements (i.e., electrodes, transducers, and / or the like), navigation elements (e.g., electromagnetic coils, radiopaque markers, and / or the like), as well as one or more sensing elements (e.g., electrodes, temperature sensors, ultrasound transducers, mechanical sensors, contact sensors, force sensors, chemical sensors, and / or the like).

[0032] In the example of FIG. 1 A and FIG. IB, catheter 110 includes a plurality of cathetermounted electrodes. For example, as illustrated in the example of FIG. IB, catheter 110 (e.g., at distal portion 116) includes at least one ablation electrode 122, one or more sensing electrodes 124, and one or more shaft electrodes 126. Ablation electrode 122 can include an electrically conductive lattice structure formed from a plurality of interconnected struts. Sensing electrodes 124 can be affixed to distal portion 116 of catheter 110 (e.g., affixed to ablation electrode 122) and configured to receive (e.g., sense) intracardiac signals (e.g., EGM signals) of heart 103 of patient 101. Shaft electrodes 126 can be positioned on a portion of shaft 112 and can also be configured for sensing intracardiac signals of heart 103 of patient 101. Ablation electrode 122, sensing electrodes 124, and / or shaft electrodes 126 can be formed from an electrically conductive material configured to transmit and / or receive electrical signals from tissue of patient 101. Catheter 110 can include one or more conductors (e.g., conductor wires, traces, and / or the like) for electronically and / or communicatively coupling ablation electrode 122, sensing electrodesDocket No.: A0013389W01 / 1289-028W001124, and / or shaft electrodes 126 to circuitry of proximal portion 118 (e.g., which can include a handle) and / or to circuitry of interface unit 150.

[0033] In some examples, and with reference to FIG. 1 A, system 100 includes an auxiliary catheter 113. Auxiliary catheter 113 can include a diagnostic catheter (e.g., a mapping catheter), a pacing device (e.g., configured to deliver a pacing stimulus to heart 103), and / or another type of catheter. For example, auxiliary catheter 113 can include a coronary sinus (CS) catheter having one or more electrodes for recording signals from heart 103 of patient 101. In some examples, auxiliary catheter 113 can include an intracardiac catheter (IC) configured to be introduced into a chamber of heart 103. In some examples, auxiliary catheter 113 includes a right ventricular apex (RVA) catheter and / or a His bundle catheter (e.g., configured to be positioned proximate to the bundle of His, also referred to as the atrioventricular bundle). In some examples, auxiliary catheter 113 can include an intracardiac echocardiography (ICE) catheter. While the example of FIG. 1 A illustrates system 100 as including one auxiliary catheter 113, system can include multiple of auxiliary catheter 113, which can include any of the catheters described in this disclosure and / or a combination thereof. In some examples, auxiliary catheter 113 is configured to measure electrograms (EGMs), including intracardiac electrograms, from heart 103 of patient 101.

[0034] In some examples, system 100 additionally or alternatively includes one or more additional devices (not illustrated in FIG. 1 A) configured to sense signals from patient 101, including implantable medical devices (IMDs). For example, system 100 can include an implanted pacing device (e.g., a pacemaker) at least partially implanted in patient 101, which can include a leadless pacing device and / or a pacing device having one or more leads implanted within heart 103 of patient 101. In some examples, system 100 includes an insertable cardiac monitoring (ICM) device comprising electrodes and configured to sense signals from patient 101. These additional devices may be configured to sense signals (e.g., EGM signals) from patient 101, and such signals can be received by interface unit (e.g., by processing circuitry 152 and via telemetry circuitry 158), such as for use by processing circuitry 152 in any instances in which processing circuitry uses sensed signals (e.g., EGM signals) discussed throughout this disclosure. In further examples, system 100 includes other sensing devices, which may be configured to remain external to patient 101 (e.g., a substrate and / or garment, such as a vest), that can include body-surface electrodes 182 and / or additional external electrodes and / or sensing elements.

[0035] In the example of FIG. 1 A, interface unit 150 includes processing circuitry 152, a storage device 154, a positioning subsystem 156, telemetry circuitry 158, a user interface 160, and an energy generator 170. In general, interface unit 150 and the components thereof may be configured to aid in the delivery of energy (e.g., ablation and / or pacing energy) to, and / orDocket No.: A0013389W01 / 1289-028W001 perform mapping (e.g., electroanatomical mapping) of, heart 103 of patient 101. Interface unit 150 may be configured to generate representations (e.g., visual representations, including virtual models) corresponding to catheter 110, heart 103, such as the associated substructures of heart 103, and output such representations (e.g., via user interface 160, which can include a visual display). Substructures of heart 103 can include a right atrium (RA), a right ventricle (RV), a left atrium (LA) and / or a left ventricle (LV), as illustrated in at least FIG. 1 A.

[0036] In some examples, processing circuitry 152 is configured to receive, process, and / or generate information, as well as control one or more operations associated with interface unit 150. Processing circuitry 152 may include one or more processors, such as any one or more of a microprocessor, a controller, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field-programmable gate array (FPGA), discrete logic circuitry, or any other processing circuitry configured to provide the functions attributed to processing circuitry 152 herein may be embodied as firmware, hardware, software or any combination thereof. In some examples, processing circuitry 152 may execute other instructions stored in storage device 154 to perform one or more operations.

[0037] Storage device 154, which can include a memory, may be configured to store information received by and / or generated by interface unit 150. Storage device 154 may include a computer-readable storage medium or computer-readable storage device. In some examples, storage device 154 includes one or more of a short-term memory or a long-term memory. Storage device 154 may include, for example, random-access memories (RAM), dynamic random-access memories (DRAM), static random-access memories (SRAM), ferroelectric random-access memories (FRAM), magnetic discs, optical discs, flash memories, or forms of electrically programmable memories (EPROM) or electrically erasable and programmable memories (EEPROM). In some examples, storage device 154 is used to store data indicative of instructions, e.g., for execution by processing circuitry 152, respectively. Storage device 154 may be configured to store location data (e.g., location data corresponding to catheter 110, heart 103, patient 101, and / or the like), anatomical information, user-input information, energy (e.g., ablation energy) parameters, EGM signals, ECG signals, and / or all of the determined information described in this disclosure, and / or the like.

[0038] In the example of FIG. 1 A, interface unit 150 includes a positioning subsystem 156. In some examples, positioning subsystem 156 is configured to determine, record, and / or predict positions and / or orientations of catheter 110 (e.g., including one or more of the components of catheter 110), anatomical features of patient 101, and / or components of system 100. In some examples, positioning subsystem 156 is configured to track (e.g., via measured positions) at least a portion of catheter 110, or components thereof, via signals and / or fields, such as magneticDocket No.: A0013389W01 / 1289-028W001 fields, electromagnetic signals, injected current signals, impedance measurements, and / or the like. Positioning subsystem 156 may be configured to record, access, and display both current (e.g., real-time or near-real time) and historical (e.g., past) locations of catheter 110 within heart 103. In some examples, positioning subsystem 156 includes one or more of an electromagnetic signal and / or magnetic field generator, a generator to inject current, and / or another energy and / or field generator for tracking a position of catheter 110 or other components of system 100. In some examples, positioning subsystem 156 additionally or alternatively includes one or more of an ultrasound generator. In some examples, positioning subsystem 156 includes one or more medical imaging modalities, such as fluoroscopy, x-ray, magnetic resonance imaging (MRI), and / or the like.

[0039] Telemetry circuitry 158 may include any suitable hardware, firmware, software or combination thereof for communicating with another device, such as navigations systems (e.g., positioning subsystem 156). Telemetry circuitry 158 may be configured to communicate using any of a variety of wireless communication schemes, such as Bluetooth® or Bluetooth Low Energy®, WiFi, 4G, or 5G, or a wired communication scheme (e.g., ethernet). Under the control of processing circuitry 152, telemetry circuitry 158 may receive downlink telemetry from, and / or send uplink telemetry to, external devices, with the aid of an antenna, or via wires.

[0040] User interface 160 (e.g., via executed instructions from processing circuitry 152) may be configured to output information from interface unit 150 to a user (e.g., a clinician). User interface 160 can be and / or include a graphical user interface (“GUI”). Additionally or alternatively, user interface 160 is configured to receive input from a user (e.g., a clinician). In some examples, user interface 160 includes a screen, display, and / or another visual output medium (e.g., augmented reality display or virtual reality display). In some examples, user interface 160 includes a button or keypad, lights, a speaker for voice commands, and the display of user interface 160 can include one or more of a liquid crystal (LCD), light-emitting diode (LED), or organic light-emitting diode (OLED) display. User interface 160 may be configured to output an indication of any of the determined information described in this disclosure.

[0041] Energy generator 170 may be configured to control delivery of energy (e.g., ablation energy or pacing energy) via catheter 110. For example, energy generator 170 may be configured and programmed to deliver pulsed, high-voltage electrical energy (e.g., electrical fields) appropriate for achieving desired pulsed, high-voltage ablation and / or pulsed radiofrequency ablation. Energy produced by energy generator 170 may include, but is not limited to, radiofrequency (RF) energy and / or pulsed field ablation (PF A) energy, including monopolar or bipolar high-voltage direct-current (DC) or alternating-current (AC) pulses for effecting irreversible electroporation (IRE), or combinations thereof. As discussed herein, PFA can includeDocket No.: A0013389W01 / 1289-028W001 irreversible electroporation and / or reversible electroporation (i.e., interrogating energy). Energy generator 170 comprises energy -generating circuitry configured to produce the energy, along with a controller (e.g., processing circuitry 152) configured to control the circuitry and, optionally, perform other computational functions.

