Annotation for electroporation ablation

Abstract

A system for performing electroporation ablation of 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, the catheter 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 a graphical representation of a model of an electric field generated in response to delivery of a pulsed electrical signal to selected electrodes of the plurality of electrodes.

Description

[Technical Field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates generally to medical systems and methods for ablating tissue in a patient, and more particularly to medical systems and methods for ablation of tissue by electroporation. [Background technology]

[0002] Ablation procedures are used to treat many different conditions in patients. Ablation can be used to treat cardiac arrhythmias, benign tumors, cancerous tumors, and to control bleeding during surgery. Ablation is typically performed using 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 surrounding tissue. The radiofrequency waves generate heat, which destroys surrounding tissue and cauterizes blood vessels. In cryoablation, a hollow needle or cryoprobe is inserted into the patient, and a low-temperature, heat-conducting fluid is circulated through the probe, freezing and destroying surrounding tissue. RF ablation and cryoablation techniques can indiscriminately destroy tissue through cellular necrosis, which can damage or destroy otherwise healthy tissue, such as tissue in the esophagus, phrenic 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. Electroporation can be reversible or irreversible, depending on the strength and duration of the electric field. If electroporation is reversible, the temporarily increased permeability of the cell membrane can be used to introduce chemicals, drugs, or deoxyribonucleic acid (DNA) into the cells prior to cell healing and recovery. Tissue recovery can occur over minutes, hours, or days after ablation is complete. If electroporation is irreversible, the affected cells are killed, for example, by programmed cell death, possibly via apoptosis, or by traumatic cell death, for example, via necrosis.

[0004] Irreversible electroporation can be used as a non-thermal ablation technique. It uses a train of short, high-voltage pulses to generate an electric field strong enough to kill cells. For cardiac tissue ablation, irreversible electroporation can be a relatively safe and effective alternative to the indiscriminate destruction of thermal ablation techniques such as RF ablation and cryoablation. Irreversible electroporation can be used to kill target tissue, such as myocardial tissue, by using a selected electric field strength and duration that is effective in killing the target tissue but ineffective in permanently damaging other cells or tissues, such as non-target myocardial tissue, red blood cells, vascular smooth muscle tissue, endothelial tissue, and nerve cells. Planning an irreversible electroporation ablation procedure can be difficult due to a lack of clear visualization or data indicating which tissues are irreversibly electroporated compared to reversibly electroporated tissue. Summary of the Invention

[0005] In Example 1, a system for performing electroporation ablation of target tissue in a chamber of a patient's heart includes a catheter including an electrode assembly having a plurality of electrodes, the catheter 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 a graphical representation of a model of an electric field generated in response to delivery of a pulsed electrical signal to selected electrodes of the plurality of electrodes on the graphical display. Prior to delivery of the pulsed electrical signal to selected electrodes of the plurality of electrodes at each of the plurality of locations, the controller is configured to generate a predicted lesion zone on an anatomical map of the heart on the graphical display corresponding to an intersection of the model of the electric field and a surface of the anatomical map. After or simultaneously with delivery of the pulsed electrical signal to selected electrodes of the plurality of electrodes at each of the plurality of locations, the controller is configured to automatically annotate the anatomical map on the graphical display by applying an ablation marker based on the predicted lesion zone corresponding to each of the plurality of locations.

[0006] In Example 2, in the system of Example 1, 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, the first overlap zone being defined by an overlapping area of ​​the corresponding ablation marker and a previously applied ablation marker.

[0007] In Example 3, in the system of Example 2, 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, the second overlap zone being defined by an overlapping area of ​​the corresponding ablation marker and two or more previously applied ablation markers.

[0008] In Example 4, in the system of Example 3, 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, in the system of any of Examples 2-4, 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, in the system of Example 5, the controller is further configured to automatically annotate the anatomical map on the graphical display to display outer boundaries of a series of ablation markers, each of which overlaps at least two spatially adjacent ablation markers.

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

[0012] In Example 8, in the system of any of Examples 1 to 7, each predicted degeneration zone and corresponding ablation marker has substantially the same geometric shape. In Example 9, in the system of any of Examples 1-8, each predicted degeneration zone and corresponding ablation marker have substantially the same visual appearance.

[0013] In Example 10, in the system of any of Examples 1-7, each predicted degeneration zone and corresponding ablation marker has a different visual appearance. In Example 11, in the system of any of Examples 1-10, the visual appearance of the predicted degeneration zone or ablation marker varies as a function of one or more ablation parameters.

[0014] In Example 12, in the system of any of Examples 2-11, each first overlap zone has a different visual appearance than each second overlap zone. In Example 13, the system of any of Examples 1-12, wherein the catheter is configured for selective delivery of monopolar and bipolar ablation energy.

[0015] In Example 14, the system of any of Examples 1-13 is included in one of an electroporation catheter system or an electroanatomical mapping system.

[0016] In Example 15, in the system of any of Examples 1-14, the anatomical map is an electroanatomical map. In Example 16, a system for performing electroporation ablation of target tissue in a chamber of a patient's heart includes a catheter including an electrode assembly having a plurality of electrodes, the catheter adapted to position the electrode assembly at a first location proximate to the target tissue, a graphical display, and a controller. Prior to delivering ablation energy to the plurality of electrodes, the controller is configured to generate on the graphical display a graphical representation of a model of an electric field generated by the plurality of electrodes. Prior to delivering ablation energy to the plurality of electrodes, the controller is also configured to generate a first predicted degeneration marker on an anatomical map of the heart on the graphical display, the first predicted degeneration marker corresponding to an intersection of the model of the electric field and a surface of the anatomical map when the electrode assembly is in the first location proximate to the target tissue. Following or concurrently with delivery of 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 degeneration marker.

[0017] In Example 17, in the system of Example 16, when the electrode assembly is in a second position proximate the target tissue and after automatically annotating the anatomical map with the first ablation marker, the controller is further configured to generate a second predicted degeneration marker on the anatomical map of the heart on the graphical display, the second predicted degeneration marker corresponding to an intersection of a model of the electric field before delivery of the ablation energy to the plurality of electrodes with a surface of the anatomical map.

[0018] In Example 18, in the system of Example 17, the controller is further configured to 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 delivery of ablation energy to the plurality of electrodes when the electrode assembly is in a second position proximate to the target tissue.

[0019] In Example 19, in the system of Example 17, the controller is further configured to generate a third predicted degeneration marker on the anatomical map of the heart on the graphical display 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, the third predicted degeneration marker being defined by an overlapping area of ​​the first ablation marker and the second predicted degeneration marker.

[0020] In Example 20, in the system of Example 19, the controller is further configured to 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 delivery of ablation energy to the plurality of electrodes when the electrode assembly is in a second position proximate to the target tissue.

[0021] In Example 21, in the system of Example 20, the third ablation marker has a different visual appearance than the first ablation marker and the second ablation marker.

[0022] In Example 22, in the system of Example 16, the first predicted degeneration marker and the first ablation marker each have a different visual appearance. In Example 23, in the system of Example 16, the catheter is configured for selective delivery of monopolar ablation energy and bipolar ablation energy, and the controller is configured to generate a model of the electric field when the catheter is configured for delivery of monopolar ablation energy that is different from when the catheter is configured for delivery of bipolar ablation energy.

[0023] In Example 24, a system for performing electroporation ablation of target tissue in a chamber of a patient's heart includes a catheter including an electrode assembly having a plurality of electrodes, the catheter adapted to position the electrode assembly at a location proximate to an ablated region of the target tissue, a graphical display, and a controller. The controller is configured to generate, on the graphical display, a graphical representation of the electrode assembly and a first ablation marker corresponding to the ablated region. The controller is configured to generate, on the graphical display, a graphical representation of a model of an electric field generated in response to delivery of a pulsed electrical signal to a selected electrode of the plurality of electrodes. Prior to delivery of the pulsed electrical signal to the selected electrode of the plurality of electrodes at the location, the controller is configured to generate, on an anatomical map of the heart on the graphical display, a predicted zone of degeneration corresponding to an intersection of the model of the electric field with a surface of the anatomical map and an overlap zone corresponding to an intersection of the predicted zone of degeneration with the first ablation marker. After or simultaneously with delivery of the pulsed electrical signal to a selected electrode of the plurality of electrodes at the location, the controller is configured to automatically annotate an anatomical map on the graphical display by applying a second ablation marker based on a predicted degeneration zone corresponding to the location and by defining an overlap zone.

[0024] In Example 25, the system of Example 24, wherein the controller is further configured to automatically identify another overlap zone spatially adjacent to the overlap zone on the anatomical map on the graphical display.

[0025] In Example 26, in the system of Example 24, the controller is further configured to automatically annotate on the graphical display a first contiguous string of spatially adjacent overlap zones that includes the overlap zone.

