Multielectrode assembly for hybrid mapping and ablation catheters - Patents.com

Abstract

The multi-electrode assembly of the present disclosure includes a plurality of electrodes and an electrode support member, a portion of which is adapted to selectively ablate tissue in contact therewith, and at least a portion of the electrodes are disposed on the electrode support member and configured to detect electrophysiological properties of the tissue. The electrode support member may be constructed of a flexible material and may be shaped to easily contact a particular anatomical structure (e.g., a straight shape, a loop shape, a spiral shape, a planar array shape, or a basket shape). The described embodiments allow for selective actuation of the electrode support member for ablation and selective actuation of the electrodes for electrophysiological mapping and / or ablation.

Description

[Technical field]

[0001] This application claims priority to Provisional Application No. 63 / 324,791, filed March 29, 2022, the entirety of which is incorporated herein by reference. [Background technology]

[0002] FIELD OF THE DISCLOSURE Embodiments described herein relate generally to catheter devices for delivering therapeutic electrical energy. In particular, a multi-electrode ablation catheter that can be used for therapeutic tissue ablation and electrophysiological 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 provides greater tissue specificity than traditional ablation. Successful ablation requires detailed mapping and navigation of catheters that deliver energy to specific targets. Summary of the Invention

[0004] Accordingly, a first aspect of the present disclosure features a multi-electrode assembly for a mapping and ablation catheter. The assembly includes a first plurality of electrodes and an electrode support member, a portion of the electrode support member adapted to provide ablation therapy, and at least a portion of the first plurality of electrodes disposed on the electrode support member and configured to detect electrophysiological properties of tissue in contact therewith. The first plurality of electrodes may be selected from the group consisting of ring electrodes, tip electrodes, tip segment electrodes, split ring electrodes, and ring segment electrodes. The electrode support member may further include a plurality of spot electrodes, printed electrodes, conductive traces, or combinations thereof. The electrode support member may further include a tip electrode configured to deliver ablation energy to tissue. The electrode support member may be configured as a planar array including two or more struts, each of the struts being on a common plane, and at least a portion of the plurality of electrodes disposed on the struts and configured to detect electrophysiological properties of tissue in contact therewith. At least one of the first plurality of electrodes includes an electrode formed on an electrically insulating substrate disposed on a surface of the strut. The first plurality of electrodes may be selected from the group consisting of ring electrodes, split ring electrodes, and ring segment electrodes. In some examples, the multi-electrode assembly further comprises a second plurality of electrodes selected from the group consisting of spot electrodes, printed electrodes, and combinations thereof, the second plurality being configured and arranged to detect electrophysiological properties of tissue in contact. At least one electrode of the first plurality may be disposed between two electrodes of the second plurality, and optionally, the electrodes of the first plurality are selected from the group consisting of spot electrodes, printed electrodes, and combinations thereof. The electrodes of the first plurality may be uniformly spaced along the struts. The surface of the struts may include exposed metal, and ablation energy may be delivered between at least two struts. The planar array may include at least four struts, and each strut may include at least four electrodes.The electrode support member may be configured as a flexible basket including a plurality of splines, with a first plurality of electrodes disposed on the splines and configured to detect an electrophysiological property of the contacted tissue. At least one of the electrodes may comprise a dielectric layer disposed between the electrode and the spline surface. The first plurality of electrodes of the flexible basket may be selected from the group consisting of ring electrodes, split ring electrodes, and ring segment electrodes. The flexible basket may further include a second plurality of electrodes attached to the surface of the splines, with the second plurality of electrodes being selected from the group consisting of spot electrodes, printed electrodes, and combinations thereof, the second plurality being configured and arranged to detect an electrophysiological property of the contacted tissue. At least one electrode of the first plurality may be disposed between two electrodes of the second plurality. The first plurality of electrodes may include at least two sets of electrodes, with the first set of electrodes having a larger total surface area than the second set of electrodes, and optionally the first plurality of electrodes being selected from the group consisting of spot electrodes, printed electrodes, and combinations thereof. The surface of the splines may include exposed metal and may transmit ablation energy between at least two of the splines. The first plurality of electrodes may include at least two sets of electrodes, the first set of electrodes having a larger total surface area than the second set of electrodes. At least the first set of electrodes may be configured to operate as a single large electrode.

[0005] The details of one or more examples are set forth below. Other features, objects, and advantages will become apparent from the specification and claims.

[0006] Various embodiments of the present disclosure are illustrated by the accompanying drawings, which are not necessarily drawn to scale, and in which like numerals with different letters represent different instances of substantially the same components. Reference will now be made to the exemplary embodiments illustrated in the figures. [Brief description of the drawings]

[0007] [Figure 1A]FIG. 1A is an isometric view of a catheter multi-electrode assembly including electrodes connected to an electrode support member in accordance with one or more embodiments of the present disclosure.

[0008] [Figure 1B] FIG. 1B is an isometric view of a linear multi-electrode assembly of a catheter including ring electrodes and segment electrodes connected to an electrode support member in accordance with one or more embodiments of the present disclosure.

[0009] [Figure 1C] FIG. 1C is an isometric view of a catheter multi-electrode assembly including an electrode support member and flexible directly-printed electrodes in accordance with one or more embodiments of the present disclosure.

[0010] [Figure 1D] FIG. 1D is an isometric view of a catheter multi-electrode assembly including a pair of electrode support members having multiple ring electrodes attached thereto, in accordance with one or more embodiments of the present disclosure, the assembly being configured to generate an electric field for ablation therapy and / or electrophysiological mapping.

[0011] [Figure 1E] FIG. 1E is an isometric view of a planar multi-electrode assembly of a catheter including an array of electrodes attached to a flexible framework of electrode support members (ie, struts) in accordance with one or more embodiments of the present disclosure.

[0012] [Figure 1F] FIG. 1F is a close-up view of the distal tip of a multi-electrode assembly 500, according to one or more embodiments of the present disclosure.

[0013] [Figure 1G] FIG. 1G is a plan view of a planar multi-electrode assembly of a catheter including an array of electrodes attached to a flexible framework of electrode support members (i.e., struts) having exposed inter-electrode regions, in accordance with one or more embodiments of the present disclosure.

[0014] [Figure 1H] FIG. 1H is an isometric view of a basket-like multi-electrode assembly of a catheter including an array of electrodes attached to a flexible framework of electrode support members (i.e., splines) having exposed inter-electrode regions, in accordance with one or more embodiments of the present disclosure.

[0015] [Figure 2A] FIG. 2A is an isometric view of a catheter linear multi-electrode assembly including at least two electrode sets (eg, a durable electrode and a flexible / direct-printed electrode) in accordance with one or more embodiments of the present disclosure.

[0016] [Figure 2B] FIG. 2B is a plan view of a planar multi-electrode assembly of a catheter including an array having at least two electrode sets (e.g., durable electrodes and flexible / direct-printed electrodes) connected to a framework of electrode support members (i.e., struts) in accordance with one or more embodiments of the present disclosure.

[0017] [Figure 2C] FIG. 2C is an isometric view of a basket-like multi-electrode assembly of a catheter including an array having at least two electrode sets (e.g., a durable electrode and a flexible / direct-printed electrode) attached to a flexible framework of an electrode support member (i.e., splines) in accordance with one or more embodiments of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0018] In an embodiment of the present disclosure, a multi-electrode assembly of a hybrid mapping and ablation catheter is described. Typically, the catheter includes a handle having a proximal end and a shaft having a proximal end and a distal end. One or more portions of the catheter body may be configured to be inserted into a patient's body and its organs / tissues. The multi-electrode assembly is provided or attached to the distal end of the shaft and is configured to easily contact a particular anatomical structure. In some examples, the shaft of the catheter body is part of the multi-electrode assembly (e.g., the shaft is provided or configured to have electrodes attached thereto).

[0019] The multi-electrode assembly of the present disclosure includes a plurality of electrodes and an electrode support member configured or adapted to selectively ablate tissue in contact therewith. The electrodes of the multi-electrode assembly may be used for various diagnostic and therapeutic purposes, including, for example, cardiac mapping and / or ablation (e.g., RF ablation and / or PFA ablation). At least a portion of the electrodes are disposed on the electrode support member and configured to detect electrophysiological properties of tissue. The multi-electrode assembly may have a linear, loop, spiral, planar array, or basket shape that is deformable to conform to the vasculature of a patient.

[0020] The electrode support member may be formed of any flexible, superelastic, pseudoelastic, or semi-rigid (e.g., deformable) material that allows sufficient contact with patient 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. Polymer-based electrode support members may have a tubular configuration. In some examples, the electrode support member is constructed entirely or partially of Nitinol, and is referred to herein as a Nitinol-based electrode support member. Nitinol is a near-stoichiometric alloy of nickel and titanium, which may contain small amounts of other metals to obtain desired properties. The electrode support member may have any length, shape, or configuration suitable or required for the desired treatment, in some examples, the cross-section of the electrode support member is rectangular, square, circular, or oval, or the cross-section of the electrode support member varies along the length of the electrode support member.

[0021] The electrode assemblies described herein include a variety of electrode configurations. The electrodes may be driven independently of one another (in an "ungrouped" configuration) or together as a larger effective electrode (in a "grouped" configuration). For example, when the electrodes are driven independently of one another, they 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 one another) to allow better control of the ablation procedure.

[0022] 1A-1H, the multi-electrode assemblies of the present disclosure may be configured to deliver ablation energy to contacted tissue via an electrode support member.

