Systems for superelastic splines with polymer insulation

Abstract

Systems for catheter splines are disclosed herein. A catheter spline includes a body made of a superelastic conductive metal material, an insulating polymer jacket made of one or more chemically compatible polymer materials in layers, and an organosilane coupling material coupling the superelastic conductive metal material to the insulating polymer jacket. A catheter includes at least two catheter splines configured in forming a polymer-insulated basket structure with a plurality of individual electrodes and / or an electrode basket structure with splines being relatively large electrodes themselves.

Description

SYSTEMS FOR SUPERELASTIC SPLINES WITHPOLYMER INSULATIONCROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 607.215 filed on December 7, 2023, which is incorporated by reference herein in its entirety.FIELD OF THE DISCLOSURE

[0002] The present disclosure relates generally to tissue ablation systems, such as cardiac tissue ablation systems. In particular, the present disclosure relates to ablative catheters including catheter splines having a superelastic conductive metal material that is coupled to an insulating polymer jacket or material via an organosilane coupling material.BACKGROUND

[0003] It is generally known that ablation therapy may be used to treat various conditions afflicting the human anatomy. For example, ablation therapy may be used in the treatment of atrial arrhythmias. When tissue is ablated, or at least subjected to ablative energy generated by an ablation generator and delivered by an ablation catheter, lesions form in the tissue. Electrodes mounted on or in ablation catheters are used to create tissue apoptosis in cardiac tissue to correct conditions such as atrial arrhythmia (including, but not limited to, ectopic atrial tachycardia, atrial fibrillation, and atrial flutter).

[0004] Arrhythmia (i.e., irregular heart rhythm) can create a variety of dangerous conditions including loss of synchronous atrioventricular contractions and stasis of blood flow which can lead to a variety of ailments and even death. It is believed that the primary cause of atrial arrhythmia is stray electrical signals within the left or right atrium of the heart. The ablation catheter imparts ablative energy (e.g., radiofrequency energy, cryoablation, lasers, chemicals, high-intensity focused ultrasound, etc.) 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.

[0005] Electroporation is anon-thermal ablation technique that involves applying strong electric fields that induce pore formation in 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 (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.

[0006] For catheters, and particularly high-voltage ablative catheters, used to deliver bipolar energy using irreversible electroporation (IRE) or pulsed field ablation (PF A), it is important to ensure that catheter electrodes are close to or contacting a vessel wall. Generally, the closer the electrodes to the vessel wall, the larger the lesion size. Accordingly, catheters, such as high-voltage ablative catheters, including relevant electrode configurations that can be placed near or in contact with the vessel wall are desirable.

[0007] Ablative catheters may include a distal functional assembly (DFA) primarily including an inflatable balloon made of an elastomeric polymer material and an electrode basket structure formed of a plurality of splines made of a superelastic and highly conductive metal material (e.g., nitinol or NiTi alloy), such that the DFA, or the electrode basket, can reversibly transit between a collapsed and an extended / expanded configuration to facilitate delivering / retracting, and properly deploying the DFA of the catheter for administrating the intended therapy of electroporation, respectively. Such a spline may require an insulating polymer material, such as an insulating polymer jacket, applied to portions of the body of the spline. How ever, insulating polymer materials / jackets in at least some known catheters generally exhibit very poor bondability to superelastic, electrically conductive, metallic bodies or materials (e.g., nitinol or NiTi alloy) of the splines, such that the insulating polymer materials / jackets may become undesirably delaminated from the superelastic spline. Accordingly, material and structuralconfigurations for making a superelastic, insulated spline as an integral entity that can prevent or reduce delamination or failure of insulating polymer materials / jackets from a superelastic metal material of the spline are highly desirable.BRIEF SUMMARY OF THE DISCLOSURE

[0008] In one aspect, a catheter spline is provided. The catheter spline includes a body comprised of a superelastic and conductive metal material, an insulating polymer jacket, and an organosilane coupling material coupling the superelastic conductive metal material to the insulating polymer jacket.

[0009] The superelastic metal material may be selected from the group consisting of nitinol or nickel titanium alloys, copper-aluminum-nickel alloys, zinc-copper-gold-iron alloys, iron-manganese-silicon alloys, copper-zinc-aluminum alloys, copper-aluminum- nickel alloys, and combinations thereof.

[0010] The insulating polymer jacket may comprise one or more thermoplastic polymer material(s). The thermoplastic polymer materials may be selected from the group consisting of thermoplastic polymers, polyester homopolymers & copolymers, nylon homopolymers & copolymers, polyolefins, polycarbonate, polysulfone, and combinations thereof and / or the group consisting of polyamide-based thermoplastic elastomers or poly(ether block amide) copolymers, polyester-based thermoplastic elastomers or poly(ester ether) copolymers, thermoplastic polyurethane elastomers (e.g., poly(ether urethane) copolymers, polycarbonate urethane) copolymers, poly(siloxane- carbonate urethane) copolymers, and poly(siloxane-ether urethane) copolymers, and combinations thereof), styrenic thermoplastic elastomers or styrenic block copolymers, thermoplastic olefins, and combinations thereof.

[0011] The insulating polymer jacket may be bi-layered and may comprise two chemically compatible polymer materials. An exterior layer of the insulating polymer jacket may be made of a thermoplastic polymer material comprising additional crosslinking agent(s) selected from the group consisting of triallyl isocyanurate, triallyl cyanurate, triallyl phosphate, pentaerythritol triallyl ether, trivinyltrimethylcyclosiloxane,trimethylolpropane trivinyl ether, trimethylolpropane tri aery I ate. pentaerythritol triacrylate, and combinations thereof.

[0012] The insulating polymer jacket may be bi-layered and may comprise two chemically compatible polymer materials, wherein an interior layer of the insulating polymer jacket is re-meltable and / or an exterior layer of the insulating polymer jacket is heat-shrinkable under heat.

[0013] The organosilane coupling material may be coupled to the superelastic conductive metal material by a chemical bond.

[0014] The organosilane coupling material may be coupled to the insulating polymer jacket or material by a physical bond and / or a physical force.

[0015] The organosilane coupling material may be produced from condensation curing of a diluted dispersion of coating comprising one or more organosilane agents. The organosilane agents may comprise one or more organofunctional groups selected from the group consisting of amino, amine, amide, epoxy, oxirane, urethane, urea, carbonate, and further comprising one or more hydrolyzable groups selected from the group consisting of alkoxy, acyloxy, oxime, hydroxyl, halogen, and combinations thereof.

[0016] The diluted organosilane dispersion of coating may comprise one or more reactive organosilane coupling agents selected from the group consisting of:(Formula I); b) compounds of Formula II(Formula II); c) compounds of Formula III(Formula III); and d) combinations thereof; Ri. R2. and R3 may each be selected from the group consisting of organofunctional moieties, oligomeric organofunctional moieties, polymeric organofunctional moieties, and combinations thereof;Li. L2. and L3 may each be selected from the group consisting of direct bonds, substituted or unsubstituted linear alkyl, substituted or unsubstituted linear C1-C10 alkyl, substituted or unsubstituted linear C2-C4 alkyl, substituted or unsubstituted branched alkyl, substituted or unsubstituted branched C1-C10 alkyl, substituted or unsubstituted branched C2-C4 alkyl, Ci alkyl. C2alkyl. C3alkyl, C4alkyl, C5alkyl, C6alkyl. C7alkyl. C8alkyl, C9alkyl, C10 alkyl, and combinations thereof;Xi, X2, and X3 may each be selected from the group consisting of hydrolyzable groups, alkoxy, acyloxy, amine, oxime, hydroxyl, halogen, non-hydrolyzable groups, substituted or unsubstituted linear alkyl, substituted or unsubstituted linear C1-C10 alkyl, substituted or unsubstituted linear C2-C4 alkyl, substituted or unsubstituted branched alkyl, substituted or unsubstituted branched C1-C10 alkyl, substituted or unsubstituted branched C2-C4 alkyl, Ci alkyl. C2alkyl, C3 alkyl, C4alkyl, C5alkyl, C6alkyl. C7alkyl, C8alkyl, C9alkyl. Cio alkyl, and combinations thereof, wherein at least one of Xi, X2. and X3 is a hydrolyzable group;Yi, Y2, and Y3 may each be selected from the group consisting of hydrolyzable groups, alkoxy, acyloxy, amine, oxime, hydroxyl, halogen, non-hydrolyzable groups, substituted or unsubstituted linear alkyl, substituted or unsubstituted linear C1-C10 alkyl, substituted or unsubstituted linear C2-C4 alkyl, substituted or unsubstituted branched alkyl, substituted or unsubstituted branched C1-C10 alkyl, substituted or unsubstituted branched C2-C4 alkyl, Ci alkyl. C2alkyl, C3 alkyl, C alkyl, C5alkyl, C6alkyl. C7 alkyl. C8alkyl, C9 alkyl, Cio alkyl, and combinations thereof, wherein at least one of Yi, Y2, and Y3 is a hydrolyzable group; andZi. Z2, and Z3 may each be selected from the group consisting of hydrolyzable groups, alkoxy, acyloxy, amine, oxime, hydroxyl, halogen, non-hydrolyzable groups, substituted or unsubstituted linear alkyl, substituted or unsubstituted linear C1-C10 alkyl, substituted or unsubstituted linear C2-C4 alkyl, substituted or unsubstituted branched alky l, substituted or unsubstituted branched C1-C10 alkyl, substituted or unsubstituted branched C2-C4 alkyl, Ci alkyl, C2 alkyl, C3 alkyl, C4 alkyl, C5 alkyl, Cs alkyl, C7 alkyl, Cs alkyl, C9 alkyl, Cio alkyl, and combinations thereof, wherein at least one of Zi, Z2, and Z3 is a hydrolyzable group.

[0017] Ri, R2, and R3 may each be selected from the group consisting of organofunctional moieties that exhibit molecular affinity and / or chemical miscibility with an interior or most interior layer of the insulating polymer jacket.

[0018] Ri, R2, and R3 may each be oligomeric or non-oligomeric moieties comprising an organofunctional group selected from the group consisting of substituted or unsubstituted and linear or branched alkyl, alkenyl, alkynyl, aryl, phenyl, benzyl, acryl, amino, hydroxy, mercapto, alkoxy, carbonyl, carboxyl, ester, carbonate, amide, isocyanate, urethane, urea, oxirane, and combinations thereof.

[0019] The diluted dispersion of coating may comprise one or more organosilane coupling agents selected from the group consisting of: a) 3-aminopropyl triethoxysilane, 3-aminopropyl trimethoxy silane, 4-aminobutyl triethoxysilane, 4-amino-3,3-dimethylbutyl trimethoxy silane, N-(2-aminoethyl)-3- aminopropyl trimethoxysilane, N-(2-aminoethyl)-3-aminopropyl triethoxysilane, N-(6- amino-hexyl)aminomethyl trimethoxysilane, N-(6-aminohexyl)aminomethyl triethoxysilane. 3-[2-(2-aminoethylamino)ethylamino]propyl trimethoxysilane, N-(2- aminoethy)-3-aminopropyl silanetriol, bis(3-trimethyoxysilylpropyl) amine. bis(3- triethyoxysilylpropyl) amine, N,N’-bis((3-trimethoxysilyl)propyl) ethylenediamine, N,N’-bis((3-triethoxysilyl)propyl) ethylenediamine, N-phenylaminomethyl trimethoxysilane, and combinations thereof; b) (3 -acetamidopropyl) trimethoxysilane, (3-acetamidopropyl) tri ethoxysilane, N, N’- bis(3-trimethoxysilylpropyl) urea, N, N’-bis(3-triethoxysilylpropyl) urea, tris(3- trimethoxysilylpropyl) isocyanurate, tris(3-triethoxysilylpropyl) isocyanurate, and combinations thereof; c) (3-glycidoxypropyl)trimethoxysilane, (3-glycidoxypropyl)triethoxysilane, 5,6- epoxyhexyltriethoxysilane, (3-glycidoxypropyl)methyldimethoxysilane, (3- glycidoxypropyl)methyldiethoxysilane, (3-glycidoxypropyl)dimethylmethoxy silane, and (3-glycidoxypropyl)dimethylethoxysilane. and combinations thereof; d) (3-glycidylpropyl)trimethoxysilane, (3-glycidoxypropyl)triethoxysilane, 5,6- epoxyhexyltriethoxy silane, (3-glycidoxypropyl)methyldimethoxysilane, (3- glycidoxypropyl)methyldiethoxysilane, (3-glycidoxypropyl)dimethylmethoxysilane. and (3-glycidoxypropyl)dimethylethoxysilane, and combinations thereof; e) (methaciyloxymethyl)methyldimethoxysilane, (methacryloxyethyl) methyldimethoxysilane, (methacryloxypropyl)trimethoxysilane,(methacryloxymethyl)trimethoxysilane, and combinations thereof; and f) combinations thereof.

[0020] In another aspect, a catheter is provided. The catheter includes a shaft, a plurality of splines forming a basket around a distal portion of the shaft, each spline extending between a proximal end that is coupled to the shaft and a distal end that is coupled to the shaft, and a balloon positioned within the basket formed by the plurality of splines. At least one spline of the plurality’ of splines is a catheter spline including a body comprised of a superelastic conductive metal material, an insulating polymer jacket, and an organosilane coupling material coupling the superelastic conductive metal material to the insulating polymer jacket.

[0021] The superelastic conductive metal material may be selected from the group consisting of nitinol or nickel titanium alloys, copper-aluminum-nickel alloys, zinccopper-gold-iron alloys, iron-manganese-silicon alloys, copper-zinc-aluminum alloys, copper-aluminum-nickel alloys, and combinations thereof.

[0022] The insulating polymer jacket may comprise one or more thermoplastic polymer material(s). The one or more thermoplastic polymer materials(s) may be selected from the group consisting of thermoplastic polymers, polyester homopolymers & copolymers, nylon homopolymers & copolymers, polyolefins, polycarbonate, polysulfone, and combinations thereof, and / or the group consisting of polyamide-based thermoplastic elastomers or poly(ether block amide) copolymers, polyester-based thermoplastic elastomers or poly(ester ether) copolymers, thermoplastic polyurethane elastomers (e.g., poly(ether urethane) copolymers, polycarbonate urethane) copolymers. poly(siloxane-carbonate urethane) copolymers, and poly(siloxane-ether urethane) copolymers, and combinations thereof), styrenic thermoplastic elastomers or styrenic block copolymers, thermoplastic olefins, and combinations thereof.

[0023] The insulating polymer jacket may be bi-layered and may comprise two chemically compatible polymer materials. An exterior layer of the insulating polymer jacket may be made of a thermoplastic polymer material comprising additional crosslinking agent(s) selected from the group consisting of trially 1 isocyanurate, triallyl cyanurate, triallyl phosphate, pentaerythritol triallyl ether, trivinyltrimethylcyclosiloxane, trimethylolpropane trivinyl ether, trimethylolpropane triacrylate, pentaerythritol triacrylate, and combinations thereof.

[0024] The insulating polymer jacket may be bi-layered and may comprise two chemically compatible polymer materials. An interior layer of the insulating polymer jacket may be re-meltable and / or the exterior layer of the insulating polymer jacket is heat-shrinkable under heat.

[0025] The organosilane coupling material may be coupled to the superelastic conductive metal material by a chemical bond.

[0026] The organosilane coupling material may be coupled to the insulating polymer jacket or material by a physical bond and / or a physical force.

[0027] The organosilane coupling material may be produced from condensation curing of a diluted dispersion of coating. The diluted dispersion of coating may comprise one or more organosilane agents comprising one or more organofunctional groups selected from the group consisting of amino, amine, amide, epoxy, oxirane, urethane, urea, carbonate, and further comprising one or more hydrolyzable groups selected from the group consisting of alkoxy, acyloxy, oxime, hydroxyl, halogen, and combinations thereof.

[0028] The foregoing and other aspects, features, details, utilities, and advantages of the present disclosure will be apparent from reading the following description and claims, and from reviewing the accompanying drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 is a schematic and block diagram view of a system for electroporation therapy.

[0030] Figure 2 is a view of a handle that may be used with the system shown in Figure 1.

[0031] Figure 3 is a side schematic view of a DFA that may be used with the system shown in Figure 1.

[0032] Figure 4 is a side schematic view of a DFA that may be used with the system shown in Figure 1.

[0033] Figure 5 is a side schematic view of a DFA that may be used with the system shown in Figure 1.

[0034] Figure 6 is a side schematic view of a DFA that may be used with the system shown in Figure 1.

[0035] Figure 7 is a side schematic view of an inner lumen that may be used with the DFA shown in Figure 6.

[0036] Figure 8 is a perspective schematic view showing splines deployed from the inner lumen shown in Figure 7.

[0037] Figure 9A is a perspective view of a DFA.

[0038] Figure 9B is a side schematic view7of the DFA shown in Figure 9A.

[0039] Figure 10A is a perspective view of a DFA.

[0040] Figure 10B is a side schematic view7of the DFA shown in Figure 10A.

[0041] Figure 10C is a schematic diagram showing the DFA of Figure 10A in a first configuration.

[0042] Figure 10D is a schematic diagram showing the DFA of Figure 10A in a first configuration.

[0043] Figure 10E is a side cross-sectional view of the DFA shown in Figure 10 A.

