High density flat balloon catheter

Abstract

The present invention relates generally to expandable catheters for use in electrophysiology, and more particularly to high density balloon catheters for use in the diagnosis and / or treatment of arrhythmia. The catheter includes an elongate catheter shaft including a proximal end and a distal end. The elongate catheter shaft defines a longitudinal axis. The catheter includes an expandable assembly having a first delivery configuration and a second deployed configuration. The balloon member includes at least one flexible frame disposed between an outer surface layer and an inner surface layer of a top surface and / or a bottom surface of the balloon member, and at least one plurality of electrodes patterned on the flexible frame. In some embodiments, the flat balloon member includes electrodes on both sides of the planar balloon member. The balloon member may include a flexible structural element disposed within the lumen.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 448,625, filed on February 27, 2023, and U.S. Provisional Patent Application No. 63 / 603,451, filed on November 28, 2023; the entire disclosures of these applications are incorporated herein by reference for all purposes. Background Art

[0003] An electrophysiology (EP) catheter can be configured for use in the diagnosis and / or treatment of cardiac arrhythmias. Arrhythmias can manifest as one or more observable medical conditions, including, for example, irregular heartbeats, loss of synchronization of atrioventricular contractions, and inadequate blood flow to the cardiac chambers, which can lead to a variety of symptomatic and / or asymptomatic illnesses, or even death. The electrical activity of a patient's heart can be measured and evaluated to determine whether the patient's heart exhibits a pathological electrical condition that is associated with the occurrence of arrhythmias. After diagnosing a pathological electrical condition, appropriate treatment methods can be used to selectively alter the patient's heart tissue to reduce or eliminate the pathological electrical condition, thereby reducing or eliminating the occurrence of arrhythmias. Treatment can include, for example, radiofrequency (RF) ablation, pulsed field ablation (PFA), cryoablation, laser ablation, chemical ablation, high-intensity focused ultrasound ablation, microwave ablation, and / or other ablative therapies. Summary of the Invention

[0004] The present invention generally relates to expandable catheters used in electrophysiology, and more specifically to high-density balloon catheters for use in diagnosing and / or treating cardiac arrhythmias. According to embodiments described herein, a substantially flat balloon member (e.g., having a double-sided balloon structure) includes an internal flexible circuit and electrodes exposed through one or both sides of the balloon member. The present design allows for the use of electrodes with a smaller surface area, tighter electrode spacing, and a variety of shape configurations (e.g., flat, rugby-ball, convex, concave, etc.) and electrode arrangements (e.g., offset horizontal and / or vertical rows), thereby providing improved diagnostic measurements while reducing manufacturing costs. For example, electrodes can be patterned in offset rows to achieve more evenly spaced electrode groupings. Associated algorithms do not need to compensate for time delays, resulting in more accurate mapping and sensing capabilities. Designs incorporating a double-sided balloon member can better determine tissue or blood contact at the electrode interface, thereby reducing or eliminating far-field effects. In some aspects of the present invention, the balloon member includes flexible structural elements to further support the rigidity and stiffness of the balloon structure and prevent kinking.

[0005] In various embodiments, a catheter comprises an elongated catheter shaft comprising a proximal end and a distal end. The elongated catheter shaft defines a longitudinal axis. The catheter comprises an expandable assembly having a first delivery configuration and a second deployment configuration. The expandable assembly comprises a balloon member having a top surface, a bottom surface, and an inner lumen. Each of the top surface and the bottom surface comprises an outer surface layer and an inner surface layer. The expandable assembly comprises a top flexible frame disposed between the outer surface layer and the inner surface layer of the top surface of the balloon member, and a bottom flexible frame disposed between the outer surface layer and the inner surface layer of the bottom surface of the balloon member. In some embodiments, a first plurality of electrodes is patterned on the top flexible frame and a second plurality of electrodes is patterned on the bottom flexible frame. The first plurality of electrodes are aligned with the second plurality of electrodes. A plurality of conductive traces are disposed on each flexible frame. Each of the plurality of conductive traces is electrically coupled to a corresponding one of the first plurality of electrodes and the second plurality of electrodes. The expandable assembly comprises a flexible structural element disposed within the inner lumen. According to various embodiments of the present disclosure, the conductive material may comprise electrodes and conductors. In addition, various conductive materials may include metals such as copper, gold, silver, platinum, iridium (IV) oxide (IrOx), titanium nickel (TiNi), etc., and alloys thereof. Conductive materials may also include polymers such as poly(3,4-ethylenedioxythiophene) (PEDOT), modified PEDOT, etc.

[0006] In at least some embodiments, the flexible structural element comprises a nickel-titanium alloy wire loop element extending along the longitudinal axis of the elongated catheter shaft to provide rigidity to the balloon member and prevent the balloon member from kinking when contacting tissue. The nickel-titanium alloy wire loop element is disposed between the top flexible frame and the bottom flexible frame.

[0007] According to some aspects, the balloon member includes a plurality of holes located on the outer surface layer of the top surface and the outer surface layer of the bottom surface of the balloon member. The plurality of holes expose the corresponding first and second plurality of electrodes. The diameters of the plurality of holes are the same as or smaller than the diameters of the corresponding first and second plurality of electrodes. The diameters of the plurality of holes are in the range of 0.25 mm to 3 mm, and the diameters of the corresponding first and second plurality of electrodes are in the range of 0.25 mm to 3 mm. The first and second plurality of electrodes are flush (e.g., point electrodes), recessed, or raised relative to the outer surface layer of the top and bottom surfaces of the balloon member. For example, the electrodes can be raised above the outer surface layer of the top surface of the balloon member to increase tissue contact between the electrodes and the tissue of interest (e.g., cardiac tissue).

[0008] In aspects, the elongated catheter shaft includes an inflation lumen. In some embodiments, the inflation lumen can be elliptical. The balloon member is un-inflated in a first delivery configuration and inflated in a second deployed configuration by a liquid or gas delivered through the elliptical inflation lumen. The expandable assembly has an intermediate configuration between the first configuration and the second configuration, where in the intermediate configuration the balloon member is unconstrained by the guide sheath and un-inflated. In aspects, the balloon member has a flattened, concave, or convex shape in the second deployed configuration. For example, the balloon member is substantially flattened in the deployed configuration. In other aspects, the balloon member has a central portion that extends outward to form a "football" shape (e.g., convex shape).

[0009] In at least some aspects, each of the first plurality of electrodes and the second plurality of electrodes are arranged in horizontal rows relative to a longitudinal axis of the elongated catheter shaft. The horizontal rows are offset such that each electrode in each row is offset from a corresponding electrode in an adjacent row. For example, each electrode in each row is equidistant from adjacent electrodes in the same row and adjacent rows. A center-to-center distance between each electrode of the first plurality of electrodes and the second plurality of electrodes is 2.5 millimeters. In aspects, the center-to-center distance between each electrode of the first plurality of electrodes and the second plurality of electrodes is in a range of 1 millimeter to 4 millimeters. In other aspects, each of the first plurality of electrodes and the second plurality of electrodes are arranged in vertical rows parallel to the longitudinal axis of the elongated catheter shaft, and the vertical rows are offset such that each electrode in each row is offset from a corresponding electrode in an adjacent row. In aspects, the horizontal and / or vertical offset is 60°. In various aspects, the horizontal and / or vertical offset is in a range of 22.5° to 60°.

[0010] In aspects, each of the first plurality of electrodes and the second plurality of electrodes are configured for independent sensing for diagnostic mapping or for energy delivery to treat cardiac arrhythmias. For example, the first plurality of electrodes can be configured to sense tissue of interest (e.g., cardiac tissue), while the second plurality of electrodes can be configured to sense other tissue or fluid (e.g., blood). In various embodiments, the first plurality of electrodes and / or the second plurality of electrodes can be independently activated and / or deactivated during use. Individual electrodes of the first plurality of electrodes and / or the second plurality of electrodes can be independently activated and / or deactivated during use.

[0011] According to aspects, each electrode of the first plurality of electrodes and the second plurality of electrodes are grouped into clusters of three or more electrodes that define a two-dimensional shape. For example, the electrode clusters are configured as equilateral triangles, where each cluster includes at least three electrodes. The electrode clusters are configured to sample electrical properties of a contacted tissue in at least two substantially transverse directions.

[0012] In some aspects, the catheter includes at least one magnetic position sensor disposed along a distal portion of the catheter shaft. The catheter may also include one or more magnetic position sensors disposed on the top flexible frame and / or the bottom flexible frame on the distal portion of the expandable assembly.

[0013] In one embodiment, the catheter includes an elongated catheter shaft comprising a proximal end and a distal end. The catheter shaft defines a longitudinal axis. The catheter includes an expandable assembly having a first delivery configuration and a second deployment configuration. The expandable assembly includes a balloon member having a substantially flat and / or planar shape in the second deployment configuration, and includes a top surface and a bottom surface. The balloon member includes a first plurality of electrodes extending within the top surface of the balloon member and exposed through the top surface and / or top surface of the balloon member, and a second plurality of electrodes extending within the bottom surface of the balloon member and exposed through the bottom surface of the balloon member. Each of the first plurality of electrodes and the second plurality of electrodes are arranged in a horizontal row relative to the longitudinal axis of the elongated catheter shaft. The horizontal rows are offset so that each electrode in each row is offset from a corresponding electrode in an adjacent row.

[0014] According to some embodiments, each electrode in each row is equidistant from adjacent electrodes in the same row and adjacent rows. In one exemplary embodiment, each electrode in the first plurality of electrodes has a diameter of 0.25 mm, resulting in an edge-to-edge spacing of 0.25 mm and a center-to-center spacing of 0.5 mm. In another embodiment, the center-to-center distance between each electrode in the first and second pluralities of electrodes is 1.0 mm. In yet another embodiment, the center-to-center distance between each electrode in the first and second pluralities of electrodes may be 1.5 mm. According to other embodiments, the center-to-center distance between each electrode in the first and second pluralities of electrodes may be 2.0 mm. In yet another embodiment, the center-to-center distance between each electrode in the first and second pluralities of electrodes may be 2.5 mm. In other embodiments, the center-to-center distance between each electrode in the first and second pluralities of electrodes may be 3.0 mm. In some aspects, the center-to-center distance between each electrode in the first and second pluralities of electrodes ranges from 0.5 mm to 3 mm. In other aspects, each electrode in the first and second pluralities of electrodes is further arranged in vertical rows parallel to the longitudinal axis of the elongated catheter shaft, and the vertical rows are offset such that each electrode in each row is offset from a corresponding electrode in an adjacent row. In some aspects, the horizontal and / or vertical offset is 60°. In various aspects, the horizontal and / or vertical offset is in the range of 22.5° to 60°.

[0015] In at least some embodiments, the expandable assembly includes a flexible structural element disposed within the lumen of the balloon member. The flexible structural element includes a nickel-titanium wire loop extending along the longitudinal axis of the elongated catheter shaft to provide rigidity to the balloon member and prevent kinking of the balloon member when contacting tissue. The nickel-titanium wire loop is disposed between the top flexible frame and the bottom flexible frame to further support the integrity of the catheter. It should be understood that the expanded balloon member can provide sufficient rigidity and / or stiffness when contacting tissue.

[0016] In some aspects, the expandable assembly includes a balloon member having a top surface, a bottom surface, and an inner cavity. Each of the top surface and the bottom surface includes an outer surface layer and an inner surface layer. The expandable assembly includes a top flexible frame disposed between the outer surface layer and the inner surface layer of the top surface of the balloon member, and a bottom flexible frame disposed between the outer surface layer and the inner surface layer of the bottom surface of the balloon member. In some embodiments, a first plurality of electrodes is patterned on the top flexible frame and a second plurality of electrodes is patterned on the bottom flexible frame. The first plurality of electrodes are aligned with the second plurality of electrodes. A plurality of conductive traces are disposed on each flexible frame. Each of the plurality of conductive traces is electrically coupled to a corresponding one of the first plurality of electrodes and the second plurality of electrodes.

[0017] In some aspects, the balloon member itself includes conductive traces disposed on an outer surface layer of the top surface and / or an outer surface layer of the bottom surface, without requiring any separate flexible frame (e.g., a polyimide flex circuit). The balloon member can include a variety of materials, including thermoplastic polyurethane (TPU), thermoplastic elastomer (TPE), polyamides including nylon or nylon elastomer (Pebax), ethylene vinyl acetate (EVA), polyvinylidene fluoride (PVDF), polyvinyl chloride (PVC), silicon, silicone, and / or composites thereof. During manufacturing, electrodes and corresponding conductive traces are constructed (e.g., disposed) on the outer surface layer of the top surface and / or the outer surface layer of the bottom surface of the balloon member, as described in further detail below.