[0023] 1A illustrates a hybrid electrophysiology mapping / ablation catheter linear multi-electrode assembly 100. Assembly 100 is configured to deliver ablation energy through exposed segments 103 of electrode support member 102, i.e., inter-electrode segments that are not covered with electrically insulating material. Exposed segments 103 are also referred to herein as "therapeutic ablation members."

[0024] The electrical conductivity of the therapeutic ablation member 103 may be enhanced by the presence of exposed metal on the surface of the therapeutic ablation member 103 or the presence of a metal core within the therapeutic ablation member 103. In some examples, the electrode support member 102 is formed of Nitinol, and the therapeutic ablation member 103 further includes a core or coating layer (not shown) of a conductive alloy, such as platinum or gold. Although the cross-section of the electrode support member 102 is depicted as rectangular, other cross-sectional shapes (e.g., circular, oval, square, or other polygonal) are within the scope of this embodiment. The configuration, shape, and size of the therapeutic ablation member 103 may vary along the length of the electrode support member 102. The shape, size, and / or configuration of the therapeutic ablation member may affect various parameters of the applied electroporation treatment.

[0025] A plurality of electrodes 104a, 104b, 104c, 104d are provided (or mounted) along a longitudinal axis of the multi-electrode assembly 100 and are disposed on an electrode support member 102 and configured to detect electrophysiological properties of tissue. As shown, the electrodes 104a, 104b, 104c, 104d are ring electrodes, although one or more of the electrodes 104a-d may be a different type of electrode (e.g., split ring electrodes, ring segment electrodes, or other durable non-printed electrodes). The ring electrodes may be constructed of materials known in the art and may be crimped or swaged to the electrode support member 102. Typically, ring electrodes, or the durable (e.g., non-printed) electrodes described above, are made of any suitable solid conductive material, such as gold, copper, platinum, iridium, and combinations thereof. A combination of two or more types of electrodes may be mounted to the electrode support member 102. The ring electrodes have an exposed conductive electrode surface, which increases the surface area of ​​the electrode in contact with the patient's tissue. An exemplary exposed electrode surface area is about 2.5 mm 2 For example, about 1 mm 2 However, depending on the nature of the catheter and the application of the electrode, a smaller or larger area may be exposed. For example, an electrode may be 0.8 mm in diameter and have a total surface area of ​​0.3 to 0.5 mm. 2 Electrodes with larger surface areas may be used for tissue ablation and electrodes with smaller surface areas may be used for mapping and / or localization, although other configurations are within the scope of this disclosure.

[0026] In one or more embodiments, the electrodes 104a-d are positioned to enhance the measurement of electrophysiological activity of the tissue. Thus, the spacing of the electrodes may vary along the longitudinal axis to adjust the delivery of ablation energy and / or measurement efficiency. For example, the smaller and closer together the electrodes are, the clearer and more localized the electrograms collected by the electrodes will be, and the better the local near-field depolarization of the tissue in contact with the electrodes will be depicted. By varying the size (e.g., width) and spacing of the ring, split ring, and ring segment electrodes, various diagnostic and / or therapeutic objectives and / or results may be achieved. Various physical patterns of the electrodes 104a-d may be accommodated by partially covering the electrodes or the support member with an insulating material after joining the full ring electrodes to the electrode support member 102. The spacing between the electrodes may vary along the length of the assembly. A multi-electrode assembly may include any number of electrodes, greater than or equal to two. For example, the plurality of electrodes may include 3, 5, 8, 12, 72, 84 or more electrodes (ring electrodes, split ring electrodes, and / or ring segment electrodes).

[0027] In some examples, electrodes 104a, 104b, 104c, and / or 104d are further configured to deliver ablation energy simultaneously with, subsequent to, or independent of therapeutic ablation member 103. Thus, both therapeutic ablation member 103 and one or more of electrodes 104a-d may be individually electrically connected to an electroporation generator, such as a power supply, via suitable wires or other suitable electrical conductors extending within the catheter shaft, and may be configured to be selectively energized (e.g., by a power supply and / or computer system) to generate an electrical potential and corresponding electric field between the therapeutic ablation member and / or a second electrode support member (not shown) having the energized therapeutic ablation member and / or electrode.

[0028] In some embodiments, for electrophysiological measurements, at least some of the electrodes 104a, 104b, 104c, and 104d and the therapeutic ablation member 103 may be driven independently of each other in a "non-grouped" configuration (i.e., may sense voltages independently of each other, may be energized independently of each other, 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 104a, 104b, 104c, and 104d and the therapeutic ablation member 103 may be driven in concert in a "grouped" configuration to form a larger effective electrode. Those skilled in the art will appreciate that any suitable combination of electrodes may be driven in concert.

[0029] Radiofrequency ablation and electroporation generally require more power and stronger electric fields to be delivered to the target tissue, which can be accommodated by increasing the effective size of the therapeutic ablation member 103. For example, the size of the therapeutic ablation member 103 may be wider and / or longer than the size of electrodes traditionally used for ablation, sensing, mapping, and diagnosis. In one or more embodiments, the multi-electrode assembly 100 is configured (e.g., positioned, spaced, and / or sized) for PFA treatment provided by the therapeutic ablation member 103 and, optionally, by one or more of the electrodes 104a-d. By energizing the electrodes and ablation members in a particular pattern, a desired scar surface area, volume, and / or depth may be obtained, such as an area of ​​continuous scar or a non-continuous scar with regularly spaced untreated tissue.

[0030] The electrodes 104a, 104b, 104c, 104d are formed (e.g., clad or deposited) on electrically insulating substrates 106a, 106b, 106c, 106d, respectively, which in some embodiments provide electrical insulation between the electrodes 104a, 104b, 104c, 104d and the electrode support member 102. The electrically insulating substrates 106a, 106b, 106c may be made of ceramic materials and / or polymers of various durometers. The electrically insulating substrates 106a, 106b, 106c, 106d may be of the same insulating material, although one or more of the electrically insulating substrates 106a-d may include a different type of insulating material than the other substrates. The electrically insulating substrates 106a-d may be formed in a variety of configurations depending on the desired application of the catheter. The electrically insulating substrates may be injection molded parts. The electrodes 104a, 104b, 104c, 104d may be selectively bonded, deposited, or coated with conductive materials onto an electrically insulating substrate by a variety of techniques, including low temperature printing fabrication (with or without sintering), electroplating, electroless plating, sputter deposition, heat, mechanical deformation, cathodic arc deposition, evaporative deposition, pulsed laser deposition, or combinations thereof. A particular electrode or segment may independently perform a specialized function (e.g., a mapping function). Thus, each electrode or electrode segment may include the same electrode parts as adjacent electrodes or electrode segments, or may include different electrode parts. Alternatively, in some examples, independent electrodes and / or segments may be electrically grouped together to perform additional functions, e.g., act as a large electrode for ablation / localization. Thus, in certain embodiments, all of the treatment members 103 and the electrodes 104a-d may be selectively energized to produce a continuous pulsed field ablation scar in the tissue. The size of the resulting scar may be approximately the size of the array 100.

[0031] In some examples, the electrodes may be electrically connected to the conductive surface of the electrode support member (i.e., the electrodes need not be configured to avoid shunting of current flow to the therapeutic ablation member). For example, FIG. 1B shows a multi-electrode assembly 200 for use in a linear hybrid electrophysiology mapping / ablation catheter, which is configured to deliver ablation energy through a therapeutic ablation member 203 of an electrode support member 202. Electrodes 204a and 204b are attached to the electrode support member, with no insulating layer between the conductive material of the electrodes and the conductive material of the support member. Electrodes 204a and 204b are attached along the longitudinal axis, disposed on the electrode support member 202, and configured to detect electrophysiological properties of the patient's tissue. Alternatively, one or more of the electrodes attached to the electrode support member include an insulating layer, as described in FIG. 1A. Such electrodes may be energized via separate conductors (e.g., wires) (not shown).

[0032] In other embodiments, electrodes 204a and / or 204b are also configured to provide ablation therapy, thereby increasing the area of ​​the assembly through which ablation energy can be delivered. Certain electrodes may independently perform specialized functions (e.g., mapping functions). Thus, each electrode may include the same electrode components as adjacent electrodes or electrode segments, or may include different electrode components. Alternatively, in some instances, independent electrodes and / or segments may be electrically grouped to perform additional functions, such as operating as a larger electrode for ablation / localization.

[0033] As discussed above, the electrical conductivity of the treatment ablation member 203 may be enhanced by the presence of exposed metal on the surface of the treatment ablation member 203. One or both of the electrodes 204a-b may exhibit a greater or lesser effective resistance than the treatment ablation member 203 and / or the electrode support member 202. As illustrated, the electrodes 204a and 204b are ring electrodes, although one or both may be selected from other types of electrodes (e.g., split ring electrodes, ring segment electrodes, or other durable non-printed electrodes). For example, splitting 204a and / or 204b may increase the number of electrodes in the distal region of the catheter without increasing the physical area of ​​that region. The number and size of the electrodes may be varied depending on the desired treatment (i.e., the electrode support member may include two or more electrodes).

[0034] Electrode 204b is located proximally from tip electrode 205 at the distal end of assembly 200. Tip electrode 205 may be a single unit or may be multiple discrete electrode segments 205a, 205b, 205c, and 205d. Although four segments are shown, the tip electrode may include 2-10 or more discrete segments. The single units or segments may be made of the same and / or similar durable materials as electrodes 204a-b. Tip electrode 205 may be configured for electrophysiological sensing, measurement, diagnosis, and / or therapy delivery. Tip electrode 205 may be constructed of a single conductive material or multi-layered materials of diamagnetic and paramagnetic materials, as described in US2018 / 0092688A1, the disclosure of which is incorporated herein in its entirety. Particular electrodes or segments may independently perform specialized functions (e.g., mapping functions), as described above. Alternatively, in some instances, independent electrodes and / or segments may be electrically grouped together to perform additional functions, e.g., act as a larger electrode for ablation / localization.

