Method for forming splines using flexible circuit assemblies and electrode assemblies including same

Abstract

A method for forming splines for an electrode assembly includes providing a structural member including a first surface and a second surface. The method also includes providing a flexible circuit assembly including a plurality of electrodes and at least one flexible circuit board having a contact surface and an outer surface opposite the contact surface. The plurality of electrodes are disposed on the outer surface of the at least one flexible circuit board. The method also includes positioning the flexible circuit assembly relative to the structural member so that a first set of electrodes is aligned with the first surface and a second set of electrodes is aligned with the second surface. The method also includes bonding the at least one flexible circuit board to at least one of the structural member and the at least one flexible circuit board.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Provisional Patent Application No. 63 / 021,737, filed May 8, 2020, the disclosure of which is incorporated herein by reference in its entirety. [Background technology]

[0002] FIELD OF THE DISCLOSURE The present disclosure relates generally to medical devices for use in the human body. More particularly, the present disclosure relates to a method of forming splines for an electrode assembly using a flexible circuit assembly.

[0003] Electrophysiology catheters are used in a variety of diagnostic, therapeutic, and / or mapping and ablation procedures to diagnose and / or correct conditions such as atrial arrhythmias, including, for example, ectopic atrial tachycardia, atrial fibrillation, and atrial flutter.

[0004] Typically, to perform such diagnostic, therapeutic, and / or mapping and ablation procedures, a catheter is deployed and manipulated through the patient's vascular system vasculature to an intended site, e.g., a site within the patient's heart. The catheter typically carries one or more electrodes that may be used, for example, for cardiac mapping or diagnosis, ablation, and / or other therapeutic delivery modes, or both. Ablation therapy may be used to treat a variety of conditions afflicting the human anatomy, including atrial or cardiac arrhythmias. When tissue is ablated, or at least subjected to ablation energy generated by an ablation generator and delivered by an ablation catheter, lesions are formed within the tissue. Electrodes mounted on or within the ablation catheter are used to create tissue necrosis within cardiac tissue to correct conditions such as atrial arrhythmias (including, but not limited to, ectopic atrial tachycardia, atrial fibrillation, and atrial flutter). Arrhythmias may cause a variety of dangerous conditions, including loss of synchronous atrioventricular contractions and stagnation of blood flow. The primary cause of atrial arrhythmias is believed to be stray electrical signals within the left or right atrium of the heart. The ablation catheter delivers ablation energy (e.g., radiofrequency energy, cryoablation, laser, chemicals, high intensity focused ultrasound, etc.) to the cardiac tissue to create damage in the cardiac tissue. This damage disrupts unwanted electrical pathways, thereby limiting or preventing the stray electrical signals that lead to arrhythmias.

[0005] Electroporation is a non-thermal ablation technique that involves applying a strong electric field that induces pore formation in cell membranes. The electric field can be induced, for example, by applying a relatively short duration pulse that can last from nanoseconds to a few milliseconds. Such pulses can be repeated to form a pulse train. When such an electric field is applied to tissue in an in vivo setting, cells in the tissue are exposed to a transmembrane potential, which opens pores on the cell wall. Electroporation can be reversible (i.e., the temporarily opened pores reseal) or irreversible (i.e., the pores remain open), causing cell destruction. For example, in the field of gene therapy, reversible electroporation is used to introduce high molecular weight therapeutic vectors into cells. In other therapeutic applications, only appropriately configured pulse trains can be used to cause cell destruction, for example, by causing irreversible electroporation.

[0006] Catheters such as basket catheters and planar catheters have electrodes distributed along a set number of splines. In particular, the electrodes are typically located on one side of each spline. Thus, the electrode density of at least some known catheters is limited by the number of splines and the number of electrodes located on each spline. The electrode assembly may be limited to a set number of splines due to the inherent difficulty of increasing the number of splines. For example, with respect to basket catheters, as the number of splines increases, the diameter of the electrode basket increases, which is undesirable since larger electrode baskets may be more difficult to deploy at smaller target locations. Alternatively, narrower splines can be used to maintain the diameter of the electrode basket, but the narrower splines limit the electrode size.

[0007] In addition, at least some known catheters, when deployed, result in a positioning force being applied to only one side of the catheter. For example, a spiral catheter is always attached at only one point (e.g., its proximal end), so that a positioning force is applied to only one side of the spiral, and therefore no force can be applied to the opposite side (e.g., 180 degrees around the spiral). Summary of the Invention

[0008] The present disclosure relates to a method of forming splines for an electrode assembly for a catheter system. The method includes providing a structural member including a first surface and a second surface. The method also includes providing a flexible circuit assembly including a plurality of electrodes and at least one flexible circuit board having a contact surface and an outer surface opposite the contact surface. The plurality of electrodes are disposed on the outer surface of the at least one flexible circuit board. The method includes positioning the flexible circuit assembly relative to the structural member such that a first electrode set of the plurality of electrodes is aligned with the first surface of the structural member and a second electrode set of the plurality of electrodes is aligned with the second surface of the structural member. The method also includes bonding the at least one flexible circuit board to at least one of the structural member and the at least one flexible circuit board of the flexible circuit assembly.

[0009] The present disclosure is further directed to an electrode assembly for a catheter system. The electrode assembly has a longitudinal axis, a proximal end, and a distal end. The electrode assembly includes at least one spline extending from the proximal end to the distal end of the electrode assembly. The at least one spline includes a structural member extending from the proximal end to the distal end of the electrode assembly. The structural member includes a first surface and a second surface. The at least one spline also includes a flexible circuit assembly including a plurality of electrodes and at least one flexible circuit board having a contact surface and an outer surface opposite the contact surface. The plurality of electrodes are disposed on the outer surface of the at least one flexible circuit board. The flexible circuit assembly is positioned relative to the structural member such that a first electrode set of the plurality of electrodes is aligned with the first surface of the structural member and a second electrode set of the plurality of electrodes is aligned with the second surface of the structural member. The at least one flexible circuit board is coupled to at least one of the structural member and the at least one flexible circuit board.

[0010] The present disclosure is further directed to a catheter system including a flexible catheter shaft, a handle coupled to a proximal end of the catheter shaft, and an electrode assembly. The electrode assembly is coupled to a distal end of the flexible catheter shaft and has a longitudinal axis, a proximal end, and a distal end. The electrode assembly includes at least one spline extending from the proximal end to the distal end of the electrode assembly. The at least one spline includes a structural member extending from the proximal end to the distal end of the electrode assembly. The structural member includes a first surface and a second surface. The at least one spline also includes a flexible circuit assembly including a plurality of electrodes and at least one flexible circuit board having a contact surface and an outer surface opposite the contact surface. The plurality of electrodes are disposed on the outer surface of the at least one flexible circuit board. The flexible circuit assembly is positioned relative to the structural member such that a first electrode set of the plurality of electrodes is aligned with the first surface of the structural member and a second electrode set of the plurality of electrodes is aligned with the second surface of the structural member. The at least one flexible circuit board is coupled to at least one of the structural member and the at least one flexible circuit board. [Brief description of the drawings]

[0011] [Figure 1] FIG. 1 is a schematic block diagram of a catheter system incorporating various embodiments of the present disclosure. [Diagram 2] 2 is a simplified schematic diagram of an exemplary visualization, navigation, and / or mapping system of the catheter system shown in FIG. 1. [Diagram 3] FIG. 2 is a perspective view of an exemplary electrode assembly suitable for use in the system of FIG. 1, shown in the form of a basket electrode assembly. [Figure 4] 2 is a perspective view of another exemplary electrode assembly suitable for use in the system of FIG. 1, shown in the form of a planar electrode assembly. [Diagram 5] FIG. 5 is an end view of an exemplary spline suitable for use in the electrode assembly shown in FIGS. 3 and 4. [Figure 6]FIG. 6 is a top view of an exemplary subassembly of a flexible circuit assembly suitable for use in forming the spline of FIG. 5. [Figure 7] 6 illustrates steps in an exemplary method for forming the spline of FIG. 5. [Figure 8] FIG. 5 illustrates an end view of another exemplary spline suitable for use in the electrode assembly shown in FIGS. 3 and 4. [Figure 9] 9 illustrates an exemplary flexible circuit assembly suitable for use in forming the spline of FIG. 8. [Figure 10] 9 illustrates steps in an exemplary method for forming the spline of FIG. 8. [Figure 11] 9 illustrates another subsequent step in the exemplary method of forming the spline of FIG. 8. [Figure 12] FIG. 5 illustrates an end view of another exemplary spline suitable for use in the electrode assembly shown in FIGS. 3 and 4. [Figure 13] 13 illustrates steps in an exemplary method for forming the spline of FIG. 12. [Figure 14] FIG. 2 is a perspective view of an exemplary subassembly in a spiral configuration suitable for use in the system shown in FIG. 1. [Figure 15] 5 is a flowchart of an exemplary method of forming splines for an electrode assembly, such as the electrode assemblies shown in FIGS. 3 and 4. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0012] Corresponding reference characters indicate corresponding parts throughout the several views of the drawings, it being understood that the drawings are not necessarily to scale.