[0044] Figures 10F-10J are schematic side cross-sectional news of the DFA show n in Figure 10A illustrating the transitioning of the DFA betw een different states.

[0045] Figure 1 OK is a side cross-sectional view of a portion of a handle that maybe used with the DFA shown in Figure 10A.

[0046] Figure 10L is a perspective view of a compression valve component, pin, and ring that may be used with the handle shown in Figure 1 K.

[0047] Figure 10M is a perspective exploded view of the compression valve component, pin, and ring shown in Figure 10L.

[0048] Figure 11 is a perspective view of a DFA.

[0049] Figure 12 is a perspective view of a DFA.

[0050] Figure 13 is a perspective view of a DFA.

[0051] Figure 14 is a perspective view of a DFA.

[0052] Figure 15 is a perspective view of a DFA.

[0053] Figure 16 is a perspective view of a DFA.

[0054] Figure 17 is a perspective view of a DFA.

[0055] Figure 18 is a perspective view of a DFA.

[0056] Figure 19 is a perspective view of a DFA.

[0057] Figure 20 is a diagram depicting an electrode spline, a portion of which is circumferentially embraced by an insulating polymer material / j acket via an intermediate organosilane coupling material in accordance with the present disclosure.

[0058] Figure 21 is a diagram depicting an electrode spline, a portion of which is longitudinally embraced by an insulating polymer material / j acket via an intermediate organosilane coupling material in accordance with the present disclosure.DETAILED DESCRIPTION OF THE DISCLOSURE

[0059] Systems for electrode splines (also referred to herein as catheter splines) are described herein. An example electrode spline or catheter spline includes a body comprised of a superelastic conductive metal material, an insulating polymer material / j acket. and an organosilane coupling material coupling the superelastic conductive metal material to the insulating polymer material / j acket.

[0060] An example catheter includes the electrode spline (also referred to herein as a catheter spline). The example catheter may be a PF A or IRE catheter.

[0061] Another example catheter includes an example DFA, which in turn includes an electrode basket formed of a plurality of electrode splines made of a superelastic and highly conductive metal material and a balloon positioned within (disposed inside) the electrode basket. The balloon may be made of an elastomeric polymer material.

[0062] Although example systems of the present disclosure are described with respect to pulmonary' vein isolation (PVI), it is contemplated that the described features of the present disclosure as described herein may be incorporated into any number of systems and any number of applications as would be appreciated by one of ordinary skill in the art based on the disclosure herein.

[0063] It should be understood that although example systems of the present disclosure are described with respect to particular splines and / or particular electrode splines, the systems disclosed herein may be used with any suitable splines, including those not specifically disclosed herein. Figure 1A is a block diagram view of a system 10 for PFA or IRE therapy. In general, system 10 includes a DFA 12 disposed at a distal end 48 of a catheter 14. As used herein, “proximal"’ refers to a direction toward the end of the catheter near the clinician and “distal” refers to a direction away from the clinician and (generally) inside the body of a patient. The electrode spline assembly / DFA includes one or more individual, electrically-isolated electrode elements. Each electrode element, also referred to herein as a catheter electrode, is individually wired such that it can be selectively paired or combined with any other electrode element to act as a bipolar or a multi-polar electrode.

[0064] System 10 may be used for IRE or PFA to destroy tissue. That is, system 10 may be used for electroporation-induced primary apoptosis therapy, which refers to the effects of delivering electrical current in such a manner as to directly cause an irreversible loss of plasma membrane (cell wall) integrity leading to its breakdown and cell apoptosis. This mechanism of cell death may be view ed as an “outside-in” process, meaning that the disruption of the outside wall of the cell causes detrimental effects to the inside of the cell.Typically, for classical plasma membrane electroporation, electric current is delivered as a pulsed electric field in the form of short-duration pulses (e g., having a 0. 1 to 20 millisecond (ms) duration) between closely spaced electrodes capable of delivering an electric field strength of about 0.1 to 1.0 kilovolts / centimeter (kV / cm). System 10 may be used, for example, with a basket and / or balloon DFA for high output (e.g., high voltage and / or high current) electroporation procedures. System 10 may be configured to deliver an electrical pulse signal having a relatively high voltage and low pulse duration.

[0065] All electrode splines of the DFA of the catheter deliver may be configured to an electric current simultaneously. Alternatively, electric current is delivered between pairs of electrode splines of the DFA of the catheter. Delivering electric current simultaneously using a plurality of electrode splines may facilitate creating a sufficiently deep lesion for electroporation. To facilitate activating electrode splines simultaneously, the splines may be switchable between being connected to a 3D mapping system (i.e., localization and navigation system) and being connected to an ablation system (i.e., ablation / electroporation generator).

[0066] IRE using the RFA catheter systems described herein may enable pulmonary vein isolation in as few as one shock or a singular train of electrical pulses, and thus, would require much shorter procedure time of ablation, compared to conventional radiofrequency (RF) ablation using relevant RF catheter systems only comprising a singular ablation tip or an array of electrodes in a loop.

[0067] It should be understood that while the energization strategies for effectuating IRE by all electrode splines of the catheter are described as involving DC pulses, systems may use variations and remain within the spirit and scope of the disclosure. For example, exponentially-decaying pulses, exponentially-increasing pulses, and combinations may be used. Further, AC pulses may be used.

[0068] Further, it should be understood that the mechanism of cell destruction in electroporation is not primarily due to heating effects, but rather to cell membrane disruption through application of a high-voltage electric field. Thus, electroporation may avoid some possible thermal effects that may occur when using radio frequency (RF) energy. This “cold therapy” thus has desirable characteristics.

[0069] With this background, and now referring again to Figure 1, system 10 includes an electrode spline assembly / DFA 12 including at least one electrode spline. Electrode spline assembly / DFA 12 is incorporated as part of a medical device such as a catheter 14 for electroporation therapy of tissue 16 in a body 17 of a patient. Figure 1 tissue 16 includes heart or cardiac tissue. It should be understood, however, that systems may be used to conduct electroporation therapy with respect to a variety of other body tissues.

[0070] Figure 1 further shows a plurality of return electrodes designated 18, 20, and 21, which are diagrammatic of the body connections that may be used by the various sub-systems included in overall system 10, such as an electroporation generator 26, an electrophysiology7(EP) monitor such as an ECG monitor 28, and a localization and navigation system 30 for visualization, mapping, and navigation of internal body structures. In Figure 1, return electrodes 18. 20. and 21 are patch electrodes. It should be understood that the illustration of a single patch electrode is diagrammatic only (for clarity) and that such sub-systems to which these patch electrodes are connected may, and typically will, include more than one patch (body surface) electrode, and may include split patch electrodes (as described herein). Alternatively, return electrodes 18, 20, and 21 may be any other type of electrode suitable for use as a return electrode including, for example, one or more electrode splines of the catheter 14. Return electrode(s) may be an electrode spline as part of electrode spline assembly / DFA 12 or part of a separate catheter or device (not shown). System 10 may further include a main computer system 32 (including an electronic control unit 50 and data storage-memory 52), which may be integrated with localization and navigation system 30. System 32 may further include conventional interface components, such as various user input / output mechanisms 34A and a display 34B, among other components.

[0071] Electroporation generator 26 is configured to energize the electrode spline(s) in accordance with an electroporation energization strategy7, which may be predetermined or may be user-selectable. For electroporation-induced primary apoptosis therapy, generator 26 may be configured to produce an electric cunent that is delivered via electrode spline assembly / DFA 12 as a pulsed electric field in the form of short-duration DC pulses (e.g., a nanosecond to several milliseconds duration, a 0.1 to 20 ms duration, orany duration suitable for electroporation) between closely spaced electrode splines capable of delivering an electric field strength (i.e., at the tissue site) of about 0.1 to 1.0 kV / cm. The amplitude and pulse duration needed for irreversible electroporation are inversely related. As pulse durations are decreased, the amplitude must be increased to achieve electroporation.

[0072] Electroporation generator 26, sometimes also referred to herein as a DC energy source, is a monophasic electroporation generator 26 configured to generate a series of DC energy pulses that all produce current in the same direction. Electroporation generator 26 may be a biphasic or polyphasic electroporation generator configured to produce DC energy pulses that do not all produce current in the same direction. In some systems, electroporation generator 26 is configured to output energy7in DC pulses at selectable energy levels, such as fifty joules, one hundred joules, two hundred joules, and the like. Other systems may have more or fewer energy settings and the values of the available setting may be the same or different. For successful electroporation, some systems utilize the two hundred joule output level. For example, electroporation generator 26 may output a DC pulse having a peak magnitude from about 300 Volts (V) to about 3,200 V at the two hundred joule output level. In some systems, the peak magnitude may be even larger (e.g., on the order of 10,000 V). Other systems may output any other suitable positive or negative voltage. For example, the systems described herein may include pulses with amplitudes from about 500 V to about 4,000 V, with pulse widths from about 200 nanoseconds to about 20 microseconds.

[0073] In some systems, a variable impedance 27 allows the electrical impedance of system 10 to be varied to limit electrical arcing. Moreover, variable impedance 27 maybe used to change one or more characteristics, such as amplitude, duration, pulse shape, and the like, of an output of electroporation generator 26. Although illustrated as a separate component, variable impedance 27 may be incorporated in catheter 14 or generator 26.

[0074] With continued reference to Figure 1, as noted above, catheter 14 may include functionality for electroporation and in certain systems also other types of ablation (e.g., RF ablation). It should be understood, however, that in those systems, variations arepossible as to the type of ablation energy provided (e.g., cryoablation, ultrasound, RF energy, etc.).

[0075] In the illustrative system, catheter 14 includes a cable connector or interface 40, a handle 42, and a shaft 44 having a proximal end 46 and a distal 48 end. Catheter 14 may also include other conventional components not illustrated herein such as a temperature sensor, additional electrodes, and corresponding conductors or leads. Connector 40 provides mechanical and electrical connection(s) for cable 56 extending from generator 26. Connector 40 may include conventional components known in the art and as shown is disposed at the proximal end of catheter 14.

[0076] Handle 42 provides a location for the clinician to hold catheter 14 and may further provide means for steering or navigating catheter shaft 44 within the body 17. For example, handle 42 may include means to change the length of a guidewire extending through catheter 14 to distal end 48 of catheter shaft 44 or means to steer catheter shaft 44. Moreover, in some systems, handle 42 may be configured to vary' the shape, size, and / or orientation of a portion of the catheter, and it will be understood that the construction of handle 42 may vary. Alternatively, catheter 14 may be robotically driven or controlled. Accordingly, rather than a clinician manipulating a handle to advance / retract and / or steer or navigate catheter 14 (and shaft 44 thereof in particular), a robotic system is used to manipulate catheter 14. Shaft 44 is an elongated, tubular, flexible member configured for movement within body 17. Shaft 44 is configured to support electrode assembly / DFA 12 as well as contain associated conductors, and possibly additional electronics used for signal processing or conditioning. Shaft 44 may also permit transport, delivery and / or removal of fluids (including irrigation fluids and bodily fluids), medicines, and / or surgical tools or instruments. Shaft 44 may be made from conventional materials, such as polymers like thermoplastics (e.g., nylons, polycarbonate, polyesters, etc.), polyamide-based or polyester- based thermoplastic elastomers (e.g., Pebax®, Hytrel®, etc.) and / or thermoplastic polyurethanes (e.g., Pellethane®, Estane®, Elasthane™, etc.) and the like, and defines one or more lumens configured to house and / or transport electrical conductors, fluids or surgical tools, as described herein. Shaft 44, along with the electrode assembly / DFA 12. may be introduced into a blood vessel or other structure within body 17 through a conventional introducer. Shaft 44 may then be advanced / retracted and / or steered or guidedthrough body 17 to a desired location such as the site of tissue 16, including through the use of guidewires or other means known in the art.

[0077] In some systems, catheter 14 includes an electrode assembly or DFA having multiple electrodes (not shown in Figure 1) distributed at the distal end of shaft 44 in a basket structure. Further, as described herein, an inflatable balloon may be contained within the basket structure.

[0078] In some systems, catheter 14 includes an electrode assembly or DFA having a plurality of electrode splines disposed at the distal end of shaft 44 and spatially laid out in a basket structure. Further, as described herein, this electrode assembly or DFA also includes an inflatable balloon made of an elastomeric polymer material disposed at the distal end of the shaft, but internally contained within the electrode basket structure formed of multiple electrode splines.

[0079] Localization and navigation system 30 may be provided for visualization, mapping and navigation of internal body structures, such as the heart anatomy of a patient. Localization and navigation system 30 may include conventional apparatus known generally in the art (e.g., an 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,’7the 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. Other technologies for locating / navigating a catheter in space, such as within the heart anatomy, (and for visualization) are known, including for example, the CARTO navigation and location system of Biosense Webster, Inc., the Rhythmia® system of Boston Scientific Scimed, Inc., the KODEX® system of Koninklijke Philips N.V., the AURORA® system of Northern Digital Inc., commonly available fluoroscopy systems, or a magnetic location system such as the gMPS system from Abbott Laboratories. In this regard, some of the localization, navigation and / or visualization system would involve a sensor be provided for producing signals indicative of catheter locations, and may include, for example one or more electrodes in the case of an impedance-based localization system, or alternatively, one or more coils (i.e., wire windings) configured to detect one or morecharacteristics of a magnetic field, for example in the case of a magnetic-field based localization system. As yet another example, system 10 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.

[0080] Pulsed field ablation (PF A) has been shown to be an effective form of ablation for treatment of cardiac arrhythmias, particularly for instantaneous pulmonary vein isolation (PVI). PFA includes delivering high voltage pulses from superelastic electrode splines disposed on a catheter (e.g., including the basket and / or balloon catheters described herein). In PFA, for example, voltage amplitudes may range from about 300 V to at least 3,200 V (or even as large as on the order as 10,000 V), and pulse widths may from hundreds of nanoseconds to tens of milliseconds.

[0081] These electric fields may be applied between adjacent electrode splines (in a bipolar approach) or betw een a one or more electrode splines and a return patch (in a monopolar approach). There are advantages and disadvantages to each of these approaches (e.g., when using the basket and / or balloon catheters described herein).

[0082] For example, regarding lesion contiguity, the monopolar approach has the potential to leave gaps in lesion coverage (referred to as dead zones) betw een electrodes or electrode splines where the field strength is low or zero, whereas the field strength in the bipolar approach generally prevents dead zones between electrodes or electrode splines.

[0083] For lesion size and proximity, the monopolar approach has a wider range of effect, and can potentially create deeper lesions with the same applied voltage. Further, the monopolar approach may be able to create lesions from a distance (e.g., generally proximate, but not necessarily contacting tissue). The bipolar approach may create smaller lesions, requiring closer proximity or contact with tissue to create transmural lesions. However, the monopolar approach may create larger lesions than are necessary, while the lesions generated using the bipolar approach may be more localized.100841 Due to a wider range of effect, the monopolar approach may cause unwanted skeletal muscle and / or nerve activation. In contrast, the bipolar approach has a constrained range of effect proportional to spatial spacing of electrodes or electrode splines and is less likely to depolarize cardiac myocytes or nerve fibers.

[0085] For the monopolar approach, only a single potential is applied in catheter wires and electrodes. Further, because all the electrodes or electrode splines are at the same polarity, the configuration is not susceptible to arcing (e.g., when using the catheter comprising an electrode basket and / or an insulating polymer balloon contained within the electrode basket, as described herein). In contrast, for the bipolar approach, the internal architecture of the catheter must be constructed to prevent arcing, as neighboring electrodes or electrode splines are at different potentials.

[0086] To monitor operation of system 10, one or more impedances between electrodes (including electrode splines) and / or return electrodes 18, 20, and 21 may be measured. For example, for system 10, impedances may be measured as described in U.S. Patent Application Publication No. 2019 / 0117113, filed on October 23. 2018, U.S. Patent Application Publication No. 2019 / 0183378, filed on December 19, 2018. and U.S. Patent Application No. 63 / 027,660, filed on May 20, 2020, all of which are incorporated by reference herein in their entirety.

[0087] Figure 2 is a view of a handle 200 that may be used with system 10 and catheter 14. Handle 200 includes a first actuator 222 and a second actuator 224. First actuator 222 may be, for example, rotatable about a rotational axis that is substantially perpendicular to a longitudinal axis of handle 200 to selectively deflect at least a portion of catheter 14. Second actuator 224 may be, for example, rotatable about the same axis as first actuator 222 to selectively lock in a deflected orientation of catheter 14. That is, first actuator 222 may be manipulated to deflect at least a portion of catheter 14 to a desired orientation, and then second actuator 224 may be manipulated to lock catheter 14 in that orientation. Accordingly, first and second actuators 222 and 224 may be connected to one or more activation wires extending through catheter 14.

[0088] Further, as shown in Figure 2, a plurality of connectors 230 are coupled to handle 200 by a cable 232. Connectors 230 may be used to connect catheter 14 to a generator, such as generator 26 (shown in Figure 1). Further, connectors 230 may provide an interface between a localization and navigation system, such as localization and navigation system 30 (shown in Figure 1). and one or more magnetic sensors included on catheter 14, as described in more detail below.

[0089] Those of skill in the art will appreciate that handle 200 is merely an example, and that any suitable handles and / or arrangement of actuators may be used to implement the systems described herein.