[0026] In Example 27, in the system of Example 26, the controller is further configured to automatically annotate on the graphical display a second contiguous string of spatially adjacent overlap zones spaced apart on the target tissue from a first contiguous string of spatially adjacent overlap zones.

[0027] In Example 28, in the system of Example 27, the controller is further configured to automatically identify on the graphical display a gap on the target tissue located between a first continuous string of spaced-apart, spatially adjacent overlap zones and a second continuous string of spaced-apart, spatially adjacent overlap zones.

[0028] In Example 29, in the system of Example 28, the controller is further configured to automatically highlight a gap on the graphical display based on a distance between a first consecutive string of the spaced-apart, spatially adjacent overlap zones and a second consecutive string of the spaced-apart, spatially adjacent overlap zones.

[0029] In Example 30, a process for use in electroporation ablation of target tissue in a chamber of a patient's heart using a catheter including an electrode assembly having a plurality of electrodes, the catheter adapted to position the electrode assembly at a plurality of locations proximate the target tissue includes generating a graphical representation of the electrode assembly on a graphical display, generating a graphical representation of a model of an electric field generated in response to delivery of a pulsed electrical signal to selected electrodes of the plurality of electrodes on the graphical display, generating a predicted zone of degeneration on an anatomical map of the heart on the graphical display corresponding to an intersection of the model of the electric field and a surface of the anatomical map prior to delivery of the pulsed electrical signal to the selected electrodes of the plurality of electrodes at each of the plurality of locations, and automatically annotating the anatomical map on the graphical display by applying ablation markers based on the predicted zone of degeneration corresponding to each of the plurality of locations after or concurrently with delivery of the pulsed electrical signal to the selected electrodes of the plurality of electrodes at each of the plurality of locations.

[0030] In Example 31, the process of Example 30 further includes generating, at each of the plurality of locations, a first overlap zone on the anatomical map on the graphical display, the first overlap zone being defined by the overlapping area of ​​the corresponding ablation marker and one previously applied ablation marker.

[0031] In Example 32, the process of Example 31 further includes generating, at each of the plurality of locations, a second overlap zone on the anatomical map on the graphical display, the second overlap zone being defined by an overlapping area between the corresponding ablation marker and two or more previously applied ablation markers.

[0032] In Example 33, the process of Example 31 further includes automatically annotating the anatomical map on the graphical display to identify each ablation marker that overlaps at least two different ablation markers.

[0033] In Example 34, the process of Example 30 further includes automatically identifying a line of degeneration of a continuous series of spatially adjacent ablation markers, including the ablation marker and previously applied ablation markers, on an anatomical map on a graphical display.

[0034] In Example 35, in the process of Example 30, the catheter is configured for selective delivery of monopolar ablation energy and bipolar ablation energy, and indicia are generated in the model of the electric field on the graphical display when the catheter is configured for delivery of monopolar ablation energy that are different from when the catheter is configured for delivery of bipolar ablation energy.

[0035] While multiple embodiments are disclosed, still other embodiments of the present disclosure will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the present disclosure. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive. [Brief explanation of the drawings]

[0036] [Figure 1] FIG. 1 is a diagram illustrating an exemplary clinical environment for treating a patient and for treating the patient's heart, the exemplary clinical environment including an exemplary electrophysiology system. [Figure 2] FIG. 2 is a block diagram illustrating an exemplary controller for use with the exemplary electrophysiology system of FIG. [Figure 3] FIG. 3 is a flow diagram illustrating an example configuration of the example controller of FIG. [Figure 4A] FIG. 4A is a schematic diagram showing an exemplary graphical representation, such as a visualization on a display of the electrophysiology system of FIG. 1, as may be configured by the exemplary controller of FIG. 2, of the surface of an anatomical map of the heart and a predicted degeneration zone intersected by a model of the electric field of an exemplary electroporation catheter configured in a first mode or monopolar mode. [Figure 4B] FIG. 4B is a schematic diagram illustrating an exemplary graphical representation, such as a visualization on a display of the electrophysiology system of FIG. 1, as may be configured by the exemplary controller of FIG. 2, including ablation markers that annotate the surface of an anatomical map of the heart based on predicted degeneration zones as shown in FIG. 4A. [Figure 4C] Figure 4C is a schematic diagram showing an exemplary graphical representation, such as a visualization on a display of the electrophysiological system of Figure 1, as may be configured by the exemplary controller of Figure 2, of the surface of the anatomical map of the heart including the ablation marker of Figure 4B and a second predicted degeneration zone intersected with a model of another electric field of an exemplary electroporation catheter configured in a first mode or a monopolar mode. [Figure 4D] FIG. 4D is a schematic diagram illustrating an exemplary graphical representation, such as a visualization on a display of the electrophysiology system of FIG. 1, as may be configured by the exemplary controller of FIG. 2, including a second ablation marker that annotates the surface of an anatomical map of the heart based on the second predicted degeneration zone as shown in FIG. 4C, and a first overlap zone defined by the overlapping area of ​​the second ablation marker and the previously applied ablation marker. [Figure 5A]FIG. 5A is a schematic diagram illustrating an exemplary graphical representation, such as a visualization on a display of the electrophysiology system of FIG. 1, as may be configured by the exemplary controller of FIG. 2, of a surface of an anatomical map of the heart intersected with a model of the electric field of an exemplary electroporation catheter configured in a second or bipolar mode. [Figure 5B] FIG. 5B is a schematic diagram illustrating an exemplary graphical representation, such as a visualization on a display of the electrophysiology system of FIG. 1, as may be configured by the exemplary controller of FIG. 2, in which ablation markers annotate the surface of an anatomical map of the heart based on predicted degeneration zones as shown in FIG. 5A. [Figure 6A] FIG. 6A is a schematic diagram illustrating an exemplary graphical representation, such as a visualization on a display of the electrophysiology system of FIG. 1, as may be configured by the exemplary controller of FIG. 2, including multiple ablation markers annotating the surface of an anatomical map of the heart arranged to include multiple overlapping zones. [Figure 6B] 6B is a schematic diagram illustrating an exemplary graphical representation, such as a visualization on a display of the electrophysiology system of FIG. 1, as may be configured by the exemplary controller of FIG. 2, including multiple ablation markers annotating the surface of the anatomical map of the heart arranged to include multiple overlap zones of FIG. 6A, including outer boundaries of a series of ablation markers that each overlap with at least two spatially adjacent ablation markers, and identifying gaps between any two spatially adjacent ablation markers that overlap with at least two different ablation markers. DETAILED DESCRIPTION OF THE INVENTION

[0037] While the present disclosure is susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. The intention, however, is not to limit the disclosure to the specific embodiments described. Rather, the disclosure is intended to cover all modifications, equivalents, and alternatives falling within the scope of the present disclosure as defined by the appended claims.

[0038] For purposes of promoting an understanding of the principles of the present disclosure, reference is made to examples shown in the drawings described below. The illustrated examples disclosed herein are not intended to be exhaustive or to limit the disclosure to the precise form disclosed in the following detailed description. Rather, these exemplary embodiments were chosen and described to enable those skilled in the art to utilize its teachings. It would not be beyond the scope of the present disclosure to require that multiple (e.g., all) features in one example be used across all examples. Therefore, a drawing should not be interpreted as having any dependency or requirement relating to any single component or combination of components illustrated therein. In addition, various components shown in the drawings may, in some examples, be combined with various of the other components shown therein (or components not shown), all of which are considered to be within the scope of the present disclosure.

[0039] The terms "couples," "coupled," "connected," "attached," and the like, along with variations thereof, are used to include both arrangements in which two or more components are in direct physical contact and arrangements in which two or more components are not in direct contact with each other (e.g., the components are "coupled" through at least a third component), but still cooperate or interact with each other.

[0040] Throughout this disclosure, including the claims, numerical terms such as first and second are used in reference to various components or features. Such use is not intended to indicate an ordering of the components or features. Rather, the numerical terms are used to aid the reader in identifying the referenced component or feature and should not be narrowly construed as providing a particular ordering of the components or features.

[0041] FIG. 1 illustrates an exemplary clinical environment 10 for treating a patient 20, such as for treating a heart 30 of the patient 20, using an electrophysiology system 50 in accordance with the present disclosure. 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, an introducer 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 system 60 to each other and to the components of the EAM system 70. Generally, the EAM mapping system 70 includes a localization field generator 80, a mapping and navigation controller 90, and a display 92. The clinical environment 10 may also include additional equipment, such as imaging equipment 94 (represented by a C-arm), and various controller elements, such as a foot controller 96, configured to enable an operator to control various aspects of the electrophysiology system 50. Clinical environment 10 may have other components and arrangements of components not shown in Figure 1. Other arrangements of connection elements, including wireless connection elements, are also contemplated.

