Map and ablate catheter

Abstract

An electrophysiology catheter is provided. The catheter includes a first elongate member, an expandable basket assembly comprising a distal hub, a plurality of flexible splines, and an interactive element assembly. The catheter further comprises a second elongate tubular member configured to receive the first elongate member. The basket assembly is slidingly compressible to fit within a lumen of the second elongate tubular member and to adjust an effective diameter and size of the basket, wherein retraction of the first elongate member within the second elongate tubular member reduces the effective diameter and size of the expandable basket assembly.

Description

[0001] MAP AND ABLATE CATHETER

[0002] CLAIM FOR PRIORITY

[0003] The present application claims the benefit of and priority to U.S. Provisional Application No. 63 / 760,433 filed on February 19, 2025 and titled, “MAP AND ABLATE CATHETER,” (the “’433 Application). The present application also claims the benefit of and priority to U.S. Provisional Application No. 63 / 840,270 filed on July 8, 2025 and titled, ““MAP AND ABLATE CATHETER,” (the “’270 Application). Each of the ’433 Application and the ’270 Application are herein incorporated, by reference, in their entirety.

[0004] FIELD OF THE DISCLOSURE

[0005] The present application relates to systems and apparatuses for catheter-based cardiac electrophysiology mapping and therapy. In particular, the present disclosure relates to electrophysiology catheters, including basket catheters and controllable expandable basket catheters, for mapping and therapy.

[0006] BACKGROUND

[0007] Heart rhythm disorders are very common, and are significant causes of morbidity, lost days from work, and death. Definitive diagnosis and / or therapeutic medical procedures have often been performed using electrode-bearing catheters (electrophysiology catheters) placed within the heart chambers.

[0008] Electrophysiology7catheters carry7one or more electrodes which may be used for mapping, ablation, diagnosis, or other therapies and / or treatments. Electrodes have been positioned along a catheter shaft or flexible spline elements in an attempt to analyse or map the electrical activity within a heart chamber and / or deliver therapy. Mapping typically involves the use or formation of external (e.g., patches on skin) electrograms and internal (e.g., catheters with electrodes) electrograms..

[0009] It is important to provide a complete and stable map of the electrical activity within a heart chamber (via, for example, recording electrograms). In particular, in order to map electrical activity in certain portions of the right atrium and the left atrium (e.g. atrial septum, region of right pulmonary7veins) devices must adequately conform to the irregular shape of the atria and their varying shapes during beating of the heart. Further, in order to provide dimensionally and spatially stable and complete electrograms, movement of the devices during a heartbeat must be minimised, retaining electrode contact with the heart 1 SL 879690S.1tissue. Cardiac mapping catheters need to be capable of providing improved and dimensionally and / or spatially stable signals for diagnosis, and more complete coverage of the heart tissue, typically in the form of electrograms. Such devices are described in EP2995250B1.

[0010] Typically in a procedure, a catheter is manipulated through a patient's vasculature to, for example, a patient’s heart. To position a catheter at a desired site within the body, some type of navigation may be used, such as using mechanical steering features incorporated into the catheter (or an introducer). In some examples, medical personnel may manually manipulate and / or operate the catheter using the mechanical steering features. In order to facilitate the advancement of catheters through a patient’s vasculature, a navigating system may be used. Such navigating systems may include, for example, electric-field-based positioning and navigating systems that are able to determine the position and orientation of the catheter (and similar devices) within the body and map features of the body. Various therapies can be delivered by the catheter to tissue with varied shapes and sizes. To better accommodate variations in tissue configurations and to provide sufficient contact with the tissue for therapy, it can be important to have multiple sensors coupled with flexible spline elements on structures, such as distal basket configurations, to map the tissue and / or to contact the tissue for therapy. The ability7to vary7the stiffness of the flexible spline elements can allow for more useful configurations of the baskets or other flexible structures (e.g., more contact with tissue for treatment, etc.). Expandable catheters comprising systems to allow the stiffness of the expandable structure to be modified are described in US11,813,41OB2 and EP3681427B1. For different size applications, different catheters can be used (as described in US2019 / 239767), which can result in multiple catheters being required for a single procedure.

[0011] Once at the intended site, electrodes mounted on or in the electrophysiology catheters are used to treat the cardiac tissue. Treatment may include radio-frequency7(RF) ablation, pulsed field ablation (PF A), cryoablation, lasers, chemicals, high-intensity focused ultrasound, etc. An ablation catheter imparts such ablative energy to cardiac tissue to create a lesion in the cardiac tissue. This lesion disrupts undesirable electrical pathways and thereby limits or prevents stray electrical signals that lead to arrhythmias. As readily apparent, such treatment requires precise control of the catheter during manipulation to and at the treatment site, which can invariably be a function of a user’s skill level.

[0012] Another ablation technique is electroporation. Electroporation is a non-thermal ablation technique that involves applying strong electric-fields that induce pore formation 2 SL 879690S.1in the cellular membrane. The electric field may be induced by applying a relatively short duration pulse which may last, for instance, from a nanosecond to several milliseconds. Such a pulse may be repeated to form a pulse train. When such an electric field is applied to tissue in an in vivo setting, the cells in the tissue are subjected to trans-membrane potential, which opens the pores on the cell wall. Electroporation may be reversible (i.e., the temporally -opened pores will reseal) or irreversible (IRE, i.e.. the pores will remain open). For example, in the field of gene therapy, reversible electroporation (i.e., temporarily open pores) is used to transfect high molecular weight therapeutic vectors into the cells. In other therapeutic applications, a suitably configured pulse train alone may be used to cause cell destruction, for instance by causing irreversible electroporation.

[0013] Typically, for classical electroporation, electric energy may be delivered as a pulsed electric field in the form of short-duration pulses (e.g., having a 10 nanosecond (ns) to 100 millisecond (ms) duration) between closely spaced electrodes capable of delivering an electric field strength of about 0.05 to 100.0 kilovolts / centimeter (kV / cm). For electroporation therapy, a generator may be configured to produce an electric energy that is delivered via a catheter as a pulsed electric field in the form of short-duration square wave pulses (e g., a nanosecond to several milliseconds duration, or any duration suitable for electroporation) between closely spaced electrodes capable of delivering an electric field strength (i.e., at the tissue site) of about 0.05 to 100.0 kV / cm.

[0014] An electroporation generator may be configured to output energy in pulses at selectable energy levels, such as 50 joules (J), 100 J, 200 J, and the like. Other generators may have more, or fewer energy settings and the values of the available setting may be the same or different (settings may include, e.g., waveform parameters, voltage, current, number of applications, etc.). For successful electroporation, some generators utilize the 200 J output level. For example, an electroporation generator may output a pulse having a peak magnitude from about 10 Volts (V) to about 20,000 V. Other generators may output any other suitable positive or negative voltage. For example, pulses may have a voltage from 2,400 V to 4,000 V. These electric fields may be applied between the catheter electrodes (e.g. adjacent electrodes) or between one or more catheter electrodes and a return patch.

[0015] EP4346667A1 describes known electroporation catheters for mapping and ablation. Given the need to shorten procedure times and the need for precision during ablation procedures, it would be desirable to provide an ablation system that allows for catheterorientation independence, wave-speed measurement, and direction of propagation, RF 3 SL 879690S.1energy, and PFA. During the course of electroporation therapy sessions, it is desirable for a catheter to both create a map and apply RF energy and / or PFA.

[0016] Is important to ensure that catheter electrodes are close to or contacting the tissue or vessel wall. Generally, the closer the electrodes to the tissue or vessel wall, the larger the lesion size. Catheter configurations that place electrodes near or in contact with the vessel wall are described in WO2022 / 251163A1. WO 2021 / 024140A1 also describes ablation catheters with a flexible tip structure which enables close contact with a vessel wall and its use in ablating small, focal lesions.

[0017] Electrophysiology catheters are traditionally ablation catheters or mapping catheters. Ablation therapies, such as for atrial fibrillation, have extended durations as the clinician must introduce an electrophysiology mapping catheter into the patient's left atrium, confirm the diagnosis, and determine an ablation therapy strategy before removing the electrophysiology' mapping catheter. An ablation catheter is then introduced to complete the ablation therapy, followed by reintroduction of the electrophysiology7mapping catheter to confirm the efficacy of the therapy. In view of the foregoing, a catheter capable of both electrophysiology mapping and ablation therapy would be desirable to limit the duration of the operation. In attempting to combine both concepts in a single catheter, compromises have had to be made: some catheters are small, but take longer to map, whilst some catheters are large but create large lesions.

[0018] SUMMARY OF THE DISCLOSURE

[0019] Variable size / shape expandable basket assembly aspect

[0020] According to a first aspect of the disclosure, there is provided an electrophysiology catheter comprising: a first elongate member comprising a proximal end and a distal end; an expandable basket assembly comprising: a distal hub; a plurality of flexible splines, wherein each spline comprises a respective spline proximal end and a spline distal end, wherein each spline comprises a super-elastic material, wherein each spline proximal end is coupled to the distal end of the first elongate member, and wherein each spline distal end is coupled to the distal hub: and an interactive element assembly. A second elongate tubular member is included, the second elongate tubular member comprising a lumen, a proximal end and a distal end, wherein the second elongate tubular member is configured to receive the first elongate member; and wherein the basket assembly is slidingly compressible to fit within the lumen of the second elongate tubular member and to adjust an effective diameter and size of the basket, wherein the basket assembly has a substantially cylindrical shape 4 SL 879690S.1when compressed within the lumen of the second elongate tubular member; and wherein the basket assembly has a radially expanded non-cylindrical shape when not compressed within the lumen of the second elongate tubular member and at least partially disposed past the distal end of the second elongate tubular member, wherein retraction of the first elongate member within the second elongate tubular member reduces the effective diameter and size of the expandable basket assembly.

[0021] Basket retraction and size

[0022] The size and shape of the expandable basket may be selectively changed depending on the use or application. The electrophysiology catheter of the present disclosure can act as a large footprint mapping and ablation catheter, able to deliver large area lesions. The expandable basket of the electrophysiology catheter can have its effective diameter and size reduced to map on a smaller scale and / or to deliver focal lesions. Retracting the first elongate member within the second elongate tubular member causes the expandable basket to retract into the second elongate tubular member, enabling the effective diameter and size of the expandable basket to be reduced. To facilitate the adjusting of diameter and size of the basket assembly, the first elongate member is slidably received within the second elongate tubular member. When the first elongate member is pulled (e.g., retracted) proximally relative to second elongate tubular member, proximal ends of the splines are also pulled proximally relative to a distal end of the second elongate tubular member, thereby retracting the basket assembly proximally within the second elongate tubular member, reducing the effective diameter and size of the expandable basket assembly.

[0023] During retraction of the first elongate member within the second elongate tubular member, the second elongate tubular member remains in position. For example, the second elongate tubular member may be fixed relative to a handle of the catheter. This is advantageous in that the second elongate tubular member can be used for deflection control and accurate positioning of the catheter.

[0024] The proximal end of the first elongate member may be coupled to the proximal end of the second elongate tubular member. The proximal end of the second elongate tubular member may comprise a thread and the proximal end of the first elongated member may comprise a thread configured to couple with the thread of the second elongate tubular member. Threading of the first elongate member distally into the second elongate tubular member may increase the effective diameter and size of the basket. Alternatively, the proximal end of the second elongate tubular member may comprise an aperture and the 5 SL 879690S.1proximal end of the first elongate member may comprise a protrusion configured to be received in the aperture of the second elongate tubular member. The aperture may comprise a longitudinal portion and at least one circumferential portion. The protrusion may slide within the longitudinal portion. Twisting of the first elongate member within the second elongate tubular member can move the protrusion into the circumferential portion of the aperture, locking the first elongate member from further sliding. There may be a number of circumferential portions of the aperture to provide for a number of different positions of the first elongate member (and thus provide for a number of different sizes and diameters of the expandable basket assembly).

[0025] Alternatively, the proximal end of the first elongate member may be coupled to a proximal end of a handle. The proximal end of the handle may comprise a thread and the proximal end of the first elongate member may comprise a thread configured to couple with the thread of the proximal end of the handle. Threading of the first elongate member distally into the handle may increase the effective diameter and size of the basket. The distal end of the handle may be coupled to the distal end of the second elongate tubular member.

[0026] The position of the proximal end of the first elongate member relative to the proximal end of the second elongate tubular member may be manually adjusted to adjust an effective diameter and size of the expandable basket assembly.

[0027] Retraction may be such that the size (diameter and volume) of the expandable basket assembly can be reduced continuously. That is. retraction might be on a continuous, sliding scale. Alternatively, there may be a number of specific fixed sizes that the expandable basket assembly can adopt. Specific fixed sizes may be denoted by set positions on the proximal end of the first elongate member. Alternatively, specific fixed sizes may be denoted by a series of notches, detents, or stops on a thread at the proximal end of the first elongate member. Set positions may act as a visual position indicator of linear motion of the first elongate member relative to the second elongate tubular member. The notches, detents or stops may provide tactile feedback to the operator indicating that the basket has achieved the next fixed size. A number of fixed size expandable basket assembly configurations may be useful for clinical settings where physicians may want to know the size / shape of the basket, for example, for applying lesions of a specific size. The catheter may be coupled to a user interface configured to display the diameter and size of the basket.

[0028] The catheter may comprise a detection mechanism. The detection mechanism may be configured to detect the position of the first elongate member relative to the second elongate tubular member, such that the size and diameter of the expandable basket 6 SL 879690S.1assembly can be determined. The detection mechanism may allow the position of the first elongate member relative to the second elongate tubular member to be measured.

[0029] The detection mechanism may be located on the second elongate tubular member so as to determine the position of the first elongate member within its lumen. When the proximal end of the second elongate tubular member comprises a thread and the proximal end of the first elongate member comprises a thread configured to couple with the thread of the second elongate tubular member, a detection mechanism may be included in the proximal end of the second elongate tubular member.

[0030] The detection mechanism may comprise a linear transducer configured to measure a linear distance travelled by the basket. Alternatively, the detection mechanism may comprise a variable resistor that is calibrated to indicate the size of the basket, for example, based on a change in resistance. The detection mechanism (e.g. linear transducer or variable resistor) may be communicatively coupled with a processor. The position may be used to determine if the expandable basket assembly has a size / diameter within a range that can generate a therapy waveform. Alternatively, the therapy waveform may span all sizes / diameters of the expandable basket assembly and the position may cause the processor to adjust lesion marker sizes. The detection mechanism may alternatively comprise a sensor. The sensor may be configured to detect a position of the actuator.

[0031] The diameter of the radially expandable basket assembly can be adjusted to sizes between 2 to 70mm. 50 to 70mm. 3 to 36mm, 15 to 28mm, 10 to 12mm, 5 to 9mm, 3 to 5mm, preferably to sizes of 24mm, 15mm, 10mm, 8mm, 5mm or 3mm. The shape of the radially expandable basket assembly may be approximated to a sphere and the volume of the expandable basket assembly can be adjusted between 4.19xl0'3to 65.45cm3. 0.014 to 7.24cm3, 1.77 to 3.05cm3, 0.52 to 0.9cm3, 0.065 to 0.38cm3, 0.014 to 0.065 cm3, preferably to volumes of 7.24cm3, 1.77cm3, 0.52cm3, 0.065cm3or 0.014 cm3.

[0032] Larger size baskets (e.g., 15 to 50mm diameter) can be used for mapping, with high-fidelity, for example to map the whole chamber of the heart. Larger size baskets can quickly map as well as quickly isolate the pulmonary veins in relatively few therapy applications. Larger size baskets can also be used to deliver larger area lesions.

[0033] Smaller size baskets (e.g., 2 to 10mm diameter) may be used to provide focal lesions to, for example, hard to reach or tight areas. Smaller size baskets may be configured to deliver radio-frequency (RF) energy and / or PF A.

[0034] 7 SL 879690S.1Splines

[0035] The splines of the expandable basket assembly are coupled to a distal hub at one end, i.e. the distal end of each spline, of the basket assembly, and are further coupled to the distal end of the first elongate member at an opposed end, i.e. the proximal end of each spline, of the expandable basket assembly.

[0036] Each spline proximal end is coupled to the distal end of the first elongate member. Coupling may be via an anchor for securably affixing the proximal end of the spline. The anchor may be securably affixed to the body of the first elongate member and / or within the lumen of the second elongate tubular member at the distal end of the second elongate tubular member.

[0037] The expandable basket assembly is deliverable through and into bodily organs, such as but not limited to the heart. In preparation for insertion of the catheter, the expandable basket assembly is slidably compressed to fit within the lumen of the second elongate tubular member. To compress the expandable basket assembly (e.g., for delivery' of the catheter), the first elongate member is slid proximally relative to the second elongate tubular member. Full retraction of the expandable basket assembly within the second elongate tubular member causes the flexible splines to collapse inward, transitioning the expandable basket assembly to a collapsed position. The splines of the expandable basket assembly may be in a compressed state within the lumen of the second elongate tubular member. The compressed basket assembly may be an approximate or substantially elongate cylindrical shape. In such a compressed state, the effective lengths of the splines betw een the distal hub and distal end of the first elongate member are substantially the same.

[0038] The expandable basket assembly is deliverable through and past the distal end of the lumen of the second elongate tubular member. The expandable basket assembly expands as it exits the distal end of the second elongate tubular member. The super-elastic material causes each of the splines to bow' outw ardly into the basket shape. The superelastic material provides stability for the expandable basket assembly, such that splines assume an expanded shape when not subjected to any external forces or biases. The superelastic material can allow the basket to hold its expanded shape during mapping and therapy uses. The expanded shape may be a radially expanded shape. The overall shape of the expanded basket assembly may be an expanded, non-cylindrical shape. The expanded basket shape can include symmetric and asymmetric basket shapes. That is, the expanded splines may be in a spherical or somewhat spherical orientation, optionally symmetrical in shape. Alternatively, the expanded splines may assume a non-spherical or substantially 8 SL 879690S.1non-spherical shape, preferably asymmetrical in shape. In particular, spline portions near the distal hub and / or spline portions near the distal end of the first elongate member may assume a non-spherical or substantially non-spherical shape, optionally an asymmetrical shape. Such an asymmetrical shape may be useful, if desired, to concentrate a greater number of splines at a particular location within the body, for example the right atrium of the heart.

[0039] Any suitably super-elastic material may be used for the splines. The super-elastic material may comprise a shape memory material. Preferably, the splines comprise or are made of nitinol.

[0040] Each spline may comprise a first surface and a second surface. The first surface of the spline may comprise an inner surface and the second surface of the spline may comprise an outer surface. The inner spline surface may face the interior of the expandable basket assembly. The outer spline surface may face the exterior of the expandable basket assembly. Each spline may further comprise two side surfaces. The first surface and / or the second surface of the spline may be substantially flat. The substantially flat first and second surfaces may be parallel to one another. The two side surfaces of the spline may be convexly rounded surfaces. The cross-sectional profile of the spline may be a rounded rectangular shape. Alternatively, the first surface and / or the second surface of the spline may be rounded or otherwise have curvature, including concave and / or convex curvatures.

[0041] The expandable basket assembly of the first aspect of the present disclosure may have any useful number of splines. For example, the expandable basket assembly may comprise 2 to 16 splines, 2 to 12 splines, 3 to 8 splines, preferably 7 or 8 splines.

[0042] The splines may be about 0.33 mm to about 0.90 mm wide, preferably 0.33 mm to about 0.64 mm wide, and about 0.05 mm to about 0.32 mm thick, preferably about 0.05 mm to about 0.254 mm thick. A preferred width is about 0.55mm. Preferred spline thickness may be 0.05mm, 0.08mm, 0.10mm or 0.15mm. A smaller thickness contributes to increased flexibility. These dimensions are non-limiting and other dimensions may suitably be used.

[0043] The expandable basket assembly may further comprise at least one tubular polymeric member, each tubular polymeric member comprising a first open end and an opposed second open end defining an open lumen therein between. The tubular polymeric member may comprise an inner member surface and an outer member surface. At least one of the plurality of flexible splines may be at least partially disposed within the lumen of the tubular polymeric member. A first portion of the outer member surface of the tubular 9 SL 879690S.1polymeric member may predominantly face the interior of the expandable basket assembly. A second portion of the outer member surface of the tubular polymeric member may predominantly face the exterior of the expandable basket assembly.

[0044] There may be a plurality of tubular polymeric members. Each of the plurality of flexible splines may be at least partially disposed within a different one of the plurality of tubular polymeric members (that is, each flexible spline is positioned within its own tubular polymeric member). A cross-sectional profde of the tubular polymeric member may be elliptical to match a cross-sectional profile of the spline, for example the rounded rectangular shape or elliptical shape of the spline. The cross-sectional profile of the tubular polymeric member may be slightly larger than the cross-sectional profile of the spline. The tubular polymeric member may include a flexible material. The tubular polymeric member may include a non-conductive material.

[0045] The spline may not be fixed to the lumen of the tubular polymeric member. The tubular polymeric member may be slidably assembled over the spline to provide some interference therebetween. The second, proximal open end of the lumen of the tubular polymeric member may be connected to the first elongate member or a proximal coupler located at a distal end of the first elongate member.

[0046] Each spline may have a proximal portion, distal portion and medial portion therebetween. The first open end of the tubular polymeric member may be secured to the distal spline portion of a spline at a position near to the distal hub and the second opposed open end of the tubular polymeric member may be secured to the proximal spline portion of a spline at a position near to the proximal end of a spline. The first open end of the tubular polymeric member may be sealingly secured to the distal spline portion at the position near to the distal hub by a seal. An intermediate medial portion of the tubular polymeric member between the first open end and the second opposed open end of the tubular polymeric member may not be secured to the medial portion of the spline. Alternatively, an intermediate medial portion of the tubular polymeric member between the first open end and the second opposed open end of the tubular polymeric member may be secured to the medial portion of the spline.

[0047] Interactive element assembly configuration

[0048] Various therapies can be delivered by the catheter to tissue with varied shapes and sizes. To better accommodate variations in tissue configurations and to provide sufficient contact with the tissue for therapy, interactive elements are formed by or coupled with the 10 SL 879690S.1flexible splines. The interactive elements can be used to map the tissue and / or provide therapy, such as ablation therapy.

[0049] The interactive element assembly comprises a plurality of interactive elements distributed on the plurality of flexible splines. The interactive element assembly may comprise at least one first interactive element distributed on a first surface of each of the plurality of flexible splines. The interactive element assembly may comprise at least one second interactive element distributed on a second surface of each of the plurality of flexible splines. The interactive element assembly may comprise a plurality of first interactive elements distributed on a first surface of each of the plurality of flexible splines; and a plurality of second interactive elements distributed on a second surface of each of the plurality of flexible splines. The term "‘distributed on7’ encompasses disposing an interactive element directly onto a surface of a spline, or disposing the interactive element indirectly onto a surface of the spline. For example, disposing the interactive element onto a substrate which is itself disposed onto a surface of the spline or disposing the interactive element onto a tubular polymeric member (surrounding the spline), or forming the interactive element from the spline itself.

[0050] Similar to the splines, the interactive elements of the interactive element assembly may comprise or be formed from a super-elastic material. The super-elastic material may comprise Nitinol. The Nitinol may be configured to form at least one interactive element of the plurality of interactive elements of the interactive element assembly. For example, the Nitinol may be configured to form the at least one first interactive element distributed on a first surface of each of the plurality of flexible splines. That is, the entirety of the first, inner surface of each spline may serve as an interactive element (e.g. an electrode). Alternatively, each spline may further comprise an insulating material (e.g.. a polyethylene terephthalate (PET) heat shrink material, polyurethane, nylon, parylene, a polyimide (e.g., PI-2771 or HD-4004 available from HD Microsystems, or KAPTON available from DuPont), a polyether block amide (such as Pebax®), and / or an epoxy (e.g., SU8 epoxy available from MicroChem Corp)) covering at least a portion of the first surface and / or second surface of the spline. Preferably the insulating material is selected from polyurethane, nylon and a polyether block amide, more preferably a poly ether block amide. At least one non-insulated (exposed) portion of the nitinol spline may correspond to an interactive element (e.g. an electrode). In particular, the first, inner surface of the spline may comprise an insulating material exposing portions of the nitinol. wherein at least one exposed portion of the inner surface of the nitinol spline corresponds to an interactive 11 SL 879690S.1element. The exposed nitinol interactive elements can be configured to generate an electric field proximate to target tissue to deliver ablation therapy.

[0051] At least one of the interactive elements may be formed by disposing the at least one of the interactive elements on to a surface of each of the plurality of flexible splines. The interactive element assembly may further comprise a plurality of electrical traces disposed on the plurality of flexible splines, each of the plurality of electrical traces coupled with a respective one of the interactive elements and a dielectric material disposed between each of the plurality of electrical traces and the flexible splines. The at least one first interactive element may be deposited on a first surface of each of the plurality of flexible splines, the plurality of electrical traces coupled with a respective one of the first interactive elements. The at least one second interactive element may be deposited on a second surface of each of the plurality of flexible splines, the plurality of electrical traces coupled with a respective one of the second interactive elements.

[0052] At least one of the interactive elements may be formed by disposing the at least one of the interactive elements on to an outer member surface of the tubular polymeric member and wherein the interactive element assembly further comprises a plurality of electrical traces disposed on an outer member surface of the tubular polymeric member, each of the plurality of electrical traces coupled with a respective one of the interactive elements, and a dielectric material disposed between each of the plurality of electrical traces and the an outer member surface of the tubular polymeric member. The at least one first interactive element and electrical traces may be deposited on a first portion of the outer member surface of the tubular polymeric member. The at least one second interactive element and electrical traces may be deposited on a second portion of the outer member surface of the tubular polymeric member.

[0053] At least one of the interactive elements may be formed by disposing the at least one of the interactive elements on to an outer member surface of the tubular polymeric member and wherein the interactive element assembly further comprises a plurality of electrical traces and a dielectric material embedded within the wall of the tubular polymeric member, each of the plurality of electrical traces coupled with a respective one of the interactive elements.

[0054] The dielectric material can be applied to the flexible splines to coat the splines in the dielectric material to provide an electrically insulative layer, upon which patterned electrical traces can be disposed. Examples of the dielectric material can include a polyethylene terephthalate (PET) heat shrink material, polyurethane, nylon, parylene, a 12 SL 879690S.1polyimide (e.g., PI-2771 or HD-4004 available from HD Microsystems, or KAPTON available from DuPont), a poly ether block amide (such as Pebax®)), and / or an epoxy (e.g., SU8 epoxy available from Mi croChem Corp). Where the splines comprise an electrically conductive material, the dielectric material can electrically insulate the electrical traces from the electrically conductive material.

[0055] An additional layer of dielectric material can be deposited over the initial layer of dielectric material and over the electrical traces. The additional layer of dielectric material can insulate multiple interactive elements (e.g. electrodes) from one another. The electrical traces and / or dielectric material may be adhesively and / or thermally secured to a surface of each of the plurality of flexible splines or each other.

[0056] Alternatively, each spline of the plurality of splines may comprise a polymer substrate, a conductive layer, and an adhesive layer. The polymer substrate may be deposited on a first surface of each of the plurality of flexible splines and the at least one first interactive element may be deposited on and coupled with the conductive layer. The polymer substrate may additionally or alternatively be deposited on a second surface of each of the plurality of flexible splines and the at least one second interactive element may be deposited on and coupled with the conductive layer. Each spline of the plurality of splines may comprise additional layers of at least one of a polymer substrate, a conductive layer, and an adhesive layer. The polymer substrate, conductive layer, and adhesive layer may be stacked to provide a high electrode count on the limited width available for each spline.

[0057] The interactive element assembly may comprise at least one flexible circuit. The interactive element assembly may comprise at least one first flexible circuit and / or at least one second flexible circuit. The at least one first flexible circuit may be deposited on the first surface (facing the interior of the expandable basket assembly) of each of the plurality of flexible splines. The at least one second flexible circuit may be deposited on the second surface (facing the exterior of the expandable basket assembly) of each of the plurality of flexible splines. As discussed in more detail below, the at least one flexible circuit may be configured to wrap around the spline, such that a portion of the flexible circuit is distributed on a first surface of each of the plurality of flexible splines and a portion of the flexible circuit is distributed on a second surface of each of the plurality of flexible splines.

[0058] Each flexible circuit comprises a polymeric substrate having an upper surface and an opposed lower surface, at least one interactive element disposed over at least part of the upper surface of the polymeric substrate, and one or more electrical traces. The electrical 13 SL 879690S.1traces can be disposed over at least a portion of the lower surface of the polymeric substrate. Additionally an / dor alternatively, the electrical traces can be disposed over at least a portion of the upper surface of the polymeric substrate. Additionally and / or alternatively, the electrical traces can be embedded within the polymeric substrate. The one or more electrical traces are in electrical communication with the interactive elements.

[0059] The electrical traces may be formed from a conductive material. The electrical traces may include one or more layers of any suitable conductive metal, including copper, a noble metal (e.g., gold, platinum, iridium, etc ), titanium and nickel. The electrical traces may include a copper layer with a gold layer on top to protect it from corrosion. The electrical traces may include a nickel layer in between copper and gold layers to retard the diffusion of the copper into the gold, thus reducing the corrosion protection offered by the gold. Optional further layers of titanium may be included. The electrical traces may include metal oxide layers. For example, the electrical traces may include a layer of platinum or iridium, which are subsequently oxidized to form platinum / iridium oxide to improve mapping performance. The conductive traces may include doped polymers ("stretchy" conductors), such as gold embedded within a liquid crystal polymer or polymers doped with copper nano wires.

