Annotation for electroporation ablation

Abstract

A system for performing electroporation ablation on target tissue in a chamber of a patient's heart is disclosed. The system includes a catheter including an electrode assembly having a plurality of electrodes, where the catheter is adapted to position the electrode assembly at a plurality of locations proximate the target tissue, a graphical display, and a controller. The controller is configured to generate a graphical representation of the electrode assembly on the graphical display. The controller is configured to generate, on the graphical display, a graphical representation of a model of the electric field generated in response to delivering the pulsed electrical signal to a selected electrode of the plurality of electrodes.

Description

Technical Field

[0001] The present disclosure generally relates to medical systems and methods for ablating patient tissue. More specifically, the present disclosure relates to medical systems and methods for ablating tissue by electroporation. Background Art

[0002] Ablation procedures are used to treat many different diseases in patients. Ablation can be used to treat arrhythmias, benign tumors, cancerous tumors, and to control bleeding during surgery. Generally, ablation is accomplished by thermal ablation techniques, including radiofrequency (RF) ablation and cryoablation. In RF ablation, a probe is inserted into the patient, and radiofrequency waves are transmitted through the probe to the surrounding tissue. The radiofrequency waves generate heat, which destroys the surrounding tissue and cauterizes blood vessels. In cryoablation, a hollow needle or cryoprobe is inserted into the patient, and a cold, thermally conductive fluid is circulated through the probe to freeze and kill the surrounding tissue. RF ablation and cryoablation techniques can kill tissue indiscriminately by causing cell necrosis, which can damage or kill other healthy tissues, such as esophageal tissue, diaphragmatic nerve cells, and tissue in the coronary arteries.

[0003] Another ablation technique uses electroporation. In electroporation or electropermeabilization, an electric field is applied to cells to increase the permeability of the cell membrane. Depending on the strength and duration of the electric field, electroporation can be reversible or irreversible. If electroporation is reversible, the temporary increase in cell membrane permeability can be used to introduce chemicals, drugs, or deoxyribonucleic acid (DNA) into the cells before the cells heal and recover. Tissue recovery can occur within minutes, hours, or days after ablation is complete. If electroporation is irreversible, the affected cells will be killed, such as via forms of cell death such as programmed cell death, such as may occur by apoptosis, or traumatic cell death, such as may occur by necrosis.

[0004] Irreversible electroporation can be used as a non-thermal ablation technique. In irreversible electroporation, short, high-voltage pulse trains are used to generate an electric field sufficient to kill cells. In the ablation of cardiac tissue, irreversible electroporation can be a relatively safe and effective alternative to thermal ablation techniques that kill indiscriminately, such as RF ablation and cryoablation. Irreversible electroporation can kill targeted tissue, such as myocardial tissue, by using a selected electric field strength and duration that is effective for killing the targeted tissue but ineffective for permanently damaging other cells or tissues, such as non-targeted myocardial tissue, red blood cells, vascular smooth muscle tissue, endothelial tissue, and nerve cells. Planning an irreversible electroporation ablation procedure can be difficult because of the lack of acute visualization or data indicating which tissues have been irreversibly electroporated compared to tissues that have been reversibly electroporated. Summary of the Invention

[0005] In Example 1, a system for performing electro - perforation ablation on target tissue in a chamber of a patient's heart, the system includes a catheter, a graphical display, and a controller. The catheter includes an electrode assembly having a plurality of electrodes, wherein the catheter is adapted to position the electrode assembly at a plurality of positions proximate to the target tissue. The controller is configured to generate a graphical representation of the electrode assembly on the graphical display. The controller is configured to generate a graphical representation of a model of an electric field generated in response to delivering a pulsed electrical signal to a selected electrode among the plurality of electrodes. Before delivering the pulsed electrical signal to the selected electrode among the plurality of electrodes at each of the plurality of positions, the controller is configured to generate a predicted lesion zone corresponding to the intersection of the model of the electric field and the surface of the anatomical map of the heart on the graphical display. After or simultaneously with delivering the pulsed electrical signal to the selected electrode among the plurality of electrodes at each of the plurality of positions, the controller is configured to automatically annotate the anatomical map on the graphical display by applying ablation markers based on the predicted lesion zone corresponding to each of the plurality of positions.

[0006] In Example 2, the system according to Example 1, wherein, at each of the plurality of positions, the controller is further configured to generate a first overlap zone on the anatomical map on the graphical display, which is defined by an overlapping zone of a corresponding ablation marker and a previously applied ablation marker.

[0007] In Example 3, the system according to Example 2, wherein, at each of the plurality of positions, the controller is further configured to generate a second overlap zone on the anatomical map on the graphical display, which is defined by an overlapping zone of a corresponding ablation marker and two or more previously applied ablation markers.

[0008] In Example 4, the system according to Example 3, wherein the ablation marker, the first overlap zone, and the second overlap zone each have a different visual appearance on the anatomical map.

[0009] In Example 5, the system according to any one of Examples 2 to 4, wherein the controller is further configured to automatically annotate the anatomical map on the graphical display to identify each ablation marker that overlaps with at least two different ablation markers.

[0010] In Example 6, the system according to Example 5, wherein the controller is further configured to automatically annotate the anatomical map on the graphical display to show the outer boundaries of a series of ablation markers, wherein each ablation marker overlaps with at least two spatially adjacent ablation markers.

[0011] In Example 7, the system according to any one of Examples 1 to 6, wherein the controller is further configured to automatically identify the gaps between any two spatially adjacent ablation markers that overlap with at least two different ablation markers.

[0012] In Example 8, the system according to any one of Examples 1 to 7, wherein each predicted lesion area has substantially the same geometric shape as the corresponding ablation marker.

[0013] In Example 9, the system according to any one of Examples 1 to 8, wherein each predicted lesion area has substantially the same visual appearance as the corresponding ablation marker.

[0014] In Example 10, the system according to any one of Examples 1 to 7, wherein each predicted lesion area has a different visual appearance from the corresponding ablation marker.

[0015] In Example 11, the system according to any one of Examples 1 to 10, wherein the visual appearance of the predicted lesion area or the ablation marker varies with one or more ablation parameters.

[0016] In Example 12, the system according to any one of Examples 2 to 11, wherein each first overlap area has a different visual appearance from each second overlap area.

[0017] In Example 13, the system according to any one of Examples 1 to 12, wherein the catheter is configured to selectively deliver monopolar ablation energy and bipolar ablation energy.

[0018] In Example 14, the system according to any one of Examples 1 to 13, wherein the system is included in one of an electroporation catheter system or an electroanatomical mapping system.

[0019] In Example 15, the system according to any one of Examples 1 to 14, wherein the anatomical map is an electroanatomical map.

[0020] In Example 16, a system for performing electroporation ablation on target tissue in a chamber of a patient's heart, the system including a catheter, a graphical display, and a controller, the catheter including an electrode assembly having a plurality of electrodes, wherein the catheter is adapted to position the electrode assembly at a first position proximate the target tissue. Before delivering ablation energy to the plurality of electrodes, the controller is configured to generate a graphical representation of an electric field model generated by the plurality of electrodes on the graphical display. Also before delivering ablation energy to the plurality of electrodes, the controller is configured to: when the electrode assembly is at the first position proximate the target tissue, generate a first predicted lesion marker on the cardiac anatomical map on the graphical display corresponding to the intersection of the model of the electric field and the surface of the anatomical map. After or simultaneously with delivering ablation energy to the plurality of electrodes, the controller is configured to automatically annotate the anatomical map on the graphical display with a first ablation marker corresponding to the first predicted lesion marker.

[0021] In Example 17, the system according to Example 16, wherein the controller is further configured to, when the electrode assembly is in a second position proximate to the target tissue and after automatically annotating the anatomical map with the first ablation marker, generate a second predicted lesion marker corresponding to the intersection of the model of the electric field and the surface of the anatomical map on the anatomical map of the heart on the graphical display before delivering ablation energy to the plurality of electrodes.

[0022] In Example 18, the system according to Example 17, wherein the controller is further configured to, when the electrode assembly is in the second position proximate to the target tissue, automatically annotate the anatomical map on the graphical display with a second ablation marker corresponding to the second predicted ablation marker after or simultaneously with delivering ablation energy to the plurality of electrodes.

[0023] In Example 19, the system according to Example 17, wherein the controller is further configured to, when the electrode assembly is in the second position proximate to the target tissue and after automatically annotating the anatomical map with the first ablation marker, generate a third predicted lesion marker defined by an overlapping region of the first ablation marker and the second predicted lesion marker on the anatomical map of the heart on the graphical display.

[0024] In Example 20, the system according to Example 19, wherein the controller is further configured to, when the electrode assembly is in the second position proximate to the target tissue, automatically annotate the anatomical map on the graphical display with a third ablation marker corresponding to the third predicted ablation marker after or simultaneously with delivering ablation energy to the plurality of electrodes.

[0025] In Example 21, the system according to Example 20, wherein the third ablation marker has a visual appearance different from that of the first ablation marker and the second ablation marker.

[0026] In Example 22, the system according to Example 16, wherein each of the first predicted lesion marker and the first ablation marker has a different visual appearance.

[0027] In Example 23, the system according to Example 16, wherein the catheter is configured for selective delivery of monopolar and bipolar ablation energy, and wherein the controller is configured to generate a model of the electric field in a different manner when the catheter is configured for delivering monopolar ablation energy than when the catheter is set for delivering bipolar ablation energy.