[0042] The electroporation catheter system 60 is configured to deliver electric field energy to target tissue within the patient's heart 30 to cause cell death in the tissue, e.g., to render the tissue unable to conduct electrical signals. The electroporation catheter system 60 is also configured to generate a graphical representation of the electric field that can be generated using the electroporation catheter 105 based on a model of the electric field and to overlay the graphical representation of the electric field or predicted or estimated lesion on an anatomical map of the patient's heart on the display 92 to assist a user in planning irreversible electroporation ablation using the electroporation catheter 105 prior to delivering energy. In an embodiment, the electroporation catheter system 60 is configured to generate the graphical representation of the electric field based on characteristics of the electroporation catheter 105 and the position of the electroporation catheter 105 within the patient 20, such as within the heart 30 of the patient 20. 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, the position of the electroporation catheter 105 within the patient 20, such as within the heart 30 of the patient 20, and the characteristics of the tissue surrounding the catheter 105, such as the measured impedance of the tissue.

[0043] The introducer sheath 110 is operable to provide a delivery conduit through which the electroporation catheter 105 may be deployed to a specific target site within the patient's heart 30. Access to the patient's heart may be gained through a blood vessel, such as a peripheral artery or vein. Once vascular access is gained, the electroporation catheter 105 may be guided within the patient's heart, for example, into a heart chamber.

[0044] 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 may include a basket, balloon, spline, structured tip, or other electrode deployment mechanism for delivering therapy. The electrode deployment mechanism includes an electrode assembly or array comprising electrodes. For example, the electrode assembly may include a plurality of spaced electrodes, or a plurality of spaced sets or groups of spaced electrodes. In some examples, electrodes, such as a plurality of spaced electrodes, may be deployed on the catheter shaft in addition to or instead of the electrodes on the electrode deployment mechanism. In one example, the plurality of electrodes may be formed from a conductive solid-surface biocompatible material and spaced apart by 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 electrode of the plurality of spaced electrodes corresponds to a separate, single lead conductor. In another example, the plurality of electrodes may be coupled to a single lead conductor. Other configurations are also contemplated. The multiple lead conductors can be insulated from one another within an insulating sheath along the catheter shaft, such as with an insulating polymer sheath. The lead conductors can be electrically coupled, e.g., directly or via an intermediate electrical conductor such as a cable, to a plug at a proximal region of the electroporation catheter 105, e.g., a plug configured to be mechanically and electrically coupled to the electroporation console 130. In one example, the electroporation console 130 is configured to provide electrical signals, such as multiple simultaneous or time-spaced electrical signals, along the lead conductors to the electrically connected electroporation catheter 105 and to a plurality of spaced electrodes. The spaced electrodes are configured to generate selected electric fields proximate the target tissue to perform electroporation based on the electrical signals from the electroporation console 130.

[0045] A selected electric field can be generated using electrodes to perform electroporation. A first electrode or group of electrodes can be selected as an anode, and a different second electrode or group of electrodes can be selected as a cathode, so that an electric field can be generated between the anode and cathode based on a signal, such as a pulse, provided to the electrodes from the electroporation console 130. The console 130 provides electrical pulses of different lengths and magnitudes to the electrodes on the catheter 105. The electrical pulses can be provided in a continuous stream of pulses or multiple separate trains of pulses. Pulse parameters of interest include the number of pulses, pulse duty cycle, pulse train spacing, pulse voltage or magnitude, including peak voltage, and voltage duration. For example, the console 130 can select two or more electrodes of an electrode assembly and provide pulses to the selected electrodes to generate an electric field between the selected electrodes and perform pulsed field ablation (PFA). For example, PFA can be performed using monophasic and biphasic waveforms. Without being bound by any particular theory, electric field strengths in the range of approximately 200-250 volts per centimeter (V / cm) with microsecond-scale pulse durations have been demonstrated to provide reversible electroporation in cardiac tissue. Electric field strengths of approximately 400 V / cm have been demonstrated to provide irreversible electroporation in cardiac tissues of interest, such as targeted myocardial and endocardial tissue, while demonstrably sparing red blood cells, vascular smooth muscle tissue, endothelial tissue, nerves, and other non-target adjacent tissues.

[0046] Additionally, the electrode assembly on the catheter 105 can be operated in a selected mode, such as a monopolar mode or a bipolar mode. During monopolar operation of the catheter 105, an electrode, a group of electrodes, or the entire electrode assembly is configured as either an anode or a cathode. None of the electrodes of the electrode assembly is configured as either a cathode or an anode. Instead, the other of the cathode or anode is provided in the form of a pad dispersive electrode that is placed 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 an anode, and a second set of one or more electrodes of the electrode assembly is configured as a cathode and generates the electric field. In this example, the pad dispersive electrode is not used, and the electric field does not extend into the patient's body, but rather through a localized portion of tissue adjacent to the electrode assembly.

[0047] The electroporation console 130 is configured to control aspects of the electroporation catheter system 60. In embodiments, the electroporation console 130 is configured to provide one or more of: modeling an electric field that may be generated by the electroporation catheter 105, often including taking into account the physical characteristics of the electroporation catheter 105, including the electrodes on the electroporation catheter 105 and their spatial relationships, and whether the electroporation catheter 105 is in bipolar or monopolar mode; generating a graphical representation of the electric field, often including taking into account the location of the electroporation catheter 105 within the patient 20 and the characteristics of the surrounding tissue; and overlaying the generated graphical representation on an anatomical map on the display 92. In some examples, the electroporation control console 130 is configured to generate the anatomical map. In some examples, the EAM system 70 is configured to generate the anatomical map for display on the display 92.

[0048] 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 memory device or memory, to control, perform, or otherwise operate aspects of the electroporation catheter system 60. The memory may be part of the one or more controllers, processors, or computers, or part of a memory device accessible over a computer network. Examples of computer networks include a local area network, a wide area network, and the Internet.

[0049] The EAM system 70 is operable to track the positions of 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 chambers of interest, or other structures of interest, such as the sinoatrial node or atrioventricular node. In one illustrative example, the EAM system 70 may include the RHYTHMIA™ HDx mapping system sold by Boston Scientific Corporation. The mapping and navigation controller 90 of the EAM system 70 also includes one or more controllers, such as a microprocessor or computer, that execute code from memory to control or perform functional aspects of the EAM system 70, and the memory may be part of one or more controllers, microprocessors, computers, or memory devices accessible over a computer network.

[0050] EAM system 70 generates a localization field via field generator 80 to define a localization volume around heart 30, and position sensors or sensing elements on the tracked device, such as sensors on electroporation catheter 105, generate outputs that can be processed by mapping and navigation controller 90 to track the position of the sensor, and therefore the corresponding device, within the localization volume. In the illustrated example, device tracking is achieved using magnetic tracking techniques, with field generator 80 being a magnetic field generator that generates a magnetic field that defines the localization volume, and the position sensors on the tracked device being magnetic sensors.

[0051] In other examples, impedance tracking methods can be used to track the positions of various devices. In such examples, the localization fields are electric fields generated by external field generator configurations such as surface electrodes, or by internal or intracardiac devices such as intracardiac catheters, or both. In these examples, the position sensing elements can comprise electrodes on the tracked devices that generate outputs that are received and processed by the mapping and navigation controller 90 to track the positions of the various position sensing electrodes within the localization volume.

[0052] EAM system 70 can include both magnetic and impedance tracking capabilities. In such instances, impedance tracking accuracy can be improved in some cases by first creating a map of the electric field induced by the field generator within the subject's cardiac chamber using a probe equipped with a magnetic position sensor, as is possible with the RHYTHMIA HDx™ mapping system. One exemplary probe is the INTELLAMAP ORION™ mapping catheter sold by Boston Scientific.

[0053] Regardless of the tracking method used, EAM system 70 utilizes the positional information of the various tracking devices, along with cardiac electrical activity acquired, for example, by electroporation catheter 105 or another catheter or probe equipped with sensing electrodes, to generate and display via display 92 a detailed three-dimensional geometrical anatomical map or representation of cardiac tissue and cavities such as heart chambers, as well as an electroanatomical map in which cardiac electrical activity of interest is superimposed on the geometrical anatomical map. Additionally, EAM system 70 can generate a graphical representation of the various tracked devices within the geometrical anatomical map or electroanatomical map.

[0054] The electroporation catheter system 60 may be combined or integrated with the EAM system 70 to enable visualization of a graphical representation of the electric field that may be generated by the electroporation catheter 105 on an anatomical map of the patient, and in some examples, on an electroanatomical map of the patient's heart. The integrated system may include capabilities to improve the efficiency of clinical workflow, including enhanced functionality to provide clinicians with a visual representation of an ablation lesion in a portion of the patient's heart created through irreversible electroporation. The integrated system may include generating a graphical representation of the electric field that may be generated by the electroporation catheter 105, generating an anatomical map, including generating an electroanatomical map, and displaying information regarding the location and field strength of the electric field that may be generated by the electroporation catheter 105.

