Integrated focal ablation catheter and expandable mapping and ablation catheter

Abstract

To provide medical probes. [Solution] Disclosed is a medical probe comprising an elongated shaft extending along a longitudinal axis and a distal electrode positioned at the distal end of the elongated shaft, the distal electrode configured to deliver ablation energy to tissue. The medical probe comprises an outer sleeve at least partially positioned around the elongated shaft and a plurality of planar members attached to the outer sleeve and extending radially outward from the longitudinal axis. Each of the plurality of planar members comprises a framework coupled to an outer member and an inner member opposite the outer member. Each of the inner and outer members includes a plurality of electrodes positioned diametrically on the inner and outer members, and the outer sleeve is configured to move axially along the elongated shaft to move the plurality of planar members axially relative to the distal electrode.

Description

Technical Field

[0001] The present invention generally relates to medical devices, and more particularly to a catheter configured to ablate tissue by pulsed field ablation.

Background Art

[0002] Cardiac arrhythmias such as atrial fibrillation (AF) occur when regions of cardiac tissue conduct electrical signals abnormally to adjacent tissue. This disrupts the normal cardiac cycle and causes asynchronous rhythms. Arrhythmias are treated surgically or by catheter ablation to stop or alter the propagation of unwanted electrical signals from one part of the heart to another.

[0003] Many current ablation approaches utilize radiofrequency (RF) electrical energy to heat tissue. RF ablation has certain rare drawbacks due to operator skill, such as an increased risk of thermal cell damage that can cause tissue carbonization, charring, steam pops, phrenic nerve paralysis, pulmonary vein stenosis, and esophageal fistulas. Cryoablation is an alternative approach to RF ablation that reduces some of the thermal risks associated with RF ablation, but can present tissue damage due to the ultra-low temperature nature of such devices. Operating a cryoablation device to selectively apply cryoablation is generally more difficult compared to RF ablation, and thus cryoablation is not feasible in certain anatomical shapes that can be reached by RF ablation devices.

[0004] Pulsed-field ablation (PFA) is a relatively new non-thermal method for ablating cardiac tissue by inducing irreversible electroporation (IRE) within the cells of a target tissue. To achieve IRE, short pulses of high-voltage electrical signals are delivered to the tissue, and the electrical signals cause irreversible permeabilization of the cell membrane. Examples of systems and devices configured for IRE ablation are described in U.S. Patent Applications Publications 2021 / 0169550(A1), 2021 / 0169567(A1), 2021 / 0169568(A1), 2021 / 0196372(A1), 2021 / 0177503(A1), and 2021 / 0186604(A1), and U.S. Patent No. 11,540,877, each of which is incorporated herein in whole by reference and attached to the appendices herein.

[0005] Areas of cardiac tissue can be mapped by catheters to identify abnormal electrical signals. Some catheter ablation procedures, particularly those involving persistent atrial fibrillation, may be performed using electrophysiological (EP) mapping to target areas of abnormal electrical signals. Such EP mapping may involve the use of diagnostic electrodes configured to monitor electrical signals within the cardiovascular system to precisely indicate the location of abnormal conductive tissue sites involved in arrhythmias. An example of an EP mapping system is described in U.S. Patent No. 5,738,096, which is incorporated herein by reference in its entirety and attached to the appendices herein. Examples of EP mapping catheters are described in U.S. Patent No. 9,907,480, U.S. Patent Publication No. 2018 / 0036078, and U.S. Patent Publication No. 2018 / 0056038, each of which is incorporated herein by reference in its entirety.

[0006] In addition to using EP mapping, some catheter ablation procedures may be performed using image-guided surgery (IGS) systems. IGS systems can allow physicians to visually track the catheter's position within the patient in real time in relation to images of the patient's anatomical structures. Some systems, including the CARTO 3® system by Biosense Webster, Inc. (Irvine, California), can offer a combination of EP mapping and IGS capabilities. [Overview of the project] [Problems that the invention aims to solve]

[0007] In many catheter ablation procedures, physicians typically first map the tissue using a mapping catheter with a large surface area (such as a balloon catheter, basket catheter, or other catheter with multiple mapping electrodes), and then insert a focal ablation catheter with a single electrode at its distal end to ablate a small area of ​​tissue, or insert an expandable ablation catheter with multiple electrodes to ablate a larger area. This process generally requires the physician to remove the mapping catheter before inserting the focal ablation catheter in order to ablate the tissue. As is understood, inserting and removing multiple catheters can prolong the time required to ablate the tissue and cause additional stress to the patient's cardiovascular system. These and other issues are addressed by the art of this disclosure as herein. [Means for solving the problem]

[0008] The technology of the present disclosure includes a medical probe comprising an elongated shaft extending along a longitudinal axis and a distal electrode positioned at the distal end of the elongated shaft. The distal electrode may be configured to deliver ablation energy to tissue. The medical probe further comprises an outer sleeve at least partially positioned around the elongated shaft and a plurality of planar members attached to the outer sleeve and extending radially outward from the longitudinal axis. Each of the plurality of planar members comprises a framework coupled to an outer member and an inner member opposite the outer member. Each of the inner and outer members includes a plurality of electrodes positioned diametrically on the inner and outer members, and the outer sleeve is configured to move axially along the elongated shaft to move the plurality of planar members axially relative to the distal electrode.

[0009] The techniques of the present disclosure further include a method comprising inserting a medical probe into a lumen of the body. The medical probe comprises an elongated shaft extending along a longitudinal axis and a distal electrode positioned at the distal end of the elongated shaft. The distal electrode may be configured to deliver ablation energy to tissue. The medical probe further comprises an outer sleeve at least partially positioned around the elongated shaft and a plurality of planar members attached to the outer sleeve and extending radially outward from the longitudinal axis. Each of the plurality of planar members comprises a plurality of electrodes, and the outer sleeve may be configured to move axially along the elongated shaft to move the plurality of planar members axially relative to the distal electrode. The method may further include sliding the outer sleeve along the elongated shaft to extend the plurality of planar members beyond the distal end of the distal electrode and receiving one or more electrophysiological signals from at least one of the plurality of electrodes positioned on the plurality of planar members. [Brief explanation of the drawing]

[0010] This specification concludes with claims that specifically identify and assert rights to the subject matter described herein, which is better understood from the following description of specific embodiments taken in conjunction with the accompanying drawings. In the drawings, similar reference numerals identify the same elements. The drawings depict one or more implementations of the device of the present invention, not as limitations but merely as examples. [Figure 1] This is a diagram illustrating an exemplary catheter-based electrophysiological mapping and ablation system according to one embodiment of the technology disclosed herein. [Figure 2A] This figure shows a mapping and ablation catheter having both a focal end effector portion and an expandable end effector portion according to one embodiment of the technology of the present disclosure, wherein the focal end effector portion is in an extendable configuration. [Figure 2B] This is a diagram of a mapping and ablation catheter according to an embodiment of the technology of the present disclosure, having both a focal end-effector portion and an expandable end-effector portion in which the focal end-effector portion is in a retracted configuration. [Figure 3A] This figure shows a focal end effector portion in an extended configuration and an expandable end effector portion in an extended configuration, according to one embodiment of the technology of the present disclosure. [Figure 3B] This figure shows a focal end effector portion in a retracted configuration and an expandable end effector portion in an extended configuration, according to one embodiment of the technology of the present disclosure. [Figure 3C] This figure shows another embodiment of a catheter having a focal end effector portion in an extended configuration and an expandable end effector portion in an extended configuration, according to one embodiment of the technology of the present disclosure. [Figure 3D] Figure 3D shows an exemplary catheter according to one embodiment of the technology of the present disclosure, in which the focal end effector portion is in a retracted configuration and the expandable end effector portion is in an expanded configuration. [Figure 4] This is a detailed view of the focal end effector portion according to one embodiment of the technology disclosed herein. [Figure 5A]This is a detailed diagram of an expandable end effector portion according to one embodiment of the technology of the present disclosure. [Figure 5B] This is a front view of a planar member of an expandable end effector portion according to one embodiment of the technology of the present disclosure. [Figure 5C] This is an enlarged view of a portion of the planar member of the expandable end effector shown in Figure 5B, according to one embodiment of the technology of the present disclosure. [Figure 6A] This is a diagram of a first exemplary electrode configuration for an exemplary planar member of an expandable end-effector portion, including an elongated, serpentine ablation electrode and a diagnostic electrode positioned along the ablation electrode. [Figure 6B] This figure shows a second exemplary electrode configuration for an exemplary planar member of an expandable end-effector portion, each including an elongated ablation electrode segmented into small parallel stripes and a diagnostic electrode positioned along the ablation electrode. [Figure 6C] This is a diagram of a third exemplary electrode configuration of an exemplary planar member of an expandable end-effector portion, which includes a rectangular, elongated ablation electrode without a diagnostic electrode. [Figure 6D] This is a diagram of a fourth exemplary electrode configuration of an exemplary planar member of an expandable end-effector portion, which includes a rectangular, elongated ablation electrode interrupted by a diagnostic electrode. [Figure 6E] This is a diagram of an exemplary electrode configuration of an exemplary end effector, including an elongated, serpentine ablation electrode. [Figure 6F] This is a diagram of an exemplary electrode configuration of an exemplary end effector, which includes a rectangular, elongated ablation electrode. [Figure 6G] This is a diagram showing an exemplary electrode configuration of an exemplary end effector including a large-area ablation electrode. [Figure 7]This is a diagram of an exemplary electrode configuration on one side of an exemplary planar member of an expandable end-effector portion, which includes an elongated ablation electrode in two ablation electrode regions, a diagnostic electrode positioned within the two ablation electrode regions, a tissue contact electrode positioned between the two ablation electrode regions, and a reference electrode positioned within the proximal region on the illustrated side of the end-effector. [Figure 8A] Figure 8A shows an alternative configuration of the insulating material in a cross-sectional view of the planar member, which is configured with an opening in the end effector as shown in Figure 5B. Figure 8B includes a polymer body region extending the width of the end effector. Figure 8C includes a high dielectric layer between each side and extends the width of the end effector, and Figure 8D includes a high dielectric tile between each side and is configured to overlap so that the end effector folds into the delivery sheath. [Figure 8B] Figure 8A shows an alternative configuration of the insulating material in a cross-sectional view of the planar member, which is configured with an opening in the end effector as shown in Figure 5B. Figure 8B includes a polymer body region extending the width of the end effector. Figure 8C includes a high dielectric layer between each side and extends the width of the end effector, and Figure 8D includes a high dielectric tile between each side and is configured to overlap so that the end effector folds into the delivery sheath. [Figure 8C] Figure 8A shows an alternative configuration of the insulating material in a cross-sectional view of the planar member, which is configured with an opening in the end effector as shown in Figure 5B. Figure 8B includes a polymer body region extending the width of the end effector. Figure 8C includes a high dielectric layer between each side and extends the width of the end effector, and Figure 8D includes a high dielectric tile between each side and is configured to overlap so that the end effector folds into the delivery sheath. [Figure 8D]FIG. 8A is a diagram of an alternative configuration of an insulating material in a cross-sectional view of a planar member, and is configured with an opening in an end effector as shown in FIG. 5B. FIG. 8B includes a polymer body region extending the width of the end effector. FIG. 8C includes a high dielectric layer between each side surface and extends the width of the end effector, and FIG. 8D includes high dielectric tiles between each side surface and is configured to overlap so as to fold the end effector into a delivery sheath. [Figure 8E] FIG. is a diagram of an exemplary electrode configuration of an exemplary end effector in which an ablation electrode surrounds the spine of a planar member or the insulating material. [Figure 8F] FIG. is a diagram of an exemplary electrode configuration of an exemplary end effector in which an ablation electrode partially surrounds the spine of a planar member or the insulating material. [Figure 9A] FIG. is a diagram of an end effector in which an ablation electrode is configured to provide a pulse of 600V to 2,600V between ablation electrode regions. [Figure 9B] FIG. 9B is a diagram of an end effector to which the procedure shown is applied to a potato model. [Figure 10A] Various examples of voltages applied across the electrodes of a planar member are shown according to an example of the technology of the present disclosure. FIGS. 10A and 10B illustrate, for each pair, a voltage applied across an electrode pair in an intersecting body configuration where one ablation electrode contacts tissue and the other electrode is on the opposite side of the end effector body and crosses the central axis of the end effector body from the first electrode region. FIG. 10C shows the voltage applied across an ablation electrode pair where both ablation electrodes of the pair contact tissue and are arranged transverse to each other across the central axis, and FIG. 10D shows the voltage applied across an ablation electrode in contact with tissue and an ablation electrode on the opposite side of the end effector that is not in contact with tissue. [Figure 10B]Examples of voltages applied across electrodes of a planar member are shown using the techniques of the present disclosure. Figures 10A and 10B illustrate the voltage applied across the electrode pair in a cross-body configuration, where one ablation electrode is in contact with tissue and the other electrode is on the opposite side of the end effector body, and the voltage is applied across the central axis of the end effector body from the first electrode region. Figure 10C shows the voltage applied across an ablation electrode pair where both ablation electrodes are in contact with tissue and are positioned across each other's central axes, and Figure 10D shows the voltage applied across an ablation electrode in contact with tissue and an ablation electrode on the opposite side of the end effector that is not in contact with tissue. [Figure 10C] Examples of voltages applied across electrodes of a planar member are shown using the techniques of the present disclosure. Figures 10A and 10B illustrate the voltage applied across the electrode pair in a cross-body configuration, where one ablation electrode is in contact with tissue and the other electrode is on the opposite side of the end effector body, and the voltage is applied across the central axis of the end effector body from the first electrode region. Figure 10C shows the voltage applied across an ablation electrode pair where both ablation electrodes are in contact with tissue and are positioned across each other's central axes, and Figure 10D shows the voltage applied across an ablation electrode in contact with tissue and an ablation electrode on the opposite side of the end effector that is not in contact with tissue. [Figure 10D] Examples of voltages applied across electrodes of a planar member are shown using the techniques of the present disclosure. Figures 10A and 10B illustrate the voltage applied across the electrode pair in a cross-body configuration, where one ablation electrode is in contact with tissue and the other electrode is on the opposite side of the end effector body, and the voltage is applied across the central axis of the end effector body from the first electrode region. Figure 10C shows the voltage applied across an ablation electrode pair where both ablation electrodes are in contact with tissue and are positioned across each other's central axes, and Figure 10D shows the voltage applied across an ablation electrode in contact with tissue and an ablation electrode on the opposite side of the end effector that is not in contact with tissue. [Figure 10E] This shows the voltage applied across a pair of electrodes in an exemplary planar member, where the electrodes are positioned opposite each other across the central axis. [Figure 10F] This shows the voltage applied across a pair of electrodes in an exemplary planar member, where the electrodes are positioned opposite each other across the central axis. [Figure 10G] This shows the voltage applied between electrodes on the same side of the central axis. [Figure 11] This figure illustrates an exemplary electrode configuration on one side of a planar member of an expandable end-effector portion, including elongated ablation electrodes in four ablation electrode regions, diagnostic electrodes positioned in at least two of the ablation electrode regions, tissue contact electrodes positioned along the longitudinal axis between the ablation electrode regions, and a reference electrode positioned in the proximal region on the illustrated side of the end-effector. [Figure 12A] An additional embodiment of the technology of this disclosure is shown, in which ablation is performed using electrodes on various planar members of an expandable end-effector portion. [Figure 12B] An additional embodiment of the technology of this disclosure is shown, in which ablation is performed using electrodes on various planar members of an expandable end-effector portion. [Figure 13A] This is a flowchart illustrating an exemplary method using a mapping and ablation catheter having both a focal end-effector portion and an expandable end-effector portion, according to one embodiment of the technology of the present disclosure. [Figure 13B] This is a flowchart of another exemplary method using a mapping and ablation catheter having both a focal end-effector portion and an expandable end-effector portion, according to one embodiment of the technology of the present disclosure. [Modes for carrying out the invention]

