Encapsulated catheters, systems, and methods associated therewith

Abstract

To provide an end effector for a catheter.SOLUTION: The end effector for a catheter includes a flexible circuit including a plurality of electrodes. The flexible circuit is positioned at least partially within an insulative material. In some examples, the end effector includes a framework spaced from the flexible circuit, and one or more position sensing loops.SELECTED DRAWING: Figure 2

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 615,600 (Attorney Docket No.: BIO6917USPSP1 - 253757.000438), filed on December 28, 2023; U.S. Provisional Patent Application No. 63 / 615,902 (Attorney Docket No.: BIO6926USPSP1 - 253757.000471), filed on December 29, 2023; U.S. Provisional Patent Application No. 63 / 615,534 (Attorney Docket No.: BIO6925USPSP1 - 253757.000472), filed on December 28, 2023; U.S. Provisional Patent Application No. 63 / 615,556 (Attorney Docket No.: BIO6924USPSP1 - 253757.000473), filed on December 28, 2023; U.S. Provisional Patent Application No. 63 / 615,574 (Attorney Docket No.: BIO6923USPSP1 - 253757.000474), filed on December 28, 2023; and U.S. Provisional Patent Application No. 63 / 615,947 (Attorney Docket No.: BIO6922USPSP1 - 253757.000475), filed on December 29, 2023, all of which are hereby incorporated by reference as if fully set forth herein.

[0002] (Field of the Invention) The present disclosure generally relates to minimally invasive medical devices, and more particularly to cardiac mapping catheters having flexible end effectors.

Background Art

[0003] Cardiac arrhythmias, such as atrial fibrillation, occur when electrical signals abnormally conduct from regions of heart tissue to adjacent tissue, thereby disrupting the normal cardiac cycle and causing asynchronous rhythms. Undesirable signal sources may be located in atrial or ventricular tissue. Unwanted signals can conduct through heart tissue to other locations, potentially causing or continuing an arrhythmia.

[0004] As measures for treating arrhythmia, there are surgical interference with the signal generation source causing arrhythmia and interference with the conduction path of such signals. More recently, it has been found that by mapping the electrical properties and cardiac volume of the endocardium and selectively ablating cardiac tissue by applying energy, it is possible to interrupt or correct the propagation of unwanted electrical signals from one part of the heart to another. The ablation process breaks the unwanted electrical pathway by forming non-conductive damaged areas.

[0005] In this two-step procedure, including mapping and subsequent ablation, usually, a catheter equipped with one or more electrical sensors is advanced into the heart, and by acquiring data at a large number of points, the electrical activity at each point within the heart is sensed and measured. Then, using these data, the target area for ablation is selected.

[0006] For higher mapping resolution, it is desirable for the mapping catheter to closely conform to the target anatomical structure. For mapping within the atrium or ventricle (e.g., the apex of the ventricle), it is desirable for the catheter to collect more data signals in a shorter time. Also, such a catheter should enable sufficient electrode contact with various tissue surfaces, such as flat, curved, irregular, or non-planar surface tissues, and be foldable for non-invasive advancement and retraction through the patient's vasculature. Existing catheters generally require rigid internal structural members to ensure that a given configuration is maintained. Rigidity is disadvantageous during operation within body organs because it may prevent the electrodes from contacting the tissue. Summary of the Invention Problems to be Solved by the Invention

[0007] Other catheters can include a flexible end effector designed to overcome this disadvantage. These catheters can include layered components that can be time-consuming, complex, and expensive to manufacture and assemble. In many cases, the electrode contact surfaces of these end effectors must be exposed through an encapsulating material via laser cutting or mechanical removal, both of which increase labor time and production costs. Also, the position of these catheters as they move through the heart is not easily tracked using conventional methods. Additionally, the design of rigid internal structural members has many drawbacks such as easy breakage of flexible circuit interconnects and unpredictable failure patterns. Thus, there is a need for an improved end effector for catheters that addresses these problems.

[0008] Furthermore, it may be desirable to provide an end effector with as small a footprint as possible in order to prevent unwanted damage to the area surrounding the targeted anatomical structure. Also, it may be desirable to provide a large number of electrodes on the end effector in order to collect a large amount of data signals and / or to maximize the available surface area provided by the end effector. However, as the number of electrodes increases, the number of corresponding electrical traces required for accurate transmission of electrical signals also increases. Providing a large number of electrical traces can be difficult considering the small footprint of the end effector. Thus, there is a need for an improved end effector for catheters that addresses these problems.

Means for Solving the Problems

[0009] The following disclosure presents solutions to the aforementioned problems.

[0010] To enable efficient manufacturing in terms of time and cost of an end effector that enhances the functionality of the mapping and ablation catheters referred to in the "Background Art" section, the present disclosure relates to an easily manufacturable end effector having enhanced aspects of mapping and ablation catheter performance (including, but not limited to, mapping resolution, electrode contact with the target anatomical structure, delivery of the end effector to the target anatomical structure, biocompatibility, end effector stiffness, and non-invasiveness).

[0011] According to the disclosed technology, an end effector is provided. The end effector can include an insulating material having a first outer surface and a second outer surface. The end effector can include a framework disposed within the insulating material. The end effector can include a first flexible circuit having a first plurality of electrodes. The first flexible circuit is disposed longitudinally along the insulating material and at least partially within the insulating material such that a first portion of the first flexible circuit is continuous with a first plane and a second portion of the first flexible circuit is continuous with a second plane. The first plane is at a first distance from the framework and the second plane is at a second distance from the framework. The second distance is less than the first distance.

[0012] An end effector is provided according to the technology of the present disclosure. The end effector can include an insulating material having a first outer surface and a second outer surface. The end effector can include a framework disposed within the insulating material. The end effector can include a first flexible circuit having a first plurality of electrodes. The first flexible circuit is disposed on or within the insulating material and each electrode of the first plurality of electrodes includes a first contact surface. The insulating material is continuous with the first contact surface such that only the first contact surface of at least a portion of the first plurality of electrodes is exposed to the surrounding environment. A first support layer is within the insulating material between the framework and the first flexible circuit.

[0013] An end effector is provided by the technology of the present disclosure. The end effector can include an insulating material having a first outer surface and a second outer surface. The end effector can include a framework disposed within the insulating material. The end effector can include a first flexible circuit having a waveform profile disposed within the insulating material. The first flexible circuit includes a first portion that is continuous with the insulating material and exposed to the surrounding environment. The first flexible circuit is spaced apart from the framework.

[0014] According to the disclosed technology, an end effector for a catheter is provided. The end effector includes a first flexible circuit extending along a longitudinal axis from a proximal portion to a distal portion of the end effector, and a second flexible circuit extending along the longitudinal axis from the proximal portion to the distal portion of the end effector. The second flexible circuit is substantially coplanar with the first flexible circuit at the distal portion of the end effector and is disposed on top of the first flexible circuit at the proximal portion of the end effector. The first flexible circuit can include one or more first electrodes disposed on the distal portion of the first flexible circuit. The proximal portion of the first flexible circuit can include one or more first electrical contacts corresponding to the one or more first electrodes. The first flexible circuit can include one or more first traces connecting the one or more first electrical contacts to the one or more first electrodes. The one or more first electrodes can include a plurality of pairs of first electrodes disposed on the distal portion of the first flexible circuit. Each first electrode of each pair of first electrodes can be spaced apart by a first predetermined longitudinal distance, and each pair of first electrodes can be spaced apart from an adjacent pair of first electrodes by a second predetermined longitudinal distance, which can be greater than the first predetermined longitudinal distance. The first predetermined longitudinal distance by which a pair of electrodes is spaced apart can be about 100 microns. Each of the electrodes can have a length of about 500 microns and a width of about 500 microns. The second flexible circuit can include one or more second electrodes disposed on the distal portion of the second flexible circuit. The proximal portion of the second flexible circuit can include one or more second electrical contacts corresponding to the one or more second electrodes. The second flexible circuit can include one or more second traces connecting the one or more second electrical contacts to the one or more second electrodes. The one or more second electrodes can include a plurality of pairs of second electrodes disposed on the distal portion of the second flexible circuit. It should be noted that the design provided herein overcomes many drawbacks of existing mapping catheters. Specifically, commercially available ECG electrodes in mapping catheters or diagnostic catheters are typically cylindrical in shape, making partial contact with tissue and partial contact with blood.This enables the collection of ECG signals through myocardial tissue, while other electrical signals propagating through blood and tissue (e.g., far - field signals) would be collected using conventional cylindrical electrodes. As a result, on one side, an electrode contacts the tissue, and on the other side, a flat electrode contacts the blood (but not the tissue), and the flat electrodes on both sides enable the cancellation of far - field signals. In other words, one of the greatest advantages of this new design is the concept of a reference electrode (i.e., an electrode that is not physically in contact with the tissue), which is very important for the unipolar signal concept. Conventionally, the reference signal for unipolar signal mapping was a single electrode without contact with the tissue, located at one position away from the tissue - contacting electrode(s) (WCT). Thus, cylindrical electrodes and a single separate reference electrode have their own drawbacks as the reference signal position is different for each different electrode. These drawbacks are addressed in the new design provided herein, where dedicated reference (non - tissue - contacting) electrodes for each electrode contacting the tissue are in substantially the same location.

[0015] The end effector can further include a frame. The distal portion of the first flexible circuit can be disposed on the frame. The distal portion of the second flexible circuit can be disposed on the frame. The proximal portion of the first flexible circuit can be disposed on the frame. The proximal portion of the second flexible circuit can be disposed on a portion of the proximal portion of the first flexible circuit. The frame can comprise first, second, third, and fourth spines. The distal portion of the first flexible circuit can include a first loop disposed above the first and second spines. The distal portion of the second flexible circuit can include a second loop disposed above the third and fourth spines. The frame can further include at least a partial gap between the first, second, third, and fourth spines. The frame can include nitinol. The distal portion of the end effector can have a width of about 9 millimeters and a length of about 20 millimeters.

[0016] According to the disclosed technology, an end effector for a catheter is provided, the end effector including a frame extending along a longitudinal axis, the frame having a first side and a second side; a first flexible circuit disposed on the first side of the frame and extending along the longitudinal axis from a proximal portion of the frame to a distal portion of the frame; and a second flexible circuit extending along the longitudinal axis from the proximal portion of the frame to the distal portion of the frame, the second flexible circuit being disposed on the first side of the frame at the distal portion of the frame and on the first flexible circuit at the proximal portion of the frame. The first flexible circuit can include one or more first electrodes disposed on the distal portion of the first flexible circuit, and the second flexible circuit can include one or more second electrodes disposed on the distal portion of the second flexible circuit. The first electrodes and the second electrodes can be arranged in electrode pairs. Each electrode of a pair of electrodes can be spaced apart by a first predetermined longitudinal distance, and each pair of electrodes can be spaced apart from an adjacent pair of electrodes by a second predetermined longitudinal distance. The second predetermined longitudinal distance can be greater than the first predetermined longitudinal distance. The first predetermined longitudinal distance corresponding to the distance between paired electrodes can be about 100 microns.

[0017] The end effector can further include a third flexible circuit disposed on the second side of the frame and extending along the longitudinal axis from the proximal portion of the frame to the distal portion of the frame, and a fourth flexible circuit extending along the longitudinal axis from the proximal portion of the frame to the distal portion of the frame, the fourth flexible circuit being disposed on the second side of the frame at the distal portion of the frame and on the third flexible circuit at the proximal portion of the frame. The third flexible circuit can include electrodes disposed on the distal portion of the third flexible circuit, and the fourth flexible circuit can include electrodes disposed on the distal portion of the second flexible circuit.

[0018] According to the disclosed technology, an end effector for a catheter is provided. The end effector includes a first flexible circuit extending along a longitudinal axis from a proximal portion to a distal portion of the end effector, and a second flexible circuit extending along the longitudinal axis from the proximal portion to the distal portion of the end effector. The second flexible circuit is substantially in the same plane as the first flexible circuit at the distal portion of the end effector and is disposed on the first flexible circuit at the proximal portion of the end effector. The first flexible circuit can include a first set of electrodes disposed on one side of the first flexible circuit and a second set of electrodes disposed on the opposite side of the first flexible circuit. The second flexible circuit includes a first set of electrodes disposed on one side of the second flexible circuit and a second set of electrodes disposed on the opposite side of the second flexible circuit. The end effector can further include a substrate disposed between the first flexible circuit and the second flexible circuit at the proximal portion and in the same plane as the first flexible circuit and the second flexible circuit at the distal portion.

[0019] An end effector for a catheter is provided according to the technology of the present disclosure. The end effector includes an insulating material, a framework, and a position sensing loop. The framework is disposed within the insulating material and is substantially planar along the longitudinal axis. The position sensing loop is spaced from the framework and coupled to the insulating material. The position sensing loop includes a central loop and a pair of side loops. The central loop is disposed above the longitudinal axis over a region near the distal portion of the insulating material. The pair of side loops are disposed generally symmetrically with respect to the longitudinal axis, and each side loop extends along the longitudinal axis from the proximal portion to the distal portion of the insulating material.

[0020] An end effector for a catheter is provided by the technology of the present disclosure. The end effector includes an insulating material, a framework, and a position sensing loop. The framework is disposed within the insulating material and is substantially planar along a longitudinal axis. The position sensing loop is disposed generally parallel to the framework and is separated from the framework by the insulating material. The position sensing loop includes a central loop, a first side loop, and a second side loop. The central loop extends along the longitudinal axis and includes a cumulative central loop surface area. The first side loop extends along the longitudinal axis and includes a first cumulative side loop surface area. The second side loop extends along the longitudinal axis and includes a second cumulative side loop surface area. The cumulative central loop surface area, the first cumulative side loop surface area, and the second cumulative side loop surface area are each in the range of about 100 to 300 square millimeters.

[0021] A framework for an end effector of a medical device is provided by the technology of the present disclosure. The framework includes a base and a first spine loop. The base is configured to connect to an elongated shaft of the medical device and extends distally along a longitudinal axis. The first spine loop extends from the base along the longitudinal axis and includes first to seventh segments. The curved first segment is connected to the base and extends distally therefrom along the longitudinal axis. The second segment has an arcuate configuration connected to the curved first segment and extends therefrom. The third segment is connected to the second segment and extends proximally therefrom along the longitudinal axis. The curved fourth segment is connected to the base and extends distally therefrom along the longitudinal axis. The arcuate fifth segment is connected to the fourth segment and extends therefrom. The sixth segment is connected to the fifth segment and extends proximally therefrom along the longitudinal axis. The arcuate seventh segment connects the third segment and the sixth segment.

[0022] Another framework for an end effector of a medical device is further provided by the technology of the present disclosure. The framework includes a base, a first spine loop, a second spine loop, a third spine loop, and a finger-shaped opening. The base is configured to connect to an elongate shaft of the medical device and extends along a longitudinal axis. The first spine loop extends from the base along the longitudinal axis and includes a first segment, a second segment, and a third segment. The first segment is connected to the base and extends distally from there along the longitudinal axis. The second segment is connected to the first segment and extends inwardly therefrom toward the longitudinal axis. The third segment is connected to the second segment and extends distally from there along the longitudinal axis. The second spine loop extends from the base along the longitudinal axis and includes a first segment, a second segment, and a third segment. The first segment is connected to the base and extends distally from there along the longitudinal axis. The second segment is connected to the first segment and extends inwardly therefrom toward the longitudinal axis. The third segment is connected to the second segment and extends distally from there along the longitudinal axis. The third spine loop connects the third segment of the first spine loop and the third segment of the second spine loop. The finger-shaped opening is defined by the base, the first spine loop, the second spine loop, and the third spine loop.

[0023] In accordance with the disclosed technology, an end effector for a medical device is further provided. The end effector includes a framework, an insulating material disposed on the framework, and a flexible circuit. The framework includes a base, a first spine loop, a second spine loop, a third spine loop, and a finger-shaped opening. The base is configured to connect to the elongated shaft of the medical device and extends along the longitudinal axis. The first spine loop extends from the base along the longitudinal axis. The second spine loop extends from the base along the longitudinal axis. The third spine loop connects the first spine loop and the second spine loop. The finger-shaped opening is defined by the base, the first spine loop, the second spine loop, and the third spine loop. The flexible circuit includes a first section and a second section. The first section is vertically spaced from the framework by the insulating material along a vertical axis. The second section is offset from the first section along the vertical axis and extends within the finger-shaped opening.

[0024] Another framework for an end effector of a medical device is further provided by the techniques of the present disclosure. The framework extends along a longitudinal axis that is coaxial with the longitudinal center of the framework and includes a base, a first spine loop, and a second spine loop. The base is configured to connect to an elongate shaft of a medical device and extends along the longitudinal axis. The first spine loop extends from the base on a first side of the longitudinal axis and includes a first distal end and a second distal end. The first distal end is connected to the base at a first longitudinal position along the longitudinal axis. The second distal end is connected to the base at a second longitudinal position along the longitudinal axis. The second spine loop extends from the base on a second side of the longitudinal axis. The second spine loop includes the first distal end and the second distal end. The first distal end is connected to the base at a third longitudinal position along the longitudinal axis. The second distal end is connected to the base at a fourth longitudinal position along the longitudinal axis. The first longitudinal position, the second longitudinal position, the third longitudinal position, and the fourth longitudinal position are each disposed along the longitudinal axis such that the framework is asymmetric with respect to the longitudinal axis.

[0025] An end effector for a medical device is further provided in accordance with the disclosed techniques. The end effector includes a framework that is substantially planar along a longitudinal axis, a flexible circuit vertically spaced from the framework along a vertical axis, and an insulating material within which the framework and the flexible circuit are disposed. The insulating material defines a first outer edge of the end effector. The first outer edge includes a processing portion configured to facilitate folding the end effector within a sheath. The processing portion includes at least one of a rounded cutout extending along at least a portion of the first outer edge, a tapered cutout extending along at least a portion of the first outer edge, a plurality of incisions defined along at least a portion of the first outer edge, or a lubricious coating extending along at least a portion of the first outer edge.

[0026] According to the technology of the present disclosure, a method of using a medical device is further provided. The method includes the step of retracting an end effector into a sheath along a longitudinal axis from a deployed configuration, the end effector having a substantially planar shape in the deployed configuration. The method includes the step of folding the end effector into a retracted configuration such that outer edges of the end effector slide past each other. The end effector has a substantially cylindrical shape or a helical shape in the retracted configuration. The first of the outer edges includes a processed portion including at least one of a rounded cutout extending along at least a portion of the first outer edge, a tapered cutout extending along at least a portion of the first outer edge, a plurality of incisions defined along at least a portion of the first outer edge, or a lubricious coating extending along at least a portion of the first outer edge.

[0027] A method of manufacturing an end effector for a medical device according to the technology of the present disclosure is further provided. The method includes the step of forming a framework that is substantially planar along a longitudinal axis. The method includes the step of disposing a flexible circuit above the framework. The method includes the step of heating an insulating material. The method includes the step of reflowing the insulating material such that the insulating material encapsulates the framework and the flexible circuit. The method includes the step of treating an outer edge of the insulating material, the outer edge including at least one of a reduced rigidity or a reduced coefficient of friction relative to a coefficient of friction or a rigidity of the outer edge prior to treatment.

[0028] To enable efficient manufacturing in terms of time and cost of an end effector that enhances the functionality of the mapping and ablation catheter referred to in the "Background Art" section, the present disclosure also relates to an easily manufacturable end effector having enhanced aspects (including but not limited to mapping resolution, electrode contact with the target anatomical structure, delivery of the end effector to the target anatomical structure, biocompatibility, end effector rigidity, and non-invasiveness) of mapping and ablation catheter performance.

[0029] Provided is an end effector for a medical instrument according to the technology of the present disclosure. The end effector includes a framework that defines a neutral plane. The end effector includes a first insulating material disposed on at least one side of the framework. The end effector includes a first flexible circuit disposed within the first insulating material and spaced from the framework along a vertical axis orthogonal to the neutral plane. The first flexible circuit includes a transition plane zone disposed proximate to the proximal end of the first flexible circuit. The first flexible circuit transitions within the transition plane zone from a first plane closer to the neutral plane to a second plane farther from the neutral plane.

[0030] Provided is an end effector according to the technology of the present disclosure. The end effector includes a framework having a first strut extending along a longitudinal axis. The end effector includes a flexible circuit aligned with the first strut and including a substrate that supports electrical traces, the flexible circuit including a plurality of bends such that the flexible circuit has a serpentine shape as the flexible circuit extends along the longitudinal axis of the strut. The first strut of the framework includes wide sections and narrow sections that extend along the longitudinal axis of the strut and alternate with each other. The narrow sections can be disposed proximate to respective vertices of the plurality of bends.

[0031] Provided is an end effector according to the technology of the present disclosure. The end effector includes a framework including a first strut extending along a longitudinal axis. The end effector includes a flexible circuit aligned with the first strut and including a substrate that supports electrical traces. The flexible circuit can include a plurality of bends such that the flexible circuit has a serpentine shape as the flexible circuit extends along the longitudinal axis of the strut. The electrical traces include rolled and annealed metal. The serpentine shape can be formed from the rolled and annealed metal along the direction of individual crystal grains of the rolled and annealed metal such that the individual crystal grains extend parallel to the longitudinal axis of the strut.

[0032] A method of manufacturing an end effector for a medical catheter is provided by the technology of the present disclosure. The method includes forming struts for a framework of the end effector and providing wide sections and narrow sections that extend along the longitudinal axis of the struts and alternate with each other. The method includes disposing electrical traces on a substrate. The method includes forming a plurality of bends in the substrate and the electrical traces. The method includes aligning the substrate and the electrical traces with the struts such that the apexes of the plurality of bends are disposed at corresponding positions of the narrow sections of the struts.

Brief Description of the Drawings

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DETAILED DESCRIPTION OF THE INVENTION

[0034] The following detailed description should be read with reference to the drawings, in which like elements in different drawings are numbered the same. The drawings are not necessarily to scale and represent selected examples and are not intended to limit the scope of the present disclosure. The detailed description is illustrative, not limiting, and shows diagrams of the principles of the disclosed technology. This description enables those skilled in the art to make and use the disclosed technology and describes some embodiments, adaptations, variations, alternatives, and uses of the disclosed technology, including what is currently considered to be the best mode for practicing the disclosed technology.

[0035] As used herein, the terms "about" or "substantially" or "generally" with respect to any numerical value or range indicate a suitable dimensional tolerance that enables a component or collection of components to function for the intended purpose described herein. More specifically, "about" or "substantially" can refer to a range of values within ±20% of the recited value. For example, "about 90%" can refer to a range of values from 70.1% or 71% to 109.9% or 110%. Additionally, as used herein, the terms "patient," "host," "user," and "subject" refer to any human or animal subject, and the use of the technology of interest in a human patient represents a preferred embodiment but is not intended to limit the system or method to human use. Similarly, the term "proximal" indicates the position closer to the operator or physician, while "distal" indicates the position farther from the operator or physician.

[0036] As contemplated herein, the vasculature of a "patient," "host," "user," and "subject" can be that of a human or any animal. It should be understood that the animal can be of various any applicable types, including but not limited to mammals, veterinary animals, livestock animals, or pet animals. As an example, the animal can be a laboratory animal (e.g., rat, dog, pig, monkey, etc.) specifically selected to have certain properties similar to those of a human. It should be understood that the subject can be, for example, any applicable human patient.

[0037] As contemplated herein, "physician" can include a physician, surgeon, technician, scientist, operator, or any other individual or delivery device associated with the delivery of a multi-electrode catheter for the treatment of drug-refractory atrial fibrillation in a subject.

[0038] As contemplated herein, "operator" can include a physician, surgeon, technician, scientist, or any other individual or delivery device associated with the delivery of a multi-electrode catheter for the treatment of drug-refractory atrial fibrillation in a subject.

[0039] As contemplated herein, the terms "ablate" or "ablation," when referring to the devices and corresponding systems of the present disclosure, are used interchangeably throughout the present disclosure to refer to non-thermal energy, such as irreversible electroporation (IRE), which is also referred to as pulsed electric field (PEF) and pulsed field ablation (PFA) throughout the present disclosure, and which is configured to reduce or prevent the generation of irregular cardiac signals within cells by utilizing non-thermal energy. When referring to the devices and corresponding systems of the present disclosure, ablating or ablation refers to non-thermal ablation of cardiac tissue in certain conditions, including but not limited to arrhythmias, atrial fibrillation ablation, pulmonary vein isolation, supraventricular tachycardia ablation, and ventricular tachycardia ablation, and is used throughout the present disclosure with reference to non-thermal ablation of cardiac tissue in certain conditions. The terms "ablate" or "ablation" also include known methods, devices, and systems for achieving various forms of physical tissue ablation, as would be understood by one of ordinary skill in the art.

[0040] As discussed herein, the terms "bipolar" and "unipolar," when used to refer to ablation schemes, describe different ablation schemes with respect to current path and electric field distribution. "Bipolar" refers to an ablation scheme that utilizes the current path between two electrodes both placed at the treatment site. The current density and the electric flux density are typically approximately equal at each of the two electrodes. "Unipolar" refers to an ablation scheme that utilizes the current path between two electrodes, where one electrode having a high current density and a high electric flux density is positioned at the treatment site and a second electrode having a relatively low current density and a lower electric flux density is positioned remotely from the treatment site.

[0041] As discussed herein, the terms "tubular" and "tube" are to be construed broadly and are not limited to a straight cylindrical structure, or a structure with a cross-section that is strictly circular, or a structure with a uniform cross-section throughout its length. For example, a tubular / shaft structure is generally illustrated as a substantially straight cylindrical structure. However, a tubular / shaft structure can have a tapered or curved outer surface without departing from the scope of the present disclosure.

[0042] The present disclosure relates to systems, methods, uses, and devices for mapping and ablation of cardiac tissue for treating cardiac arrhythmias. Ablation energy is typically delivered to cardiac tissue by the tip portion of a catheter that can deliver ablation energy along the tissue to be ablated. Some exemplary catheters include a three-dimensional structure at the tip portion and are configured to manage ablation energy from various electrodes positioned on the three-dimensional structure. Ablation procedures incorporating such exemplary catheters can be visualized using fluoroscopy.

[0043] To improve a failing heart, ablation of cardiac tissue applying thermal techniques such as radio frequency (RF) energy and cryoablation is a well-known procedure. Typically, to successfully ablate using thermal techniques, it is necessary to measure the cardiac potential at various locations in the myocardium. In addition, temperature measurements during ablation provide data that enable assessment of the effectiveness of ablation. Usually, in ablation procedures using thermal techniques, electrode potential and temperature are measured before, during, and after the actual ablation. The RF approach can have risks leading to tissue carbonization, burning, steam pop, phrenic nerve paralysis, pulmonary vein stenosis, and esophageal fistula. Cryoablation is an alternative approach to RF ablation that can reduce some of the thermal risks associated with RF ablation. However, operating a cryoablation device and selectively applying cryoablation is generally more difficult compared to RF ablation. Thus, cryoablation may not be feasible in certain anatomical shapes that can be reached by an electrical ablation device.

[0044] The present disclosure can include electrodes configured for RF ablation, cryoablation, and / or irreversible electroporation (IRE). IRE can be interchangeably referred to as pulsed electric field (PEF) ablation and pulsed field ablation (PFA) throughout the present disclosure. The IRE contemplated in the present disclosure is a non-thermal apoptosis-inducing technique that can be used for ablation of atrial arrhythmias. To ablate using IRE / PEF, a biphasic voltage pulse is applied to disrupt the cellular structure of the myocardium, resulting in apoptosis. The biphasic pulse is a non-sinusoidal waveform and can be tailored to target cells based on the electrophysiology of the cells. In contrast, to ablate using RF, a sinusoidal voltage waveform is applied to generate heat in the treatment area and indiscriminately heat all cells within the treatment area. Thus, IRE would be beneficial in reducing the possible complications known in ablation modalities or isolation modalities, having the ability to spare adjacent heat-sensitive structures or tissues. Additionally or alternatively, monophasic pulses can be utilized.