[0055] 1 is intended as an example or general overview of the various components of the system 50 and is not intended to suggest that the present disclosure is limited to any set of components or arrangement of components. For example, additional hardware components, such as a breakout box or workstation, may be included in the electrophysiology system 50.

[0056] FIG. 2 illustrates an exemplary controller 200 that can be used with the exemplary electrophysiology system 50, such as a controller for the exemplary electroporation catheter system 60, which may include a controller for the electroporation console 130; a controller for the exemplary EAM system 70, which may include a mapping and navigation controller 90; a controller for an integrated electroporation catheter system 60 and EAM system 70; or a controller for use with the electroporation catheter system 60 and EAM system 70. The controller 200, in this example, can be implemented to provide visualization of ablation alterations due to irreversible electroporation. In some examples, the controller 200 can also be implemented to provide selected annotations for regions not subjected to 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 application. The processor 202 can execute the instructions 206, which can be included in configuring the controller 200. In one example, controller 200 may be implemented to include a computing device such as a laptop computer, a workstation, a desktop computer, a tablet, or a smartphone. In such an example, controller 200 may include additional components such as a display, a touchscreen, a speaker or other output device, a keyboard or other input device, or communication circuitry such as a computer network adapter. Controller 200 may be implemented in a variety of architectures, and components such as processor 202 and memory 204 may be distributed in a variety of locations.

[0057] In one example, processor 202 may include multiple main processing cores for running an operating system and performing general-purpose tasks on the integrated circuit. Processor 202 may also include embedded logic or programmable functional units on the same integrated circuit with heterogeneous instruction set architectures. In addition to multiple general-purpose main processing cores and application processing units, controller 200 may include other devices or circuits, such as a graphics processing unit or a neural network processing unit, which may include heterogeneous or homogeneous instruction set architectures with the main processing cores. For example, controller 200 may be used to perform other tasks, such as in the case of a computing device that includes a resonant sound amplification device.

[0058] Memory 204 is an example of a computer storage medium. Computer storage media include RAM, ROM, EEPROM, flash memory or other memory technology, CD-ROM, digital versatile disk (DVD) 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 storage devices, or other storage media that can be used to store desired information and that can be accessed by processor 202. Any such computer storage medium may be part of controller 200 and implemented as memory 204. Memory 204 is a non-transitory processor-readable memory device. Thus, a propagating signal does not, in itself, qualify as a storage medium or memory 204.

[0059] Controller 200 may be configured to receive input or information from electrophysiology system 50, such as input from electroporation catheter system 60 and EAM system 70, including electroporation console 130 and mapping and navigation controller 90, for storage in memory 204 and use by instructions 206. For example, controller 200 may receive input representing an anatomical map of the heart, or cardiac map data 208, which may include data relating to representations of a geometric anatomical map of the heart and an electroanatomical map of the heart, such as from EAM system 70. Additionally, controller 200 may receive ablation parameter data 210 and ablation location data 212, such as from electroporation catheter system 60. In some examples, anatomical cardiac map data 208, ablation parameter data 210, or ablation location data 212 may be generated by controller 200 and stored in memory 204 or accessed by instructions 206. In one example, ablation parameter data 210 may include electrode configuration data 214 relating to the electrode configuration on electroporation catheter 105, including which electrodes on electroporation catheter 105 should be activated and with what polarity (anode or cathode), electrode mode data 216 relating to the mode of electroporation catheter 105, including bipolar or monopolar mode, and the electric field vector generated using electroporation catheter 105, and ablation titration data 218 relating to information regarding pulsed field ablation, including pulse energy intensity, pulse duration, whether the pulse is biphasic or monophasic, and other information related to ablation that is determinable from electroporation catheter system 60. For example, ablation parameter data 210 may be provided from electroporation console 130 based on measurements, settings, or configuration of electroporation catheter system 60.

[0060] Controller 200 is configured to generate visualization 220 with reference to an anatomical map of the heart, which may include a determined, predicted, or expected therapeutic effect, an expected degeneration effect based on settings of electroporation catheter system 60 prior to ablation, and is configured to provide ablation markers indicating degeneration location with reference to the anatomical map of the heart, including degeneration size and other information related to the ablation performed with electroporation catheter system 60. In one example, controller 200 is configured to generate a visualization of an overlapping zone of ablation markers, where two or more ablation markers include the same region of target tissue.

[0061] 3 illustrates a process 300 for configuring a controller, such as controller 200, while performing electroporation of a target tissue, such as within a chamber of a patient's heart. In one example, the controller is implemented as part of EAM system 70 and is operably coupled to electroporation catheter system 60. Process 300 includes, at 302, configuring the controller to generate a graphical representation of an electrode assembly. For example, the graphical representation of the electrode assembly at 302 may include a graphical representation of electroporation catheter 105 relative to an anatomical map of the patient's heart. The graphical representation may include a schematic representation or other indicia presenting a model of the position of the electrode assembly of electroporation catheter 105 relative to the heart, as may be determined from ablation location data 212, as provided from electroporation catheter system 60, applied to anatomical cardiac map data 208, as provided from EAM system 70. Selected electrodes of the electrode assembly are configured to generate actual or predicted electric fields within the heart, as determined from parameter data 210, as provided from electroporation catheter system 60. At 304, a graphical representation of the electric field model is generated in response to delivery of a pulsed electrical signal to selected electrodes of the plurality of electrodes. The electric field can change as the electrode assembly is moved relative to the heart, and the graphical representation of the electric field model can likewise change, such as in real time. The graphical representation of the electric field model can include areas indicative of electric fields having intensities that provide irreversible electroporation to the target tissue, indicia indicating the mode of the electrode array (such as whether the electrode array is configured to deliver monopolar or bipolar energy) in the representation of the electric field model, and other indicators of aspects of the titration scheme as determined from the ablation parameter data 210.In one example, the indicia regarding field strength, mode, and titration scheme may include associated or corresponding colors and color shading that provide a visual indication of the graphical representation.

[0062] Prior to delivery of the pulsed electrical signal to selected electrodes of the plurality of electrodes at each of the plurality of locations, a predicted degeneration zone corresponding to the intersection of the model of the electric field with the surface of the anatomical map is generated on the anatomical map of the heart on a graphical display at 306. The predicted degeneration zone can be determined from the ablation parameter data 210 and the ablation location data 212 relative to the anatomical map of the heart from cardiac map data 208. The degeneration zone can be presented, for example, as a shaded or distinct color or color-shaded area or volume relative to the surface or area of ​​the representation of the heart. The degeneration zone can represent a region of irreversible electroporation degeneration on the heart. After or simultaneously with delivery of the pulsed electrical signal to selected electrodes of the plurality of electrodes at each of the plurality of locations, the anatomical map is automatically annotated on the graphical display at 308 by applying an ablation marker based on the predicted degeneration zone corresponding to each of the plurality of locations. For example, the anatomical map of the heart can be updated to show the region of irreversible electroporation degeneration. In one example, each predicted degeneration zone and corresponding ablation marker has substantially the same visual appearance. In some examples, the anatomical map of the heart can be further updated to show the degeneration of the reversible electroporation.

[0063] In one example, the controller is further configured to generate, at 310, a first overlap zone on the anatomical map on the graphical display, defined by an overlapping area between the corresponding ablation marker and a previously applied ablation marker at each of the plurality of locations. For example, prior to delivery of the pulsed electrical signal to the selected electrode, an overlap zone corresponding to an intersection between the predicted degeneration zone and the previously applied ablation marker is generated on the anatomical map of the heart on the graphical display. After or simultaneously with delivery of the pulsed electrical signal to the selected electrode, the anatomical map is automatically annotated on the graphical display by defining the overlap zone. Furthermore, the controller can generate, at each of the plurality of locations, a second overlap zone on the anatomical map on the graphical display, defined by an overlapping area between the corresponding ablation marker and two or more previously applied ablation markers. 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 shade of color or a different color. For example, the first overlap zone has the appearance of a first shade of color, and the second overlap zone has the appearance of a second shade of color. The first shade of color may be lighter than the second shade of color. The controller may be configured to automatically annotate the anatomical map on the graphical display to identify each ablation marker that overlaps at least two different ablation markers. In another example, the controller is further configured to automatically annotate the anatomical map on the graphical display to display outer boundaries of a series of ablation markers, each of which overlaps at least two spatially adjacent ablation markers. For example, the outer boundaries of each of the overlapping series of ablation markers may be a line of a different color or shade than the color of the overlap zone.The controller may be configured to automatically identify a gap between any two spatially adjacent ablation markers that overlap at least two different ablation markers, the gap representing an area of ​​ablation that does not include an overlap zone.

