Pulsed field ablation index

Abstract

A system for performing electroporation ablation of target tissue in a heart includes a catheter with electrodes, a graphical display, and a controller. The controller generates on the display, a predicted lesion zone on an anatomical map of the heart corresponding to an electric field generated with pulsed electrical signals prior to delivery of the signals to electrodes at a location proximate target tissue. Prior to delivery of the signals to the electrodes, a pre-ablation indicator is generated on the display based on the position of the electrodes at the location. After or concurrently with delivery of the signals at each location, the controller generates an ablation indicator on the anatomical map based on the position of the electrodes at the location, the delivery of the signal, and measured changes in the target tissue.

Description

NM Ref.: 051666 / 14347BSC Ref.: 24-0043W001PULSED FIELD ABLATION INDEXCROSS REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims priority to U.S. Provisional Patent Application No. 63 / 707,688, filed October 15, 2024, the entire disclosure of which is incorporated in its entirety.TECHNICAL FIELD

[0002] The present disclosure relates to medical systems and methods for ablating tissue in a patient. More specifically, the present disclosure relates to medical systems and methods for ablation of tissue by electroporation.BACKGROUND

[0003] Ablation procedures are used to treat many different conditions in patients. Ablation can be used to treat cardiac arrhythmias, benign tumors, cancerous tumors, and to control bleeding during surgery. Usually, ablation is accomplished through thermal ablation techniques including radio-frequency (RF) ablation and cryoablation. In RF ablation, a probe is inserted into the patient and radio frequency waves are transmitted through the probe to the surrounding tissue. The radio frequency waves generate heat, which destroys surrounding tissue and cauterizes blood vessels. In cryoablation, a hollow needle or cryoprobe is inserted into the patient and cold, thermally conductive fluid is circulated through the probe to freeze and kill the surrounding tissue. RF ablation and cryoablation techniques indiscriminately kill tissue through cell necrosis, which may damage or kill otherwise healthy tissue, such as tissue in the esophagus, phrenic nerve cells, and tissue in the coronary arteries.

[0004] Another ablation technique uses electroporation. In electroporation, or electro- permeabilization, an electrical field is applied to cells in order to increase the permeability of the cell membrane. The electroporation can be reversible or irreversible, depending on the strength and duration of the electric field. If the electroporation is reversible, the temporarily increased permeability of the cell membrane can be used to introduce chemicals, drugs, or deoxyribonucleic acid (DNA) into the cell, prior to the cell healing and recovering. Tissue recovery can occur over minutes, hours, or days after the ablation is completed. If the electroporation isNM Ref.: 051666 / 14347BSC Ref.: 24-0043W001 irreversible, the affected cells are killed, such as via form of cell death, such as perhaps programmed cell death through apoptosis for example, or such as traumatic cell death through necrosis for example.

[0005] Irreversible electroporation can be used as a nonthermal ablation technique. In irreversible electroporation, trains of short, high voltage pulses are used to generate electric fields that are strong enough to kill cells. In ablation of cardiac tissue, irreversible electroporation can be a relatively safe and effective alternative to the indiscriminate killing of thermal ablation techniques, such as RF ablation and cryoablation. Irreversible electroporation can be used to kill targeted tissue, such as myocardium tissue, by using a selected electric field strength and duration that is effective to kill the targeted tissue but is not effective to permanently damage other cells or tissue, such as non-targeted myocardium tissue, red blood cells, vascular smooth muscle tissue, endothelium tissue, and nerve cells. Planning irreversible electroporation ablation procedures can be difficult due to the lack of acute visualization or data indicating which tissues have been irreversibly electroporated compared to tissues that have been reversibly electroporated.SUMMARY

[0006] In Example 1, a system for performing electroporation ablation of target tissue in a chamber of a heart, the system comprising: a catheter including an electrode assembly having a plurality of electrodes, wherein the catheter is adapted to position the electrode assembly at a location proximate the target tissue; a graphical display; and a controller configured to: prior to delivery of pulsed electrical signals to selected ones of the plurality of electrodes at the location, generate, on the graphical display, a predicted lesion zone on an anatomical map of the heart corresponding to an electric field generated with the pulsed electrical signals; prior to delivery of the pulsed electrical signals to the selected ones of the plurality of electrodes at the location, generate a pre-ablation indicator on the graphical display based on the position of the electrode assembly at the location; and after or concurrently with delivery of the pulsed electrical signals to the selected ones of the plurality of electrodes at each of the plurality of locations, generate an ablation indicator on the anatomical map based on the position of the electrode assembly atNM Ref.: 051666 / 14347BSC Ref.: 24-0043W001 the location, the delivery of the pulsed electrical signal to the selected ones of the plurality of electrodes, and measured changes in the target tissue.

[0007] In Example 2, the system of Example 1, wherein the controller is further configured to generate, on the graphical display, a model of the electrode assembly.

[0008] In Example 3, the system of Example 2, further comprising automatically annotate the anatomical map on the graphical display by applying an ablation marker based on the predicted lesion zone on the anatomical map of the heart.

[0009] In Example 4, the system of any of Examples 2-3, wherein the ablation indicator is generated on the anatomical map of the heart.

[0010] In Example 5, the system of any of Examples 2-4, wherein the anatomical map includes electroanatomical information.

[0011] In Example 6, the system of any of Examples 2-5, wherein the controller receives heart data from which to generate an electroanatomical map of the heart as the anatomical map of the heart.

[0012] In Example 7, the system of any of Examples 1-6, wherein the predicted lesion zone is based on waveform parameters and the pre-ablation indicator is based on catheter and tissue parameters.

[0013] In Example 8, the system of Examples 7, wherein the waveform parameters include ablation energy settings of anticipated pulsed electrical signals provided from the catheter.

[0014] In Example 9, the system of any of Examples 7 and 8, wherein the catheter and tissue parameters include physiological signals and electrical properties of tissue measured prior to ablation.

[0015] In Example 10, the system of any of Examples 7-9, wherein the ablation indicator is based on the waveform parameters, the catheter and tissue parameters, and response parameters.

[0016] In Example 11, the system of Example 10, wherein the response parameters include measured changes in response to the application of the pulsed electrical signal via the catheter.NM Ref.: 051666 / 14347BSC Ref.: 24-0043W001

[0017] In Example 12, the system of any of Examples 7-11, wherein the pre-ablation indicator includes a visualization on the graphical display of a value that provides a relative prediction of ablation quality prior to ablation.

[0018] In Example 13, the system of Example 12, wherein the visualization includes a numeral that is presented on the graphical display based on a numerical scale of lesion quality.

[0019] In Example 14, the system of any of Examples 10-13, wherein the ablation indicator includes a visualization on the graphical display of a value that provides a relative determination of ablation quality during or subsequent to ablation.

[0020] In Example 15, the system of Example 14, wherein the visualization of a value that provides a relative indication of lesion quality as a result of the ablation.

[0021] In Example 16, a system for performing electroporation ablation of target tissue in a chamber of a heart, the system comprising: a catheter including an electrode assembly having a plurality of electrodes, wherein the catheter is adapted to position the electrode assembly at a location proximate the target tissue; a graphical display; and a controller configured to: prior to delivery of pulsed electrical signals to selected ones of the plurality of electrodes at the location, generate, on the graphical display, a predicted lesion zone on an anatomical map of the heart corresponding to an electric field generated with the pulsed electrical signals; prior to delivery of the pulsed electrical signals to the selected ones of the plurality of electrodes at the location, generate a pre-ablation indicator on the graphical display based on the position of the electrode assembly at the location; and after or concurrently with delivery of the pulsed electrical signals to the selected ones of the plurality of electrodes at each of the plurality of locations, generate an ablation indicator on the anatomical map based on the position of the electrode assembly at the location, the delivery of the pulsed electrical signal to the selected ones of the plurality of electrodes, and measured changes in the target tissue.

[0022] In Example 17, the system of Example 16, wherein the controller is further configured to generate, on the graphical display, a model of the electrode assembly.

[0023] In Example 18, the system of Example 17, further comprising automatically annotate the anatomical map on the graphical display by applying an ablation marker based on the predicted lesion zone on the anatomical map of the heart.NM Ref.: 051666 / 14347BSC Ref.: 24-0043W001

[0024] In Example 19, the system of Example 17, wherein the ablation indicator is generated on the anatomical map of the heart.

[0025] In Example 20, the system of Example 17, wherein the anatomical map includes electroanatomical information.

[0026] In Example 21, the system of Example 17, wherein the controller receives heart data from which to generate an electroanatomical map of the heart as the anatomical map of the heart.

[0027] In Example 22, the system of Example 16, wherein the predicted lesion zone is based on waveform parameters and the pre-ablation indicator is based on catheter and tissue parameters.

[0028] In Example 23, the system of Example 22, wherein the waveform parameters include ablation energy settings of anticipated pulsed electrical signals provided from the catheter.

[0029] In Example 24, the system of Example 22, wherein the catheter and tissue parameters include physiological signals and electrical properties of tissue measured prior to ablation.