[0042] Processing circuitry 152 may be configured to control energy generator 170 to deliver ablation energy according to one or more ablation parameters. Ablation parameters may include a timing of energy delivery, and / or other parameters associated with PFA. In some examples, the ablation parameters include one or more pulse widths, one or more pulse amplitudes, one or more inter-pulse delays (e.g., timing delays between pulses in a pulse train), number of pulses in a given pulse train, number of pulse trains, inter-train timing delay, and / or other PFA parameters. As discussed herein, a given instance of delivery of ablation energy (e.g., that can be initiated via a clinician) can include a predetermined (i.e., pre-programmed) set of ablation parameters, such as predetermined pulse widths (e.g., time durations) of each of PFA pulse, a predetermined number of pulses within a given pulse train (e.g., which include a same number or different number of pulses for different pulse trains), an inter-train delay duration, and the total number of pulse trains for the given instance of PF energy delivery. Ablation parameters may additionally or alternatively include a selected combination of energy delivery elements (e.g., a subset of electrodes in examples in which catheter 110 includes multiple ablation electrodes), a suggested (e.g., target) positioning for one or more therapy delivery elements, a suggested (e.g., target) energy level (e.g., current, voltage, charge, and / or the like) to be delivered, an energy modality (e.g., RF, cryogenic, PFA, etc.) or combination of modalities, and / or the like.

[0043] In some examples, system 100 includes a recording subsystem 180. Recording subsystem 180 is configured to receive and / or record sensed signals of patient 101. Such sensed signals can include electrocardiogram (ECG) signals (e.g., acquired by one or more body-surface electrodes 182 attached to an external body surface of patient 101) and / or intracardiac electrogram (EGM) signals. EGM signals can be acquired by electrodes of catheter 110 (e.g., sensing electrodes 124 illustrated in FIG. IB), electrodes of auxiliary catheter 113, another device, and / or a combination thereof. In some examples, interface unit 150 is configured to communicate with recording subsystem 180, such as to receive information of signals received and / or recorded by recording subsystem 180. In some examples, recording subsystem 180 is configured to receive electrical signals (e.g., intracardiac electrical signals, including EGMs) from auxiliary catheter 113. Recording subsystem 180 can be electronically and / or communicatively coupled with catheter 110, auxiliary catheter 113, body-surface electrodes 182, and / or interface unit 150.Docket No.: A0013389W01 / 1289-028W001

[0044] Recording subsystem 180 can include a display and be configured to output an indication of measured ECG signals and / or EGM signals on the display. Additionally or alternatively, recording subsystem 180 may be configured to send information of ECG signals and / or EGM signals to interface unit 150, e.g., for display via user interface 160 of interface unit 150. Recording subsystem 180 may also be configured to pace heart 103 and / or may be coupled to (e.g., electronically and / or communicatively coupled to) a standalone pacing device.

[0045] The components of system 100 as described herein can be organized in any suitable manner, and may be organized differently as illustrated in FIG. 1 A. For example, the components within interface unit 150 and recording subsystem 180 may not be organized exactly as shown. In some examples, energy generator 170 comprises one or more separate energy generation devices, such as a stimulation energy generator and a separate ablation energy generator. The recording functions (e.g., of recording subsystem 180) and positioning functions (e.g., of positioning subsystem 156) may be performed by separate, connected systems, but may also be performed by a single, integrated, system.

[0046] FIG. 2A and FIG. 2B include conceptual diagrams that illustrate examples of information presented via a user interface according to the examples of this disclosure. FIG. 3 illustrates an example ECG waveform, also referred to herein as an ECG signal, and an example PFA waveform, also referred to herein as a PFA signal, on respective voltage versus time plots. The functionalities of system 100 (e.g., of interface unit 150, including processing circuitry 152) according to this disclosure will be discussed with respect to the examples of FIG. 2A and FIG. 2B, as well as FIG. 3.

[0047] Each of FIG. 2 A and FIG. 2B illustrate a user interface 260, which may be an example of user interface 160 of interface unit 150 from the example of FIG. 1A. User interface 260 can be and / or include a graphical user interface (“GUI”). In some examples, processing circuitry 152 of interface unit 150 is configured to generate one or more outputs (e.g., visual outputs, audible outputs, tactile outputs, and / or the like) via user interface 260. In some examples, processing circuitry 152 of interface unit 150 is configured to generate visualizations and / or otherwise enable visualization of measured or sensed information (e.g., signals), determined information (e.g., values, metrics, indices), recommendations, and / or the like. In some examples, processing circuitry 152 is configured to generate, and / or output (e.g., via user interface 260), information indicative of a representation (e.g., visual representations, such as to be viewable by a clinician) of heart 103, catheter 110, and / or other components of system 100 (e.g., such as auxiliary catheter 113). The representation of heart 103 can include representations of one of more of the RA, RV, LA, LV, epicardium, pericardial space, coronary vessels, adjoining veins and arteries, and / or the like. The visual representations may be considered asDocket No.: A0013389W01 / 1289-028W001 examples of three-dimensional virtual models of heart 103 (e.g., computer-generated virtual models).

[0048] In some examples, processing circuitry 152 is configured to generate and output, via user interface 260, representations of tissue of patient 101 (e.g., of heart 103), representations of components of system 100, and / or other information presented in conjunction with (e.g., overlaid on) the representations. For example, as illustrated in the examples of FIG. 2 A and FIG. 2B, processing circuitry 152 is configured to generate and output information related to delivered ablation energy and / or information related to signals sensed from patient 101. Such information can aid a clinician in assessing the efficacy of previous instances of delivered ablation energy and / or aid a clinician in assessing whether and / or where to deliver further ablation energy.

[0049] In some examples, as illustrated in the examples of FIG. 2A and FIG. 2B, processing circuitry 152 generates and outputs, via user interface 260, visual images and representations associated with a cardiac ablation procedure and / or a cardiac mapping procedure, as well as determined information related to such procedures. For example, processing circuitry 152 may be configured to generate and output, via user interface 260, an area 272 having a heart representation 274 (e.g., which may be a three-dimensional representation of heart 103 of patient 101, illustrated in FIG. 1 A). In some examples, processing circuitry 152 generates and outputs, via user interface 260, a catheter representation 276 (e.g., which may be a representation of catheter 110 of FIG. 1A).

[0050] In some examples, processing circuitry 152 is configured to generate one or more lesion tags 278A overlaid on the three-dimensional representation of the heart (e.g., heart representation 274). Lesion tags 278A can indicate information about delivery of ablation energy. For example, a location of each of lesion tags 278 A can correspond to, and / or indicate, a location at which a given instance of ablation energy is / was delivered (also referred to herein as a target site or a target location). In some examples, processing circuitry 152 generates lesions tags 278 A (e.g., on heart representation 274) at locations where PF energy is delivered (e.g., to indicate an approximate area and / or volume of tissue of heart 103 affected by a given application PF energy). Processing circuitry 152 can be configured to adjust an orientation (e.g., relative to heart representation 274), size, texture, and / or another visual property of lesions tags 278 A based on signals sensed by one or more sensing electrodes 124 and / or one or more shaft electrodes 126 of catheter 110. Additionally or alternatively, processing circuitry 152 can be configured to generate, for display, at least one therapy contour (e.g., a line or another connecting element that connects adjacent lesions tags 278 A that are within a predefined distance from one other). Additionally or alternatively, processing circuitry 152 can be configured to generate a color-Docket No.: A0013389W01 / 1289-028W001 coded three-dimensional map indicating areas of delivered energy (e.g., without generating individual tags at specific, discrete locations).

[0051] In some examples, as is illustrated in the example of FIG. 2B, processing circuitry 152 is configured to generate lesion tags 278 A having a first visual characteristic and at least one lesion tag 278B having a second visual characteristic different from the first visual characteristic. For example, lesion tag 278B can include a different color, a different pattern, a different opacity, a different size, a different shape, and / or the like, and / or a combination of such visual properties as compared to lesion tags 278A. As discussed further herein, the different visual characteristics of lesion tags 278A and lesion tag 278B can indicate, such as to a clinician, a difference in the energy delivered to respective locations and / or resulting physiological responses at the respective locations corresponding to each of lesion tags 278 A and lesion tag 278B.

[0052] FIG. 3 illustrates an ECG waveform 300 and a PF A waveform 302 (also referred to herein as ECG signal 300 and PFA signal 302). In the example of FIG. 3, voltage of the ECG signal 300 is measured in millivolts (mV) versus time, with the time being measured in milliseconds (ms). In the example of FIG. 3, the voltage of PFA waveform 302 is measured in volts (kV) versus time, with the time also being measured in microseconds (ps). Because the time and voltage axes of each of ECG signal 300 and PFA waveform 302 illustrated in the example of FIG. 3 are on different orders of magnitude, it will be appreciated that the relative amplitudes and timings of such signals may not be comparable. For example, a given application of PF energy delivery (including multiple trains of pulses as further described herein) may be completed prior to the elicited ECG signal 300.

[0053] In the example of FIG. 3, ECG waveform 300 includes a P-wave (not visible in the example of FIG. 3), a QRS complex, and a T-wave. In some examples, the QRS complex of ECG waveform 300 corresponds to ventricular depolarization of heart 103. PFA waveform 302 includes at least a first pulse train 310 having at least one PFA pulse 311 (other individual pulses unlabeled). Each PFA pulse 311 can include multiple phases, such as at least two phases. For example, PFA pulse 311 can be a bi-phasic pulse including both positive voltage and negative voltage components (as illustrated in FIG. 3), which can be separated by an inter-phase delay. PFA pulse 311 can define a pulse width having a non-zero amount of time measured from an initial time 317 (e.g., which can be measured from a point in time when each PFA pulse 311 reaches a threshold voltage change from a baseline voltage). An inter-train delay 312 (e.g., which can include a non-zero period of time) can separate the first pulse train 310 and a second pulse train 314.

[0054] In the example of FIG. 3, a pulse train period 316 includes a period of time of at least one pulse train (e.g., at least first pulse train 310 and / or a first group of pulses) and one or moreDocket No.: A0013389W01 / 1289-028W001 associated inter-train delays (e.g., first pulse train 310 and inter-train delay 312). In some examples, pulse train period 316 corresponds to (e.g., is less than or equal to) a cardiac period (e.g., an R-R interval of heart 103 during normal sinus rhythm). In some examples, pulse train period 316 is selected to maintain heart 103 in a favorable rhythm (e.g., normal sinus rhythm or a paced rhythm). In some examples, pulse train period 316 is selected to maintain heart 103 in an arrhythmic state (e.g., a clinical ventricular tachycardia). In some examples, PF ablation energy (e.g., via appropriate selection of pulse train period 316, and / or other parameters) may terminate an arrhythmia in a manner similar to anti-tachycardia pacing (ATP).