[0064] In one example, process 300 can be implemented as a set of processor-executable instructions, such as instructions 206 stored in a non-transitory memory, such as memory 204, that are executed by processor 202 to configure controller 200. The instructions for implementing process 300 can be configured to receive information, such as read cardiac map data 208, ablation parameter data 210, and ablation location data 212, from memory 204. Additionally, the instructions for implementing process 300 can be configured to annotate, adjust, or annotate cardiac map data 208 and generate a visualization, such as visualization 220, on a display of a graphical representation.

[0065] FIG. 4A illustrates a first exemplary graphical representation 400, such as a visualization on a display, such as display 92, that may be configured by controller 200 and implemented using process 300 using electrophysiology system 50 of FIG. 1. In the electrophysiology system, an electroporation catheter 105 is positioned such that a corresponding electrode assembly is proximate to a target tissue, such as the surface of a chamber of a patient's heart. As shown in FIG. 4A, first exemplary graphical representation 400 includes a first graphical representation of catheter 402, a first graphical representation of electrode assembly 404, and a graphical representation of target tissue 406, such as the surface of the target tissue from an anatomical map. Additionally, first exemplary graphical representation 400 includes a graphical representation of a first model electric field 408 generated at the electrode assembly proximate to the target tissue. In one example, a user of controller 200 can select the resolution of first model electric field 408 for the graphical representation. For example, the range or size of first model electric field 408 can be based on a threshold field strength, such as an area of ​​the electric field likely capable of causing irreversible electroporation in the target tissue. In one example, the first model electric field 408 may indicate a range of electric fields having a field strength of 400 V / cm. Additionally, the model electric field may be shown at a selected visual transparency so that a clinician may observe the proximal target tissue. In other examples, the visual appearance of the model electric field may indicate an alert, such as when the field strength is not sufficient to provide irreversible electroporation, or when the field strength is extreme or exceeds an upper threshold.

[0066] In the example of FIG. 4A , the catheter is configured in a first mode, such as a monopolar mode, although aspects of the present disclosure are not mode-dependent. During monopolar operation, an electrode, a group of electrodes, or the entire electrode assembly is configured as either an anode or a cathode, and none of the electrodes of the electrode assembly is configured as either a cathode or an anode. An electric field is generated between an activated electrode and a pad dispersion electrode via an electrical signal, such as a pulsed electrical signal, provided to the catheter. The implementation of the electric field in monopolar mode based on the pulsed signal to the target tissue may be of interest to a clinician. A first model of the electric field 408 based on the pulsed signal and the selected electrode configuration in monopolar mode is generated on the first exemplary graphical representation 400. The visual appearance of the first model 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 an electrode array configured in bipolar mode. In one example of a controller 200 generating the first exemplary graphical representation 400, the model electric field can be determined from ablation parameter data 210.

[0067] In one example, the position of the first model electric field 408 relative to the graphical representation of the target tissue 406 and the first graphical representation of the catheter 402 may change as the clinician manipulates the catheter 105 relative to the heart 30 and configures settings on the electroporation console 130. For example, as the clinician manipulates or moves the catheter 105 relative to the heart 30, a graphical representation such as the first exemplary graphical representation 400 can track the corresponding movement of the first graphical representation of the catheter 402, the first graphical representation of the electrode assembly 404, and the position of the first model electric field 408 relative to the graphical representation of the target tissue 406. Also, as the clinician changes settings on the electroporation console 130, the corresponding adjustments can be reflected in the geometry, such as the size and shape, of the model electric field 408 relative to the first graphical representation of the catheter 402 and the graphical representation of the target tissue 406, which can provide titration feedback regarding the treatment.

[0068] The first exemplary graphical representation 400 includes a modified zone 410 at the intersection of a graphical representation of the surface of the target tissue 406 and a first model electric field 408. In this example, the first modified zone 410 presents a graphical representation of the size and location relative to the target tissue of an area (or volume) of the target tissue that has undergone irreversible electroporation. In one example, the first modified zone 410 may include a visual appearance that distinguishes the first modified zone 410 from the first model electric field 408 and an unablated region of the target tissue 412.

[0069] During operation of the electroporation catheter 105 and prior to delivery of pulsed electrical signals to the electrode assembly to perform electroporation, the first modified zone 410 is a first predicted modified zone 414 that provides a visualization of the size and location relative to the target tissue of a modified zone, such as an irreversible electroporated modified zone, created with the current settings of the electroporation catheter system 60 and the current position of the catheter relative to the heart 30. As the catheter 105 moves relative to the heart 30 or as settings on the electroporation console 130 are adjusted prior to delivery of pulsed electrical signals to the electrode assembly to perform electroporation, the first predicted modified zone 414 may move or change geometry relative to other features of the first exemplary graphical representation 400 on the graphical representation of the target tissue 406. For example, the first model electric field 408 and corresponding first predicted degeneration zone 414 can move and change geometry based on changes in the shape of the group of electrodes selected to be activated, such as an expandable or flexible group of electrodes, or a single spline, double spline, or tip-only configuration of the activated electrodes.

[0070] 4B shows a second exemplary graphical representation 420, such as a visualization on a display, such as display 92, that may be configured by controller 200 using electrophysiology system 50 and implemented using process 300. For example, second exemplary graphical representation 420 may be of a time after delivering a pulsed electrical signal to electrodes to affect ablation of target tissue in a region corresponding to first predicted degeneration zone 414 on the graphical representation of target tissue 406 in first exemplary graphical representation 400 of FIG. 4A. The electrode assembly of electroporation catheter 105 is not in close proximity to the region of the heart corresponding to the graphical representation of target tissue 406, such that second exemplary graphical representation 420 does not include a graphical representation of the catheter. Second exemplary graphical representation 420 includes an ablation marker 422 in place of first predicted degeneration zone 414.

[0071] Following or concurrently with delivery of the pulsed electrical signal to electrodes of the electrode assembly proximate the target tissue, the graphical representation of the target tissue 406 is annotated by applying an ablation marker 422 based on the first predicted zone of modification 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 cardiac tissue that has been irreversibly electroporated. The ablation marker 422 may be characterized as having an ablation boundary 424 that defines an ablation zone 426 corresponding to an area on the surface of the patient's heart that has been ablated by the irreversible electroporation adjacent to an unablative region of the target tissue 412. The graphical representation of the target tissue 406 is annotated such that the ablation marker 422 is a fixture of the anatomical map, the ablation marker 422 is distinct and applied to the geometric anatomical map, and the effects of the irreversible electroporation appear on the electroanatomical map. In one example, the first predicted degeneration zone 414 and the corresponding ablation marker 422 can have substantially the same geometric shape or the same visual appearance. In another example, the first predicted degeneration zone 414 can include a visual appearance that is distinguishable from the visual appearance of the corresponding ablation marker 422 or other ablation markers.

[0072] FIG. 4C shows a third exemplary graphical representation 440, such as a visualization on a display, such as display 92, that may be configured by controller 200 using electrophysiology system 50 and implemented using process 300. For example, third exemplary graphical representation 440 may be at a later time than second exemplary graphical representation 420 of FIG. 4B. Third exemplary graphical representation 440 includes a graphical region of target tissue 406, including unablated tissue 412, and ablation markers 422 representing regions of ablated tissue. Electroporation catheter 105 has been repositioned such that the corresponding electrode assembly is proximate to the target tissue but at a position offset from the position presented in first exemplary graphical representation 400 shown in FIG. 4A. Thus, third exemplary graphical representation 440 includes a second graphical representation of catheter 442, a second graphical representation of electrode assembly 444, and a second model electric field 448. For ease of explanation, 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.

[0073] In one example, the position of the second model electric field 448 relative to the graphical representation of the target tissue 406 and the second graphical representation of the catheter 442 may change as the clinician manipulates the catheter 105 relative to the heart 30 and configures settings on the electroporation console 130. Also, as the clinician changes settings on the electroporation console 130, corresponding adjustments can be reflected in the geometry, such as the size and shape, of the model electric field 448 relative to the second graphical representation of the catheter 442 and the graphical representation of the target tissue 406.

[0074] The third exemplary graphical representation 440 includes a denaturation zone 450 at the intersection of the graphical representation of the surface of the target tissue 406 and the second model electric field 448. In this example, the second denaturation zone 450 provides a graphical representation of the size and location relative to the target tissue of the area (or volume) of target tissue that has undergone irreversible electroporation. In one example, the second denaturation zone 450 may include the second model electric field 448, the ablation marker 422, and a visual appearance that distinguishes the second denaturation zone 450 from the non-ablated region of the target tissue 412. The third exemplary graphical representation 440 includes an overlap zone 460, in which the denaturation zone 450 and the ablation marker 422 overlap. The overlap zone 460 represents a region of tissue where an electric field having an intensity that irreversibly electroporates tissue, as indicated by the second model electric field 448, intersects with an area of ​​the target tissue that was previously ablated, as indicated by the ablation marker 422.