[0030] In Example 25, the system of Example 22, wherein the ablation indicator is based on the waveform parameters, the catheter and tissue parameters, and response parameters.

[0031] In Example 26, the system of Example 25, wherein the response parameters include measured changes in response to the application of the pulsed electrical signal via the catheter.

[0032] In Example 27, the system of Example 25, wherein the pre-ablation indicator includes a visualization on the graphical display of a value that provides a relative prediction of ablation quality prior to ablation.

[0033] In Example 28, the system of Example 27, wherein the visualization includes a numeral that is presented on the graphical display based on a numerical scale of lesion quality.

[0034] In Example 29, the system of Example 25, wherein the ablation indicator includes a visualization on the graphical display of a value that provides a relative determination of ablation quality during or subsequent to ablation.NM Ref.: 051666 / 14347BSC Ref.: 24-0043W001

[0035] In Example 30, the system of Example 29, wherein the visualization of a value that provides a relative indication of lesion quality as a result of the ablation.

[0036] In Example 31, a system for performing electroporation ablation of target tissue in a chamber of a heart, the system comprising: a catheter including an electrode assembly having a plurality of electrodes, wherein the catheter is adapted to position the electrode assembly at a location proximate the target tissue; a graphical display; and a controller configured to: to generate, on the graphical display, a model of the electrode assembly; prior to delivery of pulsed electrical signals to selected ones of the plurality of electrodes at the location, generate, on the graphical display, a predicted lesion zone on an anatomical map of the heart corresponding to an electric field generated with the pulsed electrical signals, the predicted lesion zone based on ablation energy settings of anticipated pulsed electrical signals provided from the catheter; prior to delivery of the pulsed electrical signals to the selected ones of the plurality of electrodes at the location, generate a pre-ablation indicator on the graphical display based on the position of the electrode assembly at the location, the pre ablation indicator based on physiological signals and electrical properties of tissue measured prior to ablation; and after or concurrently with delivery of the pulsed electrical signals to the selected ones of the plurality of electrodes at each of the plurality of locations, generate an ablation indicator on the anatomical map based on the position of the electrode assembly at the location, the delivery of the pulsed electrical signal to the selected ones of the plurality of electrodes, and measured changes in the target tissue, wherein the ablation indicator includes a visualization on the graphical display of a value that provides a relative determination of ablation quality during or subsequent to ablation.

[0037] In Example 32, the system of Example 31, wherein the visualization of a value that provides a relative indication of lesion quality as a result of the ablation.

[0038] In Example 33, the system of Example 32, further comprising automatically annotate the anatomical map on the graphical display by applying an ablation marker based on the predicted lesion zone on the anatomical map of the heart.

[0039] In Example 34, a process for use with electroporation ablation of target tissue in a chamber of a heart with a catheter including an electrode assembly having a plurality ofNM Ref.: 051666 / 14347BSC Ref.: 24-0043W001 electrodes, the catheter adapted to position the electrode assembly at a location proximate the target tissue, the process comprising: prior to delivery of pulsed electrical signals to selected ones of the plurality of electrodes at the location, generating, on a graphical display, a predicted lesion zone on an anatomical map of the heart corresponding to an electric field generated with the pulsed electrical signals; prior to delivery of the pulsed electrical signals to the selected ones of the plurality of electrodes at the location, generating a pre-ablation indicator on the graphical display based on the position of the electrode assembly at the location; and after or concurrently with delivery of the pulsed electrical signals to the selected ones of the plurality of electrodes at each of the plurality of locations, generating an ablation indicator on the anatomical map based on the position of the electrode assembly at the location, the delivery of the pulsed electrical signal to the selected ones of the plurality of electrodes, and measured changes in the target tissue.

[0040] In Example 35, the process of Example 34, wherein the predicted lesion zone is based on ablation energy settings of anticipated pulsed electrical signals provided from the catheter, the pre-ablation indicator is based on physiological signals and electrical properties of tissue measured prior to ablation, and the ablation indicator is based on the ablation energy settings of anticipated pulsed electrical signals provided from the catheter, the physiological signals and electrical properties of tissue measured prior to ablation, and measured changes in response to the application of the pulsed electrical signal via the catheter.

[0041] While multiple embodiments are disclosed, still other embodiments of the present disclosure will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the disclosure. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.BRIEF DESCRIPTION OF THE DRAWINGS

[0042] FIG. 1 is a diagram illustrating an exemplary clinical setting for treating a patient, and for treating a heart of the patient, using an electrophysiology system.NM Ref.: 051666 / 14347BSC Ref.: 24-0043W001

[0043] FIG. 2 is a block diagram illustrating an example controller for use with the example electrophysiology system of FIG. 1.

[0044] FIG. 3 is a block diagram illustrating an example workflow of the example controller of FIG. 2.

[0045] FIG. 4 is a block diagram illustrating examples of an electrosurgical generator and electro-anatomical mapping (EAM) system of the electrophysiology system of FIG. 1.

[0046] FIG. 5 is a block diagram illustrating an example process of the controller of FIG. 2.

[0047] FIG. 6A is schematic diagram of an example graphical representation generated on a display device via the controller of FIG. 2 implementing the process of FIG. 5.

[0048] FIG. 6B is schematic diagram of another example graphical representation generated on a display device via the controller of FIG. 2 implementing the process of FIG. 5.

[0049] FIG. 7A is schematic diagram of another example graphical representation generated on a display device via the controller of FIG. 2 implementing the process of FIG. 5.

[0050] FIG. 7B is schematic diagram of another example graphical representation generated on a display device via the controller of FIG. 2 implementing the process of FIG. 5.

[0051] While the disclosure is amenable to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. The intention, however, is not to limit the disclosure to the particular embodiments described. On the contrary, the disclosure is intended to cover all modifications, equivalents, and alternatives falling within the scope of the disclosure as defined by the appended claims.DETAILED DESCRIPTION

[0052] For purposes of promoting an understanding of the principles of the present disclosure, reference is now made to the examples illustrated in the drawings, which are described below. The illustrated examples disclosed herein are not intended to be exhaustive or to limit the disclosure to the precise form disclosed in the following detailed description. Rather, these exemplary embodiments were chosen and described so that others skilled in the art may use their teachings. It is not beyond the scope of this disclosure to have a number (e.g., all) theNM Ref.: 051666 / 14347BSC Ref.: 24-0043W001 features in a given example used across all examples. Thus, no one figure should be interpreted as having any dependency or requirement related to any single component or combination of components illustrated therein. Additionally, various components depicted in a given figure may be, in examples, integrated with various ones of the other components depicted therein (and / or components not illustrated), all of which are considered to be within the ambit of the present disclosure.

[0053] FIG. 1 illustrates an example clinical setting 10 for treating a patient 20, such as for treating a heart 30 of the patient 20, using an electrophysiology system 50, in accordance with the disclosure. The electrophysiology system 50 includes an electroporation catheter system 60 and an electro-anatomical mapping (EAM) system 70. The example electroporation catheter system 60 includes an electroporation catheter 105, an introducer sheath 110, and an electroporation console 130. Additionally, the electroporation catheter system 60 includes various connecting elements, such as cables, that operably connect the components of the electroporation catheter system 60 to one another and to the components of the EAM system 70. In general, the EAM mapping system 70 includes a localization field generator 80, a mapping and navigation controller 90, and a display 92. Also, the clinical setting 10 can include additional equipment such as imaging equipment 94 (represented by the C-arm) and various controller elements, such as a foot controller 96, configured to allow an operator to control various aspects of the electrophysiology system 50. The clinical setting 10 may have other components and arrangements of components that are not shown in Fig. 1. Other arrangements of connecting elements, including wireless connecting elements, are contemplated.

[0054] The electroporation catheter system 60 is configured to deliver electric field energy to targeted tissue in the patient's heart 30 to create cell death in tissue, for example, rendering the tissue incapable of conducting electrical signals. Also, the electroporation catheter system 60 is configured to generate, based on models of electric fields, graphical representations of the electric fields that can be produced using the electroporation catheter 105 and to overlay, on the display 92, the graphical representations of the electric fields or expected or predicted lesions on an anatomical map of the patient's heart to aid a user in planning ablation by irreversible electroporation using the electroporation catheter 105 prior to delivering energy. InNM Ref.: 051666 / 14347BSC Ref.: 24-0043W001 embodiments, the electroporation catheter system 60 is configured to generate the graphical representations of the electric fields based on characteristics of the electroporation catheter 105 and the position of the electroporation catheter 105 in the patient 20, such as in the heart 30 of the patient 20. The electroporation catheter system 60 is configured to generate the graphical representations of the electric fields based on characteristics of the electroporation catheter 105 and the position of the electroporation catheter 105 in the patient 20, such as in the heart 30 of the patient 20, and the characteristics of the tissue surrounding the catheter 105, such as measured impedances of the tissue.

