High-density flat balloon catheter

Abstract

High-density flat balloon catheter The present invention relates in general to an expandable catheter used in electrophysiology, and more specifically to a high-density balloon catheter used for the diagnosis and / or treatment of cardiac arrhythmias. The catheter includes an elongated catheter shaft having a proximal end and a distal end. The elongated catheter shaft defines a longitudinal axis. The catheter includes an expandable assembly having a first delivery configuration and a second deployment configuration. The balloon member includes at least one flexible framework positioned between outward and inward layers on the upper and / or lower surfaces of the balloon member, and at least one plurality of electrodes patterned on the flexible framework. In some embodiments, a flat balloon member includes electrodes on both sides of the planar balloon member. The balloon member may include a flexible structural element positioned within an internal cavity.

Description

Technical Field

[0001] Cross - reference to related applications This application claims the priority of 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 disclosure of which is hereby incorporated by reference in its entirety for all purposes.

Background Art

[0002] Electrophysiological (EP) catheters may be configured for use in the diagnosis and / or treatment of cardiac arrhythmias. Cardiac arrhythmias may manifest as one or more observable conditions, such as, for example, irregular heart rate, loss of synchronized atrioventricular contractions, and inadequate blood flow within the heart chambers, and can lead to various symptomatic and / or asymptomatic diseases and even death. In order to determine whether a patient's heart exhibits a pathological electrical state that leads to the occurrence of cardiac arrhythmias, the electrical activity of the patient's heart may be measured and evaluated. After diagnosing the pathological electrical state, appropriate treatment methods can be used to selectively change the patient's heart tissue to reduce or eliminate the pathological electrical state, thereby reducing or eliminating the occurrence of cardiac arrhythmias. Treatment methods 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 ablation treatment methods.

Summary of the Invention

Means for Solving the Problems

[0003] The present invention relates, in general, to an expandable catheter used in electrophysiology, and more specifically, to a high-density balloon catheter used in the diagnosis and / or treatment of cardiac arrhythmias. The substantially flat balloon member (e.g., a member having a double-sided balloon structure) according to the embodiments described herein includes an internal flexible circuit and electrodes exposed from one or both sides of the balloon member. The design of the present invention allows for a smaller electrode surface area, narrower spacing between electrodes, and various shape configurations (e.g., flat, football, convex, concave, etc.) and electrode arrangements (e.g., offset horizontal and / or vertical rows), thereby providing better diagnostic measurements while reducing manufacturing costs. For example, electrodes may be patterned on an offset row to group them more evenly. More accurate mapping and sensing are possible because the relevant algorithms do not need to compensate for timing delays. Designs including a double-sided balloon member allow for better determination of contact with tissue or blood at the electrode contact surface, thereby reducing or eliminating the far-field effect. In some aspects of the present invention, the balloon member includes a flexible structural element to further enhance the rigidity and strength of the balloon structure and to prevent twisting.

[0004] In various embodiments, the catheter includes an elongated catheter shaft having a proximal and distal end. The elongated 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 an upper surface, a lower surface, and an internal cavity. Each of the upper and lower surfaces includes an outward-facing layer and an inward-facing layer. The expandable assembly includes an upper flexible framework positioned between the outward-facing and inward-facing layers of the upper surface of the balloon member, and a lower flexible framework positioned between the outward-facing and inward-facing layers of the lower surface of the balloon member. In some embodiments, a first plurality of electrodes are patterned on the upper flexible framework, and a second plurality of electrodes are patterned on the lower flexible framework. The first plurality of electrodes are aligned with the second plurality of electrodes. Each of the flexible frameworks is provided with a plurality of conductive traces. Each of the multiple conductive traces is electrically connected to a corresponding one of the first multiple electrodes and the second multiple electrodes. The expandable assembly includes flexible structural elements located within an internal cavity. According to various embodiments of this disclosure, the conductive material may include electrodes and conductors. Furthermore, various conductive materials may include metals such as copper, gold, silver, platinum, iridium(IV) oxide (IrOx), titanium nickel (TiNi), and alloys thereof. Conductive materials also include polymers such as poly(3,4-ethylenedioxythiophene) (PEDOT) and modified PEDOT.

[0005] In at least some embodiments, the flexible structural element includes a nitinol 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 twisting when it comes into contact with tissue. The nitinol wire loop element is positioned between the upper flexible framework and the lower flexible framework.

[0006] In some embodiments, the balloon member includes a plurality of openings in the outward-facing layer on the upper surface and the outward-facing layer on the lower surface of the balloon member. The plurality of openings expose each of the first plurality of electrodes and the second plurality of electrodes. The diameter of the plurality of openings is the same size as or smaller than the diameter of each of the first plurality of electrodes and the second plurality of electrodes. The diameter of the plurality of openings is 0.25 mm to 3 mm, and the diameter of each of the first plurality of electrodes and the second plurality of electrodes is 0.25 mm to 3 mm. The first plurality of electrodes and the second plurality of electrodes are flush with (e.g., spot electrodes), recessed, or protruding from the outward-facing layer on the upper and lower surfaces of the balloon member. For example, the electrodes may protrude from the outward-facing layer on the upper surface of the balloon member to increase tissue contact between the electrodes and the tissue of interest (e.g., cardiac tissue).

[0007] In various embodiments, the elongated catheter shaft includes an inflation lumen. In some embodiments, the inflation lumen may be elliptical. The balloon member is not inflated in the first delivery configuration and is inflated in the second deployment configuration by the liquid or gas supplied through the elliptical inflation lumen. The expandable assembly has an intermediate configuration between the first and second configurations, in which the balloon member is not constrained by the introducer sheath and is not inflated. In some embodiments, the balloon member has a flat, concave, or convex shape in the second deployment configuration. For example, the balloon member is substantially flat in the deployment configuration. In other embodiments, the balloon member extends outward in the central part of the balloon member, forming a “football” shape (e.g., convex shape).

[0008] In at least some embodiments, each of the first and second sets of electrodes is arranged in a transverse row with respect to the longitudinal axis of the elongated catheter shaft. The transverse rows are offset such that each electrode in each row is offset from each electrode in the adjacent row. For example, each electrode in each row is equally spaced from adjacent electrodes in the same row and adjacent electrodes in adjacent rows. The center-to-center distance between each electrode in the first and second sets of electrodes is 2.5 mm. In some embodiments, the center-to-center distance between each electrode in the first and second sets of electrodes is 1 mm to 4 mm. In other embodiments, each of the first and second sets of electrodes is arranged in a longitudinal row parallel to the longitudinal axis of the elongated catheter shaft, and the longitudinal rows are offset such that each electrode in each row is offset from each electrode in the adjacent row. In some embodiments, the transverse and / or longitudinal offset is 60°. In various embodiments, the transverse and / or longitudinal offset is 22.5° to 60°.

[0009] In various embodiments, each of the first and second plurality of electrodes is configured to sense independently for diagnostic mapping or energy supply for treating cardiac arrhythmias. For example, the first plurality of electrodes may be configured to sense tissue of interest (e.g., cardiac tissue), and the second plurality of electrodes may 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 may be independently driven and / or deactivated during use. Individual electrodes of the first plurality of electrodes and / or the second plurality of electrodes may be independently driven and / or deactivated during use.

[0010] In various embodiments, each electrode of the first plurality of electrodes and the second plurality of electrodes are grouped into groups containing three or more electrodes that define a two-dimensional shape. For example, the groups of electrodes may be configured to form an equilateral triangle, and each group contains at least three electrodes. The groups of electrodes are configured to sample the electrical characteristics of the contact tissue in at least two substantially lateral directions.

[0011] In some embodiments, the catheter includes at least one magnetic position sensor positioned along the distal portion of the catheter shaft. The catheter may further include one or more magnetic position sensors positioned on the upper flexible framework and / or the lower flexible framework at the distal portion of the expandable assembly.

[0012] In one embodiment, the catheter includes an elongated catheter shaft, which includes a proximal and 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 substantially planar shape in the second deployment configuration, and including an upper and lower surface. The balloon member includes a first plurality of electrodes extending inside the upper surface of the balloon member and exposed from the upper surface, and a second plurality of electrodes extending inside the lower surface of the balloon member and exposed from the lower surface. Each of the first plurality of electrodes and the second plurality of electrodes are arranged in transverse rows with respect to the longitudinal axis of the elongated catheter shaft. The transverse rows are offset such that each electrode in each row is offset from each electrode in the adjacent row.

[0013] According to some embodiments, each electrode on each row is equally spaced from adjacent electrodes on the same row and adjacent electrodes on adjacent rows. In one exemplary embodiment, each electrode of the first plurality of electrodes has a diameter of 0.25 mm, with an end-to-end spacing of 0.25 mm and a center-to-center spacing of 0.5 mm. In another embodiment, the center-to-center distance of the first plurality of electrodes and the center-to-center distance of the second plurality of electrodes is 1.0 mm. In yet another embodiment, the center-to-center distance of the first plurality of electrodes and the center-to-center distance of the second plurality of electrodes may be 1.5 mm. According to another embodiment, the center-to-center distance of the first plurality of electrodes and the center-to-center distance of the second plurality of electrodes may be 2.0 mm. In yet another embodiment, the center-to-center distance of the first plurality of electrodes and the center-to-center distance of the second plurality of electrodes may be 2.5 mm. In yet another embodiment, the center-to-center distance of the first plurality of electrodes and the center-to-center distance of the second plurality of electrodes may be 3.0 mm. In some embodiments, the intercenter distances of the first and second sets of electrodes are 0.5 mm to 3 mm. In other embodiments, each of the first and second sets of electrodes is further arranged in tandem columns parallel to the longitudinal axis of the elongated catheter shaft, with the columns offset such that each electrode in each column is offset from each electrode in the adjacent column. In some embodiments, the lateral and / or longitudinal offset is 60°. In various embodiments, the lateral and / or longitudinal offset is 22.5° to 60°.

[0014] In at least some embodiments, the expandable assembly includes a flexible structural element located within the internal cavity of the balloon member. The flexible structural element comprises a nitinol wire loop element extending along the longitudinal axis of the elongated catheter shaft to provide rigidity to the balloon member and prevent twisting when the balloon member contacts tissue. The nitinol wire loop element is positioned between the upper and lower flexible frameworks to further enhance the integrity of the catheter. It will be understood that the inflated balloon member provides sufficient rigidity and / or strength when the balloon member contacts tissue.

[0015] In some embodiments, the expandable assembly includes a balloon member having a top surface, a bottom surface, and an internal cavity. Each of the top and bottom surfaces includes an outward-facing layer and an inward-facing layer. The expandable assembly includes an upper flexible framework positioned between the outward-facing and inward-facing layers of the top surface of the balloon member, and a lower flexible framework positioned between the outward-facing and inward-facing layers of the bottom surface of the balloon member. In some embodiments, a first plurality of electrodes are patterned on the upper flexible framework, and a second plurality of electrodes are patterned on the lower flexible framework. The first plurality of electrodes are aligned with the second plurality of electrodes. Each flexible framework has a plurality of conductive traces. Each of the plurality of conductive traces is electrically connected to a corresponding one of the first plurality of electrodes and the second plurality of electrodes.

[0016] In some embodiments, the balloon member itself incorporates conductive traces located in the outward-facing upper layer and / or the outward-facing lower layer, eliminating the need to incorporate a separate flexible framework (e.g., a polyimide flex circuit). The balloon member may be composed of a variety of materials, including thermoplastic polyurethane (TPU), thermoplastic elastomer (TPE), polyamides including nylon and Pebax, ethylene vinyl acetate (EVA), polyvinylidene fluoride (PVDF), polyvinyl chloride (PVC), silicone, and / or composites thereof. As will be described in more detail below, the electrodes and corresponding conductive traces are constructed (e.g., positioned) in the outward-facing upper layer and / or the outward-facing lower layer of the balloon member during manufacturing.