[0045] Electroporation can be induced by applying a pulsed electric field to biological cells to cause the reversible (temporary) or irreversible (permanent) generation of pores within the cell membrane. Cells have a transmembrane electrostatic potential that increases beyond the resting potential upon application of the pulsed electric field. The transmembrane electrostatic potential remains below the threshold potential, but electroporation is reversible, meaning that the pores can close when the applied pulsed electric field is removed and the cells can self-repair and survive. When the transmembrane electrostatic potential increases beyond the threshold potential, electroporation is irreversible and the cells become permanently permeable. As a result, the cells die due to loss of homeostasis and typically die by apoptosis, leaving little or no scarring. Generally, different types of cells have different threshold potentials. For example, cardiac cells have a threshold potential of about 500 V / cm, while bone has a threshold potential of 3000 V / cm. These differences in threshold potential allow IRE to selectively target tissues based on the threshold potential.

[0046] The techniques of the present disclosure include systems and methods for applying an electrical signal from a catheter electrode disposed in the vicinity of myocardial tissue to generate ablation energy for ablating the myocardial tissue. In some embodiments, the systems and methods can be effective to ablate target tissue by inducing irreversible electroporation. In some embodiments, the present systems and methods can be effective to induce reversible electroporation as part of a diagnostic procedure. Reversible electroporation occurs when the electricity applied at the electrodes is below the electric field threshold of the target tissue, which allows the cells to repair. Reversible electroporation does not kill the cells but allows a physician to observe the effect of reversible electroporation on the electrical activation signal in the vicinity of the target location. Exemplary systems and methods for reversible electroporation are disclosed in U.S. Patent Application Publication No. 2021 / 0162210, which is incorporated herein by reference in its entirety.

[0047] The effectiveness of a pulsed electric field, as well as a pulsed electric field that induces reversible electroporation and / or irreversible electroporation, can be affected by the physical parameters of the system and the biphasic pulse parameters of the electrical signal. The physical parameters can include electrode contact area, electrode spacing, electrode shape, and the like. The examples presented herein generally include physical parameters adapted to effectively induce reversible and / or irreversible electroporation. The biphasic pulse parameters of the electrical signal can include voltage amplitude, pulse duration, pulse phase delay, inter-pulse delay, total application time, delivered energy, and the like. In some examples, the parameters of the electrical signal can be adjusted to induce both reversible electroporation and irreversible electroporation when the same physical parameters are provided. Examples of various systems and methods of ablation including IRE are presented in U.S. Patent Application Publication Nos. 2021 / 0169550(A1), 2021 / 0169567(A1), 2021 / 0169568(A1), 2021 / 0161592(A1), 2021 / 0196372(A1), 2021 / 0177503(A1), and 2021 / 0186604(A1), the entireties of each of which are incorporated herein by reference.

[0048] The following description relates to various exemplary configurations of a medical probe (and / or portions thereof), related systems, and methods of use and / or manufacture thereof.

[0049] Enclosed planar catheter having a planar shift and support layer (Figs. 1-8) Refer to FIG. 1, which shows an exemplary catheter-based electrophysiological mapping and ablation system 1010. System 1010 includes a plurality of catheters that are percutaneously inserted by physician 24 through the vasculature of patient 1023 into a chamber or vascular structure of heart 12. Typically, a delivery sheath catheter is inserted into the left atrium or right atrium near the desired location in heart 1012. Thereafter, a plurality of catheters can be inserted into the delivery sheath catheter to reach the desired location. The plurality of catheters may include catheters dedicated to sensing intracardiac electrogram (IEGM) signals, catheters dedicated to ablation, and / or catheters dedicated to both sensing and ablation. An exemplary catheter 1014 configured to sense IEGM is illustrated herein. Physician 1024 contacts catheter shaft 1090 (i.e., multi-layer end effector 10100) having the distal tip of catheter 1014 with the heart wall to sense a target site within heart 1012. For ablation, physician 1024, as above, moves the distal end of the ablation catheter to the target site for ablation.

[0050] Catheter 1014 is an exemplary catheter that optionally distributes across end effector 10100 coupled to catheter shaft 1090 and includes one, preferably a plurality of electrodes 1026 configured to sense IEGM signals, as described in more detail below. Catheter 14 may additionally include a position sensor embedded within or near end effector 10100 to track the position and orientation of end effector 10100. Optionally and preferably, the position sensor is a magnetic-based position sensor that includes a plurality of magnetic coils for sensing three-dimensional (3D) position and orientation.

[0051] Magnetic-based position sensors can operate with a position pad 1025 that includes a plurality of magnetic coils 1032 configured to generate a magnetic field within a predetermined workspace. The real-time position of the end effector 10100 of the catheter 1014 can be tracked based on the magnetic field generated by the position pad 1025 and sensed by the magnetic-based position sensors. Details of magnetic-based position sensing techniques are described in U.S. Patent Nos. 5,391,199, 5,443,489, 5,558,091, 6,172,499, 6,239,724, 6,332,089, 6,484,118, 6,618,612, 6,690,963, 6,788,967, 6,892,091, each of which is incorporated herein by reference.

[0052] System 1010 includes one or more electrode patches 1038 disposed for contact with the skin on patient 1023 to establish position referencing of the position pad 1025 and impedance-based tracking of the electrodes 1026. For impedance-based tracking, current is directed to the electrodes 1026 and sensed at the electrode-skin patches 1038, whereby the position of each electrode can be triangulated via the electrode patches 1038. Details of impedance-based position tracking techniques are described in U.S. Patent Nos. 7,536,218, 7,756,576, 7,848,787, 7,869,865, and 8,456,182, each of which is incorporated herein by reference.

[0053] Recorder 1011 displays an electrocardiogram 1021 captured by the body surface ECG electrodes 1018 and an intracardiac electrogram (IEGM) captured by the electrodes 1026 of the catheter 1014. Recorder 1011 may include pacing capabilities for pacing the rhythm of the heart and / or may be electrically connected to an independent pacer.

[0054] System 1010 may include an ablation energy generator 1050 adapted to deliver ablation energy to one or more electrodes 1026 at a distal tip of a catheter configured to ablate. The energy generated by ablation energy generator 1050 may include radiofrequency (RF) energy, pulsed-field ablation (PFA) energy, or a combination thereof, including unipolar or bipolar high-voltage DC pulses that may be used to effect irreversible electroporation (IRE), but is not limited thereto.

[0055] A patient interface unit (PIU) 1030 is an interface configured to establish electrical communication between a catheter, an electrophysiology device, a power source, and a workstation 1055 that controls the operation of system 1010. The electrophysiology devices of system 1010 may include, for example, a plurality of catheters, position pads 1025, body surface ECG electrodes 1018, electrode patches 1038, ablation energy generator 1050, and recorder 1011. Optionally and preferably, PIU 1030 additionally includes processing capabilities for implementing real-time calculations of catheter position and performing ECG calculations.

[0056] The workstation 1055 includes a memory, a processor unit having a memory or storage device loaded with appropriate operating software, and a user interface function. The workstation 1055 optionally provides a plurality of functions including: (1) modeling the endocardial anatomical structure in three dimensions (3D) and rendering it to display a model or anatomical map 1020 on a display device 1027; (2) displaying on the display device 1027 a representative visual display or image of an activation sequence (or other data) compiled from the recorded electrogram 1021 overlaid on the rendered anatomical map 20; (3) displaying the real-time position and orientation of a plurality of catheters within the heart chamber; and (4) displaying on the display device 1027 a site of interest such as a location where ablation energy is being applied. One commercially available product embodying the elements of the system 1010 is available as the CARTO (trademark) 3 system, used with the energy generator TruPulse (trademark), commercially available from Biosense Webster, Inc., 31 Technology Drive, Suite 200, Irvine, CA 92618.

[0057] FIG. 2 provides an end effector 10100 according to an embodiment of the present disclosure to achieve enhancements of end effector characteristics such as ease of manufacture, cost reduction, and desired rigidity, mapping resolution, electrode contact with a target anatomical structure, and conformity of the end effector disclosed herein to flat, curved, irregular, and / or non-planar tissue surfaces found within the target anatomical structure. The end effector 10100 can include a flexible circuit 10110 including a plurality of electrodes 10112, and each electrode of the plurality of electrodes 10112 includes a contact surface 10112c. As used herein, the term "flexible circuit" includes thin film circuits, flexible printed circuit boards, polyimide, copper, LCP, nitinol substrates, TPU, silicone, thermosetting resins, or other polymer substrates illustrated and described in a technical reference incorporated herein by reference to Appendix attached to the priority-claimed application No. 63 / 615,600, including thin film deposition via lithography and etching processes onto a substrate. In some examples, the flexible circuits described herein can be made primarily of polyimide. In other examples, it can be made of any of biocompatible polyimide, glass-reinforced epoxy laminate material, copper, or graphene, either alone or in combination. In some examples, the electrodes described herein can include at least one mapping electrode and / or at least one ablation electrode, and can be configured to detect electrophysiological signals or transmit ablation energy AC or DC from an energy generator to tissue according to various ablation methods mentioned above, such as RF, IRE, etc.

[0058] The flexible circuit 10110 can be disposed on the insulating material 10120. The insulating material 10120 can be continuous with the contact surface 10112c such that only the contact surfaces 10112c of at least a portion of the plurality of electrodes 10112 are exposed to the ambient environment. As used herein, the term "contact surface" includes a substantially flat surface and the portion of the electrode having an edge (single or plural) directly surrounding the flat surface. The electrodes 10112 can have a slightly rounded, rounded, or chamfered edge that contacts the tissue together with the substantially flat surface when the end effector 10100 is placed in contact with the tissue. As used herein, "ambient environment" refers to the organ in which the end effector 10100 is placed, or an external environment such as an operating room before being placed within a biological organ.

[0059] Note that not all of the electrodes on the end effector 10100 described herein need to be exposed through the insulating material 10120 because these unexposed electrodes can be used to sense far-field signals for noise reduction proximate to the tissue contact electrodes. Similarly, far-field signals, including noise or artifacts, can be reduced or canceled for the entire end effector having a reference electrode that does not contact the tissue and only contacts the blood. Perfusion can be provided using a perfusion port 10163a on one side and a perfusion port 10162b on the other side that are in fluid communication with a perfusion line (not shown) disposed within the catheter shaft 1090. Instead of a perfusion line separate from the catheter shaft 1090, a lumen can be formed by extrusion of the catheter shaft 90 to provide a lumen channel. Note that the port 10163a or 10162b can be configured to have sufficient diverter characteristics such that the perfusion fluid covers the mapping electrodes in the perfusion flow to prevent or reduce thrombus formation.

[0060] The flexible circuit 10110 can further include a framework 10130 that is continuous with or within the insulating material. In embodiments where the flexible circuit 10110 includes the framework 10130, the framework 10130 can be disposed directly on the flexible circuit 10110, and the insulating material 10120 is disposed neither wholly nor substantially between the two.

[0061] Stated another way, one aspect of the present disclosure provides an end effector 10100 having a planar framework 10130 that bisects two flat thermoformed portions 10120a, 10120b of a flexible insulator 10120, with at least one flexible circuit 10110 disposed on one side of the framework 10130 and a contact surface 10112c of an electrode 10112 extending to or slightly beyond the outer surface of the flexible insulator 10120. In additional or alternative examples, the contact surface 10112c of the electrode 10112 may be slightly recessed, and there may be an opening through the insulating material 10120 to ensure that the electrode 10112 is exposed.

[0062] FIG. 3 shows an exploded view of the end effector 10100, with its components disassembled vertically along the vertical axis 10V-V. The flexible circuit 10110 can be a first flexible circuit 10110, and the plurality of electrodes 10112 can be a first plurality of electrodes 10112, with each first electrode 10112 including a first contact surface 10112c. The end effector 10100 can further include a second flexible circuit 10140 having a second plurality of electrodes 10142. The second flexible circuit 10140 can be spaced apart from the first flexible circuit 10110, but each electrode of the second plurality of electrodes 10142 can have a second contact surface 1010142c.

[0063] In an embodiment having a first flexible circuit 10110 and a second flexible circuit 10140, the insulating material 10120 can be disposed between the first flexible circuit 10110 and the second flexible circuit 10140. However, the insulating material 10120 can be continuous with the second contact surface 1010142c such that only the contact surface 1010142c of each second electrode 10142 is exposed to the surrounding environment, in a manner similar to that in which the first electrode 10112 is disposed within the insulating material and exposed through the insulating material.

[0064] The electrodes 10112, 10142 can sense or receive signals generated by tissue or conduct AC or DC energy from an energy generator to the tissue. In some embodiments, there are about 92 electrodes. In some embodiments, there are about 48 electrodes. In some embodiments, there are about 64 electrodes. In some embodiments, there are about 72 electrodes. In some embodiments, there are about 98 electrodes. Details of the spacing of each pair of electrodes relative to the spacing between separate sets of electrode pairs can be found in U.S. Provisional Patent Application No. 63 / 406,673, filed on September 14, 2022, and are included in the appendix included in the corresponding application, Serial No. 63 / 615,600, which is a priority reference application.

[0065] An example where the end effector 10100 includes a framework 10130 disposed between the first flexible circuit 10110 and the second flexible circuit 10140.

[0066] The framework 10130 can be a component of the end effector 10100 that is separated and distinguished from the first flexible circuit 10110 and disposed adjacent to the first flexible circuit 10110. In this case, the insulating material 10120 can be further disposed between the framework 10130 and the second flexible circuit 10140. The framework 10130 can be formed from a planar or cylindrical stock of material using any suitable method. For example, the framework 10130 can be formed by cutting, laser cutting, stamping, etc.

[0067] The insulating material 10120 can include a first insulating material sheet 10120a and a second insulating material sheet 10120b, and these insulating material sheets are integrally fused in proximity to the framework 10130 to form a single continuous substantially planar insulating block 10120. This insulating material 10120 also serves to enhance the non-invasive nature of the end effector 10100 and to protect the object from sharp edges. The insulating material 10120 can include a polymer. The insulating material 10120 can be thermoformed around at least a portion of the first flexible circuit 10110, the second flexible circuit 10140, and the framework 10130. The polymer can include thermoplastic polyurethane (TPU) or other thermoforming or shaping materials suitable for such thermoforming.

[0068] Furthermore, although the insulating material 10120 is shown as being flat in these figures, the insulating material 10120 can be shaped, corrugated, undulated, raised, recessed, convexed, or otherwise configured such that the overall outer shape of the insulating material 10120 provides physical and / or mechanical properties such as rigidity and flexure along a plurality of axes required by the end effector 10100 mentioned above.

[0069] FIG. 4A shows a cross-section obtained as shown in FIG. 3. The first contact surface 10112c is positioned substantially parallel to the first outer surface 10122a of the insulating block 10120. The first plurality of electrodes 10112 extend perpendicularly and outwardly from the first outer surface by a first distance. Similarly, the second contact surface 10142c can be positioned substantially parallel to the second outer surface 10122b of the insulating block 10120 and extend substantially perpendicularly and outwardly from the second outer surface by a second distance.

[0070] FIG. 4B shows a similar cross-section obtained from an exemplary end effector 10100 that does not have the second flexible circuit 10140. That is, the end effector of FIG. 4B has electrodes on only one side (single-sided end effector) as compared to the end effector of FIG. 4A (or double-sided end effector) that has electrodes on both sides. FIG. 4C shows a modification of FIG. 4B in which the framework 10130 is not encapsulated within the insulating material and is disposed outside the insulating material 10120. Note that although the cross-section of the framework 10130 is shown as rectangular, the framework 10130 is not limited to such a cross-section and any suitable cross-section can be utilized.

[0071] FIG. 4D is similar to the cross-section of FIG. 4A but shows a cross-section from an exemplary end effector 10100 that does not have the framework 10130. Note that in embodiments such as FIG. 4D, the insulating material 10120 may have additional strength, or may be formed thicker, or may not be, as compared to the insulating material 10120 of the example that has the framework 10130. The additional strength of the insulating material 10120 may be to compensate for the absence of the framework 10130.

[0072] Importantly, the end effector 10100 having flush or outwardly protruding electrode contact surfaces 10112c, 10142c can be manufactured without the need to remove material to expose the electrode contact surfaces 10112c, 10142c via the methods and / or fixtures described in more detail below.

[0073] In other embodiments, the first contact surface 10112c can be located substantially in the same plane as the first outer surface 10122a of the insulating block 10120, and the second contact surface 10142c can be located in the same plane as the second outer surface 10122b of the insulating block 10120.

[0074] FIG. 5A is an exploded perspective view of an end effector 10100 with support layers (e.g., a first support layer 10302 and a second support layer 10304) according to the techniques of the present disclosure. The end effector 10100 shown in FIG. 5A is substantially similar to that shown and described with respect to FIG. 3, but support layers 10302, 10304 are added. By suspending flexible circuits such as flexible circuit 10110 and second flexible circuit 10140 within an insulating material 10120 such as a polymer matrix, the flexible circuits can maintain a degree of independence from each other. Introducing one or more support layers 10302, 10304 into the insulating material 10120 enables the end effector 10100 to utilize the different properties of different types of materials while maintaining independence from the flexible circuits and from any structural metallic components (e.g., framework 10130). Note that the support layers 10302, 10304 are shown in FIG. 5A as being “above” respective insulating materials 10120a, 10120b, but it will be understood that the support layers 10302, 10304 can be placed at any number of positions within or on (in contact with) the insulating materials 10120a, 10120b.

[0075] Materials for the support layers 10302, 10304 can include, for example, thermoplastic polyurethane (TPU), polyimide, polytetrafluoroethylene, ethylene tetrafluoroethylene, silicone, siloxane, and similar materials or polymers, or combinations thereof. The support layers 10302, 10304 can enable the end effector 10100 to remain flexible while also providing support by tension to prevent excessive stretching of the flexible circuits. In some embodiments, the support layers 10302, 10304 can be mesh polymers, thereby providing the flexibility required for the end effector 10100 while also providing the aforementioned stretch resistance.

[0076] Referring now to FIG. 5B, the figure shows an exemplary end effector 10100 that includes two separate support layers 10302, 10304. The first support layer 10302 is disposed (i) within a first sheet 10120a of insulating material and (ii) between the framework 10130 and an electrode 10112 of the end effector 10100 on the side of the framework 10130. The second support layer 10304 is disposed (i) within a second sheet of insulating material 10120b and (ii) between the framework 10130 and an electrode 10112 of the end effector 10100 on the side opposite the framework 10130. This configuration can provide robust axial support for the flexible circuit. However, in some examples, a support layer may be required only on one side of the framework 10130 to provide the necessary support for the flexible circuit. For example, FIG. 5C shows an exemplary end effector 10100 having electrodes 10112 on both sides of the end effector, but the device includes a single support layer 10302 disposed between the framework 10130 and one surface of the end effector that includes the electrode 10112. As shown in FIGS. 5D and 5E and as described above with respect to FIG. 4B, the end effector 10100 may include electrodes on only one surface. In view of this, in one example, a single support layer 10302 can be disposed between the framework 10130 and a first outer surface 10122a having an electrode (see FIG. 5D). In other embodiments, a single support layer 10302 can be disposed between the framework 10130 and a surface without an electrode on the side opposite the framework 10130 (see FIG. 5E).

[0077] Referring now to FIGS. 6A - 6F, the examples shown therein include a flexible circuit having a planar shift along its longitudinal axis 10L - L (see FIG. 3 for reference). For example, each of these examples has a flexible circuit (e.g., a first flexible circuit 10110 and a second flexible circuit 10140) disposed longitudinally along an insulating material (e.g., insulating materials 10120a, 10120b), at least partially disposed within the insulating material, and further, the flexible circuit is arranged such that a first portion of the flexible circuit is continuous with a first plane and a second portion of the flexible circuit is continuous with a second plane, the first plane being at a first distance from the framework 10130 and the second plane being at a second distance from the framework 10130, the second distance being less than the first distance. The above - described shift in the plane can be localized in a region known to experience tight bending radii when traversed through a blood vessel or an outer sheath (e.g., the tubular member 10230 of FIG. 8). Shifting the flexible circuit from the outside of the insulating materials 10120a, 10120b (where at least a portion of the electrodes is exposed) to the inside of the insulating materials 10120a, 10120b (where tight bending occurs) can ensure that the layers of the flexible circuit remain intact. Shifting the flexible circuit plane closer to a neutral axis (e.g., the framework 10130 if the end effector 10100 is centrally disposed as in FIGS. 6A - 6F) can limit the amount of stress and strain from tension and compression on the circuit. This shift can also enable the entire end effector 10100 to experience tighter bending while the bending experienced by the flexible circuit(s) is slightly less tight.

[0078] FIG. 6A shows an exemplary end effector 10100 having two flexible circuits 10110, 10140 that extend from a surface-exposed electrode 10120b into the insulating materials 10120a, 10120b and then return to another surface-exposed electrode 10120b. First, referring to the upper flexible circuit in FIG. 6A, which is the first flexible circuit 10110, the flexible circuit 10110 extends from a surface electrode in a first plane 10320, then passes through the insulating material 10120a to reach a second plane 10322, and then returns to the surface electrode in the first plane 10320. In this embodiment, the flexible circuit 10110 is in the shape of a triangular wave, where (i) the trough of the flexible circuit 10110 is the second plane 10322, (ii) the peak is at the surface electrode 10112, and (iii) the peak and the trough are connected by an inclined portion 10344.

[0079] The second flexible circuit 10140 is substantially the same as the above on the other side of the end effector 10100. For example, the second flexible circuit 10140 extends from a surface electrode in a fourth plane 10326, then enters the insulating material 10120b, reaches a third plane 10324, and then returns to the surface electrode in the fourth plane 10326.

[0080] Furthermore, in the embodiment shown in FIG. 6A, the plane within the end effector 10100 closer to the framework 10130 is at a distance from the framework 10130. In other words, the first outer surface 10122a is at a first height 10310 from the framework 10130, and thus, in this embodiment, the first distance 10328 between the framework 10130 and the first plane 10320 is equal to the first height 10310. The second outer surface 10122b is at a second height 10312 from the framework 10130, and thus, in this embodiment, the second distance 10332 between the framework 10130 and the fourth plane 10326 is equal to the second height 10312. However, the embedded planes are separated from the framework 10130 such that there is a third distance 10330 between the framework 10130 and the second plane 10322 and a fourth distance 10332 between the framework 10130 and the third plane 10324. The third distance 10330 and the fourth distance 10334 are greater than zero and maintain a constant gap between the framework 10130 and the flexible circuits 10110, 10140.

[0081] FIG. 6B shows a structure similar to that shown in FIG. 6A, but instead of the flexible circuits 10110, 10140 having a pure triangular wave pattern, the flexible circuits 10110, 10140 extend into their respective insulating materials 10120a, 10120b in the angled sections 10344, then extend over a length parallel to the framework 10130, and then return at an angle towards the surface electrodes 10112. In this case, the first flexible circuit 10110 includes a first inner planar section 10336 that extends over a length parallel to the framework 10130. The second flexible circuit 10140 includes a second inner planar section 10340 that extends over a length parallel to the framework 10130. The first inner planar section 10336 is embedded in the first insulating material 10120a within the second plane 10322, and the second inner planar section 10340 is embedded in the second insulating material 10120b within the third plane 10324. In the embodiment shown in FIG. 6B, the embedded planes 10322, 10324 are separated from the framework 10130 such that a certain gap exists between the framework 10130 and the flexible circuits 10110, 10140. For example, the third distance 10330 between the framework 10130 and the second plane 10322 is greater than 0, and the fourth distance 10334 between the framework 10130 and the third plane 10324 is greater than 0.

[0082] FIG. 6C shows a structure similar to that shown in FIG. 6B, but instead of there being a gap between the framework 10130 and the embedded planes 10322, 10324 (e.g., the third distance 10330 and the fourth distance 10334), the embedded planes 10322, 10324 are continuous with the framework 10130. For example, the first inner planar section 10336 extends along the length of the framework 10130 in direct contact with or in proximity to the framework 10130, and the second inner planar section 10340 extends along the length of the framework 10130 in direct contact with or in proximity to the framework 10130.

[0083] FIG. 6D shows a structure similar to that shown in FIGS. 6B and 6C, where each circuit has a longitudinal cross-section along the outermost plane. For example, referring first to the first sheet 10120a of insulating material, the first flexible circuit 10110 includes a first surface plane section 10338 that extends within the first plane 10320 parallel to the framework 10130 over a certain length. The first surface plane section 10338 may be embedded in the insulating material 10120a as shown, or partially embedded therein, or the first surface plane section 10338 may extend along the first outer surface 10122a. The first surface plane section 10338 enables two or more electrodes on the first outer surface 10122a to be connected to the first surface plane section 10338 before the first flexible circuit 10110 extends inwardly toward the second plane 10322. Next, referring to the second sheet 10120b of insulating material, the second flexible circuit 10140 includes a second surface plane section 10342 that extends within the fourth plane 10326 parallel to the framework 10130 over a certain length. The second surface plane section 10342 may be embedded in the insulating material 10120a as shown, or partially embedded therein, or the second surface plane section 10342 may extend along the second outer surface 10122b. The second surface plane section 10342 enables two or more electrodes on the second outer surface 10122b to be connected to the second surface plane section 10342 before the second flexible circuit 10140 extends inwardly toward the fourth plane 10324.

[0084] Referring to the bend between the planar section (e.g., sections 10338 and 10342) and the angled section 10344, the radius of curvature 10346 therebetween can be made long to prevent the crimping of the flexible circuit. For example, the angle of the angled section can change as the first portion (e.g., the surface planar section) bends or moves relative to the second section (e.g., the inner planar section). The larger the radius of curvature 10346, the more slack the flexible circuits 10110, 10140 can have to move without crimping. However, in some embodiments, as shown in FIG. 6E, one or more flexible circuits 10110, 10140 may have a corrugated profile in or at least partially within the insulating material(s) 10120a, 10120b. Similar to the example described above, the corrugated profile of the flexible circuit can have peaks and valleys. Referring to the first flexible circuit 10110 (at the top of the end effector 10100 shown in FIG. 6E), the "peaks" of the corrugated profile extend to the exposed or at least partially exposed electrodes 10112. Thus, the first plane 10320 of the "peak" is along or proximate to the first outer surface 10122a. The "valleys" of the first flexible circuit 10110 are in a second plane 10322 that can contact the framework 10130, or as shown, the third distance 10330 can be made greater than 0 to provide a gap between the first flexible circuit 10110 and the framework 10130. Referring to the second flexible circuit 10140 (at the bottom of the end effector 10100 shown in FIG. 6E), the "valleys" of the corrugated profile extend to the exposed or at least partially exposed electrodes 10142. Thus, the fourth plane 10326 of the "valley" is along or proximate to the second outer surface 10122b. The "peaks" of the second flexible circuit 10140 are in a third plane 10324 that can contact the framework 10130, or as shown, the fourth distance 10334 can be made greater than 0 to provide a gap between the second flexible circuit 10140 and the framework 10130.

[0085] Figures 6E and 6F show substantially the same end effector 10100, but the two designs have different arrangements of the electrodes 10120b. For example, in Figure 6E, the first plurality of electrodes 10112 are aligned directly opposite the second plurality of electrodes 10142. In Figure 6F, the first position of the first plurality of electrodes 10112 is longitudinally offset along the length of the end effector 10110 from the second position of the second plurality of electrodes 10142. This offset of the electrodes 10120b can provide increased and / or uniform surface area contact with the target tissue.