[0075] During manipulation of the electroporation catheter 105 and prior to delivery of a pulsed signal to the electrode assembly to perform electroporation at the second location, the second denaturation zone 450 is a second predicted denaturation zone 454 that provides a visualization of the size and location relative to the target tissue of the denaturation zone created with the current settings of the electroporation catheter system 60 and the new position of the catheter relative to the heart 30. As the catheter 105 moves correspondingly relative to the heart 30 or as settings on the electroporation console 130 are adjusted prior to delivery of a pulsed electrical signal to the electrode assembly to perform electroporation, the second predicted denaturation zone 454 can move or change geometry relative to other features of the third exemplary graphical representation 440 on the graphical representation of the target tissue 406. For example, the second model electric field 448 and corresponding second predicted denaturation zone 414 can move and change geometry based on the group of electrodes selected to be activated and the clinician's manipulation of the catheter 105 to create a selected overlap zone 460.

[0076] 4D shows a fourth exemplary graphical representation 480, such as a visualization on a display, such as display 92, that may be configured by controller 200 using electrophysiology system 50 and implemented using process 300. For example, fourth exemplary graphical representation 480 may be of a time point after delivering a pulsed electrical signal to an electrode to affect ablation of target tissue in a region corresponding to second predicted degeneration zone 454 on the graphical representation of target tissue 406 in third exemplary graphical representation 400 of FIG. 4C. The electrode assembly of electroporation catheter 105 is again not in close proximity to the region of the heart corresponding to the graphical representation of target tissue 406, such that fourth exemplary graphical representation 480 does not include a graphical representation of the catheter. Fourth exemplary graphical representation 480 includes second ablation marker 482 in place of second predicted degeneration zone 454, and includes ablation marker 422 and unablated tissue 412. The fourth example graphical representation 480 includes an overlap zone 460 where the area of ​​the ablation marker 482 intersects with the ablation marker 422 .

[0077] Following or concurrently with delivery of the pulsed electrical signal to an electrode at a second position of the electrode assembly proximate the target tissue, the graphical representation of the target tissue 406 is annotated by applying a second ablation marker 482 based on the second predicted zone of modification 454. The first ablation marker 422 and the second ablation marker 482 may represent one or more areas or volumes of patient heart tissue on the surface of the patient's heart 30 that have been irreversibly electroporated. The second ablation marker 482 may be characterized as having an ablation boundary 484 that defines an ablation zone 486 corresponding to an area of ​​the surface of the patient's heart that has been ablated by irreversible electroporation adjacent to an unablative region of the target tissue 412. The overlap zone 460 can be characterized as having an overlap boundary 488 that defines the overlap zone 460 and an overlap region 490 within the overlap boundary 488, where the overlap region 490 corresponds to an area of ​​the surface of the patient's heart that has been ablated more than once or has undergone multiple irreversible electroporations and is adjacent to an unablative region of the target tissue 412 or tissue 492 that has only been ablated once, i.e., tissue that has not undergone multiple irreversible electroporations.

[0078] The graphical representation of the target tissue 406 is annotated such that the ablation marker 482 is a fixture of the anatomical map in addition to the ablation marker 422, the ablation markers 422, 482 are distinct and applied to the geometric anatomical map, and the effects of irreversible electroporation appear on the electroanatomical map. In one example, the second predicted degeneration zone 454 and the corresponding second ablation marker 482 can have substantially the same geometric shape or the same visual appearance, which can include the same visual appearance as the first ablation marker 422. In another example, the first predicted degeneration zone 454 can include a visual appearance that is 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 ablation markers 422, 482, can be shown on the graphical representation as a selected shade of a selected color, and an overlap zone of two overlapping ablation markers, such as overlap zone 460, can be shown on the graphical representation as another shade, such as a darker shade, of the selected color. When more than two ablation markers form an overlap zone representing target tissue that has undergone more than two overlapping ablations, the overlap zone can be shown as yet another shade, such as a darker shade, of the selected color. Multiple overlap zones can be defined by the overlapping areas of an ablation marker and two or more previously applied overlapping ablation markers. In this example, the overlap zone and multiple overlap zones each have a different visual appearance on the anatomical map.

[0079] FIG. 5A shows another exemplary graphical representation 500, such as a visualization on a display, such as display 92, that may be configured by controller 200 using electrophysiology system 50 and implemented using process 300. In the electrophysiology system, an electroporation catheter 105 is positioned such that a corresponding electrode assembly is proximate to a target tissue, such as the surface of a chamber of a patient's heart. In this example, the catheter is configured in a second mode, such as a bipolar mode. During bipolar operation of catheter 105, a first set of one or more electrodes of the electrode assembly are configured as anodes, and a second set of one or more electrodes of the electrode assembly are configured as cathodes to generate an electric field. As shown in FIG. 5A, first exemplary graphical representation 500 includes a graphical representation of catheter 502, an electrode assembly 504 configured in bipolar mode, and a graphical representation of target tissue 506, such as the surface of the target tissue from an anatomical map. Additionally, exemplary graphical representation 500 includes a graphical representation of a model electric field 508 generated by the electrode assembly proximate to the target tissue. In this example, the electrodes disposed on the electrode deployment mechanism of the electrode assembly can be configured as either an anode or a cathode (as represented by a first group of electrodes 530), and the catheter includes electrodes disposed on the catheter shaft (as represented by a second group of electrodes 532) that are configured as the other of a cathode and an anode and generate the electric field.

[0080] The exemplary graphical representation 500 includes a modification zone 510 at the intersection of the graphical representation of the surface of the target tissue 506 and the model electric field 508. In this example, the modification zone 510 provides a graphical representation of the size and location relative to the target tissue of an area (or volume) of the target tissue that can undergo or has undergone irreversible electroporation. During operation of the electroporation catheter 105 in bipolar mode and prior to delivery of a pulse signal to the electrode assembly to perform electroporation, the modification zone 510 is a predicted modification 514 that provides a visualization of the size and location relative to the target tissue of a modification, such as a modification due to 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.

[0081] In some implementations, the electroporation catheter system 60 can selectively switch between monopolar and bipolar modes. The implementation of the electric field based on the pulse signal on the target tissue in monopolar mode and the implementation of the electric field in bipolar mode may be of interest to a clinician. For example, the geometry of the predicted alteration generated by a catheter in monopolar mode may differ from the geometry of the predicted alteration generated by a catheter in bipolar mode. In one example, a model electric field in a first mode, such as model electric field 508 in bipolar mode, and a predicted alteration generated by the electric field in a first mode, such as predicted alteration portion 514 in bipolar mode, can be represented using different symbols than the model electric field and the predicted alteration portion in a second mode, such as monopolar mode. In one example, the model electric field in the first mode and the corresponding predicted alteration portion can be shown in a first color, and the model electric field in the second mode and the corresponding predicted alteration portion can be shown in a second color. In addition, portions of the model electric field generated by a catheter in bipolar mode, such as portions of the field proximate the catheter shaft, may be undesirable for irreversible electroporation. Selected portions of the model electric field can be shown in one color, such as a color indicating a more desirable model electric field, and other selected portions can be shown in another color, such as a color indicating a less desirable model electric field.

[0082] 5B illustrates yet another exemplary graphical representation 520, such as a visualization on a display, such as display 92, that may be configured by controller 200 and implemented using process 300 using electrophysiology system 50. For example, yet another exemplary graphical representation 520 may be of a time point after delivering a pulsed electrical signal to an electrode to affect ablation of target tissue in a region corresponding to predicted degeneration zone 514 on the graphical representation of target tissue 506 of first exemplary graphical representation 500 of FIG. 5A. Yet another exemplary graphical representation 520 includes an ablation marker 522 in place of first predicted degeneration zone 514. In this example, the geometry of the ablation marker 522 of degeneration created with the catheter in bipolar mode differs from the geometry of the ablation marker of degeneration created with the catheter in monopolar mode.

[0083] Following or concurrently with delivery of the pulsed electrical signal to electrodes of the electrode assembly proximate the target tissue, a graphical representation of the target tissue 506 is annotated by applying an ablation marker 522 based on the first predicted zone of modification 514. The ablation marker 522 may represent an area on the surface of the patient's heart 30 that has been irreversibly electroporated or a volume of the patient's cardiac tissue. The ablation marker 522 may be characterized as having an ablation boundary 524 that defines an ablation zone 526 corresponding to an area on the surface of the patient's heart that has been ablated by irreversible electroporation adjacent to an unablative region of the target tissue 512.