[0011] The technology of this disclosure includes a catheter end effector comprising both a focal end effector portion and an expandable end effector portion. The expandable end effector portion may be configured to move axially along the longitudinal axis relative to the focal end effector portion. That is, the expandable end effector portion can slide over the focal end effector portion, thereby allowing either the focal end effector portion or the expandable end effector portion to be used alone without the other. In this way, the focal end effector portion may be used to map or ablate a small area of ​​tissue, while the expandable end effector portion may be used to map or ablate a larger area of ​​tissue as needed. Thus, the technology of this disclosure can simplify mapping and ablation procedures because a single catheter can be used for both large and small areas of tissue instead of requiring multiple catheters for the procedure.

[0012] The following detailed description should be read in reference to the drawings, where similar elements in different drawings are numbered identically. The drawings are not necessarily to scale, depict selected embodiments, and are not intended to limit the scope of the invention. The detailed description is illustrative of the principles of the invention, not limiting, but illustrating them as examples. This specification describes several embodiments, adaptations, modifications, alternatives, and uses of the invention, including those that are currently considered to be the best modes for carrying out the invention, which will make it obvious to those skilled in the art how to make and use the invention.

[0013] Where used herein, the terms “about,” “approximately,” or “generally” for any number or range indicate a preferred dimensional tolerance that enables some or all of the components to function for the intended purposes described herein. More specifically, “about” or “approximately” may refer to a range of values ​​within ±20% of the stated value; for example, “about 90%” may refer to a range of values ​​between 71% and 110%.

[0014] In addition, as used herein, the terms “patient,” “host,” “user,” and “subject” refer to any human or animal subject, and while the use of the present invention in a human patient represents a preferred embodiment, it is not intended to limit the system or method to human use.

[0015] Similarly, the term "proximal" refers to a location closer to the operator, while "distal" refers to a location further away from the operator or physician.

[0016] As discussed herein, “operator” and “user” may include physicians, surgeons, technicians, scientists, or any other individuals or delivery devices associated with the delivery of the multi-electrode catheter for the treatment disclosed herein.

[0017] As discussed herein, when the terms “bipolar” and “monopole” are used to refer to ablation schemes, they describe different IRE ablation schemes with respect to current paths and electric field distributions. “Bipolar” refers to an IRE ablation scheme that utilizes a current path between two electrodes placed near the ablation site or inside the organ being treated, where the current density and electric flux density are typically, but not necessarily, approximately equal in each of the two electrodes. “Monopole” refers to an IRE ablation scheme that utilizes a current path between two electrodes, where one electrode with high current density and high electric flux density is placed at the treatment site, and a second electrode with relatively low current density and lower electric flux density is placed at a distance from the treatment site, usually outside the body, such as on a patch on the patient's skin.

[0018] As discussed herein, the terms “biphasic pulse” and “monophase pulse” refer to the respective electrical signals. A “biphasic pulse” refers to an electrical signal having a positive voltage phase pulse (referred to herein as the “positive phase”) and a negative voltage phase pulse (referred to herein as the “negative phase”). A “monophase pulse” refers to an electrical signal having only a positive phase or only a negative phase. Preferably, the system providing the biphasic pulse is configured to prevent the application of direct current (DC) to the patient. For example, the average voltage of the biphasic pulse may be zero volts relative to ground or other common reference voltage. Each phase of the biphasic and monophasic pulses preferably has a square shape with an essentially constant voltage amplitude for most of the phase duration. The phases of the biphasic pulse may be temporally separated by an interphase delay.

[0019] Any material incorporated herein by reference includes similar terms, but to the extent that the definitions or descriptions differ, it will be understood that the definitions and / or descriptions provided herein are to be used herein for understanding the technology of this disclosure.

[0020] Features of alternative devices and systems, as well as alternative method steps, are presented in the exemplary embodiments herein. Each given exemplary embodiment presented herein can be modified to include features and / or method steps presented together with other exemplary embodiments herein, but such features and / or steps are interchangeable with the given embodiment, as can be understood by those skilled in the art and where expressly stated herein. Such modifications and variations are intended to be included within the scope of the claims.

[0021] A catheter is presented comprising an end-effector having a focal end-effector portion configured to provide an electrical signal to achieve IRE in target tissue, and an expandable end-effector portion having an elongated ablation electrode. The expandable end-effector portion may have a plurality of planar members configured to bend away from the longitudinal axis when in an expanded configuration and when in contact with tissue. In some embodiments, the catheter fits with an 8.5 French sheath. In some embodiments, each planar member includes a high-insulation layer separating the electrodes on both sides of the end-effector. To facilitate folding of the high-rigidity insulator, in some embodiments, the high-insulation layer includes tiles of insulating material that overlap when the end-effector is retracted into the sheath.

[0022] As discussed herein for illustrative purposes, the planar member of an expandable end effector includes four elongated electrode segments on each side of the planar member (a total of eight elongated electrode segments). The elongated electrode segments extend from near the distal end of the planar member to about half or more of the length of the planar member when measured from the distal end to the proximal end of the planar member. The planar member may include two or more electrode regions per side of the planar member (a total of four or more electrode regions), each electrode region including two of the elongated electrode segments connected within the end effector to function as a single electrode. Alternatively, each electrode segment may be divided in approximately half, resulting in twice the number of elongated electrode segments, each longer than half of the aforementioned elongated electrode segments. This embodiment may include four or more electrode regions per side of the end effector, a total of eight or more electrode regions. As understood, the number of electrodes (including electrode regions and electrode segments) may be more or less than those provided herein for illustrative purposes. In other words, while some examples of planar members are described herein and shown having a certain number of electrodes, those skilled in the art will understand that the art of the disclosure may include more or fewer electrodes without departing from the scope of the disclosure.

[0023] An electrical signal, including pulses to achieve IRE, can be applied between electrode pairs to achieve PFA. Ablation electrodes can be paired in various ways, and pulses can be applied between different pairs in the same PFA treatment. In some embodiments, an end effector can provide PFA to create a wound having a depth of approximately 7.5 mm in a potato model. A bipolar electrical signal can be applied between elongated ablation electrodes in various pair combinations to achieve PFA.

[0024] Each ablation electrode can be designed with a shape based on a trade-off between total edge area, total contact area, and open space for the non-ablation electrode. The applicants recognize that a larger surface area-to-periphery ratio can effectively deliver ablation energy while reducing the opportunity for electrical arc discharge. The applicants recognize that avoiding arc discharge is desirable. Conversely, serpentine electrodes increase the mechanical flexibility of the paddle. The applicants recognize that electrode flexibility can lead to improved tissue contact and catheter life, but that the geometry of a serpentine electrode has a lower area-to-periphery ratio compared to a solid electrode.

[0025] A challenge with existing ablation catheters, particularly PFA catheters, is integrating diagnostic electrodes into the end-effector assembly so that tissue can be mapped and ablated by the same end-effector. In some embodiments, the end-effectors presented herein may include, in addition to the ablation electrodes, diagnostic electrodes on a planar member of an expandable end-effector configured to receive electrical signals from tissue and map the tissue. In this configuration, the expandable end-effector can be configured for both mapping and ablation. Alternatively, or additionally, a focal end-effector may be configured, in addition to the ablation electrodes, to receive electrical signals from tissue and map the tissue. In this way, the focal end-effector can be similarly configured for both mapping and ablation.

[0026] Another challenge with existing ablation catheters is that they are generally designed to ablate only large areas of tissue (e.g., balloon, basket, plane, and other expandable catheters) or only small areas of tissue (e.g., focal ablation catheters). The technology of the present disclosure includes a catheter having both a focal end-effector portion and an expandable end-effector portion so that the disclosed catheter can ablate either large or small areas of tissue.

[0027] In some embodiments, the focal end effector and / or expandable end effector includes a pair of tissue contact electrodes for determining which portion of the end effector is in contact with the tissue.

[0028] In some embodiments, the focal end effector and / or expandable end effector includes a reference electrode configured to measure blood voltage. An ablation electrode, diagnostic electrode, or tissue contact electrode may be used as the reference electrode when not in contact with tissue. The focal end effector and / or expandable end effector may additionally or alternatively include one or more dedicated reference electrodes positioned on a portion of the end effector or shaft near a therapeutic or diagnostic electrode in a location that is unlikely to come into contact with tissue during the procedure, such as on the proximal portion of the focal end effector and / or expandable end effector.