[0017] In other embodiments, the catheter comprises a flexible silicone pad structure having a substantially flat and / or substantially planar shape. The catheter includes an elongated catheter shaft having a proximal and 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 top surface, a bottom surface, and a flexible framework positioned between the top and bottom surfaces. Multiple electrodes are patterned on the flexible framework. The multiple electrodes are arranged in transverse rows with respect to the longitudinal axis of the elongated catheter shaft, and the transverse rows are offset such that each electrode in each row is offset from each electrode in the adjacent row. Multiple conductive traces are positioned on the flexible framework connected to the multiple electrodes, and flexible structural elements are positioned within the expandable assembly. In some embodiments, the silicone pad structure includes an internal cavity between the top and bottom surfaces, and the flexible structural elements are positioned within the internal cavity. In other embodiments, the silicone pad structure does not have an internal cavity when the components are placed in a mold to form the silicone pad structure and the silicone is injection molded. In other embodiments, a laminate layer may be placed inside the internal cavity. Other structures may be provided inside the internal cavity to set the diameter of the assembly. For example, in one embodiment, the catheter includes a polyimide layer placed between the upper and lower surfaces. Other materials that may be provided inside the internal cavity to set the diameter of the assembly include relatively soft materials such as polymers in the form of thin structural members, and relatively hard materials such as metals.

[0018] In yet another embodiment, a catheter having a substantially flat and / or substantially planar shape may have only electrodes positioned on either the upper or lower surface. 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 deployment configuration. The expandable assembly includes a balloon member having an upper surface, a lower surface, and an internal cavity. In this embodiment, one of the upper and lower surfaces includes an outward-facing layer, an inward-facing layer, and a flexible framework positioned between the outward-facing and inward-facing layers. Multiple electrodes are patterned on the flexible framework, and multiple conductive traces are positioned on the flexible framework. Each of the multiple conductive traces is electrically connected to the multiple electrodes. The balloon member includes a flexible structural element positioned within the internal cavity.

[0019] The above is a simplified summary of some embodiments of the present invention to provide a basic understanding of the invention. This summary is not a detailed overview of the invention. Nor is it intended to identify the main / important elements of the invention or to limit its scope. It is solely intended to provide a simplified overview of some embodiments of the invention as a preliminary step to the more detailed description provided below.

[0020] In this specification, where the terms “planar” or similarly “plane” or “coplanar” are used, they should be understood to refer to a topological plane. In other words, “plane” may not be “flat” in Cartesian coordinates and may represent a two-dimensional distribution that is planar in a topological sense. Similarly, where the term “linear” is used in this specification, it should be understood to refer to a topological plane. In other words, “linear” may not be “straight” in Cartesian coordinates and may represent a one-dimensional distribution that is linear in a topological sense. [Brief explanation of the drawing]

[0021] [Figure 1] An example of a medical device localization system that can be used with an expandable catheter according to an embodiment of the present disclosure is shown. [Figure 2] An example of a catheter according to an embodiment of the present disclosure is shown. [Figure 3] A perspective view of an expandable electrode assembly according to an embodiment of the present disclosure is shown. [Figure 4A] A partial cross-sectional view of an expandable electrode assembly according to an embodiment of the present disclosure as viewed from above is shown. [Figure 4B] An exploded view of a conductive trace on a flexible framework of an expandable electrode assembly according to an embodiment of the present disclosure is shown. [Figure 5A] Another partial cross-sectional view of an electrode arrangement of an expandable electrode assembly according to an embodiment of the present disclosure as viewed from above is shown. [Figure 5B] Another electrode arrangement of an expandable electrode assembly according to an embodiment of the present disclosure is shown. [Figure 6] A perspective cross-sectional view of an expandable electrode assembly according to an embodiment of the present disclosure is shown. [Figure 7] Another perspective cross-sectional view of an expandable electrode assembly according to an embodiment of the present disclosure is shown. [Figure 8A] A cross-sectional view of an expandable electrode assembly according to an embodiment of the present disclosure is shown. [Figure 8B] A cross-sectional view of an expandable electrode assembly according to an embodiment of the present disclosure is shown. [Figure 8C] A cross-sectional view of an expandable electrode assembly according to an embodiment of the present disclosure is shown. [Figure 9] A perspective cross-sectional view of an expandable electrode assembly according to an embodiment of the present disclosure is shown. [Figure 10A] A perspective view of the distal end of an elongated catheter shaft according to an embodiment of the present disclosure is shown. [Figure 10B] A perspective cross-sectional view of the distal end of an elongated catheter shaft according to an embodiment of the present disclosure is shown. [Figure 10C] A cross-sectional view of the distal end of an elongated catheter shaft according to an embodiment of the present disclosure is shown. [Figure 11] This is a flowchart of the manufacturing method according to the embodiments of this disclosure. [Figure 12A] This is a perspective exploded view of an expandable electrode assembly according to an embodiment of the present disclosure. [Figure 12B] This is a perspective exploded view of an expandable electrode assembly according to an embodiment of the present disclosure. [Figure 13] A perspective view of a catheter connector according to an embodiment of the present disclosure is shown. [Modes for carrying out the invention]

[0022] The following description will explain various embodiments of the present invention. For the sake of clarity and to provide a thorough understanding of the embodiments, specific configurations and details will be described. However, it will be apparent to those skilled in the art that the present invention can be carried out without specific details. Furthermore, well-known features may be omitted or simplified to avoid obscuring the description of the embodiments.

[0023] As shown in Figure 1, the electrode assembly 101 of the high-density catheter 100 is configured to conform to tissue (e.g., cardiac tissue) and to bring the electrode 102 into contact with the tissue. In many embodiments, the electrode assembly 101 has appropriate flexibility and corresponds to appropriate deflection of the electrode assembly 101 in accordance with the appropriate contact force between the electrode assembly 101 and the tissue. For example, the electrode assembly 101 comprises a flexible balloon member (e.g., an expandable electrode assembly 202) which is configured to conform to tissue and to bring the electrode 102 into contact with the tissue. The balloon member may be made of a variety of biocompatible materials, including thermoplastic polyurethane (TPU), thermoplastic elastomer (TPE), polyamide containing nylon or Pebax, ethylene vinyl acetate (EVA), polyvinylidene fluoride (PVDF), polyvinyl chloride (PVC), silicone, and / or composites thereof. In a preferred embodiment, the balloon material is made of Pebax.

[0024] The configuration of the electrode assembly 101 described herein facilitates insertion of the electrode assembly 101 using the catheter handle 110, deployment of the electrode assembly 101 within the heart 16, and removal of the electrode assembly 101 from the patient 17 by responding to relative movement between a non-deployed configuration and a deployed configuration. In particular, the expandable electrode assembly 202 (shown in Figure 2) serves to prevent the induction of very localized strain that may occur if it is not possible to respond to relative movement. For example, upon entering a target cardiac chamber of the heart 16, the electrodes 102 extending inward on the surface of the expandable electrode assembly 202 come into contact with the tissue as the expandable electrode assembly 202 expands (e.g., inflates), contracts (e.g., deflates), advances, or retracts to receive a signal. The signal may be sent via the connector 56 to a system that analyzes the signal for localization, for example. In some embodiments, the electrode assembly 101 may be inserted into the heart 16 through an introducer or delivery catheter.

[0025] The high-density catheter 100 can be used with any suitable medical localization system, such as the systems referenced and / or described herein. For example, the high-density catheter 100 can be used with the catheter localization system and method described in U.S. Patent Publication 2020 / 0138334 A1, entitled “Method for Medical Device Localization based on Magnetic and Impedance Sensors,” the entire disclosure of which is incorporated herein by reference.

[0026] Figure 1 also shows a medical device positioning system 108 that can be used 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 such as 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 (configured as magnetic position sensors in some embodiments).

[0027] The input / output mechanism 114 may include conventional devices for interacting with a computer-based control unit, which may include one or more of the following: a keyboard, mouse, tablet, foot pedal, switch, etc. The display 116 may also include conventional devices such as a computer monitor.

[0028] The ECG monitor 120 is configured to continuously detect electrical timing signals of the cardiac organs using multiple ECG electrodes (not shown), which may be attached externally to the patient's body. The timing signals typically correspond to specific phases of the cardiac cycle. Typically, the ECG signals may be used by the control unit 112 for ECG-synchronized playback of a previously acquired series of images (cineroop). Both the ECG monitor 120 and the ECG electrodes may include conventional components.

[0029] The medical positioning system 122 is configured to function as a location identification system and is therefore configured to identify location (location identification) data relating to one or more location sensors 106 and / or electrodes 103 and to output the respective location readings.

[0030] The impedance-based medical positioning system 122 determines the position of electrode 103 by, for example, capturing and processing signals received from electrode 103 and an external electrode patch while electrode 103 is positioned within a control electric field (e.g., potential field) generated by an 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®X EP system commercially available from Abbott Laboratories, and U.S. Patent No. 7,263,397, entitled "Method and Apparatus for Catheter Navigation and Location and Mapping in the Heart," owned by a common assignee with respect to this invention. This patent is incorporated in its entirety by reference.

[0031] The high-density catheter 100 can be used with any suitable catheter system, such as the systems referenced and / or described herein. For example, the high-density catheter 100 can be used to create an electrophysiological map of electrical activity within a patient's heart to diagnose cardiac arrhythmias. It should be understood that the high-density catheter 100 may also be used for other suitable diagnostic and / or therapeutic purposes. Thus, the high-density catheter 100 may be configured to perform ablation procedures, cardiac mapping, electrophysiological (EP) studies, and other diagnostic and / or therapeutic procedures. For example, ablation procedures may include RF ablation, PFA, cryoablation, laser ablation, chemoablation, high-intensity focused ultrasound ablation, microwave ablation, and / or other ablation therapies. Embodiments are not limited to any one type of catheter, catheter-based system, or procedure.

[0032] Applicable

[0033] Ablation therapy is sometimes used to treat various diseases that impair the anatomical structure of the human body. One disease for which ablation therapy may be used is the treatment of cardiac arrhythmias. When tissue is ablated, or when tissue is at least exposed to ablation energy generated by an ablation generator and delivered by an ablation catheter, tissue damage is formed in the tissue. To correct diseases such as atrial arrhythmias (including, but not limited to, ectopic atrial tachycardia, atrial fibrillation, and atrial flutter), electrodes mounted on or inside the ablation catheter are used to cause tissue necrosis in cardiac tissue. Arrhythmias can lead to various dangerous conditions, such as loss of synchronized contraction of the atrioventricular system and blood flow stasis. The main cause of atrial arrhythmias is thought to be stray electrical signals in the left or right atrium of the heart. The ablation catheter delivers ablation energy (radiofrequency energy, PFA, cryoablation, laser, chemical agents, high-intensity focused ultrasound, etc.) to cardiac tissue, causing damage to the cardiac tissue. This damage disrupts unwanted electrical pathways, thereby limiting or blocking stray electrical signals that could lead to arrhythmias.

[0034] Electroporation is a non-thermal ablation technique that involves applying a strong electric field to create pores in the cell membrane. The electric field can be generated by applying pulses with relatively short durations, such as nanoseconds to milliseconds. These pulses can be repeated to form a pulse train. When such an electric field is applied to tissue in vivo, the cells in the tissue are exposed to transmembrane potential, causing pores to open in the cell wall. Electroporation can be reversible (i.e., the temporarily opened pores close again) or irreversible (i.e., the pores remain open), leading to cell destruction. For example, in gene therapy, reversible electroporation is used to introduce high molecular weight therapeutic vectors into cells. In other therapeutic applications, a properly configured pulse train alone may be used to induce irreversible electroporation, for example, to cause cell destruction.

[0035] In some embodiments, the high-density catheter 100 is used for electroporation-induced primary necrosis treatment. This means that an electric current is passed through the cell membrane (cell wall) to directly and irreversibly lose its integrity, resulting in cell membrane destruction and cell necrosis. This cell death mechanism can be understood as an "outside-in" process, meaning that the destruction of the outer cell wall has a detrimental effect on the inside of the cell. Typically, in conventional cell membrane electroporation, the current is delivered as a pulsed electric field (i.e., pulsed-field ablation (PFA)) in the form of short-duration pulses (e.g., duration 0.1 to 20 msec) between densely packed electrodes capable of delivering an electric field strength of approximately 0.1 to 1.0 kV / cm.

