Method for forming a spline using a flexible circuit assembly and electrode assembly including the same

Abstract

To form a spline for electrode assemblies using a flexible circuit assembly.SOLUTION: A method of forming a spline 400 for an electrode assembly includes providing a structural member 404 including a first surface and a second surface. The method also includes providing a flexible circuit assembly 402 including: a plurality of electrodes 414; and at least one flexible circuit substrate 416 having a contact surface and an outer surface opposite the contact surface. The electrodes are disposed on the outer surface of the at least one flexible circuit substrate. The method includes positioning the flexible circuit assembly relative to the structural member such 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 coupling the at least one flexible circuit substrate to at least one of the structural member and the at least one flexible circuit substrate.SELECTED DRAWING: Figure 5

Description

[Technical Field]

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

[0002] This disclosure generally relates to medical devices used in the human body. In particular, this disclosure relates to a method for forming splines for electrode assemblies using a flexible circuit assembly.

[0003] Electrophysiological catheters are used in a variety of diagnostic, therapeutic, and / or mapping and ablation procedures to diagnose and / or correct 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 to an intended site, for example, a site within the patient's heart. The catheter typically carries one or more electrodes that can be used, for example, for cardiac mapping or diagnosis, ablation, and / or other therapeutic delivery modes, or both. Ablation therapy can be used to treat a variety of conditions affecting human anatomical structures, including atrial or cardiac arrhythmias. When tissue is ablated, or at least receives ablation energy generated by an ablation generator and delivered by an ablation catheter, damage is formed within the tissue. Electrodes attached to 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 can lead to a variety of dangerous conditions, including loss of synchronous atrioventricular contraction and stasis of blood flow. The primary cause of atrial arrhythmias is thought to be stray electrical signals within the left or right atrium of the heart. Ablation catheters deliver ablation energy (e.g., radiofrequency energy, cryoablation, laser, chemicals, high-intensity focused ultrasound) to cardiac tissue, creating damage to the tissue. This damage disrupts unwanted electrical pathways, thereby limiting or preventing stray electrical signals that lead to arrhythmias.

[0005] Electroporation is a non-thermal ablation technique that involves applying a strong electric field to induce pore formation in the cell membrane. The electric field can be induced by applying relatively short-duration pulses, which can last from nanoseconds to several 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 are resealed) 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, cell destruction can be induced by using only a properly configured pulse train, for example, to induce irreversible electroporation.

[0006] Catheters, such as basket catheters and planar catheters, have electrodes distributed along a set number of splines. Specifically, electrodes are typically positioned on one side of each spline. Therefore, the electrode density of at least some known catheters is limited by the number of splines and the number of electrodes positioned on each spline. Electrode assemblies may be limited to a set number of splines due to the inherent difficulties 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 because larger electrode baskets can be more difficult to deploy to smaller target locations. Alternatively, narrower splines can be used to maintain the diameter of the electrode basket, but narrower splines limit the electrode size.

[0007] In addition, at least some known catheters, when deployed, result in positioning forces being applied to only one side of the catheter. For example, a spiral catheter is always attached to only one point (e.g., its proximal end), and as a result, positioning forces are applied to only one side of the spiral. Therefore, it is not possible to apply force to the opposite side (e.g., 180 degrees around the spiral). [Overview of the project]

[0008] This disclosure relates to a method for forming splines for an electrode assembly for a catheter system. The method includes providing a structural member having a first surface and a second surface. The method also includes providing a flexible circuit assembly having 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 arranged on the outer surface of at least one flexible circuit board. The method includes positioning the flexible circuit assembly relative to a structural member such that a first set of the plurality of electrodes aligns with the first surface of the structural member and a second set of the plurality of electrodes aligns with the second surface of the structural member. The method also includes coupling at least one flexible circuit board to at least one of the structural member and at least one flexible circuit board of the flexible circuit assembly.

[0009] This disclosure further relates 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 to the contact surface. The plurality of electrodes are arranged 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 the plurality of electrodes aligns with the first surface of the structural member, and a second set of the plurality of electrodes aligns with the second surface of the structural member. The at least one flexible circuit board is coupled to the structural member and at least one of the at least one flexible circuit board.