[0029] Embodiments of catheters, end effectors, and related methods and systems are described below in reference to the drawings.

[0030] Figure 1 shows an exemplary catheter-based electrophysiological mapping and ablation system 10. The system 10 may include multiple catheters that are inserted percutaneously by a physician 24 through the patient's vascular system into the lumen or vascular structure of the heart 12. Typically, a delivery sheath catheter (e.g., 8.5 French) is inserted into the left or right atrium near the desired location within the heart 12. The catheter can then be inserted into the delivery sheath catheter to reach the desired location. Such catheters may include a catheter dedicated to sensing intracardiac electromagnetism (IEGM) signals, a catheter dedicated to ablation, and / or a catheter dedicated to both sensing and ablation.

[0031] An exemplary catheter 14 (sometimes referred to herein as a medical probe 14) is shown herein, which includes an end effector 28 configured to provide PFA. The end effector 28 includes an ablation electrode configured to provide PFA, and optionally, a diagnostic electrode, a tissue contact electrode, and at least one reference electrode. In some embodiments, the end effector 28 includes a diagnostic electrode configured to map abnormal electrical signals of the heart to detect atrial fibrillation, and thus the end effector 28 may be configured for both sensing and mapping. In such examples, the diagnostic electrode is on the same side of the end effector and is close to the ablation electrode. The physician 24 senses a target site within the heart 12 and brings the end effector 28 into contact with the heart wall to provide ablation treatment to the target site without the need to reposition the end effector between the mapping step and the ablation step. Electrode placement is shown in more detail in subsequent figures. The electrodes may be used for two or more purposes, as will be understood by those skilled in the art who are informed by the examples presented herein.

[0032] The magnetic-based position sensor 29 may operate in conjunction with a position pad 25, which includes a plurality of magnetic coils 32 configured to generate a magnetic field within a predetermined working range. The real-time position of the end effector 28 of the catheter 14 can be tracked based on the magnetic field generated by the position pad 25 and sensed by the magnetic-based position sensor 29 located on the catheter shaft 90. Details of magnetic-based position sensing technology are described in U.S. Patents 5,391,199, 5,443,489, 5,558,091, 6,172,499, 6,239,724, 6,332,089, 6,484,118, 6,618,612, 6,690,963, 6,788,967, and 6,892,091, which are incorporated herein by reference in their entirety. The end effector 28 may further include one or more induction coils configured to provide an electrical signal to a magnetic-based position sensing system for determining the position and / or orientation of the end effector. For example, the end effector 28 may include an induction loop or coil similar to that shown in Figures 5B and 5C of U.S. Patent Application Publication No. 2024 / 0215894, which is incorporated herein by reference in its entirety and is attached to the appendices herein. In some embodiments, one or more induction coils within the end effector may be used together with a position sensor 29 to determine the position and / or orientation of the end effector.

[0033] System 10 includes one or more electrode patches 38 positioned for skin contact on the patient 23 to establish a position reference for the position pad 25 and impedance-based tracking of the electrodes 26. For impedance-based tracking, a current is directed to the electrodes 26 and sensed at the electrode skin patches 38, thereby allowing the position of each electrode to be triangulated through the electrode patches 38. This figure shows an impedance-based tracking electrode 26 attached to a catheter shaft. Additionally or alternatively, the end effector 28 may include impedance-based tracking of one or more electrodes. Details of impedance-based position tracking techniques are described in U.S. Patents 7,536,218, 7,756,576, 7,848,787, and 7,869,865 and 8,456,182, which are incorporated herein by reference in their entirety.

[0034] The recorder 11 displays the electrophysiological diagram 21 captured by the surface ECG electrodes 18. In embodiments in which the end effector 28 includes diagnostic electrodes, the recorder 11 may further display the intracardiac electrophysiological diagram (IEGM) derived from the electrical signals from the diagnostic electrodes on the end effector 28. The recorder 11 may include pacing capabilities for pacing the heart rhythm and / or may be electrically connected to a standalone pacer.

[0035] System 10 includes an ablation energy generator 50 adapted to conduct ablation energy to the ablation electrode on the end effector 28. The energy generated by the ablation energy generator 50 includes pulses that induce IRE for ablation through the PFA, and may also be configured to provide radio frequency (RF) energy to warm the tissue to facilitate PFA without significant thermal ablation, or to heat the tissue for thermal ablation in addition to PFA. The ablation energy generator 50 is preferably configured to provide a biphasic bipolar pulse to induce IRE while maintaining the tissue temperature below the thermal ablation temperature. Additionally or alternatively, the ablation generator 50 may be configured to provide a single-phase IRE pulse, a single-pole IRE pulse, a thermal ablation electrical signal, or a combination thereof. For example, the ablation energy generator 50 may be configured to provide pulses similar to those described in U.S. Patent Publication Nos. 2021 / 0169550(A1), 2021 / 0177503(A1), 2021 / 0186604(A1), and 2023 / 0009191(A1), and U.S. Patent No. 11,540,877(B2), each of which is incorporated herein by reference in whole and attached to the appendices herein. U.S. Patent No. 11,540,877(B2) corresponds to U.S. Patent Publication No. 2021 / 0161592(A1), which is incorporated herein by reference in whole.

[0036] For example, as described in U.S. Patent No. 11,540,877(B2), the generator 50 may be configured to apply a bipolar pulse having an amplitude sufficient to cause IRE in the tissue contacted by the electrode, and RF energy having sufficient power to thermally ablate the tissue contacted by the electrode. In some embodiments, the sequence of bipolar pulses includes pulses having an amplitude of at least 200 V, and the duration of each bipolar pulse is less than 20 μs. Additionally or alternatively, the RF signal has a frequency of 350 to 500 kHz and an amplitude of 10 to 200 V. The end effector may further include a temperature sensor, and the electrical signal generator may be configured to apply a signal in response to the temperature measured by the temperature sensor. In some embodiments, the IRE signal may have parameters as shown in Table 1 of U.S. Patent No. 11,540,877(B2). It should be noted that the “bipolar pulse” described in U.S. Patent No. 11,540,877(B2) is referred to herein as a “two-phase pulse” relating to the shape of an electrical signal, whereas the “bipolar pulse” as described herein relates to the arrangement of electrodes receiving the pulse as defined herein.

[0037] The patient interface unit (PIU) 30 is an interface configured to establish electrical communication between the catheter, the electrophysiological equipment, the power supply, and the workstation 55 that controls the operation of the system 10. The electrophysiological equipment of the system 10 may include, for example, multiple catheters, position pads 25, surface ECG electrodes 18, electrode patches 38, an ablation energy generator 50, and a recorder 11. Optionally, and preferably, the PIU 30 includes processing power for performing real-time calculations of the catheter position and for performing ECG calculations. The PIU 30 can control the generator 50 to provide electrical energy to the ablation electrodes of the end effector 28 in accordance with the ablation protocols described above and in the incorporated references above. The PIU 30, workstation 55, and generator 50 can be collectively considered as an ablation system console having one or more output ports configured to provide ablation energy to ablation electrodes, one or more processors, and a non-transient computer-readable medium that communicates with the processors to cause the ablation system console to provide ablation energy as described above and in the following embodiments of this specification.

[0038] In some embodiments, system 10 further includes an irrigation system configured to irrigate during IRE. For example, the end effector 28 may include one or more irrigation ports, and the irrigation system may be configured to deliver irrigation to one or more irrigation ports. In some embodiments, PIU 30 is configured to control the irrigation system to provide irrigation to the end effector 28, as described in U.S. Patent Application Publication No. 2021 / 0196372(A1), the entirety of which is incorporated herein by reference and attached to the appendices herein. The irrigation fluid can exit from the distal end of the catheter 14 through the port at the distal end of the shaft and / or through the hole in the body of the end effector 28.

[0039] The workstation 55 includes memory, a processor unit having memory or storage device loaded with appropriate operating software, and user interface functions. The workstation 55 can be configured to provide multiple functions, optionally including: (1) modeling the endocardial anatomical structure in three dimensions (3D) and rendering the model or anatomical map 20 for display on a display device 27; (2) displaying on the display device 27 an activation sequence (or other data) compiled from recorded electrophoresis 21 as representative visual markers or images superimposed on the rendered anatomical map 20; (3) displaying the real-time position and orientation of one or more catheters in the cardiac chambers; and (4) displaying on the display device 27 a site of interest, such as the site where ablation energy has been applied. One commercially available product embodying the elements of system 10 is available as the CARTO® 3 system, commercially available from Biosense Webster, Inc. (31A Technology Drive, Irvine, CA 92618).

[0040] Figures 2A and 2B show the catheter 14 in more detail. The catheter 14 (sometimes referred to herein as the medical probe 14) may be configured to be inserted into the heart 12 of a patient 23 for mapping and ablation of tissue within the heart 12. As shown, the catheter 14 may include an end effector 28, a first handle 120, and a second handle 220. The end effector 28 may be attached to the first handle 120 by an outer sleeve 122 and to the second handle 220 by an inner catheter shaft 222 (e.g., an elongated shaft). The sleeve 122 may be positioned around the inner catheter shaft 222 so that the sleeve 122 can slide along the outside of the inner catheter shaft 222.

[0041] The end effector 28 may further include a focal end effector portion 210 and an expandable end effector portion 110. The focal end effector portion 210 is attached to the distal end of the internal catheter shaft 222, and the expandable end effector portion 110 is attached to the distal end of the sleeve 122. In this way, as the physician 24 slides the first handle 120 and the second handle 220 toward each other (as shown in Figure 2A), the focal end effector portion 28 may extend beyond the distal end of the expandable end effector portion 110 so that the focal end effector 210 is configured to deliver ablation energy to a small area of ​​tissue within the heart 12 or to map its electrophysiological signals. Alternatively, if the physician moves the first handle 120 and the second handle 220 away from each other (as shown in Figure 2B), the expandable end-effector portion 110 slides beyond the distal end of the focal end-effector portion 210 so that the expandable end-effector portion 110 is configured to contact tissue to deliver ablation energy to a larger tissue area within the heart 12 or to collect electrophysiological signals from there. In other words, the physician 24 can slide the second handle 220 distally to bring the expandable end-effector portion 110 into contact with tissue and map electrophysiological signals, or the physician 24 can slide the second handle 220 proximal to expose the focal end-effector portion 210 and perform the ablation procedure.

[0042] The first handle 120 may include an actuator 124 which can be configured to deflect or bend the end effector 28 radially outward so as to move away from the longitudinal axis LA. The actuator 124 may be attached, for example, to a pull wire attached to the distal end of the internal catheter shaft 222 or to the focal end effector portion 210. When the physician 24 acts on the actuator 124, the pull wire is pulled, deflecting the end effector 28 outward from the longitudinal axis LA. As can be understood, when the internal catheter shaft 222 is deflected outward, the internal catheter shaft 222 also deflects the sleeve 122 (which is positioned around the internal catheter shaft 222) outward. In this way, when the actuator 124 is actuated, both the focal end effector portion 210 and the expandable end effector portion 110 are deflected outward from the longitudinal axis LA.

[0043] The first handle 120 may further include a first irrigation coupler 126 and a first electrical coupler 128. The first irrigation coupler 126 may be connected to an irrigation source and configured to deliver irrigation through the first handle 120 to an expandable end-effector portion 110. The expandable end-effector portion 110 may include an irrigation port configured to deliver irrigation fluid to tissue near the end-effector 28. The first electrical coupler 128 may be connected to a corresponding electrical coupler to connect the catheter 14 to the PIU 30 so that ablation energy supplied by the ablation energy generator 50 can be delivered to the expandable end-effector portion 110, and / or so that electrical signals detected by the expandable end-effector portion 110 can be analyzed and output for display.

[0044] The second handle 220 may include a second irrigation coupler 226 and a second electrical coupler 228. The second irrigation coupler 226 may be connected to an irrigation source and configured to deliver irrigation fluid to the focal end effector portion 210 through the second handle 220. The focal end effector portion 210 may include an irrigation port configured to deliver irrigation fluid to tissue near the focal end effector portion 210. The second electrical coupler 228 may be connected to a corresponding electrical coupler to connect the catheter 14 to the PIU 30 so that ablation energy supplied by the ablation energy generator 50 can be delivered to the focal end effector portion 210, and / or so that electrical signals detected by the focal end effector portion 210 can be analyzed and output for display.