[0035] In some embodiments, for electrophysiological measurements, at least some of the electrodes 204a and 204b and electrode segments 205a, 205b, 205c, and 205d may be driven independently of one another in a "non-grouped" configuration (i.e., may sense voltages 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 204a and 204b and electrode segments 205a, 205b, 205c, and 205d may be driven together in a "grouped" configuration to form a larger effective electrode. For example, in one embodiment, electrode segments 205a, 205b, 205c, and 205d are grouped together to form a first effective electrode, and electrodes 204a and 204b are grouped together to form a second effective electrode. Grouping one or more electrodes together may aid in localization (e.g., in an impedance-based localization system). Those skilled in the art will appreciate that any suitable combination of electrodes may be driven in unison.

[0036] The therapeutic ablation members may be configured as bipolar or monopolar electrode assemblies for use in bipolar or monopolar based electroporation treatments. For example, in FIG. 1B, the therapeutic ablation members 203 may be individually electrically connected to an electroporation generator, such as a power supply, via suitable electrical wires or other suitable electrical conductors extending within the catheter shaft, and may be configured to be selectively energized (e.g., by the power supply and / or computer system) with opposite polarities to generate an electrical potential and corresponding electric field therebetween for PFA therapy. One of the therapeutic ablation members 203 may be configured to function as a cathode, and another one of the therapeutic ablation members 203 may be configured to function as an anode. The configuration, shape, and size of the therapeutic ablation members may vary. The shape, size, and / or configuration of the therapeutic ablation members may affect various parameters of the applied electroporation treatment. In some examples, the therapeutic ablation members 203 are configured to perform monopolar ablation.

[0037] For example, the multi-electrode assembly 200 may be configured as a monopolar electrode assembly and may use a patch electrode (e.g., a return electrode, not shown) as the return or indifferent electrode. In monopolar treatment applications, the current path may be from the distal tip electrode 205 to the return electrode.

[0038] The distal tip electrode 205, or segments thereof (i.e., segments 205a, 205b, 205c, and 205d), may be selectively energized independent of electrodes 204a-b. In some embodiments, the distal tip electrode 205 is energized with an opposite polarity to one of the therapeutic ablation members 203 to generate an electrical potential and corresponding electric field therebetween for PFA treatment. When the distal tip electrode 205 is energized with an opposite polarity to the therapeutic ablation member 203, the electric field generated therebetween may be suitable for point PFA treatment to precisely target tissue adjacent the distal end of the multi-electrode assembly 200.

[0039] Referring now to FIG. 1C, in one or more embodiments, the plurality of electrodes is selected from flexible electrodes, such as spot electrodes, connectable to conductors via flexible circuits, such as printed conductive traces, and / or directly printed electrodes. FIG. 1C illustrates a multi-electrode assembly 300, a hybrid electrophysiology mapping / ablation catheter configured to deliver ablation energy via a therapeutic ablation member 303 of an electrode support member 302. As shown, the electrode support member 302 has attached to one of its surfaces a plurality of printed conductive traces 304 and a plurality of flexible electrodes 306. The flexible electrodes may wrap around the entire surface of the electrode support member. The portions of the electrode support member 302 that do not have electrodes attached thereto are considered therapeutic ablation members 303 and are configured to deliver ablation energy as described for the multi-electrode assemblies 100 and 200. For example, the therapeutic ablation member 303 may deliver a field strength of about 0.1-1.0 kV / cm.

[0040] As shown, the electrodes 304 are printed conductive traces and the electrodes 306 are flexible and / or directly printed electrodes. The interleaving and spacing of the conductive traces 304 and flexible electrodes 306 is merely exemplary, and other arrangements are within the scope of the present embodiments. For example, the electrodes 304 and 306 may be arranged to improve tissue electrophysiological activity measurements. The smaller and closer together the electrodes are, the sharper and more localized the electrograms collected by the electrodes will be, and thus the better they will depict the local near-field depolarization of the tissue in contact with the electrodes. By varying the size (e.g., width) and spacing of the flexible and / or directly printed electrodes, different diagnostic and / or therapeutic objectives and / or results can be achieved. In some examples, the first plurality of flexible electrodes is arranged relative to the electrode support member such that a first set of electrodes is aligned with a first surface of the support member and a second set of electrodes is aligned with a second surface of the support member.

[0041] The flexible electrodes and / or directly printed electrodes 306 may be single-sided electrodes or electrodes printed on a flexible, foldable material. The conductive traces 304 may be formed using an inkjet printing process or an additive manufacturing process. In some examples, the flexible electrodes and / or directly printed electrodes 306 are spot electrodes printed on at least one surface of the electrode support member 302 using a conductive ink. A similar printing process may be used to form the conductive trace electrodes 304. In one or more embodiments, the printed traces 304 may be used to electrically connect the flexible electrodes 306 to conductors, or the printed traces may function as conductors in the multi-electrode assembly 300. Electrical circuit printing techniques for making the electrical traces and other circuit components may include automated 3D printing techniques (including additive and / or subtractive techniques). The use of flexible electrodes and / or printed electrodes allows for a higher density of electrodes, allowing the electrodes to be in complex and intricate physical patterns without reducing the flexibility of the array as with non-printed electrodes. Having more measurement points of electrophysiological activity is advantageous because it can significantly reduce the time required to generate an electrophysiological map using an ablation catheter.

[0042] A portion of one or both of the plurality of flexible electrodes 306 or the plurality of conductive traces 304 is configured to detect an electrophysiological property of tissue. In some examples, a portion of the conductive traces 304 and the flexible electrodes 306 may be configured to be used as / with a sensor (e.g., position, pacing, strain, temperature, etc.). The catheter or multi-electrode assembly may further include components such as, but not limited to, a temperature sensor, a force sensor, additional sensors or electrodes. For example, a thermocouple may be attached to each electrode to provide a temperature measurement of the electrode. Flexible electrodes and directly printed electrodes for use in the multi-electrode assemblies of the present disclosure include those described in US2016 / 0278923A1, US2017 / 0112405A1, US2018 / 0008821A1, US2018 / 0055631, US2019 / 0328245A1, US2020 / 0107878A1, US2021 / 0022803A1, US2021 / 0153932A1, WO2018150374A1, and WO2020095250A1, the disclosures of which are incorporated herein in their entireties.

[0043] As with the other electrode configurations described herein, the electrodes of the multi-electrode assembly 300 may be selectively driven in ungrouped or grouped configurations to facilitate electrophysiological applications, ablation, and / or localization as appropriate.

[0044] Each of the electrodes 306 may be connected and communicatively connected to signal processing circuitry via electrical traces that run along an interior or exterior layer of a flexible printed circuit board (not shown). The flexible and / or directly printed electrodes 306 may be disposed on an electrically insulating layer. In some embodiments, the electrode support member 302 may be made of Nitinol. In such embodiments, the flexible electrodes 306 may be bonded directly to Nitinol, or directly to a polyether block amide (or PEBA) tube, or directly to a tube of other suitable thermoplastic elastomer tubing that houses the Nitinol member therein. The multi-electrode assembly 300 may include any number of flexible electrodes. For example, the plurality of electrodes may include 2, 3, 5, 8, 12, 72, 84 or more flexible and / or directly printed electrodes, which may be connected to a sensor or generator via printed conductive traces.

[0045] With reference to FIG. 1D, multiple electrode support members can be used as a framework for an electrode array. For example, multiple electrode support members can be arranged in parallel for use in monopolar-based electroporation therapy (e.g., as part of a system including one or more return electrodes, such as patch electrodes) or bipolar-based electroporation therapy. A multi-electrode assembly 400 can be used for hybrid electrophysiology mapping / ablation, having common planar electrode support members 402a and 402b, each of which has multiple electrodes 404 mounted thereon along a longitudinal axis. The electrode support members 402a and 402b can be individually electrically connected to an electroporation generator, such as a power supply, via suitable electrical wires or other suitable electrical conductors extending within the catheter shaft, and can be configured to be selectively energized (e.g., by a power supply and / or computer system) with opposite polarities to generate potentials and corresponding electric fields therebetween, as indicated by the arrows, for ablation therapy. The configuration, shape and size of the electrode support members can be varied to affect various parameters of the applied electroporation therapy. Although the electrodes 404 are depicted as ring electrodes disposed on a layer of electrically insulating material (see 104a-d and 106a-d in FIG. 1A), one or more of the electrodes may be another type of electrode and / or connector suitable for electrophysiological sensing, measurement, and / or diagnosis (e.g., one or more split ring electrodes, ring segment electrodes, spot electrodes, or other printed electrodes). As mentioned above, the electrodes may be connected via flexible circuits such as printed conductive traces.

[0046] As with the other electrode configurations described herein, the electrodes of the multi-electrode assembly 400 may be selectively driven in ungrouped or grouped configurations to facilitate electrophysiological applications, ablation, and / or localization as appropriate.