[0018] In other embodiments, a catheter includes a flexible silicon pad structure having a substantially flat and / or planar shape. The catheter includes an elongated catheter shaft having a proximal end and a distal end. The catheter shaft defines a longitudinal axis. The catheter includes an expandable assembly having a first delivery configuration and a second deployed configuration. The expandable assembly includes a top surface, a bottom surface, and a flexible frame disposed between the top and bottom surfaces. A plurality of electrodes are patterned on the flexible frame. The plurality of electrodes are arranged in horizontal rows relative to the longitudinal axis of the elongated catheter shaft, and the horizontal rows are offset such that each electrode in each row is offset from a corresponding electrode in an adjacent row. A plurality of conductive traces are disposed on the flexible frame and coupled to the plurality of electrodes, and a flexible structural element is disposed within the expandable assembly. In some aspects, the silicon pad structure includes an inner cavity between the top and bottom surfaces, and the flexible structural element is disposed within the inner cavity. In other aspects, when the assembly is placed in a mold and the silicon pad structure is formed by injection molding, the silicon pad structure does not have an inner cavity. In other embodiments, a laminate layer may be disposed within the inner cavity. Additional structures may be disposed within the inner cavity to set the diameter of the assembly. For example, in one embodiment, the catheter includes a polyimide layer disposed between a top surface and a bottom surface. Alternative materials may be disposed within the lumen to set the diameter of the assembly, including relatively soft materials such as polymers and relatively hard materials such as metals in the form of thin structural members.

[0019] In another embodiment, a catheter having a substantially flat and / or planar shape may include only electrodes disposed on one of the top surface or the bottom surface. The catheter includes an elongated catheter shaft comprising a proximal end and a distal end. The catheter shaft defines a longitudinal axis. The catheter includes an expandable assembly having a first delivery configuration and a second deployment configuration. The expandable assembly includes a balloon member having a top surface, a bottom surface, and an inner cavity. In this embodiment, one of the top surface and the bottom surface includes an outer surface layer and an inner surface layer, and a flexible frame disposed between the outer surface layer and the inner surface layer. A plurality of electrodes are patterned on the flexible frame, and a plurality of conductive traces are disposed on the flexible frame. Each of the plurality of conductive traces is electrically coupled to the plurality of electrodes. The balloon member includes a flexible structural element disposed within the inner cavity.

[0020] The above is a brief overview of some embodiments of the present invention, intended to provide a basic understanding of the present invention. This summary is not an exhaustive overview of the present invention. Its purpose is not to identify key / important elements of the present invention or to limit the scope of the present invention. Its sole purpose is to present some embodiments of the present invention in a simplified form as a prelude to the more detailed description below.

[0021] As used herein, the term "planar" or similar terms like "plane" or "coplanar" should be understood to refer to a topological plane. In other words, "planar" may not refer to "flat" in a Cartesian coordinate system, but rather refers to a two-dimensional distribution that is topologically planar. Similarly, as used herein, the term "linear" should be understood to refer to a topological plane. In other words, "linear" may not refer to a "straight line" in a Cartesian coordinate system, but rather refers to a one-dimensional distribution that is topologically linear. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 An example medical device positioning system that may be used in conjunction with an expandable catheter according to an embodiment of the present disclosure is shown.

[0023] Figure 2 An example catheter according to an embodiment of the present disclosure is shown.

[0024] Figure 3 Depicted is a perspective view of an expandable electrode assembly according to an embodiment of the present disclosure.

[0025] Figure 4A Depicted is a partial cross-sectional top view of an expandable electrode assembly according to an embodiment of the present disclosure.

[0026] Figure 4B Depicted is an exploded view of conductive traces on a flexible frame of an expandable electrode assembly according to an embodiment of the present disclosure.

[0027] Figure 5A Depicted is another partial cross-sectional top view of an electrode arrangement of an expandable electrode assembly according to an embodiment of the present disclosure.

[0028] Figure 5B Alternative arrangements of electrodes for an expandable electrode assembly according to embodiments of the present disclosure are depicted.

[0029] Figure 6 Depicted is a perspective cross-sectional view of an expandable electrode assembly according to an embodiment of the present disclosure.

[0030] Figure 7 Depicted is another perspective cross-sectional view of an expandable electrode assembly according to an embodiment of the present disclosure.

[0031] Figure 8A 、 8B 8C depict various cross-sectional views of an expandable electrode assembly according to an embodiment of the present disclosure.

[0032] Figure 9 Depicted is a cross-sectional perspective view of an expandable electrode assembly according to an embodiment of the present disclosure.

[0033] Figure 10ADepicted is a perspective view of the distal end of an elongated catheter shaft in accordance with an embodiment of the present disclosure.

[0034] Figure 10B Depicted is a perspective, cross-sectional view of the distal end of an elongated catheter shaft in accordance with an embodiment of the present disclosure.

[0035] Figure 10C Depicted is a cross-sectional view of the distal end of an elongated catheter shaft in accordance with an embodiment of the present disclosure.

[0036] Figure 11 is a flow chart of a manufacturing method according to an embodiment of the present disclosure.

[0037] Figure 12A and Figure 12B is a perspective exploded view of an expandable electrode assembly according to an embodiment of the present disclosure.

[0038] Figure 13 Depicted is a perspective view of a connector for a catheter, according to an embodiment of the present disclosure. DETAILED DESCRIPTION

[0039] The following description will describe various embodiments of the present invention. For ease of explanation, specific configurations and details are set forth herein to facilitate a comprehensive understanding of these embodiments. However, those skilled in the art will appreciate that the present invention can be practiced without these specific details. Furthermore, some well-known features may be omitted or simplified herein to avoid obscuring the described embodiments.

[0040] like Figure 1 As shown, the electrode assembly 101 of the high-density catheter 100 is configured to conform to tissue (e.g., cardiac tissue) to connect the electrode 102 to the tissue. In many embodiments, the electrode assembly 101 has appropriate flexibility to accommodate appropriate bending of the electrode assembly 101 in response to appropriate interfacial forces between the electrode assembly 101 and the tissue. For example, the electrode assembly 101 includes a flexible balloon member (e.g., expandable electrode assembly 202) that is configured to conform to the tissue to connect the electrode 102 to the tissue. The balloon member can comprise a variety of biocompatible materials, including thermoplastic polyurethane (TPU), thermoplastic elastomer (TPE), polyamides including nylon or nylon elastomer (Pebax), ethylene vinyl acetate (EVA), polyvinylidene fluoride (PVDF), polyvinyl chloride (PVC), silicon, silicone, and / or composites thereof. In preferred aspects, the balloon material comprises nylon elastomer (Pebax).

[0041] The configuration of the electrode assembly 101 discussed herein facilitates insertion of the electrode assembly 101 using the catheter handle 110, deployment of the electrode assembly 101 within the heart 16, and withdrawal of the electrode assembly 101 from the patient 17 by accommodating relative movement between the undeployed and deployed configurations. Figure 2 (as shown) is used to avoid localized high strain that may occur without relative motion adaptation. For example, when entering the target cavity of the heart 16, the electrode 102 extending within the surface of the expandable electrode assembly 202 will contact the tissue as the expandable electrode assembly 202 expands (e.g., inflates), contracts (e.g., deflates), advances, or retracts, thereby receiving a signal. The signal can be transmitted via the connector 56 to a system for analyzing the signal, for example, to determine positioning. In some embodiments, the electrode assembly 101 can be inserted into the heart 16 via an introducer or delivery catheter.

[0042] The high-density catheter 100 can be used in conjunction with any suitable medical device localization system, such as those referenced and / or described herein. For example, the high-density catheter 100 can be used in conjunction with the catheter localization system and method described in U.S. Patent Publication No. 2020 / 0138334A1, entitled "Method for Medical Device Localization based on Magnetic and Impedance Sensors," the entire disclosure of which is incorporated herein by reference.

[0043] Figure 1 Also shown is a schematic diagram of a medical device positioning system 108 that can be used in conjunction with the high-density catheter 100. The system 108 includes a main electronic control unit 112 (e.g., a processor) having various input / output mechanisms 114, a display 116, an electrocardiogram (ECG) monitor 120, a positioning system (e.g., a medical positioning system 122), and the high-density catheter 100. As described herein, in some embodiments, the high-density catheter 100 includes electrodes 102, 104 and one or more position sensors 106 (which, in some embodiments, are configured as magnetic position sensors).

[0044] The input / output mechanism 114 may comprise conventional means for interfacing with a computer-based control unit, such as one or more of a keyboard, mouse, tablet, foot pedals, switches, etc. The display 116 may also comprise conventional means, such as a computer monitor.

[0045] The ECG monitor 120 is configured to continuously detect electrical timing signals from the heart using a plurality of ECG electrodes (not shown), which can be externally affixed to the patient's body. The timing signals typically correspond to, for example, specific phases of the cardiac cycle. Typically, the control unit 112 can use the ECG signals to synchronously replay a previously captured image sequence (cine loop) with the ECG. Both the ECG monitor 120 and the ECG electrodes may comprise conventional components.

[0046] The medical positioning system 122 is configured to function as a positioning system and, therefore, determine position (location) data relative to one or more position sensors 106 and / or electrodes 103 and output corresponding position readings.

[0047] The impedance-based medical positioning system 122 determines the position of the electrode 103 by capturing and processing signals received from the electrode 103 and an external electrode patch while the electrode 103 is placed in a controlled electric field (e.g., an electric potential field) generated by the electrode patch. The electrical impedance-based medical positioning system ("MPS system") 122 may include various visualization, mapping, and navigation components known in the art, such as the EnSite™ XEP system available from Abbott Laboratory, or generally referred to in U.S. Patent No. 7,263,397, entitled "Method and Apparatus for Catheter Navigation and Location and Mapping in the Heart," which is owned by the common assignee of the present invention and is incorporated by reference in its entirety.

[0048] The high-density catheter 100 can be used in conjunction with any suitable catheter system, such as the catheter systems referenced and / or described herein. For example, the high-density catheter 100 can be used to generate an electrophysiological map of electrical activity within a patient's heart to diagnose arrhythmias. It should be understood that the high-density catheter 100 can be used for any other suitable diagnostic and / or therapeutic purposes. Thus, the high-density catheter 100 can be configured to perform ablation procedures, cardiac mapping, electrophysiological (EP) studies, and other diagnostic and / or therapeutic procedures. For example, ablation procedures can include radiofrequency ablation, pulsed field ablation (PFA), cryoablation, laser ablation, chemical ablation, high-intensity focused ultrasound ablation, microwave ablation, and / or other ablation therapies. The embodiments are not limited to any one type of catheter or catheter-based system or procedure.

[0049] application

[0050] Ablation therapy can be used to treat a variety of conditions that afflict the human anatomy. One condition that can be treated with ablation therapy is cardiac arrhythmias. Lesions form in tissue when it is ablated, or at least exposed to ablative energy generated by an ablation generator and delivered by an ablation catheter. Electrodes mounted on or within the ablation catheter are used to cause tissue necrosis in cardiac tissue to correct conditions such as atrial arrhythmias (including but not limited to ectopic atrial tachycardia, atrial fibrillation, and atrial flutter). Arrhythmias can lead to a variety of dangerous conditions, including loss of synchronized atrioventricular contractions and blood flow stagnation. It is generally believed that the primary cause of atrial arrhythmias is stray electrical signals within the left or right atrium of the heart. The ablation catheter delivers ablative energy (such as radiofrequency energy, PFA, cryoablation, laser, chemical agents, high-intensity focused ultrasound, etc.) to cardiac tissue, creating lesions in the tissue. These lesions disrupt undesirable electrical pathways, thereby limiting or preventing the stray electrical signals that cause the arrhythmia.

[0051] Electroporation is a non-thermal ablation technique that involves applying a strong electric field to induce the formation of pores in cell membranes. The electric field can be induced by applying pulses of relatively short duration, for example, lasting from one nanosecond to several milliseconds. Such pulses can be repeated in a train. When this electric field is applied to tissue in an in vivo environment, cells in the tissue experience a transmembrane potential, which opens pores in the cell wall. Electroporation can be reversible (i.e., the temporarily opened pores reseal) or irreversible (i.e., the pores remain open), resulting in cell destruction. For example, in the field of gene therapy, reversible electroporation is used to deliver high molecular weight therapeutic vectors into cells. In other therapeutic applications, appropriately configured pulse trains can be used alone to cause cell destruction, for example, by inducing irreversible electroporation.

[0052] In some embodiments, the high-density catheter 100 is used for electroporation-induced primary necroptosis, which refers to the delivery of electrical current in a manner that directly causes irreversible loss of plasma membrane (cell wall) integrity, leading to its destruction and cell necrosis. This cell death mechanism can be considered an "outside-in" process, meaning that damage to the cell's outer wall can have deleterious effects on the cell's interior. Typically, for classic plasma membrane electroporation, electrical current is delivered in the form of short-duration pulses (e.g., 0.1 to 20 milliseconds in duration) using a pulsed electric field (i.e., pulsed field ablation (PFA)) between closely spaced electrodes capable of delivering an electric field strength of approximately 0.1 to 1.0 kilovolts per centimeter.