[0086] As will be appreciated, any feature of the exemplary end effector 10100 described herein can be combined, as necessary, with any of the other features to improve contact with the target tissue while at the same time providing operability and strength. Figure 7 provides an example of such a combination of features, showing an end effector 10100 having a first flexible circuit 10110 extending from a surface electrode 10112 in a first plane, then into an insulating material 10120a to a second plane, then back to the surface electrode 10112 in the first plane (as shown, for example, in Figure 6A). In this example, the insulating material 10120a includes a first support layer 10302 embedded therein, which first support layer 10302 can be substantially similar to the first support layer described above with reference to Figure 5A. The end effector 10100 of Figure 7 also includes a second flexible circuit 10140, which extends from a surface electrode 10142 in a fourth plane (as shown, for example, in Figure 6A), then into the insulating material 10120b to a third plane, then back to the surface electrode 10142 in the fourth plane. In this example, the insulating material 10120b includes a second support layer 10304 embedded therein, which second support layer 10304 can be substantially similar to the second support layer described above with reference to Figure 5A.

[0087] The present disclosure provides a catheter assembly 10200 as shown in FIG. 8, which may include a tubular member 10230 configured to extend along a longitudinal axis 10L-L and deliver an end effector 10100 outside a sheath 10210. A physician 1024 can operate the catheter 200 using a handle 10220. Appropriate examples of the catheter assembly 10200 and its sub-components, such as the handle 10220, the sheath 10210, the tubular member 10230, and others not mentioned herein, are described in U.S. Patent Application Publication No. 2021 / 0369339, which is incorporated herein by reference and is attached to the appendix of U.S. Patent Application No. 63 / 615,600, which is a priority-claimed application.

[0088] End Effector with Offset Flexible Circuit (FIGS. 9-12B) Refer to FIG. 9, which shows an exemplary catheter-based electrophysiology mapping and ablation system 2010. The system 2010 includes a plurality of catheters that are percutaneously inserted by a physician 2024 through the vasculature of a patient 2023 into a chamber or vascular structure of the heart 2012. Typically, a delivery sheath catheter is inserted into the left atrium or right atrium near a desired location in the heart 2012. Thereafter, a plurality of catheters can be inserted into the delivery sheath catheter to reach the desired locations. The plurality of catheters may include a catheter dedicated to sensing intracardiac electrogram (IEGM) signals, a catheter dedicated to ablation, and / or a catheter dedicated to both sensing and ablation. An exemplary catheter 2014 configured to sense IEGM is illustrated herein. The physician 2024 contacts a catheter shaft 2090 (i.e., an end effector 20100) having a distal tip of the catheter 2014 with the heart wall to sense a target site within the heart 2012. For ablation, the physician 2024, as described above, moves the distal end of the ablation catheter to the target site for ablation.

[0089] Catheter 2014 is an exemplary catheter that includes one or preferably a plurality of electrodes 2026 that are optionally distributed over an end effector 20100 coupled to a catheter shaft 2090 and configured to sense IEGM signals, as described in more detail below. The catheter 2014 may additionally include a position sensor embedded within or near the end effector 20100 to track the position and orientation of the end effector 20100. Optionally and preferably, the position sensor is a magnetic-based position sensor that includes a plurality of magnetic coils for sensing three-dimensional (3D) position and orientation.

[0090] The magnetic-based position sensor may operate with a position pad 2025 that includes a plurality of magnetic coils 2032 configured to generate a magnetic field within a predetermined workspace. The real-time position of the end effector 20100 of the catheter 2014 can be tracked based on the magnetic field generated by the position pad 2025 and sensed by the magnetic-based position sensor. Details of magnetic-based position sensing techniques are described in U.S. Patent Nos. 5,391,199, 5,443,489, 5,558,091, 6,172,499, 6,239,724, 6,332,089, 6,484,118, 6,618,612, 6,690,963, 6,788,967, 6,892,091, each of which is incorporated herein by reference.

[0091] System 2010 includes one or more electrode patches 2038 arranged for contact with the skin on patient 2023 to establish position referencing of position pad 2025 and impedance-based tracking of electrodes 2026. For impedance-based tracking, current is directed to electrodes 2026 and sensed at electrode-skin patches 2038, whereby the position of each electrode can be triangulated via electrode patches 2038. Details of impedance-based position tracking techniques are described in U.S. Patent Nos. 7,536,218, 7,756,576, 7,848,787, 7,869,865, and 8,456,182, each of which is incorporated herein by reference.

[0092] Recorder 2011 displays an electrogram 2021 captured by body surface ECG electrodes 2018 and an intracardiac electrogram (IEGM) captured by electrodes 2026 of catheter 2014. Recorder 2011 may include pacing capabilities for pacing the rhythm of the heart and / or may be electrically connected to an independent pacer.

[0093] System 2010 may include an ablation energy generator 2050 adapted to deliver ablation energy to one or more electrodes 2026 at the distal tip of a catheter configured to ablate. The energy generated by ablation energy generator 2050 may include radiofrequency (RF) energy, pulsed-field ablation (PFA) energy, such as unipolar or bipolar high voltage DC pulses that can be used to effect irreversible electroporation (IRE), or combinations thereof, but is not limited thereto.

[0094] The patient interface unit (PIU) 2030 is an interface configured to establish electrical communication between a catheter, an electrophysiology device, a power source, and a workstation 2055 that controls the operation of the system 2010. The electrophysiology devices of the system 2010 may include, for example, a plurality of catheters, position pads 2025, body surface ECG electrodes 2018, electrode patches 2038, an ablation energy generator 2050, and a recorder 2011. Optionally, and preferably, the PIU 2030 additionally includes processing capabilities to implement real-time calculation of the catheter's position and perform ECG calculations.

[0095] The workstation 2055 includes a memory, a processor unit having a memory or storage device loaded with appropriate operating software, and user interface functions. The workstation 2055 may optionally (1) model the endocardial anatomical structure in three dimensions (3D) and render it to display a model or anatomical map 2020 on a display device 2027; (2) display on the display device 2027 a representative visual display or image of an activation sequence (or other data) compiled from the recorded potential map 2021 superimposed on the rendered anatomical map 2020; (3) display the real-time position and orientation of a plurality of catheters within the heart chamber; and (4) display on the display device 2027 regions of interest such as locations where ablation energy is being applied. One commercially available product embodying the elements of the system 2010 is available as the CARTO (trademark) 3 system, commercially available from Biosense Webster, Inc., 31 Technology Drive, Suite 200, Irvine, CA 92618.

[0096] Figures 10A and 10C are schematic drawings showing the multi-layer end effector 20100 in a generally flat / plane-like form. To achieve the desired rigidity, mapping resolution, electrode contact with the target anatomical structure, and the compatibility of the end effector 20100 disclosed herein with flat tissue surfaces, curved tissue surfaces, irregular tissue surfaces, and / or non-planar tissue surfaces found in the target anatomical structure, the end effector 20100 has at least a planar spine framework 20110, flexible circuits (e.g., flexible circuits 20122, 20132, 20212, 20222), and an insulating material forming a substrate 20130. In some embodiments, the substrate 20130 can include a suitable substrate, such as a polymeric material, to ensure that the flexible circuits are coupled to the substrate 20130 and to ensure that sharp edges of the flexible circuits are not exposed.

[0097] The end effector 20100 can extend along the longitudinal axis 20180 from the proximal portion 20106 to the distal portion 20104. In some embodiments, the end effector 20100 includes one or more flexible circuits disposed on the substrate 20130 of the end effector 20100. The flexible circuit can extend along the longitudinal axis 20180 from the proximal portion 20106 to the distal portion 20104 of the end effector 20100. In some examples, the flexible circuit layer can be made primarily of polyimide. In other embodiments, it can be made of any of biocompatible polyimide, glass-reinforced epoxy laminate material, copper, or graphene, either alone or in combination. The flexible circuit layer(s) can include conductive traces. As used herein, the term "flexible circuit" includes thin-film deposition by lithography and etching processes onto substrates such as thin-film circuits, flexible printed circuit boards, polyimide, or even nitinol substrates. Each flexible circuit can include a plurality of electrodes provided on the distal portion 20104 of the end effector 20100. Electrical contacts corresponding to each electrode can be provided at the proximal portion of the circuit, and the circuit can be disposed at the proximal portion of the end effector. Traces provided within each circuit can provide electrical contacts that are in electrical communication with the electrodes of the circuit, such that the electrical contacts can transmit electrical signals between the electrodes.

[0098] In some embodiments, the substrate 20130 includes an insulating material. The frame 20110 of the end effector 20100 can be disposed within the substrate 20130 and can be substantially planar along the longitudinal axis 20180, such that the longitudinal axis 20180 is parallel or coincident with the plane of the frame 20110. The longitudinal axis 20180 can be parallel or coaxial with the longitudinal center of the frame 20110, such that the longitudinal axis equally divides the width 108 of the end effector. In some embodiments, the frame 20110 is formed from a flexible elastic material. By way of example, the frame 20110 can be formed from a shape memory alloy such as nickel-titanium, also known as nitinol, cobalt-chromium, stainless steel, and / or other alloys that exhibit pseudoelastic properties.

[0099] The substrate 20130 can be formed from an insulating material and can at least partially encapsulate and isolate the frame 20110 and the flexible circuit. The substrate 20130 can also serve to enhance the non-traumatic nature of the end effector 20100 and protect the object from sharp edges.

[0100] FIG. 10A shows a first side of an exemplary end effector 20100 that includes a first flexible circuit 20122 and a second flexible circuit 20132. In some embodiments, the first flexible circuit 20122 and the second flexible circuit 20132 are provided on a first side of a substrate 20130. In some embodiments, the first flexible circuit 20122 and the second flexible circuit 20132 are provided on the same side of the substrate 20130. In some embodiments, at a distal portion 20104 of the end effector 20100, the first flexible circuit 20122 is provided on an opposite side of the second flexible circuit 20132 with respect to a longitudinal axis 20180. In some embodiments, the first flexible circuit 20122 includes one or more electrodes 20151 provided on the distal portion 20104 of the end effector 20100 and one or more electrical contacts 20128 provided on a proximal portion 20126 of the first flexible circuit 20122 and corresponding to the one or more electrodes 20151. The electrodes 20151 and the electrical contacts 20128 of the first flexible circuit 20122 may be referred to as the first electrodes 20151 and the first electrical contacts 20128, respectively. In some embodiments, the second flexible circuit 20132 includes one or more electrodes 20152 provided on the distal portion 20104 of the end effector 20100 and one or more electrical contacts 20138 provided on a proximal portion 20136 of the second flexible circuit 20132 and corresponding to the one or more electrodes 20152. The electrodes 20152 and the electrical contacts 20138 of the second flexible circuit 20132 may be referred to as the second electrodes 20152 and the second electrical contacts 20138, respectively.

[0101] In some embodiments, to accommodate the small area of the end effector 20100, the first flexible circuit 20122 and the second flexible circuit are coplanar at the distal portion 20104 of the end effector 20100 and are stacked on top of each other at the proximal portion 20106 of the end effector 20100. In such an example, the proximal portion 20126 of the first flexible substrate 20122 may be stacked on top of the proximal portion 20136 of the second flexible substrate 20132 at the proximal portion 20106 of the end effector 20100. This configuration can be provided such that both the electrical contacts 20128 of the first flexible circuit 20122 and the electrical contacts 20138 of the second flexible circuit 20132 are disposed on the proximal portion 20106 of the end effector 20100.

[0102] FIG. 10C shows the second side of an exemplary end effector 20100 comprising a third flexible circuit 20212 and a fourth flexible circuit 20222. In some embodiments, the third flexible circuit 20212 and the fourth flexible circuit 20222 are provided on the second side of the substrate 20130. In some embodiments, the third flexible circuit 20212 and the fourth flexible circuit 20222 are provided on the same side of the substrate 20130. In some embodiments, at the distal portion 20104 of the end effector 20100, the third flexible circuit 20212 is provided on the opposite side of the fourth flexible circuit 20222 with respect to the longitudinal axis 20180. In some embodiments, the third flexible circuit 20212 comprises one or more electrodes 20251 provided on the distal portion 20104 of the end effector 20100 and one or more electrical contacts 20218 provided on the proximal portion 20216 of the third flexible circuit 20212 and corresponding to the one or more electrodes 20251. The electrodes 20251 and the electrical contacts 20218 of the third flexible circuit 20212 may be referred to as the third electrodes 20251 and the third electrical contacts 20218, respectively. In some embodiments, the fourth flexible circuit 20222 comprises one or more electrodes 20252 provided on the distal portion 20104 of the end effector 20100 and one or more electrical contacts 20228 provided on the proximal portion 20226 of the fourth flexible circuit 20222 and corresponding to the one or more electrodes 20252. The electrodes 20252 and the electrical contacts 20228 of the fourth flexible circuit 20222 may be referred to as the fourth electrodes 20252 and the fourth electrical contacts 20288, respectively.

[0103] FIG. 10B is a schematic depiction showing details of an exemplary electrode array provided on end effector 20100. In some embodiments, the electrodes 20150 of the end effector are arranged in pairs. Electrodes 20150 within each pair can be separated by a first predetermined longitudinal distance 20Lg. Each pair of electrodes can be separated from an adjacent pair of electrodes by a second predetermined longitudinal distance 20158. The second predetermined longitudinal distance 20158 can be greater than the first predetermined longitudinal distance 20Lg. In some embodiments, the first predetermined longitudinal distance 20Lg between electrodes 20150 of a pair of electrodes is about 100 microns. In some embodiments, the second predetermined longitudinal distance 20158 between adjacent pairs of electrodes 20150 is about 1300 microns. In some embodiments, each electrode 150 has a width 20153 of about 500 microns and a length 20154 of about 500 microns.

[0104] In some versions, the distance 20Lg of the space gap separating each electrode 20150 (also referred to herein as a microelectrode) of a pair is in the range of about 50 microns to about 300 microns. In some versions, the distance 20Lg of the space gap separating each microelectrode (20150) within a pair is in the range of about 100 to about 200 microns. In some versions, the distance Lg of the space gap separating each microelectrode 20150 within a pair is about 50 microns. Further, in some versions, each microelectrode 20150 itself may have a width 20153 in the range of about 50 to about 100 microns. Each pair of microelectrodes 20150 is separated from an adjacent pair of microelectrodes 20150 by a distance of about 5.0 mm, and each microelectrode 20150 has a width 20153 of about 50 microns and a length 20154 of about 2.56 mm. In some In this embodiment, the width 20153 of the microelectrode 20150 is equal to the width 20153 of the other microelectrode 20150 of the same pair of microelectrodes, and the length 20154 of the microelectrode 20150 is equal to the length 20154 of the other microelectrode 20150 of the same pair of microelectrodes. Therefore, in this embodiment, both microelectrodes 20150, 20150 have the same surface area (length 20154 * width 20153). In a preferred embodiment, the two microelectrodes 20150, 20150 are arranged such that the length 20154 extends parallel to the longitudinal axis 20180 of the structure to which the microelectrodes 20150, 20150 are attached, and the width 20153 extends substantially parallel to the longitudinal axis 20Le - 20Le of the electrode or substantially perpendicular to the longitudinal axis 20180 of the structure to which the microelectrodes 20150, 20150 are attached. The microelectrodes 20150, 20150 are positioned such that the microelectrodes 20150, 20150 are spaced apart from each other along the length of the structure to which the microelectrodes 20150, 20150 are attached, and a gap 20Lg extends between the two closest surfaces 20150a, 20150a of the microelectrodes. For the sake of convenience in naming this embodiment, the gap 20Lg is also interpreted as being substantially parallel to the longitudinal axis 20180 of the structure to which the microelectrodes 20150, 20150 are attached. The microelectrodes 20150, 20150 are rectangular in this embodiment, but the microelectrodes 20150, 20150 may alternatively have any other suitable shape.

[0105] Note that any arrangement of electrodes may require that the pairs of electrodes of the embodiments described herein follow the following empirical rules. (1) The length 20154 of the electrode must always be at least as large as the spacing gap 20Lg between the electrodes within the same pair, and (2) the ratio of the area of the spacing gap 20Ag to the surface area 20Ae of one electrode must be less than or equal to 1. Briefly stated, this can be rephrased as (1) 20154 ≧ 20Lg and (2) 20Ag / 20Ae ≦ 1. In some versions, the gap distance 20Lg can be determined by the product with the following conversion factors. -1 And the following conversion factors.

[0106] An exemplary frame 20110 of the end effector 20100 is shown in FIG. 10C. In some embodiments, the frame 20110 of the end effector 20100 is embedded in a substrate 20130. As shown, the frame 20110 can include a first spine 20112, a second spine 20114, a third spine 20116, and a fourth spine 20118 provided at the distal portion 20104 of the end effector 20100. The spines 20112, 20114, 20116, 20118 can extend along the longitudinal axis 20180 from a base 20119 provided at the proximal section 20106 of the end effector 20100. The spines 20112, 20114, 20116, 20118 can be provided to resist bending when a force, such as a torsional force, is applied. A gap can be provided between each of the spines to increase the flexibility of the frame. These forces can occur at various times during use, such as when inserted into an introducer. This design helps prevent the electrical interconnections on the flexible circuit from breaking.

[0107] In some embodiments, the distal portion of the first flexible circuit 20122 and the distal portion of the third flexible circuit 20212 can each include a loop disposed above the first spine and a loop disposed above the second spine, respectively. In some embodiments, the distal portion of the second flexible circuit 20132 and the distal portion of the fourth flexible circuit 20222 each comprise a second loop disposed above the third spine and a second loop disposed above the fourth spine.

[0108] Figures 11A and 11B are schematic depictions showing a multi-layer end effector 20300 in a generally flat / plane-like form according to an example of the technology of the present disclosure, where FIG. 11A is a front view of the end effector 20300 and FIG. 11B is a right side view thereof. In some embodiments, the end effector 20300 includes a first flexible circuit 20312, a second flexible circuit 20322, a third flexible circuit 20332, and a fourth flexible circuit 20342. In some embodiments, the first flexible circuit 20312 and the second flexible circuit 20322, and their corresponding electrodes 20311, 20321 are in the same plane and are provided on a first side of the substrate 20330, and the third flexible circuit 20332 and the fourth flexible circuit 20342 are in the same plane and are provided on a second side of the substrate 20330. Each circuit can include a proximal portion having electrical contacts corresponding to the electrodes of the circuit. For example, the first circuit 20312 includes a contact 20318 corresponding to the electrode 20311, and the third circuit includes a contact 20338 corresponding to the electrode 20331. The electrical contacts corresponding to the electrodes of each circuit can be provided at the proximal portion of the circuit. In some embodiments, the end effector 20300 is configured such that the proximal portion 20316 of the first circuit 20312 is provided on the same side of the substrate 20330 as the proximal portion 20336 of the third circuit 20332, and the proximal portion 20326 of the second circuit 20322 is provided on the same side of the substrate 20330 as the proximal portion 20346 of the fourth circuit 20342. As disclosed above, the proximal portions of the circuits may overlap. For example, the proximal portion 20316 of the first flexible circuit 20312 may be disposed on top of the proximal portion 20336 of the third circuit 20332, and the proximal portion 20346 of the fourth circuit 20342 may be disposed on top of the proximal portion 20326 of the second circuit 20342.

[0109] Figures 12A and 12B are schematic depictions showing a multi-layer end effector 20400 in a generally flat / planar form according to an example of the technology of the present disclosure, where Figure 12A is a front view of the end effector 20400 and Figure 12B is a right side view thereof. In some embodiments, the end effector 20400 comprises a first flexible circuit 20412 having an electrode 20411 disposed at the distal end of the end effector 20400. The end effector may further comprise a second flexible circuit 20422 having an electrode 20421 disposed proximal to the electrode 20411 of the first circuit. In some embodiments, the first circuit 20412 and the second circuit 20422 are in the same plane at the distal portion of the end effector 20400. In some embodiments, the proximal portion 20416 of the first circuit 20412 is provided on the side of the substrate 20430 opposite to the proximal portion 20426 of the second circuit 20422.

[0110] In some embodiments, the end effector 20400 further includes a third flexible circuit 20432 and a fourth flexible circuit 20442. In some embodiments, the third flexible circuit 20432 includes an electrode 20431 disposed at the distal end of the end effector 20400, and the fourth flexible circuit 20442 includes an electrode 20441 disposed proximal to the electrode 20431 of the third circuit. In some embodiments, the first flexible circuit 20412 and the second flexible circuit 20322 are in the same plane and are provided on the first side of the substrate 20430, and the third flexible circuit 20432 and the fourth flexible circuit 20442 are in the same plane and are provided on the second side of the substrate 20430. Each circuit can include a proximal portion having an electrical contact corresponding to the electrode of the circuit. For example, the first circuit 20412 includes a proximal portion 20416 having a contact 20418 corresponding to the electrode 20411, and the third circuit includes a proximal portion 20436 having a contact 20438 corresponding to the electrode 20431. The electrical contacts corresponding to the electrodes of each circuit can be provided at the proximal portion of the circuit. In some embodiments, the end effector 20300 is configured such that the proximal portion 20416 of the first circuit 20412 is provided on the same side of the substrate 20430 as the proximal portion 20436 of the third circuit 20432, and the proximal portion 20426 of the second circuit 20422 is provided on the same side of the substrate 20430 as the proximal portion 20446 of the fourth circuit 20442. As disclosed above, the proximal portions of the circuits may overlap. For example, the proximal portion 20416 of the first flexible circuit 20412 may be disposed on top of the proximal portion 20436 of the third circuit 20432, and vice versa. The proximal portion 20446 of the fourth circuit 20442 may be disposed on top of the proximal portion 20426 of the second circuit 20442, or vice versa. In some embodiments, the first and third circuits may collectively be referred to as the first circuit, and the second and fourth circuits may collectively be referred to as the second circuit.

[0111] Enclosed planar catheter having a position sensing coil (Figs. 13-20) Refer to FIG. 13 showing an exemplary catheter-based electrophysiological mapping and ablation system 3010. The system 3010 includes a plurality of catheters that are percutaneously inserted by a physician 3024 through the vasculature of a patient 3023 into a chamber or vascular structure of the heart 3012. Typically, a delivery sheath catheter is inserted into the left atrium or right atrium near a desired location in the heart 3012. Thereafter, a plurality of catheters can be inserted into the delivery sheath catheter to reach the desired location. The plurality of catheters may include a catheter dedicated to sensing intracardiac electrogram (IEGM) signals, a catheter dedicated to ablation, and / or a catheter dedicated to both sensing and ablation. An exemplary catheter 3014 configured to sense IEGM is illustrated herein. The physician 3024 contacts a catheter shaft 3090 (i.e., a multi-layer end effector 30100) having a distal tip of the catheter 3014 with the heart wall to sense a target site within the heart 3012. For ablation, the physician 3024, as described above, moves the distal end of the ablation catheter to the target site for ablation.

[0112] The catheter 3014 is an exemplary catheter that is optionally distributed over an end effector 30100 coupled to the catheter shaft 3090 and includes one, preferably a plurality of electrodes 3026 configured to sense IEGM signals, as described in more detail below. The catheter 3014 may further include a position sensor (shown in FIG. 14B) embedded within or near the end effector 30100 to track the position and orientation of the end effector 30100. Optionally and preferably, the position sensor is a magnetic-based position sensor that includes a plurality of magnetic coils for sensing three-dimensional (3D) position and orientation.

[0113] Magnetic-based position sensors can operate with a position pad 3025 that includes a plurality of magnetic coils 3032 configured to generate a magnetic field within a predetermined workspace. The real-time position of the end effector 30100 of the catheter 3014 can be tracked based on the magnetic field generated by the position pad 3025 and sensed by the magnetic-based position sensors. Details of magnetic-based position sensing techniques are described in U.S. Pat. Nos. 5,391,199, 5,443,489, 5,558,091, 6,172,499, 6,239,724, 6,332,089, 6,484,118, 6,618,612, 6,690,963, 6,788,967, 6,892,091, each of which is incorporated herein by reference.

[0114] System 3010 includes one or more electrode patches 3038 disposed for contact with the skin on patient 3023 to establish position referencing of the position pad 3025 and impedance-based tracking of the electrodes 3026. For impedance-based tracking, current is directed to the electrodes 3026 and sensed at the electrode-skin patches 3038, whereby the position of each electrode can be triangulated via the electrode patches 3038. Details of impedance-based position tracking techniques are described in U.S. Pat. Nos. 7,536,218, 7,756,576, 7,848,787, 7,869,865, and 8,456,182, each of which is incorporated herein by reference.

[0115] Recorder 3011 displays the electrogram 3021 captured by the body surface ECG electrodes 3018 and the intracardiac electrogram (IEGM) captured by the electrodes 3026 of the catheter 3014. Recorder 3011 may include pacing capabilities for pacing the rhythm of the heart and / or may be electrically connected to an independent pacer.

[0116] System 3010 may include an ablation energy generator 3050 adapted to deliver ablation energy to one or more electrodes 3026 at a distal tip of a catheter configured to ablate. The energy generated by ablation energy generator 3050 may include radiofrequency (RF) energy or pulsed-field ablation (PFA) energy, or a combination thereof, including unipolar or bipolar high-voltage DC pulses such that the energy can be used to effect irreversible electroporation (IRE), but is not limited thereto.

[0117] A patient interface unit (PIU) 3030 is an interface configured to establish electrical communication between a catheter, an electrophysiology device, a power source, and a workstation 3055 that controls the operation of system 3010. The electrophysiology devices of system 3010 may include, for example, a plurality of catheters, position pads 3025, body surface ECG electrodes 3018, electrode patches 3038, ablation energy generator 3050, and recorder 3011. Optionally and preferably, PIU 3030 additionally includes processing capabilities for implementing real-time calculation of catheter position and performing ECG calculations.

[0118] The workstation 3055 includes a memory, a processor unit having a memory or storage device loaded with appropriate operating software, and user interface functionality. The workstation 3055 optionally provides a plurality of functions including: (1) modeling the endocardial anatomical structure in three dimensions (3D) and rendering it to display a model or anatomical map 3020 on a display device 3027; (2) displaying on the display device 3027 a representative visual display or image of an activation sequence (or other data) compiled from a recorded electrogram 3021 superimposed on the rendered anatomical map 3020; (3) displaying the real-time position and orientation of a plurality of catheters within the heart chamber; and (4) displaying on the display device 3027 a site of interest such as a location where ablation energy is being applied. One commercially available product embodying the elements of the system 3010 is available as the CARTO (trademark) 3 system, commercially available from Biosense Webster, Inc., 31 Technology Drive, Suite 200, Irvine, CA 92618.

[0119] FIG. 14 is a schematic exploded view showing a portion of a multi-layer end effector 30100 that is generally flat / planar in form. To achieve the desired rigidity, mapping resolution, electrode contact with the target anatomical structure, and the compatibility of the end effector 30100 disclosed herein with flat, curved, irregular, and / or non-planar tissue surfaces found in the target anatomical structure, the end effector 30100 includes at least a flexible circuit layer 30110, a framework 30120, an insulating material 30130 including one or more flexible non-conductive layers 30130a, 30130b, and one or more position sensing loops 30140 stacked along a vertical axis 3062 that is substantially orthogonal to the longitudinal axis 3060 of the end effector. In FIG. 14, the flexible circuit 30110 is provided with a plurality of electrodes 30111 (e.g., generally planar electrodes), the contact surfaces of which face upward in the figure. Note that another flexible circuit 30110 may be provided below the framework 30120 having electrodes configured to face downward in the figure.

