System for super-elastic splines with polymer insulation

Abstract

Disclosed herein are systems for catheter-like leads. The catheter-like leads include a body made of a super-elastic conductive metallic material, an insulating polymeric sheath made layer-by-layer from one or more chemically compatible polymeric materials, and a silane coupling material that couples the super-elastic conductive metallic material to the insulating polymeric sheath. The catheter includes at least two catheter-like leads configured to form a polymeric-insulated basket structure with a plurality of individual electrodes and / or an electrode basket structure of leads that are themselves relatively large electrodes.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 607,215, filed on December 7, 2023, which is incorporated herein by reference in its entirety.

[0003] Areas of publicly available content

[0004] This disclosure generally relates to tissue ablation systems, such as cardiac tissue ablation systems. Specifically, this disclosure relates to ablation catheters comprising a catheter spline having a superelastic conductive metallic material coupled to an insulating polymer sheath or material via an organosilane coupling material.

[0005] background

[0006] As is well known, ablation therapy can be used to treat various conditions that damage human anatomy. For example, ablation therapy can be used to treat atrial arrhythmias. When tissue is ablated, or at least subjected to ablation energy generated by an ablation generator and delivered by an ablation catheter, an ablation lesion is formed in the tissue. Electrodes mounted on or within the ablation catheter are used to induce tissue apoptosis in the cardiac tissue to correct conditions such as atrial arrhythmias (including, but not limited to, ectopic atrial tachycardia, atrial fibrillation, and atrial flutter).

[0007] Cardiac arrhythmias (i.e., irregular heartbeats) can cause a variety of dangerous conditions, including loss of atrioventricular synchrony and blood flow stagnation, leading to various illnesses and even death. The primary cause of atrial arrhythmias is believed to be stray electrical signals within the left or right atrium of the heart. Ablation catheters apply ablation energy (such as radiofrequency energy, cryoablation, laser, chemicals, high-intensity focused ultrasound, etc.) to the heart tissue to create an ablation focus. This ablation focus disrupts unwanted electrical pathways, thereby limiting or preventing stray electrical signals that lead to arrhythmias.

[0008] Electroporation is a non-thermal ablation technique that involves applying a strong electric field that induces the formation of pores in the cell membrane. The electric field can be induced by applying pulses of relatively short duration, lasting, for example, from nanoseconds to milliseconds. Such pulses can be repeated to form a pulse train. When such an electric field is applied to tissue in the in vivo environment, cells in the tissue undergo a transmembrane potential, causing pores to open in the cell wall. Electroporation can be reversible (i.e., the temporarily 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 opening pores) is used to transfect high molecular weight therapeutic vectors into cells. In other therapeutic applications, appropriately configured pulse trains can be used alone to induce cell destruction, for example, by inducing irreversible electroporation.

[0009] For catheters used to deliver bipolar energy using irreversible electroporation (IRE) or pulsed field ablation (PFA), especially high-voltage ablation catheters, it is important to ensure that the catheter electrode is close to or in contact with the vessel wall. Generally, the closer the electrode is to the vessel wall, the larger the ablation foci. Therefore, catheters with electrode configurations that can be placed near or in contact with the vessel wall, such as high-voltage ablation catheters, are needed.

[0010] Ablation catheters may include a distal functional assembly (DFA) primarily comprising an inflatable balloon made of an elastic polymer material and an electrode basket structure formed of multiple splined materials made of a hyperelastic and highly conductive metallic material (e.g., nitinol or NiTi alloy). This allows the DFA or electrode basket to reversibly transition between contraction and extension / expansion configurations to facilitate delivery / retreat, and appropriate deployment of the catheter for delivering the intended electroporation treatment, respectively. Such splined materials may require an insulating polymer material, such as an insulating polymer sheath, applied to a portion of the spline body. However, in at least some known catheters, the insulating polymer material / sheath typically exhibits very poor adhesion to the hyperelastic, conductive metallic body or spline material (e.g., nitinol or NiTi alloy), causing the insulating polymer material / sheath to potentially delaminate undesirably from the hyperelastic spline. Therefore, a material and structural configuration for fabricating the hyperelastic insulating spline as a monolithic entity is highly desirable, capable of preventing or reducing delamination or failure of the insulating polymer material / sheath from the hyperelastic metallic material of the spline.

[0011] A brief overview of the disclosed content

[0012] On one hand, a conduit template is provided. The conduit template includes a body made of a superelastic and conductive metallic material, an insulating polymer sheath, and an organosilane coupling material that couples the superelastic conductive metallic material to the insulating polymer sheath.

[0013] The superelastic metallic material can be selected from nickel-titanium alloys 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.

[0014] The insulating polymer sheath may comprise one or more thermoplastic polymer materials. The thermoplastic polymer materials may be selected from thermoplastic polymers, polyester homopolymers and copolymers, nylon homopolymers and copolymers, polyolefins, polycarbonates, polysulfones, and combinations thereof, and / or selected from 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, poly(carbonate urethane) copolymers, poly(siloxane-carbonate urethane) copolymers and poly(siloxane-ether urethane) copolymers, and combinations thereof), styrene thermoplastic elastomers or styrene block copolymers, thermoplastic olefins, and combinations thereof.

[0015] The insulating polymer sheath may be double-layered and may contain two chemically compatible polymer materials. The outer layer of the insulating polymer sheath may be made of a thermoplastic polymer material comprising (multiple) additional crosslinking agents selected from triallyl isocyanurate, triallyl cyanurate, triallyl phosphate, pentaerythritol triallyl ether, trivinyltrimethylcyclosiloxane, trimethylolpropane trivinyl ether, trimethylolpropane triacrylate, pentaerythritol triacrylate, and combinations thereof.

[0016] The insulating polymer sheath can be double-layered and can contain two chemically compatible polymer materials, wherein the inner layer of the insulating polymer sheath is remeltable and / or the outer layer of the insulating polymer sheath is heat-shrinkable upon heating.

[0017] Organosilanes can be chemically coupled to superelastic conductive metal materials.

[0018] Organosilanes can be physically bonded and / or physically coupled to an insulating polymer sheath or material.

[0019] Organosilane coupling materials can be manufactured by condensation curing of a diluted coating dispersion comprising one or more organosilane reagents. The organosilane reagents may contain one or more organic functional groups selected from amino, amine, amide, epoxy, ethylene oxide, urethane, urea, and carbonate, and further contain one or more hydrolyzable groups selected from alkoxy, acyloxy, oxime, hydroxyl, halogen, and combinations thereof.

[0020] The diluted coating organosilane dispersion may contain one or more reactive organosilane coupling agents selected from:

[0021] a) Compounds of Formula I

[0022] (Formula I);

[0023] b) Compounds of Formula II

[0024] (Formula II);

[0025] c) Compounds of Formula III

[0026] (Formula III); and

[0027] d) Their combination;

[0028] R1, R2, and R3 can each be selected from organic functional parts, oligomeric organic functional parts, polymeric organic functional parts, and combinations thereof;

[0029] L1, L2, and L3 can each be selected from direct bonds, substituted or unsubstituted straight-chain alkyl groups, substituted or unsubstituted straight-chain C1-C bonds, etc. 10 Alkyl, substituted or unsubstituted straight-chain C2-C4 alkyl, substituted or unsubstituted branched alkyl, substituted or unsubstituted branched C1-C 10 Alkyl, substituted or unsubstituted branched C2-C4 alkyl, C1 alkyl, C2 alkyl, C3 alkyl, C4 alkyl, C5 alkyl, C6 alkyl, C7 alkyl, C8 alkyl, C9 alkyl, C 10 Alkyl groups and combinations thereof;

[0030] X1, X2, and X3 can each be selected from hydrolyzable groups, alkoxy groups, acyloxy groups, amines, oximes, hydroxyl groups, halogens, non-hydrolyzable groups, substituted or unsubstituted straight-chain alkyl groups, and substituted or unsubstituted straight-chain C1-C2 groups. 10 Alkyl, substituted or unsubstituted straight-chain C2-C4 alkyl, substituted or unsubstituted branched alkyl, substituted or unsubstituted branched C1-C 10 Alkyl, substituted or unsubstituted branched C2-C4 alkyl, C1 alkyl, C2 alkyl, C3 alkyl, C4 alkyl, C5 alkyl, C6 alkyl, C7 alkyl, C8 alkyl, C9 alkyl, C 10 Alkyl groups and combinations thereof, wherein at least one of X1, X2 and X3 is a hydrolyzable group;

[0031] Y1, Y2, and Y3 can each be selected from hydrolyzable groups, alkoxy groups, acyloxy groups, amines, oximes, hydroxyl groups, halogens, non-hydrolyzable groups, substituted or unsubstituted straight-chain alkyl groups, and substituted or unsubstituted straight-chain C1-C2 groups. 10 Alkyl, substituted or unsubstituted straight-chain C2-C4 alkyl, substituted or unsubstituted branched alkyl, substituted or unsubstituted branched C1-C 10 Alkyl, substituted or unsubstituted branched C2-C4 alkyl, C1 alkyl, C2 alkyl, C3 alkyl, C4 alkyl, C5 alkyl, C6 alkyl, C7 alkyl, C8 alkyl, C9 alkyl, C 10Alkyl groups and combinations thereof, wherein at least one of Y1, Y2, and Y3 is a hydrolyzable group; and

[0032] Z1, Z2, and Z3 can each be selected from hydrolyzable groups, alkoxy groups, acyloxy groups, amines, oximes, hydroxyl groups, halogens, non-hydrolyzable groups, substituted or unsubstituted straight-chain alkyl groups, and substituted or unsubstituted straight-chain C1-C2 groups. 10 Alkyl, substituted or unsubstituted straight-chain C2-C4 alkyl, substituted or unsubstituted branched alkyl, substituted or unsubstituted branched C1-C 10 Alkyl, substituted or unsubstituted branched C2-C4 alkyl, C1 alkyl, C2 alkyl, C3 alkyl, C4 alkyl, C5 alkyl, C6 alkyl, C7 alkyl, C8 alkyl, C9 alkyl, C 10 Alkyl groups and combinations thereof, wherein at least one of Z1, Z2 and Z3 is a hydrolyzable group;

[0033] R1, R2 and R3 may each be selected from organic functional portions that exhibit molecular affinity and / or chemical miscibility with the innermost or innermost layer of the insulating polymer sheath.

[0034] R1, R2, and R3 can each be an oligomeric or non-oligomeric moiety containing an organic functional group selected from substituted or unsubstituted straight-chain or branched alkyl, alkenyl, alkynyl, aryl, phenyl, benzyl, acryloyl, amino, hydroxyl, mercapto, alkoxy, carbonyl, carboxyl, ester, carbonate, amide, isocyanate, urethane, urea, ethylene oxide, and combinations thereof.

[0035] The diluted coating dispersion may contain one or more organosilane coupling agents selected from:

[0036] a) 3-Aminopropyltriethoxysilane, 3-aminopropyltrimethoxysilane, 4-aminobutyltriethoxysilane, 4-amino-3,3-dimethylbutyltrimethoxysilane, N-(2-aminoethyl)-3-aminopropyltrimethoxysilane, N-(2-aminoethyl)-3-aminopropyltriethoxysilane, N-(6-aminohexyl)aminomethyltrimethoxysilane, N-(6-aminohexyl)aminomethyltriethoxysilane, 3- [2-(2-aminoethylamino)ethylamino]propyltrimethoxysilane, N-(2-aminoethyl)-3-aminopropylsilanetriol, bis(3-trimethoxysilylpropyl)amine, bis(3-triethoxysilylpropyl)amine, N,N'-bis((3-trimethoxysilyl)propyl)ethylenediamine, N,N'-bis((3-triethoxysilyl)propyl)ethylenediamine, N-phenylaminomethyltrimethoxysilane and combinations thereof;

[0037] b) (3-acetaminopropyl)trimethoxysilane, (3-acetaminopropyl)triethoxysilane, N,N'-bis(3-trimethoxysilylpropyl)urea, N,N'-bis(3-triethoxysilylpropyl)urea, tris(3-trimethoxysilylpropyl)isocyanurate, tris(3-triethoxysilylpropyl)isocyanurate, and combinations thereof;

[0038] 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;

[0039] d) (3-glycidylpropyl)trimethoxysilane, (3-glycidylpropyl)triethoxysilane, 5,6-epoxyhexyltriethoxysilane, (3-glycidylpropyl)methyldimethoxysilane, (3-glycidylpropyl)methyldiethoxysilane, (3-glycidylpropyl)dimethylmethoxysilane and (3-glycidylpropyl)dimethylethoxysilane and combinations thereof;

[0040] e) (methacryloyloxymethyl)methyldimethoxysilane, (methacryloyloxyethyl)methyldimethoxysilane, (methacryloyloxypropyl)trimethoxysilane, (methacryloyloxymethyl)trimethoxysilane, and combinations thereof; and

[0041] f) Its combination.

[0042] On the other hand, a catheter is provided. The catheter includes an axis, a plurality of splined segments forming a basket around a distal portion of the axis, each spline extending between a proximal end connected to the axis and a distal end connected to the axis, and a balloon located within the basket formed by the plurality of splined segments. At least one of the plurality of splined segments is a catheter spline comprising a body made of a superelastic conductive metallic material, an insulating polymer sheath, and an organosilane coupling material connecting the superelastic conductive metallic material to the insulating polymer sheath.

[0043] The superelastic conductive metallic material can be selected from nickel-titanium alloys 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.

[0044] The insulating polymer sheath may comprise one or more thermoplastic polymer materials. These thermoplastic polymer materials may be selected from thermoplastic polymers, polyester homopolymers and copolymers, nylon homopolymers and copolymers, polyolefins, polycarbonates, polysulfones, and combinations thereof, and / or selected from 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, poly(carbonate urethane) copolymers, poly(siloxane-carbonate urethane) copolymers and poly(siloxane-ether urethane) copolymers, and combinations thereof), styrene thermoplastic elastomers or styrene block copolymers, thermoplastic olefins, and combinations thereof.

[0045] The insulating polymer sheath may be double-layered and may contain two chemically compatible polymer materials. The outer layer of the insulating polymer sheath may be made of a thermoplastic polymer material containing additional crosslinking agents selected from triallyl isocyanurate, triallyl cyanurate, triallyl phosphate, pentaerythritol triallyl ether, trivinyltrimethylcyclosiloxane, trimethylolpropane trivinyl ether, trimethylolpropane triacrylate, pentaerythritol triacrylate, and combinations thereof.

[0046] The insulating polymer sheath can be double-layered and can contain two chemically compatible polymer materials. The inner layer of the insulating polymer sheath can be remeltable and / or the outer layer of the insulating polymer sheath is heat-shrinkable upon heating.

[0047] Organosilanes can be chemically coupled to superelastic conductive metal materials.

[0048] Organosilanes can be physically bonded and / or physically coupled to an insulating polymer sheath or material.

[0049] Organosilane coupling materials can be manufactured by condensation curing of diluted coating dispersions. The diluted coating dispersions may contain one or more organosilane reagents, said organosilane reagents containing one or more organic functional groups selected from amino, amine, amide, epoxy, ethylene oxide, urethane, urea, and carbonate, and further containing one or more hydrolyzable groups selected from alkoxy, acyloxy, oxime, hydroxyl, halogen, and combinations thereof.

[0050] The foregoing and other aspects, features, details, utility, and advantages of this disclosure will become apparent from reading the following description and claims, and from viewing the accompanying drawings. Brief description of the attached diagram

[0052] Figure 1 These are schematic diagrams and block diagrams for an electroporation treatment system.

[0053] Figure 2 It is possible to be with Figure 1 The view shown is of the handles used in the system.

[0054] Figure 3 It is possible to be with Figure 1 The diagram shows a side view of the DFA used in the system.

[0055] Figure 4 It is possible to be with Figure 1 The diagram shows a side view of the DFA used in the system.

[0056] Figure 5 It is possible to be with Figure 1 The diagram shows a side view of the DFA used in the system.

[0057] Figure 6 It is possible to be with Figure 1 The diagram shows a side view of the DFA used in the system.

[0058] Figure 7 It is possible to be with Figure 6 The diagram shows a side view of the cavity used in conjunction with the DFA.

[0059] Figure 8 It shows from Figure 7 The diagram shows a perspective view of the spline extending from the inner cavity.

[0060] Figure 9A This is a perspective view of a DFA.

[0061] Figure 9B yes Figure 9A The diagram shows a side view of the DFA.

[0062] Figure 10A This is a perspective view of a DFA.

[0063] Figure 10B yes Figure 10A The diagram shows a side view of the DFA.

[0064] Figure 10C This shows the first configuration. Figure 10A A schematic diagram of a DFA.