[0053] The high-density catheter 100 can be used to selectively modify a patient's cardiac tissue to reduce or eliminate pathological electrical conditions, thereby reducing or eliminating the occurrence of arrhythmias. The high-density catheter 100 can be configured to perform any suitable treatment, such as, but not limited to, radiofrequency (RF) ablation, pulsed field ablation (PFA), cryoablation, laser ablation, chemical ablation, high-intensity focused ultrasound ablation, microwave ablation, and / or other ablative therapies. In one embodiment, the electrodes 102 and 104 can be disposed on opposing surfaces of the high-density catheter 100, and the electrodes 102 and / or 104 can be configured to perform ablation on a per-electrode basis on the high-density catheter 100.

[0054] For example, in some embodiments, the high-density catheter 100 can be configured as a bipolar electrode assembly for bipolar-based electroporation therapy. Specifically, the electrodes 102 and 104 of the high-density catheter 100 can be individually electrically coupled to an electroporation generator (e.g., via suitable wires or other suitable electrical conductors extending through the catheter shaft 136) and configured to be selectively energized by the electroporation generator with opposite polarities to generate an electric potential and corresponding electric field between them for PFA therapy. That is, one of the electrodes 102 and 104 can be configured to function as a cathode, while the other of the electrodes 102 and 104 can be configured to function as an anode. Any suitable combination of the electrodes 102 and 104 of the electrode assembly 101 can function as both anodes and cathodes. For example, all electrodes 102 on one electrode section can function as cathodes, while all electrodes 104 on an adjacent electrode section can function as anodes. As another example, every other electrode 102 along an electrode section can function as a cathode, while every other electrode 104 along that electrode section can function as an anode. Electrodes 102, 104 may be any suitable electroporation electrodes. For example, electrodes 102, 104 may include Figure 3 The electrodes 102, 104 may have any other suitable shape or configuration. The shape, size, and / or configuration of the electrodes 102, 104 may affect various parameters of the electroporation therapy applied. For example, increasing the surface area of ​​one or both of the electrodes 102, 104 may reduce the applied voltage required to cause the same degree of tissue damage. Moreover, although each of the electrodes 102, 104 is shown as a single electrode, either or both of the electrodes 102, 104 may alternatively be implemented as two or more discrete electrodes.

[0055] Figure 2 An exemplary catheter device 200 is shown in accordance with an embodiment of the present disclosure. Figure 2 An expandable electrode assembly 202 is shown having a balloon member and a plurality of electrodes extending within and exposed through a top and / or bottom surface of the expandable electrode assembly 202 according to embodiments described herein. Figure 2 2 is shown coupled to an elongated catheter shaft 204 having a proximal end 206 and a distal end 208. Specifically, the expandable electrode assembly 202 is coupled to the distal end 208 of the elongated catheter shaft 204. At the proximal end 206 of the elongated catheter shaft 204, a handle 210 and a connector 212 are configured to electrically and physically couple the expandable electrode assembly 202 to a mapping and / or therapy system (e.g., such as a reference system) for sensing and / or energy delivery. Figure 1 Detailed description of the system 108).

[0056] Figure 3 An example of an expandable electrode assembly 300 according to an embodiment of the present disclosure is shown. The expandable electrode assembly 300 can be coupled to the distal end 208 of the elongated catheter shaft 204, as described in detail above. In various embodiments, the elongated catheter shaft 204 defines a longitudinal axis 302. The elongated catheter shaft 204 also includes one or more shaft electrodes 314. The shaft electrodes 314 can be used for impedance positioning, as described above with respect to Figure 1 As described in the electrical impedance-based medical positioning system 122.

[0057] The expandable electrode assembly 300 includes a balloon member 304 having a first delivery configuration and a second deployment configuration. In the delivery configuration, the balloon member 304 is contracted, rolled, or folded into the working lumen of the guide sheath. The balloon member 304 may also have fold lines, ribs, pleats, and / or recesses to aid in alignment and facilitate delivery of the expandable electrode assembly 300 within the guide sheath. In the first delivery configuration, the balloon member 304 is pushed out of the guide sheath (and / or the guide sheath is retracted proximally) in an unexpanded state. In the second deployment configuration, the balloon member 304 is expanded by being inflated with a gas, a liquid, or a combination thereof. The balloon member 304 may be connected to an expansion lumen extending within an elongated catheter shaft (hereinafter referred to as the expansion lumen). Figure 10C Detailed description) and is inflated with saline, oxygen, nitrogen dioxide (e.g., which can also be used for tissue cryoablation), air, or any combination thereof. These fluids are delivered through the inflation lumen to inflate and / or expand the lumen of the balloon member 304. After the procedure, the inflation gas and / or liquid can be aspirated, sucked, and / or drained through the inflation lumen and / or the catheter shaft lumen, and the balloon member 304 can be deflated and retracted into the guide sheath, thereby withdrawing the balloon member 304, along with the guide sheath, from the patient's body. In various embodiments, the inflation lumen is an elliptical inflation lumen, as discussed in more detail below.

[0058] Balloon member 304 can be either a compliant or non-compliant balloon member, depending on the material of balloon member 304 and / or the level of expansion provided by the inflation lumen used to transition balloon member 304 from a first, delivery / unexpanded configuration to a second, deployed / expanded configuration. In a preferred embodiment, balloon member 304 is made of a nylon elastomer (Pebax). The material of balloon member 304 can be processed, as described below, to allow balloon member 304 to elastically deform from a collapsed, first, delivery configuration within an introducer sheath to an intermediate configuration, in which balloon member 304 is free from the introducer sheath and unexpanded. For example, such a manufacturing process can include rolling balloon member 304 onto itself and heating the balloon member (e.g., in an oven at approximately 200°F) to thermally cure the rolled balloon member 304 in the first, delivery configuration. When balloon member 304 exits the introducer sheath, balloon member 304 elastically deforms to the intermediate configuration, which can include balloon member 304 expanded and having a substantially flat, flat shape. Balloon member 304 can further transition to a second configuration, in which balloon member 304 is expanded. In some aspects, the second configuration includes an over-expanded configuration that extends balloon member 304 beyond the flat shape, such that a central portion of balloon member 304 extends outward (e.g., in one aspect, irrigating tissue through the lumen of balloon member 304). Thus, it should be understood that balloon member 304 can include multiple expanded configurations (e.g., in an intermediate configuration, in a second expanded configuration, etc.).

[0059] In various embodiments, the balloon member 304 includes fold lines, creases, point bonds, indentations, etc. (not shown) to help guide the expansion and / or deflation of the balloon member 304. The balloon member 304 can have a flat / planar, concave, or convex shape in the second expanded configuration. For example, the balloon member 304 can have a fold line in the center of the flat shape that guides the expanded balloon member 304 into a "football" shape. In some embodiments, the central portion of the balloon member 304 can extend above the remaining top and / or bottom surfaces of the balloon member 304. In addition, although the embodiments shown in all of the figures and described herein are generally elliptical, the expandable electrode assembly 300 and / or balloon member 304 can be any shape, including a circle (e.g., as shown in FIG. Figure 5BThe expandable electrode assembly 300 and / or balloon member 304 may be formed into a "lollipop" shape as shown), a triangle, a square, a rectangle, etc., or any combination of these shapes. Various other embodiments may include the expandable electrode assembly 300 and / or balloon member 304 having a linear shape or annular shape, these shapes having one or more internal "cutouts", which will be understood by those skilled in the art based on the present disclosure. In other embodiments, the expandable electrode assembly 300 and / or balloon member 304 may be a round shape, such as a spherical, round (e.g., circular) or balloon shape. In further embodiments, the expandable electrode assembly 300 and / or balloon member 304 may be a basket-like configuration with expandable splines. Exemplary embodiments of a round or basket-like configuration with an expandable portion may include the embodiments described in U.S. Patent Publication No. 2021-0361220 A1, entitled "Uniform Mapping Balloon", the entire disclosure of which is incorporated herein by reference. Any expandable portion may be partially expanded or fully expanded before, during, and after use, or vice versa, as required by the intended application.

[0060] In various embodiments, a substantially flat balloon structure can better determine tissue or blood contact at the electrode interface. For example, one side of the substantially flat balloon structure can be configured to contact tissue of interest (e.g., cardiac tissue), while the other side of the substantially flat balloon structure can be configured to contact blood flow, for example. These discrete, independently energized, reliable electrode contacts on the flat balloon structure allow for filtering out measurements at the blood pool interface, thereby eliminating any far-field artifacts. This, in turn, provides higher-fidelity electrocardiograms (EGMs) with a higher signal-to-noise ratio compared to conventional mapping techniques known in the art. For example, conventional mapping catheters measure the average of the signal at the tissue-blood interface. The discrete contact determination and sensing functionality enabled by the present substantially flat balloon structure can reduce or eliminate such far-field effects and unwanted noise in measurements. Furthermore, the equidistant electrodes measure from known directions, and the associated algorithms do not need to compensate for time delays. The ability to have discrete contact surfaces also improves spatial resolution relative to boundaries / edges, such as high / low voltages, timing maps, and the like, compared to conventional devices.

[0061] Another advantageous feature of a substantially flat or planar expandable electrode assembly is that each surface maintains the electrodes in their desired configuration. For example, even when the distal portion of the expandable electrode assembly contacts tissue or the top or bottom surfaces flex, the electrode arrangement (e.g., the spacing between the electrodes) remains substantially fixed. This consistent and equal spacing between the electrodes, in turn, provides for improved sensing and diagnostic mapping.

[0062] As shown, balloon member 304 is in a second, expanded configuration, wherein balloon member 304 has a substantially flat shape. Balloon member 304 includes a top surface 306 and a bottom surface 308. In some embodiments, both the top surface 306 and the bottom surface 308 of balloon member 304 contain a plurality of holes 310. In other embodiments, only one of the top surface 306 and the bottom surface 308 of balloon member 304 contains a plurality of holes 310. It should be noted that other shapes besides a substantially flat shape are also contemplated as the second expanded configuration. For example, balloon member 304 can expand into a rounded spherical shape or a rounded circular shape. In other embodiments, balloon member 304 can have a "cutout" where no electrodes or material are present, resulting in balloon member 304 forming a hoop shape, with the hoop's periphery expanded. In other embodiments, balloon member 304 can have a basket-like configuration with expandable spline members that expand in the second expanded configuration. In the second deployed configuration, the expandable splines can have a linear, generally rectangular (e.g., cubic) shape, or, with the balloon member 304 in the second deployed configuration, can have a tubular (e.g., cylindrical) shape. According to some embodiments, each expandable spline can include a flexible support frame member made of a shape-memory material. In other embodiments, the splines expand such that the splines have sufficient rigidity to perform the function of a basket catheter, as will be apparent to one of ordinary skill in the art upon reading this disclosure.

[0063] In various embodiments, a plurality of electrodes 312 extend into and are exposed through the top surface 306 and / or bottom surface 308 of the balloon member 304. For example, a first plurality of electrodes may extend into and be exposed through the top surface 306, and a second plurality of electrodes (not shown) may extend into and be exposed through the bottom surface 308. In various exemplary aspects, the diameters of the plurality of apertures 310 may range from 0.25 mm to 3 mm, while the diameters of the electrodes 312 may be similarly within the range of 0.25 mm to 3 mm. In other aspects, the diameters of the plurality of apertures 310 and the diameters of the electrodes 312 may be any desired size. In preferred embodiments, the electrodes 312 are between approximately 0.002 and 0.010 larger than the apertures 310. In other embodiments, the diameters of the apertures 310 and electrodes 312 are the same. In still other embodiments, the diameters of the apertures 310 are larger than the diameters of the electrodes 312. In each embodiment, an insulating seal (not shown) may be present between the electrode 312 and the aperture 310 to reduce impedance.

[0064] In at least some embodiments, the top surface of each electrode 312 can be polished to be flush with the top of the corresponding aperture 310. For example, the top surface 306 and / or the bottom surface 308 can be substantially planar, flat, smooth, etc. In other embodiments, the top surface of each electrode 312 can be raised relative to the top of the corresponding aperture 310 (e.g., raised relative to the top surface of the balloon member 304) to improve tissue contact between the electrode 312 and the tissue of interest. For example, the electrode 312 can extend 0.1 mm to 0.5 mm above the top surface 306 of the balloon member 304. In other embodiments, the top surface of each electrode 312 can be recessed into the corresponding aperture 310. For example, the electrode 312 can extend 0.1 mm to 0.5 mm below the top surface 306 of the balloon member 304. The recessed electrodes can be coated to reduce impedance. In various embodiments, to reduce impedance, the polymer coating is not flush with the aperture 310 of the electrode 312. Both the electrode 312 and the impedance-reducing coating can be recessed to prevent wear. For example, deployment of the balloon member 304 through the sheath may cause wear of the electrode as the electrode passes through the sheath material into the vasculature. In at least some embodiments, the impedance-reducing polymer coating may substantially fill the recess (e.g., the gap between the electrode and the uppermost surface of the top surface 306). The impedance-reducing polymer coating may comprise a variety of materials, such as those described in detail in International Publication No. WO2022187161A1, entitled “Electrode with Protected Impedance Reduction Coating,” the entire disclosure of which is incorporated herein by reference. It should be understood that any embodiments describing the top surface 306 and its components may be similarly applicable to the bottom surface 308 and its components.