[0045] Figures 3A and 3B show detailed views of a first example of the end effector 28, where the focal end effector portion 210 is in the extended position in Figure 3A and in the retracted position in Figure 3B. As shown, the expandable end effector portion 110 may include a plurality of planar members 100 (four planar members 100 are shown in this example) attached to a hub 130 which is attached to the distal end of the sleeve 122. Although only a single planar member 100 is referenced in Figures 3A and 3B for simplicity, it will be understood that the expandable end effector portion 110 may include a plurality of planar members 100 extending outward from the hub 130. For example, as shown in Figures 3A and 3B, the expandable end effector portion 110 may include at least four planar members 100.

[0046] Since all planar members 100 of the expandable end-effector portion 110 extend outward from the hub 130, the planar members 100 can be configured to collectively contact large areas of tissue, detect electrophysiological signals, and / or deliver ablation energy to the tissue via electrodes. In contrast, if only small areas of tissue are intended to be ablated or mapped, the focal end-effector portion 210 can be pushed distally beyond the expandable end-effector portion 110 so that it can contact the tissue without the expandable end-effector portion 110 contacting the tissue. In this way, the end-effector 28 can be used to map and ablate both small and large areas of tissue using a single device. Electrodes can be positioned on the inward-facing side (inner surface member) and the outward-facing side (outer surface member) of the planar members 100. The inward-facing side may be configured to face the focal end-effector portion 210, and the outward-facing side may be configured to face outward away from the focal end-effector portion 210.

[0047] Figures 3C and 3D show detailed views of another example of the end effector 28, where the focal end effector portion 210 is in the extended position in Figure 3C and in the retracted position in Figure 3D. As shown in this example, the expandable end effector portion 110 may include six planar members 100 attached to a hub 130 which is attached to the distal end of the sleeve 122. In Figures 3C and 3D, for simplicity, only a single planar member 100 is referenced. As shown, the expandable end effector portion 110 may further include support members 133 extending between adjacent planar members 100, which can provide additional support to the planar members 100 and help maintain the expandable end effector portion 110 in a predetermined shape when extended. In the example shown in Figure 3C, the focal end effector portion 210 may include a non-traumatic tip 203 to help prevent tissue damage.

[0048] Since all planar members 100 of the expandable end-effector portion 110 extend outward from the hub 130, the planar members 100 can be configured to collectively contact large areas of tissue, detect electrophysiological signals, and / or deliver ablation energy to the tissue. In contrast, if only small areas of tissue are intended to be ablated or mapped, the focal end-effector portion 210 can be pushed distally beyond the expandable end-effector portion 110, allowing it to contact the tissue without the expandable end-effector portion 110 contacting the tissue. In this way, the end-effector 28 can be used to map and ablate both small and large areas of tissue using a single device.

[0049] Figure 4 shows a detailed view of the focal end effector portion 210. As shown, the focal end effector portion 210 may include a distal electrode 212 positioned on the distal tip of the inner shaft 222, a plurality of proximal electrodes 214 positioned along the inner shaft 222 proximal to the distal electrode 212, and a plurality of impedance-based tracking electrodes 26 positioned along the inner shaft 222 proximal to the proximal electrodes 214. The distal electrode 212 and the proximal electrodes 214 may each be configured to deliver ablation energy to tissue, detect electrophysiological signals along the tissue, and / or both. Thus, the distal electrode 212 may be configured to ablate a small area of ​​tissue and / or map electrophysiological signals along a small area of ​​tissue.

[0050] The proximal electrode 214 may be configured to detect electrophysiological signals along the tissue, and as a result, the inner shaft 222 may slide along the tissue to map the electrophysiological signals. Alternatively or additionally, the proximal electrode 214 may be configured together with the distal electrode 212 as a reference electrode for performing PFA ablation.

[0051] Figure 5A is a detail view of an expandable end effector 110 showing a plurality of planar members 100. As shown, each planar member 100 may include a plurality of electrodes 112 positioned spaced apart across the planar member 100 (only a single electrode 112 is referenced for simplicity). The electrodes 112 can be positioned across the planar body 140 on both a first side of the planar body 140 (as shown) and a second side of the planar body 140 opposite to the first side (not shown in Figure 5A). The electrodes 112 may be configured to deliver ablation energy to the tissue. In some embodiments, the ablation electrodes 112 may be coplanar with the planar body 140, providing a first plane to the planar member 100 corresponding to the first side of the planar body 140, and providing a second plane to the planar member 100 corresponding to the second side of the planar body 140.

[0052] The planar body 140 includes a frame 150 surrounded by a flexible electrically insulating encapsulant (shown and described in detail with respect to Figures 5B and 5C). The insulating encapsulant may consist mainly of a polymer material (e.g., thermoplastic polyurethane) or may include a higher insulating component, as will be described in more detail with respect to Figures 8B to 8D. In this way, the electrodes on the first side can be separated from the electrodes located on the second side by the insulating material. The frame 150 is elastic and provides structural support to the planar members 100, and the expandable end effector portions 110 contract into a delivery configuration for delivery through the sheath, and then self-expand into an unconstrained configuration, as shown in Figures 1 to 3B, allowing each planar member 100 to conform to a planar or substantially planar surface such as tissue, and to fold in response to retraction into the sheath. Frame 150 can be formed from superelastic materials such as nickel-titanium and / or shape memory alloys, also known as nitinol, cobalt-chromium, stainless steel, and / or other alloys exhibiting pseudoelastic and / or superelastic properties.

[0053] Figure 5B is a diagram of a planar member 100 of the expandable end-effector portion 110. The planar member 100 shown in Figure 5B and further described in relation to Figures 5A to 11 represents any one of a plurality of planar members 100 that can constitute the expandable end-effector portion 110 as described throughout this disclosure. Thus, although a single planar member 100 or a portion of a single planar member 100 is shown and described through Figures 5A to 11, it will be understood that other planar members 100 of the expandable end-effector portion 110 may have similar features.

[0054] Figure 5B shows the first side 101a of the planar member 100. The planar member 100 has a planar body 140 having a second side 101b (Figures 8A-8D, 10A-10D) opposite to the first side 101a. The second side 101b has electrodes, which are not essential but preferably arranged similarly to those on the first side 101a. When the planar member 100 is configured with similar electrode configurations on both sides 101a, 101b, both sides can be positioned against tissue during treatment. When one side of the planar member 100 is in contact with tissue, the corresponding electrode on the opposite side is in contact with body fluid (e.g., blood) and can function as a reference electrode for the electrode in contact with the tissue. Although described throughout as a first side 101a and a second side 101b, it will be understood that when one of the first side 101a and the second side 101b is oriented on an expandable end effector portion 110 facing inward toward the inner shaft 222, it may be considered an inner surface member. Similarly, when the other of the first side 101a and the second side 101b is oriented on an expandable end effector portion 110 facing outward away from the inner shaft 222, it may be considered an outer surface member.

[0055] The planar member 100 includes an ablation electrode having longitudinally elongated segments 111a, 111b, 112a, and 112b, respectively, that extend along the longitudinal axis AA defined by the catheter shaft 90. The longitudinally elongated segments 111a and 111b on the left side of the longitudinal axis AA form the first ablation electrode 111 (Figure 7). The longitudinally elongated segments 112a and 112b on the right side of the longitudinal axis AA form the second ablation electrode 112 (Figure 7). The ablation electrode has a length L2 which is at least half the total length L1 of the end effector 28 when measured from the distal end 106 of the end effector to the distal end of the shaft 90 of the medical probe 14. The ablation electrodes 111 and 112 extend to approximately the distal end 106 of the planar member 100. The length L2 of the ablation electrode defines the distal portion of the planar member 100. The planar member 100 has a width W1 measured from its leftmost and rightmost ends. As shown in the figure, the leftmost and rightmost ends of the planar member 100 define the parallel side edges of the planar member 100. When the planar body 140 is in an unconstrained configuration, as shown in Figure 5B, it is preferable that it is aligned with the longitudinal axis AA.

[0056] The ablation electrodes 111 and 112 are configured to deliver ablation energy to tissue, as will be described in more detail elsewhere in this specification. The second side 101b of the planar member 100 preferably includes an ablation electrode having a longitudinally elongated segment on the opposite side of the illustrated longitudinally elongated segments 111a, 111b, 112a, and 112b electrodes with respect to the plane defined by the planar body 140. In some embodiments, the ablation electrodes 111 and 112 are coplanar with the planar body 140 and can provide a first plane to the planar member 100 corresponding to the first side 101a of the planar body 140 and a second plane to the planar member 100 corresponding to the second side 101b of the planar body 140.

[0057] In some embodiments, the ablation electrode on the second side 101b can function as the respective reference electrode for each opposing ablation electrode on the first side 101a when the first side 101a is in contact with tissue, and vice versa. Additionally or alternatively, the ablation electrodes on both sides 101a, 101b can be paired to provide a bipolar PFA electrical signal between the paired ablation electrodes. Additionally or alternatively, the ablation electrodes on the same side can be paired to provide a bipolar PFA electrical signal between the paired ablation electrodes. The bipolar PFA electrical signal may be monophasic or biphasic.

[0058] The illustrated planar member 100 includes, on its first side 101a, optional diagnostic electrodes 113, 114 electrically isolated from the ablation electrode segments 111a, 111b, 112a, 112b. The diagnostic electrodes 113, 114 are configured to receive electrical signals from the tissue in order to map cardiac tissue and detect arrhythmias. As shown, the diagnostic electrodes 113, 114 are arranged in pairs such that the first diagnostic electrode 113 is on the left side of the longitudinal axis AA and the second diagnostic electrode 114 is on the right side of the longitudinal axis AA. The diagnostic electrodes 113, 114 are arranged diametrically along axis DA which is perpendicular to the longitudinal axis AA with respect to each other. The second side 101b of the planar member 100 preferably includes a second pair of diagnostic electrodes opposite the first pair of diagnostic electrodes with respect to the plane defined by the planar body 140.

[0059] The illustrated planar member 100 includes arbitrary tissue contact quality electrodes 115, 116 arranged in closely spaced pairs such that the impedance measured across each pair of tissue contact quality electrodes indicates that both electrodes of the pair are in contact with the tissue. As shown, the first side 101a includes a distal pair of tissue contact quality electrodes 115 positioned near the distal end 106 of the planar member 100, and a central pair of tissue contact quality electrodes 116 positioned approximately in the middle of the length L2 of the distal portion of the planar member 100. The pairs of tissue contact quality electrodes 115, 116 are spaced apart along the longitudinal axis AA. The planar body 140 of the end effector includes a central portion 104 that extends centrally along the longitudinal axis AA and along the total length L1 lacking the ablation electrodes. As shown, the tissue contact quality electrodes 115, 116 are positioned in this central portion 104. The second side 101b of the planar body 140 of the planar member 100 preferably includes a corresponding pair of tissue contact quality electrodes opposite to the pair of tissue contact quality electrodes 115, 116 on the first side 101a with respect to the plane defined by the planar body 140.

[0060] The illustrated planar member 100 includes an optional reference electrode 117 positioned on the first side 101a of the planar body 140. Additionally or alternatively, the planar member 100 may include a reference electrode similarly positioned on the second side 101b of the planar body 140. The reference electrode 117 may be used for ECG acquisition or as a reference in either a unipolar or bipolar (split or proximity pair) configuration. Its number can be as few as four per side, but can be increased as needed (to accommodate trace limitations). The signal from the reference electrode 117 may also be used for contact information to determine which part of the paddle is in contact with or adjacent to tissue.