[0047] 1E, the portions of the electrode support members that are not configured to directly deliver ablation energy may be coated with a dielectric. The multi-electrode assembly 500 includes electrode support members 502, 503, 504, and 505 (hereinafter referred to as "struts") and further includes proximal and distal regions having an outer layer 512 formed or configured of an electrically insulating material (e.g., a dielectric). The energy delivery region 507 extends between the dashed lines and is configured as a 4×5 array of electrodes 506, although other configurations (e.g., 3×8, 5×5, etc.) are within the scope of this embodiment. Suitable materials for the outer layer 512 include, but are not limited to, polyethylene terephthalate (PET), parylene, polyimide (e.g., PI-2771 or HD-4004 available from HD Microsystems), polyether block amide (PEBA), and / or adhesive (e.g., SU8 epoxy available from MicroChem Corp). If the electrode support member is made of a conductive material, the dielectric may electrically insulate an electrode (not shown) mounted on the electrode support member from the conductive material. A first region of the outer layer 512 extends continuously over the distal portions of struts 502 and 505 and struts 503 and 504, forming a flexible tip connecting the respective struts. A second region of the outer layer 512, which coats each of the struts 502-505, extends distally from the coupler to the proximal end of the energy delivery region 507.

[0048] The multi-electrode assembly 500 includes a planar array of electrodes 506 on struts 502, 503, 504, 505 within an energy delivery region 507. Each of the struts 502, 503, 504, and 505 carries multiple electrodes 506 such that the spacing of the electrodes is the same (or at least known) along the length of the strut. In other embodiments, the electrodes may be distributed non-uniformly along the strut. For example, weighting the distribution of the electrodes 506 toward the distal end of the assembly 500 such that only the distal portion of the planar array contacts the tissue to be treated may facilitate tissue mapping. The struts extend in a plane generally parallel to the longitudinal axis of the catheter shaft 508 and are connected to each other at their distal and proximal ends (e.g., at the distal ends of the coupler 514 and bushing 510).

[0049] The struts 502-505 include inter-electrode regions configured to deliver ablation energy. By precisely spacing each of the struts laterally from one another, the exposed inter-electrode regions on adjacent struts 502, 503, 504, 505 and / or the electrodes 506 on adjacent struts 502, 503, 504, 505 may be readily precisely spaced. As a result, the multiple electrodes and exposed inter-electrode regions form a bipolar pair having a known spacing. For example, in some embodiments, the spacing between the centers of the bipolar pairs may be 0.5-4 millimeters, or less than 0.5 millimeters (e.g., 0.1 millimeters). Alternatively or additionally, the spacing of the bipolar pairs may be based on end-to-end spacing. It may be desirable to consider end-to-end spacing when the electrodes 506 and / or exposed inter-electrode regions of the struts 502, 503, 504, and 505 have different relative sizes (or surface areas).

[0050] The multi-electrode assembly 500 is configured such that the spacing between struts is based on the electrode spacing desired for a given treatment. Although 20 electrodes 506 are shown in the planar array, the array of the hybrid electrophysiology mapping / ablation catheter of the present disclosure may include more or less than 20 electrodes. Each strut may have a different number of electrodes than adjacent struts. In some embodiments, the exposed inter-electrode regions on adjacent struts 502-505 may be monopolar or bipolar ablated (e.g., using a bipolar pair of exposed inter-electrode regions). This monopolar or bipolar ablation may create a particular line or pattern of scar. For example, the electrodes 506 may be sized and spaced such that the exposed inter-electrode regions of the struts are closely spaced and capable of delivering a field strength of about 0.1-1.0 kV / cm.

[0051] The electrodes 506 may receive electrical signals from the heart or other tissue, which may be used for electrophysiological studies / mapping. For example, the electrodes 506 may obtain electrophysiological information, such as the direction and velocity of cardiac signals, to enable the creation of a high-density electrical map of the cardiac tissue to support optimal treatment. The sampled electrical properties may be processed to remove signal effects based on the orientation of the catheter. In some embodiments, the electrodes 506 may perform position or position sensing functions related to tissue mapping (e.g., determining the position and / or orientation of the catheter).

[0052] The planar multi-electrode assembly 500 is connected to a distal end of a catheter shaft 508 at a bushing 510 (also referred to as a connector). The catheter shaft 508 also defines a catheter shaft longitudinal axis. In this embodiment, each of the struts 502-505 extends generally parallel to the longitudinal axis. The catheter shaft 508 may be made of a flexible material to allow for threading of the catheter through the patient's vasculature or other body lumen.

[0053] In one or more embodiments, the multi-electrode assembly 500 is adapted to conform to one or more particular tissues (e.g., cardiac tissue) and for catheter delivery / removal. For example, the collapsibility of materials such as Nitinol and / or other flexible substrates allows for easy insertion of the planar array into a delivery sheath or introducer, either for delivery of the catheter into the body or for removal of the catheter from the body at the end of a procedure. Each of the struts 502, 503, 504, 505 may be independently flexible. For example, the structure of the struts 502-505, such as the length and / or diameter and material of the struts, may be tailored to provide desired elasticity, flexibility, collapsibility, conformability, and stiffness characteristics along the struts or between multiple struts.

[0054] Although the multi-electrode assembly 500 is depicted as having ring electrodes 506, embodiments having spot electrodes or other flexible / directly printed electrodes connected to the struts are readily envisioned. The struts of the planar array may comprise flexible membranes compatible with printed circuit fabrication techniques and / or have such membranes connected to structural elements of the struts (e.g., Nitinol-based or polymer-based structural elements). Spot electrodes may be printed on the struts themselves. The printed electrodes may be electrically connected to signal processing and / or driver circuitry via traces running on or through one or more thin film layers.

[0055] The ring electrodes 506 may include electrodes of the same type or different types. For example, electrodes with a small surface area may be dedicated to electrophysiological mapping, while electrodes with a large surface area may be used for mapping, tissue ablation, and / or localization. In some examples, the multi-electrode assembly includes one or more slightly enlarged ring electrodes (e.g., for localization of the flexible array in a mapping and navigation system). Each electrode or electrode segment may be provided with the same electrode parts as adjacent electrodes or electrode segments, or may be provided with different electrode parts. Thus, a particular electrode may independently perform a specialized function (e.g., a mapping function). In some examples, independent electrodes may be electrically grouped together to perform additional functions, e.g., act as a large electrode for ablation / localization.

[0056] The electrodes 506 may be used in various bipolar configurations to facilitate measuring electrical properties of tissue in contact with the electrodes. The orthogonal bipolar pair combinations can measure unique tissue orientation specific electrical properties in two orthogonal directions. A first bipolar pair includes a pair of electrodes along the length of the struts 502, 503, 504, 505, facilitating collection of tissue electrical property data in an orientation generally parallel to the longitudinal axis of the catheter. A second orthogonal bipolar pair may extend laterally across adjacent struts 502 and 503, 503 and 504, 504 and 505, facilitating collection of tissue electrical property data in an orientation generally transverse to the longitudinal axis of the catheter. To facilitate collection of this electrical data, these bipolar electrode pairs may be treated independently by signal processing circuitry. The signal processing circuitry analyzes the received signals from the two sets of bipolar electrode pairs to identify electrophysiological information that is independent of the orientation of the tissue in contact with the electrodes.

[0057] As described above, ablation current can be passed simultaneously between the inter-electrode regions of struts 502-505, and optionally between electrodes 506 on adjacent struts, if desired. The array is configured for bipolar ablation, or alternatively, configured to pass ablation current in a monopolar mode between one or more inter-electrode regions and, for example, a patch electrode placed on the patient. Monopolar or bipolar ablation treatment techniques using the inter-electrode regions, with or without one or more of the electrodes 506, may be used to create a particular scar line or scar pattern.

[0058] As with the other electrode configurations described herein, the electrodes of the multi-electrode assembly 500 may be selectively driven in ungrouped or grouped configurations to facilitate electrophysiology applications, ablation, and / or localization as appropriate.

[0059] As seen in FIG. 1E, the distal tip includes a coupler 514 joining the flexible joints connecting struts 502 and 505 and the flexible joints connecting struts 503 and 504. These pairs of struts are not electrically connected (as shown in more detail in FIG. 1F), although other embodiments may include other types of connections. The coupler 514 may be constructed from metal or other radiopaque material to allow for fluoroscopic visualization. The coupler 514 facilitates (semi-)independent planar movement between the struts while ensuring that the struts are securely fixed within the dielectric tube 512, ensuring that the struts maintain the spaced apart planar relationship of the array and the electrodes thereon, and allowing the struts to be independently energized. For example, in one embodiment, struts 502 and 505 may be energized together to form an outer loop and struts 504 and 503 may be energized together to form an inner loop of opposite polarity, or struts 502 and 504 may be energized as cathodes and struts 503 and 505 as anodes such that adjacent struts have opposite polarity. The struts, and optionally the electrodes attached thereto, may be energized in a particular pattern to obtain a desired scar surface area (e.g., a continuous scar or a non-continuous scar with regularly spaced apart untreated tissue), volume, and / or depth. Alternatively, one or more of the junctions connecting struts 502 and 505 and the junctions connecting struts 503 and 504 may electrically connect the respective struts.

[0060] With reference to FIG. 1G, a hybrid electrophysiology mapping / ablation catheter of the present disclosure may comprise a planar array having four or more struts. For example, in FIG. 1G, a multi-electrode assembly 600 includes five struts, e.g., 601, 602, 603, 604, and 605. Each strut includes proximal and distal regions having an outer layer 612 formed or configured from an electrically insulating material as described above, and an energy delivery region 607 extending between the dashed lines. The energy delivery region 607 is configured as a 5×5 array of electrodes 606, although other array configurations are within the scope of this embodiment. A first region of the outer layer 612 extends continuously across the distal portions of struts 601 and 605 and struts 603 and 604, forming the junctions of the respective struts. A second region of the outer layer 612 extends distally from the coupler to the proximal end of the energy delivery region 607 and coats each of the struts 601-605.