[0065] Figure 10D This shows the first configuration. Figure 10A A schematic diagram of a DFA.

[0066] Figure 10E yes Figure 10A The side cross-sectional view of the DFA shown.

[0067] Figure 10F-10J yes Figure 10A The diagram shows a schematic side cross-sectional view of the DFA, illustrating the transitions of the DFA between different states.

[0068] Figure 10K It is possible to be with Figure 10A The image shows a side cross-sectional view of a portion of the handle used with the DFA.

[0069] Figure 10L It is possible to be with Figure 10K A perspective view of the compression valve components, pins, and rings used together with the handle shown.

[0070] Figure 10M yes Figure 10L The exploded perspective view of the compression valve components, pins, and rings shown.

[0071] Figure 11 This is a perspective view of a DFA.

[0072] Figure 12 This is a perspective view of a DFA.

[0073] Figure 13 This is a perspective view of a DFA.

[0074] Figure 14 This is a perspective view of a DFA.

[0075] Figure 15 This is a perspective view of a DFA.

[0076] Figure 16 This is a perspective view of a DFA.

[0077] Figure 17 This is a perspective view of a DFA.

[0078] Figure 18 This is a perspective view of a DFA.

[0079] Figure 19 This is a perspective view of a DFA.

[0080] Figure 20 It is a diagram depicting an electrode spline according to the present disclosure, a portion of which is circumferentially surrounded by an insulating polymer material / sheath via an intermediate organosilane coupling material.

[0081] Figure 21 It is a diagram depicting an electrode spline according to the present disclosure, a portion of which is longitudinally surrounded by an insulating polymer material / sheath via an intermediate organosilane coupling material.

[0082] Detailed description of the publicly disclosed information

[0083] This document describes a system for electrode splines (also referred to herein as conduit splines). Example electrode splines or conduit splines include a body made of a superelastic conductive metallic material, an insulating polymer material / sheath, and an organosilane coupling material that couples the superelastic conductive metallic material to the insulating polymer material / sheath.

[0084] One example catheter includes an electrode spline (also referred to herein as a catheter spline). This example catheter may be a PFA or IRE catheter.

[0085] Another example catheter includes an example DFA, which further comprises an electrode basket formed by multiple electrode splined electrodes made of a hyperelastic and highly conductive metallic material, and a balloon positioned within the electrode basket (located inside the electrode basket). The balloon may be made of an elastic polymer material.

[0086] Although the example systems described in this disclosure are for pulmonary vein isolation (PVI), as will be understood by those skilled in the art based on the disclosure herein, it is contemplated that the features described herein can be incorporated into any number of systems and any number of applications.

[0087] It should be understood that although the example systems described herein are for specific splines and / or specific electrode splines, the systems disclosed herein can be used with any suitable spline, including those not specifically disclosed herein. Figure 1 A is a block diagram of system 10 for PFA or IRE treatment. Typically, system 10 includes a DFA 12 disposed at the distal end 48 of catheter 14. As used herein, “proximal” refers to the direction toward the catheter tip near the clinician, and “distal” refers to the direction away from the clinician and (typically) within the patient. The electrode spline assembly / DFA includes one or more individual electrically insulated 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 multipolar electrode.

[0088] System 10 can be used for IRE or PFA to destroy tissue. That is, System 10 can be used for electroporation-induced direct apoptosis therapy, which refers to the delivery of current in a manner that directly causes irreversible loss of plasma membrane (cell wall) integrity, leading to its destruction and apoptosis. This cell death mechanism can be viewed as an "outside-in" process, meaning that disruption of the cell wall has an adverse effect on the cell interior. Typically, for classic plasma membrane electroporation, current is delivered as a pulsed electric field in the form of short-duration pulses (e.g., with a duration of 0.1 to 20 milliseconds (ms)) between closely spaced electrodes capable of delivering an electric field strength of approximately 0.1 to 1.0 kV / cm. For example, System 10 can be used with basket and / or balloon DFAs for high-output (e.g., high-voltage and / or high-current) electroporation procedures. System 10 can be configured to deliver electrical pulse signals with relatively high voltage and low pulse duration.

[0089] All electrode splines of a catheter-delivered DFA can be configured to deliver current simultaneously. Alternatively, current can be delivered between pairs of electrode splines in the catheter-delivered DFA. Simultaneous current delivery using multiple electrode splines can help generate sufficiently deep ablation foci for electroporation. To facilitate simultaneous activation of the electrode splines, the splines can be switched between being connected to a 3D mapping system (i.e., a positioning and navigation system) and being connected to an ablation system (i.e., an ablation / electroporation generator).

[0090] Compared to conventional RF ablation using associated radiofrequency (RF) catheter systems that consist of only a single ablation tip or an array of ring electrodes, IRE using the RFA catheter system described herein can achieve pulmonary vein isolation with as few as one shock or a single electrical pulse train, thus requiring a much shorter ablation procedure time.

[0091] It should be understood that although the energizing strategy for achieving IRE through all electrode splines via the catheter is described as including DC pulses, variations can be used and remain within the spirit and scope of this disclosure. For example, exponentially decaying pulses, exponentially increasing pulses, and combinations thereof can be used. Furthermore, AC pulses can be used.

[0092] Furthermore, it should be understood that the mechanism of cell damage in electroporation is not primarily due to heating effects, but rather to the disruption of the cell membrane by applying a high-voltage electric field. Therefore, electroporation can avoid some of the potential thermal effects that may occur when using radio frequency (RF) energy. Thus, this "cold therapy" possesses desirable characteristics.

[0093] In this context, and now again referring to Figure 1The system 10 includes an electrode spline assembly / DFA 12, which includes at least one electrode spline. The electrode spline assembly / DFA 12 is incorporated as part of a medical device, such as a catheter 14, for electroporation treatment of tissue 16 in a patient's body 17. Figure 1 Tissue 16 includes the heart or cardiac tissue. However, it should be understood that the system can be used for electroporation treatment of a variety of other body tissues.

[0094] Figure 1 Also shown are multiple return electrodes labeled 18, 20, and 21, which are illustrations of body connections that can be used by various subsystems included in the overall system 10, such as an electroporation generator 26, an electrophysiological (EP) monitor, an ECG monitor 28, and a localization and navigation system 30 for visualization, mapping, and navigation of internal body structures. Figure 1 In this diagram, return electrodes 18, 20, and 21 are patch electrodes. It should be understood that the illustration of a single patch electrode is merely illustrative (for clarity), and such subsystems to which these patch electrodes are connected may and will typically include more than one patch (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 catheter 14. The return electrodes (multiple) may be electrode splines as part of the electrode spline assembly / DFA 12, or as part of a separate catheter or device (not shown). System 10 may also include a host computer system 32 (including an electronic control unit 50 and a data storage memory 52) which may be integrated with the positioning and navigation system 30. System 32 may also include conventional interface components, such as various user input / output mechanisms 34A and a display 34B, as well as other components.

[0095] Electroporation generator 26 is configured to energize (multiple) electrode splines according to an electroporation energizing strategy, which may be predetermined or user-selectable. For electroporation-induced direct apoptosis therapy, generator 26 can be configured to generate a current that is delivered as a pulsed electric field between closely spaced electrode splines via the electrode spline assembly / DFA 12 in the form of short-duration DC pulses (e.g., durations from nanoseconds to milliseconds, 0.1 to 20 milliseconds, or any duration suitable for electroporation), capable of delivering an electric field strength of approximately 0.1 to 1.0 kV / cm (i.e., at the tissue site). The amplitude required for irreversible electroporation is inversely proportional to the pulse duration. As the pulse duration decreases, the amplitude must increase to achieve electroporation.

[0096] Electroporation generator 26, sometimes referred to herein as a DC energy source, is a single-phase electroporation generator 26 configured to generate a series of DC energy pulses, all of which produce current in the same direction. Electroporation generator 26 can be a two-phase or multi-phase electroporation generator configured to generate DC energy pulses, not all of which produce current in the same direction. In some systems, electroporation generator 26 is configured to output DC pulses at selectable energy levels, such as fifty joules, one hundred joules, two hundred joules, etc. Other systems may have more or fewer energy settings, and the available settings may be the same or different. For successful electroporation, some systems utilize a two hundred joule output level. For example, electroporation generator 26 can output DC pulses with peak amplitudes ranging from approximately 300 volts (V) to approximately 3200 V at a two hundred joule output level. In some systems, the peak amplitude can even be larger (e.g., around 10000 V). Other systems can output any other suitable positive or negative voltage. For example, the system described herein may include pulses with amplitudes from about 500V to about 4000V and pulse widths from about 200 nanoseconds to about 20 microseconds.

[0097] In some systems, the variable impedance 27 allows the impedance of system 10 to change to limit the arc. Furthermore, the variable impedance 27 can be used to change one or more characteristics of the output of the electroporation generator 26, such as amplitude, duration, pulse shape, etc. Although shown as a separate component, the variable impedance 27 can be incorporated into the conduit 14 or the generator 26.

[0098] Continue to refer to Figure 1 As mentioned above, catheter 14 may include electroporation functionality and, in some systems, other types of ablation (e.g., RF ablation). However, it should be understood that the type of ablation energy provided in these systems may vary (e.g., cryoablation, ultrasound, RF energy, etc.).

[0099] In the illustrated system, conduit 14 includes a cable connector or interface 40, a handle 42, and a shaft 44 having a proximal end 46 and a distal end 48. Conduit 14 may also include other conventional components not illustrated herein, such as temperature sensors, additional electrodes, and corresponding conductors or leads. Connector 40 provides multiple mechanical and electrical connections to cable(s) 56 extending from generator 26. Connector 40 may include conventional components known in the art and is positioned at the proximal end of conduit 14 as shown.

[0100] Handle 42 provides a position for the clinician to hold catheter 14 and may further provide means for manipulating or navigating catheter shaft 44 within body 17. For example, handle 42 may include means for changing the length of the guidewire extending through catheter 14 to the distal end 48 of catheter shaft 44, or means for manipulating catheter shaft 44. Furthermore, in some systems, handle 42 may be configured to change the shape, size, and / or orientation of a portion of the catheter, and it should be understood that the configuration of handle 42 can be altered. Alternatively, catheter 14 may be robotically driven or controlled. Therefore, instead of the clinician manipulating the handle to advance / retreat and / or manipulate or navigate catheter 14 (and especially its shaft 44), a robotic system is used to manipulate catheter 14. Shaft 44 is an elongated, tubular, flexible member configured to move within body 17. Shaft 44 is configured to support electrode assembly / DFA 12 and includes associated conductors, and may contain additional electronics for signal processing or modulation. Shaft 44 can also allow for the transport, delivery, and / or removal of fluids (including flushing fluids and bodily fluids), medications, and / or surgical instruments or devices. Shaft 44 can be made of conventional materials such as polymers like thermoplastics (e.g., nylon, polycarbonate, polyester, etc.), polyamide-based or polyester-based thermoplastic elastomers (e.g., Pebax®, Hytrel®, etc.), and / or thermoplastic polyurethanes (e.g., Pellethane®, Estane®, Elasthane). TM The shaft 44, along with the electrode assembly / DFA 12, is constructed and defines one or more cavities configured to receive and / or transmit electrical conductors, fluids, or surgical instruments, as described herein. The shaft 44 can then be inserted into a blood vessel or other structure within the body 17 via a conventional guide. The shaft 44 can then be advanced / retracted and / or manipulated or guided through the body 17 to a desired location, such as the location of tissue 16, including by using a guidewire or other devices known in the art.

[0101] In some systems, catheter 14 includes multiple electrodes ( Figure 1 An electrode assembly or DFA (not shown) is provided, wherein the electrodes are distributed in a basket structure at the distal end of axis 44. Furthermore, as described herein, an inflatable balloon may be contained within the basket structure.

[0102] 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 arranged in a basket structure. Furthermore, as described herein, the electrode assembly or DFA also includes an inflatable balloon made of an elastic polymer material disposed at the distal end of the shaft but internally contained within an electrode basket structure formed by the plurality of electrode splines.

[0103] A positioning and navigation system 30 may be provided for visualization, mapping, and navigation of internal body structures, such as the cardiac anatomy of a patient. The positioning and navigation system 30 may include conventional devices generally known in the art (e.g., the EnSite Precision™ system, commercially available from Abbott Laboratories; and as generally shown with reference to commonly assigned U.S. Patent No. 7,263,397 entitled “Method and Apparatus for Catheter Navigation and Location and Mapping in the Heart,” the entire disclosure of which is incorporated herein by reference). However, it should be understood that this system is merely an example and is not inherently limiting. Other techniques for locating / navigating catheters (and for visualization) in space, such as within cardiac anatomy, are known, including, for example, the CARTO navigation and positioning system from Biosense Webster, Inc., the Rhythmia® system from Boston Scientific Scimed, Inc., the KODEX® system from Koninklijke Philips NV, the AURORA® system from Northern Digital Inc., commonly used fluorescence fluoroscopy systems, or magnetic positioning systems such as the gMPS system from Abbott Laboratories. In this regard, some positioning, navigation, and / or visualization systems will involve sensors provided for generating signals indicative of catheter position and may include, for example, one or more electrodes in the case of impedance-based positioning systems, or alternatively, one or more coils (i.e., wire windings) configured to detect one or more characteristics of a magnetic field in the case of magnetic field-based positioning systems. As another example, system 10 may utilize a combination of electric field-based and magnetic field-based systems, as generally shown with reference to U.S. Patent 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.

[0104] Pulsed field ablation (PFA) has proven to be an effective form of ablation for the treatment of cardiac arrhythmias, particularly for transient pulmonary vein isolation (PVI). PFA involves the delivery of high-voltage pulses from a hyperelastic electrode spline positioned on a catheter (e.g., including the basket and / or balloon catheter described herein). For example, in PFA, the voltage amplitude can range from about 300V to at least 3200V (or even up to about 10000V), and the pulse width can range from hundreds of nanoseconds to tens of milliseconds.

[0105] These electric fields can be applied between adjacent electrode splines (in the bipolar method) or between one or more electrode splines and the return patch (in the unipolar method). Each of these methods has advantages and disadvantages (e.g., when using the basket and / or balloon catheter described herein).

[0106] For example, regarding the continuity of ablation sites, monopolar methods may leave gaps (called dead zones) in the ablation site coverage between electrodes or electrode splines, where the field strength is low or zero, while the field strength in bipolar methods generally avoids dead zones between electrodes or electrode splines.

[0107] Monopolar methods have a wider range of influence in terms of the size and proximity of the ablation site, and may produce deeper ablation sites when the same voltage is applied. Furthermore, monopolar methods can generate ablation sites from a distance (e.g., typically close to, but not necessarily in contact with, tissue). Bipolar methods may produce smaller ablation sites, requiring closer proximity or contact with tissue to create transmural ablation sites. However, monopolar methods may produce larger ablation sites than necessary, while ablation sites produced using bipolar methods may be more localized.

[0108] Because of their wider reach, monopolar methods can lead to undesirable skeletal muscle and / or neural activation. In contrast, bipolar methods have a limited reach proportional to the spatial spacing of the electrodes or electrode splines and are less likely to depolarize cardiomyocytes or nerve fibers.

[0109] In a unipolar approach, only a single potential is applied to the catheter line and electrodes. Furthermore, because all electrodes or electrode splines have the same polarity, this configuration is less susceptible to arcing (e.g., when using catheters comprising electrode baskets and / or insulated polymer balloons contained within the electrode baskets, as described herein). In contrast, for a bipolar approach, the internal structure of the catheter must be configured to prevent arcing because adjacent electrodes or electrode splines are at different potentials.

[0110] To monitor the operation of system 10, one or more impedances between electrodes (including electrode splines) and / or return electrodes 18, 20, and 21 can be measured. For example, for system 10, impedances can be measured as described in U.S. Patent Application Publication No. 2019 / 0117113, filed October 23, 2018; U.S. Patent Application Publication No. 2019 / 0183378, filed December 19, 2018; and U.S. Patent Application No. 63 / 027,660, filed May 20, 2020, all of which are incorporated herein by reference in their entirety.

[0111] Figure 2This is a view of a handle 200 that can be used with system 10 and catheter 14. Handle 200 includes a first actuator 222 and a second actuator 224. The first actuator 222 can rotate, for example, about an axis of rotation substantially perpendicular to the longitudinal axis of handle 200 to selectively deflect at least a portion of catheter 14. The second actuator 224 can rotate, for example, about the same axis as the first actuator 222 to selectively lock onto the deflection orientation of catheter 14. That is, the first actuator 222 can be manipulated to deflect at least a portion of catheter 14 to a desired orientation, and then the second actuator 224 can be manipulated to lock catheter 14 in that orientation. Therefore, the first and second actuators 222 and 224 can be connected to one or more activation lines extending through catheter 14.