[0055] The introducer sheath 110 is operable to provide a delivery conduit through which the electroporation catheter 105 can be deployed to the specific target sites within the patient's heart 30. Access to the patient's heart can be obtained through a vessel, such as a peripheral artery or vein. Once access to the vessel is obtained, the electroporation catheter 105 can be navigated to within the patient's heart, such as within a chamber of the heart.

[0056] The example electroporation catheter 105 includes an elongated catheter shaft and distal end configured to be deployed proximate target tissue, such as within a chamber of the patient's heart. The distal end includes an electrode assembly to effect treatment. The catheter 105 is capable of being formed into a plurality of configurations. For example, if the distal end region of the catheter is within the patient's vasculature or is within a sheath as a catheter assembly, such as to travel to the patient to the chamber of the heart, the electrode assembly is in a collapsed configuration to fit within the sheath. Once the catheter has reached the destination in the chamber of the heart, for example, or the sheath is retracted from the distal region of the catheter 105 (or the shaft catheter is extended past the sheath), and the electrode assembly is arranged in an expanded configuration for use. In one embodiment, the electrode assembly can assume other configurations, such as an intermediate configuration between the collapsed and expanded configurations, such as an additional use configuration.

[0057] The electrode assembly includes an electrode assembly comprising a plurality of electrodes. For example, the electrode assembly includes a plurality of spaced-apart electrodes or multiple spaced-apart sets or groups of spaced-apart electrodes. In some examples, an electrode, such as a plurality of spaced-apart electrodes, can be deployed on the catheter shaftNM Ref.: 051666 / 14347BSC Ref.: 24-0043W001 in addition to electrodes on the electrode assembly. In one example, the plurality of electrodes can be formed of a conductive, solid-surface, biocompatible material and are spaced-apart across electrical insulators. Each of the plurality of electrodes is electrically coupled to an associated elongated lead conductorthat extend along the shaft to a catheter proximal end. In one example, each electrode of the spaced-apart electrodes corresponds with a separate, single lead conductor. In another example, a plurality of electrodes may be coupled to a single lead conductor. Other configurations are contemplated. The plurality of lead conductors can be electrically insulated from one another within an electrically insulating sheath along the catheter shaft, such as with an electrically insulating polymer sheath. The lead conductors can be electrically coupled to plug in the proximal region of the electroporation catheter 105, such as a plug configured to be mechanically and electrically coupled to the electroporation console 130 and the EAM system 70, for example, either directly or via intermediary electrical conductors such as cabling.

[0058] The electrode assemblies and associated electrodes are configured for, among other things, sensing cardiac electrical signals, ablation, localization of the electrode assembly within the patient anatomy such as via the EAM system 70, signal reference, and to determine proximity to target tissue within the anatomy. In some embodiments, the catheter 105 is configured for cardiac mapping, and the electrodes are sensing, or mapping, electrodes configured to be used to collect physiological (electrical) signals to be used to generate electroanatomical maps. An example of a physiological signal that the sensing electrode can acquire includes an intracardiac electrogram (ECG) signal. In some embodiments, the catheter 105 can be a mapping and ablation catheter, and the electrodes can include ablation electrodes, or an ablation electrode assembly, that are configured to deliver ablation electric field energy and sensing electrodes, or a sensing electrode assembly, for mapping purposes. The ablation electrodes in embodiments of an electroporation catheter are configured to receive pulsed electrical signals or waveforms from the console 130 and create pulsed electric fields sufficient to ablate target tissue via irreversible electroporation. The sensing electrodes in the electrode assembly can be electrically coupled to a one or more lead conductors that extends the length of the shaft that are configured to carry an electrical signal received at the sensing electrode. InNM Ref.: 051666 / 14347BSC Ref.: 24-0043W001 some examples, an electrode in the electrode assembly can be configured to only perform an ablation or the electrode in the electrode assembly can be configured to only perform mapping. In some examples, an electrode can operate as an ablation electrode in an ablation mode of the electrophysiology system 50 and as a sensing electrode in a sensing or mapping mode of the system 50. Some examples of mapping and ablation catheters are smaller in profile or in the volume of the electrode assembly than catheters that just perform mapping, and clinicians can map a given location within the heart with fewer passes across the chamber with mapping catheters than with mapping and ablation catheters.

[0059] In one example, the electroporation console 130 is configured to provide an electrical signal, such as a plurality of concurrent or space-apart-time electrical signals, to the electrically connected electroporation catheter 105 along lead conductors to the spaced-apart electrodes. The spaced-apart electrodes are configured to generate a selected electrical field proximate the target tissue, based on the electrical signals from the electroporation console 130, to effect electroporation.

[0060] Embodiments of the present disclosure provide systems, devices, and methods for selective and rapid application of pulsed electric fields to ablate tissue by irreversible electroporation. Generally, the systems, devices, and methods described herein may be used to generate large electric field magnitudes at desired regions of interest and reduce peak electric field values elsewhere in order to reduce unnecessary tissue damage and electrical arcing. An irreversible electroporation system as described herein may include a signal generator and a processor configured to apply one or more voltage pulse waveforms to a selected set of electrodes of an ablation device to deliver energy to a region of interest (e.g., ablation energy for a set of tissue in a pulmonary vein ostium or antrum). The pulse waveforms disclosed herein may aid in therapeutic treatment of a variety of cardiac arrhythmias (e.g., atrial fibrillation). In order to deliver the pulse waveforms generated by the signal generator, one or more electrodes of the ablation device may have an insulated electrical lead configured forsustaining a voltage potential in the order of several hundred volts to several thousand volts. The electrodes may be independently addressable such that each electrode may be controlled (e.g., deliver energy)NM Ref.: 051666 / 14347BSC Ref.: 24-0043W001 independently of any other electrode of the device. In this manner, the electrodes may deliver different energy waveforms with different timing synergistically for electroporation of tissue.

[0061] Pulse waveforms for electroporation energy delivery as disclosed herein may enhance the safety, efficiency and effectiveness of energy delivery to tissue by reducing the electric field threshold associated with irreversible electroporation, thus yielding more effective ablative lesions with a reduction in total energy delivered. In some embodiments, the voltage pulse waveforms disclosed herein may be hierarchical and have a nested structure. For example, the pulse waveform may include hierarchical groupings of pulses having associated timescales. In some embodiments, the methods, systems, and devices disclosed herein may comprise one or more of the methods, systems, and devices described in International Application Serial No. PCT / US2016 / 057664, filed on Oct. 19, 2016, and titled "SYSTEMS, APPARATUSES AND METHODS FOR DELIVERY OF ABLATIVE ENERGY TO TISSUE," the contents of which are hereby incorporated by reference in its entirety.

[0062] A selected electrical field can be generated with the electrodes configured as ablation electrodes to effect electroporation. A first ablation electrode, or first group of ablation electrodes, can be selected to be an anode and a different, second ablation electrode, or second group of ablation electrodes, can be selected to be a cathode, such that electrical fields can be generated between the anode and cathode based on signals, such as pulses, provided to the ablation electrodes from the electroporation console 130. The console 130 provides electric pulses of different lengths and magnitudes to the ablation electrodes on the catheter 105. The electric pulses can be provided in a continuous stream of pulses or in multiple, separate trains of pulses. Pulse parameters of interest include the number of pulses, the duty cycle of the pulses, the spacing of pulse trains, the voltage or magnitude of the pulses including the peak voltages, and the duration of the voltages. For example, the console 130 can select two or more ablation electrodes of the electrode assembly and provides pulses to the selected electrodes to generate electric fields between the selected electrodes to provide pulsed field ablation (PFA). For example, PFA can be performed with monophasic waveforms and biphasic waveforms. Without being bound to a particular theory, electric field strengths in the range of generally 200-250 volts per centimeter (V / cm) with microsecond-scale pulse duration have been demonstrated toNM Ref.: 051666 / 14347BSC Ref.: 24-0043W001 provide reversible electroporation in cardiac tissue. Electric field strengths at approximately 400 V / cm have been demonstrated to provide irreversible electroporation in cardiac tissue of interest, such as targeted myocardium tissue and endocardium tissue, with demonstrable sparing of red blood cells, vascular smooth muscle tissue, endothelium tissue, nerves and other nontargeted proximate tissue.

[0063] Additionally, the electrode assembly on catheter 105 can be operated in a selected mode such as monopolar mode or bipolar mode. During monopolar operation of the catheter 105, an ablation electrode, a group of ablation electrodes, or the entire electrode assembly are configured as one of an anode or a cathode. None of the electrodes in the electrode assembly are configured as a the other of the cathode or the anode. Instead, the other of the cathode or the anode is provided in the form of a pad dispersive electrode located on the patient, typically on the back, buttocks, or other suitable anatomical location during electroporation. An electrical field is formed between an activated electrode of the electrode assembly and the pad dispersive electrode. During bipolar operation of the catheter 105, a first set of one or more electrodes of the electrode assembly, is configured as the anode and a second set of one or more electrodes of the electrode assembly, is configured as the cathode, to generate the electric field. In this example, a pad dispersive electrode is not used, and the electrical field is not extended in the patient's body, but rather through a localized portion of tissue proximate the electrode assembly. For example, the electrodes on the ablation electrode assembly are configured as the one of the anode or cathode and electrodes on the shaft proximate the distal end are configured as the other of the cathode or anode.

