Radiofrequency ablation and direct current electroporation catheter

Abstract

Aspects of the present disclosure relate to flexible catheters for electrophysiological mapping and ablation using high-density electrode arrays. These catheters can be used to detect the electrophysiological properties of tissue in contact with the electrodes and perform monopolar and bipolar ablation of the tissue.

Description

[0001] Cross - Reference to Related Applications

[0002] This application claims the benefit of U.S. Provisional Application No. 62 / 674,314, filed May 21, 2018, which is incorporated herein by reference in its entirety as if set forth herein in full. Technical Field

[0003] The present disclosure relates to, for example, radiofrequency ablation catheters for treating myocardial tissue within the myocardium. In particular, the present disclosure relates to basket and planar array catheters including a plurality of electrodes positioned in a high density array. Background Art

[0004] Catheters have been used in cardiac medical procedures for many years. When located at a particular location within the body, a catheter can be used, for example, to diagnose and treat arrhythmias that are inaccessible without a more invasive procedure.

[0005] Conventional ablation catheters can include, for example, a plurality of adjacent annular electrodes that surround the longitudinal axis of a basket catheter. The annular electrodes can be constructed of platinum or some other metal. These annular electrodes are relatively rigid and can deliver an ablation treatment (e.g., RF ablation energy) to treat, for example, symptoms associated with arrhythmias.

[0006] When performing an ablation treatment on myocardial tissue, the beating of the heart, particularly if the heart beat is unstable or irregular, makes it difficult to maintain sufficient contact between the electrode and the tissue for a sufficient length of time. These problems are exacerbated on contoured, irregular, or trabeculated surfaces. If contact between the electrode and the tissue cannot be sufficiently maintained, it is less likely that a high quality lesion will be created.

[0007] Typically, a focal ablation catheter is used for cardiac ablation treatments. A focal ablation catheter delivers energy between a single electrode and a ground pad. As electrophysiological mapping becomes more precise, ablation treatments may likewise become more targeted. More targeted ablation treatments will limit unnecessary tissue damage.

[0008] Ablation treatments such as for atrial fibrillation have an extended duration because the clinician must introduce an electrophysiological mapping catheter into the patient's left atrium, confirm the diagnosis and determine an ablation treatment strategy before removing the electrophysiological mapping catheter. Then an ablation catheter is introduced to complete the ablation treatment, and subsequently the electrophysiological mapping catheter is reintroduced to confirm the treatment effect. In view of the foregoing, a catheter capable of performing both electrophysiological mapping and ablation treatment will be desirable to limit the duration of the procedure.

[0009] The foregoing discussion is only intended to illustrate the art and should not be construed as a disclaimer of the scope of the claims. Summary of the Invention

[0010] Aspects of the present disclosure relate to flexible catheters for electrophysiological mapping and ablation using high-density electrode arrays. These catheters can be used to detect electrophysiological properties of tissue in contact with the electrodes and perform monopolar and / or bipolar ablation of the tissue. In particular, the present disclosure relates to planar and basket end effectors coupled to the distal end of a catheter shaft.

[0011] Multiple embodiments of the present disclosure relate to a planar array catheter, including an elongate catheter shaft and a flexible planar array coupled to the distal end of the catheter shaft. The elongate catheter shaft defines a longitudinal axis. The flexible planar array conforms to tissue and includes two or more struts extending substantially parallel to the longitudinal axis. Each strut lies in the same plane and has a plurality of electrodes coupled thereto. The plurality of electrodes detect electrophysiological properties of tissue in contact with the planar array and selectively ablate the tissue. In more specific embodiments, the plurality of electrodes in the planar array can operate in both monopolar and bipolar configurations for tissue ablation.

[0012] Multiple embodiments of the present disclosure relate to a basket catheter, including an elongate catheter shaft having a proximal end and a distal end, a flexible basket having a plurality of splines, and a plurality of electrodes mounted to the splines. The flexible basket is coupled to the distal end of the catheter shaft and conforms to tissue. The plurality of electrodes detect electrophysiological properties of tissue in contact with the basket and selectively ablate the tissue. In some specific embodiments, the basket catheter further includes a plurality of temperature sensors and an ablation controller circuit. Each temperature sensor is mechanically coupled to the spline and positioned to be in thermal communication with at least one electrode. The ablation controller circuit is communicatively coupled to the plurality of temperature sensors and the plurality of electrodes. The ablation controller circuit controls power delivery to each electrode at least in part based on the temperature measured by the temperature sensors near each electrode.

[0013] The foregoing and other aspects, features, details, utilities, and advantages of the present disclosure will be apparent from reading the following description and claims and from referring to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Various example embodiments can be more fully understood in view of the following detailed description in conjunction with the accompanying drawings, in which:

[0015] Figure 1 is a schematic diagram of an electrophysiological catheter system consistent with various embodiments of the present disclosure;

[0016] Figure 2A is an isometric side view of a basket end effector of an electrophysiological catheter consistent with various embodiments of the present disclosure;

[0017] Figure 2B is consistent with various embodiments of the present disclosure Figure 2AA close-up view of a portion of four adjacent splines of a basket end effector;

[0018] Figure 2C is a radiofrequency ablation system formed together in accordance with various embodiments of the present disclosure Figure 2A A close-up view of a portion of two adjacent splines of a basket end effector and a ground pad;

[0019] Figure 3A is a top view of a planar end effector of an electrophysiological mapping catheter in accordance with various embodiments of the present disclosure;

[0020] Figure 3B depicts a Figure 3A planar array catheter having an electrode array in contact with tissue in accordance with various embodiments of the present disclosure; and

[0021] Figure 3C depicts a Figure 3A planar array catheter covering a vasculature in accordance with various embodiments of the present disclosure.

[0022] Although the various embodiments discussed herein are susceptible to modification and alternative forms, several aspects thereof have been shown by way of example in the drawings and will be described in detail. However, it should be understood that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the scope of the present disclosure including the aspects defined in the claims. Additionally, the term "example" is used throughout this application merely for illustrative purposes and not restrictively. Detailed Description

[0023] Aspects of the present disclosure relate to flexible catheters for electrophysiological mapping and ablation using high-density electrode arrays. These catheters can be used to detect electrophysiological properties of tissue in contact with the electrodes and perform monopolar and / or bipolar ablation of the tissue. In particular, the present disclosure relates to planar and basket end effectors coupled to the distal end of a catheter shaft.