[0060] The flexible circuit polymeric substrate may comprise an insulating material, preferably a dielectric material. The polymeric substrate may comprise a polyethylene terephthalate (PET) heat shrink material, polyurethane, nylon, parylene, a polyimide (e.g., PI-2771 or HD-4004 available from HD Microsystems, or KAPTON available from DuPont), a polyether block amide (such as Pebax®), and / or an epoxy (e.g., SU8 epoxy available from Mi croChem Corp)) covering at least a portion of the first surface and / or second surface of the spline. Preferably the insulating material is selected from polyurethane, nylon and a polyether block amide, more preferably a poly ether block amide.

[0061] Each flexible circuit may include polyimide or liquid crystal polymer (LCP) to tolerate soldering temperatures. The flexible circuit may include glass. The flexible circuit may include other polymers employed along with low temperature interconnect methods (e.g., solder jetting).

[0062] The one or more electrical traces can be disposed over at least a portion of the lower surface of the polymeric substrate. Each flexible circuit may further comprise vias to provide electrical communication between the one or more electrical traces and the at least one first / second interactive elements. Alternatively, metal plated holes may be used to provide electrical communication between the one or more electrical traces and the at least 14 SL 879690S.1one first / second interactive elements. A polymeric layer may be disposed between the lower surface of the polymeric substrate and the flexible spline, such as to provide electrical insulation between the traces and the spline. The polymeric layer may be adhesively and / or thermally secured to the surface each of the plurality of flexible splines. Alternatively, the polymeric layer may be adhesively and / or thermally secured to an outer member surface of the polymeric tubular member. The polymeric layer provides an extra layer of insulation.

[0063] The one or more electrical traces can be disposed on at least a portion of the upper surface of the polymeric substrate. Each flexible circuit may further comprise a polymeric covering over the upper surface of the polymeric substrate and the electrical traces with the interactive element being substantially free of the polymeric covering. The polymeric covering may be bonded to the polymeric substrate with the use of suitable adhesives, usually acrylic adhesives. Preferably, the upper flexible circuit surface is substantially flat, i.e., the polymeric covering and the interactive elements being substantially the same height. Alternatively, the interactive elements may be raised slightly above the polymeric substrate surface. The interactive elements may be raised with the use. for example, of strips of material disposed between the polymeric substrate and the interactive elements. Alternatively, the interactive elements may be depressed slightly below the polymeric substrate surface. The polymeric covering may comprise a similar material as the polymeric substrate, but different materials may suitably be used.

[0064] The lower surface of the polymeric substrate of the flexible circuit may be adhesively and / or thermally bonded to a surface of each spline. The lower surface of the polymeric substrate of the first flexible circuit may be adhesively and / or thermally bonded to the first surface of each spline. The lower surface of the polymeric substrate of the second flexible circuit may be adhesively and / or thermally bonded to the second surface of each spline. Alternatively, the lower surface of the polymeric substrate of the first and / or second flexible circuit may be adhesively and / or thermally secured to an outer member surface of the tubular polymeric member.

[0065] For example, each flexible circuit may include an adhesive layer. The adhesive layer may include polyurethane, cyanoacrylate, polyvinyl acetate, acrylic, polyimide, epoxy, hot melt, or fluoropolymer adhesives. Alternatively, each flexible circuit may not include an adhesive layer. Thermal bonding may include the application of heat and / or compressive pressure to the layers.

[0066] The polymeric substrate of the flexible circuit may be secured to the tubular polymeric member. Specifically, the lower surface of the polymeric substrate may be 15 SL 879690S.1secured to the outer member surface of the tubular polymeric member. More specifically, the lower surface of the polymeric substrate of a first flexible circuit may be secured to a first portion of the outer member surface of the tubular polymeric member. More specifically, the lower surface of the polymeric substrate of a second flexible circuit may be secured to a second portion of the outer member surface of the tubular polymeric member. As such, the first flexible circuit predominantly faces the interior of the expandable basket assembly and the second flexible circuit predominantly faces the exterior of the expandable basket assembly.

[0067] The lower surface of the polymeric substrate of the flexible circuit may be adhesively and / or thermally bonded to the outer member surface of the tubular polymeric member.

[0068] At least a portion of the first and second flexible circuits may extend into a lumen of the first elongate member.

[0069] The flexible circuit may comprise wings. The wings may be configured to secure the flexible circuit to the flexible splines or to the tubular polymeric member. That is, the wings may wrap around the spline, such that a portion of the flexible circuit is distributed on a first surface of each of the plurality of flexible splines and a portion of the flexible circuit is distributed on a second surface of each of the plurality' of flexible splines. Or, the wings may wrap around the tubular polymeric member, such that a portion of the flexible circuit is distributed on a first portion of the outer member surface of the tubular polymeric member and a portion of the flexible circuit is distributed on a second portion of the outer member surface of the tubular polymeric member. The wings may be useful in securing the flexible circuit to flexible splines or tubular members, such as tubular polymeric members, especially where it is desirable to keep the interactive elements as substantially unidirectional flat interactive elements.

[0070] Alternatively, the wings may7protrude from each of the plurality7of flexible splines. The wings may be configured to provide larger surface area interactive elements, for example, the wings may provide a larger surface area as compared to the width of the flexible splines.

[0071] The flexible circuit polymeric substrate may be formed from the tubular polymeric member. The electrical traces can be embedded w ithin the tubular polymeric member. That is, the electrical traces may form part of the tubular polymeric member wall.

[0072] The flexible circuit may have a thickness from about 0.025mm to about 0.254mm, such as from about 0.051mm to about 0.102mm or from about 0.127mm to about 0.203mm.

[0073] 16 SL 879690S.1Type and number of interactive elements

[0074] Multiple independently energizable interactive elements may be attached to each spline.

[0075] The interactive element assembly may comprise any number of interactive elements, for example 8 to 72 interactive elements. Each one of the plurality of splines may comprise 1 to 16 first interactive elements, such as eight first interactive elements or one first interactive element. Each one of the plurality of splines may comprise 1 to 16 second interactive elements, such as eight second interactive elements or two second interactive elements.

[0076] As discussed above, the interactive element assembly may comprise a plurality of first interactive elements distributed on a first surface of each of the plurality of flexible splines and a plurality of second interactive elements distributed on a second surface of each of the plurality of flexible splines. The plurality of first and / or second interactive elements may be equally distributed on each of the plurality7of splines. Alternatively, the plurality of first and / or second interactive elements may be unequally distributed on each of the plurality of splines. The plurality of first interactive elements may be distributed in a side-by-side array on the first surface of each of the plurality of splines. The plurality of second interactive elements may be distributed in a side-by-side array on the second surface of each of the plurality of splines.

[0077] The plurality of interactive elements may be selected from one or more of an electrode, an energy delivery element, a temperature sensor (e g. a thermocouple), a force sensor, a strain gauge, a strain sensor, a position sensor, a biosensor, a diagnostic sensor, a therapy sensor, a chemical sensor, a light-emitting sensor, an acoustic sensor, an ultrasound sensor, an energy receiving and / or measuring sensor, a magnetic coil or sensor, and a thermoelectric element.

[0078] The at least one first interactive element on the first surface of the splines may be an electrode, optionally an ablation electrode. Therapy electrodes on the first inner surface of the splines can generate large ablation fields while also enabling increased efficiency in cooling and irrigation. The at least one second interactive element may be an electrode and / or a temperature sensor. Temperature sensors can indicate if good contact was made during ablation therapy, as well as providing feedback for high temperature events during radio-frequency or pulsed field ablation.

[0079] The at least one second interactive element may comprise one or more electrodes for contact assessment, one or more ablation electrodes, one or more mapping electrodes 17 SL 879690S.1and / or one or more electrodes for combined use. The at least one second interactive element may comprise one or more mapping electrodes and / or one or more electrodes for contact assessment. Therapy electrodes on the second outer surface of the splines can be used to direct energy at the tissue to be ablated. The surface area of mapping electrodes on the second outer surface of the splines may be smaller than the surface area of ablation electrodes on the second outer surface of the splines to minimize far field sensed electrical signals. Smaller size mapping electrodes can facilitate the creation of high-resolution maps. Each spline may include one or more mapping electrodes, one or more ablation electrode and / or one or more temperature sensor disposed on the outer surface of the splines. There may be any number of mapping electrodes in the expandable basket assembly ranging from any numbers between 6 to 64. There may be two mapping electrodes on each spline. Alternatively, there may be more than two mapping electrodes on each spline (e.g., 4, 6, 8, etc.).

[0080] A reference electrode may be included inside the expandable basket assembly. For example, a reference electrode may be positioned at the distal end of the first elongate member interior to the expandable basket assembly.

[0081] The plurality of first interactive elements can include a first group of electrodes, for example, ablation electrodes. The plurality7of second interactive elements can include a second group of electrodes, for example, mapping electrodes. The spatial relationships and orientation of the first group of electrodes and the spatial relationships and orientation of the electrodes in the second group of electrodes in relation to other electrodes on the same catheter is known or can be determined The spatial relationships and orientation of the electrodes in the first group of electrodes and the spatial relationships and orientation of the electrodes in the second group of electrodes in relation to other electrodes on the same catheter is constant, once the catheter is deployed. Electrodes may be grouped together in clusters or “cliques” (of three of four electrodes) to allow for measurement of multiple signals on the same plane. A “clique” may be a group of electrodes (e.g. three electrodes) in close proximity and offset at the vertices of a triangle. Cliques and clusters can be used to provide true voltage and real-time wavefront direction and speed independent of catheter orientation. This configuration satisfies the assumption of a locally plane and homogeneous propagation within the clique or cluster and can be used for “omnipolar” mapping.

[0082] The second interactive elements may comprise one or more mapping electrodes disposed proximal or distal to one or more ablation electrodes on the outer surface of the same splines. The first and second interactive elements may comprise one or more mapping 18 SL 879690S.1electrodes, disposed on different sides of the same splines. Different splines may comprise different first and / or second interactive elements. For example, the second interactive elements may comprise mapping electrodes on one spline and may comprise ablation electrodes on an adj acent spline. When the mapping electrodes and ablation electrodes are disposed on different or alternating splines, high voltage and low voltage electrical pathways can be kept separate and better insulated from each other and simplifies control.

[0083] Depending on manufacturing capabilities, cost, cunent densities, ability of the electrode material to withstand the current densities, spline width, various sizes of electrodes may be used in the catheter. For a catheter having an expandable basket assembly diameter of 3 mm (e.g., 9 French) with 56 electrodes on the second outer surface of the splines, the mapping electrodes may be approximately 0.56 mm in width and 0.5 mm in length and the ablation electrodes may be 0.56 mm in width and 0.95 mm in length. The electrodes may be spaced 0.163mm edge to edge. The dimensions of the mapping electrodes may be smaller or mid-size to provide higher mapping resolution. Alternatively, the dimensions of the mapping electrodes may be larger for diluting electric fields created when applying voltages. The dimensions of ablation electrodes may be large for large area ablations.

[0084] The plurality of first interactive elements comprises multiple different interactive elements. The plurality of second interactive elements comprises multiple different interactive elements. The plurality of second interactive elements may include at least one electrode and at least one temperature sensor.

[0085] The electrodes may comprise copper, silver, silver flake, gold, platinum, platinum black, platinum-iridium and combinations thereof. The electrode can include a biocompatible, low resistance metal. The electrode can include a material which is radiopaque. The at least one first interactive element on the inner surface of the splines may be a platinum foil ablation electrode. The interactive elements can be electrically connected (e.g., a plurality of electrical traces, wires, etc.) to a power supply, controller, an ablation generator, a localization / positioning system or other device used to, for example, delivery therapy, generate, amplify, receive, and / or process a signal.

[0086] The catheter may be configured to receive an ablative energy (e.g., PF A and / or RF energy) at the at least one ablation electrodes (first or second interactive element) and generate an electric field at the ablation electrodes. The electric field may have an electric field strength sufficient to ablate a target tissue via irreversible electroporation. The at least one first interactive element disposed on each spline can be configured to be activated 19 SL 879690S.1simultaneously to generate an electric field between the first interactive elements and a return patch. Using the catheter sufficient lesions may be generated at an applied voltage of 50 to 10,000V, for example 100V, 1,300V, 2,000 V or 2,500 V, even for a 25 mm diameter pulmonary vein. A voltage gradient of 400 to 600V / cm can be applied to cause cardiac cell death. Different electric fields may be suitable for different anatomical locations.

[0087] Each of the interactive elements may be selectively or independently energizable. Interactive elements (e.g. electrodes) can be selectively or independently switched on and off. Interactive elements can be selectively switched on and off based on a known position, diameter or size of the expandable basket assembly. Retraction of the first elongate member within the second elongate tubular member reduces the effective diameter and size of the expandable basket assembly and can cause any first and / or second interactive elements within the second elongate tubular member to be turned off. A switch can be used to turn off each interactive element. The switch may turn the interactive element off once a set impedance for the interactive element is measured. Alternatively, the switch may turn the interactive element off based on a known diameter of the basket assembly. Alternatively, and as discussed above, reduction of the effective diameter and size of the expandable basket assembly can cause any first and / or second interactive elements within the second elongate tubular member to be automatically turned off. Selectively energizing the electrodes can allow individual electrodes to act independently for mapping or ablation. Selectively energizing groups of electrodes can provide larger surface area coverage for mapping or ablation.

[0088] Each of the interactive elements may have a substantially flat upper surface. All components, i.e., splines, interactive elements, flexible circuits, interactive element elevation strips (used to raise the surface of the electrodes above the substrate, if desired), etc. may be thin, flat, planar elements. In a simple design, these elements may be stacked and adhesively bonded to each other. Alternately, the interactive elements and flexible circuits, may be arranged side-by-side or partly stacked, partly side-by-side.

[0089] Distal hub arrangement

[0090] Each spline distal end is coupled to the distal hub. The distal hub may comprise a flexible material for affixing the distal ends of the splines. The distal hub may comprise an elastomeric material for affixing the distal ends of the splines in a predetermined relationship at the distal hub. The distal hub may comprise an encapsulated and filament- 20 SL 879690S.1wrapped distal hub comprising an encapsulant and a filament for affixing the distal ends of the splines in a predetermined angular relationship at the distal hub. The distal hub and the plurality of flexible splines may be formed from a single piece of shape memory material, for example, nitinol. The distal hub allows radial movement, supporting expansion of the expandable basket assembly.

[0091] The distal hub may comprise a plurality of spline openings such that each of the splines can couple with the distal hub through one of the plurality of distal hub spline openings. The plurality of distal hub spline openings can be sized to accommodate a variety of spline sizes and / or to allow for the spline to move (e.g., pivot, slide, etc.) within the distal hub spline opening. Each of the splines may move within the spline opening, for example, during deployment of the expandable basket assembly and / or during retraction of the expandable basket assembly, during adjustment of the basket size / diameter, or at other suitable times during usage of the catheter.

[0092] The distal hub can have a diameter sized to fit within the second elongated tubular member. This can allow the expandable basket assembly to be deployed from the second elongated tubular member, for example, when the first elongate member is pushed forward out of the second elongated tubular member.

[0093] The splines may have a spline shape for increased contact between proximal portions of the spline and tissue. Each spline may have a proximal portion, distal portion and medial portion therebetween. Each of the plurality of splines can have a first spline shape, where the spline comprises one or more curved portions. The curved portions can have a different radii, especially at the distal portion of the splines and the proximal portion of the splines. The multiple radii for the curve portions can allow a portion of the spline, and therefore a portion of the interactive elements on the spline, to contact tissue first. The greater the amount of the distal spline portion and / or the proximal spline portion that is parallel to the tissue (i.e., flatter), the greater the amount of interactive elements that can contact the tissue.

[0094] When the expandable basket assembly is in the radially expanded non-cylindrical shape, the distal portions of the splines may comprise distal incurvate inwards bends and distal excurvate outward bends. When the expandable basket assembly is in the radially expanded non-cylindrical shape the proximal portions of the splines may comprise proximal recurves comprising proximal incurvate bends and proximal excurvate bends.

[0095] In the present disclosure, a distal bend is described as incurvate and / or inward because an apex is directed towards the interior of the expandable basket assembly. In the 21 SL 879690S.1present disclosure, a distal bend is described as excurvate and / or outward because an apex is directed away from the interior of the expandable basket assembly. Incurvate distal bends are useful in controlling angles from which the splines exit from or emerge into the distal hub, i.e., directed toward the exterior of the expandable basket assembly. Excurvate distal bends turn the splines back in a proximal direction towards the proximal end of the elongate tubular member. The distal curvature creates a distal M-shaped spline curve. An advantage of the M-shaped curve is that the distal hub is located closer towards the interior of the expandable basket assembly when the basket is deployed or is in its radially expanded state. This feature keeps the distal hub away from distal heart tissue as the distal spline portions may extend beyond the distal hub in the longitudinal direction of the expandable basket assembly.

[0096] The proximal recurves impart several important features to the expandable basket assembly. The proximal recurves allow for the geometry and flexibility of individual splines to vary7at the proximal end which allows the expandable basket assembly to become asymmetric and to better conform to the contours of cardiac structures (e.g., the right atrium). Further, the proximal recurves allow for better placement of interactive elements at the proximal atrial tissue. Furthermore, the flexibility and geometry of the proximal recurves also permit enhanced interactive element-tissue contact for the interactive elements placed not only on the proximal spline portions, but also on the medial spline portions and distal spline portions.

[0097] Further details of spline shapes and distal hub configurations may be found in WO2019 / 108664A2 “Controllable expandable catheter” filed on 28 November 2018 and US2019239767A1 “Basket sty le cardiac mapping catheter having an atraumatic, metallic two-part distal tip for detection of cardiac rhythm disorders” filed on 8 February 2019, the contents of which are incorporated herein by reference.

[0098] Other features

[0099] The first elongate member may be a tubular member comprising an irrigation fluid lumen. The first elongate member may comprise one or more irrigation ports. It may be advantageous to distribute irrigation fluid directly to the inner cavity of the expandable basket assembly to move heat away from the ablation electrodes. The second elongate tubular member may further comprise an irrigation fluid lumen. The second elongate tubular member may comprise one or more irrigation ports. The fluid lumen may run longitudinally from the proximal end of the second elongate tubular member to the distal 22 SL 879690S.1end of the second elongate tubular member where the one or more irrigation ports may be located. The irrigation fluid lumen of the first elongate member may be coincident with the lumen of the second elongate tubular member. For example, there may be a space between the outer surface of the first elongate member and the inner surface of the lumen of the second elongate tubular member, such that irrigation fluid is able to flow in this space.

[0100] The one or more irrigation ports may be positioned near electrodes located on the shaft of the second elongate tubular member. For example, one or more irrigation ports may be located adjacent to or near the one or more shaft electrodes discussed below. The irrigation fluid lumen may be configured to receive at least one of contrast agent, a mapping catheter, a guidewire, and a shape sensing fiber.

[0101] The first elongate member may comprise at least one magnetic position sensor, for example at the distal hub of the expandable basket assembly. At least one magnetic position sensor may be included in at least one of the plurality of flexible splines. The distal end of the first elongate member may comprise at least one magnetic position sensor. The second elongate tubular member may also comprise at least one magnetic position sensor, for example at the distal end of the second elongate tubular member. The magnetic position sensors can provide accurate positioning of the distal end of the catheter where it contacts the tissue.

[0102] The magnetic position sensors may include one or more of magnetic coils or solid-state magnetic position sensors (for example, MEMS magnetic sensors). The magnetic sensors can allow the catheter to be tracked in a localization and navigation system (e g., a magnetic-field based positioning system).

[0103] The first elongate member may comprise at least one electrode at or near the distal end of the first elongate member. The distal hub may comprise at least one electrode, for example a distal tip electrode. The distal tip electrode at the distal hub may be a radiofrequency electrode. A conductive element may be coupled to the electrode at the distal tip. The conductive element may form part of one or more of the flex circuits that are disposed on the plurality of flexible splines or on the one or more tubular polymeric members. Additionally, and / or alternatively, the conductive element may extend through the one or more tubular polymeric members to the distal hub. Additionally, and / or alternatively, the conductive element may extend through a deflection control member to the distal hub. Additionally, and / or alternatively, the conductive element may extend through a fluid lumen that extends out to the distal hub.

[0104] The second elongate tubular member may comprise at least one electrode at or near 23 SL 879690S.1the distal end of the second elongate tubular member (a shaft electrode). The at least one electrode at or near the distal end of the second elongate tubular member may be a ring electrode or a tip electrode. The shaft electrode may be configured to function as a return electrode. The shaft electrode may comprise a wrapped electrode that is helically wrapped around the catheter shaft. The shaft electrode may comprise a single elongated electrode. The shaft electrode (e.g., a return electrode) may be configured to be positioned within the patient and remote from the spline electrodes (e.g., lesion-generating electrodes). The catheter can be configured to apply energy between i) a spline electrode and ii) a return patch (configured to be positioned on the exterior of the patient) and the at least one return electrode to generate lesions proximate the spline electrode. Further details regarding intravascular return electrodes can be found in US 18 / 626.400 "‘SYSTEMS AND METHODS FOR ENERGY DELIVERY” filed on 4 April 2024 , the contents of which are incorporated herein by reference. The at least one electrode at or near the distal end of the second elongate tubular member may act as a position sensor and can allow the catheter to be tracked in a localization and navigation system (e.g., an electric-field based localization system). The at least one electrode at or near the distal end of the second elongate tubular member may additionally or alternatively act in concert with the interactive element assembly to produce an electric field. The at least one electrode at or near the distal end of the second elongate tubular member may be used for impedance calibration. The second elongate tubular member may comprise electrodes along its body. The body electrodes may be for impedance calibration. The body electrodes may act as return electrodes.

[0105] When electrodes on the inner surfaces of the splines are activated, the inner cavity of the expandable basket assembly may be held at a single voltage potential. The electric field of the expandable basket assembly may emanate outward.

[0106] The second elongate tubular member may comprise at least one temperature sensor at or near the distal end of the second elongate tubular member.

[0107] A number of mechanisms may be used to enable better visualisation of the catheter. At least one ultrasound device may be included in the catheter, e.g. on one or more of the plurality of splines for contact or lesion assessment. A spiral cut may be applied to the outer or inner surface of the tubular polymeric members to provide echoes for ultrasound. Alternatively or additionally, a platinum wire may be incorporated in each spline for visualisation under fluoroscopy.

[0108] In addition to the distal hub, further couplers or hubs may be included in the electrophysiology catheter. These couplers / hubs can be used to join subassemblies of the 24 SL 879690S.1catheter (e.g. expandable basket assembly, tubular polymeric members, etc.) to the first elongate member. The couplers / hubs may act as mounts for other components such as magnetic position sensors, temperature sensors, electrodes and the like. The couplers / hubs may be used as manifolds or contain irrigation ports for irrigation fluids.

[0109] The catheter may further comprise a handle coupled to the proximal end of the second elongate tubular member.

[0110] The catheter may further comprise a deflection control member coupled with the distal hub and extending through the inner lumen of the first elongate member. The deflection control member may be configured to allow shaping of the expandable basket assembly and distal hub. The distal hub could be pulled proximally to make a rounded distal tip of the basket assembly. The deflection control member may be configured to adjust a stiffness of the expandable basket assembly, from a first stiffness to a second stiffness, and maintain the first stiffness or the second stiffness. The deflection control member can have a deflection control member distal end that can be coupled with a portion of the expandable basket assembly (e.g., the distal hub) and a deflection control member proximal end that can be coupled with a control mechanism.

[0111] The handle may comprise a control mechanism, such as a selective movement limiter. The selective movement limiter may couple with the proximal end of the deflection control member to limit a longitudinal movement of the deflection control member. The deflection control member may be configured to move freely when the selective movement limiter is not coupled with the deflection control member.

[0112] The deflection control member may comprise one or more of a rigid material, a semi-rigid material, and a flexible material. The rigid material may comprise a polymer, the semi-rigid material may comprise a polymer, and the flexible material may comprise a metal or a polymer. A rigid or semi-rigid material is useful for stiffness control. A flexible material is useful for shaping.

[0113] The deflection control member can be used to support a desired shape / configuration of the expanded, deployed basket. For example, the deflection control member can provide support (i.e., rigidity, stiffness) to the expanded basket to maintain a specific deployed shape. For example, the deflection control member can provide support to the expanded basket to maintain the width (with respect to a longitudinal axis of the catheter) of a first deployed shape. Without the support of the deflection control member, the expanded basket can have a "softer" structure (i.e., reduced rigidity, more flexible) allowing the expanded basket to float with the rigidity of the expanded basket controlled by the stiffness of the 25 SL 879690S.1splines only. Adjustment of the deflection control member could allow additional deflection of the expanded basket as the splines and / or distal hub contact tissue (e.g., the distal hub could move more, allowing the spline distal ends and the spline proximal ends to have a greater range of motion, depending on the force exerted on the catheter and the material properties of the splines / basket).

[0114] When the deflection control member is not engaged / used the expanded basket can have a first stiffness profile and the expanded basket can have a second stiffness profile when the deflection control member is fully engaged and providing maximum support to the expanded basket. Additional variations in support provided by the deflection control member can allow for additional stiffness profiles of the basket (e.g., a third stiffness profile, a fourth stiffness profile, etc.). There can be clinical scenarios where a physician could use the rigidity at the low end (e.g., when the deflection control member is not being used to control the stiffness / rigidity of the expanded basket) allowing the expanded basket to be softer and less stiff / less rigid. This can allow for safer delivery / manoeuvrability of the expanded basket as a softer basket is easier to navigate and the basket is less likely to damage tissue (e.g., during a soft apposition with tissue). Once the expanded basket is positioned at a desired location, the stiffness of the expanded basket can be increased for a firmer / stiffer configuration to provide optimal surface contact between the splines and the tissue proximate the splines (e.g., optimal contact between interactive elements on the splines and the tissue).

[0115] Further mechanisms may be envisaged for deflection control, such as the use of a pressurized shaft (the first elongate member and / or the second elongate tubular member) or pressurized splines.

[0116] The selective movement limiter may comprise a first portion and a second portion, where the first portion is in a fixed position and the second portion is movable to engage with the deflection control member. Engagement can be by clamping the deflection control member with the first portion in order to limit the longitudinal movement of the deflection control member.

[0117] The selective movement limiter may comprise a first portion and a second portion, where the first portion and the second portion are movable to engage with the deflection control member. Engagement can be by clamping the deflection control member with the first portion in order to limit the longitudinal movement of the deflection control member.

[0118] The second elongate tubular member may have an inner lumen diameter of about 2.5 French (0.825 mm), about 4 French (1.32 mm), about 6 French (1.98 mm), about 8

[0119] 26 SL 879690S.1French, or between 2.5 French (0.825 mm) to 8.5 French (2.805 mm). The second elongate tubular member may be a 6 to 8.5 French (1.98 to 2.805mm inner diameter) tube, for example, 6 French (2.805 mm).

[0120] The catheter may further comprise at least one pull wire disposed longitudinally along the length of the second elongate tubular member. The second elongate tubular member may comprise at least one steering ring located at or near its distal end. The steering ring may be within a distal portion of the second elongate tubular member. The distal end of the at least one pull wire can be connected to the at least one steering ring. The steering ring located at the distal end of the second elongate tubular member advantageously enables maximum manoeuvrability of the catheter for all sizes / diameters of the expandable basket assembly.

[0121] The handle may comprise a steering mechanism. The proximal end of the at least one pull wire may be connected to the steering mechanism.

[0122] The pull wire may be a flat wire having a substantially rectangular cross-section. The pull wire may have a width of at least 0.178mm and a thickness of at least 0.076mm.

[0123] The handle may comprise a thread. The thread on the proximal end of the second elongate member may be configured to interface with the thread on the handle, in addition to, or alternatively to the thread on the first elongate member. The handle may comprise the detection mechanism, such as the detection mechanism discussed above. The detection mechanism may allow the position of the first elongate member to be measured.

[0124] Kit

[0125] According to a second aspect of the disclosure, there is provided a kit comprising the electrophysiolog)’ catheter according to the first aspect and an introducer catheter. The introducer catheter may comprise a tubular inner liner, a torque transfer layer surrounding at least a portion of the inner liner, and an outer sheath formed over the torque transfer layer. The electrophysiology catheter is configured to be received within the lumen of the tubular inner liner. The torque transfer layer may comprise at least two braided flat wires. The braided flat wires may be substantially rectangular in cross-section. The braided flat wires may have a width of at least 0.178mm and a thickness of at least 0.076mm. The tubular inner liner may have an inner lumen diameter of at least 6 French, for example 8.5 French.

[0126] 27 SL 879690S.1Single spline aspect

[0127] According to a third aspect of the disclosure, there is provided an electrophysiology catheter, comprising an elongate tubular member comprising a lumen, a proximal end and a distal end; an expandable structure with an expandable configuration and a collapsed configuration; at least one first interactive element and at least one second interactive element. The expandable structure comprises a single curved spline having a proximal end and a distal end, a proximal portion, a distal portion and a medial portion therebetween. The single curved spline comprises an outer convex surface, an inner concave surface and two side surfaces. The spline comprises a super-elastic material. The spline proximal end is coupled to the distal end of the first elongate member. The at least one first interactive element is distributed on the inner concave surface of the curved flexible spline and the at least one second interactive element is distributed on the outer convex surface of the curved flexible spline.