[0090] Figure 3 is a side schematic view of a DFA 300 that may be used with system 10 (shown in Figure 1). DFA 300 includes a shaft 302 and a balloon 304 coupled to a distal portion 305 of shaft 302. In this system, catheter 300 includes a first electrode 308 at a proximal end 310 of balloon 304, and a second electrode 312 at a distal end 314 of balloon 304. DFA 300 is shown positioned within a pulmonary' vein 320.

[0091] Figure 4 is a side schematic view of a DFA 400 that may be used with system 10 (shown in Figure 1). DFA 400 includes a shaft 400 and a balloon 404 coupled to a distal portion 406 of shaft 402. In this system, catheter 400 includes a plurality of electrodes 412 proximate a distal end 414 of balloon 404. Unlike second electrode 312 (shown in in Figure 3). electrodes 412 expand outward from balloon 404 to be closer to the w all of pulmonary vein 320. In this system, DFA 400 includes eight electrodes 412 (for clarity, only five are showor). Alternatively, DFA 400 may include any suitable number of electrodes 412.

[0092] In this system, each electrode 412 is coupled to a corresponding spline (not shown). During delivery, the coupled splines and electrodes 412 fit into an inner lumen of DFA 400. Upon deployment of DFA 400, splines expand outward (e.g., similar to an umbrella) such that electrodes 412 are proximate, or even contacting, the wall of pulmonary vein 320. Using DFA 400, sufficient lesions may be generated at an applied voltage of 1,400 V to 2,500 V, even for a 25 mm diameter pulmonary7vein.

[0093] Figure 5 is a side schematic view of a DFA 500 that may be used with system 10 (shown in Figure 1). DFA 500 includes a shaft 502 and a balloon 504 coupled to a distal portion 506 of shaft 502. In this system, DFA 500 includes a plurality of electrodes 512 proximate a distal end 514 of balloon 504. Unlike second electrode 312 (shown in in Figure 3). electrodes 512 are arranged on a loop 516 to be closer to the wall of pulmonary vein 320. During delivery, loop 516 comprising a plurality of electrodes 512 fits into an inner lumen of DFA 500. Upon deployment of DFA 400, loop 516 deploys such that electrodes 512 are proximate, or even contacting, the wall of pulmonary vein 320.

[0094] In this system, DFA 500 includes fourteen electrodes 512 (for clarity, only half of loop 514 and eight electrodes 512 are shown). Alternatively, DFA 500 may include any suitable number of electrodes 512. Using DFA 500, sufficient lesions may be generated at an applied voltage of 2,000 V or 2,500 V, even for a 25 mm diameter pulmonary vein.

[0095] Figure 6 is a side schematic view' of a DFA 600 that may be used with system 10 (shown in Figure 1). DFA 600 includes a shaft 602 and a balloon 604 coupled to a distal portion 606 of shaft 602. In this system, DFA 600 includes a plurality of preshaped splines 612 that function as electrodes, i.e., electrode splines. During delivery, splines, or electrode splines 612 may fit into an inner lumen of DFA 600 or may embrace balloon 604. In implementations where splines or electrode splines 612 fit into the inner lumen, splines 612 may expand radially outward when deployed such that splines 612 are proximate, or even contacting, the 'all of pulmonary vein 320.

[0096] In the system shown, DFA 600 includes twelve splines or electrode splines 612 (although only seven splines 612 are shown). Alternatively, DFA 600 may include any suitable number of splines 612. For example, DFA 600 may include ten to sixteen splines 612 in some systems.

[0097] Splines 612 may be fabricated from nickel titanium alloys (e.g., Nitinol) and / or other superelastic metallic alloys. Further, the entirety of each spline 612 may serve as an electrode, or portions of each spline 612 may be covered with an insulating polymer material (e.g., a poly(ethylene terephthalate) (PET) heat shrinkable material, or poly(ether block amide) (PEBA) material), or thermoplastic polyurethane, and the like), such that onlynon-insulation portions of each spline 612 serve as electrodes. The insulating polymer material may also be referred to herein as an insulating polymer jacket. Further, in some implementations, multiple independently energizable electrodes may be attached to each spline 612. Using DFA 600, sufficient lesions may be generated at an applied voltage of 2,000 V or 2.500 V, even for a 25 mm diameter pulmonary vein.

[0098] Splines or electrode splines 612 may be formed, for example, by laser cutting a metallic tubing (e.g., made of Nitinol and / or other superelastic metallic alloys) into multiple strips, and heat-setting the strips to form a shape that conforms with balloon 604.

[0099] Figure 7 is a side schematic view of an inner lumen 630 of DFA 600, with splines 612 stored inside inner lumen 630 (e.g., during delivery of DFA 600 and prior to deployment of splines 612). Figure 8 is a perspective schematic view showing splines 612 deployed from inner lumen 630.

[0100] Splines 612 may all be electrically connected to one another as a single electrode or may each be individual electrodes. When splines 612 are individual electrodes, each spline 612 may be selectively energizable to form different energization sequences and / or patterns. In general, each spline 612 has the same polarity, to avoid arcing issues.

[0101] Splines 612 may all have the same length, or at least some of splines 612 may have different lengths. Further, splines 612 may include insulation covering at least a portion of each spline 612. The insulation on each spline 612 may have the same length, or at least some splines 612 may have insulation with different lengths. In addition, in some systems, DFA 600 includes a distal electrode (not shown) positioned distal of splines 612. The distal electrode may be used to perform point ablation (e.g., by creating a bipole between the distal electrode and one of splines 612), and / or may be used for visualization / mapping purposes (e.g., using the distal electrode in combination with an electrode on shaft 602).[01021 Figure 9A is a perspective view of a DFA 900. and Figure 9B is a side schematic view of DFA 900. DFA 900 includes a shaft 902 and a plurality of splines 904 surrounding a distal portion 906 of shaft 902. Each spline 904 includes a proximal end 910 coupled to shaft 902 and a distal end 912 coupled to shaft 902. From proximal end 910, spline 904 extends radially outward to an inflection point 914, and then extends radially inward to distal end 912. Figure 9B shows DFA 900 positioned within pulmonary vein 320.

[0103] A body of each spline 904 is made of a superelastic and highly electrically conductive metal material (e.g., Nitinol), and functions as a relatively large electrode. In this system, alternating splines 904 alternate polarities. That is, each positive spline 904 is positioned between two negative splines 904 and vice-versa. Alternatively, any suitable polarization scheme may be used.

[0104] To control the ablation zone of each spline or electrode spline 904, such as the ablation zone effectuated by the electrode basket structure of the DFA comprised of a plurality of splines 904, portions of each spline 904 may be covered with, or encased by, an insulating polymer material / jacket 920 that is physico-chemically coupled to the body of spline 904. Insulating polymer material / jacket 920 may be a heat-shrinkable or ordinary polymer tubing or polymer coating in one or more layers. More generally, as will be appreciated by those of skill in the art, in the systems described herein, the insulating polymer material / jacket may include at least one layer of a meltable material. Further, as will be appreciated by those of skill in the art, in the systems described herein, the insulating polymer material / jacket may include at least layer of a heat-shrinkable material.

[0105] In the system shown in Figures 9A and 9B. portions of spline 904 in the vicinity of inflection point 914 towards distal end 912 or between inflection point 914 and distal end 912 are generally exposed and act as an electrode that is near or in contact with the pulmonary7vein 320 when splines 904 or DFA 900 is deployed (see Figure 9B). Alternatively, any suitable insulation configuration may be used.[01061 During catheter delivery into or retraction from the body of a patient, splines 904 may be collapsed and be oriented substantially parallel to shaft 902. Subsequently, to perform ablation, splines 904 of DFA 900 are deployed with inflection points 914 extending radially outward.

[0107] Notably, as compared to DFAs 300, 400, 500, and 600 (shown in Figures 3, 4, 5, and 6), DFA 900 facilitates ablating a more proximal and wider portion of the pulmonary vein 320.

[0108] Splines or electrode splines 904 may all have the same length, or at least some of splines 904 may have different lengths. Further, insulating polymer material / jacket 920 embracing proximal and distal portions of each spline 904 may have the same length, or at least some splines 904 may have insulating polymer material / jacket 920 with different lengths. In addition, in some systems, DFA 900 includes a distal electrode (not shown) positioned distal of the electrode basket structure formed of a plurality7of splines 904. The distal electrode may be used to perform point ablation (e.g., by creating a bipole between the distal electrode and one of splines 904), and / or may be used for visualization / mapping purposes (e.g.. using the distal electrode in combination with an electrode on shaft 902).

[0109] Figure 10A is a perspective view of a DFA 1000, and Figure 10B is a side schematic view of DFA 1000. DFA 1000 includes a shaft 1002 and a plurality of electrode splines 1004 spatially laid out and coupled to a distal portion 1006 of shaft 1002, similar to DFA 900 (shown in Figure 9). However, in contrast to DFA 900, DFA 1000 includes a balloon 1008 internally enclosed by an electrode basket structure as formed of a plurality of splines 1004. Balloon 1008 is made of an elastomeric polymer material and may be selectively inflated to occupy the space of the electrode basket structure as formed by splines 1004. Notably, balloon 1008 functions as an electrical insulator, and generally reduces energy losses relative to DFA 900 to possibly result in increased lesion size.

[0110] Each spline 1004 includes a proximal end 1010 coupled to shaft 1002 and a distal end 1012 coupled to shaft 1002. From proximal end 1010, spline 1004 extends radially outward to an inflection point 1014, and then extends radially inw ard to distal end 1012. Figure 10B shows DFA 1000 positioned within the pulmonary vein 320.

[0111] During catheter delivery into, and retraction from, the body of a patient, the electrode basket structure formed of multiple splines 1004 and balloon 1008 may be collapsed and deflated, respectively. To perform ablation, splines 1004 are deployed with inflection points 1014 extending radially outward, and balloon 1008 is selectively inflated to occupy the space of the electrode basket structure formed by a plurality of splines 1004.

[0112] In some systems, the shape of balloon 1008 may be selectively changed to improve ablation. For example, Figure 10C is a schematic diagram showing DFA 1000 in a first configuration 1030, and Figure 10D is a schematic diagram showing DFA 1000 in a second configuration 1032. In second configuration 1032, splines 1004 are axially compressed relative to first configuration 1030, such that the effective diameters of splines 1004 at inflection points could be greater.

[0113] To facilitate selectively transitioning DFA 1000 between the first and second configurations 1030 and 1032, an inner shaft member (not shown in Figures 10A- 10D) may be slidably positioned w ithin shaft 1002, with a distal end of inner shaft member coupled to a distal end 1034 of balloon 1008 and splines 1004. When the inner shaft member is pulled proximally relative to shaft 1002, distal end 1034 of balloon 1008 and splines 1004 are also pulled proximally relative to a proximal end 1036 of balloon 1008 and splines 1004, thereby compressing balloon 1008 and splines 1004 axially. The position of the inner shaft member relative to shaft 1002 may be held in place using a suitable locking mechanism (e.g., a Tuohy Borst compression valve), as described in detail herein.

[0114] Figure 10E is a side cross-sectional view of DFA 1000. As shown in Figure 10E, DFA 1000 may include one or more magnetic sensors (e.g., to facilitate determining a position and / or orientation of DFA 1000 within a patient). In this system, a hollow-core magnetic sensor 1050 is positioned proximate distal end 1034 of balloon 1008. Hollow-core magnetic sensor 1050 allow s for a central lumen 1052 of shaft 1002 to extend therethrough. Hollow-core magnetic sensor 1050 may have, for example, sensing capabilities over five degrees of freedom (enabling detecting position in x, y. and z directions). Central lumen 1052 may be used, for example, to house a guidewire, to house a small diameter mapping catheter, and / or to inject contrast into the patient (e.g., tofacilitate determining a position of DFA 1000). Further, in some systems, two or more electrodes (not shown) are coupled to shaft 1002 to facilitate impedance-based localization.

[0115] DFA 1000 also includes two solid-core magnetic sensors 1060 positioned proximate proximal end 1032 of balloon 1008. Solid-core magnetic sensors 1060 may be, for example, embedded in shaft 1002, but located outside central lumen 1052. Solid-core magnetic sensors 1060 each individually have sensing capabilities over five degrees of freedom, but combined, have sensing capabilities over six degrees of freedom (enabling detecting position in x. y, and z directions, as well as detecting roll of DFA 1000).

[0116] In this system, central lumen 1052 facilitates delivering a fluid to the interior of balloon 1008 to selectively inflate balloon 1008. The fluid may include saline or a mixture of saline and contrast agent. In some systems, shaft 1002 may include irrigation holes (not shown) that provide fluid communication between central lumen 1052 and the interior of balloon 1008. Further, in some systems, central lumen 1052 enables infusing contrast agent distal of DFA 1000, which may assist a user in assessing blood flow through pulmonary vein 320 and assessing whether DFA 1000 may occlude the blood flow through the pulmonary vein 320.

[0117] Figures 10F-10J are schematic side cross-sectional views of DFA 1000 illustrating the transitioning of DFA 1000 between different states. As shown in Figure 10F, in this system, shaft 1002 includes an outer shaft element 1062 and an inner shaft element 1064, both of which are tubular components. Inner shaft element 1064 is axially slidable within outer shaft element 1062 and defines central lumen 1052 therethrough. Outer shaft element 1062 may have a French size of, for example, 11.5 French. Alternatively, outer shaft element 1062 may have any suitable dimensions.

[0118] A valve 1066 at a distal end of inner shaft element 1064 controls access to central lumen 1052. For example, as noted above, contrast agent may be flushed through central lumen 1052 into the patient to confirm pulmonary vein occlusion. As another example, a mapping catheter (e.g., a 3 French mapping catheter) may extend into the patient through central lumen 1052. As yet another example, a guidewire may extend through central lumen 1052. Those of skill in the art will appreciate that occlusion may be monitored using any suitable technique. For example, pressure monitoring may be used toassess occlusion of the vein, contrast injection may be used to assess occlusion of the vein using fluoroscopy, and / or ultrasound (e g., Doppler) may be used to assess occlusion.

[0119] As shown in Figure 10F, a channel 1070 is defined between outer shaft element 1062 and inner shaft element 1064 in this system. Channel 1070 is in fluid communication with an interior of balloon 1008. Further, a stopcock valve 1072 (e.g., a three-way stopcock valve) enables inflating and deflating balloon as desired, by controlling fluid flow to the interior of balloon 1008.

[0120] In some systems, a shape sensing fiber may extend through central lumen 1052 and / or channel 1090. The shape sensing fiber may be a fiber optic fiber that enables a user to precisely determine the position and orientation of the shape sensing fiber, and thus the position and orientation of shaft 1002.

[0121] In this system, DFA 1000 further includes a compression valve 1080 that facilitates securing a position of outer shaft element 1062 relative to inner shaft element 1064. Specifically, with compression valve 1080 open, inner shaft element 1064 is slidable relative to outer shaft element 1062. Once inner shaft element 1064 is located at a desired position, compression valve 1080 may be closed to prevent inner shaft element 1064 from sliding relative to outer shaft element 1026. Compression valve 1080 also seals off a proximal end of channel 1070.

[0122] As shown in Figure 10F, each spline 1004 extends between a distal end 1084 of outer shaft element 1026 and a distal end 1086 of inner shaft element 1064. Accordingly, by sliding inner shaft element distal end 1086 relative to outer shaft element distal end 1084, the shape of splines 1004 is adjustable.

[0123] Figure 10F shows splines 1004 in a neutral position, with balloon 1008 deflated. Specifically, in this system, splines 1004 are made of a superelastic and conductive metal material (e.g., Nitinol) such that splines 1004 assume the shape shown in Figure 10F when not subjected to any external forces or biases.

[0124] To compress DFA 1000 (e.g., for delivery of DFA 1000), inner shaft element 1064 is slid distally relative to outer shaft element 1062. This causes splines 1004 to collapse inward towards inner shaft element 1064, transitioning DFA 1000 to a collapsed state, as shown in Figure 10G. In Figure 10G. balloon 1008 is deflated. DFA 1000 may be locked in the collapsed state using compression valve 1080.

[0125] Referring now to Figure 10H, during therapy, balloon 1008 is inflated to fill the space between splines 1004. Specifically, as shown in Figure 10H, with balloon 1008 inflated, balloon 1008 generally conforms to the shape of the electrode basket formed by a plurality of splines 1004.

[0126] As discussed above in connection with Figures 10C and 10D, the electrode basket structure formed by a plurality of splines 1004 may also be compressed to increase an outer diameter of DFA 1000. Specifically, as shown in Figure 101, when inner shaft element 1064 is slid proximally relative to outer shaft element 1062, this causes splines 1004 to flex outward , transitioning DFA 1000 to a compressed state. In Figure 101, balloon 1008 is deflated. DFA 1000 may be locked in the compressed state using compression valve 1080.

[0127] Referring now to Figure 10J, in the compressed state, balloon 1008 may be inflated to fill the space between splines 1004. Specifically, as shown in Figure 10J, with balloon 1008 inflated, balloon 1008 generally conforms to the shape of the basket formed by splines 1004 in the compressed position.