[0024] To perform electrophysiological mapping of the myocardium, pacing is carried out. During the pacing procedure, adjacent electrodes are assigned to bipolar pairs, and each bipolar pair samples the electrical characteristics of the tissue between the pair. The resulting electrical signals are received and processed by a controller circuit. The controller circuit performs electrophysiological mapping by correlating the signal samples from each bipolar pair with the location of the tissue sampled by the bipolar pair. The electrograms from each bipolar pair can be analyzed, and various electrical characteristics can be visually indicated on the electrophysiological mapping diagram by color coding (or other visual indication schemes, such as shading, patterns, etc.). In some embodiments, the color coding can be based on the electrogram voltage (e.g., mean, average, maximum, etc.) at each location. In other embodiments, the number of times the electrical signal exceeds a threshold voltage (or the voltage slope changes sign) during a sampling window can be visually displayed on the mapping diagram. In other embodiments, the total energy sampled during a time window can be displayed. Various other methods of fractionation accounting are known and can be used as one or more factors for the resulting color coding displayed on the electrophysiological mapping diagram. Clinicians can use these electrophysiological mapping diagrams to verify diagnoses, gain insights into desired ablation treatment strategies, and verify treatment effectiveness.

[0025] Aspects of the present disclosure relate to an intravascular catheter having an end effector capable of performing electrophysiological mapping and monopolar / bipolar radiofrequency ablation therapy. Historically, cardiac ablation therapy has been performed using a point-by-point ablation technique that delivers energy between a single electrode located at the distal tip of the catheter and a ground pad electrically coupled to the patient's chest. However, high-density electrophysiological mapping catheters have facilitated improved diagnostic specificity, such that clinicians can use electrophysiological mapping diagrams to more precisely target ablation therapy to problematic tissue (e.g., tissue containing arrhythmia foci). This is particularly desirable because clinicians wish to minimize ablation of healthy myocardial tissue as much as possible to maintain the healthy function of the left atrium. To further improve the workflow of ablation therapy, aspects of the present disclosure relate to using a single catheter to perform electrophysiological mapping of the left atrium as well as ablation therapy. By incorporating such functionality into a single catheter, the length of the ablation therapy (and operating room time) can be reduced. More specific embodiments of the present disclosure relate to controlling the ablation depth of the ablation catheter. Improved three-dimensional electrophysiological mapping indicating the electrophysiological characteristics of the subsurface of the contacted myocardial tissue facilitates such embodiments. Ablation therapy can then be customized to provide depth-varying tissue ablation therapy throughout the left atrium using a combination of monopolar and bipolar radiofrequency tissue ablation.

[0026] In many adults, the depth of myocardial tissue is typically less than 3 millimeters and often less than 2 millimeters. Aspects of the present disclosure relate to customizing tissue ablation treatment for a patient to, for example, alleviate symptoms associated with arrhythmia by varying the treatment depth of the ablation treatment and treating only the damaged tissue. For example, the treatment plan for an ablation treatment can use a combination of monopolar RF (ablation between a single electrode and a ground pad) and bipolar RF mode (ablation between electrodes on a catheter) to vary the ablation treatment depth. This variable-depth ablation treatment therapy reduces the risk to sensitive tissues such as the phrenic nerve. In more specific embodiments, multiplexed or selected sequential energy delivery for lesion formation can be used to further customize the ablation treatment.

[0027] In some specific aspects of the present disclosure, a basket catheter including 8 splines is disclosed. Each spline is composed of a shape memory material that returns to a semi-circular shape when exiting the introducer. Each spline is circumferentially distributed around the basket uniformly relative to the other splines. When deployed, the 8 splines form a substantially circular basket. Each spline includes a row of electrodes extending along the length of the spline. The electrodes can be distributed uniformly along the length of the spline or non-uniformly along the length of the spline for special applications. For example, the distribution of the electrodes can be weighted towards the distal end of the basket, where the basket catheter is intended to, for example, diagnose arrhythmia. Many arrhythmias are triggered by stray electrical signals emanating from one or more pulmonary veins. Assuming a transseptal approach to reach the left atrium, the distal end of the basket (including its high-density electrode array) will be oriented by the clinician based on the pulmonary veins. Once placed within the left atrium, the basket catheter is capable of electrophysiological mapping of the left atrium, ablating myocardial tissue near the pulmonary veins to alleviate symptoms associated with atrial fibrillation, and remapping the left atrium to verify the effectiveness of the treatment.

[0028] In some specific aspects of the present disclosure, a planar array catheter including five struts is disclosed. Each strut can be aligned with and extend parallel to the longitudinal axis of the catheter shaft. Each strut is coupled to the other struts of the planar array at the proximal and distal ends. Each strut includes a row of electrodes extending along the length of the strut. In some specific embodiments, the electrodes are distributed uniformly along the length of the strut and between adjacent struts of the planar array. According to various embodiments, the planar catheter array of the present disclosure can include at least four struts, five struts, six struts, seven struts, or even eight struts. In Figure 3A the illustrated embodiment, the array contains five struts.

[0029] The electrodes disclosed herein can be annular electrodes and / or printed (dot) electrodes on a substrate (e.g., a flexible circuit board). Advantageously, the printed electrodes can be spaced more closely than the annular electrodes. In some embodiments, for example, printed electrodes spaced 0.1 mm have been successfully deployed in planar array catheters. More typically, the annular electrodes and the printed electrodes have advantageously been spaced 0.5 mm to 4 mm. It has been found that, for example, in many cardiovascular applications, such electrode spacing promotes the desired electrophysiological mapping granularity. Moreover, the high-density positioning of electrodes around a planar array or basket catheter can facilitate customizable ablation therapy that minimizes the amount of tissue damage required to mitigate the effects of an arrhythmia such as atrial fibrillation in a patient.

[0030] Traditional mapping catheter designs use bipolar electrode configurations to detect, measure, and display electrical signals from the heart, and use point-by-point ablation catheters with unipolar electrode configurations to facilitate tissue ablation. However, aspects of the present disclosure relate to using a combination of unipolar and bipolar configurations on a catheter to facilitate, for example, the treatment of atrial fibrillation. The relevant choice of unipolar or bipolar ablation therapy at a given tissue location can be based, for example, on the desired ablation depth or width. In some specific embodiments, an ablation controller circuit can receive an electrophysiological map of a target tissue region and determine the type of ablation therapy to be received by each tissue region within the target tissue region. Alternatively, a clinician can manually design an ablation therapy based on the provided electrophysiological map or otherwise consent to / modify the treatment strategy designed by the ablation controller circuit.