[0036] By selectively altering the patient's cardiac tissue using a high-density catheter 100, pathological electrical conditions can be reduced or eliminated, thereby reducing or eliminating the occurrence of cardiac arrhythmias. The high-density catheter 100 may be configured to be used to perform any appropriate treatment, such as (but not limited to) radio frequency (RF) ablation, pulsed-field ablation (PFA), cryoablation, laser ablation, chemical ablation, high-intensity focused ultrasound ablation, microwave ablation, and / or other ablation therapies. In one embodiment, electrodes 102, 104 may be positioned on the opposing surfaces of the high-density catheter 100, and electrodes 102 and / or 104 may be configured to perform electrode-to-electrode ablation on the high-density catheter 100.

[0037] For example, in some embodiments, the high-density catheter 100 may be configured as a bipolar electrode assembly used in bipolar-based electroporation therapy. Specifically, for PFA therapy, the electrodes 102 and 104 of the high-density catheter 100 may be individually electrically connected to an electroporation generator (e.g., via a suitable electrical wire or other suitable electrical conductor extending within the catheter shaft 136) and are configured to be selectively energized by the electroporation generator in opposite polarities to generate a potential and a corresponding electric field between them. That is, one of the electrodes 102 and 104 may be configured to function as a cathode, and the other of the electrodes 102 and 104 may be configured to function as an anode. The electrodes 102 and 104 of the electrode assembly 101 may be arbitrarily and appropriately combined to be used as an anode and a cathode. For example, all electrodes 102 on one of a plurality of electrode sections may be used as cathodes, and all electrodes 104 on one adjacent electrode section of a plurality of electrode sections may be used as anodes. As another example, electrodes 102 along one of the multiple electrode sections may be used as cathodes every other electrode, and the remaining electrodes 104 along that electrode section may be used as anodes. Electrodes 102 and 104 may be any suitable electroporation electrodes. For example, electrodes 102 and 104 may have spot electrodes as shown in Figure 3. Electrodes 102 and 104 may have any other suitable shape or configuration. The shape, size, and / or configuration of electrodes 102 and 104 can affect various parameters of the electroporation treatment being applied. For example, increasing the surface area of ​​one or both electrodes 102 and 104 will reduce the applied voltage required to produce the same level of tissue destruction. Although electrodes 102 and 104 are shown as single electrodes, either one or both of electrodes 102 and 104 may instead be embodied as two or more discrete electrodes.

[0038] Figure 2 shows an example of a catheter device 200 according to an embodiment of the present disclosure. Figure 2 shows an expandable electrode assembly 202 according to an embodiment described herein, the expandable electrode assembly 202 having a balloon member and a plurality of electrodes extending inside the upper and / or lower surfaces of the expandable electrode assembly 202 and exposed from the upper and / or lower surfaces. Figure 2 shows the expandable electrode assembly 202 connected to an elongated catheter shaft 204 having a proximal end 206 and a distal end 208. In particular, the expandable electrode assembly 202 is connected 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 electronically and physically connect the expandable electrode assembly 202 to a mapping and / or therapeutic system for sensing and / or energy delivery (e.g., system 108 detailed with reference to Figure 1).

[0039] Figure 3 shows an example of an expandable electrode assembly 300 according to an embodiment of the present disclosure. The expandable electrode assembly 300 may be connected to the distal end 208 of an elongated catheter shaft 204, as detailed above. In various embodiments, the elongated catheter shaft 204 defines a longitudinal axis 302. The elongated catheter shaft 204 further includes one or more shaft electrodes 314. The shaft electrodes 314 are for impedance localization, as described above with respect to the electrical impedance-based medical positioning system 122 in Figure 1.

[0040] 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 deflated, rolled up, or folded within the functional lumen of the introducer sheath. To facilitate the alignment and delivery of the expandable electrode assembly 300 within the introducer sheath, the balloon member 304 may further have fold lines, ribs, pleats, and / or recesses. In the first delivery configuration, the balloon member 304 is advanced forward in a deflated state to exit the introducer sheath (and / or the introducer sheath retracts proximally). In the second deployment configuration, the balloon member 304 is inflated and expanded with a gas, liquid, or a combination thereof. The balloon member 304 may be connected to an inflation lumen (detailed below with reference to Figure 10C) extending within an elongated catheter shaft and may be inflated with saline solution, oxygen, nitrogen dioxide (for example, also usable for tissue cryotherapy ablation), air, or any combination thereof. Such fluids are supplied through the inflation lumen to inflate and / or expand the internal cavity of the balloon member 304. After the procedure, the inflation gas and / or liquid may be aspirated, suctioned, and / or evacuated through the inflation lumen and / or catheter shaft lumen, and the balloon member 304 may deflate and be retracted into the introducer sheath so that the balloon member 304 and the introducer sheath can be removed together from the patient. In various embodiments, the inflation lumen is an elliptical inflation lumen, as will be further detailed below.

[0041] The balloon member 304 may be a conforming balloon member or a non-conforming balloon, depending on the material of the balloon member 304 and / or the level of expansion provided through the expansion lumen to transition the balloon member 304 from a first delivery configuration / contracted configuration to a second unfolded configuration / expanded configuration. In a preferred embodiment, the material of the balloon member 304 is Pebax. The material of the balloon member 304 may be processed such that the balloon member 304 can elastically deform from a contracted first delivery configuration within an introducer sheath to an intermediate configuration that is neither constrained by the introducer sheath nor expanded, as described later. For example, such a manufacturing process may include winding up the balloon member 304 itself and heating the balloon member (e.g., in an oven at about 200°F) to heat-cur the wound-up balloon member 304 in the first delivery configuration. As the balloon member 304 exits the introducer sheath, it elastically deforms into an intermediate configuration, in which the balloon member 304 is unfolded and has a substantially planar, flat shape. The balloon member 304 may further transition to a second configuration in which it is inflated. In some embodiments, the second configuration includes an over-inflated configuration that expands the balloon member 304 beyond its flat shape so that the central portion of the balloon member 304 expands outward (for example, in one embodiment, to perfuse tissue through the internal cavity of the balloon member 304). Thus, it will be understood that the balloon member 304 may have multiple expansion configurations (e.g., an intermediate configuration, a second unfolded configuration, etc.).

[0042] In various embodiments, the balloon member 304 includes fold lines, creases, dot connections, indentations, etc. (not shown) to facilitate the inflation and / or deflation of the balloon member 304. The balloon member 304 may have a flat / planar shape, a concave shape, or a convex shape in the second unfolded configuration. For example, the balloon member 304 may have a fold line passing through the center of a flat shape, so that the inflated balloon member 304 becomes a “football” shape. In some embodiments, the central portion of the balloon member 304 may extend above the rest of the upper and / or lower surfaces of the balloon member 304. Furthermore, the shape of the expandable electrode assembly 300 and / or balloon member 304 is substantially elliptical in the embodiments shown and described herein, but may be any shape including circular (e.g., forming a “lollipop” shape as shown in Figure 5B), triangular, square, rectangular, or any combination of various shapes. In various other embodiments, the expandable electrode assembly 300 and / or balloon member 304 may have a linear or hoop shape with one or more internal “cutouts,” which will be understood by those skilled in the art in view of this disclosure. In yet another embodiment, the expandable electrode assembly 300 and / or balloon member 304 may have a rounded shape, such as spherical, circular (e.g., circular), or balloon-shaped. In yet another embodiment, the expandable electrode assembly 300 and / or balloon member 304 may be a basket configuration having an inflatable spline. Exemplary embodiments of a basket having a rounded shape or inflatable portion include those 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 inflatable portion may be partially inflated to fully inflated or vice versa before, during, and after use in its intended application as desired.

[0043] In various embodiments, a substantially flat balloon member allows for better determination of tissue or blood contact at the electrode contact surface. For example, one side of the substantially flat balloon member may be configured to contact the tissue of interest (e.g., cardiac tissue), and the other side may be configured to contact blood flow, etc. By providing such discrete and reliable electrode contact points, which are independently energized, on the flat balloon structure, measurements at the blood pool contact surface can be eliminated, and far-field artifacts can be removed. This allows for a more faithful electromorphic map (EGM) with a better signal-to-noise ratio compared to conventional mapping techniques known in the art. For example, conventional mapping catheters measure the average signal at the contact surface between tissue and blood. The discrete contact determination and sensing enabled by the substantially flat balloon structure of the present invention reduces or eliminates far-field effects and unwanted noise in the measurement. Furthermore, the equally spaced electrodes measure from known directions, eliminating the need for the associated algorithm to compensate for timing delays. Furthermore, the discrete contact surfaces improve spatial resolution regarding boundaries / edges, such as high / low voltage and timing maps, compared to conventional devices.

[0044] A further advantage of a nearly flat or planar expandable electrode assembly is that each surface can maintain the electrodes in a desired configuration. For example, even if the distal portion of the expandable electrode assembly comes into contact with tissue or the upper / lower surfaces are bent, the electrode arrangement (e.g., the spacing between electrodes) remains virtually unchanged. This consistent and uniform spacing of electrodes improves sensing and diagnostic mapping.

[0045] As illustrated, the balloon member 304 is in a second unfolded configuration in which the balloon member 304 has a substantially flat shape. The balloon member 304 comprises an upper surface 306 and a lower surface 308. In some embodiments, each of the upper surface 306 and the lower surface 308 of the balloon member 304 includes a plurality of openings 310. In other embodiments, only one of the upper surface 306 and the lower surface 308 of the balloon member 304 includes a plurality of openings 310. It should be noted that other shapes other than a substantially flat shape are also possible for the second unfolded configuration. For example, when inflated, the balloon member 304 may be a rounded sphere or a rounded circle. In other embodiments, the balloon member 304 may have a “cutout” where electrodes and material are absent, in which case the balloon member 304 has a hoop shape, and the outer circumference of the hoop shape is inflated. In yet another embodiment, the balloon member 304 may be a basket having an inflatable spline member that is inflated in the second unfolded configuration. The inflatable spline may have a linear, substantially rectangular (e.g., cuboidal) shape in the second deployment configuration, or it may be tubular (e.g., cylindrical) when the balloon member 304 is in the second deployment configuration. According to some embodiments, each of the inflatable splines may include a flexible support frame member made of a shape memory material. In other embodiments, the spline is inflated to become stiff enough to perform the function of a basket catheter. This will be apparent to those skilled in the art upon reading this disclosure.

[0046] In various embodiments, multiple electrodes 312 extend inside the upper surface 306 and / or lower surface 308 of the balloon member 304 and are exposed from the upper surface 306 and / or lower surface 308. For example, a first set of electrodes may extend inside the upper surface 306 and be exposed from the upper surface 306, and a second set of electrodes (not shown) may extend inside the lower surface 308 and be exposed from the lower surface 308. In various exemplary embodiments, the multiple openings 310 may have a diameter of 0.25 mm to 3 mm, and the electrodes 312 may similarly have a diameter of 0.25 mm to 3 mm. In other embodiments, the diameters of the multiple openings 310 and the electrodes 312 may be any desired dimensions. In a preferred embodiment, the electrodes 312 are about 0.002 mm to about 0.010 mm larger than the openings 310. In other embodiments, the diameter of the openings 310 is the same as the diameter of the electrodes 312. In yet another embodiment, the diameter of the opening 310 is larger than the diameter of the electrode 312. In each embodiment, an insulating seal (not shown) may be provided between the electrode 312 and the opening 310 to reduce impedance.

[0047] In at least some embodiments, the upper surface of each electrode 312 may be polished to be flush with the top of the opening 310. For example, the upper surface 306 and / or lower surface 308 may be substantially planar, flat, smooth, etc. In other embodiments, the upper surface of each electrode 312 is raised above the top of the opening 310 (e.g., protruding from the upper surface of the balloon member 304) to improve tissue contact between the electrode 312 and the tissue of interest. For example, the electrode 312 may extend 0.1 mm to 0.5 mm above the upper surface 306 of the balloon member 304. In yet another embodiment, the upper surface of each electrode 312 may be recessed into the opening 310. For example, the electrode 312 may extend 0.1 mm to 0.5 mm below the upper surface 306 of the balloon member 304. If the electrode is recessed, the electrode may be coated to reduce impedance. In various embodiments, the impedance-reducing polymer coating is not flush with the opening 310 of the electrode 312. Both the electrode 312 and the impedance-reducing coating may be recessed for protection against wear. For example, wear on the electrode may occur as the balloon member 304 moves through the sheath during the process of the electrode entering the vascular system through the sheath material. In at least some embodiments, the impedance-reducing polymer coating may substantially fill recesses (e.g., gaps between the electrode and the uppermost surface of the upper surface 306). The impedance-reducing polymer coating may include a variety of materials, such as those detailed in International Publication No. WO2022187161 A1, entitled “Electrode with Protected Impedance Reduction Coating,” the entire disclosure of which is incorporated herein by reference. Embodiments describing the upper surface 306 and its components should be understood to be equally applicable to the lower surface 308 and its components.