[0010] This disclosure further relates to a catheter system comprising a flexible catheter shaft, a handle coupled to the proximal end of the catheter shaft, and an electrode assembly. The electrode assembly is coupled to the 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 comprising 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 arranged 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 the plurality of electrodes aligns with the first surface of the structural member, and a second set of the plurality of electrodes aligns with the second surface of the structural member. At least one flexible circuit board is coupled to at least one of the structural members and the at least one flexible circuit board. [Brief explanation of the drawing]

[0011] [Figure 1] This is a schematic block diagram of a catheter system incorporating various embodiments of the present disclosure. [Figure 2] Figure 1 is a simplified schematic diagram illustrating an exemplary visualization, navigation, and / or mapping system of the catheter system shown. [Figure 3] This is a perspective view of an exemplary electrode assembly suitable for use in the system shown in Figure 1, in the form of a basket electrode assembly. [Figure 4] This is a perspective view of another exemplary electrode assembly suitable for use in the system shown in Figure 1, shown in the form of a planar electrode assembly. [Figure 5] Figures 3 and 4 show exemplary end views of splines suitable for use in electrode assemblies. [Figure 6]Figure 5 is a top view of an exemplary subassembly of a flexible circuit assembly suitable for use in forming the spline. [Figure 7] The steps in an exemplary method for forming the spline shown in Figure 5 are illustrated. [Figure 8] Figures 3 and 4 show another exemplary end view of a spline suitable for use in the electrode assembly shown. [Figure 9] Figure 8 shows an exemplary flexible circuit assembly suitable for use when forming the spline. [Figure 10] The steps in an exemplary method for forming the spline shown in Figure 8 are illustrated. [Figure 11] Another subsequent step in an exemplary method for forming the spline shown in Figure 8 is illustrated. [Figure 12] Figures 3 and 4 show another exemplary end view of a spline suitable for use in the electrode assembly shown. [Figure 13] The steps in an exemplary method for forming the spline shown in Figure 12 are illustrated. [Figure 14] Figure 1 is a perspective view of an exemplary subassembly with a helical configuration suitable for use in the system shown. [Figure 15] This is a flowchart illustrating an exemplary method for forming splines for an electrode assembly, such as the electrode assembly shown in Figures 3 and 4. [Modes for carrying out the invention]

[0012] Matching reference numerals indicate parts that match across several figures in the drawing. It should be understood that the drawing is 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 vascular system 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 disposing a structural member within a tubular member and subsequently disposing electrodes on an outer surface of the tubular member.

[0014] Unlike some known electrode assemblies, the disclosed embodiments enable the formation of a spline by directly coupling electrodes to one or more surfaces of a structural member via a flexible circuit board, thereby eliminating the need for an intermediate tubular member. Further, the disclosed embodiments enable the placement of electrodes on two or more surfaces of a single spline, thereby enabling the placement of more electrodes on a single spline. Such an arrangement improves the electrode density around the electrode assembly, which can improve the accuracy of mapping and / or ablation procedures and thus can result in a more consistent, improved patient outcome.

[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). Generally, various embodiments include an electrode assembly disposed at the distal end of a 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) into 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 so as to be selectively paired or combined with any other electrode element to function as a bipolar or multipolar electrode.

[0016] System 100 may be used for irreversible electroporation for tissue ablation. In particular, system 100 may be used for electroporation-induced primary necrosis therapy, which refers to the effect (result) of delivering an electric current in such a way as to directly cause an irreversible loss of integrity of the plasma membrane (cell wall) that results in its disruption and cell death. This mechanism of cell death can be regarded as an "outside-in" process, meaning that the disruption of the outer wall of the cell causes harmful effects inside the cell. Typically, for classical plasma membrane electroporation, the electric current is delivered as a pulsed electric field (i.e., pulsed-field ablation (PFA)) in the form of short-term pulses (e.g., with a duration of 0.1 to 20 ms) between adjacent but separated electrodes that can deliver an electric field strength of about 0.1 to 1.0 kV / cm.

[0017] System 100 includes an electrode assembly 102 comprising at least one catheter electrode configured to be used 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 herein as internal body structures 106. As another example, the electrode assembly 102 may be used for tissue ablation therapy (e.g., electroporation therapy) of structures 106 within the body 108. In the illustrated embodiment, structures 106 include the patient's vascular system and / or heart or cardiac tissue. However, it should be understood that embodiments may be used to perform mapping, diagnosis, and / or ablation therapy on various other body structures and / or tissues.

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

[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 a mapping function, as further described herein. In such embodiments, the power supply 110 includes a signal generator which is coupled to the patch electrode 116 and configured to excite the patch electrode 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 one or more sensors (e.g., sensor 138), additional electrodes, and other conventional components not shown herein, such as corresponding conductors or lead wires. The connector 118 provides mechanical and electrical connections for cables 114 extending from a power supply 110 and / or a visualization, navigation, and mapping system 112, and is located at the proximal end of the catheter 104 as shown.

