Hybrid Mapping and Pulsed Field Ablation Catheter

Abstract

Hybrid Mapping and Pulsed Field Ablation Catheter An embodiment of the present disclosure describes a hybrid catheter having a flexible array of electrodes configured for both mapping and providing high power ablation. In one embodiment, a hybrid mapping and ablation catheter is provided having a planar assembly having a plurality of flexible arms and a plurality of electrodes disposed on each arm of the plurality of flexible arms, at least one arm comprising a first lumen housing a strut extending along a length of at least one of the flexible arms, and a second lumen and a third lumen housing conductive wires configured to independently energize one or more of the plurality of electrodes disposed on the flexible arms and deliver pulsed field ablation energy to tissue.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to Provisional Application No. 63 / 327,908, filed April 6, 2022, which is incorporated herein by reference in its entirety.

[0002] FIELD OF THE DISCLOSURE Embodiments described herein relate generally to catheter devices for delivering therapeutic electrical energy. In particular, a hybrid catheter usable for high power therapeutic tissue ablation and mapping is described.

[0003] Pulsed field ablation (PFA) utilizes controlled electric fields to ablate tissue and leave scars through a process called irreversible electroporation (IRE). PFA offers greater tissue specificity than traditional ablation, and its power requirements (tens of amps of current and hundreds to thousands of voltage levels) are higher / greater than those of high-density mapping catheters. Successful ablation requires detailed mapping and navigation of the catheter to deliver energy to specific targets. Summary of the Invention [Problem to be solved by the invention]

[0004] In embodiments of the present disclosure, hybrid catheters having flexible arrays of electrodes configured for both mapping and delivery of high power ablation are described, e.g., catheters are provided that are configured or adapted to withstand the voltage stresses associated with delivery of high power ablation. [Means for solving the problem]

[0005] Accordingly, a first aspect of the present disclosure features a hybrid mapping and ablation catheter comprising an elongate deformable shaft with a proximal end and a distal end, and a distal end assembly connected to the deformable shaft and extending distally from the shaft, the distal end assembly being a planar assembly having a plurality of flexible arms and a plurality of electrodes disposed on each arm of the plurality of arms, at least one arm comprising a first lumen housing a strut extending along a length of at least one of the flexible arms, and a second lumen and a third lumen housing a conductive wire configured to independently energize one or more of the plurality of electrodes disposed on the flexible arms to deliver pulsed field ablation energy to tissue. The first lumen may be centrally located in the arm, and the second lumen and the third lumen are diametrically opposed. The catheter may further include a connector connecting the distal end assembly to the deformable shaft, and an adhesive is disposed around the proximal ends of the plurality of flexible arms and the connector. In some examples, the catheter further includes an adhesive disposed around a distal portion of the flexible arm having the first, second, and third lumens. Optionally, the catheter may further include a dielectric layer disposed on at least one of the flexible arms, and a portion of the plurality of electrodes is disposed on the dielectric layer. The dielectric layer may include parylene. Optionally, the catheter further includes a pull ring disposed proximal to the distal tip assembly, the deformable shaft includes a distal deflectable portion, first and second pull wires extend along the deformable shaft, an actuator is operably connected to the proximal ends of the first and second pull wires and adapted to selectively deflect the distal deflectable portion, distal ends of the first and second pull wires pass through the pull ring and are secured to the distal end of the deformable shaft, and the pull ring is electrically insulated from the electrodes attached to the distal tip assembly.The deformable shaft may further include a plurality of conductive wires electrically connected to the plurality of electrodes, the conductive wires extending along the deformable shaft and through the pull ring, the pull wires and the conductive wires being surrounded by a tubular material at the distal deflectable section to electrically insulate the pull ring. The distal deflectable section may extend distally from the deformable shaft and define first and second pairs of diametrically opposed lumens, the two lumens of the first pair housing the pull wires and at least one lumen of the second pair housing the plurality of conductive wires surrounded by the tubular material. The tubular material may include polyethylene terephthalate (PET). The pull ring may include a dielectric layer. In some examples, the catheter further includes a handle assembly connected to a proximal end of the deformable shaft, the handle assembly including an electromechanical pin-and-socket connector, the pin-and-socket connector configured to provide an electrical channel to each electrode attached to the flexible arm. The electrical channels in the connector may be electrically isolated by the size and location of the pins of the pin-and-socket connector. The connector may further include at least one flexible circuit. Optionally, the flexible circuit forms a high density wiring interface.