[0048] Figure 4A shows an expandable electrode assembly 300 including a balloon member 304 according to an embodiment described herein, with the top surface removed to show various internal components of the balloon member 304. In some embodiments, the balloon member 304 includes an upper flexible framework 402 corresponding to the top surface and a lower flexible framework 404 corresponding to the bottom surface. In other embodiments, the balloon member 304 includes a single flexible framework corresponding to a single plane of the balloon member 304.

[0049] The upper flexible framework 402 and the lower flexible framework 404 may be composed of a variety of flexible circuit materials, including polyimide, thermoplastics, Pebax, polyurethane, and similar polymers. In various embodiments, the lower flexible framework 404 may be identical to the upper flexible framework 402 (e.g., the same size, shape, layout, etc.) and correspond to the same components as the upper flexible framework 402. However, Figure 4A shows only the components corresponding to the upper flexible framework 402. In various embodiments, the upper flexible framework 402 and the lower flexible framework 404 may not have the same shape, size, or layout. For example, the electrodes located on the upper flexible framework 402 and the lower flexible framework 404 may not be the same on the upper surface 306 and the lower surface 308 of the balloon member 304. For example, when the upper flexible framework 402 and the lower flexible framework 404 are viewed from above, the branches of the upper flexible framework 402 and the branches of the lower flexible framework 404 may be arranged alternately with each other.

[0050] The upper flexible framework 402 is patterned with a first set of electrodes 406. Each of the first set of electrodes 406 is arranged in a row 408 with respect to the longitudinal axis 302 defined by the elongated catheter shaft 204. For example, the first set of electrodes 406 are arranged on a row 408 that is perpendicular to the longitudinal axis 302 (for example, offset by 90° from the longitudinal axis 302). The row 408 is offset such that each electrode of the first set of electrodes 406 is offset from each electrode in the adjacent row. For example, each electrode in one row 408 is positioned equally between two electrodes in an adjacent row 408. In one embodiment, the offset is 60°. The offset may be between 22.5° and 60°.

[0051] In a preferred embodiment, each electrode on each row is equally spaced from adjacent electrodes on the same row and adjacent electrodes on adjacent rows. For example, the center-to-center distance of electrodes on a row is the same as the center-to-center distance between an electrode and two electrodes on an adjacent row (one electrode located between these two electrodes). In other embodiments, the center-to-center distance of the first plurality of electrodes is about 0.5 mm to about 4 mm. In an exemplary embodiment, each electrode of the first plurality of electrodes has a diameter of 0.25 mm, an end-to-end spacing of 0.25 mm, and a center-to-center spacing of 0.5 mm. According to the various configurations described herein, the spatial and electrical arrangement of electrodes improves the resolution of the image obtained from the mapping system and provides a high-fidelity signal. In various embodiments, narrower spacing is preferred because it reduces the need for timing compensation between signals, thus improving the resolution of the image obtained from the mapping system. Similarly, each of the first set of electrodes 406 may be arranged in a series of columns 410 parallel to the longitudinal axis 302 defined by the elongated catheter shaft 204. The columns 410 may be offset such that each electrode in each column is offset from each electrode in the adjacent column. For example, one electrode in the first column may be located between two adjacent electrodes in the adjacent column.

[0052] Similarly, it should be understood that the lower flexible framework 404 is patterned with a second set of electrodes (not shown). In a preferred embodiment, the first set of electrodes 406 and the second set of electrodes are aligned such that the electrodes on the upper surface of the balloon member 304 coincide with the electrodes on the lower surface of the balloon member 304. In some embodiments, the first set of electrodes 406 and the second set of electrodes are not aligned with each other.

[0053] Figure 4B shows an exploded view of the conductive traces 412 on the flexible framework 402 of the expandable electrode assembly 300. In various embodiments, multiple conductive traces 412 are located on each of the upper flexible framework 402 and the lower flexible framework 404. Multiple conductive traces 412 on each flexible framework are electrically connected to the corresponding one of the first multiple electrodes 406 and the second multiple electrodes. Note that while multiple conductive traces 412 would actually be electrically connected to each electrode of the first multiple electrodes 406, not all of the multiple conductive traces 412 are shown in Figure 4 for simplification. In embodiments where electrodes are located on only one flexible framework of the balloon member 304, a single multiple conductive trace 412 would be provided to be electrically connected to each of the multiple electrodes, as will be apparent to those skilled in the art upon reading this disclosure. Embodiments of conductive traces and electrodes arranged in a flexible framework (e.g., a flex circuit) may be implemented in accordance with any embodiment described in U.S. Patent No. 11,642,064, filed on February 4, 2020, entitled "High Density Electrode Mapping Catheter," which has been assigned to the assignees of this Spec. This entire document is incorporated herein by reference.

[0054] As shown in Figure 4B, the first plurality of electrodes 406 are arranged on the upper flexible framework 402, and the second plurality of electrodes 407 are arranged on the lower flexible framework 404. In various embodiments, each of the first plurality of electrodes 406 and the second plurality of electrodes 407 is configured to independently sense or supply energy in any of the applications detailed above. For example, each plurality may be selectively deactivated, or one or more electrodes of the plurality may be selectively deactivated. In various embodiments, each of the first plurality of electrodes 406 and the second plurality of electrodes 407 may contain any number of electrodes. In one exemplary embodiment, each of the first plurality of electrodes 406 and the second plurality of electrodes contains 37 electrodes, with a total of 74 electrodes distributed along and across the longitudinal axis 302 of the balloon member 304. However, the number of electrodes used on the upper surface 306 and the lower surface 308 may be any number. For example, in some embodiments, the first plurality of electrodes 406 and / or the second plurality of electrodes 407 include 100 or fewer electrodes. In some embodiments, the upper surface 306 and the lower surface 308 include the same number of electrodes. In other embodiments, the upper surface 306 and the lower surface 308 include different numbers of electrodes. The shape and configuration of the electrodes may be any. For example, the electrodes may be bar electrodes, spot electrodes, square electrodes, diamond electrodes, round electrodes, or any combination thereof.

[0055] Next, referring to Figure 5A, the expandable electrode assembly 300 includes a flexible balloon member (e.g., a balloon member) 304 having a first plurality of electrodes 406 patterned on the upper flexible framework 402. As detailed with respect to Figures 4A-4B, the first plurality of electrodes 406 are patterned in offset horizontal rows 408.

[0056] As shown in Figure 5A, each electrode of the first plurality of electrodes 406 is grouped into a group 502 comprising three or more electrodes defining a two-dimensional shape. For example, a group comprising three or more electrodes may be defined according to the embodiment described in U.S. Patent Publication 2020 / 0214635, entitled "Catheter with High-Density Mapping Electrodes," or it may be defined using the relevant algorithm described in U.S. Patent No. 10,758,137, entitled "Orientation Independent Sensing, Mapping, Interface and Analysis Systems and Methods." The entirety of these documents is incorporated herein by reference. The electrode group 502 is preferably configured in an equilateral triangular shape, and each group has at least three electrodes based on the equal offset spacing detailed above. In various embodiments, as further described in U.S. Patent Publication 2020 / 0214635, the electrode group 502 is configured to sample the electrical properties of the contact tissue in at least two substantially lateral directions. In one embodiment, the offset between electrodes is 60°, as shown by the offset 504 in Figure 5A. In various embodiments, the group 502, which includes three or more electrodes defining a two-dimensional shape, may be arranged on a linear balloon member that forms a linear catheter having a cylindrical (e.g., tubular) or rectangular parallelepiped three-dimensional shape. In other embodiments, the expandable electrode assembly 300 may be a basket assembly and may include a plurality of balloon members 304 as splines of the basket assembly. For example, the group 502, which includes three or more electrodes defining a two-dimensional shape, may be arranged on a linear balloon member, and these plurality of linear balloon members may form a basket assembly having an expandable spline. In yet another embodiment, as will be apparent to those skilled in the art by reading this disclosure, the group 502, which includes three or more electrodes, may be arranged on a hoop-shaped balloon member, for example, on a linear balloon member formed in a circular shape with holes.

[0057] In other embodiments, the first plurality of electrodes 406 are arranged in any desired configuration. For example, as shown in Figure 5B, the first plurality of electrodes 406 may be arranged in concentric rings, spaced evenly along the circumference of each ring. In various other embodiments, the first plurality of electrodes 406 are not spaced evenly apart. Rather, the first plurality of electrodes 406 may be arranged within a high-density electrode zone on the upper surface of the balloon member 304. Thus, the electrode density can be adjusted to create various configurations for use in wide-area mapping, partial mapping, or localized mapping.

[0058] Referring now to Figure 6, a cross-section of the balloon member 304 is shown. As shown, the balloon member 304 includes an upper surface 306, a lower surface 308, and an internal cavity 602. In various embodiments, the upper surface 306 includes an outward-facing layer 604 and an inward-facing layer 606. The lower surface 308 similarly includes an outward-facing layer 608 and an inward-facing layer (not shown). The internal cavity 602 is defined by the inward-facing layer 606 of the upper surface 306 and the inward-facing layer of the lower surface 308. In various embodiments, the upper flexible framework 402 is positioned between the outward-facing layer 604 and the inward-facing layer 606 of the upper surface 306 of the balloon member 304. Similarly, the lower flexible framework 404 is positioned between the outward-facing layer 608 and the inward-facing layer of the lower surface 308 of the balloon member 304. In the configuration in which electrodes are placed on only one side of the balloon member, the flexible framework may be positioned between the upward layer and the downward layer with electrodes placed on one side of the flexible framework.

[0059] As shown in Figure 6, the balloon member 304 includes a first set of multiple openings 610 provided in the outward-facing layer 604 of the upper surface 306 of the balloon member 304, and a second set of multiple openings 612 provided in the outward-facing layer 608 of the lower surface 308 of the balloon member 304. Each of the first set of multiple openings 610 and the second set of multiple openings 612 is configured to expose the corresponding of the first set of multiple electrodes and the second set of multiple electrodes (not shown). The first set of multiple electrodes and the second set of multiple electrodes may be flush with the outward-facing layer 604 of the upper surface 306 and the outward-facing layer 608 of the lower surface 308 of the balloon member 304, recessed, or protruding.

[0060] Referring next to Figure 7, the balloon member 304 is shown with its top surface and various related components removed to make the internal cavity 602 more visible. The outward-facing layer 608 of the lower surface 308 of the balloon member 304 is illustrated to have a lower flexible framework 404. As shown in Figure 7, a flexible structural element 702 is positioned within the internal cavity 602 of the balloon member 304 to provide rigidity and prevent the balloon member 304 from twisting when it is deployed in the patient's body. In various embodiments, the flexible structural element 702 comprises a nitinol 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 has any configuration, including a shape that extends along the outer circumference of the balloon member 304, an inner flat shape that substantially reflects the outer circumference of the balloon member 304 (when viewed from diagonally above), and a branched shape that extends from the longitudinal axis. In various embodiments, the nitinol wire loop element is positioned between the upper flexible framework and the lower flexible framework.

[0061] In some embodiments, the expandable electrode assembly 300 and balloon member 304 do not include the flexible structural element 702 if sufficient rigidity is obtained by the expansion of the balloon and / or balloon material to avoid twisting and / or other undesirable bending. For example, over-inflating the balloon member 304 can create a firm, rigid structure that prevents undesirable bending when the balloon member 304 is deployed, and limiting the expansion of the balloon member 304 as needed can increase flexibility for conforming to the tissue of interest. In particular, to conform to uneven tissue surfaces, it may be desirable to temporarily and gradually deflate the balloon member 304.