[0128] Figure 10K is a side cross-sectional view of a portion of a handle 1090 that may be used with DFA 1000. Handle 1090 includes a housing 1091 and a compression valve unit 1092 (e g., including compression valve 1080) positioned within housing 1091. Further, handle 1090 includes a rotatable knob 1093 coupled to compression valve unit 1092 at a distal end of housing 1091. By rotating knob 1093, a user can selectively open and close compression valve 1080 to secure a position of inner shaft element 1064 as desired.[01291 Further, as shown in Figure 10K. a positioning component 1094 is coupled to a distal end of inner shaft element 1064. With compression valve 1080 open, positioning component 1094 may be slid axially relative to housing 1091 to slide inner shaft element 1064 relative to outer shaft element 1062, as described above. A first fluid supply line 1095 (i.e., for supplying fluid to central lumen 1052) and a second fluid supply line 1096 (i.e., for supplying fluid to channel 1070) are also shown in Figure 10K.

[0130] To prevent rotation of positioning component 1094 and first fluid supply line 1095 relative to housing 1091, a pin 1097 non-rotatably couples positioning component 1094 to compression valve component 1092. Specifically, as shown in a perspective view in Figure 10L and in an exploded view in Figure 10M, a ring 1098 couples pin 1097 to compression valve component 1092. Ring 1098 has protrusions 1099 that engage slots defined in compression valve component 1092 and pin 1097 so that pin 1097 (and by extension, positioning component 1094) is not capable of rotation relative to compression valve component 1092.

[0131] In some systems, one or more lumens (lumen) are defined within outer shaft element 1062 (e.g.. between an inner and outer surface of outer shaft element 1062). The lumens may be used to route electrical wires (i.e., for supplying power to splines 1004) and / or activation wires (i.e., for controlling an orientation of DFA 1000) through DFA 1000. For example, in one system, positive electrical wires that supply energy to positive splines 1004 are all routed through a first lumen, and negative electrical wires that supplyenergy to negative splines are all routed through a second, separate lumen. This effectively isolates the positive electrical wires from the negative electrical wires.

[0132] Each electrical wire may be coupled to an associated electrode spline 1004, for example, through a weld, with the weld and proximal ends of the splines arranged on a proximal coupler component (not shown). Further, in some systems, a strain relief component (not shown) is coupled to an exterior of the inner shaft element 1064 distal of the outer shaft element 1062, to prevent inner shaft element 1064 from excess bending.

[0133] DFA 1000 provides several advantages. For example, the combination of balloon 1008 and splines 1004 facilitates straightforward delivery- and deployment of DFA 1000. Further, balloon 1008 drives more energy into ablated tissue, and stabilizes splines1004 to prevent lateral movement. In addition, using splines 1004 as electrodes instead of individual smaller electrodes facilitates reducing the cost and increasing the reliability of DFA 1000.

[0134] Splines 1004 may all have the same length, or at least some of splines 1004 may have different lengths. Further, insulating polymer material / jacket made of any suitable polymer material(s) (e.g., polyamide-based, or polyester-based, thermoplastic elastomers, thermoplastic polyurethanes, and the like) can be applied on each of electrode splines 1004. and may have the same length, or at least some of electrode splines 1004 may have insulating polymer materials / jackets at different lengths. In addition, in some systems, DFA 1000 includes a distal electrode (not shown) positioned distal of splines 1004. The distal electrode may be used to perform point ablation (e.g., by creating a bipole between the distal electrode and one of splines 1004), and / or may be used for visualization / mapping purposes (e.g., using the distal electrode in combination with an electrode on shaft 1002).

[0135] Figure 11 is a perspective view of a DFA 1100. DFA 1100 includes a shaft 1102 and a plurality of splines 1104 surrounding a distal portion 1106 of shaft 1102. Each spline 1 104 includes a proximal end 11 10 coupled to shaft 1 102 and a distal end 1 1 12 coupled to shaft 1102. From proximal end 1110 to distal end 1112, spline 1104 has an arcuate shape that extends radially outward.

[0136] In this system, each spline 1104 includes a plurality of individual electrodes 1120. For example, each spline 1104 may include a superelastic conductive metal material (e.g., Nitinol) embedded or insulated by a polymer tube 1122, with individual electrodes 1120 attached to an exterior of polymer tube 1122. In the system shown, each insulated spline 1104 includes two electrodes 1120 securely attached onto it. Further, as shown in Figure 11, electrodes 1120 are generally positioned closer to distal end 1112 than proximal end 1110 to correspond to portions of spline 1104 that will contact pulmonary vein 320.

[0137] Alternatively, each insulated spline 1104 may include any suitable number and arrangement of electrodes 1120 securely affixed on it. For example, in some systems, each insulated spline 1104 includes four electrodes 1120 securely affixed on it.

[0138] In this system, alternating electrodes securely affixed on splines 1104 alternate polarities. That is, electrodes 1120 affixed on a particular spline 1104 have the same polarity7, but electrodes 1120 affixed on a particular spline 1104 have a different polarity than electrodes 1120 affixed on adjacent splines 1104. Alternatively, any suitable polarization scheme may be used. During delivery, the basket structure formed of a plurality of insulated splines 1104 may be collapsed in a collapsed state towards shaft 1102. Subsequently, to perform ablation, the basket structure formed of a plurality7of splines 1104 are deployed to be compressed radially outward in a compressed state.

[0139] Including multiple electrodes 1 120 on each polymer-insulated spline 1104, instead of the splines 1104 themselves made of a superelastic metal material being electrodes 1120, improves the ability7of DFA 1100 to perform various mapping routines, as each electrode 1120 can be used as an individual sensor for acquiring mapping data.

[0140] Splines 1104 may7all have the same length, or at least some of splines 1004 may have different lengths. Further, insulating polymer material / jacket (e.g., a PET or PEBA material) on each spline 1104 may have the same length, or at least some splines 1104 may have insulating polymer material / jacket with different lengths. In addition, in some systems, DFA 1100 includes a distal electrode (not shown) positioned distal of splines 1104. The distal electrode may be used to perform point ablation (e.g., by creating a bipole between the distal electrode and one of splines 1104), and / or may be used for visualization / mapping purposes (e.g., using the distal electrode in combination with an electrode on shaft 1102).

[0141] Figure 12 is a perspective view of an alternative system of a DFA 1200. DFA 1200 includes a shaft 1202 and a plurality of splines 1204 surrounding a distal portion 1206 of shaft 1202, similar to DFA 1100 (shown in Figure 11). However, in contrast to DFA 1100, DFA 1200 includes a balloon 1208 enclosed by7the basket structure formed of a plurality7of polymer-insulated splines 1204. Balloon 1208 may be selectively inflated to fill the space between splines 1204. Notably, balloon 1208 functions as an insulator, and generally reduces energy losses relative to DFA 1200, which may result in increased lesion size.[01421 Each spline 1204 includes a proximal end 1210 coupled to shaft 1202 and a distal end 1212 coupled to shaft 1202. From proximal end 1210 to distal end 1212, spline 1204 has an arcuate shape that extends radially outward.

[0143] In this system, each spline 1204 includes a plurality of individual electrodes 1220 securely affixed on it. For example, each spline 1204 may include a superelastic metal material (e.g., Nitinol) as embedded or insulated by a polymer tube 1222, with individual electrodes 1220 securely affixed on an exterior of polymer tube 1222. In the system shown, each insulated spline 1204 includes two electrodes 1220. Further, as shown in Figure 12, electrodes 1220 are generally positioned closer to distal end 1212 than proximal end 1210 to correspond to portions of insulated spline 1204 that will contact pulmonary7vein 320.

[0144] Alternatively, each insulated spline 1204 may include any suitable number and arrangement of electrodes 1220. For example, in some systems, each insulated spline 1204 includes four electrodes 1220.

[0145] In this system, electrodes 1220 securely affixed on alternating insulated splines 1204 alternate polarities. That is, electrodes 1220 securely affixed on a particular insulated spline 1204 have the same polarity7, but electrodes 1220 securely affixed on an adjacent insulated splines 1204 to this particular insulated spline 1204 have a different polarity. Alternatively, any suitable polarization scheme may be used. During delivery, the basket structure as formed of a plurality of insulated splines 1204 may be collapsed in a collapsed state towards shaft 1202. Subsequently, to perform ablation, the basket structure as formed of a plurality7of insulated splines 1204 are deployed to be compressed in a compressed state radially outwards shaft 1202.

[0146] Polymer-insulated splines 1204 may all have the same length, or at least some of insulated splines 1204 may have different lengths. Further, insulating polymer material / jacket (e.g., PET heat shrinkable tube, or Pebax® PEBA copolymer, thermoplastic polyurethane, etc.) embedding or embracing each of superelastic splines 1204 may have the same length, or at least some insulated splines 1204 may have insulating polymer material / jacket at different lengths. In addition, in some systems, DFA 1200 includes a distal electrode (not shown) positioned distal of insulated splines 1204. The distalelectrode may be used to perform point ablation (e.g.. by creating a bipole between the distal electrode and one of splines 1204), and / or may be used for visualization / mapping purposes (e.g., using the distal electrode in combination with an electrode on shaft 1202).

[0147] Figure 13 is a perspective view of a DFA 1300. DFA 1300 includes a shaft 1302 and a plurality of splines 1304 surrounding a distal portion 1306 of shaft 1302. Each spline 1304 includes a proximal end 1310 coupled to shaft 1302 and a distal end 1312 coupled to shaft 1302. From proximal end 1310, spline 1304 extends radially outw ard to an inflection point 1314, and then extends radially inward to distal end 1312.

[0148] Splines 1304 are made of a superelastic metal material (e.g., Nitinol), and function as relatively large electrodes themselves. In this system, alternating electrode splines 1304 alternate polarities. That is, each positive electrode spline 1304 is positioned between two negative electrode splines 1304 and vice-versa. Alternatively, any suitable polarization scheme may be used.

[0149] To control the ablation zone of each electrode spline 1304. portions of each electrode spline 1304 may be covered or insulated by an insulating polymer material / jacket 1320 (e.g., PET, PEBA, thermoplastic polyurethane, and etc.), and the exposed portions of splines 1304 function as electrodes. In Figure 13, inflection point 1314 and portions of spline 1304 between inflection point 1314 and distal end 1312 are generally- exposed, while portions of spline 1304 between inflection point 1314 and proximal end 1310 are generally insulated. This results in the portions of spline 1304 that contact pulmonary vein 320 being exposed and act as electrodes. Alternatively, any suitable insulation configuration may be used.

[0150] As shown in Figure 13, each spline 1304 includes a spread member 1330. Spread member 1330 includes a first end 1332, a second end 1334, a first branch 1336, and a second branch 1338. From first end 1332, first and second branches 1336 and 1338 extend away from one another, before they extend back towards one another and rejoin at second end 1334.

[0151] Spread member 1330 may be fabricated, for example, using laser cuting. In this system, all of spread member 1330 is exposed (i.e., not covered with any insulating polymer material / jacket). Alternatively, portions of spread member 1330 may be covered with an insulating polymer material / j acket.

[0152] Including spread members 1330 on splines 1304 reduces the extent of circumferential gaps between splines 1304, which facilitates increasing lesion volume. Further, additional splines 1304 may be included to further reduce the extent of the circumferential gaps.

[0153] In some systems, at least one of splines 1304 includes multiple spread members 1330. instead of a single spread member 1330. Further, as show n in Figure 13, spread members 1330 are longitudinally aligned with one another in DFA 1300. However, in some systems, at least some spread members 1330 are longitudinally offset relative to one another.

[0154] Further, although spread members 1330 are shown as having two branches 1336 and 1338 with substantially equal lengths, spread members 1330 may have different numbers of branches and / or branches with unequal lengths. Further, in some systems, a spread member 1330 may be formed from two separates splines 1304, instead of a single spline 1304 forming spread member 1330.

[0155] During delivery, the electrode basket structure formed of a plurality of splines 1304 may be collapsed inwards tow ards shaft 1302. Further, when the electrode basket formed of splines 1304 collapse, first and second branches 1336 and 1338 of each spread member 1330 also collapse inwards towards one another, reducing the overall profile of DFA 1300. Subsequently, to perform ablation, the electrode basket structure of splines 1304 are deployed in a compressed state with inflection points 1314 (of splines 1304) extending radially outward.

[0156] Electrode splines 1304 may all have the same length, or at least some of electrode splines 1304 may have different lengths. Further, insulating polymer material / jacket partially applied on each electrode spline 1304 may have the same length, or at least some electrode splines 1304 may have an insulating polymer material / jacketwith different lengths. In addition, in some systems, DFA 1300 includes a distal electrode (not shown) positioned distal of electrode splines 1304. The distal electrode may be used to perform point ablation (e.g., by creating a bipole between the distal electrode and one of splines 1304), and / or may be used for visualization / mapping purposes (e.g., using the distal electrode in combination with an electrode on shaft 1302).

[0157] Figure 14 is a perspective view of a DFA 1400. DFA 1400 includes a shaft 1402 and a plurality of splines 1404 surrounding a distal portion 1406 of shaft 1402. However, in contrast to DFA 1300 (shown in Figure 13), DFA 1400 includes a balloon 1408 enclosed by splines 1404. Balloon 1408 may be selectively inflated to fill the space between splines 1404. Notably, balloon 1408 functions as an insulator, and generally reduces energy' losses relative to DFA 1300, which may result in increased lesion size.

[0158] Each spline 1404 includes a proximal end 1410 coupled to shaft 1402 and a distal end 1412 coupled to shaft 1402. From proximal end 1410, spline 1404 extends radially outward to an inflection point 1414, and then extends radially inward to distal end 1412.

[0159] Splines 1404 are made of a superelastic conductive metal material (e.g., Nitinol), and function as relatively large electrodes. In this system, alternating electrode splines 1404 alternate polarities. That is, each positive spline 1404 is positioned between two negative splines 1404 and vice-versa. Alternatively, any suitable polarization scheme may be used.

[0160] To control the ablation zone of each electrode spline 1404. portions of each electrode spline 1404 may be covered or insulated by an insulating polymer material / jacket 1420 (e.g., PET, PEBA copolymer, thermoplastic polyurethane, etc.), and the exposed portions of splines 1404 function as electrodes. In Figure 14, inflection point 1414 and portions of spline 1404 between inflection point 1414 and distal end 1412 are generally exposed, while portions of spline 1404 between inflection point 1414 and proximal end 1410 are generally insulated. This results in the portions of spline 1404 that contact pulmonary vein 320 being exposed and act as electrodes. Alternatively, any suitable insulation configuration may be used.

[0161] As shown in Figure 14. each spline 1404 includes a spread member 1430. Spread member 1430 includes a first end 1432, a second end 1434, a first branch 1436, and a second branch 1438. From first end 1432, first and second branches 1436 and 1438 extend away from one another, before they extend back towards one another and rejoin at second end 1434.

[0162] Spread member 1430 may be fabricated, for example, using laser cutting. In this system, all of spread member 1430 is exposed (i.e., not covered with any insulating polymer material / jacket). Alternatively, portions of spread member 1430 may be covered with an insulating polymer material / jacket.

[0163] Including spread members 1430 on splines 1404 reduces the extent of circumferential gaps between electrode splines 1404, which facilitates increasing lesion volume. Further, additional electrode splines 1404 may be included to further reduce the extent of the circumferential gaps.

[0164] In some systems, at least one of electrode splines 1404 includes multiple spread members 1430. instead of a single spread member 1430. Further, as shown in Figure 14, spread members 1430 are longitudinally aligned with one another in DFA 1400. However, in some systems, at least some spread members 1430 are longitudinally offset relative to one another.

[0165] During delivery, the electrode basket structure as formed of a plurality of electrode splines 1404 may be collapsed in a collapsed state inwards towards shaft 1402. Further, when the electrode basket structure of splines 1404 is collapsed, first and second branches 1436 and 1438 of each spread member 1430 of electrode splines 1404 are also collapsed inwards towards one another, reducing the overall profile of DFA 1400. Subsequently, to perform ablation, the electrode basket structure formed of a plurality of electrode splines 1404 are deployed in a compressed state with inflection points 1414 of splines 1404 extending radially outward.

[0166] Electrode splines 1404 may all have the same length, or at least some of electrode splines 1404 may have different lengths. Further, an insulating polymer material / jacket applied on portions of each electrode spline 1404 may have the samelength, or at least some electrode splines 1404 may have the insulating polymer material / jacket with different lengths. In addition, in some systems, DFA 1400 includes a distal electrode (not show n) positioned distal of splines 1404. The distal electrode may be used to perform point ablation (e.g., by creating a bipole between the distal electrode and one of splines 1404). and / or may be used for visualization / mapping purposes (e.g., using the distal electrode in combination with an electrode on shaft 1402).

[0167] Figure 15 is a perspective view of a DFA 1500. DFA 1500 includes a shaft 1502 and a plurality’ of splines 1504 surrounding and disposed at a distal portion 1506 of shaft 1502. Each spline 1504 includes a proximal end 1510 coupled to shaft 1502 and a distal end 1512 coupled to shaft 1502. From proximal end 1510, spline 1504 extends radially outward to an inflection point 1514, and then extends radially inward to distal end 1512.

[0168] Splines 1504 are made of a superelastic and conductive metal material (e.g., Nitinol), and function as relatively large electrodes. In this system, alternating electrode splines 1504 alternate polarities. That is, each positive electrode spline 1504 is positioned between two negative electrode splines 1504 and vice-versa. Alternatively, any suitable polarization scheme may be used.