[0120] The end effector 30100 is shown exploded in an orthogonal direction along the vertical axis 3062. Only one side of the end effector 30100 (e.g., the upper side with respect to the orientation shown in FIG. 13) is shown, but as described above, the opposite side of the end effector (e.g., the lower side) may include other structures such as, but not limited to, insulating material, one or more additional flexible circuits, and one or more additional position sensing loops.

[0121] The flexible circuit 30110 can extend along the longitudinal axis 3060 from the proximal portion (i.e., the upper right section of FIG. 14) to the distal portion (i.e., the lower left section of FIG. 14) of the end effector 30100. In some examples, the flexible circuit layer 30110 can be made primarily of polyimide. In other embodiments, it can be made of any of biocompatible polyimide, glass-reinforced epoxy laminate material, copper, or graphene, either alone or in combination. The flexible circuit layer(s) can include conductive traces. As used herein, the term "flexible circuit" includes thin film circuits, flexible printed circuit boards, and thin film deposition by lithography and etching processes onto substrates such as polyimide or even nitinol substrates.

[0122] The framework 30120 is disposed within the insulating material 30130, is substantially planar along the longitudinal axis 3060, and is configured such that the longitudinal axis 3060 is parallel or coincident with the framework 30120. The framework 30120 can include a first side 30122 (forming a first plane) and an opposite second side 30124 (forming a second plane) with respect to the longitudinal axis 3060. The framework 30120 is also generally parallel to the plane defined by the flexible circuit 30110, and the planar electrodes 30111 are aligned along at least one of the first plane or the second plane, with each electrode being spaced apart from the first plane or the second plane. In the embodiment shown in FIG. 14, a plurality of position sensing loops 30140 are provided that are sandwiched between and generally parallel to the flexible circuit 30110 and the spine framework 30120. In some embodiments, the framework 30120 is formed from a flexible elastic material. By way of example, the framework can be formed from a shape memory alloy such as nickel-titanium, also known as nitinol, cobalt-chromium, stainless steel, and / or other alloys that exhibit pseudoelastic and / or superelastic properties.

[0123] The first non-conductive flexible layer 30130a can at least partially enclose and separate one side of the framework 30120 and the sensing loop 30140. Further, the second non-conductive flexible layer 30130b can at least partially enclose and separate the flexible circuit 30110 and the other side of the sensing loop 30140. This insulating material 30130 also serves to enhance the non-invasive nature of the end effector 30100 and to protect the object from sharp edges.

[0124] Each sensing loop 30140 has one or more coils 30140a, and each of the one or more coils 30140a has a surface area (i.e., the area enclosed by each coil 30140a of the loop 30140). Further, each sensing loop 30140 has a cumulative surface area that is the product of the number of its coils 30140a and the area enclosed by a single coil 30140a (in other words, the sum of the surface areas of all the coils within the loop 30140). The amount of energy received by each sensing loop 30140 is proportional to the size of the coil 30140a (e.g., proportional to the cumulative surface area of the coil 30140a) when exposed to a magnetic field. The cumulative surface area of each loop 30140 defines the cumulative position sensing area of that loop 30140. In order for the magnetic field to act to most effectively track the position of the end effector 30100, the cumulative surface area in the technology of the present disclosure is from about 100 to 300 square millimeters. In some embodiments, the cumulative surface area is at least about 200 square millimeters.

[0125] Referring to FIGS. 14 - 16, the sensing loop 30140 of this example includes a central loop 30142 and a pair of side loops 30144, 30146. In some embodiments (e.g., as seen in FIG. 14), the sensing loops 30140 can be in the same plane. As best seen in FIGS. 14 and 16, the central loop 30142 partially overlaps both the first loop 30144 and the second loop 30146 when viewed in a direction along the vertical axis 3062. However, in other embodiments, it will be understood that the loops 30142, 30144, 30146 do not overlap, provided that the cumulative surface area of each of the loops 30142, 30144, 30146 falls within the above - mentioned range.

[0126] As discussed above, each of the loops 30142, 30144, 30146 is configured to generate an electric current when subjected to a magnetic field. Each of the loops 30142, 30144, 30146 can include a conductive material formed into a loop of one or more coils 30140a. The loops 30142, 30144, 30146 can be provided with conducting wires for conducting the current induced on each of the loops 30142, 30144, 30146 to the PIU 3030. As will be understood, it is possible to detect the position of the plurality of loops 30142, 30144, 30146 by attaching them to the end - effector 30100. In this way, the physician 3024 can more accurately determine the position of the end - effector 110 before using the end - effector 30100 for the purposes described above.

[0127] In addition to the above, the central loop 30142 is disposed above the longitudinal axis 3060 when viewed in the direction along the vertical axis 3062 (see particularly FIG. 16). In this embodiment, the central loop 30142 is substantially parallel to the longitudinal axis 3060 and is disposed within a plane extending along the longitudinal axis 3060 so as to have a design symmetric with respect to the longitudinal axis 3060. In an alternative, the central loop 30142 need not necessarily be symmetric with respect to the longitudinal axis 3060. The central loop 30142 is also disposed above a region near the distal portion 30130a1 of the insulating material 30130 (as illustrated by its extent with respect to the first non-conductive flexible layer 30130a in FIGS. 14 and 16). The central loop 30142 conforms to the configuration of the legs / sections 30130a3 of the first non-conductive flexible layer 30130a.

[0128] In this embodiment, a pair of side loops 30144, 30146 (referred to herein as the first side loop 30144 and the second side loop 30146) are disposed generally symmetrically with respect to the longitudinal axis 3060. In other embodiments, the side loops 30144, 30146 need not necessarily be symmetric. Each is disposed within one plane. In the illustrated example of FIG. 14, the side loop planes are coplanar with each other and are parallel or coplanar with the plane of the central loop 30142 (as well as the plane of the flexible circuit 30110 and the plane of the framework 30120). Each side loop 30144, 30146 extends from the proximal portion 30130a1 to the distal portion 30130a2 of the insulating material 30130 as illustrated by their extent with respect to the first non-conductive flexible layer 30130a in FIG. 16. The pair of side loops 30144, 30146 conforms to the configuration of the legs / sections 30130a3 of the first non-conductive flexible layer 30130a.

[0129] In addition to the above, each coil 30142a of the central loop 30140 has a central loop surface area 30143, while each coil 30140a of the first side loop 30144 has a first side loop surface area 30145, and each coil 30140a of the second side loop 30146 has a second side loop surface area 30147. For each loop 30142, 30144, 30146, the product of the loop surface area 30143, 145, 147 and the number of its coils results in the aforementioned cumulative surface area of the loops 30142, 30144, 30146.

[0130] In some embodiments, the surface area 30143 of one coil 30140a of the central loop 30142 is at least about 69 square millimeters. In some embodiments, the surface area 30145 of one coil 30140a of the first side loop 30144 and the surface area 30147 of one coil 30140a of the second side loop 30146 are each at least 59 square millimeters. Since each loop is wound to have a plurality of coils 30140a, the cumulative surface area of each loop 30142, 30144, 30146 can be made to fall within the ranges described above.

[0131] In addition to the above, referring to FIG. 16, the end effector 30100 has an overall length 30L1 (e.g., about 20 - 25 mm), an overall width 30W1 (e.g., about 9 - 12 mm), and an overall area 30101 (i.e., the area of the plane generally defined by the end effector 30100 along the vertical axis 3062). In some embodiments, the overall area 30101 is from about 100 square millimeters to 350 square millimeters.

[0132] FIG. 15A is a schematic depiction showing the central loop 30142 of the end effector 30100 of FIG. 14. Referring particularly to FIG. 15A, the central loop 30142 can include first to fifth legs 30142a - 30142e. The first leg 30142a extends in an arcuate shape and defines the distal end of the central loop 30142. The second leg 30142b extends substantially linearly from the first leg 30142a in the proximal direction 30PD of the end effector 30100 and is angled (i.e., non - parallel) with respect to the longitudinal axis 3060. The third leg 30142c extends substantially linearly from the second leg 30142b in the distal direction 30DD of the end effector 30100 and is angled (i.e., non - parallel) with respect to the longitudinal axis 3060. The fourth leg 30142d extends substantially linearly from the third leg 30142c in the proximal direction of the end effector 30100 and is angled (i.e., non - parallel) with respect to the longitudinal axis 3060. The fifth leg 30142e extends substantially linearly from the fourth leg 30142d in the distal direction 30DD of the end effector 30100, connects with the first leg 30142a to form a loop, and is angled (i.e., non - parallel) with respect to the longitudinal axis 3060. Also, a plurality of central loop connectors 30142f connect the respective legs 30142a - 30142e described above. Of course, the illustrated central loop 30142 is exemplary, and it will be understood that in other implementations, it can take on different shapes / forms without departing from the spirit and scope of the present disclosure.

[0133] FIG. 15B is a schematic depiction showing the two side loops 30144, 30146 of the end effector 30100 of FIG. 14. Compared with the central loop 30142, in this embodiment, the two side loops 30144, 30146 are laterally offset from the longitudinal axis 3060 when viewed in the direction along the vertical axis 3062.

[0134] Referring specifically to FIG. 15B, the first side loop 30144 can include sixth to ninth legs 30144a - 30144d (the numbering continues from the numbering of the central loop 30142 for clarity in the description). The sixth leg 30144a defines the distal end of the first side loop 30144 and extends in an arc. The seventh leg 30144b extends linearly from the sixth leg 30144a in the proximal direction PD of the end effector 30100 and is substantially parallel to the longitudinal axis 3060. The eighth leg 30144c extends in an arc from the seventh leg 30144b in the proximal direction 30PD of the end effector 30100. The ninth leg 30144d extends linearly from the eighth leg 30144c in the distal direction 30DD of the end effector 30100 and is substantially parallel to the longitudinal axis 3060, connecting to the sixth leg 30144a to form a loop. Also, a plurality of first side loop connectors 30144e connect the respective legs 30144a - 30144d described above. As best seen in FIGS. 14 and 16, all legs 30144a - 30144d of the first side loop 30144 are designed to extend along the leg / section 30130a3 of the insulating material 30130 (see FIG. 14). Of course, the illustrated first side loop 30144 is exemplary, and it will be understood that without departing from the spirit and scope of the present disclosure, it can take different shapes / form factors in other implementations (such as those described below with respect to FIGS. 18 and 19).

[0135] Continuing to refer to FIG. 15B, the second side loop 30146 can include tenth to thirteenth legs 30146a - 30146d (the numbering continues from the numbering of the first side loop 30144 for clarity in the description). As described above, the second side loop 30146 is symmetric with the first side loop 30144 with respect to the longitudinal axis 3060. In other words, the second side loop 30146 is, in this embodiment, a mirror image of the first side loop 30144 with respect to the longitudinal axis. However, note that asymmetries and symmetries across different planes are envisioned embodiments. The tenth leg 30146a defines the distal end of the second side loop 30146 and extends in an arc. The eleventh leg 30146b extends linearly from the tenth leg 30146a in the proximal direction 30PD of the end effector 30100. The twelfth leg 30146c extends arcuately from the eleventh leg 30146b in the proximal direction 30PD of the end effector 30100. The thirteenth leg 30146d extends linearly from the twelfth leg 30146c in the distal direction 30DD of the end effector 30100 and is substantially parallel to the longitudinal axis 3060 and connects to the tenth leg 30146a to form a loop. Also, a plurality of second side loop connectors 30146e connect the respective legs 30146a - 30146d described above. As best seen in FIG. 16, all legs 30146a - 30146d of the second side loop 30146 are designed to extend along the leg / section 30130a3 of the insulating material 30130. Of course, the illustrated second side loop 30146 is exemplary, and it will be understood that it can take different shapes / form factors in other implementations (such as those described below with respect to FIGS. 18 and 19) without departing from the spirit and scope of the present disclosure.

[0136] FIG. 17 is a schematic exploded view showing a modified configuration of the end effector 30100 of FIG. 14. The example of FIG. 17 can be embodied and function in the same manner as described above with respect to FIGS. 14-16, except for the stratification of the central loop 30142 and the side loops 30144, 30146. Therefore, the repeated description of this example is omitted from the present disclosure. As shown in FIG. 17, rather than providing the positioning sensing loop 30140 along the vertical axis 3062 on the same side of the framework 30120 within the same layer, the loop 30140 can be positioned within different layers and / or on the side / plane opposite to / on the plane of the framework 30120.

[0137] As shown in FIG. 17, the first non-conductive flexible layer 30130a can at least partially enclose and separate the lower side of the framework 30120 and the central loop 30142. The second non-conductive flexible layer 30130b can at least partially enclose and separate one side of the side loops 30142, 30144 and the upper side of the framework. Further, the third non-conductive flexible layer 30130c can at least partially enclose and separate the other side of the side loops 30142, 30144 and the flexible circuit 30110. Of course, other layered configurations can be used without departing from the spirit and scope of the present disclosure.

[0138] 18 and 19, an alternative configuration of side loops 30144', 30146' is shown. This is identical to the example described above with respect to Figures 14-17, except for the routing of the ninth leg 30144d' and the thirteenth leg 30146d'. In this embodiment, the ninth leg 30144d' includes a proximal section 30144d1' that is non-parallel to the longitudinal axis 3060, and a distal section 30144d2' that is substantially parallel to the longitudinal axis 3060 (Figure 18B), with the proximal section 30144d1' curving away from the longitudinal axis 3060. It will be understood that the other legs / joints 30144a'-30144c', 30144e' and 30146a'-30146c', 30146e' may otherwise be configured similarly to their counterparts 30144a-30144c, 30144e and 30146a-30146c, 30146e, respectively, in the previous embodiments (and as shown in Figures 15B and 16).

[0139] The embodiment described herein employs the use of three loops 30140. Of course, it will be understood that any number of loops (e.g., 1, 2, 3, 4, 5, etc.) may be used without departing from the spirit and scope of the present disclosure, provided that the cumulative surface area of ​​each loop 30140 (each including one or more coils 30140a) falls within the ranges discussed above.

[0140] The present disclosure provides a catheter assembly 30200 as shown in FIG. 20, which may include a tubular member 30230 extending along a longitudinal axis 3060 and configured to deliver an end effector 30100 out of a sheath 30210. A physician 3024 can manipulate the catheter 30200 using a handle 30220. Suitable examples of the catheter assembly 30200 and its subcomponents, such as the handle 30220, the sheath 30210, the tubular member 30230, and others not mentioned herein, are described in U.S. Patent Application Publication No. 2021 / 0369339, which is incorporated herein by reference.

[0141] Enclosed catheter with framework (Figs. 21 to 42) Refer to Fig. 21 which shows an exemplary catheter-based electrophysiological mapping and ablation system 4010. System 4010 includes a plurality of catheters that are percutaneously inserted by physician 4024 through the vasculature of patient 4023 into a chamber or vascular structure of heart 4012. Typically, a delivery sheath catheter is inserted into the left atrium or right atrium near the desired location in heart 4012. Thereafter, a plurality of catheters can be inserted into the delivery sheath catheter to reach the desired location. The plurality of catheters may include a catheter dedicated to sensing intracardiac electrogram (IEGM) signals, a catheter dedicated to ablation, and / or a catheter dedicated to both sensing and ablation. An exemplary catheter 4014 configured to sense IEGM is illustrated herein. Physician 4024 contacts catheter shaft 4090 (i.e., multi-layer end effector 40100) having a distal tip of catheter 4014 with the heart wall to sense a target site within heart 4012. For ablation, physician 4024, as above, moves the distal end of the ablation catheter to the target site for ablation.

[0142] Catheter 4014 is an exemplary catheter that optionally distributes over end effector 40100 coupled to catheter shaft 4090 and includes one, preferably a plurality of electrodes 4026 configured to sense IEGM signals, as described in more detail below. Catheter 4014 may additionally include a position sensor embedded within or near end effector 40100 to track the position and orientation of end effector 40100. Optionally and preferably, the position sensor is a magnetic-based position sensor that includes a plurality of magnetic coils for sensing three-dimensional (3D) position and orientation.

[0143] Magnetic-based position sensors can operate with a position pad 4025 that includes a plurality of magnetic coils 4032 configured to generate a magnetic field within a predetermined workspace. The real-time position of the end effector 40100 of the catheter 4014 can be tracked based on the magnetic field generated by the position pad 4025 and sensed by the magnetic-based position sensors. Details of magnetic-based position sensing techniques are described in U.S. Patent Nos. 5,391,199, 5,443,489, 5,558,091, 6,172,499, 6,239,724, 6,332,089, 6,484,118, 6,618,612, 6,690,963, 6,788,967, 6,892,091, each of which is incorporated herein by reference.

[0144] System 4010 includes one or more electrode patches 4038 disposed for contact with the skin on patient 4023 to establish position referencing of the position pad 4025 and impedance-based tracking of the electrodes 4026. For impedance-based tracking, current is directed to the electrodes 4026 and sensed at the electrode-skin patches 4038, whereby the position of each electrode can be triangulated via the electrode patches 4038. Details of impedance-based position tracking techniques are described in U.S. Patent Nos. 7,536,218, 7,756,576, 7,848,787, 7,869,865, and 8,456,182, each of which is incorporated herein by reference.

[0145] Recorder 4011 displays an electrogram 4021 captured by the body surface ECG electrodes 4018 and an intracardiac electrogram (IEGM) captured by the electrodes 4026 of the catheter 4014. Recorder 4011 may include pacing capabilities for pacing the rhythm of the heart and / or may be electrically connected to an independent pacer.

[0146] System 4010 may include an ablation energy generator 4050 adapted to deliver ablation energy to one or more electrodes 4026 at a distal tip of a catheter configured to ablate. The energy generated by ablation energy generator 4050 may include radiofrequency (RF) energy, pulsed-field ablation (PFA) energy, or a combination thereof, including unipolar or bipolar high-voltage DC pulses such as may be used to effect irreversible electroporation (IRE), but is not limited thereto.

[0147] A patient interface unit (PIU) 4030 is an interface configured to establish electrical communication between the catheter, an electrophysiology device, a power source, and a workstation 4055 that controls the operation of system 4010. The electrophysiology devices of system 4010 may include, for example, multiple catheters, position pads 4025, body surface ECG electrodes 4018, electrode patches 4038, ablation energy generator 4050, and recorder 4011. Optionally and preferably, PIU 4030 additionally includes processing capabilities for implementing real-time calculation of the position of the catheter and performing ECG calculations.

[0148] The workstation 4055 includes a memory, a processor unit having a memory or a storage device loaded with appropriate operating software, and a user interface function. The workstation 4055 optionally provides a plurality of functions including: (1) modeling the endocardial anatomical structure in three dimensions (3D) and rendering it to display a model or anatomical map 4020 on a display device 4027; (2) displaying on the display device 4027 a representative visual display or image of an activation sequence (or other data) compiled from a recorded electrogram 4021 superimposed on the rendered anatomical map 4020; (3) displaying the real-time positions and orientations of a plurality of catheters within the heart chamber; and (4) displaying on the display device 4027 a site of interest such as a location where ablation energy is being applied. One commercially available product embodying the elements of the system 4010 is available as the CARTO (trademark) 3 system, commercially available from Biosense Webster, Inc., 31 Technology Drive, Suite 200, Irvine, CA 92618.

[0149] FIG. 22 is a schematic descriptive exploded view showing a portion of a multi-layer end effector 40100 in a generally flat / planar form. To achieve the desired rigidity, mapping resolution, electrode contact with the target anatomical structure, and compatibility of the end effector 40100 disclosed herein to flat, curved, irregular, and / or non-tissue surfaces found in the target anatomical structure, the end effector 40100 has a flexible upper circuit layer 40120A, a framework 40110, and a flexible lower circuit layer 40120B, with an insulating material 40130 (see FIG. 23) partially encapsulating the circuit layers and the framework while keeping these components separated from each other in a direction orthogonal to the longitudinal axis 4060.

[0150] It should be understood that the end effector can also include other structures such as, but not limited to, one or more position sensing loops (not shown).

[0151] The flexible circuit 40120A or 40120B can extend along the longitudinal axis 4060 from the proximal portion of the end effector 40100 (i.e., the upper right section of the circuit 40120 in FIG. 22) to the distal portion (i.e., the lower left section of the circuit 40120 in FIG. 22). In some examples, the flexible circuit layer 40120 can be made primarily of polyimide. In other embodiments, it can be made of any of biocompatible polyimide, glass-reinforced epoxy laminate material, copper, or graphene, either alone or in combination. The flexible circuit layer(s) 40120 can include conductive traces. As used herein, the term "flexible circuit" includes thin film circuits, flexible printed circuit boards, and thin film deposition by lithography and etching processes onto substrates such as polyimide or even nitinol substrates. For ease of understanding, in the following description, either or both of the flexible circuits 40120A and 40120B are referred to as the flexible circuit 40120.

[0152] The framework 40110 is disposed within the insulating material 40130 (see FIG. 23), generally along the longitudinal axis 4060, such that the longitudinal axis 4060 is parallel or coincident with the framework plane 40FP of the framework 40110. The longitudinal axis 4060 is parallel or coaxial with the longitudinal center LC of the framework 40110, where the longitudinal center 40LC is an imaginary straight line that bisects the framework 40110 in the width direction. The framework plane 40FP is also generally parallel to the plane defined by the flexible circuit 40120. In some embodiments, the framework 40110 is formed from a superelastic material. By way of example, the framework 40110 can be formed from a shape memory alloy such as nickel-titanium, also known as nitinol, cobalt-chromium, stainless steel, and / or other alloys that exhibit pseudoelastic and / or superelastic properties.

[0153] The first non-conductive flexible layer 40130A of the insulating material 40130 can at least partially encapsulate and separate the framework 40110 and the flexible circuit 40120. Further, the second non-conductive flexible layer 40130B can at least partially encapsulate and separate the flexible circuit 40120 and the other side of the sensing loop 40140. This insulating material 40130 also serves to enhance the non-traumatic nature of the end effector 40100 and to protect the object from sharp edges.

[0154] FIG. 23 is a schematic depiction showing the framework 40110 of the end effector 40100 embedded in the insulating material 40130. As shown, the framework 40110 includes a base 40112, a central first spine loop 40114, and two side spines 40116, 40118 (i.e., a left spine 40116 and a right spine 40118) on opposite sides of the first spine loop 40114. The base 40112 is connected to the elongate shaft 4014A (FIG. 21) of the medical device 4014 and extends along the longitudinal axis 4060. The spines 40114, 40116, 40118 extend from the base 40112 along the longitudinal axis 4060.

[0155] As seen in FIG. 24, the central first spine loop 40114 is configured to increase the rigidity along the center of the framework 40110 and resist bending when forces 40F, such as torsional forces, are applied. These forces 40F can occur at various times during use, such as when inserted into an introducer. This design helps prevent the electrical interconnects on the flexible circuit 40120 that extend along the longitudinal center 40LC from breaking.

[0156] In addition to the above, referring to FIG. 25, a first spine loop 40114 including features that resist bending is shown in more detail. The first spine loop 40114 includes first through seventh segments 40114A - 40114G. The curved first segment 40114A is connected to the base 40112 and extends distally in the distal direction 40DD along the longitudinal axis 4060 from the base 40112. The curved first segment 40114A includes (1) a first section 40114A1 angled with respect to the longitudinal axis 4060 and directly connected to the base 40112, and (2) a second section 40114A2 generally parallel to the longitudinal axis 4060 and connected to the first section 40114A1. The second segment 40114B is arcuate and is connected to and extends from the curved first segment 40114A. The third segment 40114C is connected to the second segment 40114B and extends proximally in the proximal direction 40PD along the longitudinal axis 4060 therefrom. The curved fourth segment 40114D of the fourth segment 40114D2 is connected to the base 40112 and extends distally in the distal direction 40DD along the longitudinal axis 4060 therefrom. Similar to the curved first segment 40114A, the fourth segment 40114D2 of the curved fourth segment 40114D includes (1) a first section 40114D1 angled with respect to the longitudinal axis 4060 and directly connected to the base 40112, and (2) a second section 40114D2 generally parallel to the longitudinal axis 4060 and connected to the first section 40114D1. The fifth segment 40114E is arcuate and is connected to and extends from the fourth segment 40114D2 to the curved fourth segment 40114D. The sixth segment 40114F is connected to the fifth segment 40114E and extends proximally in the proximal direction 40PD along the longitudinal axis 4060 therefrom. The seventh segment 40114G is arcuate (resembling a teardrop shape), bisected by the longitudinal axis 4060, and connects the third segment 40114C and the sixth segment 40114F to assist with the aforementioned bending resistance.

[0157] Cumulatively, the segments 40114A - 40114G of the first spine loop 40114 define an opening 40115 that includes two finger-shaped openings 40F1, 40F2 (thus, note that the opening 40115 is also referred to herein as a finger-shaped opening since it comprises two openings in this finger-shaped form). Further, the curved first segment 40114A, second segment 40114B, and third segment 40114C are symmetric with respect to the longitudinal axis 4060 and longitudinal center 40LC to the curved fourth segment 40114D of the fourth segment 40114D2, fifth segment 40114E, and sixth segment 40114F.

[0158] The base 40112 includes (1) a first section 40112A that connects to the elongated shaft 4014A and (2) a second section 40112B that extends into the finger-shaped opening 40115 for connection to the seventh segment 40114G. Thus, the second section 40112B effectively divides the finger-shaped opening 40115 into two half portions (i.e., the two finger-shaped openings 40F1, 40F2).

[0159] As particularly seen in FIG. 25, the second spine loop 40116 is connected to the first section 40112A of the base 40112 via a pair of end sections 40116A. Similarly, the third spine loop 118 is connected to the opposite side of the first section 40112A of the base 40112 via a pair of end sections 40118A.

[0160] FIG. 26 is a schematic depiction showing a slightly modified framework 40110' of the end effector 40100' (relative to the aforementioned framework 40110) embedded in the insulating material 40130. As shown, similar to the previous example, the framework 40110' includes a base 40112', a central first spine loop 40114', and two side spines 40116', 40118' (i.e., a left spine 40116' and a right spine 40118') on opposite sides of the first spine loop 40114'. The base 40112' is connected to the elongated shaft 4014A (FIG. 21) of the medical device 4014 and extends along the longitudinal axis 4060. The spines 40114', 40116', 40118' extend from the base 40112' along the longitudinal axis 4060.

[0161] As seen in FIG. 27, similar to the previous example, the central first spine loop 40114' is configured to increase rigidity along the center of the framework 40110' and resist bending when a force 40F, e.g., a torsional force, is applied. These forces 40F can occur at various times during use, such as when inserted into the introducer. As described above, this design helps prevent breakage of the electrical interconnects on the flexible circuit 40120 that extends along the longitudinal center 40LC.

[0162] In addition to the above, referring to FIG. 28, a first spine loop 40114' including features resistant to bending is shown in more detail. The first spine loop 40114 includes first to seventh segments 114A' to 114G' configured in the same manner as the examples described in FIGS. 22 to 25. The curved first segment 40114A' is connected to the base 40112 and extends distally 40DD along the longitudinal axis 4060 from the base 40112. The curved first segment 40114A' includes (1) a first section 40114A1' angled with respect to the longitudinal axis 4060 and directly connected to the base 40112', and (2) a second section 40114A2' generally parallel to the longitudinal axis 4060 and connected to the first section 40114A1'. The second segment 40114B' is arcuate and is connected to and extends from the curved first segment 40114A'. The third segment 40114C' is connected to the second segment 40114B' and extends proximally 40PD along the longitudinal axis 4060 therefrom. The curved fourth segment 40114D' of the fourth segment 40114D2 is connected to the base 40112' and extends distally 40DD along the longitudinal axis 4060 therefrom. Similar to the curved first segment 40114A', the curved fourth segment 40114D' of the fourth segment 40114D2 includes (1) a first section 40114D1' angled with respect to the longitudinal axis 4060 and directly connected to the base 40112', and (2) a second section 40114D2' generally parallel to the longitudinal axis 4060 and connected to the first section 40114D1'. The fifth segment 40114E' is arcuate and is connected to and extends from the curved fourth segment 40114D' of the fourth segment 40114D2. The sixth segment 40114F' is connected to the fifth segment 40114B' and extends proximally 40PD along the longitudinal axis 4060 therefrom. The seventh segment 40114G' is arcuate (resembling a teardrop shape), bisected by the longitudinal axis 4060, and connects the third segment 40114C' and the sixth segment 40114F' to assist in the aforementioned bending resistance.