[0062] The internal cavity 602 includes one or more magnetic position sensors 704 (e.g., position sensor 106 detailed with respect to Figure 1). In various embodiments, the magnetic position sensors 704 are located distal to the expandable electrode assembly on the upper flexible framework and / or the lower flexible framework 404 (as shown). The magnetic position sensors 704 are connected to the upper flexible framework and / or the lower flexible framework 404 and are parallel to the longitudinal axis of the catheter shaft.

[0063] Next, referring to Figures 8A to 8C, various cross-sections of the balloon member 304 show combinations of an upper surface 306 having an outward-facing layer 604 and an inward-facing layer 606, a lower surface 308 having an outward-facing layer 608 and an inward-facing layer 802, an upper flexible framework 402, a lower flexible framework 404, a first set of multiple openings 610, a second set of multiple openings 612, a flexible structural element 702, a magnetic position sensor 704, and an internal cavity 602.

[0064] For example, as shown in Figure 8A, a perspective cross-sectional view of a balloon member 304 according to one embodiment shows the relative positions of the upper surface 306, the lower surface 308, the first plurality of openings 610, the second plurality of openings 612, the flexible structural element 702, the magnetic position sensor 704, and the internal cavity 602. In at least some embodiments, the magnetic position sensor 704 is offset diagonally with respect to the flexible structural element 702.

[0065] In another example, Figure 8B includes a front cross-sectional view of the balloon member 304, showing the upper surface 306 relative to the lower surface 308, a first set of multiple openings 610 penetrating the upper surface 306 and the outward-facing layer 604, and a second set of multiple openings 612 penetrating the lower surface 308 and the outward-facing layer 608. The magnetic position sensor 704 is shown within the internal cavity 602. The upper flexible framework 402, the lower flexible framework 404, and the flexible structural element 702 are not shown in this figure.

[0066] In yet another example, Figure 8C includes a front cross-sectional view of the balloon member 304, showing the upper surface 306 relative to the lower surface 308, a first set of multiple openings 610 penetrating the outward-facing layer 604 and the upper surface 306, and a second set of multiple openings 612 penetrating the outward-facing layer 608 and the lower surface 308. As shown in Figure 8C, the upper flexible framework 402 is sandwiched between the outward-facing layer 604 and the inward-facing layer 606 of the upper surface 306. Similarly, the lower flexible framework 404 is sandwiched between the outward-facing layer 608 and the inward-facing layer 802 of the lower surface 308. The internal cavity 602 is defined by the inward-facing layer 606 of the upper surface 306 and the inward-facing layer 802 of the lower surface 308. The magnetic position sensor 704 and the flexible structural element 702 are not shown in this figure.

[0067] In various embodiments, the balloon member 304, including the various components described above, is formed by twin-sheet thermoforming. Twin-sheet thermoforming may involve vacuum forming or pressure forming two sheets simultaneously using two molds on each platen. Once forming is complete, the upper and lower platens are quickly joined together (for example, so as not to lose surface temperature). For example, after forming, the upper flexible framework 402, a plurality of conductive traces 412, and a first plurality of electrodes 406 are stacked between the outward-facing layer 604 and the inward-facing layer 606 of the upper surface 306. The lower flexible framework 404, a plurality of conductive traces 412, and a second plurality of electrodes are stacked between the outward-facing layer 608 and the inward-facing layer 802 of the lower surface 308. The first plurality of openings 610 and the second plurality of openings 612 are formed on the upper surface 306 and the lower surface 308 before or after twin-sheet thermoforming. In various embodiments, a sealant and / or insulating layer is provided between the electrodes and / or conductive traces prior to twin-sheet thermoforming. In at least some embodiments, the magnetic position sensor 704 is connected to the upper flexible framework 402 and / or the lower flexible framework 404 during the twin-sheet thermoforming process and laminated together with the other components. For example, the magnetic position sensor 704 is structurally incorporated into the upper surface 306 and / or the lower surface 308. In various embodiments, magnetic sensors of various designs may be incorporated into the upper surface 306 and / or the lower surface 308. For example, in some embodiments, magnetic sensors including the sensor described in U.S. Patent No. 11,439,318, titled "Active Magnetic Position Sensor," may be used. The entire disclosure of this document is incorporated herein by reference. In various embodiments, a printed version of a passive pickup coil may be used, such as the one described in U.S. Patent Publication 2022 / 0008011 A1, titled "Printed Sensor Coil," the entire disclosure of this document is incorporated herein by reference. The twin-sheet thermoforming process substantially fixes the relative positions of the various components inside the upper surface 306 and / or lower surface 308.This process enables batch manufacturing, allowing for reduced product costs while providing more features (e.g., high-quality EGM and spatial resolution) at the same or lower cost. For example, the features of the embodiments described herein can be manufactured with significantly shorter touch times compared to conventional designs.

[0068] Next, referring to Figure 9, a catheter shaft 204 is shown, which is connected at its distal end 208 to an expandable electrode assembly 300. In particular, according to at least some embodiments, the expandable electrode assembly 300 is connected to the distal end 208 of the catheter shaft 204 via 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 oblique offset, and when the parts of the two-part proximal coupler 902 are aligned with respect to each other, a shaft magnetic position sensor 904 (e.g., position sensor 106 detailed with respect to Figure 1) and a corresponding magnetic sensor wire 906 are housed. For example, the shaft magnetic position sensor 904 is offset with respect to the longitudinal axis of the catheter shaft 204. In at least some embodiments, the offset shaft magnetic position sensor 904 is positioned at an angle of 11° with respect to the longitudinal axis of the catheter shaft 204, or with respect to the magnetic position sensor 704 (not shown in Figure 9).

[0069] Referring to Figures 10A to 10C, various embodiments of the catheter shaft 204 are shown. In various embodiments, the catheter shaft 204 includes a non-flexible portion extending distally from a handle (such as a handle 210) and a flexible portion extending distally from the distal end of the non-flexible portion. As shown in Figure 10A, the catheter shaft 204 (in particular the flexible portion of the catheter shaft 204) includes one or more compression coils 1002 that extend at least partially in the longitudinal direction of the pull wire lumen 1004. For example, each pull wire lumen 1004 may include one compression coil 1002. The compression coil 1002 may be partially attached to at least a portion of the interior of the pull wire lumen 1004. As shown, a pull wire 1006 extends through the pull wire lumen 1004. In at least some embodiments, a compression coil adapter 1008 is provided at one or both distal ends of the compression coil 1002. The compression coil adapter 1008 extends around the distal end of the compression coil 1002 and extends beyond the length of the compression coil 1002 into the pull wire lumen 1004 to accommodate the size of the central lumen 1010, which has an expansion lumen 1012 inside. As shown, the magnetic sensor wire 906 extends through the central lumen 1010 into the catheter shaft 204. Further wiring 1014 (e.g., electrode wiring) may extend through the central lumen 1010 into the catheter shaft 204.

[0070] Furthermore, as shown in Figure 10A, an expansion lumen 1012 is provided to expand and contract the expandable electrode assembly with a gas, liquid, or a combination thereof. For example, the expansion lumen 1012 terminates inside the internal cavity 602 of the balloon member 304, and the gas and / or liquid inflates the balloon member 304. In various embodiments, the expandable electrode assembly may be perfused using the same expansion lumen 1012 used to expand and contract the expandable electrode assembly. For example, the expansion lumen 1012 may be configured to supply saline solution to prevent clogging on and / or around the expandable electrode assembly. The first plurality of openings 610 and / or the second plurality of openings 612 are configured to allow fluid to flow out through the openings. For example, some or all of the openings are not sealed and / or partially sealed so that a desired amount of perfusion fluid can pass through them. The operator may choose to over-inflate the expandable balloon assembly with saline solution during use, which flows out through the first set of openings 610 and / or the second set of openings 612.

[0071] Figure 10B shows a cross-section of the catheter shaft 204, which shows a compression coil 1002 and a compression coil adapter 1008 that extend at least partially within the pull wire lumen 1004, and an expansion lumen 1012 that extends at least partially into the central lumen 1010.

[0072] Figure 10C shows another cross-section of the catheter shaft 204, showing the compression coil 1002 within the pull wire lumen 1004 and the expansion lumen 1012 within the central lumen 1010. As shown in Figure 10C, the cross-section of the expansion lumen may transition from a circular or substantially rounded shape to a flattened ellipse. This transition may occur within the central lumen 1010 or where the expansion lumen 1012 enters the internal cavity 602 of the balloon member 304.

[0073] In other embodiments of this disclosure, the expandable electrode assembly comprises a substantially flat pad having a similar configuration. The pad expandable electrode assembly expands from an introducer sheath, as in other embodiments described herein. The pad structure is preferably a silicone pad structure. The pad expandable assembly includes a top surface, a bottom surface, and a flexible framework positioned between the top and bottom surfaces. Multiple electrodes and corresponding conductive traces may be patterned on the flexible framework according to any embodiment described herein, such as a laterally offset pattern (as described with respect to at least Figures 4 and 5A). In some embodiments, the silicone pad structure includes an internal cavity between the top and bottom surfaces, and the flexible structural elements are positioned within the internal cavity. In other embodiments, the silicone pad structure does not have an internal cavity when the components are placed in a mold and silicone is injection molded to form the silicone pad structure.

[0074] Figure 11 is a flowchart of a method for manufacturing an expandable electrode assembly, such as any expandable electrode assembly among those described herein, 1100. In one embodiment, the electrodes and corresponding conductive traces may be constructed (e.g., placed) on the outer layer of the upper surface and / or the outer layer of the lower surface of the balloon member. The balloon member may be composed of a variety of biocompatible materials, including thermoplastic polyurethane (TPU), thermoplastic elastomer (TPE), polyamide containing nylon or Pebax, ethylene vinyl acetate (EVA), polyvinylidene fluoride (PVDF), polyvinyl chloride (PVC), silicon, silicone, and / or composites thereof. In particular, as detailed above, in one embodiment, assembling the expandable electrode assembly 300 includes placing the electrodes and / or conductive traces on the balloon material.

[0075] As illustrated, step 1102 includes arranging a plurality of electrodes in a first layer of balloon material. The electrodes may have any size and configuration as described herein. In one exemplary embodiment, the electrodes are gold electrode pads having a diameter of 1 mm and a height of 0.002 mm. In other embodiments, a thin sheet of gold is attached to the first layer of balloon material. In some embodiments, the opening formed in step 1108 exposes a portion of the thin sheet of gold to form an electrode.

[0076] Step 1104 includes arranging a plurality of conductive traces on a first layer of balloon material to correspond to a plurality of electrodes. In one embodiment, the plurality of conductive traces are drawn with conductive epoxy ink. The plurality of conductive traces are arranged to connect a plurality of electrodes. In various embodiments, an insulating layer may be provided between each of the plurality of conductive traces. In at least some embodiments, a stencil is used to form the plurality of conductive traces.

[0077] In other embodiments, step 1104 includes applying a conductive epoxy to the first layer of the balloon material with the multiple electrodes arranged thereon. For example, a conductive ink may be applied to the first layer of the balloon material with the multiple electrodes arranged thereon.

[0078] Step 1106 includes laminating a plurality of electrodes and a plurality of conductive traces between a second layer of balloon material and a first layer of balloon material. As detailed herein, the two layers of balloon material may be joined and / or sealed using a twin-sheet thermoforming process.

[0079] Step 1108 includes forming a plurality of openings in a first layer of balloon material. The plurality of openings correspond to a plurality of electrodes, which extend inside the plurality of openings and are exposed through the plurality of openings. In various embodiments, the plurality of openings are laser-etched from the first layer of balloon material. In some embodiments, the exposed electrodes may be coated with an insulating coating. In various embodiments, a conductive impedance-reducing coating may be applied. For example, the conductive impedance-reducing coating may include poly(3,4-ethylenedioxythiophene) (PEDOT), Pebax, titanium nitride, etc., or any other material detailed in relation to International Publication No. WO2022187161 A1, which is referenced above and incorporated in whole by reference. In at least some embodiments, instead of, or in addition to, applying a conductive impedance-reducing coating, the surface of the layer may be physically altered. As those skilled in the art will see from reading this disclosure, physical modifications may include increasing the roughness of the first layer to change the impedance (not conductivity), and increasing the surface area of ​​the first layer to increase the contact area. In some embodiments, the individual electrodes include a copper trace and a gold-plated copper pad. The gold insulates the copper component of the electrode. According to some embodiments, the electrodes may further include a conductive impedance-reducing insulating layer. For example, to reduce impedance and obtain a suitable signal-to-noise ratio, the electrodes may be further coated with iridium oxide. In various embodiments, the uncoated flexible electrodes may be plated with precious metals including gold, palladium, platinum, alloys thereof (such as platinum-iridium (PtIr)), and combinations thereof.