[0013] The present disclosure generally relates to medical devices for use in the human body. The present disclosure provides a medical device including a spline for an electrode assembly for a catheter system for use in the human vasculature for medical procedures such as mapping and / or ablation procedures, and a method of forming the spline. The electrode assembly of the present disclosure includes at least one spline including a structural member and a flexible circuit assembly. The flexible circuit assembly includes at least one flexible circuit board and a plurality of electrodes disposed on an outer surface of the at least one flexible circuit board. The flexible circuit assembly is positioned relative to the structural member such that the electrodes are aligned with both a first surface and a second surface of the structural member. At least some known electrode assemblies include a spline formed by placing a structural member within a tubing and then placing an electrode on the outer surface of the tubing.

[0014] Unlike some known electrode assemblies, the disclosed embodiments allow for the splines to be formed by directly bonding electrodes to one or more surfaces of a structural member via a flexible circuit board, thereby eliminating the need for intermediate tubing. Additionally, the disclosed embodiments allow for electrodes to be placed on two or more surfaces of a single spline, thereby allowing more electrodes to be placed on a single spline. Such an arrangement improves electrode density around the circumference of the electrode assembly, which can improve the accuracy of mapping and / or ablation procedures, and therefore can result in more consistent and improved patient outcomes.

[0015] Referring now to the drawings, FIG. 1 is a schematic block diagram of a catheter system 100 suitable for diagnostic purposes, anatomical mapping and / or ablation therapy (e.g., electroporation therapy). In general, various embodiments include an electrode assembly disposed at the distal end of the catheter shaft. As used herein, "proximal" refers to the direction toward the end of the catheter near the clinician, and "distal" refers to the direction away from the clinician and (generally) toward the body of the individual. The electrode assembly includes one or more individual, electrically insulated electrode elements. Each electrode element, also referred to herein as a catheter electrode, is individually wired such that it can be selectively paired or combined with any other electrode element to function as a bipolar or multipolar electrode.

[0016] The system 100 may be used for irreversible electroporation to destroy tissue. In particular, the system 100 may be used for electroporation-induced primary necrosis therapy, which refers to the effect (outcome) of delivering electric current in such a way that it directly causes irreversible loss of plasma membrane (cell wall) integrity resulting in its destruction and cell necrosis. This mechanism of cell death can be considered as an "outside-in" process, meaning that destruction of the outer wall of the cell causes deleterious effects on the interior of the cell. Typically, for classical plasma membrane electroporation, electric current is delivered as a pulsed electric field in the form of short duration pulses (e.g., 0.1-20 ms duration) between closely spaced but spaced electrodes capable of delivering a field strength of about 0.1-1.0 kV / cm (i.e., pulsed electric field ablation (PFA)).

[0017] The system 100 includes an electrode assembly 102 including at least one catheter electrode configured for use as described below. The electrode assembly 102 is incorporated as part of a medical device, such as a catheter 104 for electroporation therapy, diagnosis, mapping, and / or treatment procedures. For example, the electrode assembly 102 may be used to map one or more structures 106 within a patient's body 108, also referred to herein as internal body structures 106. As another example, the electrode assembly 102 may be used for ablation therapy (e.g., electroporation therapy) of tissue of the structures 106 within the body 108. In the illustrated embodiment, the structures 106 include the patient's vasculature and / or heart or cardiac tissue. However, it should be understood that the embodiments may be used to perform mapping, diagnosis, and / or ablation therapy on various other body structures and / or tissues.

[0018] The system 100 also includes additional subsystems, such as a power source 110 and a visualization, navigation, and mapping system 112 for visualization, mapping, and navigation of the internal body structures 106. The power source 110 is any power source configured to energize or excite the electrodes of the electrode assembly 102 and / or generate electrical and / or magnetic fields to perform appropriate functions during a medical procedure. For example, the power source 110 includes a radio frequency (RF) ablation and / or electroporation generator such that the system 100 can be used for RF ablation and electroporation procedures. In such an embodiment, the power source 110 is configured to energize the electrodes according to an ablation strategy, which may be predetermined or selectable by a user. When used for an RF ablation procedure, the power source 110 outputs radio frequency (RF) energy to the catheter 104 via a cable 114. The RF energy exits the catheter 104 through the electrodes of the electrode assembly 102 (e.g., using bipolar electrode stimulation). Dissipation of the RF energy within the body increases the temperature near the electrodes, thereby allowing RF ablation to occur.

[0019] In some embodiments, the system 100 includes one or more return electrodes 116 (e.g., patch electrodes) for monopolar electrode stimulation or for performing mapping functions, as described further herein. In such embodiments, the power source 110 includes a signal generator coupled to the patch electrodes 116 and configured to excite the patch electrodes 116 to generate an electric field within the body 108.

[0020] In the illustrated embodiment, the catheter 104 includes a cable connector or interface 118, a handle 120, and a shaft 122 having a proximal end 124 and a distal end 126. The catheter 104 may also include other conventional components not shown herein, such as one or more sensors (e.g., sensor 138), additional electrodes, and corresponding conductors or leads. The connector 118 provides a mechanical and electrical connection for a cable 114 extending from the power source 110 and / or visualization, navigation, and mapping system 112, and is disposed at the proximal end of the catheter 104 as shown.

[0021] The handle 120 provides a place for the physician to hold the catheter 104 and may further provide a means for steering or guiding the shaft 122 within the body 108. For example, the handle 120 may include a means for changing the length of one or more guidewires that extend through the catheter 104 to the distal end 126 of the shaft 122 or other means to the steering shaft 122. Additionally, in some embodiments, the handle 120 may be configured to change the shape, size, and / or orientation of a portion of the catheter. It will be understood that the configuration of the handle 120 may vary. In an alternative exemplary embodiment, the catheter 104 may be robotically driven or controlled. Thus, rather than a clinician manipulating a handle to advance / retreat and / or steer or guide the catheter 104 (and particularly its shaft 122), a robot is used to manipulate the catheter 104.

[0022] The shaft 122 is an elongated, tubular, flexible member configured to move within the body 108. The shaft 122 is configured to support the electrode assembly 102 and to contain associated conductors and possibly additional electronics used for signal processing or conditioning. The shaft 122 may also allow for the transport, delivery, and / or removal of fluids (including irrigation fluids and bodily fluids), medications, and / or surgical tools or instruments. The shaft 122 may be made from conventional materials, such as polyurethane, and defines one or more lumens configured to accommodate and / or transport conductors, fluids, or surgical tools. The shaft 122 may be introduced into a blood vessel or other structure 106 within the body 108 via a conventional introducer. The shaft 122 may then be advanced, retracted, and / or steered or guided through the body 108 to a desired location within the structure 106, through the use of a guidewire or other means known in the art.