[0031] A basket catheter for ablation therapy consistent with the present disclosure can include a plurality of electrodes distributed around one or more splines forming a basket. Each electrode can operate in a unipolar or bipolar configuration or in both configurations simultaneously. That is, a single electrode can simultaneously transmit radiofrequency energy to an adjacent electrode on the basket catheter and a patch electrode on the patient's chest. In some more specific embodiments, a thermocouple can be placed under (or otherwise in close proximity to) one or more of the electrodes to enable temperature-controlled radiofrequency tissue ablation.

[0032] Details of various embodiments of the present disclosure are described below with specific reference to the drawings.

[0033] Figure 1 is a schematic diagram of an electrophysiological catheter system consistent with various embodiments of the present disclosure.

[0034] Now referring to the drawings, where like reference numerals are used in the various views to identify the same components, Figure 1Generally shown is an electrophysiological catheter system 10 for force detection. The system 10 has an elongate medical device 19 including a sensor assembly 11 (e.g., a plurality of electrodes for electrophysiological mapping and ablation), and the elongate medical device 19 is configured for use in a medical procedure within the body. The elongate medical device 19 can be used for diagnosing, visualizing, and / or treating tissue 13 (e.g., the heart or other tissue) within the body. For example, the medical device 19 can be used for ablation treatment of tissue 13 or for mapping purposes within a patient's body 14. Figure 1 Also shown are various subsystems included in the overall system 10. The system 10 can include a main computer system 15 (including an electronic control unit 16 and a data storage device 17, such as a memory). In addition to other components, the computer system 15 can also include conventional interface components, such as various user input / output mechanisms 18A and a display 18B. Information provided by the sensor assembly 11 can be processed by the computer system 15 and data can be provided to a clinician via the input / output mechanism 18A and / or the display 18B or in other ways described herein.

[0035] In Figure 1 an illustrative embodiment, the elongate medical device 19 can include a cable connector or interface 20, a handle 21, and a tubular body or shaft 22 having a proximal end 23 and a distal end 24. The elongate medical device 19 can also include other conventional components not shown herein, such as a temperature sensor, additional electrodes, and corresponding conductors or wires. The connector 20 can provide mechanical, fluid, and / or electrical connections for cables 25, 26 extending respectively from a reservoir 12, a pump 27, and the computer system 15. The connector 20 can include conventional components known in the art and, as shown, can be disposed at the proximal end of the elongate medical device 19.

[0036] The handle 21 provides a portion for a user to grasp or hold the elongate medical device 19 and can also provide a mechanism for manipulating or guiding the shaft 22 within the patient's body 14. For example, the handle 21 can include a mechanism configured to change the tension on a wire extending through the elongate medical device 19 to the distal end 24 of the shaft 22, or some other mechanism for manipulating the shaft 22. The handle 21 can be conventional in the prior art and it should be understood that the configuration of the handle 21 can vary.

[0037] The computer system 15 can perform many of the functions described herein using software, hardware, firmware, and / or logic. The computer system 15 can be a combination of hardware and instructions to share information. The hardware can include, for example, processing resources 16 and / or a memory 17 (e.g., a non-transitory computer-readable medium (CRM) database, etc.). As used herein, the processing resources 16 can include multiple processors capable of executing instructions stored by the memory resources 17. The processing resources 16 can be integrated in a single device or distributed among multiple devices. The instructions (e.g., computer-readable instructions (CRI)) can include instructions stored on the memory 17 and executable by the processing resources 16 for force detection.

[0038] The memory resources 17 are communicatively coupled to the processing resources 16. As used herein, the memory 17 can include multiple memory components capable of storing instructions executable by the processing resources 16. Such a memory 17 can be, for example, a non-transitory computer-readable storage medium. The memory 17 can be integrated in a single device or distributed among multiple devices. Additionally, the memory 17 can be fully or partially integrated in the same device as the processing resources 16, or the memory 17 can be separate but accessible to the device and the processing resources 16. Thus, it should be noted that the computer system 15 can be implemented on a user device and / or a collection of user devices, on a mobile device and / or a collection of mobile devices, and / or on a combination of a user device and a mobile device.

[0039] The memory 17 can be communicatively coupled to the processing resources 16 via a communication link (e.g., a path). The communication link can be local or remote to the computing device associated with the processing resources 16. Examples of local communication links can include an electronic bus inside the computing device, where the memory 17 is one of a volatile, non-volatile, fixed, and / or removable storage medium that communicates with the processing resources 16 via the electronic bus.

[0040] Figure 2A is an isometric side view of a basket end effector (also referred to as a basket catheter) of an electrophysiology catheter that is consistent with various embodiments of the present disclosure. Figure 2A The basket catheter 201 is shown in a deployed configuration. The basket 201 includes a plurality of splines 210 1-8 , which are coupled to the catheter shaft 205 at the proximal end and to the distal cap 215 (or coupled to each other) at the distal end. Although this embodiment presents a basket consisting of eight splines 210 1-8 it is readily envisioned that basket catheters having three or more splines can be designed depending on the intended clinical application and the desired electrophysiological mapping granularity. To facilitate expansion / contraction of the basket, the splines 210 1-8It can be composed of a shape memory alloy (such as Nitinol), which returns to a semi-circular shape after leaving the introducer. In other embodiments, the basket catheter can utilize deployment members to expand / contract the basket.

[0041] In this embodiment, each spline 210 1-8 includes a plurality of electrodes 211 distributed around the length of each spline 1-N . Although the embodiment shown in Figure 2A -C depicts electrodes 211 regularly distributed along the length of each spline 1-N , other embodiments may include electrodes unevenly distributed along the spline. For example, in pulmonary vein electrophysiological mapping applications, only the distal portion of the basket may contact the tissue proximal to the pulmonary vein. Thus, the distribution of electrodes 211 1-N can be weighted towards the distal end of the basket 201 to facilitate enhanced electrophysiological mapping granularity near the pulmonary vein.

[0042] The electrodes 211 1-N can be used in various bipolar configurations to facilitate measurement of the electrical properties of the tissue in contact with the electrodes. The first bipolar pair can include a pair of electrodes 211 along the length of the spline 210, thus facilitating collection of tissue electrical property data in a direction substantially parallel to the longitudinal axis of the catheter. The second orthogonal bipolar pair can extend transversely across adjacent splines 210, thus facilitating collection of tissue electrical property data in a direction substantially perpendicular to the longitudinal axis of the catheter. To facilitate collection of this electrical data, these bipolar electrode pairs can be independently addressed by a signal processing circuit. The signal processing circuit analyzes the signals received from the various bipolar electrode pairs to assemble an electrophysiological mapping diagram that visualizes the electrophysiological data sensed by the basket catheter of the tissue in contact with the electrodes.