[0021] The handle 120 may provide a place for the physician to hold the catheter 104 and further provide means for maneuvering or guiding the shaft 122 within the body 108. For example, the handle 120 may include means for changing the length of one or more guidewires extending through the catheter 104 to the distal end 126 of the shaft 122, or to other means to the maneuvering shaft 122. Furthermore, 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 structure of the handle 120 may also change. In an alternative exemplary embodiment, the catheter 104 may be driven or controlled by a robot. Thus, the catheter 104 is operated using a robot rather than the clinician operating the handle to move the catheter 104 forward / backward and / or maneuver or guide it.

[0022] The shaft 122 is an elongated, tubular, flexible member configured to move within the body 108. The shaft 122 supports the electrode assembly 102 and is configured to include associated conductors and, optionally, additional electronic equipment used for signal processing or adjustment. The shaft 122 may also allow for the transport, delivery, and / or removal of fluids (including irrigation fluids and body fluids), drugs, and / or surgical tools or instruments. The shaft 122 may be made from a conventional material 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 advance, retract, and / or be maneuvered or guided through the body 108 to a desired position within the structure 106, with the use of a guidewire or other means known in the art.

[0023] In embodiments of this 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 that can be selectively configured between a folded configuration and an extended configuration. For example, the electrode assembly 102 may be delivered to the target location in a folded 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 unfolded to an extended 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 embodiments of this disclosure, the electrode assembly 102 is then energized using a power supply 110 to perform a medical procedure at the target location. The electrode assembly 102 may include a plurality of electrodes thereon (e.g., electrodes 226 shown in Figures 3 to 5). The electrode assembly 102 and / or catheter shaft 122 may include one or more sensors 138 in or on it.

[0024] Sensors 138 mounted in or on the shaft 122 and / or in or on the electrode assembly 102 may be provided for a variety of diagnostic and therapeutic purposes, including, for example, electrophysiological studies and cardiac mapping. In exemplary embodiments, one or more of the sensors 138 are provided to perform position-sensing functions. More specifically, one or more of the sensors 138 are configured to be positioning sensors, for example, in particular, to provide a visualization, navigation, and mapping system 112 with information regarding the location (e.g., position and orientation) of the catheter 104 and its distal end 126 at a particular time. Sensors 138 may comprise one of several types of sensors, such as, for example, electrodes (e.g., tip electrodes and ring electrodes) or magnetic sensors (e.g., magnetic coils), but not limited to these. 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 internal body structures 106 by, for example, determining the location of an 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 commonly known in the art (e.g., Abbott Laboratories' EnSite® Velocity® or EnSite® Precision® cardiac mapping and visualization systems, or the EnSite® NavX® system, as commonly shown with reference to Abbott Laboratories' commercially available and generally transferred U.S. Patent No. 7,263,397, “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. Patent 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 disclosure of which is incorporated herein by reference. In various embodiments, the visualization, navigation, and mapping system 112 uses the electrodes of electrode assembly 102 as bipolar pairs for visualization, mapping, and navigation of internal body structures 106. However, it should be understood that this system is illustrative and not inherently limiting.For example, other techniques are known for visualizing / navigating / mapping catheters in space, including commonly available fluorescence 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 location, navigation, and / or visualization systems will provide sensors for generating signals indicating catheter position information, which may include, for example, one or more electrodes in the case of an impedance-based location 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 location system.

[0026] System 100 may further include a main computer system 130, which in certain embodiments may be integrated with a 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 may further include a display device 136, which may be integrated with and / or coupled to the computer system 130. The catheter 104, and therefore 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] Figure 2 is a simplified schematic diagram of the visualization, navigation, and / or mapping system 112 of system 100 (shown in Figure 1). Referring to Figures 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 are called "belly patches."B Except for B , the patch electrodes 116 are provided to generate signals used, for example, in determining the position and orientation of the catheter 104 and during its guidance. In one embodiment, the patch electrodes 116 are disposed orthogonally on the surface of the patient's body 108 and are used to generate an electric field specific to the axis 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. The patch electrodes 116 Y1 , 116 Y2 may be arranged along the second (y) axis, and the patch electrodes 116 Z1 , 116 Z2 may be arranged along the third (z) axis. In other embodiments, the generated dipole may not be on one axis. For example, it may be a dipole between electrode 116 X1 and 116 Y1 . 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 appropriate software, thereby sequentially coupling pairs of electrodes 116 to a signal generator (e.g., power supply 110). The excitation of each pair of electrodes 116 generates an electric field within the body 108 and within regions of interest such as the patient's heart. The potential of the non-excited electrodes 116 with respect to the reference patch 116 B [[ID=to]], for example, is filtered by a low-pass filter 142, converted by an analog-to-digital converter 144, and supplied to the ECU 132 for use as a reference.