[0084] In the above example, the predicted degeneration zone or ablation marker can be presented on the graphical representation as a mark indicating the geometry of irreversible electroporation on the surface of the structure on the anatomical map, or as a marker indicating the geometry of irreversible electroporation on the surface and indicating depth and volume within the tissue. In the latter case, the predicted degeneration zone or ablation marker can be a three-dimensional representation on the presented graphical representation. The depth can be adjusted based on an understanding of the depth effect of repeated ablation in the case of overlapping zones.

[0085] The above examples describe configurations of the controller to place ablation markers to indicate regions of tissue undergoing irreversible ablation. In some examples, the controller may be configured to place markers to indicate regions affected by electric fields that are not strong enough to generate irreversible electroporation. For example, selected indicia may be applied to annotate regions of reversible electroporation or regions that have received treatment that is not strong enough to generate reversible electroporation. Additionally, the controller may be configured to apply annotations to regions without simultaneous or subsequent delivery of pulsed electrical signals to the electrodes. In one example, areas that may be annotated without associated ablation may include structures or areas surrounding structures, such as the sinoatrial node or atrioventricular node, such as to provide an indication to avoid performing ablation in such regions of the heart. In some examples, the annotations may be temporary, such as for regions of reversible electroporation or regions without associated ablation.

[0086] FIG. 6A illustrates an exemplary graphical representation 600 of ablated target tissue for visualization on a display, such as display 92, that may be configured by controller 200 and implemented using process 300 using electrophysiology system 50. Graphical representation 600 of ablated target tissue includes a line of degeneration 602 representing irreversibly electroporated tissue 604 adjacent to non-ablated tissue 606. Degeneration line 602 is defined by a plurality of ablation markers 608a-608i, generated, for example, by the methods described in this disclosure, to provide the clinician with a visual indication of the overall status of the ablation procedure, such as to assess the likelihood that a complete conduction block has been achieved. In this example, first ablation marker 608a represents a first end 610 of degeneration line 602, and ninth ablation marker 608i represents a second end 612 of degeneration line 602. However, it will be readily understood that the specific number and location of individual ablation markers may vary in a given procedure. Additionally, in the illustrated example, each ablation marker 608a-608i is depicted as being generally oval in shape. However, this oval shape is merely for ease of explanation for purposes of this disclosure. That is, the ablation markers 608a-608i can take on any number of shapes and appearances, as described elsewhere herein.

[0087] As described above, a modification line, such as modification line 602, represents a length of tissue that has been continuously and irreversibly electroporated from a first end to a second end and includes multiple ablation markers. Continuously connected ablation markers 608a-608i may be ablation markers that touch each other or may include overlapping regions. Modification line 602 is characterized as having at least two spatially adjacent ablation markers that form a continuous modification line boundary 614 adjacent to non-ablated tissue (represented by element 606 in FIG. 6A ) as its outer limit, defining a modification region 616 of ablated tissue 604 within modification line boundary 614.

[0088] In one example, a controller, such as controller 200 of FIG. 2, can be configured to automatically identify and annotate a degeneration line, such as degeneration line 602, and can be implemented in process 300 at 310 of FIG. 3. The controller can determine whether an ablation marker is spatially adjacent to another ablation marker to form a degeneration line and automatically annotate the degeneration line on the graphical representation. For example, the controller can be configured to automatically highlight consecutive degeneration line boundaries 614 with a visual indicia or to automatically highlight spatially adjacent ablation markers on the graphical representation with a distinguishing shade or color. In one example, a degeneration line is automatically identified in real time when the graphical representation presents two or more spatially adjacent ablation markers. In another example, a degeneration line can be automatically identified at a time selected via a control. The automatic identification of a degeneration line provides feedback to the clinician regarding whether multiple nearby ablation markers are separated by non-ablated tissue. In one example, the controller can be configured to automatically highlight the space of non-ablated tissue located between multiple ablation markers, such as with an indicia to provide a visual alert to the user.

[0089] The modification line 602 in this example includes multiple overlap zones 614, which represent areas of tissue with overlapping regions of ablation, such as tissue that has undergone two or more irreversible electroporation steps, and can provide a clinician with a visual indication of the likelihood that complete transmural modification has been produced. For example, the first ablation marker 608a and the second ablation marker 608b intersect in the region of the target tissue as shown, forming a first overlap zone 614a. The first ablation marker 608a, the second ablation marker 608b, and the third ablation marker 608c also intersect as shown, forming a second overlap zone 614b. The first overlap zone 614a shown is an overlap zone of two markers because it is formed by two intersecting applications of irreversible electroporation to the same area of ​​tissue. The second overlap zone 614b shown is a three-marker overlap zone because it is formed by three applications of intersecting irreversible electroporation to the same area of ​​tissue. Overlap zones involving more than three applications of intersecting irreversible electroporation to an area of ​​tissue are also contemplated. The nine ablation markers 608a-608i of the denaturation line 602 form fourteen overlap zones 614a-614n as shown. Each overlap zone 614a-614n, such as overlap zone 614n, can be characterized as having an overlap boundary 616 that defines the overlap zone, such as 614n, and an overlap region 618 within the overlap boundary 616.

[0090] FIG. 6B illustrates an exemplary graphical representation 650 of ablated target tissue in a visualization on a display, such as display 92, that may be configured by controller 200 using electrophysiology system 50 and implemented using process 300 to highlight overlapping zones, such as overlapping zones 614a-614n, at 310. Areas of overlapping ablation have a higher probability of permanent degeneration than areas of non-overlapping ablation, where the target tissue receives only a single, irreversible electroporation. Therefore, a clinician may find it desirable to form and identify contiguous strings of overlapping zones within the tissue. In one example, a controller, such as controller 200 of FIG. 2, may be configured to automatically identify and annotate contiguous strings of two or more overlapping zones on graphical representation 650, such as first contiguous string 652 and second contiguous string 654, at 310 of FIG. 3. A first continuous string of overlap zones 652 includes multiple consecutive, spatially adjacent overlap zones, such as overlap zones 614a-614i, where overlap zone 614a is spatially adjacent to overlap zone 614b, continuing through overlap zone 614i. A second continuous string of overlap zones 654 includes multiple consecutive, spatially adjacent overlap zones, such as overlap zones 614j-614n, where overlap zone 614j is spatially adjacent to overlap zone 614k, which is spatially adjacent to overlap zone 614l, which is spatially adjacent to overlap zone 614m, which is spatially adjacent to overlap zone 614n. Continuous string 652 can be characterized by a string boundary 660 and a continuous region 662 of spatially adjacent overlap zones within string boundary 660. The continuous string 654 can be characterized by a string boundary 670 and a continuous region 672 of spatially adjacent overlap zones within the string boundary 670 .

[0091] The controller can determine whether an overlap zone is spatially adjacent to another overlap zone to form a contiguous string and automatically annotate the contiguous string on the graphical representation. For example, the controller can be configured to automatically highlight the contiguous string with a visual indicia, such as highlighted string boundaries 662, 672, or with a shade or color that distinguishes spatially adjacent overlap zones on the graphical representation. In one example, the contiguous string is automatically identified in real time when the graphical representation presents two or more spatially adjacent overlap zones. In another example, the contiguous string can be automatically identified at a time selected via a control.

[0092] The automatic identification of consecutive strings 652, 654 provides feedback to the clinician as to whether the degeneration line includes non-overlapping sections, such as gaps 680, of consecutive strings 652, 654 on the graphical representation 650. In one example, the controller may be configured to automatically highlight gaps 680, such as via a visual alert, if gaps 680 are likely to be of interest to the clinician, as determined by the controller. The controller may be configured to determine whether a gap may be of interest, such as by determining that consecutive strings and gaps are included in the degeneration line, whether the distance or centroid distance between overlap zones proximate to the gap is within a threshold amount, or other determination.

[0093] It is fully understood that, unless expressly or implicitly stated to the contrary in the specification or claims themselves, methods including one or more steps, in the order recited, are not intended to limit the scope of the claims. It is also fully understood that the illustrated methods are merely examples of many disclosed examples, and that certain steps may be added or omitted without departing from the scope of the present disclosure. Such steps may include incorporating devices, systems, or methods, or components thereof, as well as those that are well understood, routine, and conventional in the art.