[0043] In various embodiments consistent with the present disclosure, the spline 210 can be formed of a flexible electronic circuit board, where each electrode 211 is coupled thereto and communicatively coupled to the signal processing circuit via electrical traces extending along the internal or external layers of the flexible printed circuit board. In some specific embodiments, each spline 210 can be composed of Nitinol. In such embodiments, the flexible circuit can be directly bonded to the Nitinol, or alternatively, the flexible circuit can be directly bonded to a Pebax TM tube that internally houses the Nitinol spline.

[0044] In some embodiments, the diameter of the electrodes 211 can be 0.8 mm, with a total surface area of 0.5 mm 2。The sizes and shapes of the electrodes 211 on the basket catheter 201 need not be the same. For example, embodiments consistent with the present disclosure may include electrodes capable of performing electrophysiological mapping, RF tissue ablation, and optionally facilitating localization in impedance or hybrid-based catheter navigation systems (e.g., MediGuide TM systems and / or EnSite TM NavX TM systems).

[0045] Although in some embodiments it may be desirable to have equal spacing between all of the electrodes 211 on and between the splines 210, knowledge of the relative spacing between each of the electrodes forming a bipolar pair is sufficient to accurately capture electrical characteristic data of the tissue in contact with the electrodes. In some specific embodiments, the edge-to-edge spacing of one or more bipolar pairs of electrodes may be between 2 - 2.5 millimeters. In other specific embodiments, the center-to-center spacing of the electrodes in a bipolar pair may be between 0.5 - 4 millimeters.

[0046] In some specific embodiments, some of the electrodes 211 on the basket 201 may be multipurpose while other electrodes are single-purpose. For example, some electrodes may serve simultaneously as navigation, ablation, and electrophysiological mapping electrodes, other electrodes may only serve as electrophysiological mapping electrodes, and still other electrodes may only serve as navigation electrodes.

[0047] As Figure 2A further shown, the distal cap 215 may serve multiple purposes, including coupling the distal ends of the splines 210 1-8 (near the longitudinal axis of the catheter) to each other and providing the most distal surface of the catheter to prevent accidental injury to the tissue in contact therewith.

[0048] In various embodiments consistent with the present disclosure, each spline of the basket catheter may be coupled to one or more manipulation wires that, when actuated, expand and / or contract the splines to form a desired shape.

[0049] Although the present disclosure relates to a basket catheter 201 having eight electrodes 211 on each spline 210, various other embodiments are readily envisioned. For example, the basket catheter may include more or fewer splines and / or more or fewer electrodes on each respective spline.

[0050] As discussed in more detail below, a particular advantage of a basket catheter that can perform electrophysiological mapping and ablation therapy simultaneously is that it reduces the procedure time, because the clinician does not need to replace the electrophysiological mapping catheter with an ablation catheter after confirming the treatment strategy. Moreover, since the relative positions of the target tissues for ablation are already known by virtue of the electrophysiological mapping and the static position of the basket catheter within the patient's left atrium, the need for magnetic and / or impedance-based positioning of the ablation catheter within the patient's myocardium can be reduced.

[0051] Figure 2B is consistent with various embodiments of the present disclosure Figure 2A four adjacent splines 210 of the basket 201 1-4 A close-up view of a portion. Each spline 210 includes a plurality of electrodes 211 1-12 , which can be used to sense the electrophysiological characteristics of the tissue (usually operating in a bipolar configuration with another adjacent electrode), and / or ablate the tissue in contact therewith. The electrodes can ablate the tissue using a bipolar configuration or a monopolar configuration, in which, for example, one or more electrodes are paired with a ground pad coupled to the patient's chest. As Figure 2B shown, a plurality of bipolar electrode pairs 212 are shown 1-N . These pairs can extend along the longitudinal axis of the spline, perpendicular to the longitudinal axis of the spline, or the electrode pairs can extend diagonally between two adjacent splines. Such a system can perform electrophysiological mapping using a bipolar configuration of electrodes spanning the surface of the basket catheter, and / or perform precise tissue ablation therapy that limits necrosis of healthy tissue. For example, based on the generated electrophysiological map of the tissue in the patient's left atrium, a bipolar ablation therapy can be implemented that ablates only the tissue that is prone to transmitting stray electrical signals and / or the myocardial tissue containing arrhythmia foci (which may generate such electrical signals).

[0052] A particular benefit of bipolar ablation therapy is that, since the positive and negative electrodes are very close, the actual energy delivered to the target tissue is known. In addition, bipolar ablation therapy also limits the energy delivery to non-target tissue due to the relative proximity of the electrodes.

[0053] Although Figure 2B depicts bipolar pairs of electrodes that are adjacent to each other, it is easy to envision other bipolar pair arrangements. For example, non-adjacent electrode pairs. For example, when the electrodes are operating in a bipolar arrangement, tissue ablation can be achieved for the tissue near the electrodes 2111 and 211 12 . In some embodiments, a first number of electrodes (e.g., electrodes 211 1-3 ) on a first spline 2101 can be paired with a second number of electrodes (e.g., electrodes 211 4-6)Operate together in a bipolar configuration. In still other embodiments, the first number of electrodes on the first spline 2101 (e.g., electrode 211 1-3 ) can operate together with the third number of electrodes on the third spline 2103 (e.g., electrode 211 7-9 ) in a bipolar configuration. Additionally, the first number of electrodes on the first spline 2101 (e.g., electrode 211 1-3 ) can operate together with the fourth number of electrodes on the fourth spline 2104 (e.g., electrode 211 10-12 ) in a bipolar configuration.

[0054] Figure 2C are two adjacent splines 210 Figure 2A of the basket catheter 201 that together form the radiofrequency ablation system 299 1-2 and a close-up view of the ground pad 214. As discussed in Figure 2B , each spline 210 includes a plurality of electrodes 211 1-4 . Each electrode can be paired with another adjacent electrode to facilitate bipolar electrophysiological mapping and / or tissue ablation (e.g., bipolar electrode pair 212 1-N ). Alternatively or concurrently, the electrodes 211 1-4 can also be paired with the ground pad 214 to operate in a monopolar ablation treatment configuration (e.g., monopolar electrode pair 213 1-N ). During ablation treatment, the electrodes operating in a monopolar configuration will achieve a greater depth of lesion, while the bipolar configuration electrodes will create more precisely located lesions.

[0055] Figure 3A is a top view of a planar array 301 of electrophysiological mapping catheters consistent with various embodiments of the present disclosure. The planar array 301 of electrophysiological mapping catheters includes a high-density array of electrodes 311 1-N . The planar array 301 forms a flexible array of electrodes 311 1-N . The electrode array is coupled to a flexible frame of struts 310 1-5 that extend in a plane substantially parallel to the longitudinal axis of the catheter shaft 305. Each strut is precisely laterally separated from each other to facilitate precise spacing between the electrodes 311 1-5 on adjacent struts 310 1-N , and the struts are coupled to each other at the distal and proximal ends (e.g., at the distal tip 315 and the cannula 308).