[0028] As described above, the catheter 104 includes an electrode assembly 102 coupled thereto. In exemplary embodiments, the electrode assembly 102 includes a plurality of splines, each spline including one or more electrodes (e.g., electrodes 414 shown in Figures 5-13) mounted in or on it, and in some embodiments, these plurality of electrodes are electrically connected to a power supply 110 and / or ECU 132 to provide one or more diagnostic or therapeutic purposes as described herein. In exemplary embodiments, the electrode assembly 102 is placed in an electric field generated within the body 108 by exciting a patch electrode 116. When placed in the electric field, the electrodes on the electrode assembly 102 receive a voltage that depends on their positions between the patch electrodes 116 and the position of each electrode relative to the tissue of the anatomical structure 106 being mapped. The position of each electrode on the electrode assembly 102 relative to the anatomical structure 106 can be determined by comparing the voltage measurements taken between each electrode on the electrode assembly 102 and the patch electrodes 116. Next, this positional information may be used by the ECU 132 to generate models such as surface models and / or maps of anatomical structures, or models corresponding to anatomical structures. Thus, when moving the catheter 104 along the surface of a desired anatomical structure 106, for example, the electrode assembly 102 can be used to collect positional data points corresponding to the electrode on it and thus to the surface of the anatomical structure 106. These positional data points can then be used by the ECU 132 to generate or construct, for example, a surface model of the anatomical structure. Furthermore, the information received from the electrode assembly 102 can 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 means for creating a graphical user interface (GUI) on the display device 136.

[0029] The ECU132 may include, for example, a programmable microprocessor or microcontroller, or an application-specific integrated circuit (ASIC). The ECU132 may include a central processing unit (CPU) and an input / output (I / O) interface through which it may receive a plurality of input signals, including, for example, signals generated by an electrode assembly 102. The ECU132 may generate a plurality of output signals, including, for example, output signals used to control a display device 136. The ECU132 may be configured to perform various functions, such as those described herein, using appropriate programming instructions or code. Thus, in one embodiment, the ECU132 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 a display device 136. The ECU 132 may also be configured to generate a GUI (graphical user interface), through which the user can 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 the 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] Figure 3 is a perspective view of an exemplary electrode assembly 102 suitable for use in 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 to 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., for supplying 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, but each spline 208 may include more or fewer than eight electrodes 214.

[0032] The electrodes 214 may be used for a variety of diagnostic and therapeutic purposes, including, 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 a power supply 110 (e.g., via a suitable wire or other suitable conductor extending through the catheter shaft 122) and may be configured to be selectively energized in opposite polarities (e.g., by the power supply 110 and / or computer system 130) to generate potential and corresponding electric fields in between for IRE therapy. That is, one of the electrodes 214 may be configured to function as a cathode and the other 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 electroporation treatment being applied. 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, 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 power supply 110 is configured to energize the electrodes according to the ablation strategy as described above.

[0033] Figure 4 is a perspective view of another exemplary electrode assembly 102 suitable for use in system 100, shown in the form of planar electrode assembly 300. 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, and 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, which 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 joined 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 as relatively flat or planar in Figure 4, it should be understood that the paddle 302 may be bent, curled, twisted, torn, and / or otherwise deformed. Thus, the plane defined by the paddle 302 and the splines 312, 314, 316, and 318 may be deformed accordingly so that the plane is a non-planar 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 an irrigation agent to one or more portions of the splines 312-318.

[0034] Multiple splines may further comprise varying numbers 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 electrode.

[0035] The electrodes 322 may be used for a variety of diagnostic and therapeutic purposes, including, 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 a power supply 110 (e.g., via a suitable wire or other suitable conductor extending through the catheter shaft 122), and for IRE therapy, they may be configured to be selectively energized in opposite polarities (e.g., by the power supply 110 and / or computer system 130) to generate potential and corresponding electric fields in between. That is, one of the electrodes 322 may be configured to function as a cathode, and the other 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 is understood that the shape, size, and / or configuration of electrode 322 may affect various parameters of the electroporation treatment being applied.

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

[0037] The structural member 404 may be constructed from a variety of suitable materials, including, but not limited to, metal alloys, stainless steel, copper-aluminum-nickel alloys, alloys containing zinc, copper, gold, and / or iron, polymers containing any of the above materials, shape memory polymers, and / or combinations thereof. In some embodiments, the structural member 404 may be constructed from a non-metallic material, such as a formed rigid plastic material. In exemplary embodiments, the structural member 404 is composed of a shape memory alloy. One particularly preferred shape memory alloy for use is Nitinol, a nickel-titanium (NiTi) alloy. Nitinol is a nearly stoichiometric alloy of nickel and titanium and may contain small amounts of other metals to achieve desired properties. Nickel-titanium alloys are highly elastic and are commonly referred to as "hyperelastic" or "pseudoelastic." Such memory shape alloys tend to have temperature-induced phase transitions that bring the material to a preferred configuration, which can be fixed by heating the material above a certain transition temperature to induce a phase change in its material. When an alloy is cooled and returned to its original state, it tends to "recall" the shape it had during heat treatment and, unless constrained by other factors, adopt that shape.