[0163] Cumulatively, the segments 40114A' to 40114G' of the first spine loop 40114' define a finger-shaped opening 40115' that includes two finger-shaped openings 40F1' and 40F2'. Further, the curved first segment 40114A', the second segment 40114B', and the third segment 40114C' are symmetric with respect to the longitudinal axis 4060 and the longitudinal center 40LC with the curved fourth segment 40114D' of the fourth segment 40114D2, the fifth segment 40114E', and the sixth segment 40114F' of the first spine loop 40114'.

[0164] The base 40112' includes (1) a first section 40112A' that connects to the elongated shaft 4014A and (2) a second section 40112B' that extends into the finger-shaped opening 40115 for connection to the seventh segment 40114G. Thus, the second section 40112B' effectively divides the opening 40115' into two half portions (i.e., two finger-shaped openings 40F1' and 40F2'). Further, the first section 40112A' and the second section 40112B' each define one or more apertures 40113' therein.

[0165] As particularly seen in FIG. 28, the second spine loop 40116' has a pair of end sections 40116A'. One end section 40116A' is connected to the first section 40112A' of the base 40112', and the other end section 40116A' is connected to the curved first segment 40114A' of the first spine loop 40114. Similarly, the third spine loop 40118 has a pair of end sections 40118A'. One end section 40118A' is connected to the opposite side of the first section 40112A' of the base 40112', and the other end section 40118A' is connected to the curved fourth segment 40114D' of the fourth segment 40114D2 of the first spine loop 40114'.

[0166] FIG. 29 is a schematic descriptive perspective view showing another framework 40210 of another end effector 40200. FIG. 30 is a schematic descriptive view showing the framework 40210 embedded in the insulating material 40130 together with the flexible circuit 40220 assembled therewith. FIGS. 31-32 are cross-sectional views of FIG. 30.

[0167] Referring now to FIGS. 29-32, as described above, another example of a framework 40210 for another end effector 40200 is shown. In particular, as seen in FIGS. 30-32, the end effector 40200 also includes an insulating material 40130 disposed on the framework 40210 and a flexible circuit 40220. In use, the flexible circuit 40220 is subjected to stresses / loads that can lead to its failure at one or more points. The example shown in these figures reduces the stress applied thereto by routing a section of the flexible circuit to the neutral plane 40NP of the framework 40210, the details of which will be described below.

[0168] Similar to the previous example, the framework 40210 can be formed from a superelastic material. By way of example, the framework can be formed from a shape memory alloy such as nitinol, cobalt chromium, stainless steel, and / or other alloys that exhibit pseudoelastic and / or superelastic properties.

[0169] The framework 40210 includes a base 40212, a first spine loop 40214, a second spine loop 40216, and a third spine loop 40218. The base 40212 is connected to the elongated shaft 4014A of the medical device 4014 and extends along the longitudinal axis 4060. The framework 40210 also has a framework plane 40FP that extends along the neutral plane 40NP of the framework 40210.

[0170] The first spine loop 40214 extends from the base 40212 along the longitudinal axis 4060 and includes a first segment 40214A, a second segment 40214B, and a third segment 40214C. The first segment 40214A is connected to the base 40212 and extends distally 40DD along the longitudinal axis 4060 therefrom. The second segment 40214B is connected to the first segment 40214A and extends inwardly toward the longitudinal axis 4060 therefrom. The third segment 40214C is connected to the second segment 40214B and extends distally 40DD along the longitudinal axis 4060 therefrom. In some embodiments, the third segment 40214C extends substantially parallel to the longitudinal axis 4060.

[0171] The second spine loop 40216 extends from the opposite side of the base 40212 along the longitudinal axis 4060 (compared to the first spine loop 40214) and includes a first segment 40216A, a second segment 40216B, and a third segment 40216C. The first segment 40216A is connected to the base 40212 and extends distally 40DD along the longitudinal axis 4060 therefrom. The second segment 40216B is connected to the first segment 40216A and extends inwardly toward the longitudinal axis 4060 therefrom. The third segment 40216C is connected to the second segment 40216B and extends distally 40DD along the longitudinal axis 4060 therefrom. In some embodiments, the third segment 40216C extends substantially parallel to the longitudinal axis 4060.

[0172] The third spine loop 40218 connects the third segment 40214C of the first spine loop 40214 and the third segment 40216C of the second spine loop 40216, and is bisected by the longitudinal axis 4060 and the longitudinal center of the framework 40210 (similarly to the previous example, the longitudinal center 40LC is coaxial with the longitudinal axis 4060). In some embodiments, the third spine loop 40218 has a wavy form that aids in the lateral flexibility and foldability of the framework 40210. In these embodiments, the undulations can be modified to adjust the lateral resistance of the framework 40210. In other embodiments, the third spine loop 40218 can be omitted.

[0173] To facilitate the flexible circuit 40220 having a section extending along the neutral plane 40NP, the framework 40210 has a hollow design. In other words, the framework 40210 has a finger-shaped opening 40211 defined by its base 40212, the first spine loop 40214, the second spine loop 40216, and the third spine loop 40218.

[0174] As best illustrated and exemplified in FIG. 31, the flexible circuit 40220 has a first section 40222 that is vertically spaced from the framework 40210 along the vertical axis 4062 by an insulating material 40130 and is disposed parallel to the framework plane FP. The first section 40222 also includes a peripheral section 40222A that is disposed directly above the first spine loop 40214, the second spine loop 40216, and the third spine loop 40218.

[0175] Best shown and illustrated in FIG. 32, the flexible circuit 40220 is offset from a first section 40222 along a vertical axis 4062 (see FIG. 32 in comparison to FIG. 31) and further includes a second section 40224 extending along a framework plane 40FP within a finger-shaped opening 40211 defined by a framework 40210. The second section 40224 of the flexible circuit 40220 also includes a peripheral section 40224A extending along an inner surface of a first spine loop 40214 and an inner surface of a second spine loop 40216 from an intermediate section of the framework 40210 to a base 40212.

[0176] In addition to the above, the flexible circuit 40220 includes a transition section 40223 connecting the first section 40222 and the second section 40224 of the flexible circuit. Referring to FIGS. 29 and 30, the transition section 40223 is disposed proximal to a second segment 40214B of the first spine loop 40214 and a second segment 40216B of the second spine loop 40216 along a longitudinal axis 4060, and both second segments 40214B, 40216B function as connection segments between a first segment and a third segment of the first spine loop 40214 and the second spine loop 40216, respectively.

[0177] FIG. 33 is a schematic depiction showing yet another design of a framework 40310 embedded in an insulating material 40130 of an end effector 40300 for a medical device 4014. The framework 40310 extends along a longitudinal axis 4060 that is coaxial with a longitudinal center 40LC of the framework 40310. The framework 40310 includes a base 40312, a first spine loop 40314 extending from the base 40312 on one side of the longitudinal axis 4060, and a second spine loop 40316 extending from the base 40312 on the opposite side of the longitudinal axis 4060. In some embodiments, the base 40312 and the spines 40314, 40316 are monolithic members (i.e., a single integral component).

[0178] The base 40312 includes a first section 40312A and a second section 40312B. The first section 40312A is connected to the elongated shaft 4014A, and the second section 40312B extends in the distal direction 40DD away from the first section 40312A. In some embodiments, the base 40312 is bisected by the longitudinal axis 4060 and is substantially symmetric with respect to the longitudinal axis 4060.

[0179] The first spine loop 40314 has a first distal end 40314A connected to the base 40312 at a first longitudinal position along the longitudinal axis 4060 and a second distal end 40314B connected to the base 40312 at a second longitudinal position along the longitudinal axis 4060, and defines a first finger-shaped opening 40315. Note that "longitudinal position" (in this example and other examples) refers to the longitudinal component of the position of the element being referenced and excludes the lateral component of the position (i.e., the distance from the longitudinal axis of the element being referenced). With respect to the orientation of the framework 40310 in FIG. 13, the longitudinal component is similar to the y coordinate in a Cartesian coordinate system.

[0180] Similarly, the second spine loop 40316 has a first distal end 40316A connected to the base 40312 at a third longitudinal position along the longitudinal axis 4060 and a second distal end 40316B connected to the base 40312 at a fourth longitudinal position along the longitudinal axis 4060, and defines a second finger-shaped opening 40317.

[0181] The first longitudinal position, the second longitudinal position, the third longitudinal position, and the fourth longitudinal position of the respective distal ends 40314A, 40314B, 40316A, 40316B are arranged along the longitudinal axis 4060 such that the framework 40310 is asymmetric with respect to the longitudinal axis 4060.

[0182] In particular, in the embodiment shown in FIG. 33, the first distal end 40314A of the first spine loop 40314 and the first distal end 40316A of the second spine loop 40316 are connected to the first section 40312A of the base 40312 such that the first longitudinal position and the third longitudinal position are the same or substantially the same. Further, the second distal end 40314B of the first spine loop 40314 and the second distal end 40316B of the second spine loop 40316 are connected to the second section 40312B. More specifically, the second distal end 40314B of the first spine loop 40314 is connected to the proximal end of the second section 40312B, and the second distal end 40316B of the second spine loop 40316 is connected to the distal end of the second section 40312B such that the second longitudinal position and the fourth longitudinal position are spaced apart by a predetermined distance 40D1 along the longitudinal axis 4060. This configuration of the ends 40314A, 40314B, 40316A, 40316B results in a first finger-shaped opening 40315 having an area that is partially smaller than the area of the second finger-shaped opening 4040317.

[0183] FIG. 34 is a schematic depiction showing another example of a framework 40310' similar to the framework 40310 of FIG. 33, embedded in an insulating material 40130, for an end effector 40300' of a medical device 4014. The framework 40310' extends along a longitudinal axis 4060 that is coaxial with the longitudinal center LC of the framework 40310'. The framework 40310' includes a base 40312', a first spine loop 40314' extending from the base 40312' on one side of the longitudinal axis 4060, and a second spine loop 40316' extending from the base 40312' on the opposite side of the longitudinal axis 4060. In some embodiments, the base 40312' and the spines 40314', 40316' are monolithic members.

[0184] The base 40312’ includes a first section 40312A’ and a second section 40312B’. The first section 40312A’ is connected to the elongated shaft 4014A’, and the second section 40312B’ extends in the distal direction 40DD away from the first section 40312A’. In some embodiments, the base 40312’ is bisected by the longitudinal axis 4060 and is substantially symmetric with respect to the longitudinal axis 4060.

[0185] The first spine loop 40314’ has a first distal end 40314A’ connected to the base 40312’ at a first longitudinal position along the longitudinal axis 4060 and a second distal end 40314B’ connected to the base 40312’ at a second longitudinal position along the longitudinal axis 4060, and defines a first finger-shaped opening 40315’.

[0186] Similarly, the second spine loop 40316’ has a first distal end 40316A’ connected to the base 40312’ at a third longitudinal position along the longitudinal axis 4060’ and a second distal end 40316B’ connected to the base 40312’ at a fourth longitudinal position along the longitudinal axis 4060, and defines a second finger-shaped opening 4040317’.

[0187] Similar to the previous example, the first longitudinal position, the second longitudinal position, the third longitudinal position, and the fourth longitudinal position of the respective distal ends 40314A’, 40314B’, 40316A’, 40316B’ are arranged along the longitudinal axis 4060 such that the framework 40310’ is asymmetric with respect to the longitudinal axis 4060.

[0188] In particular, in the embodiment shown in FIG. 34, the first distal end 40314A' of the first spine loop 40314' and the first distal end 40316A' of the second spine loop 40316' are connected to the first section 40312A' of the base 40312' such that the first longitudinal position and the third longitudinal position are separated by a predetermined distance 40D1' along the longitudinal axis 4060 (the third longitudinal position is closer to the proximal end of the base 40312' than the first longitudinal position). Further, the second distal end 40314B' of the first spine loop 40314' and the second distal end 40316B' of the second spine loop 40316' are connected to the second section 40312B' such that the second longitudinal position and the fourth longitudinal position are the same or substantially the same along the longitudinal axis 4060. This configuration of the ends 40314A', 40314B', 40316A', 40316B' results in a first finger-shaped opening 40315' having an area that is, in part, smaller than the area of the second finger-shaped opening 40317'.

[0189] FIG. 35 is a schematic depiction showing the end effectors 40300, 40300' of FIGS. 33 and 34 inserted into an introducer 4080 having an inlet 4082 and a sheath 4084. FIG. 36 is a schematic depiction showing the end effectors 40300, 40300' inserted into the finger-shaped opening 4084A of the introducer 4080. The introducer 4080 is used to fold either of the end effectors 40300, 40300' shown above. Due to the asymmetric design of the respective sides 40302, 40302' and 40304, 40304' of the end effectors 40300, 40300', one side of the end effectors 40300, 40300' can be made to (1) initiate insertion into the introducer 4080 and / or (2) require less force from the sidewall of the introducer 4080 for folding within the finger-shaped opening 4084A. In this way, the folding pattern of the end effectors 40300, 40300' can be made more predictable.

[0190] It should be noted that although the framework 40110 is shown as lying on a common plane, it is well within the scope of the present disclosure for the spine loops to be offset on different planes or for the framework 40110 itself to be curved about a central axis to define a cylindrical framework.

[0191] 37A-40B, which show schematic depictions of exemplary end effectors 40300", 40300A", 40300B", 40300C" that include treated edges for optimized retraction and / or folding thereof. For example, similar to the previously described embodiments of FIGS. 33-36, these embodiments of end effectors 40300", 40300A", 40300B", 40300C" allow for a consistent folded shape and reduce retraction forces of the end effectors. It should be noted that the treated edges described herein may be applied to any of the end effectors described in this application without departing from the spirit and scope of the present disclosure.

[0192] Referring to FIG. 37A, a top view of the end effector 40300” is shown. Similar to the embodiment of FIG. 33, the end effector 40300” includes a framework (see FIG. 22 showing, for example, the framework 40110, not explicitly shown in these figures) embedded in insulating materials 40302”, 40304”. The end effector 40300” extends along a longitudinal axis 4060 that is coaxial with the longitudinal center of the end effector 40300”. The framework can be symmetric or asymmetric and is substantially planar along its longitudinal axis 4060. As used herein, similar to the terms “about” and “approximately” described above, the term “substantially planar” is noted to include frameworks having a slight curvature with respect to their forms along the longitudinal axis 4060. In other words, frameworks that are not completely flat are fully encompassed within the spirit and scope of the present disclosure. Further, those skilled in the art will understand that the end effector 40300” described herein may include other features of the foregoing embodiments. For example, the end effector 40300” can include one or more flexible circuit layers 40120A, 40120B including substantially planar electrodes and / or sensing loop layers, and the flexible circuits are disposed within the insulating materials 40302”, 40304” and are vertically spaced apart from the framework 40110 along a vertical axis.

[0193] As seen in FIG. 37A, the insulating materials 40302”, 40304” of the end effector 40300” are divided into a first side 40302” and a second side 40304” with respect to the longitudinal axis 4060, and each side has respective outer edge portions (e.g., a first outer edge portion 40303” and a second outer edge portion 40305”) in the range farthest from the longitudinal axis 4060. At least one of the edges 40303”, 40305” includes a processing portion for assisting in folding / folding over of the end effector 40300”.

[0194] In the present embodiment of FIGS. 37A - 37B, both outer edge portions 40303”, 40305” include tapered cuts such that the outer edge portions 40303”, 40305” form a non - perpendicular angle with respect to the substantially flat front and rear surfaces of the insulating material (see the upper and lower portions of the end effector 40300” in FIG. 37A). In some embodiments, the tapered cuts are substantially parallel to each other.

[0195] FIG. 37B is a schematic depiction showing the end effector 40300” of FIG. 37A inserted into the opening 4084A of an introducer 4080 having an inlet portion 4082 and a sheath 4084 (see FIG. 35). The introducer 4080 is used to fold the end effector 40300”. Due to the tapered cut design of one or more of the respective outer edge portions 40303”, 40305” of the end effector 40300”, the outer edge portions 40303”, 40305” of the end effector 40300” can be made to slide past each other more readily (rather than abutting and causing the end effector 40300” to buckle irregularly). In this way, the folding pattern of the end effector 40300” can be made more predictable.

[0196] FIG. 38A is a top view of another end effector 40300A” that is identical to the end effector 40300” of FIG. 37A but has different and / or additional end processing. Specifically, the insulating materials 40302A”, 40304A” of the end effector 40300A” are divided into a first side 40302A” and a second side 40304A” with respect to the longitudinal axis 4060, and each side has its respective outer edge portion (e.g., the first outer edge portion 40303A” and the second outer edge portion 40305A”) in the range furthest from the longitudinal axis 4060. At least one of the edges (e.g., the second edge 40305A”) includes a processing portion 40306A” to assist in folding / folding over of the end effector 40300A”.

[0197] In the present embodiment of FIGS. 38A - 38B, at least a part of the second outer edge portion 40305A” includes a lubricating coating 40306A” which is, but not limited to, polytetrafluoroethylene (PTFE). In some embodiments, both outer edge portions 40303A”, 40305A” can have a portion (or the whole) coated with the lubricating coating 40306A”. It should be noted that this exemplary end effector 40300A” also includes rounded cuts at both outer edge portions 40302A”, 40304A”.

[0198] FIG. 38B is a schematic depiction showing the end effector 40300A” of FIG. 38A inserted into the opening 4084A of an introducer 4080 having an inlet portion 4082 and a sheath 4084 (see FIG. 35). The introducer 4080 is used to fold the end effector 40300A”. Due to the lubricating coating 40306A” and / or the rounding of one or more of the respective outer edge portions 40303A”, 40305A” of the end effector 40300A”, friction is reduced, enabling the outer edge portions 40303A”, 40305A” of the end effector 40300A” to slide past each other more easily. In this additional or alternative way, the folding pattern of the end effector 40300A” can be made more predictable.

[0199] FIG. 39A is a top view of yet another end effector 40300B” which is identical to the end effectors 40300”, 40300A” of FIGS. 37A - 38B but has different and / or additional end treatments. Specifically, the insulating materials 40302B”, 40304B” of the end effector 40300B” are divided into a first side 40302B” and a second side 40304CB” with respect to the longitudinal axis 4060, and each side has its respective outer edge (e.g., the first outer edge portion 40303B” and the second outer edge portion 40305B”) in the range farthest from the longitudinal axis 4060. At least one of the edges (e.g., the second edge portion 40305B”) includes a processing portion 40306B” to assist in folding / folding over of the end effector 40300B”.

[0200] In the present embodiment of FIGS. 39A - 39B, at least a portion of the second outer edge portion 40305B” includes a plurality of cuts 40306B” formed in an insulating material in a direction toward the longitudinal axis 4060 and in a direction substantially perpendicular to the longitudinal axis. In some embodiments, both outer edge portions 40303B”, 40305B” can have a portion (or all) having the cuts 40306B”. The cuts 40306B” function to soften at least one side of the insulating material to make deformation more possible.

[0201] FIG. 39B is a schematic depiction showing the end effector 40300B” of FIG. 39A inserted into the opening 4084A of an introducer 4080 having an inlet portion 4082 and a sheath 4084 (see FIG. 35). The introducer 4080 is used to fold the end effector 40300B”. Due to the cuts 40306B” in at least a portion of the second outer edge portion 40305B” of the end effector 40300B”, the flexibility of the second outer edge portion 40305B” is increased, enabling the outer edge portion 40305B” to be folded inwardly relative to the first outer edge portion 40303B” when the two edge portions 40303B”, 40305B” engage each other. In this additional or alternative way, the folding pattern of the end effector 40300B” can be made more predictable.

[0202] FIG. 40A is a top view of yet another end effector 40300C” that is the same as the end effectors 40300”, 40300A”, 40300C” of FIGS. 37A - 39B but has different and / or additional end processing. Specifically, the insulating materials 40302C”, 40304C” of the end effector 40300C” are divided into a first side 40302C” and a second side 40304C” with respect to the longitudinal axis 4060, and each side has its respective outer edge portion (e.g., a first outer edge portion 40303C” and a second outer edge portion 40305C”) in the range furthest from the longitudinal axis 4060. At least one of the edges (e.g., the second edge 40305C”) includes a process similar to that of the end effector 40300” to assist in folding / folding over of the end effector 40300C”.

[0203] In the present embodiment of FIGS. 40A - 40B, a single outer edge portion 40305C” includes a tapered cutout such that the second outer edge portion 40305C” forms a non - perpendicular angle with respect to the substantially flat front and rear surfaces of the insulating material (see the upper and lower portions of the end effector 40300C” in FIG. 40A). In the version where a single tapered cutout is employed, the cutout can extend a distance 40D” in a direction towards the longitudinal axis 4060. The distance 40D” is optimized to increase the flexibility of the second outer edge portion 40305C” and allows the outer edge portion 40305C” to collapse inwardly relative to the first outer edge portion 40303C” when the two edges 40303C”, 40305C” engage with each other.

[0204] Figure 40B is a schematic depiction showing the end effector 40300C of Figure 40A inserted into the opening 4084A of an introducer 4080 having an inlet portion 4082 and a sheath 4084 (see Figure 35). The introducer 4080 is used to fold the end effector 40300. Due to the tapered cutout design of the second outer edge portion 40305C of the end effector 40300C, the second outer edge portion 40305C can be folded inwardly with respect to the first outer edge portion 40303C when the two edge portions 40303C, 40305C engage with each other. In this way, the folding pattern of the end effector 40300C can be made more predictable.

[0205] As will be appreciated by those skilled in the art, the examples described with respect to Figures 37A - 40B can be combined with each other without departing from the spirit and scope of the present disclosure. By way of non - limiting example, the lubricity coating 40306A can be used to cover the tapered cutout(s) of the end effector 40300 described in Figures 37A - 37B.

[0206] In addition to the above - described embodiments of Figures 37A - 40B, referring to Figure 41, a method 40410 of using a medical device can include the following. The end effector is retracted (40412) into the sheath along the longitudinal axis from the deployed configuration. As described above, the end effector is substantially planar in the deployed configuration. The end effector is folded (40414) into a retracted configuration such that the outer edge portions of the end effector slide over each other. In the retracted configuration, the end effector has substantially one of a cylindrical shape or a helical shape at the retracted position. Further, the first of the outer edge portions has one or more of the aforementioned processes, which assist in the folding of the end effector.

[0207] In addition to the above-described embodiments of FIGS. 37A - 40B, referring to FIG. 42, a method 40420 of manufacturing an end effector for a medical device can include the following. A framework that is substantially planar along a longitudinal axis is formed (40422). A flexible circuit is disposed on the framework (40424) and is spaced apart in a direction perpendicular to the framework. An insulating material is heated (40426) and reflowed (40428) such that the insulating material at least partially encapsulates the framework and the flexible circuit. An outer edge portion of the insulating material is processed (40430) to have a reduced rigidity and / or a reduced coefficient of friction relative to the original (i.e., pre - processed) coefficient of friction and / or original rigidity of the outer edge portion.

[0208] Enclosed planar catheter with flexible circuit extending to neutral axis (FIGS. 43 - 51) Refer to FIG. 43, which shows an exemplary catheter - based electrophysiology mapping and ablation system 5010. The system 5010 includes a plurality of catheters that are percutaneously inserted by a physician 5024 through the vasculature of a patient 5023 into a chamber or vascular structure of the heart 5012. Typically, a delivery sheath catheter is inserted into the left atrium or right atrium near a desired location in the heart 5012. Thereafter, a plurality of catheters can be inserted into the delivery sheath catheter to reach the desired locations. The plurality of catheters may include a catheter dedicated to sensing intracardiac electrogram (IEGM) signals, a catheter dedicated to ablation, and / or a catheter dedicated to both sensing and ablation. An exemplary catheter 5014 configured to sense IEGM is illustrated herein. The physician 5024 contacts a catheter shaft (i.e., the multi - layer end effector 50100) having a distal tip of the catheter 5014 with the heart wall to sense a target site within the heart 5012. For ablation, the physician 5024, as described above, moves the distal end of the ablation catheter to the target site for ablation.

[0209] As will be described in more detail below, the catheter 5014 is an exemplary catheter that optionally distributes across an end effector 50100 coupled to a catheter shaft and includes one, preferably a plurality of electrodes 50112 configured to sense IEGM signals. The catheter 5014 may further include a position sensor (see, e.g., the electromagnetic coils 50330 of FIGS. 49A-49C) embedded within or near the end effector 50100 to track the position and orientation of the end effector 50100. Optionally and preferably, the position sensor is a magnetic-based position sensor that includes a plurality of magnetic coils for sensing three-dimensional (3D) position and orientation (see the distal loop 50334, the first side loop 50336a, and the second side loop 50336b of FIG. 49B).

[0210] The magnetic-based position sensor may operate with a position pad 5025 that includes a plurality of magnetic coils 5032 configured to generate a magnetic field within a predetermined workspace. The real-time position of the end effector 50100 of the catheter 5014 may be tracked based on the magnetic field generated by the position pad 5025 and sensed by the magnetic-based position sensor. Details of magnetic-based position sensing techniques are described in U.S. Pat. Nos. 5,391,199, 5,443,489, 5,558,091, 6,172,499, 6,239,724, 6,332,089, 6,484,118, 6,618,612, 6,690,963, 6,788,967, 6,892,091, each of which is incorporated herein by reference.

[0211] System 5010 includes one or more electrode patches 5038 arranged for contact with the skin on patient 5023 to establish a position reference of position pad 5025 and impedance-based tracking of electrodes 50112. For impedance-based tracking, current is directed to electrodes 50112 and sensed at electrode-skin patches 5038, whereby the position of each electrode can be triangulated via electrode patches 5038. Details of impedance-based position tracking techniques are described in U.S. Patent Nos. 7,536,218, 7,756,576, 7,848,787, 7,869,865, and 8,456,182, each of which is incorporated herein by reference.

[0212] Recorder 5011 displays an electrogram 5021 captured by body surface ECG electrodes 5018 and an intracardiac electrogram (IEGM) captured by electrodes 50112 of catheter 5014. Recorder 5011 may include pacing capabilities for pacing the rhythm of the heart and / or may be electrically connected to an independent pacer.

[0213] System 5010 may include an ablation energy generator 5050 adapted to deliver ablation energy to one or more electrodes 50112 at the distal tip of a catheter configured to ablate. The energy generated by ablation energy generator 5050 may include radiofrequency (RF) energy, pulsed-field ablation (PFA) energy, or a combination thereof, including unipolar or bipolar high voltage DC pulses that may be used to effect irreversible electroporation (IRE), but is not limited thereto.

[0214] The patient interface unit (PIU) 5030 is an interface configured to establish electrical communication between a catheter, an electrophysiological device, a power source, and a workstation 5055 that controls the operation of the system 5010. The electrophysiological devices of the system 5010 may include, for example, a plurality of catheters, position pads 5025, body surface ECG electrodes 5018, electrode patches 5038, an ablation energy generator 5050, and a recorder 5011. Optionally and preferably, the PIU 5030 additionally includes processing capabilities for implementing real-time calculation of the catheter position and performing ECG calculations.