[0055] In some examples, processing circuitry 152 is configured to use information associated with PFA waveform 302 and information of a sensed signal (e.g., ECG waveform 300) of patient 101, such as to determine other clinically relevant information (e.g., metrics, indices, recommendations, and / or the like). Sensed signals from patient 101 can include one or more of an electrocardiogram (ECG) signal, such as illustrated in FIG. 3 via ECG waveform 300, and / or an electrogram (EGM). The determined information can include a morphology match between (a) a template signal of a target morphology and (b) a sensed signal of patient 101 (e.g., which can include one or more of the ECG signal and the EGM signal). Another example of determined information can include time delay information. The time delay information can include and / or reflect a time delay between the pulsed field energy and the resulting sensed signal of patient 101. For example, the time delay can be based on (e.g., measured between) a time when at least one pulse of PFA energy is delivered and a time when the at least one sensed signal is generated or sensed. In some examples, the time delay information includes a change in the time delay (e.g., over a plurality of discrete cardiac activation cycles), which can reflect a dissociation trend and / or progressive delay. Said another way, the dissociation trend and / or progressive delay can include and / or be reflected by a change in the time delay over a plurality of discrete cardiac activations cycles.

[0056] Such determined information can aid a clinician in determining whether previous pulse trains and / or applications of PFA energy were effective in resolving an arrhythmia (e.g., by reducing or eliminating the instance or severity of the arrhythmia) and / or whether to continue to deliver further PFA energy to tissue. For example, processing circuitry 152 may be configured to generate and output (e.g., via user interface 260 of FIG. 2A or FIG. 2B) indications of the determined information, such as to enable a clinician to determine whether previous applications of PFA energy were effective in resolving an arrhythmia, either temporarily or permanently, and / or whether to continue to deliver further PFA energy to tissue. Additionally or alternatively, processing circuitry 152 may be configured to generate and output, based on the determinedDocket No.: A0013389W01 / 1289-028W001 information, recommendations (also referred to herein as recommendation outputs) about whether to deliver further PFA energy and / or to cease further delivery of PFA energy.

[0057] In some examples, and with reference to PFA waveform 302 of FIG. 3, processing circuitry 152 receives information of at least one PFA pulse 311 of pulsed field ablation (PFA) energy delivered to heart 103 heart of a patient 101. With reference to FIG. 1A, energy generator 170 may be configured to deliver a plurality of pulse trains (e.g., at least first pulse train 310 and second pulse train 314) of PFA energy to heart 103 of patient 101 via catheter 110, such as via one or more catheter-mounted electrodes of catheter 110. As illustrated in the example of FIG. 3, each of the pulse trains (e.g., at least first pulse train 310 and second pulse train 314) can include multiple of PFA pulses (e.g., multiple of PFA pulse 311). Processing circuitry 152 may be configured to receive information of an initial time 317, which can be considered as a start of a first PFA pulse 311 and / or a start of first pulse train 310.

[0058] In some examples, processing circuitry 152 receives other information corresponding to PFA pulse 311, first pulse train 310, pulse train period 316, and / or other information of about PFA waveform 302. In some examples, processing circuitry 152 receives other information corresponding to PF energy delivery, such as an associated temperature rise of tissue (e.g., as measured by sensing electrodes 124), an impedance (e.g., as measured by sensing electrodes 124), a contact force (e.g., as measured by one or more force sensors carried by catheter 110), a position / orientation (e.g., as measured by positioning subsystem 156), a total duration and / or number of all pulse trains, and / or the like. Such information can be used by processing circuitry 152 to determine a level of sufficiency (and / or a level of effectiveness) of ablation energy, as further discussed herein.

[0059] In some examples, and with reference to ECG waveform 300 of FIG. 3, processing circuitry 152 receives information of at least one sensed signal of patient 101 (e.g., a portion of an ECG signal 300). For example, processing circuitry 152 can receive timing information related to at least the QRS complex of ECG waveform 300. ECG signal 300 of FIG. 3 is an example ECG waveform generated by (e.g., in response to) PF energy (e.g., by PF waveform 302) delivered to heart 103 of patient 101. ECG signal 300 may be distorted from typical ECG signals due to being responsive to PF energy. For example, ECG signal 300 may define a relatively wide QRS complex (e.g., caused by stimulation of the ventricle without using the normal high-speed conduction system of heart 103).

[0060] As discussed elsewhere in this disclosure, PFA pulses can, in some cases, cause capture of cardiac tissue, which can result in measurable cardiac activity (e.g., measurable via ECG and / or EGM signals), in a similar manner as pacing pulses. In this way, the sensed signal of patient 101 (e.g., ECG and / or EGM signals) can be caused by and / or be generated in response to,Docket No.: A0013389W01 / 1289-028W001 at least in part, the PFA energy delivered to heart 103 of patient 101. Thus, processing circuitry 152 can receive the information of sensed signals (e.g., ECG signals and EGM signals) of patient 101 in response to delivery of PF energy. ECG signals and EGM signals caused, at least in part, by PFA energy can also be referred to herein as a stimulated electrocardiogram (ECG) or stimulated electrogram (EGM). Accordingly, ECG waveform 300 of FIG. 3 may be the sensed signal that is generated in response to delivery of PFA waveform 302.

[0061] In some examples, processing circuitry 152 is configured to receive timing information related to at least a portion of ECG waveform 300 (e.g., a specific time or range of times associated with a portion of ECG signal 300, such as an absolute time of QRS complex of ECG waveform 300), which can be generated in response to PFA energy (e.g., from PFA waveform 302). For example, processing circuitry 152 can receive a time 318, which is associated with the start of a Q-wave of the QRS complex of ECG waveform 300 (and / or another portion of ECG waveform 300 associated with ventricular activity). In the example of FIG. 3, time 318 is a non-zero time with respect to (e.g., after) initial time 317 (e.g., which can be associated with first PFA pulse 311 of PFA waveform 302). While the example of FIG. 3 illustrates an ECG waveform, processing circuitry 152 may additionally or alternatively receive information of an EGM signal, which may include timing information related to relevant cardiac activity (e.g., ventricular activity).

[0062] In some examples, processing circuitry 152 is configured to receive information of at least one sensed signal of patient 101 (e.g., ECG signals and / or EGM signals) from one or more sources (e.g., via a least one electrode, which can include at least one intracardiac and / or bodysurface electrodes). For example, and with reference to FIG. 1A, processing circuitry 152 may be configured to receive information of ECG signals via body-surface electrodes 182 (e.g., via recording subsystem 180). As another example, and with reference to FIG. 1A, processing circuitry 152 can receive information of EGM signals via one or more catheter-mounted electrodes (e.g., affixed to catheter 110 and / or auxiliary catheter 113). In some examples, the catheter-mounted electrodes used for measuring EGMs signals (e.g., electrodes of auxiliary catheter 113) are mounted on a different catheter from the electrodes that deliver ablation energy to tissue of heart 103 (e.g., electrode 122 of catheter 110). Using a separate catheter with respective electrodes for sensing EGMs and delivering PF ablation energy can help preserve signal quality of the sensed EGMs, which may facilitate the use of such sensed EGMs for the determination of other information as described in this disclosure.

[0063] In some examples, processing circuitry 152 determines time delay information. The time delay information can include a time delay, such as a time delay based on a time when the at least one pulse is delivered and a time when the at least one sensed signal (e.g., ECG signalDocket No.: A0013389W01 / 1289-028W001 and / or EGM signal) of patient 101 is generated or sensed. For example, and with reference to FIG. 3, processing circuitry 152 determines a time delay 320 between at least one PFA pulse and a portion of a subsequent ECG signal (also referred to herein as a “stimulated ECG”). In some examples, processing circuitry 152 measures time delay 320 for each cardiac cycle of a plurality of cardiac cycles (e.g., a plurality of ECG waveforms 300). Additionally or alternatively, processing circuitry 152 may determine a time delay between the at least one PFA pulse and a portion of an EGM signal (e.g., a portion of an EGM signal indicative of ventricular activity). Such a time delay may indicate whether the PFA energy caused the resulting measurable cardiac activity, or if the measurable cardiac activity is unrelated to the delivered PFA energy. Such a time delay may also indicate whether the PFA energy is being delivered within a channel of slow conduction within the cardiac tissue, or if the PFA energy is being delivered to cardiac tissue with more typical conduction.

[0064] In some examples, processing circuitry 152 measures time delay 320 between a relevant portion of the PFA pulse (e.g., initial time 317 associated with PFA pulse 311 of pulse train 310) and a portion of elicited resulting cardiac activity (e.g., a portion of ECG signal 300, such as the Q-wave of ECG signal 300 as indicated by time 318). Time delay 320 can be, for example, on the order of milliseconds (ms), such as 1 ms to 100 ms (inclusive). In some examples, processing circuitry 152 attempts to determine a time delay for each pulse train of a plurality pulse trains (e.g., at least first pulse train 310 and second pulse train 314). While the example of FIG. 3A illustrates time delay 320 measured between initial time 317 (which may be a start of first pulse train 310 of PFA waveform 302), and time 318 (which may correspond to the Q-wave of ECG signal 300), processing circuitry 152 may additionally or alternatively measure time delay 320 between other portions of PFA waveform 302 and ECG signal 300. For example, the start of time delay 320 may include a time corresponding to a middle of first pulse train 310, a time corresponding to an end of first pulse train 310, a time corresponding to a time after a predetermined number of pulses of first pulse train 310, and / or another relevant time. As another example, the end of the time delay 320 may include another relevant portion of ECG signal 300, such as a time corresponding to the R-wave, S-wave, or another relevant portion of ECG signal 300. Additionally or alternatively, the end of the time delay 320 can include a buffer from a relevant portion of ECG signal 300 (e.g., a predetermined buffer time after the Q-wave of ECG signal 300).