[0065] According to the embodiments described in this disclosure, Figure 4A An expandable electrode assembly 300 including a balloon member 304 is depicted, shown with the top surface removed to reveal various internal components of the balloon member 304. In some embodiments, the balloon member 304 includes a top flexible frame 402 associated with the top surface and a bottom flexible frame 404 associated with the bottom surface. In other embodiments, the balloon member 304 includes a single flexible frame associated with a single plane of the balloon member 304.

[0066] The top flexible frame 402 and the bottom flexible frame 404 can comprise a variety of flexible circuit materials, including polymers such as polyimide, thermoplastic, nylon elastomer (Pebax), polyurethane, etc. In various embodiments, the bottom flexible frame 404 can be identical to the top flexible frame 402 (e.g., including the same size, shape, layout, etc.) and associated with the same components as the top flexible frame 402, although Figure 4AOnly components associated with the top flexible frame 402 are shown. In various embodiments, the top flexible frame 402 and the bottom flexible frame 404 are not identical in shape, size, layout, etc. For example, the electrodes disposed on the top flexible frame 402 and the bottom flexible frame 404 are not mirrored on the top surface 306 and the bottom surface 308 of the balloon member 304. For example, in a top view of the top flexible frame 402 and the bottom flexible frame 404, the branches of the top flexible frame 402 and the bottom flexible frame 404 can interlace with each other.

[0067] The first plurality of electrodes 406 is patterned onto the top flexible frame 402. Each of the first plurality of electrodes 406 is arranged in a horizontal row 408 relative to a longitudinal axis 302 defined by the elongated catheter shaft 204. For example, the first plurality of electrodes 406 is arranged in horizontal rows 408 that are perpendicular to the longitudinal axis 302 (e.g., offset by 90° from the longitudinal axis 302). The horizontal rows 408 are offset such that each electrode in the first plurality of electrodes 406 is offset from a corresponding electrode in an adjacent row. For example, each electrode in a horizontal row 408 can be equally spaced between two electrodes in an adjacent horizontal row 408. In one embodiment, the offset is 60°. The offset can be in a range of 22.5° to 60°.

[0068] In preferred embodiments, each electrode in a row is equally spaced from adjacent electrodes in the same row and in an adjacent row. For example, the center-to-center distance between each electrode in a row is the same as the center-to-center distance between an electrode and two electrodes in adjacent rows that are positioned therebetween. In other embodiments, the center-to-center distance between each electrode in the first plurality of electrodes is between about 0.5 millimeters and about 4 millimeters. In one exemplary embodiment, each electrode in the first plurality of electrodes has a diameter of 0.25 millimeters, such that the edge-to-edge spacing is 0.25 millimeters and the center-to-center spacing is 0.5 millimeters. According to the various configurations described herein, the spatial and electrical arrangement of the electrodes can improve the resolution of the resulting image of the mapping system and improve the high fidelity signals. In various aspects, tighter spacing is preferred because it reduces the temporal compensation between signals and improves the resolution of the resulting image of the mapping system. Similarly, each electrode in the first plurality of electrodes 406 can be arranged in vertical rows 410 that are parallel to the longitudinal axis 302 defined by the elongated catheter shaft 204. The vertical rows 410 can be offset such that each electrode in a row is offset from a corresponding electrode in an adjacent row. For example, an electrode in a first vertical row can be positioned between two adjacent electrodes in an adjacent row.

[0069] It should be understood that a second plurality of electrodes (not shown) is patterned in a similar manner onto bottom flexible frame 404. In a preferred embodiment, first plurality of electrodes 406 and second plurality of electrodes are aligned such that the electrodes on the top surface of balloon member 304 match the electrodes on the bottom surface of balloon member 304. In some aspects, first plurality of electrodes 406 and second plurality of electrodes are not aligned with each other.

[0070] Figure 4B An exploded view of the conductive traces 412 on the flexible frame 402 of the expandable electrode assembly 300 is depicted. In various embodiments, a plurality of conductive traces 412 are provided on each of the top flexible frame 402 and the bottom flexible frame 404. The plurality of conductive traces 412 on each flexible frame are electrically coupled to a respective one of the first plurality of electrodes 406 and the second plurality of electrodes. Note that for simplicity, not all of the plurality of conductive traces 412 are shown in FIG. 4 , although in practice, the plurality of conductive traces 412 are electrically coupled to each of the first plurality of electrodes 406. In embodiments where electrodes are provided on only one flexible frame in the balloon member 304, a single plurality of conductive traces 412 will be provided to electrically couple to the respective plurality of electrodes, as will be apparent to one of ordinary skill in the art upon reading this disclosure. Embodiments of conductive traces and electrodes disposed on a flexible frame (e.g., as a flexible circuit) can be implemented according to any of the aspects described in U.S. Patent No. 11,642,064, filed on February 4, 2020, assigned to the assignee herein, and entitled “High Density Electrode Mapping Catheter,” the entire contents of which are incorporated herein by reference.

[0071] like Figure 4BAs shown, a first plurality of electrodes 406 and a second plurality of electrodes 407 are disposed on the top flexible frame 402 and the bottom flexible frame 404, respectively. In various embodiments, each of the first plurality of electrodes 406 and the second plurality of electrodes 407 is configured for independent sensing or energy delivery for any of the applications described in detail above. For example, each group of electrodes can be selectively deactivated, or one or more electrodes in the plurality of electrodes can be selectively deactivated. In various embodiments, each of the first plurality of electrodes 406 and the second plurality of electrodes 407 can include any number of electrodes. In one exemplary aspect, each of the first plurality of electrodes 406 and the second plurality of electrodes 407 includes 37 electrodes, for a total of 74 electrodes, distributed along the longitudinal axis 302 of the balloon member 304, but any number of electrodes can be used on the top surface 306 and the bottom surface 308. For example, in some embodiments, the first plurality of electrodes 406 and / or the second plurality of electrodes 407 include less than or equal to 100 electrodes. In some aspects, the top surface 306 and the bottom surface 308 include the same number of electrodes. In other aspects, the top surface 306 and the bottom surface 308 include different numbers of electrodes. The electrodes can be of any shape or configuration. For example, the electrodes can be strips, dots, squares, diamonds, circular electrodes, or any combination thereof.

[0072] Now refer to Figure 5A , the expandable electrode assembly 300 includes a flexible balloon member (eg, balloon member) 304 having a first plurality of electrodes 406 patterned on a top flexible frame 402. The first plurality of electrodes 406 are patterned into horizontally offset rows 408, as in combination with Figures 4A-4B Described in detail.

[0073] like Figure 5AAs shown, each electrode of the first plurality of electrodes 406 is grouped into a cluster 502 of three or more electrodes defining a two-dimensional shape. For example, a cluster of three or more electrodes can be defined according to the embodiments described in U.S. Patent Publication No. 2020 / 0214635, entitled “Catheter with High-Density Mapping Electrodes,” and using the associated algorithms described in U.S. Patent No. 10,758,137, entitled “Orientation Independent Sensing, Mapping, Interface and Analysis Systems and Methods,” the entire disclosure of which is incorporated herein by reference. Based on the equal offset spacing described in detail above, the clusters 502 of electrodes are preferably configured as equilateral triangles, each cluster having at least three electrodes. In various embodiments, the electrode clusters 502 are configured to sample electrical properties of the contacting tissue in at least two substantially lateral directions, as further described in U.S. Patent Publication No. 2020 / 0214635. In one embodiment, as Figure 5A As shown by the offset 504 in the figure, the offset between the electrodes is 60°. In various embodiments, a cluster 502 of three or more electrodes defining a two-dimensional shape can be arranged on a linear balloon member to form a linear catheter having a cylindrical (e.g., tubular) or cubical three-dimensional shape. In other embodiments, the expandable electrode assembly 300 can be a basket assembly comprising multiple balloon members 304 as splines of the basket assembly. For example, a cluster 502 of three or more electrodes defining a two-dimensional shape can be arranged on a linear balloon member, and multiple such linear balloon members can form a basket assembly having expandable splines. In another embodiment, a cluster 503 of three or more electrodes can be arranged on an annular shape, for example, a linear balloon member formed as a circle with a through hole. This will be apparent to those skilled in the art after reading this disclosure.

[0074] In other embodiments, the first plurality of electrodes 406 are arranged in any desired configuration. Figure 5B As shown, the first plurality of electrodes 406 can be arranged in concentric rings with uniform spacing along the circumference of each ring. In various other aspects, the spacing of the first plurality of electrodes 406 is not equal. Instead, the first plurality of electrodes 406 can be arranged in a high-density electrode region on the top surface of the balloon member 304. In this way, the electrode density can be adjusted to accommodate various configurations based on global, regional, or local mapping applications.

[0075] Now refer to Figure 6, shows a cross-section of a balloon member 304. As shown, balloon member 304 includes a top surface 306, a bottom surface 308, and an inner lumen 602. In various embodiments, top surface 306 includes an outer surface layer 604 and an inner surface layer 606. Bottom surface 308 similarly includes an outer surface layer 608 and an inner surface layer (not shown). The inner surface layer 606 of top surface 306 and the inner surface layer of bottom surface 308 define the inner lumen 602. In various embodiments, top flexible frame 402 is disposed between outer surface layer 604 and inner surface layer 606 of the top surface 306 of balloon member 304. Similarly, bottom flexible frame 404 is disposed between outer surface layer 608 and inner surface layer of the bottom surface 308 of balloon member 304. In aspects where electrodes are disposed on only one surface of the balloon member, the flexible frame can be disposed between the top and bottom surface layers, with the electrodes disposed on one side of the flexible frame.

[0076] like Figure 6 As shown, balloon member 304 includes a first plurality of holes 610 located on outer surface layer 604 of top surface 306 of balloon member 304 and a second plurality of holes 612 located on outer surface layer 608 of bottom surface 308 of balloon member 304. First plurality of holes 610 and second plurality of holes 612 are each configured to expose a corresponding first plurality of electrodes and a second plurality of electrodes (not shown). The first plurality of electrodes and the second plurality of electrodes can be flush, recessed, or raised relative to outer surface layer 604 of top surface 306 of balloon member 304 and outer surface layer 608 of bottom surface 308 of balloon member 304.

[0077] Reference Figure 7 , the top surface of the balloon member 304 and various associated components have been removed to facilitate viewing of the inner cavity 602. The figure shows the outer surface layer 608 of the bottom surface 308 of the balloon member 304, which has the bottom flexible frame 404. Figure 7 As shown, a flexible structural element 702 is disposed within the lumen 602 of the balloon member 304 to provide rigidity and prevent kinking when the balloon member 304 is deployed within a patient. In various embodiments, the flexible structural element 702 comprises a nickel-titanium alloy wire loop element extending along a longitudinal axis (e.g., longitudinal axis 302) defined by an elongated catheter shaft (e.g., elongated catheter shaft 204). In other embodiments, the flexible structural element 702 can have any configuration, including extending along the perimeter of the balloon member 304, having an internal flattened shape that substantially mirrors the perimeter of the balloon member 304 (when viewed from a top perspective), having a forked shape extending from the longitudinal axis, and the like. In various embodiments, the nickel-titanium alloy wire loop element is disposed between the top flexible frame and the bottom flexible frame.

[0078] In some aspects, the expandable electrode assembly 300 and balloon member 304 do not include a flexible structural element 702, where inflation of the balloon and / or the balloon material provides sufficient rigidity to avoid kinking and / or any other unwanted bending. For example, over inflation of the balloon member 304 can create a substantially rigid structure to prevent unwanted bending as the balloon member 304 is deployed, while under inflation of the balloon member 304 can create additional flexibility as needed to accommodate the tissue of interest. It can be desirable to temporarily and progressively deflate the balloon member 304 to accommodate particularly uneven tissue surfaces.