[0006] The catheter may be configured to operate within a range of about 500 volts to at least about 2000 volts by optionally further comprising a connector connecting the distal end assembly to the deformable shaft, an adhesive disposed around the proximal ends and connector of the plurality of flexible arms, an adhesive disposed around the distal ends of the flexible arms having first, second and third lumens, a parylene layer on at least one of the flexible arms, and a plurality of electrodes disposed on the parylene layer. In some examples, the catheter further includes a pull ring disposed proximal to the distal tip assembly, the deformable shaft including a distal deflectable portion, first and second pull wires extending along the deformable shaft, and an actuator operably connected to the proximal ends of the first and second pull wires and adapted to selectively deflect the distal deflectable portion, the distal ends of the first and second pull wires extending through the pull ring and secured to the distal end of the deformable shaft, the pull ring being electrically insulated from the electrodes attached to the distal tip assembly. The catheter may further include a conductive wire electrically insulated from the pull ring by a polyethylene terephthalate layer surrounding the conductive wire or a dielectric layer disposed on the pull ring, and / or a handle assembly connected to the proximal end of the deformable shaft, the handle assembly including an electromechanical pin-and-socket connector configured to provide an electrical channel to each electrode attached to the flexible arm.

[0007] The details of one or more embodiments are set forth in the description below. Other features, objects, and advantages will become apparent from the description and claims. [Brief description of the drawings]

[0008] Various embodiments of the present disclosure are illustrated by the accompanying drawings, which are not necessarily drawn to scale, in which the same numerals accompanied by different letters represent different instances of substantially similar components. Reference is made to the exemplary embodiments illustrated in the drawings.

[0009] [Figure 1] FIG. 1 is a schematic diagram of a catheter that performs one or more diagnostic and / or therapeutic functions.

[0010] [Diagram 2] FIG. 2 is a perspective view of one embodiment of a catheter for use with the system of FIG. 1, the catheter including a catheter handle and a catheter shaft, in accordance with one or more embodiments of the present disclosure.

[0011] [Diagram 3] 3A-C show various views of a pin-and-socket connection system for the catheter of FIG.

[0012] [Figure 4] FIG. 4 is a cross-sectional view of a portion of the catheter shaft shown in FIG. 2 showing an electrically isolated pull ring.

[0013] [Figure 5A] 5A is a plan view of a high density electrode grid assembly of the catheter shown in FIG. 1. FIG.

[0014] [Figure 5B] FIG. 5B is a perspective view of a connector of the high density electrode grid assembly shown in FIG. 5A.

[0015] [Figure 5C] FIG. 5C is a plan view of the distal end of the high density electrode grid assembly shown in FIG. 5A in accordance with one or more embodiments of the present disclosure.

[0016] [Figure 6]Figures 6A-F are cross-sectional views of an embodiment of an arm of the high density electrode grid assembly of the catheter shown in Figure 5C at line 6. A and B show a triple lumen configuration with and without a wire, respectively. C and D show another triple lumen configuration with and without an arm foundation and wire, respectively. E and F show another triple lumen configuration with and without an arm foundation and wire, respectively. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0017] In an embodiment of the present disclosure, a hybrid mapping and ablation catheter is described.

[0018] The electrode assemblies described herein include various electrode configurations. The electrodes may be driven independently of each other (in a "non-grouped" configuration) or together as a larger effective electrode (in a "grouped" configuration). For example, when driven independently of each other, the electrodes may be used in mapping and / or EGM applications. In contrast, multiple electrodes may be driven together to function as a composite electrode for ablation and / or near-field impedance navigation applications. Additionally, different subsets of the electrodes may be selectively driven (relative to each other) to allow better control of the ablation procedure.

[0019] 1 illustrates an exemplary embodiment of an electrophysiological system 10 for performing one or more diagnostic and / or therapeutic functions, including components for monitoring the temperature of an electrode and components for monitoring the contact force between the electrode and tissue before, during, and / or after an ablation procedure on tissue 24 of a patient 22. In the exemplary embodiment, tissue 24 is cardiac or myocardial tissue, although system 10 is applicable to ablation procedures on other body tissues.

[0020] System 10 includes subsystems 26, including an ablation generator and a control system for communicating with and / or controlling one or more components of system 10 and the mapping system. Subsystems 26 may further include one or more of a navigation system, an imaging system, and any other systems or subsystems configured to perform examination, diagnostic, and / or therapeutic functions of system 10 (e.g., positioning, recording, stimulation, and / or visualization systems).