[0028] In Example 24, a system for performing electroporation ablation on target tissue in a chamber of a patient's heart, the system includes a catheter, a graphical display, and a controller. The catheter includes an electrode assembly having a plurality of electrodes, wherein the catheter is adapted to position the electrode assembly at a location proximate to an ablation region of the target tissue. The controller is configured to generate a graphical representation of the electrode assembly and a first ablation marker corresponding to the ablation region on the graphical display. The controller is configured to generate a graphical representation of a model of an electric field generated in response to delivering a pulsed electrical signal to a selected one of the plurality of electrodes. Before delivering the pulsed electrical signal to the selected one of the plurality of electrodes at the location, the controller is configured to generate a predicted lesion area corresponding to an intersection of the model of the electric field and the surface of the anatomical map on the graphical display of the heart, and an overlap area corresponding to an intersection of the predicted lesion area and the first ablation marker. After or simultaneously with delivering the pulsed electrical signal to the selected one of the plurality of electrodes at the location, the controller is configured to automatically annotate the anatomical map on the graphical display by applying a second ablation marker based on the predicted lesion area corresponding to the location and by defining the overlap area.

[0029] In Example 25, the system according to Example 24, wherein the controller is further configured to automatically identify, on the anatomical map on the graphical display, another overlap area that is spatially adjacent to the overlap area.

[0030] In Example 26, the system according to Example 24, wherein the controller is further configured to automatically annotate, on the graphical display, a first continuous string of spatially adjacent overlap areas that includes the overlap area.

[0031] In Example 27, the system according to Example 26, wherein the controller is further configured to automatically annotate, on the graphical display, a second continuous string of spatially adjacent overlap areas that are spaced apart from the first continuous string of spatially adjacent overlap areas on the target tissue.

[0032] In Example 28, the system according to Example 27, wherein the controller is further configured to automatically identify, on the graphical display, a gap on the target tissue that is disposed between the spaced-apart first continuous string of spatially adjacent overlap areas and the second continuous string of spatially adjacent overlap areas.

[0033] In Example 29, the system according to Example 28, wherein the controller is further configured to automatically highlight the gap on the graphical display based on the distance between the spaced-apart first continuous string of spatially adjacent overlap areas and the second continuous string of spatially adjacent overlap areas.

[0034] In Example 30, a method for use with electropermanent ablation of target tissue in a chamber of a patient's heart using a catheter including an electrode assembly having a plurality of electrodes, where the catheter is adapted to position the electrode assembly at a plurality of positions proximate the target tissue. The method includes generating a graphical representation of the electrode assembly on a graphical display; generating a graphical representation of an electric field model generated in response to delivering a pulsed electrical signal to a selected electrode of the plurality of electrodes; generating, on a cardiac anatomy map on the graphical display, a predicted lesion zone corresponding to an intersection of the electric field model and the surface of the anatomy map prior to delivering the pulsed electrical signal to the selected electrode at each of the plurality of positions; and automatically annotating the cardiac anatomy map on the graphical display by applying ablation markers based on the predicted lesion zone corresponding to each of the plurality of positions after or simultaneously with delivering the pulsed electrical signal to the selected electrodes at the plurality of positions.

[0035] In Example 31, the method according to Example 30, and at each of the plurality of positions, further generating a first overlap zone defined by an overlap zone of a corresponding ablation marker and a previously applied ablation marker on the anatomy map on the graphical display.

[0036] In Example 32, the method according to Example 31, and at each of the plurality of positions, further generating a second overlap zone defined by an overlap zone of a corresponding ablation marker and two or more previously applied ablation markers on the anatomy map on the graphical display.

[0037] In Example 33, the method according to Example 31, and further automatically annotating the anatomy map on the graphical display to identify each ablation marker that overlaps with at least two different ablation markers.

[0038] In Example 34, the method according to Example 30, and further automatically identifying, on the anatomy map on the graphical display, a lesion line including a spatially adjacent series of ablation markers including ablation markers and previously applied ablation markers.

[0039] In Example 35, the method according to Example 30, where the catheter is configured for selective delivery of monopolar and bipolar ablation energy, and an indicator is generated in the electric field model on the graphical display in a different manner when the catheter is configured for delivering monopolar ablation energy than when the catheter is configured for delivering bipolar ablation energy.

[0040] Although multiple embodiments are disclosed, other embodiments of the present disclosure will be apparent to those skilled in the art from the following detailed description, which illustrates and describes illustrative embodiments of the present disclosure. Accordingly, the drawings and detailed description are to be regarded as illustrative rather than restrictive in nature. BRIEF DESCRIPTION OF THE DRAWINGS

[0041] Figure 1 FIG. is a diagram showing an exemplary clinical environment for treating a patient and for treating the patient's heart, the exemplary clinical environment having an exemplary electrophysiology system.

[0042] Figure 2 FIG. is showing in connection with Figure 1 block diagram of an exemplary controller for use with an exemplary electrophysiology system.

[0043] Figure 3 FIG. is showing Figure 2 flowchart of an exemplary configuration of an exemplary controller.

[0044] Figure 4A FIG. is a schematic diagram showing an exemplary graphical representation of a cardiac anatomical surface intersecting an electric field model and a predicted lesion zone of an exemplary electroporation catheter configured in a first or monopolar mode, such as can be visualized on a display of an electrophysiology system configured by an exemplary controller of Figure 2 configured by an exemplary controller of Figure 1 the electrophysiology system.

[0045] Figure 4B FIG. is a schematic diagram showing an exemplary graphical representation of ablation markers including annotating the cardiac anatomical surface based on the predicted lesion zone shown in Figure 4A such as can be visualized on a display of an electrophysiology system configured by an exemplary controller of Figure 2 configured by an exemplary controller of Figure 1 the electrophysiology system.

[0046] Figure 4C FIG. is a schematic diagram showing an exemplary graphical representation of a cardiac anatomical surface including ablation markers intersecting another electric field model and a second predicted lesion zone of an exemplary electroporation catheter configured in a first or monopolar mode, such as can be visualized on a display of an electrophysiology system configured by an exemplary controller of Figure 4B such as can be visualized on a display of an electrophysiology system configured by an exemplary controller of Figure 2 configured by an exemplary controller of Figure 1 the electrophysiology system.

[0047] Figure 4D FIG. is a schematic diagram showing an exemplary graphical representation including a second ablation marker annotating the cardiac anatomical surface based on the second predicted lesion zone shown in Figure 4C and a first overlap zone defined by an overlap region of the second ablation marker and a previously applied ablation marker, such as can be visualized on a display of an electrophysiology system configured by an exemplary controller of Figure 2 configured by an exemplary controller of Figure 1 the electrophysiology system.

[0048] Figure 5A FIG. is a schematic diagram showing an exemplary graphical representation of a cardiac anatomical surface intersecting an electric field model of an exemplary electroporation catheter configured in a second or bipolar mode, such as can be by Figure 2of an example controller configuration Figure 1 visualization on a display of an electrophysiology system

[0049] Figure 5B is a schematic diagram showing an example graphical representation of ablation marks annotating the surface of a cardiac anatomy map based on a predicted lesion zone, such as can be Figure 5A visualized on a display of an electrophysiology system of an example controller configuration as shown Figure 2 of an example controller configuration Figure 1 visualization on a display of an electrophysiology system

[0050] Figure 6A is a schematic diagram showing an example graphical representation including a plurality of ablation marks annotating the surface of a cardiac anatomy map arranged to include a plurality of overlapping regions, such as can be Figure 2 visualized on a display of an electrophysiology system of an example controller configuration Figure 1 as shown

[0051] Figure 6B is a schematic diagram showing an example graphical representation (such as can be Figure 2 configured by an example controller Figure 1 visualized on a display of an electrophysiology system) that includes a plurality of ablation marks annotating the surface of a cardiac anatomy map arranged to include Figure 6A a plurality of overlapping regions, and includes an outer boundary of a series of ablation marks, where each ablation mark overlaps at least two spatially adjacent ablation marks, and identifies a gap between any two spatially adjacent ablation marks that overlap at least two different ablation marks

[0052] Although the present disclosure is applicable to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. However, the intention is not to limit the present disclosure to the specific embodiments described. On the contrary, the present disclosure is intended to cover all modifications, equivalents, and alternatives falling within the scope of the present disclosure as defined by the appended claims Detailed Description

[0053] For purposes of promoting an understanding of the principles of the present disclosure, reference is now made to the examples illustrated in the accompanying drawings, which are described below. The illustrated examples disclosed herein are not intended to be exhaustive or to limit the present disclosure to the precise forms disclosed in the following detailed description. Rather, the exemplary embodiments are chosen and described so that others skilled in the art may utilize their teachings. Having multiple (e.g., all) features used in all examples in one example does not exceed the scope of the present disclosure. Thus, no single drawing should be construed as having any dependence on or requirement for any individual component or combination of components shown therein. Additionally, in the examples, various components depicted in the drawings may be integrated with various components (or components not shown) among other components depicted therein, and such situations are considered to be within the scope of the present disclosure.

[0054] The terms “coupled,” “is coupled,” “is connected,” “is attached,” etc., and variations thereof are used to encompass both arrangements where two or more components are in direct physical contact, and arrangements where two or more components are not in direct contact with each other but still cooperate or interact (e.g., components are “coupled” via at least a third component).

[0055] Throughout the present disclosure, including the claims, numerical terms (such as first and second) are used to refer to various components or features. Such use is not intended to denote an order of components or features. Rather, the numerical terms are used to assist the reader in identifying the referenced components or features and should not be construed narrowly as providing a specific order of components or features.