[0061] The planar member 100 includes a proximal portion defined by a proximal length L3 that lacks the ablation electrode. The reference electrode 117 may be positioned in this proximal portion. As discussed herein, an ablation electrode, diagnostic electrode, or tissue-contact electrode may be used as a reference electrode for the corresponding electrode on the opposite side that contacts tissue. Each of these electrodes is positioned in the distal portion of the planar member 100 defined by the length L2 of the ablation electrode and may be positioned in contact with tissue if desired by the physician 24 (Figure 1). Preferably, the reference electrode 117 is positioned such that the physician 24 cannot or at least very unlikely to position the reference electrode 117 in contact with tissue, but nevertheless is positioned relatively close to an electrode configured to contact tissue. For example, the planar member 100 may be configured to bend so that the majority of the proximal portion does not contact tissue while the distal portion of the first side 101a is in contact with tissue. By being positioned in the proximal portion, the reference electrode 117 cannot or is unlikely to contact tissue during the procedure. In other words, the end effector is configured such that most of the first side 101a of the distal portion conforms to a plane, while the reference electrode is bent so as to be separated from the plane. In such embodiments, the illustrated reference electrode 117 is a dedicated reference electrode rather than a multipurpose electrode.

[0062] In some embodiments, at least the ablation electrode, diagnostic electrode, and tissue contact electrode are coplanar with the planar member 100, providing a first plane to the planar member 100 corresponding to the first side 101a of the planar body 140, and providing a second plane to the planar member 100 corresponding to the second side 101b of the planar body. Any combination of the ablation electrodes 111, 112 and the other electrodes 113, 114, 115, 116, 117 may include an exposed conductive layer in a flexible printed circuit board, and may include silver epoxy and / or conductive ink.

[0063] The illustrated planar body 140 includes openings 102, 105 between the first side 101a and the second side 101b. The openings 102, 105 may be sized, shaped, or otherwise configured to allow the end effector to bend through the sheath catheter. The openings 102, 105 may be sized, molded, or otherwise configured to fold or expand when the end effector is pressed against a non-planar tissue surface to provide conformal contact with the non-planar tissue surface. The applicants recognize that consistent contact of the ablation electrode to non-planar tissue may produce improved damage compared to less conformal electrode contact. In some embodiments, the distal end may not be completely closed to allow for greater flexibility and a larger area. In some embodiments, the EM loop extends through a paddle spine between the openings. The outer opening 102 is located between the elongated ablation electrode segments 111a, 111b, 112a, and 112b of the respective ablation electrodes 111 and 112. The inner opening 105 is located between the inner elongated ablation electrode segments 111b and 112b and the central portion 104.

[0064] Figure 5C is an enlarged view of a portion of an exemplary planar member 100 shown in Figure 5B. The planar body 140 includes a frame 150 surrounded by a flexible electrically insulating seal 142. The insulating seal may consist mainly of a polymer material (e.g., thermoplastic polyurethane) or may include a higher insulating component, as will be described in more detail in relation to Figures 8B to 8D. In this way, the electrode on the first side 101a can be separated from the electrode located on the second side 101b by the insulating material. The frame 150 is elastic and provides structural support to the planar member 100, and the expandable end effector portion 110 contracts into a delivery configuration for delivery through the sheath and then self-expands into an unconstrained configuration, as shown in Figures 1 to 3B, allowing each planar member 100 to conform to a planar or substantially planar surface such as tissue and to fold as it retracts into the sheath. Frame 150 can be formed from superelastic materials such as nickel-titanium and / or shape memory alloys, also known as nitinol, cobalt-chromium, stainless steel, and / or other alloys exhibiting pseudoelastic and / or superelastic properties.

[0065] The illustrated portion of the planar body 140 is divided into three segments: an outer segment containing an outer elongated ablation electrode segment 111a, an inner segment containing an inner elongated ablation electrode segment 111b, and a central portion 104. The planar body 140 includes a second outer segment and a second inner segment to the right of the planar body, as shown in Figure 5B but not in Figure 5C, resulting in the planar body 140 having a total of five segments. The outer segment has a width W4, the inner segment has a width W3, and the central portion 104 has a width W2. In the illustrated example, the body segment widths W2, W3, and W4 are approximately equal to each other. Each elongated ablation electrode segment 111a, 111b has a width W5 that is more than half, or about 80%, of the width of the outer body segment width W4 and the inner body segment width W3. The ablation electrode segment width W5 is about 10% of the total width W1 of the planar member 100.

[0066] The elongated ablation electrode segments 111a and 111b are positioned to the left or right of each other. Each of the elongated ablation electrode segments 111a and 111b extends distally to approximately the distal edge of the planar body 140. Due to the curvature of the distal edge, the length L2 of the distal portion of the inner ablation electrode segment 111b is defined, while the length L5 of the outer ablation electrode segment 111a is shorter than the length L2 of the inner ablation electrode segment 111b.

[0067] The illustrated diagnostic electrode 113 is positioned entirely on the outer segment of the planar body 140 and within the width W5 and length L5 of the outward longitudinally extending ablation electrode segment 111a. The diagnostic electrode 113 has a width W7 of less than half, preferably about one-third, of the width W5 of the outward longitudinally extending ablation electrode segment 111a. The diagnostic electrode 113 has a length L4 of less than half, less than about one-fifth, or less than one-tenth of the length L5 of the outward longitudinally extending ablation electrode segment 111a.

[0068] Each elongated ablation electrode segment 111a, 111b has a meandering shape. The meandering shape of the ablation electrode segment 111a extending in the outer longitudinal direction bends around three of the four sides of the diagnostic electrode 113. As shown in the figure, the meandering shape has a path width W6 which is approximately equal to the width W7 of the diagnostic electrode W7 and about one-third of the width W5 of the ablation electrode segment 111a extending in the outer longitudinal direction.

[0069] The planar member 100 further includes electrical traces 118, 119 having insulated, meandering conductive portions. The illustrated electrical traces 118, 119 extend longitudinally and form meandering paths within the central portion 104. The illustrated electrical traces 118, 119 form electrical connections to the central pair of tissue contact quality electrodes 116 and the distal pair of tissue contact quality electrodes 115.

[0070] Figure 6A is a diagram of a first alternative electrode configuration of an exemplary planar member 100, including one exemplary configuration of an ablation electrode 111 and a diagnostic electrode 113. Similar to Figures 5B and 5C, the ablation electrode 111 includes a meandering longitudinally extending segment having a total width W5 and a path width W6. While the configurations in Figures 5B and 5C include only one diagnostic electrode 113 per ablation electrode 111, the example in Figure 6A includes six diagnostic electrodes 113 per ablation electrode 111. The planar member 100 may include one, two, three, four, five, or six diagnostic electrodes 113 per ablation electrode 111. Each diagnostic electrode is similarly sized to have a width W7 that is approximately 1.5 times the path width W6 of the ablation electrode 111 and approximately half the total width W5 of the elongated segment of the ablation electrode 111. The diagnostic electrode 113 is surrounded on two or three sides by each of the elongated segments of the ablation electrode 111.

[0071] Figure 6B shows a second alternative electrode configuration of an exemplary planar member 100, including an ablation electrode 111 having elongated segments, each segmented into small parallel stripes, and a diagnostic electrode 113 positioned along the elongated ablation electrode segments. Each elongated segment has multiple conductive stripes extending parallel to each other to form the overall shape of each elongated segment, similar to that shown in Figure 6A. Other ablation electrode shapes shown herein, and their alternatives as understood by those skilled in the art, can also be divided into multiple conductive stripes extending parallel to each other, similar to that shown in Figure 6B. This configuration increases the total edge length of the ablation electrode, providing a different electric field profile in the tissue compared to a similarly shaped solid ablation electrode (e.g., as shown in Figure 6A).

[0072] Figure 6C shows a third exemplary electrode configuration of an exemplary end effector, including a rectangular elongated segment of the ablation electrode 111 without a diagnostic electrode 113. The total width W5 of the electrode segment is utilized for the ablation electrode 111 to maximize its surface area. The diagnostic electrode may be located elsewhere on the planar body, for example, in the central portion 104.

[0073] Figure 6D shows a fourth exemplary electrode configuration of an exemplary end effector, which includes a rectangular elongated segment of the ablation electrode 111 interrupted by the diagnostic electrode 113. Compared to the continuous rectangular electrode segment shown in Figure 6C, the segmented elongated ablation electrode segment can have greater flexibility for bending the planar body 140 away from the longitudinal axis AA, at the expense of the total area of ​​the ablation electrode.

[0074] Figure 6E shows an exemplary electrode configuration of an exemplary planar member 100, which includes an elongated, serpentine ablation electrode 111. The elongated segment is serpentine, similar to that shown in Figure 6A. In one embodiment, the trace width W6 is approximately 0.28 mm, the electrode segment width W5 is approximately 1 mm, the ablation electrode surface area is approximately 10.1 square mm, the perimeter is approximately 67.7 mm, and the perimeter-to-area ratio is approximately 7:1.

[0075] Figure 6F shows an exemplary electrode configuration of an exemplary end effector, including a rectangular elongated ablation electrode 111. The elongated segment is solid, as shown in Figure 6C, meaning the trace width is equal to the total width. In one embodiment, the electrode segment width W5 is approximately 1 mm, the ablation electrode surface area is approximately 16.8 square mm, the perimeter is approximately 37.4 mm, and the perimeter-to-area ratio is approximately 2:1.

[0076] Figure 6G shows an exemplary electrode configuration of an exemplary end effector including a large-area ablation electrode 111. In one embodiment, the electrode segment width W5 is approximately 3.5 mm, the ablation electrode surface area is approximately 28.8 square mm, the perimeter is approximately 24.8 mm, and the perimeter-to-area ratio is approximately 1:1.

[0077] Figure 7 is a diagram of an exemplary electrode configuration on one side of an exemplary planar member 100, which includes elongated ablation electrodes 111, 112 in two ablation electrode regions 121, 122, diagnostic electrodes 113, 114 positioned within the two ablation electrode regions 121, 122, tissue contact electrodes 115, 116 positioned between the two ablation electrode regions 121, 122, and a reference electrode 117 positioned in the proximal region on the illustrated side of the planar member 100. In some embodiments, the total area of ​​each ablation electrode 111, 112 within each electrode region 121, 122 is approximately 7.5 mm². 2 In Figure 7, it can be seen that there are two individual ablation electrodes 111a and 111b on the left side and two individual ablation electrodes 112a and 112b on the right side. The left electrodes 111a and 111b are connected to a pulse field generator, which can deliver a biphasic pulse field between electrodes 111a and 111b. The right electrodes 112a and 112b are connected to a pulse field generator, which can deliver a biphasic pulse field between electrodes 112a and 112b. Alternatively, each of the left electrodes 111a and 111b can be connected to a generator together with each of the right electrodes 112a and 112b, which can deliver a bipolar pulse between the left and right electrodes. For example, a bipolar electrode pair can be formed by one or more left electrodes 111a and 111b and one or more right electrodes 112a and 112b.

[0078] The center line CC is shown in Figure 7 and indicates the line of symmetry of the electrode configuration and / or the planar member 100. As shown in the figure, the electrode configuration is symmetrical with respect to the center line CC. Preferably, at least the ablation electrodes 111 and 112 are symmetrical with respect to the center line CC. The planar member 100 may have a shape symmetrical with respect to the center line CC, as shown in the figure. In an alternative embodiment, the planar member 100 may not be symmetrical with respect to the center line CC.

[0079] The illustrated side of the planar member 100 has a left half that is to the left of the center line CC and a right half that is to the right of the center line CC. The first ablation electrode 111 defines a first electrode region 121 that is entirely on the left half of the planar member 100. The second ablation electrode 112 defines a second electrode region 122 that is entirely on the right half of the planar member 100. The tissue contact electrodes 115 and 116 are arranged in pairs, each positioned across the center line CC on the illustrated side of the planar member 100. The distal pair of tissue contact electrodes 115 is close to the distal end 106 of the planar member 100. The central pair of tissue contact electrodes 116 is proximal to the distal pair 115 and crosses the center line CC. The reference electrode 117 is positioned on the illustrated side of the planar member 100, crossing the center line CC.