[0021] A hybrid mapping and ablation catheter 11 is part of an electrophysiology system 10. The catheter 11 includes an elongated shaft 18 attached to a control handle 12 and configured to move within a patient 22. The catheter 11 may be steerable, for example, by incorporating an actuator in the handle 12 connected to one or more steering wires that extend through the elongated catheter shaft 18 and terminate in one or more pull rings in a distal region 20. The catheter 11 may be an irrigated catheter, may be configured to be connected to a suitable source of irrigation fluid and / or an irrigation pump, and / or may include force feedback capabilities. Such features are not shown in the drawings or described in detail herein, as they are not necessary for an understanding of the present disclosure. However, by way of example only, catheter 11 may incorporate various aspects and features of the following catheters, all from Abbott Laboratories: FlexAbility™ Ablation Catheter, Sensor Enabled™; Advisor™ HG Grid Mapping Catheter, Sensor Enabled™; TactiCath™ Quartz Contact Force Ablation Catheter, Sensor Enabled™; TactiFlex™ Ablation Catheter, Sensor Enabled™.

[0022] The catheter 11 further includes a number of electrodes (not shown) mounted in or on the distal portion 40 of the elongate shaft 18 (see FIG. 5A). The electrodes may be used, for example, during operation with a positioning system, an ablation system, a recording system, a stimulation system, a visualization system, a navigation system, and / or a mapping system (e.g., subsystem 26). The electrodes may be configured to provide signals indicative of both a position and an orientation of at least a portion of the elongate shaft 18. The handle 12 may provide a mechanical and electrical connection via a connector 14 to a cable 16 extending to the subsystem 26. The connector 14 provides a mechanical and electrical connection to one or more wires extending, for example, from the subsystem 26 to one or more electrodes or sensors attached to the catheter 11. In other embodiments, the connector 14 may provide a mechanical, electrical, and / or fluid connection to wires extending from other components of the system 10.

[0023] The handle 12 provides a place for a clinician to hold the catheter 11 and may also provide a means for manipulating or guiding the elongate shaft 18 within the body or its tissues (e.g., tissue 24) as is known in the art. Catheter handles are common in the art, and it will be understood that the configuration of the handle 12 may vary.

[0024] Figure 2 illustrates one exemplary embodiment of a catheter 11 suitable for use with the system 10 shown in Figure 1. In Figure 2, the catheter 11 includes an elongated, flexible, generally cylindrical hollow shaft 22 and an ergonomically shaped control handle 120. In some embodiments, the catheter 11 may include additional components such as, for example, but not limited to, steering wires and actuators, irrigation lumens and ports, pressure sensors, contact sensors, temperature sensors, additional electrodes and corresponding conductors or leads, and / or ablation elements (e.g., ablation electrodes, etc.).

[0025] As shown in FIG. 2, the control handle 120 includes a housing 126 that extends from a proximal end 128 to a distal end 130 along a longitudinal axis 132. The housing 126 defines a longitudinally extending internal cavity. In some embodiments, a fluid lumen (not shown) may be located within the internal cavity (e.g., in an irrigation configuration). The shaft 122 has a proximal end 134 that is connected to the control handle 120 and a distal end 140. In some embodiments, the distal end 136 of the catheter shaft 122 is deflectable, and the control handle 120 is configured to control the deflection of the deflectable distal end 136.

[0026] Although a variety of materials can be used to construct the catheter shaft 122, typically the catheter shaft 122 is constructed of an electrically non-conductive material. The catheter shaft 122 serves as at least a portion of the blood contacting segment of the catheter 11 and is inserted into the patient's blood vessel by methods and means well known in the art. The catheter shaft 122 includes an elongated body 138 extending from a proximal end 134 to a distal end 136. Further, the elongated body 138 defines at least one lumen (not shown) extending from the proximal end 134 to the distal end 136. A distal electrode assembly 140 (shown in FIG. 5A) extends from the distal end 136 of the catheter shaft 122. The distal electrode assembly 140 includes a plurality of electrodes (shown in FIG. 5A) that may be used for various diagnostic and therapeutic purposes including, but not limited to, cardiac mapping and / or ablation.