[0064] The EAM system 70 is operable to track the location of the various components of the electroporation catheter system 60, and to generate high-fidelity three-dimensional anatomical and electro-anatomical maps of the heart, including portions of the heart such as cardiac chambers of interest or other structures of interest such as the sinoatrial node or atrioventricular node. In one illustrative example, the EAM system 70 can include the RHYTHMIA™ HDx mapping system marketed by Boston Scientific Corporation. Also, the mapping and navigation controller 90 of the EAM system 70 includes one or more controllers, such as microprocessors or computers, that execute code out of memory to control or performNM Ref.: 051666 / 14347BSC Ref.: 24-0043W001 functional aspects of the EAM system 70, in which the memory, can be part of the one or more controllers, microprocessors, computers, or part of a memory device accessible through a computer network.

[0065] The EAM system 70 generates a localization field, via the field generator 80, to define a localization volume about the heart 30, and a location sensor or sensing element on a tracked device, such as sensors on the electroporation catheter 105, generate an output that can be processed by the mapping and navigation controller 90 to track the location of the sensor, and consequently, the corresponding device, within the localization volume. In the illustrated example, the device tracking is accomplished using magnetic tracking techniques, in which the field generator 80 is a magnetic field generator that generates a magnetic field defining the localization volume, and location sensors on the tracked devices are magnetic field sensors.

[0066] In other examples, impedance tracking methodologies may be employed to track the locations of the various devices. In such examples, the localization field is an electric field generated, for example, by an external field generator arrangement, such as surface electrodes, by intra-body or intra-cardiac devices, such as an intracardiac catheter, or both. In these examples, the location sensing elements can constitute electrodes on the tracked devices that generate outputs received and processed by the mapping and navigation controller 90 to track the location of the various location sensing electrodes within the localization volume.

[0067] The EAM system 70 can be equipped for both magnetic and impedance tracking capabilities. In such examples, impedance tracking accuracy can, in some instances be enhanced by first creating a map of the electric field induced by the electric field generator within the cardiac chamber of interest using a probe equipped with a magnetic location sensor, as is possible using the RHYTHMIA HDx™ mapping system. One exemplary probe is the INTELLAMAP ORION™ mapping catheter marketed by Boston Scientific Corporation.

[0068] Regardless of the tracking methodology employed, the EAM system 70 utilizes the location information for the various tracked devices, along with cardiac electrical activity acquired by, for example, the electroporation catheter 105 or another catheter or probe equipped with sensing electrodes, to generate, and display via the display 92, detailed three- dimensional geometric anatomical maps or representations of the heart tissue and voids such asNM Ref.: 051666 / 14347BSC Ref.: 24-0043W001 cardiac chambers as well as electro-anatomical maps in which cardiac electrical activity of interest is superimposed on the geometric anatomical maps. Furthermore, the EAM system 70 can generate a graphical representation of the various tracked devices within the geometric anatomical map or the electro-anatomical map.

[0069] Each cardiac physiological (electrical) signal can include several intracardiac electrograms (EGMs) sensed within a patient's heart and may include any number of features that may be ascertained by aspects of the system 50. Examples of cardiac physiological signal features include activation times, activations, activation waveforms, filtered activation waveforms, minimum voltage values, maximum voltages values, maximum negative time- derivatives of voltages, instantaneous potentials, voltage amplitudes, dominant frequencies, and peak-to-peak voltages. A cardiac physiological signal feature can refer to one or more features extracted from one or more cardiac physiological signals, derived from one or more features that are extracted from one or more cardiac physiological signals. Additionally, a representation, on a cardiac or a surface map, of a cardiac physiological signal feature may represent one or more cardiac physiological signal features, an interpolation of several cardiac physiological signal features. Each cardiac physiological signal also can be associated with a set of respective position coordinates that corresponds to the location at which the cardiac physiological signal was sensed. Each of the respective position coordinates for the sensed cardiac physiological signals can include three-dimensional Cartesian coordinates, polar coordinates, or another coordinate system. The cardiac physiological signals may be sensed on the cardiac surfaces, and the respective position coordinates can be on the endocardial surface, epicardial surface, in the midmyocardium of the patient's heart, or in a vicinity.

[0070] During a signal-acquisition stage of a cardiac mapping procedure, the catheter 105 is displaced to multiple locations within the heart chamber into which the catheter 105 is inserted. At each location to which the catheter 105 is moved, the electrodes and sensors acquire physiological signals resulting from the electrical activity in the heart along with positional, or spatial, information of the catheter 105. The spatial information is used in building a three- dimensional grid of the anatomy during mapping. To perform a mapping procedure and reconstruct physiological information on the endocardium surface, the EAM system 70 may alignNM Ref.: 051666 / 14347BSC Ref.: 24-0043W001 a coordinate system of the catheter 105 with the endocardium surface's coordinate system, or vice versa. Alternatively, or additionally, the grid may be used to capture EGMs, and select mapping values based on statistical distributions associated with nodes of the grid. The EAM system 70 also can perform post-processing operations on the physiological information to extract and display useful features of the information to the operator of the system 50.

[0071] In generating an example electroanatomical map, a data stream including multiple signals, such as signals received from the mapping electrodes of the catheter 105, is input into the EAM system 70. During the automated electroanatomical mapping process, the data stream provides a collection of physiological and location signals that serve as an input to the mapping process. The signals may be collected directly by the mapping system, obtained from another system using an analog or digital interface, or both. The data stream can include signals such as unipolar and / or bipolar intracardiac EGMs, surface electrocardiograms (ECGs), electrode location information originating from one or more of a variety of methodologies, tissue proximity information, catheter force information, catheter to tissue contact information, catheter temperature, acoustic information, catheter electrical coupling information, catheter deployment shape information, electrode properties, respiration phase, blood pressure, and other physiological information. Sensors on distal end of the catheter 105 or elsewhere in the electrophysiological system 50, such as thermocouples, pressure sensors, and other transducers can be applied to detect physiological information during a procedure and present the physiological signals as electrical signals to the electroporation catheter system 60 or EAM system 70. For the generation of specific types of maps, one or more signals may be used as one or more references to trigger and align the data stream relative to a cycle or clock, which can be used to create beat datasets. Beat metrics can be determined from the beat datasets. A beat acceptance process can be applied to determine which beat datasets will make up a map dataset. The map dataset may be stored in association with a three-dimensional grid that is dynamically generated during data acquisition.

[0072] Surface geometry data of the cardiac surface is generated, such as generated concurrently, during the data acquisition process using acceptance metrics employing a surface geometry construction process. This process constructs surface geometry using data such asNM Ref.: 051666 / 14347BSC Ref.: 24-0043W001 electrode locations and catheter shape contained in the data stream. Additionally, or alternatively, previously collected surface geometry of the cardiac surface can be used as an input to surface geometry data. Previously collected geometry may have been collected using a different map dataset or using a different modality such as computerized tomography (CT), magnetic resonance imaging (MRI), ultrasound, or rotational angiography and registered to the catheter locating system. A surface map generation process is employed to generate surface map data from the map dataset and surface geometry data.

[0073] The electrophysiology system 50 is capable of detecting, or is configured to detect, electrical characteristics, such as impedance, which can correspond with several properties including myocardial tissue proximity to an electrode and lesion parameters. For example, the system 50 utilizes impedance measurements to sense contact between an electrode on the catheter 105 and tissue priorto ablation and changes in pre-ablation to post-ablation impedance measurements of tissue or whether impedance in tissue has passed a certain threshold to determine the scope of the lesion. In general, the impedance of a given medium is determined based upon applying a known voltage or current to a given medium and measuring the resulting current or voltage. In some embodiments, impedance measurements of a given medium can be obtained by injecting current between two electrodes and measuring the resulting voltage between two electrodes in the electrical field resulting from the injected current. In one example, the controller, such as controller of the electroporation console 130 or the mapping and navigation controller 90, can select and inject a current between any two electrodes on the catheter 105 and measure a resulting voltage between the same or different electrodes. The ratio of the voltage potential to the applied current provides an indication of the impedance of the medium through which the current traveled, which can be determined via the controller.

[0074] The depiction of the electrophysiology system 50 shown in FIG. 1 is intended for illustration or a general overview of the various components of the system 50 and is not intended to imply that the disclosure is limited to any set of components or arrangement of the components. For example, additional hardware components, such as breakout boxes or workstations, can be included in the electrophysiology system 50.NM Ref.: 051666 / 14347BSC Ref.: 24-0043W001

[0075] FIG. 2 illustrates an example controller 200 that can be used with the example electrophysiology system 50, such as a controller of the example electroporation catheter system 60, which may include a controller of the electroporation console 130 or generator, a controller of the example EAM system 70, which may include a mapping and navigation controller 90, a controller of an integrated electroporation catheter system 60 and EAM system 70, or a controller for use with the electroporation catheter system 60 and EAM system 70. The controller 200 can include a processor 202 and a memory 204. The memory 204 stores processor executable instructions 206. In one example, the processor executable instructions can be in the form of a program, such as a computer program or application. The processor 202 can execute the instructions 206 that can be included in configuring the controller 200. In one example, the controller 200 can be implemented to include a computing device such as a laptop computer, a workstation, a desktop computer, a tablet, or a smartphone. In such examples, the controller 200 can include additional components such as a display, a touchscreen, speakers or other output devices, a keyboard or other input devices, or communication circuitry such as computer network adapters.

