Radiofrequency ablation and DC electroporation catheters

Abstract

This disclosure provides a flexible catheter for both electrophysiological mapping and ablation using a high-density array of electrodes. [Solution] This catheter can be used to detect the electrophysiological properties of the tissue 13 in contact with the electrode, and to perform unipolar and bipolar ablation of the tissue.

Description

[Technical Field]

[0001] Cross-reference of related applications This application claims the interests of U.S. Provisional Patent Application No. 62 / 674,314, filed on 21 May 2018, and is incorporated herein by reference as if it were fully described herein.

[0002] This disclosure relates, for example, to radiofrequency ablation catheters for treating myocardial tissue within the muscle of the heart. More specifically, this disclosure relates to basket catheters and planar array catheters having multiple electrodes located within a high-density array. [Background technology]

[0003] Catheters have been used in cardiac medical procedures for many years. They are used, for example, to diagnose and treat cardiac arrhythmias and can be positioned in specific locations within the body that are otherwise inaccessible, without the need for more invasive surgery.

[0004] Conventional ablation catheters may, for example, comprise multiple adjacent ring electrodes surrounding the longitudinal axis of a basket catheter. These ring electrodes may be made of platinum or some other metal. Such ring electrodes are relatively rigid and can provide ablation therapy (e.g., RF ablation energy) for treating conditions associated with cardiac arrhythmias.

[0005] When performing ablation therapy on myocardial tissue, a particularly unstable or irregular heartbeat makes it difficult to maintain adequate contact between the electrode and the tissue for a sufficient period of time. These problems are exacerbated on uneven, irregular, or trabeculogenic surfaces. If adequate contact between the electrode and the tissue cannot be maintained, the likelihood of achieving high-quality changes is low.

[0006] Typically, cardiac ablation therapy is performed using a focal point ablation catheter. The focal point ablation catheter supplies energy between a single electrode and a ground pad. As electrophysiological mapping becomes more accurate, ablation therapy can similarly be more targeted. More targeted ablation therapy limits damage to unnecessary tissue.

[0007] For ablation therapy for atrial fibrillation and the like, the duration is extended because the clinician must introduce an electrophysiological mapping catheter into the patient's left atrium, confirm the diagnosis, and determine the ablation therapy procedure before removing the electrophysiological mapping catheter. After introducing the ablation catheter and completing the ablation therapy, the electrophysiological mapping catheter is subsequently reintroduced to confirm the effectiveness of the therapy. Considering the above, a catheter capable of both electrophysiological mapping and ablation therapy should be desirable to limit the duration of the surgery.

Summary of the Invention

Means for Solving the Problems

[0008] The foregoing discussion is only intended to explain the field and should not be construed as a negation or interpretation of the claims.

[0009] Aspects of the present disclosure are directed to a flexible catheter for both electrophysiological mapping and ablation using a high-density electrode array. Using such a catheter, the electrophysiological properties of the tissue in contact with the electrode can be detected, and monopolar and / or bipolar ablation of the tissue can be performed. Specifically, the present disclosure relates to both planar and basket-type end effectors coupled to the distal end of a catheter shaft.

[0010] Some embodiments of this disclosure relate to a planar array catheter comprising an elongated catheter shaft and a flexible planar array connected to the distal end of the catheter shaft. The catheter shaft defines a longitudinal axis. The flexible planar array has two or more struts that abut along the tissue and extend substantially parallel to the longitudinal axis. Each strut has a plurality of electrodes arranged in a common plane and connected to the strut. The plurality of electrodes detect the electrophysiological properties of the tissue in contact with the planar array and selectively ablate the tissue. In more specific embodiments, the plurality of electrodes of the planar array can operate in both unipolar and bipolar configurations for tissue ablation.

[0011] Another embodiment of the present disclosure relates to a basket catheter comprising an elongated catheter shaft having a proximal and distal end, a flexible basket having a plurality of splines, and a plurality of electrodes attached to the plurality of splines. The flexible basket, coupled to the distal end of the catheter shaft, abuts along the tissue. The plurality of electrodes detect the electrophysiological properties of the tissue in contact with the basket and selectively ablate the tissue. In some specific embodiments, the basket catheter further comprises a plurality of temperature sensors and an ablation controller circuit. Each temperature sensor is mechanically coupled to a spline and arranged to be in thermal communication with at least one of the electrodes. The ablation controller circuit is communicatively coupled to the plurality of temperature sensors and the plurality of electrodes. The ablation controller circuit controls the power supply to each electrode, at least in part, based on the temperature near each electrode as measured by the temperature sensors.

[0012] The aforementioned and other aspects, features, details, usefulness, and advantages of this disclosure will become apparent upon reading the following description and claims and examining the accompanying drawings.

[0013] Various exemplary embodiments can be better understood by considering the following detailed description along with the accompanying drawings. [Brief explanation of the drawing]

[0014] [Figure 1] This is a schematic diagram of an electrophysiological catheter system consistent with various embodiments of the present disclosure.

[0015] [Figure 2A] This is an isometric side view of a basket-type end effector for an electrophysiological catheter, consistent with various embodiments of the present disclosure.

[0016] [Figure 2B] Figure 2A is a magnified view of a portion of four adjacent splines of the basket-type end effector, consistent with various embodiments of this disclosure.

[0017] [Figure 2C] Figure 2A shows a portion of two adjacent splines of the basket-type end effector, consistent with various embodiments of the present disclosure, and an enlarged view of the grounding pad that, together with the basket, forms a high-frequency ablation system.

[0018] [Figure 3A] This is a top view of a planar end effector of an electrophysiological mapping catheter, consistent with various embodiments of the present disclosure.

[0019] [Figure 3B] Figure 3A shows a planar array catheter comprising an array of electrodes that come into contact with tissue, consistent with various embodiments of this disclosure.

[0020] [Figure 3C] Figure 3A shows a planar array catheter on a vascular structure, consistent with various embodiments of this disclosure. [Modes for carrying out the invention]

[0021] The various embodiments discussed herein may be applicable to modified and alternative forms, which are shown in the drawings as examples and will be described in detail. However, it should be understood that the invention is not intended to be limited to the individual embodiments described. Rather, it is intended to encompass all modifications, equivalents, and alternative forms within the scope of this disclosure, including the forms defined in the claims. In addition, the term “example” used throughout this application is for illustrative purposes only and not limiting.

[0022] Aspects of this disclosure relate to flexible catheters for both 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 to perform unipolar and / or bipolar ablation of the tissue. More specifically, this disclosure relates to both planar and basket-type end effectors connected to the distal end of the catheter shaft.