[0080] Figures 8A to 8D illustrate alternative configurations of insulating materials in cross-section of the planar body 140. In each figure, the second side 101b of the planar body 140 is shown opposite the first side 101a. The ablation electrodes 131 and 132 are shown on the second side 101b, opposite to the ablation electrodes 111 and 112 on the first side. The opposing ablation electrodes 131 and 132 overlap with the ablation electrodes 111 and 112 on the first side 101a, preferably overlapping with most of the ablation electrodes 111 and 112 on the first side 101a, and may be symmetrical with respect to the ablation electrodes 111 and 112 on the first side 101a with respect to the plane defined by the planar member 100. The cross-section of the planar member 100 has been simplified for illustrative purposes, omitting the frame 150, electrical traces, and other such features. Furthermore, although the ablation electrodes 111, 112, 131, and 132 are only labeled in Figure 8A for simplicity, it will be understood that the ablation electrodes 111, 112, 131, and 132 are similarly arranged in Figures 8B to 8D.

[0081] The ablation electrodes 111, 112, 131, and 132 are shown protruding from the planar body 140, but alternatively, they may be recessed within the planar body 140 to provide smooth planes on each of their respective sides 101a and 101b. The ablation electrodes 111, 112, 131, and 132 may have approximately equal surface areas relative to each other. Each segment 111a, 111b, 112a, 112b, 131a, 131b, 132a, and 132b of the ablation electrodes are shown to be continuous across their width. Alternatively, some or all of the segments may include parallel stripes similar to those shown in Figure 6B, resulting in a segmented cross-sectional profile.

[0082] The various configurations shown in Figures 8B to 8D provide different levels of electrical insulation between the electrodes on both sides of the planar body 140. The electrical insulation can be adjusted to direct the electric field lines between the bipolar pairs of ablation electrodes on both sides of the planar body 140 during PFA application, thereby directing the electroporation of cells within the target tissue.

[0083] Figure 8A is configured with an opening in the end effector as shown in Figure 5B. Figure 8B includes a polymer body region 143 that forms an insulating material extending across the width of the planar body 140. Essentially, some or all of the openings 102, 105 (and other unreferenced openings) of the exemplary planar member 100 shown in Figures 5B and 5C may include their respective thin polymer-filled regions that lack a framework or any electrical circuits. When configured in this way, the planar body 140 can provide additional electrical insulation between electrodes on both sides of the planar body 140 (compared to the openings 102, 105) while maintaining sufficient flexibility for operations for positioning against tissue and transporting through a sheath.

[0084] Figure 8C includes a planar high dielectric layer 144 positioned between each side and extending across the width of the end effector. The dielectric layer 144 overlaps and is parallel to each of the ablation electrodes 111, 112, 113, and 114. The planar high dielectric layer 144 may contain a ceramic-doped polymer, which still provides sufficient flexibility while providing additional electrical insulation between the electrodes on both sides of the planar body compared to the polymer alone. As shown, the planar high dielectric layer 144 extends across most of the total width W1 of the planar body 140. The planar body 140 includes the planar high dielectric layer 140 and includes longitudinally elongated regions (e.g., corresponding to openings 102, 105 in Figures 5B and 5C) that lack a framework and electrical circuits.

[0085] Figure 8D includes a high-dielectric tile 145 located between each side 101a, 101b and configured to overlap to fold the planar member 100 into the delivery sheath. The high-dielectric tile 145 may include ceramic plates that extend longitudinally through each segment of the body and overlap between segments to correspond to the openings 102, 105 shown in Figures 5B and 5C. The high-dielectric tile or longitudinally extending ceramic plate may be angled with respect to the plane defined by the planar body 140 such that the tile / plate 145 overlaps longitudinally with respect to each other when the end effector retracts into the sheath.

[0086] Figure 8E shows an exemplary electrode 111 configuration of a planar member 100 in which the ablation electrode 111 wraps around the spine or insulating material of the planar body 140. Figure 8F shows an exemplary electrode 111 configuration of a planar member 100 in which the ablation electrode 111 partially wraps around the spine or insulating material of the planar body 140. Each electrode in Figures 8E and 8F can be operated separately to form a bipolar pair that is symmetrical or asymmetrical with respect to the center line CC, as in embodiments further discussed herein.

[0087] Figure 9A shows an end planar member 100 configured such that the ablation electrodes provide a pulse of 1,200 V between the ablation electrode regions. In some embodiments, the planar member 100 is configured to provide PFA electrical pulses having voltages of approximately 600 V and approximately 2,600 V between pairs of ablation electrodes 111, 112, 131, and 132. As shown in Figure 9A, the planar member 100 is configured to provide electrical pulses with amplitudes of approximately 600 V to approximately 2,600 V between a bipolar pair including the ablation electrode on the left side of the planar member 100 that is in contact with the tissue, i.e., electrode 111, and the electrode on the right side of the planar member 100 that is not in contact with the tissue, i.e., electrode 132. Similarly, electrodes 112 and 131 are paired. The paired electrodes are on either side of the planar body 140 and do not overlap.

[0088] In some embodiments, cardiac electrical signals may be measured from one or more diagnostic electrodes positioned on the side of the planar member 100 that is in contact with tissue. In some embodiments, tissue contact may be measured from a pair of tissue contact electrodes positioned on the side of the planar member 100 that is in contact with tissue. In some embodiments, a reference electrical signal may be measured from a reference electrode positioned on the tissue-contacting side of the planar member 100, the reference electrode itself not in contact with tissue.

[0089] Figure 9B is a diagram of a planar member 100 to which the process shown in Figure 9A is applied to a potato model 160. The PFA electrical signal applied to the ablation electrodes results in damage 161 having a depth D1 of approximately 7.5 millimeters (mm). To create the damage, a first bipolar PFA electrical signal is applied to the first and second ablation electrodes, the first ablation electrode being positioned on the first side of the planar body of the planar member 100, and the second ablation electrode being positioned on the second side of the planar member 100, not overlapping with the first ablation electrode (i.e., ablation electrode pair 111, 132). The first bipolar PFA electrical signal consists of 60 pulses having a magnitude of approximately 600V to approximately 2,600V and a total duration of approximately 4 seconds. A second bipolar PFA electrical signal is applied between the third and fourth ablation electrodes, the third ablation electrode being positioned on the first side of the planar member 100 and overlapping with the second ablation electrode, and the fourth ablation electrode being positioned on the second side of the planar member 100 and overlapping with the second ablation electrode, i.e., ablation electrode pairs 112 and 131. The second bipolar PFA electrical signal consists of 60 pulses having a magnitude of approximately 600V to approximately 2,600V and a total duration of approximately 4 seconds.

[0090] Figures 12A, 12B, 13, and 14 illustrate ablation electrode pair configurations for the application of bipolar PFA electrical pulses having voltages of approximately 600V and approximately 2,600V in an embodiment in which the planar member 100 includes a total of four ablation electrodes 111, 112, 131, and 132. As will be described in more detail in relation to Figure 9A, the planar member 100 preferably includes a total of 2 to 8 ablation electrodes. The pattern of ablation electrode pairs can be adapted based on the total number of ablation electrodes in the planar member 100, as will be understood by those skilled in the art who are informed by the disclosure herein.

[0091] Figures 10A and 10B show crossing body pairs for ablation electrodes as described in relation to Figures 9A and 9B. The pair of ablation electrodes are symmetrical with respect to the center line CC (shown in Figure 7) and are located on either side of the planar body 140. A voltage is applied across the electrode pairs in the electrode regions, with each pair having the ablation electrode in the first electrode region in contact with the tissue, and the other electrode region on the opposite side of the planar member 100, crossing the center line CC from the first electrode region.

[0092] Figures 10A and 10B show pairs of two different electrode regions. Figure 10A shows elongated segments 111a and 111b of the ablation electrode 111 which have a positive charge, while elongated segments 132a and 132b of the ablation electrode 132 have a negative charge. This shows a positive voltage pulse configured to induce electroporation in the tissue in contact with either side 101a and 101b of the planar body 140. A biphasic pulse may be applied, in which case the polarity switches or alternates between having a positive charge on the ablation electrode 132 which is not in contact with the tissue and a negative charge on the ablation electrode 111 which is in contact with the tissue, as shown in Figure 10A. As shown in Figure 10A, a series of bipolar pulses (which may include biphasic and / or monophasic pulses) can be applied between the bipolar ablation electrode pair 111, 132, and then a series of bipolar pulses can be applied between the bipolar ablation electrode pair 112, 131 as shown in Figure 10B.

[0093] Figure 10C shows an ablation electrode pair configuration in which the pair of ablation electrodes are symmetrical with respect to the center line CC (shown in Figure 7) and on the same side of the planar body 140. As shown, a voltage is applied across electrodes 111, 112 on one side 101a of the planar body 140 that is in contact with the tissue. Electrodes 131, 132 that are not in contact with the tissue can function as reference electrodes. A biphasic pulse may be applied, in which case the polarity switches or alternates, as shown in Figure 10C, with a positive charge on the right ablation electrode 112 and a negative charge on the left ablation electrode 111. A series of bipolar pulses can be applied between the bipolar ablation electrode pair 111, 112.

[0094] Figure 10D illustrates an ablation electrode pair configuration in which a pair of ablation electrodes overlap and are located on opposite sides of a planar body. The voltage is applied across the ablation electrodes 111, 112 that are in contact with the tissue to the ablation electrodes 131, 132 on the opposite side of the planar body 140 that are not in contact with the tissue. A biphasic pulse may be applied, in which case the polarity switches or alternates, as shown in Figure 10D, with positive charges on the ablation electrodes 131, 132 that are not in contact with the tissue and negative charges on the ablation electrodes 111, 112 that are in contact with the tissue. A series of bipolar pulses may be applied between the bipolar ablation electrode pair to activate both electrodes 111, 112 that are in contact with the tissue simultaneously, as shown in the figure. Alternatively, a series of bipolar pulses may be applied to the first ablation electrode pair while the second pair is de-energized, and then a series of bipolar pulses may be applied to the second ablation electrode pair while the first pair is de-energized.

[0095] Figures 10E and 10F illustrate the voltage applied across an electrode pair, where the pair of electrodes are positioned across the central axis from each other. The pair is asymmetrical with respect to the centerline, with one electrode (or set of electrodes) of the pair closer to the centerline than the other. In this configuration, the electrode segments on both sides of the end effector body can act as a unit and be electrically coupled within the planar member 100. For example, electrodes 111a and 131a can form a bipolar pair with electrodes 112b and 132b, as shown in Figure 10E. Similarly, electrodes 111b and 131b can form a bipolar pair with electrodes 112a and 132a, as shown in Figure 10F.

[0096] Alternatively, although not shown, only electrodes on the side surface of the planar member 100 in contact with the tissue may be activated. For example, ablation electrodes 111a and 112b may form a bipolar pair in Figure 10E, while the opposing ablation electrodes 131a and 132b are off. Similarly, in Figure 10F, ablation electrodes 111b and 112a may form a bipolar pair as in Figure 10E, while the opposing ablation electrodes 131b and 132a are off. A series of bipolar pulses (which may include biphasic pulses and / or monophasic pulses) can be applied between the bipolar ablation electrode pairs and alternately switched between the bipolar configurations of Figures 10E and 10F, as shown in Figure 10E and then in Figure 10F.

[0097] Figure 10G shows another example in which ablation electrodes 131a and 131b are considered to be in contact with tissue. In this example, ablation electrodes 131a and 131b are no longer connected to each other but are connected separately to the generator, and as a result a biphasic pulsed field can be provided between these two tissues in contact with the ablation electrodes to allow electron flow between 131a and 131b. Similarly, ablation electrodes 131c and 131d (in tissue contact) are no longer connected to each other but are connected separately to the generator, and as a result a biphasic pulsed field can be provided between these two tissue-contact ablation electrodes to allow electron flow between them.

[0098] Figure 11 is a diagram of an exemplary electrode configuration on one side of an exemplary planar member 100, including elongated ablation electrodes 171, 172, 173, and 174 in four ablation electrode regions 181, 182, 183, and 184, diagnostic electrodes 113 and 114 positioned in at least two of the ablation electrode regions 181 and 182, tissue contact electrodes 115 and 116 positioned along the center line CC between the ablation electrode regions, and a reference electrode 117 positioned in the proximal region on the illustrated side of the planar member 100. Embodiments of the planar member 100 described herein include, but are not limited to, exactly four ablation electrodes 111, 112, 131, and 132, and embodiments shown in Figure 11 include up to eight ablation electrodes, including those indicated as 171, 172, 173, and 174, and corresponding overlapping ablation electrodes on the opposite side of the planar body, which are not shown. However, it will be understood that the planar member 100 may contain only one ablation electrode or may contain more than eight ablation electrodes, depending on the specific configuration.