[0056] As Figure 3A shown, five struts 310 1-5Each of them can carry multiple electrodes 311, and the spacing of the electrodes along the length of the strut is the same (or at least known). Similarly, the spacing between the electrodes 311 of the struts 310 across the array can also be equal (or at least known). The result is a plurality of electrode bipolar pairs with known spacing. For example, in some embodiments, the center-to-center electrode spacing of the bipolar pairs can be between 0.5 - 4 mm. In more specific embodiments, the center-to-center electrode spacing of the bipolar pairs can be less than 0.5 mm (e.g., 0.1 mm). Although this embodiment relates to bipolar pairs with equal center-to-center spacing, various other embodiments of the electrode array consistent with this disclosure can include electrode arrays with equal edge-to-edge spacing. For example, in some embodiments, the edge-to-edge electrode spacing can be between 0.5 - 4 mm. In more specific embodiments, the edge-to-edge electrode spacing can be less than 0.5 mm (e.g., 0.1 mm). In the case where the electrodes 311 of the array 301 have different relative sizes (or surface areas), it may be desirable to consider the edge-to-edge spacing.

[0057] Although Figure 3A the planar array 301 in depicts five struts 310 1-5 , the catheter can include more or fewer struts, and the spacing between each corresponding strut is based on the desired electrode spacing for a given electrophysiological application. Additionally, although Figure 3A the planar array 301 depicted in shows 20 electrodes 311, the planar array can include more or fewer than 20 electrodes, and each strut does not need to have the same number of electrodes as adjacent struts.

[0058] In some embodiments, the electrodes 311 1-N can be used for diagnostic, therapeutic, and / or mapping procedures. For example but not limited to, the electrodes 311 can be used for electrophysiological studies, pacing, cardiac mapping, and ablation. In some embodiments, the electrodes 311 can perform monopolar and / or bipolar tissue ablation therapy. The ablation therapy can create a specific line or pattern of lesions. In some embodiments, the electrodes 311 can receive electrical signals from pacing electrodes, which can be used for electrophysiological studies / mapping. Importantly, since the electrode spacing between adjacent electrodes on the strut 310 and the electrode spacing between those electrodes on adjacent struts is the same (or otherwise known), bipolar pairs with varying relative orientations can be sampled to determine the electrical properties of the tissue in contact with the bipolar pairs. In some embodiments, the electrodes 311 can perform positioning or position sensing functions related to positioning (e.g., determining the positioning and / or orientation of the catheter 301).

[0059] The planar array 301 is coupled to the distal end of the catheter shaft 305 at a cannula 308 (also referred to as a connector). The catheter shaft 305 may also define a catheter shaft longitudinal axis. In the present embodiment, each strut 310 1-5 extends parallel to the longitudinal axis. The catheter shaft 305 may be made of a flexible material such that it can pass through a patient's tortuous vasculature. In some embodiments, the catheter shaft 305 may include one or more annular electrodes disposed along the length of the catheter shaft. The annular electrodes may be used, for example, in diagnostic, therapeutic, positioning, and / or mapping procedures. In one embodiment, the planar array 301 may include one or more magnetic field sensors configured for an electromagnetic positioning system, such as the MediGuide TM system, sold by St. Jude Medical, Inc. of St. Paul, Minnesota.

[0060] The planar array 301 may be adapted to conform to tissue (e.g., cardiac tissue). For example, when the planar array contacts tissue, each strut 310 1-5 may deflect independently to conform to the tissue. The ability of the planar array to deflect in response to tissue may be particularly beneficial when the planar array contacts contoured, irregular, or trabeculated tissue. In some embodiments, the struts 310 (or the underlying structure of the struts) may be constructed of a flexible or spring-like material such as nitinol and / or a flexible substrate. The construction of the planar array struts 310 1-5 (including, for example, the length and / or diameter of the struts, and the material) may be adjusted to achieve desired elastic, flexible, foldable, compliant, and stiffness characteristics. Moreover, in some embodiments, it may be desirable to vary one or more characteristics from the proximal end to the distal end of the struts, or between or among the plurality of struts forming the planar array 301. The foldability of materials such as nitinol and / or the flexible substrate provides an additional advantage in facilitating insertion of the planar array into a delivery sheath or introducer, both during delivery of the catheter into the body and during removal of the catheter from the body at the end of the procedure.

[0061] Planar array catheters, including high-density electrode arrays located thereon, can be used, for example, to: (1) define regional propagation maps of specific size areas on the heart wall; (2) identify complex graded atrial electrograms for ablation; (3) identify local focused potentials between electrodes to obtain higher electrogram resolution; and / or (4) more precisely target ablation areas. In addition, the catheters described herein may find application in epicardial and / or endocardial use, and more specifically for treating symptoms associated with Brugada syndrome. For example, the planar array embodiments depicted herein may be used in epicardial surgery, where the planar array of electrodes is located between the surface of the myocardium and the pericardium. Alternatively, the planar array can be used in endocardial surgery to scan and / or analyze the inner surface of the myocardium and create a high-density map of the electrical properties of the cardiac tissue.

[0062] Although various embodiments of the planar array 301 disclosed in the present disclosure are depicted as having a plurality of planar arrays 301 coupled to the support posts 310, 1-5 Ring electrode 311 1-N , but embodiments with point electrodes coupled to pillars are readily conceivable. Moreover, in yet other embodiments, the pillars of the planar array may include flexible films compatible with printed circuit manufacturing techniques and / or such films having structural elements coupled to the pillars (e.g., nitinol-based structural elements). In such embodiments, the point electrodes may be printed onto the pillars themselves. In the flexible printed circuit embodiments of the present disclosure, the printed electrodes may be electrically coupled to signal processing circuits and / or driver circuits via traces extending on or within one or more film layers. Since many electrophysiological mapping applications require high signal fidelity, it is desirable to limit the transmission length of analog signals, shield the transmission lines themselves, and / or convert the analog signals into digital signals close to the source of the analog signals. Therefore, aspects of the present disclosure relate to placing signal processing circuits (e.g., analog-to-digital converters, signal conditioning such as noise filtering and bandpass filters) and / or driver circuits on pillars 310. 1-5 on or immediately adjacent to it.