[0061] The multi-electrode assembly 600 includes an array of electrodes 606. Each of the struts 601, 602, 603, 604, and 605 may carry multiple electrodes 606 within an energy delivery region 607, with the spacing of the electrodes along the length of the planar array being the same (or at least known). The framework formed by the struts 601, 602, 603, 604, and 605 is flexible and extends in a plane generally parallel to the longitudinal axis of the catheter shaft 608. The struts 601, 602, 603, 604, and 605 are connected to each other at distal and proximal ends (e.g., distal tip 614 and bushing 610). The struts 601, 602, 603, 604, and 605 include inter-electrode regions configured to deliver ablation energy directly. By precisely spacing each of the struts laterally from one another, the exposed inter-electrode areas on adjacent struts and / or the electrodes 606 on adjacent struts may be readily precisely spaced. As a result, the multiple electrodes and exposed inter-electrode areas form a bipolar pair having a known spacing. For example, in some embodiments, the spacing between the centers of the bipolar pairs may be 0.5-4 millimeters, or less than 0.5 millimeters (e.g., 0.1 millimeters). Alternatively or additionally, the spacing of the bipolar pairs may be based on end-to-end spacing. It may be desirable to take end-to-end spacing into account when the electrodes 606 and / or exposed inter-electrode areas of the struts 601-605 have different sizes (or surface areas) from one another. The electrodes 606 may be sized and spaced such that the exposed inter-electrode areas of the struts are closely spaced and capable of delivering a field strength of approximately 0.1-1.0 kV / cm.

[0062] The multi-electrode assembly 600 includes five struts, with spacing between the struts based on the desired spacing of exposed inter-electrode area and / or the desired electrode spacing for a given treatment. Additionally, while the planar array shows 25 electrodes 606, the hybrid electrophysiology mapping / ablation catheters of the present disclosure may include more or less than 25 electrodes. Each strut may have a different number of electrodes than adjacent struts.

[0063] In some embodiments, the exposed inter-electrode regions on adjacent struts form bipolar pairs 601 and 602, 602 and 603, 603 and 604, and 604 and 605. The multi-electrode assembly 600 may perform monopolar or bipolar ablation (e.g., using the bipolar pairs of exposed inter-electrode regions). This monopolar or bipolar ablation may result in the formation of specific lines or patterns of scarring. In some embodiments, the electrodes 606 may receive electrical signals from the heart or other tissue, which may be used for electrophysiological studies / mapping, as described above.

[0064] The multi-electrode assembly 600 is connected to a distal end of a catheter shaft 608 at a bushing 610 (e.g., a connector). The catheter shaft 608 may define a longitudinal axis of the catheter shaft. In this embodiment, each of the struts 601-605 extends generally parallel to the longitudinal axis. The catheter shaft 608 may be made of a flexible material to allow for threading of the catheter through the patient's vasculature or other body cavity.

[0065] In one or more embodiments, as described above, the multi-electrode assembly 600 is adapted to conform to one or more particular tissues (e.g., cardiac tissue) and also to deliver / remove catheters. Each strut 601, 602, 603, 604, 605 may be independently flexible. The structure of the struts 601-605, e.g., the length and / or diameter and materials of the struts, may be tailored to obtain desired elasticity, flexibility, collapsibility, conformability, and stiffness characteristics along the struts or between multiple struts.

[0066] Although the multi-electrode assembly 600 is depicted as having ring electrodes 606, embodiments having spot electrodes or other flexible / directly printed electrodes connected to the struts, as described above, are readily envisioned. The ring electrodes 606 may include a single type of electrode of various sizes, or may include various types of electrodes of various sizes. For example, electrodes with a small surface area may be used exclusively for electrophysiological mapping, while electrodes with a large surface area may be used for mapping, tissue ablation, and / or localization. In some examples, the multi-electrode assembly includes one or more slightly enlarged ring electrodes (e.g., for localization of flexible arrays in mapping and navigation systems).

[0067] The electrodes 606 may be used in various bipolar configurations to facilitate measuring electrical properties of tissue in contact with the electrodes. The combination of orthogonal bipolar pairs may measure unique orientation-specific electrical properties of tissue in two orthogonal orientations. A first bipolar pair may include a pair of electrodes along the length of the struts 601, 602, 603, 604, 605, facilitating collection of tissue electrical property data in a direction generally parallel to the longitudinal axis of the catheter. A second orthogonal bipolar pair may extend laterally across adjacent struts 601 and 602, 602 and 603, 603 and 604, 604 and 605, facilitating collection of tissue electrical property data in a direction generally transverse to the longitudinal axis of the catheter. To facilitate collection of this electrical data, these bipolar electrode pairs may be treated independently by signal processing circuitry. The signal processing circuitry analyzes the received signals from the two sets of bipolar electrode pairs to identify electrophysiological information that is independent of the orientation of the tissue in contact with the electrodes.

[0068] As discussed above, ablation current can be passed between the inter-electrode regions of struts 601-605 and, optionally, between electrodes 606, if desired. The array is configured for bipolar ablation or configured to pass ablation current in a monopolar mode between one or more inter-electrode regions and, for example, a patch electrode placed on the patient. Monopolar or bipolar ablation treatment techniques utilizing the inter-electrode regions with or without one or more of electrodes 606 may be used to create specific scar lines or scar patterns. For example, in one embodiment, struts 601 and 605 may be energized together to form an outer loop, and struts 604 and 602 may be energized together to form an inner loop of opposite polarity. Strut 603 may be selectively energized to have the same polarity as the outer loop. Struts 601, 603, and 605 may be energized as cathodes, and struts 602 and 604 may be energized as anodes. The struts, and optionally the electrodes attached thereto, may be energized in a particular pattern to obtain a desired scar surface area (e.g., a continuous scar or a non-continuous scar with regularly spaced intervals of untreated tissue), scar volume, and / or scar depth.

[0069] As with the other electrode configurations described herein, the electrodes of the multi-electrode assembly 600 may be selectively driven in ungrouped or grouped configurations to facilitate electrophysiological applications, ablation, and / or localization as appropriate.

[0070] Non-planar arrangements of electrode support members are also provided, as shown in FIG. 1H. For example, multi-electrode assembly 700 represents the distal end of a basket-like catheter. Multi-electrode assembly 700 includes multiple electrode support members 702 (hereafter referred to as splines), each of which includes multiple electrodes 706. Splines 702 may be collapsed to be guided through an introducer and may expand once the basket exits the distal end of the introducer. Each of electrodes 706 may be configured for global and / or regional mapping, as in various embodiments of the present disclosure.

[0071] The splines 702 are connected to a catheter shaft 708 at the proximal end and extend to a distal coupler 714 at the distal end, where the splines terminate. As shown, the splines 702 are uniformly distributed in the circumferential direction for global mapping, but in various embodiments of the present disclosure, one or more of the splines may be adjusted to provide a greater or lesser density of electrodes in a portion of the array. In this embodiment, a basket constructed with eight splines is presented, but basket catheters having three or more splines are readily envisioned, with the design depending on the intended clinical application and / or desired electrophysiological mapping accuracy. To facilitate the expansion / contraction of the basket, a deployment member 704 extends along the basket's longitudinal axis, and may be a pull wire extending between the catheter handle and the distal coupler 714. The basket is expanded / contracted by manipulating the pull wire. In other embodiments, the deployment member 704 may be a lumen that is manipulated by a manipulator on the catheter handle to expand / contract the basket. In some examples, the splines 702 are formed from a shape memory alloy (eg, Nitinol) that allows the basket to return to a spherical shape after exiting the introducer.

[0072] The electrodes 706 are distributed along the length of each spline. In the embodiment shown in FIG. 1H, the electrodes 706 are regularly distributed along the length of each spline, but in other embodiments, the electrodes may be distributed unevenly along the splines. For example, only the distal portion of the basket may be in contact with the tissue to be treated, in which case the distribution of the electrodes 706 may be weighted toward the distal end of the basket 700 to facilitate mapping of the tissue. The electrodes 706 may be sized and spaced such that the exposed inter-electrode regions of the splines 702 are closely spaced and capable of delivering a field strength of approximately 0.1-1.0 kV / cm.

[0073] Each spline includes a proximal region and a distal region having an outer layer 712 formed or constructed from an electrically insulating material as described above. A first region of the outer layer 712 extends continuously across the distal portion of the strut 702 and a second region of the outer layer 712 extends distally from the shaft 708 to the proximal end of the electrode 706.

[0074] The multi-electrode assembly 700 includes exposed inter-electrode regions of splines 702 configured to deliver ablative energy to contacted tissue. Each inter-electrode region of the splines 702 may be paired with another adjacent inter-electrode region along the same spline or between adjacent splines to facilitate bipolar tissue ablation. Alternatively or simultaneously, the inter-electrode regions of the splines 702 may be paired with a patch electrode (not shown) to operate in a monopolar ablation treatment configuration. The size and spacing of the electrodes 706 may be varied to determine the area of ​​the exposed inter-electrode regions, thereby obtaining a desired scar surface area, scar volume, and / or scar depth.