[0023] In an embodiment of the present disclosure, the electrode assembly 102 is coupled to the distal end 126 of the shaft 122 to deliver the electrode assembly 102 to a target location within the patient's body 108. In some embodiments, the electrode assembly 102 is an electrode basket selectively configurable between a collapsed configuration and an expanded configuration. For example, the electrode assembly 102 may be delivered to the target location in a collapsed configuration (e.g., within the catheter shaft 122 and / or within a separate guide tube (not specifically shown)). In this example, the electrode assembly 102 is then deployed to the expanded configuration at the target location to perform a medical procedure (e.g., an ablation or mapping procedure). In some embodiments, the electrode assembly 102 is in the form of a planar or grid electrode assembly including paddles coupled to the catheter body. In an embodiment of the present disclosure, the electrode assembly 102 is then energized using the power source 110 to perform the medical procedure at the target location. The electrode assembly 102 may include multiple electrodes thereon (e.g., electrode 226 shown in Figures 3-5). The electrode assembly 102 and / or the catheter shaft 122 may include one or more sensors 138 therein or thereon.

[0024] Sensors 138 mounted in or on the shaft 122 and / or in or on the electrode assembly 102 may be provided for various diagnostic and therapeutic purposes, including, for example, electrophysiological studies and cardiac mapping. In an exemplary embodiment, one or more of the sensors 138 are provided to perform a position sensing function. More specifically, one or more of the sensors 138 are configured to be, for example, a positioning sensor that provides information to the visualization, navigation, and mapping system 112 regarding the location (e.g., position and orientation) of the catheter 104 and its distal end 126 at a particular time, among other things. The sensor 138 may comprise one of several types of sensors, such as, for example, but not limited to, electrodes (e.g., tip and ring electrodes) or magnetic sensors (e.g., magnetic coils). It will be understood that the number, shape, orientation, and purpose of the sensors may vary.

[0025] The visualization, navigation, and mapping system 112 may be provided for visualization, mapping, and navigation of the internal body structure 106, for example, by determining the location of the electrode assembly 102, one or more splines, and / or specific electrodes thereon. These locations may be projected onto a geometric anatomical model. The visualization, navigation, and mapping system 112 may include conventional devices generally known in the art (e.g., Abbott Laboratories' EnSite™ Velocity™ or EnSite™ Precision™ cardiac mapping and visualization systems, or the EnSite™ NavX™ system, commercially available from Abbott Laboratories and generally as described with reference to commonly assigned U.S. Pat. No. 7,263,397, entitled "Method and Apparatus for Catheter Navigation and Location and Mapping in the Heart," the entire disclosure of which is incorporated herein by reference). Other systems and components suitable for use with the visualization, navigation, and mapping system 112 are described, for example, in U.S. Pat. No. 7,885,707, entitled "Method of Scaling Navigation Signals to Account for Impedance Drift in Tissue," and U.S. Patent Application Publication No. 2018 / 0296111, entitled "Orientation Independent Sensing, Mapping, Interface and Analysis System and Methods," the entire disclosures of which are incorporated herein by reference. In various embodiments, the visualization, navigation, and mapping system 112 uses the electrodes of the electrode assembly 102 as a bipolar pair for visualization, mapping, and navigation of the internal body structures 106. However, it should be understood that this system is merely exemplary and not limiting in nature.Other techniques are known for visualizing / navigating / mapping a catheter in space, including commonly available fluoroscopy systems, such as Biosense Webster, Inc.'s CARTO navigation and location system, Northern Digital Inc.'s AURORA® system, or magnetic location systems, such as the gMPS system from MediGuide Ltd. In this regard, some of the localization, navigation, and / or visualization systems may provide sensors for generating signals indicative of catheter location information, including, for example, one or more electrodes in the case of an impedance-based localization system, or one or more coils (i.e., wire windings) configured to detect one or more characteristics of a magnetic field in the case of a magnetic field-based localization system.

[0026] The system 100 may further include a main computer system 130, which in certain embodiments may be integrated with the visualization, navigation, and mapping system 112. The computer system 130 may include an electronic control unit (ECU) 132 and a memory 134. The computer system 130 further includes a display device 136, which may be integrated into and / or coupled to the computer system 130. The catheter 104, and thus the electrode assembly 102, may be coupled to the computer system 130 and / or the visualization, navigation, and mapping system 112 using a wired or wireless connection.

[0027] 2 is a simplified schematic diagram of the visualization, navigation, and / or mapping system 112 of the system 100 (shown in FIG. 1). With reference to FIGS. 1 and 2, the visualization, navigation, and mapping system 112 may include, among other components, a number of patch electrodes 116, an ECU 132, and a display device 136. The patch electrodes 116, referred to as a "belly patch,"B Except for the catheter 104, the patch electrodes 116 are provided to generate signals that are used, for example, in determining the position and orientation of, and guiding, the catheter 104. In one embodiment, the patch electrodes 116 are positioned orthogonally on the surface of the patient's body 108 and are used to generate axis-specific electric fields within the body 108. For example, in one exemplary embodiment, the patch electrodes 116 X1 , 116 X2 may be arranged along the first (x) axis. Y1 , 116 Y2 may be disposed along the second (y) axis, and the patch electrode 116 Z1 , 116 Z2 may be disposed along a third (z) axis. In other embodiments, the dipole generated may not be on one axis, for example, electrode 116 X1 and 116 Y1 The patch electrodes 116 may be dipoles between the body 108 and the patient's heart. Each of the patch electrodes 116 may be coupled to a multiplex switch 140. In an exemplary embodiment, the ECU 132 is configured to provide a control signal to the switch 140 via suitable software to sequentially couple pairs of the electrodes 116 to a signal generator (e.g., the power supply 110). Excitation of each pair of the electrodes 116 generates an electric field within the body 108 and within a region of interest, such as the patient's heart. The berry patch 116 B The potential of the non-excited electrode 116 relative to the reference may be filtered, for example, by a low pass filter 142, converted by an analog to digital converter 144, and provided to the ECU 132 for use as a reference.

[0028] As described above, the catheter 104 includes an electrode assembly 102 coupled thereto. In an exemplary embodiment, the electrode assembly 102 includes a plurality of splines, each of which includes one or more electrodes (e.g., electrode 414 shown in FIGS. 5-13) mounted therein or thereon, and in some embodiments, these multiple electrodes are electrically connected to the power source 110 and / or the ECU 132 to provide one or more diagnostic or therapeutic purposes as described herein. In an exemplary embodiment, the electrode assembly 102 is placed within an electric field that is generated within the body 108 by exciting the patch electrodes 116. Once placed within the electric field, the electrodes on the electrode assembly 102 experience a voltage that depends on their position between the patch electrodes 116 and the position of each electrode relative to the tissue of the anatomical structure 106 being mapped. Comparison of voltage measurements made between each electrode on the electrode assembly 102 and the patch electrodes 116 can be used to determine the position of each electrode on the electrode assembly 102 relative to the anatomical structure 106. This position information may then be used by the ECU 132 to generate a model, such as, for example, a surface model and / or map of the anatomical structure or a model corresponding to the anatomical structure. Thus, as the catheter 104 is moved along the surface of the desired anatomical structure 106, for example, the electrode assembly 102 may be used to collect position data points corresponding to the positions of the electrodes thereon and thus the surface of the anatomical structure 106. These position data points may then be used by the ECU 132, for example, to generate or build a surface model of the anatomical structure. Additionally, information received from the electrode assembly 102 may also be used to display the position and orientation of the electrode assembly 102 and / or the tip of the catheter 104 on a display device, such as the display device 136. Thus, among other things, the ECU 132 of the visualization, navigation, and mapping system 112 generates display signals used to control the display device 136 and provides a means for creating a graphical user interface (GUI) on the display device 136.