[0056] Figure 1 An exemplary clinical environment 10 for using an electrophysiology system 50 to treat a patient 20 (such as for treating a heart 30 in patient 20) in accordance with the present disclosure is shown. The electrophysiology system 50 includes an electroporation catheter system 60 and an electroanatomical mapping (EAM) system 70. The exemplary electroporation catheter system 60 includes an electroporation catheter 105, a guiding sheath 110, and an electroporation console 130. Additionally, the electroporation catheter system 60 includes various connection elements, such as cables, that operably connect the components of the electroporation catheter 60 to each other and to the components of the EAM system 70. Generally, the EAM mapping system 70 includes a positioning field generator 80, a mapping and navigation controller 90, and a display 92. Additionally, the clinical environment 10 may include additional equipment, such as imaging equipment 94 (represented by a C-arm) and various controller elements configured to allow an operator to control various aspects of the electrophysiology system 50, such as a foot controller 96. The clinical environment 10 may have Figure 1 other components and component arrangements not shown. Other arrangements of connection elements may be envisioned, including wireless connection elements.

[0057] The electroporation catheter system 60 is configured to deliver electric field energy to targeted tissue in a patient's heart 30 to create cell death in the tissue, e.g., render the tissue unable to conduct electrical signals. Additionally, the electroporation catheter system 60 is configured to generate a graphical representation of the electric field that can be produced using the electroporation catheter 105 based on an electric field model and superimpose the graphical representation of the electric field or the anticipated or predicted lesion on a patient heart anatomy on a display 92 to assist a user in planning ablation using the electroporation catheter 105 for irreversible electroporation prior to delivering the energy. In an embodiment, the electroporation catheter system 60 is configured to generate a graphical representation of the electric field based on the characteristics of the electroporation catheter 105 and the position of the electroporation catheter 105 in a patient 20 (such as in the patient's 20 heart 30). The electroporation catheter system 60 is configured to generate a graphical representation of the electric field based on the characteristics of the electroporation catheter 105 and the position of the electroporation catheter 105 in a patient 20 (such as in the patient's 20 heart 30) and the characteristics of the tissue surrounding the catheter 105 (such as the measured tissue impedance).

[0058] The introducer sheath 110 is operable to provide a delivery conduit through which the electroporation catheter 105 can be deployed to a particular target site within the patient's heart 30. Access to the patient's heart can be obtained through a blood vessel (such as a peripheral artery or vein). Once access to the blood vessel is obtained, the electroporation catheter 105 can be guided into the patient's heart, such as within a chamber of the heart.

[0059] The exemplary electroporation catheter 105 includes an elongated catheter shaft and a distal end configured to be deployed adjacent to a target tissue, such as within a chamber of a patient's heart. The distal end can include a basket structure, a balloon, splines, a configured tip, or other electrode deployment mechanism to effect treatment. The electrode deployment mechanism includes an electrode assembly or an array of electrodes. For example, the electrode assembly can include a plurality of spaced-apart electrodes or multiple sets or groups of spaced-apart electrodes. In some examples, electrodes (such as a plurality of spaced-apart electrodes) can be deployed on the catheter shaft, in addition to or instead of electrodes on the electrode deployment mechanism. In one example, a plurality of electrodes can be formed of a conductive, solid surface, biocompatible material and spaced apart across an insulator. Each of the plurality of electrodes is electrically coupled to a corresponding elongated lead conductor that extends along the shaft to the proximal end of the catheter. In one example, each of the spaced-apart electrodes corresponds to a separate individual lead conductor. In another example, a plurality of electrodes can be coupled to a single lead conductor. Other configurations are contemplated. The plurality of lead conductors can be insulated from each other within an insulating sheath along the catheter shaft, such as using an insulating polymer sheath. The lead conductors can be electrically coupled to a plug in a proximal region of the electroporation catheter 105, such as a plug configured to be mechanically and electrically coupled, for example, directly or via an intermediate electrical conductor such as wiring, to an electroporation console 130. In one example, the electroporation console 130 is configured to provide electrical signals, such as multiple simultaneous or timed electrical signals, along the lead conductors to the electrically connected electroporation catheter 105 to electrodes spaced apart to generate a selected electric field adjacent to the target tissue to effect electroporation.

[0060] Electroporation can be achieved by generating a selected electric field with electrodes. A first electrode or a first set of electrodes can be selected as the anode, and a different second electrode or a second set of electrodes can be selected as the cathode, such that an electric field can be generated between the anode and the cathode based on signals (such as pulses) provided to the electrodes from the electroporation console 130. The console 130 provides electrical pulses of different lengths and amplitudes to the electrodes on the catheter 105. The electrical pulses can be provided as a continuous stream of pulses or as multiple, individual pulse trains. Pulse parameters of interest include the number of pulses, the duty cycle of the pulses, the interval between pulse trains, the voltage or amplitude of the pulses (including peak voltage), and the duration of the voltage. For example, the console 130 can select two or more electrodes of the electrode assembly and provide pulses to the selected electrodes to generate an electric field therebetween, thereby providing pulsed field ablation (PFA). For example, PFA can be performed with single-phase waveforms and biphasic waveforms. Without being limited to a particular theory, an electric field strength having a pulse duration in the microsecond range and typically in the range of 200 to 250 volts per centimeter (V / cm) has been shown to provide reversible electroporation in cardiac tissue. An electric field strength of approximately 400 V / cm has been shown to provide irreversible electroporation in cardiac tissue of interest (such as targeted myocardial tissue and endocardial tissue), while significantly preserving red blood cells, vascular smooth muscle tissue, endothelial tissue, nerves, and other non-targeted nearby tissues.

[0061] In addition, the electrode assembly on the catheter 105 can operate in a selected mode (such as monopolar mode or bipolar mode). During monopolar operation of the catheter 105, an electrode, a set of electrodes, or the entire electrode assembly is configured as one of the anode or the cathode. None of the electrodes in the electrode assembly is configured as 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 electric field is formed between the 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 an electric field. In this example, the pad dispersive electrode is not used, and the electric field does not extend within the patient, but instead extends locally through the tissue adjacent to the electrode assembly.

[0062] The electroporation console 130 is configured to control aspects of the electroporation catheter system 60. In an embodiment, the electroporation console 130 is configured to provide one or more of the following: model the electric fields that can be generated by the electroporation catheter 105, which generally includes considering the physical characteristics of the electroporation catheter 105, including the electrodes and the spatial relationship of the electrodes on the electroporation catheter 105, and whether the electroporation catheter 105 is in a bipolar or monopolar mode; generate a graphical representation of the electric field, which generally includes considering the position of the electroporation catheter 105 in the patient 20 and the characteristics of the surrounding tissue; and overlay the generated graphical representation on an anatomical map on the display 92. In some examples, the electroporation console 130 is configured to generate an anatomical map. In some examples, the EAM system 70 is configured to generate an anatomical map for display on the display 92.

[0063] The electroporation console 130 includes a controller, such as one or more controllers, processors, or computers, that execute instructions or code (such as processor-executable instructions) from a non-transitory computer-readable medium (such as a storage device or memory) to cause (such as control or execute) aspects of the electroporation catheter system 60. The memory can be part of one or more controllers, processors, or computers, or can be part of a storage device accessible via a computer network. Examples of computer networks include local area networks, wide area networks, and the Internet.

[0064] The EAM system 70 is operable to track the positions of the various components of the electroporation catheter system 60 and generate high-fidelity three-dimensional anatomical and electroanatomical maps of the heart, including portions of the heart, such as a chamber of interest or other structures of interest, such as the sinoatrial node or the atrioventricular node. In an illustrative example, the EAM system 70 can include the RHYTHMIA TM HDx Mapping System, sold by Boston Scientific Corporation. Additionally, the mapping and navigation controller 90 of the EAM system 70 includes one or more controllers, such as microprocessors or computers, that execute code in memory to control or execute functional aspects in the EAM system 70, where the memory can be part of one or more controllers, microprocessors, computers, or can be part of a storage device accessible via a computer network.

[0065] The EAM system 70 generates a localization field via a field generator 80 to define a localization volume around the heart 30, and a position sensor or sensing element on the tracked device (such as a sensor on the electroporation catheter 105) generates an output that can be processed by the mapping and navigation controller 90 to track the position of the sensor within the localization volume, and thus track the position of the corresponding device. In the example shown, magnetic tracking technology is used to implement device tracking, where the field generator 80 is a magnetic field generator that generates a magnetic field defining the localization volume, and the position sensor on the tracked device is a magnetic field sensor.

[0066] In other examples, an impedance tracking method can be employed to track the positions of various devices. In these examples, the localization field is an electric field generated, for example, by an external field generator arrangement (such as surface electrodes), an in-vivo or intracardiac device (such as an intracardiac catheter), or both. In these examples, the position sensing elements can constitute electrodes on the tracked device, and these electrodes generate an output that is received and processed by the mapping and navigation controller 90 to track the positions of the various position sensing electrodes within the localization volume.

[0067] The EAM system 70 can be equipped with magnetic and impedance tracking capabilities. In these examples, in some cases, the impedance tracking accuracy can be improved by first creating an electric field map induced by an electric field generator using a probe equipped with a magnetic position sensor within the cardiac chamber of interest, as possible with the RHYTHMIA HDx TM mapping system. An exemplary probe is the INTELLAMAP ORION TM mapping catheter sold by Boston Scientific Corporation.