[0075] The electrodes 706 may be used in various bipolar configurations to facilitate measuring electrical properties of tissue in contact with the electrodes. The combination of orthogonal bipolar pairs can measure unique direction-specific electrical properties of tissue in two orthogonal directions. A first bipolar pair includes a pair of electrodes along the length of the splines 702 and facilitates collection of tissue electrical property data in an orientation generally parallel to the longitudinal axis of the catheter. A second orthogonal bipolar pair extends laterally across adjacent splines 702 and facilitates collection of tissue electrical property data in an orientation generally transverse to the longitudinal axis of the catheter. To facilitate collection of this electrical data, these bipolar electrode pairs may be treated independently by signal processing circuitry. The signal processing circuitry analyzes the received signals from the two sets of bipolar electrode pairs to identify electrophysiological information that is independent of the orientation of the tissue in contact with the electrodes.

[0076] As with the other electrode configurations described herein, the electrodes of the multi-electrode assembly 700 may be selectively driven in ungrouped or grouped configurations to facilitate electrophysiological applications, ablation, and / or localization as appropriate.

[0077] In some embodiments, the electrodes 706 have a diameter of 0.8 millimeters and a total surface area of ​​0.5 mm 2 Electrodes 706 on the multi-electrode assembly 700 need not be the same size and shape. For example, embodiments consistent with the present disclosure may include small size electrodes (e.g., 0.8 millimeter diameter) for electrophysiological mapping and large size electrodes capable of both electrophysiological mapping or ablation and having impedance large enough to facilitate localization in an impedance-based or hybrid-based catheter navigation system. In some examples, the small electrophysiological mapping electrodes may be connected to the tissue-facing surface of the spline so as to be in direct contact with the tissue, and the large non-contact navigation electrodes may be connected to the inner-facing surface of the spline 702. Some of the electrodes 706 of the multi-electrode assembly 700 may be multipurpose and others may be single-purpose. For example, some of the electrodes may function as ablation electrodes and navigation electrodes or electrophysiological mapping electrodes, others may function only as electrophysiological mapping electrodes, and still others may function only as navigation electrodes. By energizing the inter-electrode regions, and optionally the electrodes attached thereto, in a particular pattern, a desired scar surface area (e.g., a continuous scar or a non-continuous scar with regularly spaced intervals of untreated tissue), scar volume, and / or scar depth may be obtained.

[0078] Although all electrodes 706 are depicted with equal spacing both on and between splines 702, the relative spacing between the electrodes forming a bipolar pair may be varied to accurately obtain orientation-specific electrical property data of the tissue in contact with the electrodes. In some embodiments, the end-to-end spacing of one or more of the bipolar pairs of electrodes may be between 2-2.5 mm and / or the center-to-center spacing of the electrodes of the bipolar pair may be between 0.5-4 mm.

[0079] 2A-2C, embodiments of the present disclosure include a multi-electrode assembly configured to deliver ablation energy and receive electrophysiological information via attached electrodes, in some examples, ablation energy is delivered only by electrodes attached to one or more surfaces of the assembly.

[0080] For example, FIG. 2A illustrates a linear hybrid electrophysiology mapping / ablation catheter multi-electrode assembly 800 that includes an electrode support member 802 having attached (or affixed) along a longitudinal axis a first plurality of electrodes 804a, 804b, and 804c configured and arranged to deliver ablation energy and a second plurality of electrodes 810 and 808 configured to detect electrophysiological properties of tissue. Electrode 804b is disposed proximally from a tip electrode 806 at the distal end of the assembly 800. As illustrated, the tip electrode 806 is a single unit, although multiple discrete electrode segments are within the scope of this embodiment as described for the multi-electrode assembly 200. The tip electrode 806 may be configured for electrophysiological sensing, measurement, diagnosis, and / or therapy delivery.

[0081] Electrodes 804a, 804b, 804c, 806, 810, and / or 808 may be attached to an electrode support member 802. The electrode support member 802 may be coated with a layer of electrically insulating material. Electrodes 804a-c and 806 may be selected from the durable non-printed electrodes described above. For example, electrodes 804a and 804b may be ring electrodes, electrode 804c may be a split ring electrode or a ring segment electrode, and tip electrode 806 may include a conductive shell. Each of electrodes 804a, 804b, 804c, 806, 810, and / or 808 may include electrode components mounted within or on a shell that are the same or different from adjacent electrodes. For example, electrodes with smaller surface areas may be used exclusively for electrophysiological mapping, while electrodes with larger surface areas may be used for mapping, tissue ablation, and / or localization. In some examples, the multi-electrode assembly includes one or more slightly enlarged ring electrodes (e.g., for localization of the flexible array in mapping and navigation systems). The split ring electrode 804c does not completely surround the electrode support member to which it is attached, but is attached to the electrode support member so that it does not become dislodged from the electrode support member as the electrode support member passes through the patient's body (e.g., the vasculature). One or more of the electrodes 804a and 804b may be split, and / or all of 804a, 804b, and 804c may be ring electrodes. The number and size of the electrodes may vary depending on the desired treatment. In some examples, the electrode support member may include more or less than four electrodes.

[0082] Electrodes 804a, 804b, 804c, and / or 806 may be configured as a bipolar or multipolar electrode assembly for use in bipolar or multipolar based electroporation treatments. For example, 804a-c and 806 may be individually electrically connected to an electroporation generator, such as a power supply, via suitable electrical wires or other suitable electrical conductors extending through the catheter shaft, and may be selectively energized (e.g., by the power supply and / or computer system) with opposite polarity to create an electrical potential and corresponding electric field therebetween for PFA treatment. One of 804a, 804b, and 804c may be configured to function as a cathode, and another one of the electrodes may be configured to function as an anode. The shape, size, and / or configuration of the treatment ablation member may affect various parameters of the applied electroporation treatment. In some examples, the electrodes are configured to perform monopolar ablation.

[0083] The multi-electrode assembly 800 may be configured as a monopolar electrode assembly and may use a patch electrode (e.g., a return electrode (not shown)) as a return or indifferent electrode. For example, in monopolar treatment applications, the current path may be from the distal tip electrode 806 to the return electrode.

[0084] Distal tip electrode 806, or a segment thereof, may be selectively energized independent of electrodes 804a-c. In some embodiments, distal tip electrode 806 is energized with an opposite polarity to one of electrodes 804a, 804b, and 804c to create an electrical potential and corresponding electric field therebetween for PFA treatment. When distal tip electrode 806 is energized with an opposite polarity to distal electrode 804b, the resulting electric field therebetween may be suitable for precisely targeting point PFA treatment to tissue adjacent the distal end of multi-electrode assembly 800.

[0085] At least one region of the electrode support member 802 has a plurality of flexible electrodes 808 and a plurality of flexible electrodes 810 attached thereto. A portion of one or both of the plurality of flexible electrodes 808 and the plurality of flexible electrodes 810 configured to detect at least an electrophysiological property of tissue. For example, a portion of the flexible electrodes 808 and 810 may be configured for use with a sensor (e.g., a position sensor, a spacing sensor, a strain sensor, a temperature sensor, etc., as described for the multi-electrode assembly 300 above). The electrode support member 802 may include a flexible thin film compatible with printed circuit manufacturing techniques and / or such a thin film may be connected to a structural element (e.g., a Nitinol or polymer-based structural element) of the electrode support member. Spot electrodes may be printed on the electrode support member itself. The printed electrodes may be electrically connected to signal processing circuitry and / or driver circuitry via traces extending on or through one or more thin film layers.

[0086] The electrodes 808 and 810 may be directly printed electrodes. The arrangement and spacing of the flexible electrodes 808 and 810 are merely exemplary, and other arrangements are within the scope of the present embodiment. For example, the electrodes 808 and 810 may be arranged to enhance the measurement of electrophysiological activity of tissue. By varying the size (e.g., width) and spacing of the flexible electrodes and / or directly printed electrodes, various diagnostic and / or therapeutic objectives and / or results may be achieved. The spacing between the electrodes may vary along the length of the assembly. The flexible electrodes and / or directly printed electrodes 808 and 810 may be single-sided electrodes or may be electrodes printed on a flexible, foldable material. In some examples, the flexible electrodes and / or directly printed electrodes are spot electrodes printed on at least a portion of the surface of the electrode support member 802 using a conductive ink. The flexible electrodes may wrap around the entire surface of the electrode support member.

[0087] The electrode support member 802 may further include conductive traces (not shown) formed using an inkjet printing process or an additive manufacturing process. In one or more embodiments, the printed conductive traces may be used to electrically connect the electrodes to the conductors, or the printed traces may function as the conductors of the multi-electrode assembly 800. The use of flexible and / or printed electrodes allows for a higher density of electrodes, allowing for complex and intricate physical patterns of electrodes without making the array less flexible than durable non-printed electrodes. Increasing the number of measurement points of electrophysiological activity can advantageously reduce the time required to create an electrophysiological map using an ablation catheter.

[0088] Each of the flexible electrodes 808 and 810 may be connected, or communicatively connected, to signal processing circuitry via electrical traces that run along an internal or external layer of a flexible printed circuit board (not shown). The flexible electrodes may be disposed on an electrically insulating substrate. The multi-electrode assembly 800 may include any number of flexible electrodes. For example, the plurality of electrodes may include 2, 3, 5, 8, 12, 72, 84 or more flexible electrodes and / or directly printed electrodes.

[0089] As with the other electrode configurations described herein, the electrodes of the multi-electrode assembly 800 may be selectively driven in ungrouped or grouped configurations to facilitate electrophysiological applications, ablation, and / or localization as appropriate.