[0215] The workstation 5055 includes a memory, a processor unit having a memory or storage device loaded with appropriate operating software, and user interface functions. The workstation 5055 may optionally (1) model the endocardial anatomical structure in three dimensions (3D) and render it for display on a display device 5027 as a model or anatomical map 5020, (2) display on the display device 5027 a representative visual display or image of the activation sequence (or other data) compiled from the recorded potential map 5021 superimposed on the rendered anatomical map 5020, (3) display the real-time position and orientation of a plurality of catheters within the heart chamber, and (4) display on the display device 5027 regions of interest such as locations where ablation energy is being applied. One commercially available product embodying the elements of the system 5010 is available as the CARTO (trademark) 3 system, marketed by Biosense Webster, Inc., 31 Technology Drive, Suite 200, Irvine, CA, 92618.

[0216] FIG. 44 provides an end effector 50100 according to an embodiment of the present disclosure to achieve enhancements in end effector characteristics such as ease of manufacture, cost reduction, and desired rigidity, mapping resolution, electrode contact with the target anatomical structure, and compatibility of the end effector disclosed herein to flat, curved, irregular, and / or non-planar tissue surfaces found within the target anatomical structure. The end effector 50100 can include a flexible circuit 50110 that includes a plurality of electrodes 50112, and each electrode of the plurality of electrodes 50112 includes a contact surface 50112c. As used herein, the term “flexible circuit” includes thin film circuits, flexible printed circuit boards, polyimide, copper, LCP, nitinol substrates, TPU, silicone, thermosetting resins, or other polymer substrates such as those illustrated and described in the attached technical reference incorporated herein by reference in its entirety from the priority cross-referenced application, Ser. No. 63 / 615,574, including thin film deposition via lithography and etching processes onto a substrate. In some examples, the flexible circuit layer described herein can be made primarily of polyimide. In other examples, it can be made of any of biocompatible polyimide, glass-reinforced epoxy laminate material, copper, or graphene, either alone or in combination. In some examples, the electrodes described herein can include at least one mapping electrode and / or at least one ablation electrode and can be configured to detect electrophysiological signals or transmit ablation energy AC or DC from an energy generator to tissue according to various ablation methods mentioned previously, such as RF, IRE, etc.

[0217] The flexible circuit 50110 can be disposed on the insulating material 50120. The insulating material 50120 can be continuous with the contact surface 50112c such that only the contact surfaces 50112c of at least a portion of the plurality of electrodes 50112 are exposed to the ambient environment. As used herein, the term "contact surface" includes a substantially flat surface and the portion of the electrode having an edge (s) directly surrounding the flat surface. The electrode 50112 can have a slightly rounded, rounded, or chamfered edge that contacts the tissue along with the substantially flat surface when the end effector 50100 is placed in contact with the tissue. As used herein, "ambient environment" refers to the organ in which the end effector 50100 is placed, or an external environment such as an operating room prior to being placed within a biological organ.

[0218] Note that all of the electrodes on the end effector 50100 described herein need not be exposed through the insulating material 50120 because these non-exposed electrodes can be used to sense far-field signals for noise reduction in proximity to the tissue contact electrodes. Similarly, far-field signals, including noise or artifacts, can be reduced or canceled for the entire end effector having a reference electrode that contacts only blood and not tissue. Perfusion can be provided using a perfusion port 50163a on one side and a perfusion port 50162b on the other side that are in fluid communication with a perfusion line (not shown) disposed within the catheter shaft. Instead of a perfusion line separate from the catheter shaft, a lumen can be formed by extrusion of the catheter shaft to provide a lumen channel. Note that the port 50163a or 50162b can be configured to have sufficient diverter characteristics such that the perfusion fluid covers the mapping electrodes in the perfusion flow to prevent or reduce thrombus formation.

[0219] Flexible circuit 50110 can further include a framework 50130 that is continuous with or within the insulating material. In embodiments where flexible circuit 50110 includes framework 50130, framework 50130 can be disposed directly on flexible circuit 50110, and insulating material 50120 is disposed either not at all or only minimally therebetween.

[0220] In other words, one aspect of the present disclosure provides an end effector 50100 having a planar framework 50130 that bisects two flat thermoformed portions 50120a, 50120b of flexible insulator 50120, with at least one flexible circuit 50110 disposed on one side of framework 50130 and the contact surface 50112c of electrode 50112 extending up to or slightly beyond the outer surface of flexible insulator 50120. In additional or alternative examples, the contact surface 50112c of electrode 50112 may be slightly recessed and there may be an opening through insulating material 50120 to ensure that electrode 50112 is exposed.

[0221] FIG. 45 shows an exploded view of end effector 50100, the components of which are exploded vertically along vertical axis 50V-V. Flexible circuit 50110 can be a first flexible circuit 50110, and the plurality of electrodes 50112 can be a first plurality of electrodes 50112, each first electrode 50112 including a first contact surface 50112c. End effector 50100 can further include a second flexible circuit 50140 having a second plurality of electrodes 50142. Second flexible circuit 50140 can be spaced apart from first flexible circuit 50110, but each electrode of the second plurality of electrodes 50142 can have a second contact surface.

[0222] In an embodiment having a first flexible circuit 50110 and a second flexible circuit 50140, the insulating material 50120 can be disposed between the first flexible circuit 50110 and the second flexible circuit 50140, but the insulating material 50120 can be continuous with the second contact surface 50142c such that only the contact surface 50142c of each second electrode 50142 is exposed to the surrounding environment, in a manner similar to that in which the first electrode 50112 is disposed within the insulating material and exposed through the insulating material.

[0223] The electrodes 50112, 50142 can sense or receive signals generated by tissue, or conduct AC or DC energy from an energy generator to tissue. In some embodiments, there are about 92 electrodes. In some embodiments, there are about 48 electrodes. In some embodiments, there are about 64 electrodes. In some embodiments, there are about 72 electrodes. In some embodiments, there are about 98 electrodes. Details of the spacing of each pair of electrodes relative to the spacing between separate sets of electrode pairs can be found in U.S. Provisional Patent Application No. 63 / 406,673, filed September 14, 2022, and are included in the appendix included in priority application No. 63 / 615,574 and incorporated by reference.

[0224] An example where the end effector 50100 includes a framework 50130 disposed between the first flexible circuit 50110 and the second flexible circuit 50140.

[0225] The framework 50130 can be a component of the end effector 50100 that is separated and distinct from the first flexible circuit 50110 and disposed in proximity to the first flexible circuit 50110. In this case, the insulating material 50120 can be further disposed between the framework 50130 and the second flexible circuit 50140. The framework 50130 can be formed from planar or cylindrical stock of material using any suitable method. For example, the framework 50130 can be formed by cutting, laser cutting, stamping, etc.

[0226] The insulating material 50120 can include a first insulating material sheet 50120a and a second insulating material sheet 50120b, and these insulating material sheets are integrally fused in proximity to the framework 50130 to form a single continuous generally planar insulating block 50120. This insulating material 50120 also serves to enhance the non-traumatic nature of the end effector 50100 and to protect the object from sharp edges. The insulating material 50120 can include a polymer. The insulating material 50120 can be thermoformed around at least a portion of the first flexible circuit 50110, the second flexible circuit 50140, and the framework 50130. The polymer can include thermoplastic polyurethane (TPU) or other thermoforming or shaping materials suitable for such thermoforming.

[0227] Furthermore, although the insulating material 50120 is shown as being flat in these figures, the insulating material 50120 can be shaped, corrugated, undulated, raised, recessed, convexed, or otherwise configured such that the overall outer shape of the insulating material 50120 provides physical and / or mechanical properties such as rigidity and flexure along a plurality of axes required by the end effector 50100 mentioned above.

[0228] FIG. 46A shows a cross-section obtained as shown in FIG. 45. The first contact surface 50112c is positioned substantially parallel to the first outer surface 50122a of the insulating block 50120. The first plurality of electrodes 50112 extend perpendicularly and outwardly from the first outer surface by a first distance. Similarly, the second contact surface 50142c can be positioned substantially parallel to the second outer surface 50122b of the insulating block 50120 and extend substantially perpendicularly and outwardly from the second outer surface by a second distance.

[0229] Figure 46B shows a similar cross-section obtained from an exemplary end effector 50100 that does not have the second flexible circuit 50140. That is, the end effector of Figure 46B has electrodes on only one side (single-sided end effector), as compared to the end effector of Figure 46A (or double-sided end effector) that has electrodes on both sides. Figure 46C shows a modification of Figure 46B where the framework 50130 is not encapsulated within the insulating material and is disposed outside the insulating material 50120. Note that although the cross-section of the framework 50130 is shown as rectangular, the framework 50130 is not limited to such a cross-section and any suitable cross-section can be utilized.

[0230] Figure 46D is similar to the cross-section of Figure 46A but shows a cross-section from an exemplary end effector 50100 that does not have the framework 50130. Note that in embodiments such as Figure 46D, the insulating material 50120 may have additional strength, or may be formed thicker, or may not be, as compared to the insulating material 50120 of embodiments that have the framework 50130. The additional strength of the insulating material 50120 may be to compensate for the absence of the framework 50130.

[0231] Importantly, the end effector 50100 having flush or outwardly protruding electrode contact surfaces 50112c, 50142c can be manufactured without the need to remove material to expose the electrode contact surfaces 50112c, 50142c via the methods and / or fixtures described in more detail below.

[0232] In other embodiments, the first contact surface 50112c can be located substantially in the same plane as the first outer surface 50122a of the insulating block 50120, and the second contact surface 50142c can be located in the same plane as the second outer surface 50122b of the insulating block 50120.

[0233] As described throughout this disclosure, the end effector 50100 according to the described embodiments should be flexible to traverse a patient's vasculature. However, when flexible circuits (e.g., the first flexible circuit 50110 and the second flexible circuit 50140) are disposed far from the neutral axis (e.g., the framework 50130), e.g., when there are layers of insulating material 50120 as shown in FIGS. 45, 46A, and 46B, significant tensile and compressive strains can be applied to both the insulating material 50120 and the flexible circuits. The strain can be highest at the location of the most bent end effector 50100. Accordingly, this disclosure provides a solution to the problem of the strain applied to the circuits when the circuits are bent. FIGS. 47-50B illustrate such an exemplary solution by providing a transition plane zone 50300 positioned proximal to the end effector 210 at the location of the maximum amount of bending of the end effector 50100 when the end effector 50100 is traversing a vasculature structure. In this transition plane zone 50300, the flexible circuits positioned on that side of the end effector 50100 transition from a first plane (see 50130P in FIGS. 48C and 49C) closer to the neutral plane to a second plane farther from the neutral plane.

[0234] Referring now to FIG. 47, the end effector 50100 shown therein is similar to that shown in FIG. 45, but a transition plane zone 50300 is added. The example shown in the figure includes a framework 50130 as described above, and also includes a first flexible circuit 50110 on one side of the framework 50130 and a second flexible circuit 50140 on a second side of the framework 50130. As will be described with reference to FIG. 48A, the end effector 50100 is contemplated to include a flexible circuit on only one side. The proximal end 50250 of the end effector 50100 includes the tails of the respective components, and the tails extend within a sheath 50210 (see FIG. 44) to support the end effector 50100. For purposes of illustration, the flexible circuit can include one or more circuit tails 50310. The example shown in FIG. 47 includes a first flexible circuit 50110 having a first circuit tail 50310a and a second flexible circuit 50140 having a second circuit tail 50310b. The framework 50130 also includes a framework tail 50320 (see also FIG. 48B).

[0235] The transition between the tail section (e.g., tails 50310, 50310a, 50310b, and / or 50322) and the more distal portion of the end effector 50100 may be subject to the greatest bending strain when the end effector 50100 is deployed or used, and thus this can be the location of the transition plane zone 50300, i.e., the transition plane zone 50300 can be positioned distally of the tail section (e.g., tails 50310, 50310a, 50310b, and / or 50322). Referring now to the first flexible circuit 50110, the circuit near the first circuit tail 50310a can be positioned in a plane at a first distance 50302 from the framework 50130. Moving in the distal direction, the first flexible circuit 50110 transitions to a second plane at a second distance 50304 from the framework 50130, and the second distance 50304 is smaller (i.e., a shorter distance) than the first distance 50302. Moving in the distal direction, the first flexible circuit 50110 further transitions to a third plane at a third distance 50306 from the framework 50130, and the third distance 50306 is greater (i.e., a longer distance) than the second distance 50304. Thus, the first flexible circuit 50110 transitions in the transition plane zone 50300 from a plane closer to the neutral plane 50130P to a different plane farther from the neutral plane 50130P (see also FIGS. 48C and 49C). The flexible circuit is spaced from the framework along a vertical axis 50L-L orthogonal to the neutral plane 50130P (see also FIGS. 48C and 49C). The neutral plane in the example shown in FIG. 47 is the plane in which the framework 50130 extends. However, the end effector 50100 does not include the framework 50130 (see FIG. 46D), and in these embodiments, it is contemplated that the neutral plane 50130P can be located at a point within or on the insulating material 50120. It is also contemplated that the end effector 50100 having the framework 50130 can have a neutral axis that is not in the same plane as the framework 50130.Referring back to the transition zone, in some embodiments, the first distance 50302 and the third distance 50306 are the same, and the section of the first flexible circuit 50110 having the electrode 50112 near the distal end 50252 is in the same plane as the tail 50310a (see also the tail 50310 in FIGS. 48A-48C) at the proximal end 50250.

[0236] As shown in FIG. 47, the end effector 50100 can include a flexible circuit (e.g., the first flexible circuit 50110 and the second flexible circuit 50140) that includes a serpentine connection 50322 in a plane on the distal side of the transition plane zone 50300. For example, between two adjacent electrodes, e.g., the proximal electrode 50113a and the distal electrode 50113b, the first flexible circuit 50110 can have a serpentine connection 50322 that provides the illustrated non-linear pattern that allows for a greater degree of bending with respect to the first flexible circuit 50110. In other words, the serpentine connection 50322 allows the first flexible circuit 50110 to bend more easily within a plane that is the same but transverse to the longitudinal axis 50L-L. The serpentine connection 50322 can begin on the distal side of the transition plane zone 50300 as shown, or the serpentine connection 50322 can begin at the transition plane zone 50300.

[0237] Figures 48A - 48C show an embodiment similar to that shown in Figure 47, but the end effector 50100 includes a first flexible circuit 50110 on one side of the framework 50130 and does not include a second circuit (see the second flexible circuit of Figure 47) on the other side. This example may be similar to that shown in Figure 46B, but involves the addition of a transition plane zone 50300 as shown. This example shows how the electrodes 50112 can be arranged on only one side of the end effector 50100. Figure 48A is a top view of the end effector 50100 and shows a side of the end effector 50100 with the first flexible circuit 50110 having the electrodes 50112. Figure 48B, which is a bottom view of the end effector 50100, shows the side of the end effector 50100 without the flexible circuit. These figures also show a single circuit tail 50310 (see Figure 48A) and a framework tail 50320 (see Figure 48B) that extends proximally with the circuit tail 50310.

[0238] Figure 48C is a side view of end effector 50100, showing details of the distance between first flexible circuit 50110 and neutral plane 50130P at different positions along longitudinal axis 50L-L. In Figure 48C, neutral plane 50130P is labeled as being in the same plane as framework 50130, which is by way of several examples. Proximal to transition plane zone 50300, first flexible circuit 50110 is at a first distance 50302, and then first flexible circuit 50110 moves closer to neutral plane 50130P within transition plane zone 50300, i.e., to a second distance 50304. Distally, first flexible circuit 50110 is at a second distance 50304 within the zone, and then first flexible circuit 50110 moves further away from neutral plane 50130P, i.e., to a third distance 50306. End effector 50100 can include first insulating layer 50120 as described above, and first flexible circuit 50110 can travel within or on first insulating layer 50120. In some embodiments, as shown in Figure 48C, at least a portion of first plurality of electrodes 50112 can extend from first outer surface 50122a defined by insulating material 50120. Further, first outer surface 50122a can remain planar and can be parallel to neutral plane 50130P, and first flexible circuit 50110 can travel within or on first insulating layer 50120 with respect to vertical axis 50V-V. As will be understood, the example shown in Figure 47 can appear substantially similar to the example shown in Figure 48C, but the device is in a mirror image state along the plane of framework 50130 such that the left side includes first flexible circuit 50110 and first insulating material 50120 and the right side includes second flexible circuit 50140 and second insulating material. As will be understood and as described above, the first and second insulating materials in this example can be a continuous material. That is, insulating material 50120 can include first insulating material sheet 50120a and second insulating material sheet 50120b that are integrally fused together in proximity to framework 50130 to form a single continuous generally planar insulating mass 50120.

[0239] Figures 49A - 49C show an embodiment similar to that shown in Figures 47 and 48A - 48C, where the end effector 50100 includes a first flexible circuit 50110 on one side of the framework 50130 and a second flexible circuit with an electromagnetic coil 50330 on the opposite side. The first flexible circuit 50110 in Figures 49A - 49C is substantially the same as the circuit described with reference to Figures 48A - 48C. The electromagnetic coil 50330 on the opposite side (Figure 49B) can be used as a position sensor for placing the end effector 50100 within the patient, as described above with reference to Figure 43. For example, the magnetic coil 5032 (see Figure 43) can generate a magnetic field, and the electromagnetic coil 50330 can be used to track those magnetic fields when the device is deployed. In some embodiments, the electromagnetic coil 50330 can be separated into distinct loops, such as the distal loop 50334, the first side loop 50336a, and the second side loop 50336b shown in Figure 49B. The distal loop 50334, the first side loop 50336a, and the second side loop 50336b can detect the magnetic fields individually and triangulate the currents generated in the loops to map the position of the end effector 50100.

[0240] Referring now to FIG. 49C, the electromagnetic coil 50330 on one side of the end effector 50100 can also include the planar shift described above. In the transition plane zone 50300, the electromagnetic coil 50330 positioned on this side of the end effector 50100 transitions from a first plane closer to the neutral plane (see 50130P in FIG. 49C) to a second plane farther from the neutral plane. The electromagnetic coil 50330 can include a coil tail 50332 similar to the circuit tail 50310 described above. The transition between the coil tail 50332 and the more distal portion of the electromagnetic coil 50330 can be subject to the greatest bending strain when the end effector 50100 is deployed or used. Thus, the transition plane zone 50300 is positioned distally of the coil tail 50332. Referring now to the electromagnetic coil 50330, the coils near the coil tail 50332 can be positioned in a plane at a first distance 50338 from the framework 50130. Moving in the distal direction, the electromagnetic coil 50330 transitions to a second plane at a second distance 50340 from the framework 50130, where the second distance 50340 is less than (i.e., shorter than) the first distance 50338. Moving in the distal direction, the electromagnetic coil 50330 further transitions to a third plane at a third distance 50342 from the framework 50130, where the third distance 50342 is greater than (i.e., longer than) the second distance 50340. Thus, the electromagnetic coil 50330 transitions within the transition plane zone 50300 from a plane closer to the neutral plane 50130P (see FIG. 49C) to different planes farther from the neutral plane 50130P.

[0241] As described herein, the end effector 50100 can, here, include any combination of the circuits described herein on either side of the end effector 50100. By way of example, the end effector 50100 can have an electrode circuit (e.g., a first flexible circuit 50110 having electrodes 50112 as shown in FIGS. 48A - 48C) on only one side. The end effector 50100 can have electrode circuits on both sides (e.g., a first flexible circuit 50110 having electrodes 50112 and a second flexible circuit 50140 having electrodes 50142 as shown in FIG. 47). The end effector 50100 can have an electrode circuit on one side and a coil on the other side (e.g., a first flexible circuit 50110 having electrodes 50112 on one side and an electromagnetic coil 50330 on the other side as shown in FIGS. 49A - 49C). The end effector 50100 can have only an electromagnetic coil 50330 on one side and no electrode circuit on the other side.

[0242] FIG. 50A is an exploded perspective view of an end effector 50100 having a transition plane zone 50300 on the proximal side and having alternating levels of insulating sheets (e.g., distal insulating material sheet 50420a, intermediate insulating material sheet 50420b, and / or proximal insulating material sheet 50420c). As described above, the flexible circuits and / or electromagnetic coils described herein can be embedded within and / or on an insulating material (see insulating material 50120, first sheet of insulating material 50120a, and second sheet of insulating material 50120b above). Thus, each circuit can be translated planar as described herein by changing its position within a continuous sheet of insulating material. Planar translation is also contemplated to be created by a separate sheet of material having a thickness equal to the aforementioned distance from 50130P (see, e.g., FIGS. 48C and 49C). Referring now to the example of FIG. 50A, the end effector 50100 can include a distal insulating material sheet 50420a disposed between a framework 50130 and a first plurality of electrodes 50112 (the example shown in FIG. 50A includes electrodes on the distal side, but it is understood that the embodiments shown in both FIGS. 50A and 50B are equally applicable to any of the examples described herein, including examples having an electromagnetic coil 50330). The distal insulating material sheet 50420a can be tapered proximally near the transition plane zone 50300 so as to allow the circuits on that side of the end effector 50100 to translate closer to the neutral plane 50130P. The end effector 50100 can include an intermediate insulating material sheet 50420b disposed within the transition plane zone 50300, whereby at least a portion of the circuits / coils on that side of the end effector 50100 are disposed between the intermediate insulating material sheet 50420b and the framework 50130. For example, in this section, a circuit (e.g., first flexible circuit 50110) is closer to the neutral plane 50130P and more insulating material is disposed over the circuit. The end effector 50100 can also include a proximal insulating material sheet 50420c positioned between the framework 50130 and a tail (e.g., circuit tail 50310).The proximal insulation material sheet 50420c can be tapered distally so as to enable planar transition of the first flexible circuit 50110. The distal insulation material sheet 50420a can have a thickness equal to the third distances 50306, 50342, the intermediate insulation material sheet 50420b can have a thickness equal to the second distances 50304, 50340, and the proximal insulation material sheet 50420c can have a thickness equal to the first distances 50302, 50338.

[0243] Figure 50B is an exploded perspective view of the end effector 50100 having a transition plane zone 50300 on the proximal side and alternating level layers of insulating sheet flexible circuits on both sides of the end effector 50100. The example shown in Figure 50B is substantially the same as the example shown in Figure 50A, except that the example shown in Figure 50B includes a circuit (e.g., the second flexible circuit 50140) on the opposite side of the end effector from the first circuit 50110. The upper side of the image is the same as that shown in Figure 50A, but the circuit tail is labeled as the first circuit tail 50310a. The opposite side includes the second distal insulation material sheet 50420d, the second intermediate insulation material sheet 50420e, and the second proximal insulation material sheet 50420f.

[0244] The second distal insulating material sheet 50420a may be proximally tapered near the transition plane zone 50300 to allow the circuit on that side of the end effector 50100 to migrate closer to the neutral plane 50130P. The end effector 50100 can include a second intermediate insulating material sheet disposed within the transition plane zone 50300 such that at least a portion of the circuit / coil on that side of the end effector 50100 is disposed between the second intermediate insulating material sheet 50420e and the framework 50130. For example, in this section, the circuit (e.g., the second flexible circuit 50140) is closer to the neutral plane 50130P and more insulating material is disposed on the circuit and more on the surface side. The end effector 50100 can also include a second proximal insulating material sheet 50420f positioned between the framework 50130 and the tail (e.g., the second circuit tail 50320b). The second proximal insulating material sheet 50420f can be distally tapered to allow for planar migration of the second flexible circuit 50140. The second distal insulating material sheet 50420d can have a thickness equal to the third distances 50306, 50342, the second intermediate insulating material sheet 50420e can have a thickness equal to the second distances 50304, 50340, and the second proximal insulating material sheet 50420f can have a thickness equal to the first distances 50302, 50338.

[0245] The present disclosure provides a catheter assembly 50200 as shown in FIG. 51 that can include a tubular member 50230 extending along a longitudinal axis 50L-L and configured to deliver an end effector 50100 outside of a sheath 50210. A physician 5024 can operate the catheter 200 using a handle 50220. Suitable examples of the catheter assembly 50200 and its sub-components such as the handle 50220, the sheath 50210, the tubular member 50230, and others not mentioned herein are described in U.S. Patent Application Publication No. 2021 / 0369339, which is incorporated herein by reference and which is included in the appendix of U.S. Patent Application No. 63 / 615,574, which is a priority-claimed application.

[0246] Flexible Serpentine Circuit for Medical Probes (Figs. 52-58) Refer to FIG. 52, which shows an exemplary catheter-based electrophysiology mapping and ablation system 6010. The system 6010 includes a plurality of catheters that are percutaneously inserted by a physician 6024 through the vasculature of a patient 6023 into a chamber or vascular structure of the heart 6012. Typically, a delivery sheath catheter is inserted into the left atrium or right atrium near a desired location in the heart 6012. Thereafter, a plurality of catheters can be inserted into the delivery sheath catheter to reach the desired locations. The plurality of catheters may include a catheter dedicated to sensing intracardiac electrogram (IEGM) signals, a catheter dedicated to ablation, and / or a catheter dedicated to both sensing and ablation. An exemplary catheter 6014 configured to sense IEGM is illustrated herein. The physician 6024 contacts the catheter shaft (i.e., the multi-layer end effector 60100) having the distal tip of the catheter 6014 with the heart wall to sense a target site within the heart 6012. For ablation, the physician 6024, as above, moves the distal end of the ablation catheter to the target site for ablation.

[0247] The catheter 6014 is an exemplary catheter that optionally distributes over an end effector 60100 coupled to the catheter shaft and includes one or preferably a plurality of electrodes 60112 configured to sense IEGM signals, as described in more detail below. The catheter 6014 may additionally include a position sensor embedded within or near the end effector 60100 to track the position and orientation of the end effector 60100. Optionally and preferably, the position sensor is a magnetic-based position sensor that includes a plurality of magnetic coils for sensing three-dimensional (3D) position and orientation.

[0248] Magnetic-based position sensors can operate with a position pad 6025 that includes a plurality of magnetic coils 6032 configured to generate a magnetic field within a predetermined work space. The real-time position of the end effector 60100 of the catheter 6014 can be tracked based on the magnetic field generated by the position pad 6025 and sensed by the magnetic-based position sensor. Details of magnetic-based position sensing techniques are described in U.S. Patent Nos. 5,391,199, 5,443,489, 5,558,091, 6,172,499, 6,239,724, 6,332,089, 6,484,118, 6,618,612, 6,690,963, 6,788,967, 6,892,091, each of which is incorporated herein by reference.

[0249] System 6010 includes one or more electrode patches 6038 disposed for contact with the skin on patient 6023 to establish position referencing of position pad 6025 and impedance-based tracking of electrodes 60112. For impedance-based tracking, current is directed to electrodes 60112 and sensed at electrode-skin patches 6038, whereby the position of each electrode can be triangulated via electrode patches 6038. Details of impedance-based position tracking techniques are described in U.S. Patent Nos. 7,536,218, 7,756,576, 7,848,787, 7,869,865, and 8,456,182, each of which is incorporated herein by reference.

[0250] Recorder 6011 displays an electrocardiogram 6021 captured by body surface ECG electrodes 6018 and an intracardiac electrogram (IEGM) captured by electrodes 60112 of catheter 6014. Recorder 6011 may include pacing capabilities for pacing the rhythm of the heart and / or may be electrically connected to an independent pacer.