[0038] The flexible circuit assembly 402 includes at least one flexible circuit designed to bend or flex during 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. Figure 6 is a top view of each of the first and second subassemblies of the flexible circuit assembly 402 (shown in Figure 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. Referring to Figures 5 and 6, each of the first subassembly 410 and the second subassembly 412 includes a plurality of electrodes 414 arranged on a flexible circuit board 416. Each flexible circuit board 416 of subassemblies 410, 412 includes an outer surface 418 opposite to a contact surface (e.g., an inner surface) 420 (shown in Figure 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 board 416 is a flexible printed circuit, such as a polyimide flexible circuit. In one example, the flexible circuit board 416 may be a Kapton® polyimide flexible circuit.

[0039] The electrodes 414 are arranged on the outer surface 418 of each flexible circuit board 416. The electrodes 414 may be any suitable type of electrode, such as a single-sided electrode arranged on the outer surface 418 or an electrode printed on the flexible circuit board 416. In exemplary embodiments, the first subassembly 410 and the second subassembly 412 each include a single flexible circuit with electrodes on one side of the flexible circuit. The illustrated embodiment includes 12 electrodes arranged on the outer surface 418, but other embodiments may include more or fewer than 12 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 8 to 12 electrodes on each of the subassemblies 410 and 412. Furthermore, 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, rounded or spherical. The plurality of electrodes 414 of the first subassembly 410 may be interchangeably referred to herein as the “first electrode set”, and the plurality of electrodes 414 of the second subassembly 412 may be interchangeably referred to herein as the “second electrode set”.

[0040] Figure 7 shows step 500 in an exemplary method for forming the spline 400 (shown in Figure 5). Referring to Figures 5-7, the exemplary method for 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 of the first subassembly 410 (e.g., the first electrode set) align with the first surface 406 of the structural member 404 and the electrodes 414 of the second subassembly 412 (e.g., the second electrode set) align with the second surface 408 of the structural member 404. The exemplary method further includes joining the flexible circuit boards 416 to each other at their respective first edges 422 and their respective second edges 424, as indicated by the arrow 426 in Figure 7. The flexible circuit boards 416 may be joined at their respective first edges 422 and their respective second edges 424 using an adhesive material 428 (shown in Figure 5). In one embodiment, the opening (e.g., a gap in space) formed by joining the respective first edges 422 and the respective second edges 424 may be completely filled with adhesive material 428. The adhesive material 428 may be applied to 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 bonding the flexible circuit board 416 together.

[0041] In other embodiments, the flexible circuit boards 416 are heat-sealed together. In some embodiments, the flexible circuit boards 416 are bonded only 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, respectively, so that the bonded flexible circuit boards 416 can move and slide freely relative to the structural member 404. In other embodiments, one or both of the flexible circuit boards 416 are directly bonded 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 for the electrode 414.

[0042] Figure 8 shows an end view of another exemplary spline 600 suitable for use in electrode assembly 102 (shown in Figure 1). In particular, spline 600 may be incorporated into a basket electrode assembly 200 (both shown in Figure 3) as one or more of splines 208. Additionally or alternatively, spline 600 may be incorporated into a planar electrode assembly 300 as one or more of splines 312, 314, 316, 318 (all shown in Figure 4). Spline 600 may be substantially similar to or have substantially similar configurations to spline 400 as described above. Spline 600 includes structural members 404 and flexible circuit assembly 602. Structural members 404 extend from the proximal end 601 to the distal end (not shown) of spline 600. The flexible circuit boards 416 may be joined to each other using adhesive material 428. In one embodiment, openings (e.g., gaps between spaces) formed by joining the flexible circuit boards 416 may be completely filled with adhesive material 428.

[0043] Figure 9 is a top view of a flexible circuit assembly 602 of the spline 600 (shown in Figure 8). Referring to Figures 8 and 9, the flexible circuit assembly 602 includes a first subassembly 410 and a second subassembly 412. Each of the subassemblies 410 and 412 includes a plurality of electrodes 414 arranged on the outer surface 418 of the flexible circuit board 416. In the embodiments shown in Figures 8 and 9, the first subassembly 410 and the second subassembly 412 of the flexible circuit assembly 602 are joined to each other by a fold line 604. The fold line 604 may include any fragile lines that facilitate folding or bending of the subassemblies 410 and 412 joined by the fold line 604, such as notches, break lines, creases, perforations, and combinations thereof.