[0090] Another exemplary embodiment configured to deliver ablation energy and receive electrophysiological information by attached electrodes is shown in FIG. 2B. FIG. 2B shows a hybrid electrophysiology mapping / ablation catheter multi-electrode assembly 900 including electrode support members 902a, 902b, 902c, and 902d (hereinafter referred to as "struts") coated with an electrically insulating material (e.g., a dielectric). Suitable materials include, but are not limited to, polyethylene terephthalate (PET), parylene, polyimide (e.g., PI-2771 or HD-4004 available from HD Microsystems), polyether block amide (PEBA), and / or adhesive (e.g., SU8 epoxy available from MicroChem Corp). If the electrode support member is made of a conductive material, the dielectric can electrically insulate the electrodes attached thereon from the conductive material. Thus, a particular electrode may independently perform a specialized function (e.g., a mapping function). In some instances, independent electrodes may be electrically grouped to perform additional functions, for example, to act as a larger electrode for ablation / localization.

[0091] The multi-electrode assembly 900 includes a planar array of a first plurality of electrodes 904 and a second plurality of electrodes 906 on struts 902a, 902b, 902c, 902d, with the spacing of the electrodes along the length of the struts being the same (or at least known). In other embodiments, the electrodes may be distributed non-uniformly along the struts. For example, if only the distal portion of the planar array is in contact with the tissue to be treated, the distribution of the electrodes 904 and 906 may be weighted toward the distal end of the assembly 900 to facilitate mapping of the tissue or delivery of therapy. The struts extend in a plane generally parallel to the longitudinal axis of the catheter shaft 908 and are connected to each other at their distal and proximal ends (e.g., at a distal tip coupler 914 and a bushing 910).

[0092] The electrodes 904 are configured to deliver ablation energy. By precisely spacing each of the struts laterally relative to one another, the electrodes 904 on the same strut 902a, 902b, 902c, and / or 902d and / or on adjacent struts 902a-d may be readily precisely spaced. As a result, the multiple electrodes form a bipolar pair having a known spacing. For example, in some embodiments, the center-to-center spacing of the bipolar pair may be between 0.5-4 mm, or less than 0.5 millimeters (e.g., 0.1 mm). Alternatively or additionally, the spacing of the bipolar pair may be based on end-to-end spacing.

[0093] The multi-electrode assembly 900 is configured such that the spacing between each strut corresponds to the electrode spacing desired for a given treatment. Although 18 electrodes 904 are shown in the planar array, the hybrid electrophysiology mapping / ablation catheter of the disclosed array may include more or less than 18 electrodes. Each strut may have a different number of electrodes than adjacent struts. In some embodiments, the electrodes 904 on adjacent struts 902a-d may perform monopolar or bipolar ablation (e.g., using a bipolar pair). This monopolar or bipolar ablation may result in the formation of a particular scar line or scar pattern.

[0094] The electrodes 906 may receive electrical signals from the heart or other tissue, which may be used for electrophysiological studies / mapping. For example, the electrodes 906 may obtain electrophysiological information, such as the direction and velocity of cardiac signals, allowing the creation of a high-density electrical map of the cardiac tissue to support optimal treatment. The sampled electrical properties may be processed to remove signal effects based on the orientation of the catheter. In some embodiments, the electrodes 906 may perform location or position sensing functions related to tissue mapping (e.g., determining the position and / or orientation of the catheter).

[0095] The planar multi-electrode assembly 900 is connected to the distal end of a catheter shaft 908 at a bushing 910 (also called a connector). In this embodiment, each of the struts 902a-d extends generally parallel to a longitudinal axis defined by the catheter shaft 908, which may be made of a flexible material, allowing the catheter to be passed through a patient's vasculature or other body cavity.

[0096] In one or more embodiments, the multi-electrode assembly 900 is adapted to conform to one or more particular tissues (e.g., cardiac tissue) and further adapted for catheter delivery / removal. For example, the collapsibility of materials such as Nitinol and / or other flexible substrates allows for easy insertion of the planar array into a delivery sheath or introducer, either for delivery of the catheter into the body or for removal of the catheter from the body at the end of a procedure. Each of the struts 902a-d may be independently flexible. The structure of the struts 902a-d, such as the length and / or diameter and material of the struts, may be tailored to obtain desired elasticity, flexibility, collapsibility, conformability, and stiffness characteristics along the struts or between multiple struts.

[0097] The multi-electrode assembly 900 includes a plurality of electrodes 904 as described in one or more embodiments above. For example, the electrodes 904 may be selected from ring electrodes, split ring electrodes, and ring segment electrodes. The electrodes 904 may be a single type of electrode or a variety of separate types of electrodes. Electrodes with large surface areas may be used for mapping, tissue ablation, and / or localization. As described for the multi-electrode assemblies 400-600, ablation current may be passed simultaneously between the electrodes 904 of the struts 902a-d, and optionally between the electrodes 906 on adjacent struts, if desired. The array is configured for bipolar ablation or, alternatively, in a monopolar mode, to pass ablation current between one or more electrodes 904 and, for example, a patch electrode placed on the patient. A particular scar line or scar pattern may be formed using monopolar or bipolar ablation treatment techniques utilizing the electrodes 904, with or without the electrodes 906.

[0098] The multi-electrode assembly 900 further includes a plurality of flexible electrodes 906 as described in one or more embodiments above. The flexible electrodes 906 include spot electrodes or other flexible / directly printed electrodes connected to the struts. The struts of the planar array may comprise a flexible thin film compatible with printed circuit manufacturing techniques and / or such a film may be connected to the structural elements of the struts (e.g., Nitinol-based structural elements). The spot electrodes may be printed on the struts themselves. The printed electrodes may be electrically connected to signal processing and / or driver circuitry via traces running on or through one or more thin film layers.

[0099] The flexible electrodes 906 may be used in various bipolar configurations to facilitate measuring electrical properties of tissue in contact with the electrodes. The orthogonal bipolar pair combinations can measure unique direction-specific electrical properties of tissue in two orthogonal directions. A first bipolar pair includes a pair of electrodes along the length of the struts 902a-d and facilitates collection of tissue electrical property data in a direction generally parallel to the longitudinal axis of the catheter. A second orthogonal bipolar electrode pair extends laterally across adjacent struts 902a and 902b, 902b and 902c, and 902c and 902d and facilitates collection of tissue electrical property data in a direction generally transverse to the longitudinal axis of the catheter. The bipolar electrode pairs may be independently addressed by signal processing circuitry. The signal processing circuitry analyzes the received signals from the two bipolar electrode pairs to determine electrophysiological information that is independent of the orientation of the tissue in contact with the electrodes.

[0100] The distal tip includes a coupler 914 joining the distal tip formed by the junctions connecting struts 902a and 902d, which may or may not be electrically connected (as described for multi-electrode assembly 500), and the junctions connecting struts 902b and 902c. Coupler 914 may be constructed from metal or other radiopaque material that allows for fluoroscopic visualization. The coupler may facilitate (semi-)independent planar movement between the struts while ensuring that the struts are fixed within the array, e.g., a dielectric tube, maintaining the spaced apart relationship of the array and the electrodes thereon, and allowing the struts to be independently energized. For example, in one embodiment, struts 902a and 902d may be energized together to form an outer loop and struts 902b and 902c may be energized together to form an inner loop of opposite polarity, or struts 902a and 902c may be energized as cathodes and struts 902b and 902d may be energized as anodes such that adjacent struts have opposite polarities. By energizing the struts, and optionally the electrodes attached thereto, in a particular pattern, a desired scar surface area (e.g., a continuous scar or a non-continuous scar with regularly spaced apart untreated tissue), scar volume, and / or scar depth may be obtained. Alternatively, one or more of the junctions connecting struts 902a and 902d and the junctions connecting struts 902b and 902c may electrically connect the respective struts.

[0101] As with the other electrode configurations described herein, the electrodes of the multi-electrode assembly 900 may be selectively driven in ungrouped or grouped configurations to facilitate electrophysiological applications, ablation, and / or localization as appropriate.

[0102] FIG. 2C illustrates another embodiment of a multi-electrode assembly configured to deliver ablation energy and receive electrophysiological information via attached electrodes. FIG. 2C illustrates the distal end of a basket-like catheter. The multi-electrode assembly 1000 includes a plurality of electrode support members 1002 (also referred to as splines), each of which includes a first plurality of electrodes 1004 and a second plurality of electrodes 1006. The splines 1002 may be folded to be guided through the introducer and may unfold as the basket exits the distal end of the introducer. As with various embodiments of the present disclosure, each of the electrodes 1004 may be configured to deliver ablation energy and each of the electrodes 1006 may be configured for global and / or regional mapping.

[0103] The splines 1002 are connected to a catheter shaft 1008 at the proximal end and extend to a distal coupler 1010 at the distal end where the splines terminate. Although the splines 1002 are depicted as being uniformly distributed circumferentially for global mapping, one or more of the splines may be arranged to provide a higher or lower density of electrodes. In this embodiment, a basket constructed with eight splines is presented, but basket catheters having three or more splines are readily envisioned, the design depending on the intended clinical application and / or desired electrophysiological mapping accuracy. To facilitate expansion / contraction of the basket, a deployment member (not shown) may extend along the longitudinal axis of the basket, and as described for the multi-electrode assembly 700, the deployment member may be a pull wire or lumen extending between the catheter handle and the distal coupler 1010. In some examples, the splines 1002 are formed of a shape memory alloy (e.g., Nitinol), which allows the basket to return to a spherical shape after exiting the introducer.

[0104] The electrodes 1004 and 1006 may be distributed evenly, unevenly, or biased along the length of each spline depending on the tissue being treated. Each electrode 1004 is positioned between a pair of electrodes 1006, although the placement and spacing of the electrodes 1004 may be altered depending on the type of tissue, the treatment desired, and the scar being formed.