[0112] In addition, such as Figure 2 As shown, multiple connectors 230 are connected to the handle 200 via cables 232. Connectors 230 can be used to connect the conduit 14 to a generator, such as generator 26 (e.g., Figure 1 (As shown). Furthermore, connector 230 can provide a positioning and navigation system, such as positioning and navigation system 30 (e.g., Figure 1 The interface between the conduit 14 and one or more magnetic sensors included on the conduit 14 is described in more detail below.

[0113] Those skilled in the art will understand that the handle 200 is merely an example, and any suitable arrangement of handles and / or actuators can be used to implement the system described herein.

[0114] Figure 3 It can be used with system 10 ( Figure 1 A schematic side view of the DFA 300 used together (shown). The DFA 300 includes a shaft 302 and a balloon 304 connected to a distal portion 305 of the shaft 302. In this system, the catheter 300 includes a first electrode 308 located at the proximal end 310 of the balloon 304 and a second electrode 312 located at the distal end 314 of the balloon 304. The DFA 300 is shown as being located within a pulmonary vein 320.

[0115] Figure 4 It can be used with system 10 ( Figure 1 A side schematic view of a DFA 400 used together (as shown). The DFA 400 includes a shaft 400 and a balloon 404 connected to a distal portion 406 of the shaft 402. In this system, the catheter 400 includes a plurality of electrodes 412 near the distal end 414 of the balloon 404. Unlike the second electrode 312 (as shown...), Figure 3As shown), electrode 412 extends outward from balloon 404 to be closer to the wall of pulmonary vein 320. In this system, DFA 400 includes eight electrodes 412 (only five are shown for clarity). Alternatively, DFA 400 may include any suitable number of electrodes 412.

[0116] In this system, each electrode 412 is connected to a corresponding spline (not shown). During delivery, the coupled spline and electrode 412 are assembled into the lumen of the DFA 400. As the DFA 400 is deployed, the spline expands outward (e.g., similar to an umbrella), bringing the electrode 412 close to or even in contact with the wall of the pulmonary vein 320. Using the DFA 400, sufficient ablation foci can be generated even for pulmonary veins with a diameter of 25 mm at applied voltages of 1400V to 2500V.

[0117] Figure 5 It can be used with system 10 ( Figure 1 A side schematic view of a DFA 500 used in conjunction with (as shown). The DFA 500 includes a shaft 502 and a balloon 504 connected to a distal portion 506 of the shaft 502. In this system, the DFA 500 includes a plurality of electrodes 512 near the distal end 514 of the balloon 504. (The second electrode 312 is shown as...) Figure 3 Unlike the previous version (shown), electrode 512 is positioned on ring 516, closer to the wall of pulmonary vein 320. During delivery, ring 516, including multiple electrodes 512, is assembled into the lumen of DFA 500. When DFA 400 is deployed, ring 516 unfolds, bringing electrode 512 close to or even in contact with the wall of pulmonary vein 320.

[0118] In this system, the DFA 500 includes fourteen electrodes 512 (for clarity, only half of the ring 514 and eight electrodes 512 are shown). Alternatively, the DFA 500 may include any suitable number of electrodes 512. Using the DFA 500, sufficient ablation foci can be generated even for pulmonary veins with a diameter of 25 mm at an applied voltage of 2000V or 2500V.

[0119] Figure 6 It can be used with system 10 ( Figure 1A schematic side view of a DFA 600 used together (shown). The DFA 600 includes a shaft 602 and a balloon 604 connected to a distal portion 606 of the shaft 602. In this system, the DFA 600 includes a plurality of pre-formed splines 612, i.e., electrode splines, which serve as electrodes. During delivery, the splines or electrode splines 612 may be fitted into the lumen of the DFA 600 or may surround the balloon 604. In embodiments where the splines or electrode splines 612 are fitted into the lumen, the skeleton 612 may expand radially outward upon deployment, such that the splines 612 approach or even contact the wall of the pulmonary vein 320.

[0120] In the illustrated system, the DFA 600 includes 12 splines or electrode splines 612 (although only 7 splines 612 are shown). Alternatively, the DFA 600 may include any suitable number of splines 612. For example, in some systems, the DFA 600 may include ten to sixteen splines 612.

[0121] The spline 612 can be made of a nickel-titanium alloy (e.g., nitinol) and / or other hyperelastic metal alloys. Furthermore, each spline 612 can be used entirely as an electrode, or a portion of each spline 612 can be covered with an insulating polymer material (e.g., heat-shrinkable polyethylene terephthalate (PET), poly(ether block amide) (PEBA), or thermoplastic polyurethane, etc.), such that only the non-insulating portion of each spline 612 serves as an electrode. The insulating polymer material may also be referred to herein as an insulating polymer sheath. Additionally, in some embodiments, multiple independently energized electrodes can be connected to each spline 612. Using the DFA 600, sufficient ablation foci can be generated even for pulmonary veins with a diameter of 25 mm at an applied voltage of 2000V or 2500V.

[0122] For example, a template or electrode template 612 can be formed by laser cutting a metal tube (e.g., made of nitinol and / or other superelastic metal alloys) into multiple strips and heat-shaping the strips to form a shape that fits the balloon 604.

[0123] Figure 7 This is a schematic side view of the cavity 630 of the DFA 600, in which the spline 612 is stored (e.g., during the delivery of the DFA 600 and before the spline 612 is unfolded). Figure 8 This is a perspective view showing the spline 612 unfolded from the inner cavity 630.

[0124] Splines 612 can all be electrically connected to each other as single electrodes, or each can be a separate electrode. When splines 612 are separate electrodes, each spline 612 can be selectively energized to form different energizing sequences and / or patterns. Typically, each spline 612 has the same polarity to avoid arcing problems.

[0125] Splines 612 may all have the same length, or at least some splines 612 may have different lengths. Furthermore, each spline 612 may include an insulator covering at least a portion of it. The insulator on each spline 612 may have the same length, or at least some splines 612 may have insulators of different lengths. Additionally, in some systems, the DFA 600 includes a distal electrode (not shown) located at the distal end of each spline 612. The distal electrode may be used to perform point ablation (e.g., by forming a bipolar between the distal electrode and one of the splines 612), and / or may be used for visualization / mapping purposes (e.g., by combining the electrode on axis 602 and the distal electrode).

[0126] Figure 9A This is a perspective view of the DFA 900. Figure 9B This is a side schematic view of the DFA 900. The DFA 900 includes an axis 902 and a plurality of splines 904 surrounding a distal portion 906 of the axis 902. Each spline 904 includes a proximal end 910 connected to the axis 902 and a distal end 912 connected to the axis 902. The spline 904 extends radially outward from the proximal end 910 to an inflection point 914, and then radially inward to the distal end 912. Figure 9B The DFA 900 is shown located within the pulmonary vein 320.

[0127] Each skeleton 904 is made of a highly elastic and electrically conductive metallic material (e.g., nitinol) and serves as a relatively large electrode. In this system, the polarities of the alternating splines 904 alternate. That is, each positive electrode spline 904 is located between two negative electrode splines 904, and vice versa. Alternatively, any suitable polarization scheme can be used.

[0128] To control the ablation region of each spline or electrode spline 904, such as the ablation region achieved by the electrode basket structure of the DFA, the DFA is composed of a plurality of splines 904, a portion of which may be covered or wrapped with an insulating polymer material / sheath 920 coupled to the body of the spline 904 by a physicochemical method. The insulating polymer material / sheath 920 may be one or more layers of heat-shrinkable or conventional polymer tubing or polymer coating. More generally, as those skilled in the art will understand, in the systems described herein, the insulating polymer material / sheath may include at least one layer of fusible material. Furthermore, as those skilled in the art will understand, in the systems described herein, the insulating polymer material / sheath may include at least one layer of heat-shrinkable material.

[0129] exist Figure 9A and 9B In the system shown, a portion of spline 904 near the inflection point 914 toward the distal end 912 or between the inflection point 914 and the distal end 912 is typically exposed and acts as an electrode near or in contact with the pulmonary vein 320 when spline 904 or DFA 900 is deployed (see [link to system diagram]). Figure 9B Alternatively, any suitable insulation structure may be used.

[0130] During the delivery or withdrawal of the catheter into or from the patient, the spline 904 can contract and orient itself substantially parallel to axis 902. Subsequently, for ablation, the spline 904 of the DFA 900 is unfolded, with inflection point 914 extending radially outward.

[0131] It is worth noting that, compared with DFA 300, 400, 500 and 600 (such as... Figure 3 , 4 Compared to (as shown in Figures 5 and 6), the DFA 900 helps to ablate closer and wider portions of the pulmonary vein 320.

[0132] The spline or electrode spline 904 may all have the same length, or at least some splines 904 may have different lengths. Furthermore, the insulating polymer material / sheath 920 surrounding the proximal and distal portions of each spline 904 may have the same length, or at least some splines 904 may have insulating polymer material / sheath 920 of different lengths. Additionally, in some systems, the DFA 900 includes a distal electrode (not shown) located at the distal end of an electrode basket structure formed by a plurality of splines 904. The distal electrode can be used for point ablation (e.g., by forming a bipolar between the distal electrode and one of the spline 904), and / or for visualization / mapping purposes (e.g., by combining the electrode on axis 902 and the distal electrode).

[0133] Figure 10AThis is a perspective view of a DFA 1000. Figure 10B This is a schematic side view of the DFA 1000. Similar to the DFA 900 (as shown in Figure 9), the DFA 1000 includes a shaft 1002 and a plurality of electrode splines 1004 spatially arranged and connected to the distal portion 1006 of the shaft 1002. However, unlike the DFA 900, the DFA 1000 includes a balloon 1008 enclosed within an electrode basket structure formed by the plurality of splines 1004. The balloon 1008 is made of an elastic polymer material and can be selectively inflated to occupy the space of the electrode basket structure formed by the splines 1004. Notably, the balloon 1008 acts as an electrical insulator and generally reduces energy loss relative to the DFA 900, which may result in an increased ablation zone size.

[0134] Each spline 1004 includes a proximal end 1010 connected to the shaft 1002 and a distal end 1012 connected to the shaft 1002. The spline 1004 extends radially outward from the proximal end 1010 to the inflection point 1014, and then radially inward to the distal end 1012. Figure 10B The DFA 1000 is shown located within the pulmonary vein 320.

[0135] During catheter delivery into and withdrawal from the patient, the electrode basket structure formed by multiple spline 1004 and balloon 1008 can be contracted and reduced, respectively. For ablation, the spline 1004 expands, the inflection point 1014 extends radially outward, and the balloon 1008 is selectively inflated to occupy the space of the electrode basket structure formed by the multiple spline 1004.

[0136] In some systems, the shape of the balloon 1008 can be selectively modified to improve ablation. For example, Figure 10C This is a schematic diagram showing the DFA 1000 in the first configuration 1030. Figure 10D This is a schematic diagram showing the DFA 1000 in the second configuration 1032. In the second configuration 1032, the spline 1004 is axially compressed relative to the first configuration 1030, so that the effective diameter of the spline 1004 at the inflection point can be larger.

[0137] To facilitate the selective switching of the DFA 1000 between the first and second configurations 1030 and 1032, the inner shaft member ( Figure 10A-10D(Not shown) is slidably positioned within shaft 1002, with the distal end of the inner shaft member connected to the distal end 1034 of balloon 1008 and spline 1004. When the inner shaft member is pulled proximally relative to shaft 1002, the distal end 1034 of balloon 1008 and spline 1004 are also pulled proximally relative to the proximal end 1036 of balloon 1008 and spline 1004, thereby axially compressing balloon 1008 and spline 1004. As described in detail herein, the position of the inner shaft member relative to shaft 1002 can be held in place using a suitable locking mechanism (e.g., a Tuohy Borst compression valve).

[0138] Figure 10E This is a side cross-sectional view of the DFA 1000. (Example) Figure 10E As shown, the DFA 1000 may include one or more magnetic sensors (e.g., to help determine the location and / or orientation of the DFA 1000 within the patient). In this system, a hollow magnetic sensor 1050 is located near the distal end 1034 of the balloon 1008. The hollow magnetic sensor 1050 allows a central lumen 1052 of the shaft 1002 to extend through it. The hollow magnetic sensor 1050 may have sensing capabilities, for example, more than five degrees of freedom (capable of detecting position in the x, y, and z directions). The central lumen 1052 can be used, for example, to accommodate a guidewire, a small-diameter mapping catheter, and / or to inject contrast agent into the patient (e.g., to help determine the location of the DFA 1000). Furthermore, in some systems, two or more electrodes (not shown) are connected to the shaft 1002 to aid in impedance-based localization.

[0139] The DFA 1000 also includes two solid magnetic sensors 1060 located near the proximal end 1032 of the balloon 1008. The solid magnetic sensors 1060 may, for example, be embedded in the shaft 1002, but are located outside the central cavity 1052. Each of the solid magnetic sensors 1060 individually has more than five degrees of freedom of sensing capability, but together they have more than six degrees of freedom of sensing capability (capable of detecting position in the x, y, and z directions, as well as detecting the rolling of the DFA 1000).

[0140] In this system, the central lumen 1052 facilitates the delivery of fluid to the interior of the balloon 1008 for selective inflation of the balloon 1008. The fluid may include saline or a mixture of saline and contrast agent. In some systems, the central lumen 1002 may include an infusion port (not shown) providing fluid communication between the central lumen 1052 and the interior of the balloon 1008. Furthermore, in some systems, the central lumen 1052 is capable of infusing contrast agent distal to the DFA 1000, which can help the user assess blood flow through the pulmonary vein 320 and assess whether the DFA 1000 obstructs blood flow through the pulmonary vein 320.

[0141] Figure 10F-10J This is a schematic side cross-sectional view of the DFA 1000, illustrating the transitions of the DFA 1000 between different states. Figure 10F As shown, in this system, shaft 1002 includes an outer shaft element 1062 and an inner shaft element 1064, both of which are tubular components. The inner shaft element 1064 is axially slidable within the outer shaft element 1062 and defines a central cavity 1052 passing through it. The outer shaft element 1062 may have a French dimension, for example, 11.5 French. Alternatively, the outer shaft element 1062 may have any suitable dimension.

[0142] A valve 1066 located distal to the inner axial element 1064 controls access to the central lumen 1052. For example, as described above, contrast agent can flow into the patient through the central lumen 1052 to confirm pulmonary vein obstruction. As another example, a mapping catheter (e.g., a 3French mapping catheter) can be extended into the patient through the central lumen 1052. As yet another example, a guidewire can be extended through the central lumen 1052. Those skilled in the art will understand that any suitable technique can be used to monitor the obstruction. For example, pressure monitoring can be used to assess venous obstruction, contrast agent injection can be used to assess venous obstruction using fluoroscopy, and / or ultrasound (e.g., Doppler) can be used to assess the obstruction.

[0143] like Figure 10F As shown, in this system, a channel 1070 is defined between an outer shaft element 1062 and an inner shaft element 1064. The channel 1070 is in fluid communication with the interior of the balloon 1008. Furthermore, a stopcock valve 1072 (e.g., a three-way stopcock valve) controls the flow of fluid into the balloon 1008, enabling the balloon to inflate and contract as desired.

[0144] In some systems, shape-sensing fibers may extend through the central cavity 1052 and / or channel 1090. The shape-sensing fiber may be an optical fiber, which allows the user to precisely determine the position and orientation of the shape-sensing fiber, thereby determining the position and orientation of axis 1002.

[0145] In this system, the DFA 1000 also includes a compression valve 1080, which helps to fix the position of the outer shaft element 1062 relative to the inner shaft element 1064. Specifically, as the compression valve 1080 opens, the inner shaft element 1064 can slide relative to the outer shaft element 1062. Once the inner shaft element 1064 is in the desired position, the compression valve 1080 can close to prevent the inner shaft element 1064 from sliding relative to the outer shaft element 1026. The compression valve 1080 also seals the proximal end of the passage 1070.

[0146] like Figure 10FAs shown, each spline 1004 extends between the distal end 1084 of the outer shaft element 1026 and the distal end 1086 of the inner shaft element 1064. Therefore, the shape of the spline 1004 is adjustable by sliding the distal end 1086 of the inner shaft element relative to the distal end 1084 of the outer shaft element.

[0147] Figure 10F The spline 1004 is shown in a neutral position, with the balloon 1008 contracted. Specifically, in this system, the spline 1004 is made of a superelastic and conductive metallic material (e.g., nitinol), such that the spline 1004 exhibits [a certain property] when not subjected to any external force or bias. Figure 10F The shape shown.