[0063] In the embodiment including the ring electrode 311 1-NIn an embodiment of the planar array 301, the annular electrodes of the high-density electrode array may include the same type of electrodes or various different electrode types. For example, electrodes with a smaller surface area can be dedicated to electrophysiological mapping, while electrodes with a larger surface area can be used for mapping, tissue ablation, and / or localization. In some specific embodiments, the electrode array may include one or more slightly enlarged annular electrodes. These slightly enlarged electrodes can be used, for example, to more precisely position the flexible array in a mapping and navigation system. If desired, ablation current can also be driven between these enlarged electrodes for bipolar ablation, or alternatively, ablation current can be driven in a monopolar mode between one or more of these enlarged annular electrodes and, for example, a ground electrode or patch electrode located on the patient (e.g., on the patient's back). Similarly, in some embodiments, the electrodes 311 1-N may all be capable of performing monopolar or bipolar ablation therapy. Alternatively or concurrently, current can propagate between one or more enlarged electrodes and any one or all of the electrodes. Such monopolar or bipolar ablation therapy techniques can be used to create specific lesion lines or lesion patterns. Also as Figure 3A shown, there may be a distal tip 315 where one or more struts 310 1-5 converge. The distal tip 315 can be constructed of metal or some other radiopaque material to provide fluoroscopic visualization. The distal tip 315 can also facilitate the (semi)-independent planar movement between the struts 310 1-5 .

[0064] In some embodiments of the present disclosure, the mapping catheter 301 may include a steering wire that extends the length of the catheter shaft 305. Before reaching the cannula 308 that couples the catheter shaft 305 to the struts 310 1-5 of the planar array 301, the steering wire can be coupled to a steering ring that receives the tension from the proximal end of the steering wire and facilitates the manipulation of the catheter shaft 305 and the planar array 301 through the patient's vasculature. As further shown in Figure 3A , each strut 310 1-5 includes a plurality of electrodes 311 1-N distributed along the length of the strut. In this embodiment, each electrode is equally spaced from each adjacent electrode. When the controller circuit samples the electrical signals of bipolar pairs of electrodes within the planar array 301, each bipolar pair will detect various electrical characteristics indicative of the health of the tissue in contact with the electrodes. Five struts 310 1-5 are designed to hold the electrodes 311 1-N in a spaced relationship such that each bipolar pair of electrodes captures electrophysiological data of the tissue across a known distance.

[0065] Although many embodiments of the present disclosure relate to electrophysiological mapping, embodiments of the present disclosure may also be configured for pacing (as well). For example, one or more electrodes 311 1-N may send pacing signals to, for example, cardiac tissue.

[0066] Although not shown in Figure 3A , various embodiments of the planar array catheter 301 may include one or more flush ports. For example, in this embodiment, a proximal flush port may be located on / at the distal end of the proximal cannula 308, and the proximal flush port is positioned to deliver a flush agent to the electrode-bearing struts 310 1-5 at or near the point where it exits the distal end of the proximal cannula, which is mounted on the distal end of the catheter shaft 305. In some more specific embodiments, a second, distal flush port may be located near the distal intersection of the struts 310 1-5 and on or near the distal tip 315. In yet other embodiments, multiple flush ports may be present at different locations along the struts 310 if desired. In the case where more than one flush port is provided at the proximal and / or distal ends of the planar array 301, it may be beneficial for a more uniform distribution of the flush agent at or near the proximal / distal vertices of the struts 310.

[0067] Figure 3B Depicted is Figure 3A the planar array catheter 300 having an array 301 of electrodes 311 that contact tissue 325 1-N . In this embodiment, the tissue 305 is depicted as trabecular, irregular, or contoured tissue. As Figure 3B shown, the flexible struts of the planar array including the flexible struts 3101 conform to the tissue 325, enabling the physician to place the planar array 301 (and its electrodes 311 1-N ) in constant contact with the tissue 325. Each strut 310 1-5 can deflect independently to conform to the tissue. As a result, the electrical signals sampled by the planar array (indicating the electrical activity of the tissue) exhibit enhanced accuracy, thus having higher diagnostic value. Each flexible strut includes a plurality of electrodes 311 1-N , and is coupled to other adjacent struts of the planar array 301 at the distal member 315 and the cannula 308. The cannula 308 also couples the planar array 301 to the shaft 305.

[0068] Figure 3C Depicted is the Figure 3A planar array catheter 300 covering the vasculature 330 consistent with various embodiments of the present disclosure. In some embodiments of the present disclosure, the catheter 300 may include a steering wire that extends the length of the catheter shaft 305. At the struts 310 that couple the catheter shaft 305 to the planar array 301 upon reaching1-5 Prior to the cannula 308, the manipulation wire can be coupled to a pull ring that receives the tension from the proximal end of the manipulation wire and facilitates the manipulation of the catheter shaft 305 and the planar array 301 through the patient's vasculature. As Figure 3C further shown, each strut 310 1-5 includes a plurality of electrodes 311 distributed along the length of the strut 1-N . In this embodiment, each electrode is equally spaced. When the controller circuit samples the electrical signals of bipolar pairs of electrodes within the planar array 301, each bipolar pair will detect various electrical characteristics indicative of the health of the tissue in contact with the electrodes.

[0069] In Figure 3C , the vasculature 330 is the left atrium of the myocardium, where the planar array 301 extends across four pulmonary veins 331 1-4 . For discussion purposes, electrophysiological mapping of the patient's left atrium has been completed, and the clinician has confirmed the patient's diagnosis of atrial fibrillation. Based on the electrophysiological mapping obtained near the pulmonary veins 331, the clinician has determined that stray electrical signals emanate from the right superior pulmonary vein 3311 and the right inferior pulmonary vein 3313. Therefore, the clinician has determined that the right superior and right inferior pulmonary veins must be isolated from the left atrium to alleviate the patient's atrial fibrillation symptoms. Then, a plurality of electrodes circumferentially around each target pulmonary vein can be selected and used in one or both of the monopolar / bipolar configurations to perform tissue ablation around the pulmonary vein. The resulting lesions 332 1-2 each surround the corresponding pulmonary vein and exhibit electrical characteristics that inhibit the distribution of electrical signals in the left atrium from the arrhythmia foci within the pulmonary vein.

[0070] Although aspects of the present disclosure have been presented as being readily applicable to radiofrequency ablation techniques, aspects of the present disclosure are also readily applicable to irreversible electroporation (also known as DC ablation). Additionally, although bipolar and monopolar RF techniques have been disclosed herein, variations of such techniques are also contemplated. For example, a bipolar ablation configuration can include alternating adjacent electrode polarities on the electrode array, while the ground pad has a negative polarization. In one monopolar ablation configuration, the ground pad can have an alternating polarity over time, while the adjacent electrodes carry alternating polarities. Additionally, aspects of the present disclosure have discussed the diagnosis and treatment of arrhythmias (e.g., atrial fibrillation); however, the present disclosure is readily applicable to the diagnosis and treatment of a variety of different diseases (e.g., Brugada syndrome).