[0099] The planar member 100 preferably includes a total of 2 to 8 ablation electrodes. The planar member 100 preferably includes exactly 2, 3, or 4 ablation electrodes on each side of the planar body 140. Each ablation electrode preferably overlaps with the corresponding ablation electrode on the opposite side of the planar body such that the ablation electrode is symmetrical with respect to the plane defined by the planar body 140. Fewer ablation electrodes can be achieved by electrically connecting combinations of ablation electrodes within the planar member 100 or other locations within the catheter 14. Increasing the number of ablation electrodes can be achieved by dividing the ablation electrodes into two parts configured to be electrically insulated from each other within the catheter 14 and to be operated independently by the generator 50. Figure 11 shows one embodiment in which the ablation electrode 111 on the left side of the center line CC, as shown in Figure 7, is segmented into two electrodes, namely the upper left ablation electrode 171 and the lower left ablation electrode 173. Similarly, as shown in Figure 7, the ablation electrode 112 to the right of the center line CC is segmented into two electrodes, namely the upper right ablation electrode 172 and the lower right ablation electrode 174. Preferably, all ablation electrodes 171, 172, 173, and 174 have approximately the same surface area as each other.

[0100] Ablation electrodes can be paired in various combinations to provide a bipolar PFA electrical signal between the paired electrodes. Table 1 includes an overview of selected exemplary ablation electrode pairs based on the examples presented herein. As will be understood by those skilled in the art who are informed by the disclosure herein, pairs can be operated simultaneously and / or sequentially in various combinations to achieve PFA of the target tissue.

[0101] [Table 1]

[0102] In another alternative embodiment (not shown), segments 111a and 111b of the left ablation electrode 111 shown in Figure 5B may be electrically insulated from each other to form separate ablation electrodes. In an embodiment where all elongated ablation electrode segments form independent electrodes, the planar member 100 includes a total of eight elongated ablation electrodes. The exemplary ablation electrode configurations illustrated and described herein are non-limiting, and numerous other ablation electrode configurations are possible. In each ablation electrode configuration, the ablation electrodes may be paired according to the same concepts outlined in Table 1.

[0103] In addition to performing ablation between various electrodes on a single planar member 100, the art of the present disclosure may be further configured to perform ablation between electrodes on other planar members 100 of an expandable end-effector portion 110. For example, as shown in Figures 12A and 12B, the expandable end-effector portion 110 may include a plurality of planar members 100, each containing electrodes (six planar members are shown in Figures 12A and 12B, labeled A to H, but it is understood that the expandable end-effector portion 110 may include more or fewer than six planar members 100), according to any of the examples shown and described herein. The art of the present disclosure may be configured to perform ablation between electrodes on two or more planar members 100 of the expandable end-effector portion 110. For example, as shown in Figure 12A, electrodes on adjacent planar members 100 may be electrically connected to perform ablation. For example, an electrode on planar member A may be electrically connected to an electrode on planar member B to perform ablation. The same can be achieved with planar members C and D, planar members E and F, planar members G and H, planar members A and H, planar members G and F, planar members E and D, and planar members C and B.

[0104] Alternatively, as shown in Figure 12B, ablation may be performed between electrodes on planar members 100 that span mutually expandable end-effector portions 110. For example, ablation can be performed between planar members A and E, between planar members B and F, between planar members C and G, and between planar members D and H.

[0105] As can be understood, electrodes on planar member 100 can be configured to perform ablation on any of the other planar members. For example, electrodes on planar member A can be configured to perform ablation together with electrodes on planar members B, C, D, E, F, G, and / or H. Similarly, electrodes on planar member B can be configured to perform ablation together with electrodes on planar members A, C, D, E, F, G, and / or H, and so on for the other planar members. That is, various examples of performing ablation using electrodes on planar members A-H are shown and illustrated in Figures 12A and 12B, but it will be understood that the art of this disclosure can also include performing ablation using any combination of electrodes on planar member 100.

[0106] Furthermore, although it is shown that only electrodes on two planar members are configured to perform ablation together, it will be understood that various other combinations of electrodes on the planar members 100 can be implemented. For example, an electrode on one planar member (e.g., planar member A) can be configured to perform ablation together with electrodes on two or more other planar members (e.g., planar members B and C, planar members B, C, D, planar members B, C, D, and E, etc.). In other words, electrodes on various planar members 100 can be configured to perform ablation together to ablate a desired area of ​​tissue and to achieve a desired ablation profile (damaged side, depth, etc.) for a particular application.

[0107] Furthermore, ablation can be completed by sequencing various combinations of electrodes on the planar members 100, as desired. For example, ablation can be completed using all electrodes on all of the planar members 100 by sequencing various combinations of two planar members 100. For example, this sequence may include performing ablation between planar member A and planar member B, then between planar member C and planar member D, then between planar member E and planar member F, then between planar member G and planar member H. Alternatively, this sequence may include performing ablation between planar member A and planar member C, then between planar member B and planar member D, then between planar member C and planar member E, then between planar member D and planar member F, then between planar member E and planar member G, then between planar member F and planar member A, then between planar member H and planar member B. Alternatively, as yet another example, this sequence may include performing ablation between planar member A and planar member E, then between planar member B and planar member G, and then between planar member D and planar member H.

[0108] Figures 13A and 13B show flowcharts of methods 1300A and 1300B for performing tissue mapping and ablation according to the art of this disclosure. Methods 1300A and 1300B are provided for illustrative purposes and may include any of the features and methods disclosed herein. Therefore, methods 1300A and 1300B should not be limited to the specific steps and order of steps shown and described herein.

[0109] Method 1300A, shown in Figure 13A, may include inserting a medical probe into a body lumen (1302) and sliding an outer sleeve along an inner catheter shaft to extend an expandable end-effector portion having multiple planar members beyond the distal end of a focal end-effector portion (1304). Method 1300A may further include receiving one or more electrophysiological signals from at least one mapping electrode positioned on the expandable end-effector portion (1306) and generating a map representing the electrophysiological signals propagating through the tissue (1308). Method 1300A may further include retracting the outer sleeve to extend the focal end-effector portion beyond the distal ends of the multiple planar members (1310) and delivering ablation energy to the tissue via the focal end-effector portion (1312). As described above, Method 1300A can be used to complete a mapping procedure using an expandable end-effector portion and then to ablate tissue using a focal end-effector portion to ablate a relatively small area of ​​tissue. The ablation procedure may include ablating tissue at identified locations to stop the propagation of abnormal signals through the tissue.

[0110] Method 1300B, shown in Figure 13B, may include inserting a medical probe into a body lumen (1302) and sliding an outer sleeve along an inner catheter shaft to extend an expandable end-effector portion having multiple planar members beyond the distal end of a focal end-effector portion (1304). Method 1300B may further include receiving one or more electrophysiological signals from at least one mapping electrode positioned on the expandable end-effector portion (1306) and generating a map representing the electrophysiological signals propagating through the tissue (1308). Method 1300B may further include delivering ablation energy to the tissue using at least one electrode positioned on one of the multiple planar members (1314). As described above, Method 1300B can be used to ablate a relatively large area of ​​tissue by completing a mapping procedure using the expandable end-effector portion and then ablating the tissue using the same expandable end-effector portion. Ablation of tissue by method 1300B using an expandable end effector may include any of the various combinations of electrodes for performing ablation as described herein. The ablation procedure may include ablation of tissue at identified locations to stop the propagation of abnormal signals through the tissue.

[0111] To be understood, methods 1300A and 1300B described herein are not intended to be limited to the specific steps described or to a specific order of the steps described. That is, methods 1300A and 1300B may include other intervening steps not expressly described herein and / or may be performed in various orders. Thus, although methods 1300A and 1300B are described as having specific steps and presented in a specific order, methods 1300A and 1300B are not limited in that way.

[0112] The following clauses enumerate non-limiting embodiments of this disclosure.

[0113] Clause 1: A medical probe comprising: an elongated shaft extending along a longitudinal axis; a distal electrode positioned at the distal end of the elongated shaft and configured to deliver ablation energy to tissue; an outer sleeve at least partially positioned around the elongated shaft; and a plurality of planar members attached to the outer sleeve and extending radially outward from the longitudinal axis, each of the plurality of planar members comprising a framework coupled to an outer member and an inner member opposite to the outer member, each of the inner member and the outer member including a plurality of electrodes arranged diametrically on the inner member and the outer member, and the outer sleeve being configured to move axially along the elongated shaft to move the plurality of planar members axially relative to the distal electrode.

[0114] Clause 2: The medical probe according to Clause 1, wherein the outer sleeve is configured to move a plurality of planar members beyond the distal end of the distal electrode.

[0115] Clause 3: The medical probe according to Clause 1 or 2, wherein at least one electrode among a plurality of electrodes on each of the plurality of planar members is configured to detect an electrophysiological signal.

[0116] Clause 4: A medical probe according to any one of Clauses 1 to 3, wherein at least one electrode among a plurality of electrodes on each of the plurality of planar members is configured to deliver ablation energy to tissue.

[0117] Clause 5: The medical probe described in Clause 4 is configured to deliver ablation energy to cause irreversible electroporation of tissue.

[0118] Clause 6: A medical probe as described in any one of Clauses 1 to 5, wherein the distal electrode is configured to deliver radiofrequency (RF) ablation energy to tissue.

[0119] Clause 7: A medical probe according to any one of Clauses 1 to 6, wherein each of the planar members comprises a first set of electrodes on a first side of the planar member and a second set of electrodes on a second side of the planar member.

[0120] Clause 8: The medical probe according to Clause 7, wherein the first plurality of electrodes and the second plurality of electrodes are separated by a dielectric material.

[0121] Clause 9: A medical probe according to any one of Clauses 1 to 8, wherein each of the planar members comprises a first flexible circuit on a first side of the planar member and a second flexible circuit on a second side of the planar member.

[0122] Clause 10: The medical probe described in Clause 9, wherein the first flexible circuit and the second flexible circuit are separated by a dielectric material.

[0123] Clause 11: A medical probe according to Clause 7 or 10, wherein the dielectric material includes thermoplastic polyurethane.

[0124] Clause 12: The medical probe according to Clause 11, wherein the dielectric material further comprises an insulating material dispersed throughout at least a portion of the thermoplastic polyurethane.

[0125] Clause 13: A medical probe according to any one of Clauses 7 to 12, further comprising one or more spines disposed within a dielectric material.

[0126] Clause 14: A medical probe according to any one of Clauses 1 to 13, wherein each of the multiple electrodes includes a serpentine shape.

[0127] Clause 15: A medical probe as described in any one of Clauses 1 to 14, wherein each electrode among the multiple electrodes has a length of at least twice its width.

[0128] Clause 16: A medical probe according to any one of Clauses 1 to 15, wherein each electrode of a plurality of electrodes includes conductive ink printed on its respective planar member.

[0129] Clause 17: A medical probe according to any one of Clauses 1 to 16, wherein multiple electrodes on each of the planar members of a plurality of planar members are configured to deliver ablation energy to tissue, and the medical probe further comprises one or more processors and a memory for storing instructions configured, when executed by the one or more processors, to control the delivery of ablation energy to the multiple electrodes.

[0130] Clause 18: The medical probe according to Clause 17, wherein the instruction, when executed by one or more processors, is configured to cause the medical probe to deliver ablation energy between a first electrode and a second electrode of a planar member.

[0131] Clause 19: The medical probe according to Clause 18, wherein, when executed by one or more processors, the instruction causes the medical probe to deliver ablation energy between a first electrode on the tissue-facing side of a given planar member and a second electrode on the non-tissue-facing side of a given planar member.

[0132] Clause 20: The medical probe according to Clause 18, wherein the first and second electrodes are positioned on opposite sides of a plane that extends perpendicularly through the longitudinal axis of the planar member.