[0023] Pacing is performed to conduct electrophysiological mapping of the cardiac muscle. During pacing, adjacent electrodes are assigned to dipole pairs, and each dipole pair samples the electrical properties of the tissue between them. The resulting electrical signals are received and processed by a controller circuit. The controller circuit creates an electrophysiological map by associating the signal samples from each dipole pair with the locations of the tissue sampled by the dipole pair. The potential diagrams from each dipole pair can be analyzed, and various electrical properties can be visually represented on the electrophysiological map by color coding (or other visual representation methods, e.g., shading, patterning). In some embodiments, the color coding may be based on the voltage of the potential diagram at each location (e.g., center, mean, maximum). In other embodiments, the number of times the electrical signal exceeds a threshold voltage (or the voltage gradient changes) during the sampling window period may be visually displayed on the map. In yet another embodiment, the total energy sampled during the time window period may be displayed. Various other methods of fractionation accounting are known and may be used as one or more factors in the resulting color coding displayed on the electrophysiological map. These electrophysiological maps can be used by clinicians to validate diagnoses, gain insights into desirable ablation therapy procedures, and verify the effectiveness of the therapy.

[0024] Aspects of this disclosure relate to intravascular catheters equipped with an end-effector capable of electrophysiological mapping and unipolar / bipolar radiofrequency ablation therapy. Historically, cardiac ablation therapy has been performed using a one-to-one ablation technique, supplying energy between a single electrode located at the distal tip of the catheter and a grounding pad electrically coupled to the patient's chest. However, high-density electrophysiological mapping catheters easily improve diagnostic identification, thereby allowing clinicians to use electrophysiological maps to more accurately target problematic tissue (e.g., tissue containing arrhythmic lesions) for ablation therapy. This is particularly desirable because clinicians want to minimize the ablation of healthy myocardial tissue as much as possible in order to maintain healthy function of the left atrium. To further improve the workflow of ablation therapy, aspects of this disclosure relate to performing both left atrium electrophysiological mapping and ablation therapy using a single catheter. Combining such functions within a single catheter can reduce the length of ablation therapy (and operating room time). More specific embodiments of this disclosure relate to controlling the ablation depth of an ablation catheter. Such embodiments are facilitated by improved three-dimensional electrophysiological mapping that reveals the subsurface electrophysiological properties of the contacting myocardial tissue. Ablation therapy can then be customized to provide tissue ablation therapy with varying depths across the entire left atrium by using a combination of unipolar and bipolar radiofrequency tissue ablators.

[0025] In many adults, the depth of myocardial tissue is typically less than 3 millimeters, and often less than 2 millimeters. Aspects of this disclosure relate to customizing patient tissue ablation therapy, for example, by varying the treatment depth of ablation therapy to treat only damaged tissue, thereby alleviating symptoms associated with cardiac arrhythmias. For example, a treatment plan for ablation therapy may utilize a combination of unipolar RF mode (ablation between a single electrode and a grounding pad) and bipolar RF mode (ablation between electrodes on a catheter) to vary the depth of ablation therapy. Treatment with such variable-depth ablation therapy reduces the risk to vulnerable tissues such as the phrenic nerve. In more specific embodiments, multiplexed or selected continuous energy deliveries that form variations may be utilized to further customize ablation therapy.

[0026] In certain aspects of this disclosure, a basket catheter having eight splines is disclosed. Each spline is composed of a shape-memory material that returns to a semicircular shape when exiting the introducer. Each spline is evenly distributed circumferentially around the basket relative to the other splines. When expanded, the eight splines form a substantially circular basket. Each spline is provided with a row of electrodes extending along the longitudinal direction of the spline. The electrodes may be uniformly distributed along the longitudinal direction of the spline, or, for specific applications, non-uniformly distributed along the longitudinal direction of the spline. For example, the electrode distribution may be weighted toward the distal end of the basket if the basket catheter is intended, for example, to diagnose cardiac arrhythmias. Many cardiac arrhythmias are caused by stray electrical signals originating from one or more pulmonary veins. Assuming a transseptal approach to the left atrium, a clinician would orient the distal end of a basket with a high-density array of electrodes toward the pulmonary veins. Once placed in the left atrium, the basket catheter allows for electrophysiological mapping of the left atrium, ablation of myocardial tissue adjacent to the pulmonary veins to alleviate symptoms associated with atrial fibrillation, and remapping of the left atrium to verify the effectiveness of the therapy.

[0027] In some specific embodiments of this disclosure, a planar array catheter comprising five struts is disclosed. Each strut is aligned with the longitudinal axis of the catheter shaft and can extend parallel to the longitudinal axis. Each strut is connected to other struts of the planar array at its proximal and distal ends. Each strut comprises a row of electrodes extending along the longitudinal direction of the strut. In some specific embodiments, the electrodes are evenly distributed between adjacent struts of the planar array along the longitudinal direction of the strut. According to various embodiments, the planar catheter array of this disclosure may comprise at least four, five, six, seven, or possibly even eight struts. In the embodiment shown in Figure 3A, the array comprises five struts.

[0028] The electrodes disclosed herein may be ring electrodes and / or printed (spot) electrodes on a substrate (e.g., a flexible circuit board). Printed electrodes are advantageous because they can be arranged at closer intervals than ring electrodes. In some embodiments, for example, printed electrodes are successfully arranged at 0.1 mm intervals on a planar array catheter. More typically, ring electrodes and printed electrodes are advantageous when arranged at intervals of 0.5 mm to 4 mm. Such electrode spacing has been found to easily provide the desired electrophysiological mapping granularity in many cardiovascular applications, for example. Furthermore, by positioning electrodes at high density around a planar array or basket catheter, customizable ablation therapies can be facilitated that minimize the amount of altered tissue needed to mitigate the effects of cardiac arrhythmias such as atrial fibrillation in patients.

[0029] Conventional mapping catheter designs use a bipolar electrode configuration to detect, measure, and display electrical signals from the heart, and a unipolar electrode configuration in catheters that ablate tissue one site at a time to facilitate tissue ablation. However, various aspects of this disclosure relate to the use of a combination of unipolar and bipolar configurations on a catheter, for example, to facilitate the treatment of atrial fibrillation. Whether to perform unipolar or bipolar ablation at a given tissue location may be selected by comparison, for example, based on the desired depth or width of ablation. In some specific embodiments, an ablation controller circuit can receive an electrophysiological map of a target tissue area and determine the type of ablation therapy each tissue region within the target tissue area will receive. Alternatively, a clinician can manually design the ablation therapy based on the provided electrophysiological map, or otherwise approve / modify the treatment procedure designed by the ablation controller circuit.

[0030] A basket catheter for ablation therapy consistent with this disclosure may comprise multiple electrodes distributed around one or more splines forming a basket. Each electrode can operate in a unipolar or bipolar configuration, or both simultaneously. That is, a single electrode can simultaneously transmit radiofrequency energy to adjacent electrodes on the basket catheter and to a patch electrode on the patient's chest. In some more specific embodiments, thermocouples may be positioned below (or in close proximity to) one or more electrodes to enable temperature-controlled radiofrequency tissue ablation.