[0148] To compress the DFA 1000 (e.g., to deliver the DFA 1000), the inner shaft element 1064 slides distally relative to the outer shaft element 1062. This causes the spline 1004 to contract inward toward the inner shaft element 1064, transferring the DFA 1000 to a contracted state, as... Figure 10G As shown. In Figure 10G During this process, balloon 1008 contracts. The DFA 1000 can be locked in the contracted state using compression valve 1080.

[0149] Now for reference Figure 10H During treatment, the balloon 1008 inflates to fill the space between the spline 1004. Specifically, as... Figure 10H As shown, as the balloon 1008 inflates, the balloon 1008 typically conforms to the shape of the electrode basket formed by multiple splines 1004.

[0150] As described above Figure 10C and 10D The electrode basket structure, formed by multiple splines 1004, discussed above, can also be compressed to increase the outer diameter of the DFA 1000. Specifically, as... Figure 10I As shown, when the inner shaft element 1064 slides proximally relative to the outer shaft element 1062, this causes the spline 1004 to bend outward, putting the DFA 1000 into a compressed state. Figure 10I During this process, balloon 1008 contracts. The DFA 1000 can be locked in a compressed state using compression valve 1080.

[0151] Now for reference Figure 10J In a compressed state, the balloon 1008 can inflate to fill the space between the spline 1004. Specifically, as... Figure 10J As shown, as the balloon 1008 inflates, the balloon 1008 typically conforms to the shape of the basket formed by the spline 1004 in the compressed position.

[0152] Figure 10KThis is a side cross-sectional view of a portion of a handle 1090 that can be used with a DFA 1000. The handle 1090 includes a housing 1091 and a compression valve unit 1092 (e.g., including a compression valve 1080) located within the housing 1091. Furthermore, the handle 1090 includes a rotatable knob 1093 connected to the compression valve unit 1092 at the distal end of the housing 1091. By rotating the knob 1093, the user can selectively open and close the compression valve 1080 to fix the position of the inner shaft element 1064 as desired.

[0153] In addition, such as Figure 10K As shown, positioning component 1094 is connected to the distal end of inner shaft element 1064. With compression valve 1080 open, positioning component 1094 can slide axially relative to housing 1091, allowing inner shaft element 1064 to slide relative to outer shaft element 1062, as described above. A first fluid supply line 1095 (i.e., for supplying fluid to central cavity 1052) and a second fluid supply line 1096 (i.e., for supplying fluid to channel 1070) are also... Figure 10K As shown in the image.

[0154] To prevent the positioning component 1094 and the first fluid supply line 1095 from rotating relative to the housing 1091, pin 1097 non-rotatably connects the positioning component 1094 to the compression valve component 1092. Specifically, as Figure 10L Perspective and Figure 10M As shown in the exploded view, ring 1098 connects pin 1097 to compression valve component 1092. Ring 1098 has a protrusion 1099 that engages a slot defined in compression valve component 1092 with pin 1097, such that pin 1097 (and, by means of an extension, positioning member 1094) cannot rotate relative to compression valve component 1092.

[0155] In some systems, one or more cavities are defined within the outer shaft element 1062 (e.g., between the inner and outer surfaces of the outer shaft element 1062). These cavities can be used to guide wires (i.e., for powering the spline 1004) and / or activation wires (i.e., for controlling the orientation of the DFA 1000) through the DFA 1000. For example, in one system, all positive wires supplying power to the positive spline 1004 are guided through a first cavity, and all negative wires supplying power to the negative spline are guided through a second, separate cavity. This effectively isolates the positive and negative wires.

[0156] Each wire can be connected, for example, by welding to an associated electrode spline 1004, with the welding point and the proximal end of the spline arranged on a proximal coupling component (not shown). Furthermore, in some systems, a strain relief component (not shown) is connected to the outside of the inner shaft element 1064, away from the outer shaft element 1062, to prevent excessive bending of the inner shaft element 1064.

[0157] The DFA 1000 offers several advantages. For example, the combination of balloon 1008 and spline 1004 facilitates direct delivery and deployment of the DFA 1000. Furthermore, balloon 1008 drives more energy into the ablated tissue and stabilizes spline 1004 to prevent lateral movement. Additionally, using spline 1004 as the electrode, rather than a separate, smaller electrode, helps reduce costs and increase the reliability of the DFA 1000.

[0158] Splines 1004 may all have the same length, or at least some splines 1004 may have different lengths. Furthermore, an insulating polymer material / sheath made of any suitable polymer material (e.g., polyamide-based or polyester-based thermoplastic elastomers, thermoplastic polyurethanes, etc.) may be applied to each electrode spline 1004 and may have the same length, or at least some electrode splines 1004 may have insulating polymer material / sheaths of different lengths. Additionally, in some systems, the DFA 1000 includes a distal electrode (not shown) located at the distal end of the spline 1004. The distal electrode may be used for point ablation (e.g., by forming a bipolar between the distal electrode and one of the splines 1004), and / or for visualization / mapping purposes (e.g., by combining the electrode on axis 1002 and the distal electrode).

[0159] Figure 11 This is a perspective view of DFA 1100. DFA 1100 includes an axis 1102 and a plurality of splines 1104 surrounding a distal portion 1106 of the axis 1102. Each spline 1104 includes a proximal end 1110 connected to the axis 1102 and a distal end 1112 connected to the axis 1102. From the proximal end 1110 to the distal end 1112, the spline 1104 has a radially outwardly extending arcuate shape.

[0160] In this system, each spline 1104 includes multiple individual electrodes 1120. For example, each spline 1104 may include a superelastic conductive metallic material (e.g., nitinol) embedded or insulated through a polymer tube 1122, with the individual electrodes 1120 connected to the outside of the polymer tube 1122. In the illustrated system, each insulated spline 1104 includes two electrodes 1120 securely connected thereto. Furthermore, as... Figure 11 As shown, electrode 1120 is typically positioned closer to distal end 1112 than proximal end 1110, corresponding to the portion of spline 1104 that will contact pulmonary vein 320.

[0161] Alternatively, each insulating strip 1104 may include any suitable number and arrangement of electrodes 1120 securely fixed thereon. For example, in some systems, each insulating strip 1104 includes four electrodes 1120 securely fixed thereon.

[0162] In this system, the alternating electrodes firmly fixed to the spline 1104 have alternating polarities. That is, the electrodes 1120 fixed to a particular spline 1104 have the same polarity, but the electrodes 1120 fixed to a particular spline 1104 have different polarities than the electrodes 1120 fixed to adjacent splines 1104. Alternatively, any suitable polarization scheme can be used. During delivery, the basket structure formed by the multiple insulating splines 1104 can be contracted toward the axis 1102 in a contracted state. Subsequently, for ablation, the basket structure formed by the multiple splines 1104 is unfolded and thus compressed radially outward in a compressed state.

[0163] Including multiple electrodes 1120 on each polymer-insulated spline 1104, instead of the spline 1104 itself made of a hyperelastic metallic material as electrodes 1120, improves the ability of the DFA 1100 to perform various calibration procedures, because each electrode 1120 can be used as a separate sensor for acquiring calibration data.

[0164] Splines 1104 may all have the same length, or at least some splines 1104 may have different lengths. Furthermore, the insulating polymer material / sheath (e.g., PET or PEBA material) on each spline 1104 may have the same length, or at least some splines 1104 may have insulating polymer material / sheaths of different lengths. Additionally, in some systems, the DFA 1100 includes a distal electrode (not shown) located at the distal end of the spline 1104. The distal electrode can be used for point ablation (e.g., by forming a bipolar between the distal electrode and one of the splines 1104), and / or for visualization / mapping purposes (e.g., by combining the electrode on axis 1102 and the distal electrode).

[0165] Figure 12 This is a perspective view of the alternative systems to the DFA 1200. Similar to the DFA 1100 (e.g.) Figure 11As shown, the DFA 1200 includes an axis 1202 and a plurality of splines 1204 surrounding a distal portion 1206 of the axis 1202. However, unlike the DFA 1100, the DFA 1200 includes a balloon 1208 surrounded by a basket structure formed of a plurality of polymer insulating skeletons 1204. The balloon 1208 can be selectively inflated to fill the space between the splines 1204. Notably, the balloon 1208 serves as an insulator and generally reduces energy loss relative to the DFA 1200, which may result in an increase in the size of the ablation site.

[0166] Each spline 1204 includes a proximal end 1210 connected to the shaft 1202 and a distal end 1212 connected to the shaft 1202. From the proximal end 1210 to the distal end 1212, the spline 1204 has a radially outwardly extending arcuate shape.

[0167] In this system, each spline 1204 includes a plurality of individual electrodes 1220 securely fixed thereto. For example, each spline 1204 may include a superelastic metallic material (e.g., nitinol) embedded or insulated through a polymer tube 1222, with the individual electrodes 1220 securely fixed to the exterior of the polymer tube 1222. In the illustrated system, each insulated spline 1204 includes two electrodes 1220. Furthermore, as... Figure 12 As shown, electrode 1220 is typically positioned closer to distal end 1212 than proximal end 1210, corresponding to the portion of insulating strip 1204 that will contact pulmonary vein 320.

[0168] Alternatively, each insulating spline 1204 may include any suitable number and arrangement of electrodes 1220. For example, in some systems, each insulating spline 1204 includes four electrodes 1220.

[0169] In this system, the electrodes 1220, firmly fixed to alternating insulating strips 1204, have alternating polarities. That is, electrodes 1220 firmly fixed to a particular insulating strip 1204 have the same polarity, but electrodes 1220 firmly fixed to adjacent insulating strips 1204 have different polarities. Alternatively, any suitable polarization scheme can be used. During delivery, the basket structure formed by the plurality of insulating strips 1204 can be contracted toward the axis 1202 in a contracted state. Subsequently, for ablation, the basket structure formed by the plurality of insulating strips 1204 is unfolded and compressed radially outward toward the axis 1202 in a compressed state.

[0170] The polymer insulating strips 1204 may all have the same length, or at least some of the insulating strips 1204 may have different lengths. Furthermore, the insulating polymer material / sheath embedded in or surrounding each hyperelastic strip 1204 (e.g., PET heat-shrinkable tubing, or Pebax® PEBA copolymer, thermoplastic polyurethane, etc.) may have the same length, or at least some of the insulating strips 1204 may have insulating polymer material / sheaths of different lengths. Additionally, in some systems, the DFA 1200 includes a distal electrode (not shown) located at the distal end of the insulating strip 1204. The distal electrode may be used for point ablation (e.g., by forming a bipolar between the distal electrode and one of the strips 1204), and / or for visualization / calibration purposes (e.g., by combining the electrode on shaft 1202 and the distal electrode).

[0171] Figure 13 This is a perspective view of DFA 1300. DFA 1300 includes an axis 1302 and a plurality of splines 1304 surrounding a distal portion 1306 of the axis 1302. Each spline 1304 includes a proximal end 1310 connected to the axis 1302 and a distal end 1312 connected to the axis 1302. The spline 1304 extends radially outward from the proximal end 1310 to an inflection point 1314, and then radially inward to the distal end 1312.

[0172] Spline 1304 is made of a hyperelastic metallic material (e.g., nitinol) and serves itself as a relatively large electrode. In this system, the polarities of the alternating electrode splines 1304 alternate. That is, each positive electrode spline 1304 is located between two negative electrode splines 1304, and vice versa. Alternatively, any suitable polarization scheme can be used.

[0173] To control the ablation area of ​​each electrode template 1304, a portion of each electrode template 1304 may be covered or insulated with an insulating polymer material / sheath 1320 (e.g., PET, PEBA, thermoplastic polyurethane, etc.), and the exposed portion of the template 1304 serves as the electrode. Figure 13 In the spline 1304, the portion between inflection point 1314 and distal end 1312 is typically exposed, while the portion between inflection point 1314 and proximal end 1310 is typically insulated. This results in the portion of spline 1304 that contacts the pulmonary vein 320 being exposed and serving as an electrode. Alternatively, any suitable insulation structure may be used.

[0174] like Figure 13As shown, each spline 1304 includes an extension member 1330. The extension member 1330 includes a first end 1332, a second end 1334, a first branch 1336, and a second branch 1338. From the first end 1332, the first and second branches 1336 and 1338 extend away from each other, and then they extend back toward each other and rejoin at the second end 1334.

[0175] The extension member 1330 can be manufactured, for example, using laser cutting. In this system, all extension members 1330 are exposed (i.e., not covered with any insulating polymer material / sheath). Alternatively, portions of the extension member 1330 may be covered with insulating polymer material / sheath.

[0176] Including an extension member 1330 on the spline 1304 reduces the circumferential gap between the splines 1304, which helps to increase the volume of the ablation zone. Additionally, additional splines 1304 may be included to further reduce the circumferential gap.

[0177] In some systems, at least one spline 1304 includes multiple extension members 1330, rather than a single extension member 1330. Furthermore, as... Figure 13 As shown, the extension members 1330 are longitudinally aligned with each other in the DFA 1300. However, in some systems, at least some of the extension members 1330 are longitudinally offset relative to each other.

[0178] Furthermore, although the extension member 1330 is shown as having two branches 1336 and 1338 of substantially equal length, the extension member 1330 may have a different number of branches and / or branches of unequal length. Additionally, in some systems, the extension member 1330 may be formed from two separate splines 1304, rather than from a single spline 1304.

[0179] During delivery, the electrode basket structure formed by multiple splines 1304 can contract inward toward axis 1302. Furthermore, as the electrode basket formed by the splines 1304 contracts, the first and second branches 1336 and 1338 of each extension member 1330 also contract inward toward each other, reducing the overall profile of the DFA 1300. Subsequently, for ablation, the electrode basket structure of the splines 1304 unfolds in a compressed state, wherein the inflection point 1314 (of the splines 1304) extends radially outward.

[0180] Electrode splines 1304 may all have the same length, or at least some electrode splines 1304 may have different lengths. Furthermore, the insulating polymer material / sheath partially applied to each electrode spline 1304 may have the same length, or at least some electrode splines 1304 may have insulating polymer material / sheaths of different lengths. Additionally, in some systems, the DFA 1300 includes a distal electrode (not shown) located at the distal end of the electrode spline 1304. The distal electrode can be used for point ablation (e.g., by forming a bipolar between the distal electrode and one of the splines 1304), and / or for visualization / mapping purposes (e.g., by combining the electrode on axis 1302 and the distal electrode).

[0181] Figure 14 This is a perspective view of DFA 1400. DFA 1400 includes an axis 1402 and multiple splines 1404 surrounding a distal portion 1406 of the axis 1402. However, compared to DFA 1300 (such as...), Figure 13 Compared to (as shown), the DFA 1400 includes a balloon 1408 surrounded by spline 1404. The balloon 1408 can be selectively inflated to fill the space between the spline 1404. Notably, the balloon 1408 acts as an insulator and generally reduces energy loss compared to the DFA 1300, which can lead to an increase in the size of the ablation site.

[0182] Each spline 1404 includes a proximal end 1410 connected to the shaft 1402 and a distal end 1412 connected to the shaft 1402. The spline 1404 extends radially outward from the proximal end 1410 to an inflection point 1414, and then radially inward to the distal end 1412.

[0183] Spline 1404 is made of a superelastic conductive metallic material (e.g., nitinol) and serves as a relatively large electrode. In this system, the polarities of the alternating electrode splines 1404 alternate. That is, each positive electrode spline 1404 is located between two negative electrode splines 1404, and vice versa. Alternatively, any suitable polarization scheme can be used.

[0184] To control the ablation area of ​​each electrode template 1404, a portion of each electrode template 1404 may be covered or insulated with an insulating polymer material / sheath 1420 (e.g., PET, PEBA copolymer, thermoplastic polyurethane, etc.), with the exposed portion of the template 1404 serving as the electrode. Figure 14 In the spline 1404 section, the portion between inflection point 1414 and distal end 1412 is typically exposed, while the portion between inflection point 1414 and proximal end 1410 is typically insulated. This results in the portion of spline 1404 that contacts the pulmonary vein 320 being exposed and serving as an electrode. Alternatively, any suitable insulation structure may be used.

[0185] like Figure 14 As shown, each spline 1404 includes an extension member 1430. The extension member 1430 includes a first end 1432, a second end 1434, a first branch 1436, and a second branch 1438. From the first end 1432, the first and second branches 1436 and 1438 extend away from each other, and then they extend back toward each other and rejoin at the second end 1434.

[0186] The extension member 1430 can be manufactured, for example, using laser cutting. In this system, all extension members 1430 are exposed (i.e., without any insulating polymer material / sheath). Alternatively, portions of the extension member 1430 may be covered with insulating polymer material / sheath.