[0065] In some examples, the time delay information based on (e.g., measured between) PFA pulses and resulting sensed signals of patient 101, such as time delay 320 illustrated in the example of FIG. 3, can indicate the presence or the absence of a target cardiac arrythmia. For example, time delay 320 can indicate a relationship of a particular location within heart 103 ofDocket No.: A0013389W01 / 1289-028W001 patient with a feature of the target arrythmia (e.g., an exit of a critical isthmus of the target arrhythmia). In some cases, time delay 320 being within a particular window and / or consistent over multiple instances of PFA energy delivery can indicate that the PFA energy is consistently stimulating the heart (i.e., capturing the cardiac tissue) and / or whether the PFA energy was delivered within, or near the exit of, a critical isthmus of a reentrant arrhythmia. Additionally or alternatively, the time delay based on (e.g., measured between) PFA pulses and resulting sensed signals of patient 101 can enable a clinician to determine whether to deliver further PFA energy to heart 103 to the patient 101 and / or whether to cease further delivery of PFA energy to heart 103 to the patient 101. As discussed herein, processing circuitry 152 can be confirmed to generate and output (e.g., via user interface 260 of at least FIG. 2A) a recommendation (also referred to herein as a recommendation output) corresponding to delivery of PFA energy based on the determined time delay.

[0066] One or more of parameters (e.g., a number, a duration, an amplitude, a timing, and / or the like) of the various components of PFA waveform 302 (e.g., timing of each PFA pulse, the inter-phase delay, inter-train delay 312, pulse train period 316, and / or the like) can be selected or programmed to elicit a unique (e.g., selected) cardiac response of heart 103. PFA waveform 302 can be synchronized to a synchronization signal (e.g., a “sync pulse”). The synchronization signal can correspond to ECG signal 300 (and / or a preceding ECG signal that precedes PFA waveform 302 in time). In some examples, processing circuitry 152 may be configured to synchronize PFA waveform 302 with a portion of a preceding sensed signal (e.g., ECG signal), such as via a synchronization signal. Alternatively, the synchronization signal can correspond to a pacing signal. In some examples, processing circuitry 152 and / or energy generator 170 may be configured to synchronize PFA waveform 302 with a portion of a preceding pacing pulse, such as via a synchronization signal. In some examples, processing circuitry 152 is configured to vary and / or adjust the delay from the synchronization signal to the onset of PFA waveform 302 (e.g., first PFA pulse 311), such as to maintain a stable rhythm of heart 103 or, alternatively, to provoke an arrhythmia of heart 103. In some examples, processing circuitry 152 is configured to receive input (e.g., from a user, such as a clinician) of a length of inter-train delay 312, and / or of the length of the overall pulse train period 316. In some examples, processing circuitry 152 is configured to select (e.g., automatically select without user input), and / or receive input of, the inter-train delay length (e.g., inter-train delay 312), e.g., such that the timing between trains (e.g., between first pulse train 310 and second pulse train 314) is greater than or equal to a period of the heartbeat cycle of heart 103. As another example, processing circuitry 152 may be configured to select (e.g., automatically select without user input), and / or receive input (e.g., from a user) of, the length of the overall pulse train period 316, e.g., such that the pulse train period 316 is lessDocket No.: A0013389W01 / 1289-028W001 than or equal to a period of the heartbeat cycle of heart 103. The heartbeat cycle of heart 103 can include, for example, a normal sinus heartbeat cycle, a paced cycle length, a tachycardia cycle length, a bradycardia cycle length, and / or one or more premature beats.

[0067] In some examples, processing circuitry 152 is configured to control, define, and / or adjust one or more energy (e.g., ablation energy) parameters (e.g., of energy generator 170) to facilitate feedback related to PF energy delivery, such as for determining the sufficiency and / or effectiveness of ablation energy delivered to heart 103 of patient 101. For example, in some examples, processing circuitry 152 is configured to vary one or more energy parameters (i.e., pulse width, pulse amplitude, timing delay between pulses, number of pulses in a given pulse train, pulse period, number of pulse trains, inter-train timing delay, and / or other PF parameters) over the course of a given instance of PF energy delivery and / or over multiple instances of PF energy delivery.

[0068] In one example, processing circuitry 152 is configured to deliver, via energy generator 170, a series of pulse trains with a first period (e.g., pulse train period 316, also referred to herein as SI) followed by one or more additional pulse trains with a different pulse period and / or reduced coupling interval (e.g., which can be referred to as S2, S3, etc.). Such variation in pulse period may facilitate induction or termination of a particular arrhythmia of interest. In some examples, at least a first pulse train period 316 (“SI”) can include an inter-train delay having a first duration (e.g., 600 ms), and later pulse trains can have one or more different pulse train periods (S2, S3, etc.) having inter-train delays of at least a second duration (e.g., 300 ms).

[0069] Processing circuitry 152 may be configured to maintain one or more of a constant number of pulses in a given train and / or a constant train duration even over multiple trains having different pulse periods and / or different inter-train delays. As another example, processing circuitry 152 may be configured to vary (e.g., continuously vary) the pulse train period 316 over the course of multiple consecutive pulse trains to maintain consistent capture of heart 103 (e.g., via adjusting one or more of the duration of pulse trains 310, 314 and / or adjusting inter-train delay 312). Such configurations of processing circuitry 152 and / or energy generator 170 can obviate “Wenckebach” behavior with progressive stimulus-to-response delay followed by loss of capture. Additionally or alternatively, such configurations of processing circuitry 152 and / or of energy generator 170 can enable processing circuitry 152 to determine whether different ablation parameters elicited a different response in the sensed signal of patient 101 (e.g., ECG signal 300). In some examples, processing circuitry 152 and / or energy generator 170 is configured to determine a sufficiency and / or effectiveness of ablation energy after (e.g., in response to) each delivered pulse train of multiple pulse trains and / or after each instance of PF energy delivery.Docket No.: A0013389W01 / 1289-028W001

[0070] In some examples, processing circuitry 152 is configured to perform other operations to facilitate feedback related to PF energy delivery. In some examples, processing circuitry 152 is configured to interleave non-ablative energy pulses (e.g., pacing pulses) with PF energy pulses, such as to maintain an elicited cardiac response (e.g., an elicited or evoked arrhythmia) of heart 103 of a patient 101. For example, processing circuitry 152 may be configured to control energy generator 170 to interleave one or more pacing pulses between trains of PF A pulses (e.g., between first pulse train 310 and second pulse train 314 in the example of FIG. 3, such as within inter-train delay 312). Additionally or alternatively, processing circuitry 152 may be configured to control energy generator 170 to interleave one or more pacing pulses within a particular PF A pulse train (e.g., within PF A pulse train 310). In some examples, parameters of the interleaved pacing pulses (e.g., the number, duration, amplitude, other relevant parameters, and / or a combination thereof) correspond to one or more parameters of a target arrhythmia (e.g., the type and / or timing of the target arrhythmia, the location of the source of the arrythmia, other relevant parameters, and / or a combination thereof).

[0071] Processing circuitry 152 can be configured to control energy generator 170 deliver pacing pulses during any time relative to the mechanical cycle and / or electrical cycle of heart 103. In some examples, processing circuitry 152 is configured to control energy generator 170 deliver one or more pacing pulses prior to a PF energy pulse train (e.g., prior to each PFA energy train). In some examples, delivering pacing pulses prior to a PF energy pulse train (e.g., prior to each PFA energy train) ensures that the PF energy (e.g., PFA) is delivered during a refractory period of heart 103. In some examples, delivering pacing pulses prior to a PF energy pulse train (e.g., prior to each PFA energy train) ensures that the PF energy (e.g., PFA) is delivered during a particular phase of the cardiac cycle (e.g., the end diastole, during contraction, and / or another phase). Delivery of PF energy (e.g., PFA) during a particular phase of the cardiac cycle (e.g., the end diastole) can be desirable as tissue (e.g., of heart 103) is relatively thinner, which can result in a relatively deeper lesion. Deeper lesions may lead to a relatively more favorably therapeutic outcome (e.g., treatment of a target arrhythmia). Delivery of PF energy (e.g., PFA) during contraction of heart 103 can maximize contact between a portion of catheter 110 and tissue of heart 103, which can enable relatively more efficient and / or relatively more therapeutically effective delivery of PF energy (e.g., PFA).

[0072] Various configurations of system 100 for delivering pacing pulses are contemplated. In some examples, processing circuitry 152 is configured to control energy generator 170 to deliver pacing pulses via catheter 110 (e.g., via any of ablation electrode 122, one or more sensing electrodes 124, and one or more shaft electrodes 126). Additionally or alternatively, processing circuitry 152 can be configured to deliver pacing pulses from a separate pacing deviceDocket No.: A0013389W01 / 1289-028W001(e.g., from an implantable pacing device, an external pacing device, from auxiliary catheter 113, and / or the like).

[0073] In further examples, processing circuitry 152 is configured to monitor the sensed signals of patient 101 (e.g., EGMs or ECG) elicited by the delivery of PF pulse trains and adjust the pulse train period of successive pulse trains (e.g., pulse train period 316) delivered by energy generator 170 based on (e.g. in response to) the sensed signals of patient 101. Such a configuration of processing circuitry 152 and / or energy generator 170 can facilitate consistent capture of heart 103 (e.g., facilitate consistent an elicited response of heart 103). In such instances in which is desirable to mitigate or avoid arrhythmia induction during PF ablation, maintaining consistent capture (e.g., via varying and / or adjusting the pulse train period) can enable a reduced likelihood and / or instance of arrhythmia induction during PF ablation. In some examples, processing circuitry 152 and / or energy generator 170 are configured to stop further delivery of energy if an undesired arrhythmia is detected (e.g., ventricular fibrillation or bradycardia).