[0031] Details of various embodiments of this disclosure are described below with specific reference to the figures.

[0032] Figure 1 is a schematic diagram of an electrophysiological catheter system consistent with various embodiments of this disclosure.

[0033] Herein, referring to drawings where similar reference numbers are used to identify identical components in various figures, Figure 1 shows an overall force-detecting electrophysiological catheter system 10, comprising an elongated medical device 19 having a sensor assembly 11 (e.g., multiple electrodes for electrophysiological mapping and ablation) configured for use in the body for medical procedures. The elongated medical device 19 can be used for the diagnosis, visualization, and / or treatment of tissues 13 in the body (such as cardiac tissue or other tissues). For example, the medical device 19 may be used for tissue ablation therapy or mapping purposes in the patient's body 14. Figure 1 further shows various subsystems that may be provided in the overall system 10. The system 10 may comprise a main computer system 15 (equipped with an electronic control unit 16 and a data storage device 17, e.g., memory). The computer system 15 may further comprise conventional interface components, among other components, such as various user input / output mechanisms 18A and displays 18B. The computer system 15 can process information provided from the sensor assembly 11 and provide data to the clinician via the input / output mechanism 18A and / or the display 18B, or in any other manner described herein.

[0034] In the exemplary embodiment shown in Figure 1, the elongated medical device 19 may comprise a cable connector or cable interface 20, a handle 21, and a tubular body or shaft 22 having a proximal end 23 and a distal end 24. The elongated medical device 19 may also comprise other conventional components not shown herein, such as a temperature sensor, additional electrodes, and corresponding conductors or leads. The connector 20 can provide mechanical, fluid, and / or electrical connections for cables 25, 26 extending from the fluid reservoir 12 and pump 27, and the computer system 15, respectively. The connector 20 may comprise conventional components known in the art and may be located at the proximal end of the elongated medical device 19, as shown.

[0035] The handle 21 includes a portion for the user to grasp or hold the elongated medical device 19, and may further include a mechanism for manipulating or guiding the shaft 22 within the patient's body 14. For example, the handle 21 may include a mechanism configured to change the tension of a pull wire extending through the elongated medical device 19 to the distal end 24 of the shaft 22, or some other mechanism for manipulating the shaft 22. The handle 21 may be conventional in the art, and the configuration of the handle 21 may vary.

[0036] Computer system 15 can perform some of the functions described herein by utilizing software, hardware, firmware, and / or logic. Computer system 15 may be a combination of hardware and instructions for sharing information. Hardware may include, for example, processing resources 16 and / or memory 17 (e.g., a computer-readable medium (CRM) database). Processing resources 16 as used herein may comprise several processors capable of executing instructions stored by memory resources 17. Processing resources 16 may be integrated into a single device or distributed across multiple devices. Instructions (e.g., computer-readable instructions (CRIs)) may include instructions stored in memory 17 that are executable by processing resources 16 for force detection.

[0037] The memory resource 17 is communicatively coupled to the processing resource 16. The memory 17 used herein may comprise several memory components capable of storing instructions executed by the processing resource 16. Such memory 17 may be, for example, a non-temporary computer-readable storage medium. The memory 17 may be integrated into a single device or distributed across multiple devices. Furthermore, the memory 17 may be fully or partially integrated into the same device as the processing resource 16, or it may be configured separately but accessible from that device and the processing resource 16. It should be noted that the computer system 15 can therefore be implemented on user devices and / or sets of user devices, mobile devices and / or sets of mobile devices, and / or combinations of user devices and mobile devices.

[0038] Memory 17 may be communicatively coupled to processing resources 16 via a communication link (e.g., a path). The communication link may be local or remote to the computer processing device associated with processing resources 16. If memory 17 is one of the volatile, non-volatile, fixed, and / or removable storage media that communicates with processing resources 16 via an electron bus, an example of a local communication link may include an electron bus inside the computer processing device.

[0039] Figure 2A is an isometric side view of a basket-type end effector (also referred to as a basket catheter) of an electrophysiological catheter, consistent with various embodiments of the present disclosure. The basket catheter 201 in Figure 2A is shown in an enlarged form. The basket 201 has multiple splines 210 connected to the catheter shaft 205 at its proximal end and to (or to) the distal cap 215 at its distal end. 1~8 This embodiment consists of eight splines 210 1~8While a basket composed of the above is presented, a basket catheter with three or more splines, designed according to the intended clinical application and desired electrophysiological mapping particle size, is easily conceivable. To facilitate the inflation / deflation of the basket, spline 210 1~8 It may be made of a shape memory alloy (e.g., Nitinol) that returns to a semicircular shape after exiting the introducer. In yet another embodiment, the basket catheter can be expanded / contracted using a deployment member.

[0040] In this embodiment, spline 210 1~8 Each of these consists of multiple electrodes 211, which are distributed throughout each spline of a predetermined length. 1~N The embodiment shown in Figures 2A to 2C features electrodes 211 regularly dispersed along the longitudinal direction of each spline. 1~N While this is shown, other embodiments may include electrodes that are unevenly distributed along the spline. For example, in electrophysiological mapping applications of pulmonary veins, only the distal portion of the basket may be in contact with the proximal tissue of the pulmonary veins. Therefore, electrode 211 1~N The dispersion is weighted toward the distal end of basket 201, which can easily increase the granularity of the electrophysiological mapping closer to the pulmonary veins.

[0041] electrode 211 1~NIt may be used in various bipolar configurations to facilitate the measurement of the electrical properties of the tissue in contact with the electrodes. The first dipole pair may include a pair of electrodes 211 along the longitudinal direction of the spline 210, facilitating the collection of electrical property data of the tissue in a direction substantially parallel to the longitudinal axis of the catheter. The second orthogonal dipole pair can span adjacent splines 210, facilitating the collection of electrical property data of the tissue in a direction substantially transverse to the longitudinal axis of the catheter. To facilitate the collection of this electrical data, these bipolar electrode pairs may be individually addressable by a signal processing circuit. The signal processing circuit analyzes the signals received from the various bipolar electrode pairs and assembles an electrophysiological map that visualizes the electrophysiological data of the tissue in contact with the electrodes sensed by the basket catheter.

[0042] In various embodiments consistent with the present disclosure, the spline 210 can be formed of a flexible electronic circuit board, and each of the electrodes 211 is coupled to the electronic circuit board and communicatively coupled to a signal processing circuit via an electrical trace extending along an inner or outer layer of the flexible printed circuit board. In some particular embodiments, the splines 210 can each be made of nitinol. In such embodiments, the flex circuit may be directly coupled to the nitinol or, alternatively, the flex circuit may be directly coupled to a Pebax® tube that houses the nitinol splines internally.