[0027] In at least some embodiments in which the distal end 136 is deflectable, the control handle 120 includes at least one actuator 142 that allows an operator to selectively adjust the deflectable distal portion 136 of the catheter shaft 122. This selective adjustment is accomplished using one or more pull wires (see, e.g., FIG. 4) disposed within the lumen of the catheter 2. The pull wires extend through the elongate body 138 and terminate in one or more pull rings in the distal shaft.

[0028] The catheter shaft 122 is defined by an elongate body 138 and includes multiple lumens extending from the proximal end 134 to the distal end 136. For example, the distal end 136 of the catheter shaft 122 may include four lumens (not shown) through which the electrical conductor wires and / or control wires may extend. The electrical conductor wires typically extend from the control handle to the distal end. The electrical conductor wires and / or control wires may be any of the types of electrical conductor wires or control wires known in the art, including, but not limited to, those described in, for example, US2021 / 0128230A1 and US2015 / 0119859A1, which are incorporated herein by reference. The lumens carrying the electrical conductor wires may be partially or completely surrounded or enveloped by an insulating material.

[0029] Additionally or alternatively, the insulating material may be provided in other configurations, such as by a tubular configuration. The tube may be coextensive with the electrical conductor wire (i.e., the length of the tube is not limited to the length of the catheter shaft). While conventional catheters include polyimide tubes, the insulating material for the electrical conductor wire of the hybrid mapping and ablation catheter of the present disclosure may include high density polyethylene, polyaryletherketone, polyetheretherketone, polyurethane, polypropylene, oriented polypropylene, polyethylene, crystallized polyethylene terephthalate, polyethylene terephthalate, polyester, polyetherimide, acetyl, ceramic, and various combinations thereof to enhance electrical insulation around the conductor wire.

[0030] 1 may be disposed at the proximal end 128 of the control handle 120. Each electrode of the distal electrode assembly 140 may be connected to a conductive wire that extends through the catheter shaft 122 and the control handle 120 to the wire connector. The wire connector is adapted to be connected to one or more devices of the subsystem 26.

[0031] 3A-3C, an electromechanical pin-and-socket connector can be used as the connector 14. FIGS. 3A and 3B show two embodiments of a male connector disposed at the proximal end 128 of FIG. 2. FIG. 3C shows an exemplary female connector 320 of the subsystem 26 configured to electrically connect with the male connector. In some examples, the connector 14 is a pin connector, such as a male connector 314 having a number of pins 316 configured to mate with corresponding portions of a socket connector, such as a female connector 320 having a number of sockets 322, and an engagement shaft 318. Each pin and each socket are electrically and mechanically connected or coupled to provide an electrical channel between the catheter 2 and the subsystem 26. The pins 316 of the male connector 314 and the sockets 322 of the female connector 320 are configured to correspond to each other when the connectors are mated. The male and female connectors may be secured to ensure proper orientation. To ensure positive contact between the pins and sockets, the mating of the connectors may be enhanced by a spring force, a compression force, a mechanical connection, or other means.

[0032] The number and type of pins 316 are configured to allow all of the electrodes on the distal tip assembly to be electrically connected during the PFA procedure. For example, if the distal tip is a high density electrode assembly with an array of 18 or more electrodes, the male connector 314 may include a pin for each electrode. The connector is preferably configured so that liquids will not wet the electrical or other components if spilled during normal use. In another embodiment, the connector 14 may include sockets instead of pins and may mate with a matching pin connector.

[0033] The data channels in the connector may be insulated from one another by the size and location of the pins and / or the size and spacing of the conductors that correspond to the nodes on the flexible circuit. The number of data channels carried by a connector depends on the size of the connector's pins and the overall size of the connector itself. The pins must also be rigid enough to maintain proper performance of the connector, which places a lower limit on the size of the pins. Thus, to increase the number of data channels in a pin-socket connector, the connector must be increased in size to accommodate the increased number of pins. This often requires an increase in the size of the proximal end of the handle of the medical device, which is not always desirable.

[0034] FIG. 3B illustrates a connector including a flexible circuit and adapted to connect with a conventional socket connector, such as female connector 320. A flexible circuit allows for a larger capacity of data channels while being easier to assemble. For example, the number of data channels carried by the connector depends in part on the size / spacing of the conductors corresponding to the nodes of the flexible circuit. The flexible circuit connector 360 includes a flexible circuit 366 having a base region 362 and a tab region 364. Each tab 364 includes a flexible circuit 366 that forms a high density wiring interface. On the opposite side (not shown) of the base region 362 of the flexible circuit 366, a number of pins are electrically connected to each of the contact nodes 370. A cover 372 may surround the pins and provide a mechanical means for connecting to a matching socket connector. In another embodiment, the flexible circuit connector 360 may include sockets instead of pins and may be connected to a matching pin connector. In either embodiment, the matching connector may be a conventional socket connector or a pin connector.