[0029] The ECU 132 may include, for example, a programmable microprocessor or microcontroller, or may include an application specific integrated circuit (ASIC). The ECU 132 may include a central processing unit (CPU) and an input / output (I / O) interface, through which the ECU 132 may receive a number of input signals, including, for example, signals generated by the electrode assembly 102. The ECU 132 may generate a number of output signals, including, for example, an output signal used to control the display device 136. The ECU 132 may be configured to perform various functions, such as those described herein, with appropriate programming instructions or code. Thus, in one embodiment, the ECU 132 is programmed with one or more computer programs encoded on a computer-readable storage medium to perform the functions described herein.

[0030] The ECU 132 may be configured to construct a geometric anatomical model of the structure 106 for display on the display device 136. The ECU 132 may also be configured to generate a GUI (graphical user interface) through which a user may view, among other things, the geometric anatomical model and / or the control electrode assembly 102. The anatomical model may include a 3D model or a two-dimensional (2D) model. To display data and images generated by the ECU 132, the display device 136 may include one or more conventional computer monitors or other display devices known in the art.

[0031] 3 is a perspective view of an exemplary electrode assembly 102 suitable for use in the system 100, shown in the form of a basket electrode assembly 200. The basket electrode assembly 200 includes a basket 202 coupled to a catheter body 204 (e.g., shaft 122) by a suitable proximal connector 206. The basket 202 includes a plurality of splines 208 and a distal coupler 210 at which each of the splines 208 terminates. In some embodiments, such as the illustrated embodiment, the basket electrode assembly 200 may also include an irrigation tube 212 (e.g., to supply fluid to the basket electrode assembly 200). In other embodiments, the irrigation tube 212 may be omitted. Each of the plurality of splines 208 includes at least one electrode 214. In the illustrated embodiment, each of the plurality of splines includes eight electrodes 214, although each spline 208 may include more or less than eight electrodes 214.

[0032] The electrodes 214 may be used for various diagnostic and therapeutic purposes, including, for example, but not limited to, cardiac mapping and / or ablation (e.g., RF ablation or irreversible electroporation (IRE) ablation). For example, in some embodiments, the electrode assembly 200 may be configured as a bipolar electrode assembly for use in bipolar-based electroporation therapy. Specifically, the electrodes 214 may be individually electrically coupled to an electroporation generator, such as the power source 110 (e.g., via suitable wires or other suitable electrical conductors extending through the catheter shaft 122), and may be configured to be selectively energized (e.g., by the power source 110 and / or the computer system 130) with opposite polarities to generate an electrical potential and corresponding electric field therebetween for IRE therapy. That is, one of the electrodes 214 may be configured to function as a cathode and another one of the electrodes 214 may be configured to function as an anode. The electrodes 214 may be any suitable electroporation electrodes. The electrodes 214 may have any other shape or configuration. It is understood that the shape, size, and / or configuration of the electrodes 214 may affect various parameters of the applied electroporation treatment. For example, increasing the surface area of ​​one or more electrodes 214 may reduce the applied voltage required to cause the same level of tissue destruction. In various embodiments, any combination of electrodes 214 may be configured as electrode pairs, including, for example, but not limited to, adjacent electrodes, non-adjacent electrodes, electrodes on adjacent splines, electrodes on non-adjacent splines, and any other combination of electrodes that enables the system 100 to function as described herein. In some embodiments, the generator 110 is configured to energize the electrodes according to an ablation strategy, as described above.

[0033] 4 is a perspective view of another exemplary electrode assembly 102 suitable for use in the system 100, shown in the form of a planar electrode assembly 300. The planar electrode assembly 300 includes a paddle 302 coupled to a catheter body 304 (e.g., shaft 122). In the illustrated embodiment, the catheter body 304 includes body electrodes 306, 308, 310 coupled thereto. In the illustrated embodiment, the paddle 302 includes a first spline 312, a second spline 314, a third spline 316, and a fourth spline 318 that are coupled to the catheter body 304 by a proximal coupler and coupled to each other at the distal end of the paddle 302 by a distal connector. In one embodiment, the first spline 312 and the fourth spline 318 can be one continuous segment, and the second spline 314 and the third spline 316 can be another continuous segment. In other embodiments, the various splines may be separate segments coupled together. The first spline 312, the second spline 314, the third spline 316, and the fourth spline 318 are generally aligned in the same (topological) plane. Although the paddle 302 is shown in FIG. 4 as being relatively flat or planar, it should be understood that the paddle 302 may bend, curl, twist, buckle, and / or otherwise deformed. Thus, the plane defined by the paddle 302 and the splines 312, 314, 316, 318 may be correspondingly deformed such that the plane is a non-flat topological plane. In the illustrated embodiment, the planar electrode assembly 300 also includes an irrigation port 320 at the distal end of the catheter body 304. The irrigation port 320 is positioned to deliver irrigation agent to a portion of one or more of the splines 312-318.

[0034] The multiple splines may further comprise a varying number of electrodes 322. The electrodes in the illustrated embodiment may include single-sided electrodes or electrodes printed on a flexible, bendable material. The electrodes may be evenly spaced along one or more surfaces of the spline. In other embodiments, the electrodes may be evenly or unevenly spaced and the electrodes may include any other suitable type of electrodes.

[0035] The electrodes 322 may be used for various diagnostic and therapeutic purposes, including, for example, but not limited to, cardiac mapping and / or ablation (e.g., RF ablation or IRE ablation). For example, in some embodiments, the electrode assembly 300 may be configured as a bipolar electrode assembly for use in bipolar-based electroporation therapy. Specifically, the electrodes 322 may be individually electrically coupled to an electroporation generator, such as the power source 110 (e.g., via suitable wires or other suitable electrical conductors extending through the catheter shaft 122), and may be configured to be selectively energized (e.g., by the power source 110 and / or the computer system 130) with opposite polarities to generate an electrical potential and corresponding electric field therebetween for IRE therapy. That is, one of the electrodes 322 may be configured to function as a cathode and another one of the electrodes 322 may be configured to function as an anode. The electrodes 322 may be any suitable electroporation electrodes. The electrodes 322 may have any other shape or configuration. It will be appreciated that the shape, size, and / or configuration of the electrodes 322 may affect various parameters of the applied electroporation treatment.

[0036] FIG. 5 illustrates an end view of an exemplary spline 400 suitable for use in an electrode assembly described herein (e.g., electrode assemblies 102, 200, 300). In particular, the spline 400 may be incorporated into the basket electrode assembly 200 as one or more splines 208 (both shown in FIG. 3). Additionally or alternatively, the spline 400 may be incorporated into the planar electrode assembly 300 as one or more splines 312, 314, 316, 318 (all shown in FIG. 4). In the illustrated embodiment, the spline 400 includes a flexible circuit assembly 402 and a structural member 404. The structural member 404 extends from a proximal end 401 of the spline 400 to a distal end (not shown in FIG. 5) and generally provides structural support to the spline 400 and its components (e.g., the flexible circuit assembly 402). The structural member 404 includes a first surface 406 and a second surface 408 (both shown in FIG. 7). In the illustrated embodiment, the structural member 404 has a rectangular cross-section, with the first surface 406 and the second surface 408 located on opposite sides of the structural member 404. In other embodiments, the structural member 404 may have a cross-sectional shape other than rectangular, and the first surface 406 and the second surface 408 may be on non-opposite sides of the structural member 404. Additionally, in the exemplary embodiment, the structural member 404 is a single continuous member that extends the entire length of the spline 400 (i.e., from the proximal end 401 to the distal end).

[0037] The structural members 404 may be constructed from a variety of suitable materials, including, for example, but not limited to, metal alloys, stainless steel, copper-aluminum-nickel alloys, alloys including zinc, copper, gold, and / or iron, polymers including any of the above materials, shape memory polymers, and / or combinations thereof. In some embodiments, the structural members 404 may be constructed from non-metallic materials, such as, for example, molded hard plastic materials. In an exemplary embodiment, the structural members 404 are comprised of a shape memory alloy. One particularly preferred shape memory alloy for use is Nitinol, a nickel-titanium (NiTi) alloy. Nitinol is a near stoichiometric alloy of nickel and titanium, which may contain small amounts of other metals to achieve desired properties. Nickel-titanium alloys are highly elastic, commonly referred to as "superelastic" or "pseudoelastic." Such shape memory alloys tend to have a temperature-induced phase change that results in a material having a preferred configuration that can be fixed by heating the material above a certain transition temperature to induce a phase change in the material. When the alloy is cooled back down, it "remembers" the shape it was in during heat treatment and tends to assume that shape unless restrained.