[0169] To control the ablation zone as effectuated by the electrode basket structure formed of electrode splines 1504, portions of each electrode spline 1504 may be covered or insulated by an insulating polymer material / jacket 1520, and the exposed portions of splines 1504 function as electrodes. In Figure 15, inflection point 1514 and portions of spline 1504 in the vicinity of inflection point 1514 tow ards distal end 1512 are generally exposed, while other portions of spline 1504, including distal end 1512 and proximal end 1510, are generally insulated by applying an insulating polymer material / jacket 1520. This results in the exposed (electrode) portions of splines 1504 being in contact with, or in close proximity to, the pulmonary vein 320 when DFA 1500 is properly deployed. Alternatively, any suitable insulation configuration may be used.

[0170] As shown in Figure 15, each electrode spline 1504 includes a tapered member 1530. Tapered member 1530 includes a first end 1532 and a second end 1534. From first end 1532, a width of tapered member 1530 tapers outward along a first taperedportion 1540. the width stays substantially constant along a middle portion 1542. and the width tapers back inward along a second tapered portion 1544 towards second end 1534. In some systems, tapered member 1530 includes only a single tapered portion.

[0171] Tapered member 1530 may be fabricated, for example, using laser cutting. In this system, all of tapered member 1530 is exposed (i. e. , not covered with insulating polymer material / jacket). Alternatively, portions of tapered member 1530 may be covered by an insulating polymer material / jacket. Further in this system, tapered member 1530 functions as an individual electrode. Alternatively, tapered member 1530 may be split and functions as multiple individual electrodes (e.g., by disposing the insulating polymer material / jacket on multiple portions of tapered member 1530).

[0172] Including tapered members 1530 on splines 1504 reduces the extent of circumferential gaps between electrode splines 1504, which facilitates increasing lesion volume. Further, additional electrode splines 1504 may be included to further reduce the extent of the circumferential gaps.

[0173] In some systems, at least one of electrode splines 1504 includes multiple tapered members 1530, instead of a single tapered member 1530. Further, as shown in Figure 15, tapered members 1530 are longitudinally aligned with one another in DFA 1500. However, in some systems, at least some tapered members 1530 are longitudinally offset relative to one another.

[0174] During catheter delivery' into, or retraction from, the body of a patient, splines 1504, along with the electrode basket structure formed of a plurality of splines 1504. may be collapsed inwards towards shaft 1502. Subsequently, to perform ablation, splines 1504, along with the electrode basket structure formed of multiple splines 1504, will be compressed to expand or extend radially outward when deployed.

[0175] Electrode splines 1504 may all have the same length, or at least some of electrode splines 1504 may have different lengths. Further, an insulating polymer material / jacket applied on each electrode spline 1504 may have the same length, or at least some electrode splines 1504 may have an insulating polymer material / jacket with different lengths. In addition, in some systems, DFA 1500 includes a distal electrode (not shown)positioned distal of the electrode basket structure as formed of a plurality of splines 1504. The distal electrode may be used to perform point ablation (e.g., by creating a bipole between the distal electrode and one of splines 1504), and / or may be used for visualization / mapping purposes (e.g., using the distal electrode in combination with an electrode on shaft 1502).

[0176] Figure 16 is a perspective view of a DFA 1600. DFA 1600 includes a shaft 1602 and a plurality of splines 1604 surrounding a distal portion 1606 of shaft 1602. However, in contrast to DFA 1500 (shown in Figure 15), DFA 1600 includes a balloon 1608 enclosed by an electrode basket structure formed of a plurality of electrode splines 1604. Balloon 1608 may be selectively inflated to fill the space enclosed by the electrode basket structure formed of a plurality of electrode splines 1604. Notably, balloon 1608 functions as an electrical insulator, and generally reduces energy losses relative to DFA 1500. which may result in increased lesion size.

[0177] Each of electrode splines 1604 includes a proximal end 1610 coupled to shaft 1602 and a conductor wire (not shown) and a distal end 1612 coupled to shaft 1602. From proximal end 1610, electrode spline 1604 extends radially outward to an inflection point 1614, and then extends radially inward to distal end 1612.

[0178] Electrode splines 1604 are made of a superelastic and conductive metal material (e.g., Nitinol). and function as relatively large electrodes. In this system, alternating electrode splines 1604 alternate polarities. That is, each positive electrode spline 1604 is positioned between two negative electrode splines 1604 and vice-versa. Alternatively, any suitable polarization scheme may be used.

[0179] To control the ablation zone as effectuated by the electrode basket structure formed of a plurality of electrode splines 1604, portions of each electrode spline 1604 may be covered or insulated by an insulating polymer material / jacket 1620, and the exposed portions of splines 1604 function as electrodes. In the system shown in Figure 16, portion of each spline 1604 in the vicinity of inflection point 1614 towards distal end 1612 are generally exposed, w hile other portions of each spline 1604, including distal end 1612 and proximal end 1620, are generally insulated. As such, when DFA 1600 is deployed and the electrode basket structure formed of a plurality of electrode splines 1604 is properlycompressed in a compressed state, the exposed (electrode) portion of each spline 1604 would be expanded or extended radially outward to be near or in contact with the pulmonary vein 320. Alternatively, any suitable insulation configuration may be used.

[0180] As shown in Figure 16, each electrode spline 1604 includes a tapered member 1630. Tapered member 1630 includes a first end 1632 and a second end 1634. From first end 1632, a width of tapered member 1630 tapers outward along a first tapered portion 1640, the width stays substantially constant along a middle portion 1642, and the width tapers back inward along a second tapered portion 1644 towards second end 1634. In some systems, tapered member 1530 includes only a single tapered portion.

[0181] Tapered member 1630 may be fabricated, for example, using laser cutting. In this system, all of tapered member 1630 is exposed (i.e. , not covered with insulating polymer material / jacket) to act as electrode for electrode spline 1604. Alternatively, portions of tapered member 1630 may be covered or insulated by an insulating polymer material / jacket. Further in this system, tapered member 1630 functions as an individual electrode. Alternatively, tapered member 1630 may be split into multiple individual electrodes (e.g., by disposing the insulating polymer material / jacket on multiple portions of taper member 1630).

[0182] Including tapered members 1630 on electrode splines 1604 reduces the extent of circumferential gaps between electrode splines 1604, which facilitates increasing lesion volume. Further, additional electrode splines 1 04 may be included to further reduce the extent of the circumferential gaps.

[0183] In some systems, at least one of electrode splines 1604 includes multiple tapered members 1630, instead of a single tapered member 1630. Further, as shown in Figure 16, tapered members 1630 are aligned with one another along the circumferential direction of shaft 1602 in DFA 1600 when DFA 1600 is collapsed in a collapsed state. However, in some systems, at least some tapered members 1630 are longitudinally aligned, or parallel to one another with some offset gap betw een them, along the circumferential direction of shaft 1602 in DFA 1600 when DFA 1600 collapsed.

[0184] During catheter delivery into, or retraction from, the body of a patient, the electrode basket structure formed of a plurality of electrode splines 1604, or DFA 1600, may be collapsed in a collapsed state inwards towards shaft 1602. Subsequently, to perform ablation. DFA 1600 including the electrode basket structure formed of electrode splines 1604 is deployed, and will be compressed in a compressed state, such that electrode splines 1604 expand or extend radially outward to be in close proximity' to, or in contact with, the pulmonary vein for effectuating ablation.

[0185] Electrode splines 1604 may all have the same length, or at least some of electrode splines 1604 may have different lengths. Further, an insulating polymer material / jacket applied on each electrode spline 1604 may have the same length, or at least some electrode splines 1604 may have an insulating polymer material / jacket with different lengths. In addition, in some systems, DFA 1600 includes a distal electrode (not shown) positioned distal of splines 1604. The distal electrode may be used to perform point ablation (e.g., by creating a bipole between the distal electrode and one of splines 1604), and / or may be used for visualization / mapping purposes (e.g., using the distal electrode in combination with an electrode on shaft 1602).

[0186] Due at least in part to the length of the exposed portions of electrode splines 1604, DFA 1600 including the electrode basket structure formed of a plurality' of electrode splines 1604 as described herein may, in some systems, create lesions having a length in a range from approximately 1.0 to 1.5 centimeters. This results in a wide band of lesions to help prevent breakthrough, as opposed to lesions in at least some known systems (which may have a length of approximately 4 or 5 mm). This is clinically important as lesions are often not homogenous. Further, the larger lesion length may result in ablating a large area of the PV antrum. This is advantageous, as the PV antrum includes many transition tissue fibers that may be pro-arrhythmic.

[0187] In the sy stems described herein, electrode splines are generally straight. However, electrode splines may have any suitable shape. For example, in some systems, electrode splines may have a sigmoidal shape, which may facilitate relieving stresses when the splines are compressed or collapsed.[01881 In addition, although the systems described herein are shown with a particular number of electrode splines, those of skill in the art will appreciate that any suitable number of electrode splines may be included in DFA 1600. For example, DFA 1600 may include four, six, eight, ten, twelve, fourteen, sixteen, eighteen, or twenty' electrode splines in some systems.

[0189] As noted above, DFAs as described herein, including DFA 1600, can also include a balloon enclosed by the electrode basket structures formed of a plurality' of (insulated and / or electrode) splines made of a superelastic metal material (e.g., ni tinol), where the balloon functions as an electrical insulator, and generally reduces energy losses. This is because the balloon causes the electrode splines, and / or electrodes securely affixed on insulated splines, to primarily transfer energy' outward, away from the balloon, resulting in the energy predominantly being transferred to target tissue instead of into the blood pool.

[0190] During PFA therapy, at least some known systems may generate microbubbles, which may be undesirable. However, it has been observed that increased current density at electrodes results in increased microbubble formation. Accordingly, reduced current density’ generally results in reduced microbubble formation. In at least some of the systems described herein, DFAs comprising some basket structures formed of a plurality' of (insulated and / or electrode) splines can create a relatively large surface area (e.g., in systems where a relatively long, exposed portion of the splines functions as the electrode). This larger surface area results in lower current density, and thus reduced microbubble formation (in addition to being more efficient at delivering energy to target tissue as discussed above).

[0191] Those of skill in the art will appreciate that the various systems of many DFAs as disclosed in the above, including DFA 1600, may be implemented independently from one another or in any' suitable combination.

[0192] Further, the DFAs described herein, including DFA 1600, may have any suitable dimensions. For example, in some systems, the DFAs comprising relevant electrode basket structures formed of a plurality' of electrode and / or insulated splines as described herein can have an expanded diameter in a range of about 28-35 mm, when deployed and properly compressed in a compressed state. Alternatively, the DFAsdescribed herein may have a smaller expanded diameter (e.g.. in a range of about 8-10 mm).

[0193] For example, Figure 17 is a perspective view of a DFA, namely DFA 1700. DFA 1700 includes a shaft 1702 and a plurality of electrode splines 1704 that are disposed and coupled to a distal portion 1706 of shaft 1702 in forming an electrode basket structure. DFA 1700 also includes a balloon 1708 enclosed by the electrode basket structure formed of a plurality of electrode splines 1704. Balloon 1708 may be selectively inflated to fdl the space within the electrode basket structure of electrode splines 1704. Notably, balloon 1708 functions as an electrical insulator, and generally reduces energy losses, which may result in increased lesion size.

[0194] Relative to DFAs 300, 400. 500, 600, 900, 1000, 1100, 1200, 1300, 1400, 1500, and 1600, DFA 1700 may be smaller, with a more simplified design, which may result in reduced manufacturing costs. For example, DFAs 300, 400, 500, 600, 900, 1000, 1100, 1200, 1300, 1400, 1500, and 1600 may have a diameter in a range of about 28-35 mm with the DFA comprising relevant basket structures are deployed and properly compressed in some collapsed states, in order to facilitate performing PVI. In contrast, DFA 1700 comprising relevant electrode basket structures of electrode splines 1704, when deployed and properly compressed in a compressed state, may have a diameter in a range of about 8-10 mm (e.g., a diameter of 9 mm). Further, when properly collapsed in a collapsed state. DFA 1700 may be deliverable using a 7.5 French introducer.

[0195] DFA 1700 with the smaller diameter in its properly compressed state allows to generate smaller, more focused lesions. For example, DFA 1700 may be used to treat gaps that remain after one of DFAs 300, 400, 500, 600, 900, 1000, 1100, 1200, 1300, 1400, 1500, and 1600 has been used to perform PVI. Accordingly, DFA 1700 may be used to supplement ablative procedures following primary ablative procedures as performed with use of some ablation catheter system comprising one of DFAs 300, 400, 500, 600, 900, 1000, 1100, 1200. 1300, 1400, 1500, and 1600. As another example, DFA 1700 may be used to treat other targets, such as the posterior wall.[01961 By computerized clinical simulations, it has been demonstrated that DFA 1700 generates lesions substantially consistently, regardless of the orientation of DFA 1700 to target tissue. For example, lesions having a depth of at least 4 mm can be virtually achieved with relevant catheter system when DFA 1700 or catheter shaft 1702 is disposed at angles of approximately 10°, 45°, and 90° relative to a surface of the target tissue.

[0197] In the system shown, each of electrode splines 1704 includes an exposed portion 1710 that functions as an electrode, and an insulated portion 1712 proximal of exposed portion 1710. In some systems, another insulated portion 1712 is included distal of exposed portion 1710. Alternatively, this distal insulated portion 1712 may be omitted. Although electrode splines 1704 are show ed as having a constant width, those of skill in the art will appreciated that other spline shapes may be used (e.g., tapered shapes, split shapes, etc.).

[0198] To perform ablation, a voltage (e.g., 1500 V) is applied to DFA 1700. Specifically, the voltage may be applied between electrode splines 1704 in accordance with a bipolar approach. Alternatively, the voltage may be applied between one or more electrode splines 1704 and a separate electrode (e.g., a body patch electrode) under a monopolar approach. Further, voltages may be applied to electrode splines 1704 concurrently, or sequentially (e.g., via multiplexing).

[0199] DFA 1700 includes two electrode splines 1704. Alternatively, more electrode splines may be included. For example. Figure 18 is a perspective view of a DFA, namely DFA 1800, which includes four electrode splines 1804, and Figure 19 is a perspective view of a DFA, namely DFA 1900, which includes six splines 1904. Aside from the number of electrode splines, DFAs 1800 and 1900 are substantially similar to DFA 1700.

[0200] Turning now7to systems of the structural construction & material composition of those splines, i.e., those "‘insulated splines” that are entirely polymer- insulated and have some ‘‘independent” electrodes securely affixed in place and those “electrode splines” that are partially polymer-insulated and have their exposed portion(s) act as electrodes, in accordance with the present disclosure, Figure 20 is an illustration of an electrode spline 2000 in its cross sectional view. Spline 2000 includes a body 2002made of a superelastic and conductive metal material (e.g., NiTi alloy or nitinol). an insulating polymer material / jacket 2006 made of one or more polymer material, and an organosilane coupling material 2004 physico-chemically coupling the superelastic conductive metal material 2002 to the contacting polymer material comprised of the insulating polymer material / jacket 2006. In the example system, an entire surface of the body 2002 of spline 2000 is coated with the organosilane coupling material 2004. Alternatively, only one or more portions of the body 2002 in its longitudinal direction, corresponding to portions of spline 2000 that are to be circumferentially covered or insulated by an insulating polymer material / jacket, may be coated. This spline 2000 may be, for example, any of the (insulated or electrode) splines described herein, including splines 612, splines 904, splines 1004, splines 1 104, splines 1204, splines 1304, splines 1404, splines 1504, splines 1604, splines 1704, splines 1804, and splines 1904.

[0201] Figure 21 is an illustration of another example system of a spline 2100 in a cross-sectional view along its longitudinal direction. The spline 2100 includes a body 2102 made of a superelastic, conductive metal material (e.g., NiTi alloy or nitinol), an insulating polymer material / jacket 2106, and an organosilane coupling material 2104 chemically- coupling the superelastic, conductive metal material or body 2102 to the contacting (or interior) polymer material of the insulating polymer material / jacket 2106. In this system, one or more longitudinal portions of body 2102 of spline 2100, where an insulating polymer material / jacket is present only, are coated with the organosilane coupling material 2104. This spline 2100 may be, for example, any of the splines described herein, including splines 612, splines 904, splines 1004, splines 1104, splines 1204, splines 1304, splines 1404, splines 1504, splines 1604, splines 1704, splines 1804, and splines 1904.

[0202] Generally, the superelastic conductive metal material may be any of suitable metallic materials known in the art that facilitates fabricating a spline as described herein. In some systems, the superelastic conductive metal material is selected from the group consisting of shape memory- alloys.

[0203] In some systems, the superelastic conductive metal material is selected from the group consisting of nitinols or nickel titanium alloys superalloys, and other prevalent shape-memory- alloys, such as copper-zinc-aluminum alloys, copper-aluminum-nickel alloys, zinc-copper-gold-iron alloys, iron-manganese-silicon alloys, etc. and combinations thereof. Nitinols or nickel titanium alloys are highly preferred because of excellent superelasticity, outstanding electrical conductivity, and proven biocompatibility and biostability of material for medical device applications.

[0204] Generally, the insulating polymer material / jacket may be made of any one or more suitable polymer materials known in the art that facilitates fabricating a spline as described herein. The insulating polymer material / jacket may be made of one, tw o, three, four, or more than four different but chemically compatible polymer materials configured in one or more self-adherent polymer layers that can be made via polymer coextrusion processes known in the art.