[0076] In one example, the processor 202 may include a plurality of main processing cores to run an operating system and perform general-purpose tasks on an integrated circuit. The processor 202 may also include built-in logic or a programmable functional unit, also on the same integrated circuit with a heterogeneous instruction-set architecture. In additional to multiple general-purpose, main processing cores and the application processing unit, controller 200 can include other devices or circuits such as graphics processing units or neural network processing units, which may include heterogeneous or homogenous instruction set architectures with the main processing cores.

[0077] Memory 204 is an example of computer storage media. Computer storage media includes RAM, ROM, EEPROM, flash memory or other memory technology, CD-ROM, digital versatile discs (DVD) or other optical storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, USB flash drive, flash memory card, or other flash storage devices, or other storage medium that can be used to store the desired information and that can be accessed by the processor 202. Any such computer storage media may be part of theNM Ref.: 051666 / 14347BSC Ref.: 24-0043W001 controller 200 and implemented as memory 204. Memory 204 is a non-transitory, processor readable memory device. Accordingly, a propagating signal by itself does not qualify as storage media or memory 204.

[0078] In embodiments, the controller 200 is implemented with any combination of hardware and programming to configure the functions. In one embodiment, the programming includes processor executable instructions 206 stored on at least one non-transitory machine- readable storage medium, such as a memory device 204 and the hardware includes at least one processing resource 202, such as a microprocessor, to execute those instructions. In some embodiments, the hardware includes other electronic circuitry to at least partially implement at least one feature of the controller 200. In some embodiments, the at least one machine-readable storage medium stores instructions that, when executed by the processor, at least partially implement some or all features of controller and accesses data structures stored on a memory device coupled to the processor. In some embodiments, controller 200 includes the at least one machine-readable storage medium storing the instructions and the at least one processing resource to execute a method. The processor-executable instructions may be in the form of an application, such as a computer application or module of a computer application. The controller 200 in embodiments includes a processor operably connected to a memory device. The memory device can store processor executable instructions configured to control the processor, such as a program. Examples of a memory device can include a non-volatile memory device and a volatile memory device. Memory device can include various combinations of one or both of non-volatile memory devices and volatile memory devices.

[0079] In other embodiments, the functionalities of the controller 200 and method may be at least partially implemented in the form of electronic circuitry. Examples of electronic circuitry include integrated circuits including ASICs and programmable logic devices, such as field programmable gate arrays. A field programmable gate array is a type of integrated circuit that can be programmed or reprogrammed after manufacture and include programable logic blocks and interconnects that are configured to perform various digital functions. The logic blocks can be configured to perform combinational functions or as logic gates. Logic blocks can also include memory elements, such as flip-flops or more complete memory devices including volatile andNM Ref.: 051666 / 14347BSC Ref.: 24-0043W001 non-volatile memory aspects that can include look up tables. Functions can be defined via a hardware description language in an electronic design automation tool to create a binary file to configure the electronic circuitry. Those skilled in the art recognize that descriptions of methods or processes can be implemented in such electronic circuitry.

[0080] The controller 200 is configured to receive inputs or information from the electrophysiology system 50, such as inputs from the electroporation catheter system 60 and EAM system 70 including the electroporation console 130 via the catheter 105 and the mapping and navigation controller 90, for storage in memory 204 and use by the instructions 206. For example, the controller 200 can receive heart data 208 from which the controller is configured to generate an anatomical map of the heart such as an electroanatomical map of the heart in a procedure on a graphical display, such as display 92. In addition, the controller 200 is configured to receive waveform parameters 210, catheter and tissue parameters 212, and response parameters 214. In one embodiment, waveform parameters 210 relate to and include ablation energy settings from the generator 130 related to anticipated pulsed electrical signals and can vary based on the type of catheter 105 used in the procedure. Catheter and tissue parameters 212 relate to and include parameters prior to ablation and the application of pulsed electrical signals via the catheter such as physiological signals and electrical properties of tissue to be measured bythe controller 200 prior to ablation. Response parameters 214 relate to and include measured changes in response to the application of the pulsed electrical signals via the catheter.

[0081] The controller 200 is configured to generate outputs such as visualizations 220 that can include predicted or anticipated effects of therapy prior to the application of the pulsed electrical signals as well as measured effects of therapy and assessments in response to the pulsed electrical signals. In one embodiment, the controller generates the visualizations 220 via the EAM system 70 along with the anatomical map 222. In one embodiment, the anatomical map 222 is presented with a model of the catheter 224 superimposed on the anatomical map 222 to indicate on the display 92 the relative location of the catheter 105 within the heart. In one embodiment, the controller 200 is configured to generate a field tag 230 on the graphical display based on the waveform parameters 210. The field tag 230 is an embodiment of a predicted lesion zone on an anatomical map of the heart corresponding to an electric field generated with theNM Ref.: 051666 / 14347BSC Ref.: 24-0043W001 pulsed electrical signals. The field tag 230 is presented on the graphical display as superimposed on the anatomical map, such as at the location of the model distal end of the catheter, that provides a visualization of the anticipated size of the electrical field that would result from a corresponding anticipated ablation. In one example, the visualization can include an anticipated lesion size that remains on the anatomical map 220 in response to the ablation.

[0082] In the embodiment, the controller 200 is configured to generate a pre-ablation indicator 232 on the graphical display based on the catheter and tissue parameters 212. For example, the pre-ablation indicator 232 is a visualization of a value that provides a relative prediction of ablation quality prior to ablation. In one example, the visualization is a color widget that is presented on the graphical display based on the prediction with relation to a color scale as determined from the value. In another example, the visualization is numeral that is presented on the graphical display based on a numerical scale of lesion quality such as a numerical or integer scale having a range of 1-10. The value can be normalized to the scale. For instance, the widget can be green or the numeral 8 to indicate a likely high-quality or robust ablation and red or the numeral 2 to indicate a likely low-quality or weak ablation. In one embodiment, the pre-ablation indicator 232 is incorporated in the visualization of the field tag 230, such as the field tag takes on the color from the color scale.

[0083] In the embodiment, the controller 200 is configured to generate an ablation indicator as a pulsed field index 234 on the graphical display based on the waveform parameters 210, the catheter and tissue parameters 212, and the response parameter 214 during or after the application of the pulsed electrical signals. The ablation indicator includes a visualization on the graphical display of a value that provides a relative determination of ablation quality during or subsequent to ablation. For example, the pulsed field index 234 can include a visualization of a value that provides a relative indication of lesion quality as a result of the ablation. In one example, the pulsed field index 234 includes a visualization similar to the pre-ablation indicator 232, such as a colored widget or numeral based on a scale, to indicate a relative quality of the lesion with respect to the scale as determined from the value. In another example, the visualization is numeral that is presented on the graphical display based on a numerical scale of lesion quality such as a scale having a range of 1-10. The value can be normalized to the scale.NM Ref.: 051666 / 14347BSC Ref.: 24-0043W001For instance, the widget can be green or the numeral 8 to indicate a likely high-quality ablation and red or the numeral 2 to indicate a likely low-quality ablation.

[0084] FIG. 3 illustrates an embodiment of a workflow 300 of the controller 200 in generating visualizations 220. The controller 200 is configured to receive waveform parameters 210, catheter and tissue parameters 212, and response parameters 214. Prior to the application of the pulsed electrical signals, the controller 200 is configured to generate a field tag 230 on the graphical display based on the waveform parameters 210. The field tag 230 is presented on the graphical display as a visualization 220 that is superimposed on the anatomical map generated via the EAM system 70, such as at the location of the model distal end of the catheter. Prior to the application of the pulsed electrical signals, the controller 200 is configured to generate a preablation indicator 232 on the graphical display based on the catheter and tissue parameters 212. The pre-ablation indicator 232 is transmitted to a graphical display, such as display device 92, to provide a visualization 220, such as a visualization presented alongside the anatomical map generated with the EAM system 70. The controller 200 is configured to generate a pulsed field index 234 on the graphical display based on the waveform parameters 210, the catheter and tissue parameters 212, and the response parameter 214 during or after the application of the pulsed electrical signals. In embodiments, the pulsed field index 234 can is transmitted to a graphical display, such as display device 92, to provide a visualization 220, such as a visualization presented as a widget alongside the anatomical map generated with the EAM system 70, as a lesion marker to replace or be superimposed on the field tag 230 on the anatomical map, or a combination of the widget and lesion marker.