[0035] 4, the elongate body 138 may include a pull ring 522 that interfaces with the distal shaft coupler 530. A pull wire 532 (e.g., a steering wire) may pass through the pull ring 522 and connect to the electrode assembly. In some embodiments, the pull wire may be manipulated to deflect the catheter shaft 122. A plurality of conductive wires (not shown) and / or pull wires 523 may extend through the center of the pull ring 522. In one example, the conductive wires may be electrically connected to one or more sensors and / or electrodes. The pull wires are anchored distally from the pull ring 522. The conductive wires and each pull wire extends through the pull ring 522. The pull wire 524 is anchored within the distal shaft by an anchor 526. The conductive wires and / or pull wires extending the distance between the distal end and the pull ring 522 are surrounded by a tubular material, electrically insulating the pull ring 522. For example, the conductive wires and pull wires may be surrounded by a tube 534 made of a chemically inert, biologically stable, and biocompatible material, such as polyetherimide, polyimide, PTFE, or other high temperature polymers. In some embodiments, the pull ring 522 includes a dielectric layer for electrical insulation. Exemplary dielectric layer materials include, but are not limited to, chemically inert, biologically stable, and biocompatible materials, such as polymers, such as parylene, polyimide, polyetheretherketone (PEEK), polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE) (e.g., Teflon), polyether block amide (e.g., PEBAX), polyurethane, epoxy resin (e.g., SU-8), and mixtures thereof. This layer may be applied as a coating in addition to or instead of surrounding the conductive wires or pull wires. The pull ring 522 may be partially coated. For example, the inside of the pull ring 522 may include a layer of a dielectric material, such as polyetherimide, polyimide, PTFE, or other high temperature polymer, to electrically insulate the pull ring.

[0036] 5A-C show an embodiment of a distal electrode assembly 140, which includes a plurality of electrodes attached or disposed on an electrode support member configured as a planar array. The distal electrode assembly 140 has a shape that facilitates maneuverability in and / or contact with a particular anatomical structure. The electrode support member may include a base structure made of any flexible, superelastic, pseudoelastic, or semi-rigid (e.g., deformable) material that allows sufficient maneuverability within the patient's tissue for efficient mapping and / or ablation. Suitable materials include, for example, metal alloys, stainless steels (including spring stainless steels sold under the trade names Elgiloy® and Hastelloy®), copper-aluminum-nickel alloys, CoCrNi alloys (e.g., sold under the trade name Phynox), MP35N®, CoCrMo alloys, alloys including zinc, copper, gold, and / or iron, polymers including any of the above materials, shape memory polymers, and / or combinations thereof. In some examples, the electrode support member is constructed in whole or in part from Nitinol, which is a nearly stoichiometric alloy of nickel and titanium, and may contain small amounts of other metals to obtain desired properties. The electrode support member may have any length, shape, or configuration suitable or necessary for a desired treatment. In some examples, the cross-section of the electrode support member may be rectangular, square, circular, or elliptical, or may vary in cross-section along the length of the electrode support member.

[0037] The distal electrode assembly 140 may be adapted to conform to tissue (e.g., cardiac tissue). For example, the distal electrode assembly 140 may be deflectable, allowing the flexible framework to conform to tissue. In some embodiments, the arm configuration (e.g., including arm length and / or diameter) and material may be adjusted or tailored to provide desired resilience, flexibility, collapsibility, conformability, and stiffness properties, including one or more properties that may vary, for example, from the proximal end of an arm to the distal end of the arm or between multiple arms that make up a paddle structure. The collapsibility of materials such as Nitinol and / or flexible substrates provides an added benefit of facilitating the planar structure being placed into a delivery catheter or introducer during delivery of the catheter into the body and removal of the catheter from the body at the end of a procedure.