[0187] Including an extension member 1430 on the spline 1404 reduces the circumferential gap between the electrode splines 1404, which helps to increase the volume of the ablation zone. Additionally, additional electrode splines 1404 may be included to further reduce the circumferential gap.

[0188] In some systems, at least one electrode spline 1404 includes multiple extension members 1430, rather than a single extension member 1430. Furthermore, as... Figure 14 As shown, the extension members 1430 are longitudinally aligned with each other in the DFA 1400. However, in some systems, at least some of the extension members 1430 are longitudinally offset relative to each other.

[0189] During delivery, the electrode basket structure formed by multiple electrode splines 1404 can contract inward toward axis 1402 in a contracted state. Furthermore, as the electrode basket structure of the splines 1404 contracts, the first and second branches 1436 and 1438 of each extension member 1430 of the electrode splines 1404 also contract inward toward each other, reducing the overall profile of the DFA 1400. Subsequently, for ablation, the electrode basket structure formed by the multiple electrode splines 1404 unfolds in a compressed state, wherein the inflection points 1414 of the splines 1404 extend radially outward.

[0190] Electrode splines 1404 may all have the same length, or at least some electrode splines 1404 may have different lengths. Furthermore, the insulating polymer material / sheath applied to portions of each electrode spline 1404 may have the same length, or at least some electrode splines 1404 may have insulating polymer material / sheaths of different lengths. Additionally, in some systems, the DFA 1400 includes a distal electrode (not shown) located at the distal end of the spline 1404. The distal electrode can be used for point ablation (e.g., by forming a bipolar between the distal electrode and one of the splines 1404), and / or for visualization / mapping purposes (e.g., by combining the electrode on axis 1402 and the distal electrode).

[0191] Figure 15 This is a perspective view of a DFA 1500. The DFA 1500 includes an axis 1502 and a plurality of splines 1504 surrounding and positioned around and disposed at the distal portion 1506 of the axis 1502. Each spline 1504 includes a proximal end 1510 connected to the axis 1502 and a distal end 1512 connected to the axis 1502. The spline 1504 extends radially outward from the proximal end 1510 to an inflection point 1514, and then radially inward to the distal end 1512.

[0192] Spline 1504 is made of a superelastic and conductive metallic material (e.g., nitinol) and serves as a relatively large electrode. In this system, the polarities of the alternating electrode splines 1504 alternate. That is, each positive electrode spline 1504 is located between two negative electrode splines 1504, and vice versa. Alternatively, any suitable polarization scheme can be used.

[0193] To control the ablation region achieved by the electrode basket structure formed by the electrode spline 1504, a portion of each electrode spline 1504 may be covered or insulated with an insulating polymer material / sheath 1520, and the exposed portion of the spline 1504 serves as an electrode. Figure 15 In this configuration, the portion of spline 1504 near inflection point 1514, facing distal end 1512, is typically exposed, while the other portions of spline 1504, including distal end 1512 and proximal end 1510, are typically insulated by applying an insulating polymer material / sheath 1520. This results in the exposed (electrode) portion of spline 1504 being in contact with or very close to the pulmonary vein 320 when the DFA 1500 is properly deployed. Alternatively, any suitable insulation structure may be used.

[0194] like Figure 15As shown, each electrode spline 1504 includes a tapered member 1530. The tapered member 1530 includes a first end 1532 and a second end 1534. From the first end 1532, the width of the tapered member 1530 gradually decreases outward along the first tapered portion 1540, remains substantially constant along the middle portion 1542, and gradually decreases inward toward the second end 1534 along the second tapered portion 1544. In some systems, the tapered member 1530 includes only a single tapered portion.

[0195] The tapered member 1530 can be manufactured, for example, using laser cutting. In this system, all tapered members 1530 are exposed (i.e., without an insulating polymer material / sheath). Alternatively, portions of the tapered member 1530 may be covered with an insulating polymer material / sheath. Furthermore, in this system, the tapered member 1530 serves as a single electrode. Alternatively, the tapered member 1530 can be separated and used as multiple separate electrodes (e.g., by providing insulating polymer material / sheaths on multiple portions of the tapered member 1530).

[0196] Including a tapered member 1530 on the spline 1504 reduces the circumferential gap between the electrode splines 1504, which helps to increase the volume of the ablation zone. Additionally, additional electrode splines 1504 may be included to further reduce the circumferential gap.

[0197] In some systems, at least one electrode spline 1504 includes multiple tapered members 1530, rather than a single tapered member 1530. Furthermore, as... Figure 15 As shown, the tapered members 1530 are longitudinally aligned with each other in the DFA 1500. However, in some systems, at least some of the tapered members 1530 are longitudinally offset relative to each other.

[0198] During the delivery or removal of the catheter from the patient, the spline 1504 and the electrode basket structure formed by multiple splines 1504 can retract inward toward the axis 1502. Subsequently, for ablation, the spline 1504 and the electrode basket structure formed by multiple splines 1504 will be compressed to expand or extend radially outward upon deployment.

[0199] Electrode splines 1504 may all have the same length, or at least some electrode splines 1504 may have different lengths. Furthermore, the insulating polymer material / sheath applied to each electrode spline 1504 may have the same length, or at least some electrode splines 1504 may have insulating polymer material / sheaths of different lengths. Additionally, in some systems, the DFA 1500 includes a distal electrode (not shown) located at the distal end of an electrode basket structure formed by a plurality of splines 1504. The distal electrode can be used for point ablation (e.g., by forming a bipolar between the distal electrode and one of the splines 1504), and / or for visualization / mapping purposes (e.g., by combining the electrode on axis 1502 and the distal electrode).

[0200] Figure 16 This is a perspective view of DFA 1600. DFA 1600 includes an axis 1602 and multiple splines 1604 surrounding a distal portion 1606 of the axis 1602. However, compared to DFA 1500 (such as...), Figure 15 Compared to the DFA 1500 (as shown), the DFA 1600 includes a balloon 1608 surrounded by an electrode basket structure formed by multiple electrode splines 1604. The balloon 1608 can be selectively inflated to fill the space surrounded by the electrode basket structure formed by the multiple electrode splines 1604. Notably, the balloon 1608 acts as an electrical insulator and generally reduces energy loss compared to the DFA 1500, which may result in an increase in the size of the ablation site.

[0201] Each electrode spline 1604 includes a proximal end 1610 connected to a shaft 1602 and a wire (not shown) and a distal end 1612 connected to the shaft 1602. The electrode spline 1604 extends radially outward from the proximal end 1610 to an inflection point 1614 and then radially inward to the distal end 1612.

[0202] Electrode spline 1604 is made of a superelastic and conductive metallic material (e.g., nitinol) and serves as a relatively large electrode. In this system, the polarities of the alternating electrode splines 1604 alternate. That is, each positive electrode spline 1604 is located between two negative electrode splines 1604, and vice versa. Alternatively, any suitable polarization scheme can be used.

[0203] To control the ablation region achieved by the electrode basket structure formed by multiple electrode spline 1604, a portion of each electrode spline 1604 may be covered or insulated by an insulating polymer material / sheath 1620, and the exposed portion of the spline 1604 serves as an electrode. Figure 16In the system shown, the portion of each spline 1604 near the inflection point 1614 facing the distal end 1612 is typically exposed, while the other portions of each spline 1604, including the distal end 1612 and the proximal end 1620, are typically insulated. Thus, when the DFA 1600 is deployed and the electrode basket structure formed by the multiple electrode splines 1604 is appropriately compressed in a compressed state, the exposed (electrode) portion of each spline 1604 will expand or extend radially outward to approach or contact the pulmonary vein 320. Alternatively, any suitable insulation configuration may be used.

[0204] like Figure 16 As shown, each electrode spline 1604 includes a tapered member 1630. The tapered member 1630 includes a first end 1632 and a second end 1634. Starting from the first end 1632, the width of the tapered member 1630 gradually decreases outward along the first tapered portion 1640, remains substantially constant along the middle portion 1642, and gradually decreases inward toward the second end 1634 along the second tapered portion 1644. In some systems, the tapered member 1530 includes only a single tapered portion.

[0205] The tapered member 1630 can be manufactured, for example, using laser cutting. In this system, all tapered members 1630 are exposed (i.e., without an insulating polymer material / sheath) to serve as electrodes for the electrode spline 1604. Alternatively, portions of the tapered member 1630 may be covered or insulated with an insulating polymer material / sheath. Furthermore, in this system, the tapered member 1630 is used as a separate electrode. Alternatively, the tapered member 1630 may be divided into multiple separate electrodes (e.g., by providing an insulating polymer material / sheath on multiple portions of the tapered member 1630).

[0206] Including a tapered member 1630 on the electrode spline 1604 reduces the circumferential gap between the electrode splines 1604, which helps to increase the volume of the ablation zone. Furthermore, additional electrode splines 1604 may be included to further reduce the circumferential gap.

[0207] In some systems, at least one electrode spline 1604 comprises multiple tapered members 1630, rather than a single tapered member 1630. Furthermore, as... Figure 16 As shown, when the DFA 1600 is contracted, the tapered members 1630 are aligned with each other along the circumferential direction of the shaft 1602 in the DFA 1600. However, in some systems, when the DFA 1600 is contracted, at least some of the tapered members 1630 are longitudinally aligned with each other along the circumferential direction of the shaft 1602 in the DFA 1600, or parallel, with some offset gaps between them.

[0208] During catheter delivery into or withdrawal from the patient, the electrode basket structure formed by multiple electrode spline 1604 or DFA 1600 can retract inward toward axis 1602 in a contracted state. Subsequently, for ablation, the DFA 1600, including the electrode basket structure formed by the electrode spline 1604, is deployed and compressed in a compressed state, causing the electrode spline 1604 to expand or extend radially outward to closely approach or contact the pulmonary vein for ablation.

[0209] Electrode splines 1604 may all have the same length, or at least some electrode splines 1604 may have different lengths. Furthermore, the insulating polymer material / sheath applied to each electrode spline 1604 may have the same length, or at least some electrode splines 1604 may have insulating polymer material / sheaths of different lengths. Additionally, in some systems, the DFA 1600 includes a distal electrode (not shown) located at the distal end of the spline 1604. The distal electrode can be used for point ablation (e.g., by forming a bipolar between the distal electrode and one of the splines 1604), and / or for visualization / mapping purposes (e.g., by combining the electrode on axis 1602 and the distal electrode).

[0210] At least in part due to the length of the exposed portion of the electrode spline 1604, in some systems, including the DFA 1600, which comprises an electrode basket structure formed by multiple electrode splines 1604 as described herein, ablation foci ranging in length from approximately 1.0 to 1.5 cm can be produced. This results in a wider ablation foci band, unlike the ablation foci in at least some known systems, which may have a length of approximately 4 or 5 mm. This is clinically important because ablation foci are often not homogeneous. Furthermore, the larger ablation foci length allows for the ablation of a larger area of ​​the PV vestibule. This is advantageous because the PV vestibule includes many transitional tissue fibers that may be proarrhythmic.

[0211] In the systems described herein, the electrode splines are typically straight. However, electrode splines can have any suitable shape. For example, in some systems, electrode splines can have an S-shape, which can help release stress when the spline is compressed or contracted.

[0212] Furthermore, although the system described herein is shown with a specific number of electrode splines, those skilled in the art will understand that any suitable number of electrode splines can be included in the DFA 1600. For example, in some systems, the DFA 1600 may include four, six, eight, ten, twelve, fourteen, sixteen, eighteen, or twenty electrode splines.

[0213] As described above, the DFA described herein, including the DFA 1600, may also include a balloon surrounded by an electrode basket structure formed of multiple (insulating and / or electrode) splints made of a hyperelastic metallic material (e.g., nitinol), wherein the balloon acts as an electrical insulator and generally reduces energy loss. This is because the balloon causes the electrode splints and / or electrodes firmly fixed to the insulating splints to primarily transfer energy outward and away from the balloon, resulting in energy being primarily transferred to the target tissue rather than entering the blood pool.

[0214] During PFA treatment, microbubble formation can occur in at least some known systems, which may be undesirable. However, increased current density at the electrodes has been observed to lead to increased microbubble formation. Therefore, reduced current density generally results in reduced microbubble formation. In at least some of the systems described herein, DFAs comprising basket structures formed from multiple (insulating and / or electrode) splines can generate relatively large surface areas (e.g., in systems where relatively long exposed portions of the splines are used as electrodes). This larger surface area results in lower current densities, thereby reducing microbubble formation (in addition to more efficient energy delivery to the target tissue as discussed above).

[0215] Those skilled in the art will understand that the various systems of many DFAs disclosed above, including the DFA 1600, can be implemented independently of each other or in any suitable combination.

[0216] Furthermore, the DFAs described herein, including the DFA 1600, can have any suitable size. For example, in some systems, DFAs comprising an associated electrode basket structure formed of multiple electrodes and / or insulating splines as described herein can have an extended diameter in the range of approximately 28–35 mm when unfolded and appropriately compressed in a compressed state. Alternatively, the DFAs described herein can have a smaller extended diameter (e.g., in the range of approximately 8–10 mm).

[0217] For example, Figure 17 This is a perspective view of the DFA, specifically the DFA 1700. The DFA 1700 includes a shaft 1702 and multiple electrode splines 1704, which are positioned and connected to the distal portion 1706 of the shaft 1702 to form an electrode basket structure. The DFA 1700 also includes a balloon 1708 surrounded by the electrode basket structure formed by the multiple electrode splines 1704. The balloon 1708 can be selectively inflated to fill the space within the electrode basket structure of the electrode splines 1704. Notably, the balloon 1708 acts as an electrical insulator and generally reduces energy loss, which can lead to an increase in the size of the ablation site.

[0218] Compared to DFAs 300, 400, 500, 600, 900, 1000, 1100, 1200, 1300, 1400, 1500, and 1600, the DFA 1700 can be smaller and have a simplified design, which enables lower manufacturing costs. For example, DFAs 300, 400, 500, 600, 900, 1000, 1100, 1200, 1300, 1400, 1500, and 1600 can have diameters ranging from approximately 28 to 35 mm, where the associated basket structure of the DFA is unfolded and appropriately compressed in a partially contracted state to facilitate PVI. Conversely, the DFA 1700, which includes the associated electrode basket structure of electrode spline 1704, can have a diameter ranging from approximately 8 to 10 mm (e.g., a diameter of 9 mm) when unfolded and appropriately compressed in a compressed state. In addition, when properly contracted in a contracted state, the DFA 1700 can be delivered using a 7.5 French guide.

[0219] The smaller diameter of the DFA 1700 in its properly compressed state results in smaller, more concentrated ablation foci. For example, the DFA 1700 can be used to treat gaps remaining after one of the DFA 300, 400, 500, 600, 900, 1000, 1100, 1200, 1300, 1400, 1500, and 1600 has already been used for PVI. Therefore, the DFA 1700 can be used as a supplementary ablation procedure after a primary ablation using one of the ablation catheter systems including the DFA 300, 400, 500, 600, 900, 1000, 1100, 1200, 1300, 1400, 1500, and 1600. As another example, the DFA 1700 can be used to treat other targets, such as the posterior wall.

[0220] Computerized clinical simulations have demonstrated that the DFA 1700 consistently produces ablation foci regardless of its orientation relative to the target tissue. For example, when the DFA 1700 or catheter axis 1702 is positioned at angles of approximately 10°, 45°, and 90° relative to the surface of the target tissue, ablation foci with a depth of at least 4 mm can actually be achieved using the associated catheter system.

[0221] In the illustrated system, each electrode spline 1704 includes an exposed portion 1710 serving as an electrode, and an insulating portion 1712 adjacent to the exposed portion 1710. In some systems, the distal end of the exposed portion 1710 includes another insulating portion 1712. Alternatively, this distal insulating portion 1712 may be omitted. Although the electrode spline 1704 is shown as having a constant width, those skilled in the art will understand that other spline shapes (e.g., tapered, split, etc.) may be used.

[0222] To perform ablation, a voltage (e.g., 1500 V) is applied to the DFA 1700. Specifically, the voltage can be applied between the electrode spline 1704 according to a bipolar method. Alternatively, in a unipolar method, the voltage can be applied between one or more electrode spline 1704 and a single electrode (e.g., a body patch electrode). Furthermore, the voltage can be applied to the electrode spline 1704 simultaneously or sequentially (e.g., via multiplexing).

[0223] The DFA 1700 includes two electrode splines 1704. Alternatively, more electrode splines may be included. For example, Figure 18 This is a perspective view of the DFA 1800, which includes four electrode splines 1804. Figure 19 This is a perspective view of the DFA 1900, which includes six splines 1904. Except for the number of electrode splines, the DFA 1800 and 1900 are essentially similar to the DFA 1700.