[0068] Regardless of the tracking method employed, the EAM system 70 utilizes the position information of various tracked devices, as well as the cardiac electrical activity acquired, for example, by the electroporation catheter 105 or another catheter or probe equipped with sensing electrodes, to generate and display via the display 92 a detailed three-dimensional geometric anatomical map or representation of the cardiac tissue and voids (such as cardiac chambers), as well as an electroanatomical map (where the cardiac electrical activity of interest is superimposed on the geometric anatomical map). In addition, the EAM system 70 can generate a graphical representation of the various tracked devices within the geometric anatomical map or electroanatomical map.

[0069] The electroporation catheter system 60 can be combined with or integrated into the EAM system 70 to allow a graphical representation of the electric field that can be generated by the electroporation catheter 105 to be visualized on an anatomical map of the patient and (in some cases) on an electroanatomical map of the patient's heart. The integrated system can include the ability to improve the efficiency of the clinical workflow, including enhancing the visual representation provided to the clinician of the ablation lesion of the portion of the patient's heart created by irreversible electroporation. The integrated system can include generating a graphical representation of the electric field that can be generated by the electroporation catheter 105, generating an anatomical map including generating an electroanatomical map, and displaying information related to the location and electric field strength of the electric field that can be generated by the electroporation catheter 105.

[0070] Figure 1 The depiction of the electrophysiological system 50 shown is intended to illustrate or overview the various components of the system 50 and is not intended to mean that the present disclosure is limited to any set of components or arrangement of components. For example, additional hardware components such as a junction box or a workstation can be included in the electrophysiological system 50.

[0071] Figure 2 An example controller 200 is shown that can be used with the example electrophysiological system 50, such as a controller of the example electroporation catheter system 60 (which can include the controller of the electroporation console 130), a controller of the example EAM system 70 (which can include the mapping and navigation controller 90), a controller of the integrated electroporation catheter system 60 and EAM system 70, or a controller used with the electroporation catheter system 60 and EAM system 70. In this example, the controller 200 can be implemented to provide visualization of the ablation lesion of irreversible electroporation. In some examples, the controller 200 can also be implemented to provide selected annotations in areas that have not undergone irreversible electroporation. 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 an application program. The processor 202 can execute the instructions 206 that can be included in the configured 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 computer, or a smartphone. In these examples, the controller 200 can include additional components such as a display, a touch screen, a speaker, or other output devices, a keyboard or other input devices, or a communication circuit (such as a computer network adapter). The controller 200 can be implemented in various architectures and components (such as the processor 202 and the memory 204), and the components can be distributed in various locations.

[0072] In one example, the processor 202 may include multiple main processing cores to run an operating system and perform general tasks on the integrated circuit. The processor 202 may also include built-in logic or programmable functional units, which may also be on the same integrated circuit with a heterogeneous instruction set architecture. In addition to the multiple general-purpose main processing cores and application processing units, the controller 200 may also include other devices or circuits, such as a graphics processing unit or a neural network processing unit, which may include an instruction set architecture that is heterogeneous or homogeneous with the main processing cores. For example, the controller 200 may be used to perform other tasks, such as in the case of a computing device including a resonant sound amplification device.

[0073] The memory 204 is an example of a computer storage medium. Computer storage media include RAM, ROM, EEPROM, flash memory or other storage technologies, CD-ROM, digital versatile disks (DVDs) or other optical storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, USB flash drives, flash memory cards or other flash memory devices, or other storage media that can be used to store the required information and can be accessed by the processor 202. Any such computer storage medium may be part of the controller 200 and is implemented as the memory 204. The memory 204 is a non-transitory, processor-readable memory device. Thus, a propagated signal itself does not qualify as a storage medium or the memory 204.

[0074] The controller 200 can be configured to receive inputs or information from the electrophysiology system 50, such as inputs from the electroporation catheter system 60 and the EAM system 70 including the electroporation console 130 and the mapping and navigation controller 90, for storage in the memory 204 and use by the instructions 206. For example, the controller 200 can receive, such as from the EAM system 70, an input representative of a cardiac anatomical map or cardiac map data 208, which can include data representing the cardiac geometric anatomy and the cardiac electroanatomical map. Additionally, the controller 200 can receive ablation parameter data 210 and ablation location data 212, such as from the electroporation catheter system 60. In some examples, the anatomical cardiac map data 208, ablation parameter data 210, or ablation location data 212 can be generated by the controller 200 for storage in the memory 204 or access by the instructions 206. In one example, the ablation parameter data 210 can include: electrode configuration data 214 regarding the electrode configuration on the electroporation catheter 105 (including which electrodes on the electroporation catheter 105 will be activated and in what polarity (anode or cathode)), electrode mode data 216 regarding the mode of the electroporation catheter 105 (including bipolar mode or monopolar mode and the electric field vector generated with the electroporation catheter 105), and ablation titration data 218 regarding information about pulsed field ablation (including pulse energy intensity, pulse time, whether the pulse is biphasic or monophasic) and other information about ablation determinable from the electroporation catheter system 60. For example, the ablation parameter data 210 can be provided from the electroporation console 130 based on measurements, settings, or configurations of the electroporation catheter system 60.

[0075] The controller 200 is configured to generate a visualization 220, which can include a predicted or expected treatment effect (such as an expected lesion effect) determined based on the pre-ablation settings of the electroporation catheter system 60 with reference to the cardiac anatomical map, and provide ablation markers on the reference cardiac anatomical map showing the lesion locations, which ablation markers include the lesion size and other information about the ablation performed with the electroporation catheter system 60. In one example, the controller 200 is configured to generate a visualization of the overlapping regions of the ablation markers, where two or more ablation markers include the same region of the target tissue.

[0076] Figure 3Process 300 is shown for configuring a controller, such as controller 200, while performing electroporation on a target tissue, such as a chamber of a patient's heart. In one example, the controller is implemented as part of an EAM system 70 and is operatively coupled to an electroporation catheter system 60. Process 300 includes configuring the controller at 302 to generate a graphical representation of an electrode assembly. For example, the graphical representation of the electrode assembly at 302 can include a graphical representation of the electroporation catheter 105 relative to an anatomical view of the patient's heart. The graphical representation can include a schematic or other indicator that presents a model of the position of the electrode assembly of the electroporation catheter 105 relative to the heart, such as can be determined based on ablation location data 212 (such as provided from the electroporation catheter system 60) applied to anatomical heart map data 208 (such as provided from the EAM system 70). Selected electrodes of the electrode assembly are configured to generate an actual or predicted electric field within the heart as determined according to parameter data 210 (such as provided from the electroporation catheter system 60). At 304, a graphical representation of a model of an electric field generated in response to delivering a pulsed electrical signal to selected electrodes among a plurality of electrodes is generated. The electric field can vary as the electrode assembly is moved relative to the heart, and the graphical representation of the model of the electric field can also vary (such as, in real time). The graphical representation of the model of the electric field can include: an indication of a region of the electric field (the electric field having an intensity that provides irreversible electroporation in the tissue of interest), an indicator in the representation of the model of the electric field indicating a pattern of the electrode array (such as whether the electrode array is configured to deliver monopolar energy or bipolar energy), and other indicators of aspects of a titration scheme (such as determined according to ablation parameter data 210). In one example, the indicators regarding field strength, pattern, and titration scheme can include associated or corresponding colors and hues that provide a visual indication of the graphical representation.

[0077] Before delivering a pulsed electrical signal to a selected electrode of a plurality of electrodes at each of a plurality of locations, at 306, a predicted lesion zone corresponding to an intersection of a model of an electric field and a surface of an anatomical map is generated on a graphical display of a cardiac anatomical map. The predicted lesion zone can be determined relative to the cardiac anatomical map from cardiac map data 208 based on ablation parameter data 210 and ablation location data 212. The lesion zone can be presented as, for example, a shaded area or volume, or a distinguishable color or hue, relative to a surface or region of a representation of the heart. The lesion zone can represent an area of irreversible electroporation damage on the heart. After or simultaneously with delivering the pulsed electrical signal to the selected electrode of the plurality of electrodes at each of the plurality of locations, at 308, the anatomical map is automatically annotated on the graphical display by applying ablation marks based on the predicted lesion zone corresponding to each of the plurality of locations. For example, the anatomical map of the heart can be updated to indicate the area of irreversible electroporation damage. In one example, each predicted lesion zone and corresponding ablation mark have substantially the same visual appearance. In some examples, the anatomical map of the heart can be further updated to indicate the damage of reversible electroporation.

[0078] In one example, at 310, the controller is further configured to generate a first overlap zone on the anatomical map on the graphical display defined by an overlap zone of a corresponding ablation mark with a previously applied ablation mark at each of the plurality of locations. For example, before delivering the pulsed electrical signal to the selected electrode, an overlap zone corresponding to an intersection of the predicted lesion zone and the previously applied ablation mark is generated on the anatomical map of the heart on the graphical display. After or simultaneously with delivering the pulsed electrical signal to the selected electrode, the anatomical map is automatically annotated on the graphical display by defining the overlap zone. Additionally, the controller can generate a second overlap zone on the anatomical map on the graphical display defined by an overlap zone of a corresponding ablation mark with two or more previously applied ablation marks at each of the plurality of locations. For example, the first overlap zone and the second overlap zone each have a different visual appearance on the anatomical map, such as a different hue or a different color. For example, the first overlap zone has an appearance of a first hue, and the second overlap zone has an appearance of a second hue. The first hue can be lighter than the second hue. The controller can be configured to automatically annotate the anatomical map on the graphical display to identify each ablation mark that overlaps with at least two different ablation marks. In another example, the controller is further configured to automatically annotate the anatomical map on the graphical display to show an outer boundary of a series of ablation marks, where each ablation mark overlaps with at least two spatially adjacent ablation marks. For example, the outer boundary of the series of overlapping ablation marks can be a line of a color or a different hue that is different from the color of the overlap zone. The controller can be configured to automatically identify a gap between any two spatially adjacent ablation marks that overlap with at least two different ablation marks, where the gap represents an ablation region that does not include the overlap zone.