[0080] In at least some embodiments, multiple conductive traces converge at the distal end of the catheter shaft. In one embodiment, the multiple conductive traces form a meandering pattern along the remaining length of the catheter shaft. In some embodiments, the meandering pattern on the catheter shaft may be separate from the conductive epoxy ink used in the previous deposition. The meandering pattern prevents the conductive traces from breaking during extension and compression of the catheter shaft, as well as when the catheter shaft is bent. The meandering pattern further prevents trace breakage during extension, increasing the flexibility of the expandable electrode assembly.

[0081] In other embodiments for manufacturing expandable electrode assemblies, a combination of copper and thermoplastic-containing material may be used to construct (e.g., place) electrodes and corresponding conductive traces on the outer layers of the upper and / or lower surfaces of a balloon member. In some embodiments, the copper is placed on the balloon material. For example, the copper may be layered on a thermoplastic sheet. The copper may be coated with a photoresist, and a desired circuit layer may be drawn on the photoresist according to approaches known in the art. In various embodiments, photochemical etching is used to selectively remove the copper using chemical reagents to create an etched pattern (e.g., a circuit layout). In some embodiments, the photoresist circuit layout may be gold-plated. By combining the photoresist and imaging processes, unwanted copper is etched away to form multiple electrodes and corresponding multiple traces. Thus, the electrodes and corresponding conductive traces may be constructed (e.g., placed) on the balloon material (e.g., a thermoplastic sheet). According to any embodiment described herein, openings corresponding to the formed electrodes may be formed to expose the electrode material. In various embodiments, the manufacturing process may be electrolytic or electroless. For example, the hardness of materials like gold can vary depending on the manufacturing process.

[0082] As shown in Figure 12A, 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 shows a close view of the conductive traces 1204 provided on the layer 1206 of balloon material, which has a conductive adhesive 1208 extending along the ends of the conductive traces 1204. As further shown in Figures 12A to 12B, in at least some embodiments, a ribbon cable 1210 may be connected to and extending from the conductive traces 1204.

[0083] Figure 13 shows a connector 1300 for a catheter system according to an embodiment of the present disclosure. Various signals collected from electrodes on an expandable electrode assembly are sent via the connector 1300 to a system for analyzing the signals, for example, for localization. The connector 1300 is configured to electronically and physically connect the expandable electrode assembly to a mapping and / or therapeutic system for sensing and / or energy delivery (e.g., system 108 detailed with reference to Figure 1).

[0084] Other variations are also within the spirit of the invention. Therefore, while the invention is open to various modifications and alternative structures, those illustrated and detailed above are specific exemplary embodiments of the invention. However, it should be understood that the invention is not intended to be limited to the specific forms disclosed, but rather to encompass all modifications, alternative structures, and equivalents that fall within the spirit and scope of the invention as expressed in the appended claims.

[0085] Example of an embodiment

[0086] In one or more embodiments, the catheter includes an elongated catheter shaft having a proximal and 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 an upper surface, a lower surface, and an internal cavity. Each of the upper and lower surfaces includes an outward-facing layer and an inward-facing layer. The expandable assembly further includes an upper flexible framework positioned between the outward-facing and inward-facing layers of the upper surface of the balloon member, a lower flexible framework positioned between the outward-facing and inward-facing layers of the lower surface of the balloon member, a first plurality of electrodes patterned on the upper flexible framework, and a second plurality of electrodes patterned on the lower flexible framework. The first plurality of electrodes are aligned with the second plurality of electrodes. The expandable assembly includes a plurality of conductive traces positioned on each flexible framework, each of which is electrically connected to a corresponding one of the first plurality of electrodes and the second plurality of electrodes. The expandable assembly includes a flexible structural element located within an internal cavity. Optionally, the flexible structural element includes a nitinol wire loop element extending along the longitudinal axis of an elongated catheter shaft. Optionally, the nitinol wire loop element is located between an upper flexible framework and a lower flexible framework. Optionally, the expandable assembly further includes a first delivery configuration and a second deployment configuration. In the second deployment configuration, the balloon member may have a flat, concave, or convex shape. The expandable assembly may have an intermediate configuration between the first delivery configuration and the second deployment configuration, in which the balloon member is not constrained by the introducer sheath and does not need to be inflated. The balloon member may include a plurality of openings in the outward-facing layers of the upper and lower surfaces of the balloon member, the openings configured to expose a plurality of corresponding first electrodes and a plurality of second electrodes. The diameters of the multiple openings may be the same size as, or smaller than, the diameters of the corresponding first and second multiple electrodes.The multiple openings may have a diameter of 0.25 mm to 3 mm, and each of the first and second sets of electrodes may have a diameter of 0.25 mm to 3 mm. Optionally, the first and second sets of electrodes may be flush, recessed, or protruding with respect to the outward-facing layers on the upper and lower surfaces of the balloon member. Optionally, the elongated catheter shaft may include an elliptical expansion lumen connected to the internal cavity of the balloon member, the balloon member being uninflated in the first delivery configuration and inflated in the second deployment configuration by a liquid or gas supplied through the elliptical expansion lumen. Optionally, each of the first and second sets of electrodes may be arranged in transverse rows with respect to the longitudinal axis of the elongated catheter shaft. The transverse rows may be offset such that each electrode in each row is offset from the electrodes in the adjacent row. Each of the first and second sets of electrodes may be arranged in longitudinal rows parallel to the longitudinal axis of the elongated catheter shaft. The columns may be offset such that each electrode in each column is offset from the electrodes in the adjacent column. The offset may be 60°. The offset may be between 22.5° and 60°. Each electrode in each column may be equally spaced from adjacent electrodes in the same column and adjacent electrodes in adjacent columns. Each of the first and second sets of electrodes may be for independent sensing or energy supply. Each electrode in the first and second sets of electrodes may be grouped into groups of three or more electrodes that define a two-dimensional shape. The electrode groups may be triangular in shape, and each group has at least three electrodes. The electrode groups may sample the electrical properties of the contact tissue in at least two substantially transverse directions. Optionally, the center-to-center distance of the first and second sets of electrodes is between 0.5 mm and 4 mm. The catheter may include at least one magnetic position sensor positioned along the distal end of the elongated catheter shaft. The catheter may include one or more magnetic position sensors located on the upper or lower flexible framework at the distal end of the expandable assembly. Optionally, the balloon member is rounded in the second deployment configuration.Optionally, the balloon member is a cylindrical or rectangular parallelepiped linear balloon member in the second unfolded configuration. Optionally, the expandable assembly is a basket assembly having multiple balloon members, each balloon member being cylindrical or rectangular parallelepiped in the second unfolded configuration.

[0087] In one or more embodiments, the catheter includes an elongated catheter shaft having a proximal and 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 deployment configuration. The expandable assembly includes a balloon member having a substantially flat shape in the second deployment configuration and including an upper and lower surface. A first plurality of electrodes extend inside the upper surface of the balloon member and are exposed through the upper surface. A second plurality of electrodes extend inside the lower surface of the balloon member and are exposed through the lower surface. Each of the first plurality of electrodes and the second plurality of electrodes is arranged in transverse rows with respect to the longitudinal axis of the elongated catheter shaft. The transverse rows are offset such that each electrode in each row is offset from the electrode in the adjacent row. Optionally, the offset is 60°. Optionally, the offset is 22.5° to 60°. Each of the first plurality of electrodes and the second plurality of electrodes may be arranged in longitudinal rows parallel to the longitudinal axis of the elongated catheter shaft. The columns may be offset such that each electrode in each column is offset from the electrodes in the adjacent column. Each electrode in each column may be equally spaced from adjacent electrodes in the same column and adjacent electrodes in adjacent columns. Each electrode in the first plurality of electrodes and each electrode in the second plurality of electrodes may be grouped into groups containing three or more electrodes that define a two-dimensional shape. Optionally, the electrode groups may be equilateral triangular in shape, and each group may contain at least three electrodes. The electrode groups may sample the electrical properties of the contact tissue in at least two substantially transverse directions. Optionally, the center-to-center distance of the first plurality of electrodes and the center-to-center distance of the second plurality of electrodes is 0.5 mm. Optionally, the center-to-center distance of the first plurality of electrodes and the center-to-center distance of the second plurality of electrodes is 0.5 mm to 4 mm. The catheter may further include a flexible structural element located within the internal cavity of the balloon member. The flexible structural element may include a nitinol wire loop element extending along the longitudinal axis of the elongated catheter shaft. The upper and lower surfaces of the balloon member may each include an outward-facing layer and an inward-facing layer.The catheter may further include a plurality of electrodes arranged on the outward-facing upper and outward-facing lower layers, and a plurality of conductive traces arranged on the outward-facing upper and outward-facing lower layers. Optionally, the balloon member includes thermoplastic polyurethane (TPU), thermoplastic elastomer (TPE), polyamide containing nylon or Pebax, ethylene vinyl acetate (EVA), polyvinylidene fluoride (PVDF), polyvinyl chloride (PVC), silicone, and / or composites thereof. Optionally, the catheter further includes an upper flexible framework arranged between the outward-facing and inward-facing upper layers of the balloon member, a lower flexible framework arranged between the outward-facing and inward-facing lower layers of the balloon member, a first plurality of electrodes arranged on the upper flexible framework, a second plurality of electrodes arranged on the lower flexible framework, and a plurality of conductive traces arranged on each of the flexible frameworks, each of the plurality of conductive traces being electrically connected to the corresponding one of the first plurality of electrodes and the second plurality of electrodes. The balloon member may include a plurality of openings in the outward-facing layers of the upper and lower surfaces of the balloon member, the plurality of openings exposing the corresponding first plurality of electrodes and the second plurality of electrodes. The diameter of the plurality of openings may be the same size as the diameter of the corresponding first plurality of electrodes and the second plurality of electrodes, or may be smaller. The elongated catheter shaft may include an elliptical expansion lumen connected to the internal cavity of the balloon member, the balloon member being uninflated in the first delivery configuration and inflated in the second deployment configuration by a liquid or gas supplied through the elliptical expansion lumen. Optionally, the catheter may include at least one magnetic position sensor located along the distal end of the elongated catheter shaft. Optionally, the catheter may include one or more magnetic position sensors located at the distal end of an expandable assembly. Optionally, each of the first plurality of electrodes and the second plurality of electrodes is configured for independent sensing or energy supply.The expandable assembly may have an intermediate configuration between a first delivery configuration and a second deployment configuration, in which the balloon member is not constrained by the introducer sheath and is not inflated.

[0088] In one or more embodiments, the catheter includes an elongated catheter shaft including a proximal and distal end. The elongated catheter shaft defines a longitudinal axis. The catheter includes an expandable assembly having a first delivery configuration and a second unfolded configuration including a substantially planar shape. The expandable assembly includes a top surface, a bottom surface, a flexible framework positioned between the top and bottom surfaces, and a plurality of electrodes patterned on the flexible framework. The plurality of electrodes are arranged in transverse rows with respect to the longitudinal axis of the elongated catheter shaft. The transverse rows are offset such that each electrode in each row is offset from the electrodes in adjacent rows. The catheter further includes a plurality of conductive traces positioned on the flexible framework and electrically connected to the plurality of electrodes, and flexible structural elements positioned within the expandable assembly. Optionally, the expandable assembly includes a silicone pad. Optionally, the expandable assembly includes an internal cavity between the top and bottom surfaces. Optionally, the expandable assembly does not include an internal cavity between the top and bottom surfaces.

[0089] In one or more embodiments, the catheter includes an elongated catheter shaft having a proximal end and a distal end. The elongated 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 an upper surface, a lower surface and an internal cavity. A flexible framework is positioned between the upper and lower surfaces. The expandable assembly includes a plurality of electrodes patterned on the flexible framework, a plurality of conductive traces positioned on the flexible framework and electrically connected to the plurality of electrodes, and a flexible structural element positioned within the internal cavity.