[0094] The connecting lines shown in the various figures contained herein are intended to represent example functional relationships and / or physical couplings between the various elements. It should be noted that many alternative or additional functional relationships or physical connections may exist in an actual system. However, benefits, advantages, solutions to problems, and any elements that may give rise to or make more noticeable any benefit, advantage, or solution should not be construed as critical, required, or essential features or elements. Accordingly, the scope should not be limited by anything other than the appended claims, and references to elements in the singular are not intended to mean "only one" unless expressly so stated, but rather "one or more." Furthermore, when a phrase similar to "at least one of A, B, or C" is used in the claims, the phrase is intended to be interpreted to mean that in an embodiment, only A may be present, in an embodiment, only B may be present, in an embodiment, only C may be present, or any combination of elements A, B, or C, e.g., A and B, A and C, B and C, or A, B, and C, may be present in a single embodiment.

[0095] In the detailed description herein, references to "one embodiment," "an embodiment," "an exemplary embodiment," etc. indicate that the described embodiment may include a particular feature, structure, or characteristic, but not all embodiments necessarily include the particular feature, structure, or characteristic. Moreover, such phrases do not necessarily refer to the same embodiment. Furthermore, when a particular feature, structure, or characteristic is described in connection with an embodiment, it is within the knowledge of one of ordinary skill in the art having the benefit of this disclosure to affect such feature, structure, or characteristic in connection with other embodiments, whether or not explicitly described. After reading the description, it will be apparent to one of ordinary skill in the art how to implement the present disclosure in alternative embodiments.

[0096] Furthermore, no element, component, or method step of this disclosure is intended to be made available to the public regardless of whether that element, component, or method step is expressly recited in a claim. No claim element herein is to be construed under the provisions of 35 U.S.C. 112(f) unless that element is expressly recited using the phrase "means for." As used herein, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus comprising a list of elements may include not only those elements, but also other elements not expressly listed or elements inherent to such process, method, article, or apparatus.

[0097] Various modifications and additions can be made to the exemplary embodiments described without departing from the scope of the present disclosure. For example, while the embodiments described above refer 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 equivalents thereof.

Claims

1. 1. A system for performing electroporation ablation of target tissue in a chamber of a patient's heart, comprising: a catheter including an electrode assembly having a plurality of electrodes, the catheter adapted to position the electrode assembly at a plurality of locations proximate the target tissue; A graphical display; Controller and wherein the controller generating a graphical representation of the electrode assembly on the graphical display; generating on the graphical display a graphical representation of a model of an electric field generated in response to delivery of a pulsed electrical signal to selected ones of the plurality of electrodes; generating, prior to delivery of the pulsed electrical signal to the selected one of the plurality of electrodes at each of the plurality of locations, a predicted degeneration zone on the anatomical map of the heart on the graphical display corresponding to an intersection of the model of the electric field with a surface of the anatomical map; automatically annotating the anatomical map on the graphical display by applying ablation markers based on the predicted degeneration zones corresponding to each of the plurality of locations after or simultaneously with delivery of the pulsed electrical signal to the selected one of the plurality of electrodes at each of the plurality of locations. The system is configured as follows:

2. 2. The system of 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, the first overlap zone being defined by an overlapping area of ​​the corresponding ablation marker and a previously applied ablation marker.

3. 3. The system of 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, the second overlap zone being defined by an overlapping area of ​​the corresponding ablation marker and two or more previously applied ablation markers.

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

5. The system of 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 marker that overlaps with at least two different ablation markers.

6. 6. The system of claim 5, wherein the controller is further configured to automatically annotate the anatomical map on the graphical display to display outer boundaries of a series of ablation markers, each of which overlaps at least two spatially adjacent ablation markers.

7. The system of any one of claims 1 to 6, wherein the controller is further configured to automatically identify gaps between any two spatially adjacent ablation markers that overlap at least two different ablation markers.

8. The system of any one of claims 1 to 7, wherein each predicted degeneration zone and the corresponding ablation marker have substantially the same geometric shape.

9. The system of any one of claims 1 to 8, wherein each predicted degeneration zone and the corresponding ablation marker have substantially the same visual appearance.

10. The system of any one of claims 1 to 7, wherein each predicted degeneration zone and the corresponding ablation marker has a different visual appearance.

11. The system of any one of claims 1 to 10, wherein the visual appearance of the predicted degeneration zone or the ablation marker varies as a function of one or more ablation parameters.

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

13. The system of any one of claims 1 to 12, wherein the catheter is configured for selective delivery of monopolar and bipolar ablation energy.

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

16. 1. A system for performing electroporation ablation of target tissue in a chamber of a patient's heart, comprising: a catheter including an electrode assembly having a plurality of electrodes, the catheter adapted to position the electrode assembly at a first location proximate the target tissue; A graphical display; Controller and wherein the controller prior to delivering ablation energy to the plurality of electrodes; generating on the graphical display a graphical representation of a model of the electric field generated by the plurality of electrodes; generating a first predicted degeneration marker on the anatomical map of the heart on the graphical display when the electrode assembly is in a first position proximate to the target tissue, the first predicted degeneration marker corresponding to an intersection of the model of the electric field with a surface of the anatomical map; automatically annotating the anatomical map on the graphical display with a first ablation marker corresponding to the first predicted degeneration marker after or simultaneously with delivery of ablation energy to the plurality of electrodes. The system is configured as follows:

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

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

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

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

21. The system of claim 20 , wherein the third ablation marker has a different visual appearance than the first and second ablation markers.

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

23. 17. The system of claim 16, wherein the catheter is configured for selective delivery of monopolar and bipolar ablation energy, and the controller is configured to generate a model of the electric field differently when the catheter is configured for delivery of monopolar ablation energy than when the catheter is configured for delivery of bipolar ablation energy.

24. 1. A system for performing electroporation ablation of target tissue in a chamber of a patient's heart, comprising: a catheter including an electrode assembly having a plurality of electrodes, the catheter adapted to position the electrode assembly in proximity to an ablated region of the target tissue; A graphical display; Controller and wherein the controller generating, on the graphical display, a graphical representation of the electrode assembly and a first ablation marker corresponding to the ablated region; generating on the graphical display a graphical representation of a model of an electric field generated in response to delivery of a pulsed electrical signal to selected ones of the plurality of electrodes; generating, on the anatomical map of the heart on the graphical display, a predicted degeneration zone corresponding to an intersection of the model of the electric field with a surface of the anatomical map and an overlap zone corresponding to an intersection of the predicted degeneration zone with the first ablation marker prior to delivery of the pulsed electrical signal to the selected electrode of the plurality of electrodes at the location; automatically annotating the anatomical map on the graphical display by applying a second ablation marker based on the predicted degeneration zone corresponding to the location and by defining the overlap zone after or simultaneously with delivery of the pulsed electrical signal to the selected electrode of the plurality of electrodes at the location. The system is configured as follows:

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

26. 25. The system of claim 24, wherein the controller is further configured to automatically annotate on the graphical display a first contiguous string of spatially adjacent overlap zones that includes the overlap zone.

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

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

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

30. 1. A process for use in electroporation ablation of target tissue in a chamber of a patient's heart using a catheter including an electrode assembly having a plurality of electrodes, the catheter adapted to position the electrode assembly at a plurality of locations proximate the target tissue, the process comprising: generating a graphical representation of said electrode assembly on a graphical display; generating on the graphical display a graphical representation of a model of an electric field generated in response to delivery of a pulsed electrical signal to selected ones of the plurality of electrodes; generating, prior to delivery of the pulsed electrical signal to the selected one of the plurality of electrodes at each of the plurality of locations, a predicted degeneration zone on the anatomical map of the heart on the graphical display corresponding to an intersection of the model of the electric field with a surface of the anatomical map; automatically annotating the anatomical map on the graphical display by applying ablation markers based on the predicted degeneration zones corresponding to each of the plurality of locations after or simultaneously with delivery of the pulsed electrical signal to the selected one of the plurality of electrodes at each of the plurality of locations. The process includes:

31. 31. The process of claim 30, further comprising: generating, at each of the plurality of locations, a first overlap zone on the anatomical map on the graphical display defined by an overlapping area of ​​the corresponding ablation marker and a previously applied ablation marker.

32. 32. The process of claim 31, further comprising: generating, at each of the plurality of locations, a second overlap zone on the anatomical map on the graphical display defined by an overlapping area of ​​the corresponding ablation marker and two or more previously applied ablation markers.

33. 32. The process of claim 31, further comprising automatically annotating the anatomical map on the graphical display to identify each ablation marker that overlaps at least two different ablation markers.

34. 31. The process of claim 30, further comprising automatically identifying, on the anatomical map on the graphical display, a line of degeneration of a continuous series of spatially adjacent ablation markers, including the ablation marker and previously applied ablation markers.

35. 31. The process of claim 30, wherein the catheter is configured for selective delivery of monopolar and bipolar ablation energy, and wherein the model of the electric field on the graphical display is marked differently when the catheter is configured for delivery of monopolar ablation energy than when the catheter is configured for delivery of bipolar ablation energy.

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