[0079] The lumen 602 contains one or more magnetic position sensors 704 (such as, for example, the magnetic position sensors 106 described in detail in the incorporated by reference U.S. Patent No. 8,549,751). In various embodiments, the magnetic position sensors 704 are disposed on the top flexible frame and / or the bottom flexible frame 404 of the expandable electrode assembly distal portion (as shown). The magnetic position sensors 704 are coupled to the top flexible frame and / or the bottom flexible frame 404 and parallel to the longitudinal axis of the catheter shaft. Figure 1

[0080] Referring now to Figures 8A-8C various cross sections of the balloon member 304 are shown with the combination of the top surface 306 having an outer surface layer 604 and an inner surface layer 606, the bottom surface 308 having an outer surface layer 608 and an inner surface layer 802, the top flexible frame 402, the bottom flexible frame 404, the first plurality of holes 610, the second plurality of holes 612, the flexible structural element 702, the magnetic position sensors 704, and the lumen 602.

[0081] For example, as Figure 8A shown, a perspective cross section of the balloon member 304 shows the relative positions of the top surface 306, the bottom surface 308, the first plurality of holes 610, the second plurality of holes 612, the flexible structural element 702, the magnetic position sensors 704, and the lumen 602, according to one embodiment. In at least some embodiments, the magnetic position sensors 704 can be offset at an angle relative to the flexible structural element 702.

[0082] In another example, Figure 8B a front view including a cross section of the balloon member 304 is shown with the top surface 306 relative to the bottom surface 308, the first plurality of holes 610 extending through the top surface 306 and through the outer surface layer 604, the second plurality of holes 612 extending through the bottom surface 308 and through the outer surface layer 608. The magnetic position sensors 704 are shown within the lumen 602. In this view, the top flexible frame 402, the bottom flexible frame 404, and the flexible structural element 702 are removed.

[0083] In yet another example, Figure 8C ​A cross-sectional view of the balloon member 304 is included, showing the top surface 306 relative to the bottom surface 308, a first plurality of holes 610 extending through the top surface 306 and through the outer surface layer 604, and a second plurality of holes 612 extending through the bottom surface 308 and through the outer surface layer 608. Figure 8C As shown, the top flexible frame 402 is sandwiched between the outer surface layer 604 and the inner surface layer 606 of the top surface 306. Similarly, the bottom flexible frame 404 is sandwiched between the outer surface layer 608 and the inner surface layer 802 of the bottom surface 308. The inner cavity 602 is defined by the inner surface layer 606 of the top surface 306 and the inner surface layer 802 of the bottom surface 308. In this view, the magnetic position sensor 704 and the flexible structural element 702 are removed.

[0084] In various embodiments, the balloon member 304, including the various components described above, is formed using a dual-sheet thermoforming process. The dual-sheet thermoforming process can involve simultaneously vacuum-forming or pressure-forming two sheets using two molds on each platen. After forming, the top and bottom platens are quickly brought together (e.g., to prevent surface temperature loss). For example, after forming, the outer surface layer 604 and the inner surface layer 606 of the top surface 306 have the top flexible frame 402, the plurality of conductive traces 412, and the first plurality of electrodes 406 laminated therebetween. The outer surface layer 608 and the inner surface layer 802 of the bottom surface 308 have the bottom flexible frame 404, the plurality of conductive traces 412, and the second plurality of electrodes 406 laminated therebetween. The first plurality of apertures 610 and the second plurality of apertures 612 can be formed in the top surface 306 and the bottom surface 308, respectively, before or after the dual-sheet thermoforming process. In various embodiments, a sealant and / or insulating layer is positioned between the electrodes and / or the conductive traces before the dual-sheet thermoforming process. In at least some embodiments, magnetic position sensor 704 is coupled to top flexible frame 402 and / or bottom flexible frame 404 and laminated with other components during the dual-sheet thermoforming process. For example, magnetic position sensor 704 is structurally integrated into top surface 306 and / or bottom surface 308. In various embodiments, magnetic sensors of various designs may be incorporated into top surface 306 and / or bottom surface 308. For example, in some embodiments, magnetic sensors including those discussed in U.S. Patent No. 11,439,318 (entitled “Active Magnetic Position Sensor”), the entire disclosure of which is incorporated herein by reference, may be used. In various embodiments, printed passive pickup coils, such as those discussed in U.S. Patent Publication No. 2022 / 0008011A1, entitled “Printed Sensor Coil,” the entire disclosure of which is incorporated herein by reference, may be used. The dual-sheet thermoforming process substantially fixes the positions of the various components within top surface 306 and / or bottom surface 308 relative to one another. Implementation of this process enables mass production and reduces costs while providing more functionality (e.g., higher quality EGM and spatial resolution) at the same or lower cost. For example, embodiments described herein can be manufactured with significantly less touch-time than conventional designs.

[0085] Reference Figure 9, shows the catheter shaft 204 coupled to the expandable electrode assembly 300 at the distal end 208 of the catheter shaft 204. Specifically, according to at least some embodiments, the expandable electrode assembly 300 is coupled to the distal end 208 of the catheter shaft 204 using a proximal coupler 902. According to at least some embodiments, the proximal coupler 902 is a two-part proximal coupler. In at least some embodiments, each part of the two-part proximal coupler 902 has an angular offset that accommodates the shaft magnetic position sensor 904 (e.g., relative to the proximal end of the shaft) when each part of the two-part proximal coupler 902 is aligned with each other. Figure 1 Detailed description of the position sensor 106) and the corresponding magnetic sensor line 906. For example, the axis magnetic position sensor 904 is offset relative to the longitudinal axis of the catheter shaft 204. In at least some embodiments, the offset axis magnetic position sensor 904 is positioned at an angle of 11 degrees relative to the longitudinal axis of the catheter shaft 204 or relative to the magnetic position sensor 704 ( Figure 9 (not shown) is positioned at an 11° angle.

[0086] refer to Figures 10A-10C , various embodiments of a catheter shaft 204 are shown. In various embodiments, the catheter shaft 204 includes a non-deflectable portion extending distally from a handle (such as handle 210), and a deflectable portion extending distally from a distal end of the non-deflectable portion. Figure 10A As shown, the catheter shaft 204 (particularly the deflectable portion of the catheter shaft 204 ) includes one or more compression coils 1002 that extend at least partially along the length of a puller wire lumen 1004 . For example, each puller wire lumen 1004 can include a compression coil 1002 . The compression coil 1002 can be partially secured to at least a portion of the interior of the puller wire lumen 1004 . As shown, each puller wire 1006 extends through the puller wire lumen 1004 . In at least some embodiments, a compression coil adapter 1008 is disposed at the distal end of one or both of the compression coils 1002 . The compression coil adapter 1008 extends around the distal end of the compression coil 1002 and beyond the length of the compression coil 1002 into the puller wire lumen 1004 to accommodate the size of a central lumen 1010 having an inflation lumen 1012 disposed therein. The magnetic sensor wire 906 can extend through the central lumen 1010 into the catheter shaft 204 as shown. Additional wires 1014 (eg, electrode wires) may extend through the central lumen 1010 into the catheter shaft 204 .

[0087] like Figure 10AAs further shown, an inflation lumen 1012 is provided for inflating and deflating the expandable electrode assembly with gas, liquid, or a combination thereof. For example, the inflation lumen 1012 terminates at the lumen 602 of the balloon member 304, and the gas and / or liquid expands the balloon member 304. In various embodiments, the same inflation lumen 1012 used to inflate and deflate the expandable electrode assembly can be used to irrigate the expandable electrode assembly. For example, the inflation lumen 1012 can be configured to deliver saline solution to prevent clotting on and / or around the expandable electrode assembly. The first plurality of holes 610 and / or the second plurality of holes 612 can be configured to allow a certain amount of fluid to be secreted therethrough. For example, some or all of the holes can be unsealed and / or partially sealed to provide a desired amount of irrigation fluid therethrough. In use, a physician can choose to over-inflate the expandable balloon assembly with saline solution, causing saline solution to be secreted through the first plurality of holes 610 and / or the second plurality of holes 612.

[0088] Figure 10B A cross-section of the catheter shaft 204 is depicted showing the compression coil 1002 and the compression coil adapter 1008 extending at least partially into the puller wire lumen 1004 , and the inflation lumen 1012 extending at least partially into the central lumen 1010 .

[0089] Figure 10C Different cross-sections of the catheter shaft 204 are depicted showing the compression coil 1002 in the puller lumen 1004 and the inflation lumen 1012 in the central lumen 1010. Figure 10C As shown, the inflation lumen can transition from a circular cross-section (or a substantially circular cross-section) to a flattened, oval cross-section. This transition can occur through central lumen 1010 or when inflation lumen 1012 passes into lumen 602 of balloon member 304.

[0090] In other embodiments of the present disclosure, an expandable electrode assembly comprises a generally flat spacer having a similar configuration. The spacer expandable electrode assembly is expanded from a guide sheath in a manner similar to the other embodiments described herein. The spacer structure is preferably a silicon spacer structure. The spacer expandable assembly comprises a top surface and a bottom surface, and a flexible frame disposed between the top surface and the bottom surface. A plurality of electrodes and corresponding conductive traces may be patterned onto the flexible frame according to any of the embodiments described herein, for example in a horizontally offset pattern (see at least FIG. 4 and FIG. 5 ). Figure 5A In some aspects, the silicon pad structure includes an inner cavity between the top and bottom surfaces, and the flexible structural element is disposed in the inner cavity. In other aspects, when the component is placed in the mold and the silicon is injection molded into the silicon pad structure, the silicon pad structure does not have an inner cavity.

[0091] Figure 11is a flow chart of a method 1100 of manufacturing an expandable electrode assembly, such as any expandable electrode assembly described herein. In one embodiment, electrodes and corresponding conductive traces can be constructed (e.g., disposed) onto an outer surface layer of a top surface and / or an outer surface layer of a bottom surface of a balloon member. The balloon member can comprise a variety of biocompatible materials, including thermoplastic polyurethane (TPU), thermoplastic elastomer (TPE), polyamides including nylon or nylon elastomers (Pebax), ethylene vinyl acetate (EVA), polyvinylidene fluoride (PVDF), polyvinyl chloride (PVC), silicon, silicone, and / or composites thereof. Specifically, one embodiment of assembling the expandable electrode assembly 300 as described in detail above includes disposing electrodes and / or conductive traces onto the balloon material.

[0092] As shown, step 1102 includes placing a plurality of electrodes on the first layer of balloon material. The electrodes can have any size and configuration described herein. In one exemplary aspect, the electrodes are gold electrode pads having a diameter of 1 mm and a height of 0.002 mm. In other aspects, a thin gold sheet is applied to the first layer of balloon material. In some aspects, the holes formed in step 1108 expose portions of the thin gold sheet to form the electrodes.

[0093] Step 1104 includes placing a plurality of conductive traces on the first layer of balloon material corresponding to the plurality of electrodes. In one embodiment, the plurality of conductive traces are drawn using conductive epoxy ink. The plurality of conductive traces are arranged to connect the plurality of electrodes. In various embodiments, an insulating layer may be applied between each of the plurality of conductive traces. In at least some aspects, a template is used to create the plurality of conductive traces.

[0094] In other aspects, step 1104 includes applying a conductive epoxy to the first layer of balloon material provided with the plurality of electrodes. For example, a conductive ink can be applied to the first layer of balloon material provided with the plurality of electrodes.

[0095] Step 1106 includes laminating a plurality of electrodes and a plurality of conductive traces between the second layer of balloon material and the first layer of balloon material. The two layers of balloon material can be connected and / or sealed using a double sheet thermoforming process as described in detail herein.

[0096] Step 1108 includes forming a plurality of holes in the first layer of balloon material. The plurality of holes correspond to the plurality of electrodes such that the plurality of electrodes extend within and are exposed through the plurality of holes. In various embodiments, the plurality of holes are removed from the first layer of balloon material by laser etching. In some aspects, an insulating coating can be applied to the exposed electrodes. In various embodiments, a conductive impedance-reducing coating is applied. For example, the conductive impedance-reducing coating can include poly(3,4-ethylenedioxythiophene) (PEDOT), Pebax, titanium nitride, or any other material as described in detail in International Publication No. WO 2022187161 Al, which is incorporated by reference herein in its entirety. In at least some embodiments, the surface of the layer can be physically modified instead of or in conjunction with adding a conductive impedance-reducing coating. The physical modification can include increasing the roughness of the first layer to change the impedance (but not the conductivity), and increasing the surface area of the first layer to increase the contact area, as will be appreciated by one of ordinary skill in the art upon reading the present disclosure. In some embodiments, the individual electrodes include gold-plated copper traces and copper pads. The gold insulates the copper components of the electrodes. According to some embodiments, the electrodes can also include a conductive impedance-reducing insulating layer. For example, the electrodes can be further coated with iridium oxide to reduce impedance and achieve sufficient signal-to-noise ratio. In various embodiments, the uncoated flexible electrodes can be plated with a noble metal, including gold, palladium, platinum, alloys thereof such as platinum iridium (PtIr), combinations thereof, and the like.