[0133] Clause 21: The medical probe according to Clause 19, wherein the first electrode and the second electrode are located on the same side of a plane that extends perpendicularly through the longitudinal axis of the planar member.

[0134] Clause 22: A method comprising inserting a medical probe into a lumen of a body, wherein the medical probe comprises: an elongated shaft extending along a longitudinal axis; a distal electrode positioned at the distal end of the elongated shaft and configured to deliver ablation energy to tissue; an outer sleeve at least partially positioned around the elongated shaft; and a plurality of planar members attached to the outer sleeve and extending radially outward from the longitudinal axis, each of the plurality of planar members comprising a plurality of electrodes, and the outer sleeve being configured to move axially along the elongated shaft to move the plurality of planar members axially relative to the distal electrode; sliding the outer sleeve along the elongated shaft to extend the plurality of planar members beyond the distal end of the distal electrode; and receiving one or more electrophysiological signals from at least one of the plurality of electrodes positioned on the plurality of planar members.

[0135] Clause 23: The method according to Clause 22, further comprising generating an electrophysiological map based at least partially on one or more electrophysiological signals.

[0136] Clause 24: The method according to Clause 22 or 23, further comprising applying ablation energy to tissue through at least one electrode among a plurality of electrodes.

[0137] Clause 25: The method according to Clause 24, wherein the ablation energy is configured to cause irreversible electroporation of the tissue.

[0138] Clause 26: The method according to Clause 24, wherein the ablation energy is conducted between the first electrode and the second electrode of the planar member.

[0139] Clause 27: The method according to Clause 26, wherein the ablation energy is conducted between a first electrode on the side facing the structure of a given planar member and a second electrode on the side not facing the structure of a given planar member.

[0140] Clause 28: The method according to Clause 27, wherein the first and second electrodes are located on opposite sides of a plane that extends perpendicularly through the longitudinal axis of the planar member.

[0141] Clause 29: The method according to Clause 27, wherein the first electrode and the second electrode are located on the same side of a plane that extends perpendicularly through the longitudinal axis of the planar member.

[0142] Clause 30: The method according to Clause 22 or 23, further comprising sliding the outer sleeve proximal along an elongated shaft to extend the distal electrode beyond the distal ends of a plurality of planar members.

[0143] Clause 31: The method according to Clause 25, further comprising applying ablation energy to tissue via a distal electrode.

[0144] Clause 32: Ablation energy is the method described in Clause 27, including radio frequency (RF) ablation energy.

[0145] While exemplary embodiments of the subject matter included herein have been illustrated and described, further adaptations of the methods and systems described herein can be achieved by appropriate modifications without departing from the claims. For example, the planar member 100 may have an alternative shape or may include an alternative material, and the electrical signals used to achieve PFA may be modified to suit the specific shape and material of the planar member 100. Thus, insofar as there are variations of the invention that are within the spirit of this disclosure or equivalent to the invention found in the claims, this patent is intended to encompass such variations as well. Some such modifications should be obvious to those skilled in the art. For example, the examples, embodiments, geometric shapes, materials, dimensions, proportions, steps, etc., discussed above are exemplary. Therefore, the claims should not be limited to the specific details of the structure and operation described in the specification and drawings.

[0146] [Implementation Method] (1) A medical probe, A long, slender shaft extending along its longitudinal axis, A distal electrode positioned at the distal end of the elongated shaft, configured to deliver ablation energy to the tissue, An outer sleeve, at least partially positioned around the elongated shaft, A medical probe comprising: a plurality of planar members attached to the outer sleeve and extending radially outward from the longitudinal axis, each of the plurality of planar members comprising a framework coupled to an outer member and an inner member opposite to the outer member, each of the inner member and the outer member comprising a plurality of electrodes arranged diametrically on the inner member and the outer member, and the outer sleeve being configured to move axially along the elongated shaft to move the plurality of planar members axially relative to the distal electrode. (2) The medical probe according to Embodiment 1, wherein the outer sleeve is configured to move the plurality of planar members beyond the distal end of the distal electrode. (3) The medical probe according to Embodiment 1, wherein at least one electrode among the plurality of electrodes on each of the plurality of planar members is configured to detect an electrophysiological signal. (4) The medical probe according to Embodiment 1, wherein at least one electrode of the plurality of electrodes on each of the plurality of planar members is configured to deliver ablation energy to tissue. (5) The medical probe according to Embodiment 4, wherein the ablation energy is configured to cause irreversible electroporation of the tissue.

[0147] (6) The medical probe according to Embodiment 1, wherein each of the plurality of planar members is provided with at least four electrodes on the first side of the planar member and at least four electrodes on the second side of the planar member. (7) The medical probe according to Embodiment 1, wherein the plurality of electrodes on the inner surface member and the plurality of electrodes on the outer surface member are separated by a dielectric material. (8) The medical probe according to Embodiment 1, wherein each of the plurality of planar members is provided with a first flexible circuit on the first side of the planar member and a second flexible circuit on the second side of the planar member. (9) The medical probe according to Embodiment 8, wherein the first flexible circuit and the second flexible circuit are separated by a dielectric material. (10) The medical probe according to Embodiment 9, wherein the dielectric material includes thermoplastic polyurethane.

[0148] (11) The medical probe according to Embodiment 10, wherein the dielectric material further comprises an insulating material dispersed over at least a portion of the thermoplastic polyurethane. (12) The medical probe according to Embodiment 1, wherein each of the plurality of electrodes includes a serpentine shape. (13) The medical probe according to Embodiment 1, wherein each electrode among the plurality of electrodes has a length of at least twice its width. (14) The medical probe according to Embodiment 1, wherein each of the plurality of electrodes includes conductive ink printed on the respective planar member. (15) The plurality of electrodes on each of the plurality of planar members are configured to deliver ablation energy to tissue, and the medical probe is One or more processors, The medical probe according to Embodiment 1, further comprising: a memory for storing instructions configured to control the delivery of ablation energy to the plurality of electrodes in order to deliver ablation energy between a first electrode and a second electrode of the planar member, when executed by the one or more processors.

[0149] (16) When the instruction is executed by one or more processors, the medical probe will A medical probe according to embodiment 15, configured to deliver ablation energy between a first electrode on the side of a given planar member facing the tissue and a second electrode on the side of the given planar member not facing the tissue. (17) The medical probe according to embodiment 15, wherein the first electrode and the second electrode are arranged on both sides of the center line of the planar member. (18) The medical probe according to embodiment 15, wherein the first electrode and the second electrode are arranged on the same side of the central axis of the planar member. (19) The plurality of electrodes on each of the plurality of planar members are configured to deliver ablation energy to tissue, and the medical probe is One or more processors, The medical probe according to Embodiment 1, further comprising: a memory for storing instructions configured to control the delivery of ablation energy to a plurality of electrodes in order to deliver ablation energy between a first electrode disposed on a first planar member of the plurality of planar members and a second electrode disposed on a second planar member of the plurality of planar members, when executed by the one or more processors; (20) A method, The medical probe is inserted into a lumen of the body, and the medical probe is A long, slender shaft extending along its longitudinal axis, A distal electrode positioned at the distal end of the elongated shaft, configured to deliver ablation energy to the tissue, An outer sleeve, at least partially positioned around the elongated shaft, A plurality of planar members are attached to the outer sleeve and extend radially outward from the longitudinal axis, each of which has multiple electrodes, and the outer sleeve is configured to move axially along the elongated shaft, thereby moving the plurality of planar members axially relative to the distal electrode, and the insertion is performed by the plurality of planar members. The outer sleeve is slid along the elongated shaft so that the plurality of planar members extend beyond the distal end of the distal electrode, A method comprising receiving one or more electrophysiological signals from at least one electrode among the plurality of electrodes arranged on the plurality of planar members.

Claims

1. A medical probe, A long, slender shaft extending along its longitudinal axis, A distal electrode positioned at the distal end of the elongated shaft, configured to deliver ablation energy to the tissue, An outer sleeve, at least partially positioned around the elongated shaft, A medical probe comprising: a plurality of planar members attached to the outer sleeve and extending radially outward from the longitudinal axis, each of the plurality of planar members comprising a framework coupled to an outer member and an inner member opposite to the outer member, each of the inner member and the outer member comprising a plurality of electrodes arranged diametrically on the inner member and the outer member, and the outer sleeve being configured to move axially along the elongated shaft to move the plurality of planar members axially relative to the distal electrode.

2. The medical probe according to claim 1, wherein the outer sleeve is configured to move the plurality of planar members beyond the distal end of the distal electrode.

3. The medical probe according to claim 1, wherein at least one electrode among the plurality of electrodes on each of the plurality of planar members is configured to detect an electrophysiological signal.

4. The medical probe according to claim 1, wherein at least one electrode among the plurality of electrodes on each of the plurality of planar members is configured to deliver ablation energy to tissue.

5. The medical probe according to claim 4, wherein the ablation energy is configured to cause irreversible electroporation of the tissue.

6. The medical probe according to claim 1, wherein each of the plurality of planar members is provided with at least four electrodes on a first side of the planar member and at least four electrodes on a second side of the planar member.

7. The medical probe according to claim 1, wherein the plurality of electrodes on the inner surface member and the plurality of electrodes on the outer surface member are separated by a dielectric material.

8. The medical probe according to claim 1, wherein each of the plurality of planar members is provided with a first flexible circuit on the first side of the planar member and a second flexible circuit on the second side of the planar member.

9. The medical probe according to claim 8, wherein the first flexible circuit and the second flexible circuit are separated by a dielectric material.

10. The medical probe according to claim 9, wherein the dielectric material includes thermoplastic polyurethane.

11. The medical probe according to claim 10, wherein the dielectric material further comprises an insulating material dispersed over at least a portion of the thermoplastic polyurethane.

12. The medical probe according to claim 1, wherein each of the plurality of electrodes includes a serpentine shape.

13. The medical probe according to claim 1, wherein each electrode among the plurality of electrodes has a length of at least twice its width.

14. The medical probe according to claim 1, wherein each of the plurality of electrodes includes conductive ink printed on the respective planar member.

15. The plurality of electrodes on each of the plurality of planar members are configured to deliver ablation energy to tissue, and the medical probe is One or more processors, The medical probe according to claim 1, further comprising: a memory for storing instructions configured to control the delivery of ablation energy to the plurality of electrodes in order to deliver ablation energy between a first electrode and a second electrode of the planar member, when executed by the one or more processors.

16. When the instruction is executed by one or more processors, the medical probe will be subjected to the following: The medical probe according to claim 15, configured to deliver ablation energy between a first electrode on the side of a given planar member facing the tissue and a second electrode on the side of the given planar member not facing the tissue.

17. The medical probe according to claim 15, wherein the first electrode and the second electrode are arranged on both sides of the center line of the planar member.

18. The medical probe according to claim 15, wherein the first electrode and the second electrode are arranged on the same side of the central axis of the planar member.

19. The plurality of electrodes on each of the plurality of planar members are configured to deliver ablation energy to tissue, and the medical probe is One or more processors, The medical probe according to claim 1, further comprising: a memory for storing instructions configured to control the delivery of ablation energy to a plurality of electrodes in order to deliver ablation energy between a first electrode disposed on a first planar member among the plurality of planar members and a second electrode disposed on a second planar member among the plurality of planar members, when executed by the one or more processors;

20. It is a method, The medical probe is inserted into a lumen of the body, and the medical probe is A long, slender shaft extending along its longitudinal axis, A distal electrode positioned at the distal end of the elongated shaft, configured to deliver ablation energy to the tissue, An outer sleeve, at least partially positioned around the elongated shaft, A plurality of planar members are attached to the outer sleeve and extend radially outward from the longitudinal axis, each of which has multiple electrodes, and the outer sleeve is configured to move axially along the elongated shaft, thereby moving the plurality of planar members axially relative to the distal electrode, and the insertion is performed by the plurality of planar members. The outer sleeve is slid along the elongated shaft so that the plurality of planar members extend beyond the distal end of the distal electrode, A method comprising receiving one or more electrophysiological signals from at least one electrode among the plurality of electrodes arranged on the plurality of planar members.

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