[0128] When the spline is in the collapsed configuration it can be configured to fit inside an elongated medical device. The curved spline may be a smooth curve. The curved spline may be shaped like a section of an ellipse or circle. Alternatively, the curved spline may be a non-uniform curve. For example, the radius of curvature of the curved spline may vary along its length to create a non-uniform curve. The curvature at the distal and proximal ends of the curved spline may be independently adjusted. That is, the curvature of each of the proximal portion, medial portion and distal portion of the curved spline may be the same or different.

[0129] The length of the line segment of the expanded curved spline measured from the distal tip of the curved spline to the distal tip of the elongate tubular member (the segment length, the arc length, etc.) may be 10 to 60mm, 20 to 40mm. 30 to 40mm. or 20mm. The maximum radius of curvature of the expanded curved spline may be 5 to 20mm, 10 to 20mm, 10 to 15mm, or 15mm.

[0130] The angle that the proximal portion of the curved spline makes with a longitudinal axis of the elongate tubular member may be 30 to 60 degrees, 30 to 50 degrees. 30 to 45 degrees, or 45 degrees, or an angle within a range defined by any two of the foregoing values. These dimensions are non-limiting and other dimensions may suitably be used. The distal tip of the curved spline may align with the longitudinal axis of the elongate tubular member. Alternatively, the distal tip of the curved spline may be offset from the longitudinal axis of the elongate tubular member. For example, the distal tip of the curved spline may extend beyond the longitudinal axis of the elongate tubular member (an 28 SL 879690S.1“enhanced linear” configuration). The distal tip of the curved spline may extend around 0 to 5 mm beyond the longitudinal axis of the elongate tubular member. The distal tip extending beyond the longitudinal axis may facilitate head-on tissue apposition (i.e. head-on lesion creation).

[0131] The proximal portion, distal portion and medial portion of the spline can each comprise interactive elements that can be selectively energized.

[0132] The proximal end of the spline may be rotatably coupled to the distal end of the first elongate member. The single curved spline may be rotated in situ to contact a large area of tissue. Alternatively, the single curved spline may be held in a fixed position and ablation therapy delivered in a single ablation line.

[0133] A deflection control member may be included. The deflection control member may be coupled with the distal end of the curved spline and extend through the inner lumen of the first elongate member, wherein the deflection control member may be configured to adjust a stiffness of the curved spline, from a first stiffness to a second stiffness, and maintain the first stiffness or the second stiffness. The handle may comprise a selective movement limiter, wherein the selective movement limiter couples with the deflection control member to limit a longitudinal movement of the deflection control member, wherein the deflection control member is configured to move freely when the selective movement limiter is not coupled with the deflection control member.

[0134] The spline may comprise any material suitable for the splines discussed for the first aspect of the disclosure. At least one of the first interactive elements may be formed by depositing a material on the inner concave surface of the spline, and / or wherein at least one of the second interactive elements may be formed by depositing a material on the outer convex surface of the spline. The catheter may further comprise a plurality of electrical traces disposed on the spline, each of the plurality of electrical traces coupled with a respective one of the first or second interactive elements; and a dielectric material disposed between each of the plurality of electrical traces and the spline.

[0135] The single spline may further comprise a polymer substrate, a conductive layer, and an adhesive layer.

[0136] The single spline aspect may further comprise a first flexible circuit and / or a second flexible circuit. The first flexible circuit may comprise: a polymeric substrate having an upper surface and an opposed lower surface, wherein the at least one first interactive element is disposed over at least part of the upper surface of the polymeric substrate; and one or more electrical traces disposed over at least a portion of the lower surface of the 29 SL 879690S.1polymeric substrate or over at least a portion of the upper surface of the polymeric substrate, the one or more electrical traces being in electrical communication with the at least one first interactive elements. The second flexible circuit may comprise: a polymeric substrate having an upper surface and an opposed lower surface, wherein the at least one second interactive element is disposed over at least part of the upper surface of the polymeric substrate; and one or more electrical traces disposed over at least a portion of the lower surface of the polymeric substrate or over at least a portion of the upper surface of the polymeric substrate, the one or more electrical traces being in electrical communication with the at least one second interactive elements.

[0137] The lower surface of the polymeric substrate of the first flexible circuit may be adhesively and / or thermally bonded to the inner concave surface of the spline. The lower surface of the polymeric substrate of the second flexible circuit may be adhesively and / or thermally bonded to the outer convex surface of the spline.

[0138] The one or more electrical traces may be disposed over at least a portion of the lower surface of the polymeric substrate and further comprise vias to provide said electrical communication between the one or more electrical traces and the at least one first interactive elements. At least one polymeric member may be included. The polymeric member may be disposed between the lower surface of the polymeric substrate and the flexible spline. The polymeric member may be adhesively and / or thermally secured to the first surface of the spline.

[0139] The one or more electrical traces may be disposed over at least a portion of the upper surface of the polymeric substrate. A polymeric covering may be included over the upper surface of the polymeric substrate. The electrical traces with the one or more first / second interactive elements may be substantially free of the polymeric covering.

[0140] The expandable structure may further comprise a tubular polymeric member. The tubular polymeric member having a first open end and an opposed second open end defining an open lumen therein between, the tubular polymeric member comprising an inner member surface and an outer member surface. The spline may be at least partially disposed within the lumen of the tubular polymeric member.

[0141] The lower surface of the polymeric substrate of the first flexible circuit may be secured to a first portion of the outer member surface of the tubular polymeric member. The lower surface of the polymeric substrate of the second flexible circuit may be secured to a second portion of the outer member surface of the tubular polymeric member.

[0142] The one or more first interactive elements and the one or more second interactive 30 SL 879690S.1elements may be selected from any of the above-mentioned interactive elements described for the first aspect of the disclosure.

[0143] The elongate tubular member may further include an irrigation fluid lumen. The elongate tubular member may include one or more irrigation ports.

[0144] Other features may be included in the third aspect of the disclosure, such as magnetic position sensors, additional electrodes, temperature sensors, pull wires and steering mechanisms, as described above for the first and second aspects of the disclosure.

[0145] Mapping and ablation expandable assembly aspect

[0146] According to a fourth aspect of the disclosure, there is provided an electrophysiology catheter comprising: a first elongate member comprising a proximal end, an inner lumen and a distal end; an expandable assembly comprising; a plurality of flexible splines, wherein each spline comprises a respective spline proximal end and a spline distal end, wherein each spline comprises Nitinol, wherein each spline proximal end is coupled to the distal end of the first elongate member; wherein the assembly has a radially expanded non-cylindrical shape when deployed; and an interactive element assembly comprising a plurality of interactive elements. Each spline comprises a first surface and a second surface, wherein the first surface of the splines comprises an inner surface and the second surface of the splines comprises an outer surface, wherein the inner spline surface faces the interior of the expandable assembly and the outer spline surface faces the exterior of the expandable assembly when the expandable assembly is in an undeployed configuration. The Nitinol of the entire first surface of each of the plurality of flexible splines is configured to form a first interactive element of the plurality of interactive elements and wherein a plurality of second interactive elements are distributed on the second surface of each of the plurality of flexible splines.

[0147] The expandable assembly is firm but flexible for stability on tissue contact.

[0148] Splines

[0149] The proximal ends of the plurality of splines of the expandable assembly are coupled to the distal end of the first elongate member at one end, i.e. the proximal end, of the expandable assembly. Coupling may be direct or indirect. The spline distal ends are not connected to the first elongate member.

[0150] The distal ends of the plurality of splines may be free (i.e. not tethered or coupled to another component). The plurality' of splines may align along the first elongate member 31 SL 879690S.1in an undeployed configuration and fold out (e.g. like an umbrella) from the undeployed to the deployed configuration. In a deployed, expanded configuration, the splines of the expanded assembly may form an array with the splines pointing radially out from a longitudinal axis of the first elongate member (an expanded radial array). The radial array may be a planar array, wherein the plane may be disposed at 80 to 130 degrees to the longitudinal axis of the first elongate member in a deployed, expanded configuration. Each of the plurality of splines may form an angle of 80 to 130 degrees, approximately a 90 degree angle with the longitudinal axis of the first elongate member, in the deployed, expanded configuration. The inner spline surface is a non-tissue contacting surface in the deployed, radially expanded array. The outer spline surface contacts the tissue in the deployed, radially expanded array.

[0151] The expandable assembly may comprise a single piece of nitinol forming the plurality of flexible splines. That is, the plurality of flexible splines may be made from a single piece of nitinol (e.g., cut from, stamped from, etc.). The plurality of flexible splines may form a single continuous entity.

[0152] The splines of the expandable assembly may instead be coupled to the distal end of the first elongate member at one end, i.e. the proximal end, of the expandable assembly and also be coupled to each other or to a distal hub of the expandable assembly at an opposed end, i.e. the distal end. of the expandable assembly. This forms the expandable assembly into an expandable basket assembly. The inner spline surface faces the interior of the expandable basket assembly and the outer spline surface faces the exterior of the expandable basket assembly when the expandable basket assembly is in a deployed radially expanded configuration.

[0153] When electrodes on the inner surfaces of the splines of the expandable basket assembly are activated, the inner cavity of the expandable basket assembly is held at a single voltage potential. The electric field of the expandable basket assembly emanates outward.

[0154] The expandable basket assembly may comprise a single piece of nitinol forming the distal hub and the plurality of flexible splines. That is, the distal hub and plurality of flexible splines may be made from a single piece of nitinol. The distal hub and plurality of flexible splines may form a single continuous entity7. Alternatively, the distal hub and plurality of flexible splines may each be individually fabricated and the coupling of the spline distal end with the distal hub may comprise j oining the spline distal end to the distal hub.

[0155] Each spline proximal end is coupled to the distal end of the first elongate member.

[0156] 32 SL 879690S.1Coupling may be via an anchor for securably affixing the proximal end of the spline. The anchor may be securably affixed to the body of the elongate tubular member and / or within the lumen of the first elongate member at the distal end of the elongate tubular member.

[0157] The expandable assembly is deliverable through and into bodily organs, such as but not limited to the heart. In preparation for insertion of the catheter, the expandable assembly is compressed to fit within a lumen of an insertion device (which may include a delivery catheter or second elongate tubular member).

[0158] The expandable assembly is deliverable through and past the distal end of the lumen of the insertion device. The expandable assembly expands as it exits the distal end of the insertion device. The nitinol causes each of the splines to bow outwardly into the expanded radially-spaced array or expanded basket. The nitinol provides stability for the expandable assembly, such that splines assume an expanded shape when not subjected to any external forces or biases. The nitinol can allow the expanded assembly to hold its expanded shape during mapping and therapy use. The expanded shape may be a radially expanded shape. The overall shape of the expanded assembly may be an expanded, non-cylindrical shape. The expanded assembly can include symmetric and asymmetric shapes. In particular, spline portions near the distal hub and / or spline portions near the distal end of the first elongate member may assume an asymmetric shape. Such an asymmetric shape may be useful, if desired, to concentrate a greater number of splines at a particular location within the body, for example the right atrium of the heart. The expanded splines in the expanded basket assembly may be in a spherical or somewhat spherical orientation, optionally symmetric in shape. Alternatively, the expanded splines in the expanded basket assembly may assume a non-spherical or substantially non-spherical shape, preferably asymmetric.

[0159] Each spline may further comprise two side surfaces. The first side surface and / or the second side surface of the spline may be substantially flat. The substantially flat first and second side surfaces may be parallel to one another. The two side surfaces of the spline may be convexly rounded surfaces. The cross-sectional profile of the spline may be a rounded rectangular shape. Alternatively, the first side surface and / or the second side surface of the spline may be rounded or otherwise have curvature, including concave and / or convex curvatures.

[0160] The catheter may comprise a second expandable basket assembly surrounding the first expandable basket assembly. The expandable basket assembly may be a first expandable basket assembly, and the plurality of second interactive elements distributed on the second surface of each of the plurality of flexible splines of the first expandable basket 33 SL 879690S.1assembly consist of thenitinol of the entire second surface of the plurality of flexible splines such that the whole of the first expandable basket assembly forms the interactive element assembly. The second expandable basket assembly may comprise: a second distal hub; a second plurality of flexible splines, wherein each spline comprises a respective spline proximal end and a spline distal end, wherein each spline comprises Nitinol, wherein each spline proximal end is coupled to the distal end of the first elongate member, and wherein each spline distal end is coupled to the first distal hub; wherein the second basket assembly has a radially expanded non-cylindrical shape when deployed; and a second interactive element assembly comprising a plurality of interactive elements. Each spline of the second plurality of flexible splines may comprise a first surface and a second surface, wherein the first surface of the splines comprises an inner surface and the second surface of the splines comprises an outer surface, wherein the inner spline surface faces the interior of the second expandable basket assembly and the outer spline surface faces the exterior of the second expandable basket assembly, and wherein the plurality of interactive elements of the second interactive element assembly are distributed on the second surface of each of the second plurality of flexible splines of the second expandable basket assembly. The inner spline surface of the splines of the second expandable basket assembly faces the exterior of the first expandable basket assembly.

[0161] The first expandable basket assembly may be coupled to the second expandable basket assembly. Specifically, the distal hub of the first expandable basket assembly may be coupled to the distal hub of the second expandable basket assembly. The outer diameter of the first radially expandable basket assembly can be 8 to 9mm. The outer diameter of the second radially expandable basket assembly can be 10 to 11mm. The first expandable basket assembly may provide ablation energy. The plurality of interactive elements (e.g. electrodes) of the second expandable basket assembly may be used for mapping. The second interactive element assembly of the second expandable basket assembly may comprise flexible circuits as discussed in detail below.

[0162] The expandable basket assembly of the fourth aspect of the present disclosure may have any useful number of splines. For example, the expandable basket assembly may comprise 2 to 16 splines, 2 to 12 splines, 3 to 8 splines, preferably 7 or 8 splines. Where a second expandable basket assembly is included, the total number of splines may be 6 to 16 splines, preferably 14 splines (the first expandable basket assembly may include 3 to 7 splines and the second expandable basket assembly may include 3 to 7 splines).

[0163] The splines may be about 0.33 mm to about 0.90 mm wide, preferably 0.33 mm to 34 SL 879690S.1about 0.64 mm wide, and about 0.05 mm to about 0.32 mm thick, preferably about 0.05 mm to about 0.254 mm thick. A preferred width is about 0.55mm. Preferred spline thickness may be 0.05mm, 0.08mm, 0.10mm or 0.15mm. The spline thickness, along with placement of electrodes on the elongate tubular member, can be used to vary the flexibility of the catheter. A smaller thickness contributes to increased flexibility. These dimensions are non-limiting and other dimensions may suitably be used.

[0164] Interactive element assembly configuration

[0165] Various therapies can be delivered by the catheter to tissue with varied shapes and sizes. To better accommodate variations in tissue configurations and to provide sufficient contact with the tissue for therapy, interactive elements are formed by or coupled with the flexible splines. The interactive elements can be used to map the tissue and / or provide therapy, such as ablation therapy.

[0166] The interactive element assembly comprises a plurality of interactive elements distributed on the plurality of flexible splines. The term “distributed on” encompasses disposing an interactive element directly onto a surface of a spline, or disposing the interactive element indirectly onto a surface of the spline, for example, disposing the interactive element onto a substrate which is itself disposed onto a surface of the spline or disposing the interactive element onto a tubular polymeric member (surrounding the spline), or forming the interactive element from the spline itself.

[0167] The Nitinol of the splines is configured to form at least one first interactive element distributed on a first surface of each of the plurality of flexible splines That is, the entirety of the first, inner surface of each spline (of the first expandable basket assembly) serves as an interactive element (e.g. an electrode). The Nitinol of the splines can be configured to delivery ablation therapy.

[0168] Each spline may further comprise an insulating material covering at least a portion of the first and / or second surface of the spline. At least one non-insulated (exposed) portion of the nitinol spline may correspond to an interactive element (e g. an electrode). In particular, the first, inner surface of the spline may comprise an insulating material exposing portions of the nitinol, wherein at least one exposed portion of the inner surface of the nitinol spline corresponds to a first interactive element. The second, outer surface of the spline may comprise an insulating material exposing portions of the nitinol, wherein at least one exposed portion of the inner surface of the nitinol spline corresponds to a second interactive element. The exposed nitinol interactive elements can be configured to generate 35 SL 879690S.1an electric field proximate to target tissue to deliver ablation therapy.

[0169] The insulating material may be selected from one or more of a polyethylene terephthalate (PET) heat shrink material, polyurethane, nylon, parylene, a polyimide (e.g., PI-2771 or HD-4004 available from HD Microsystems, or KAPTON available from DuPont), a polyether block amide (such as Pebax®), and / or an epoxy (e.g., SU8 epoxy available from Mi croChem Corp) covering at least a portion of the first surface and / or second surface of the spline. The insulating material may be selected from polyurethane, nylon and a polyether block amide; in some cases, the insulating material is a polyether block amide.

[0170] At least one of the plurality of second interactive elements may be formed by depositing a material on a second surface of each of the plurality of flexible splines. The interactive element assembly may further comprise a plurality’ of electrical traces disposed on the second surface of each of plurality’ of flexible splines, each of the plurality’ of electrical traces coupled with a respective one of the second interactive elements and a dielectric material disposed between each of the plurality’ of electrical traces and the second surface of each of flexible splines. An adhesive layer may also be included.

[0171] The dielectric material can be applied to the flexible splines to coat the splines in the dielectric material to provide an electrically insulative layer, upon which patterned electrical traces can be disposed. Examples of the dielectric material can include a polyethylene terephthalate (PET) heat shrink material, polyurethane, nylon, parylene, a polyimide (e.g., PI-2771 or HD-4004 available from HD Microsystems, or KAPTON available from DuPont), a poly ether block amide (such as Pebax®), and / or an epoxy (e.g., SU8 epoxy available from Mi croChem Corp) covering at least a portion of the first surface and / or second surface of the spline. The dielectric material may be selected from polyurethane, nylon and a polyether block amide; in some cases, the dielectric material is a poly ether block amide. The dielectric material can electrically insulate the electrical traces from the electrically conductive material of the splines.

[0172] An additional layer of dielectric material can be deposited over the initial layer of dielectric material and over the electrical traces. The additional layer of dielectric material can insulate multiple interactive elements (e.g. electrodes) from one another.

[0173] Each spline of the plurality’ of splines may comprise additional layers of at least one of a polymer substrate, a conductive layer, and / or an adhesive layer. The polymer substrate, conductive layer, and adhesive layer may be stacked to provide a high electrode count on the limited width available.

[0174] 36 SL 879690S.1The interactive element assembly may comprise at least one flexible circuit. The interactive element assembly may comprise at least one first flexible circuit and / or at least one second flexible circuit. The at least one first flexible circuit may be deposited on the first surface (facing the interior of the expandable assembly) of each of the plurality of flexible splines. The at least one second flexible circuit may be deposited on the second surface (facing the exterior of the expandable assembly) of each of the plurality of flexible splines. As discussed in more detail below, the at least one flexible circuit may be configured to wrap around the spline, such that a portion of the flexible circuit is distributed on a first surface of each of the plurality of flexible splines and a portion of the flexible circuit is distributed on a second surface of each of the plurality of flexible splines.

[0175] Each flexible circuit comprises a polymeric substrate having an upper surface and an opposed lower surface, at least one interactive element disposed over at least part of the upper surface of the polymeric substrate, and one or more electrical traces. The electrical traces can be disposed over at least a portion of the lower surface of the polymeric substrate. In addition and / or alternatively, the electrical traces can be disposed over at least a portion of the upper surface of the polymeric substrate. In addition and / or alternatively, the electrical traces can be embedded within the polymeric substrate. The one or more electrical traces are in electrical communication with the interactive elements.

[0176] The electrical traces may be formed from a conductive material. The electrical traces may include one or more layers of any suitable conductive metal, including copper, a noble metal (e.g., gold, platinum, iridium), titanium and / or nickel. The electrical traces may include a copper layer with a gold layer on top to protect it from corrosion. The electrical traces may include a nickel layer in between copper and gold layers to retard the diffusion of the copper into the gold, thus reducing the corrosion protection offered by the gold. The electrical traces may include metal oxide layers. For example, the electrical traces may include a layer of platinum or iridium, which are subsequently oxidized to form platinum / iridium oxide to improve mapping performance. The conductive traces may include doped polymers (“stretchy” conductors), such as gold embedded within a liquid crystal polymer or polymers doped with copper nanowires.

[0177] The flexible circuit polymeric substrate may comprise an insulating material, such as a dielectric material. The polymeric substrate may be selected from one or more of a polyethylene terephthalate (PET) heat shrink material, polyurethane, nylon, parylene, a polyimide (e.g., PI-2771 or FID-4004 available from HD Microsystems, or KAPTON available from DuPont), a poly ether block amide (such as Pebax®), and / or an epoxy (e.g.,

[0178] 37 SL 879690S.1SU8 epoxy available from Mi croChem Corp) covering at least a portion of the first surface and / or second surface of the spline. The insulating material is selected from polyurethane, nylon and a polyether block amide; in some cases, the insulating material is a polyether block amide.

[0179] Each flexible circuit may include polyimide or liquid crystal polymer (LCP) to tolerate soldering temperatures. The flexible circuit may include glass. The flexible circuit may include other polymers employed along with low temperature interconnect methods (e.g., solder jetting).

[0180] The one or more electrical traces can be disposed over at least a portion of the lower surface of the polymeric substrate. Each flexible circuit may further comprise vias to provide electrical communication between the one or more electrical traces and the at least one first / second interactive elements. Alternatively, metal plated holes may be used to provide electrical communication between the one or more electrical traces and the at least one first / second interactive elements. A polymeric layer may be disposed between the lower surface of the polymeric substrate and the flexible spline, such as to provide electrical insulation between the traces and the spline. The polymeric layer may be adhesively and / or thermally secured to the surface of each of the plurality of flexible splines. Alternatively, the polymeric layer may be adhesively and / or thermally secured to an outer member surface of the polymeric tubular member. The polymeric layer provides an extra layer of insulation.

[0181] The one or more electrical traces can be disposed on at least a portion of the upper surface of the polymeric substrate. Each flexible circuit may further comprise a polymeric covering over the upper surface of the polymeric substrate and the electrical traces with the interactive element being substantially free of the polymeric covering. The polymeric covering may be bonded to the polymeric substrate with the use of suitable adhesive, usually acrylic adhesive. The upper flexible circuit surface may be substantially flat, i.e., the polymeric covering and the interactive elements being substantially the same height. Alternatively, the interactive elements may be raised slightly above the polymeric substrate surface. The interactive elements may be raised with the use, for example, of strips of material disposed between the polymeric substrate and the interactive elements. Alternatively, the interactive elements may be depressed slightly below the polymeric substrate surface. The polymeric covering may comprise a similar material as the polymeric substrate, but different materials may suitably be used.

[0182] The lower surface of the polymeric substrate of the flexible circuit may be adhesively and / or thermally bonded to a surface of each spline. The lower surface of the 38 SL 879690S.1polymeric substrate of the first flexible circuit may be adhesively and / or thermally bonded to the first surface of each spline. The lower surface of the polymeric substrate of the second flexible circuit may be adhesively and / or thermally bonded to the second surface of each spline. Alternatively, the lower surface of the polymeric substrate of the first and / or second flexible circuit may be adhesively and / or thermally secured to an outer member surface of the polymeric tubular member.

[0183] For example, each flexible circuit may include an adhesive layer. The adhesive layer may include polyurethane, cyanoacrylate, polyvinyl acetate, acrylic, polyimide, epoxy, hot melt or fluoropolymer adhesives. Alternatively, each flexible circuit may not include an adhesive layer. Thermal bonding may include the application of heat and / or compressive pressure to the layers.

[0184] Where the expandable assembly forms a shape with the splines pointing radially outwards from the first elongate member, the polymeric substrate of the flexible circuit may extend between each of the plurality of splines. That is, the polymeric substrate may¬ be circular in shape, disposed over the first surface of each spline, as well as extending therebetween. Additionally or alternatively, the polymeric substrate may be circular in shape, disposed over the second surface of each spline, as well as extending therebetween. One or more additional electrodes may be disposed over a part of the surface of the polymeric substrate, corresponding to the part of the substrate between the splines.

[0185] At least a portion of the first and second flexible circuits may extend into a lumen of the first elongate member.

[0186] The flexible circuit may comprise wings. The wings may be configured to secure the flexible circuit to the flexible splines. That is, the wings may wrap around the spline, such that a portion of the flexible circuit is distributed on a first surface of each of the plurality of flexible splines and a portion of the flexible circuit is distributed on a second surface of each of the plurality of flexible splines. The wings may7be useful in securing the flexible circuit to flexible splines, especially where it is desirable to keep the interactive elements as substantially unidirectional flat interactive elements.

[0187] Alternatively, the wings may protrude from each of the plurality of flexible splines. The wings may be configured to provide larger surface area interactive elements, for example, the wings may provide a larger surface area as compared to the width of the flexible splines.

[0188] The flexible circuit may have a thickness from about 0.025mm to about 0.254mm, preferably from about 0.051mm to about 0.102mm preferably from about 0.127mm to 39 SL 879690S.1about 0.203mm.

[0189] In an alternative arrangement to the plurality of flexible splines, the expandable basket assembly may comprise a braided or mesh basket. The braided or mesh basket comprises a plurality of interconnected flexible nitinol struts which function in the same manner as the flexible splines herein discussed. That is, the interconnected nitinol struts of the braided or mesh basket have a first and a second surface, wherein the first surface may comprise an inner surface and may be configured to form a first interactive element. The second surface may comprise an outer surface and the plurality of second interactive elements are distributed on the second surface of each of the plurality of flexible nitinol struts. The mesh basket may be made of a single piece of material with interconnections between struts, or may be made from individual struts coupled together (e.g. adhesively or thermally bonded) to form the interconnections between struts.

[0190] Alternatively, and / or additionally, the expandable basket assembly may include an inflatable balloon internal to the expandable basket. The inflated balloon may abut the splines of the expandable basket assembly and can stabilise the expandable basket assembly. The balloon may be retractable into an inner lumen of the first elongate member. The balloon may be patterned with conductive material, for example using a plating process. A balloon comprising a conductive material may be configured as an electrode, preferably an ablation electrode.

[0191] Type and number of interactive elements

[0192] Multiple independently energizable interactive elements may be attached to each spline. The interactive element assembly may comprise any number of interactive elements, for example 8 to 72 interactive elements, 28 interactive elements, etc. Each one of the plurality of splines may comprise 1 to 16 first interactive elements, such as 7 first interactive elements, one first interactive element, etc. Where the expandable basket assembly comprises a single piece of nitinol, or where the first interactive elements on the inner surface of each spline are configured to energise together (“ganged” together), the interactive element assembly may comprise a single first interactive element.

[0193] Each one of the plurality of splines may comprise 1 to 28 second interactive elements, such as 4 second interactive elements. That is, 4 second interactive elements may be placed on the outer surface of each of the seven flexible splines.

[0194] The plurality of second interactive elements may be equally distributed on each of the plurality of splines. Alternatively, the plurality of second interactive elements may be 40 SL 879690S.1unequally spaced on each of the plurality of splines. The plurality of second interactive elements may be distributed in a side-by-side array on the second surface of each of the plurality of splines.

[0195] The plurality of interactive elements may be selected from one or more of an electrode, an energy delivery element, a temperature sensor (e.g. a thermocouple), a force sensor, a strain gauge, a strain sensor, a position sensor, a biosensor, a diagnostic sensor, a therapy sensor, a chemical sensor, a light-emitting sensor, an acoustic sensor, an ultrasound sensor, an energy receiving and / or measuring sensor, a magnetic coil or sensor, and a thermoelectric element.

[0196] The at least one first interactive element on the first surface of the splines may be an electrode, optionally an ablation or therapy electrode. Therapy electrodes on the first inner surface of the splines can generate large ablation fields while also enabling increased efficiency in cooling and irrigation. The at least one second interactive element may be an electrode and / or a temperature sensor. Temperature sensors can indicate if good contact was made during ablation therapy, as well as providing feedback for high temperature events during radio-frequency or pulsed field ablation.

[0197] The at least one second interactive element may comprise one or more electrodes for contact assessment, one or more ablation electrodes, one or more mapping electrodes, and / or one or more electrodes for combined use. The at least one second interactive element may comprise one or more mapping electrodes and / or one or more electrodes for contact assessment. Therapy electrodes on the second outer surface of the splines can be used to direct energy' at the tissue to be ablated. The surface area of mapping electrodes on the second outer surface of the splines may be smaller than the surface area of ablation electrodes on the second outer surface of the splines to minimize far field sensed electrical signals. Smaller size mapping electrodes can facilitate the creation of high-resolution maps. Each spline may include one or more mapping electrodes, one or more ablation electrodes and / or one or more temperature sensors disposed on the outer surface of the splines. There may be any number of mapping electrodes in the expandable basket assembly ranging from any numbers between 6 to 64. There may be four mapping electrodes on the outer surface of each spline. Alternatively, there may be two or more mapping electrodes on each spline (e.g., 4, 6, 8, etc.).

[0198] Ablation energy' delivery may be from the first interactive element of each of the splines, i.e. from the Nitinol of the entire first (inner) surface of each of the plurality of flexible splines. In addition, energy delivery may be from the exposed sides of the struts 41 SL 879690S.1and / or exposed portions of the second surface of the splines forming second interactive elements. Alternatively, ablation energy may be delivered from the electrodes as part of the flexible circuits on the second surface of each of the plurality of flexible splines or exposed portions of the second surface of the splines forming second interactive elements.