[0038] The high density planar array (or "paddle" configuration) of electrodes 602 shown in FIG. 5A comprises four side-by-side, longitudinally extending arms 603, 604, 605, 606 that may form a flexible framework in which the electrodes 602 are disposed. The arms 603-606 are connected by a coupler 660 that defines the distal-most point of the catheter 11. The arms are laterally spaced apart from one another. Each of the four arms carries a plurality of electrodes 602 that are spaced apart along the length of each of the four arms. Although the electrodes 602 are illustrated as ring electrodes, split ring electrodes, ring segment electrodes (or other durable electrodes), flexible electrodes and / or printed electrodes, or combinations thereof may be used in place of any of the ring electrodes. Additionally, one or more of the arms 603-606 may include one or more flexible circuits and / or printed conductive traces. 5A shows four arms, the distal end assembly 140 may be configured with more or less arms. Additionally, while eighteen electrodes are shown (e.g., five electrodes on the first outer arm 603 and the second outer arm 606 and four electrodes on the first inner arm 604 and the second inner arm 605), the catheter may include more or less than eighteen electrodes. Additionally, the first outer arm 603 and the second outer arm 606 may include more or less than five electrodes, and the first inner arm 604 and the second inner arm 605 may include more or less than four electrodes.

[0039] In some embodiments, the electrodes 602 may be used in diagnostic, therapeutic, and / or mapping procedures, such as electrophysiological studies, pacing, cardiac mapping, ablation, etc. In some embodiments, the electrodes 602 may be used to perform monopolar or bipolar ablation, which may result in the formation of specific lines or patterns of scarring. In some embodiments, the electrodes 602 may receive electrical signals from the heart, which may be used in electrophysiological studies. In some embodiments, the electrodes 602 may perform location sensing functions related to cardiac mapping. In some embodiments, the catheter 10 may include a catheter shaft 122. As shown, the catheter shaft 122 has a proximal portion 680 disposed at its distal end, with a shaft electrode 618 attached to the proximal portion 680. In a non-limiting example, the shaft electrode is a ring electrode or ring segment electrode, although other electrodes may be used depending on the desired application. The shaft electrode 618 may be configured for diagnostic, therapeutic, and / or mapping procedures. Although four shaft electrodes 618 are shown, embodiments having fewer or more than four electrodes are within the scope of the present disclosure. A connector 682 disposed at the distal end of the catheter shaft 122 is configured to hold the four longitudinally extending arms 603, 604, 605, 606 in a plane. In some examples, the electrodes 602 are disposed directly on the underlying structure forming each of the arms 603, 604, 605, and 606, which may be constructed of a flexible material, metal, or alloys thereof. In some embodiments, the underlying structure is inserted into a tube, such as a non-conductive tube and / or heat shrink tube, that extends from the distal end of the connector 682. The electrodes 602 may then be attached, applied, or disposed on the outside of the tube.

[0040] In some embodiments, at least some of the arms 603, 604, 605, and 606 may be electrically conductive and selectively drivable as electrodes. Additionally, in some embodiments, for electrophysiological measurements, the electrodes 602 and at least some of the arms 603, 604, 605, and 606 may be driven independently of one another in a "non-grouped" configuration (i.e., may sense voltage independently of one another, may be energized independently of one another, may be energized with different polarities, and / or may be energized with different voltages). In contrast, for ablation applications, two or more of the electrodes 602 and arms 603, 604, 605, and 606 may be driven in unison in a "grouped" configuration to form a larger effective electrode. One skilled in the art will appreciate that any suitable combination of electrodes may be driven in unison.

[0041] In some embodiments, adhesive 694 (illustrated as solid triangles) may be disposed around the proximal ends of the transition arms and connector 682. Non-limiting examples of suitable adhesives include biocompatible epoxies and the like. Adhesive 694 may also be disposed slightly distal to the most distal electrode 602 and / or coupler 660. For example, in the embodiment shown in the center of FIG. 5C, adhesive 694 is disposed on each arm of the dense planar array at the distal transition end of the outer tube (e.g., heat shrink tubing and / or non-conductive tubing, as described above). Adhesive 694 is disposed at the chamfer between the diameter of the tube and the arm.