[0105] As described above, the multi-electrode assembly 1000 includes a plurality of electrodes 1004. For example, the electrodes 1004 may be selected from ring electrodes, split ring electrodes, and ring segment electrodes. The electrodes 1004 may be selected from the same type of robust electrodes or from a variety of different types of electrodes. For example, electrodes with a small surface area may be used exclusively for electrophysiological mapping, while electrodes with a large surface area may be used for mapping, tissue ablation, and / or localization. In some examples, the multi-electrode assembly includes one or more slightly enlarged ring electrodes (e.g., for localization of flexible arrays in mapping and navigation systems). In some examples, ablation energy is delivered only by the electrodes 1004. Each electrode 1004 may be paired with another adjacent electrode along the same spline or between adjacent splines to facilitate bipolar tissue ablation. Alternatively or simultaneously, the electrodes 1004 may be paired with a patch electrode (not shown) to operate in a monopolar ablation treatment configuration.

[0106] The electrodes 1004 on the basket 1000 do not have to be the same size and shape. For example, embodiments consistent with the present disclosure may include small size electrodes (e.g., 0.8 mm diameter) for electrophysiological mapping and larger size electrodes capable of both electrophysiological mapping or ablation and with impedance large enough to facilitate localization in an impedance or hybrid based catheter navigation system.

[0107] In some examples, small electrophysiological mapping electrodes may be connected to the tissue-facing surfaces of the splines for direct contact with the tissue, and large non-contact navigation electrodes are connected to the inward-facing surfaces of the splines 1002. Some of the electrodes 1004 on the basket 1000 may be multipurpose, while others are single-purpose. For example, some of the electrodes may function as ablation and navigation electrodes or electrophysiological mapping electrodes, others may function only as electrophysiological mapping electrodes, and still others may function only as navigation electrodes. The size and spacing of the electrodes 1004 may be varied to allow for flexibility of the array and to define the area of ​​the electrodes 1006.

[0108] As described for embodiments 300, 800, etc., the multi-electrode assembly 1000 further includes a plurality of flexible electrodes 1006. The flexible electrodes 1006 include spot electrodes or other flexible / direct printed electrodes connected to at least one surface of the splines. The splines of the basket array may comprise flexible membranes compatible with printed circuit manufacturing techniques and / or such membranes may be connected to structural elements of the struts (e.g., Nitinol-based structural elements). The spot electrodes may be printed on the struts themselves. The printed electrodes may be electrically connected to signal processing and / or driver circuitry via traces 1007, shown in close-up, that run on or through one or more membrane layers.

[0109] The electrodes 1006 may be used in various bipolar configurations to facilitate measuring electrical properties of tissue in contact with the electrodes. The combination of orthogonal bipolar pairs may measure unique orientation-specific electrical properties of tissue in two orthogonal orientations. A first bipolar pair may include a pair of electrodes along the length of the splines 1002, facilitating collection of tissue electrical property data in a direction generally parallel to the longitudinal axis of the catheter. A second orthogonal bipolar pair extends laterally across adjacent splines 1002, facilitating collection of tissue electrical property data in a direction substantially transverse to the longitudinal axis of the catheter. To facilitate collection of this electrical data, these bipolar electrode pairs may be treated independently by signal processing circuitry. The signal processing circuitry analyzes the received signals from the two sets of bipolar electrode pairs to identify electrophysiological information that is independent of the orientation of the tissue in contact with the electrodes.

[0110] As with the other electrode configurations described herein, the electrodes of the multi-electrode assembly 1000 may be selectively driven in ungrouped or grouped configurations to facilitate electrophysiological applications, ablation, and / or localization as appropriate.

[0111] The multi-electrode assemblies 100, 200, 300, 400, 500, 600, 700, 800, 900, and 1000 are suitable for use in catheters for diagnostic purposes, anatomical mapping, and / or ablation therapy (e.g., electroporation therapy). The multi-electrode assemblies of the present disclosure, capable of both electrophysiological mapping and ablation therapy, can reduce procedure time by eliminating the need to exchange the electrophysiological mapping catheter for an ablation catheter after confirming a treatment strategy. Furthermore, the multi-electrode assemblies of the present disclosure can be used, in particular, for electroporation-induced primary necrosis therapy, to deliver ablation energy suitable for irreversible electroporation to destroy tissue. In some examples, when the exposed inter-electrode regions (e.g., tissue ablation members) of the electrodes, struts or splines are closely spaced, the current may be delivered as a pulsed electric field in the form of brief pulses (e.g., 0.1-20 ms duration) capable of delivering a field strength of about 0.1-1.0 kV / cm (i.e., pulsed electric field ablation (PFA)).

[0112] Advantages of the 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 the speed of map generation or the 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 allow for tissue-specific scar formation within short treatment times.

[0113] 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 within 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.

[0114] The terms "proximal" and "distal" are used throughout this specification with reference to a clinician manipulating one end of an instrument that is 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.

[0115] Any patent document or other disclosure material that is incorporated herein by reference, in whole or in part, is incorporated herein to the extent that the incorporated material does not contradict existing definitions, descriptions, or other disclosures set forth herein.

Claims

1. 1. A multi-electrode assembly for a mapping and ablation catheter, comprising: a first plurality of electrodes; An electrode support member; Equipped with a portion of the electrode support member adapted to provide ablation therapy; A multi-electrode assembly, wherein at least a portion of the first plurality of electrodes are disposed on the electrode support member and configured to sense electrophysiological properties of contacted tissue.

2. The multi-electrode assembly of claim 1 , wherein the first plurality of electrodes is selected from the group consisting of ring electrodes, tip electrodes, tip segment electrodes, split ring electrodes, and ring segment electrodes.

3. The multi-electrode assembly of claim 2 , wherein the electrode support member further comprises a plurality of spot electrodes, a plurality of printed electrodes, a plurality of conductive traces, or a combination thereof.

4. The multi-electrode assembly of claim 3 , wherein the electrode support member further comprises a tip electrode configured to deliver ablation energy to the tissue.

5. the electrode support member is configured as a planar array including two or more struts; Each of the struts lies in a common plane; The multi-electrode assembly of claim 1 , wherein at least a portion of the plurality of electrodes are disposed on the struts and configured to sense electrophysiological properties of the tissue in contact with the planar array.

6. The multi-electrode assembly of claim 5 , wherein at least one of the first plurality of electrodes comprises an electrode formed on an electrically insulating substrate disposed on a surface of the strut.

7. The multi-electrode assembly of claim 5 , wherein the first plurality of electrodes is selected from the group consisting of ring electrodes, split ring electrodes, and ring segment electrodes.

8. a second plurality of electrodes selected from the group consisting of spot electrodes, printed electrodes, and combinations thereof; The multi-electrode assembly of claim 7 , wherein the second plurality is constructed and arranged to sense an electrophysiological property of the tissue in contact therewith.

9. 9. The multi-electrode assembly of claim 8, wherein at least one electrode of the first plurality is disposed between two electrodes of the second plurality.

10. The multi-electrode assembly of claim 5 , wherein the first plurality of electrodes is selected from the group consisting of spot electrodes, printed electrodes, and combinations thereof.

11. The multi-electrode assembly of claim 5 , wherein the first plurality of electrodes are uniformly spaced along the struts.

12. a surface of the strut comprises exposed metal; The multi-electrode assembly of claim 11 , wherein the surface is capable of transmitting ablation energy between the at least two struts.

13. the planar array includes at least four struts; The multi-electrode assembly of claim 5 , wherein each strut includes at least four electrodes.

14. the electrode support member is configured as a flexible basket including a plurality of splines; The multi-electrode assembly of claim 1 , wherein the first plurality of electrodes is disposed on the splines and configured to sense electrophysiological properties of contacted tissue.

15. The multi-electrode assembly of claim 14 , wherein at least one of the electrodes includes a dielectric layer disposed between the electrode and a spline surface.

16. 15. The multi-electrode assembly of claim 14, wherein the first plurality of electrodes is selected from the group consisting of ring electrodes, split ring electrodes, and ring segment electrodes.

17. a second plurality of electrodes attached to a surface of the spline; the second plurality is selected from the group consisting of spot electrodes, printed electrodes, and combinations thereof; 17. The multi-electrode assembly of claim 16, wherein the second plurality is constructed and arranged to sense an electrophysiological property of the tissue in contact therewith.

18. 20. The multi-electrode assembly of claim 17, wherein at least one electrode of the first plurality is disposed between two electrodes of the second plurality.

19. the first plurality of electrodes includes at least two electrode sets; 17. The multi-electrode assembly of claim 16, wherein the first set of electrodes has a greater total surface area than the second set of electrodes.

20. The multi-electrode assembly of claim 14 , wherein the first plurality of electrodes is selected from the group consisting of spot electrodes, printed electrodes, and combinations thereof.

21. the spline surface comprises exposed metal; The multi-electrode assembly of claim 14 , wherein the surface is capable of transmitting ablation energy between at least two splines.

22. the first plurality of electrodes includes at least two electrode sets; 22. The multi-electrode assembly of claim 21, wherein the first set of electrodes has a greater total surface area than the second set of electrodes.

23. 23. The multi-electrode assembly of claim 22, wherein at least the first set of electrodes are configured to operate as a single large electrode.

24. The multi-electrode assembly of claim 1 , wherein at least some of the electrodes in the electrode group comprising the first plurality of electrodes and the electrode support member are configured to be driven independently of one another in a non-grouped configuration.

25. The multi-electrode assembly of claim 1 , wherein at least some of the electrodes in the electrode group comprising the first plurality of electrodes and the electrode support member are configured to be driven in unison in a grouped configuration.

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