[0043] In some embodiments, the electrode 211 has a diameter of 0.8 millimeters and a total surface area of 0.5 mm 2The electrodes 211 of the basket catheter 201 do not need to be uniform in size and shape. For example, embodiments consistent with the present disclosure may include electrodes that facilitate electrophysiological mapping, RF tissue ablation, and optionally impedance-based or hybrid-based catheter guidance systems (e.g., the MediGuide® system and / or the EnSite® NavX® system, both commercially available from Abbott).

[0044] In some embodiments, it may be desirable to have equal spacing between all electrodes 211 on a single spline 210 and between all electrodes 211 between splines, but knowledge of the relative spacing between each electrode forming a dipole pair is sufficient to accurately capture electrical property data of the tissue in contact with the electrodes. In some specific embodiments, the end-to-end spacing of one or more dipole pairs of electrodes may be between 2 and 2.5 millimeters. In yet other specific embodiments, the center-to-center spacing of electrodes in a dipole pair may be between 0.5 and 4 millimeters.

[0045] In some specific embodiments, some of the electrodes 211 on the basket 201 may be multi-purpose, while others may be single-purpose. For example, some electrodes may function as both induction, ablation, and electrophysiological mapping electrodes, others may function only as electrophysiological mapping electrodes, and yet others may function only as induction electrodes.

[0046] As further shown in Figure 2A, the distal cap 215 is spline 210 1~8 The distal ends of the catheters may serve several purposes, including connecting them together on the dorsal surface (near the longitudinal axis of the catheter) and providing the most distal surface of the catheter to prevent unintended trauma to tissue in contact with the distal cap.

[0047] In various embodiments consistent with this disclosure, each spline of the basket catheter can be connected to one or more operating wires that, when activated, expand and / or contract the splines to form a desired shape.

[0048] This disclosure relates to a basket catheter 201 having eight electrodes 211 on each spline 210, but various other embodiments are readily conceivable. For example, the basket catheter may have more or fewer splines and / or more or fewer electrodes on each spline.

[0049] As will be discussed in more detail below, one unique advantage of the basket catheter, which allows for both electrophysiological mapping and ablation therapy, is reduced surgical time. This is because the clinician does not need to replace the electrophysiological mapping catheter with an ablation catheter after confirming the treatment procedure. Furthermore, because the relative location of the ablation target tissue is known due to the effect of electrophysiological mapping and the static position of the basket catheter in the patient's left atrium, the need for magnetic-based and / or impedance-based positioning of the ablation catheter within the patient's cardiac muscle can be reduced.

[0050] Figure 2B shows four adjacent splines 210 of basket 201 in Figure 2A, consistent with various embodiments of this disclosure. 1~4 This is a magnified view of a part of it. Each of the splines 210 has several electrodes 211 1~12 They are equipped with electrodes that may be used to sense the electrophysiological properties of tissue (often operating in a bipolar configuration with another adjacent electrode) and / or to ablate the tissue in contact with the electrode. The electrodes can ablate tissue using a bipolar configuration, or a unipolar configuration in which one or more electrodes are paired with, for example, a grounding pad attached to the patient's chest. As shown in Figure 2B, several pairs of bipolar electrodes 212 1~NThese are shown. These pairs can extend along the longitudinal axis of the spline, traverse the longitudinal axis of the spline, or the electrode pair can traverse diagonally between two adjacent splines. Such a system can perform electrophysiological mapping using a bipolar configuration of electrodes across the entire 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, bipolar ablation therapy can be performed to ablate only myocardial tissue containing tissues that are prone to transmitting stray electrical signals and / or arrhythmic lesions (which may generate such electrical signals).

[0051] One unique advantage of bipolar ablation therapy is that, because the positive and negative electrodes are in close proximity, the actual energy delivered to the target tissue is known. Furthermore, bipolar ablation therapy limits energy delivery to non-target tissue due to the relatively proximal position of the electrodes.

[0052] Figure 2B shows a dipole pair of electrodes that are close together and adjacent to each other, but other arrangements of dipole pairs are easily conceivable. For example, electrode pairs that are not close together and adjacent to each other. For example, when the electrodes operate in a dipole configuration, tissue ablation may occur with electrodes 2111 and 211 12 This may be performed on tissue adjacent to the first spline 2101. In some embodiments, several first electrodes (e.g., electrode 211) are placed on the first spline 2101. 1~3 ) is a second set of electrodes (e.g., electrode 211) on the second spline 2102. 4~6 ) can operate in a bipolar configuration. In yet another embodiment, several first electrodes (e.g., electrode 211) on the first spline 2101 may be used. 1~3 ) is a third electrode on the third spline 2103 (for example, electrode 211 7~9 It can operate in a bipolar configuration with ). Furthermore, several first electrodes (e.g., electrode 211) on the first spline 2101 1~3 ) is a fourth electrode on the fourth spline 2104 (for example, electrode 21110~12 It can operate in a bipolar configuration with ).

[0053] Figure 2C shows the two adjacent splines 210 of the basket catheter 201 in Figure 2A. 1~2 This is an enlarged view of the grounding pad 214, which together with and as part of the high-frequency ablation system 299. As discussed in Figure 2B, each spline 210 is connected to several electrodes 211 1~4 Each electrode may be paired with another adjacent electrode to facilitate electrophysiological mapping and / or tissue ablation at the bipolar electrode (e.g., bipolar electrode pair 212). 1~N Alternatively, or simultaneously, electrode 211 1~4 Also, the configuration of unipolar ablation therapy (e.g., unipolar electrode pair 213) 1~N To operate in this manner, it may be paired with a grounding pad 214. During ablation therapy, electrodes operating in a unipolar configuration will result in deeper changes, while electrodes in a bipolar configuration will produce more precisely placed changes.

[0054] Figure 3A is a top view of a planar array 301 of an electrophysiological mapping catheter, consistent with various embodiments of this disclosure. The planar array 301 of the electrophysiological mapping catheter comprises electrodes 311 1~N It has a high-density array. The planar array 301 has electrodes 311 1~N This forms a flexible array of electrodes. This array of electrodes extends along a strut 310 that is approximately parallel to the longitudinal axis of the catheter shaft 305. 1~5 It is connected to a flexible framework. Each strut is positioned precisely laterally apart from the adjacent strut 310 1~5 Upper electrode 311 1~N This facilitates precise spacing between them. The struts are connected to each other at their distal and proximal ends (for example, at the distal tip 315 and bush 308).