[0074] Processing circuitry 152 may be configured to determine a progressive delay and / or dissociation state. In some examples, the progressive delay and / or dissociation state refers to the consistency (and / or lack thereof) of timing (e.g., delay) of the ECG signal (and / or the EGM signal) elicited in response to delivered PFA energy (e.g., a PFA pulse train) over multiple PFA pulse trains or multiple instances of discrete applications of the PFA energy. Progressive delay can include and / or be reflected by a change (e.g., increase) in the time delay over a plurality of discrete cardiac activations cycles and / or over a plurality of discrete applications of PFA energy delivery. For example, a change (e.g., increase) in the time delay between the time associated with PFA energy delivery (e.g., initial time 317) and the time associated with a portion of the sensed signal of patient 101 (e.g., time 318, which can be associated with a Q-wave), otherwise referred to as progressive delay, can indicate that the PFA energy delivery is influencing conduction in the area targeted by the ablation delivery and / or that the PFA energy delivery is affecting the arrhythmia circuit. Similarly, a lack of consistency of timing (e.g., delay) between the time associated with PFA energy delivery (e.g., initial time 317) and the time associated with a portion of the sensed signal of patient 101 (e.g., time 318, which can be associated with a Q- wave), otherwise referred to as dissociation, can indicate that an elicited response from heart 103 (e.g., including an arrhythmia) is no longer being caused by PFA energy delivered to an area of heart 103 and / or that the arrhythmia circuit has been treated in the targeted area, either temporarily or permanently. In some examples, processing circuitry 152 is configured to generate and output (e.g., via user interface 260 of at least FIG. 2A) a recommendation (also referred toDocket No.: A0013389W01 / 1289-028W001 herein as a recommendation output) corresponding to delivery of PF A energy based on the determined progressive delay and / or the dissociation state of heart 103.

[0075] In some examples, processing circuitry 152 determines a dissociation state of heart 103. In some examples, the dissociation state can include a complete dissociation state (e.g., when delivered PFA energy no longer causes an elicited cardiac response of heart 103 and / or is no longer synchronized with the sensed signal of heart 103). In some examples, the dissociation state can include a non-dissociation state (e.g., when delivered PFA energy causes an elicited cardiac response of heart 103 and / or is synchronized with the sensed signal of heart 103). The dissociation state can include a state of heart 103 at a given timepoint (e.g., a timepoint along the progressive delay). A dissociation trend can indicate a trend toward either a complete dissociation state or a non-dissociation state across recent applications of PF energy.

[0076] In some examples, processing circuitry 152 determines the dissociation state and / or progressive delay in response to time delay information. For example, in some examples, processing circuitry 152 determines a complete dissociation state in response to determining that the time delay is not consistent over a plurality of discrete cardiac activation cycles. For example, after succussive ablations, the time between the pulsed field energy and the resulting cardiac activation may get larger and / or inconsistent, which can indicate complete dissociation. In such cases, processing circuitry 152 can generate an output indicating the dissociation state (e.g., complete dissociation), which can indication to a clinician that the series of ablations sufficiently addressed the arrhythmia circuit in the target location, either temporarily or permanently. In some examples, processing circuitry 152 determines a non-dissociation state in response to determining a consistent or slowly changing time delay between the pulsed field energy and the resulting cardiac activation.

[0077] In some examples, processing circuitry 152 is configured to determine a morphology match between (a) a template signal of a target morphology and (b) at least one sensed signal of the patient (e.g., at least a portion of an ECG signal and / or EGM signal). In some cases, the template signal is associated with a cardiac arrhythmia (e.g., ventricular tachycardia or premature ventricular contractions). The target morphology can be a signal morphology associated with the cardiac arrhythmia. The template signal can be recorded (e.g., via recording subsystem 180) from patient 101 prior to ablation and / or mapping (e.g., any time before the ECG signal and / or the EGM signal that are generated in response to PFA energy are received by processing circuitry 152). In other examples, the template signal is not specific to patient 101, but can be a signal representative of a cardiac arrhythmia of interest that is stored (e.g., via storage device 154) and recalled by processing circuitry 152.Docket No.: A0013389W01 / 1289-028W001

[0078] The morphology match at a given location can correspond to the appropriateness of ablation at the given location for resolving the arrythmia. In some examples, the morphology match (e.g., a relatively high morphology match to a target arrhythmia) at a given location corresponds to an appropriate ablation site (e.g., increased likelihood that ablation energy delivered to the particular area will at least partially help resolve the arrhythmia). In some examples, a relatively high morphology match (e.g., a match above a predetermined threshold) at a target location indicates an origin of an arrhythmia at the target location (e.g., when the target arrhythmia includes a PVC). In some examples, a relatively high morphology match (e.g., a match above a predetermined threshold) at a target location indicates an exit site and / or slow channel of an arrhythmia at the target location (e.g., when the target arrhythmia includes VT and where the arrhythmia is breaking out of a critical isthmus). In some examples, a reduction in a morphology match over the course of multiple PFA energy trains or multiple PFA applications indicates successful treatment of the arrhythmia circuit in the target location. In some examples, more than one target morphology is simultaneously used for morphology matching, and a change in the target morphology having the best match over the course of multiple PFA energy trains or multiple PFA applications indicates successful treatment of the arrhythmia circuit in the target location.

[0079] In some examples, processing circuitry 152 determines a morphology match using a matching algorithm. For example, processing circuitry 152 can apply an algorithm (e.g., a normalized correlation coefficient algorithm) to one or more sensed signals of patient 101 to determine information (e.g., a metric, a distance, a value, and / or the like) associated with the morphology match. In some examples, as illustrated in the examples of FIG. 2A and FIG. 2B, the determined information associated with the morphology match includes a match percentage value (e.g., 95 percent match, 70 percent match, or another percentage value). A relatively high (e.g., close) match, as discussed herein, can include a match percentage value above a predetermined threshold value (e.g., greater than or equal to 50 percent, greater than or equal to 75 percent, greater than or equal to 80 percent, greater than or equal to 90 percent, greater than or equal to 95 percent, and / or another suitable threshold). In examples in which the matching algorithm determines a distance or other value that tends to increase with differences between the template signal of a target morphology and the at least one sensed signal of the patient, a relatively high (e.g., close) match can include a distance or other value that is lower than a predetermined threshold value, and a relatively low (e.g., distant) match can include a distance or other value that is higher than a predetermined threshold value.

[0080] In some examples, processing circuitry 152 determines a morphology match between the at least one sensed signal of the patient 101 and a plurality of template signals (e.g., at least aDocket No.: A0013389W01 / 1289-028W001 first template signal and second template signal). In some examples, processing circuitry 152 determines a relative match between the at least one sensed signal of the patient 101 and each of the plurality of template signals. For example, processing circuitry 152 can determine which match between the at least one sensed signal of the patient 101 and each of the plurality of template signals is a relatively better (e.g., best) match.

[0081] In some examples, processing circuitry 152 generates one or more outputs, e.g., via user interface 260 of FIG. 2A and / or FIG. 2B, associated with the information determined from PFA pulses and sensed signals of patient 101. For example, processing circuitry 152 may be configured to generate, via user interface 260, an output indicating one or more of a morphology match, a change in a morphology match, a change in the target morphology with the best match, a time delay, a progressive delay, and / or a dissociation trend. In some examples, processing circuitry 152 is configured to assign and / or adjust a visual property (e.g., color, shading, pattern, texture, opaqueness, size, shape, and / or the like, and / or a combination of such properties) of lesion tags 278A, such as to indicate a morphology match (e.g., a match percentage value), a change in a morphology match (e.g., a reduction in match percentage value), a change in the target morphology with the best match (e.g., from a first target morphology to a second, different target morphology), a time delay, a progressive delay, and / or a dissociation trend. Additionally or alternatively, processing circuitry 152 can generate other visual indicia (e.g., a map such as a color coded map), for display, to indicate any of the determined information discussed herein (e.g., a morphology match, a change in a morphology match, a change in the target morphology with the best match, a time delay, a progressive delay, a dissociation trend, and / or the like).

[0082] In some examples, processing circuitry 152 is configured to generate and output multiple plots (e.g., ECG waveform 300 and PFA waveform 302 illustrated in FIG. 3), such as via user interface 260 of at least FIG. 2 A. As discussed, processing circuitry 152 can be configured to generate and output multiple plots overlaid on one another (e.g., a “live” ECG and a plot of a template signal).

[0083] In some examples, processing circuitry 152 is configured to generate and / or output a recommendation (e.g., a recommendation output) corresponding to delivery of PFA energy based on one or more of a morphology match, a change in a morphology match, a change in the target morphology with the best match, a time delay information, a progressive delay, and / or a dissociation trend. For example, processing circuitry 152 can indicate to a clinician whether to deliver further PFA energy to heart 103 of patient 101, or to cease further delivery of PFA energy to heart 103 of patient 101 based on one or more of a morphology match, a time delay, a progressive delay, a dissociation trend, and / or the like.Docket No.: A0013389W01 / 1289-028W001

[0084] In some examples, processing circuitry 152 is configured to generate the output indicating the morphology match based on the relative match between the at least one sensed signal of the patient 101 and one of a plurality of template signals (e.g., either of a first template signal and a second template signal). For example, any of the outputs generated by processing circuitry 152 discussed herein can be based on which template signals (e.g., of at least the first template signal and the second template signal) has a relatively better match to the at least one sensed signal of the patient 101. In some examples, processing circuitry 152 is configured to generate one or more outputs (e.g., the morphology match, the change in a morphology match, the change in the target morphology, and / or the like) using the template signal with the best (e.g., closest) match to the at least one sensed signal of the patient 101. In some examples, processing circuitry 152 does not generate outputs for template signals that have a relatively lesser match.

[0085] In some examples, processing circuitry 152 is configured to generate and output an indicator to indicate a time delay, a level of a morphology match, a target morphology with a best match, and / or a level of dissociation. For example, processing circuitry may be configured to output a first indicator that sufficient dissociation has not occurred (e.g., a red indicator), a second indicator that progressive delay has occurred (e.g., a yellow indicator) and / or a third indicator that complete dissociation has occurred (e.g., a green indicator). In some examples, and with reference to FIG. 2A and FIG. 2B, processing circuitry 152 is configured to overlay one or more indicators (e.g., colors, textures, and / or the like) overlaid on heart representation 274 to indicate the time delay, the level of a morphology match, the target morphology with the best match, and / or a level of dissociation. In some examples, the overlaid indicators can indicate the sufficiency and / or quality of ablation energy delivered to a particular area of heart 103 (e.g., red for low sufficiency or equality of ablation effect, yellow for intermediate sufficiency or quality of ablation effect, green for high sufficiency or quality of ablation effect).