[0042] Also, as shown in FIG. 5C, in one embodiment of the distal end assembly in which the base structure of the arms 603′, 604′, 605′, and 606′ is constructed of Nitinol, the arms are at least partially covered with a dielectric layer 610. For example, the surfaces of the arms to which the electrodes are attached may be coated or covered with a dielectric material. The dielectric layer 610 may be formed of a biocompatible material that is chemically inert, biologically stable, and has high dielectric properties. In some examples, the material may be applied as a very thin layer. Exemplary dielectric layers may include thin coatings of polyester, polyamide, polyimide, and blends of polyurethane and polyimide. In one embodiment, by way of example only, the dielectric layer 610 may be, but is not limited to, parylene (e.g., parylene C, parylene N) or acrylated urethane. In various embodiments, the thickness of the dielectric layer 610 may be in the range of about 0.0001 mm to about 0.05 mm, or in the range of about 0.0003 mm to about 0.0006 mm. The dielectric layer may be applied to the arm by spray coating, dip coating, or other chemical vapor deposition methods known in the art. Alternatively, the dielectric layer 610 may be obtained by placing a heat shrink or polymer tube over the Nitinol base structure. Exemplary heat shrink or polymer tube materials include fluorinated ethylene-propylene copolymer (FEP), polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), and the like. In some embodiments where the electrode support member is a conductive material, the dielectric layer 610 may electrically insulate the electrodes and / or conductive traces from the conductive material.

[0043] 6A-6F show cross-sectional views of various triple lumen embodiments of any one of the arms 603'-606' at line 6-6 in FIG. 5C. FIGS. 6B, 6D, and 6F show non-limiting embodiments of the packing of the lumens shown in FIGS. 6A, 6C, and 6E, respectively. The arm base structure 702 (e.g., struts) may be housed in the main lumen 704 (shown as 704' and 704''), and the smaller lumens 708, 708', and 708'' may house wires 706 for sensors, interacting elements, and / or fluids. The cross-section of the triple lumen may be bilaterally symmetrical (e.g., FIGS. 6A and 6B), or the lumens may be arranged asymmetrically (FIG. 6C). The lumens may be defined by a layer of dielectric material disposed around the base structure 702. The dielectric material may be any electrically insulating material that provides inter-electrode insulation along the struts. As shown, the layer of dielectric material is the same material as dielectric layer 610. Various current passing patterns of the electrodes may be selectively implemented to obtain a desired scar surface area, volume, and / or depth, such as as a continuous scar area or areas of non-continuous scar with regularly spaced apart untreated tissue. The electrodes attached to the surfaces of the arms may be independently configured to facilitate measurement of electrical properties of the tissue.

[0044] Advantages of the presently disclosed catheters include, but are not limited to, a robust yet maneuverable configuration that facilitates high-density mapping of electrophysiological activity in hard-to-reach areas before and after ablation without compromising speed of mapping or efficiency of therapy delivery. The high-power ablation and efficient remapping capabilities of the disclosed catheters may improve treatment outcomes. For example, embodiments of the present disclosure enable tissue-specific scar formation within short treatment times.

[0045] The above examples are for the purpose of illustrating the above invention and should not be construed as narrowing its scope. The scope of the present disclosure should be determined by the appended claims and their legal equivalents. Modifications and changes may be made without departing from the scope of one or more embodiments of the present disclosure. Various features and aspects of the disclosed embodiments may be combined with each other or substituted for each other to form various embodiments.

[0046] The terms "proximal" and "distal" are used throughout this specification with reference to a clinician manipulating one end of an instrument used to treat a patient. Thus, the term "proximal" refers to the portion of the instrument closest to the clinician and the term "distal" refers to the portion furthest from the clinician. However, surgical instruments may be used in many orientations and positions, and these terms are not intended to be limiting and absolute.

[0047] Any patent document or other disclosure material that is incorporated by reference herein, in whole or in part, is incorporated to the extent that the incorporated material does not contradict existing definitions, statements, or other disclosures set forth in this disclosure.

Claims

1. 1. A hybrid mapping and ablation catheter, comprising: an elongate deformable shaft having a proximal end and a distal end; a distal tip assembly extending distally from the distal end of the deformable shaft; Equipped with the distal end assembly being a planar assembly having a plurality of flexible arms and a plurality of electrodes disposed on each arm of the plurality of flexible arms; At least one arm comprises: a first lumen housing a strut extending along a length of at least one of the flexible arms; a second lumen and a third lumen housing conductive wires configured to independently energize one or more of the plurality of electrodes disposed on the flexible arm to deliver pulsed field ablation energy to tissue; A catheter comprising:

2. The catheter of claim 1 , wherein the first lumen is centrally located in the arm and the second and third lumens are diametrically opposed.

3. a connector connecting the distal end assembly to the deformable shaft; The catheter of claim 1 , further comprising an adhesive disposed about the proximal ends of the flexible arms.