[0055] As shown in Figure 3A, five struts 310 1~5Each of the struts may carry a plurality of electrodes 311, the electrodes being spaced the same (or at least known) along the longitudinal direction of the strut. Similarly, the spacing between electrodes 311 spanning the struts 310 of the array may also be equal (or at least known). The result is a dipole pair of multiple electrodes with known spacings. For example, in some embodiments, the center spacing of the electrodes in the dipole pair may be between 0.5 and 4 mm. In more specific embodiments, the center spacing of the electrodes in the dipole pair may be less than 0.5 mm (e.g., 0.1 mm). While this embodiment deals with dipole pairs with equal center spacing, various other embodiments of electrode arrays consistent with this disclosure may include electrode arrays with equal end-to-end spacing. For example, in some embodiments, the end-to-end spacing of the electrodes may be between 0.5 and 4 mm. In more specific embodiments, the end-to-end spacing of the electrodes may be less than 0.5 mm (e.g., 0.1 mm). If the electrodes 311 of array 301 have varying relative sizes (or surface areas), it may be desirable to consider the spacing from edge to edge.

[0056] The planar array 301 in Figure 3A consists of five struts 310 1~5 While the diagram shows that the catheter may have more or fewer struts at intervals between each strut, based on the desired electrode spacing for a given electrophysiological application, the planar array 301 shown in Figure 3A has 20 electrodes 311, but the planar array may have more or fewer electrodes than 20, and each strut may not have the same number of electrodes as the adjacent struts.

[0057] In some embodiments, electrode 311 1~NIt may be used in diagnostic, therapeutic, and / or mapping procedures. For example, but not limited to, the electrode 311 may be used for electrophysiological studies, pacing, cardiac mapping, and ablation. In some embodiments, the electrode 311 may perform unipolar and / or bipolar tissue ablation therapy. Ablation therapy can produce specific lines or patterns of change. In some embodiments, the electrode 311 can receive electrical signals from a pacing electrode, which may be used for electrophysiological studies / mapping. Importantly, since the electrode spacing between adjacent electrodes on a strut 310 and the electrode spacing between electrodes on adjacent struts are the same (or otherwise known), dipole pairs with various relative orientations can be sampled to determine the electrical properties of the tissue in contact with the dipole pair. In some embodiments, the electrode 311 may perform a location or position sensing function in relation to localization (e.g., determining the location and / or orientation of a catheter 310).

[0058] The planar array 301 is connected to the distal end of the catheter shaft 305 by a bush 308 (also called a connector). The catheter shaft 305 may also define the longitudinal axis of the catheter shaft. In this embodiment, a strut 310 1~5 Each of these extends parallel to the longitudinal axis. The catheter shaft 305 may be made of a flexible material so that it can be inserted through the patient's tortuous vascular structure. In some embodiments, the catheter shaft 305 may comprise one or more ring electrodes arranged along the longitudinal direction of the catheter shaft. The ring electrodes may be used, for example, in diagnostic, therapeutic, localization, and / or mapping procedures. In one embodiment, the planar array 301 may comprise one or more magnetic field sensors configured for use with an electromagnetic localization system, such as the MediGuide® system sold by St. Jude Medical, Inc. in St. Paul, Minnesota.

[0059] The planar array 301 may be fitted to contact along tissue (e.g., cardiac tissue). For example, when the planar array is in contact with the tissue, each strut 310 1~5 Each can bend separately to contact the tissue. The ability of the planar array to bend in accordance with the tissue can be particularly beneficial when the planar array is in contact with uneven, irregular, or trabeculatically formed tissue. In some embodiments, the strut 310 (or the substructure of the strut) may be made of a flexible or spring-like material such as nitinol and / or a flexible substrate. Planar Array Strut 310 1~5 The structure (including, for example, the length and / or diameter of the struts, and the material) may be adjusted to achieve desired elastic, flexible, bendable, conformable, and rigid properties. Furthermore, in some embodiments, it may be desirable to vary one or more properties from the proximal end to the distal end of the strut, or between or within the struts forming the planar array 301. The collapsibility of materials such as nitinol and / or flexible substrates provides the additional advantage of allowing the planar array to be easily inserted into the delivery sheath or introducer, whether when delivering the catheter into the body or when removing the catheter from the body at the end of surgery.

[0060] A planar array catheter equipped with a high-density electrode array positioned above it may be used, for example, for: (1) defining a map showing local propagation over an area of ​​a specific size of the cardiac wall; (2) identifying a complex-subdivided atrial electrophoresis for ablation; (3) identifying localized local potentials between electrodes to improve the resolution of the electrophoresis; and / or (4) more precisely targeting the area to be ablated. Furthermore, the catheter described herein may be applied to epicardial and / or endocardial use, more specifically, to the treatment of symptoms associated with Brugada syndrome. For example, the planar array embodiment shown herein may be used in epicardial procedures when the planar array of electrodes is positioned between the myocardial surface and the pericardium. Alternatively, the planar array can be used in endocardial surgery to sweep and / or analyze the inner surface of the myocardium to create a high-density map of the electrical properties of cardiac tissue.

[0061] Various embodiments of the planar array 301 disclosed herein include strut 310 1~5 Ring electrode 311 connected to 1~NAlthough shown as comprising, embodiments comprising spot electrodes connected to struts are readily conceivable. Furthermore, in yet another embodiment, the planar array struts may comprise a flexible thin film suitable for printed circuit manufacturing techniques and / or such thin film may be coupled to structural elements of the struts (e.g., nitinol-based structural elements). In such embodiments, the spot electrodes may be printed on the struts themselves. In embodiments of the flexible printed circuits of the present disclosure, the printed electrodes may be electrically coupled to signal processing circuits and / or drive circuits via traces extending on or within one or more thin film layers. Many electrophysiological mapping applications require high signal fidelity, so it is desirable to limit the transmission length of analog signals, shield the transmission lines themselves, and / or convert analog signals to digital signals near the analog signal source. Therefore, embodiments of the present disclosure connect signal processing circuits (e.g., analog-to-digital converters, noise filtering, and signal conditioning such as bandpass filters) and / or drive circuits to struts 310 1~5 This is intended for placement above or in close proximity to the strut.