[0086] In some examples, processing circuitry 152 is configured to generate recommendations (also referred to herein as a recommendation output) based on the morphology match, the target morphology with the best match, the time delay information, the progressive delay, and / or the dissociation trend. With reference to the example of FIG. 2A, the recommendation to deliver further PFA energy can include an indication of where to deliver the PFA energy. For example, processing circuitry 152 may be configured to generate and output an indication of a highlighted area 279 overlaid on heart representation 274 (e.g., which represents a recommendation to deliver further ablation energy to the area encompassed by highlighted area 279). In some examples, the recommendation to deliver further PFA energy or cease further delivery of PFA energy is indicated by a visual prompt (e.g., via text or figures), and / or an audible prompt. In some examples, processing circuitry 152 generates and / or outputs theDocket No.: A0013389W01 / 1289-028W001 recommendation to deliver further PFA energy (e.g., highlighted area 279) based on one or more of the morphology match, the target morphology with the best match, the time delay information, the progressive delay, the dissociation trend, and / or other factors, and / or a combination thereof.

[0087] In some examples, processing circuitry 152 is configured to control, define, and or adjust one more parameters of pulsed energy based on (e.g., in response to) the sensed signal of patient 101. In some examples, as discussed herein, processing circuitry 152 is configured to detect a change in the at least one sensed signal of patient 101 (e.g., a change in a morphology match, a change in the target morphology with the best match, a time delay, a progressive delay, a dissociation trend, and / or a change in any other relevant parameters of the at least one sensed signal of patient 101). Processing circuitry 152 can be configured to adjust one or more energy parameters of the pulsed field energy based on (e.g., in response to) the change in the at least one sensed signal of patient 101. Processing circuitry 152 can be configured to control energy generator 170 to adjust the one or more energy parameters of the pulsed field energy. In some examples, to adjust one or more energy parameters of the pulsed field energy, processing circuitry 152 is configured control energy generator 170 to induce an arrhythmia in heart 103. In some examples, to adjust one or more energy parameters of the pulsed field energy, processing circuitry 152 is configured control energy generator 170 to maintain a stable cardiac rhythm of heart 103. In some examples, to adjust one or more energy parameters of the pulsed field energy, processing circuitry 152 is configured control energy generator 170 to cease delivery of pulsed field energy to heart 103 of the patient 101.

[0088] As illustrated in the examples of FIG. 2 A and / or FIG. 2B, processing circuitry 152 may be configured to generate and output, via user interface 260, information (e.g., via one or more additional boxes) associated the cardiac ablation and / or mapping procedure and determined information related to such procedure. In some examples, processing circuitry 152 is configured to receive user input, such as a user selection, and selectively display information via user interface 260 based on the user selection.

[0089] In some examples, processing circuitry 152 generates, via user interface 260, one or more boxes indicating continuously and / or periodically acquired information from patient 101. Example box 280 includes an indication of a heart rate of patient 101.

[0090] Example box 282 includes one or more previously recorded template signals (e.g., ECG signals) of patient 101, at least some of which can be associated with a target arrhythmia. In some examples, processing circuitry 152 is configured to generate, for display via user interface 260, a waveform indicative of one or more template signals. In some examples, processing circuitry 152 is configured to receive a selection of a template signal from a plurality of template signals. The plurality of template signals can include, for example, at least a first template signalDocket No.: A0013389W01 / 1289-028W001 and a second template signal. Template signals can include, for example, a normal sinus rhythm template signal (“NSR” in the example of FIG. 2A and FIG. 2B). Template signals can also include multiple signals of a given type of arrhythmia (e.g., PVC1 and PVC2 in the example of FIG. 2A and FIG. 2B).

[0091] Example box 284 can include an indication of a selected signal morphology. The selected morphology can include an arrhythmia (e.g., PVC in the example of FIG. 2 A and FIG. 2B). The selected arrhythmia indicated in box 284 can include a selected arrhythmia used by processing circuitry 152 for determination of the progressive delays and / or dissociation state (as discussed elsewhere herein). The selected arrhythmia can correspond to the previously recorded template signals of the selected arrhythmia. In some examples, processing circuitry 152 is configured to receive user input, such as a selection, of one of a plurality of morphologies and / or of a plurality of arrythmias.

[0092] Other boxes can include examples of outputs generated by processing circuitry 152 according to the examples of this disclosure. Example box 286 includes an overlay of the previously recorded template signal and a live sensed signal (e.g., ECG signal) of patient 101. Such an overlay generated by processing circuitry 152 can provide a clinician of a visual indication of how a live ECG signal compares to one or more previously recorded template signals associated with an arrhythmia, which may provide a visual indication of the morphology match. Example box 288 includes an indication of the morphology match (e.g., expressed as a percentage match in the example of FIG. 2A and FIG. 2B). Example, boxes 286 and 288 are examples of an output, generated by processing circuitry 152, that indicates the morphology match. Example box 290 includes an indication of a time delay (e.g., the time delay between the pulsed field energy and the resulting sensed signal of patient 101, which can include one or more of an ECG signal and EGM signal). Box 290 is an example of an output, generated by processing circuitry 152, that indicates the time delay. Example box 292 includes an indication of an EGM signal (e.g., EGM waveform) recorded from patient 101. Example box 294 includes an indication of dissociation (also referred to as dissociation trend and / or progressive delay throughout this disclosure), which can include a graph of the determined time delay over multiple instances (trains or applications) of delivered PF energy. Box 294 is an example of an output, generated by processing circuitry 152, that indicates the determined dissociation trend and / or progressive delay.

[0093] In some examples, processing circuitry 152 is configured to determine a level of sufficiency (and / or a level of effectiveness) of ablation energy. In some examples, the level of sufficiency (and / or the level of effectiveness) of ablation energy can correspond to whether or not the ablation energy resolved an arrhythmia and / or whether such resolution may be temporary orDocket No.: A0013389W01 / 1289-028W001 permanent. For example, a first level of sufficiency of ablation energy can correspond to an instance of delivered ablation energy that does not resolve an arrhythmia. A second level of sufficiency of ablation energy can correspond to an instance of delivered ablation energy that does resolve an arrhythmia. Because the determined information discussed in this disclosure (e.g., morphology match, time delay information, dissociation trend, progressive delay, a combination thereof, and / or the like) can indicate whether an arrythmia was resolved, such determined information can enable processing circuitry 152 to determine the level of sufficiency of ablation energy for a given instances of delivery of ablation energy (e.g., a given pulse train and / or series of pulse trains). In this way, processing circuitry 152 may be configured to provide feedback regarding the appropriateness of the ablation energy (e.g., delivered to a particular location and / or target site) and / or the immediate effects of the PFA energy.

[0094] In some examples, processing circuitry 152 is configured to determine a level of sufficiency of ablation energy based on determined information (e.g., the morphology match, the time delay information, the dissociation trend, progressive delay, a combination thereof, and / or other determined information). For example, if a morphology match between a sensed signal of patient 101 and a template signal of a target morphology is above a threshold value (e.g., indicating a relative high match) after a given instance of PFA energy delivered to patient 101, processing circuitry 152 determines a low level of sufficiency (e.g., indicating that the PFA energy was not successful in resolving the arrythmia). Alternatively, if a morphology match between a sensed signal of patient 101 and the template signal of a target morphology is below the threshold value (e.g., indicating a relative low match) after a given instance of PFA energy delivered to patient 101, processing circuitry 152 determines a high level of sufficiency (e.g., indicating that the PFA energy delivered to the particular location was successful in treating the arrhythmia circuit in the target location). As another example, if a time delay between the PFA energy delivery and the resulting sensed signal of patient 101 (e.g., having an arrhythmia) is within a predetermined time delay range, processing circuitry 152 determines a low level of sufficiency (e.g., indicating that the PFA energy delivered to the particular location was not successful in resolving the arrythmia). Alternatively, if the time delay between the PFA energy delivery and the resulting sensed signal of patient 101 is not within (e.g., is outside of) the predetermined time delay range, processing circuitry 152 determines a high level of sufficiency (e.g., indicating that the PFA energy delivered to the particular location was successful in resolving the arrythmia).

[0095] With respect to the progressive delay and / or dissociation trend, processing circuitry 152 may be configured to determine a level of sufficiency of ablation energy over a series of pulse trains and / or discrete applications of PFA energy. For example, when the time delay and / orDocket No.: A0013389W01 / 1289-028W001 morphology match changes over the pulse trains and / or series of discrete applications of PFA energy (e.g., which can indicate dissociation and / or a progressive delay), processing circuitry 152 determines a high level of sufficiency (e.g., indicating that the PFA energy delivered to the particular location was at least partially successful in resolving the arrhythmia). Alternatively, when the time delay and / or morphology match does not change (e.g., remains substantially consistent) over the series of discrete applications of PFA energy (e.g., which can indicate no dissociation and / or no progressive delay), processing circuitry 152 determines a low level of sufficiency (e.g., indicating that the PFA energy delivered to the particular location was not successful in resolving the arrhythmia).

[0096] In some examples, processing circuitry 152 is configured to generate an output of an indication of the determined level of sufficiency of PFA energy. For example, and with reference to FIG. 2A and FIG. 2B, processing circuitry 152 may be configured to assign a visual characteristic to a lesion tag of lesion tags 278A and / or lesion tag 278B (e.g., with the visual characteristic corresponding to the determined level of sufficiency of ablation energy). In some examples, the visual characteristic assigned to a lesion tag of lesion tags 278 A and / or lesion tag 278B corresponds to the level of sufficiency of ablation energy for each lesion tag of the at least one lesion tag. With reference to the example of FIG. 2B, processing circuitry 152 is configured to generate lesion tags 278A having a first visual characteristic corresponding to a first level of sufficiency of ablation energy and at least lesion tag 278B having a second visual characteristic different from the first visual characteristic and corresponding to second level of sufficiency of ablation energy. In some examples, lesion tag 278B (e.g., including the second visual characteristic thereof) indicates the dissociation state (e.g., complete dissociation). In such instances, such different visual characteristics of lesion tags 278 A and lesion tag 278B can indicate to a clinician whether to deliver further (e.g., additional) instances of pulsed field energy to heart 103 of patient 101 and / or whether to cease further delivery of PFA energy to heart 103 of patient 101. In this way, processing circuitry 152 is configured to provide information about the immediate effects of the ablation energy delivered to particular location (e.g., as determined by sensed signals from patient 101 without a subsequent mapping procedure).