4. The catheter of claim 3 , further comprising an adhesive disposed about a distal portion of the flexible arm that includes the first lumen, the second lumen, and the third lumen.

5. further comprising a dielectric layer on at least one of the flexible arms; The catheter of claim 1 , wherein a portion of the plurality of electrodes is disposed on the dielectric layer.

6. The catheter of claim 5 , wherein the dielectric layer comprises parylene.

7. a pull ring disposed proximally of the distal end assembly; the deformable shaft comprising a distal deflectable portion; A first pull wire and a second pull wire extend along the deformable shaft. an actuator operably connected to a proximal end of the first pull wire and the second pull wire and adapted to selectively deflect the distal deflectable portion; a distal end of the first pull wire and a distal end of the second pull wire extend through the pull ring and are secured to a distal end of the deformable shaft; The catheter of claim 1 , wherein the pull ring is electrically insulated from the electrode attached to the distal tip assembly.

8. the deformable shaft further comprising a plurality of conductive wires electrically connected to the plurality of electrodes; the conductive wire extends along the deformable shaft and through the pull ring; The catheter of claim 7 , wherein the pull wire and the conductive wire are surrounded by a tubular material within the distal deflectable section to electrically insulate the pull ring.

9. the distal deflectable portion extends distally from the deformable shaft and defines first and second pairs of diametrically opposed lumens; two lumens of the first pair accommodate pull wires; The catheter of claim 8 , wherein at least one lumen of the second pair contains a plurality of conductive wires surrounded by the tubular material.

10. The catheter of claim 9 , wherein the tubular material comprises polyethylene terephthalate.

11. The catheter of claim 7 , wherein the pull ring comprises a dielectric layer.

12. a handle assembly connected to the proximal end of the deformable shaft; the handle assembly includes an electromechanical pin-socket connector; The catheter of claim 1 , wherein the pin-and-socket connector is configured to provide an electrical channel to each electrode attached to the flexible arm.

13. The catheter of claim 12, wherein the electrical channels of the connector are electrically isolated by the location and size of pins of the pin-socket connector.

14. The catheter of claim 12 , wherein the connector further comprises at least one flexible circuit.

15. The catheter of claim 14 , wherein the flexible circuit forms a high density wiring interface.

16. 10. The catheter of claim 1, configured to operate within a range of about 500 volts to at least about 2000 volts.

17. a connector for connecting the distal end assembly to the deformable shaft, the connector having an adhesive disposed around the proximal ends of the plurality of flexible arms and the connector; an adhesive disposed about a distal portion of the flexible arm, the distal portion including the first lumen, the second lumen, and the third lumen; 17. The catheter of claim 16, further comprising a parylene layer on at least one of the flexible arms, the plurality of electrodes being disposed on the parylene layer.

18. a pull ring disposed proximally from the distal tip assembly, the deformable shaft including a distal deflectable portion; a first pull wire and a second pull wire extending along the deformable shaft; an actuator operably coupled to a proximal end of the first pull wire and the second pull wire and adapted to selectively deflect the distal deflectable portion; a distal end of the first pull wire and a distal end of the second pull wire extend through the pull ring and are secured to a distal end of the deformable shaft; The catheter of claim 17 , wherein the pull ring is electrically insulated from the electrode attached to the distal tip assembly.

19. 20. The catheter of claim 18, further comprising a conductive wire electrically insulated from the pull ring by a polyethylene terephthalate layer surrounding the conductive wire or a dielectric layer disposed on the pull ring.

20. a handle assembly connected to the proximal end of the deformable shaft; the handle assembly includes an electromechanical pin-socket connector; The catheter of claim 19, wherein the pin-and-socket connector is configured to provide an electrical channel to each electrode attached to the flexible arm.

21. The catheter of claim 1 , wherein at least some of the plurality of electrodes are configured to be driven independently of one another in a non-grouped configuration.

22. The catheter of claim 1 , wherein at least some of the plurality of electrodes are configured to be driven in unison in a grouped configuration.

23. The catheter of claim 1 , wherein each arm is electrically conductive and configured to operate as an electrode.

24. 24. The catheter of claim 23, wherein at least some of the electrodes in the electrode grouping and each arm are configured to be actuated independently of one another in a non-grouped configuration.

25. 24. The catheter of claim 23, wherein at least some of the electrodes in the electrode group and each arm are configured to be actuated in unison in a grouped configuration.

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