[0205] The insulating polymer material / jacket may encase one or more portions of the body or all of the body of a spline along the longitudinal direction of the spline. The interior, or the most interior, polymer layer of the insulating polymer material / jacket should be thermoplastic or chemically uncrosslinked in nature, while other polymer layers of the insulating polymer material / jacket may be chemically crosslinkable.

[0206] In some systems, the insulating polymer material / jacket can be made in a tubular preform. In some systems, the insulating polymer material / jacket can be made in a bi-layer tubular preform.

[0207] In some systems, one or more polymer materials for making the insulating polymer material / jacket include thermoplastic polymer materials selected from the group consisting of polyester homopolymer & copolymers (e.g., poly(ethylene terephthalate), poly(butylene terephthalate), etc.), nylon or polyamide homopolymer & copolymers (e.g., nylon 11, nylon 12, nylon 612, etc ), poly(bisphenol A carbonate), polysulfones, polyethersulfones, polyetherimides, polyethylenes, polypropylene homopolymers & copolymers, and combinations thereof.

[0208] In some systems, one or more polymer materials for making the insulating material / polymer jacket are selected from the group consisting of thermoplastic elastomers, including polyamide-based thermoplastic elastomers or poly(ether block amide) (PEBA) copolymers, polyester-based thermoplastic elastomers or poly(ester ether) blockcopolymers, thermoplastic polyurethane elastomers (e.g., poly(ether urethane) copolymers, polycarbonate urethane) copolymers, poly(siloxane-carbonate urethane) copolymers, poly(siloxane-ether urethane) copolymers, and the like), styrenic thermoplastic elastomers or styrenic block copolymers, thermoplastic olefins, and combinations thereof.

[0209] In some systems, one or more polymer materials for making the insulating material / polymer jacket are selected from the group consisting of thermoplastic polymer materials preferably selected from the group consisting of polyamide-based thermoplastic elastomers (e.g., Pebax®. Vestamide® E. etc ), thermoplastic polyurethane elastomers (e.g.. Pellethane®, Estane®, Pearl thane™. Elasthane™, Tecobax™, Texoflex™, Tecothane™, Carbothane™, Bionate®, Carbosil®, Pursil®, Biospan®, Elast-Eon™, Desmopan®, etc.), polyester-based thermoplastic elastomers (e.g., Hytrel®, Amitel®, etc.), and combinations thereof.

[0210] In some systems, one or more polymer materials for making the insulating material / polymer jacket may further include some polymer additives (e.g., UV stabilizer, antioxidant, etc.), colorants, and / or pigments.

[0211] In some systems, the insulating polymer material / j acket may be bi-layered and applied to one or more portions of the body of a spline onto which the organosilane coupling material is coated. The insulating polymer material / j acket may be made of one or more polymer materials in a bilayer tubular preform, and then applied to one or more portions of the body of a spline onto which the organosilane coupling material is coated. The interior, or most interior, polymer layer of the jacket may be comprised of a thermoplastic polymer or a thermoplastic elastomer material. The interior, or most interior, polymer layer may optionally including some polymer additive(s) (e.g., UV stabilizer, antioxidant, etc.) as disclosed above. The other polymer layer(s), in particular, the exterior, or most exterior, polymer layer, of the insulating material / polymer jacket may be comprised of a melt-extrudable, radiation-crosslinkable polymer compound based on a thermoplastic polymer or a thermoplastic elastomer. The thermoplastic polymer or a thermoplastic elastomer may optionally include a polymer additive (e.g., UV stabilizer, antioxidant, etc.). Further, the thermoplastic polymer or a thermoplastic elastomer may compositionally include one or more crosslinking agents, which would promote polymercrosslinking therein. Those of skill in the art will appreciate that, in various systems, at least one layer of the insulating polymer material / jacket (including an inner layer or exterior layer) may include a re-meltable material. Further, those of skill in the art will appreciate that, in various systems, at least one layer of the insulating polymer material / jacket (including an inner layer or exterior layer) may include a heat-shrinkable material.

[0212] The crosslinking agent for a melt-extrudable, radiation-crosslinkable polymer compound may be selected from the group of organic substances consisting of irradiation-activable polyfunctional (>3) crosslinkable groups, such as triallyl groups (e.g., triallyl isocyanurate (TAIC), triallyl cyanurate (TAC), triallyl phosphate, pentaerythritol triallyl ether, etc.), trivinyl groups (e.g., trivinyltrimethylcyclosiloxane, trimethylolpropane trivinyl ether, etc.), triacrylate groups (e.g., trimethylolpropane triacrylate (TMPTA). pentaerythritol triacrylate (PAT A), etc.), and combinations thereof.

[0213] In some systems, the organosilane coupling material, i.e., a functional, crosslinked poly siloxane material is formed in situ on one or more portions of the body of a spline. The organosilane coupling material may be formed when an applicable dispersion or solution of coating is applied and cured on the one or more portions of the body of the spline. The organosilane coupling material may be coupled to the superelastic conductive metal material of the body of the spline by a covalent chemical bond, i.e., metallo-siloxane covalent bonds. In some systems, the organosilane coupling material, i.e., a functional, crosslinked polysiloxane material is formed in situ on one or more portions of the body of a spline when an applicable dispersion or solution of coating is applied and cured thereon, and coupled to the superelastic conductive metal material of the body of the spline by a covalent chemical bond, i.e., metallo-siloxane covalent bonds.

[0214] In some systems, the organosilane coupling material, i.e., a functional, crosslinked polysiloxane material is formed in situ when an applicable dispersion or solution of coating is applied and cured. The organosilane coupling material may be intimately coupled to a metallic oxide surface (e.g., a hydroxylated metallic oxide surfce) of the body of a spline via a covalent chemical bond, i.e., a metallosiloxane bond. Insome systems, the organosilane coupling material, i.e., a functional, crosslinked polysiloxane material is formed in situ when an applicable dispersion or solution of coating is applied and cured, is intimately coupled to a hydroxylated metallic oxide surface of the body of a spline via a covalent chemical bond, i.e., a metallosiloxane bond.

[0215] Generally, the organosilane coupling material may be coupled to the superelastic conductive metal material in any suitable configuration that facilitates fabricating a spline as described herein. In some systems, the organosilane coupling material is coupled to the superelastic conductive metal material only on the terminal portions of the body of a spline. As used herein, a terminal portion of the body of the spline is a portion of the body that is on an end of the body of the spline.

[0216] In some systems, the organosilane coupling material is coupled to the metallic body of a spline in entirety. In some preferred systems, the organosilane coupling material is selectively applied only on one or more portions of the hydroxylated metallic body of a spline, such that it also imparts chemical coupling to the interior or most interior polymer layer of an insulating material / polymer jacket intimately encasing the portion(s) of a spline via intermolecular forces, such as hydrogen bonding, van der Waal forces, and the like.

[0217] In some systems, the organosilane coupling material is coupled to the interior or most interior insulating polymer material / jacket by a physical bond and / or a physical force. In some systems, the organosilane coupling material is molecularly interlocked with the interior or most interior polymer layer of the insulating polymer jacket. In some systems, the organosilane coupling material is coupled to the interior or most interior polymer layer by van der Waal forces.

[0218] Generally, the organosilane coupling material may be formed of any suitable polymer dispersion or solution system comprising one or more reactive organosilane coupling agents described herein. That is, an organosilane coupling material may be formed from a reactive dispersion or solution containing one or more reactive organosilane coupling agent(s). Such a reactive organosilane coupling agent may molecularly comprise one, or two, or three silicon atoms and can be classified as monopodal, dipodal, and tripodal organosilane agents. As a metalloid, a silicon atom intetravalence can covalently bond to at least one organofunctional moiety (R) via an alkyl spacer (L) and to at least one hydrolyzable moiety (X) that can chemically interact with an inorganic substance, including superelastic metallic alloys, e.g., nitinol or NiTi alloy. In some particular systems, the organosilane coupling agent is selected from:

[0219] monopodal organosilane substances according to Formula I:(Formula I);

[0220] dipodal organosilane substances according to Formula II:(Formula II);

[0221] tripodal organosilane substances according to Formula III:(Formula III); and

[0222] and combinations thereof;

[0223] wherein:Ri, R2. and R- are each selected from the group consisting of organofunctional moieties, oligomeric organofunctional moieties, polymeric organofunctional moieties, and combinations thereof;Li, L2, and L? are each selected from the group consisting of direct bonds, substituted or unsubstituted linear alkyl, substituted or unsubstituted linear Ci-Cio alkyl, substituted or unsubstituted linear C2-C4 alkyl, substituted or unsubstituted branched alkyl, substituted or unsubstituted branched C1-C10 alkyl, substituted or unsubstituted branched C2-C4 alkyl, Ci alkyl. C2 alkyd. C3 alkyl, C4 alkyl, C5 alkyl, Cg alkyl, C7 alkyl, Cs alkyl, C9 alkyl, C10 alkyl, and combinations thereof;Xi, X2, and X3 are each selected from hydrolyzable groups (e.g., alkoxy, acyloxy, amine, oxime, hydroxyl, and halogen) or from non-hydrolyzable alkyl groups (e.g., substituted or unsubstituted linear alkyl, substituted or unsubstituted linear C1-C10 alkyl, substituted or unsubstituted linear C2-C4 alkyl, substituted or unsubstituted branched alkyl, substituted or unsubstituted branched C1-C10 alkyl, substituted or unsubstituted branched C2- C4 alkyl, Ci alkyl, C2 alkyl, C3 alkyl, C4 alkyl, C5 alkyl, Cg alkyl, C7 alkyl. Cs alkyl, C9 alkyl, C10 alkyl, and combinations thereof), wherein at least one of Xi. X2. and X3 is a hydrolyzable group;Yi, Y2, and Y3 are each selected from hydrolyzable groups (e g., alkoxy, acyloxy, amine, oxime, hydroxyl, halogen) or from non-hydrolyzable alkyl groups (e.g., substituted or unsubstituted linear alkyl, substituted or unsubstituted linear C1-C10 alkyl, substituted or unsubstituted linear C2-C4 alkyl, substituted or unsubstituted branched alkyl, substituted or unsubstituted branched C1-C10 alkyl, substituted or unsubstituted branched C2-C4 alkyl, Ci alkyl. C2 alkyd. C3 alkyl, C4 alkyl, C5 alkyl, Cg alkyl, C7 alkyl, Cs alkyl, C9 alkyl, C10 alkyl, and combinations thereof); andZi, Z2, and Z3 are each selected from hydrolyzable groups (e.g., alkoxy, acyloxy, amine, oxime, hydroxyl, and halogen) or from non-hydrolyzable alkyl groups (e.g., substituted or unsubstituted linear alkyl, substituted or unsubstituted linear C1-C10 alkyl, substituted or unsubstituted linear C2-C4 alkyl, substituted or unsubstituted branched alkyl, substituted or unsubstituted branched C1-C10 alkyl, substituted or unsubstituted branched C2- C4alkyl, Ci alkyl, C2alkyl. C3alkyl, C4alkyl, C5alkyl, Cg alkyl, C7alkyl. C8alkyl, C9alkyl, C10 alkyl, and combinations thereof).

[0224] In some systems, Ri, R2, and R3 are each selected from the group consisting of organofunctional moieties that exhibit molecular affinity and / or chemical miscibility with the interior or most interior layer of an insulating polymer material / jacket. In these systems, the molecular affinity' and / or chemical miscibility between the organofunctional moieties of the organosilane coupling agent and the interior or most interior polymer layer of the insulating polymer material / jacket results in intimate physical or molecular coupling at the interface via strong intermol ecul ar forces and interfacial molecular diffusion & entanglement between two materials (i.e., the interior / most interior polymer layer of the insulating polymer material / jacket and the organosilane coupling material).

[0225] In some systems, Ri, R2, and R3 are each oligomeric or non-oligomeric moieties comprising a functional group selected from the groups consisting of substituted or unsubstituted and linear or branched alkyl, alkenyl, alkynyl, aryl, phenyl, benzyl, acryl, amino, hydroxy, mercapto, alkoxy, carbonyl, carboxyl, ester, carbonate, amide, isocyanate, urethane, urea, oxirane, and combinations thereof.

[0226] In some systems, the organosilane coupling agent is selected from the group consisting of: i) organosilane coupling agents including amino or amine organofunctional groups, including, but not limited to, 3-aminopropyl triethoxysilane. 3-aminopropyl trimethoxysilane, 4-aminobutyl triethoxysilane, 4-amino-3,3-dimethylbutyl trimethoxysilane, N-(2-aminoethyl)-3-aminopropyl trimethoxysilane, N-(2- aminoethyl)-3-aminopropyl triethoxysilane, N-(6-amino-hexyl)aminomethyl trimethoxysilane. N-(6-aminohexyl)aminomethyl triethoxysilane, 3-[2-(2- aminoethylaminojethylamino] propyl trimethoxysilane, N-(2-aminoethy)-3- aminopropyl silanetriol, bis(3-trimethyoxysilylpropyl) amine, bis(3- triethyoxysilylpropyl) amine, N,N'-bis((3-trimethoxysilyl)propyl) ethylenediamine, N,N’ -bis((3 -tri ethoxy sily l)propy 1) ethylenediamine, N-phenylaminomethyl trimethoxysilane, etc., and combinations thereof; ii) organosilane coupling agents including urethane or urea groups, including, but not limited to, (3 -acetamidopropyl) trimethoxysilane, (3-acetamidopropyl)tri ethoxysilane. N, N?-bis(3-trimethoxysilylpropyl) urea, N, N’-bis(3- tri ethoxysilylpropyl) urea, tris(3-trimethoxysilylpropyl) isocyanurate, tris(3- triethoxysilylpropyl) isocyanurate, etc., and combinations thereof; iii) organosilane coupling agents including oxirane groups, including, but not limited to, (3-glycidoxypropyl)trimethoxysilane, (3- glycidoxypropyl)triethoxysilane, 5,6-epoxyhexyltriethoxysilane, (3- glycidoxypropyl)methyldimethoxysilane, (3- glycidoxypropyl)methyldiethoxysilane, (3- glycidoxypropyl)dimethylmethoxysilane, and (3- glycidoxypropyl)dimethylethoxy silane, etc., and combinations thereof; iv) organosilane coupling agents including acrylic or vinyl groups, including, but not limited to, (methacryloxymethyl)methyldimethoxysilane, (methacryloxyethyl) methyldimethoxysilane, (methacryloxypropyl)trimethoxysilane,(meth aery I oxy methy I )tri methoxy silane, etc., and combinations thereof; and combinations thereof.

[0227] In some systems, the organosilane coupling material may be produced from condensation curing of a diluted dispersion of coating. The dispersion of coating may comprise one or more organosilane agents comprising one or more organofunctional groups selected from the group consisting of amino, amine, amide, epoxy, oxirane, urethane, urea, carbonate. The dispersion of coating may further comprise one or more hydrolyzable groups selected from the group consisting of alkoxy, acyloxy, oxime, hydroxyl, halogen, and combinations thereof. In some systems, the organosilane coupling material is produced from condensation curing of a diluted dispersion of coating comprising one or more organosilane agents comprising one or more organofunctional groups selected from the group consisting of amino, amine, amide, epoxy, oxirane, urethane, urea, carbonate, and further comprising one or more hydrolyzable groups selected from the group consisting of alkoxy, acyloxy, oxime, hydroxyl, halogen, and combinations thereof.

[0228] In some systems, the organosilane coupling material is a self-assembled monolayer that continuously covers and covalently bonds to the hydroxylated body of a spline in entirety. The organosilane coupling material may bond via a covalent metallo- siloxane bond (e.g., -Ti-O-Si-). In some systems, the organosilane coupling material is a self-assembled monolayer that continuously covers and covalently bonds to the hydroxylated body of a spline in entirety via a covalent metallo-siloxane bond (e.g., -Ti-O- Si-). The presence of such organosilane material in about one molecule thickness generally has an insignificant impact on electrical impedance of the spline.

[0229] In an alternative system, the organosilane coupling material is a micron- or submicron-sized organometallic polymer layer selectively covering the body of a spline only in portions onto which the insulating polymer material / jacket is present.

[0230] To achieve a suitable organosilane coupling material, an organosilane dispersion of coating including one or more organosilane coupling agents may be prepared as a diluted dispersion. The diluted dispersion may have a concentration of 0. 1 to 10 %(v / v), preferably 0.5 to 5.0 %(v / v), within a solvent system. To achieve a suitable organosilane coupling material, an organosilane dispersion of coating including one or more organosilane coupling agents may be prepared as a diluted dispersion having a concentration of 0.1 to 10 %(v / v), preferably 0.5 to 5.0 %(v / v), within a solvent system.

[0231] In some systems, the solvent system for preparing an organosilane dispersion is compositionally comprised of one or more volatile carrier solvents. The one or more volatile carrier solvents may be selected from the group of hydrocarbon solvents (e.g., hexane, heptane, toluene, ethylbenzene, etc.), alcohols (e.g., methanol, ethanol, isopropyl alcohol, etc.), ketones (e.g.. acetone, methyl isobutyl ketone, etc.), ethers (e.g., propylene glycol ether, ethylene glycol monobutyl ether, etc.), esters (e.g., ethyl acetate, N-butyl acetate, etc.), and combinations thereof. In some systems, the solvent system for preparing an organosilane dispersion is compositionally comprised of one or more volatile carrier solvents selected from the group of hydrocarbon solvents (e.g.. hexane, heptane, toluene, ethylbenzene, etc.), alcohols (e.g.. methanol, ethanol, isopropyl alcohol, etc ), ketones (e.g., acetone, methyl isobutyl ketone, etc ), ethers (e.g..propylene glycol ether, ethylene glycol monobutyl ether, etc.), esters (e.g., ethyl acetate, N-butyl acetate, etc.), and combinations thereof.