[0062] Ring electrode 311 1~NIn embodiments of the planar array 301, the ring electrodes of the high-density electrode array may include electrodes of the same type or a variety of different types of electrodes. For example, electrodes with a smaller surface area may be used exclusively for electrophysiological mapping, while electrodes with a larger surface area may be used for mapping, tissue ablation, and / or localization. In some specific embodiments, the electrode array may include one or more slightly enlarged ring electrodes. Such slightly enlarged electrodes can be used, for example, for more precise localization of the flexible array in the mapping and guidance system. If necessary, it may be possible to drive an ablation current between these enlarged electrodes for bipolar ablation, or alternatively, to drive an ablation current in unipolar mode between one or more of these enlarged ring electrodes and, for example, a ground electrode or a patch electrode on the patient (e.g., on the patient's back). Similarly, in some embodiments, electrode 311 1~N All of these may be capable of performing unipolar or bipolar ablation therapy. Alternatively, or in parallel, current may flow between one or more expansion electrodes and any one or all electrodes. This unipolar or bipolar ablation therapy technique can be used to create specific lines or patterns of change. As can also be seen in Figure 3A, one or more struts 310 1~5 A distal tip 315 may be provided to integrate the two. This distal tip 315 may be made of metal or some other radiopaque material to enable visualization by fluoroscopy. The distal tip 315 may further include a strut 310 1~5 This can facilitate (semi-)independent planar motion between them.

[0063] In some embodiments of the present disclosure, the mapping catheter 301 may include a manipulative wire that extends the length of the catheter shaft 305. The manipulative wire moves the catheter shaft 305 to the struts 310 of the planar array 301. 1~5Before reaching the bush 308 to which it connects, the proximal end of the operating wire is connected to an operating ring that receives tension, which can facilitate the manipulation of the catheter shaft 305 and planar array 301 through the patient's vascular structure. As further shown in Figure 3A, strut 310 1~5 Each of these consists of multiple electrodes 311 distributed along the longitudinal direction of the strut. 1~N It is equipped with. In this embodiment, each electrode is positioned at equal intervals from each adjacent electrode. When the controller circuit samples electrical signals from the dipole pairs of electrodes in the planar array 301, each dipole pair will detect various electrical characteristics that indicate the health of the tissue in contact with the electrode. Five struts 310 1~5 Electrode 311 1~N The electrodes are designed to maintain a spaced-out relationship, so that each pair of electrode dipole data can capture electrophysiological data over a known distance in the tissue.

[0064] While many embodiments of this disclosure concern electrophysiological mapping, embodiments of this disclosure may also be configured (similarly) for pacing. For example, one or more electrodes 311 1~N This allows pacing signals to be transmitted, for example, to cardiac tissue.

[0065] Although not shown in Figure 3A, various embodiments of the planar array catheter 301 may have one or more irrigation ports. For example, the proximal irrigation port may be located on or at the distal end of the proximal bush 308, and the proximal irrigation port may be located on the strut 310 that supports the electrode. 1~5 However, in this embodiment, the irrigation fluid is supplied to the point where it emerges from or near the distal end of the proximal bushing attached to the distal end of the catheter shaft 305. In some more specific embodiments, the second distal irrigation port is located on the strut 310 1~5They may be located near the distal confluence, on or near the distal tip 315. In yet another embodiment, multiple irrigation ports may be located at various positions along the strut 310 as needed. When multiple irrigation ports are located at the proximal and / or distal ends of the planar array 301, the irrigation fluid can be easily and more uniformly dispersed at or near the proximal / distal apex of the strut 310.

[0066] Figure 3B shows the electrode 311 in contact with tissue 325. 1~N Figure 3A shows a planar array catheter 300 equipped with array 301. The tissue 305 in this embodiment is shown as trabeculafformed, irregular, or undulating tissue. As shown in Figure 3B, the flexible strut of the planar array, equipped with a flexible strut 3101, is used by a physician to connect the planar array 301 (and the electrodes 311 of the planar array). 1~N ) enables positioning so as to follow the tissue 325 and to make stable contact with the tissue 325. Each strut 310 1~5 Each of the flexible struts can flex independently to contact the tissue. As a result, the accuracy of the electrical signals (indicating the electrical activity of the tissue) sampled by the planar array is improved, thereby making the diagnostic values ​​more accurate. Each of the flexible struts has multiple electrodes 311 1~N It is equipped with a distal member 315 and a bush 308 which connect to other adjacent struts of the planar array 301. The bush 308 further connects the planar array 301 to the shaft 305.

[0067] Figure 3C shows the planar array catheter 300 of Figure 3A on a vascular structure 330, consistent with various embodiments of the present disclosure. In some embodiments of the present disclosure, the catheter 300 may include a manipulative wire that extends the length of the catheter shaft 305. The manipulative wire moves the catheter shaft 305 to the struts 310 of the planar array 301. 1~5Before reaching the bush 308 to which it connects, the steering wire is connected to a pull ring that receives tension from its proximal end, which can facilitate the manipulation of the catheter shaft 305 and planar array 301 through the patient's vascular structure. As further shown in Figure 3C, the strut 310 1~5 Each of these consists of multiple electrodes 311 distributed along the longitudinal direction of the strut. 1~N The system includes the following: In this embodiment, each electrode is arranged at equal intervals. When the controller circuit samples electrical signals from the dipole pairs of electrodes in the planar array 301, each dipole pair will detect various electrical characteristics that indicate the health of the tissue in contact with the electrode.

[0068] In Figure 3C, the vascular structure 330 is the left atrium of the heart muscle, and the planar array 301 is the four pulmonary veins 331 1~4 It extends across. For consideration, electrophysiological mapping of the patient's left atrium is completed and the clinician confirms the diagnosis of the patient's atrial fibrillation. Based on the electrophysiological mapping acquired in close proximity to the pulmonary vein 331, the clinician determined that the stray electrical signals were originating from the right superior pulmonary vein 3311 and the right inferior pulmonary vein 3313. Therefore, the clinician determined that the right superior and right inferior pulmonary veins needed to be isolated from the left atrium to alleviate the patient's atrial fibrillation symptoms. Next, to perform tissue ablation around the pulmonary veins, multiple electrodes circumferentially surrounding each of the target pulmonary veins are selected and may be used in either a unipolar / bipolar configuration or both. Resulting changes 332 1~2 Each of these structures surrounds its respective pulmonary vein and exhibits electrical properties that suppress the dispersion of stray electrical signals from arrhythmia lesions within the pulmonary veins within the left atrium.

[0069] While aspects of this disclosure have been presented as readily applicable to radiofrequency ablation techniques, aspects of this disclosure are also readily applicable to irreversible electroporation (also known as DC ablation). Furthermore, while bipolar and unipolar RF techniques are disclosed herein, variations of such techniques are also conceivable. For example, in a bipolar ablation configuration, the polarities of adjacent electrodes on the electrode array may be alternating with a negatively polarized grounding pad. In a unipolar ablation configuration, the grounding pad may alternately acquire different polarities over time, with adjacent electrodes having alternatingly different polarities. Furthermore, while aspects of this disclosure have been discussed including the diagnosis and treatment of cardiac arrhythmias (e.g., atrial fibrillation), this disclosure is readily applicable to the diagnosis and treatment of several different diseases, such as Brugada syndrome.