[0071] Some additional embodiments consistent with the present disclosure may relate to high-voltage direct current (“DC”) ablation (bipolar or monopolar configurations). In such embodiments, the high-voltage DC may include a voltage between 400 and 4,000 volts and minimize current consumption to achieve a voltage gradient rather than a goal of current delivery.

[0072] U.S. Provisional Application No. 62 / 414,634, filed Oct. 28, 2016, U.S. Provisional Application No. 62 / 572,186, filed Oct. 13, 2017, and U.S. Application No. 15 / 793,093, filed Oct. 25, 2017, all generally relate to flexible, high-density mapping catheters and are hereby incorporated by reference as if set forth in full herein.

[0073] Although various embodiments of a high density electrode catheter are disclosed herein, the teachings of the present disclosure can be readily applied to various other catheter embodiments disclosed, for example, in the following patents and patent applications, which are incorporated herein by reference: U.S. Provisional Application No. 61 / 753,429, filed Jan. 16, 2013; U.S. Provisional Application No. 60 / 939,799, filed May 23, 2007; U.S. Application No. 11 / 853,759, filed Sep. 11, 2007, now U.S. Patent No. 8,187,267, issued May 29, 2012; U.S. Provisional Application No. 60 / 947,791, filed Jul. 3, 2007; U.S. Application No. 12 / 167,736, filed Jul. 3, 2008, now U.S. Patent No. 8,206,404, issued Jun. 26, 2012; U.S. Application No. 12 / 667,338, filed Jan. 20, 2011 (371 date), published as U.S. Patent Application Publication No. US 2011 / 0118582 A1; U.S. Application No. 12 / 651,074, filed Dec. 31, 2009, published as U.S. Patent Application Publication No. US 2010 / 0152731 A1; U.S. Application No. 12 / 436,977, filed May 7, 2009, published as U.S. Patent Application Publication No. US 2010 / 0286684 A1; U.S. Application No. 12 / 723,110, filed Mar. 12, 2010, published as U.S. Patent Application Publication No. US 2010 / 0174177 A1; U.S. Provisional Application No. 61 / 355,242, filed Jun. 16, 2010; U.S. Application No. 12 / 982,715, filed Dec. 30, 2010, published as U.S. Patent Application Publication No. US 2011 / 0288392 A1; U.S. Application No. 13 / 159,446, filed Jun. 14, 2011, published as U.S. Patent Application Publication No. US 2011 / 0313417 A1; International Application No. PCT / US2011 / 040629, filed Jun. 16, 2011, published as International Publication No. WO 2011 / 159861 A2; U.S. Application No. 13 / 162,392, filed Jun. 16, 2011, published as U.S. Patent Application Publication No. US 2012 / 0010490 A1; U.S. Application No. 13 / 704,619, filed Dec. 16, 2012, which is the national stage of International Patent Application No. PCT / US2011 / 040781, published as International Publication No. WO 2011 / 159955 A1, filed Jun. 16, 2011;

[0074] Aspects of the present disclosure may be implemented in conjunction with OIS / OT class signal processing algorithms for electrophysiological mapping. OIS / OT and related algorithms are discussed in more detail in U.S. Provisional Application No. 61 / 944,426, filed Feb. 25, 2014, U.S. Application No. 15 / 118,522, filed Feb. 25, 2015, and International Application No. PCT / US2014 / 011940, filed Jan. 16, 2014, which are incorporated herein by reference as if fully set forth herein. Other embodiments of the present disclosure may be implemented in conjunction with various other algorithm types for electrophysiological mapping. For example, embodiments consistent with the present disclosure may utilize electro-signal post-processing techniques and electrophysiological mapping algorithms disclosed in the following publications, which are incorporated herein by reference: Magtibay et al., JAHA 2017 (J Am Heart Assoc. 2017;6:e006447. DOI:10.1161 / JAHA.117.006447) (see, e.g., pages 6 and 7, and the section entitled “Omnipoles Provide the Largest Possible Bipolar Voltages”); and Haldar et al., Circulation AE 2017 (Circ Arrhythm Electrophysiol. 2017;10:e005018. DOI:10.1161 / CIRCEP.117.005018) (see, e.g., page 6, the section entitled “Omnipolar Voltage Amplitude Correlates to Largest Measurable Bipolar Vpp”, and FIG. 4).

[0075] The various embodiments presented herein are suitable for applications of point electrodes coupled to flexible electronic circuits, where the flexible electronic circuits may also (partially) include splines and struts of planar catheters and basket catheters, respectively. Other embodiments may relate to the use of annular electrodes crimped or swaged onto the splines and struts and include materials well known in the art. The annular electrodes are electrically coupled to a signal processing circuit using wires. The annular electrodes positioned along the splines and struts form bipolar pairs of electrodes, and the spacing between the electrodes is known. In other embodiments, the annular electrodes may be swaged or crimped onto a flexible circuit board including at least a portion of the splines and / or struts of the various catheters disclosed herein.

[0076] Although the above has described multiple embodiments to a certain degree of particularity, those skilled in the art can make various changes to the disclosed embodiments without departing from the spirit of the present disclosure. It is intended that all content included in the above description or shown in the accompanying drawings be interpreted as illustrative only and not restrictive. Changes in details or structures can be made without departing from the teachings. The foregoing description and the appended claims are intended to cover all such modifications and variations.

[0077] Multiple embodiments of various devices, systems, and methods are described herein. Numerous specific details are set forth to provide a thorough understanding of the overall structure, function, manufacture, and use of the embodiments described in the specification and shown in the drawings. However, those skilled in the art will understand that these embodiments can be practiced without such specific details. In other instances, well-known operations, components, and elements have not been described in detail so as not to obscure the embodiments described in the specification. Those of ordinary skill in the art will understand that the embodiments described and shown herein are non-limiting examples, and thus it can be understood that the specific structural and functional details disclosed herein can be representative and do not necessarily limit the scope of the embodiments, the scope of which is defined only by the appended claims.

[0078] References throughout the specification to "multiple embodiments", "some embodiments", "one embodiment", "an embodiment", etc. mean that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the phrases "in multiple embodiments", "in some embodiments", "in one embodiment", "in an embodiment", etc. appearing throughout the specification do not necessarily all refer to the same embodiment. Additionally, the particular features, structures, or characteristics can be combined in any suitable manner in one or more embodiments. Thus, a particular feature, structure, or characteristic shown or described in connection with one embodiment can be incorporated in whole or in part with the features, structures, or characteristics of one or more other embodiments without limitation.