[0232] Generally, two or more splines may be incorporated in any suitable catheter, including the multiple DFAs described herein.

[0233] In some systems, a catheter is provided. The catheter may include a shaft, a plurality of splines forming an electrode basket structure around a distal portion of the shaft, each spline extending between a proximal end that is coupled to the shaft and a distal end that is coupled to the shaft, and a balloon positioned within the basket formed by the plurality of splines. At least one spline of the plurality of spines is a spline including a body having a superelastic conductive metal material, a mono- or bi -lay er insulating polymer material / jacket, and an organosilane coupling material coupling the superelastic conductive metal material to the interior polymer layer of the insulating polymer material / jacket.

[0234] In some systems, the catheter is an electroporation catheter. In some systems, at least one spline of the plurality of splines includes at least one energizable electrode. In some systems, each spline of the plurality of splines includes at least one energizable electrode.

[0235] In some systems, the sphne includes a body made of a superelastic conductive metal material (e g., NiTi alloy) and having a nanosized, metal oxide (e.g., TiCh) surface. The metal oxide thickness may be < 5 to 100 nm, for example 10 to 90 nm, 25 to 75 nm or 5 to 50 nm thick. In some systems, the spline includes a body made of a superelastic conductive metal material (e.g.. NiTi alloy) and having a nanosized, hydroxylated metal oxide (e.g., TiCh) surface of < 5 to 100 nm in thickness, an insulating polymer material / jacket made of one or more polymer material(s), and an organosilane coupling material intimately coupling the body of the sphne to the interior or most interior polymer layer of the insulating polymer material / jacket.

[0236] In some systems, the organosilane coupling material is coupled to the superelastic conductive material by a chemical bond. In some systems, the chemical bond is a metallo-siloxane bond.

[0237] In some systems, the organosilane coupling material is coupled to the body of the spline comprised of the nanosized thin oxide surface and the superelastic, electrically conductive material by a chemical bond. In some systems, the chemical bond is a covalent chemical bond. In some systems, the chemical bond is a metallo-siloxane bond.

[0238] In some systems, the organosilane coupling material is coupled to the insulating polymer material / jacket by a physical bond and / or a physical force (e.g., an intermolecular force). In some systems, the organosilane coupling material is molecularly interlocked with the insulating polymer material / jacket via interfacial diffusion and molecular entanglement. In some systems, the organosilane coupling material is coupled to the insulating polymer material / jacket by intermolecular forces including van der Waal forces and hydrogen bonding.EXAMPLES

[0239] Without further elaboration, it is believed that one skilled in the art using the preceding description can utilize the present disclosure to its fullest extent. The following Examples are. therefore, to be construed as merely illustrative, and not limiting of the disclosure in any way whatsoever. The starting material for the following Examples may not have necessarily been prepared by a particular preparative run whose procedure is described in other Examples. It also is understood that any numerical range recited herein includes all values from the lower value to the upper value. For example, if a range is stated as 10-50, it is intended that values such as 12-30, 20-40, or 30-50, etc., are expressly enumerated in this specification. These are only examples of what is specifically intended, and all possible combinations of numerical values between and including the lowest value and the highest value enumerated are to be considered to be expressly stated in this application.

[0240] Example 1. Formation of an organosilane coupling material of a spline.

[0241] A diluted dispersion of coating for forming an organosilane coupling material intimately covering the body of a spline in portions or entirety is prepared at a concentration of 0.1 v / v% to 10 v / v%, preferably 0.5 v / v% to 5 v / v%, in a co-solvent system. The dispersion may include one or more organosilane coupling agents. The co-solvent system may include a volatile alcohol (such as methanol, ethanol, isopropyl alcohol, or the like), a volatile ketone (e.g., acetone, methyl isobutyl ketone, or the like), a volatile ether (e.g., propylene glycol ether, ethylene glycol monobutyl ether, or the like), and / or a volatile ester (e.g., ethyl acetate, N -but l acetate, or the like). The diluted dispersion may also include a hydrolyzing agent for any applicable organosilane agents, such as water, at a relative volume ratio of water vs. the organosilane coupling agent(s) of about 1: 10 to 100: 1, preferably 1 :5 to 5: 1.

[0242] In some systems, any diluted organosilane dispersion taken from the below table can be utilized for preparing the coated body of the spline including a similar, but different, organosilane coupling material.

[0243] The diluted organosilane dispersion including one or more organosilane coupling agent(s) is applied to the body of a spline. Prior to the application of the diluted dispersion of coating, the body of the spline is shape-set and physico-chemically treated. The resultant surface (e.g., a nano-sized oxide surface) for the body of the spline may be further hydroxylated.

[0244] The application of a diluted organosilane dispersion may be conducted through any suitable coating means. After coating, the carrier solvents of the dispersion subsequently evaporate. Once applied and cured, the organosilane coupling agent(s) within the dispersion chemically converts to a solidified, organosilane coupling material imparting a metallo-siloxane covalent bond chemically tethered to the superelastic metal material of the body of the spline. The resultant organosilane coupling material covalently tethered tothe body of the spline may be molecularly porous and has a thickness of about 5 nm to about 100 microns, more preferably about 5 nm to 10 microns, more preferably about 5nm to 1 micron, and more preferably about 5 nm to 100 nm.

[0245] The insulating polymer material / ] acket in a tubular preform is then applied and coupled to the coated body of the spline via the organosilane coupling material.

[0246] In some systems, the body of a spline made of a superelastic conductive metal material, i.e., nitinol alloy, is shape-set and treated to have a very thin metal oxide (e.g., TiCh) surface layer of about 5 to 50 nm, followed by adequate hydrothermal treatment. Onto the so-treated body of the spline, any collective combination of a diluted organosilane dispersion and an insulating polymer material / j acket preform, taken from the table below, are sequentially applied to form the spline including a resultant organosilane coupling material coupled to the body and the reflowed insulating polymer material / j acket intimately embracing the spline.

[0247] Those of skill in the art will appreciate that the above table are only example materials. More generally, the insulating polymer material / jacket may be bilayered and comprise an interior layer comprising a polyamide and an exterior layer comprising a poly ether block amide. The insulating polymer material / jacket may be bilayered and comprise an intenor layer compnsing an uncrosslinked thermoplastic polyurethane elastomer and an exterior layer comprising a crosslinked thermoplastic polyurethane elastomers. The insulating polymer material / jacket may be bi-layered and comprise an interior layer comprising an uncrosslinked poly ether block amide and an exterior layer comprising a crosslinked thermoplastic polyurethane elastomers. The insulating polymer material / jacket may be bi-layered and comprise an interior layer comprising an uncrosslinked thermoplastic polyurethane elastomer and an exterior layer comprising a crosslinked polyether block amide.

[0248] It was discovered herein that delamination of insulating polymer material / jacket from splines (e.g., insulated or electrode splines) could be reduced or prevented by coupling the superelastic conductive metal material to the interior or most interior polymer layer of an insulating polymer material / jacket with use of an organosilane coupling material disposed between the spline and the insulating polymer material / jacket.

[0249] Although certain systems of this disclosure have been described above with a certain degree of particularity, those skilled in the art could make numerous alterations to the disclosed systems without departing from the scope of this disclosure, which is defined by the appended claims. All directional references (e.g., upper, lower, upward, downw ard, left, right, leftward, rightward, top, bottom, above, below', vertical, horizontal, clockwise, and counterclockwise) are only used for identification purposes to aid the reader’s understanding of the present disclosure, and do not create limitations, particularly as to the position, orientation, or use of the disclosure. Joinder references (e.g.,atached, coupled, connected, and the like) are to be construed broadly and may include intermediate members between a connection of elements and relative movement between elements. As such, joinder references do not necessarily infer that two elements are directly connected and in fixed relation to each other. It is intended that all mater contained in the above description or shown in the accompanying drawings shall be interpreted as illustrative only and not limiting. Changes in detail or structure may be made without departing from the spirit of the disclosure as defined in the appended claims.

[0250] When introducing elements of the present disclosure or the preferred system(s) thereof, the articles “a”, "an", '‘the”, and ‘“said” are intended to mean that there are one or more of the elements. The terms ‘'comprising”, “including”, and “having” are intended to be inclusive and mean that there may be additional elements other than the listed elements.

[0251] As various changes could be made in the above constructions without departing from the scope of the disclosure, it is intended that all mater contained in the above description or shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense. Whereby the invention is defined in the appended claims.

[0252] The following are numbered clauses of the invention:1. A catheter spline comprising: a body comprising a superelastic conductive metal material; an insulating polymer jacket; and an organosilane coupling material coupling the superelastic conductive metal material to the insulating polymer jacket.2. The catheter spline in accordance with clause 1, wherein the superelastic conductive metal material is selected from the group consisting of nitinol or nickel titanium alloys, copper-aluminum-nickel alloys, zinc-copper-gold-iron alloys, iron-manganese-silicon alloys, copper-zinc-aluminum alloys, copper-aluminum-nickel alloys, and combinations thereof.3. The catheter spline in accordance with clause 1 or 2, wherein the insulating polymer jacket comprises one or more thermoplastic polymer material(s) selected from the group consisting of thermoplastic polymers, polyester homopolymers & copolymers, nylon homopolymers & copolymers, polyolefins, polycarbonate, polysulfone, and combinations thereof and / or the group consisting of polyamide-based thermoplastic elastomers or poly(ether block amide) copolymers, polyester-based thermoplastic elastomers or poly(ester ether) copolymers, thermoplastic polyurethane elastomers (e.g., poly(ether urethane) copolymers, polycarbonate urethane) copolymers, poly(siloxane- carbonate urethane) copolymers, and poly(siloxane-ether urethane) copolymers, and combinations thereof), styrenic thermoplastic elastomers or styrenic block copolymers, thermoplastic olefins, and combinations thereof.4. The catheter spline in accordance any preceding clause, wherein the insulating polymer jacket is bi-layered and comprises two chemically compatible polymer materials, and wherein an exterior layer of the insulating polymer jacket is made of a thermoplastic polymer material comprising additional crosslinking agent(s) selected from the group consisting of triallyl isocyanurate, triallyl cyanurate, triallyl phosphate, pentaerythritol triallyl ether, trivinyltrimethylcyclosiloxane, trimethylolpropane trivinyl ether, trimethylolpropane triacrylate, pentaerythritol triacrylate, and combinations thereof.5. The catheter spline in accordance with any of clauses 1 to 3, wherein the insulating polymer jacket is bi-layered comprises two chemically compatible polymer materials, and wherein an interior layer of the insulating polymer jacket is re-meltable and / or an exterior layer of the insulating polymer jacket is heat-shrinkable under heat.6. The catheter spline in accordance with any preceding clause, wherein the organosilane coupling material is coupled to the superelastic conductive metal material by a chemical bond.7. The catheter spline in accordance with any of clauses 1 to 6, wherein the organosilane coupling material is coupled to the insulating polymer jacket or material by a physical bond and / or a physical force.8. The catheter spline in accordance with any of clauses 1 to 6, wherein the organosilane coupling material is produced from condensation curing of a diluted dispersion of coating comprising one or more organosilane agents comprising one or more organofunctional groups selected from the group consisting of amino, amine, amide, epoxy, oxirane, urethane, urea, carbonate, and further comprising one or more hydrolyzable groups selected from the group consisting of alkoxy, acyloxy, oxime, hydroxyl, halogen, and combinations thereof.9. The catheter spline in accordance with clause 8, wherein the diluted organosilane dispersion of coating comprises one or more reactive organosilane coupling agents selected from the group consisting of: a) compounds of Formula I(Formula I); b) compounds of Formula II x2— S ri— L-, — R2- L2— S ri— Y2Y3 (Formula II); c) compounds of Formula III(Formula III); and d) combinations thereof: wherein:Ri. R2, and R3 are each selected from the group consisting of organofunctional moieties. oligomeric organofunctional moieties. polymenc organofunctional moieties, and combinations thereof;Li. L2, and L3 are each selected from the group consisting of direct bonds, substituted or unsubstituted linear alkyl, substituted or unsubstituted linear C1-C10 alkyl, substituted or unsubstituted linear C2-C4 alkyl, substituted or unsubstituted branched alkyl, substituted or unsubstituted branched C1-C10 alkyl, substituted or unsubstituted branched C2-C4 alkyl, Ci alkyl, C2 alkyl, C3 alkyl, C4 alkyl, C5 alkyl, Ce alkyl, C7 alkyl, Cs alkyl, C9 alkyl, C10 alkyl, and combinations thereof;Xi, X2, and X3 are each selected from the group consisting of hydrolyzable groups, alkoxy, acyloxy, amine, oxime, hydroxyl, halogen, non-hydrolyzable groups, substituted or unsubstituted linear alkyl, substituted or unsubstituted linear C1-C10 alkyl, substituted or unsubstituted linear C2-C4 alkyl, substituted or unsubstituted branched alkyl, substituted or unsubstituted branched C1-C10 alkyl, substituted or unsubstituted branched C2-C4 alkyl, Ci alkyl, C2 alkyl, C3 alkyl, C4alkyl, C5alkyl, C6alkyl, C7 alkyl, C8alkyl, C9 alkyl, C10 alkyl, and combinations thereof, wherein at least one of Xi, X2, and X3 is a hydrolyzable group;Yi. Y2, and Y3 are each selected from the group consisting of hydrolyzable groups, alkoxy, acyloxy, amine, oxime, hydroxyl, halogen, non-hydrolyzable groups, substituted or unsubstituted linear alkyl, substituted or unsubstituted linear C1-C10 alkyl, substitutedor unsubstituted linear C2-C4 alkyl, substituted or unsubstituted branched alkyl, substituted or unsubstituted branched C1-C10 alkyl, substituted or unsubstituted branched C2-C4 alkyl. Ci alky 1, C2alkyl, C3alkyl. C4alkyl, C5alkyl, C6alkyl, C7alkyl, C8alkyl, C9alkyl, C10 alkyl, and combinations thereof, wherein at least one of Y 1. Y2, and Y3 is a hydrolyzable group; andZi, Z2, and Z3are each selected from the group consisting of hydrolyzable groups, alkoxy, acyloxy, amine, oxime, hydroxyl, halogen, non-hydrolyzable groups, substituted or unsubstituted linear alkyl, substituted or unsubstituted linear C1-C10 alkyl, substituted or unsubstituted linear C2-C4 alkyl, substituted or unsubstituted branched alkyl, substituted or unsubstituted branched C1-C10 alkyl, substituted or unsubstituted branched C2-C4 alkyl, Ci alky 1, C2alkyl, C3alkyl, C4alkyl, C5alkyl, C6alkyl, C7alkyl, C8alkyl, C9alkyl, C10 alkyl, and combinations thereof, wherein at least one of Zi, Z2, and Z3is a hydrolyzable group.10. The catheter spline in accordance with clause 9, wherein Ri, R2, and R3are each selected from the group consisting of organofunctional moieties that exhibit molecular affinity and / or chemical miscibility with an interior or most interior layer of the insulating polymer jacket.11. The catheter spline in accordance with clause 9 or 10, wherein Ri, R2. and R3are each oligomeric or non-oligomeric moieties comprising an organofunctional group selected from the group consisting of substituted or unsubstituted and linear or branched alkyl, alkenyl, alkynyl, ary l, phenyl, benzy l, acryl, amino, hydroxy, mercapto, alkoxy, carbonyl, carboxyl, ester, carbonate, amide, isocyanate, urethane, urea, oxirane, and combinations thereof.12. The catheter spline in accordance with any of clauses 8 to 11, wherein the diluted dispersion of coating comprising one or more organosilane coupling agents selected from the group consisting of: a) 3-aminopropyl triethoxysilane, 3-aminopropyl trimethoxy silane, 4-aminobutyl tri ethoxy silane. 4-amino-3,3-dimethylbutyl trimethoxy silane, N-(2-aminoethyl)-3- aminopropyl trimethoxysilane, N-(2-aminoethyl)-3-aminopropyl triethoxysilane, N-(6-amino-hexyl)aminomethyl trimethoxysilane, N-(6-aminohexyl)aminomethyl triethoxysilane, 3-[2-(2-aminoethylamino)ethylamino]propyl trimethoxysilane, N-(2- aminoethy)-3 -aminopropyl silanetriol, bis(3-trimethyoxysilylpropyl) amine, bis(3- triethyoxysilylpropyl) amine, N,N'-bis((3-trimethoxysilyl)propyl) ethylenediamine, N,N’-bis((3-triethoxysilyl)propyl) ethylenediamine, N-phenylaminomethyl trimethoxysilane, and combinations thereof; b) (3 -acetamidopropyl) trimethoxy silane, (3-acetamidopropyl) tri ethoxysilane, N, N’- bis(3-trimethoxysilylpropyl) urea, N, N’-bis(3-tri ethoxy silylpropyl) urea, tris(3- trimethoxysilylpropyl) isocyanurate, tris(3-triethoxysilylpropyl) isocyanurate, and combinations thereof; c) (3-glycidoxypropyl)trimethoxysilane, (3-glycidoxypropyl)triethoxysilane, 5,6- epoxyhexyltriethoxysilane, (3-glycidoxypropyl)methyldimethoxysilane, (3- glycidoxypropyl)methyldiethoxysilane, (3-glycidoxypropyl)dimethylmethoxysilane, and (3-glycidoxypropyl)dimethylethoxysilane, and combinations thereof; d) (3-glycidylpropyl)trimethoxysilane, (3-glycidoxypropyl)triethoxysilane. 5,6- epoxyhexyltriethoxysilane, (3-glycidoxypropyl)methyldimethoxysilane, (3- glycidoxypropyl)methyldiethoxysilane, (3-glycidoxypropyl)dimethylmethoxysilane, and (3-glycidoxypropyl)dimethylethoxysilane. and combinations thereof; e) (methacryloxymethyl)methyldimethoxysilane, (methacryl oxyethyl) methyldimethoxysilane, (methacryloxypropyl)trimethoxysilane,(methacryloxymethyl)trimethoxysilane, and combinations thereof; and f) combinations thereof.13. A catheter comprising: a shaft; a plurality of splines forming a basket around a distal portion of the shaft, each spline extending between a proximal end that is coupled to the shaft and a distal end that is coupled to the shaft; anda balloon positioned within the basket formed by the plurality of splines; wherein at least one spline of the plurality of spines is a catheter spline comprising: a body comprising a superelastic conductive metal material; an insulating polymer jacket; and an organosilane coupling material coupling the superelastic conductive metal material to an interior or most interior layer of the insulating polymer jacket.14. The catheter in accordance with clause 13, wherein the superelastic conductive metal material is selected from the group consisting of nitinol or nickel titanium alloys, copper-aluminum-nickel alloys, zinc-copper-gold-iron alloys, iron- manganese-silicon alloys, copper-zinc-aluminum alloys, copper-aluminum-nickel alloys, and combinations thereof.15. The catheter in accordance with clause 13 or 14, wherein the insulating polymer jacket comprises one or more thermoplastic polymer material(s) selected from the group consisting of thermoplastic polymers, polyester homopolymers & copolymers, nylon homopolymers & copolymers, polyolefins, polycarbonate, polysulfone, and combinations thereof, and / or the group consisting of polyamide-based thermoplastic elastomers or poly(ether block amide) copolymers, polyester-based thermoplastic elastomers or poly(ester ether) copolymers, thermoplastic polyurethane elastomers (e.g., poly(ether urethane) copolymers, polycarbonate urethane) copolymers, poly (siloxanecarbonate urethane) copolymers, and poly(siloxane-ether urethane) copolymers, and combinations thereof), styrenic thermoplastic elastomers or styrenic block copolymers, thermoplastic olefins, and combinations thereof.16. The catheter in accordance with clauses 13 to 15, wherein the insulating polymer jacket is bi-layered and comprises tw o chemically compatible polymer materials, and wherein an exterior layer of the insulating polymer jacket is made of a thermoplastic polymer material comprising additional crosslinking agent(s) selected from the group consisting of triallyl isocyanurate, triallyl cyanurate, triallyl phosphate, pentaerythritol triallyl ether, trivinyltrimethylcyclosiloxane, trimethylolpropane trivinylether, trimethylolpropane triacrylate, pentaerythritol triacrylate, and combinations thereof.17. The catheter in accordance with clauses 13 to 15, wherein the insulating polymer jacket is bi-layered and comprises two chemically compatible polymer materials, and wherein an interior layer of the insulating polymer jacket is re-meltable and / or the exterior layer of the insulating polymer jacket is heat-shrinkable under heat.18. The catheter in accordance with any of clauses 13 to 17. wherein the organosilane coupling material is coupled to the superelastic conductive metal material by a chemical bond. 19. The catheter in accordance with any of clauses 13 to 17. wherein the organosilane coupling material is coupled to the insulating polymer jacket or material by a physical bond and / or a physical force.20. The catheter in accordance with any of clauses 13 to 18. wherein the organosilane coupling material is produced from condensation curing of a diluted dispersion of coating comprising one or more organosilane agents comprising one or more organofunctional groups selected from the group consisting of amino, amine, amide, epoxy, oxirane, urethane, urea, carbonate, and further comprising one or more hydrolyzable groups selected from the group consisting of alkoxy, acyloxy, oxime, hydroxyl, halogen, and combinations thereof.