[0070] Another embodiment consistent with this disclosure relates to high-voltage direct current (DC) ablation (in a bipolar or unipolar configuration). In such embodiments, the high-voltage DC may be between 400 and 4000 volts, and the current draw may be minimal, as the target is a voltage gradient rather than a current supply.

[0071] U.S. Provisional Patent Application No. 62 / 414,634, filed on 28 October 2016, U.S. Provisional Patent Application No. 62 / 572,186, filed on 13 October 2017, and U.S. Patent Application No. 15 / 793,093, filed on 25 October 2017, all generally pertain to flexible, high-density mapping catheters and are incorporated by reference as fully described herein.

[0072] While various embodiments of high-density electrode catheters are disclosed herein, the teachings of this disclosure can be readily applied to various other catheter embodiments disclosed, for example, in the following patents and patent applications incorporated herein by reference. U.S. Provisional Patent Application No. 61 / 753,429 filed on January 16, 2013; U.S. Provisional Patent Application No. 60 / 939,799 filed on May 23, 2007; U.S. Patent Application No. 11 / 853,759 filed on September 11, 2007, which is now U.S. Patent No. 8,187,267, for which a patent certificate was issued on May 29, 2012; U.S. Provisional Patent Application No. 60 / 947,791 filed on July 3, 2007; U.S. Patent Application No. 12 / 167,736 filed on July 3, 2008, which is now U.S. Patent No. 8,206,404, for which a patent certificate was issued on June 26, 2012; U.S. Patent Application No. 12 / 667,338 filed on January 20, 2011 (dated under Section 371 of the U.S. Patent Act (371) A patent filed on December 31, 2009, under the US Patent Application Publication No. 2011 / 0118582A1, a patent filed on December 31, 2009, under the US Patent Application Publication No. 12 / 651,074, under the US Patent Application Publication No. 2010 / 0152731A1, a patent filed on May 7, 2009, under the US Patent Application Publication No. 12 / 436,977, under the US Patent Application Publication No. 2010 / 0286684A1, a patent filed on March 12, 2010, under the US Patent Application Publication No. 12 / 723,110, under the US Patent Application Publication No. 2010 / 0174177A1, on June 16, 2010 U.S. Provisional Patent Application No. 61 / 355,242 filed, U.S. Patent Application No. 12 / 982,715 filed on 30 December 2010 and published as U.S. Patent Publication No. 2011 / 0288392A1, U.S. Patent Application No. 13 / 159,446 filed on 14 June 2011 and published as U.S. Patent Publication No. 2011 / 0313417A1, International Patent Application No. PCT / US2011 / 040629 filed on 16 June 2011 and published as International Publication No. 2011 / 159861A2, U.S. Patent Application No. 13 / 162 filed on 16 June 2011,Patent No. 392, published as U.S. Patent Application Publication No. 2012 / 0010490A1; U.S. Patent Application No. 13 / 704,619, filed on 16 December 2012, which is the national phase of International Patent Application PCT / US2011 / 040781, filed on 16 June 2011, and published as International Publication No. 2011 / 159955A1.

[0073] Various aspects of this disclosure can be implemented in conjunction with OIS / OT-like signal processing algorithms for electrophysiological mapping. OIS / OT and related algorithms are discussed in more detail in U.S. Provisional Patent Application No. 61 / 944,426 filed February 25, 2014, U.S. Patent Application No. 15 / 118,522 filed February 25, 2015, and International Patent Application No. PCT / US2014 / 011940 filed January 16, 2014, and are incorporated herein by reference as if they were fully disclosed herein. Further embodiments of this disclosure can be implemented in conjunction with various other types of algorithms for electrophysiological mapping. For example, embodiments consistent with this disclosure can utilize electrode signal post-processing techniques and electrophysiological mapping algorithms disclosed in the following publications and incorporated herein by reference. Magtibay et al., JAHA2017 (Journal of the American Heart Association 2017;6:e006447.DOI:10.1161 / JAHA.117.006447) (see, for example, pages 6 and 7, and the paragraph titled "Omnipoles Provide the Largest Possible Bipolar Voltages"), and Haldar et al., CirculationAE2017 (Circulation, Arrhythmia and Electrophysiology 2017;10:e005018.DOI:10.1161 / CIRCEP.117.005018) (see, for example, page 6, the paragraph titled "Omnipolar Voltage Amplitude Correlates to Largest Measurable Bipolar Vpp", and Figure 4).

[0074] Various embodiments presented herein can be applied to spot electrodes coupled to flexible electronic circuits, where the flexible electronic circuits may also comprise (partially) splines and struts of planar catheters and basket catheters, respectively. Further embodiments may focus on the use of ring electrodes crimped or riveted to splines and struts, and comprising materials well known in the art. The ring electrodes are electrically coupled to a signal processing circuit using lead wires. The ring electrodes, positioned along splines and struts, form a pair of electrode dipole pairs with a known distance between them. In yet another embodiment, the ring electrodes may be riveted or crimped to a flexible circuit board comprising at least a portion of splines and / or struts of various catheters disclosed herein.

[0075] While several embodiments have been described above with a certain degree of specificity, those skilled in the art may make many modifications to the disclosed embodiments without departing from the spirit of the disclosure. All matters included in the above description or shown in the accompanying drawings are intended to be construed as illustrative and not limiting. Detailed or structural modifications can be made without departing from the current teachings. The foregoing description and the following claims are intended to encompass all such modifications and variations.

[0076] Various embodiments of various devices, systems, and methods are described herein. Numerous specific details are given to provide a complete understanding of the overall structure, function, manufacture, and use of the embodiments, as described in the specification and shown in the accompanying drawings. However, those skilled in the art will understand that embodiments may be carried out without such specific details. In other examples, well-known operations, components, and elements are not described in detail so as not to obscure the embodiments described herein. Those skilled in the art will understand that the embodiments described and illustrated herein are non-limiting examples. Accordingly, it will be understood that the specific structural and functional details disclosed herein are typical and do not necessarily limit the scope of the embodiments, and the scope of the embodiments is defined solely by the appended claims.

[0077] The descriptions throughout this specification such as “various embodiments,” “several embodiments,” “one embodiment,” and “embodiment” mean that a particular feature, structure, or characteristic described in relation to an embodiment is included in at least one embodiment. Therefore, the occurrences of phrases such as “in various embodiments,” “several embodiments,” “one embodiment,” and “in an embodiment” throughout this specification do not necessarily all refer to the same embodiment. Furthermore, a particular feature, structure, or characteristic may be combined in any preferred manner in one or more embodiments. Thus, a particular feature, structure, or characteristic illustrated or described in relation to one embodiment may be combined, in whole or in part, with features, structures, or characteristics of one or more other embodiments, without limitation.