[0038] The flexible circuit assembly 402 includes at least one flexible circuit designed to bend or flex in use, and is typically mounted on a flexible substrate. In the illustrated embodiment, the flexible circuit assembly 402 includes a first subassembly 410 and a second subassembly 412. FIG. 6 is a top view of each of the first and second subassemblies of the flexible circuit assembly 402 (shown in FIG. 5). In the illustrated embodiment, the first subassembly 410 and the second subassembly 412 are identical, but in other embodiments, the first subassembly 410 and the second subassembly 412 may have different configurations. With reference to FIGS. 5 and 6, each of the first subassembly 410 and the second subassembly 412 includes a plurality of electrodes 414 disposed on a flexible circuit substrate 416. Each flexible circuit substrate 416 of the subassemblies 410, 412 includes an outer surface 418 opposite a contact surface (e.g., inner surface) 420 (shown in FIG. 7). Each flexible circuit board 416 also includes a first longitudinal edge 422 and a second longitudinal edge 424. In one embodiment, the flexible circuit boards 416 are flexible printed circuits, such as polyimide flexible circuits. In one example, the flexible circuit boards 416 may be Kapton® polyimide flexible circuits.

[0039] Electrodes 414 are disposed on an outer surface 418 of each flexible circuit board 416. The electrodes 414 may be any suitable type of electrodes, such as single-sided electrodes disposed on the outer surface 418 or electrodes printed on the flexible circuit board 416. In an exemplary embodiment, the first subassembly 410 and the second subassembly 412 each include a single flexible circuit including electrodes on one side of the flexible circuit. The illustrated embodiment includes twelve electrodes disposed on the outer surface 418, although other embodiments may include more or less than twelve electrodes. For example, the first subassembly 410 and the second subassembly 412 may include any suitable number of electrodes that enable the system 100 to function as described herein. In one example, the spline 400 may include between eight and twelve electrodes on each of the subassemblies 410, 412. Additionally, the electrodes 414 are rectangular or pseudo-rectangular (i.e., rounded rectangles) in the illustrated embodiment. In other embodiments, the electrodes 414 may have any suitable shape or configuration that enables the spline 400 to function as described herein, including, for example, without limitation, rounded or spherical. The plurality of electrodes 414 of the first subassembly 410 may be referred to interchangeably herein as a "first electrode set," and the plurality of electrodes 414 of the second subassembly 412 may be referred to interchangeably herein as a "second electrode set."

[0040] FIG. 7 illustrates steps 500 in an exemplary method of forming the spline 400 (shown in FIG. 5). With reference to FIGS. 5-7, the exemplary method of forming the spline 400 includes positioning the structural member 404 between the first subassembly 410 and the second subassembly 412 such that the electrodes 414 (e.g., a first set of electrodes) of the first subassembly 410 are aligned with the first surface 406 of the structural member 404 and the electrodes 414 (e.g., a second set of electrodes) of the second subassembly 412 are aligned with the second surface 408 of the structural member 404. The exemplary method further includes bonding the flexible circuit boards 416 to one another at the respective first edges 422 and the respective second edges 424, as indicated by arrows 426 in FIG. 7. The flexible circuit boards 416 may be bonded to one another at the respective first edges 422 and the respective second edges 424 using an adhesive material 428 (shown in FIG. 5). In one embodiment, the openings (e.g., space gaps) formed by bonding each first edge 422 and each second edge 424 may be completely filled with adhesive material 428. The adhesive material 428 may be applied on one or both contact surfaces 420 of the flexible circuit board 416. The adhesive material 428 may be a biocompatible adhesive or any suitable material for adhering the flexible circuit boards 416 together.

[0041] In other embodiments, the flexible circuit boards 416 are heat sealed together. In some embodiments, the flexible circuit boards 416 are only bonded to each other and not fixed to the structural member 404. For example, the flexible circuit boards 416 of the first subassembly 410 and the second subassembly 412 may be bonded only at their respective first and second edges 422 and 424 such that the bonded flexible circuit boards 416 are free to move and slide relative to the structural member 404. In other embodiments, one or both of the flexible circuit boards 416 are bonded directly to the structural member 404 at the first surface 406 and / or the second surface 408. In an exemplary embodiment, the structural member 404 is sandwiched between two separate subassemblies 410, 412 to form a double-sided spline of the electrode 414.

[0042] FIG. 8 illustrates an end view of another exemplary spline 600 suitable for use with the electrode assembly 102 (shown in FIG. 1). In particular, the spline 600 may be incorporated into the basket electrode assembly 200 (both shown in FIG. 3) as one or more of the splines 208. Additionally or alternatively, the spline 600 may be incorporated into the planar electrode assembly 300 as one or more of the splines 312, 314, 316, 318 (all shown in FIG. 4). The spline 600 may be substantially similar to or have a substantially similar configuration as the spline 400, as described above. The spline 600 includes a structural member 404 and a flexible circuit assembly 602. The structural member 404 extends from a proximal end 601 to a distal end (not shown) of the spline 600. The flexible circuit boards 416 may be bonded together using an adhesive material 428. In one embodiment, the openings (eg, space gaps) formed by bonding the flexible circuit boards 416 may be completely filled with the adhesive material 428.

[0043] FIG. 9 is a top view of the flexible circuit assembly 602 of the spline 600 (shown in FIG. 8). With reference to FIGS. 8 and 9, the flexible circuit assembly 602 includes a first subassembly 410 and a second subassembly 412. Each of the subassemblies 410, 412 includes a plurality of electrodes 414 disposed on an outer surface 418 of a flexible circuit substrate 416. In the embodiment shown in FIGS. 8 and 9, the first subassembly 410 and the second subassembly 412 of the flexible circuit assembly 602 are joined together at a fold line 604. The fold line 604 may include any line of weakness that facilitates folding or bending of the subassemblies 410, 412 joined at the fold line 604, such as, for example, a score line, a break line, a crease, a perforation line, and combinations thereof.

[0044] FIG. 10 illustrates a step 700 in an exemplary method of forming a spline 600 (shown in FIG. 8 ) using a flexible circuit assembly 602. As shown in FIG. 10 , the exemplary method of forming the spline 600 includes positioning the structural members 404 adjacent the subassemblies 410, 412 (both) near the contact surface 420 such that the structural members 404 are proximate the fold line 604. FIG. 11 illustrates another subsequent step 800 in the exemplary method of forming the spline 600. As shown in FIG. 11 , the exemplary method of forming the spline 600 also includes folding the flexible circuit assembly 602 at the fold line 604 and around the structural member 404 such that the electrodes 414 (e.g., a first electrode set) of the first subassembly 410 are coupled proximate to the first surface 406 of the structural member 404 and the electrodes 414 (e.g., a second electrode set) of the second subassembly 412 are coupled proximate to the second surface 408 of the structural member 404. An exemplary method of forming the spline 600 also includes bonding the flexible circuit boards 416 of the subassemblies 410, 412 to one another at the longitudinal edges 606 of the flexible circuit assembly 602, as indicated by arrows 608 in FIG. 10. As shown in FIG. 8, the flexible circuit boards 416 may be bonded at the edges 606 using an adhesive material 428. In some embodiments, the flexible circuit boards 416 of the first subassembly 410 and the second subassembly 412 are bonded only to one another and are not fixed to the structural member 404. For example, the flexible circuit boards 416 of the first and second subassemblies 410, 412 may be bonded only at the longitudinal edges 606 such that the bonded flexible circuit boards 416 are free to move and slide relative to the structural member 404. In other embodiments, one or both of the flexible circuit boards 416 are bonded directly to the structural member 404 at the first surface 406 and / or the second surface 408.