[0097] In at least some embodiments, the plurality of conductive traces converge at the distal end of the catheter shaft. In one embodiment, the plurality of conductive traces form a serpentine pattern along the remaining length of the catheter shaft. In some embodiments, the serpentine pattern on the catheter shaft can be separated from any conductive epoxy ink previously deposited. The serpentine pattern prevents the conductive traces from breaking during catheter shaft stretching and compression, and prevents the conductive traces from breaking when the catheter shaft is bent. The serpentine pattern further prevents the traces from breaking during stretching, thereby increasing the flexibility of the expandable electrode assembly.

[0098] In other embodiments of manufacturing an expandable electrode assembly, a combination of copper and thermoplastic materials can be used to construct (e.g., dispose) electrodes and corresponding conductive traces onto the outer surface layer of the top and / or bottom surfaces of the balloon member. In some aspects, the copper is disposed onto the balloon material. For example, the copper can be laminated onto a thermoplastic sheet. The copper can be coated with a photoresist according to methods known in the art, and the desired circuit layer can be imaged onto the photoresist. In various aspects, a photochemical etching process is used to selectively remove the copper using a chemical reagent to create an etched pattern (e.g., a circuit layout). In some aspects, the photoresist circuit layout can be gold-plated. The combination of the photoresist and imaging process etches away the unwanted copper, thereby forming a plurality of electrodes and a plurality of corresponding traces. Thus, the electrodes and corresponding conductive traces can be constructed (e.g., dispose) onto the balloon material (e.g., a thermoplastic sheet). Holes corresponding to the formed electrodes can be formed according to any of the aspects described herein to expose the electrode material. In various embodiments, the manufacturing process can be electrolytic or electroless. For example, different manufacturing processes can provide different hardnesses, such as for gold.

[0099] like Figure 12A As shown, a plurality of electrodes 1202 and a plurality of conductive traces 1204 corresponding to the plurality of electrodes 1202 are deposited on a layer 1206 of balloon material. Figure 12B A close up view of conductive traces 1204 on a layer of balloon material 1206 is shown with conductive adhesive 1208 extending along the ends of the conductive traces 1204. Figures 12A-12B As further shown, in at least some embodiments, a ribbon cable 1210 can be coupled to and extend from the conductive trace 1204 .

[0100] Figure 13 A connector 1300 for a catheter system according to an embodiment of the present disclosure is depicted. Various signals collected from electrodes on an expandable electrode assembly can be transmitted via the connector 1300 to a system for analyzing the signals, for example, for determining location. The connector 1300 is configured to electrically and physically couple the expandable electrode assembly to a mapping and / or therapy system (e.g., a reference system) for sensing and / or energy delivery. Figure 1 Detailed description of the system 108).

[0101] Other variations are within the spirit and scope of the invention. Therefore, while the invention is susceptible to various modifications and alternative constructions, certain embodiments thereof have been shown in the drawings and described in detail above. However, it should be understood that the invention is not intended to be limited to the specific form or forms disclosed, but rather, the invention is intended to cover all modifications, alternative constructions, and equivalents falling within the spirit and scope of the invention as defined by the appended claims.

[0102] Exemplary embodiments

[0103] In one or more embodiments, a catheter includes an elongated catheter shaft including a proximal end and a distal end. The elongated catheter shaft defines a longitudinal axis. The catheter further includes an expandable assembly. The expandable assembly includes a balloon member having a top surface, a bottom surface, and a lumen. Each of the top surface and the bottom surface includes an outer surface layer and an inner surface layer. The expandable assembly further includes a top flexible frame disposed between the outer surface layer and the inner surface layer of the top surface of the balloon member, a bottom flexible frame disposed between the outer surface layer and the inner surface layer of the bottom surface of the balloon member, a first plurality of electrodes patterned on the top flexible frame, and a second plurality of electrodes patterned on the bottom flexible frame. The first plurality of electrodes is aligned with the second plurality of electrodes. The expandable assembly includes a plurality of conductive traces disposed on the respective flexible frames, and each of the plurality of conductive traces is electrically coupled with a respective one of the first plurality of electrodes and the second plurality of electrodes. The expandable assembly includes a flexible structural element disposed within the lumen. Optionally, the flexible structural element includes a nickel-titanium wire ring element extending along the longitudinal axis of the elongated catheter shaft. Optionally, the nickel-titanium wire ring element is disposed between the top flexible frame and the bottom flexible frame. Optionally, the expandable assembly further includes a first delivery configuration and a second deployed configuration. In the second deployed configuration, the balloon member can have a flat, concave, or convex shape. The expandable assembly can have an intermediate configuration between the first delivery configuration and the second deployed configuration, and in the intermediate configuration, the balloon member can be unconstrained by a guiding sheath and not inflated. The balloon member can include a plurality of holes on the outer surface layers of the top surface and the bottom surface of the balloon member, the plurality of holes configured to expose the respective first plurality of electrodes and the second plurality of electrodes. The plurality of holes can have a diameter that is the same as or smaller than a diameter of the respective first plurality of electrodes and the second plurality of electrodes. The plurality of holes can have a diameter in a range of 0.25 millimeters to 3 millimeters, and the respective first and second plurality of electrodes can have a diameter in a range of 0.25 millimeters to 3 millimeters. Optionally, the first plurality of electrodes and the second plurality of electrodes are flush, recessed, or raised relative to the outer surface layers of the top surface and the bottom surface of the balloon member. Optionally, the elongated catheter shaft includes an oval inflation lumen connected to the lumen of the balloon member, and the balloon member is not inflated in the first delivery configuration and inflated in the second deployed configuration by a liquid or a gas delivered through the oval inflation lumen. Optionally, each of the first plurality of electrodes and the second plurality of electrodes is arranged in a horizontal row relative to the longitudinal axis of the elongated catheter shaft. The horizontal rows can be offset such that each electrode in each row is offset from a respective electrode in an adjacent row. Each of the first plurality of electrodes and the second plurality of electrodes can be arranged in a vertical row parallel to the longitudinal axis of the elongated catheter shaft. The vertical rows can be offset such that each electrode in each row is offset from a respective electrode in an adjacent row. The offset can be 60°. The offset can be in a range of 22.5° to 60°. Each electrode in each row can be equally spaced from adjacent electrodes in the same row and adjacent rows.Each electrode in the first plurality of electrodes and the second plurality of electrodes can be used for independent sensing or energy delivery. Each electrode in the first plurality of electrodes and the second plurality of electrodes can be grouped into a cluster of three or more electrodes defining a two-dimensional shape. The electrode cluster can be an equilateral triangle, each cluster having at least three electrodes. The electrode cluster can sample electrical properties of contacting tissue in at least two substantially transverse directions. Optionally, the center-to-center distance between each electrode in the first plurality of electrodes and the second plurality of electrodes is in the range of 0.5 mm to 4 mm. The catheter can include at least one magnetic position sensor disposed along the distal portion of the elongated catheter shaft. The catheter can include one or more magnetic position sensors disposed on a top flexible frame or a bottom flexible frame of the distal portion of the expandable assembly. Optionally, the balloon member is circular in the second deployed configuration. Optionally, the balloon member is a cylindrical or cubic linear balloon member in the second deployed configuration. Optionally, the expandable assembly is a basket assembly having a plurality of balloon members, each of which is cylindrical or cubic in the second deployed configuration.

[0104] In one or more embodiments, a catheter includes an elongated catheter shaft having a proximal end and a distal end. The elongated catheter shaft defines a longitudinal axis. The catheter further includes an expandable assembly having a first delivery configuration and a second deployed configuration. The expandable assembly includes a balloon member having a substantially flat shape in the second deployed configuration and including a top surface and a bottom surface. A first plurality of electrodes extends within the top surface of the balloon member and is exposed through the top surface of the balloon member. A second plurality of electrodes extends within the bottom surface of the balloon member and is exposed through the bottom surface of the balloon member. Each electrode in the first and second pluralities of electrodes is arranged in a horizontal row relative to the longitudinal axis of the elongated catheter shaft. The horizontal rows are offset such that each electrode in each row is offset from a corresponding electrode in an adjacent row. Optionally, the offset is 60°. Optionally, the offset is in the range of 22.5° to 60°. Each electrode in the first and second pluralities of electrodes can be arranged in a vertical row parallel to the longitudinal axis of the elongated catheter shaft. The vertical rows can be offset such that each electrode in each row is offset from a corresponding electrode in an adjacent row. Each electrode in each row can be equidistant from adjacent electrodes in the same row and adjacent rows. Each of the first plurality of electrodes and the second plurality of electrodes may be grouped into a cluster of three or more electrodes defining a two-dimensional shape. Optionally, the electrode cluster is an equilateral triangle, and each cluster may include at least three electrodes. The electrode cluster may sample electrical properties of the contacted tissue in at least two substantially transverse directions. Optionally, the center-to-center distance between each of the first plurality of electrodes and the second plurality of electrodes is 0.5 mm. Optionally, the center-to-center distance between each of the first plurality of electrodes and the second plurality of electrodes is in the range of 0.5 mm to 4 mm. The catheter may further include a flexible structural element disposed within the lumen of the balloon member. The flexible structural element may include a nickel-titanium alloy wire loop element extending along the longitudinal axis of the elongated catheter shaft. Each of the top and bottom surfaces of the balloon member may include an outer surface layer and an inner surface layer, respectively. The catheter may further include a plurality of electrodes disposed on the outer surface layer of the top surface and the outer surface layer of the bottom surface, and a plurality of conductive traces disposed on the outer surface layer of the top surface and the outer surface layer of the bottom surface. Optionally, the balloon member comprises thermoplastic polyurethane (TPU), thermoplastic elastomer (TPE), polyamide including nylon or nylon elastomer (Pebax), ethylene vinyl acetate (EVA), polyvinylidene fluoride (PVDF), polyvinyl chloride (PVC), silicon, silicone, and / or composites thereof. Optionally, the catheter further comprises: a top flexible frame disposed between the outer surface layer and the inner surface layer of the top surface of the balloon member; a bottom flexible frame disposed between the outer surface layer and the inner surface layer of the bottom surface of the balloon member; a first plurality of electrodes disposed on the top flexible frame; a second plurality of electrodes disposed on the bottom flexible frame; and a plurality of conductive traces disposed on each flexible frame, wherein each of the plurality of conductive traces is electrically coupled to a corresponding one of the first plurality of electrodes and the second plurality of electrodes.The balloon member may include a plurality of holes in the outer surface layer of the top and bottom surfaces of the balloon member to expose the corresponding first and second plurality of electrodes. The diameters of the plurality of holes may be the same as or smaller than the diameters of the corresponding first and second plurality of electrodes. The elongated catheter shaft may include an elliptical inflation lumen connected to the inner lumen of the balloon member, wherein the balloon member is uninflated in a first delivery configuration and inflated by liquid or gas delivered through the elliptical inflation lumen in a second deployed configuration. Optionally, the catheter may include at least one magnetic position sensor disposed along the distal portion of the elongated catheter shaft. Optionally, the catheter may include one or more magnetic position sensors disposed on the distal portion of the expandable assembly. Optionally, each of the first and second plurality of electrodes is configured for independent sensing or energy delivery. The expandable assembly may have an intermediate configuration between the first delivery configuration and the second deployed configuration, wherein in the intermediate configuration, the balloon member is unconstrained by the guide sheath and uninflated.

[0105] In one or more embodiments, the catheter comprises an elongated catheter shaft comprising a proximal end and a distal end. The elongated catheter shaft defines a longitudinal axis. The catheter further comprises an expandable assembly having a first delivery configuration and a second deployment configuration comprising a substantially planar shape. The expandable assembly comprises a top surface, a bottom surface, a flexible frame disposed between the top surface and the bottom surface, and a plurality of electrodes patterned on the flexible frame. The plurality of electrodes are arranged in horizontal rows relative to the longitudinal axis of the elongated catheter shaft. The horizontal rows are offset such that each electrode in each row is offset from a corresponding electrode in an adjacent row. The catheter further comprises a plurality of conductive traces disposed on the flexible frame and electrically coupled to the plurality of electrodes and a flexible structural element disposed within the expandable assembly. Optionally, the expandable assembly comprises a silicon pad. Optionally, the expandable assembly comprises an inner cavity between the top surface and the bottom surface. Optionally, the expandable assembly does not comprise an inner cavity between the top surface and the bottom surface.

[0106] In one or more embodiments, a catheter comprises an elongated catheter shaft comprising a proximal end and a distal end. The elongated catheter shaft defines a longitudinal axis. The catheter comprises an expandable assembly having a first delivery configuration and a second deployment configuration. The expandable assembly comprises a balloon member having a top surface, a bottom surface, and an inner lumen. A flexible frame is disposed between the top surface and the bottom surface. The expandable assembly comprises a plurality of electrodes patterned on the flexible frame, a plurality of conductive traces disposed on the flexible frame and electrically coupled to the plurality of electrodes, and a flexible structural element disposed within the inner lumen.