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

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

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

[0047] As shown in Figure 13, an exemplary method for forming the spline 900 includes inserting a structural member 404 into a cavity 906 of a flexible tubular substrate 904. The exemplary method for forming the spline 900 further includes compressing the flexible tubular substrate 904 (e.g., by applying force to the outer surface 908) such that a first electrode set 414 of the flexible circuit assembly 902 is coupled in close proximity to the first surface 406 of the structural member 404, and a second electrode set 414 of the flexible circuit assembly 902 is coupled in close proximity to the second surface 408 of the structural member 404. The adhesive material 428 may also be applied to the contact surface (e.g., inner surface) 910 of the flexible tubular substrate 904, and 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 opening (e.g., a gap in space) formed by compressing the flexible tubular substrate 904 may be completely filled with the adhesive material 428.

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

[0049] Figure 14 is a perspective view of one of the subassemblies 410, 412 arranged in a helical configuration 1100 suitable for use in system 100 (shown in Figure 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 unfolding the individual subassemblies 410, 412 into a desired helical shape 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 a helical configuration 1100 and are lengthened to reduce the outer diameter of the helical configuration 1100. More specifically, in these embodiments, the flexible circuit board 416 of one subassembly 410, 412 may be wound into a coil and extended for insertion as a single long linear catheter in system 100. In the illustrated embodiment, the electrode 414 is positioned on the outer surface 418 of the flexible circuit board 416. The electrode 414 may be any suitable type of electrode, such as a single-sided electrode placed on the outer surface 418 or an electrode printed on a flexible circuit board 416. In some embodiments, the individual subassemblies 410, 412, including the structural member 404, may be wound in a helical configuration.

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

[0051] While some steps in the exemplary method are numbered, such numbering does not indicate that the steps must be performed in the order they are listed. Therefore, certain steps do not need to be performed in the exact order they are presented unless the explanation specifically requires such an order. Steps may be performed in the listed order or in another appropriate order.

[0052] While 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 this disclosure. Therefore, it should be understood that many modifications can be made to the exemplary embodiments and examples, and other configurations can be devised, without departing from the spirit and scope of this disclosure as defined by the claims. Accordingly, this application is intended to encompass modifications and variations of these embodiments and their equivalents.