[0085] In embodiments, the waveform parameters 210 are provided to the controller 200 from the electroporation console 130 and are related to generator output such as energy settings of the generator in anticipation of (in the case of field tags 230) or in application of (in the case of pulsed field index 234) the pulsed electrical signals. In embodiments, the waveform parameters 210 can be based on the catheter used for ablation and the generator output can be selected based on the catheter of the procedure. Waveform parameters 210 include ablation or energy settings related to waveform type, energy delivery, and time of waveform, such as pulse delivery. In embodiments, waveform type parameters include whether the waveform is biphasicNM Ref.: 051666 / 14347BSC Ref.: 24-0043W001 or monophasic and whether the waveform is bipolar or monopolar. Energy settings or energy delivery parameters include an amount of voltage, current, charge, frequency, and other measurable or derivable parameters of the electrical signal such as joules, watts, and amperes. Time and pulse delivery parameters include information based on the packets of the electrical signal to be delivered for ablation, pulses in the electrical signal to be delivered for the ablation signal, and the rate and number of repetitions of electrical signal application to tissue.

[0086] In embodiments, the catheter and tissue parameters 212 are provided to the controller 200 from the electroporation console 130 and the mapping and navigation controller 90 and are related to properties measured prior to ablation. Catheter and tissue parameters 212 include measurements related to catheter or electrode force against tissue and catheter stability, which can include location change or force change over a given duration of time. Other catheter and tissue parameters 212 include local impedance, such as impedance measured at the electrodes, electrode surface area, rate of irrigation of the tissue with a fluid, as well as factors related to the location of the tissue to be ablated. For instance, factors related to the location of the tissue include location specific predictors such as whether an infarct is identified by local impedance and whether the location has been previously ablated. Other location factors considered include the type of tissue to be ablated such as whether the tissue is atrial tissue or ventricular tissue. For instance, atrial tissue may wrap around the catheter or the electrodes more than ventricular tissue while under catheter force, which can create wider lesions. Ventricular tissue may compress more than atrial tissue while under catheter force, which can create deeper lesions. In embodiments, the catheter and tissue parameters 212 can be based on the catheter used for ablation. In one example, catheters or controllers with force sensing capability can include force sensing parameters into the catheter and tissue parameters whereas catheters without force sensing capabilities may rely more on impedance and EGM measurements to supplant force sensing factors in determining the pre-ablation indicator 232.

[0087] In embodiments, the response parameters 214 are provided to the controller 200 from the electroporation console 130 and the mapping and navigation controller 90 and are related to measured changes in response to the application of the pulsed electrical signals via the catheter. Measured changes can include changes in impedance as compared from before theNM Ref.: 051666 / 14347BSC Ref.: 24-0043W001 ablation to after the ablation, changes in EGM readings or the presence of EGMs in the tissue as compared from before the ablation to after the ablation, changes in the force applied to the catheter or the stability of the catheter as compared from before the ablation to after the ablation, and changes in temperature, such as the rise in temperature of the tissue compared from before the ablation to after the ablation. Another measured change can relate to waveform changes during the ablation. In one example, the electrical current ramp or current ramping in each pulse during the ablation may change. In one example, the current of a square wave pulse may rise from the trailing edge to the leading edge, and this rise or change in current may be more pronounced in pulses at the beginning of the ablation than at the end of the ablation. The amount of current ramp in a pulse and the change in current ramps over pulses can be applied by the controller to determine the pulsed field index 234.

[0088] In embodiments, the response parameters 214 can be based on the catheter used for ablation. In one example, catheters or controllers with force sensing capability can include force sensing parameters into the catheter and tissue parameters whereas catheters without force sensing capabilities may rely more on impedance and EGM measurements to supplant force sensing factors in determining the pulse field index 234.

[0089] The generation of the field tags 230, pre-ablation indicator 232, and pulsed field ablation index 234 as visualizations are based on the waveform parameters 210, current and tissue parameters 212 and response parameters 214. In the particular case of workflow 300, the visualizations incorporate factors such as catheter stability, electrical coupling to the tissue, measured temperature changes in the tissue, and generator output including changes in current ramp. Additionally, acute validation of lesions created via electroporation indicate a strong relationship with contact force of the catheter to the electrodes. The workflow 300 applies a metric that that improves consistency of lesion prediction and validation that accounts for the received factors in pulse field ablation delivery. For instance, the pulsed field index 234 applies a weighted calculation to account for the parameters 210, 212, 214 for lesion quality. Factors related to current or energy and to time and pulse via the energy delivery parameters 210 parameters provide for enhanced field tags 230. Factors related to catheter stability, force, and positioning provide for enhanced predictability of lesion formation and are incorporated in theNM Ref.: 051666 / 14347BSC Ref.: 24-0043W001 pre-ablation indicator 232. In some embodiments, the workflow 300 is calibrated for tissue type, such as atrial or ventricular, based on catheter location information relative to the heart as determined with reference to the anatomical map 222. In another embodiment, the lesion can be annotated to provide information as whether the application of pulsed field ablation was in monopolar mode or bipolar mode of the catheter. For instance, fields near the shaft of the distal end of the catheter, often included when electrodes on the shaft are implemented in a bipolar mode, can be annotated to indicate there is insufficient lesion depth at those locations.

[0090] FIG 4 illustrates an example configuration of an embodiment the electroporation console 130, or generator, of the electroporation catheter system 60 coupled to the mapping and navigation controller 90 of the EAM system 70. The electroporation console 130 includes generator processing circuitry 402 and generator communication circuitry 404. The mapping and navigation controller 90 includes EAM processing circuitry 412 and EAM communication circuitry 414. In one embodiment, the EAM processing circuitry 414 is implemented as controller 200. Generator communication circuitry 404 transmits data including generator settings, generator outputs, measurements and physiological signals and electrical properties received from the catheter as applied in generator processing circuitry to the EAM communication circuitry 414. EAM communication circuitry 414 provides the received information to the EAM processing circuitry 414.

[0091] Figure 5 illustrates a process 500 of configuring a controller, such as controller 200 (or processing circuitry 414), while performing an electroporation of target tissue, such as in a chamber of a patient's heart. In one example, the controller is implemented as part of the EAM system 70 and operably coupled to the electroporation catheter system 60 as indicated in FIG. 4. In one example, process 500 can be implemented as set of processor-executable instructions, such as instructions 206, stored in a non-transitory memory, such as memory 204 to be executed by a processor 202 to configure controller 200 according to the workflow 300. The instructions to implement process 500 can be configured to receive information, such as to retrieve from memory 204 and to transmit signals to output devices including graphical displays such as display 92 to render visualizations 220 as well as other outputs such as audio alarms.NM Ref.: 051666 / 14347BSC Ref.: 24-0043W001

[0092] Process 500 includes configuring the controller to generate a graphical representation of the distal end of the catheter, such as the electrode assembly of the catheter superimposed on an anatomical map of the heart at 502. For example, the graphical representation of the electrode assembly includes a graphical representation 224 of the electroporation catheter 105 with respect to its location on an anatomical map 222 of the patient's heart. The graphical representation of the catheter 224 can include a schematic representation or other indicia that presents a model of the location of the electrode assembly of the electroporation catheter 105 with respect to the heart such as may be determined from the ablation location data applied to the anatomical heart map data, such as generated with the EAM system 70. The controller 200 is configured to receive waveform parameters 210, catheter and tissue parameters 212, and response parameters 214 from the electrophysiological system 50 at 504.

[0093] Prior to delivery of pulsed electrical signals to selected ones of the plurality of electrodes at the location, the controller 200 is configured to generate, on the graphical display, a predicted lesion zone on an anatomical map of the heart corresponding to an electric field generated with the pulsed electrical signals at 506. The predicted lesion zone corresponds with a field tag 230 generated via waveform parameters 210.

[0094] Prior to delivery of the pulsed electrical signals to the selected ones of the plurality of electrodes at the location, the controller 200 is configured to generate a pre-ablation indicator 232 on the graphical display based on the position of the electrode assembly at the location such as the catheter and tissue parameters 212 at 508.

[0095] After or concurrently with delivery of the pulsed electrical signals to the selected ones of the plurality of electrodes at each of the plurality of locations, generate an ablation indicator 234 on the graphical display based on the position of the electrode assembly at the location, the delivery of the pulsed electrical signal to the selected ones of the plurality of electrodes, and measured changes in the target tissue, which correspond with the waveform parameters 210, current and tissue parameters 212 and response parameters 214 at 510.