[0199] All the second interactive elements on the second surface of the splines may be configured for mapping purposes. Alternatively, the second interactive elements on the second surface of the splines may be configured for different purposes, for example, there may be ablation electrodes and mapping electrodes as well as other interactive elements such as temperature sensors etc. The electrodes may be of different sizes. Larger electrodes may be configured for ablation (e.g. large area lesion creation). Smaller electrodes may be configured for mapping (e.g. high-density mapping) or may be ganged together for ablation.

[0200] The spatial relationships and orientation of the electrodes of the second interactive elements in relation to other electrodes on the same catheter is constant, once the catheter is deployed. Electrodes may be grouped together in clusters or “cliques" (of three of four electrodes) to allow for measurement of multiple signals on the same plane. A "clique” may be a group of electrodes (e.g. three electrodes) in close proximity and offset at the vertices of a triangle. Cliques and clusters can be used to provide true voltage and real-time wavefront direction and speed independent of catheter orientation. This configuration satisfies the assumption of a locally plane and homogeneous propagation within the clique or cluster and can be used for “omnipolar” mapping.

[0201] A reference electrode may be included within the expandable basket assembly. For example, a reference electrode may be positioned at the distal end of the first elongate member interior to the expandable basket assembly when in the undeployed configuration.

[0202] Depending on manufacturing capabilities, cost, cunent densities, ability of the electrode material to withstand the current densities, and spline width, various sizes of electrodes may be used in the catheter. For a catheter having a basket assembly diameter with 56 electrodes on the second outer surface of the splines, the mapping electrodes may be approximately 0.56 mm in width and 0.5 mm in length and the ablation electrodes may be 0.56 mm in width and 0.95 mm in length. The electrodes may be spaced 0.163 mm edge to edge. The dimensions of the mapping electrodes may be smaller or mid-size to provide higher mapping resolution. Alternatively, the dimensions of the mapping electrodes may be larger for diluting electric fields created when applying voltages. The dimensions of ablation electrodes may be large for large area ablations.

[0203] 42 SL 879690S.1The electrodes which comprise the second interactive elements may include copper, silver, silver flake, gold, platinum, platinum black, platinum-iridium and combinations thereof. The electrode can include a biocompatible, low resistance metal. The electrode can include a material which is radiopaque.

[0204] The interactive elements can be electrically connected (e.g., a plurality of electrical traces, wires, etc.) to a power supply, controller, an ablation generator, a positionmg / localization system or other device used to, for example, delivery therapy, generate, amplify, receive, and / or process a signal.

[0205] The catheter may be configured to receive an ablative energy (e.g., PFA and / or RF energy) at the at least one ablation electrodes (first or second interactive element) and generate an electric field at the ablation electrodes. The electric field may have an electric field strength sufficient to ablate a target tissue via irreversible electroporation. The at least one first interactive element disposed on each spline can be configured to be activated simultaneously to generate an electric field between the first interactive elements and a return patch. Using the catheter sufficient lesions may be generated at an applied voltage of 50 to 10,000 V. for example 100 V. 1.300 V. 2.000 V or 2,500 V. even for a 25 mm diameter pulmonary vein. A voltage gradient of 400 to 600 V / cm can be applied to cause cardiac cell death. Different electric fields may be suitable for different anatomical locations.

[0206] Each of the interactive elements may be selectively or independently energizable. Interactive elements (e.g. electrodes) can be selectively or independently switched on and off. Selectively energizing the electrodes can allow individual electrodes to act independently for mapping or ablation. Selectively energizing groups of electrodes can provide larger surface area coverage for mapping or ablation.

[0207] Each of the interactive elements may have a substantially flat upper surface.

[0208] Other features

[0209] The first elongate member may be a tubular member comprising an irrigation fluid lumen. The first elongate member may comprise one or more irrigation ports. It may be advantageous to distribute irrigation fluid directly to the inner cavity of the expandable basket assembly to move heat away from the ablation electrodes.

[0210] The one or more irrigation ports may be positioned near electrodes located on the shaft of the first elongate member. For example, one or more irrigation ports may be located adjacent to or near the one or more shaft electrodes discussed below. The irrigation fluid 43 SL 879690S.1lumen may be configured to receive at least one of contrast agent, a mapping catheter, a guidewire, and a shape sensing fiber.

[0211] A localization and navigation system may be provided for visualization, mapping and navigation of internal body structures. Features of this system are discussed above.

[0212] The first elongate member may comprise at least one magnetic position sensor, such as at the distal end of the first elongate member. The distal hub of the expandable basket assembly may comprise at least one magnetic position sensor. At least one magnetic position sensor may be included in at least one of the plurality of flexible splines. The magnetic position sensors can provide accurate positioning of the distal end of the catheter where it contacts the tissue.

[0213] The magnetic position sensors may include one or more of magnetic coils or solid-state magnetic position sensors (for example, MEMS magnetic sensors).

[0214] For forming the expandable assembly into an expandable basket assembly, each spline distal end is coupled to a distal hub. The distal hub may comprise a flexible material for affixing the distal ends of the splines. The distal hub may comprise an elastomeric material for affixing the distal ends of the splines in a predetermined relationship at the distal hub. The distal hub may comprise an encapsulated and filament-wrapped distal hub comprising an encapsulant and a filament for affixing the distal ends of the splines in a predetermined angular relationship at the distal hub. The distal hub and the plurality of flexible splines may be formed from a single piece of shape memory material, for example nitinol. The distal hub allows radial movement, supporting expansion of the basket assembly.

[0215] The distal hub may comprise at least one electrode, for example a distal tip electrode. The distal tip electrode at the distal hub may be a radio-frequency electrode. A conductive element may be coupled to the electrode at the distal tip. The conductive element may form part of one or more of the flex circuits that are disposed on the plurality of flexible splines. Additionally, and / or alternatively, the conductive element may extend through a deflection control member to the distal hub. Additionally, and / or alternatively, the conductive element may extend through a fluid lumen that extends out to the distal hub.

[0216] The first elongate member may comprise at least one electrode at or near the distal end of the first elongate member. The at least one electrode at or near the distal end of the first elongate member may be a ring electrode or a spot electrode (“a shaft electrode”). The at least one electrode at or near the distal end of the first elongate member may act as a position sensor and can allow the catheter to be tracked in a localization and navigation 44 SL 879690S.1system (e.g., an electric-field based positioning system). The at least one electrode at or near the distal end of the first elongate member may additionally or alternatively act in concert with the interactive element assembly to produce an electric field. The at least one electrode at or near the distal end of the first elongate member may be used for impedance calibration (e.g. as a return electrode). The shaft electrode may be configured to function as a return electrode. The shaft electrode may comprise a wrapped electrode that is helically wrapped around the first elongate member. The shaft electrode may comprise a single elongated electrode. The shaft electrode (return electrode) may be configured to be positioned within the patient and remote from the spline electrodes (lesion-generating electrodes). The catheter can be configured to apply energy between i) a spline electrode and ii) a return patch (configured to positioned on the exterior of the patient) and the at least one return electrode to generate lesions proximate the spline electrode. Further details regarding intravascular return electrodes can be found in US 18 / 626,400 “SYSTEMS AND METHODS FOR ENERGY DELIVERY” filed on 4 April 2024 , the contents of which are incorporated herein by reference.

[0217] A first electrode at the distal end of the first elongate member is a referred as a “distal shaft electrode” and a second electrode, proximal to the “distal shaft electrode” is referred to as a “proximal shaft electrode”. The spacing between the distal shaft electrode and the expandable assembly may be 2.5 to 4.5mm. preferably 3 to 4mm. The spacing between the distal shaft electrode and the proximal shaft electrode may be 1.5 to 3.5mm, preferably 2 to 3mm. The distal shaft electrode and the proximal shaft electrode may each be ring electrodes. The height or length of the ring shaft electrodes in the longitudinal direction may be 2.5 to 3.5mm, preferably 2.66mm or 3mm.

[0218] When the expandable assembly is an expandable basket assembly and electrodes on the inner surfaces of the splines are activated, the inner cavity of the expandable basket may be held at a single voltage potential. The electric field emanates outward.

[0219] A number of mechanisms may be used to enable better visualisation of the catheter. For example, at least one ultrasound device may be included in the catheter, e.g. on one or more of the plurality of splines. A spiral cut may be applied to the outer or inner surface of the tubular polymeric members to provide echos for ultrasound. Alternatively and / or additionally, a platinum wire may be incorporated in each spline for visualisation under fluoroscopy.

[0220] In addition to the distal hub, further couplers or hubs may be included in the electrophysiology catheter. These couplers / hubs can be used to join subassemblies of the 45 SL 879690S.1catheter (e g. expandable assembly, expandable basket assembly) to the first elongate member. The couplers / hubs may act as mounts for other components such as magnetic position sensors, temperature sensors, electrodes and the like. The couplers / hubs may be used as manifolds or contain irrigation ports for irrigation fluids.

[0221] The catheter may further comprise a handle coupled to the proximal end of the second elongate tubular member.

[0222] The catheter may further comprise a deflection control member coupled with the distal hub and extending through the inner lumen of the first elongate member. The deflection control member may be configured to allow shaping of the expandable assembly when it is an expandable basket assembly. The distal hub could be pulled proximally to make a rounded distal tip of the expandable basket assembly. The deflection control member may be configured to adjust a stiffness of the expandable basket assembly, from a first stiffness to a second stiffness, and maintain the first stiffness or the second stiffness. The deflection control member can have a deflection control member distal end that can be coupled with a portion of the expandable basket assembly (e.g., the distal hub) and a deflection control member proximal end that can be coupled with a control mechanism.

[0223] The handle may comprise a control mechanism, such as a selective movement limiter. The selective movement limiter may couple with the proximal end of the deflection control member to limit a longitudinal movement of the deflection control member. The deflection control member may be configured to move freely when the selective movement limiter is not coupled with the deflection control member.

[0224] The deflection control member may comprise one or more of a rigid material, a semi-rigid material, and a flexible material. The rigid material may comprise a polymer, the semi-rigid material may comprise a polymer, and the flexible material may comprise a metal or a polymer. A rigid or semi-rigid material is useful for stiffness control. A flexible material is useful for shaping.

[0225] The deflection control member can be used to support a desired shape / configuration of the expanded basket. For example, the deflection control member can provide support (i.e., rigidity, stiffness) to the expanded basket to maintain a specific deployed shape. For example, the deflection control member can provide support to the expanded basket to maintain the width (with respect to a longitudinal axis of the catheter) of a first deployed shape. Without the support of the deflection control member, the expanded basket can have a "softer" structure (i.e., reduced rigidity, more flexible) allowing the expanded basket to float with the rigidity of the expanded basket controlled by the stiffness of the splines only.

[0226] 46 SL 879690S.1Adjustment of the deflection control member could allow additional deflection of the expanded basket as the splines and / or distal hub contact tissue (e.g.. the distal hub could move more, allowing the spline distal ends and the spline proximal ends to have a greater range of motion, depending on the force exerted on the catheter and the material properties of the splines / basket).

[0227] When the deflection control member is not engaged / used the expanded basket can have a first stiffness profile and the expanded basket can have a second stiffness profile when the deflection control member is fully engaged and providing maximum support to the expanded basket. Additional variations in support provided by the deflection control member can allow for additional stiffness profiles of the basket (e.g., a third stiffness profile, a fourth stiffness profile, etc.). There can be clinical scenarios where a physician could use the rigidity at the low end (e.g., when the deflection control member is not being used to control the stiffness / rigidity of the expanded basket) allowing the expanded basket to be softer and less stiff / less rigid. This can allow for safer delivery / manoeuvrability of the expanded basket as a softer basket is easier to navigate and the basket is less likely to damage tissue (e.g., during a soft apposition with tissue). Once the expanded basket is positioned at a desired location, the stiffness of the expanded basket can be increased for a firmer / stiffer configuration to provide optimal surface contact between the splines and the tissue proximate the splines (e.g., optimal contact between interactive elements on the splines and the tissue).

[0228] The selective movement limiter may comprise a first portion and a second portion, where the first portion is in a fixed position and the second portion is movable to engage with the deflection control member. Engagement can be by clamping the deflection control member with the first portion in order to limit the longitudinal movement of the deflection control member.

[0229] The selective movement limiter may comprise a first portion and a second portion, where the first portion and the second portion are movable to engage with the deflection control member. Engagement can be by clamping the deflection control member with the first portion in order to limit the longitudinal movement of the deflection control member.

[0230] The second elongate tubular member may have an inner lumen diameter of about 2.5 French (0.825 mm), about 4 French (1.32 mm), about 6 French (1.98 mm), about 8 French, or between 2.5 French (0.825 mm) to 8.5 French (2.805 mm). For example, the second elongate tubular member may be a 6 to 8.5 French ( 1.98 to 2.805mm inner diameter) tube, such as a 6 French (1.98 mm) tube.

[0231] 47 SL 879690S.1The catheter may further comprise at least one pull wire disposed longitudinally along the length of the first elongate member. The first elongate member may comprise at least one steering ring located at or near its distal end. The distal end of the at least one pull wire can be connected to the at least one steering ring. The steering ring may be within a distal portion of the first elongate member. The steering ring located at the distal end of the first elongate member advantageously enables maximum manoeuvrability of the catheter for all sizes / diameters of the expandable basket assembly.

[0232] The handle may comprise a steering mechanism. The proximal end of the at least one pull wire may be connected to the steering mechanism.

[0233] The pull wire may be a flat wire having a substantially rectangular cross-section. The pull wire may have a width of at least 0.178mm and a thickness of at least 0.076mm.

[0234] The catheter may comprise a detection mechanism. The detection mechanism may be configured to detect the position of the first elongate member, for example to measure linear distance travelled. The detection mechanism may be included in the proximal end of the first elongate member. The detection may include a position indicator.

[0235] The handle may comprise a thread. The thread on the proximal end of the second elongate member may be configured to interface with the thread on the handle, in addition to, or alternatively to the thread on the first elongate member. The handle may comprise the detection mechanism, such as a the detection mechanisms discussed above, e.g. including a variable resistor communicatively coupled with a processor. The detection mechanism may allow the position of the first elongate member to be measured.

[0236] Variable size of the expandable basket assembly

[0237] The catheter of the fourth aspect of the disclosure may further comprise a second elongate tubular member comprising a lumen, a proximal end and a distal end. The second elongate tubular member may be configured to receive the first elongate member and the expandable basket assembly may be slidingly compressible to fit within the lumen of the second elongate tubular member and to adjust an effective diameter and size of the basket. The expandable basket assembly may have a substantially cylindrical shape when compressed within the lumen of the second elongate tubular member and wherein the basket assembly may have a radially expanded non-cylindrical shape when not compressed within the lumen of the second elongate tubular member and at least partially disposed past the distal end of the second elongate tubular member. Retraction of the first elongate member within the second elongate tubular member can reduce the effective diameter and 48 SL 879690S.1size of the expandable basket assembly.

[0238] The size and shape of the expandable basket may be selectively changed depending on the use or application. The electrophysiology catheter of the present disclosure can act as a large footprint mapping and ablation catheter, able to deliver large area lesions. The expandable basket of the electrophysiology catheter can have its effective diameter and size reduced to map on a smaller scale and / or to deliver focal lesions. Retracting the first elongate member within the second elongate tubular member causes the expandable basket to retract into the second elongate tubular member, enabling the effective diameter and size of the expandable basket to be reduced. To facilitate the adjusting of diameter and size of the basket assembly, the first elongate member may be slidingly received within the second elongate tubular member. When the first elongate member is pulled proximally relative to second elongate tubular member, proximal end of splines are also pulled proximally relative to a distal end of the second elongate tubular member, thereby retracting the basket assembly proximally within the second elongate tubular member, reducing the effective diameter and size of the expandable basket assembly.

[0239] During retraction of the first elongate member within the second elongate tubular member, the second elongate tubular member remains in position. For example, the second elongate tubular member may be fixed relative to a handle of the catheter. This is advantageous in that the second elongate tubular member can be used for deflection control and accurate positioning of the catheter.

[0240] The proximal end of the first elongate member may be coupled to the proximal end of the second elongate tubular member. The proximal end of the second elongate tubular member may comprise a thread and the proximal end of the first elongated member may comprise a thread configured to couple with the thread of the second elongate tubular member. Threading of the first elongate member distally into the second elongate tubular member may increase the effective diameter and size of the basket. Alternatively, the proximal end of the second elongate tubular member may comprise an aperture and the proximal end of the first elongated member may comprise a protrusion configured to be received in the aperture of the second elongate tubular member. The aperture may compnse a longitudinal portion and at least one circumferential portion. The protrusion may slide within the longitudinal portion. Twisting of the first elongate member within the second elongate tubular member can move the protrusion into the circumferential portion of the aperture, locking the first elongate member from further sliding. There may be a number of circumferential portions of the aperture to provide for a number of different positions of 49 SL 879690S.1the first elongate member (and thus size and diameter of the expandable basket assembly). Alternatively, the proximal end of the first elongate member may be coupled to a proximal end of a handle. The proximal end of the handle may comprise a thread and the proximal end of the first elongated member may comprise a thread configured to couple with the thread of the proximal end of the handle. Threading of the first elongate member distally into the handle may increase the effective diameter and size of the basket. The distal end of the handle may be coupled to the distal end of the elongate tubular member.

[0241] The position of the proximal end of the first elongate member relative to the proximal end of the second elongate tubular member may be manually adjusted to adjust an effective diameter and size of the expandable basket assembly.

[0242] Retraction may be such that the size (diameter and volume) of the expandable basket assembly can be reduced continuously. That is, retraction might be on a sliding scale. Alternatively, there may be a number of specific fixed sizes that the expandable basket can adopt. Specific fixed sizes may be denoted by set positions on the proximal end of the first elongate member. Alternatively, specific fixed sizes may be denoted by a series of notches, detents or stops on a thread at the proximal end of the first elongate member. Set positions may act as a visual position indicator of linear motion of the first elongate member relative to the second elongate member. The notches, detents or stops may provide tactile feedback to the operator indicating that the basket has achieved the next fixed size. A number of fixed size expandable basket configurations may be useful for clinical setting where physicians may want to know the size / shape of the basket, for example, for applying lesions of a specific size. The catheter may be coupled to a user interface configured to display the diameter and size of the basket.

[0243] The catheter may comprise a detection mechanism. The detection mechanism may be configured to detect the position of the first elongate member relative to the second elongate tubular member, such that the size and diameter of the expandable basket assembly can be determined. The detection mechanism may allow the position of the first elongate member to be measured.

[0244] The detection mechanism may be located on the second elongate tubular member so as to determine the position of the first elongate member within its lumen. When the proximal end of the second elongate tubular member comprises a thread and the proximal end of the first elongate member comprises a thread configured to couple with the thread of the second elongate tubular member, a detection mechanism may be included in the proximal end of the second elongate tubular member.

[0245] 50 SL 879690S.1The detection mechanism may comprise a linear transducer configured to measure linear distance travelled by the basket. Alternatively, the detection mechanism may comprise a variable resistor that is calibrated to indicate the size of the basket, for example, based on a change in resistance. The detection mechanism (e.g. linear transducer or variable resistor) may be communicatively coupled with a processor. The position may be used to determine if the expandable basket has a size / diameter within a range that can generate a therapy waveform. Alternatively, the therapy waveform may span all size / diameters of the expandable basket and the position may cause the processor to adjust lesion marker sizes. The detection mechanism may alternatively comprise a sensor. The sensor may be configured to detect a position of the actuator.

[0246] The diameter of the radially expandable basket assembly can be adjusted to sizes between 2 to 36mm, 15 to 28mm, 10 to 12mm, 5 to 9mm, or 3 to 5mm, for example sizes of 24mm, 15mm, 10mm, 9mm, 5mm or 3mm. The shape of the radially expandable basket assembly may be approximated to a sphere and the volume of the basket assembly can be adjusted between 4.19xl0-3to 24.43cm3, 1.77 to 11.49cm3, 0.52 to 0.9cm3, 0.065 to 0.38cm3, or 0.014 to 0.065 cm3, for example volumes of 7.24cm3, 1.77cm3, 0.52cm3, 0.38cm3, 0.065cm3or 0.014cm3.

[0247] This range of basket sizes can be used for mapping, with high-fidelity7, for example to map the whole chamber of the heart. Reduced basket sizes may be used to provide focal lesions, for example, to hard to reach or tight areas. All size baskets may be configured to deliver radio-frequency (RF) energy and / or PF A.

[0248] Features which are described above regarding the variable size / shape expandable basket assembly aspect may be readily combined with features of the fourth aspect, the mapping and ablation expandable basket assembly.

[0249] Kit

[0250] According to a fifth aspect of the disclosure, there is provided a kit comprising the electrophysiology catheter of the fourth aspect and an introducer catheter. The introducer catheter may comprise a tubular inner liner, a torque transfer layer surrounding at least a portion of the inner liner, and an outer sheath formed over the torque transfer layer. The electrophysiology7catheter is configured to be received within the lumen of the tubular inner liner. The torque transfer layer may comprise at least two braided flat wires. The braided flat wires may be substantially rectangular in cross-section. The braided flat wires may have a width of at least 0.178mm and a thickness of at least 0.076mm. The tubular inner 51 SL 879690S.1liner may have an inner lumen diameter of at least 6 French, preferably 8.5 French.

[0251] Systems

[0252] A localization (positioning) and navigation system may be provided for use with any of the catheters described herein for visualization, mapping and navigation of internal body structures. The localization and navigation system may include conventional apparatus known generally in the art (e.g., an EnSite™ X system or EnSite Precision™ System, commercially available from Abbott Laboratories, and as generally shown with reference to commonly assigned U.S. Pat. No. 7,263,397 titled “Method and Apparatus for Catheter Navigation and Location and Mapping in the Heart,” the entire disclosure of which is incorporated herein by reference). It should be understood, however, that this system is an example only, and is not limiting in nature. In this regard, some of the localization, navigation and / or visualization system would involve a sensor be provided for producing signals indicative of catheter location information, and may include, for example one or more electrodes in the case of an electric-field-based localization system, or alternatively, one or more magnetic sensors (e.g. coils (i.e., wire windings), or solid-state sensors) configured to detect one or more characteristics of a magnetic field, for example in the case of a magnetic-field based localization system. As yet another example, the system may utilize a combination electric field-based and magnetic field-based system as generally shown with reference to U.S. Pat. No. 7,536,218 entitled “Hybrid Magnetic-Based and Impedance Based Position Sensing,” the disclosure of which is incorporated herein by reference in its entirety.

[0253] A magnetic-field-based localization system may employ magnetic fields to detect the position and orientation of the catheter within the body. In such a system, a magnetic field generator may be employed having three orthogonally arranged coils to create a magnetic field within the body and to control the strength, orientation, and frequency of the field. The magnetic field generator may be located above or below the patient (e.g., under a patient table) or in another appropriate location. Magnetic fields are generated by the coils and current or voltage measurements for one or more magnetic position sensors associated with the catheter are obtained. The measured currents or voltages are proportional to the distance of the sensors from the coils, thereby allowing determination of a position of the sensors within a coordinate system of the magnetic-field-based positioning system.

[0254] An electric-field-based localization system may be provided to determine the position and orientation of the catheter within the body. The electric-field-based 52 SL 879690S.1localization system operates based upon the principle that when low amplitude electrical signals are passed through the thorax, the body acts as a voltage divider (or potentiometer or rheostat) such that the electrical potential or field strength measured at one or more electrodes on the catheter may be used to determine the position of the electrodes, and, therefore, of the catheter, relative to a pair of external patch electrodes using Ohm's law and the relative location of a reference electrode (e.g., in the coronary’ sinus). As the catheter moves within the body, and within the electric field generated by the electric-field-based positioning system, the voltage readings from the electrodes change, thereby indicating the location of catheter within the electric field and within the coordinate system established by the system.

[0255] As discussed above, the interactive element assembly, in particular the interactive elements can be electrically connected (e.g., via a plurality of electrical traces, wires, etc.) to a positioning system, in particular to an electric-field based localization system and / or a magnetic-field based localization system.

[0256] Electric fields may be applied between electrodes of the interactive element assembly or between the electrodes of the interactive element assembly and a return patch. For example, the catheter may be configured to sense and / or apply a signal between different electrodes of the interactive element assembly on the splines. Alternatively, the catheter may be configured to sense and / or apply a signal between electrodes of the interactive element assembly on the splines and electrodes on the first elongate member or second elongate tubular member, or patch electrodes on a patient. The catheter may also be configured to sense and / or apply a signal between electrodes of the interactive element assembly on the splines and return electrodes on the first / second elongate member and a patch electrode on a patient.

[0257] The system may include a signal generator configured for generating a pulse waveform. The system may further include a cardiac stimulator coupled to the signal generator and configured for generating a pacing signal for cardiac stimulation during use, and for transmitting an indication of the pacing signal to the signal generator. The signal generator may be configured for generating the pulse waveform in synchronization with the indication of the pacing signal. The system may comprise a processor configured to receive mapping data and record signals from the catheter. The system may be coupled to any of the catheters described herein, wherein the catheter is configured for receiving the pulse waveform.

[0258] There catheters described herein can be used in a variety of methods, for example,

[0259] 53 SL 879690S.1for mapping and ablating cardiac tissue.

[0260] Features which are described in the context of separate aspects of the disclosure may be used together and / or be interchangeable. Similarly, features described in the context of a single embodiment may also be provided separately or in any suitable subcombination.

[0261] BRIEF DESCRIPTION OF THE DRAWINGS

[0262] The invention is further illustrated with reference to the following figures in which: Figures 1A-1D are isometric views of a distal end portion of an electrophysiology catheter according to a first aspect of the disclosure with an expandable basket assembly in a deployed, radially expanded configuration. Figure 1A shows the basket fully expanded having a diameter of 24mm. In figures IB to ID the expandable basket is partially retracted within the second elongate tubular member resulting in basket diameters of 18mm, 12mm and 9mm respectively.

[0263] Figure 2 is an exploded diagram of a distal end portion of an electrophysiology catheter showing the first elongate member extending past the distal end of the second elongate tubular member and the expandable basket assembly in a deployed, radially expanded configuration.

[0264] Figures 3 A. 3B and 3C are diagrammatic views of a catheter system that is designed to perform one or more diagnostic and / or therapeutic functions, in accordance with the present disclosure.

[0265] Figure 4 is an isometric view7of a distal end of the first elongate member including an alternative expandable basket assembly in a deployed, radially expanded configuration according to a first aspect of the disclosure. The basket assembly comprising a plurality of splines where one or more of the splines includes an electrode on a first surface and one or more electrodes on a second surface.

[0266] Figures 5A and 5B show a portion of the first (Figure 5B) and second ( Figure 5A) surfaces of the splines with an interactive element assembly.

[0267] Figures 5C-5F show a portion of the first and second surfaces of the splines with alternative interactive element assemblies and flexible circuits.

[0268] Figure 5G is an isometric view7of an expandable basket assembly in a deployed, radially expanded configuration comprising a winged flexible circuit.

[0269] Figure 6A is a cross-sectional view of a portion of a spline tube assembly.

[0270] Figure 6B is an exploded cross-section view of the spline of Figure 6A.

[0271] 54 SL 879690S.1Figure 6C is an isometric view of a distal end of the first elongate member including an expandable basket assembly in a deployed, radially expanded configuration. The expandable basket assembly comprising a plurality of splines and a plurality of tubular polymeric members where one or more of the splines includes at least one electrode on a first portion of the outer member surface of the tubular polymeric member and one or more electrodes and / or thermocouples on a second portion of the outer member surface of the tubular polymeric member.

[0272] Figures 7A and 7B are isometric views of a distal end portion of an electrophysiology7catheter with an expandable basket assembly in a deployed, radially expanded configuration and having additional components at the distal end of the second elongate tubular member.

[0273] Figure 8A illustrates one example of electroporation field generated by a catheter having electrodes on the inside surface and outside surface of the splines.

[0274] Figures 8B to 8F illustrate examples of electroporation field generated by an electrophysiology catheter when the expandable basket assembly is of differing diameters / sizes.

[0275] Figures 8G to 81 illustrate examples of electroporation field generated by an electrophysiology7catheter when the expandable basket assembly is of minimum diameter / size.

[0276] Figure 9 is a side view of a distal end portion of an electrophysiology catheter with an expandable basket assembly comprising multiple splines and a deflection control member.

[0277] Figure 10A and 10B are end views of a distal end portion of alternative electrophysiology catheters with an expandable basket assembly comprising a plurality7of splines and a lumen suitable for irrigation.

[0278] Figure 11 is an isometric view of a distal end portion of an electrophysiology catheter according to a third aspect of the disclosure. The catheter has an expandable structure comprising a single curved spline.

[0279] Figures 12A through 12C are isometric views of a distal end portion of an electrophysiology catheter comprising a single curved spline according to the third aspect of the disclosure. The catheter of Figures 12B and 12C includes a deflection control member.

[0280] Figure 13 is an isometric view of a distal end portion of an electrophysiology catheter according to a fourth aspect of the disclosure.

[0281] 55 SL 879690S.1Figure 14A is an isometric view of a distal end portion of an alternative electrophysiology catheter according to a fourth aspect of the disclosure, and Figure and 14B is a distal end view of an expandable assembly of the catheter of Figure 14A.

[0282] Figure 15 is an isometric views of a distal end portion of an alternative electrophysiology' catheter according to a fourth aspect of the disclosure.

[0283] Figure 16A is a schematic representation of an expandable assembly of an alternative electrophysiology catheter according to a fourth aspect of the disclosure, and Figure 16B is a distal end view of an expandable assembly of an alternative electrophysiology7catheter according to a fourth aspect of the disclosure.