[0079] In one example, process 300 may be implemented as a set of processor-executable instructions (such as instructions 206) stored in a non-transitory memory (such as memory 204) to be executed by processor 202 to configure controller 200. The instructions implementing process 300 may be configured to receive information, such as retrieving cardiac map data 208, ablation parameter data 210, and ablation location data 212 from memory 204. In addition, the instructions implementing process 300 may be configured to annotate, adjust, or write to cardiac map data 208, and generate visualizations, such as visualization 220, on a display of a graphical representation.

[0080] Figure 4A A first example graphical representation 400 is shown, such as a visualization on a display (such as display 92), which may be utilized by controller 200 Figure 1 The electrophysiology system 50 is configured and implemented using the process 300. In the electrophysiology system, the electroporation catheter 105 has been positioned so that the corresponding electrode assembly is close to the target tissue, such as the surface of the patient's heart chamber. Figure 4A As shown, the first example graphical representation 400 includes a first graphical representation of a catheter 402, a first graphical display of an electrode assembly 404, and a graphical representation of a target tissue 406 (such as a surface of the target tissue) from an anatomical diagram. In addition, the first example graphical representation 400 includes a graphical representation of a first model electric field 408 generated by an electrode assembly close to the target tissue. In one example, a user of the controller 200 can select a resolution of the first model electric field 408 for the graphical representation. For example, the extent or magnitude of the first model electric field 408 can be based on a threshold value of an electric field strength (such as an electric field region that may produce irreversible electroporation in the target tissue). In one example, the first model electric field 408 can indicate an electric field range with an electric field strength of 400V / cm. In addition, the model electric field can be indicated with a selected visual transparency so that a clinician can observe nearby target tissue. In other examples, the visual appearance of the model electric field can indicate an alarm, such as whether the field strength is insufficient to provide irreversible electroporation, or whether the field strength is extreme or exceeds an upper threshold.

[0081] exist Figure 4AIn an example, the catheter is configured in a first mode, such as a monopolar mode, although aspects of the present disclosure are mode independent. During monopolar operation, an electrode, a set of electrodes, or the entire electrode assembly is configured as one of an anode or a cathode, and none of the electrodes in the electrode assembly is configured as the other of the cathode or the anode. An electric field is generated between the activated electrode and the pad dispersive electrode via an electrical signal provided to the catheter, such as a pulsed electrical signal. Implementing the electric field in monopolar mode based on the pulsed signal with respect to the target tissue may be of interest to a clinician. A first modeled electric field 408 based on the pulsed signal and a selected electrode configuration in monopolar mode is generated on a first example graphical representation 400. The visual appearance of the first modeled electric field 408 may also be based on the mode, such as a first color representing an electrode array configured in monopolar mode and a second color representing a circuit array configured in bipolar mode. In an example where the controller 200 generates the first example graphical representation 400, the modeled electric field may be determined based on ablation parameter data 210.

[0082] In an example, when a clinician manipulates the catheter 105 with respect to the heart 30 and configures the settings on the electroporation console 130, the graphical representation of the first modeled electric field 408 with respect to the target tissue 406 and the position of the first graphical representation of the catheter 402 may change. For example, when a clinician manipulates or moves the catheter 105 with respect to the heart 30, the graphical representation, such as the first example graphical representation 400, may track the corresponding movement of the first graphical representation of the catheter 402, the first graphical display of the electrode assembly 404, and the graphical representation of the first modeled electric field 408 with respect to the target tissue 406. Additionally, when a clinician changes the settings of the electroporation console 130, the corresponding adjustments may be reflected in the geometry, such as size and shape, of the modeled electric field 408 with respect to the first graphical representation of the catheter 402 and the graphical representation of the target tissue 406, which may provide titration feedback regarding the treatment.

[0083] The first example graphical representation 400 includes a lesion area 410 located at the intersection of the graphical representation of the surface of the target tissue 406 and the first modeled electric field 408. In this example, the first lesion area 410 presents a graphical representation of the area (or volume) of the target tissue that has undergone irreversible electroporation relative to the size and position of the target tissue. In an example, the first lesion area 410 may include a visual appearance that differentiates the first lesion area 410 from the unablated regions of the first modeled electric field 408 and the target tissue 412.

[0084] During manipulation of the electroporation catheter 105 and before the pulse signal is delivered to the electrode assembly to achieve electroporation, the first lesion area 410 is a first predicted lesion 414 that provides visualization of the size and location of the lesion (such as the lesion formed via irreversible electroporation) created with the current settings of the electroporation catheter system 60 and the current position of the catheter relative to the heart 30 relative to the target tissue. Before the pulse electrical signal is delivered to the electrode assembly to achieve electroporation, as the catheter 105 moves correspondingly relative to the heart 30 or the settings of the electroporation console 130 are adjusted, the first predicted lesion area 414 can move or change geometry on the graphical representation of the target tissue 406 and relative to other features of the first example graphical representation 400. For example, the first model electric field 408 and the corresponding first predicted lesion area 414 can move and change geometry based on the shape change of the expandable or flexible electrode group or the electrode group selected to be activated (such as a single spline configuration, a double spline configuration, or a tip-only configuration of the activated electrode).

[0085] Figure 4B A second example graphical representation 420 is shown, such as a visualization on a display (such as display 92), which may be configured by controller 200 using electrophysiology system 50 and implemented using process 300. For example, second example graphical representation 420 may be in the process of delivering a pulsed electrical signal to an electrode to affect a Figure 4A The second example graphical representation 420 is a diagram of a time after ablation of target tissue in an area corresponding to the first predicted lesion area 414 on the graphical representation of target tissue 406 in the first example graphical representation 400. The electrode assembly of the electroporation catheter 105 is not proximate to the heart area corresponding to the graphical representation of the target tissue 406, so that the second example graphical representation 420 does not include a graphical representation of the catheter. The second example graphical representation 420 includes an ablation marker 422 in place of the first predicted lesion area 414.

[0086] After or simultaneously with delivering a pulsed electrical signal to an electrode at a location of an electrode assembly proximate to a target tissue, an ablation marker 422 is applied to annotate a graphical representation of the target tissue 406 by applying the ablation marker 422 based on a first predicted lesion zone 414. The ablation marker 422 may represent an area on the surface of the patient's heart 30 or a volume of the patient's heart tissue that has been irreversibly electroporated. The ablation marker 422 is characterized by having an ablation boundary 424 that delineates an ablation zone 426 corresponding to an area on the surface of the patient's heart that has been ablated by irreversible electroporation of an unablated region adjacent to the target tissue 412. The graphical representation of the target tissue 406 is annotated such that the ablation marker 422 becomes a fixed element of the anatomical map, and the ablation marker 422 is distinct and applied to the geometric anatomical map, as well as to the irreversible electroporation, and its effect is also present on the electroanatomical map. In one example, the first predicted lesion zone 414 and the corresponding ablation marker 422 may have substantially the same geometric shape or the same visual appearance. In another example, the first predicted lesion zone 414 may include a visual appearance distinguishable from the visual appearance of the corresponding ablation marker 422 or other ablation markers.

[0087] Figure 4C A third example graphical representation 440 is shown, such as a visualization on a display (such as display 92), which may be configured by the controller 200 using the electrophysiology system 50 and implemented with the process 300. For example, the third example graphical representation 440 may be at some time after the Figure 4B second example graphical representation 420. The third example graphical representation 440 includes a graphical region of the target tissue 406, including the unablated tissue 412 and the ablation marker 422 representing the region of ablated tissue. The electroporation catheter 105 has been repositioned such that the corresponding electrode assembly is proximate to the target tissue but at a location offset from the Figure 4A location presented in the first example graphical representation 400 shown. Accordingly, the third example graphical representation 440 includes a second graphical representation of the catheter 442, a second illustration of the electrode assembly 444, and a second modeled electric field 448. For ease of illustration, the ablation parameter data 210 used to model the third graphical representation 440 is substantially similar to the first graphical representation 400, including the monopolar mode in which the catheter is configured.

[0088] In one example, when a clinician manipulates the catheter 105 relative to the heart 30 and configures the settings on the electroporation console 130, the graphical representation of the second modeled electric field 448 relative to the target tissue 406 and the position of the second graphical representation of the catheter 442 can change. Additionally, when the clinician changes the settings of the electroporation console 130, the corresponding adjustments can be reflected in the geometry (such as size and shape) of the modeled electric field 448 relative to the second graphical representation of the catheter 442 and the graphical representation of the target tissue 406.

[0089] A third example graphical representation 440 includes a lesion area 450 located at the intersection of the graphical representation of the surface of the target tissue 406 and the second modeled electric field 448. In this example, the second lesion area 450 presents a graphical representation of the area (or volume) of the target tissue that has undergone irreversible electroporation relative to the size and position of the target tissue. In one example, the second lesion area 450 can include a visual appearance that differentiates the second lesion area 450 from the second modeled electric field 448, the ablation marker 422, and the non-ablated region of the target tissue 412. The third example graphical representation 440 also includes an overlap area 460 where the lesion area 450 overlaps the ablation marker 422. The overlap area 460 represents the tissue area where the electric field (as indicated by the second modeled electric field 448) having an intensity for irreversible electroporation of the tissue intersects the region of the target tissue that has been previously ablated (as shown by the ablation marker 422).