[0078] It will be understood that the terms “proximal” and “distal” may be used throughout this specification in relation to the manipulation of one end of an instrument used by a clinician to treat a patient. “Proximal” refers to the part of the instrument closest to the clinician, and “distal” refers to the part furthest from the clinician. It will further be understood that, for brevity and clarity, spatial terms such as “vertical,” “horizontal,” “up,” and “down” may be used herein in relation to the illustrated embodiments. However, surgical instruments may be used in many orientations and positions, and these terms are not intended to be restrictive or absolute.

[0079] Any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated only to the extent that the incorporated material does not conflict with existing definitions, descriptions, or other disclosure material contained herein. Therefore, to the extent necessary, disclosures expressly contained herein take precedence over any conflicting material incorporated by reference herein. Any material or part of material that is said to be incorporated by reference but conflicts with existing definitions, descriptions, or other disclosure material contained herein is incorporated only to the extent that it does not create a conflict between the incorporated material and the existing disclosure material.

Claims

1. A planar array catheter, A slender catheter shaft having a proximal end and a distal end and defining a longitudinal axis, A flexible planar array, Connected to the distal end of the catheter shaft, It is configured to contact the organization, It has two or more struts that extend substantially parallel to the longitudinal axis, Each of the two or more struts is arranged in a common plane and has a planar array with multiple electrodes connected to the strut, Equipped with, A planar array catheter in which the plurality of electrodes are configured and arranged to detect the electrophysiological properties of tissue in contact with the planar array and to selectively ablate the tissue.

2. The planar array catheter according to claim 1, wherein the plurality of electrodes of the planar array are further configured to perform radiofrequency tissue ablation and to operate in both unipolar and bipolar configurations for tissue ablation.

3. One or more of the aforementioned multiple electrodes are spot electrodes, The planar array catheter according to claim 1, wherein one or more of the two or more struts are equipped with a flexible electronic circuit board that is capable of communicating with the plurality of electrodes and is mechanically coupled to them.

4. The aforementioned planar array catheter further, A plurality of temperature sensors, each of which is mechanically connected to the strut and arranged to enable thermal communication with at least one of the plurality of electrodes, An ablation controller circuit is communicatively coupled to the plurality of temperature sensors and the plurality of electrodes, wherein the ablation controller circuit is configured and arranged to control the power supply to each electrode at least partially based on the temperature near each electrode measured by the plurality of temperature sensors, A planar array catheter according to claim 1, comprising:

5. The planar array further comprises an ablation controller circuit that is communicatively coupled to the plurality of electrodes. The ablation controller circuit is, From the plurality of electrodes, signals indicating the electrophysiological characteristics of the tissue in contact with the planar array are received. An electrophysiological map of the aforementioned tissue is generated, Control the ablation therapy of the tissue based at least partially on the electrophysiological map. A planar array catheter according to claim 1, configured and arranged in such manner.

6. The planar array catheter according to claim 5, wherein the ablation controller circuit is further configured and arranged to operate the plurality of electrodes in a unipolar or bipolar configuration during the ablation therapy, depending on the desired characteristics of the changes at each electrode.

7. The planar array catheter according to claim 1, wherein the plurality of electrodes include a pair of bipolar electrodes, each electrode on an adjacent strut of the planar array.

8. The bipolar electrode pair is configured to sample the electrical properties of the contacting tissue and to perform controlled tissue ablation therapy. The planar array catheter according to claim 7, wherein the plurality of electrodes are further configured to operate in a unipolar configuration in combination with a grounding pad electrically bonded to the patient's skin in order to facilitate changes in the transmurality of the tissues in contact.

9. The planar array catheter according to claim 1, wherein the plurality of electrodes include a pair of bipolar electrodes that diagonally extend across adjacent struts of the planar array.

10. It is a basket catheter. A slender catheter shaft having a proximal end and a distal end, A flexible basket is connected to the distal end of the catheter shaft and is equipped with multiple splines, configured to contact the tissue, Multiple electrodes attached to the multiple splines, Equipped with, A basket catheter in which the plurality of electrodes are configured and arranged to detect the electrophysiological properties of tissue in contact with the basket and to selectively ablate the tissue.

11. The basket catheter according to claim 10, wherein the plurality of electrodes on the plurality of splines are further configured to perform radiofrequency tissue ablation and to operate in both unipolar and bipolar configurations for tissue ablation.

12. One or more of the aforementioned multiple electrodes are spot electrodes, The basket catheter according to claim 10, wherein the plurality of splines are equipped with a flexible electronic circuit board that is capable of communicating with and mechanically coupled to the plurality of electrodes.

13. The aforementioned basket catheter further comprises, A plurality of temperature sensors, each of which is mechanically connected to the spline and arranged to enable thermal communication with at least one of the plurality of electrodes, An ablation controller circuit is communicatively coupled to the plurality of temperature sensors and the plurality of electrodes, wherein the ablation controller circuit is configured and arranged to control the power supply to each electrode at least partially based on the temperature near each electrode measured by the plurality of temperature sensors, A basket catheter according to claim 10, comprising:

14. The basket catheter further comprises an ablation controller circuit that is communicatively coupled to the plurality of electrodes. The ablation controller circuit is, From the plurality of electrodes, signals indicating the electrophysiological characteristics of the tissue in contact with the basket are received. An electrophysiological map of the aforementioned tissue is generated, Control the ablation therapy of the tissue based at least partially on the electrophysiological map. The basket catheter according to claim 10, configured and arranged in such manner.

15. The basket catheter according to claim 14, wherein the ablation controller circuit is further configured and arranged to operate the electrodes in a unipolar or bipolar configuration during the ablation therapy, depending on the desired characteristics of the changes at each electrode.

16. The ablation controller circuit is further configured and arranged to operate the plurality of electrodes in a bipolar configuration and to supply high voltage DC to the contacting tissue to affect tissue ablation, and The basket catheter according to claim 14, wherein the ablation controller circuit is further configured and arranged to minimize current draw to the plurality of electrodes and to supply a desired voltage gradient.

17. The basket catheter according to claim 10, wherein the plurality of electrodes include pairs of bipolar electrodes that diagonally extend across adjacent splines of the basket.

18. The bipolar electrode pair is configured to sample the electrical properties of the contacting tissue and to perform controlled tissue ablation therapy. The basket catheter according to claim 17, wherein the plurality of electrodes are further configured in a unipolar configuration to work in combination with a grounding pad electrically coupled to the patient's chest in order to facilitate changes in the transmurality of the tissues in contact.

19. The basket catheter according to claim 10, wherein the plurality of electrodes include a pair of bipolar electrodes having electrodes on adjacent splines.

20. The planar array catheter according to claim 1, wherein the plurality of electrodes of the planar array are further configured to operate in a bipolar configuration and to supply a high voltage DC to the contacting tissue to affect tissue ablation.

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