[0284] DETAILED DESCRIPTION OF THE DISCLOSURE

[0285] Electrophysiology catheters are needed to create lesions at numerous anatomical sites using PFA and / or RF energy. There has been a trade-off between high resolution maps and very focal precise lesion sizes, and lower resolution maps and larger lesions using nonthermal PFA energy. There are no known catheters which are able to span the entire size range to act as a large mapping catheter for quick but high-fidelity maps and delivering large area lesions. It would also be advantageous to be able to deliver focal lesions in relatively difficult to reach areas, while also having excellent maneuverability' and stability' . It would also be advantageous to use fewer device appositions to construct lesion lines, and also to deliver PFA and / or RF energy. It would also be advantageous to be able to deliver PFA and / or RF energy with increase mapping capabilities. The present disclosure also seeks to provide a solution to these problems. The present disclosure will noyv be further elaborated by reference to the figures which are non-limiting.

[0286] Figures 1 A tolD are isometric views of a distal end portion of an electrophysiology catheter 10 according to a first aspect of the disclosure. Figure 1A illustrates the catheter 10 having a first elongate member 20 comprising a proximal end 22 and a distal end 24 and an expandable basket assembly 30. The expandable basket assembly 30 includes a distal hub 32, eight flexible splines 34, and an interactive element assembly 40. As shoyvn in Figure 2, each spline 34 comprises a respective spline proximal end 35 and a spline distal end 36, where each spline proximal end 35 is coupled to the distal end 24 of the first elongate member 20, and where each spline distal end 36 is coupled to the distal hub 32. The first elongate member 20 is received in a lumen 56 (shown in dotted lines in Figure 2) of a second elongate tubular member 50.

[0287] The expandable basket assembly 30 is slidingly compressible to fit within the lumen 56 SL 879690S.1

[0288]

[0289] non-cylindrical shape when not compressed within the lumen 56 of the second elongate tubular member and at least partially disposed past a distal end 54 of the second elongate tubular member. Retraction of the first elongate member 20 within the second elongate tubular member 50 slidingly compresses the expandable basket assembly 30, reducing the effective diameter and size of the expandable basket assembly 30 as shown in Tigures 1A to ID. Figure 1 A shows a fully expanded basket assembly 30 having a diameter of 24mm. In Figures IB to ID the expandable basket 30 is partially retracted within the second elongate tubular member 50 resulting in basket diameters of 18mm, 12mm and 9mm respectively. The Figures are not necessarily to scale.

[0290] Although specific sizes of the expandable basket assembly 30 are shown, retraction of the first elongate member 20 within the second elongate tubular member 50 might be on a continuous, sliding scale such that the size of the expandable basket assembly 30 may be varied continuously.

[0291] Figures 3 A. 3B and 3C are diagrammatic views of a catheter system that is designed to perform one or more diagnostic and / or therapeutic functions, in accordance with the present disclosure. The proximal end 22 of the first elongate member 20 comprises a thread 220 which is configured to be coupled to a corresponding thread 520 at the proximal end 52 of the second elongate tubular member 50 as illustrated in Figure 3B or to a corresponding thread 600 at the proximal end 62 of handle 60 as illustrated in Figure 3C. The distal end 64 of handle 60 is coupled to the proximal end 52 of the second elongate tubular member 50. The first elongate member 20 is received in the lumen 56 of the second elongate tubular member 50.

[0292] A detection mechanism (not shown) may be located at the proximal end 52 of the second elongate tubular member 50 or the proximal end 62 of the handle 60 so as to determine the position of the first elongate member 20. Threading of the first elongate member 20 into the second elongate tubular member 50 or the handle 60 may be detected by the detection mechanism and configured to determine the size / diameter of the expandable basket assembly 30.

[0293] Figure 4 is an isometric view of an alternative expandable basket assembly 30 of an electrophysiology7catheter 10 having seven splines 34. The splines 34 are made of nitinol. The distal hub 32 and the splines 34 are formed from a single piece of nitinol. Each spline 34 proximal end 35 is coupled to the distal end 24 of the first elongate member 20, and each spline distal end 36 is coupled to the distal hub 32. The first elongate member 20 can 57 SL 879690S.1be received in a lumen 56 of a second elongate tubular member 50 (not shown).

[0294] The interactive element assembly 40 includes an electrode 42 on a first surface 342 of each of the splines 34, one or more electrodes 44 on a second surface 344 of the splines and a flexible circuit 46 disposed on the second surface 344 of each of the splines 34. Specifically, the nitinol is configured to form the electrode 42 on the inner surface 342 of each of the flexible splines 34. One or more temperature sensors 48 (e.g. thermocouples) may be included on the second surface 344 of the splines 34 in place of or in addition to the electrodes 44.

[0295] The flexible circuit 46 includes a polymeric substrate 462 having an upper surface 463 and an opposed lower surface. The electrodes 44 are disposed over at least part of the upper surface 463 of the polymeric substrate. One or more electrical traces are embedded within the polymeric substrate 462 and are in electrical communication with the electrodes 44. An electrode 432 is located at the distal hub 32. A magnetic sensor may be included at the distal hub 32 in place of the electrode 432, or in addition to electrode 432 but positioned on the interior of the expandable basket assembly 30.

[0296] Figures 5A and 5B show a portion of the first surface 342 (5 A) and second surface 344 (5B) of the splines 34 in an alternative arrangement. In this arrangement, the interactive element assembly 40 includes an electrode 42 deposited on a first surface 342 of each of the splines 34 and one or more electrodes 44 and thermocouples 48 on a second surface 344 of the splines 34. A dielectric material 49 is deposited onto the surface 342, 344 of the splines 34, and the electrodes 42 or 44 and / or thermocouples 48 are deposited on top of the dielectric material 49. Electrical traces (not show n) may be deposited on at least a portion of the lower surface of the dielectric material 49, and / or the electrical traces can be deposited on at least a portion of the upper surface of the dielectric material 49, and / or the electrical traces can be embedded within the dielectric material 49. The one or more electrical traces are in electrical communication with a respective one of the electrodes 42, 44 and / or thermocouples 48. The dielectric material 49 may be the same as or different to the polymeric substrate 462 of a flexible circuit.

[0297] The size and arrangement of the interactive elements, including electrodes 42 and 44 and thermocouples 48, on the first and second spline surfaces 342, 344 can be varied according to the required application. For example, a variety of different interactive element arrangements including a flexible circuit 46 are illustrated in Figures 5C to 5F, where the spline 34 is made from nitinol. The surface shown may be the first (inner) spline surface 342 and / or the second (outer) spline surface 344. The first and / or second spline 58 SL 879690S.1surface 342, 344 includes a polymeric substrate 462 having an upper surface 463 and an opposed lower surface (not shown). Electrical traces can be disposed over at least a portion of the lower surface of the polymeric substrate, and / or the electrical traces can be disposed over at least a portion of the upper surface 463 of the polymeric substrate, and / or the electrical traces can be embedded within the polymeric substrate 462. The one or more electrical traces are in electrical communication with the interactive elements. At least one interactive element, which can include electrodes 42, 44 and thermocouples 48, is disposed over at least part of the upper surface 463 of the polymeric substrate.

[0298] The polymeric substrate 462 may comprise a dielectric material, such as a polyimide material (e.g., PI-2771 or HD-4004 available from HD Microsystems, or KAPTON available from DuPont), a polyether block amide (such as Pebax®), and / or an epoxy (e.g., SU8 epoxy available from MicroChem Corp).

[0299] Figure 5C shows a first arrangement in which a single large electrode 42, 44 is deposited over the surface of the polymeric substrate 462. Thermocouples, optionally thermocouples 48, are deposited over and electrically isolated from the large electrode 42, 44. The single large electrode 42, 44 can be used to provide deeper lesions for ablation therapy.

[0300] Figure 5D shows a second arrangement in which multiple electrodes 42, 44 are deposited over the surface of the polymeric substrate 462. A thermocouple, optionally thermocouples 48. is deposited over and electrically isolated from one of the multiple electrodes 42, 44.

[0301] Figure 5E shows a third arrangement in which a single large electrode 42, 44 is deposited over the surface of the polymeric substrate 462. Thermocouples, optionally thermocouples 48. and smaller electrodes 42’, 44' are deposited over and electrically isolated from the large electrode 42, 44. The smaller electrodes 42’, 44’ can be used for mapping resolution. In this third arrangement, the smaller electrodes 42’, 44’ are offset and arranged in groups of three at the vertices of a triangle (“cliques’’) to enable omnipolar mapping. The smaller electrodes 42’, 44' are arranged in close proximity to satisfy the assumption of a locally plane and homogeneous propagation within the clique.

[0302] Figure 5F shows a fourth arrangement in which an electrode material is deposited over the surface of the polymeric substrate 462 (not shown). A polymeric covering 467 is deposited over the upper surface of the polymeric substrate 462 and electrode material, with the electrodes 42, 44. 42’, 44' being substantially free of the polymeric covering 467. There is a single mid-size electrode 42,44 and multiple smaller electrodes 42’, 44’.

[0303] 59 SL 879690S.1The interactive elements may be distributed from the proximal end to distal end of the splines 34 of the expandable basket assembly 30. That is, the arrangements shown in figures 5B i) to iv) may be repeated along the length of the splines 34 to provide full coverage from proximal end to distal end. Full coverage of the splines 34 may allow tissue contact / therapy in any orientation of the basket assembly 30. Alternatively, the arrangements shown in figures 5B i) to iv) may be located at a specific portion of the spline. For example, the interactive elements may be clustered or grouped together along the length of the splines 34. Additionally, or alternatively, the smaller interactive elements may be clustered or grouped together along the length of the splines 34. Clusters can allow for packing density relief of the electrical traces.

[0304] Figure 5G is an isometric view of an expandable basket assembly 30 comprising a flexible circuit 46 of the interactive element assembly. The flexible circuit 46 includes wings 466 which protrude (e.g., generally circumferentially) from each of the plurality of flexible splines 34. The wings 466 provide a larger surface area for the electrodes 44 which are deposited on to the flexible circuit 46.

[0305] Figure 6A is a perspective view of a portion of a spline 34 within a tubular polymeric member 38. Figure 6B is an exploded cross-section view of the spline 34 of Figure 6A. The tubular polymeric member 38 is disposed over the splines 34 except at distal end of the expandable basket assembly 30 where the splines 34 emerge from the distal hub 32 (as illustrated in figure 6C). The tubular polymeric members 38 have a first open end and an opposed second open end defining an open lumen 380 therein between. In this arrangement, the splines 34 are not fixed to lumen 380 of the tubular polymeric member 38. The tubular polymeric member 38 is slidingly assembled over the spline 34 to provide some interference there between. The tubular polymeric member 38 may comprise an inner member surface and an outer member surface 388. A first portion of the outer member surface of the tubular polymeric member predominantly faces the interior of the expandable basket assembly 30. A second portion of the outer member surface of the tubular polymeric member predominantly faces the exterior of the expandable basket assembly 30.

[0306] The first interactive elements, such as electrodes 42, are disposed on the first portion of the outer member surface 388, facing the interior of the expandable basket assembly 30. The second interactive elements, such as electrodes 44 and / or thermocouples 48, are disposed on the second portion of the outer member surface 388, facing the exterior of the expandable basket assembly 30. A flexible circuit 46 is disposed on the outer member surface 388 and comprises a polymeric substrate 462 and electrical traces 465 in electrical 60 SL 879690S.1communication with the first interactive elements 42 and second interactive elements 44. The number of first and second interactive elements 42. 44, 48 may vary.

[0307] Figure 6B depicts a cross-section of a spline 34. The spline 34 has a flat or substantially flat first surface 342, a flat or substantially flat second surface 344, and convexly rounded sidewalls 345, 346. The cross-sectional profile of the spline 34 is a rounded rectangular shape.

[0308] Figure 6C is an isometric view of a distal end 24 of the first elongate member 20 including an expandable basket assembly 30 comprising six splines 34 and six tubular polymeric members 38. The tubular polymeric member 38 are disposed over the splines 34 except at distal end of the expandable basket assembly 30 where the distal end 36 of the splines emerge from the distal hub 32. The first interactive elements, such as small electrodes 42’, are disposed on the first portion of the outer member surface 388, facing the interior of the expandable basket assembly 30. The second interactive elements, such as large electrodes 44, small electrodes 44’ and / or thermocouples 48, are disposed on the second portion of the outer member surface 388, facing the exterior of the expandable basket assembly 30. The large electrodes 44’ are deposited on top of the polymeric member surface 388 for ablation, and the smaller electrodes 44’ are deposited on top of and electrically insulated from the larger ablation electrodes 44. The smaller electrodes 44’ are used for mapping. A flexible circuit 46 is disposed on the outer member surface 388 and comprises a polymeric substrate 462 and electrical traces 465 in electrical communication with the first interactive elements 42’ and second interactive elements 44, 44’. The number of first and second interactive elements 42, 44, 44’, 48 may vary to that shown.

[0309] As shown in figure 6C, the smaller interactive elements 42’, 44’, 48 are clustered or grouped together at the proximal portion, medial portion and distal portion of the spline 34. Clusters can allow for packing density relief of the electrical traces.

[0310] Figure 7 is an isometric view of a distal end portion of an electrophysiology catheter 10 with an expandable basket assembly 30 and having additional components at the distal end 54 of the second elongate tubular member 50. Specifically, the second elongate tubular member 50 has two ring electrodes 70, 72 at or near the distal end 54 of the second elongate tubular member. The catheter 10 further comprises at least one pull wire 82 disposed longitudinally along the length of the second elongate tubular member 50. The second elongate tubular member 50 may comprise at least one steering ring 80 located near its distal end 54. The distal end of the at least one pull wire 82 is connected to the at least one steering ring 80. The catheter 10 may comprise further additional components at or near 61 SL 879690S.1the distal end 54 of the second elongate tubular member, including additional electrodes (such as ring or tip electrodes), magnetic position sensors, steering rings, pull wires, temperature sensors etc.

[0311] Figure 8A illustrates one example of electroporation field generated by an electrophysiology' catheter 10 having electrodes 42 and 44 on the inside surface and outside surface of the splines 34 and electrodes 70, 72, 74, 76 on the distal end 54 of the second elongate tubular member. When electrodes 42 on the first inner surface 342 of the splines 34 or first portion of the outer member surface 388 facing the interior of the expandable basket assembly 30 are selectively activated (energised), the inner cavity of the basket 30 is held at a single voltage potential. The electric field then emanates uniformly outward. The interactive element assembly 40 electrodes 42 and 44 may interact with one another or with electrodes 70, 72, 74, 76 on the second elongate tubular member 50. As shown, the electric field gives a nearly uniform depth in all tissue facing directions radially from the expandable basket assembly 30, where electroporation ablation is desired to occur, while also containing the field within the inner surface of the splines so that more proximal tissue is not ablated where not desired. Alternatively, the interactive element assembly 40 interacts with a surface patch electrode. The surface patch may be disposed at a patient’s skin. In such examples, the ablation from the catheter to the surface patch (not shown) may cause a deeper lesion and also protect circuits within the catheter 10 from high voltages.

[0312] Figures 8B to 8F illustrate examples of electroporation field generated by an electrophysiology catheter 10 having electrodes 42 and 44 on the inside surface and outside surface of the splines 34 when the expandable basket assembly 30 is of differing diameters / sizes. As shown, the electric field gives anearly uniform depth in all tissue facing directions radially from the expandable basket assembly 30 when the basket is of any size / diameter. When the basket 30 is fully retracted (Figure 8F) a uniform field is also achieved. The field distance and strength reduces as the size of the expandable basket assembly 30 is reduced.

[0313] Figures 8G to 81 illustrate examples of electroporation field generated by an electrophysiology catheter when the expandable basket assembly 30 is of minimal diameter / size and / or fully retracted within the second elongated tubular member 50. In this arrangement, the expandable basket assembly 30 and second elongate tubular member 50 can be used as a linear ablation catheter. A number of different configurations may be used. For example, in a first configuration illustrated in figure 8G the expandable basket assembly 30 acts as the anode and electrodes 70, 72, 74, 76 on the distal end 54 of the 62 SL 879690S.1second elongate tubular member act as the cathodes. This may be useful for PFA field shaping. The electric field is a greater depth at the distal tip of the catheter 10. In a second configuration illustrated in figure 8H the expandable basket assembly 30 acts as the anode and electrodes 70, 72, 74, 76 on the distal end 54 of the second elongate tubular member act as the cathodes. This may be particularly useful for PFA . The electric field is ellipsoid in shape. In a third configuration illustrated in figure 81 the expandable basket assembly 30 acts as the anode and electrode 70 on the distal end 54 of the second elongate tubular member also acts as an anode. This may be useful for PFA and RF ablation.

[0314] Figure 9 is a side view of a distal end portion of an electrophysiology catheter 10 with an expandable basket assembly 30 comprising eight splines 34 and a deflection control member 90. The deflection control member 90 is coupled with the distal hub 32 and extends through an inner lumen 26 (not shown) of the first elongate member 20. The deflection control member 90 is configured to allow- shaping of the expandable basket assembly 30 and distal hub 32. That is, the deflection control member 90 can move longitudinally, which can cause the basket to change shape. Pulling the distal hub 32 proximally can create a rounded distal tip of the basket assembly 30. The deflection control member 90 can be configured to additionally or alternatively adjust a stiffness of the expandable basket assembly 30, from a first stiffness to a second stiffness, and maintain the first stiffness or the second stiffness.

[0315] The deflection control member 90 has a deflection control member distal end that is coupled with the distal hub 32 and a deflection control member proximal end (not shown) that can be coupled with a control mechanism. The control mechanism can be located in a handle 60 (not shown).

[0316] Figures 10A and 10B are perspective views of a distal end portion of an electrophysiology catheter 10 with an expandable basket assembly 30 comprising a plurality of splines 34. Figure 10A is a perspective view' of a distal end of the electrophysiology' catheter 10 having an irrigation tube 58 running through the centre of the first elongate member 20. Irrigation fluid can be delivered to the interior of the expandable basket assembly 30 via the lumen of the irrigation tube 58. Figure 10B is a perspective view of a distal end of an alternative electrophysiology catheter 10 having an irrigation lumen coincident with the lumen 56 of the second elongate tubular member 50. There is a space between the outer surface of the first elongate member 20 and the inner surface of the lumen 56 of the second elongate tubular member, such that irrigation fluid is able to flow' in this space (fluid flow in the direction of the arrows). Irrigation fluid can flow 63 SL 879690S.1around the first elongate member 20 and be delivered to the splines 34 of the expandable basket assembly 30 via the irrigation lumen 56.

[0317] It will be apparent that the features illustrated in any of figures 1 to 10 relating to the first aspect of the disclosure may be readily combinable.

[0318] Figure 11 is an isometric view of a distal end portion of an electrophysiology catheter 100 according to a third aspect of the disclosure. The catheter 100 has an first elongate member 200 comprising a lumen 260, a proximal end 220 (not shown) and a distal end 240. An expandable structure 300 with an expandable configuration and a collapsed configuration is coupled to the distal end 240 of the first elongate member 200. The expandable structure 300 comprises a single curved spline 340 having a proximal end 350 and a distal end 360, a proximal portion 370, a distal portion 390 and a medial portion 380 therebetween. The single curved spline 340 has an outer convex surface 3440, an inner concave surface 3420. The spline comprises a super-elastic material. The spline proximal end 350 is coupled to the distal end 240 of the first elongate member 200. At least one first interactive element 420 (not shown) is distributed on the inner concave surface 3420 of the curved flexible spline and at least one second interactive element 440, 480 (not shown) is distributed on the outer convex surface 3440 of the curved flexible spline.

[0319] As illustrated in Figure 11, the radius of curvature of the proximal portion 370 of the single spline is less than the radius of curvature of the medial portion 380 and distal portion 390.

[0320] Figure 12A is an isometric view of a distal end portion of an electrophysiology catheter 100 having a single curved spline 340. The single curved spline 340 has a segment length AL, a radius of curvature Re and makes an angle a with the longitudinal axis L of the elongate tubular member 200. In the electrophysiology catheter illustrated, the segment length AL is about 40mm, the radius of curvature Rcis 15mm and the angle a the proximal portion 370 of the spline makes with the longitudinal axis L of the elongate tubular member 200 is 45°.

[0321] Figure 12B and 12C are isometric views of a distal end portion of an electrophysiology catheter 100 having a single curved spline 340 and a deflection control member 900. The deflection control member 900 is coupled with the distal end 360 of the curved spline and extends through an inner lumen 260 of the first elongate member 200. The deflection control member 900 can be configured to adjust a stiffness of the curved spline 340, from a first stiffness to a second stiffness, and maintain the first stiffness or the second stiffness. The curved spline 340 can be retracted inside a second elongate tubular 64 SL 879690S.1member 500 for delivery.

[0322] The interactive element configuration can be the same as described above for the first aspect of the disclosure. That is the first interactive elements 420 may be deposited on the inner concave surface 3420 of the curved flexible spline and the second interactive elements 440, 480 may be distributed on the outer convex surface 3440 of the curved flexible spline in the same manner as the first interactive element 42 and second interactive elements 44, 48 are deposited on the splines 34 of the expandable basket assembly 30. Corresponding arrangements are shown in figures 4, and 5A to 5D.

[0323] Figure 13 is an isometric view of a distal end portion of an electrophysiology catheter according to a fourth aspect of the disclosure. The catheter 10 has a first elongate member 20 comprising a proximal end 22 (not shown) and a distal end 24 and an expandable basket assembly 30. The expandable basket assembly 30 includes a distal hub 32, seven flexible splines 34, and an interactive element assembly 40 (akin to that illustrated in figure 4). The splines 34 and distal hub 32 are made from a single piece of nitinol. The interactive element assembly 40 includes an electrode 42 which is formed from the entirety of the first surface 342 of each of the splines, multiple electrodes 44 (and additionally thermocouples 48, although not shown) on a second surface 344 of the splines and a flexible circuit 46 disposed on the second surface 344 of each of the splines.

[0324] The flexible circuit 46 includes a polymeric substrate 462 having an upper surface and an opposed lower surface. The electrodes 44 are disposed over at least part of the upper surface of the polymeric substrate. One or more electrical traces are embedded within the polymeric substrate 462 and are in electrical communication with the electrodes 44. Two ring electrodes 70, 72 are located at or near the distal end 24 of the first elongate member 20.

[0325] Figure 14A is an isometric view of a distal end portion of an alternative electrophysiology catheter according to a fourth aspect of the disclosure and figure 14B is a distal-end view'. The catheter 10 comprises a second expandable basket assembly 30’ surrounding the first expandable basket assembly 30. The first splines 34 and first distal hub 32 of the first expandable basket assembly 30 are made from a single piece of nitinol. The first interactive element assembly 40 includes an electrode which is formed from the entirety of the first surface of each of the first splines, and an electrode 44 w hich is formed from the entirety of the second surface 344 of each of the first splines. That is, the whole of the first expandable basket assembly 30 forms the interactive element assembly 40 and may be configured as an ablation electrode.

[0326] 65 SL 879690S.1The second expandable basket assembly 30' also includes a second distal hub 32’, seven flexible second splines 34', and a second interactive element assembly 40’ (which may be similar to that illustrated in figure 4). The second splines 34’ and second distal hub 32’ are made from a single piece of nitinol. The first distal hub 32 of the first expandable basket assembly 30 is coupled to the second distal hub 32’ of the second expandable basket assembly 30’. As shown in figure 14B, the first expandable basket assembly 30 is rotationally offset with respect to the second expandable basket assembly 30’ such that the first splines 34 are rotated with respect to the second splines 34’. The second interactive element assembly 40’ includes an electrode w hich is formed from the entirety of the first surface of each of the second splines, and an electrode 44’ which is formed from the entirety of the second surface 344’ of each of the second splines. That is. the whole of the second expandable basket assembly 30’ forms the interactive element assembly 40’ and can be configured as an ablation electrode. Alternatively (and not shown), the second interactive element assembly 40’ may include multiple electrodes 44’ on the second, outer surface 344’ of the splines and a flexible circuit 46’ disposed on the second, outer surface 344’ of each of the splines. The multiple electrodes 44’ of the second interactive element assembly 40’ may be configured as mapping electrodes, contact assessment electrodes and / or ablation electrodes. Tw o ring electrodes 70, 72 are located at or near the distal end 24 of the first elongate member 20. The electrodes 70,72 are double ring electrodes (providing an increased size shaft electrode). Detection of contact between the first expandable basket assembly 30 and the second expandable basket assembly 30’ can be used to indicate that tissue contact has been made.

[0327] Figure 15 is an isometric view- of a distal end portion of an alternative electrophysiology catheter 10 according to a fourth aspect of the disclosure in a deployed, expanded configuration. The catheter 10 has a first elongate member 20 comprising a proximal end 22 (not shown) and a distal end 24 and an expandable assembly 30. The expandable assembly 30 includes seven flexible splines 34, and an interactive element assembly 40 (akin to that illustrated in figure 4). The splines 34 are made from nitinol and each have a first surface and a second surface 344 (shown in figure 15). In the expanded, deployed configuration the splines 34 point radially outward from the distal end of the first elongate member 20. Each spline 34 forms an angle of around 80 to 130 degrees with the longitudinal axis of the first elongate member 20. The interactive element assembly 40 includes multiple electrodes 42 disposed on the first surface of each of the splines, multiple electrodes 44 and thermocouples 48 (not shown) on a second surface 344 of the splines, a 66 SL 879690S.1first flexible circuit 46 disposed on the first surface of each of the splines and a second flexible circuit 46 disposed on the second surface 344 of each of the splines. As shown in figure 15, two ring electrodes 70, 72 are located at or near the distal end 24 of the first elongate member 20.

[0328] The flexible circuit 46 includes a polymeric substrate 462 having an upper surface 463 and an opposed lower surface 464 (not shown). The electrodes 42.44 are disposed over at least part of the upper surface 463 of the polymeric substrate. One or more electrical traces 465 (not shown) are embedded within the polymeric substrate 462 and are in electrical communication with the electrodes 42, 44.

[0329] The proximal ends 35 of the plurality of splines of the expandable assembly 30 are coupled to the distal end 24 of the first elongate member 20. The plurality of splines 34 fold out (e.g. like an umbrella) from the un deployed (aligned along the length of the first elongate member 20) to the deployed configuration (radially expanded). The distal ends 36 of the plurality of splines of the expandable assembly 30 are free such that in a deployed, expanded configuration, the splines 34 point radially outwards from the first elongate member 20. The plurality of splines 34 of the expanded assembly 30 form an approximately 90-degree angle with longitudinal axis L of the first elongate member 20, such that the splines 34 of the radially expanded assembly 30 form a planar array in the deployed configuration.

[0330] Figure 16A is a schematic representation of an expandable assembly 30 of an alternative electrophysiology catheter 10 according to a fourth aspect of the disclosure and 16B is a distal end view of an expandable assembly 30 of an alternative electrophysiology catheter 10 according to a fourth aspect of the disclosure, both in a deployed configuration. The expandable assembly 30 of figure 16A includes six flexible splines 34. The expandable assembly 30 of figure 16B includes seven flexible splines 34. The splines 34 are made from nitinol and each have a second surface 344 (shown) and a first surface 342 (not shown). The interactive element assembly 40 includes multiple electrodes 42 disposed on the first surface 342 of each of the splines (not shown) and multiple electrodes 44 (and optionally thermocouples 48) on the second surface 344 of the splines.

[0331] The expandable assembly 30 further comprises a flexible circuit 46 disposed on the first and second surfaces 342, 344 of each of the splines and extending therebetween. The flexible circuit 46 comprises a polymeric substrate 462 (preferably a polyether block amide or polyurethane substrate). The polymeric substrate 462 is circular in shape, covering each of the splines 34 and extending therebetween. Electrodes 44 are disposed 67 SL 879690S.1over at least a first part of the upper surface 463 of the polymeric substrate, corresponding to the positions of the splines 34. Electrodes 44 are disposed at the proximal and distal ends of the splines 34. An increased number of electrodes 44 may be present at the proximal end as compared to the distal end of the splines 34. Additional electrodes 45 are disposed over at least a second part of the upper surface 463 of the polymeric substrate, corresponding to the part of the substrate 462 between the splines 34. Electrodes 44 function as mapping electrodes, while electrodes 45 function as ablation electrodes. One or more electrical traces 465 (not shown) are embedded within the polymeric substrate 462 and are in electrical communication with the electrodes 44, 45.

[0332] It will be appreciated that the terms “proximal’' and “distal"’ may be used throughout the specification with reference to a clinician manipulating one end of an instrument used to treat a patient. The term “proximal” refers to the portion of the instrument closest to the clinician and the term “distal” refers to the portion located furthest from the clinician. It will be further appreciated that for conciseness and clarity, spatial terms such as “vertical,” “horizontal,” “up,” and “down” may be used herein with respect to the illustrated catheters. However, surgical instruments may be used in many orientations and positions, and these terms are not intended to be limiting and absolute.

[0333] Although the electrophysiology7catheters and kits described herein mainly address electrophysiological procedures in patient heart (e.g., sensing and tissue ablation), the catheters, kits and systems described herein can also be used in other applications, such as in electrophysiological procedures carried out on other organs of a patient, and in electrophysiological procedures carried out in patient lung(s) and in treatment of renal denervation.