[0251] System 6010 may include an ablation energy generator 6050 adapted to transmit ablation energy to one or more electrodes 60112 at a distal tip of a catheter configured to ablate. The energy generated by ablation energy generator 6050 may include radiofrequency (RF) energy, pulsed-field ablation (PFA) energy, or a combination thereof, including unipolar or bipolar high-voltage DC pulses that may be used to effect irreversible electroporation (IRE), but is not limited thereto.

[0252] A patient interface unit (PIU) 6030 is an interface configured to establish electrical communication between the catheter, the electrophysiology equipment, the power source, and a workstation 6055 that controls the operation of system 6010. The electrophysiology equipment of system 6010 may include, for example, multiple catheters, position pads 6025, body surface ECG electrodes 6018, electrode patches 6038, ablation energy generator 6050, and recorder 6011. Optionally and preferably, PIU 6030 additionally includes processing capabilities for implementing real-time calculation of the catheter's position and performing ECG calculations.

[0253] The workstation 6055 includes a memory, a processor unit having a memory or storage device loaded with appropriate operating software, and a user interface function. The workstation 6055 optionally provides a plurality of functions including: (1) modeling the endocardial anatomical structure in three dimensions (3D) and rendering it to display a model or anatomical map 6020 on a display device 6027; (2) displaying on the display device 6027 a representative visual display or image of an activation sequence (or other data) compiled from the recorded potential map 6021 superimposed on the rendered anatomical map 6020; (3) displaying the real-time position and orientation of a plurality of catheters within the heart chamber; and (4) displaying on the display device 27 a site of interest such as a location where ablation energy is being applied. One commercially available product embodying the elements of the system 6010 is available as the CARTO (trademark) 3 system, commercially available from Biosense Webster, Inc., 31 Technology Drive, Suite 200, Irvine, CA, 92618.

[0254] FIG. 53 provides an end effector 60100 according to an embodiment of the present disclosure to achieve enhancements of end effector characteristics such as desired stiffness, electrode contact with a target anatomical structure, and conformity of the end effector disclosed herein to flat, curved, irregular, and / or non-planar tissue surfaces found within the target anatomical structure. The end effector 60100 can include a flexible circuit 60110 that includes a plurality of electrodes 60112, and each electrode of the plurality of electrodes 60112 includes a contact surface 60112c. As used herein, the term "flexible circuit" includes components of electrical traces (e.g., electrical trace 60200) disposed on a substrate (e.g., substrate 60206). Additional information regarding exemplary electrical traces and substrates is provided below with respect to FIGS. 54-56. The end effector 60100 can further include a second flexible circuit 60140 having a second plurality of electrodes (positioned below the electrodes 60112). The second flexible circuit 60140 can be substantially similar to the first flexible circuit 60110, but each electrode of the second plurality of electrodes can have a second contact surface. In some embodiments, the electrodes described herein can include at least one mapping electrode and / or at least one ablation electrode and can be configured to detect electrophysiological signals or transmit ablation energy AC or DC from an energy generator to tissue according to various ablation methods mentioned above, such as RF, IRE, etc.

[0255] The first flexible circuit 60110 and / or the second flexible circuit 60140 (collectively referred to as flexible circuits 60110, 60140) can be disposed on or within the insulating material 60120. The insulating material 60120 can be continuous with the contact surface 60112c such that only the contact surfaces 60112c of at least a portion of the plurality of electrodes 60112 are exposed to the surrounding environment. As used herein, the term "contact surface" includes a substantially flat surface and the portion of the electrode having an edge (single or plural) directly surrounding the flat surface. The electrode 60112 can have a slightly rounded, rounded, or chamfered edge that contacts the tissue along with the substantially flat surface when the end effector 60100 is placed in contact with the tissue. As used herein, "surrounding environment" refers to the organ in which the end effector 60100 is placed, or the external environment such as an operating room before being placed within a biological organ.

[0256] It should be noted that not all of the electrodes 60112 on the end effector 60100 described herein need to be exposed through the insulating material 60120, as these unexposed electrodes can be used to sense far-field signals for noise reduction in proximity to the tissue contact electrodes. Similarly, far-field signals including noise or artifacts can be reduced or canceled for the entire end effector having a reference electrode that contacts only blood and not tissue. Perfusion can be provided using a perfusion port 60163a on one side and a perfusion port 60162b on the other side that are in fluid communication with a perfusion line (not shown) disposed within the catheter shaft. Instead of a perfusion line separate from the catheter shaft, a lumen can be formed by extrusion of the catheter shaft to provide a lumen channel. It should be noted that the port 60163a or 60162b can be configured to have sufficient diverter characteristics such that the perfusion fluid covers the mapping electrodes in the perfusion flow to prevent or reduce thrombus formation.

[0257] The end effector 60100 further includes a framework 60130 that supports flexible circuits 60110, 60140. The framework 60130 can be a flexible material that enables the end effector 60100 to traverse the vascular system. The framework 60130 is contemplated to be a shape memory material such as a copper-aluminum-nickel or preferably a nickel-titanium (NiTi / nitinol) alloy, and / or an alloy containing zinc, copper, and gold. Additional information regarding an exemplary framework 60130 is provided below with respect to FIG. 56. The framework 60130 may be continuous with the insulating material 60120 or may be inside the insulating material 60120. The flexible circuits 60110, 60140 can be disposed directly on the framework 60130 with little or no insulating material 60120 between the two. In other embodiments, the framework 60130 and the flexible circuits 60110, 60140 can be spaced apart along a vertical axis 60V-V on different planes. The framework 60130 can include one or more struts 60142 that extend along the longitudinal axis 60L-L of the end effector 60100. Each strut 60145 can include individual strands of an electrical trace 60200 that extend along the longitudinal axis 60L'-L' of each strut 60142.

[0258] FIG. 54A is a detailed view of an electrical trace 60200 showing a cross-section of alternating grain lengths in their crystal structure according to the techniques of the present disclosure, and FIG. 54B is a detailed view of the rolled and annealed metal. The electrical trace 60200 in any of the embodiments described herein is a conductor that connects one or more electrodes 60112 (see FIG. 53) to a signal and / or current generator (e.g., PIU 6030 of FIG. 52) or receiver. The electrical trace 60200 can be disposed on a substrate 60206 as described with reference to FIG. 55. The electrical trace 60200 can be, for example, a thin film deposited on the substrate 60604 via a lithography and / or etching process, or simply adhered to the substrate 60604 or applied in other ways. The electrical trace 60200 includes a rolled and annealed metal such as copper or an alloy thereof, for example, a rolled and annealed metal including a copper, manganese, and nickel alloy. In a preferred embodiment, rolled annealed copper is used for the electrical trace 60200 as described below. Rolled and annealed metals are preferred due to their flexibility. With respect to manufacturing, the rolled and annealed metal can start as an electrodeposited metal having a more perpendicular grain structure. These electrodeposited metals are then subjected to a rolling and annealing process, which stretches and elongates the grain structure and increases their flexibility and ability to mechanically bend. Further, the rolled structure forms individual grains (i.e., the individual longer grains 60202 shown in FIG. 54B), and all of these grains extend essentially parallel to the direction of the roll of the rolled and annealed metal.

[0259] The alternating structure can be formed, for example, by annealing and / or rolling a metal foil to a greater extent at the location of the longer grain section 60202. FIG. 54A shows such an example where the crystal structure is alternating. However, in practice, it may be difficult to produce these alternating crystal structures, and the crystal structure being alternating may be undesirable as it may provide areas for breakage or other failures. Therefore, an alternative design is to provide a longer grain section 60202 and a shorter grain section 60204 via a cutting process. FIG. 54B shows an example of an electrical trace 60200 rolled such that all the longer grain sections 60202 are arranged parallel to the direction of the roll. The direction of the roll can then be parallel to the direction of each individual strut 60145 (see FIG. 55). Instead of having different grain structures throughout, the roll is substantially uniform along its length, and the electrical trace 60200 is formed to be parallel to a roll of annealed rolled metal (i.e., elongated grains). Thus, the longer grain section 60202 and the shorter grain section 60204 can be generated through the process of cutting or forming the electrical trace 60200 from the rolled and annealed metal. The sheet of rolled and annealed metal can comprise elongated grains extending in the longitudinal direction. Next, the meandering shape of the electrical trace 60200 has longer grains (i.e., longer grain sections 60202) because the section of the meandering shape at the bend is cut parallel to the roll of the metal, and shorter grains (i.e., shorter grain sections 60204) because the section of the meandering shape in the middle of the bend is cut perpendicular to the roll of the metal, so it can be cut from the long sheet of roll-annealed metal. Thus, the alternating structure of the longer grain section 60202 at the bend 60212 and the shorter grain section 60204 outside the bend 60212 facilitates and eases the bending of the electrical trace 60200 at the apex 60216 (see FIG. 56).This example where the meandering shape of the electrical trace 60200 is cut in the direction of the roll of the rolled annealed metal is shown in the examples provided in FIGS. 55 and 56. It will be understood that the electrical trace 60200 can be cut into the rolled and annealed metal via lithography, masking and etching, laser cutting, or similar processes.

[0260] FIG. 55 is a top view of a flexible circuit 60110 having an electrical trace 60200 as shown in FIG. 54B applied to a substrate 60206 according to the techniques of the present disclosure. The substrate 60206 can be made primarily of polyimide. In other embodiments, the substrate 60206 can be made of any of biocompatible polyimide, glass-reinforced epoxy laminate material, copper, or graphene, either alone or in combination. The flexible circuits 60110, 60140 described herein can have a meandering structure that allows for a greater degree of bending with respect to the first flexible circuit 60110, as shown. In other words, the meandering layout can enable the flexible circuits 60110, 60140 to bend more easily in the left-right direction (i.e., left / right on an axis transverse to the longitudinal axis 60L-L) within their planes. Referring again to the lamellar structure of the electrical trace 60200, the rolled annealed metal therein has good bending resistance in the direction of the crystal grains (i.e., along the longitudinal axis 60L-L, see FIG. 52), but the bending resistance orthogonal to the direction of the crystal grains is smaller. Accordingly, the alternating crystal grain structure described above can be aligned with the bent portions 60212 of the electrical trace 60200 (see the bent portions labeled in FIG. 56). Accordingly, the longest continuous sections of the crystal grains are arranged at the positions of the plurality of bent portions 60212 within the meandering structure, and the shorter crystal grain sections 60204 are arranged outside the bent portions (e.g., within a few seconds of the meandering pattern extending more perpendicularly with respect to the longitudinal axis 60L'-L'). This orientation of the crystal grains is to facilitate bending at the apex of the bent portion (see apex 60214 in FIG. 56).

[0261] FIG. 56 is a top view of flexible circuits 60110, 60140 of FIG. 55 applied to a support framework 60130 according to the techniques of the present disclosure. To further facilitate and ease the bending at the bends 60212 of the electrical traces 60200, each strut 60145 of the end effector 60100 can include a wide section 60208 and a narrow section 60210 that extend along the longitudinal axis 60L'-L' of the strut 60145. The terms "wide" and "narrow" refer to the width of the strut 60145 in a direction extending transverse to the longitudinal axis 60L'-L' of the strut 60145. Thus, the narrow section 60210 defines a notch 60218. The wide section 60208 provides more support and thus the strut 60145 is encouraged to bend at the narrow section 60210. Each bend 60212 includes a vertex 60214, and the vertices 60214 of the plurality of bends 60212 extend into the notch 60218 so as to project at least partially beyond the strut 60145. The projecting portion is labeled as projecting portion 60216 in FIG. 56. Considering the design, the vertices 60214 of the bends 60212 of the electrical trace 60200 are located in the narrow section 60210, the aforementioned long crystal grains 60202 of the electrical trace 60200 are located at the bends 60212 of the narrow section 60210, and the strut 60145 is encouraged and eased to bend at the narrow section 60210.

[0262] As will be appreciated, any of the beneficial features described herein can be used alone or in combination with any of the other novel features, so it is not necessary to combine all of the above features. For example, the formation of the electrical trace 60200 having the longer grain section 60202 / shorter grain section 60204 described herein can be used in any flexible circuit including bends. The strut 60145 having the wide section 60208 and the narrow section 60210 can be used in any flexible circuit including the bend 60212 or with any flexible circuit not having the serpentine bend 60212. The exemplary flexible circuits 60110, 60140 shown in FIG. 55 can be used on a framework 60130 not including the wide section 60208 and the narrow section 60210.

[0263] The present disclosure provides a catheter assembly 60300 as shown in FIG. 57, which may include a tubular member 60230 configured to extend along the longitudinal axis 60L-L and deliver the end effector 60100 outside the sheath 60240. A physician 6024 can operate the catheter 60300 using the handle 60220. Suitable examples of the catheter assembly 60300 and its sub-components, such as the handle 60220, the sheath 60240, the tubular member 60230, and others not mentioned herein, are described in U.S. Patent Application Publication No. 2021 / 0369339, which is incorporated herein by reference and is included in the appendix of U.S. Patent Application No. 63 / 615,947, which is a priority-claimed application.

[0264] FIG. 58 is a flowchart showing a method 60700 for manufacturing an end effector 60100 for a medical catheter according to the technology of the present disclosure. The method 60700 includes a step 60705 of forming struts 60145 for a framework 60130 of the end effector 60100, and a step of providing alternating wide sections 60208 and narrow sections 60210 extending along the longitudinal axis 60L'-L' of the struts 60145. The method 60700 includes a step 60710 of disposing an electrical trace 60200 on a substrate 60206. The method 60700 includes a step 60715 of forming a plurality of bends 60212 in the substrate 60206 and the electrical trace 60200. The method 60700 includes a step 60720 of aligning the substrate 60206 and the electrical trace 60200 with the struts 60145 such that the vertices 60214 of the plurality of bends 60212 are disposed at corresponding positions of the narrow sections 60210 of the struts 60145. As described above, the electrical trace 60200 can include a roll annealed metal, preferably roll annealed copper or a copper alloy.

[0265] The method 60700 can end after step 60720, but in other embodiments, additional steps can be performed in accordance with the present disclosure. For example, the method 60700 can include forming a serpentine shape from the roll annealed metal by cutting the electrical trace along the direction of the individual crystal grains of the roll annealed metal such that the individual crystal grains extend parallel to the longitudinal axis of the strut. The electrical trace can have longer crystal grain sections and shorter crystal grain sections. The longer crystal grain sections 60202 can be disposed at the locations of the plurality of bends 60212. The narrow section 60210 defines a notch 60218, and the vertices 60214 of the plurality of bends 60212 extend into the notch 60218 so as to project at least partially beyond the first strut 60145 (see the projection 60216 in FIG. 56).

[0266] The technology of the present disclosure described herein can be further understood in accordance with the following clauses.

[0267] Clause 1: An end effector comprising: an insulating material having a first outer surface and a second outer surface; a framework disposed within the insulating material; and a first flexible circuit including a first plurality of electrodes, the first flexible circuit being disposed longitudinally along the insulating material and at least partially within the insulating material, wherein a first portion of the first flexible circuit is continuous with a first plane and a second portion of the first flexible circuit is continuous with a second plane, the first plane being at a first distance from the framework, the second plane being at a second distance from the framework, the second distance being less than the first distance, and the first flexible circuit.

[0268] Clause 2: The end effector according to clause 1, wherein each electrode of the first plurality of electrodes comprises a first contact surface disposed on the first outer surface.

[0269] Clause 3: The end effector according to clause 1 or 2, wherein the first outer surface is at a first height from the framework, and the first distance is equal to the first height.

[0270] Clause 4: The end effector according to any one of clauses 1 to 3, wherein the first flexible circuit comprises a first surface planar section extending over a first length in the first plane, and the first surface planar section extends parallel to the framework.

[0271] Clause 5: The end effector according to clause 4, wherein a first electrode of the first plurality of electrodes is disposed within the first surface planar section.

[0272] Clause 6: The end effector according to clause 4, wherein a first electrode and a second electrode of the first plurality of electrodes are disposed within the first surface planar section.

[0273] Clause 7: The end effector according to any one of clauses 4 to 6, wherein the first surface planar section is disposed on the first outer surface.

[0274] Clause 8: The first flexible circuit includes a first inner planar section that extends over a second length in a second plane, and the first inner planar section extends parallel to the framework, and the end effector according to any one of Clauses 1 to 7.

[0275] Clause 9: When dependent on any one of Clauses 4 to 7, the end effector according to Clause 8, further comprising a plurality of inner planar sections and a plurality of outer planar sections.

[0276] Clause 10: The second distance is approximately 0 such that a second portion of the first flexible circuit contacts the framework, and the end effector according to any one of Clauses 1 to 9.

[0277] Clause 11: The second portion of the first flexible circuit is disposed in a portion of the end effector configured to be bent during use, and the end effector according to any one of Clauses 1 to 10.

[0278] Clause 12: The first portion and the second portion are connected by an angled section, and the end effector according to any one of Clauses 1 to 11.

[0279] Clause 13: The angle of the angled section changes as the first portion bends or moves relative to the second portion, and the end effector according to Clause 12.

[0280] Clause 14: The second outer surface has a second height from the framework, and the end effector further comprises a second flexible circuit having a plurality of second electrodes, and the second flexible circuit is disposed longitudinally along and at least partially within an insulating material, and a third portion of the second flexible circuit is continuous with a third plane and a fourth portion of the second flexible circuit is continuous with a fourth plane, and the third plane is at a third distance from the framework and the fourth plane is at a fourth distance from the framework, and the fourth distance is shorter than the third distance, and the end effector according to any one of Clauses 1 to 13.

[0281] Clause 15: The end effector according to clause 14, wherein each of the second plurality of electrodes includes a second contact surface disposed on the second outer surface.

[0282] Clause 16: The end effector according to clause 14 or 15, wherein the third distance is equal to the second height.

[0283] Clause 17: The end effector according to any one of clauses 14 to 16, wherein the second flexible circuit includes a second surface planar section extending over the second length in the third plane, and the second surface planar section extends parallel to the framework.

[0284] Clause 18: The end effector according to clause 17, wherein a third electrode of the second plurality of electrodes is disposed within the second surface planar section.

[0285] Clause 19: The end effector according to clause 17, wherein a third electrode and a fourth electrode of the first plurality of electrodes are disposed within the second surface planar section.

[0286] Clause 20: The end effector according to any one of clauses 17 to 19, wherein the second surface planar section is disposed on the second outer surface.

[0287] Clause 21: The end effector according to any one of clauses 14 to 20, wherein the first flexible circuit includes a second inner planar section extending over the second length in the second plane, and the second inner planar section extends parallel to the framework.

[0288] Clause 22: The end effector according to any one of clauses 1 to 21, further comprising a first support layer disposed within an insulating material between the framework and the first flexible circuit.

[0289] Clause 23: The end effector according to clause 22, wherein the first support layer includes a polymer film.

[0290] Clause 24: The first support layer is the end effector according to Clause 22, which includes a mesh polymer.

[0291] Clause 25: The insulating material is the end effector according to any one of Clauses 22 to 24, which includes at least one of thermoplastic polyurethane (TPU), silicone, or siloxane.

[0292] Clause 26: The first support layer is the end effector according to any one of Clauses 22 to 25, which includes at least one of polyamide or ethylene tetrafluoroethylene (ETFE).

[0293] Clause 27: The first flexible circuit is the end effector according to Clause 1, which has a corrugated profile disposed within the insulating material.

[0294] Clause 28: An end effector comprising: an insulating material having a first outer surface and a second outer surface; a framework disposed within the insulating material; a first flexible circuit comprising a first plurality of electrodes, the first flexible circuit being disposed on or within the insulating material, each electrode of the first plurality of electrodes having a first contact surface, the insulating material being continuous with the first contact surface such that only the first contact surfaces of at least a portion of the first plurality of electrodes are exposed to the surrounding environment, and the first support layer being disposed within the insulating material between the framework and the first flexible circuit; An end effector comprising.

[0295] Clause 29: The first support layer is the end effector according to Clause 28, which includes a polymer film.

[0296] Clause 30: The first support layer is the end effector according to Clause 28 or 29, which includes a mesh polymer.

[0297] Clause 31: The insulating material is the end effector according to any one of Clauses 28 to 30, which includes at least one of thermoplastic polyurethane (TPU), silicone, or siloxane.

[0298] Clause 32: The first support layer includes at least one of polyamide or ethylene tetrafluoroethylene (ETFE), and is the end effector according to any one of Clauses 28 to 31.

[0299] Clause 33: A second flexible circuit including a second plurality of electrodes, the second flexible circuit being disposed on or within an insulating material, each electrode of the second plurality of electrodes having a second contact surface, and further including the second flexible circuit, the insulating material being continuous with the second contact surface, and only the second contact surfaces of at least a portion of the second plurality of electrodes being exposed to the ambient environment, and is the end effector according to any one of Clauses 28 to 32.

[0300] Clause 34: The end effector according to Clause 33, further including a second support layer disposed inside the insulating material between the framework and the second flexible circuit.

[0301] Clause 35: The second support layer includes a polymer film, and is the end effector according to Clause 34.

[0302] Clause 36: The second support layer includes a mesh polymer, and is the end effector according to Clause 34.

[0303] Clause 37: The second support layer includes at least one of polyamide or ethylene tetrafluoroethylene (ETFE), and is the end effector according to any one of Clauses 34 to 36.

[0304] Clause 38: The first flexible circuit is disposed longitudinally along the insulating material and at least partially within the insulating material, and is positioned such that a first portion of the first flexible circuit is continuous with a first plane and a second portion of the first flexible circuit is continuous with a second plane, the first plane being at a first distance from the framework, the second plane being at a second distance from the framework, and the second distance being smaller than the first distance, and is the end effector according to any one of Clauses 28 to 37.

[0305] Clause 39: The first outer surface is at a first height from the framework, and the first distance is equal to the first height, the end effector according to Clause 38.

[0306] Clause 40: The first flexible circuit includes a first superficial planar section extending over a first length in a first plane, and the first superficial planar section extends parallel to the framework, the end effector according to Clause 38 or 39.

[0307] Clause 41: The first electrode among the first plurality of electrodes is disposed inside the first superficial planar section, the end effector according to Clause 40.

[0308] Clause 42: The first electrode and the second electrode among the first plurality of electrodes are disposed inside the first superficial planar section, the end effector according to Clause 40.

[0309] Clause 43: The first superficial planar section is disposed on the first outer surface, the end effector according to any one of Clauses 40 to 42.

[0310] Clause 44: The first flexible circuit includes a second inner planar section extending over a second length in a second plane, and the second inner planar section extends parallel to the framework, the end effector according to any one of Clauses 38 to 43.

[0311] Clause 45: When dependent on any one of Clauses 39 to 42, further including a plurality of inner planar sections and a plurality of superficial planar sections, the end effector according to Clause 44.

[0312] Clause 46: The second distance is approximately 0 such that the second portion of the first flexible circuit contacts the framework, the end effector according to any one of Clauses 38 to 45.

[0313] Clause 47: The second portion of the first flexible circuit is the end effector according to any one of Clauses 38 to 46, which is disposed at the bent portion of the end effector.

[0314] Clause 48: The end effector according to any one of Clauses 38 to 47, wherein the first portion and the second portion are connected by an angled section.

[0315] Clause 49: The end effector according to Clause 48, wherein the angle of the angled section changes as the first portion bends or moves relative to the second portion.

[0316] Clause 50: The second outer surface has a second height from the framework, the end effector further includes a second flexible circuit having a plurality of second electrodes, the second flexible circuit is disposed at least partially longitudinally along and inside the insulating material, the third portion of the second flexible circuit is continuous with a third plane, and the fourth portion of the second flexible circuit is continuous with a fourth plane, the third plane is at a third distance from the framework, the fourth plane is at a fourth distance from the framework, and the fourth distance is shorter than the third distance, the end effector according to any one of Clauses 38 to 49.

[0317] Clause 51: The end effector according to Clause 50, wherein each electrode of the plurality of second electrodes includes a second contact surface disposed on the second outer surface.

[0318] Clause 52: The end effector according to Clause 50 or 51, wherein the third distance is equal to the second height.

[0319] Clause 53: The end effector according to any one of Clauses 50 to 52, wherein the second flexible circuit includes a second surface planar section extending over a second length in the third plane, and the second surface planar section extends parallel to the framework.

[0320] Clause 54: The third electrode among the second plurality of electrodes is the end effector according to Clause 53, which is disposed within the second superficial planar section.

[0321] Clause 55: The third and fourth electrodes of the first plurality of electrodes are the end effector according to Clause 53, which are disposed within the second superficial planar section.

[0322] Clause 56: The second superficial planar section is the end effector according to any one of Clauses 53 to 55, which is disposed on the second outer surface.

[0323] Clause 57: The first flexible circuit includes a second inner planar section that extends over a second length within the second plane, and the second inner planar section extends parallel to the framework. The end effector according to any one of Clauses 50 to 56.

[0324] Clause 58: An end effector comprising: an insulating material having a first outer surface and a second outer surface; a framework disposed within the insulating material; and a first flexible circuit having a waveform profile disposed within the insulating material, the first flexible circuit being continuous with the insulating material and having a first portion exposed to the surrounding environment and spaced apart from the framework.

[0325] Clause 59: The end effector according to Clause 58, further comprising a second flexible circuit having a waveform profile disposed within the insulating material, the second flexible circuit being continuous with the insulating material and having a second portion exposed to the surrounding environment, and the second flexible circuit being spaced apart from the framework.

[0326] Clause 60: The end effector according to Clause 59, wherein the first portion of the first flexible circuit comprises a first plurality of electrodes, and the second portion of the second flexible circuit comprises a second plurality of electrodes.

[0327] Clause 61: The end effector according to Clause 60, wherein the first plurality of electrodes are aligned longitudinally along the length of the end effector on the opposite side of the second plurality of electrodes.

[0328] Clause 62: The end effector according to Clause 60, wherein a first position of the first plurality of electrodes is offset longitudinally along the length of the end effector from a second position of the second plurality of electrodes.

[0329] Clause 63: The end effector according to Clause 58, further comprising a first support layer disposed inside an insulating material between the framework and the first flexible circuit.

[0330] Clause 64: The end effector according to Clause 63, wherein the first support layer includes a polymer film.

[0331] Clause 65: The end effector according to Clause 63, wherein the first support layer includes a mesh polymer.

[0332] Clause 66: The end effector according to any one of Clauses 63 to 65, wherein the insulating material includes at least one of thermoplastic polyurethane (TPU), silicone, or siloxane.

[0333] Clause 67: The end effector according to any one of Clauses 63 to 66, wherein the first support layer includes at least one of polyamide or ethylene tetrafluoroethylene (ETFE).

[0334] Clause 68: A catheter end effector comprising: a first flexible circuit extending along a longitudinal axis from a proximal portion to a distal portion of the end effector; and a second flexible circuit extending along the longitudinal axis from the proximal portion to the distal portion of the end effector, the second flexible circuit being substantially in the same plane as the first flexible circuit at the distal portion of the end effector and disposed on the first flexible circuit at the proximal portion of the end effector.

[0335] Clause 69: The end effector according to clause 68, wherein the first flexible circuit includes one or more first electrodes disposed at a distal portion of the first flexible circuit.

[0336] Clause 70: The end effector according to clause 69, wherein a proximal portion of the first flexible circuit includes one or more first electrical contacts corresponding to the one or more first electrodes.

[0337] Clause 71: The end effector according to clause 70, wherein the first flexible circuit includes one or more first traces connecting the one or more first electrical contacts to the one or more first electrodes.

[0338] Clause 72: The end effector according to any one of clauses 69 to 71, wherein the one or more first electrodes include a plurality of pairs of first electrodes disposed on a distal portion of the first flexible circuit.

[0339] Clause 73: The end effector according to clause 72, wherein each first electrode of each pair of the first electrodes is spaced apart by a first predetermined longitudinal distance, and each pair of the first electrodes is spaced apart from an adjacent pair of the first electrodes by a second predetermined longitudinal distance, and the second predetermined longitudinal distance is greater than the first predetermined longitudinal distance.