[0090] During the manipulation of the electroporation catheter 105 and before delivering a pulse signal to the electrode assembly to effect electroporation at a second location, the second lesion area 450 is a second predicted lesion 454 that provides a visualization of the size and position of the lesion created with the current settings of the electroporation catheter system 60 and the new position of the catheter relative to the heart 30 relative to the target tissue. Before delivering the pulsed electrical signal to the electrode assembly to effect electroporation, as the catheter 105 is correspondingly moved relative to the heart 30 or the settings of the electroporation console 130 are adjusted, the second predicted lesion area 454 can move or the geometry can change on the graphical representation of the target tissue 406 and relative to the other features of the third example graphical representation 440. For example, the second modeled electric field 448 and the corresponding second predicted lesion area 414 can move and change geometry based on the selected electrode groups to be activated while the clinician manipulates the catheter 105 to generate the selected overlap area 460.

[0091] Figure 4D A fourth example graphical representation 480 is shown, such as a visualization on a display (such as display 92), which can be configured by the controller 200 using the electrophysiology system 50 and implemented with process 300. For example, the fourth example graphical representation 480 can be in a state of delivering a pulsed electrical signal to the electrodes to affect theFigure 4C The time after ablation of the target tissue in the region corresponding to the second predicted lesion zone 454 on the graphical representation of the target tissue 406 of 400 in Figure 4C . The electrode assembly of the electroporation catheter 105 is again not close to the cardiac region corresponding to the graphical representation of the target tissue 406, such that the fourth example graphical representation 480 does not include a graphical representation of the catheter. The fourth example graphical representation 480 includes a second ablation marker 482 in place of the second predicted lesion zone 454, and includes the ablation marker 422 and the unablated tissue 412. The fourth example graphical representation 480 also includes an overlap zone 460, wherein the region of the ablation marker 482 intersects with the ablation marker 422.

[0092] After or simultaneously with delivering the pulsed electrical signal to the electrodes at the second position of the electrode assembly proximate to the target tissue, the graphical representation of the target tissue 406 is annotated by applying the second ablation marker 482 based on the second predicted lesion zone 454. The first ablation marker 422 and the second ablation marker 482 may represent one or more regions on the surface of the patient's heart 30, or the volume of the patient's cardiac tissue that has been irreversibly electroporated. The second ablation marker 482 is characterized by having an ablation boundary 484 that outlines an ablation zone 486 corresponding to the region on the surface of the patient's heart that has been ablated by irreversible electroporation in the unablated region adjacent to the target tissue 412. The overlap zone 460 is characterized by having an overlap boundary 488 that outlines the overlap zone 460 and an overlap region 490 within the overlap boundary 488, the overlap region 490 corresponding to the region on the surface of the patient's heart that has been ablated more than once or has undergone multiple irreversible electroporations, and being adjacent to the unablated region of the target tissue 412 or the tissue 492 that has been ablated only once, i.e., the tissue that has not undergone multiple irreversible electroporations.

[0093] The graphical representation of the target tissue 406 is annotated such that, in addition to the ablation marker 422, the ablation marker 482 becomes a fixed element of the anatomical map, and the ablation markers 422, 482 are distinct and applied to the geometric anatomical map, as well as to irreversible electroporation, and their effects are also present on the electroanatomical map. In one example, the second predicted lesion zone 454 and the corresponding second ablation marker 482 may have substantially the same geometric shape or the same visual appearance, which may include the same visual appearance as the first ablation marker 422. In another example, the first predicted lesion zone 454 may include a visual appearance distinguishable from the visual appearance of the corresponding ablation marker 482 or other ablation markers, such as the ablation marker 422. In one example, each ablation marker, such as the ablation markers 422, 482, may be indicated on the graphical representation as a selected hue of a selected color, and the overlapping region of two overlapping ablation markers, such as the overlapping region 460, may be indicated on the illustration as another hue of the selected color, such as a darker hue. In the case where more than two ablation markers form an overlapping region representing target tissue that has undergone more than two overlapping ablations, the overlapping region may be represented by another hue of the selected color, such as a darker shade. The plurality of overlapping regions may be defined by ablation markers and the overlapping regions of two or more previously applied overlapping ablation markers. In this example, one or more of the overlapping regions each have a different visual appearance on the anatomical map.

[0094] Figure 5A Another example graphical representation 500 is shown, such as a visualization on a display (such as display 92), which may be configured by the controller 200 using the electrophysiology system 50 and implemented with the process 300. In the electrophysiology system, the electroporation catheter 105 has been positioned such that the corresponding electrode assembly is proximate to the target tissue, such as the surface of a patient's heart chamber. In this example, the catheter is configured in a second mode, such as a bipolar mode. During bipolar operation of the catheter 105, the first set of one or more electrodes of the electrode assembly is configured as an anode, and the second set of one or more electrodes of the electrode assembly is configured as a cathode to generate an electric field. As Figure 5A shown, the first example graphical representation 500 includes a graphical representation of the catheter 502, a graphical representation of the electrode assembly 504 configured in a bipolar mode, and a graphical representation of the target tissue 506 (such as the surface of the target tissue) from the anatomical map. Additionally, the example graphical representation 500 includes a graphical representation of the modeled electric field 508 generated by the electrode assembly proximate to the target tissue. In this example, the electrodes located on the electrode deployment mechanism of the electrode assembly may be configured as anodes or cathodes (as shown by the first set of electrodes 530), and the catheter includes electrodes located on the catheter shaft (as shown by the second set of electrodes 532), which are configured as the other of the cathode and anode to generate an electric field.

[0095] The exemplary graphical representation 500 includes a damage region 510 located at the intersection of the graphical representation on the surface of the target tissue 506 and the modeled electric field 508. In this example, the damage region 510 presents a graphical representation of the area (or volume) of the target tissue that can or has undergone irreversible electroporation relative to the size and position of the target tissue. During manipulation of the electroporation catheter 105 in bipolar mode and prior to delivering a pulse signal to the electrode assembly to effect electroporation, the damage region 510 is a predicted damage 514 that provides visualization of the size and position of the damage (such as damage formed via irreversible electroporation) created with the current settings of the electroporation catheter system 60 in bipolar mode and the current position of the catheter relative to the heart 30 relative to the target tissue.

[0096] In some embodiments, the electroporation catheter system 60 can be selectively switched between monopolar mode and bipolar mode. The differences between implementing the electric field in monopolar mode and in bipolar mode based on the pulse signal relative to the target tissue may be of interest to a clinician. For example, the geometry of the predicted damage created by the catheter in monopolar mode is different from the geometry of the predicted damage created by the catheter in bipolar mode. In one example, the modeled electric field in a first mode (such as the mode electric field 508 in bipolar mode) and the predicted damage created with the electric field in the first mode (such as the predicted damage 514 in bipolar mode) can be represented by indicators different from those of the modeled electric field and predicted damage in a second mode (such as monopolar mode), respectively. In one example, the modeled electric field in the first mode and the corresponding predicted damage can be indicated by a first color, and the mode electric field in the second mode and the corresponding predicted damage can be indicated by a second color. Additionally, portions of the modeled electric field created by the catheter in bipolar mode (such as portions near the catheter axis) may not be suitable for irreversible electroporation. Selected portions of the modeled electric field can be indicated by one color (such as a color indicating a more desirable modeled electric field), and other selected portions can be indicated by another color (such as a color indicating a less desirable modeled electric field).

[0097] Figure 5B Another exemplary graphical representation 520 is shown, such as a visualization on a display (such as display 92), which can be configured by the controller 200 using the electrophysiology system 50 and implemented with the process 300. For example, another exemplary graphical representation 520 can be in delivering a pulsed electrical signal to the electrodes to affect the Figure 5AThe time after ablation of the target tissue in a region corresponding to the predicted lesion zone 514 on the graphical representation of the target tissue 506 of the first example graphical representation 500. Another example graphical representation 520 includes ablation markers 522 in place of the first predicted lesion zone 514. In this example, the geometry of the ablation markers 522 of lesions created with a catheter in bipolar mode is different from the geometry of the ablation markers of lesions created with a cannula in monopolar mode.

[0098] After or simultaneously with delivering a pulsed electrical signal to an electrode at a location of an electrode assembly proximate to the target tissue, the graphical representation of the target tissue 506 is annotated by applying ablation markers 522 based on the first predicted lesion zone 514. The ablation markers 522 can represent a region on the surface of the patient's heart 30 that has been irreversibly electroporated or a volume within the patient's heart tissue. The ablation markers 522 are characterized by having an ablation boundary 524 that delineates an ablation zone 526 corresponding to the region of the surface of the patient's heart that has been ablated by irreversible electroporation through an unablated region adjacent to the target tissue 512.

[0099] In the above examples, the predicted lesion zone or ablation markers can be presented on the graphical representation as an indicator of the geometry of irreversible electroporation on the surface of a structure in an anatomical diagram, or as a marker indicating the geometry of irreversible electroporation on the surface as well as indicating the depth and volume of penetration into the tissue. In the latter case, the predicted lesion zone or ablation markers can be a three-dimensional representation on the presented graphical representation. In the case of an overlapping region, the depth can be adjusted based on an understanding of the depth effect of repeated ablation.