[0045] FIG. 12 illustrates an end view of another exemplary spline 900 suitable for use with the electrode assembly 102 (shown in FIG. 1). In particular, the spline 900 may be incorporated into the basket electrode assembly 200 (both shown in FIG. 3) as one or more of the splines 208. Additionally or alternatively, the spline 900 may be incorporated into the planar electrode assembly 300 as one or more of the splines 312, 314, 316, 318 (all shown in FIG. 4). The spline 900 includes a structural member 404 and a flexible circuit assembly 902. The structural member 404 has been described above with respect to the spline 400 (shown in FIG. 5) and the spline 600 (shown in FIG. 8). FIG. 13 illustrates a step 1000 in an exemplary method of forming the spline 900 (shown in FIG. 12). 12 and 13, the flexible circuit assembly 902 of the spline 900 includes a flexible tubular substrate 904 defining a cavity 906 therein. In one embodiment, the flexible tubular substrate 904 is a flexible printed circuit formed into the shape of a compressible cylindrical tube.

[0046] A plurality of electrodes 414 are disposed on an outer surface 908 of the flexible tubular substrate 904. The electrodes 414 may have the same configuration as described above with reference to spline 400 (shown in FIG. 5) and spline 600 (shown in FIG. 8). The flexible circuit assembly 902 includes two sets (a first set and a second set) of electrodes 414 disposed on opposite sides of the flexible tubular substrate 904. Each set of electrodes 414 may include any suitable number of electrodes 414 that enables the spline 900 to function as described herein. For example, each set of electrodes 414 may include between 8 and 12 electrodes.

[0047] 13, an exemplary method of forming the spline 900 includes inserting a structural member 404 into a cavity 906 of a flexible tubular substrate 904. The exemplary method of forming the spline 900 further includes compressing the flexible tubular substrate 904 (e.g., by applying a force to an exterior surface 908) such that a first electrode set 414 of the flexible circuit assembly 902 is proximately coupled to a first surface 406 of the structural member 404 and a second electrode set 414 of the flexible circuit assembly 902 is proximately coupled to a second surface 408 of the structural member 404. An adhesive material 428 may be applied on a contact surface (e.g., an interior surface) 910 of the flexible tubular substrate 904 such that when the flexible tubular substrate 904 is compressed, the contact surface 910 of the flexible tubular substrate 904 adheres to the structural member 404. In one embodiment, the openings (e.g., space gaps) formed by compressing the flexible tubular substrate 904 may be completely filled with the adhesive material 428.

[0048] Although the splines and spline forming methods of the present disclosure are described with reference to particular electrode assemblies (e.g., basket electrode assembly 200 and planar electrode assembly 300), it should be understood that the disclosed splines and spline forming methods are not limited to use in the particular electrode assembly structures shown and described herein, but may be incorporated into any other suitable electrode assembly that enables system 100 (shown in FIG. 1 ) to function as described herein.

[0049] FIG. 14 is a perspective view of one of the subassemblies 410, 412 arranged in a spiral configuration 1100 suitable for use in the system 100 (shown in FIG. 1). In the illustrated embodiment, the structural member 404 is omitted. In other embodiments, the individual subassemblies 410, 412 may be coupled to a structural member, such as the structural member 404, to facilitate deployment of the individual subassemblies 410, 412 into a desired spiral or other desired shape, for example, to facilitate contact with a particular anatomical structure. The individual subassemblies 410, 412 are wound along the length of the subassemblies 410, 412 to form the spiral configuration 1100 and are lengthened to reduce the outer diameter of the spiral configuration 1100. More specifically, in these embodiments, the flexible circuit board 416 of one of the subassemblies 410, 412 may be coiled and extended for insertion as one long linear catheter in the system 100. In the illustrated embodiment, the electrodes 414 are disposed on an outer surface 418 of the flexible circuit board 416. The electrodes 414 may be any suitable type of electrodes, such as single-sided electrodes disposed on an exterior surface 418 or electrodes printed on a flexible circuit board 416. In some embodiments, the individual subassemblies 410, 412, including the structural member 404, may be wound into a spiral configuration.

[0050] FIG. 15 is a flow chart of an exemplary method 1200 of forming a spline, such as spline 400 (shown in FIG. 5), spline 600 (shown in FIG. 8), or spline 900 (shown in FIG. 12), for use in an electrode assembly (e.g., electrode assembly 102 shown in FIG. 1). The method 1200 includes providing 1202 a structural member (e.g., structural member 404) including a first surface and a second surface. The method 1200 also includes providing 1204 a flexible circuit assembly (e.g., flexible circuit assembly 402, flexible circuit assembly 602, or flexible circuit assembly 902) including a plurality of electrodes and at least one flexible circuit substrate (e.g., flexible circuit substrate 416 or flexible tubular substrate 904). The at least one flexible circuit substrate includes a contact surface and an outer surface opposite the contact surface. A plurality of electrodes are disposed on the outer surface of the at least one flexible circuit substrate. The method 1200 also includes positioning 1206 the flexible circuit assembly relative to the structural member such that a first electrode set of the plurality of electrodes is aligned with a first surface of the structural member and a second electrode set of the plurality of electrodes is aligned with a second surface of the structural member. The method 1200 also includes coupling 1208 the at least one flexible circuit board to at least one of the structural member and the at least one flexible circuit board.

[0051] Although some steps of the exemplary methods are numbered, such numbering does not indicate that the steps must be performed in the order recited. Thus, certain steps do not have to be performed in the exact order in which they are presented, unless the description therefor specifically requires such order. The steps may be performed in the order recited or in another suitable order.

[0052] Although the embodiments and examples disclosed herein have been described with reference to specific embodiments, it should be understood that these embodiments and examples are merely illustrative of the principles and applications of the present disclosure. It is therefore to be understood that many changes can be made to the exemplary embodiments and examples, and other configurations can be devised, without departing from the spirit and scope of the present disclosure as defined by the claims. It is therefore intended that this application cover modifications and variations of these embodiments and their equivalents.