[0097] The determined information and associated indications generated and output via user interface 260, by processing circuitry 152, can reduce or eliminate the need for performing additional mapping after the ablation procedure, as the relevant information regarding an arrhythmia (e.g., ventricular arrhythmia) can be obtained in conjunction with delivery of PF ablation energy. Moreover, because a clinician can ascertain the effects of a given application of PF energy delivery over the course of a series of applications of PF energy delivery, a clinician may be able to more accurately determine the location and / or cause of a given type of arrythmia.Docket No.: A0013389W01 / 1289-028W001

[0098] An example technique for determining, and generating an output indicative of, a morphology match and / or time delay information is illustrated in FIG. 4. The technique is described with reference to system 100 of FIG. 1A and FIG. IB, but may be applicable to any of the systems and components described in this disclosure. The technique includes receiving, by processing circuitry 152, information of at least one pulse of pulsed field energy delivered to a location of heart 103 of patient 101 (400). The technique further includes receiving, by the processing circuitry 152 and from at least one electrode (e.g., body-surface electrodes 182 and / or a catheter-mounted electrode, such as one or more of sensing electrodes 124 and shaft electrodes 126), information of at least one sensed signal of patient 101 in response to delivery of the pulsed field energy (402). As discussed throughout this disclosure, the at least one sensed signal of patient 101 can include an ECG signal and / or an EGM signal of patient 101. The technique can further include determining, by processing circuitry 152, a morphology match between (a) a template signal of a target morphology and (b) the at least one sensed signal of the patient (404). The technique can further include determining, by processing circuitry 152, time delay information. The time delay information can include and / or reflect a time delay based on a time when the at least one pulse of pulsed field energy is delivered and a time when the at least one sensed signal is generated or sensed (406). The technique further includes generating, via user interface 160, an output indicating one or more of (a) the morphology match and (b) the time delay information (408). In examples in which only one of (a) the morphology match or (b) the time delay information is presented to the user, steps for determining the other of (a) the morphology match and (b) the time delay information may be omitted.

[0099] An example technique for quantifying and providing feedback regarding a morphology match between signals is illustrated in FIG. 5. The technique is described with reference to system 100 of FIG. 1 A and FIG. IB, but may be applicable to any of the systems and components described in this disclosure. The technique includes navigating catheter 110 to a target site within heart 103 of patient 101 (500). As discussed herein, catheter 110 can include elongated body (e.g., shaft 112) and a plurality of electrodes (e.g., ablation electrode 122, sensing electrodes 124, and / or shaft electrodes 126) at distal portion 116 of shaft 112. The technique further includes delivering pulsed field energy to the target site using one or more of the plurality of electrodes (502). The technique further includes gathering a sensed signal from patient 101, such as one or more of a stimulated ECG signal or stimulated EGM signal (504). The sensed signal from patient 101, such as one or more of a stimulated ECG signal or stimulated EGM signal, can be gathered (e.g., sensed) from one or more electrodes (e.g., body-surface electrodes 182 and / or a catheter-mounted electrode, such as one or more of sensing electrodes 124 and shaft electrodes 126). The technique further includes quantifying a morphology match between the oneDocket No.: A0013389W01 / 1289-028W001 or more stimulated ECG or EGM and a template signal (506). The technique further includes providing feedback based on the morphology match (508). For example, the feedback can include an output via user interface 160 indicating the morphology match.

[0100] This disclosure includes the following non-limiting examples.

[0101] Example 1 : A method includes receiving, by processing circuitry, information of at least one pulse of pulsed field energy delivered to a location of a heart of a patient; receiving, by the processing circuitry and from at least one electrode, information of at least one sensed signal of the patient in response to delivery of the pulsed field energy, wherein the at least one sensed signal of the patient includes one or more of an electrocardiogram (ECG) signal and an electrogram (EGM) signal of the patient; determining, by the processing circuitry, one or more of: a morphology match between (a) a template signal of a target morphology and (b) the at least one sensed signal of the patient, and time delay information, the time delay information including a time delay based on a time when the at least one pulse is delivered and a time when the at least one sensed signal is generated or sensed; and generating, via a user interface, an output indicating one or more of (a) the morphology match and (b) the time delay information.

[0102] Example 2: The method of example 1, further includes generating, via the user interface and based on one or more of the morphology match and the time delay information, a recommendation output including: a recommendation to deliver further pulsed field energy to the heart to the patient, or a recommendation to cease further delivery of pulsed field energy to the heart of the patient.

[0103] Example 3: The method of any of examples 1 and 2, further includes determining, by the processing circuitry, a progressive delay, wherein the progressive delay includes a change in the time delay over a plurality of discrete cardiac activations cycles; and generating, via the user interface, an output indicating the progressive delay.

[0104] Example 4: The method of example 3, further includes generating, via the user interface and based on the progressive delay, a recommendation output including: a recommendation to deliver further pulsed field energy to the heart to the patient, or a recommendation to cease further delivery of pulsed field energy to the heart of the patient.

[0105] Example 5: The method of any of examples 1-4, further includes determining, by the processing circuitry, a level of sufficiency of ablation energy based on one or more of: the morphology match, and (b) the time delay information; and generating, via the user interface, an output indicating the level of sufficiency of ablation energy.

[0106] Example 6: The method of example 5, further includes generating at least one lesion tag overlaid on a three-dimensional representation of the heart of the patient, the at least one lesion tag corresponding to the location at which the pulsed field energy was delivered, whereinDocket No.: A0013389W01 / 1289-028W001 generating the output indicating the level of sufficiency of ablation energy includes assigning a visual characteristic to the at least one lesion tag, the visual characteristic corresponding to the level of sufficiency of ablation energy for each lesion tag of the at least one lesion tag.

[0107] Example 7: The method of any of examples 1-6, wherein the template signal is associated with a cardiac arrhythmia.

[0108] Example 8: The method of example 7, wherein the cardiac arrhythmia includes ventricular tachycardia or premature ventricular contraction (PVC).

[0109] Example 9: The method of any of examples 1-8, wherein the template signal is a first template signal, and wherein generating the output indicating the morphology match is based on a relative match between the at least one sensed signal of the patient and either of the first template signal and a second template signal.

[0110] Example 10: The method of any of examples 1-9, wherein the template signal is recorded from the patient prior to receiving the at least one sensed signal of the patient.

[0111] Example 11 : The method of any of examples 1-10, wherein the pulsed field energy comprises a plurality of pulse trains of pulsed field energy delivered to the location of the heart.

[0112] Example 12: The method of any of examples 1-11, wherein the time when the at least one pulse is delivered corresponds to a time of a first pulse of a pulse train of the plurality of pulse trains.

[0113] Example 13: The method of any of examples 1-12, wherein the time when the at least one sensed signal is generated or sensed is associated with a QRS complex.

[0114] Example 14: The method of example 13, wherein the time when the at least one sensed signal is generated or sensed is associated with a Q-wave of the QRS complex.

[0115] Example 15: The method of any of examples 1-14, wherein the pulsed field energy is delivered to the location of the heart via one or more catheter-mounted electrodes.

[0116] Example 16: The method of any of examples 1-15, wherein the at least one electrode includes a plurality of body-surface electrodes, wherein receiving information of the at least one sensed signal of the patient includes receiving information of the ECG signal from the plurality of body-surface electrodes.

[0117] Example 17: The method of any of examples 1-16, wherein the at least one electrode includes a catheter-mounted electrode, and wherein receiving information of the at least one sensed signal of the patient includes receiving information of the EGM signal from the cathetermounted electrode.

[0118] Example 18: The method of any of examples 1-17, wherein the at least one sensed signal of the patient is caused, at least in part, by the pulsed field energy delivered to the heart of the patient.Docket No.: A0013389W01 / 1289-028W001

[0119] Example 19: The method of any of examples 1-18, wherein the method further includes: detecting, by the processing circuitry, a change in the at least one sensed signal of the patient, and adjusting, by the processing circuitry, one or more energy parameters of the pulsed field energy in response to the change in the at least one sensed signal of the patient.

[0120] Example 20: The method of example 19, wherein adjusting one or more energy parameters of the pulsed field energy in response to the change in the at least one sensed signal of the patient includes performing one or more of: controlling, by the processing circuitry, an energy generator to induce an arrhythmia; controlling, by the processing circuitry, the energy generator to maintain a stable cardiac rhythm; and controlling, by the processing circuitry, the energy generator to cease delivery of pulsed field energy to the heart of the patient.

[0121] Example 21 : A system includes at least one electrode; and processing circuitry configured to: receive information of at least one pulse of pulsed field energy delivered to a location of a heart of a patient; receive, from the at least one electrode, information of at least one sensed signal of the patient in response to delivery of the pulsed field energy, wherein the at least one sensed signal of the patient includes one or more of an electrocardiogram (ECG) signal and an electrogram (EGM) signal of the patient; determine one or more of: a morphology match between (a) a template signal of a target morphology and (b) the at least one sensed signal of the patient, and time delay information, the time delay information including a time delay based on a time when the at least one pulse is delivered and a time when the at least one sensed signal is generated or sensed; and generate, via a user interface, an output indicating one or more of (a) the morphology match and (b) the time delay.

[0122] Example 22: The system of example 21, wherein the processing circuitry is configured to: generate, via the user interface and based on one or more of the morphology match and the time delay information, a recommendation output including: a recommendation to deliver further pulsed field energy to the heart to the patient, or a recommendation to cease further delivery of pulsed field energy to the heart of the patient.

[0123] Example 23: The system of any of examples 21 and 22, wherein the processing circuitry is configured to: determine a progressive delay, wherein the progressive delay includes a change in the time delay over a plurality of discrete cardiac activations cycles; and generate, via the user interface, an output indicating the progressive delay.

[0124] Example 24: The system of example 23, wherein the processing circuitry is configured to: generate, via the user interface and based on the progressive delay, a recommendation output including: a recommendation to deliver further pulsed field energy to the heart to the patient, or a recommendation to cease further delivery of pulsed field energy to the heart of the patient.Docket No.: A0013389W01 / 1289-028W001

[0125] Example 25: The system of any of examples 21-24, wherein the processing circuitry is configured to: determine a level of sufficiency of ablation energy based on one or more of: the morphology match, and (b) the time delay information; and generate, via the user interface, an output indicating the level of sufficiency of ablation energy.