[0334] Numerous specific details are set forth to provide a thorough understanding of the overall structure, function, manufacture, and use of the catheters as described in the specification and illustrated in the accompanying drawings. It will be understood by those skilled in the art, however, that the catheters may be practiced without such specific details. In other instances, well-known operations, components, and elements have not been described in detail so as not to obscure the catheters described in the specification. Those of ordinary skill in the art will understand that the catheters described and illustrated herein are non-limiting examples, and thus it can be appreciated that the specific structural and functional details disclosed herein may be representative and do not necessarily limit the scope of the disclosure, the scope of which is defined solely by the appended claims. The particular features, structures, or characteristics described herein for the catheters may be 68 SL 879690S.1combined in any suitable manner.

[0335] It will be appreciated that any item, feature, parameter or component described herein may, where appropriate, relate to any of the aspects of the present disclosure.

[0336] The invention is defined in the appended claims. A non-exhaustive list of aspects of the invention set out in the numbered clauses is useful for understanding the invention:

[0337] Embodiments

[0338] 1. An electrophysiology catheter, comprising:

[0339] a first elongate member comprising a lumen, a proximal end and a distal end; an expandable structure with an expanded configuration and a collapsed configuration, the expandable structure comprising a single curved spline having a proximal end and a distal end, a proximal portion, a distal portion and a medial portion therebetween, wherein the spline comprises an outer convex surface, an inner concave surface and two side surfaces, wherein the spline comprises a super-elastic material; wherein the proximal end of the spline is coupled to the distal end of the first elongate member; and

[0340] at least one first interactive element distributed on the inner concave surface of the curved flexible spline and at least one second interactive element distributed on the outer convex surface of the curved flexible spline.

[0341] 2. The electrophysiology catheter according to clause 1, wherein when the spline is in the collapsed configuration it is configured to fit inside an elongated medical device.

[0342] 3. The electrophysiology catheter according to clause 1 or 2, wherein a radius of curvature varies along a length of the curved spline to create a non-uniform curve.

[0343] 4. The electrophysiology catheter according to any of clauses 1 to 3, wherein a segment length of the expanded curved spline is 10 to 60mm, 20 to 40mm, 30 to 40mm, preferably 20mm.

[0344] 5. The electrophysiology catheter according to any of clauses 1 to 4, wherein a maximum radius of curvature of the expanded curved spline is 5 to 20mm, 10 to 20mm, 10 to 15mm, preferably 15mm.

[0345] 69 SL 879690S.16. The electrophysiology catheter according to any of clauses 1 to 5, wherein an angle that the proximal portion of the curved spline makes with a longitudinal axis of the elongated tubular member is 30 to 60 degrees, 30 to 50 degrees, 30 to 45 degrees, preferably 45 degrees.

[0346] 7. The electrophysiology catheter according to any of clauses 1 to 6, wherein the proximal portion, distal portion and medial portion of the spline can each comprise interactive elements that can be selectively energized.

[0347] 8. The electrophysiology catheter according to any of clauses 1 to 7, wherein the proximal end of the spline is rotatably coupled to the distal end of the first elongate member.

[0348] 9. The electrophysiology catheter according to any of clauses 1 to 8, further comprising a deflection control member and a handle:

[0349] wherein the deflection control member is coupled with the distal end of the curved spline and extending through the inner lumen of the first elongate member, wherein the deflection control member is configured to adjust a stiffness of the curved spline, from a first stiffness to a second stiffness, and maintain the first stiffness or the second stiffness: and

[0350] wherein the handle comprises a selective movement limiter, wherein the selective movement limiter couples with the deflection control member to limit a longitudinal movement of the deflection control member, wherein the deflection control member is configured to move freely when the selective movement limiter is not coupled with the deflection control member.

[0351] 10. The electrophysiology catheter according to any of clauses 1 to 9, wherein the super-elastic material of the spline comprises a shape memory material, preferably Nitinol.

[0352] 11. The electrophysiology catheter according to clause 10, wherein the spline comprises an insulating material covering portions of the spline, wherein at least one exposed portion of the spline corresponds to the a first interactive element and / or at least one other exposed portion of the spline corresponds to the a second interactive element.

[0353] 70 SL 879690S.112. The electrophysiology catheter according to any of clauses 1 to 11, wherein at least one of the first interactive elements is formed by depositing a material on the inner concave surface of the spline, and / or wherein at least one of the second interactive elements is formed by depositing a material on the outer convex surface of the spline, wherein the catheter further comprises:

[0354] a plurality of electrical traces disposed on the spline, each of the plurality of electrical traces coupled with a respective one of the first or second interactive elements; and

[0355] a dielectric material disposed between each of the plurality7of electrical traces and the spline.

[0356] 13. The electrophysiology catheter according to any of clauses 1 to 12, wherein the spline further comprises a polymer substrate, a conductive layer, and an adhesive layer.

[0357] 14. The electrophysiology catheter according to any of any of clauses 1 to 13, further comprising a first flexible circuit and / or a second flexible circuit.

[0358] 15. The electrophysiology catheter according to clause 14, wherein the first flexible circuit comprises:

[0359] a polymeric substrate having an upper surface and an opposed lower surface, wherein the at least one first interactive element disposed over at least part of the upper surface of the polymeric substrate; and

[0360] one or more electrical traces disposed over at least a portion of the lower surface of the polymeric substrate or over at least a portion of the upper surface of the polymeric substrate, the one or more electrical traces being in electrical communication with the at least one first interactive elements, and

[0361] wherein the second flexible circuit comprises:

[0362] a polymeric substrate having an upper surface and an opposed lower surface, wherein the at least one second interactive element disposed over at least part of the upper surface of the polymeric substrate; and

[0363] one or more electrical traces disposed over at least a portion of the lower surface of the polymeric substrate or over at least a portion of the upper surface of the polymeric substrate, the one or more electrical traces being in electrical communication with the at least one second interactive elements.

[0364] 71 SL 879690S.116. The electrophysiology catheter of clause 15, wherein the lower surface of the polymeric substrate of the first flexible circuit is adhesively and / or thermally bonded to the inner concave surface of the spline, and wherein the lower surface of the polymeric substrate of the second flexible circuit is adhesively and / or thermally bonded to the outer convex surface of the spline.

[0365] 17. The electrophysiology catheter according to clause 15 or 16, wherein the one or more electrical traces are disposed over at least a portion of the lower surface of the polymeric substrate and further comprising vias to provide the electrical communication between the one or more electrical traces and the at least one first interactive elements.

[0366] 18. The electrophysiology catheter according to clause 17, further comprising at least one polymeric member, the polymeric member disposed between the lower surface of the polymeric substrate and the flexible spline, wherein the polymeric member is adhesively and / or thermally secured to the inner concave surface of the spline.

[0367] 19. The electrophysiology catheter according to clause 17 or 18, wherein the one or more electrical traces are disposed over at least a portion of the upper surface of the polymeric substrate and further comprising a polymeric covering over the upper surface of the polymeric substrate and the electrical traces with the one or more first / second interactive elements being substantially free of the polymeric covering.

[0368] 20. The electrophysiology catheter according to clause 19, wherein the expandable structure further comprises a tubular polymeric member, the tubular polymeric member comprising a first open end and an opposed second open end defining an open lumen therein between, the tubular polymeric member comprising an inner member surface and an outer member surface, wherein the spline is at least partially disposed within the lumen of the tubular polymeric member.

[0369] 21. The electrophysiology7catheter according to clause 20, wherein the lower surface of the polymeric substrate of the first flexible circuit is secured to a first portion of the outer member surface of the tubular polymeric member, and wherein the lower surface of the polymeric substrate of the second flexible circuit is secured to a second portion of the outer member surface of the tubular polymeric member.

[0370] 72 SL 879690S.122. The electrophysiology catheter according to any of clauses 1 to 21, wherein the one or more first interactive elements and the one or more second interactive elements are selected from one or more of an electrode, an energy delivery element, a temperature sensor, a force sensor, a strain gauge, a strain sensor, a position sensor, a biosensor, a diagnostic sensor, a therapy sensor, a chemical sensor, a light-emitting sensor, an acoustic sensor, an ultrasound sensor, an energy receiving and / or measuring sensor, a magnetic coil or sensor, and a thermoelectric element.

[0371] 23. The electrophysiology7catheter according to clause 22, wherein the electrodes comprise copper, gold, platinum, platinum black, platinum-iridium and combinations thereof.

[0372] 24. The electrophysiology' catheter according to any of clauses 1 to 23, wherein the interactive element, the at least one first interactive elements and / or the at least one second interactive elements have a substantially flat upper surface.

[0373] 25. The electrophysiology7catheter according to any of clauses 1 to 24, wherein the first elongate member further comprises an irrigation fluid lumen, wherein the first elongate member comprises one or more irrigation ports.

[0374] 26. The electrophysiology7catheter according to any of clauses 1 to 25, wherein the first elongate member comprises at least one magnetic position sensor.

[0375] 27. The electrophysiology catheter according to any of clauses 1 to 26, wherein the spline comprises 1 to 16 first interactive elements and 1 to 16 second interactive elements, preferably 8 first interactive elements and 8 second interactive elements, preferably 1 first interactive element and 8 second interactive elements.

[0376] 28. The electrophysiology catheter according to any of clauses 1 to 27, further comprising at least one pull wire disposed longitudinally along the length of the first elongate member.

[0377] 29. The electrophysiology7catheter according to clause 28, wherein the first elongate member comprises at least one steering ring located at or near its distal end, and wherein the distal end of the at least one pull wire is connected to the at least one steering ring.

[0378] 73 SL 879690S.130. The electrophysiology catheter according to clause 29 further comprising a handle, wherein the handle further comprises a steering mechanism and the proximal end of the at least one pull wire is connected to the steering mechanism.

[0379] 31. The electrophysiology catheter according to any of clauses 1 to 30, further comprising a second elongate tubular member having a proximal end coupled to the proximal end of the first elongate member.

[0380] 32. The electrophysiology' catheter according to clause 31 , wherein the proximal end of the second elongate tubular member comprising a thread and the proximal end of the first elongate member comprises a thread configured to couple with the thread of the second elongate tubular member, and wherein threading of the proximal end of the first elongate member into the second elongate tubular member increases an effective curvature and size of the spline.

[0381] 33. The electrophysiology catheter according to clauses 31 or 32, wherein a position of the proximal end of the first elongate member relative to the proximal end of the second elongate tubular member can be manually controlled to adjust an effective curvature and size of the spline.

[0382] 34. The electrophysiology catheter according to any one of clauses 31 to 33, further comprising a detection mechanism configured to detect the position of the first elongate member relative to the second elongate tubular member, such that the size and curvature of the spline can be determined.

[0383] 35. The electrophysiology catheter according to any of clauses 1 to 34 wherein the super-elastic material causes the spline to bow outwardly into the expanded configuration.

[0384] 36. The electrophysiology catheter according to any of clauses 1 to 35, wherein the super-elastic material comprises Nitinol and the Nitinol is configured to form at least one interactive element, preferably the at least one first interactive element distributed on the inner concave surface of the curved spline.

[0385] 74 SL 879690S.137. The electrophysiology catheter according to any of clauses 14 to 36, wherein the first elongate member is a tubular member and at least a portion of the first flexible circuit extends into a lumen of the first elongate member.

[0386] 38. The electrophysiology catheter according to any of clauses 14 to 37, wherein the first flexible circuit or the second flexible circuit comprises wings.

[0387] 39. The electrophysiology catheter according to any of clauses 14 to 38, wherein the first flexible circuit has a thickness from about 0.025mm to about 0.254mm.

[0388] 40. The electrophysiology catheter according to any of clauses 22 to 39, wherein the electrodes comprise a biocompatible, low resistance metal, optionally wherein the electrodes comprise copper, silver, silver-flake, gold, platinum, platinum black, platinumiridium and combinations thereof.

[0389] 41. The electrophysiology catheter according to any of clauses 31 to 40, wherein retraction of the first elongate member within the second elongate tubular member reduces the effective curvature and size of the expanded spline, causing any interactive element within the second elongate tubular member to be turned off.

[0390] 42. The electrophysiology catheter according to any of clauses 1 to 42, wherein the at least one first interactive element and / or the at least one second interactive element has a substantially flat upper surface.

[0391] 43. The electrophysiology7catheter according to any of clauses 31 to 42, wherein the second elongate tubular member comprises an irrigation fluid lumen, wherein the second elongate tubular member comprises one or more irrigation ports.

[0392] 44. The electrophysiology7catheter according to any of clauses 31 to 43, yvherein a distal end of the second elongate tubular member comprises at least one magnetic position sensor.

[0393] 45. The electrophysiology7catheter according to any of clauses 9 to 44, yvherein the selective movement limiter comprises a first portion and a second portion, yvhere the first portion is in a fixed position and the second portion is movable to engage with the deflection control member by clamping the deflection control member with the first portion in order to limit the longitudinal movement of the deflection control member.

[0394] 75 SL 879690S.146. The electrophysiology catheter according to any of clauses 9 to 45, wherein the selective movement limiter comprises a first portion and a second portion, where the first portion and the second portion are movable to engage with the deflection control member by clamping the deflection control member in order to limit the longitudinal movement of the deflection control member.

[0395] 47. The electrophysiology catheter according to any of clauses 31 to 46, wherein the second elongate tubular member has an inner lumen diameter of at least 2.5 French (0.825 mm), at least 4 French (1.32 mm), at least 6 French (1.98 mm), at least 8 French.

[0396] 48. The electrophysiology catheter according to any of clauses 31 to 47, further comprising at least one pull wire disposed longitudinally along the length of the second elongate tubular member.

[0397] 49. The electrophysiology catheter according to clause 48, wherein the second elongate tubular member comprises at least one steering ring located at or near its distal end, and wherein the distal end of the at least one pull wire is connected to the at least one steering ring.

[0398] 50. The electrophysiology catheter according to clause 48 when dependent on clause 30, wherein the handle further comprises a steering mechanism and the proximal end of the at least one pull wire is connected to the steering mechanism.

[0399] 51. The electrophysiology catheter according to clause 48 to 50, wherein the pull wire is a flat wire having a substantially rectangular cross-section and, optionally, having a width of at least 0.178mm and a thickness of at least 0.076mm.

[0400] 52. The electrophysiology catheter according to any one of clauses 31 to 51, further comprising an handle coupled to the proximal end of the second elongate tubular member.

[0401] 53. The electrophysiology catheter according to clause 52, wherein the handle comprises a thread and a thread on the proximal end of the first elongate member is configured to interface with the thread on the handle.

[0402] 76 SL 879690S.154. An electrophysiology catheter comprising:

[0403] a first elongate member comprising a proximal end and a distal end;

[0404] an expandable basket assembly comprising:

[0405] a distal hub;

[0406] a plurality of flexible splines, wherein each spline comprises a respective spline proximal end and a spline distal end, wherein each spline comprises a super-elastic material, wherein each spline proximal end is coupled to the distal end of the first elongate member, and wherein each spline distal end is coupled to the distal hub;

[0407] and

[0408] an interactive element assembly; and

[0409] a second elongate tubular member comprising a lumen, a proximal end and a distal end, wherein the second elongate tubular member is configured to receive the first elongate member; and

[0410] wherein the expandable basket assembly is slidingly compressible to fit within the lumen of the second elongate tubular member and to adjust an effective diameter and size of the basket, wherein the expandable basket assembly has a substantially cylindrical shape when compressed within the lumen of the second elongate tubular member; and wherein the expandable basket assembly has a radially expanded non-cylindrical shape when not compressed within the lumen of the second elongate tubular member and at least partially disposed past the distal end of the second elongate tubular member, wherein retraction of the first elongate member within the second elongate tubular member reduces the effective diameter and size of the expandable basket assembly.

[0411] 55. The electrophysiology catheter of clause 54, wherein the proximal end of the first elongate member is coupled to the proximal end of the second elongate tubular member.

[0412] 56. The electrophysiology catheter of clause 55, wherein the proximal end of the second elongate tubular member comprises a thread and the proximal end of the first elongated member comprises a thread configured to couple with the thread of the second elongate tubular member, and wherein threading of the proximal end of the first elongate member into the second elongate tubular member increases the effective diameter and size of the basket.

[0413] 77 SL 879690S.157. The electrophysiology catheter of clause 54, clause 55, or clause 56, wherein a position of the proximal end of the first elongate member relative to the proximal end of the second elongate tubular member can be manually controlled to adjust an effective diameter and size of the expandable basket assembly.

[0414] 58. The electrophysiology catheter according to any one of clauses 54 to 57, wherein the catheter comprises a detection mechanism configured to detect the position of the first elongate member relative to the second elongate tubular member, such that the size and diameter of the expandable basket assembly can be determined.

[0415] 59. The electrophysiology catheter according to any one of clauses 54 to 58, wherein the diameter of the radially expanded basket assembly can be adjusted between 2 to 50mm, 3 to 36mm, 15 to 28mm, 10 to 12mm, 5 to 9mm, 3 to 5mm.

[0416] 60. The electrophysiology catheter according to any one of clauses 54 to 59, wherein the shape of the radially expanded basket assembly is approximated to a sphere and the volume of the basket assembly can be adjusted between 4.19xl0'3to 65.45cm3, 0.014 to 7.24cm3, 1.77 to 3.05cm3, 0.52 to 0.9cm3, 0.065 to 0.38cm3, 0.014 to 0.065 cm3.

[0417] 61. The electrophysiology catheter according to any one of clauses 54 to 60, wherein the super-elastic material causes each of the splines to bow outwardly into the radially expanded basket shape.

[0418] 62. The electrophysiology catheter according to any one of clauses 54 to 61, wherein the super-elastic material comprises a shape memory material, preferably Nitinol.

[0419] 63. The electrophysiology catheter according to any one of clauses 54 to 62, wherein each spline comprises a first surface and a second surface, wherein the first surface of the splines comprises an inner surface and the second surface of the splines comprises an outer surface, wherein the inner surface faces the interior of the expandable basket assembly and the outer spline surface faces the exterior of the expandable basket assembly.

[0420] 64. The electrophysiology catheter according to any one of clauses 54 to 63, wherein the expandable basket assembly further comprises at least one tubular polymeric member, each tubular polymeric member comprising a first open end and an opposed second open end defining an open lumen therein between, the tubular polymeric member

[0421] 78 SL 879690S.1comprising an inner member surface and an outer member surface, wherein at least one of the plurality of flexible splines is at least partially disposed within the lumen of the tubular polymeric member.

[0422] 65. The electrophysiology catheter according to clause 64, wherein a first portion of the outer member surface of the tubular polymeric member predominantly faces the interior of the expandable basket assembly and a second portion of the outer member surface of the tubular polymeric member predominantly faces the exterior of the expandable basket assembly.

[0423] 66. An electrophysiology catheter according to any of clauses 64 or 65, further comprising:

[0424] a plurality of tubular polymeric members;

[0425] wherein each of the plurality of flexible splines are at least partially disposed within a different one of the plurality of tubular polymeric members.

[0426] 67. The electrophysiology catheter according to any one of clauses 54 to 66, wherein the interactive element assembly comprises a plurality of interactive elements distributed on the plurality of flexible splines, at least one first interactive element of the plurality of interactive elements is distributed on a first surface of each of the plurality of flexible splines.

[0427] 68. The electrophysiology catheter according to clause 67, wherein the superelastic material comprises Nitinol and the Nitinol is configured to form at least one interactive element of the plurality7of interactive elements of the interactive element assembly, preferably the at least one first interactive element distributed on a first surface of each of the plurality of flexible splines.

[0428] 69. The electrophysiology catheter according to clause 68, wherein each spline comprises an insulating material covering at least a portion of the first surface of the spline, wherein at least one exposed portion of the spline corresponds to a first interactive element.

[0429] 70. The electrophysiology catheter according to clause 67, wherein at least one of the interactive elements is formed by disposing the at least one of the interactive elements on a surface of each of the plurality of flexible splines, and wherein the interactive element assembly further comprises:

[0430] 79 SL 879690S.1a plurality of electrical traces disposed on the plurality of flexible splines, each of the plurality of electrical traces coupled with a respective one of the interactive elements; and

[0431] a dielectric material disposed between each of the plurality of electrical traces and the flexible splines.

[0432] 71. The electrophysiology catheter according to clause 67 when dependent on claims 64 to 66, wherein at least one of the interactive elements is formed by disposing the at least one of the interactive elements on to an outer member surface of the tubular polymeric member and wherein the interactive element assembly further comprises: a plurality of electrical traces disposed on an outer member surface of the tubular polymeric member, each of the plurality of electrical traces coupled with a respective one of the interactive elements; and

[0433] a dielectric material disposed between each of the plurality of electrical traces and the outer member surface of the tubular polymeric member.

[0434] 72. The electrophysiology catheter according to clause 67 when dependent on claims 64 to 66, wherein at least one of the interactive elements is formed by disposing the at least one of the interactive elements on to an outer member surface of the tubular polymeric member and wherein the interactive element assembly further comprises: a plurality of electrical traces and a dielectric material embedded within the wall of the tubular polymeric member, each of the plurality of electrical traces coupled with a respective one of the interactive elements.

[0435] 73. The electrophysiology catheter according to clause 67, wherein each spline of the plurality of splines further comprises a polymer substrate, an electrical trace, and an adhesive layer.

[0436] 74. The electrophysiology catheter according to clause 67, wherein the interactive element assembly further comprises at least one flexible circuit, preferably at least one first flexible circuit disposed on a first surface of each of the plurality of flexible splines and / or at least one second flexible circuit disposed on a second surface of each of the plurality of flexible splines.

[0437] 80 SL 879690S.175. The electrophysiology catheter according to clause 74, wherein the flexible circuit comprises:

[0438] a polymeric substrate having an upper surface and an opposed lower surface, wherein at least one interactive element is disposed over at least part of the upper surface of the polymeric substrate; and

[0439] one or more electrical traces i) disposed over at least a portion of the lower surface of the polymeric substrate, and / or

[0440] ii) disposed over at least a portion of the upper surface of the polymeric substrate, and / or

[0441] iii) embedded within the polymeric substrate, the one or more electrical traces being in electrical communication with the at least one interactive elements.

[0442] 76. The electrophysiology catheter according to clause 75, wherein the one or more electrical traces are disposed over at least a portion of the lower surface of the polymeric substrate, further comprising vias to provide the electrical communication between the one or more electrical traces and the at least one interactive element.

[0443] 77. The electrophysiology catheter according to clause 76, further comprising a polymeric layer disposed between the lower surface of the polymeric substrate and the flexible spline, optionally

[0444] wherein the polymeric layer is adhesively and / or thermally secured to a surface of each of the plurality of flexible spline or, when dependent on claims 11 to 13, to an outer member surface of the polymeric tubular member.

[0445] 78. The electrophysiology catheter according to clause 75, wherein the one or more electrical traces are disposed over at least a portion of the upper surface of the polymeric substrate and further comprising a polymeric covering over the upper surface of the polymeric substrate, and wherein the electrical traces with the at least one interactive element are substantially free of the polymeric covering.

[0446] 79. The electrophysiology catheter according to clauses 75 to 78, wherein the lower surface of the polymeric substrate is adhesively and / or thermally bonded to a surface of each of the plurality of flexible splines or, when dependent on claims 64 to 66, to an outer member surface of the polymeric tubular member.

[0447] 81 SL 879690S.180. The electrophysiology catheter according to clause 77 or 79 when dependent on claim 65, wherein the lower surface of the polymeric substrate of a first flexible circuit is secured to the first portion of the outer member surface of the tubular polymeric member, and

[0448] wherein the lower surface of the polymeric substrate of a second flexible circuit is secured to the second portion of the outer member surface of the tubular polymeric member.

[0449] 81. The electrophysiology catheter according to clauses 74 to 80, wherein the first elongate member is a tubular member and at least a portion of the flexible circuit extends into a lumen of the first elongate member.

[0450] 82. The electrophysiology catheter according to clauses 74 to 80, wherein the flexible circuit comprises wings.

[0451] 83. The electrophysiology catheter according to clauses 76 to 82, wherein the flexible circuit has a thickness from about 0.025mm to about 0.254mm.

[0452] 84. The electrophysiology catheter according to any of clauses 71 to 83, wherein each one of the plurality of splines comprises 1 to 16 first interactive elements and 1 to 16 second interactive elements.

[0453] 85. The electrophysiology catheter according to any of clauses 71 to 84, wherein the plurality of interactive elements are selected from one or more of an electrode, an energy delivery element, a temperature sensor, a force sensor, a strain gauge, a strain sensor, a position sensor, a biosensor, a diagnostic sensor, a therapy sensor, a chemical sensor, a light-emitting sensor, an acoustic sensor, an ultrasound sensor, an energy receiving and / or measuring sensor, a magnetic coil or sensor, and a thermoelectric element, preferably, wherein the at least one first interactive elements are electrodes and the plurality of second interactive elements are selected from an electrode and a temperature sensor.

[0454] 86. The electrophysiology catheter according to clause 85, wherein the electrodes comprise a biocompatible, low resistance metal, optionally wherein the electrodes comprise copper, silver, silver-flake, gold, platinum, platinum black, platinumiridium and combinations thereof.

[0455] 82 SL 879690S.187. The electrophysiology catheter according to any of clauses 71 to 86, wherein retraction of the first elongate member within the second elongate tubular member reduces the effective diameter and size of the expandable basket assembly, causing any interactive element within the second elongate tubular member to be turned off.

[0456] 88. The electrophysiology catheter according to any of clauses 71 to 87, wherein each of the plurality of interactive elements has a substantially flat upper surface.

[0457] 89. The electrophysiology catheter according to any one of claims 54 to 88, wherein the distal hub comprises:

[0458] a) an encapsulated and filament-wrapped distal hub comprising an encapsulant and a filament for affixing the distal ends of the splines in a predetermined angular relationship at the distal hub, or

[0459] b) a plurality of spline openings such that each of the splines can couple with the distal hub through one of the plurality of distal hub spline openings, or

[0460] c) an elastomeric material for affixing the distal ends of the splines in a predetermined relationship at the distal hub, or

[0461] d) a flexible material for affixing the distal ends of the splines.

[0462] 90. The electrophysiology catheter of any one of clauses 54 to 89, wherein the first elongate member is a tubular member comprising an irrigation fluid lumen, optionally comprising one or more irrigation ports.

[0463] 91. The electrophysiology catheter of any of one of clauses 54 to 90, wherein the second elongate tubular member comprises an irrigation fluid lumen, wherein the second elongate tubular member comprises one or more irrigation ports.

[0464] 92. The electrophysiology catheter of any one of clauses 54 to 91, wherein the first elongate member comprises at least one magnetic position sensor, and / or, wherein the distal hub comprises at least one magnetic position sensor.

[0465] 93. The electrophysiology catheter of any one of clauses 54 to 92, wherein the distal end of the second elongate tubular member comprises at least one magnetic position sensor.

[0466] 83 SL 879690S.194. The electrophysiology catheter of any one of clauses 54 to 93, wherein the distal hub comprises a distal tip electrode.

[0467] 95. The electrophysiology catheter according to any one of clauses 54 to 94, further comprising a handle coupled to the proximal end of the second elongate tubular member.

[0468] 96. The electrophysiology catheter according to clause 95, wherein the first elongate member is a tubular member comprising an inner lumen, the catheter further comprising:

[0469] a deflection control member coupled with the distal hub and extending through the inner lumen of the first elongate member; and

[0470] wherein the handle comprises a selective movement limiter, wherein the selective movement limiter couples with the deflection control member to limit a longitudinal movement of the deflection control member, wherein the deflection control member is configured to move freely when the selective movement limiter is not coupled with the deflection control member.

[0471] 97. The electrophysiology catheter according to clause 96, wherein the selective movement limiter comprises a first portion and a second portion, where the first portion is in a fixed position and the second portion is movable to engage with the deflection control member by clamping the deflection control member with the first portion in order to limit the longitudinal movement of the deflection control member.

[0472] 98. The electrophysiology catheter according to clause 96, wherein the selective movement limiter comprises a first portion and a second portion, where the first portion and the second portion are movable to engage with the deflection control member by clamping the deflection control member in order to limit the longitudinal movement of the deflection control member.

[0473] 99. The electrophysiology catheter according to any one of clauses 54 to 98, wherein the second elongate tubular member has an inner lumen diameter of at least 2.5 French (0.825 mm), at least 4 French (1.32 mm), at least 6 French (1.98 mm), at least 8 French, preferably 8.5 French (2.805 mm).

[0474] 84 SL 879690S.1100. The electrophysiology catheter according to any one of clauses 54 to 99, further comprising at least one pull wire disposed longitudinally along the length of the second elongate tubular member.

[0475] 101. The electrophysiology catheter according to clause 100, wherein the second elongate tubular member comprises at least one steering ring located at or near its distal end, and wherein the distal end of the at least one pull wire is connected to the at least one steering ring.

[0476] 102. The electrophysiology catheter according to clause 100 when dependent on claim 95, wherein the handle further comprises a steering mechanism and the proximal end of the at least one pull wire is connected to the steering mechanism.

[0477] 103. The electrophysiology catheter according to any one of clauses 100 to 102, wherein the pull wire is a flat wire having a substantially rectangular cross-section and, optionally, having a width of at least 0.178mm and a thickness of at least 0.076mm.

[0478] 104. The electrophysiology catheter according to any one of clauses 95 to 103, wherein the handle comprises a thread and a thread on the proximal end of the first elongate member is configured to interface with the thread on the handle.

[0479] 105. A kit comprising the electrophysiology catheter according to any preceding claim and an introducer catheter, wherein the introducer catheter comprises:

[0480] a tubular inner liner;

[0481] a torque transfer layer surrounding at least a portion of the inner liner, wherein the torque transfer layer comprises at least two braided flat wires; and

[0482] an outer sheath formed over the torque transfer layer;

[0483] wherein the second elongate tubular member of the electrophysiology catheter is configured to be received within the lumen of the tubular inner liner.