Claims

WHAT IS CLAIMED IS:

1. A catheter spline comprising: a body comprising a superelastic conductive metal material; an insulating polymer jacket; and an organosilane coupling material coupling the superelastic conductive metal material to the insulating polymer jacket.

2. The catheter spline in accordance with claim 1, wherein the superelastic conductive metal material is selected from the group consisting of mtinol or nickel titanium alloys, copper-aluminum-nickel alloys, zinc-copper-gold-iron alloys, iron-manganese- silicon alloys, copper-zinc-aluminum alloys, copper-aluminum-nickel alloys, and combinations thereof.

3. The catheter spline in accordance with claim 1, wherein the insulating polymer jacket comprises one or more thermoplastic polymer material(s) selected from the group consisting of thermoplastic polymers, polyester homopolymers & copolymers, nylon homopolymers & copolymers, polyolefins, polycarbonate, polysulfone, and combinations thereof, and / or the group consisting of polyamide-based thermoplastic elastomers or poly(ether block amide) copolymers, polyester-based thermoplastic elastomers or poly(ester ether) copolymers, thermoplastic polyurethane elastomers (e.g., poly (ether urethane) copolymers, polycarbonate urethane) copolymers, poly(siloxane-carbonate urethane) copolymers, and poly(siloxane-ether urethane) copolymers, and combinations thereof), styrenic thermoplastic elastomers or styrenic block copolymers, thermoplastic olefins, and combinations thereof.

4. The catheter spline in accordance with claim 1. wherein the insulating polymer jacket is bi -layered and comprises two chemically compatible polymer materials, and wherein an exterior layer of the insulating poly mer j acket is made of a thermoplastic polymer material comprising additional crosslinking agent(s) selected from the group consisting of triallyl isocyanurate. triallyl cyanurate, triallyl phosphate, pentaerythritol triallyl ether,trivinyltrimethylcyclosiloxane. trimethylolpropane trivinyl ether, trimethylolpropane triacrylate, pentaerythritol triacrylate, and combinations thereof.

5. The catheter spline in accordance with claim 1, wherein the insulating polymer jacket is bi-layered and comprises two chemically compatible polymer materials, and wherein an interior layer of the insulating polymer jacket is re-meltable and / or an exterior layer of the insulating polymer jacket is heat-shrinkable under heat.

6. The catheter spline in accordance with claim 1. wherein the organosilane coupling material is coupled to the superelastic conductive metal material by a chemical bond.

7. The catheter spline in accordance with claim 1. wherein the organosilane coupling material is coupled to the insulating polymer jacket or material by a physical bond and / or a physical force.

8. The catheter spline in accordance with claim 1. wherein the organosilane coupling material is produced from condensation curing of a diluted dispersion of coating comprising one or more organosilane agents comprising one or more organofunctional groups selected from the group consisting of amino, amine, amide, epoxy, oxirane, urethane, urea, carbonate, and further comprising one or more hydrolyzable groups selected from the group consisting of alkoxy, acyloxy. oxime, hydroxyl, halogen, and combinations thereof.

9. The catheter spline in accordance with claim 8, wherein the diluted organosilane dispersion of coating comprises one or more reactive organosilane coupling agents selected from the group consisting of: a) compounds of Formula I(Formula I): b) compounds of Formula IT(Formula II); c) compounds of Formula III(Formula III); and d) combinations thereof; wherein:Rl, R2, and R3 are each selected from the group consisting of organofunctional moieties, oligomeric organofunctional moieties, polymeric organofunctional moieties, and combinations thereof;LI, L2, and L3 are each selected from the group consisting of direct bonds, substituted or unsubstituted linear alkyl, substituted or unsubstituted linear Cl -CIO alkyl, substituted or unsubstituted linear C2-C4 alkyl, substituted or unsubstituted branched alkyl, substituted or unsubstituted branched Cl -C IO alkyl, substituted or unsubstituted branched C2-C4 alkyl, Cl alky l, C2 alkyl, C3 alkyd, C4 alkyl, C5 alkyd, C6 alkyd, C7 alkyl, C8 alkyl, C9 alkyl, CIO alkyl, and combinations thereof; XI , X2, and X3 are each selected from the group consisting of hydrolyzable groups, alkoxy, acy doxy, amine, oxime, hydroxyl, halogen, non-hydrolyzable groups, substituted or unsubstituted linear alkyl, substituted or unsubstituted linear Cl -CIO alkyl, substituted or unsubstituted linear C2-C4 alkyl, substituted or unsubstituted branched alkyl, substituted or unsubstituted branched Cl -CIO alkyl, substituted or unsubstituted branched C2-C4 alkyd, Clalkyl. C2 alkyl, C3 alkyl, C4 alkyl, C5 alkyl. C6 alkyl, C7 alkyl, C8 alkyl, C9 alkyl. CIO alkyl, and combinations thereof, wherein at least one of XI, X2, and X3 is a hydrolyzable group;Yl. Y2, and Y3 are each selected from the group consisting of hydrolyzable groups, alkoxy, acyloxy, amine, oxime, hydroxyl, halogen, non-hydrolyzable groups, substituted or unsubstituted linear alky l, substituted or unsubstituted linear Cl -CIO alkyl, substituted or unsubstituted linear C2-C4 alkyl, substituted or unsubstituted branched alky l, substituted or unsubstituted branched Cl -CIO alkyl, substituted or unsubstituted branched C2-C4 alkyl, Cl alkyl, C2 alkyl, C3 alkyl, C4 alkyl, C5 alkyl, C6 alkyl, C7 alkyl, C8 alkyl, C9 alkyl, CIO alkyl, and combinations thereof, wherein at least one of Yl, Y2, and Y3 is a hydrolyzable group; andZl, Z2, and Z3 are each selected from the group consisting of hydrolyzable groups, alkoxy, acyloxy, amine, oxime, hydroxyl, halogen, non-hydrolyzable groups, substituted or unsubstituted linear alkyl, substituted or unsubstituted linear C1-C10 alkyl, substituted or unsubstituted linear C2-C4 alkyl, substituted or unsubstituted branched alkyl, substituted or unsubstituted branched Cl -CIO alkyl, substituted or unsubstituted branched C2-C4 alkyl. Cl alkyl, C2 alkyl, C3 alkyl, C4 alky l, C5 alkyl, C6 alkyl, C7 alkyl, C8 alkyd, C9 alkyl, CI O alkyl, and combinations thereof, wherein at least one of Zl, Z2, and Z3 is a hydrolyzable group.

10. The catheter spline in accordance with claim 9, wherein Rl, R2, and R3 are each selected from the group consisting of organo functional moieties that exhibit molecular affinity and / or chemical miscibility with an interior or most interior layer of the insulating polymer jacket.

11. The catheter spline in accordance with claim 9, wherein Rl, R2, and R3 are each oligomeric or non-oligomeric moieties comprising an organofunctional group selected from the group consisting of substituted or unsubstituted and linear or branched alkyl, alkenyl, alkynyl, aryl, phenyl, benzyl, acryl, amino, hydroxy, mercapto, alkoxy, carbonyl, carboxyl, ester, carbonate, amide, isocyanate, urethane, urea, oxirane, and combinations thereof.

12. The catheter spline in accordance with claim 8, wherein the diluted dispersion of coating comprising one or more organosilane coupling agents selected from the group consisting of: a) 3-aminopropyl triethoxysilane. 3-aminopropyl trimethoxysilane. 4-aminobulyl triethoxysilane. 4-amino-3,3-dimethylbutyl trimethoxysilane, N-(2-aminoethyl)-3- aminopropyl trimethoxysilane, N-(2-aminoethyl)-3-aminopropyl triethoxysilane, N-(6- amino-hexyl)aminomethyl trimethoxysilane, N-(6-aminohexyl)aminomethyl triethoxysilane, 3-[2-(2-aminoethylamino)ethylamino]propyl trimethoxy silane, N-(2- aminoethy)-3-aminopropyl silanetriol, bis(3-trimethyoxysilylpropyl) amine, bis(3- triethyoxysilylpropyl) amine, N,N’-bis((3-trimethoxysilyl)propyl) ethylenediamine, N,N’- bis((3-triethoxysilyl)propyl) ethylenediamine, N-phenylaminomethyl trimethoxysilane, and combinations thereof; b) (3-acetamidopropyl) trimethoxysilane, (3-acetamidopropyl) triethoxysilane, N, N’-bis(3-trimethoxysilylpropyl) urea, N, N’-bis(3-triethoxysilylpropyl) urea, tris(3- trimethoxysilylpropyl) isocyanurate, tris(3-triethoxysilylpropyl) isocyanurate, and combinations thereof; c) (3-glycidoxypropyl)trimethoxysilane, (3-glycidoxypropyl)triethoxysilane, 5,6- epoxyhexyltriethoxy silane, (3-glycidoxypropyl)methyldimethoxysilane, (3- glycidoxypropyl)methyldiethoxysilane, (3-glycidoxypropyl)dimethylmethoxysilane, and (3-glycidoxypropyl)dimethylethoxysilane, and combinations thereof; d) (3-glycidylpropyl)trimethoxysilane, (3-glycidoxypropyl)triethoxysilane, 5,6- epoxyhexyltriethoxysilane, (3-glycidoxypropyl)methyldimethoxysilane, (3- glycidoxypropyl)methyldiethoxysilane, (3-glycidoxypropyl)dimethylmethoxysilane, and (3-glycidoxypropyl)dimethylethoxysilane, and combinations thereof; e) (methacryloxymethyl)methyldimethoxysilane, (methacryl oxy ethyl) methyldimethoxysilane, (methacryl oxypropyl)trimethoxysilane,(methacryloxymethyl)trimethoxysilane, and combinations thereof; and f) combinations thereof.

13. A catheter comprising: a shaft; a plurality of splines forming a basket around a distal portion of the shaft, each spline extending between a proximal end that is coupled to the shaft and a distal end that is coupled to the shaft; and a balloon positioned within the basket formed by the plurality of splines; wherein at least one spline of the plurality of splines is a catheter spline comprising: a body comprising a superelastic conductive metal material; an insulating polymer jacket; and an organosilane coupling material coupling the superelastic conductive metal material to an interior or most interior layer of the insulating polymer jacket.

14. The catheter in accordance with claim 13, wherein the superelastic conductive metal material is selected from the group consisting of nitinol or nickel titanium alloys, copper-aluminum-nickel alloys, zinc-copper-gold-iron alloys, iron-manganese-silicon alloys, copper-zinc-aluminum alloys, copper-aluminum-nickel alloys, and combinations thereof.

15. The catheter in accordance with claim 13, wherein the insulating polymer jacket comprises one or more thermoplastic polymer material(s) selected from the group consisting of thermoplastic polymers, polyester homopolymers & copolymers, nylon homopolymers & copolymers, polyolefins, polycarbonate, polysulfone. and combinations thereof, and / or the group consisting of polyamide-based thermoplastic elastomers or poly(ether block amide) copolymers, polyester-based thermoplastic elastomers or poly(ester ether) copolymers, thermoplastic polyurethane elastomers (e.g., poly(ether urethane) copolymers, polycarbonate urethane) copolymers. poly(siloxane-carbonate urethane) copolymers, and poly(siloxane-ether urethane) copolymers, and combinations thereof), styrenic thermoplastic elastomers or styrenic block copolymers, thermoplastic olefins, and combinations thereof.

16. The catheter in accordance with claim 13, wherein the insulating polymer jacket is bi-layered and comprises two chemically compatible polymer materials, and wherein an exterior layer of the insulating polymer jacket is made of a thermoplastic polymer material comprising additional crosslinking agent(s) selected from the group consisting of triallyl isocyanurate. triallyl cyanurate, triallyl phosphate, pentaerythritol triallyl ether, trivinyltrimethylcyclosiloxane, trimethylolpropane trivinyl ether, trimethylolpropane triacrylate, pentaerythritol triacrylate, and combinations thereof.

17. The catheter in accordance with claim 13, wherein the insulating polymer jacket is bi-layered and comprises two chemically compatible polymer materials, and wherein an interior layer of the insulating polymer jacket is re-meltable and / or the exterior layer of the insulating polymer jacket is heat-shrinkable under heat.

18. The catheter in accordance with claim 13, wherein the organosilane coupling material is coupled to the superelastic conductive metal material by a chemical bond.

19. The catheter in accordance with claim 13, wherein the organosilane coupling material is coupled to the insulating polymer jacket by a physical bond and / or a physical force.

20. The catheter in accordance with claim 13, wherein the organosilane coupling material is produced from condensation curing of a diluted dispersion of coating comprising one or more organosilane agents comprising one or more organofunctional groups selected from the group consisting of amino, amine, amide, epoxy, oxirane, urethane, urea, carbonate, and further comprising one or more hydrolyzable groups selected from the group consisting of alkoxy, acyloxy, oxime, hydroxyl, halogen, and combinations thereof.

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