[0090] In one or more embodiments, the catheter includes an elongated catheter shaft having a proximal and distal end. The elongated catheter shaft defines a longitudinal axis. The catheter includes an expandable assembly having a linear balloon member having an upper surface, a lower surface, and an internal cavity. Each of the upper and lower surfaces has an outward-facing layer and an inward-facing layer. The expandable assembly includes an upper flexible framework positioned between the outward-facing and inward-facing layers of the upper surface of the balloon member, a lower flexible framework positioned between the outward-facing and inward-facing layers of the lower surface of the balloon member, a first plurality of electrodes patterned on the upper flexible framework, and a second plurality of electrodes patterned on the lower flexible framework. The first plurality of electrodes are aligned with the second plurality of electrodes. The expandable assembly includes a plurality of conductive traces positioned on each of the flexible frameworks, each of which is electrically connected to the corresponding one of the first plurality of electrodes and the second plurality of electrodes. The expandable assembly includes flexible structural elements located within an internal cavity.

[0091] In one or more embodiments, the catheter includes an elongated catheter shaft having a proximal and distal end. The elongated catheter shaft defines a longitudinal axis. The catheter includes an expandable assembly having a hoop-shaped balloon member having an upper surface, a lower surface, and an internal cavity. Each of the upper and lower surfaces has an outward-facing layer and an inward-facing layer. The expandable assembly includes an upper flexible framework positioned between the outward-facing and inward-facing layers of the upper surface of the balloon member, a lower flexible framework positioned between the outward-facing and inward-facing layers of the lower surface of the balloon member, a first plurality of electrodes patterned on the upper flexible framework, and a second plurality of electrodes patterned on the lower flexible framework. The first plurality of electrodes are aligned with the second plurality of electrodes. The expandable assembly includes a plurality of conductive traces positioned on each of the flexible frameworks, each of which is electrically connected to the corresponding one of the first plurality of electrodes and the second plurality of electrodes. The expandable assembly includes flexible structural elements located within an internal cavity.

[0092] In one or more embodiments, the catheter includes an elongated catheter shaft having a proximal and distal end. The elongated catheter shaft defines a longitudinal axis. The catheter includes an expandable assembly having a circular balloon member having an upper surface, a lower surface, and an internal cavity. Each of the upper and lower surfaces has an outward-facing layer and an inward-facing layer. The expandable assembly includes an upper flexible framework positioned between the outward-facing and inward-facing layers of the upper surface of the balloon member, a lower flexible framework positioned between the outward-facing and inward-facing layers of the lower surface of the balloon member, a first plurality of electrodes patterned on the upper flexible framework, and a second plurality of electrodes patterned on the lower flexible framework. The first plurality of electrodes are aligned with the second plurality of electrodes. The expandable assembly includes a plurality of conductive traces positioned on each of the flexible frameworks, each of which is electrically connected to the corresponding one of the first plurality of electrodes and the second plurality of electrodes. The expandable assembly includes flexible structural elements located within an internal cavity.

[0093] In one or more embodiments, the catheter includes an elongated catheter shaft having a proximal and distal end. The elongated catheter shaft defines a longitudinal axis. The catheter includes an expandable assembly having a balloon member having an upper surface, a lower surface, and an internal cavity. Each of the upper and lower surfaces has an outward-facing layer and an inward-facing layer. The expandable assembly includes an upper flexible framework positioned between the outward-facing and inward-facing layers of the upper surface of the balloon member, a lower flexible framework positioned between the outward-facing and inward-facing layers of the lower surface of the balloon member, a first plurality of electrodes patterned on the upper flexible framework, and a second plurality of electrodes patterned on the lower flexible framework. The first plurality of electrodes are aligned with the second plurality of electrodes. The expandable assembly includes a plurality of conductive traces positioned on each of the flexible frameworks, each of which is electrically connected to the corresponding one of the first plurality of electrodes and the second plurality of electrodes. The expandable assembly includes a flexible structural element positioned within the internal cavity. The expandable assembly further includes a first delivery configuration and a second unfolding configuration, wherein the expandable assembly has a flat shape in the second unfolding configuration.

[0094] In one or more embodiments, the catheter includes an elongated catheter shaft having a proximal and distal end. The elongated catheter shaft defines a longitudinal axis. The catheter includes an expandable assembly having a balloon member having an upper surface, a lower surface, and an internal cavity. Each of the upper and lower surfaces has an outward-facing layer and an inward-facing layer. The expandable assembly includes an upper flexible framework positioned between the outward-facing and inward-facing layers of the upper surface of the balloon member, a lower flexible framework positioned between the outward-facing and inward-facing layers of the lower surface of the balloon member, a first plurality of electrodes patterned on the upper flexible framework, and a second plurality of electrodes patterned on the lower flexible framework. The first plurality of electrodes are aligned with the second plurality of electrodes. The expandable assembly includes a plurality of conductive traces positioned on each of the flexible frameworks, each of which is electrically connected to the corresponding one of the first plurality of electrodes and the second plurality of electrodes. The expandable assembly includes a flexible structural element positioned within the internal cavity. The expandable assembly further includes a first delivery configuration and a second unfolding configuration, wherein the expandable assembly has a convex shape in the second unfolding configuration.

[0095] In one or more embodiments, the catheter includes an elongated catheter shaft having a proximal and distal end. The elongated catheter shaft defines a longitudinal axis. The catheter includes an expandable assembly having a balloon member having an upper surface, a lower surface, and an internal cavity. Each of the upper and lower surfaces has an outward-facing layer and an inward-facing layer. The expandable assembly includes an upper flexible framework positioned between the outward-facing and inward-facing layers of the upper surface of the balloon member, a lower flexible framework positioned between the outward-facing and inward-facing layers of the lower surface of the balloon member, a first plurality of electrodes patterned on the upper flexible framework, and a second plurality of electrodes patterned on the lower flexible framework. The first plurality of electrodes are aligned with the second plurality of electrodes. The expandable assembly includes a plurality of conductive traces positioned on each of the flexible frameworks, each of which is electrically connected to the corresponding one of the first plurality of electrodes and the second plurality of electrodes. The expandable assembly includes a flexible structural element positioned within the internal cavity. The expandable assembly further includes a first delivery configuration and a second unfolding configuration, wherein the expandable assembly has a concave shape in the second unfolding configuration.

[0096] In the context describing the present invention (in particular in the context of the following claims), it should be understood that “a,” “an,” “the,” and similar words are used to cover both singular and plural forms unless otherwise specified herein or unless it is clearly inconsistent with the context. The words “equip,” “have,” “include,” and “contain” should be interpreted as open-ended words (i.e., “include, but not limited to”) unless otherwise specified herein. The word “connected” should be interpreted as being partially or entirely contained, attached, or joined inside, even if something is intervening. Unless otherwise specified herein, the descriptions of value ranges are intended to be merely abbreviations for individually referring to each value that falls within the range, and each value is incorporated herein as if it were individually described herein. All methods described herein may be performed in any appropriate order unless otherwise specified herein or unless it is clearly inconsistent with the context. Any examples or illustrative statements provided herein (e.g., "etc.") are used solely for the purpose of making embodiments of the invention easier to understand and, unless otherwise noted, do not limit the scope of the invention. Nothing in this specification should be construed as indicating that any non-claimed element is essential for carrying out the invention.

[0097] This specification describes preferred embodiments of the Invention, including the best known modes for the inventors to carry out the Invention. By reading the foregoing description, those skilled in the art will see variations of these preferred embodiments. The inventors believe that those skilled in the art will appropriately adopt such variations, and that the Invention will be carried out in ways other than those specifically described herein. Accordingly, the Invention includes all variations and equivalents of the subject matter described in the claims appended herein as permitted by applicable law. Furthermore, unless otherwise stated herein or if the context is clearly inconsistent, any combination of variations of the elements described above is incorporated into the Invention.

[0098] All references cited herein, including publications, patent applications, and patents, are incorporated herein by reference to the same extent as they are incorporated herein by reference, provided that each reference is clearly and individually stated to be incorporated herein by reference.

Claims

1. It is a catheter, A slender catheter shaft having a proximal end and a distal end, with a defined longitudinal axis, Extensible assemblies and Equipped with, The aforementioned expandable assembly is A balloon member having an upper surface, a lower surface, and an internal cavity, wherein each of the upper surface and the lower surface has an outward-facing layer and an inward-facing layer, An upper flexible framework is disposed between the outward-facing layer and the inward-facing layer on the upper surface of the balloon member, A lower flexible framework is disposed between the outward-facing layer and the inward-facing layer on the lower surface of the balloon member, A plurality of first electrodes patterned on the upper flexible framework, A second plurality of electrodes patterned on the lower flexible framework, wherein the first plurality of electrodes are aligned with the second plurality of electrodes, A plurality of conductive traces arranged in each of the flexible frameworks, each of the plurality of conductive traces being electrically connected to a corresponding one of the first plurality of electrodes and the second plurality of electrodes, A flexible structural element disposed within the aforementioned internal cavity, A catheter equipped with [a specific feature / equipment].

2. The catheter according to claim 1, wherein the flexible structural element comprises a nitinol wire loop element extending along the longitudinal axis of the elongated catheter shaft.

3. The catheter according to claim 2, wherein the nitinol wire loop element is positioned between the upper flexible framework and the lower flexible framework.

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

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

6. The expandable assembly has an intermediate configuration between the first delivery configuration and the second deployment configuration, The catheter according to any one of claims 1 to 5, wherein in the intermediate configuration, the balloon member is not constrained by the introducer sheath and is not inflated.

7. The balloon member is provided in the outward-facing layers of the upper and lower surfaces of the balloon member and has a plurality of openings configured to expose the corresponding first plurality of electrodes and the second plurality of electrodes, The catheter according to any one of claims 1 to 6, wherein the diameters of the plurality of openings are the same size as, or smaller than, the diameters of the corresponding first plurality of electrodes and second plurality of electrodes.

8. The plurality of openings have a diameter of 0.25 mm to 3 mm. The catheter according to any one of claims 1 to 7, wherein each of the first plurality of electrodes and the second plurality of electrodes has a diameter of 0.25 mm to 3 mm.

9. The catheter according to any one of claims 1 to 8, wherein the first plurality of electrodes and the second plurality of electrodes are flush with, recessed, or protruding from the outward-facing layers on the upper and lower surfaces of the balloon member.

10. The elongated catheter shaft comprises an elliptical inflatable lumen connected to the internal cavity of the balloon member, The catheter according to any one of claims 1 to 9, wherein the balloon member is not inflated in the first delivery configuration and is inflated in the second deployment configuration by a liquid or gas supplied through the elliptical expansion lumen.

11. Each of the first plurality of electrodes and the second plurality of electrodes is arranged in a transverse row with respect to the longitudinal axis of the elongated catheter shaft. The catheter according to any one of claims 1 to 10, wherein the horizontal rows are offset such that each electrode in each row is offset from the electrodes in the adjacent row.

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

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

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

15. The catheter according to any one of claims 1 to 14, wherein each electrode on each row is spaced equally apart from adjacent electrodes on the same row and adjacent electrodes on adjacent rows.

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

17. The catheter according to any one of claims 1 to 16, wherein each electrode of the first plurality of electrodes and each electrode of the second plurality of electrodes are grouped into a group including three or more electrodes that define a two-dimensional shape.

18. The aforementioned group of electrodes is arranged in an equilateral triangle shape. Each group has at least three electrodes, The catheter according to claim 17, wherein the group of electrodes is configured to sample the electrical properties of contact tissue in at least two substantially transverse directions.

19. The catheter according to any one of claims 1 to 18, wherein the intercenter distance of the first plurality of electrodes and the intercenter distance of the second plurality of electrodes are 0.5 mm to 4 mm.

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

21. The catheter according to any one of claims 1 to 20, further comprising one or more magnetic position sensors disposed in the upper flexible framework or the lower flexible framework at the distal portion of the expandable assembly.