[0100] The above examples describe the configuration of a controller to place ablation markers to indicate regions of tissue that have undergone irreversible ablation. In some examples, the controller can be configured to place markers to indicate regions that have been affected by an electric field that is insufficient to create irreversible electroporation. For example, selected indicators can be applied to annotate regions of reversible electroporation or regions that have undergone a treatment that is insufficient to create reversible electroporation. Additionally, the controller can be configured to annotate a region without simultaneously or subsequently delivering a pulsed electrical signal to an electrode. In one example, regions that can be annotated without associated ablation can include regions around a structure or structures (such as the sinoatrial node or atrioventricular node) to provide an indication to avoid performing ablation in such regions of the heart. In some examples, the annotation can be temporary, such as for regions of reversible electroporation or regions without associated ablation.

[0101] Figure 6AAn example graphical representation 600 of ablated target tissue visualized on a display (such as display 92) is shown, which can be configured by controller 200 with electrophysiology system 50 and implemented with process 300. The graphical representation 600 of the ablated target tissue includes a lesion line 602 representing irreversibly electroporated tissue 604 proximate to unablated tissue 606. The lesion line 602 is defined by a plurality of ablation markers 608a through 608i, generated, for example, in the manner described in this disclosure, to provide a visual indication of the overall status of an ablation procedure, such as to assess the likelihood of achieving complete conduction block. In this example, the first ablation marker 608a represents the first end 610 of the lesion line 602, and the ninth ablation marker 608i represents the second end 612 of the lesion line 602. However, it will be readily understood that the specific number and location of the corresponding ablation markers may vary in a given procedure. Additionally, in the example shown, the shapes of the corresponding ablation markers 608a through 608i are depicted as being generally oval. However, for the purposes of this disclosure, this oval shape is merely for illustrative convenience. That is, the ablation markers 608a through 608i may be presented in any number of shapes and appearances, as discussed elsewhere herein.

[0102] As described above, a lesion line (such as lesion line 602) represents the length of irreversibly electroporated tissue that is continuous from a first end to a second end and includes a plurality of ablation markers. The ablation markers 608a through 608i that are connected in series may be ablation markers that are in contact with each other, or may be ablation markers that include an overlapping region. The lesion line 602 is characterized by having at least two spatially adjacent ablation markers that form a continuous lesion line boundary 614 adjacent to unablated tissue (represented by element 606 in Figure 6A ), and as an outer boundary of the lesion line 602, outlines a lesion region 616 of ablated tissue 604 within the lesion line boundary 614.

[0103] In one example, a controller (such as Figure 2 controller 200) may be configured to automatically identify and annotate a lesion line (such as lesion line 602), and in Figure 3At 310, it is implemented using process 300. The controller can determine whether ablation marks are spatially adjacent to another ablation mark to form a lesion line and automatically annotate the lesion line on the graphical representation. For example, the controller can be configured to automatically highlight the continuous lesion line boundary 614 with a visual indicator or automatically highlight spatially adjacent ablation marks on the graphical representation with a distinguishable hue or color. In one example, when the graphical representation presents two or more spatially adjacent ablation marks, the lesion line is automatically identified in real time. In another example, the lesion line can be automatically identified at a selected time via a control. The automatic identification of the lesion line provides feedback to the clinician regarding whether multiple nearby ablation marks are separated by non-ablated tissue. In one example, the controller can be configured to automatically highlight the space of non-ablated tissue disposed between multiple ablation marks, such as providing a visual alert to the user with an indicator.

[0104] The lesion line 602 of this example also includes a plurality of overlap regions 614, which represent tissue regions having overlapping ablation regions, such as tissue regions that have undergone more than one irreversible electroporation step, which can provide a visual indicator to the clinician of the likelihood of a complete, transmural lesion having been created. For example, as shown, a first ablation mark 608a and a second ablation mark 608b intersect in a region of the target tissue to form a first overlap region 614a. Additionally, as shown, a first ablation mark 608a, a second ablation mark 608b, and a third ablation mark 608c intersect to form a second overlap region 614b. The shown first overlap region 614a is a double-mark overlap region because the first overlap region 614a is formed by applying two intersecting irreversible electroporations to the same tissue region. The shown second overlap region 614b is a triple-mark overlap region because the second overlap region 614b is formed by applying three intersecting irreversible electroporations to the same tissue region. Overlap regions with more than three intersecting irreversible electroporations applied to a tissue region are also contemplated. As shown, nine ablation marks 608a through 608i of the lesion line 602 form fourteen overlap regions 614a through 614n. Each of the overlap regions 614a through 614n (such as overlap region 614n) is characterized by having an overlap boundary 616 that outlines the overlap region (such as 614n) and an overlap area 618 within the overlap boundary 616.

[0105] Figure 6BAn example graphical representation 650 of ablated target tissue in a visualization on a display (such as display 92) is shown, which can be configured by controller 200 using electrophysiology system 50 and implemented at 310 with process 300, highlighting overlapping regions, such as overlapping regions 614a through 614n. The overlapping ablation regions include a higher probability of persistent damage than non-overlapping ablation regions, in which the tissue of interest has only received a single dose of irreversible electroporation. Thus, a clinician may find it desirable to form and identify a continuous string of overlapping regions in the tissue. In one example, at Figure 3 310, a controller (such as Figure 2 controller 200) can be configured to automatically identify and annotate two or more overlapping regions in a continuous string on graphical representation 650, such as first continuous string 652 and second continuous string 654. The overlapping regions of first continuous string 652 include a plurality of contiguous spatially adjacent overlapping regions, such as overlapping regions 614a through 614i, where overlapping region 614a is spatially adjacent to overlapping region 614b, and so on to overlapping region 614i. The overlapping regions of second continuous string 654 include a plurality of contiguous spatially adjacent overlapping regions, such as overlapping regions 614j through 614n, where overlapping region 614j is spatially adjacent to overlapping region 614k, overlapping region 614k is spatially adjacent to overlapping region 614l, overlapping region 614l is spatially adjacent to overlapping region 614m, and overlapping region 614m is spatially adjacent to overlapping region 614n. First continuous string 652 can be characterized by string boundary 660 and continuous region 662 of spatially adjacent overlapping regions within string boundary 660. Second continuous string 654 can be characterized by string boundary 670 and continuous region 672 of spatially adjacent overlapping regions within string boundary 670.

[0106] The controller can determine whether an overlapping region is spatially adjacent to another overlapping region to form a continuous string and automatically annotate the continuous string on the graphical representation. For example, the controller can be configured to automatically highlight the continuous string with a visual indicator (such as highlighted string boundaries 662, 672), or automatically highlight the spatially adjacent overlapping regions on the graphical representation with a distinguishable hue or color. In one example, when the graphical representation presents two or more spatially adjacent overlapping regions, the continuous string is automatically identified in real time. In another example, the continuous string can be automatically identified at a selected time via a control.

[0107] The automatic identification of the continuous strings 652, 654 provides feedback to the clinician regarding whether the injury line includes a non-overlapping portion, such as the gap 680 between the continuous strings 652 and 654 on the graphical representation 650. In one example, if the controller determines that the gap 680 may be of interest to the clinician, the controller may be configured to automatically highlight the gap 680, such as via a visual alert. The controller may be configured to determine whether the gap is of interest based on, such as determining whether the continuous string and the gap are included in the injury line, whether the distance or centroid distance between overlapping regions proximate to the gap is within a threshold amount, or other determinations.

[0108] It is well known that for a method comprising one or more steps, the recited order is not a limitation of the claim unless the specification or the claim itself has an express or implicit contrary statement. It is also determinable that the methods shown are only some examples of the many examples disclosed, and certain steps may be added or omitted without departing from the scope of the present disclosure. These steps may include combining devices, systems or methods or their components, as well as devices, systems or methods or their components well known in the art, routine and conventional in the art.

[0109] The connecting lines shown in the various figures included herein are intended to represent exemplary functional relationships and / or physical couplings between various elements. It should be noted that there may be many alternative or additional functional relationships or physical connections in an actual system. However, benefits, advantages, solutions to problems, and any elements that may cause any benefit, advantage or solution to occur or become more apparent should not be construed as critical, essential or fundamental features or elements. Accordingly, the scope is only limited by the appended claims, where a reference to a singular element does not mean "one and only one" unless expressly stated, but rather "one or more". Further, in the case of a phrase such as "at least one of A, B or C" being used in the claims, the phrase is intended to be interpreted to mean that in an embodiment, A may exist alone, B may exist alone, C may exist alone, or any combination of elements A, B and C may exist in a single embodiment; for example, A and B, A and C, B and C, or A and B and C.

[0110] In the detailed description herein, references to "one embodiment", "an embodiment", "example embodiment", etc. indicate that the described embodiment may include a particular feature, structure, or characteristic, but every embodiment may not necessarily include the particular feature, structure, or characteristic. Moreover, such phrases do not necessarily refer to the same embodiment. Further, when a particular feature, structure, or characteristic is described in connection with an embodiment, it is considered within the knowledge of one of ordinary skill in the art, in light 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, one or more persons of ordinary skill in the relevant art will be clear how to implement the present disclosure in alternative embodiments.

[0111] Furthermore, any element, component, or method step in the present disclosure is not intended to be dedicated to the public, whether or not such element, component, or method step is explicitly recited in the claims. No element of any claim herein shall be construed under the provisions of 35 U.S.C. 112(f) unless the element is expressly recited using the phrase "means for". As used herein, the term "comprising", "including", or any other variation thereof is intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus.

[0112] 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 relate to particular features, the scope of the present 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 that fall within the scope of the claims, together with all their equivalents.