[0053] This specification uses examples to disclose the invention, including the best mode, and enables any person skilled in the art to implement the disclosure, including fabricating and using any device or system, and carrying out any incorporated method. The patentable scope of this disclosure is defined by the claims and may include other examples that are conceivable to a person skilled in the art. If the components are identical to those described in the claims, or include equivalent components that are not significantly different from those described in the claims, such other examples shall be within the scope of the claims. The following items are elements described in the claims at the time of filing the patent application. (Item 1) A method for forming a spline for an electrode assembly for a catheter system, To provide a structural member including a first surface and a second surface, To provide a flexible circuit assembly comprising a plurality of electrodes and at least one flexible circuit board having a contact surface and an outer surface opposite the contact surface, wherein the plurality of electrodes are arranged on the outer surface of the at least one flexible circuit board, Positioning the flexible circuit assembly with respect to the structural member such that a first set of electrodes among the plurality of electrodes aligns with the first surface of the structural member, and a second set of electrodes among the plurality of electrodes aligns with the second surface of the structural member, A method comprising 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. (Item 2) The method according to item 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 is further comprising bonding the at least one flexible circuit board to the structural member using an adhesive. (Item 3) The method according to item 2, wherein bonding the at least one flexible circuit board to the structural member comprises using the adhesive to bond 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. (Item 4) The method according to item 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 includes thermally fusing the at least one flexible circuit board to 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 with respect to the structural member comprises positioning the structural member between the first flexible circuit board and the second flexible circuit board. The method according to item 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 aligns with the first surface of the structural member and the second electrode set of the plurality of electrodes aligns with the second surface of the structural member. (Item 6) The method of item 5, wherein joining the first flexible circuit board and the second flexible circuit board at their respective first and second edges is performed by joining the first flexible circuit board and the second flexible circuit board using an adhesive so that the first flexible circuit board and the second flexible circuit board are slidable with respect 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 by a fold line. The method according to item 1, wherein forming the splines involves bending the first flexible circuit board along the fold line and around the structural member with respect to the second flexible circuit board, such that the first electrode set aligns with the first surface of the structural member and the second electrode set aligns with the second surface of the structural member. (Item 8) The method according to item 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 board of the flexible circuit assembly comprises a tubular substrate defining a cavity therein, The method according to item 1, wherein positioning the flexible circuit assembly with respect to the structural member comprises inserting the structural member into the cavity of the tubular substrate. (Item 10) The method of item 9, further comprising compressing the tubular substrate such that the first electrode set aligns with the first surface of the structural member and the second electrode set aligns with the second surface of the structural member, for positioning the flexible circuit assembly with respect to the structural member. (Item 11) The structural member is made of nitinol, as described in item 1. (Item 12) The method according to item 1, wherein the at least one flexible circuit board is a flexible printed circuit. (Item 13) The structural member is the method according to item 1, wherein the structural member includes a plurality of separate members. (Item 14) The method according to item 1, further comprising incorporating the formed spline into a planar electrode assembly. (Item 15) The method according to item 1, further comprising incorporating the formed spline into a basket electrode assembly. (Item 16) The method according to item 1, further comprising winding the at least one flexible circuit board around the length of the at least one flexible circuit board to form a helical structure. (Item 17) An electrode assembly for a catheter system, The electrode assembly has a longitudinal axis, a proximal end, and a distal end. The electrode assembly comprises at least one spline extending from the proximal end to the distal end of the electrode assembly, The aforementioned at least one spline is A structural member extending from the proximal end to the distal end of the electrode assembly, including a first surface and a second surface, A flexible circuit assembly comprising a plurality of electrodes and at least one flexible circuit board having a contact surface and an outer surface opposite to the contact surface, wherein the plurality of electrodes are arranged 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 among the plurality of electrodes aligns with the first surface of the structural member, and a second set of electrodes among the plurality of electrodes aligns with the second surface of the structural member. An electrode assembly wherein 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. The electrode assembly according to item 17, wherein the first flexible circuit board and the second flexible circuit board are joined at their respective first and second longitudinal edges such that the first set of electrodes among the plurality of electrodes aligns with the first surface of the structural member and the second set of electrodes among the plurality of electrodes aligns with the second surface of the structural member. (Item 19) The flexible circuit assembly includes at least two flexible circuit boards joined together by fold lines, The electrode assembly according to item 17, wherein the flexible circuit assembly is bent along the fold line and around the structural member such that the first electrode set aligns with the first surface of the structural member and the second electrode set aligns with the second surface of the structural member. (Item 20) It is a catheter system, Flexible catheter shaft and A handle is attached to the proximal end of the catheter shaft, An electrode assembly coupled to the distal end of the flexible catheter shaft, having a longitudinal axis, a proximal end, and a distal end, wherein the electrode assembly comprises at least one spline extending from the proximal end to the distal end of the electrode assembly, The aforementioned at least one spline is A structural member extending from the proximal end to the distal end of the electrode assembly, including a first surface and a second surface, A flexible circuit assembly comprising a plurality of electrodes and at least one flexible circuit board having a contact surface and an outer surface opposite to the contact surface, wherein the plurality of electrodes are arranged 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 among the plurality of electrodes aligns with the first surface of the structural member, and a second set of electrodes among the plurality of electrodes aligns with the second surface of the structural member. A catheter system wherein 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. A method for forming a spline for an electrode assembly for a catheter system, To provide structural members, To provide a flexible circuit assembly including a first electrode set disposed on a first flexible circuit board and a second electrode set disposed on a second flexible circuit board, The structural member is positioned between the first flexible circuit board and the second flexible circuit board, and the first flexible circuit board and the second flexible circuit board are coupled together. Each of the first flexible circuit board and the second flexible circuit board includes a first edge and a second edge, A method for connecting the first flexible circuit board and the second flexible circuit board, comprising connecting the first flexible circuit board and the second flexible circuit board at their respective first edges and second edges such that the first electrode set faces a first direction away from the structural member, and the second electrode set faces a second direction away from the structural member and different from the first direction.

2. The method according to claim 1, further comprising coupling the flexible circuit assembly to the structural member.

3. The method according to claim 2, wherein bonding the flexible circuit assembly to the structural member comprises bonding at least one contact surface between the first flexible circuit board and the second flexible circuit board to the structural member using an adhesive.

4. The method according to claim 1, wherein joining the first flexible circuit board and the second flexible circuit board includes thermal fusion bonding the first flexible circuit board and the second flexible circuit board.

5. The method according to claim 1, wherein joining the first flexible circuit board and the second flexible circuit board at their respective first and second edges is performed by joining the first flexible circuit board and the second flexible circuit board using an adhesive so that the first flexible circuit board and the second flexible circuit board are slidable with respect to the structural member.