[0096] FIG. 6A illustrates a first example graphical representation 601 generated via an embodiment of the controller 200 implementing an embodiment of process 500. The firstT1NM Ref.: 051666 / 14347BSC Ref.: 24-0043W001 example graphical representation 601 is generated in an example procedure prior to delivery of pulsed electrical signals. The first example graphical representation 601 includes a graphical representation of the electrode assembly 606 of the electroporation catheter 105 and an anatomical map of the region of the heart 608 indicating the relative position or location or the electroporation catheter 105 with respect to the patient's heart. The first example graphical representation 601 is an example of a graphical representation prior to delivery of the pulsed electrical signals. Prior to delivery of pulsed electrical signals to selected ones of the plurality of electrodes at the location, the first graphical representation includes a predicted lesion zone ablation tag 610 on the anatomical map of the heart 608 corresponding to an electric field generated with the pulsed electrical signals at 506 of process 500. The predicted lesion zone 610 is corresponds with a field tag 230 generated via waveform parameters 210. The process 500 automatically annotates the anatomical map 608 on the first example graphical representation by applying an ablation marker based on the predicted lesion zone. Also prior to delivery of the pulsed electrical signals to the selected ones of the plurality of electrodes at the location, the first example graphical representation 601 includes a widget 612 corresponding to a pre-ablation indicator 232 based on the position of the electrode assembly at the location such as the catheter and tissue parameters 212 at 508. The widget 612 indicates a likelihood of successful ablation given the waveform parameters 210 and catheter and tissue parameters 212 of the catheter 105 with respect to the heart via an indicum such as a color or value from a relative scale. In the first example graphical representation 601, the widget 612 is colored green or blue to indicate a likelihood of successful ablation. The first graphical representation 601 includes other information of interest to a clinician such as electroanatomical information.

[0097] FIG. 6B illustrates a second example graphical representation 602 generated via an embodiment of the controller 200 implementing an embodiment of process 500. The second example graphical representation 602 is an example of a graphical representation after or concurrently with delivery of the pulsed electrical signals to the first example graphical representation 601 of FIG. 6A. The second example graphical representation 602 includes a graphical representation of the electrode assembly 626 of the electroporation catheter 105 and an anatomical map of the region of the heart 628 indicating the relative position or location orNM Ref.: 051666 / 14347BSC Ref.: 24-0043W001 the electroporation catheter 105 with respect to the patient's heart. In the illustrated example, the graphical representation can provide an indication of the region of the heart subjected to irreversible electroporation 630 from the delivery of the pulsed electrical signals. In the illustrated example, the indicated region 630 is colored green or blue to signify a relatively robust ablation. Also, the second example graphical representation 602 includes a widget 632 corresponding with the ablation indicator 234 based on the position of the electrode assembly at the location, the delivery of the pulsed electrical signal to the selected ones of the plurality of electrodes, and measured changes in the target tissue, which correspond with the waveform parameters 210, current and tissue parameters 212 and response parameters 214 at 510. The widget 632 indicates a relative success of the ablation such as a color, for example green or blue, and a value from a relative scale. In the illustrated example, the relative scale includes integer values from 0 to 10, in which 0 is a failed ablation and 10 is the most robust ablation. Based on the waveform parameters 210, current and tissue parameters 212 and response parameters 214 determined at 510, the widget 632 presents a numerical value of 8 in green indicating a robust ablation.

[0098] FIG. 7A illustrates a third example graphical representation 701 generated via an embodiment of the controller 200 implementing an embodiment of process 500. The third example graphical representation 701 is generated in an example procedure prior to delivery of pulsed electrical signals. The first example graphical representation 701 includes a graphical representation of the electrode assembly 706 of the electroporation catheter 105 and an anatomical map of the region of the heart 708 indicating the relative position or location or the electroporation catheter 105 with respect to the patient's heart. The third example graphical representation 701 is an example of a graphical representation prior to delivery of the pulsed electrical signals. Prior to delivery of pulsed electrical signals to selected ones of the plurality of electrodes at the location, the first graphical representation includes a predicted lesion zone 710 on the anatomical map of the heart 708 corresponding to an electric field generated with the pulsed electrical signals at 506 of process 500. The predicted lesion zone 710 is corresponds with a field tag 230 generated via waveform parameters 210. The process 500 automatically annotates the anatomical map 708 on the first example graphical representation by applying an ablationNM Ref.: 051666 / 14347BSC Ref.: 24-0043W001 marker based on the predicted lesion zone. Also prior to delivery of the pulsed electrical signals to the selected ones of the plurality of electrodes at the location, the third example graphical representation 701 includes a widget 712 corresponding to a pre-ablation indicator 232 based on the position of the electrode assembly at the location such as the catheter and tissue parameters 212 at 508. The widget 712 indicates a likelihood of successful ablation given the waveform parameters 210 and catheter and tissue parameters 212 of the catheter 105 with respect to the heart via an indicum such as a color or value from a relative scale. In the third example graphical representation 701, the widget 712 is colored red to indicate a likelihood of an unsuccessful or wanting ablation. Upon such indication, the clinician can attempt to redeploy the catheter and not deliver energy. The third example graphical representation 701 includes other information of interest to a clinician such as electroanatomical information.

[0099] FIG. 7B illustrates a fourth example graphical representation 702 generated via an embodiment of the controller 200 implementing an embodiment of process 500. The fourth example graphical representation 702 is an example of a graphical representation after or concurrently with delivery of the pulsed electrical signals to the third example graphical representation 701 in FIG. 7A. The second example graphical representation 702 includes a graphical representation of the electrode assembly 726 of the electroporation catheter 105 and an anatomical map of the region of the heart 728 indicating the relative position or location or the electroporation catheter 105 with respect to the patient's heart. In the illustrated example, the graphical representation can provide an indication of the region of the heart subjected to irreversible electroporation 730 from the delivery of the pulsed electrical signals. In the illustrated example, the indicated region 730 is colored red to signify a relatively weak ablation. Also, the fourth example graphical representation 702 includes a widget 732 corresponding with the ablation indicator 234 based on the position of the electrode assembly at the location, the delivery of the pulsed electrical signal to the selected ones of the plurality of electrodes, and measured changes in the target tissue, which correspond with the waveform parameters 210, current and tissue parameters 212 and response parameters 214 at 510. The widget 732 indicates a relative success of the ablation such as a color, for example red, and a value from a relative scale. In the illustrated example, the relative scale includes integer values from 0 to 10, in whichNM Ref.: 051666 / 14347BSC Ref.: 24-0043W0010 is a failed ablation and 10 is the most robust ablation. Based on the waveform parameters 210, current and tissue parameters 212 and response parameters 214 determined at 510, the widget 732 presents a numerical value of 2 in red indicating a weak ablation. Upon such indication, the clinician can attempt to redeploy the catheter and redeliver energy.

[0100] It is well understood that methods that include one or more steps, the order listed is not a limitation of the claim unless there are explicit or implicit statements to the contrary in the specification or claim itself. It is also well settled that the illustrated methods are just some examples of many examples disclosed, and certain steps may be added or omitted without departing from the scope of this disclosure. Such steps may include incorporating devices, systems, or methods or components thereof as well as what is well understood, routine, and conventional in the art.

[0101] The connecting lines shown in the various figures contained herein are intended to represent exemplary functional relationships and / or physical couplings between the various elements. It should be noted that many alternative or additional functional relationships or physical connections may be present in a practical system. However, the benefits, advantages, solutions to problems, and any elements that may cause any benefit, advantage, or solution to occur or become more pronounced are not to be construed as critical, required, or essential features or elements. The scope is accordingly to be limited by nothing other than the appended claims, in which reference to an element in the singular is not intended to mean "one and only one" unless explicitly so stated, but rather "one or more." Moreover, where a phrase similar to "at least one of A, B, or C" is used in the claims, it is intended that the phrase be interpreted to mean that A alone may be present in an embodiment, B alone may be present in an embodiment, C alone may be present in an embodiment, or that any combination of the elements A, B or C may be present in a single embodiment; for example, A and B, A and C, B and C, or A and B and C. The terms "couples," "coupled," "connected," "attached," and the like along with variations thereof are used to include both arrangements wherein two or more components are in direct physical contact and arrangements wherein the two or more components are not in direct contact with each other (e.g., the components are "coupled" via at least a third component), but still cooperate or interact with each other.NM Ref.: 051666 / 14347BSC Ref.: 24-0043W001

[0102] In the detailed description herein, references to "one embodiment," "an embodiment," "an example embodiment," etc., indicate that the embodiment described may include a particular feature, structure, or characteristic, but every embodiment may not necessarily include the particular feature, structure, or characteristic. Moreover, such phrases are not necessarily referring to the same embodiment. Further, when a particular feature, structure, or characteristic is described in connection with an embodiment, it is submitted that it is within the knowledge of one skilled in the art with the benefit of the present disclosure to affect such feature, structure, or characteristic in connection with other embodiments whether or not explicitly described. After reading the description, it will be apparent to one skilled in the relevant art(s) how to implement the disclosure in alternative embodiments.

[0103] Various modifications and additions can be made to the exemplary embodiments discussed without departing from the scope of the present disclosure. For example, while the embodiments described above refer to particular features, the scope of this disclosure also includes embodiments having different combinations of features and embodiments that do not include all of the described features. Accordingly, the scope of the present disclosure is intended to embrace all such alternatives, modifications, and variations as fall within the scope of the claims, together with all equivalents thereof.