[0224] Now we turn to the system of the structural construction and material composition of those splines, namely, those "insulating splines" that are fully polymer-insulated and have some "independent" electrodes firmly fixed in place according to this disclosure, and those "electrode splines" that are partially polymer-insulated and have their exposed (multiple) portions as electrodes. Figure 20 This is an illustration of a cross-sectional view of an electrode spline 2000. The spline 2000 comprises a body 2002 made of a superelastic and conductive metallic material (e.g., a NiTi alloy or nitinol), an insulating polymer material / sheath 2006 made of one or more polymer materials, and an organosilane coupling material 2004 that couples the superelastic conductive metallic material 2002 to a contact polymer material composed of the insulating polymer material / sheath 2006 via a physicochemical method. In the example system, the entire surface of the body 2002 of the spline 2000 is coated with the organosilane coupling material 2004. Alternatively, one or more portions of the body 2002 may be coated only in its longitudinal direction, the one or more portions corresponding to the portions of the spline 2000 that will be circumferentially covered or insulated by the insulating polymer material / sheath. The spline 2000 can be any (insulation or electrode) spline described herein, including spline 612, spline 904, spline 1004, spline 1104, spline 1204, spline 1304, spline 1404, spline 1504, spline 1604, spline 1704, spline 1804 and spline 1904.

[0225] Figure 21This is an illustration of a cross-sectional view along the longitudinal direction of another example system of spline 2100. Spline 2100 includes a body 2102 made of a superelastic conductive metallic material (e.g., NiTi alloy or nitinol), an insulating polymer material / sheath 2106, and an organosilane coupling material 2104 that chemically couples the superelastic conductive metallic material or body 2102 to the contact (or interior) polymer material of the insulating polymer material / sheath 2106. In this system, one or more longitudinal portions of the body 2102 of spline 2100 (where only the insulating polymer material / sheath is present) are coated with the organosilane coupling material 2104. The spline 2100 can be any spline described herein, including spline 612, spline 904, spline 1004, spline 1104, spline 1204, spline 1304, spline 1404, spline 1504, spline 1604, spline 1704, spline 1804 and spline 1904.

[0226] Typically, the hyperelastic conductive metallic material can be any suitable metallic material known in the art that is helpful in fabricating splines as described herein. In some systems, the hyperelastic conductive metallic material is selected from shape memory alloys.

[0227] In some systems, the superelastic conductive metallic material is selected from nitinol or nitinol superalloys, as well as other common shape memory alloys, such as copper-zinc-aluminum alloys, copper-aluminum-nickel alloys, zinc-copper-gold-iron alloys, iron-manganese-silicon alloys, and combinations thereof. Nitinol or nitinol superalloys are highly preferred due to their excellent superelasticity, outstanding conductivity, and proven biocompatibility and biostability for medical device applications.

[0228] Typically, the insulating polymer material / sheath can be made from any one or more suitable polymer materials known in the art that facilitate the manufacture of the strips described herein. The insulating polymer material / sheath can be made from one, two, three, four, or more different but chemically compatible polymer materials configured into one or more self-adhesive polymer layers, which can be manufactured via polymer co-extrusion methods known in the art.

[0229] The insulating polymer material / sheath may wrap one or more portions or the entire body of the spline along its longitudinal direction. The innermost or innermost polymer layer of the insulating polymer material / sheath should be thermoplastic or inherently non-chemically cross-linked, while the other polymer layers of the insulating polymer material / sheath may be chemically cross-linked.

[0230] In some systems, the insulating polymer material / sheath can be manufactured as a tubular preform. In other systems, the insulating polymer material / sheath can be manufactured as a double-layered tubular preform.

[0231] In some systems, one or more polymeric materials used to manufacture the insulating polymeric material / sheath include thermoplastic polymeric materials selected from polyester homopolymers and copolymers (e.g., polyethylene terephthalate, polybutylene terephthalate, etc.), nylon or polyamide homopolymers and copolymers (e.g., nylon 11, nylon 12, nylon 612, etc.), poly(bisphenol A carbonate), polysulfone, polyethersulfone, polyetherimide, polyethylene, polypropylene homopolymers and copolymers, and combinations thereof.

[0232] In some systems, one or more polymeric materials used to manufacture the insulating material / polymer sheath are selected from thermoplastic elastomers, including polyamide-based thermoplastic elastomers or poly(ether block amide) (PEBA) copolymers, polyester-based thermoplastic elastomers or poly(ester ether) block copolymers, thermoplastic polyurethane elastomers (e.g., poly(ether urethane) copolymers, poly(carbonate urethane) copolymers, poly(siloxane-carbonate urethane) copolymers, poly(siloxane-ether urethane) copolymers, etc.), styrene thermoplastic elastomers or styrene block copolymers, thermoplastic olefins, and combinations thereof.

[0233] In some systems, one or more polymeric materials used to manufacture the insulating / polymer sheath are selected from thermoplastic polymeric materials, preferably polyamide-based thermoplastic elastomers (e.g., Pebax). ® Vestamide ® E, etc.), thermoplastic polyurethane elastomers (e.g., Pellethane) ® Estane ® Pearlthane TM Elasthane TM Tecobax TM Texoflex TM Tecothane TM Carbothane TM Bionate ® Carbosil ® Pursil ® Biospan ® Elast-Eon TM Desmopan ® (etc.), polyester-based thermoplastic elastomers (e.g., Hytrel) ® Arnitel ® (etc.) and their combinations.

[0234] In some systems, one or more polymeric materials used to manufacture the insulating material / polymer sheath may further contain polymeric additives (e.g., UV stabilizers, antioxidants, etc.), colorants, and / or pigments.

[0235] In some systems, the insulating polymer material / sheath may be double-layered and applied to one or more portions of a spline body coated with an organosilane coupling material. The insulating polymer material / sheath may be made of one or more polymer materials in the form of a double-layered tubular preform, and then applied to one or more portions of the spline body coated with an organosilane coupling material. The innermost or innermost polymer layer of the sheath may be composed of a thermoplastic polymer or thermoplastic elastomer material. The innermost or innermost polymer layer may optionally contain several polymer additives (e.g., UV stabilizers, antioxidants, etc.), as disclosed above. Other polymer layers(s) of the insulating material / polymer sheath, particularly the outermost or outermost polymer layer, may be composed of melt-extruded, radiation-crosslinkable polymer compounds based on thermoplastic polymers or thermoplastic elastomers. The thermoplastic polymers or thermoplastic elastomers may optionally contain polymer additives (e.g., UV stabilizers, antioxidants, etc.). Furthermore, the thermoplastic polymer or thermoplastic elastomer may contain one or more crosslinking agents in its composition, which will promote crosslinking of the polymer therein. Those skilled in the art will understand that in various systems, at least one layer (including an inner or outer layer) of the insulating polymer material / sheath may contain a remeltable material. Furthermore, those skilled in the art will understand that in various systems, at least one layer (including an inner or outer layer) of the insulating polymer material / sheath may contain a heat-shrinkable material.

[0236] Crosslinking agents for melt-extruded, radiation-crosslinkable polymer compounds may be selected from organic substances composed of radiation-activated 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 (PATA), etc.) and combinations thereof.

[0237] In some systems, organosilane coupling materials, i.e., functionalized cross-linked polysiloxane materials, are formed in situ on one or more portions of the spline matrix. Organosilane coupling materials can be formed when an applicable coating dispersion or solution is applied to and cured on one or more portions of the spline matrix. The organosilane coupling material can be coupled to the hyperelastic conductive metal material of the spline matrix via covalent chemical bonds, i.e., metal-siloxane covalent bonds. In some systems, when an applicable coating dispersion or solution is applied to and cured on one or more portions of the spline matrix, organosilane coupling materials, i.e., functionalized cross-linked polysiloxane materials, are formed in situ on one or more portions of the spline matrix and coupled to the hyperelastic conductive metal material of the spline matrix via covalent chemical bonds, i.e., metal-siloxane covalent bonds.

[0238] In some systems, organosilane coupling materials, i.e., functionalized cross-linked polysiloxane materials, are formed in situ during the coating and curing of applicable coating dispersions or solutions. These organosilane coupling materials can be tightly coupled to the metal oxide surface of the sample host (e.g., a hydroxylated metal oxide surface) via covalent bonds, i.e., metallosiloxane bonds. In some systems, organosilane coupling materials, i.e., functionalized cross-linked polysiloxane materials, are formed in situ during the coating and curing of applicable coating dispersions or solutions, and are tightly coupled to the hydroxylated metal oxide surface of the sample host via covalent bonds, i.e., metallosiloxane bonds.

[0239] Typically, organosilane coupling materials can be coupled to a superelastic conductive metal material in any suitable configuration that facilitates the fabrication of splines as described herein. In some systems, the organosilane coupling material is coupled to the superelastic conductive metal material only at the end portion of the spline body. As used herein, the end portion of the spline body is a part of the body located at the end of the spline body.

[0240] In some systems, the organosilane coupling material is integrally coupled to the metal body of the sample. In some preferred systems, the organosilane coupling material is selectively applied only to one or more portions of the hydroxylated metal body of the sample, such that it also imparts chemical coupling to the innermost or innermost polymer layer of the insulating material / polymer sheath that tightly surrounds the sample(s) of the sample via intermolecular forces such as hydrogen bonds, van der Waals forces, etc.

[0241] In some systems, the organosilane coupling material is physically bonded and / or physically force-coupled to the innermost or innermost insulating polymer material / sheath. In some systems, the organosilane coupling material is molecularly interlocked with the innermost or innermost polymer layer of the insulating polymer sheath. In some systems, the organosilane coupling material is coupled to the innermost or innermost polymer layer via van der Waals forces.

[0242] Typically, organosilane coupling materials can be formed from any suitable polymer dispersion or solution system containing one or more reactive organosilane coupling agents described herein. That is, organosilane coupling materials can be formed from reactive dispersions or solutions containing one or more reactive organosilane coupling agents. Such reactive organosilane coupling agents can contain one, two, or three silicon atoms in their molecular structure and can be classified as monopodal, dipodal, and tripopodal organosilane reagents. As a quasi-metallic compound, the tetravalent silicon atom can be covalently bonded to at least one organic functional moiety (R) via an alkyl spacer group (L) and covalently bonded to at least one hydrolyzable moiety (X) that can chemically interact with an inorganic substance, including superelastic metal alloys such as nitinol or NiTi alloys. In some specific systems, the organosilane coupling agent is selected from:

[0243] Monopodial organosilanes according to Formula I:

[0244] (Formula I);

[0245] Bipedal organosilicones according to Formula II:

[0246] (Formula II);

[0247] According to Formula III, the following are tripod organosilanes:

[0248] (Formula III); and

[0249] and their combinations;

[0250] in:

[0251] R1, R2 and R3 are each selected from organic functional parts, oligomeric organic functional parts, polymeric organic functional parts and combinations thereof;

[0252] L1, L2, and L3 are each selected from direct bonds, substituted or unsubstituted straight-chain alkyl groups, and substituted or unsubstituted straight-chain C1-C bonds. 10 Alkyl, substituted or unsubstituted straight-chain C2-C4 alkyl, substituted or unsubstituted branched alkyl, substituted or unsubstituted branched C1-C 10 Alkyl, substituted or unsubstituted branched C2-C4 alkyl, C1 alkyl, C2 alkyl, C3 alkyl, C4 alkyl, C5 alkyl, C6 alkyl, C7 alkyl, C8 alkyl, C9 alkyl, C 10 Alkyl groups and combinations thereof;

[0253] X1, 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 straight-chain alkyl, substituted or unsubstituted straight-chain C1-C). 10 Alkyl, substituted or unsubstituted straight-chain C2-C4 alkyl, substituted or unsubstituted branched alkyl, substituted or unsubstituted branched C1-C 10 Alkyl, substituted or unsubstituted branched C2-C4 alkyl, C1 alkyl, C2 alkyl, C3 alkyl, C4 alkyl, C5 alkyl, C6 alkyl, C7 alkyl, C8 alkyl, C9 alkyl, C 10 Alkyl groups and combinations thereof), wherein at least one of X1, X2 and X3 is a hydrolyzable group;

[0254] Y1, 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 straight-chain alkyl, substituted or unsubstituted straight-chain C1-C). 10 Alkyl, substituted or unsubstituted straight-chain C2-C4 alkyl, substituted or unsubstituted branched alkyl, substituted or unsubstituted branched C1-C 10 Alkyl, substituted or unsubstituted branched C2-C4 alkyl, C1 alkyl, C2 alkyl, C3 alkyl, C4 alkyl, C5 alkyl, C6 alkyl, C7 alkyl, C8 alkyl, C9 alkyl, C 10 Alkyl groups and combinations thereof); and

[0255] Z1, 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 straight-chain alkyl, substituted or unsubstituted straight-chain C1-C). 10 Alkyl, substituted or unsubstituted straight-chain C2-C4 alkyl, substituted or unsubstituted branched alkyl, substituted or unsubstituted branched C1-C 10 Alkyl, substituted or unsubstituted branched C2-C4 alkyl, C1 alkyl, C2 alkyl, C3 alkyl, C4 alkyl, C5 alkyl, C6 alkyl, C7 alkyl, C8 alkyl, C9 alkyl, C 10 Alkyl groups and combinations thereof.

[0256] In some systems, R1, R2, and R3 are each selected from organic functional portions exhibiting molecular affinity and / or chemical miscibility with the innermost or innermost layer of the insulating polymer material / sheath. In these systems, the molecular affinity and / or chemical miscibility between the organic functional portion of the organosilane coupling agent and the innermost or innermost polymer layer of the insulating polymer material / sheath results in tight physical or molecular coupling at the interface via strong intermolecular forces and interfacial molecular diffusion and entanglement between the two materials (i.e., the innermost / innermost polymer layer of the insulating polymer material / sheath and the organosilane coupling material).

[0257] In some systems, R1, R2, and R3 are each oligomeric or non-oligomeric moieties containing functional groups selected from substituted or unsubstituted straight-chain or branched alkyl, alkenyl, alkynyl, aryl, phenyl, benzyl, acryloyl, amino, hydroxyl, mercapto, alkoxy, carbonyl, carboxyl, ester, carbonate, amide, isocyanate, urethane, urea, ethylene oxide, and combinations thereof.

[0258] In some systems, the organosilane coupling agent is selected from:

[0259] i) Organosilanes comprising amino or amine functional groups, including but not limited to 3-aminopropyltriethoxysilane, 3-aminopropyltrimethoxysilane, 4-aminobutyltriethoxysilane, 4-amino-3,3-dimethylbutyltrimethoxysilane, N-(2-aminoethyl)-3-aminopropyltrimethoxysilane, N-(2-aminoethyl)-3-aminopropyltriethoxysilane, N-(6-aminohexyl)aminomethyltrimethoxysilane, N-(6-aminohexyl) Aminomethyltriethoxysilane, 3-[2-(2-aminoethylamino)ethylamino]propyltrimethoxysilane, N-(2-aminoethyl)-3-aminopropylsilanetriol, bis(3-trimethoxysilylpropyl)amine, bis(3-triethoxysilylpropyl)amine, N,N'-bis((3-trimethoxysilyl)propyl)ethylenediamine, N,N'-bis((3-triethoxysilyl)propyl)ethylenediamine, N-phenylaminomethyltrimethoxysilane, and combinations thereof;

[0260] ii) Organosilanes including urethane or urea groups, including but not limited to (3-acetaminopropyl)trimethoxysilane, (3-acetaminopropyl)triethoxysilane, N,N'-bis(3-trimethoxysilylpropyl)urea, N,N'-bis(3-triethoxysilylpropyl)urea, tris(3-trimethoxysilylpropyl)isocyanurate, tris(3-triethoxysilylpropyl)isocyanurate, and combinations thereof;

[0261] iii) Organosilanes including ethylene oxide 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)dimethylethoxysilane, and combinations thereof;

[0262] iv) Organosilane coupling agents including acrylic or vinyl groups, including but not limited to (methacryloyloxymethyl)methyldimethoxysilane, (methacryloyloxyethyl)methyldimethoxysilane, (methacryloyloxypropyl)trimethoxysilane, (methacryloyloxymethyl)trimethoxysilane, and combinations thereof;

[0263] and their combinations.

[0264] In some systems, organosilane coupling materials can be manufactured by the condensation and curing of a diluted coating dispersion. The coating dispersion may contain one or more organosilane reagents, said organosilane reagents containing one or more organic functional groups selected from amino, amine, amide, epoxy, ethylene oxide, urethane, urea, and carbonate. The coating dispersion may further contain one or more hydrolyzable groups selected from alkoxy, acyloxy, oxime, hydroxyl, halogen, and combinations thereof. In some systems, organosilane coupling materials are manufactured by the condensation and curing of a diluted coating dispersion containing one or more organosilane reagents, said organosilane reagents containing one or more organic functional groups selected from amino, amine, amide, epoxy, ethylene oxide, urethane, urea, and carbonate, and further containing one or more hydrolyzable groups selected from alkoxy, acyloxy, oxime, hydroxyl, halogen, and combinations thereof.