[0126] Example 26: The system of example 25, wherein the processing circuitry is configured to: generate at least one lesion tag overlaid on a three-dimensional representation of the heart of the patient, the at least one lesion tag corresponding to the location at which the pulsed field energy was delivered, wherein to generate the output indicating the level of sufficiency of ablation energy, the processing circuitry is configured to assign a visual characteristic to the at least one lesion tag, the visual characteristic corresponding to the level of sufficiency of ablation energy for each lesion tag of the at least one lesion tag.

[0127] Example 27: The system of any of examples 21-26, wherein the template signal is associated with a cardiac arrhythmia.

[0128] Example 28: The system of example 27, wherein the cardiac arrhythmia includes ventricular tachycardia or premature ventricular contraction (PVC).

[0129] Example 29: The system of any of examples 21-28, wherein the template signal is a first template signal, and wherein the processing circuitry is configured to generate the output indicating the morphology match based on a relative match between the at least one sensed signal of the patient and either of the first template signal and a second template signal.

[0130] Example 30: The system of any of examples 21-29, wherein the template signal is recorded from the patient prior to the at least one sensed signal of the patient being received by the processing circuitry.

[0131] Example 31 : The system of any of examples 21-30, wherein the pulsed field energy comprises a plurality of pulse trains of pulsed field energy delivered to the location of the heart.

[0132] Example 32: The system of any of examples 21-31, wherein the time when the at least one pulse is delivered corresponds to a time of a first pulse of a pulse train of the plurality of pulse trains.

[0133] Example 33: The system of any of examples 21-32, wherein the time when the at least one sensed signal is generated or sensed is associated with a QRS complex.

[0134] Example 34: The system of example 33, wherein the time when the at least one sensed signal is generated or sensed is associated with a Q-wave of the QRS complex.

[0135] Example 35: The system of any of examples 21-34, wherein the pulsed field energy is delivered to the location of the heart via one or more catheter-mounted electrodes.

[0136] Example 36: The system of any of examples 21-35, wherein the at least one electrode includes a plurality of body-surface electrodes, wherein to receive information of the at least oneDocket No.: A0013389W01 / 1289-028W001 sensed signal of the patient, the processing circuitry is configured to receive information of the ECG signal from the plurality of body-surface electrodes.

[0137] Example 37: The system of any of examples 21-36, wherein the at least one electrode includes a catheter-mounted electrode, and wherein to receive information of the at least one sensed signal of the patient, the processing circuitry is configured to receive information of the EGM signal from the catheter-mounted electrode.

[0138] Example 38: The system of any of examples 21-37, wherein the at least one sensed signal of the patient is caused, at least in part, by the pulsed field energy delivered to the heart of the patient.

[0139] Example 39: The system of any of examples 21-38, wherein the processing circuitry is configured to: detect, a change in the at least one sensed signal of the patient, and adjust one or more energy parameters of the pulsed field energy in response to the change in the at least one sensed signal of the patient.

[0140] Example 40: The system of example 39, wherein to adjust the one or more energy parameters of the pulsed field energy in response to the change in the at least one sensed signal of the, the processing circuitry is configured to perform one or more of: control an energy generator to induce an arrhythmia; control the energy generator to maintain a stable cardiac rhythm; and control the energy generator to cease delivery of pulsed field energy to the heart of the patient.

[0141] Example 41 : A method includes navigating a catheter with an elongated body and a plurality of electrodes at a distal portion of the elongated body to a target site within a heart of a patient; delivering pulsed field energy to the target site using one or more of the plurality of electrodes; gathering one or more of a stimulated electrocardiogram (ECG) or stimulated electrogram (EGM) from one or more electrodes; quantifying a morphology match between the one or more stimulated ECG or EGM and a template signal; and providing feedback based on the morphology match.

[0142] Example 42: The method of example 41, wherein quantifying the morphology match includes generating a visualization of the morphology match.

[0143] Example 43: The method of any of examples 41 and 42, wherein providing feedback includes providing feedback regarding an appropriateness of the pulsed field energy delivered at the target site.

[0144] Example 44: The method of any of examples 41-43, wherein providing feedback includes providing feedback regarding an immediate effect of the pulsed field energy delivered at the target site.Docket No.: A0013389W01 / 1289-028W001

[0145] Example 45: The method of example 44, wherein providing feedback includes providing feedback regarding a time delay between the pulsed field energy delivered at the target site and the one or more stimulated ECG or EGM.

[0146] As used herein, the terms “distal” and proximal” define a position or direction with respect to the treating clinician or clinician’s control device (e.g., control handle). “Distal” or “distally” can refer to a position distant from or in a direction away from the clinician or clinician’s control device. “Proximal” and “proximally” can refer to a position near or in a direction toward the clinician or clinician’s control device.

[0147] As used herein, “about,” “essentially,” and / or “approximately” (or another similar term) may indicate the exact value and / or nearly the exact value to the extent permitted by manufacturing tolerances. “About,” “essentially,” and / or “approximately” can also refer to a certain percentage of the recited value (e.g., within about 1 percent, 5 percent, or 10 percent). For example, a length of about 10 mm can refer to a length of 10 mm to the extent permitted by manufacturing tolerances, or a length of 10 mm + / - 0.1 mm, + / - 0.5 mm, or + / - 1 mm.

[0148] It should be understood that various aspects disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. It should also be understood that, depending on the example, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the techniques).

[0149] In one or more examples, the described processes and techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. Computer-readable media may include non-transitory computer-readable media, which corresponds to a tangible medium such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer).

[0150] In addition, it should be noted that system described herein may not be limited to treatment of a human patient. In alternative examples, the system may be implemented in nonhuman patients, e.g., primates, canines, equines, pigs, and felines. These other animals may undergo clinical or research therapies that may benefit from the subject matter of this disclosure.

[0151] Instructions may be executed by one or more processors, such as one or more digital signal processors (DSPs), general purpose microprocessors, application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated orDocket No.: A0013389W01 / 1289-028W001 discrete logic circuitry. Accordingly, the term “processor” as used herein may refer to any of the foregoing structure or any other physical structure suitable for implementation of the described techniques. Also, the techniques could be fully implemented in one or more circuits or logic elements.

[0152] Various examples have been described. These and other examples are within the scope of the following claims.

Claims

Docket No.: A0013389W01 / 1289-028W001WHAT IS CLAIMED IS:

1. A system comprising: at least one electrode; and processing circuitry configured to: receive information of at least one pulse of pulsed field energy delivered to a location of a heart of a patient; receive, from the at least one electrode, information of at least one sensed signal of the patient in response to delivery of the pulsed field energy, wherein the at least one sensed signal of the patient includes one or more of an electrocardiogram (ECG) signal and an electrogram (EGM) signal of the patient; determine one or more of: a morphology match between (a) a template signal of a target morphology and (b) the at least one sensed signal of the patient, and time delay information, the time delay information including a time delay based on a time when the at least one pulse is delivered and a time when the at least one sensed signal is generated or sensed; and generate, via a user interface, an output indicating one or more of (a) the morphology match and (b) the time delay.

2. The system of claim 1, wherein the processing circuitry is configured to: generate, via the user interface and based on one or more of the morphology match and the time delay information, a recommendation output including: a recommendation to deliver further pulsed field energy to the heart to the patient, or a recommendation to cease further delivery of pulsed field energy to the heart of the patient.

3. The system of any of claims 1 and 2, wherein the processing circuitry is configured to: determine a progressive delay, wherein the progressive delay includes a change in the time delay over a plurality of discrete cardiac activations cycles; and generate, via the user interface, an output indicating the progressive delay.

4. The system of claim 3, wherein the processing circuitry is configured to:Docket No.: A0013389W01 / 1289-028W001 generate, via the user interface and based on the progressive delay, a recommendation output including: a recommendation to deliver further pulsed field energy to the heart to the patient, or a recommendation to cease further delivery of pulsed field energy to the heart of the patient.

5. The system of any of claims 1-4, wherein the processing circuitry is configured to: determine a level of sufficiency of ablation energy based on one or more of:(a) the morphology match, and(b) the time delay information; and generate, via the user interface, an output indicating the level of sufficiency of ablation energy.

6. The system of claim 5, wherein the processing circuitry is configured to: generate at least one lesion tag overlaid on a three-dimensional representation of the heart of the patient, the at least one lesion tag corresponding to the location at which the pulsed field energy was delivered, wherein to generate the output indicating the level of sufficiency of ablation energy, the processing circuitry is configured to assign a visual characteristic to the at least one lesion tag, the visual characteristic corresponding to the level of sufficiency of ablation energy for each lesion tag of the at least one lesion tag.

7. The system of any of claims 1-6, wherein the template signal is associated with a cardiac arrhythmia.

8. The system of claim 7, wherein the cardiac arrhythmia includes ventricular tachycardia or premature ventricular contraction (PVC).

9. The system of any of claims 1-8, wherein the template signal is a first template signal, and wherein the processing circuitry is configured to generate the output indicating the morphology match based on a relative match between the at least one sensed signal of the patient and either of the first template signal and a second template signal.Docket No.: A0013389W01 / 1289-028W00110. The system of any of claims 1-9, wherein the template signal is recorded from the patient prior to the at least one sensed signal of the patient being received by the processing circuitry.

11. The system of any of claims 1-10, wherein the pulsed field energy comprises a plurality of pulse trains of pulsed field energy delivered to the location of the heart.

12. The system of any of claims 1-11, wherein the time when the at least one pulse is delivered corresponds to a time of a first pulse of a pulse train of the plurality of pulse trains.

13. The system of any of claims 1-12, wherein the time when the at least one sensed signal is generated or sensed is associated with a QRS complex.

14. The system of any of claims 1-13, wherein the pulsed field energy is delivered to the location of the heart via one or more catheter-mounted electrodes.

15. The system of any of claims 1-14, wherein the processing circuitry is configured to: detect, a change in the at least one sensed signal of the patient, and adjust one or more energy parameters of the pulsed field energy in response to the change in the at least one sensed signal of the patient.

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