[0053] This specification uses examples to disclose the invention, including the best mode, and also enables any person skilled in the art to practice the disclosure, including making and using any device or system, and practicing any incorporated methods. The patentable scope of the disclosure is defined by the claims, and may include other examples that occur to those skilled in the art. Such other examples are intended to be within the scope of the claims if the elements are no different from those recited in the claims, or include equivalent elements not significantly different from those recited in the claims. The following items are elements of the claims as filed: (Item 1) 1. A method of forming a spline for an electrode assembly for a catheter system, comprising: Providing a structural member including a first surface and a second surface; providing a flexible circuit assembly including a plurality of electrodes and at least one flexible circuit board having a contact surface and an outer surface opposite the contact surface, the plurality of electrodes being disposed on the outer surface of the at least one flexible circuit board; positioning the flexible circuit assembly relative to the structural member such that a first electrode set of the plurality of electrodes is aligned with the first surface of the structural member and a second electrode set of the plurality of electrodes is aligned with the second surface of the structural member; and bonding the at least one flexible circuit board to at least one of the structural member and the at least one flexible circuit board of the flexible circuit assembly. (Item 2) 2. The method of claim 1, wherein bonding the at least one flexible circuit board to at least one of the structural member and the at least one flexible circuit board comprises bonding the at least one flexible circuit board to the structural member using an adhesive. (Item 3) 3. The method of claim 2, wherein bonding the at least one flexible circuit board to the structural member comprises bonding the contact surface of the at least one flexible circuit board to at least one of the first surface and the second surface of the structural member using the adhesive. (Item 4) 2. The method of claim 1, wherein coupling the at least one flexible circuit board to at least one of the structural member and the at least one flexible circuit board comprises heat fusing the at least one flexible circuit board to the at least one of the structural member and the at least one flexible circuit board. (Item 5) the at least one flexible circuit board includes a first flexible circuit board and a separate second flexible circuit board; each of the first flexible circuit board and the second flexible circuit board includes a first longitudinal edge and a second longitudinal edge; positioning the flexible circuit assembly relative to the structural member comprises positioning the structural member between the first flexible circuit board and the second flexible circuit board; 2. The method of claim 1, wherein bonding the at least one flexible circuit board to at least one of the structural member and the at least one flexible circuit board comprises bonding the first flexible circuit board and the second flexible circuit board at their respective first longitudinal edges and their respective second longitudinal edges such that the first electrode set of the plurality of electrodes is aligned with the first surface of the structural member and the second electrode set of the plurality of electrodes is aligned with the second surface of the structural member. (Item 6) 6. The method of claim 5, wherein bonding the first flexible circuit board and the second flexible circuit board at the respective first edges and the respective second edges comprises bonding the first flexible circuit board and the second flexible circuit board using an adhesive such that the first flexible circuit board and the second flexible circuit board are slidable relative to the structural member. (Item 7) the flexible circuit assembly includes a first flexible circuit board and a second flexible circuit board joined to the first flexible circuit board at a fold line; 2. The method of claim 1, wherein forming the splines comprises folding the first flexible circuit board at the fold lines relative to the second flexible circuit board and around the structural member such that the first electrode set is aligned with the first surface of the structural member and the second electrode set is aligned with the second surface of the structural member. (Item 8) 8. The method of claim 7, wherein bonding the at least one flexible circuit board to at least one of the structural member and the at least one flexible circuit board comprises bonding the first flexible circuit board to the second flexible circuit board using an adhesive. (Item 9) the at least one flexible circuit substrate of the flexible circuit assembly comprises a tubular substrate defining a cavity therein; 2. The method of claim 1, wherein positioning the flexible circuit assembly relative to the structural member comprises inserting the structural member into the cavity of the tubular substrate. (Item 10) 10. The method of claim 9, wherein positioning the flexible circuit assembly relative to the structural member further comprises compressing the tubular substrate such that the first electrode set is aligned with the first surface of the structural member and the second electrode set is aligned with the second surface of the structural member. (Item 11) Item 14. The method of item 1, wherein the structural member is comprised of Nitinol. (Item 12) 2. The method of claim 1, wherein the at least one flexible circuit board is a flexible printed circuit. (Item 13) 2. The method of claim 1, wherein the structural member comprises a plurality of separate members. (Item 14) 2. The method of claim 1, further comprising incorporating the formed splines into a planar electrode assembly. (Item 15) 2. The method of claim 1, further comprising incorporating the formed splines into a basket electrode assembly. (Item 16) Item 10. The method of item 1, further comprising wrapping the at least one flexible circuit board around a length of the at least one flexible circuit board to form a spiral configuration. (Item 17) 1. An electrode assembly for a catheter system, comprising: the electrode assembly having a longitudinal axis, a proximal end, and a distal end; the electrode assembly comprising at least one spline extending from the proximal end to the distal end of the electrode assembly; The at least one spline is a structural member extending from the proximal end to the distal end of the electrode assembly and including a first surface and a second surface; a flexible circuit assembly including a plurality of electrodes and at least one flexible circuit board having a contact surface and an outer surface opposite the contact surface, the plurality of electrodes being disposed on the outer surface of the at least one flexible circuit board; the flexible circuit assembly is positioned relative to the structural member such that a first electrode set of the plurality of electrodes is aligned with the first surface of the structural member and a second electrode set of the plurality of electrodes is aligned with the second surface of the structural member; The at least one flexible circuit board is coupled to at least one of the structural member and the at least one flexible circuit board. (Item 18) the flexible circuit assembly includes a first flexible circuit board and a separate second flexible circuit board; each of the first flexible circuit board and the second flexible circuit board includes a first longitudinal edge and a second longitudinal edge; the structural member is disposed between the first flexible circuit board and the second flexible circuit board; Item 18. The electrode assembly of item 17, wherein the first flexible circuit board and the second flexible circuit board are joined at the first longitudinal edge and the second longitudinal edge, respectively, such that the first electrode set of the plurality of electrodes is aligned with the first surface of the structural member and the second electrode set of the plurality of electrodes is aligned with the second surface of the structural member. (Item 19) The flexible circuit assembly includes at least two flexible circuit boards joined at fold lines; Item 18. The electrode assembly of item 17, wherein the flexible circuit assembly is folded at the fold lines and around the structural member such that the first electrode set is aligned with the first surface of the structural member and the second electrode set is aligned with the second surface of the structural member. (Item 20) 1. A catheter system comprising: A flexible catheter shaft; a handle coupled to a proximal end of the catheter shaft; an electrode assembly coupled to a distal end of the flexible catheter shaft, the electrode assembly having a longitudinal axis, a proximal end, and a distal end, the electrode assembly comprising at least one spline extending from the proximal end to the distal end of the electrode assembly; The at least one spline is a structural member extending from the proximal end to the distal end of the electrode assembly and including a first surface and a second surface; a flexible circuit assembly including a plurality of electrodes and at least one flexible circuit board having a contact surface and an outer surface opposite the contact surface, the plurality of electrodes being disposed on the outer surface of the at least one flexible circuit board; the flexible circuit assembly is positioned relative to the structural member such that a first electrode set of the plurality of electrodes is aligned with the first surface of the structural member and a second electrode set of the plurality of electrodes is aligned with the second surface of the structural member; The at least one flexible circuit board is coupled to at least one of the structural member and the at least one flexible circuit board.

Claims

1. 1. A method of forming a spline for an electrode assembly for a catheter system, comprising: Providing a structural member including a first surface and a second surface; providing a flexible circuit assembly including a plurality of electrodes and at least one flexible circuit board having a contact surface and an exterior surface opposite the contact surface, the plurality of electrodes being disposed on the exterior surface of the at least one flexible circuit board; positioning the flexible circuit assembly relative to the structural member such that a first electrode set of the plurality of electrodes is aligned with the first surface of the structural member and a second electrode set of the plurality of electrodes is aligned with the second surface of the structural member; and coupling the at least one flexible circuit board to at least one of the structural member and the at least one flexible circuit board of the flexible circuit assembly; the at least one flexible circuit board includes a first flexible circuit board and a separate second flexible circuit board; each of the first flexible circuit board and the second flexible circuit board includes a first longitudinal edge and a second longitudinal edge; positioning the flexible circuit assembly relative to the structural member comprises positioning the structural member between the first flexible circuit board and the second flexible circuit board; the coupling of the at least one flexible circuit board to at least one of the structural member and the at least one flexible circuit board comprises coupling the first flexible circuit board and the second flexible circuit board at their respective first longitudinal edges and their respective second longitudinal edges such that the first electrode set of the plurality of electrodes is aligned with the first surface of the structural member and the second electrode set of the plurality of electrodes is aligned with the second surface of the structural member.

2. 10. The method of claim 1, wherein coupling the at least one flexible circuit board to at least one of the structural member and the at least one flexible circuit board comprises coupling the at least one flexible circuit board to the structural member using an adhesive.

3. 3. The method of claim 2, wherein coupling the at least one flexible circuit board to the structural member comprises coupling the contact surface of the at least one flexible circuit board to at least one of the first surface and the second surface of the structural member using the adhesive.

4. 2. The method of claim 1, wherein coupling the at least one flexible circuit board to at least one of the structural member and the at least one flexible circuit board comprises heat fusing the at least one flexible circuit board to the at least one of the structural member and the at least one flexible circuit board.

5. 2. The method of claim 1, wherein bonding the first flexible circuit board and the second flexible circuit board at the respective first longitudinal edges and the respective second longitudinal edges comprises bonding the first flexible circuit board and the second flexible circuit board using an adhesive such that the first flexible circuit board and the second flexible circuit board are slidable relative to the structural member.