[0484] 106. The kit according to clause 105, wherein the braided flat wires are substantially rectangular in cross-section and, optionally, have a width of at least 0.178mm and a thickness of at least 0.076mm.

[0485] 107. The kit according to clause 105 or 106, wherein the tubular inner liner has an inner lumen diameter of at least 6 French, preferably 8.5 French.

[0486] 85 SL 879690S.1108. An electrophysiology catheter comprising:

[0487] a first elongate member comprising a proximal end, an inner lumen and a distal end;

[0488] an expandable assembly comprising:

[0489] a plurality of flexible splines, wherein each spline comprises a respective spline proximal end and a spline distal end, wherein each spline comprises Nitinol, wherein each spline proximal end is coupled to the distal end of the first elongate member;

[0490] wherein the expandable assembly has a radially expanded non-cylindrical shape when deployed;

[0491] and

[0492] an interactive element assembly comprising a plurality of interactive elements; wherein each spline comprises a first surface and a second surface, wherein the first surface of the splines comprises an inner surface and the second surface of the splines comprises an outer surface, wherein the inner spline surface faces the interior of the assembly and the outer spline surface faces the exterior of the assembly when in an undeployed configuration, and

[0493] wherein the Nitinol of the entire first surface of each of the plurality of flexible splines is configured to form a first interactive element of the plurality of interactive elements and wherein a plurality of second interactive elements are distributed on the second surface of each of the plurality of flexible splines.

[0494] 109. The electrophysiology catheter according to clause 108, wherein the expandable assembly comprises a single piece of nitinol forming the plurality of flexible splines.

[0495] 110. The electrophysiology catheter according to clause 108, wherein the expandable assembly comprises a distal hub and wherein each spline distal end is coupled to the distal hub to form the expandable assembly into an expandable basket assembly.

[0496] 111. The electrophysiology catheter according to clause 110, wherein the expandable basket assembly comprises a single piece of nitinol forming the distal hub and the plurality of flexible splines.

[0497] 86 SL 879690S.1112. The electrophysiology catheter according to clause 110 or 111, wherein the expandable basket assembly is a first expandable basket assembly, and the plurality of second interactive elements distributed on the second surface of each of the plurality of flexible splines of the first expandable basket assembly consist of the nitinol of the entire second surface of the plurality7of flexible splines such that the whole of the first expandable basket assembly forms the interactive element assembly; the catheter further comprising:

[0498] a second expandable basket assembly surrounding the first expandable basket assembly, the second expandable basket assembly comprising:

[0499] a second distal hub;

[0500] a second plurality7of flexible splines, wherein each spline comprises a respective spline proximal end and a spline distal end, wherein each spline comprises Nitinol, wherein each spline proximal end is coupled to the distal end of the first elongate member, and wherein each spline distal end is coupled to the second distal hub;

[0501] wherein the second basket assembly has a radially expanded non-cylindrical shape when deployed;

[0502] and

[0503] a second interactive element assembly comprising a plurality of interactive elements;

[0504] wherein each spline of the second plurality of flexible splines comprises a first surface and a second surface, wherein the first surface of the splines comprises an inner surface and the second surface of the splines comprises an outer surface, wherein the inner spline surface faces the interior of the second expandable basket assembly and the outer spline surface faces the exterior of the second expandable basket assembly, and wherein the plurality7of interactive elements of the second interactive element assembly are distributed on the second surface of each of the second plurality of flexible splines of the second expandable basket assembly.

[0505] 113. The electrophysiology catheter according to any one of clauses 108 to 112, wherein each spline comprises an insulating material covering at least a portion of the second surface of the spline, wherein at least one exposed portion of the second surface of the spline corresponds to a second interactive element.

[0506] 87 SL 879690S.1114. The electrophysiology catheter according to any one of clauses 108 to 113, wherein at least one of the plurality of second interactive elements is formed by depositing a material on a second surface of each of the plurality of flexible splines, and wherein the interactive element assembly further comprises;

[0507] a plurality of electrical traces disposed on the second surface of the plurality' of flexible splines, each of the plurality of electrical traces coupled with a respective one of the second interactive elements; and

[0508] a dielectric material disposed between each of the plurality of electrical traces and the second surface of each of the plurality of flexible splines, and

[0509] an adhesive layer.

[0510] 115. The electrophysiology catheter according to any one of clauses 108 to 114, wherein the interactive element assembly further comprises at least one flexible circuit disposed on the second surface of each of the plurality of flexible splines.

[0511] 116. The electrophysiology catheter according to clause 114, wherein the flexible circuit comprises:

[0512] a polymeric substrate having an upper surface and an opposed lower surface, wherein at least one second interactive element is disposed over at least part of the upper surface of the polymeric substrate; and

[0513] one or more electrical traces i) disposed over at least a portion of the lower surface of the polymeric substrate, and / or

[0514] ii) disposed over at least a portion of the upper surface of the polymeric substrate, and / or

[0515] iii) embedded within the polymeric substrate, the one or more electrical traces being in electrical communication with the at least one interactive elements.

[0516] 117. The electrophysiology catheter according to clause 116, wherein the one or more electrical traces are disposed over at least a portion of the lower surface of the polymeric substrate and further comprising vias to provide the electrical communication between the one or more electrical traces and the at least one interactive element.

[0517] 88 SL 879690S.1118. The electrophysiology' catheter according to clause 117, further comprising a polymeric layer disposed between the lower surface of the polymeric substrate and the flexible spline, optionally,

[0518] wherein the polymeric layer is adhesively and / or thermally secured to the second surface of each of the plurality of flexible spline.

[0519] 119. The electrophysiology catheter according to clause 117, wherein the one or more electrical traces are disposed over at least a portion of the upper surface of the polymeric substrate and further comprising a polymeric covering over the upper surface of the polymeric substrate, and wherein the electrical traces with the at least one interactive element are substantially free of the polymeric covering.

[0520] 120. The electrophysiology' catheter according to clauses 117 to 119, wherein the lower surface of the polymeric substrate is adhesively and / or thermally bonded to the second surface of each of the plurality of flexible splines.

[0521] 121. The electrophysiology7catheter according to clauses 115 to 120, wherein at least a portion of the flexible circuit extends into the lumen of the first elongate member.

[0522] 122. The electrophysiology catheter according to clauses 115 to 121 , wherein the flexible circuit comprises wings.

[0523] 123. The electrophysiology catheter according to clauses 115 to 122, wherein the flexible circuit has a thickness from about 0.025mm to about 0.254mm, optionally from about 0.127mm to about 0.203mm.

[0524] 124. The electrophysiology catheter according to any of clauses 108 to 123, wherein each one of the plurality of splines comprises 1 to 16 first interactive elements and 1 to 28 second interactive elements, preferably 7 first interactive elements and 4 second interactive elements, preferably 1 first interactive element and 4 second interactive elements.

[0525] 125. The electrophysiology catheter according to any of clauses 108 to 124, wherein the plurality of interactive elements are selected from one or more of an electrode, an energy’ delivery element, a temperature sensor, a force sensor, a strain gauge, a strain sensor, a position sensor, a biosensor, a diagnostic sensor, a therapy sensor, a chemical

[0526] 89 SL 879690S.1sensor, a light-emiting sensor, an acoustic sensor, an ultrasound sensor, an energy receiving and / or measuring sensor, a magnetic coil or sensor, and a thermoelectric element, preferably wherein the first interactive elements are electrodes and the plurality of second interactive elements are selected from an electrode and a temperature sensor.

[0527] 126. The electrophysiology catheter according to clause 125, wherein the electrodes comprise a biocompatible, low resistance metal, optionally wherein the electrodes comprise copper, silver, silver-flake, gold, platinum, platinum black, platinumiridium and combinations thereof.

[0528] 127. The electrophysiology catheter according to any of clauses 108 to 126, wherein each of the interactive elements has a substantially flat upper surface.

[0529] 128. The electrophysiology catheter according to any of clauses 108 to 127, wherein the Nitinol causes each of the splines to bow outwardly into an expandable basket shape.

[0530] 129. The electrophysiology catheter of any of clauses 108 to 128, wherein the elongate tubular member comprises an irrigation fluid lumen, optionally comprising one or more irrigation ports.

[0531] 130. The electrophysiology catheter of any of clauses 108 to 129, wherein the elongate tubular member comprises at least one magnetic position sensor, and / or, wherein the distal hub comprises at least one magnetic position sensor.

[0532] 131. The electrophysiology catheter of any of clauses 108 to 130, wherein the distal hub comprises a distal tip electrode, preferably a radio-frequency electrode.

[0533] 132. The electrophysiology catheter of any of clauses 108 to 131, wherein the first elongate member comprises at least one electrode at or near the distal end of the first elongate member.

[0534] 133. The electrophysiology catheter according to any of clauses 108 to 132, further comprising a handle coupled to the proximal end of the elongate tubular member.

[0535] 90 SL 879690S.1134. A kit comprising the electrophysiology catheter according to any of clauses 85 to 109 and an introducer catheter, wherein the introducer catheter comprises:

[0536] a tubular inner liner;

[0537] a torque transfer layer surrounding at least a portion of the inner liner, wherein the torque transfer layer comprises at least two braided flat wires; and

[0538] an outer sheath formed over the torque transfer layer;

[0539] wherein the first elongate member of the electrophysiology catheter is configured to be received within the lumen of the tubular inner liner.

[0540] 135. A method of performing a cardiac procedure, the method comprising: introducing an electrophysiology catheter comprising an expandable basket assembly into a patient with the basket assembly slidingly compressed within a second elongate tubular member and having a substantially cylindrical shape within a lumen of the second elongate tubular member;

[0541] advancing the expandable basket assembly passed a distal end of the second elongate tubular member to permit the basket assembly to assume a radially expanded non-cylindrical shape within a cardiac chamber;

[0542] adjusting an effective diameter and / or size of the expanded basket assembly in situ by moving a first elongate member relative to the second elongate tubular member to optimize tissue contact for mapping and / or therapy;

[0543] acquiring cardiac mapping signals using interactive elements on the basket assembly to generate electrograms or mapping data of cardiac tissue; and

[0544] delivering therapeutic energy through one or more electrodes of the basket assembly to form one or more lesions in cardiac tissue, the therapeutic energy’ comprising pulsed field ablation and / or radio-frequency energy.

[0545] 136. The method of clause 135, wherein adjusting the effective diameter and / or size comprises retracting the first elongate member proximally relative to the second elongate tubular member to reduce the effective basket diameter for focal therapy or to increase contact in tight anatomies.

[0546] 137. The method of clauses 135 or 136, wherein mapping signals are acquired using a plurality of mapping electrodes disposed on an outer surface of splines of the basket assembly, the plurality of mapping electrodes having dimensions selected to provide high- 91 SL 879690S.1resolution mapping.

[0547] 138. The method of any one of clauses 135 to 137, further comprising selectively energizing individual electrodes or groups of electrodes of the basket assembly for mapping and / or ablation based on the basket diameter, size, or position.

[0548] 139. The method of any one of clauses 135 to 138, wherein delivering pulsed field ablation comprises applying a voltage in a range from about 50 V to about 10,000 V to generate an electric field sufficient to cause irreversible electroporation, optionally achieving voltage gradients of about 400 V / cm to about 600 V / cm.

[0549] 140. The method of any one of clauses 135 to 139, wherein delivering pulsed field ablation comprises energizing electrodes on an inner surface of the splines to hold an interior of the basket at a single voltage potential such that the electric field emanates outward toward tissue.

[0550] 141. The method of any one of clauses 135 to 140, wherein delivering therapeutic energy comprises energizing electrodes of the basket assembly relative to one or more electrodes on a distal end of the second elongate tubular member to shape an ablation field when the basket is at minimum diameter or retracted.

[0551] 142. The method of any one of clauses 135 to 141 , wherein delivering therapeutic energy comprises energizing electrodes of the basket assembly relative to a patient return patch to produce deeper lesions and protect catheter circuitry.

[0552] 143. The method of any one of clauses 135 to 142, wherein the cardiac procedure includes pulmonary vein isolation achieved by mapping and ablating tissue at or near a pulmonary vein ostium using the adjustable-diameter basket assembly.

[0553] 144. The method of any one of clauses 135 to 143, further comprising irrigating the interior of the basket assembly and / or regions adjacent shaft-mounted electrodes via irrigation ports to manage heat during therapy and / or to support mapping visibility.

[0554] 145. The method of any one of clauses 135 to 144, further comprising using the basket assembly at a larger effective diameter to map a substantial portion of a heart chamber and at a smaller effective diameter to deliver focal lesions in hard-to-reach areas.

[0555] 92 SL 879690S.1146. The method of any one of clauses 135 to 145, wherein the interactive elements comprise ablation electrodes on an inner surface of splines and mapping electrodes and / or temperature sensors on an outer surface of splines, the interactive elements being in electrical communication with a controller or ablation generator.

[0556] 147. The method of any one of clauses 135 to 146. further comprising visualizing the catheter using ultrasound reflections from spline structures and / or radiopaque elements for positioning and lesion assessment during mapping and ablation.

[0557] 148. The method of any one of clauses 135 to 147. wherein mapping and ablation are performed without removing the catheter between mapping, therapy delivery, and verification, thereby reducing overall procedure time.

[0558] 149. The method of any one of clauses 135 to 148, wherein the catheter is navigated and localized in the heart using a positioning / localization system while mapping data are recorded and utilized to guide ablation.

[0559] 150. A method of manufacturing an expandable basket assembly for an electroporation catheter, the method comprising:

[0560] providing a plurality of flexible splines comprising a super-elastic material and having a first surface and a second surface, the first surface configured as an inner surface facing an interior of the expandable basket assembly and the second surface configured as an outer surface facing an exterior of the expandable basket assembly;

[0561] coupling a distal end of each spline to a distal hub and coupling a proximal end of each spline to a distal end of a first elongate member;

[0562] depositing a first portion of an interactive element assembly on the first surface of each of the plurality of flexible splines;

[0563] depositing a second portion of the interactive element assembly on the second surface of each of the plurality of flexible splines,

[0564] wherein depositing the first and second portions comprises depositing at least one flexible circuit including a polymeric substrate and electrical traces, and disposing the flexible circuit so that a first flexible circuit is on the first surface of each spline of the plurality of flexible splines and a second flexible circuit is on the second surface of each spline of the plurality of flexible splines; and

[0565] 93 SL 879690S.1bonding the polymeric substrate of the flexible circuit to the respective spline surface,

[0566] wherein the interactive element assembly comprises a plurality of interactive elements distributed on the first and second surfaces and in electrical communication with the electrical traces; and

[0567] wherein the basket assembly is configured to be slidingly compressed within a second elongate tubular member and to expand to a radially expanded non-cylindrical shape when deployed from the second elongate tubular member.

[0568] 151. The method of clause 150, wherein depositing comprises depositing a dielectric or polymeric substrate onto the spline surfaces and depositing electrodes and / or temperature sensors on top of the dielectric or polymeric substrate on the first and second surfaces.

[0569] 152. The method of clauses 150 or 151, further comprising disposing at least one tubular polymeric member over at least one spline with the spline at least partially within a lumen of the tubular polymeric member, and depositing the first portion of the interactive element assembly on a first portion of an outer surface of the tubular polymeric member facing the basket interior and depositing the second portion on a second portion of the outer surface facing the basket exterior.

[0570] 153. The method of any one of clauses 150 to 152, wherein the super-elastic material comprises nitinol and at least one interactive element is formed by exposing portions of the nitinol at one or both of the first and second surfaces.

[0571] 154. The method of any one of clauses 150 to 153, wherein depositing includes wrapping a flexible circuit with wings around the spline such that a portion of the flexible circuit is distributed on the first surface and a portion is distnbuted on the second surface.

[0572] 155. The method of any one of clauses 150 to 154, wherein the interactive elements include mapping electrodes on the second surface and ablation electrodes on at least one of the first and second surfaces.

[0573] 156. The method of any one of clauses 150 to 155, further comprising configuring the distal hub with spline openings to permit movement of the spline ends during deployment and retraction.

[0574] 94 SL 879690S.1157. The method of any one of clauses 150 to 156, wherein the flexible circuits are bonded using an adhesive selected from polyurethane, cyanoacrylate, polyvinyl acetate, acrylic, polyimide, epoxy, hot melt, or fluoropolymer adhesives, and / or thermally bonded under heat and / or pressure.

[0575] 158. The method of any one of clauses 150 to 157, wherein the electrical traces comprise one or more conductive metal layers selected from copper, gold, platinum, iridium, titanium, and nickel.

[0576] 159. The method ofany one of clauses 150to 158, wherein the plurality of splines form an expandable basket assembly with 2 to 16 splines.

[0577] 95 SL 879690S.1

Claims

CLAIMS1. An electrophysiology catheter, comprising:a first elongate member comprising a lumen, a proximal end and a distal end; an expandable structure with an expanded configuration and a collapsed configuration, the expandable structure comprising a single curved spline having a proximal end and a distal end, a proximal portion, a distal portion and a medial portion therebetween, wherein the spline comprises an outer convex surface, an inner concave surface and two side surfaces, wherein the spline comprises a super-elastic material; wherein the proximal end of the spline is coupled to the distal end of the first elongate member; andat least one first interactive element distributed on the inner concave surface of the curved flexible spline and at least one second interactive element distributed on the outer convex surface of the curved flexible spline.

2. The electrophysiology catheter according to claim 1, wherein when the spline is in the collapsed configuration it is configured to fit inside an elongated medical device.

3. The electrophysiology catheter according to claim 1 or 2, wherein a radius of curvature varies along a length of the curved spline to create a non-uniform curve.

4. The electrophysiology7catheter according to any of claims 1 to 3, wherein a segment length of the expanded curved spline is 10 to 60mm, 20 to 40mm, 30 to 40mm, preferably 20mm.

5. The electrophysiology catheter according to any of claims 1 to 4, wherein a maximum radius of curvature of the expanded curved spline is 5 to 20mm, 10 to 20mm, 10 to 15mm, preferably 15mm.

6. The electrophysiology catheter according to any of claims 1 to 5, wherein an angle that the proximal portion of the curved spline makes with a longitudinal axis of the elongated tubular member is 30 to 60 degrees, 30 to 50 degrees, 30 to 45 degrees, preferably 45 degrees.96 SL 879690S.

17. The electrophysiology' catheter according to any of claims 1 to 6, wherein the proximal portion, distal portion and medial portion of the spline can each comprise interactive elements that can be selectively energized.

8. The electrophysiology7catheter according to any of claims 1 to 7, wherein the proximal end of the spline is rotatably coupled to the distal end of the first elongate member.

9. The electrophysiology catheter according to any of claims 1 to 8, further comprising a deflection control member and a handle:wherein the deflection control member is coupled with the distal end of the curved spline and extending through the inner lumen of the first elongate member, wherein the deflection control member is configured to adjust a stiffness of the curved spline, from a first stiffness to a second stiffness, and maintain the first stiffness or the second stiffness; andwherein the handle comprises a selective movement limiter, wherein the selective movement limiter couples with the deflection control member to limit a longitudinal movement of the deflection control member, wherein the deflection control member is configured to move freely when the selective movement limiter is not coupled with the deflection control member.

10. The electrophysiology7catheter according to any of claims 1 to 9, wherein the super-elastic material of the spline comprises a shape memory material, preferably Nitinol.

11. The electrophysiology catheter according to claim 10, wherein the spline comprises an insulating material covering portions of the spline, wherein at least one exposed portion of the spline corresponds to the a first interactive element and / or at least one other exposed portion of the spline corresponds to the a second interactive element.

12. The electrophysiology7catheter according to any of claims 1 to 11, wherein at least one of the first interactive elements is formed by depositing a material on the inner concave surface of the spline, and / or wherein at least one of the second interactive elements is formed by depositing a material on the outer convex surface of the spline, wherein the 97 SL 879690S.1catheter further comprises:a plurality’ of electrical traces disposed on the spline, each of the plurality of electrical traces coupled with a respective one of the first or second interactive elements; anda dielectric material disposed between each of the plurality of electrical traces and the spline.

13. The electrophysiology catheter according to any of claims 1 to 12, wherein the spline further comprises a polymer substrate, a conductive layer, and an adhesive layer.

14. The electrophysiology catheter according to any of any of claims 1 to 13, further comprising a first flexible circuit and / or a second flexible circuit.

15. The electrophysiology catheter according to claim 14, wherein the first flexible circuit comprises:a polymeric substrate having an upper surface and an opposed lower surface, wherein the at least one first interactive element disposed over at least part of the upper surface of the polymeric substrate; andone or more electrical traces disposed over at least a portion of the lower surface of the polymeric substrate or over at least a portion of the upper surface of the polymeric substrate, the one or more electrical traces being in electrical communication with the at least one first interactive elements, andwherein the second flexible circuit comprises:a polymeric substrate having an upper surface and an opposed lower surface, wherein the at least one second interactive element disposed over at least part of the upper surface of the polymeric substrate; andone or more electrical traces disposed over at least a portion of the lower surface of the polymeric substrate or over at least a portion of the upper surface of the polymeric substrate, the one or more electrical traces being in electrical communication with the at least one second interactive elements.

16. The electrophysiology catheter of claim 15, wherein the lower surface of the polymeric substrate of the first flexible circuit is adhesively and / or thermally bonded to the inner concave surface of the spline, and wherein the lower surface of the polymeric 98 SL 879690S.1substrate of the second flexible circuit is adhesively and / or thermally bonded to the outer convex surface of the spline.

17. The electrophysiology catheter according to claim 15 or 16, wherein the one or more electrical traces are disposed over at least a portion of the lower surface of the polymeric substrate and further comprising vias to provide the electrical communication between the one or more electrical traces and the at least one first interactive elements.

18. The electrophysiology7catheter according to claim 71 , further comprising at least one polymeric member, the polymeric member disposed between the lower surface of the polymeric substrate and the flexible spline, wherein the polymeric member is adhesively and / or thermally secured to the inner concave surface of the spline.

19. The electrophysiology' catheter according to claim 69 or 70, wherein the one or more electrical traces are disposed over at least a portion of the upper surface of the polymeric substrate and further comprising a polymeric covering over the upper surface of the polymeric substrate and the electrical traces with the one or more first / second interactive elements being substantially free of the polymeric covering.

20. The electrophysiology catheter according to claim 69, wherein the expandable structure further comprises a tubular polymeric member, the tubular polymeric member comprising a first open end and an opposed second open end defining an open lumen therein between, the tubular polymeric member comprising an inner member surface and an outer member surface, wherein the spline is at least partially disposed within the lumen of the tubular polymeric member.

21. The electrophysiology catheter according to claim 20, wherein the lower surface of the polymeric substrate of the first flexible circuit is secured to a first portion of the outer member surface of the tubular polymeric member, and wherein the lower surface of the polymeric substrate of the second flexible circuit is secured to a second portion of the outer member surface of the tubular polymeric member.

22. The electrophysiology catheter according to any of claims 1 to 21, wherein the one or more first interactive elements and the one or more second interactive elements 99 SL 879690S.1are selected from one or more of an electrode, an energy delivery element, a temperature sensor, a force sensor, a strain gauge, a strain sensor, a position sensor, a biosensor, a diagnostic sensor, a therapy sensor, a chemical sensor, a light-emitting sensor, an acoustic sensor, an ultrasound sensor, an energy receiving and / or measuring sensor, a magnetic coil or sensor, and a thermoelectric element.

23. The electrophysiology catheter according to claim 22, wherein the electrodes comprise copper, gold, platinum, platinum black, platinum-iridium and combinations thereof.

24. The electrophysiology catheter according to any of claims 1 to 23, wherein the interactive element, the at least one first interactive elements and / or the at least one second interactive elements have a substantially flat upper surface.

25. The electrophysiology catheter according to any of claims 1 to 24, wherein the first elongate member further comprises an irrigation fluid lumen, wherein the first elongate member comprises one or more irrigation ports.

26. The electrophysiology catheter according to any of claims 1 to 25, wherein the first elongate member comprises at least one magnetic position sensor.

27. The electrophysiology7catheter according to any of claims 1 to 26, wherein the spline comprises 1 to 16 first interactive elements and 1 to 16 second interactive elements, preferably 8 first interactive elements and 8 second interactive elements, preferably 1 first interactive element and 8 second interactive elements.

28. The electrophysiology catheter according to any of claims 1 to 27, further comprising at least one pull wire disposed longitudinally along the length of the first elongate member.

29. The electrophysiology catheter according to claim 28, wherein the first elongate member comprises at least one steering ring located at or near its distal end, and wherein the distal end of the at least one pull wire is connected to the at least one steering ring.100 SL 879690S.

130. The electrophysiology catheter according to claim 29 further comprising a handle, wherein the handle further comprises a steering mechanism and the proximal end of the at least one pull wire is connected to the steering mechanism.

31. The electrophysiology catheter according to any of claims 1 to 30, further comprising a second elongate tubular member having a proximal end coupled to the proximal end of the first elongate member.

32. The electrophysiology catheter according to claim 31, wherein the proximal end of the second elongate tubular member comprising a thread and the proximal end of the first elongate member comprises a thread configured to couple with the thread of the second elongate tubular member, and wherein threading of the proximal end of the first elongate member into the second elongate tubular member increases an effective curvature and size of the spline.

33. The electrophysiology catheter according to claims 31 or 32, wherein a position of the proximal end of the first elongate member relative to the proximal end of the second elongate tubular member can be manually controlled to adjust an effective curvature and size of the spline.

34. The electrophysiology catheter according to any one of claims 31 to 33, further comprising a detection mechanism configured to detect the position of the first elongate member relative to the second elongate tubular member, such that the size and curvature of the spline can be determined.

35. The electrophysiology catheter according to any of claims 1 to 34 wherein the super-elastic material causes the spline to bow outwardly into the expanded configuration.

36. The electrophysiology catheter according to any of claims 1 to 35, wherein the super-elastic material comprises Nitinol and the Nitinol is configured to form at least one interactive element, preferably the at least one first interactive element distributed on the inner concave surface of the curved spline.101 SL 879690S.

137. The electrophysiology catheter according to any of claims 14 to 36, wherein the first elongate member is a tubular member and at least a portion of the first flexible circuit extends into a lumen of the first elongate member.

38. The electrophysiology catheter according to any of claims 14 to 37, wherein the first flexible circuit or the second flexible circuit comprises wings.

39. The electrophysiology7catheter according to any of claims 14 to 38, wherein the first flexible circuit has a thickness from about 0.025mm to about 0.254mm.

40. The electrophysiology catheter according to any of claims 22 to 39, wherein the electrodes comprise a biocompatible, low resistance metal, optionally wherein the electrodes comprise copper, silver, silver-flake, gold, platinum, platinum black, platinumiridium and combinations thereof.

41. The electrophysiology catheter according to any of claims 31 to 40, wherein retraction of the first elongate member within the second elongate tubular member reduces the effective curvature and size of the expanded spline, causing any interactive element within the second elongate tubular member to be turned off.

42. The electrophysiology7catheter according to any of claims 1 to 42, yvherein the at least one first interactive element and / or the at least one second interactive element has a substantially flat upper surface.

43. The electrophysiology catheter according to any of claims 31 to 42, yvherein the second elongate tubular member comprises an irrigation fluid lumen, wherein the second elongate tubular member comprises one or more irrigation ports.

44. The electrophysiology catheter according to any of claims 31 to 43, yvherein a distal end of the second elongate tubular member comprises at least one magnetic position sensor.

45. The electrophysiology catheter according to any of claims 9 to 44, yvherein 102 SL 879690S.1the selective movement limiter comprises a first portion and a second portion, where the first portion is in a fixed position and the second portion is movable to engage with the deflection control member by clamping the deflection control member with the first portion in order to limit the longitudinal movement of the deflection control member.

46. The electrophysiology catheter according to any of claims 9 to 45, wherein the selective movement limiter comprises a first portion and a second portion, where the first portion and the second portion are movable to engage with the deflection control member by clamping the deflection control member in order to limit the longitudinal movement of the deflection control member.

47. The electrophysiology catheter according to any of claims 31 to 46, wherein the second elongate tubular member has an inner lumen diameter of at least 2.5 French (0.825 mm), at least 4 French (1.32 mm), at least 6 French (1.98 mm), at least 8 French.

48. The electrophysiology catheter according to any of claims 31 to 47, further comprising at least one pull wire disposed longitudinally along the length of the second elongate tubular member.

49. The electrophysiology catheter according to claim 48, wherein the second elongate tubular member comprises at least one steering ring located at or near its distal end, and wherein the distal end of the at least one pull wire is connected to the at least one steering ring.

50. The electrophysiology catheter according to claim 48 when dependent on claim 30, wherein the handle further comprises a steering mechanism and the proximal end of the at least one pull wire is connected to the steering mechanism.

51. The electrophysiology catheter according to claim 48 to 50, wherein the pull wire is a flat wire having a substantially rectangular cross-section and, optionally, having a width of at least 0.178mm and a thickness of at least 0.076mm.

52. The electrophysiology catheter according to any one of claims 31 to 51, further comprising an handle coupled to the proximal end of the second elongate tubular 103 SL 879690S.1member.

53. The electrophysiology catheter according to claim 52, wherein the handle comprises a thread and a thread on the proximal end of the first elongate member is configured to interface with the thread on the handle.