Claims

NM Ref.: 051666 / 14347BSC Ref.: 24-0043W001CLAIMSWe claim:

1. A system for performing electroporation ablation of target tissue in a chamber of a heart, the system comprising: a catheter including an electrode assembly having a plurality of electrodes, wherein the catheter is adapted to position the electrode assembly at a location proximate the target tissue; a graphical display; and a controller configured to: prior to delivery of pulsed electrical signals to selected ones of the plurality of electrodes at the location, generate, on the graphical display, a predicted lesion zone on an anatomical map of the heart corresponding to an electric field generated with the pulsed electrical signals; prior to delivery of the pulsed electrical signals to the selected ones of the plurality of electrodes at the location, generate a pre-ablation indicator on the graphical display based on the position of the electrode assembly at the location; and after or concurrently with delivery of the pulsed electrical signals to the selected ones of the plurality of electrodes at each of the plurality of locations, generate an ablation indicator on the anatomical map based on the position of the electrode assembly at the location, the delivery of the pulsed electrical signal to the selected ones of the plurality of electrodes, and measured changes in the target tissue.

2. The system of claim 1, wherein the controller is further configured to generate, on the graphical display, a model of the electrode assembly.NM Ref.: 051666 / 14347BSC Ref.: 24-0043W0013. The system of claim 2, further comprising automatically annotate the anatomical map on the graphical display by applying an ablation marker based on the predicted lesion zone on the anatomical map of the heart.

4. The system of any of claims 2-3, wherein the ablation indicator is generated on the anatomical map of the heart.

5. The system of any of claims 2-4, wherein the anatomical map includes electroanatomical information.

6. The system of any of claims 2-5, wherein the controller receives heart data from which to generate an electroanatomical map of the heart as the anatomical map of the heart.

7. The system of any of claims 1-6, wherein the predicted lesion zone is based on waveform parameters and the pre-ablation indicator is based on catheter and tissue parameters.

8. The system of claim 7, wherein the waveform parameters include ablation energy settings of anticipated pulsed electrical signals provided from the catheter.

9. The system of any of claims 7 and 8, wherein the catheter and tissue parameters include physiological signals and electrical properties of tissue measured prior to ablation.

10. The system of any of claims 7-9, wherein the ablation indicator is based on the waveform parameters, the catheter and tissue parameters, and response parameters.

11. The system of claim 10, wherein the response parameters include measured changes in response to the application of the pulsed electrical signal via the catheter.

12. The system of any of claims 7-11, wherein the pre-ablation indicator includes a visualization on the graphical display of a value that provides a relative prediction of ablation quality prior to ablation.NM Ref.: 051666 / 14347BSC Ref.: 24-0043W00113. The system of claim 12, wherein the visualization includes a numeral that is presented on the graphical display based on a numerical scale of lesion quality.

14. The system of any of claims 10-13, wherein the ablation indicator includes a visualization on the graphical display of a value that provides a relative determination of ablation quality during or subsequent to ablation.

15. The system of claim 14, wherein the visualization of a value that provides a relative indication of lesion quality as a result of the ablation.

16. A system for performing electroporation ablation of target tissue in a chamber of a heart, the system comprising: a catheter including an electrode assembly having a plurality of electrodes, wherein the catheter is adapted to position the electrode assembly at a location proximate the target tissue; a graphical display; and a controller configured to: prior to delivery of pulsed electrical signals to selected ones of the plurality of electrodes at the location, generate, on the graphical display, a predicted lesion zone on an anatomical map of the heart corresponding to an electric field generated with the pulsed electrical signals; prior to delivery of the pulsed electrical signals to the selected ones of the plurality of electrodes at the location, generate a pre-ablation indicator on the graphical display based on the position of the electrode assembly at the location; and after or concurrently with delivery of the pulsed electrical signals to the selected ones of the plurality of electrodes at each of the plurality of locations, generate an ablation indicator on the anatomical map based on theNM Ref.: 051666 / 14347BSC Ref.: 24-0043W001 position of the electrode assembly at the location, the delivery of the pulsed electrical signal to the selected ones of the plurality of electrodes, and measured changes in the target tissue.

17. The system of claim 16, wherein the controller is further configured to generate, on the graphical display, a model of the electrode assembly.

18. The system of claim 17, further comprising automatically annotate the anatomical map on the graphical display by applying an ablation marker based on the predicted lesion zone on the anatomical map of the heart.

19. The system of claim 17, wherein the ablation indicator is generated on the anatomical map of the heart.

20. The system of claim 17, wherein the anatomical map includes electroanatomical information.

21. The system of claim 17, wherein the controller receives heart data from which to generate an electroanatomical map of the heart as the anatomical map of the heart.

22. The system of claim 16, wherein the predicted lesion zone is based on waveform parameters and the pre-ablation indicator is based on catheter and tissue parameters.

23. The system of claim 22, wherein the waveform parameters include ablation energy settings of anticipated pulsed electrical signals provided from the catheter.

24. The system of claim 22, wherein the catheter and tissue parameters include physiological signals and electrical properties of tissue measured prior to ablation.

25. The system of claim 22, wherein the ablation indicator is based on the waveform parameters, the catheter and tissue parameters, and response parameters.

26. The system of claim 25, wherein the response parameters include measured changes in response to the application of the pulsed electrical signal via the catheter.NM Ref.: 051666 / 14347BSC Ref.: 24-0043W00127. The system of claim 25, wherein the pre-ablation indicator includes a visualization on the graphical display of a value that provides a relative prediction of ablation quality prior to ablation.

28. The system of claim 27, wherein the visualization includes a numeral that is presented on the graphical display based on a numerical scale of lesion quality.

29. The system of claim 25, wherein the ablation indicator includes a visualization on the graphical display of a value that provides a relative determination of ablation quality during or subsequent to ablation.

30. The system of claim 29, wherein the visualization of a value that provides a relative indication of lesion quality as a result of the ablation.

31. A system for performing electroporation ablation of target tissue in a chamber of a heart, the system comprising: a catheter including an electrode assembly having a plurality of electrodes, wherein the catheter is adapted to position the electrode assembly at a location proximate the target tissue; a graphical display; and a controller configured to: generate, on the graphical display, a model of the electrode assembly; prior to delivery of pulsed electrical signals to selected ones of the plurality of electrodes at the location, generate, on the graphical display, a predicted lesion zone on an anatomical map of the heart corresponding to an electric field generated with the pulsed electrical signals, the predicted lesion zone based on ablation energy settings of anticipated pulsed electrical signals provided from the catheter;NM Ref.: 051666 / 14347BSC Ref.: 24-0043W001 prior to delivery of the pulsed electrical signals to the selected ones of the plurality of electrodes at the location, generate a pre-ablation indicator on the graphical display based on the position of the electrode assembly at the location, the pre ablation indicator based on physiological signals and electrical properties of tissue measured prior to ablation; and after or concurrently with delivery of the pulsed electrical signals to the selected ones of the plurality of electrodes at each of the plurality of locations, generate an ablation indicator on the anatomical map based on the position of the electrode assembly at the location, the delivery of the pulsed electrical signal to the selected ones of the plurality of electrodes, and measured changes in the target tissue, wherein the ablation indicator includes a visualization on the graphical display of a value that provides a relative determination of ablation quality during or subsequent to ablation.

32. The system of claim 31, wherein the visualization of a value that provides a relative indication of lesion quality as a result of the ablation.

33. The system of claim 32, further comprising automatically annotate the anatomical map on the graphical display by applying an ablation marker based on the predicted lesion zone on the anatomical map of the heart.

34. A process for use with electroporation ablation of target tissue in a chamber of a heart with a catheter including an electrode assembly having a plurality of electrodes, the catheter adapted to position the electrode assembly at a location proximate the target tissue, the process comprising: prior to delivery of pulsed electrical signals to selected ones of the plurality of electrodes at the location, generating, on a graphical display, a predicted lesion zone on an anatomical map of the heart corresponding to an electric field generated with the pulsed electrical signals;NM Ref.: 051666 / 14347BSC Ref.: 24-0043W001 prior to delivery of the pulsed electrical signals to the selected ones of the plurality of electrodes at the location, generating a pre-ablation indicator on the graphical display based on the position of the electrode assembly at the location; and after or concurrently with delivery of the pulsed electrical signals to the selected ones of the plurality of electrodes at each of the plurality of locations, generating an ablation indicator on the anatomical map based on the position of the electrode assembly at the location, the delivery of the pulsed electrical signal to the selected ones of the plurality of electrodes, and measured changes in the target tissue.

35. The process of claim 34, wherein the predicted lesion zone is based on ablation energy settings of anticipated pulsed electrical signals provided from the catheter, the pre-ablation indicator is based on physiological signals and electrical properties of tissue measured prior to ablation, and the ablation indicator is based on the ablation energy settings of anticipated pulsed electrical signals provided from the catheter, the physiological signals and electrical properties of tissue measured prior to ablation, and measured changes in response to the application of the pulsed electrical signal via the catheter.

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