Claims

1. A system for performing electroporation ablation on target tissue in a chamber of a patient's 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 plurality of locations proximate the target tissue; A graphical display; and A controller configured to: Generate a graphical representation of the electrode assembly on the graphical display; Generate a graphical representation of a model of an electric field generated in response to delivering a pulsed electrical signal to a selected electrode among the plurality of electrodes; Generate a predicted lesion zone corresponding to an intersection of the model of the electric field and a surface of the anatomical map of the heart on the graphical display prior to delivering the pulsed electrical signal to the selected electrode among the plurality of electrodes at each of the plurality of locations; and Automatically annotate the anatomical map on the graphical display by applying ablation marks based on the predicted lesion zones corresponding to each of the plurality of locations after or simultaneously with delivering the pulsed electrical signal to the selected electrode among the plurality of electrodes at each of the plurality of locations.

2. The system according to claim 1, wherein, At each of the plurality of locations, the controller is further configured to generate a first overlap zone on the anatomical map on the graphical display defined by an overlap region of a corresponding ablation mark and a previously applied ablation mark.

3. The system according to claim 2, wherein At each of the plurality of locations, the controller is further configured to generate a second overlap zone on the anatomical map on the graphical display defined by an overlap region of the corresponding ablation mark and two or more previously applied ablation marks.

4. The system according to claim 3, wherein The ablation marks, the first overlap zone, and the second overlap zone each have a different visual appearance on the anatomical map.

5. The system according to any one of claims 2 to 4, wherein, The controller is further configured to automatically annotate the anatomical map on the graphical display to identify each ablation mark that overlaps with at least two different ablation marks.

6. The system according to claim 5, wherein, The controller is further configured to automatically annotate the anatomical map on the graphical display to show an outer boundary of a series of ablation marks, wherein each ablation mark overlaps with at least two spatially adjacent ablation marks.

7. The system according to any one of claims 1 to 6, wherein, The controller is further configured to automatically identify a gap between any two spatially adjacent ablation marks that overlap with at least two different ablation marks.

8. The system according to any one of claims 1 to 7, wherein, Each predicted lesion zone has a substantially same geometry as a corresponding ablation mark.

9. The system according to any one of claims 1 to 8, wherein, Each predicted lesion zone has a substantially same visual appearance as a corresponding ablation mark.

10. The system according to any one of claims 1 to 7, wherein Each predicted lesion zone has a different visual appearance from a corresponding ablation mark.

11. The system according to any one of claims 1 to 10, wherein, The visual appearance of the predicted lesion zone or the ablation mark varies with one or more ablation parameters.

12. The system according to any one of claims 2 to 11, wherein Each first overlap zone has a different visual appearance from each second overlap zone.

13. The system according to any one of claims 1 to 12, wherein, The catheter is configured to selectively deliver monopolar ablation energy and bipolar ablation energy.

14. The system according to any one of claims 1 to 13, wherein, The system is included in one of an electroporation catheter system or an electroanatomical mapping system.

15. The system according to any one of claims 1 to 14, wherein, The anatomical map is an electroanatomical map.

16. A system for performing electroporation ablation on target tissue in a chamber of a patient's heart, the system comprising: A catheter, the catheter including an electrode assembly having a plurality of electrodes, wherein the catheter is adapted to position the electrode assembly at a first position proximate to the target tissue; A graphical display; and A controller configured to: Before delivering ablation energy to the plurality of electrodes: Generate a graphical representation of a model of the electric field generated by the plurality of electrodes on the graphical display; and When the electrode assembly is at the first position proximate to the target tissue, generate a first predicted lesion marker corresponding to the intersection of the model of the electric field and the surface of the anatomical map of the heart on the graphical display; and After or simultaneously with delivering ablation energy to the plurality of electrodes, automatically annotate the anatomical map on the graphical display with a first ablation marker corresponding to the first predicted lesion marker.

17. The system according to claim 16, wherein The controller is further configured to, when the electrode assembly is at a second position proximate to the target tissue, and after automatically annotating the anatomical map with the first ablation marker, before delivering the ablation energy to the plurality of electrodes, generate a second predicted lesion marker corresponding to the intersection of the model of the electric field and the surface of the anatomical map of the heart on the graphical display.

18. The system according to claim 17, wherein The controller is further configured to, when the electrode assembly is at the second position proximate to the target tissue, after or simultaneously with delivering ablation energy to the plurality of electrodes, automatically annotate the anatomical map on the graphical display with a second ablation marker corresponding to a second predicted ablation marker.

19. The system according to claim 17, wherein The controller is further configured to, when the electrode assembly is at the second position proximate to the target tissue, and after automatically annotating the anatomical map with the first ablation marker, generate a third predicted lesion marker defined by an overlapping region of the first ablation marker and the second predicted lesion marker on the anatomical map of the heart on the graphical display.

20. The system according to claim 19, wherein The controller is further configured to, when the electrode assembly is at the second position proximate to the target tissue, after or simultaneously with delivering the ablation energy to the plurality of electrodes, automatically annotate the anatomical map on the graphical display with a third ablation marker corresponding to a third predicted ablation marker.

21. The system according to claim 20, wherein The third ablation marker has a visual appearance different from that of the first ablation marker and the second ablation marker.

22. The system according to claim 16, wherein, The first predicted lesion marker and the first ablation marker each have a different visual appearance.

23. The system according to claim 16, wherein, The catheter is configured for selective delivery of monopolar ablation energy and bipolar ablation energy, and wherein the controller is configured to generate the model of the electric field in a manner different from when the catheter is configured for delivery of bipolar ablation energy when the catheter is configured for delivery of monopolar ablation energy.

24. A system for performing electroporation ablation on target tissue in a chamber of a patient's heart, the system comprising: A catheter, the catheter including an electrode assembly having a plurality of electrodes, wherein the catheter is adapted to position the electrode assembly at a position proximate to an ablation region of the target tissue; A graphical display; and A controller configured to: Generate a graphical representation of the electrode assembly and a first ablation marker corresponding to the ablation region on the graphical display; Generate a graphical representation of a model of the electric field generated in response to delivering a pulsed electrical signal to a selected electrode among the plurality of electrodes on the graphical display; Before delivering the pulsed electrical signal to the selected electrode among the plurality of electrodes at the location, generate a predicted lesion area corresponding to the intersection of the model of the electric field and the surface of the anatomical map of the heart on the graphical display, and an overlap area corresponding to the intersection of the predicted lesion area and the first ablation marker; and After or simultaneously with delivering the pulsed electrical signal to the selected electrode among the plurality of electrodes at the location, automatically annotate the anatomical map on the graphical display by applying a second ablation marker based on the predicted lesion area corresponding to the location and by defining the overlap area.

25. The system according to claim 24, wherein, The controller is further configured to automatically identify on the anatomical map on the graphical display another overlap area that is spatially adjacent to the overlap area.

26. The system according to claim 24, wherein, The controller is further configured to automatically annotate on the graphical display a first consecutive string of spatially adjacent overlap areas including the overlap area.

27. The system according to claim 26, wherein The controller is further configured to automatically annotate on the graphical display a second consecutive string of spatially adjacent overlap areas that are spaced apart from the first consecutive string of spatially adjacent overlap areas on the target tissue.

28. The system according to claim 27, wherein The controller is further configured to automatically identify on the graphical display a gap on the target tissue that is provided between the spaced-apart first consecutive string of spatially adjacent overlap areas and the second consecutive string of spatially adjacent overlap areas.

29. The system according to claim 28, wherein The controller is further configured to automatically highlight the gap on the graphical display based on the distance between the spaced-apart first consecutive string of spatially adjacent overlap areas and the second consecutive string of spatially adjacent overlap areas.

30. A method for use with electropermeabilization ablation of target tissue in a chamber of a patient's heart using a catheter, the catheter including an electrode assembly having a plurality of electrodes, wherein, The catheter is adapted to position the electrode assembly at a plurality of positions close to the target tissue, and the method includes: Generate a graphical representation of the electrode assembly on the graphical display; Generate a graphical representation of a model of the electric field generated in response to delivering a pulsed electrical signal to a selected electrode among the plurality of electrodes on the graphical display; Before delivering the pulsed electrical signal to the selected electrode among the plurality of electrodes at each of the plurality of positions, generate a predicted lesion area corresponding to the intersection of the model of the electric field and the surface of the anatomical map of the heart on the graphical display; and After or simultaneously with delivering the pulsed electrical signal to the selected electrode among the plurality of electrodes at each of the plurality of positions, automatically annotate the anatomical map on the graphical display by applying an ablation marker based on the predicted lesion area corresponding to each of the plurality of positions.

31. The method according to claim 30, and at each of the plurality of positions, a first overlap area defined by an overlap area of a corresponding ablation marker and a previously applied ablation marker is further generated on the anatomical map on the graphical display.

32. The method according to claim 31, and at each of the plurality of positions, a second overlapping region defined by an overlapping region of the corresponding ablation mark with two or more previously applied ablation marks is further generated on the anatomical diagram on the graphical display.

33. The method according to claim 31, and further automatically annotating the anatomical diagram on the graphical display to identify each ablation mark that overlaps with at least two different ablation marks.

34. The method according to claim 30, and further automatically identifying, on the anatomical diagram on the graphical display, a lesion line of a continuous series of spatially adjacent ablation marks including the ablation mark and the previously applied ablation marks.

35. The method according to claim 30, wherein, The catheter is configured for selective delivery of monopolar ablation energy and bipolar ablation energy, and when the catheter is configured for delivery of monopolar ablation energy, indicators are generated in a model of the electric field on the graphical display in a manner different from when the ablation catheter is configured for delivery of bipolar ablation energy.

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