[0107] In one or more embodiments, the catheter includes an elongated catheter shaft comprising a proximal end and a distal end. The elongated catheter shaft defines a longitudinal axis. The catheter includes an expandable assembly having a linear balloon member having a top surface, a bottom surface, and an inner lumen. Each of the top surface and the bottom surface has an outer surface layer and an inner surface layer. The expandable assembly includes: a top flexible frame disposed between the outer surface layer and the inner surface layer of the top surface of the balloon member; a bottom flexible frame disposed between the outer surface layer and the inner surface layer of the bottom surface of the balloon member; a first plurality of electrodes patterned on the top flexible frame; and a second plurality of electrodes patterned on the bottom flexible frame. The first plurality of electrodes are aligned with the second plurality of electrodes. The expandable assembly includes a plurality of conductive traces disposed on each flexible frame, and each of the plurality of conductive traces is electrically coupled to a corresponding one of the first plurality of electrodes and the second plurality of electrodes. The expandable assembly includes a flexible structural element disposed within the inner lumen.

[0108] In one or more embodiments, the catheter includes an elongated catheter shaft comprising a proximal end and a distal end. The elongated catheter shaft defines a longitudinal axis. The catheter includes an expandable assembly having an annular balloon member having a top surface, a bottom surface, and an inner lumen. Each of the top surface and the bottom surface has an outer surface layer and an inner surface layer. The expandable assembly includes: a top flexible frame disposed between the outer surface layer and the inner surface layer of the top surface of the balloon member; a bottom flexible frame disposed between the outer surface layer and the inner surface layer of the bottom surface of the balloon member; a first plurality of electrodes patterned on the top flexible frame; and a second plurality of electrodes patterned on the bottom flexible frame. The first plurality of electrodes are aligned with the second plurality of electrodes. The expandable assembly includes a plurality of conductive traces disposed on each flexible frame, and each of the plurality of conductive traces is electrically coupled to a corresponding one of the first plurality of electrodes and the second plurality of electrodes. The expandable assembly includes a flexible structural element disposed within the inner lumen.

[0109] In one or more embodiments, the catheter includes an elongated catheter shaft comprising a proximal end and a distal end. The elongated catheter shaft defines a longitudinal axis. The catheter includes an expandable assembly having a circular balloon member having a top surface, a bottom surface, and an inner lumen. Each of the top surface and the bottom surface has an outer surface layer and an inner surface layer. The expandable assembly includes: a top flexible frame disposed between the outer surface layer and the inner surface layer of the top surface of the balloon member; a bottom flexible frame disposed between the outer surface layer and the inner surface layer of the bottom surface of the balloon member; a first plurality of electrodes patterned on the top flexible frame; and a second plurality of electrodes patterned on the bottom flexible frame. The first plurality of electrodes are aligned with the second plurality of electrodes. The expandable assembly includes a plurality of conductive traces disposed on each flexible frame, and each of the plurality of conductive traces is electrically coupled to a corresponding one of the first plurality of electrodes and the second plurality of electrodes. The expandable assembly includes a flexible structural element disposed within the inner lumen.

[0110] In one or more embodiments, the catheter includes an elongated catheter shaft comprising a proximal end and a distal end. The elongated catheter shaft defines a longitudinal axis. The catheter includes an expandable assembly having a balloon member having a top surface, a bottom surface, and an inner lumen. Each of the top surface and the bottom surface has an outer surface layer and an inner surface layer. The expandable assembly includes: a top flexible frame disposed between the outer surface layer and the inner surface layer of the top surface of the balloon member; a bottom flexible frame disposed between the outer surface layer and the inner surface layer of the bottom surface of the balloon member; a first plurality of electrodes patterned on the top flexible frame; and a second plurality of electrodes patterned on the bottom flexible frame. The first plurality of electrodes are aligned with the second plurality of electrodes. The expandable assembly includes a plurality of conductive traces disposed on each flexible frame, and each of the plurality of conductive traces is electrically coupled to a corresponding one of the first plurality of electrodes and the second plurality of electrodes. The expandable assembly includes a flexible structural element disposed within the inner lumen. The expandable assembly also includes a first delivery configuration and a second deployment configuration, and the expandable assembly has a flat shape in the second deployment configuration.

[0111] In one or more embodiments, the catheter includes an elongated catheter shaft comprising a proximal end and a distal end. The elongated catheter shaft defines a longitudinal axis. The catheter includes an expandable assembly having a balloon member having a top surface, a bottom surface, and an inner lumen. Each of the top surface and the bottom surface has an outer surface layer and an inner surface layer. The expandable assembly includes: a top flexible frame disposed between the outer surface layer and the inner surface layer of the top surface of the balloon member; a bottom flexible frame disposed between the outer surface layer and the inner surface layer of the bottom surface of the balloon member; a first plurality of electrodes patterned on the top flexible frame; and a second plurality of electrodes patterned on the bottom flexible frame. The first plurality of electrodes are aligned with the second plurality of electrodes. The expandable assembly includes a plurality of conductive traces disposed on each flexible frame, and each of the plurality of conductive traces is electrically coupled to a corresponding one of the first plurality of electrodes and the second plurality of electrodes. The expandable assembly includes a flexible structural element disposed within the inner lumen. The expandable assembly also includes a first delivery configuration and a second deployment configuration, and the expandable assembly has a convex shape in the second deployment configuration.

[0112] In one or more embodiments, the catheter includes an elongated catheter shaft comprising a proximal end and a distal end. The elongated catheter shaft defines a longitudinal axis. The catheter includes an expandable assembly having a balloon member having a top surface, a bottom surface, and an inner lumen. Each of the top surface and the bottom surface has an outer surface layer and an inner surface layer. The expandable assembly includes: a top flexible frame disposed between the outer surface layer and the inner surface layer of the top surface of the balloon member; a bottom flexible frame disposed between the outer surface layer and the inner surface layer of the bottom surface of the balloon member; a first plurality of electrodes patterned on the top flexible frame; and a second plurality of electrodes patterned on the bottom flexible frame. The first plurality of electrodes are aligned with the second plurality of electrodes. The expandable assembly includes a plurality of conductive traces disposed on each flexible frame, and each of the plurality of conductive traces is electrically coupled to a corresponding one of the first plurality of electrodes and the second plurality of electrodes. The expandable assembly includes a flexible structural element disposed within the inner lumen. The expandable assembly also includes a first delivery configuration and a second deployment configuration, and the expandable assembly has a concave shape in the second deployment configuration.

[0113] In the context of describing the present invention (especially in the following claims), the use of the terms "a," "an," and "the," and similar referents should be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The terms "comprising," "having," "including," and "containing" should be construed as open-ended terms (i.e., meaning "including, but not limited to") unless otherwise indicated. The term "connected" should be construed as partly or completely contained within, attached to, or connected together, even if there are other intervening items. Recitation of ranges of values ​​herein is merely intended as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or clearly contradicted by context. Any and all examples or exemplary language (e.g., "such as") provided herein are intended merely to better illuminate embodiments of the invention and do not constitute a limitation on the scope of the invention unless otherwise indicated. No language in this specification should be construed as indicating any unclaimed element as essential to the practice of the invention.

[0114] The preferred embodiments of the present invention are described herein, including the best modes for carrying out the present invention known to the inventors. After reading the foregoing description, those skilled in the art will appreciate the various variations of these preferred embodiments. The inventors expect those skilled in the art to appropriately adopt these variations, and the inventors intend that the present invention can be implemented in a manner different from that specifically described herein. Therefore, the present invention includes all modifications and equivalents to the subject matter described in the appended claims as permitted by applicable law. Furthermore, unless otherwise specified herein or clearly contradicted by context, the present invention encompasses any combination of the above-described elements in all their possible variations.

[0115] All references, including publications, patent applications, and patents, cited herein are hereby incorporated by reference to the same extent as if each reference were individually and specifically indicated to be incorporated by reference and were set forth in its entirety herein.

Claims

1. A catheter, comprising: an elongated catheter shaft comprising a proximal end and a distal end, the elongated catheter shaft defining a longitudinal axis; as well as An expandable assembly, wherein the expandable assembly comprises: a balloon member having a top surface, a bottom surface, and an inner lumen, each of the top surface and the bottom surface having an outer surface layer and an inner surface layer; a top flexible frame disposed between the outer surface layer and the inner surface layer of the top surface of the balloon member; a bottom flexible frame disposed between the outer surface layer and the inner surface layer of the bottom surface of the balloon member; a first plurality of electrodes patterned on the top flexible frame; a second plurality of electrodes patterned on the bottom flexible frame, wherein the first plurality of electrodes are aligned with the second plurality of electrodes; a plurality of conductive traces disposed on each flexible frame, each conductive trace of the plurality of conductive traces being electrically coupled to a respective one of the first plurality of electrodes and the second plurality of electrodes; and A flexible structural element is disposed within the inner cavity.

2. The catheter of claim 1, wherein the flexible structural element comprises a nickel titanium alloy wire loop element extending along the longitudinal axis of the elongated catheter shaft.

3. The catheter of claim 2, wherein the nickel-titanium wire loop element is disposed between the top flexible frame and the bottom flexible frame.

4. The catheter of any one of claims 1 to 3, wherein the expandable assembly further comprises a first delivery configuration and a second deployed configuration.

5. The catheter of any one of claims 1 to 4, wherein the balloon member has a flat, concave, or convex shape in the second expanded configuration.

6. The catheter of any one of claims 1 to 5, wherein the expandable assembly has an intermediate configuration between the first delivery configuration and the second deployed configuration, wherein In the intermediate configuration, the balloon member is free from the introducer sheath and is uninflated.

7. A catheter according to any one of claims 1 to 6, wherein the balloon member includes a plurality of holes on the outer surface layer of the top surface and the bottom surface of the balloon member, the plurality of holes being configured to expose the corresponding first plurality of electrodes and the second plurality of electrodes, wherein the diameters of the plurality of holes are the same as or smaller than the diameters of the corresponding first plurality of electrodes and the second plurality of electrodes.

8. The catheter of any one of claims 1 to 7, wherein the diameter of the plurality of holes is in the range of 0.25 mm to 3 mm, and the diameter of the respective first and second pluralities of electrodes is in the range of 0.25 mm to 3 mm.

9. The catheter of any one of claims 1 to 8, wherein the first and second pluralities of electrodes are flush, recessed, or raised relative to outer surface layers of the top and bottom surfaces of the balloon member.

10. The catheter of any one of claims 1 to 9, wherein the elongated catheter shaft comprises an elliptical inflation lumen connected to the lumen of the balloon member, wherein the balloon member is uninflated in the first delivery configuration and inflated in the second deployment configuration by liquid or gas delivered through the elliptical inflation lumen.

11. The catheter of any one of claims 1 to 10, wherein each of the first plurality of electrodes and the second plurality of electrodes are arranged in a horizontal row relative to the longitudinal axis of the slender catheter shaft, wherein the horizontal rows are offset so that each electrode in each row is offset from a corresponding electrode in an adjacent row.

12. The catheter of any one of claims 1 to 11, wherein each of the first plurality of electrodes and the second plurality of electrodes are arranged in vertical rows parallel to the longitudinal axis of the elongated catheter shaft, wherein the vertical rows are offset such that each electrode in each row is offset from a corresponding electrode in an adjacent row.

13. The catheter of claim 11 or 12, wherein the offset is 60°.

14. The catheter of claim 11 or 12, wherein the offset is in the range of 22.5° to 60°.

15. The catheter of any one of claims 1 to 14, wherein each electrode in each row is equidistant from adjacent electrodes in the same and adjacent rows.

16. The catheter of any one of claims 1 to 15, wherein each electrode of the first plurality of electrodes and the second plurality of electrodes is configured for independent sensing or energy delivery.

17. The catheter of any one of claims 1 to 16, wherein each electrode of the first and second pluralities of electrodes is grouped into a cluster of three or more electrodes defining a two-dimensional shape.

18. The catheter of claim 17, wherein the electrode clusters are configured as equilateral triangles, each cluster having at least three electrodes, the electrode clusters being configured to sample electrical properties of contacted tissue in at least two substantially transverse directions.

19. The catheter of any one of claims 1 to 18, wherein a center-to-center distance between each electrode of the first plurality of electrodes and the second plurality of electrodes is in the range of 0.5 mm to 4 mm.

20. The catheter of any one of claims 1 to 19, further comprising at least one magnetic position sensor disposed along a distal portion of the elongated catheter shaft.

21. The catheter of any one of claims 1 to 20, further comprising one or more magnetic position sensors disposed on the top flexible frame or the bottom flexible frame of the distal portion of the expandable assembly.

22. The catheter of any one of claims 1 to 21, wherein the balloon member is circular in the second expanded configuration.

23. The catheter of any one of claims 1 to 22, wherein the balloon member is a cylindrical or cubic linear balloon member in the second expanded configuration.