54. An electrophysiology catheter comprising:a first elongate member comprising a proximal end and a distal end;an expandable basket assembly comprising:a distal hub;a plurality of flexible splines, wherein each spline comprises a respective spline proximal end and a spline distal end, wherein each spline comprises a super-elastic material, wherein each spline proximal end is coupled to the distal end of the first elongate member, and wherein each spline distal end is coupled to the distal hub;andan interactive element assembly; anda second elongate tubular member comprising a lumen, a proximal end and a distal end, wherein the second elongate tubular member is configured to receive the first elongate member; andwherein the expandable basket assembly is slidingly compressible to fit within the lumen of the second elongate tubular member and to adjust an effective diameter and size of the basket, wherein the expandable basket assembly has a substantially cylindrical shape when compressed within the lumen of the second elongate tubular member; and wherein the expandable basket assembly has a radially expanded non-cylindrical shape when not compressed within the lumen of the second elongate tubular member and at least partially disposed past the distal end of the second elongate tubular member, wherein retraction of the first elongate member within the second elongate tubular member reduces the effective diameter and size of the expandable basket assembly.

55. The electrophysiology catheter of claim 54, wherein the proximal end of the first elongate member is coupled to the proximal end of the second elongate tubular member.

56. The electrophysiology catheter of claim 55, wherein the proximal end of the 104 SL 879690S.1second elongate tubular member comprises a thread and the proximal end of the first elongated member comprises a thread configured to couple with the thread of the second elongate tubular member, and wherein threading of the proximal end of the first elongate member into the second elongate tubular member increases the effective diameter and size of the basket.

57. The electrophysiology catheter of claim 54, claim 55, or claim 56, wherein a position of the proximal end of the first elongate member relative to the proximal end of the second elongate tubular member can be manually controlled to adjust an effective diameter and size of the expandable basket assembly.

58. The electrophysiology catheter according to any one of claims 54 to 57, wherein the catheter comprises a detection mechanism configured to detect the position of the first elongate member relative to the second elongate tubular member, such that the size and diameter of the expandable basket assembly can be determined.

59. The electrophysiology catheter according to any one of claims 54 to 58, wherein the diameter of the radially expanded basket assembly can be adjusted between 2 to 50mm, 3 to 36mm, 15 to 28mm, 10 to 12mm, 5 to 9mm, 3 to 5mm.

60. The electrophysiology catheter according to any one of claims 54 to 59, wherein the shape of the radially expanded basket assembly is approximated to a sphere and the volume of the basket assembly can be adjusted between 4.19xl0'3to 65.45cm3, 0.014 to 7.24cm3, 1.77 to 3.05cm3, 0.52 to 0.9cm3, 0.065 to 0.38cm3, 0.014 to 0.065 cm3.

61. The electrophysiology catheter according to any one of claims 54 to 60, wherein the super-elastic material causes each of the splines to bow outwardly into the radially expanded basket shape.

62. The electrophysiology catheter according to any one of claims 54 to 61, wherein the super-elastic material comprises a shape memory material, preferably Nitinol.

63. The electrophysiology catheter according to any one of claims 54 to 62, wherein each spline comprises a first surface and a second surface, wherein the first surface 105 SL 879690S.1of the splines comprises an inner surface and the second surface of the splines comprises an outer surface, wherein the inner surface faces the interior of the expandable basket assembly and the outer spline surface faces the exterior of the expandable basket assembly.

64. The electrophysiology catheter according to any one of claims 54 to 63, wherein the expandable basket assembly further comprises at least one tubular polymeric member, each tubular polymeric member comprising a first open end and an opposed second open end defining an open lumen therein between, the tubular polymeric member comprising an inner member surface and an outer member surface, wherein at least one of the plurality of flexible splines is at least partially disposed within the lumen of the tubular polymeric member.

65. The electrophysiology catheter according to claim 64, wherein a first portion of the outer member surface of the tubular polymeric member predominantly faces the interior of the expandable basket assembly and a second portion of the outer member surface of the tubular polymeric member predominantly faces the exterior of the expandable basket assembly.

66. An electrophysiology catheter according to any of claims 64 or 65, further comprising:a plurality of tubular polymeric members;wherein each of the plurality of flexible splines are at least partially disposed within a different one of the plurality of tubular polymeric members.

67. The electrophysiology catheter according to any one of claims 54 to 66, wherein the interactive element assembly comprises a plurality' of interactive elements distributed on the plurality of flexible splines, at least one first interactive element of the plurality of interactive elements is distributed on a first surface of each of the plurality of flexible splines.

68. The electrophysiology catheter according to claim 67, wherein the superelastic material comprises Nitinol and the Nitinol is configured to form at least one interactive element of the plurality of interactive elements of the interactive element assembly, preferably the at least one first interactive element distributed on a first surface 106 SL 879690S.1of each of the plurality of flexible splines.

69. The electrophysiology catheter according to claim 68, wherein each spline comprises an insulating material covering at least a portion of the first surface of the spline, wherein at least one exposed portion of the spline corresponds to a first interactive element.

70. The electrophysiology catheter according to claim 67, wherein at least one of the interactive elements is formed by disposing the at least one of the interactive elements on a surface of each of the plurality of flexible splines, and wherein the interactive element assembly further comprises:a plurality of electrical traces disposed on the plurality of flexible splines, each of the plurality of electrical traces coupled with a respective one of the interactive elements; anda dielectric material disposed between each of the plurality of electrical traces and the flexible splines.

71. The electrophysiology catheter according to claim 67 when dependent on claims 64 to 66, wherein at least one of the interactive elements is formed by disposing the at least one of the interactive elements on to an outer member surface of the tubular polymeric member and wherein the interactive element assembly further comprises: a plurality of electrical traces disposed on an outer member surface of the tubular polymeric member, each of the plurality of electrical traces coupled with a respective one of the interactive elements; anda dielectric material disposed between each of the plurality of electrical traces and the outer member surface of the tubular polymeric member.

72. The electrophysiology7catheter according to claim 67 when dependent on claims 64 to 66, wherein at least one of the interactive elements is formed by disposing the at least one of the interactive elements on to an outer member surface of the tubular polymeric member and wherein the interactive element assembly further comprises: a plurality of electrical traces and a dielectric material embedded within the wall of the tubular polymeric member, each of the plurality of electrical traces coupled with a respective one of the interactive elements.107 SL 879690S.

173. The electrophysiology' catheter according to claim 67, wherein each spline of the plurality of splines further comprises a polymer substrate, an electrical trace, and an adhesive layer.

74. The electrophysiology catheter according to claim 67, wherein the interactive element assembly further comprises at least one flexible circuit, preferably at least one first flexible circuit disposed on a first surface of each of the plurality of flexible splines and / or at least one second flexible circuit disposed on a second surface of each of the plurality7of flexible splines.

75. The electrophysiology catheter according to claim 74. wherein the flexible circuit comprises:a polymeric substrate having an upper surface and an opposed lower surface, wherein at least one interactive element is disposed over at least part of the upper surface of the polymeric substrate; andone or more electrical traces i) disposed over at least a portion of the lower surface of the polymeric substrate, and / orii) disposed over at least a portion of the upper surface of the polymeric substrate, and / oriii) embedded within the polymeric substrate, the one or more electrical traces being in electrical communication with the at least one interactive elements.

76. The electrophysiology catheter according to claim 75, wherein the one or more electrical traces are disposed over at least a portion of the lower surface of the polymeric substrate, further comprising vias to provide the electrical communication between the one or more electrical traces and the at least one interactive element.

77. The electrophysiology catheter according to claim 76, further comprising a polymeric layer disposed between the lower surface of the polymenc substrate and the flexible spline, optionallywherein the polymeric layer is adhesively and / or thermally secured to a surface of each of the plurality' of flexible spline or, when dependent on claims 11 to 13, to an outer member surface of the polymeric tubular member.108 SL 879690S.

178. The electrophysiology catheter according to claim 75, wherein the one or more electrical traces are disposed over at least a portion of the upper surface of the polymeric substrate and further comprising a polymeric covering over the upper surface of the polymeric substrate, and wherein the electrical traces with the at least one interactive element are substantially free of the polymeric covering.

79. The electrophysiology catheter according to claims 75 to 78, wherein the lower surface of the polymeric substrate is adhesively and / or thermally bonded to a surface of each of the plurality of flexible splines or, when dependent on claims 64 to 66, to an outer member surface of the polymeric tubular member.

80. The electrophysiology catheter according to claim 77 or 79 when dependent on claim 65, wherein the lower surface of the polymeric substrate of a first flexible circuit is secured to the first portion of the outer member surface of the tubular polymeric member, andwherein the lower surface of the polymeric substrate of a second flexible circuit is secured to the second portion of the outer member surface of the tubular polymeric member.

81. The electrophysiology catheter according to claims 74 to 80, wherein the first elongate member is a tubular member and at least a portion of the flexible circuit extends into a lumen of the first elongate member.

82. The electrophysiology catheter according to claims 74 to 80, wherein the flexible circuit comprises wings.

83. The electrophysiology catheter according to claims 76 to 82, wherein the flexible circuit has a thickness from about 0.025mm to about 0.254mm.

84. The electrophysiology catheter according to any of claims 71 to 83, wherein each one of the plurality of splines comprises 1 to 16 first interactive elements and 1 to 16 second interactive elements.

85. The electrophysiology catheter according to any of claims 71 to 84, wherein 109 SL 879690S.1the plurality of interactive elements are selected from one or more of an electrode, an energy delivery element, a temperature sensor, a force sensor, a strain gauge, a strain sensor, a position sensor, a biosensor, a diagnostic sensor, a therapy sensor, a chemical sensor, a light-emitting sensor, an acoustic sensor, an ultrasound sensor, an energy receiving and / or measuring sensor, a magnetic coil or sensor, and a thermoelectric element, preferably, wherein the at least one first interactive elements are electrodes and the plurality of second interactive elements are selected from an electrode and a temperature sensor.

86. The electrophysiology catheter according to claim 85, wherein the electrodes comprise a biocompatible, low resistance metal, optionally wherein the electrodes comprise copper, silver, silver-flake, gold, platinum, platinum black, platinumiridium and combinations thereof.

87. The electrophysiology catheter according to any of claims 71 to 86, wherein retraction of the first elongate member within the second elongate tubular member reduces the effective diameter and size of the expandable basket assembly, causing any interactive element within the second elongate tubular member to be turned off.

88. The electrophysiology catheter according to any of claims 71 to 87, wherein each of the plurality of interactive elements has a substantially flat upper surface.

89. The electrophysiology catheter according to any one of claims 54 to 88, wherein the distal hub comprises:e) an encapsulated and filament-wrapped distal hub comprising an encapsulant and a filament for affixing the distal ends of the splines in a predetermined angular relationship at the distal hub, orf) a plurality' of spline openings such that each of the splines can couple with the distal hub through one of the plurality of distal hub spline openings, org) an elastomeric material for affixing the distal ends of the splines in a predetermined relationship at the distal hub, orh) a flexible material for affixing the distal ends of the splines.

90. The electrophysiology catheter of any one of claims 54 to 89, wherein the first elongate member is a tubular member comprising an irrigation fluid lumen, optionally 11b SL 879690S.1comprising one or more irrigation ports.

91. The electrophysiology catheter of any of one of claims 54 to 90, wherein the second elongate tubular member comprises an irrigation fluid lumen, wherein the second elongate tubular member comprises one or more irrigation ports.

92. The electrophysiology catheter of any one of claims 54 to 91, wherein the first elongate member comprises at least one magnetic position sensor, and / or, wherein the distal hub comprises at least one magnetic position sensor.

93. The electrophysiology catheter of any one of claims 54 to 92, wherein the distal end of the second elongate tubular member comprises at least one magnetic position sensor.

94. The electrophysiology catheter of any one of claims 54 to 93, wherein the distal hub comprises a distal tip electrode.

95. The electrophysiology catheter according to any one of claims 54 to 94, further comprising a handle coupled to the proximal end of the second elongate tubular member.

96. The electrophysiology catheter according to claim 95, wherein the first elongate member is a tubular member comprising an inner lumen, the catheter further comprising;a deflection control member coupled with the distal hub and extending through the inner lumen of the first elongate member; andwherein the handle comprises a selective movement limiter, wherein the selective movement limiter couples with the deflection control member to limit a longitudinal movement of the deflection control member, wherein the deflection control member is configured to move freely when the selective movement limiter is not coupled with the deflection control member.

97. The electrophysiology catheter according to claim 96, wherein the selective movement limiter comprises a first portion and a second portion, where the first portion is 111 SL 879690S.1in a fixed position and the second portion is movable to engage with the deflection control member by clamping the deflection control member with the first portion in order to limit the longitudinal movement of the deflection control member.

98. The electrophysiology catheter according to claim 96, wherein the selective movement limiter comprises a first portion and a second portion, where the first portion and the second portion are movable to engage with the deflection control member by clamping the deflection control member in order to limit the longitudinal movement of the deflection control member.

99. The electrophysiology catheter according to any one of claims 54 to 98, wherein the second elongate tubular member has an inner lumen diameter of at least 2.5 French (0.825 mm), at least 4 French (1.32 mm), at least 6 French (1.98 mm), at least 8 French, preferably 8.5 French (2.805 mm).

100. The electrophysiology catheter according to any one of claims 54 to 99, further comprising at least one pull wire disposed longitudinally along the length of the second elongate tubular member.

101. The electrophysiology catheter according to claim 100, wherein the second elongate tubular member comprises at least one steering ring located at or near its distal end, and wherein the distal end of the at least one pull wire is connected to the at least one steering ring.

102. The electrophysiology catheter according to claim 100 when dependent on claim 44, wherein the handle further comprises a steering mechanism and the proximal end of the at least one pull wire is connected to the steering mechanism.

103. The electrophysiology catheter according to claim 100 to 102, wherein the pull wire is a flat wire having a substantially rectangular cross-section and, optionally, having a width of at least 0.178mm and a thickness of at least 0.076mm.

104. The electrophysiology catheter according to any one of claims 95 to 103, wherein the handle comprises a thread and a thread on the proximal end of the first elongate 112 SL 879690S.1member is configured to interface with the thread on the handle.

105. A kit comprising the electrophysiology catheter according to any preceding claim and an introducer catheter, wherein the introducer catheter comprises:a tubular inner liner;a torque transfer layer surrounding at least a portion of the inner liner, wherein the torque transfer layer comprises at least two braided flat wires: andan outer sheath formed over the torque transfer layer;wherein the second elongate tubular member of the electrophysiology catheter is configured to be received within the lumen of the tubular inner liner.

106. The kit according to claim 105, wherein the braided flat wires are substantially rectangular in cross-section and, optionally, have a width of at least 0.178mm and a thickness of at least 0.076mm.

107. The kit according to claim 105 to 106, wherein the tubular inner liner has an inner lumen diameter of at least 6 French, preferably 8.5 French.

108. An electrophysiology- catheter comprising:a first elongate member comprising a proximal end, an inner lumen and a distal end:an expandable assembly comprising:a plurality of flexible splines, wherein each spline comprises a respective spline proximal end and a spline distal end, wherein each spline comprises Nitinol, wherein each spline proximal end is coupled to the distal end of the first elongate member;wherein the expandable assembly has a radially expanded non-cylindrical shape when deployed; andan interactive element assembly comprising a plurality- of interactive elements; wherein each spline comprises a first surface and a second surface, wherein the first surface of the splines comprises an inner surface and the second surface of the splines comprises an outer surface, yvherein the inner spline surface faces the interior of the assembly and the outer spline surface faces the exterior of the assembly when in an undeployed configuration, and113 SL 879690S.1wherein the Nitinol of the entire first surface of each of the plurality of flexible splines is configured to form a first interactive element of the plurality of interactive elements and wherein a plurality of second interactive elements are distributed on the second surface of each of the plurality of flexible splines.

109. The electrophysiology catheter according to claim 108, wherein the expandable assembly comprises a single piece of nitinol forming the plurality of flexible splines.

110. The electrophysiology catheter according to claim 108, wherein the expandable assembly comprises a distal hub and wherein each spline distal end is coupled to the distal hub to form the expandable assembly into an expandable basket assembly.

111. The electrophysiology catheter according to claim 110, wherein the expandable basket assembly comprises a single piece of nitinol forming the distal hub and the plurality of flexible splines.

112. The electrophysiology7catheter according to claim 110 or 111, wherein the expandable basket assembly is a first expandable basket assembly, and the plurality of second interactive elements distributed on the second surface of each of the plurality7of flexible splines of the first expandable basket assembly consist of the nitinol of the entire second surface of the plurality7of flexible splines such that the whole of the first expandable basket assembly forms the interactive element assembly; the catheter further comprising:a second expandable basket assembly surrounding the first expandable basket assembly, the second expandable basket assembly comprising:a second distal hub;a second plurality7of flexible splines, wherein each spline comprises a respective spline proximal end and a spline distal end, wherein each spline comprises Nitinol, wherein each spline proximal end is coupled to the distal end of the first elongate member, and wherein each spline distal end is coupled to the second distal hub;wherein the second basket assembly has a radially expanded non-cylindrical shape when deployed;anda second interactive element assembly comprising a plurality of interactive 114 SL 879690S.1elements:wherein each spline of the second plurality of flexible splines comprises a first surface and a second surface, wherein the first surface of the splines comprises an inner surface and the second surface of the splines comprises an outer surface, wherein the inner spline surface faces the interior of the second expandable basket assembly and the outer spline surface faces the exterior of the second expandable basket assembly, and wherein the plurality of interactive elements of the second interactive element assembly are distributed on the second surface of each of the second plurality of flexible splines of the second expandable basket assembly.

113. The electrophysiology catheter according to any one of claims 108 to 112, wherein each spline comprises an insulating material covering at least a portion of the second surface of the spline, wherein at least one exposed portion of the second surface of the spline corresponds to a second interactive element.

114. The electrophysiology catheter according to claim 108 to 113, wherein at least one of the plurality of second interactive elements is formed by depositing a material on a second surface of each of the plurality of flexible splines, and wherein the interactive element assembly further comprises;a plurality of electrical traces disposed on the second surface of the plurality of flexible splines, each of the plurality of electrical traces coupled with a respective one of the second interactive elements; anda dielectric material disposed between each of the plurality' of electrical traces and the second surface of each of the plurality of flexible splines, andan adhesive layer.

115. The electrophysiology catheter according to claim 108 to 114, wherein the interactive element assembly further comprises at least one flexible circuit disposed on the second surface of each of the plurality of flexible splines.

116. The electrophysiology7catheter according to claim 115, wherein the flexible circuit comprises:a polymeric substrate having an upper surface and an opposed lower surface, wherein at least one second interactive element is disposed over at least part of the upper 115 SL 879690S.1surface of the polymeric substrate; andone or more electrical traces i) disposed over at least a portion of the lower surface of the polymeric substrate, and / orii) disposed over at least a portion of the upper surface of the polymeric substrate, and / oriii) embedded within the polymeric substrate, the one or more electrical traces being in electrical communication with the at least one interactive elements.

117. The electrophysiology catheter according to claim 116, wherein the one or more electrical traces are disposed over at least a portion of the lower surface of the polymeric substrate and further comprising vias to provide the electrical communication between the one or more electrical traces and the at least one interactive element.

118. The electrophysiology catheter according to claim 117, further comprising a polymeric layer disposed between the lower surface of the polymeric substrate and the flexible spline, optionally,wherein the polymeric layer is adhesively and / or thermally secured to the second surface of each of the plurality' of flexible spline.

119. The electrophysiology catheter according to claim 116, wherein the one or more electrical traces are disposed over at least a portion of the upper surface of the polymeric substrate and further comprising a polymeric covering over the upper surface of the polymeric substrate, and wherein the electrical traces with the at least one interactive element are substantially free of the polymeric covering.

120. The electrophysiology catheter according to claims 116 to 119, wherein the lower surface of the polymeric substrate is adhesively and / or thermally bonded to the second surface of each of the plurality of flexible splines.

121. The electrophysiology catheter according to claims 115 to 120, wherein at least a portion of the flexible circuit extends into the lumen of the first elongate member.

122. The electrophysiology catheter according to claims 115 to 121, wherein the flexible circuit comprises wings.116 SL 879690S.1123. The electrophysiology catheter according to claims 115 to 122, wherein the flexible circuit has a thickness from about 0.025mm to about 0.254mm, optionally from about 0.127mm to about 0.203mm.

124. The electrophysiology catheter according to any of claims 108 to 123, wherein each one of the plurality of splines comprises 1 to 16 first interactive elements and 1 to 28 second interactive elements, preferably 7 first interactive elements and 4 second interactive elements, preferably 1 first interactive element and 4 second interactive elements.

125. The electrophysiology catheter according to any of claims 109 to 125, wherein the plurality of interactive elements are selected from one or more of an electrode, an energy delivery element, a temperature sensor, a force sensor, a strain gauge, a strain sensor, a position sensor, a biosensor, a diagnostic sensor, a therapy sensor, a chemical sensor, a light-emitting sensor, an acoustic sensor, an ultrasound sensor, an energy receiving and / or measuring sensor, a magnetic coil or sensor, and a thermoelectric element, preferably wherein the first interactive elements are electrodes and the plurality of second interactive elements are selected from an electrode and a temperature sensor.

126. The electrophysiology catheter according to claim 125, wherein the electrodes comprise a biocompatible, low resistance metal, optionally wherein the electrodes comprise copper, silver, silver-flake, gold, platinum, platinum black, platinumiridium and combinations thereof.

127. The electrophysiology catheter according to any of claims 108 to 126, wherein each of the interactive elements has a substantially flat upper surface.

128. The electrophysiology catheter according to any of claims 108 to 127, wherein the Nitinol causes each of the splines to bow outwardly into an expandable basket shape.

129. The electrophysiology catheter of any of claims 108 to 128. wherein the elongate tubular member comprises an irrigation fluid lumen, optionally comprising one or 117 SL 879690S.1more irrigation ports.

130. The electrophysiology catheter of any of claims 108 to 129, wherein the elongate tubular member comprises at least one magnetic position sensor, and / or, wherein the distal hub comprises at least one magnetic position sensor.

131. The electrophysiology catheter of any of claims 108 to 130, wherein the distal hub comprises a distal tip electrode, preferably a radio-frequency electrode.

132. The electrophysiology catheter of any of claims 108 to 131, wherein the first elongate member comprises at least one electrode at or near the distal end of the first elongate member.

133. The electrophysiology catheter according to any of claims 108 to 132, further comprising a handle coupled to the proximal end of the elongate tubular member.

134. A kit comprising the electrophysiology catheter according to any of claims 85 to 109 and an introducer catheter, wherein the introducer catheter comprises:a tubular inner liner;a torque transfer layer surrounding at least a portion of the inner liner, wherein the torque transfer layer comprises at least two braided flat wires; andan outer sheath formed over the torque transfer layer;wherein the first elongate member of the electrophysiology catheter is configured to be received within the lumen of the tubular inner liner.

135. A method of performing a cardiac procedure, the method comprising: introducing an electrophysiology catheter comprising an expandable basket assembly into a patient with the basket assembly slidingly compressed within a second elongate tubular member and having a substantially cylindrical shape within a lumen of the second elongate tubular member;advancing the expandable basket assembly passed a distal end of the second elongate tubular member to permit the basket assembly to assume a radially expanded non-cylindrical shape within a cardiac chamber;118 SL 879690S.1adjusting an effective diameter and / or size of the expanded basket assembly in situ by moving a first elongate member relative to the second elongate tubular member to optimize tissue contact for mapping and / or therapy;acquiring cardiac mapping signals using interactive elements on the basket assembly to generate electrograms or mapping data of cardiac tissue; anddelivering therapeutic energy through one or more electrodes of the basket assembly to form one or more lesions in cardiac tissue, the therapeutic energy comprising pulsed field ablation and / or radio-frequency energy.

136. The method of claim 135, wherein adjusting the effective diameter and / or size comprises retracting the first elongate member proximally relative to the second elongate tubular member to reduce the effective basket diameter for focal therapy or to increase contact in tight anatomies.

137. The method of claims 135 or 136, wherein mapping signals are acquired using a plurality of mapping electrodes disposed on an outer surface of splines of the basket assembly, the plurality of mapping electrodes having dimensions selected to provide high-resolution mapping.

138. The method of any one of claims 135 to 137. further comprising selectively energizing individual electrodes or groups of electrodes of the basket assembly for mapping and / or ablation based on the basket diameter, size, or position.

139. The method of any one of claims 135 to 138, wherein delivering pulsed field ablation comprises applying a voltage in a range from about 50 V to about 10,000 V to generate an electric field sufficient to cause irreversible electroporation, optionally achieving voltage gradients of about 400 V / cm to about 600 V / cm.

140. The method of any one of claims 135 to 139, wherein delivering pulsed field ablation comprises energizing electrodes on an inner surface of the splines to hold an interior of the basket at a single voltage potential such that the electric field emanates outward toward tissue.

141. The method of any one of claims 135 to 140, wherein delivering therapeutic 119 SL 879690S.1energy comprises energizing electrodes of the basket assembly relative to one or more electrodes on a distal end of the second elongate tubular member to shape an ablation field when the basket is at minimum diameter or retracted.

142. The method of any one of claims 135 to 141, wherein delivering therapeutic energy comprises energizing electrodes of the basket assembly relative to a patient return patch to produce deeper lesions and protect catheter circuitry.

143. The method of any one of claims 135 to 142, wherein the cardiac procedure includes pulmonary vein isolation achieved by mapping and ablating tissue at or near a pulmonary vein ostium using the adjustable-diameter basket assembly.

144. The method of any one of claims 135 to 143, further comprising irrigating the interior of the basket assembly and / or regions adjacent shaft-mounted electrodes via irrigation ports to manage heat during therapy and / or to support mapping visibility.

145. The method of any one of claims 135 to 144, further comprising using the basket assembly at a larger effective diameter to map a substantial portion of a heart chamber and at a smaller effective diameter to deliver focal lesions in hard-to-reach areas.

146. The method of any one of claims 135 to 145, wherein the interactive elements comprise ablation electrodes on an inner surface of splines and mapping electrodes and / or temperature sensors on an outer surface of splines, the interactive elements being in electrical communication with a controller or ablation generator.

147. The method of any one of claims 135 to 146, further comprising visualizing the catheter using ultrasound reflections from spline structures and / or radiopaque elements for positioning and lesion assessment during mapping and ablation.

148. The method of any one of claims 135 to 147, wherein mapping and ablation are performed without removing the catheter between mapping, therapy delivery, and verification, thereby reducing overall procedure time.

149. The method of any one of claims 135 to 148, wherein the catheter is 120 SL 879690S.1navigated and localized in the heart using a positioning / localization system while mapping data are recorded and utilized to guide ablation.

150. A method of manufacturing an expandable basket assembly for an electroporation catheter, the method comprising:providing a plurality of flexible splines comprising a super-elastic material and having a first surface and a second surface, the first surface configured as an inner surface facing an interior of the expandable basket assembly and the second surface configured as an outer surface facing an exterior of the expandable basket assembly;coupling a distal end of each spline to a distal hub and coupling a proximal end of each spline to a distal end of a first elongate member;depositing a first portion of an interactive element assembly on the first surface of each of the plurality of flexible splines;depositing a second portion of the interactive element assembly on the second surface of each of the plurality of flexible splines,wherein depositing the first and second portions comprises depositing at least one flexible circuit including a polymeric substrate and electrical traces, and disposing the flexible circuit so that a first flexible circuit is on the first surface of each spline of the plurality of flexible splines and a second flexible circuit is on the second surface of each spline of the plurality of flexible splines; andbonding the polymeric substrate of the flexible circuit to the respective spline surface,wherein the interactive element assembly comprises a plurality of interactive elements distributed on the first and second surfaces and in electrical communication with the electrical traces; andwherein the basket assembly is configured to be slidingly compressed within a second elongate tubular member and to expand to a radially expanded non-cylindrical shape when deployed from the second elongate tubular member.

151. The method of claim 150, wherein depositing comprises depositing a dielectric or polymeric substrate onto the spline surfaces and depositing electrodes and / or temperature sensors on top of the dielectric or polymeric substrate on the first and second surfaces.121 SL 879690S.1152. The method of claims 150 or 151, further comprising disposing at least one tubular polymeric member over at least one spline with the spline at least partially within a lumen of the tubular polymeric member, and depositing the first portion of the interactive element assembly on a first portion of an outer surface of the tubular polymeric member facing the basket interior and depositing the second portion on a second portion of the outer surface facing the basket exterior.

153. The method of any one of claims 150 to 152, wherein the super-elastic material comprises nitinol and at least one interactive element is formed by exposing portions of the nitinol at one or both of the first and second surfaces.

154. The method of any one of claims 150 to 153, wherein depositing includes wrapping a flexible circuit with wings around the spline such that a portion of the flexible circuit is distributed on the first surface and a portion is distributed on the second surface.

155. The method of any one of claims 150 to 154, wherein the interactive elements include mapping electrodes on the second surface and ablation electrodes on at least one of the first and second surfaces.

156. The method of any one of claims 150 to 155, further comprising configuring the distal hub with spline openings to permit movement of the spline ends during deployment and retraction.

157. The method of any one of claims 150 to 156, wherein the flexible circuits are bonded using an adhesive selected from polyurethane, cyanoacrylate, polyvinyl acetate, acrylic, polyimide, epoxy, hot melt, or fluoropolymer adhesives, and / or thermally bonded under heat and / or pressure.

158. The method of any one of claims 150 to 157, wherein the electrical traces comprise one or more conductive metal layers selected from copper, gold, platinum, iridium, titanium, and nickel.

159. The method of any one of claims 150 to 158, wherein the plurality of splines form an expandable basket assembly with 2 to 16 splines.122 SL 879690S.1

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