[0079] It should be understood that the terms "proximal" and "distal" can be used throughout the specification with reference to a clinician operating on one end of an instrument for treating a patient. The term "proximal" refers to the portion of the instrument closest to the clinician, and the term "distal" refers to the portion farthest from the clinician. It will be further understood that, for the sake of brevity and clarity, spatial terms such as "vertical", "horizontal", "upward", and "downward" can be used herein with respect to the illustrated embodiments. However, surgical instruments can be used in many orientations and positions, and these terms are not restrictive and absolute.

[0080] Any patents, publications or other publicly available materials described as being incorporated herein by reference are incorporated herein in whole or in part only to the extent that such incorporated materials are not in conflict with the existing definitions, statements or other publicly available materials set forth in this disclosure. Accordingly, and to the extent necessary, the disclosure expressly set forth herein supersedes any conflicting materials incorporated herein by reference. Any material or portion thereof that is described as being incorporated herein by reference but that conflicts with the existing definitions, statements or other publicly available materials set forth herein is incorporated only to the extent that the incorporated material does not conflict with the existing publicly available materials.

Claims

1. A planar array catheter, comprising: An elongate catheter shaft including a proximal end and a distal end and defining a longitudinal axis; And A flexible planar array coupled to the distal end of the catheter shaft, the planar array configured to conform to tissue and including two or more struts extending generally parallel to the longitudinal axis, each of the struts being in the same plane and having a plurality of electrodes coupled thereto, Wherein the plurality of electrodes are configured and arranged to detect electrophysiological properties of tissue in contact with the planar array and to operate in a combination of bipolar and monopolar configurations to effect ablation therapy of the contacted tissue; And Wherein a controller circuit is communicatively coupled to the electrodes and is configured and arranged to receive signals from the electrodes indicative of electrophysiological properties of the tissue in contact with the planar array, generate an electrophysiological map of the contacted tissue, operate one or more pairs of the electrodes in the combination of the bipolar and monopolar configurations at least in part based on the electrophysiological map to effect the ablation therapy of the contacted tissue, and control a treatment depth of the ablation therapy using the combination of the bipolar and monopolar configurations, wherein operation of the planar array in each of the bipolar and monopolar configurations respectively includes applying a voltage difference between 400 and 4000 volts to create irreversible electroporation.

2. The planar array catheter according to claim 1, wherein, One or more of the plurality of electrodes are point electrodes and one or more of the struts include a flexible electronic circuit board communicatively and mechanically coupled to the plurality of electrodes.

3. The planar array catheter according to claim 1, wherein, The planar array catheter further includes: a plurality of temperature sensors, each of the temperature sensors being mechanically coupled to one of the struts and positioned to be in thermal communication with at least one of the electrodes; the controller circuit communicatively coupled to the plurality of temperature sensors and the plurality of electrodes, and the controller circuit being configured and arranged to control power delivery to each electrode at least in part based on the temperature measured by the temperature sensors proximate each electrode.

4. The planar array catheter according to claim 1, wherein, The controller circuit is further configured and arranged to operate the electrodes in the monopolar or bipolar configuration during the ablation therapy according to desired lesion characteristics at each electrode.

5. The planar array catheter according to claim 1, wherein, The plurality of electrodes include bipolar electrode pairs including electrodes on adjacent struts of the planar array.

6. The planar array catheter according to claim 5, wherein, The bipolar electrode pairs are configured to sample electrical properties of the contacted tissue and effect a controlled tissue ablation therapy; and wherein the plurality of electrodes are further configured to operate in a monopolar configuration with a ground pad conductively coupled to the patient's skin to facilitate a transmural lesion of the contacted tissue.

7. The planar array catheter according to claim 1, wherein, The plurality of electrodes include bipolar electrode pairs that extend diagonally across adjacent struts of the planar array.

8. A basket catheter, comprising: An elongate catheter shaft including a proximal end and a distal end; A flexible basket including a plurality of splines, the flexible basket coupled to the distal end of the catheter shaft and configured to conform to tissue; A plurality of electrodes mounted to the splines; The plurality of electrodes are configured and arranged to detect electrophysiological characteristics of tissue in contact with the flexible basket and operate in a combination of bipolar and monopolar configurations to perform ablation therapy on the contacted tissue; and a controller circuit is communicatively coupled to the electrodes and is configured and arranged to receive signals from the electrodes indicative of electrophysiological characteristics of the tissue in contact with the flexible basket, generate an electrophysiological map of the contacted tissue, operate one or more pairs of the electrodes in the combination of the bipolar configuration and the monopolar configuration at least in part based on the electrophysiological map to perform the ablation therapy on the contacted tissue, and control a treatment depth of the ablation therapy using the combination of the bipolar configuration and the monopolar configuration, wherein operation of the electrodes in each of the bipolar configuration and the monopolar configuration includes applying a voltage difference between 400 and 4000 volts to produce irreversible electroporation.

9. The basket catheter according to claim 8, wherein, One or more of the plurality of electrodes are point electrodes, and the spline includes a flexible electronic circuit board that is communicatively and mechanically coupled to the plurality of electrodes.

10. The basket catheter according to claim 8, wherein, The basket catheter further includes: a plurality of temperature sensors, each of the temperature sensors being mechanically coupled to one of the splines and positioned to be in thermal communication with at least one of the electrodes; and the controller circuit is communicatively coupled to the plurality of temperature sensors and the plurality of electrodes, and the controller circuit is configured and arranged to control power delivery to each electrode at least in part based on the temperature measured by the temperature sensors near each electrode.

11. The basket catheter according to claim 8, wherein, The controller circuit is further configured and arranged to operate the electrodes in the monopolar configuration or the bipolar configuration during the ablation therapy according to desired lesion characteristics at each electrode.

12. The basket catheter according to claim 8, wherein, The plurality of electrodes include bipolar electrode pairs that extend diagonally across adjacent splines of the flexible basket.

13. The basket catheter according to claim 12, wherein, The bipolar electrode pairs are configured to sample electrical characteristics of the contacted tissue and perform a controlled tissue ablation therapy; and wherein the plurality of electrodes are further configured to operate in a monopolar configuration with a ground pad conductively coupled to the patient's chest to facilitate a transmural lesion of the contacted tissue.

14. The basket catheter according to claim 8, wherein, The plurality of electrodes include bipolar electrode pairs that include electrodes on adjacent splines.

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