24. The catheter of any one of claims 1 to 23, wherein the expandable assembly is a basket assembly having a plurality of balloon members, wherein each balloon member is cylindrical or cubic in the second deployed configuration.

25. A catheter comprising: an elongated catheter shaft comprising a proximal end and a distal end, the elongated catheter shaft defining a longitudinal axis; as well as An expandable assembly having a first delivery configuration and a second deployed configuration, wherein the expandable assembly comprises: a balloon member having a substantially flat shape in the second expanded configuration and comprising a top surface and a bottom surface; a first plurality of electrodes extending within and exposed through the top surface of the balloon member; and A second plurality of electrodes extending within and exposed through the bottom surface of the balloon member, wherein each electrode of the first plurality of electrodes and the second plurality of electrodes are arranged in horizontal rows relative to the longitudinal axis of the slender catheter shaft, and wherein the horizontal rows are offset so that each electrode in each row is offset from a corresponding electrode in an adjacent row.

26. The catheter of claim 25, wherein the offset is 60°.

27. The catheter of claim 25 or 26, wherein the offset is in the range of 22.5° to 60°.

28. A catheter according to any one of claims 25 to 27, wherein each of the first plurality of electrodes and the second plurality of electrodes are arranged in vertical rows parallel to the longitudinal axis of the slender catheter shaft, and wherein the vertical rows are offset so that each electrode in each row is offset from the corresponding electrode in an adjacent row.

29. The catheter of any one of claims 25 to 28, wherein each electrode in each row is equidistant from adjacent electrodes in the same and adjacent rows.

30. The catheter of any one of claims 25 to 29, wherein each electrode of the first and second pluralities of electrodes is grouped into clusters of three or more electrodes defining a two-dimensional shape.

31. The catheter of claim 30, wherein the electrode clusters are configured as equilateral triangles, each cluster having at least three electrodes, the electrode clusters being configured to sample electrical properties of contacting tissue in at least two substantially transverse directions.

32. The catheter of claim 25, wherein a center-to-center distance between each electrode of the first plurality of electrodes and the second plurality of electrodes is 0.5 mm.

33. The catheter of claim 25, wherein a center-to-center distance between each electrode of the first plurality of electrodes and the second plurality of electrodes is in the range of 0.5 mm to 4 mm.

34. The catheter of any one of claims 25 to 33, further comprising a flexible structural element disposed within the lumen of the balloon member.

35. The catheter of claim 34, wherein the flexible structural element comprises a nickel titanium alloy wire loop element extending along the longitudinal axis of the elongated catheter shaft.

36. The catheter of any one of claims 25 to 35, wherein each of the top and bottom surfaces of the balloon member comprises an outer surface layer and an inner surface layer.

37. The catheter of claim 36, further comprising a plurality of electrodes disposed on the outer surface layer of the top surface and the outer surface layer of the bottom surface; and a plurality of conductive traces disposed on the outer surface layer of the top surface and the outer surface layer of the bottom surface.

38. The catheter of claim 37, wherein the balloon member comprises thermoplastic polyurethane (TPU), thermoplastic elastomer (TPE), polyamide including nylon or nylon elastomer, ethylene vinyl acetate (EVA), polyvinylidene fluoride (PVDF), polyvinyl chloride (PVC), silicon, silicone and / or composites thereof.

39. The catheter of claim 36, further comprising: a top flexible frame disposed between the outer surface layer and the inner surface layer of the top surface of the balloon member; a bottom flexible frame disposed between the outer surface layer and the inner surface layer of the bottom surface of the balloon member; a first plurality of electrodes disposed on the top flexible frame; a second plurality of electrodes disposed on the bottom flexible frame; as well as A plurality of conductive traces are disposed on each flexible frame, each conductive trace of the plurality of conductive traces being electrically coupled to a respective one of the first plurality of electrodes and the second plurality of electrodes.

40. A catheter according to claim 36, wherein the balloon member includes a plurality of holes located on the outer surface layer of the top surface and the bottom surface of the balloon member, and the plurality of holes are configured to expose the corresponding first plurality of electrodes and the second plurality of electrodes, wherein the diameters of the plurality of holes are the same as or smaller than the diameters of the corresponding first plurality of electrodes and the second plurality of electrodes.

41. The catheter of claim 34, wherein the elongated catheter shaft comprises an elliptical inflation lumen connected to the lumen of the balloon member, wherein the balloon member is uninflated in the first delivery configuration and is inflated by a liquid or gas delivered through the elliptical inflation lumen in the second deployment configuration.

42. The catheter of any one of claims 25 to 41, further comprising at least one magnetic position sensor disposed along a distal portion of the elongated catheter shaft.

43. The catheter of any one of claims 25 to 42, further comprising one or more magnetic position sensors disposed on a distal portion of the expandable assembly.

44. The catheter of any one of claims 25 to 43, wherein each electrode of the first plurality of electrodes and the second plurality of electrodes is configured for independent sensing or energy delivery.

45. The catheter of any one of claims 25 to 44, wherein the expandable assembly has an intermediate configuration between the first delivery configuration and the second deployed configuration, wherein In the intermediate configuration, the balloon member is free from the introducer sheath and is uninflated.

46. ​​A catheter comprising: an elongated catheter shaft comprising a proximal end and a distal end, the elongated catheter shaft defining a longitudinal axis; as well as An expandable assembly having a first delivery configuration and a second deployed configuration comprising a substantially planar shape, wherein the expandable assembly comprises: top surface; bottom surface; a flexible frame disposed between the top surface and the bottom surface; a plurality of electrodes patterned on the flexible frame, wherein the plurality of electrodes are arranged in horizontal rows relative to a longitudinal axis of the elongated catheter shaft, wherein the horizontal rows are offset such that each electrode in each row is offset from a corresponding electrode in an adjacent row; a plurality of conductive traces disposed on the flexible frame and electrically coupled to the plurality of electrodes; and A flexible structural element is disposed within the expandable assembly.

47. The catheter of claim 46, wherein the expandable component comprises a silicone pad.

48. The catheter of claim 46 or 47, wherein the expandable member comprises a lumen between the top surface and the bottom surface.

49. The catheter of claim 46 or 47, wherein the expandable member does not include a lumen between the top surface and the bottom surface.

50. A catheter comprising: an elongated catheter shaft comprising a proximal end and a distal end, the elongated catheter shaft defining a longitudinal axis; as well as An expandable assembly having a first delivery configuration and a second deployed configuration, wherein the expandable assembly comprises: a balloon member having a top surface, a bottom surface, and an inner lumen; a flexible frame disposed between the top surface and the bottom surface; a plurality of electrodes patterned on the flexible frame; a plurality of conductive traces disposed on the flexible frame and electrically coupled to the plurality of electrodes; and A flexible structural element is disposed within the inner cavity.

51. A catheter comprising: an elongated catheter shaft comprising a proximal end and a distal end, the elongated catheter shaft defining a longitudinal axis; as well as An expandable assembly, wherein the expandable assembly comprises: a linear balloon member having a top surface, a bottom surface, and an inner lumen, each of the top surface and the bottom surface having an outer surface layer and an inner surface layer; a top flexible frame disposed between the outer surface layer and the inner surface layer on the top surface of the balloon member; a bottom flexible frame disposed between the outer surface layer and the inner surface layer of the bottom surface of the balloon member; a first plurality of electrodes patterned on the top flexible frame; a second plurality of electrodes patterned on the bottom flexible frame, wherein the first plurality of electrodes are aligned with the second plurality of electrodes; a plurality of conductive traces disposed on each flexible frame, each conductive trace of the plurality of conductive traces being electrically coupled to a respective one of the first plurality of electrodes and the second plurality of electrodes; and A flexible structural element is disposed within the inner cavity.

52. A catheter comprising: an elongated catheter shaft comprising a proximal end and a distal end, the elongated catheter shaft defining a longitudinal axis; as well as An expandable assembly, wherein the expandable assembly comprises: an annular balloon member having a top surface, a bottom surface, and an inner lumen, each of the top surface and the bottom surface having an outer surface layer and an inner surface layer; a top flexible frame disposed between the outer surface layer and the inner surface layer on the top surface of the balloon member; a bottom flexible frame disposed between the outer surface layer and the inner surface layer of the bottom surface of the balloon member; a first plurality of electrodes patterned on the top flexible frame; a second plurality of electrodes patterned on the bottom flexible frame, wherein the first plurality of electrodes are aligned with the second plurality of electrodes; a plurality of conductive traces disposed on each flexible frame, each conductive trace of the plurality of conductive traces being electrically coupled to a respective one of the first plurality of electrodes and the second plurality of electrodes; and A flexible structural element is disposed within the inner cavity.

53. A catheter comprising: an elongated catheter shaft comprising a proximal end and a distal end, the elongated catheter shaft defining a longitudinal axis; as well as An expandable assembly, wherein the expandable assembly comprises: a rounded balloon member having a top surface, a bottom surface, and an inner cavity, each of the top surface and the bottom surface having an outer surface layer and an inner surface layer; a top flexible frame disposed between the outer surface layer and the inner surface layer on the top surface of the balloon member; a bottom flexible frame disposed between the outer surface layer and the inner surface layer of the bottom surface of the balloon member; a first plurality of electrodes patterned on the top flexible frame; a second plurality of electrodes patterned on the bottom flexible frame, wherein the first plurality of electrodes are aligned with the second plurality of electrodes; a plurality of conductive traces disposed on each flexible frame, each conductive trace of the plurality of conductive traces being electrically coupled to a respective one of the first plurality of electrodes and the second plurality of electrodes; and A flexible structural element is disposed within the inner cavity.

54. A catheter comprising: an elongated catheter shaft comprising a proximal end and a distal end, the elongated catheter shaft defining a longitudinal axis; as well as An expandable assembly, wherein the expandable assembly comprises: a balloon member having a top surface, a bottom surface, and an inner lumen, each of the top surface and the bottom surface having an outer surface layer and an inner surface layer; a top flexible frame disposed between the outer surface layer and the inner surface layer on the top surface of the balloon member; a bottom flexible frame disposed between the outer surface layer and the inner surface layer of the bottom surface of the balloon member; a first plurality of electrodes patterned on the top flexible frame; a second plurality of electrodes patterned on the bottom flexible frame, wherein the first plurality of electrodes are aligned with the second plurality of electrodes; a plurality of conductive traces disposed on each flexible frame, each conductive trace of the plurality of conductive traces being electrically coupled to a respective one of the first plurality of electrodes and the second plurality of electrodes; and A flexible structural element disposed within the inner cavity, The expandable component further includes a first delivery configuration and a second deployment configuration, and the expandable component has a flat shape in the second deployment configuration.

55. A catheter comprising: an elongated catheter shaft comprising a proximal end and a distal end, the elongated catheter shaft defining a longitudinal axis; as well as An expandable assembly, wherein the expandable assembly comprises: a balloon member having a top surface, a bottom surface, and an inner lumen, each of the top surface and the bottom surface having an outer surface layer and an inner surface layer; a top flexible frame disposed between the outer surface layer and the inner surface layer on the top surface of the balloon member; a bottom flexible frame disposed between the outer surface layer and the inner surface layer of the bottom surface of the balloon member; a first plurality of electrodes patterned on the top flexible frame; a second plurality of electrodes patterned on the bottom flexible frame, wherein the first plurality of electrodes are aligned with the second plurality of electrodes; a plurality of conductive traces disposed on each flexible frame, each conductive trace of the plurality of conductive traces being electrically coupled to a respective one of the first plurality of electrodes and the second plurality of electrodes; and A flexible structural element disposed within the inner cavity, The expandable component further comprises a first delivery configuration and a second deployment configuration, and the expandable component has a convex shape in the second deployment configuration.

56. A catheter comprising: an elongated catheter shaft comprising a proximal end and a distal end, the elongated catheter shaft defining a longitudinal axis; as well as An expandable assembly, wherein the expandable assembly comprises: a balloon member having a top surface, a bottom surface, and an inner lumen, each of the top surface and the bottom surface having an outer surface layer and an inner surface layer; a top flexible frame disposed between the outer surface layer and the inner surface layer on the top surface of the balloon member; a bottom flexible frame disposed between the outer surface layer and the inner surface layer of the bottom surface of the balloon member; a first plurality of electrodes patterned on the top flexible frame; a second plurality of electrodes patterned on the bottom flexible frame, wherein the first plurality of electrodes are aligned with the second plurality of electrodes; a plurality of conductive traces disposed on each flexible frame, each conductive trace of the plurality of conductive traces being electrically coupled to a respective one of the first plurality of electrodes and the second plurality of electrodes; and A flexible structural element disposed within the inner cavity, The expandable component further comprises a first delivery configuration and a second deployment configuration, and the expandable component has a concave shape in the second deployment configuration.

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