6. A method of forming a spline for an electrode assembly for a catheter system, comprising: Providing a structural member including a first surface and a second surface; providing a flexible circuit assembly including a plurality of electrodes and at least one flexible circuit board having a contact surface and an exterior surface opposite the contact surface, the plurality of electrodes being disposed on the exterior surface of the at least one flexible circuit board; positioning the flexible circuit assembly relative to the structural member such that a first electrode set of the plurality of electrodes is aligned with the first surface of the structural member and a second electrode set of the plurality of electrodes is aligned with the second surface of the structural member; and coupling the at least one flexible circuit board to at least one of the structural member and the at least one flexible circuit board of the flexible circuit assembly; the flexible circuit assembly includes a first flexible circuit board and a second flexible circuit board joined to the first flexible circuit board at a fold line; forming the splines comprises folding the first flexible circuit board at the fold lines relative to the second flexible circuit board and around the structural member such that the first electrode set is aligned with the first surface of the structural member and the second electrode set is aligned with the second surface of the structural member; the first flexible circuit board includes a first longitudinal edge opposite the fold line; the second flexible circuit board includes a second longitudinal edge opposite the fold line; wherein coupling the at least one flexible circuit board to at least one of the structural member and the at least one flexible circuit board comprises abutting the first longitudinal edge of the first flexible circuit board and the second longitudinal edge of the second flexible circuit board to couple the first flexible circuit board to the second flexible circuit board.

7. 7. The method of claim 6, wherein bonding the at least one flexible circuit board to at least one of the structural member and the at least one flexible circuit board comprises bonding the first flexible circuit board to the second flexible circuit board using an adhesive.

8. The method of claim 1 , wherein the structural member is comprised of Nitinol.

9. The method of claim 1 , wherein the at least one flexible circuit board is a flexible printed circuit.

10. The method of claim 1 , wherein the structural member comprises a plurality of separate members.

11. The method of claim 1 , further comprising incorporating the formed splines into a planar electrode assembly.

12. 12. The method of any one of claims 1 to 11, further comprising incorporating the formed splines into a basket electrode assembly.

13. The method of claim 1 , further comprising coiling each of the at least one flexible circuit board to form a spiral configuration.

14. 1. An electrode assembly for a catheter system, comprising: the electrode assembly having a longitudinal axis, a proximal end, and a distal end; the electrode assembly comprising at least one spline extending from the proximal end to the distal end of the electrode assembly; The at least one spline is a structural member extending from the proximal end to the distal end of the electrode assembly and including a first surface and a second surface; a flexible circuit assembly including a plurality of electrodes and at least one flexible circuit board having a contact surface and an outer surface opposite the contact surface, the plurality of electrodes being disposed on the outer surface of the at least one flexible circuit board; the flexible circuit assembly is positioned relative to the structural member such that a first set of electrodes of the plurality of electrodes is aligned with the first surface of the structural member and a second set of electrodes of the plurality of electrodes is aligned with the second surface of the structural member; the at least one flexible circuit board is coupled to at least one of the structural member and the at least one flexible circuit board; The flexible circuit assembly includes a first flexible circuit board and a separate second flexible circuit board; each of the first flexible circuit board and the second flexible circuit board includes a first longitudinal edge and a second longitudinal edge; the structural member is disposed between the first flexible circuit board and the second flexible circuit board; an electrode assembly, wherein the first flexible circuit board and the second flexible circuit board are joined at their respective first longitudinal edges and their respective second longitudinal edges such that the first electrode set of the plurality of electrodes is aligned with the first surface of the structural member and the second electrode set of the plurality of electrodes is aligned with the second surface of the structural member.

15. An electrode assembly for a catheter system, comprising: the electrode assembly having a longitudinal axis, a proximal end, and a distal end; the electrode assembly comprising at least one spline extending from the proximal end to the distal end of the electrode assembly; The at least one spline is a structural member extending from the proximal end to the distal end of the electrode assembly and including a first surface and a second surface; a flexible circuit assembly including a plurality of electrodes and at least one flexible circuit board having a contact surface and an outer surface opposite the contact surface, the plurality of electrodes being disposed on the outer surface of the at least one flexible circuit board; the flexible circuit assembly is positioned relative to the structural member such that a first set of electrodes of the plurality of electrodes is aligned with the first surface of the structural member and a second set of electrodes of the plurality of electrodes is aligned with the second surface of the structural member; the at least one flexible circuit board is coupled to at least one of the structural member and the at least one flexible circuit board; The flexible circuit assembly includes a first flexible circuit board and a second flexible circuit board joined at a fold line; the flexible circuit assembly is folded at the fold lines and around the structural member such that the first electrode set is aligned with the first surface of the structural member and the second electrode set is aligned with the second surface of the structural member; the first flexible circuit board includes a first longitudinal edge opposite the fold line; the second flexible circuit board includes a second longitudinal edge opposite the fold line; an electrode assembly, wherein the first flexible circuit board and the second flexible circuit board are joined together with the first longitudinal edge of the first flexible circuit board and the second longitudinal edge of the second flexible circuit board abutting each other.

16. 1. A catheter system comprising: A flexible catheter shaft; a handle coupled to a proximal end of the flexible catheter shaft; an electrode assembly coupled to a distal end of the flexible catheter shaft, the electrode assembly having a longitudinal axis, a proximal end, and a distal end, the electrode assembly comprising at least one spline extending from the proximal end to the distal end of the electrode assembly; The at least one spline is a structural member extending from the proximal end to the distal end of the electrode assembly and including a first surface and a second surface; a flexible circuit assembly including a plurality of electrodes and at least one flexible circuit board having a contact surface and an outer surface opposite the contact surface, the plurality of electrodes being disposed on the outer surface of the at least one flexible circuit board; the flexible circuit assembly is positioned relative to the structural member such that a first set of electrodes of the plurality of electrodes is aligned with the first surface of the structural member and a second set of electrodes of the plurality of electrodes is aligned with the second surface of the structural member; the at least one flexible circuit board is coupled to at least one of the structural member and the at least one flexible circuit board; The flexible circuit assembly includes a first flexible circuit board and a separate second flexible circuit board; each of the first flexible circuit board and the second flexible circuit board includes a first longitudinal edge and a second longitudinal edge; the structural member is disposed between the first flexible circuit board and the second flexible circuit board; a catheter system, wherein the first flexible circuit board and the second flexible circuit board are joined at their respective first longitudinal edges and their respective second longitudinal edges such that the first electrode set of the plurality of electrodes is aligned with the first surface of the structural member and the second electrode set of the plurality of electrodes is aligned with the second surface of the structural member.

17. A catheter system comprising: A flexible catheter shaft; a handle coupled to a proximal end of the flexible catheter shaft; an electrode assembly coupled to a distal end of the flexible catheter shaft, the electrode assembly having a longitudinal axis, a proximal end, and a distal end, the electrode assembly comprising at least one spline extending from the proximal end to the distal end of the electrode assembly; The at least one spline is a structural member extending from the proximal end to the distal end of the electrode assembly and including a first surface and a second surface; a flexible circuit assembly including a plurality of electrodes and at least one flexible circuit board having a contact surface and an outer surface opposite the contact surface, the plurality of electrodes being disposed on the outer surface of the at least one flexible circuit board; the flexible circuit assembly is positioned relative to the structural member such that a first set of electrodes of the plurality of electrodes is aligned with the first surface of the structural member and a second set of electrodes of the plurality of electrodes is aligned with the second surface of the structural member; the at least one flexible circuit board is coupled to at least one of the structural member and the at least one flexible circuit board; The flexible circuit assembly includes a first flexible circuit board and a second flexible circuit board joined at a fold line; the flexible circuit assembly is folded at the fold lines and around the structural member such that the first electrode set is aligned with the first surface of the structural member and the second electrode set is aligned with the second surface of the structural member; the first flexible circuit board includes a first longitudinal edge opposite the fold line; the second flexible circuit board includes a second longitudinal edge opposite the fold line; A catheter system, wherein the first flexible circuit board and the second flexible circuit board are joined together with the first longitudinal edge of the first flexible circuit board and the second longitudinal edge of the second flexible circuit board abutting each other.

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