[0265] In some systems, the organosilane coupling material is a self-assembled monolayer that continuously covers and covalently bonds to the hydroxylated host of the sample. The organosilane coupling material can be bonded via covalent metal-siloxane bonds (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 host of the sample via covalent metal-siloxane bonds (e.g., -Ti-O-Si-). The presence of such an organosilane material, approximately one molecule thick, typically has no significant effect on the electrical impedance of the sample.

[0266] In the alternative systems, the organosilane coupling material is a micron or submicron-sized organometallic polymer layer, which selectively has an insulating polymer material / sheath partially covering the spline body only on it.

[0267] To obtain a suitable organosilane coupling agent material, the organosilane dispersion of a coating containing one or more organosilane coupling agents can be prepared as a diluted dispersion. The diluted dispersion can have a concentration of 0.1% to 10% (volume / volume), preferably 0.5% to 5.0% (volume / volume), in a solvent system.

[0268] In some systems, the solvent system used to prepare organosilane dispersions is composed of one or more volatile carrier solvents. These volatile carrier solvents may be selected from hydrocarbon solvents (e.g., hexane, heptane, toluene, ethylbenzene, etc.), alcohols (e.g., methanol, ethanol, isopropanol, 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.

[0269] Typically, two or more splines can be combined in any suitable conduit, including the multiple DFAs described herein.

[0270] In some systems, a conduit is provided. The conduit may include a shaft, a plurality of splined sections forming an electrode basket structure around the distal portion of the shaft, each spline extending between a proximal end connected to the shaft and a distal end connected to the shaft, and a balloon located within the basket formed by the plurality of splined sections. At least one of the plurality of splined sections is a spline comprising a body having a superelastic conductive metallic material, a single or double layer of insulating polymer material / sheath, and an organosilane coupling material coupling the superelastic conductive metallic material to an inner polymer layer of insulating polymer material / sheath.

[0271] In some systems, the catheter is an electroporation catheter. In some systems, at least one of the multiple splines includes at least one electrically conductive electrode. In some systems, each of the multiple splines includes at least one electrically conductive electrode.

[0272] In some systems, the spline comprises a body made of a superelastic conductive metallic material (e.g., a NiTi alloy) and having a nanoscale metal oxide (e.g., TiO2) surface. The metal oxide thickness can 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 comprises a body made of a superelastic conductive metallic material (e.g., a NiTi alloy) and having a nanoscale hydroxylated metal oxide (e.g., TiO2) surface with a thickness <5 to 100 nm, an insulating polymer material / sheath made of one or more polymer materials, and an organosilane coupling material tightly coupling the spline body to the innermost or innermost polymer layer of the insulating polymer material / sheath.

[0273] In some systems, organosilane coupling materials are chemically coupled to superelastic conductive materials. In other systems, the chemical bond is a metal-siloxane bond.

[0274] In some systems, organosilane coupling materials are chemically coupled to a spline matrix composed of a nanoscale thin oxide surface and a superelastic conductive material. In some systems, the chemical bonds are covalent bonds. In some systems, the chemical bonds are metal-siloxane bonds.

[0275] In some systems, the organosilane coupling material is coupled to the insulating polymer material / sheath via physical bonding and / or physical forces (e.g., intermolecular forces). In some systems, the organosilane coupling material is molecularly interlocked with the insulating polymer material / sheath via interfacial diffusion and molecular entanglement. In some systems, the organosilane coupling material is coupled to the insulating polymer material / sheath via intermolecular forces including van der Waals forces and hydrogen bonds. Example

[0276] Without further elaboration, it is believed that those skilled in the art can make full use of the foregoing description. Therefore, the following embodiments are to be interpreted as illustrative only and are in no way intended to limit the scope of this disclosure. The starting materials of the following embodiments may not necessarily be prepared by the specific preparation operations described in other embodiments. It should also be understood that any numerical ranges described herein include all values ​​from lower to higher values. For example, if the range is stated as 10-50, it is intended that such values ​​as 12-30, 20-40, or 30-50 are explicitly listed in this specification. These are merely examples of what is intended to be illustrative, and all possible combinations of values ​​between and including the listed minimum and maximum values ​​are considered to be explicitly stated in this application.

[0277] Example 1: Formation of organosilanes coupling materials for the sample.

[0278] In a co-solvent system, a diluted coating dispersion for forming an organosilane coupling material that partially or completely and tightly covers the sample body is prepared at a concentration of 0.1 v / v% to 10 v / v%, preferably 0.5 v / v% to 5 v / v%. The coating dispersion may contain one or more organosilane coupling agents. The co-solvent system may include volatile alcohols (such as methanol, ethanol, isopropanol, etc.), volatile ketones (such as acetone, methyl isobutyl ketone, etc.), volatile ethers (such as propylene glycol ether, ethylene glycol monobutyl ether, etc.), and / or volatile esters (such as ethyl acetate, n-butyl acetate, etc.). The diluted dispersion may also contain a hydrolysant of any suitable organosilane reagent, such as water, in a relative volume ratio of water to (various) organosilane coupling agents of about 1:10 to 100:1, preferably 1:5 to 5:1.

[0279] In some systems, any diluted organosilane dispersion taken from the table below can be used to prepare a substrate for coating splines comprising similar but different organosilane coupling materials.

[0280]

[0281] A diluted organosilane dispersion containing one or more organosilane coupling agents is applied to the sample matrix. Prior to application of the diluted coating dispersion, the sample matrix undergoes shaping and physicochemical treatment. The surface of the resulting sample matrix (e.g., a nanoscale oxide surface) may be further hydroxylated.

[0282] The diluted organosilane dispersion can be applied by any suitable coating method. After coating, the carrier solvent of the dispersion subsequently evaporates. Once applied and cured, the organosilane coupling agents (multiple types) in the dispersion chemically transform into a cured organosilane coupling material, which provides metal-siloxane covalent bonds and is chemically tethered to the hyperelastic metallic material of the spline host. The resulting covalently tethered organosilane coupling material to the spline host can be molecularly porous, with a thickness of about 5 nm to about 100 μm, more preferably about 5 nm to 10 μm, more preferably about 5 nm to 1 μm, and more preferably about 5 nm to 100 nm.

[0283] Then, an insulating polymer material / sheath in the form of a tubular preform is applied and coupled to the coated body of the spline via an organosilane coupling material.

[0284] In some systems, a spline body made of a superelastic conductive metallic material, i.e., a nickel-titanium alloy, is shaped and treated to have a very thin metal oxide (e.g., TiO2) surface layer of about 5 to 50 nm, followed by thorough hydrothermal treatment. Any combination of diluted organosilane dispersions and insulating polymer material / sheath preforms taken from the table below is sequentially applied to the thus-treated spline body to form a spline comprising the resulting organosilane coupling material coupled to the body and a reflow insulating polymer material / sheath tightly surrounding the spline.

[0285]

[0286] Those skilled in the art will understand that the above tables are merely example materials. More generally, the insulating polymer material / sheath may be bilayered and include an inner layer comprising a polyamide and an outer layer comprising a polyether block amide. The insulating polymer material / sheath may be bilayered and include an inner layer comprising an uncrosslinked thermoplastic polyurethane elastomer and an outer layer comprising a crosslinked thermoplastic polyurethane elastomer. The insulating polymer material / sheath may be bilayered and include an inner layer comprising an uncrosslinked polyether block amide and an outer layer comprising a crosslinked thermoplastic polyurethane elastomer. The insulating polymer material / sheath may be bilayered and include an inner layer comprising an uncrosslinked thermoplastic polyurethane elastomer and an outer layer comprising a crosslinked polyether block amide.

[0287] This paper discovers that by using an organosilane coupling material disposed between the spline and the insulating polymer material / sheath to couple the superelastic conductive metal material to the innermost or innermost polymer layer of the insulating polymer material / sheath, delamination of the insulating polymer material / sheath from the spline (e.g., insulating or electrode spline) can be reduced or prevented.

[0288] Although certain systems of this disclosure have been described above with a degree of specificity, those skilled in the art can make various modifications to the disclosed systems without departing from the scope of this disclosure as defined by the appended claims. All references to directions (e.g., up, down, upward, downward, left, right, leftward, rightward, top, bottom, above, below, vertical, horizontal, clockwise, and counterclockwise) are for identification purposes only to aid the reader's understanding of this disclosure and do not constitute a limitation, particularly not a limitation on the location, orientation, or purpose of this disclosure. References to connections (e.g., attachment, coupling, connection, etc.) should be interpreted broadly and may include intermediate members between element connections and relative movement between elements. Therefore, a reference to connection does not necessarily imply that two elements are directly connected and have a fixed relationship with each other. All content contained in the foregoing specification or shown in the drawings is intended to be interpreted as illustrative only and not restrictive. Changes to details or structures may be made without departing from the spirit of this disclosure as defined by the appended claims.

[0289] In describing elements of this disclosure or its preferred systems(s), the articles “a,” “an,” “the,” and “said” are intended to indicate the presence of one or more elements. The terms “comprising,” “including,” and “having” are intended to be inclusive and mean that other elements may be present in addition to those listed.

[0290] Because various changes can be made to the above construction without departing from the scope of this disclosure, all content contained in the foregoing specification or shown in the drawings is intended to be illustrative and not restrictive. Therefore, the invention is defined in the appended claims.

[0291] The following are the numbered clauses of this invention:

[0292] 1. A catheter strip comprising:

[0293] The main body contains a superelastic conductive metallic material;

[0294] Insulating polymer sheath; and

[0295] Organosilanes are used to couple superelastic conductive metal materials to an insulating polymer sheath.

[0296] 2. The catheter template according to Clause 1, wherein the superelastic conductive metallic material is selected from nickel-titanium 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.

[0297] 3. The conduit sample according to Clause 1 or 2, wherein the insulating polymer sheath comprises one or more thermoplastic polymer materials selected from thermoplastic polymers, polyester homopolymers and copolymers, nylon homopolymers and copolymers, polyolefins, polycarbonates, polysulfones and combinations thereof, and / or selected from 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, poly(carbonate urethane) copolymers, poly(siloxane-carbonate urethane) copolymers and poly(siloxane-ether urethane) copolymers and combinations thereof), styrene thermoplastic elastomers or styrene block copolymers, thermoplastic olefins and combinations thereof.

[0298] 4. The conduit sample according to any of the preceding clauses, wherein the insulating polymer sheath is double-layered and comprises two chemically compatible polymer materials, and wherein the outer layer of the insulating polymer sheath is made of a thermoplastic polymer material comprising (a variety of) additional crosslinking agents selected from triallyl isocyanurate, triallyl cyanurate, triallyl phosphate, pentaerythritol triallyl ether, trivinyltrimethylcyclosiloxane, trimethylolpropane trivinyl ether, trimethylolpropane triacrylate, pentaerythritol triacrylate, and combinations thereof.

[0299] 5. The conduit sample according to any one of clauses 1 to 3, wherein the insulating polymer sheath is double-layered, comprising two chemically compatible polymer materials, and wherein the inner layer of the insulating polymer sheath is remeltable and / or the outer layer of the insulating polymer sheath is heat-shrinkable upon heating.

[0300] 6. The conduit template according to any of the preceding clauses, wherein the organosilane coupling material is chemically coupled to the superelastic conductive metal material.

[0301] 7. The conduit strip according to any one of Clauses 1 to 6, wherein the organosilane coupling material is physically bonded and / or physically force-coupled to the insulating polymer sheath or material.

[0302] 8. The conduit sample according to any one of Clauses 1 to 6, wherein the organosilane coupling material is manufactured by condensation curing of a diluted coating dispersion, the coating dispersion comprising one or more organosilane reagents, the organosilane reagents comprising one or more organic functional groups selected from amino, amine, amide, epoxy, ethylene oxide, urethane, urea, carbonate, and further comprising one or more hydrolyzable groups selected from alkoxy, acyloxy, oxime, hydroxyl, halogen, and combinations thereof.

[0303] 9. The conduit sample according to Clause 8, wherein the diluted coating organosilane dispersion comprises one or more reactive organosilane coupling agents selected from:

[0304] a) Compounds of Formula I

[0305] (Formula I);

[0306] b) Compounds of Formula II

[0307] (Formula II);

[0308] c) Compounds of Formula III

[0309] (Formula III); and

[0310] d) Their combination;

[0311] in:

[0312] R1, R2 and R3 are each selected from organic functional parts, oligomeric organic functional parts, polymeric organic functional parts and combinations thereof;

[0313] L1, L2, and L3 are each selected from direct bonds, substituted or unsubstituted straight-chain alkyl groups, and substituted or unsubstituted straight-chain C1-C bonds. 10 Alkyl, substituted or unsubstituted straight-chain C2-C4 alkyl, substituted or unsubstituted branched alkyl, substituted or unsubstituted branched C1-C 10 Alkyl, substituted or unsubstituted branched C2-C4 alkyl, C1 alkyl, C2 alkyl, C3 alkyl, C4 alkyl, C5 alkyl, C6 alkyl, C7 alkyl, C8 alkyl, C9 alkyl, C 10 Alkyl groups and combinations thereof;

[0314] X1, X2, and X3 are each selected from hydrolyzable groups, alkoxy groups, acyloxy groups, amines, oximes, hydroxyl groups, halogens, non-hydrolyzable groups, substituted or unsubstituted straight-chain alkyl groups, and substituted or unsubstituted straight-chain C1-C2 groups. 10 Alkyl, substituted or unsubstituted straight-chain C2-C4 alkyl, substituted or unsubstituted branched alkyl, substituted or unsubstituted branched C1-C 10 Alkyl, substituted or unsubstituted branched C2-C4 alkyl, C1 alkyl, C2 alkyl, C3 alkyl, C4 alkyl, C5 alkyl, C6 alkyl, C7 alkyl, C8 alkyl, C9 alkyl, C 10 Alkyl groups and combinations thereof, wherein at least one of X1, X2 and X3 is a hydrolyzable group;

[0315] Y1, Y2, and Y3 are each selected from hydrolyzable groups, alkoxy groups, acyloxy groups, amines, oximes, hydroxyl groups, halogens, non-hydrolyzable groups, substituted or unsubstituted straight-chain alkyl groups, and substituted or unsubstituted straight-chain C1-C2 groups. 10 Alkyl, substituted or unsubstituted straight-chain C2-C4 alkyl, substituted or unsubstituted branched alkyl, substituted or unsubstituted branched C1-C 10 Alkyl, substituted or unsubstituted branched C2-C4 alkyl, C1 alkyl, C2 alkyl, C3 alkyl, C4 alkyl, C5 alkyl, C6 alkyl, C7 alkyl, C8 alkyl, C9 alkyl, C 10 Alkyl groups and combinations thereof, wherein at least one of Y1, Y2 and Y3 is a hydrolyzable group;

[0316] Z1, Z2, and Z3 are each selected from hydrolyzable groups, alkoxy groups, acyloxy groups, amines, oximes, hydroxyl groups, halogens, non-hydrolyzable groups, substituted or unsubstituted straight-chain alkyl groups, and substituted or unsubstituted straight-chain C1-C2 groups. 10 Alkyl, substituted or unsubstituted straight-chain C2-C4 alkyl, substituted or unsubstituted branched alkyl, substituted or unsubstituted branched C1-C 10 Alkyl, substituted or unsubstituted branched C2-C4 alkyl, C1 alkyl, C2 alkyl, C3 alkyl, C4 alkyl, C5 alkyl, C6 alkyl, C7 alkyl, C8 alkyl, C9 alkyl, C 10 Alkyl groups and combinations thereof, wherein at least one of Z1, Z2 and Z3 is a hydrolyzable group.

[0317] 10. The conduit strip according to Clause 9, wherein R1, R2 and R3 are each selected from organic functional portions exhibiting molecular affinity and / or chemical miscibility with the innermost or innermost layer of the insulating polymer sheath.

[0318] 11. The catheter sample according to Clause 9 or 10, wherein R1, R2 and R3 are each oligomeric or non-oligomeric portions containing an organic functional group selected from substituted or unsubstituted straight-chain or branched alkyl, alkenyl, alkynyl, aryl, phenyl, benzyl, acryloyl, amino, hydroxyl, mercapto, alkoxy, carbonyl, carboxyl, ester, carbonate, amide, isocyanate, urethane, urea, ethylene oxide and combinations thereof.