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

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

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

25. It is a catheter, A slender catheter shaft having a proximal end and a distal end, with a defined longitudinal axis, An expandable assembly having a first delivery configuration and a second deployment configuration, Equipped with, The aforementioned expandable assembly is In the second unfolded configuration, a balloon member having a substantially flat shape and comprising an upper surface and a lower surface, A plurality of first electrodes extending inside the upper surface of the balloon member and exposed from the upper surface of the balloon member, A plurality of second electrodes extending inside the lower surface of the balloon member and exposed from the lower surface of the balloon member, Equipped with, Each of the first plurality of electrodes and the second plurality of electrodes is arranged in a transverse row with respect to the longitudinal axis of the elongated catheter shaft. A catheter in which the horizontal rows are offset such that each electrode in each row is offset from the electrodes in the adjacent row.

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

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

28. Each of the first plurality of electrodes and the second plurality of electrodes is arranged in a vertical column parallel to the longitudinal axis of the elongated catheter shaft. The catheter according to any one of claims 25 to 27, wherein the columns are offset such that each electrode on each column is offset from the electrodes on adjacent columns.

29. The catheter according to any one of claims 25 to 28, wherein each electrode on each row is spaced equally apart from adjacent electrodes on the same row and adjacent electrodes on adjacent rows.

30. The catheter according to any one of claims 25 to 29, wherein each electrode of the first plurality of electrodes and each electrode of the second plurality of electrodes are grouped into a group including three or more electrodes that define a two-dimensional shape.

31. The aforementioned group of electrodes is arranged in an equilateral triangle shape. Each group has at least three electrodes, The catheter according to claim 30, wherein the group of electrodes is configured to sample the electrical properties of contact tissue in at least two substantially transverse directions.

32. The catheter according to claim 25, wherein the intercenter distance of the first plurality of electrodes and the intercenter distance of the second plurality of electrodes are 0.5 mm.

33. The catheter according to claim 25, wherein the intercenter distance of the first plurality of electrodes and the intercenter distance of the second plurality of electrodes are 0.5 mm to 4 mm.

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

35. The catheter according to claim 34, wherein the flexible structural element comprises a nitinol wire loop element extending along the longitudinal axis of the elongated catheter shaft.

36. The catheter according to any one of claims 25 to 35, wherein the upper surface and the lower surface of the balloon member each have an outward-facing layer and an inward-facing layer.

37. A plurality of electrodes arranged on the outward-facing layer on the upper surface and the outward-facing layer on the lower surface, A plurality of conductive traces are arranged on the outward-facing layer on the upper surface and the outward-facing layer on the lower surface, The catheter according to claim 36, further comprising:

38. The catheter according to claim 37, wherein the balloon member is composed of thermoplastic polyurethane (TPU), thermoplastic elastomer (TPE), polyamide containing nylon or Pebax, ethylene vinyl acetate (EVA), polyvinylidene fluoride (PVDF), polyvinyl chloride (PVC), silicone, and / or composite materials thereof.

39. An upper flexible framework is disposed between the outward-facing layer and the inward-facing layer on the upper surface of the balloon member, A lower flexible framework is disposed between the outward-facing layer and the inward-facing layer on the lower surface of the balloon member, The first plurality of electrodes arranged in the upper flexible framework, The second set of electrodes arranged in the lower flexible framework, A plurality of conductive traces arranged in each of the flexible frameworks, each of the plurality of conductive traces being electrically connected to a corresponding one of the first plurality of electrodes and the second plurality of electrodes, The catheter according to claim 36, further comprising:

40. The balloon member is provided in the outward-facing layers of the upper and lower surfaces of the balloon member and has a plurality of openings configured to expose the corresponding first plurality of electrodes and the second plurality of electrodes, The catheter according to claim 36, wherein the diameters of the plurality of openings are the same size as, or smaller than, the diameters of the corresponding first plurality of electrodes and the second plurality of electrodes.

41. The elongated catheter shaft comprises an elliptical inflatable lumen connected to the internal cavity of the balloon member, The catheter according to claim 34, wherein the balloon member is not inflated in the first delivery configuration and is inflated in the second deployment configuration by a liquid or gas supplied through the elliptical expansion lumen.

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

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

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

45. The expandable assembly has an intermediate configuration between the first delivery configuration and the second deployment configuration, The catheter according to any one of claims 25 to 44, wherein in the intermediate configuration, the balloon member is not constrained by the introducer sheath and is not inflated.

46. It is a catheter, A slender catheter shaft having a proximal end and a distal end, with a defined longitudinal axis, An expandable assembly having a first delivery configuration and a second unfolding configuration having a substantially planar shape, Equipped with, The aforementioned expandable assembly is Top surface and, The bottom and, A flexible framework is disposed between the upper surface and the lower surface, A plurality of electrodes patterned on the flexible framework, wherein the plurality of electrodes are arranged in transverse rows with respect to the longitudinal axis of the elongated catheter shaft, and the transverse rows are offset such that each electrode in each row is offset from the electrodes in adjacent rows, Arranged within the flexible framework are a plurality of conductive traces electrically connected to the plurality of electrodes, A flexible structural element located within the expandable assembly, A catheter equipped with [a specific feature / equipment].

47. The catheter according to claim 46, wherein the expandable assembly comprises a silicone pad.

48. The catheter according to claim 46 or 47, wherein the expandable assembly comprises an internal cavity between the upper surface and the lower surface.

49. The catheter according to claim 46 or 47, wherein the expandable assembly does not have an internal cavity between the upper surface and the lower surface.

50. It is a catheter, A slender catheter shaft having a proximal end and a distal end, with a defined longitudinal axis, An expandable assembly having a first delivery configuration and a second deployment configuration, Equipped with, The aforementioned expandable assembly is A balloon member having an upper surface, a lower surface, and an internal cavity, A flexible framework is disposed between the upper surface and the lower surface, Multiple electrodes patterned on the aforementioned flexible framework, Arranged within the flexible framework are a plurality of conductive traces electrically connected to the plurality of electrodes, A flexible structural element disposed within the aforementioned internal cavity, A catheter equipped with [a specific feature / equipment].

51. It is a catheter, A slender catheter shaft having a proximal end and a distal end, with a defined longitudinal axis, Extensible assemblies and Equipped with, The aforementioned expandable assembly is A linear balloon member having an upper surface, a lower surface, and an internal cavity, wherein each of the upper surface and the lower surface has an outward-facing layer and an inward-facing layer, An upper flexible framework is disposed between the outward-facing layer and the inward-facing layer on the upper surface of the balloon member, A lower flexible framework is disposed between the outward-facing layer and the inward-facing layer on the lower surface of the balloon member, A plurality of first electrodes patterned on the upper flexible framework, A second plurality of electrodes patterned on the lower flexible framework, wherein the first plurality of electrodes are aligned with the second plurality of electrodes, A plurality of conductive traces arranged in each of the flexible frameworks, each of the plurality of conductive traces being electrically connected to a corresponding one of the first plurality of electrodes and the second plurality of electrodes, A flexible structural element disposed within the aforementioned internal cavity, A catheter equipped with [a specific feature / equipment].

52. It is a catheter, A slender catheter shaft having a proximal end and a distal end, with a defined longitudinal axis, Extensible assemblies and Equipped with, The aforementioned expandable assembly is A hoop-shaped balloon member having an upper surface, a lower surface, and an internal cavity, wherein each of the upper surface and the lower surface has an outward-facing layer and an inward-facing layer, An upper flexible framework is disposed between the outward-facing layer and the inward-facing layer on the upper surface of the balloon member, A lower flexible framework is disposed between the outward-facing layer and the inward-facing layer on the lower surface of the balloon member, A plurality of first electrodes patterned on the upper flexible framework, A second plurality of electrodes patterned on the lower flexible framework, wherein the first plurality of electrodes are aligned with the second plurality of electrodes, A plurality of conductive traces arranged in each of the flexible frameworks, each of the plurality of conductive traces being electrically connected to a corresponding one of the first plurality of electrodes and the second plurality of electrodes, A flexible structural element disposed within the aforementioned internal cavity, A catheter equipped with [a specific feature / equipment].

53. It is a catheter, A slender catheter shaft having a proximal end and a distal end, with a defined longitudinal axis, Extensible assemblies and Equipped with, The aforementioned expandable assembly is A circular balloon member having an upper surface, a lower surface, and an internal cavity, wherein each of the upper surface and the lower surface has an outward-facing layer and an inward-facing layer, An upper flexible framework is disposed between the outward-facing layer and the inward-facing layer on the upper surface of the balloon member, A lower flexible framework is disposed between the outward-facing layer and the inward-facing layer on the lower surface of the balloon member, A plurality of first electrodes patterned on the upper flexible framework, A second plurality of electrodes patterned on the lower flexible framework, wherein the first plurality of electrodes are aligned with the second plurality of electrodes, A plurality of conductive traces arranged in each of the flexible frameworks, each of the plurality of conductive traces being electrically connected to a corresponding one of the first plurality of electrodes and the second plurality of electrodes, A flexible structural element disposed within the aforementioned internal cavity, A catheter equipped with [a specific feature / equipment].

54. It is a catheter, A slender catheter shaft having a proximal end and a distal end, with a defined longitudinal axis, Extensible assemblies and Equipped with, The aforementioned expandable assembly is A balloon member having an upper surface, a lower surface, and an internal cavity, wherein each of the upper surface and the lower surface has an outward-facing layer and an inward-facing layer, An upper flexible framework is disposed between the outward-facing layer and the inward-facing layer on the upper surface of the balloon member, A lower flexible framework is disposed between the outward-facing layer and the inward-facing layer on the lower surface of the balloon member, A plurality of first electrodes patterned on the upper flexible framework, A second plurality of electrodes patterned on the lower flexible framework, wherein the first plurality of electrodes are aligned with the second plurality of electrodes, A plurality of conductive traces arranged in each of the flexible frameworks, each of the plurality of conductive traces being electrically connected to a corresponding one of the first plurality of electrodes and the second plurality of electrodes, A flexible structural element disposed within the aforementioned internal cavity, Equipped with, The expandable assembly further comprises a first delivery configuration and a second deployment configuration. The expandable assembly is a catheter having a flat shape in the second deployed configuration.

55. It is a catheter, A slender catheter shaft having a proximal end and a distal end, with a defined longitudinal axis, Extensible assemblies and Equipped with, The aforementioned expandable assembly is A balloon member having an upper surface, a lower surface, and an internal cavity, wherein each of the upper surface and the lower surface has an outward-facing layer and an inward-facing layer, An upper flexible framework is disposed between the outward-facing layer and the inward-facing layer on the upper surface of the balloon member, A lower flexible framework is disposed between the outward-facing layer and the inward-facing layer on the lower surface of the balloon member, A plurality of first electrodes patterned on the upper flexible framework, A second plurality of electrodes patterned on the lower flexible framework, wherein the first plurality of electrodes are aligned with the second plurality of electrodes, A plurality of conductive traces arranged in each of the flexible frameworks, each of the plurality of conductive traces being electrically connected to a corresponding one of the first plurality of electrodes and the second plurality of electrodes, A flexible structural element disposed within the aforementioned internal cavity, Equipped with, The expandable assembly further comprises a first delivery configuration and a second deployment configuration. The expandable assembly is a catheter having a convex shape in the second unfolded configuration.

56. It is a catheter, A slender catheter shaft having a proximal end and a distal end, with a defined longitudinal axis, Extensible assemblies and Equipped with, The aforementioned expandable assembly is A balloon member having an upper surface, a lower surface, and an internal cavity, wherein each of the upper surface and the lower surface has an outward-facing layer and an inward-facing layer, An upper flexible framework is disposed between the outward-facing layer and the inward-facing layer on the upper surface of the balloon member, A lower flexible framework is disposed between the outward-facing layer and the inward-facing layer on the lower surface of the balloon member, A plurality of first electrodes patterned on the upper flexible framework, A second plurality of electrodes patterned on the lower flexible framework, wherein the first plurality of electrodes are aligned with the second plurality of electrodes, A plurality of conductive traces arranged in each of the flexible frameworks, each of the plurality of conductive traces being electrically connected to a corresponding one of the first plurality of electrodes and the second plurality of electrodes, A flexible structural element disposed within the aforementioned internal cavity, Equipped with, The expandable assembly further comprises a first delivery configuration and a second deployment configuration. The expandable assembly is a catheter having a concave shape in the second unfolded configuration.

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