6. A method for forming a spline for an electrode assembly for a catheter system, To provide structural members, To provide a flexible circuit assembly including a first electrode set disposed on a first flexible circuit board and a second electrode set disposed on a second flexible circuit board, The structural member is positioned between the first flexible circuit board and the second flexible circuit board, and the first flexible circuit board and the second flexible circuit board are coupled together. The first flexible circuit board is joined to the second flexible circuit board by a fold line. Forming the splines involves bending the first flexible circuit board along the fold lines and around the structural member with respect to the second flexible circuit board, such that the first electrode set faces a first direction away from the structural member, and the second electrode set faces a second direction away from the structural member and different from the first direction. The first flexible circuit board includes a first edge opposite to the fold line, The second flexible circuit board includes a second edge opposite to the fold line, A method for joining the first flexible circuit board and the second flexible circuit board, comprising bringing the first edge of the first flexible circuit board and the second edge of the second flexible circuit board into contact with each other.

7. The method according to claim 6, wherein joining the first flexible circuit board and the second flexible circuit board is performed by joining the first flexible circuit board and the second flexible circuit board using an adhesive.

8. The method according to any one of claims 1 to 7, wherein the structural member is made of nitinol.

9. The method according to any one of claims 1 to 8, wherein the first flexible circuit board and the second flexible circuit board are flexible printed circuits.

10. The method according to any one of claims 1 to 9, wherein the structural member includes a plurality of separate members.

11. The method according to any one of claims 1 to 10, further comprising incorporating the formed spline into a planar electrode assembly.

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

13. The method according to claim 1, further comprising winding the first flexible circuit board and the second flexible circuit board into a coil to form a helical structure.

14. An electrode assembly for a catheter system, The electrode assembly comprises at least one spline, The at least one spline is, Structural members and A flexible circuit assembly comprising a first electrode set disposed on a first flexible circuit board and a second electrode set disposed on a second flexible circuit board, The first flexible circuit board and the second flexible circuit board are coupled together. Each of the first flexible circuit board and the second flexible circuit board includes a first edge and a second edge, The structural member is disposed between the first flexible circuit board and the second flexible circuit board. An electrode assembly in which the first flexible circuit board and the second flexible circuit board are joined at their respective first and second edges such that the first electrode set faces a first direction away from the structural member, and the second electrode set faces a second direction away from the structural member and different from the first direction.

15. An electrode assembly for a catheter system, The electrode assembly comprises at least one spline, The at least one spline is, Structural members and A flexible circuit assembly comprising a first electrode set disposed on a first flexible circuit board and a second electrode set disposed on a second flexible circuit board, The first flexible circuit board and the second flexible circuit board are coupled together. The first flexible circuit board and the second flexible circuit board are joined together by a fold line. The flexible circuit assembly is bent along the fold line and around the structural member such that the first electrode set faces a first direction away from the structural member, and the second electrode set faces a second direction away from the structural member and different from the first direction. The first flexible circuit board includes a first edge opposite to the fold line, The second flexible circuit board includes a second edge opposite to the fold line, An electrode assembly in which the first flexible circuit board and the second flexible circuit board are joined together with the first edge of the first flexible circuit board and the second edge of the second flexible circuit board in contact with each other.

16. It is a catheter system, Flexible catheter shaft and A handle is attached to the proximal end of the flexible catheter shaft, An electrode assembly coupled to the distal end of the flexible catheter shaft, comprising the electrode assembly having at least one spline, The at least one spline is, Structural members and A flexible circuit assembly comprising a first electrode set disposed on a first flexible circuit board and a second electrode set disposed on a second flexible circuit board, The first flexible circuit board and the second flexible circuit board are coupled together. Each of the first flexible circuit board and the second flexible circuit board includes a first edge and a second edge, The structural member is disposed between the first flexible circuit board and the second flexible circuit board. A catheter system in which the first flexible circuit board and the second flexible circuit board are joined at their respective first and second edges such that the first electrode set faces a first direction away from the structural member, and the second electrode set faces a second direction away from the structural member and different from the first direction.

17. It is a catheter system, Flexible catheter shaft and A handle is attached to the proximal end of the flexible catheter shaft, An electrode assembly coupled to the distal end of the flexible catheter shaft, comprising the electrode assembly having at least one spline, The at least one spline is, Structural members and A flexible circuit assembly comprising a first electrode set disposed on a first flexible circuit board and a second electrode set disposed on a second flexible circuit board, The first flexible circuit board and the second flexible circuit board are coupled together. The first flexible circuit board and the second flexible circuit board are joined together by a fold line. The flexible circuit assembly is bent along the fold line and around the structural member such that the first electrode set faces a first direction away from the structural member, and the second electrode set faces a second direction away from the structural member and different from the first direction. The first flexible circuit board includes a first edge opposite to the fold line, The second flexible circuit board includes a second edge opposite to the fold line, A catheter system in which the first flexible circuit board and the second flexible circuit board are joined together with the first edge of the first flexible circuit board and the second edge of the second flexible circuit board in contact with each other.

Images