[0319] 12. The conduit sample according to any one of clauses 8 to 11, wherein the diluted coating dispersion comprises one or more organosilane coupling agents selected from:

[0320] a) 3-Aminopropyltriethoxysilane, 3-aminopropyltrimethoxysilane, 4-aminobutyltriethoxysilane, 4-amino-3,3-dimethylbutyltrimethoxysilane, N-(2-aminoethyl)-3-aminopropyltrimethoxysilane, N-(2-aminoethyl)-3-aminopropyltriethoxysilane, N-(6-aminohexyl)aminomethyltrimethoxysilane, N-(6-aminohexyl)aminomethyltriethoxysilane, 3- [2-(2-aminoethylamino)ethylamino]propyltrimethoxysilane, N-(2-aminoethyl)-3-aminopropylsilanetriol, bis(3-trimethoxysilylpropyl)amine, bis(3-triethoxysilylpropyl)amine, N,N'-bis((3-trimethoxysilyl)propyl)ethylenediamine, N,N'-bis((3-triethoxysilyl)propyl)ethylenediamine, N-phenylaminomethyltrimethoxysilane and combinations thereof;

[0321] b) (3-acetaminopropyl)trimethoxysilane, (3-acetaminopropyl)triethoxysilane, N,N'-bis(3-trimethoxysilylpropyl)urea, N,N'-bis(3-triethoxysilylpropyl)urea, tris(3-trimethoxysilylpropyl)isocyanurate, tris(3-triethoxysilylpropyl)isocyanurate, and combinations thereof;

[0322] 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;

[0323] d) (3-glycidylpropyl)trimethoxysilane, (3-glycidylpropyl)triethoxysilane, 5,6-epoxyhexyltriethoxysilane, (3-glycidylpropyl)methyldimethoxysilane, (3-glycidylpropyl)methyldiethoxysilane, (3-glycidylpropyl)dimethylmethoxysilane and (3-glycidylpropyl)dimethylethoxysilane and combinations thereof;

[0324] e) (methacryloyloxymethyl)methyldimethoxysilane, (methacryloyloxyethyl)methyldimethoxysilane, (methacryloyloxypropyl)trimethoxysilane, (methacryloyloxymethyl)trimethoxysilane, and combinations thereof; and

[0325] f) Its combination.

[0326] 13. A catheter comprising:

[0327] axis;

[0328] Multiple splines form a basket around the distal portion of the axis, each spline extending between the proximal end connected to the axis and the distal end connected to the axis; and

[0329] A balloon located within a basket formed by multiple splines;

[0330] At least one of the plurality of splines is a catheter spline, the catheter spline comprising:

[0331] The main body contains a superelastic conductive metallic material;

[0332] Insulating polymer sheath; and

[0333] A superelastic conductive metallic material is coupled to an organosilane coupling material in the innermost or innermost layer of an insulating polymer sheath.

[0334] 14. The catheter according to Clause 13, wherein the superelastic conductive metallic material is selected from nitinol or nitinol 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.

[0335] 15. The conduit according to Clause 13 or 14, wherein the insulating polymer sheath comprises one or more thermoplastic polymer materials selected from thermoplastic polymers, polyester homopolymers and copolymers, nylon homopolymers and copolymers, polyolefins, polycarbonates, polysulfones and combinations thereof, and / or selected from 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, poly(carbonate urethane) copolymers, poly(siloxane-carbonate urethane) copolymers and poly(siloxane-ether urethane) copolymers and combinations thereof), styrene thermoplastic elastomers or styrene block copolymers, thermoplastic olefins and combinations thereof.

[0336] 16. The conduit according to clauses 13 to 15, wherein the insulating polymer sheath is double-layered and comprises two chemically compatible polymer materials, and wherein the outer layer of the insulating polymer sheath is made of a thermoplastic polymer material comprising (a variety of) additional crosslinking agents selected from triallyl isocyanurate, triallyl cyanurate, triallyl phosphate, pentaerythritol triallyl ether, trivinyltrimethylcyclosiloxane, trimethylolpropane trivinyl ether, trimethylolpropane triacrylate, pentaerythritol triacrylate, and combinations thereof.

[0337] 17. The conduit according to Clauses 13 to 15, wherein the insulating polymer sheath is double-layered and comprises two chemically compatible polymer materials, and wherein the inner layer of the insulating polymer sheath is remeltable and / or the outer layer of the insulating polymer sheath is heat-shrinkable upon heating.

[0338] 18. The conduit according to any one of Clauses 13 to 17, wherein the organosilane coupling material is chemically coupled to a superelastic conductive metal material.

[0339] 19. The conduit according to any one of Clauses 13 to 17, wherein the organosilane coupling material is physically bonded and / or physically force-coupled to the insulating polymer sheath or material.

[0340] 20. The conduit according to any one of Clauses 13 to 18, wherein the organosilane coupling material is manufactured by condensation curing of a diluted coating dispersion comprising one or more organosilane reagents, the organosilane reagents comprising one or more organic functional groups selected from amino, amine, amide, epoxy, ethylene oxide, urethane, urea, carbonate, and further comprising one or more hydrolyzable groups selected from alkoxy, acyloxy, oxime, hydroxyl, halogen, and combinations thereof.

Claims

1. A catheter spline, comprising: The main body contains a superelastic conductive metallic material; Insulating polymer sheath; and The organosilane coupling material is used to couple the superelastic conductive metal material to the insulating polymer sheath.

2. The catheter template according to claim 1, wherein the superelastic conductive metal material is selected from nitinol or nickel-titanium alloy, copper-aluminum-nickel alloy, zinc-copper-gold-iron alloy, iron-manganese-silicon alloy, copper-zinc-aluminum alloy, copper-aluminum-nickel alloy, and combinations thereof.

3. The conduit sample according to claim 1, wherein the insulating polymer sheath comprises one or more thermoplastic polymer materials selected from thermoplastic polymers, polyester homopolymers and copolymers, nylon homopolymers and copolymers, polyolefins, polycarbonates, polysulfones and combinations thereof, and / or selected from 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, poly(carbonate urethane) copolymers, poly(siloxane-carbonate urethane) copolymers and poly(siloxane-ether urethane) copolymers and combinations thereof), styrene thermoplastic elastomers or styrene block copolymers, thermoplastic olefins and combinations thereof.

4. The conduit strip according to claim 1, wherein the insulating polymer sheath is double-layered and comprises two chemically compatible polymer materials, and wherein the outer layer of the insulating polymer sheath is made of a thermoplastic polymer material comprising (multiple) additional crosslinking agents selected from triallyl isocyanurate, triallyl cyanurate, triallyl phosphate, pentaerythritol triallyl ether, trivinyltrimethylcyclosiloxane, trimethylolpropane trivinyl ether, trimethylolpropane triacrylate, pentaerythritol triacrylate, and combinations thereof.

5. The conduit strip according to claim 1, wherein the insulating polymer sheath is double-layered and comprises two chemically compatible polymer materials, and wherein the inner layer of the insulating polymer sheath is remeltable and / or the outer layer of the insulating polymer sheath is heat-shrinkable upon heating.

6. The conduit template according to claim 1, wherein the organosilane coupling material is chemically coupled to the superelastic conductive metal material.

7. The conduit strip according to claim 1, wherein the organosilane coupling material is physically bonded and / or physically force-coupled to the insulating polymer sheath or material.

8. The conduit sample according to claim 1, wherein the organosilane coupling material is manufactured by condensation curing of a diluted coating dispersion, the coating dispersion comprising one or more organosilane reagents, the organosilane reagents comprising one or more organic functional groups selected from amino, amine, amide, epoxy, ethylene oxide, urethane, urea, carbonate, and further comprising one or more hydrolyzable groups selected from alkoxy, acyloxy, oxime, hydroxyl, halogen, and combinations thereof.

9. The conduit sample according to claim 8, wherein the diluted coating organosilane dispersion comprises one or more reactive organosilane coupling agents selected from: a) Compounds of Formula I (Equation I); b) Compounds of Formula II (Formula II); c) Compounds of Formula III (Formula III); and d) Their combination; in: R1, R2 and R3 are each selected from organic functional parts, oligomeric organic functional parts, polymeric organic functional parts and combinations thereof; L1, L2, and L3 are each selected from direct bonds, substituted or unsubstituted straight-chain alkyl groups, and substituted or unsubstituted straight-chain C1-C bonds. 10 Alkyl, substituted or unsubstituted straight-chain C2-C4 alkyl, substituted or unsubstituted branched alkyl, substituted or unsubstituted branched C1-C 10 Alkyl, substituted or unsubstituted branched C2-C4 alkyl, C1 alkyl, C2 alkyl, C3 alkyl, C4 alkyl, C5 alkyl, C6 alkyl, C7 alkyl, C8 alkyl, C9 alkyl, C 10 Alkyl groups and combinations thereof; X1, X2, and X3 are each selected from hydrolyzable groups, alkoxy groups, acyloxy groups, amines, oximes, hydroxyl groups, halogens, non-hydrolyzable groups, substituted or unsubstituted straight-chain alkyl groups, and substituted or unsubstituted straight-chain C1-C2 groups. 10 Alkyl, substituted or unsubstituted straight-chain C2-C4 alkyl, substituted or unsubstituted branched alkyl, substituted or unsubstituted branched C1-C 10 Alkyl, substituted or unsubstituted branched C2-C4 alkyl, C1 alkyl, C2 alkyl, C3 alkyl, C4 alkyl, C5 alkyl, C6 alkyl, C7 alkyl, C8 alkyl, C9 alkyl, C 10 Alkyl groups and combinations thereof, wherein at least one of X1, X2 and X3 is a hydrolyzable group; Y1, Y2, and Y3 are each selected from hydrolyzable groups, alkoxy groups, acyloxy groups, amines, oximes, hydroxyl groups, halogens, non-hydrolyzable groups, substituted or unsubstituted straight-chain alkyl groups, and substituted or unsubstituted straight-chain C1-C2 groups. 10 Alkyl, substituted or unsubstituted straight-chain C2-C4 alkyl, substituted or unsubstituted branched alkyl, substituted or unsubstituted branched C1-C 10 Alkyl, substituted or unsubstituted branched C2-C4 alkyl, C1 alkyl, C2 alkyl, C3 alkyl, C4 alkyl, C5 alkyl, C6 alkyl, C7 alkyl, C8 alkyl, C9 alkyl, C 10 Alkyl groups and combinations thereof, wherein at least one of Y1, Y2 and Y3 is a hydrolyzable group; Z1, Z2, and Z3 are each selected from hydrolyzable groups, alkoxy groups, acyloxy groups, amines, oximes, hydroxyl groups, halogens, non-hydrolyzable groups, substituted or unsubstituted straight-chain alkyl groups, and substituted or unsubstituted straight-chain C1-C2 groups. 10 Alkyl, substituted or unsubstituted straight-chain C2-C4 alkyl, substituted or unsubstituted branched alkyl, substituted or unsubstituted branched C1-C 10 Alkyl, substituted or unsubstituted branched C2-C4 alkyl, C1 alkyl, C2 alkyl, C3 alkyl, C4 alkyl, C5 alkyl, C6 alkyl, C7 alkyl, C8 alkyl, C9 alkyl, C 10 Alkyl groups and combinations thereof, wherein at least one of Z1, Z2 and Z3 is a hydrolyzable group.

10. The catheter strip according to claim 9, wherein R1, R2 and R3 are each selected from organic functional portions exhibiting molecular affinity and / or chemical miscibility with the innermost or innermost layer of the insulating polymer sheath.

11. The catheter strip according to claim 9, wherein R1, R2 and R3 are each oligomeric or non-oligomeric portions containing organic functional groups, said organic functional groups being selected from substituted or unsubstituted straight-chain or branched alkyl, alkenyl, alkynyl, aryl, phenyl, benzyl, acryloyl, amino, hydroxyl, mercapto, alkoxy, carbonyl, carboxyl, ester, carbonate, amide, isocyanate, urethane, urea, ethylene oxide and combinations thereof.

12. The conduit sample according to claim 8, wherein the diluted coating dispersion comprises one or more organosilane coupling agents, the organosilane coupling agent being selected from: a) 3-Aminopropyltriethoxysilane, 3-aminopropyltrimethoxysilane, 4-aminobutyltriethoxysilane, 4-amino-3,3-dimethylbutyltrimethoxysilane, N-(2-aminoethyl)-3-aminopropyltrimethoxysilane, N-(2-aminoethyl)-3-aminopropyltriethoxysilane, N-(6-aminohexyl)aminomethyltrimethoxysilane, N-(6-aminohexyl)aminomethyltriethoxysilane, 3- [2-(2-aminoethylamino)ethylamino]propyltrimethoxysilane, N-(2-aminoethyl)-3-aminopropylsilanetriol, bis(3-trimethoxysilylpropyl)amine, bis(3-triethoxysilylpropyl)amine, N,N'-bis((3-trimethoxysilyl)propyl)ethylenediamine, N,N'-bis((3-triethoxysilyl)propyl)ethylenediamine, N-phenylaminomethyltrimethoxysilane and combinations thereof; b) (3-acetaminopropyl)trimethoxysilane, (3-acetaminopropyl)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-epoxyhexyltriethoxysilane, (3-glycidoxypropyl)methyldimethoxysilane, (3-glycidoxypropyl)methyldiethoxysilane, (3-glycidoxypropyl)dimethylmethoxysilane and (3-glycidoxypropyl)dimethylethoxysilane and combinations thereof; d) (3-glycidylpropyl)trimethoxysilane, (3-glycidylpropyl)triethoxysilane, 5,6-epoxyhexyltriethoxysilane, (3-glycidylpropyl)methyldimethoxysilane, (3-glycidylpropyl)methyldiethoxysilane, (3-glycidylpropyl)dimethylmethoxysilane and (3-glycidylpropyl)dimethylethoxysilane and combinations thereof; e) (methacryloyloxymethyl)methyldimethoxysilane, (methacryloyloxyethyl)methyldimethoxysilane, (methacryloyloxypropyl)trimethoxysilane, (methacryloyloxymethyl)trimethoxysilane, and combinations thereof; and f) Its combination.

13. A catheter comprising: axis; Multiple splines form a basket around the distal portion of the axis, each spline extending between the proximal end connected to the axis and the distal end connected to the axis; as well as A bladder located within a basket formed by the plurality of splines; At least one of the plurality of splines is a catheter spline, the catheter spline comprising: The main body contains a superelastic conductive metallic material; Insulating polymer sheath; and The superelastic conductive metal material is coupled to the organosilane coupling material of the innermost layer or the innermost layer of the insulating polymer sheath.

14. The catheter according to claim 13, wherein the superelastic conductive metal material is selected from 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 conduit of claim 13, wherein the insulating polymer sheath comprises one or more thermoplastic polymer materials selected from thermoplastic polymers, polyester homopolymers and copolymers, nylon homopolymers and copolymers, polyolefins, polycarbonates, polysulfones and combinations thereof, and / or selected from 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, poly(carbonate urethane) copolymers, poly(siloxane-carbonate urethane) copolymers and poly(siloxane-ether urethane) copolymers and combinations thereof), styrene thermoplastic elastomers or styrene block copolymers, thermoplastic olefins and combinations thereof.

16. The catheter of claim 13, wherein the insulating polymer sheath is double-layered and comprises two chemically compatible polymer materials, and wherein the outer layer of the insulating polymer sheath is made of a thermoplastic polymer material comprising (multiple) additional crosslinking agents selected from triallyl isocyanurate, triallyl cyanurate, triallyl phosphate, pentaerythritol triallyl ether, trivinyltrimethylcyclosiloxane, trimethylolpropane trivinyl ether, trimethylolpropane triacrylate, pentaerythritol triacrylate, and combinations thereof.

17. The conduit of claim 13, wherein the insulating polymer sheath is double-layered and comprises two chemically compatible polymer materials, and wherein the inner layer of the insulating polymer sheath is remeltable and / or the outer layer of the insulating polymer sheath is heat-shrinkable upon heating.

18. The conduit according to claim 13, wherein the organosilane coupling material is chemically coupled to the superelastic conductive metal material.

19. The conduit of claim 13, wherein the organosilane coupling material is physically bonded and / or physically force-coupled to the insulating polymer sheath.

20. The conduit of claim 13, wherein the organosilane coupling material is manufactured by condensation curing of a diluted coating dispersion, the coating dispersion comprising one or more organosilane reagents, the organosilane reagents comprising one or more organic functional groups selected from amino, amine, amide, epoxy, ethylene oxide, urethane, urea, carbonate, and further comprising one or more hydrolyzable groups selected from alkoxy, acyloxy, oxime, hydroxyl, halogen, and combinations thereof.

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