[0340] Clause 74: The end effector according to clause 73, wherein the first predetermined longitudinal distance is about 100 microns.

[0341] Clause 75: The end effector according to any one of clauses 69 to 74, wherein each of the one or more first electrodes has a length of about 500 microns and a width of about 500 microns.

[0342] Clause 76: The end effector according to any one of clauses 69 to 75, wherein the second flexible circuit includes one or more second electrodes disposed on a distal portion of the second flexible circuit.

[0343] Clause 77: The proximal portion of the second flexible circuit includes one or more second electrical contacts corresponding to one or more second electrodes, and the end effector described in Clause 76.

[0344] Clause 78: The second flexible circuit includes one or more second traces that connect one or more second electrical contacts to one or more second electrodes, and the end effector described in Clause 77.

[0345] Clause 79: One or more second electrodes include a plurality of pairs of second electrodes disposed on the distal portion of the second flexible circuit, and the end effector described in any one of Clauses 76 to 78.

[0346] Clause 80: The end effector further includes a frame. The distal portion of the first flexible circuit is disposed on the frame, the distal portion of the second flexible circuit is disposed on the frame, the proximal portion of the first flexible circuit is disposed on the frame, and the proximal portion of the second flexible circuit is disposed on a part of the proximal portion of the first flexible circuit, and the end effector described in any one of Clauses 75 to 79.

[0347] Clause 81: The frame includes a first spine, a second spine, a third spine, and a fourth spine. The distal portion of the first flexible circuit includes a first loop disposed above the first spine and the second spine, and the distal portion of the second flexible circuit includes a second loop disposed above the third spine and the fourth spine, and the end effector described in Clause 80.

[0348] Clause 82: The frame further includes at least a partial gap between the first spine, the second spine, the third spine, and the fourth spine, and the end effector described in Clause 81.

[0349] Clause 83: The frame includes nitinol, and the end effector described in any one of Clauses 80 to 82.

[0350] Clause 84: The distal portion of the end effector is the end effector according to any one of Clauses 68 to 83, having a width of about 9 millimeters.

[0351] Clause 85: The distal portion of the end effector is the end effector according to any one of Clauses 68 to 84, having a width of about 20 millimeters.

[0352] Clause 86: An end effector for a catheter, comprising a frame extending along a longitudinal axis, the frame having a first side and a second side, a first flexible circuit disposed on the first side of the frame and extending along the longitudinal axis from the proximal portion to the distal portion of the frame, and a second flexible circuit extending along the longitudinal axis from the proximal portion to the distal portion of the frame, the second flexible circuit being disposed on the first side of the frame at the distal portion of the frame and being disposed on the first flexible circuit at the proximal portion of the frame.

[0353] Clause 87: The end effector according to Clause 86, wherein the first flexible circuit comprises one or more first electrodes disposed on the distal portion of the first flexible circuit, and the second flexible circuit comprises one or more second electrodes disposed on the distal portion of the second flexible circuit.

[0354] Clause 88: The end effector according to Clause 87, wherein the one or more first electrodes and the one or more second electrodes are arranged as pairs of electrodes, each pair of electrodes being spaced apart by a first predetermined longitudinal distance, and each pair of electrodes being spaced apart from an adjacent pair of the first electrodes by a second predetermined longitudinal distance, the second predetermined longitudinal distance being greater than the first predetermined longitudinal distance.

[0355] Clause 89: The end effector according to Clause 88, wherein the first predetermined longitudinal distance is about 100 microns.

[0356] Clause 90: A third flexible circuit disposed on a second side of the frame and extending from a proximal portion to a distal portion of the frame along the longitudinal axis, and a fourth flexible circuit extending along the longitudinal axis from a proximal portion to a distal portion of the frame, the fourth flexible circuit being disposed on the second side of the frame at the distal portion of the frame and disposed on top of the third flexible circuit at the proximal portion of the frame. The end effector according to any one of Clauses 86 to 89 further comprises the fourth flexible circuit.

[0357] Clause 91: The third flexible circuit comprises one or more third electrodes disposed on a distal portion of the third flexible circuit, and the fourth flexible circuit comprises one or more fourth electrodes disposed on a distal portion of the second flexible circuit. The end effector according to Clause 90.

[0358] Clause 92: A first flexible circuit extending along the longitudinal axis from a proximal portion to a distal portion of the end effector, and a second flexible circuit extending along the longitudinal axis from a proximal portion to a distal portion of the end effector, the second flexible circuit being substantially in the same plane as the first flexible circuit at the distal portion of the end effector and disposed on top of the first flexible circuit at the proximal portion of the end effector. The end effector for a catheter comprises the second flexible circuit.

[0359] Clause 93: The first flexible circuit can include a first set of electrodes disposed on one side of the first flexible circuit and a second set of electrodes disposed on the opposite side of the first flexible circuit, and the second flexible circuit includes a first set of electrodes disposed on one side of the second flexible circuit and a second set of electrodes disposed on the opposite side of the second flexible circuit. The end effector according to Clause 92.

[0360] Clause 94: A substrate disposed between the first flexible circuit and the second flexible circuit at the proximal portion, and further including a substrate that is in the same plane as the first flexible circuit and the second flexible circuit at the distal portion. The end effector according to Clause 93.

[0361] Clause 95: An end effector for a catheter, comprising an insulating material, a framework disposed within the insulating material and substantially planar along a longitudinal axis, a position sensing loop spaced from the framework and coupled to the insulating material, the position sensing loop including a central loop disposed over a region near a distal portion of the insulating material along the longitudinal axis, and a pair of side loops disposed generally symmetrically with respect to the longitudinal axis, each side loop extending from a proximal portion to a distal portion of the insulating material along the longitudinal axis. An end effector comprising the same.

[0362] Clause 96: The end effector according to Clause 95, wherein the pair of side loops includes a first side loop and a second side loop.

[0363] Clause 97: An end effector for a catheter, comprising an insulating material, a framework disposed within the insulating material and substantially planar along a longitudinal axis, and a position sensing loop disposed generally parallel to the framework and separated from the framework by the insulating material, the position sensing loop including a central loop extending along the longitudinal axis and including a cumulative central loop surface area, a first side loop extending along the longitudinal axis and including a first cumulative side loop surface area, and a second side loop extending along the longitudinal axis and including a second cumulative side loop surface area, wherein the cumulative central loop surface area, the first cumulative side loop surface area, and the second cumulative side loop surface area are each in the range of about 100 to 300 square millimeters.

[0364] Clause 98: The central loop comprises one or more central loop coils, each central loop coil defining a central loop surface area, the first side loop comprises one or more first side loop coils, each first side loop coil defining a first side loop surface area, the second side loop comprises one or more second side loop coils, each second side loop coil defining a second side loop surface area, the cumulative central loop surface area includes the sum of the central loop surface areas of the one or more central loop coils, the first cumulative side loop surface area includes the sum of the first side loop surface areas of the one or more first side loop coils, and the second cumulative side loop surface area includes the sum of the second side loop surface areas of the one or more second side loop coils, the end effector according to Clause 97.

[0365] Clause 99: The central loop comprises a first leg defining a distal end of the central loop, a second leg extending proximally from the first leg in the proximal direction of the end effector, a third leg extending distally from the second leg in the distal direction of the end effector, a fourth leg extending proximally from the third leg in the proximal direction of the end effector, and a fifth leg extending distally from the fourth leg and connecting to the first leg, the end effector according to any one of Clauses 95 to 98.

[0366] Clause 100: The first leg extends arcuately, and the second leg, the third leg, the fourth leg, and the fifth leg extend substantially linearly, the end effector according to Clause 99.

[0367] Clause 101: The second leg, the third leg, the fourth leg, and the fifth leg are angled with respect to the longitudinal axis, the end effector according to Clause 100.

[0368] Clause 102: The central loop includes a plurality of central loop connections, the end effector according to any one of Clauses 95 to 101.

[0369] Clause 103: The first side loop includes a sixth leg defining the distal end of the first side loop, a seventh leg extending proximally from the sixth leg towards the end effector, an eighth leg extending proximally from the seventh leg towards the end effector, and a ninth leg extending distally from the eighth leg and connecting to the sixth leg. The end effector according to any one of Clauses 96 to 102.

[0370] Clause 104: The seventh leg and the ninth leg extend substantially parallel to the longitudinal axis. The end effector according to Clause 103.

[0371] Clause 105: The ninth leg includes a proximal section that is non-parallel to the longitudinal axis and a distal section that is substantially parallel to the longitudinal axis. The end effector according to Clause 103.

[0372] Clause 106: The proximal section bends away from the longitudinal axis. The end effector according to Clause 105.

[0373] Clause 107: The sixth leg and the eighth leg extend in an arc. The end effector according to any one of Clauses 103 to 106.

[0374] Clause 108: The first side loop includes a plurality of first side loop connection parts. The end effector according to any one of Clauses 96 to 107.

[0375] Clause 109: The second side loop includes a tenth leg defining the distal end of the second side loop, an eleventh leg extending proximally from the tenth leg towards the end effector, a twelfth leg extending proximally from the eleventh leg towards the end effector, and a thirteenth leg extending distally from the twelfth leg and connecting to the tenth leg. The end effector according to any one of Clauses 96 to 108.

[0376] Clause 110: The end effector according to Clause 109, wherein the eleventh leg and the thirteenth leg extend substantially parallel to the longitudinal axis.

[0377] Clause 111: The end effector according to Clause 109, wherein the thirteenth leg comprises a proximal section that is non-parallel to the longitudinal axis and a distal section that is substantially parallel to the longitudinal axis.

[0378] Clause 112: The end effector according to Clause 111, wherein the proximal section bends away from the longitudinal axis.

[0379] Clause 113: The end effector according to any one of Clauses 109 to 112, wherein the tenth leg and the third second loop section extend in an arc.

[0380] Clause 114: The end effector according to any one of Clauses 96 to 113, wherein the second side loop includes a plurality of second side loop connection parts.

[0381] Clause 115: The end effector according to any one of Clauses 95 to 114, wherein the central loop is symmetric with respect to the longitudinal axis.

[0382] Clause 116: The end effector according to any one of Clauses 96 to 115, wherein the first side loop and the second side loop are laterally offset from the longitudinal axis.

[0383] Clause 117: The end effector according to any one of Clauses 96 to 116, wherein the second side loop is a mirror image of the first side loop with respect to the longitudinal axis.

[0384] Clause 118: The end effector according to Clause 98, wherein each central loop surface area is at least about 69 square millimeters.

[0385] Clause 119: The end effector according to Clause 98 or 118, wherein each first side loop surface area is at least about 59 square millimeters.

[0386] Clause 120: The end effector according to any one of Clauses 98 and 118 - 119, wherein each second side loop surface area is at least about 59 square millimeters.

[0387] Clause 121: The end effector according to any one of Clauses 96 - 120, wherein the central loop, the first side loop, the second side loop, and the framework are stacked along a vertical axis that is substantially perpendicular to the longitudinal axis.

[0388] Clause 122: The end effector according to any one of Clauses 96 - 121, wherein the insulating material comprises a first non - conductive flexible layer, and the central loop, the first side loop, and the second side loop are separated from the framework by the first non - conductive flexible layer.

[0389] Clause 123: The end effector according to any one of Clauses 96 - 121, wherein the insulating material comprises a first non - conductive flexible layer and a second non - conductive flexible layer, the central loop is separated from the framework by the first non - conductive flexible layer, and the first side loop and the second side loop are separated from the framework by the second non - conductive flexible layer.

[0390] Clause 124: The end effector according to any one of Clauses 96 - 123, wherein the framework extends in a first plane, the intermediate loop extends in a second plane, the first side loop extends in a third plane, and the second side loop extends in a fourth plane.

[0391] Clause 125: The end effector according to Clause 124, wherein the first plane is parallel to the second plane, the third plane, and the fourth plane.

[0392] Clause 126: The end effector according to any one of Clauses 124 - 125, wherein the third plane and the fourth plane are in the same plane.

[0393] Clause 127: The end effector according to any one of Clauses 124 to 126, wherein the second plane is coplanar with the third plane and the fourth plane.

[0394] Clause 128: The end effector according to any one of Clauses 124 to 126, wherein the second plane is on the first side of the first plane along the vertical axis, and the second plane and the third plane are on the second opposite side of the first plane along the vertical axis.

[0395] Clause 129: The end effector according to any one of Clauses 97 to 128, having an overall length of about 20 to 25 millimeters and an overall width of about 9 to 12 millimeters.

[0396] Clause 130: The end effector according to any one of Clauses 95 to 129, further comprising at least one flexible circuit disposed generally parallel to the framework and separated from the framework by an insulating material, the flexible circuit including a plurality of electrodes disposed on the flexible circuit.

[0397] Clause 131: A framework for an end effector of a medical device, comprising a base configured to connect to an elongated shaft of the medical device, the base extending distally along a longitudinal axis, and a first spine loop extending from the base along the longitudinal axis, the first spine loop including a curved first segment connected to the base and extending distally along the longitudinal axis therefrom, a second segment connected to the curved first segment and having an arcuate configuration extending therefrom, a third segment connected to the second segment and extending proximally along the longitudinal axis therefrom, a curved fourth segment connected to the base and extending distally along the longitudinal axis therefrom, a fifth segment connected to the fourth segment and having an arcuate configuration extending therefrom, a sixth segment connected to the fifth segment and extending proximally along the longitudinal axis therefrom, and a seventh arcuate segment connecting the third segment and the sixth segment. The framework comprising the first spine loop.

[0398] Clause 132: The arcuate seventh segment is connected to the base and is the framework according to Clause 131.

[0399] Clause 133: The first spine loop defines two finger-shaped openings, and the base includes a first section configured to connect to an elongated shaft and a second section extending into the finger-shaped opening for connection to the seventh segment, which is the framework according to Clause 132.

[0400] Clause 134: The framework according to Clause 133, wherein the second section of the base defines one or more apertures therein.

[0401] Clause 135: The framework according to Clause 133, further comprising a second spine loop connected to the first section of the base and extending along the longitudinal axis therefrom.

[0402] Clause 136: The second spine loop includes a pair of end sections connected to the first section of the base, which is the framework according to Clause 135.

[0403] Clause 137: The second spine loop includes a pair of end sections, one end section being connected to the first section of the base and the other end section being connected to the first segment of the first spine loop, which is the framework according to Clause 135.

[0404] Clause 138: The framework according to any one of Clauses 135 to 137, further comprising a third spine loop connected to the first section of the base and extending along the longitudinal axis therefrom.

[0405] Clause 139: The third spine loop includes a pair of end sections connected to the first section of the base, which is the framework according to Clause 138.

[0406] Article 140: The third spine loop includes a pair of end sections, where one end section connects to the first section at the base, and the other end section connects to the fourth segment of the first spine loop, the framework described in Article 138.

[0407] Article 141: The first segment, the second segment, and the third segment are symmetric with the fourth segment, the fifth segment, and the sixth segment with respect to the longitudinal axis, the framework described in any one of Articles 131 - 140.

[0408] Article 142: The longitudinal axis substantially bisects the seventh segment, the framework described in any one of Articles 131 - 141.

[0409] Article 143: The longitudinal axis is coaxial with the longitudinal center of the framework, the framework described in any one of Articles 131 - 142.

[0410] Article 144: The framework described in any one of Articles 131 - 143, including a superelastic material.

[0411] Clause 145: A framework for an end effector of a medical device, comprising a base configured to connect to an elongate shaft of the medical device, the base extending along a longitudinal axis, a first spine loop extending from the base along the longitudinal axis, the first spine loop being connected to the base and having a first segment extending distally from there along the longitudinal axis, a second segment connected to the first segment and extending inwardly therefrom toward the longitudinal axis, and a third segment connected to the second segment and extending distally from there along the longitudinal axis; a second spine loop extending from the base along the longitudinal axis, the second spine loop being connected to the base and having a first segment extending distally from there along the longitudinal axis, a second segment connected to the first segment and extending inwardly therefrom toward the longitudinal axis, and a third segment connected to the second segment and extending distally from there along the longitudinal axis; a third spine loop connecting the third segment of the first spine loop and the third segment of the second spine loop; and a finger-shaped opening defined by the base, the first spine loop, the second spine loop, and the third spine loop.

[0412] Clause 146: The framework according to Clause 145, wherein the third spine loop includes a wavy configuration.

[0413] Clause 147: The framework according to any one of Clauses 145 to 146, wherein the third segment of the first spine loop and the third segment of the second spine loop extend substantially parallel to the longitudinal axis.

[0414] Clause 148: The framework according to any one of Clauses 145 to 147, wherein the longitudinal axis bisects the third segment.

[0415] Clause 149: The framework according to any one of Clauses 145 to 148, wherein the longitudinal axis is coaxial with the longitudinal center of the framework.

[0416] Clause 150: The framework according to any one of Clauses 145 to 149, comprising a superelastic material.

[0417] Clause 151: An end effector for a medical device, comprising a base configured to connect to an elongate shaft of the medical device, the base extending along a longitudinal axis, a first spine loop extending from the base along the longitudinal axis, a second spine loop extending from the base along the longitudinal axis, a third spine loop connecting the first spine loop and the second spine loop, a finger-shaped opening defined by the base, the first spine loop, the second spine loop, and the third spine loop, an insulating material disposed on the framework, and a flexible circuit comprising a first section vertically spaced from the framework along a vertical axis by the insulating material and a second section offset from the first section along the vertical axis and extending into the finger-shaped opening.

[0418] Clause 152: The end effector according to Clause 151, wherein the first section of the flexible circuit is disposed parallel to the framework plane of the framework.

[0419] Clause 153: The end effector according to any one of Clauses 151 to 152, wherein the second section of the flexible circuit extends along the framework plane of the framework.

[0420] Clause 154: The end effector according to any one of Clauses 152 to 153, wherein the framework plane extends along the neutral plane of the end effector.

[0421] Clause 155: The end effector according to any one of Clauses 151 to 154, wherein the first section of the flexible circuit including a peripheral section is disposed directly above the first spine loop, the second spine loop, and the third spine loop.

[0422] Clause 156: The second section of the flexible circuit includes a peripheral section extending along the inner surface of the first spine loop and the inner surface of the second spine loop, and is the end effector according to any one of Clauses 151 to 155.

[0423] Clause 157: The end effector further includes a transition section connecting the first section and the second section, and the transition section is disposed proximal to the connection segment of the first spine loop and the connection segment of the second spine loop along the longitudinal axis, and is the end effector according to any one of Clauses 151 to 156.

[0424] Clause 158: A framework for the end effector of a medical device, the framework extending along a longitudinal axis that is coaxial with the longitudinal center of the framework and configured to connect to the elongated shaft of the medical device, a base extending along the longitudinal axis, a first spine loop extending from the base on a first side of the longitudinal axis, the first spine loop having a first distal end connected to the base at a first longitudinal position along the longitudinal axis and a second distal end connected to the base at a second longitudinal position along the longitudinal axis, a second spine loop extending from the base on a second side of the longitudinal axis, the second spine loop having a first distal end connected to the base at a third longitudinal position along the longitudinal axis and a second distal end connected to the base at a fourth longitudinal position along the longitudinal axis, and the first longitudinal position, the second longitudinal position, the third longitudinal position, and the fourth longitudinal position are respectively disposed along the longitudinal axis such that the framework is asymmetric with respect to the longitudinal axis.

[0425] Clause 159: The first spine loop and the base define a first finger-shaped opening, the second spine loop and the base define a second finger-shaped opening, and the first finger-shaped opening has an area smaller than the area of the second finger-shaped opening, and is the framework according to Clause 158.

[0426] Clause 160: The base is the framework according to any one of Clauses 158 to 159, which is symmetric with respect to the longitudinal axis.

[0427] Clause 161: The base is a first section configured to connect to an elongated shaft, the first section to which the first distal end of the first spine loop and the first distal end of the second spine loop are connected, and a second section extending from the first section, the second section to which the second distal end of the first spine loop and the second distal end of the second spine loop are connected, the framework according to any one of Clauses 158 to 160.

[0428] Clause 162: The second distal end of the first spine loop is connected to the proximal end of the second section, and the second distal end of the second spine loop is connected to the distal end of the second section, the framework according to Clause 161.

[0429] Clause 163: The second distal end of the first spine loop is connected to the distal end of the second section, and the second distal end of the second spine loop is connected to the distal end of the second section, the framework according to Clause 161.

[0430] Clause 164: The first longitudinal position and the third longitudinal position are the same, the framework according to any one of Clauses 158 to 162.

[0431] Clause 165: The second longitudinal position and the fourth longitudinal position are separated by a predetermined distance along the longitudinal axis, the framework according to any one of Clauses 158 to 162 and Clause 164.

[0432] Clause 166: The first longitudinal position and the third longitudinal position are separated by a predetermined distance along the longitudinal axis, the framework according to any one of Clauses 158 to 161 and Clause 163.

[0433] Article 167: The second longitudinal position and the fourth longitudinal position are the same, and the framework described in any one of Articles 158 to 161, Article 163, and Article 166.

[0434] Article 168: The base, the first spine loop, and the second spine loop are monolithic members, and the framework described in any one of Articles 158 to 167.

[0435] Article 169: An end effector for a medical device, comprising a framework that is substantially planar along a longitudinal axis, a flexible circuit vertically spaced from the framework along a vertical axis, and an insulating material in which the framework and the flexible circuit are disposed inside. The insulating material defines a first outer edge of the end effector, and the first outer edge includes a processing portion configured to facilitate folding the end effector into a sheath. The processing portion includes at least one of a rounded notch extending along at least a portion of the first outer edge, a tapered notch extending along at least a portion of the first outer edge, a plurality of incisions defined along at least a portion of the first outer edge, or a lubricious coating extending along at least a portion of the first outer edge, and the insulating material.

[0436] Article 170: The processing portion includes a rounded notch, and the insulating material further includes a second outer edge including a second outer edge processing portion configured to facilitate folding the end effector into the sheath of the end effector. The second outer edge processing portion includes at least one of a rounded notch extending along at least a portion of the second outer edge, a tapered notch extending along at least a portion of the second outer edge, a plurality of incisions defined along at least a portion of the second outer edge, or a lubricious coating extending along at least a portion of the second outer edge, and the insulating material. The end effector according to Article 169.

[0437] Clause 171: The processing part has a tapered cut, and the insulating material further includes a second outer edge part including a second outer edge processing part configured to facilitate folding of the sheath of the end effector. The second outer edge processing part includes at least one of a rounded cut extending along at least a part of the second outer edge, a tapered cut extending along at least a part of the second outer edge, a plurality of cuts defined along at least a part of the second outer edge, or a lubricating coating extending along at least a part of the second outer edge. The end effector according to Clause 169.

[0438] Clause 172: The processing part has a plurality of cuts. The end effector according to any one of Clauses 169 to 171.

[0439] Clause 173: The processing part has a lubricating coating. The end effector according to any one of Clauses 169 to 172.

[0440] Clause 174: A method of using a medical device, the method including: a step of retracting an end effector into a sheath along a longitudinal axis from a deployed configuration, the end effector having a substantially planar shape in the deployed configuration; and a step of folding the end effector into a retracted configuration such that outer edges of the end effector slide past each other, the end effector having a substantially cylindrical shape or a helical shape in the retracted configuration, and a first outer edge of the outer edges including a processing part including at least one of a rounded cut extending along at least a part of the first outer edge, a tapered cut extending along at least a part of the first outer edge, a plurality of cuts defined along at least a part of the first outer edge, or a lubricating coating extending along at least a part of the first outer edge.

[0441] Clause 175: A method of manufacturing an end effector for a medical device, the method comprising: forming a framework that is substantially planar along a longitudinal axis; disposing a flexible circuit on the framework; heating an insulating material; reflowing the insulating material so that the insulating material encapsulates the framework and the flexible circuit; and treating an outer edge portion of the insulating material, the treating being configured so that the outer edge portion has at least one of a reduced stiffness or a reduced coefficient of friction relative to a coefficient of friction or stiffness of the outer edge portion prior to treatment.

[0442] Clause 176: An end effector comprising a plurality of planar frameworks extending along a plane, each of the frameworks having a first plane and an opposing second plane, each of the first and second planes including at least one pair of electrodes, at least one pair of electrodes being configured to contact cardiovascular tissue, each pair of electrodes including first and second electrodes spaced from each other along a longitudinal axis by a gap area located between the electrodes, the gap area having a gap distance relative to the longitudinal axis, (i) a length of one of the electrodes along the longitudinal axis being greater than or equal to the gap distance, (ii) a ratio of an area defined by the gap area to an area of one of the electrode areas being less than or equal to 1, the gap distance being determined by a product with the following conversion factor, the end effector. -1 The end effector is determined by the product with the following conversion factor.

[0443] Clause 177: An end effector comprising: a framework defining a neutral plane; a first insulating material disposed on at least one side of the framework; and a first flexible circuit disposed within the first insulating material and spaced from the framework along a vertical axis orthogonal to the neutral plane, the first flexible circuit including a transition planar zone located proximate a proximal end of the first flexible circuit, the first flexible circuit transitioning within the transition planar zone from a first plane closer to the neutral plane to a second plane further from the neutral plane.

[0444] Clause 178: The end effector according to clause 177, wherein the first flexible circuit further comprises a first plurality of electrodes disposed on a portion of the first flexible circuit that is continuous with the second plane and distal to the transition plane zone.

[0445] Clause 179: The end effector according to clause 177 or 178, wherein the proximal end of the first flexible circuit comprises a tail extending proximally from the transition plane zone, and the tail transitions from the first plane to a proximal plane that is further from the neutral plane within the transition plane zone.

[0446] Clause 180: The end effector according to clause 179, wherein the proximal plane and the second plane are in the same plane.

[0447] Clause 181: The end effector according to any one of clauses 178 to 180, wherein at least a portion of the first plurality of electrodes extends from a surface defined by the first insulating material.

[0448] Clause 182: The end effector according to any one of clauses 177 to 181, further comprising a second insulating material disposed on at least one side of the framework and a second flexible circuit disposed within the second insulating material, the second flexible circuit being spaced from the framework along a vertical axis and transitioning within the transition plane zone from a third plane closer to the neutral plane to a fourth plane further from the neutral plane.

[0449] Clause 183: The end effector according to clause 182, wherein the second flexible circuit comprises a second plurality of electrodes.

[0450] Clause 184: The end effector according to clause 183, wherein at least a portion of the second plurality of electrodes extends from a surface defined by the second insulating material.

[0451] Clause 185: The end effector according to clause 183 or 184, wherein the second plurality of electrodes are located on a portion of the second flexible circuit that is in the fourth plane and distal to the transition plane zone.

[0452] Clause 186: The second flexible circuit further includes an electromagnetic planar coil, and the end effector described in Clause 182.

[0453] Clause 187: The second insulating material is disposed on the side of the framework opposite to the first insulating material, and the end effector described in Clause 182.

[0454] Clause 188: The electromagnetic coil of the second flexible circuit includes a distal loop and two side loops positioned close to the surface defined by the second insulating material, and the end effector described in Clause 187.

[0455] Clause 189: The proximal end of the second flexible circuit includes a tail extending proximally from the transition plane zone away from the electromagnetic coil, and the tail transitions from a third plane to a proximal plane farther from the neutral plane within the transition plane zone, and the end effector described in Clause 187.

[0456] Clause 190: The proximal plane and the fourth plane are on the same plane, and the end effector described in Clause 189.

[0457] Clause 191: Two adjacent electrodes among the first plurality of electrodes are connected by a serpentine connection, and the end effector described in any of the preceding clauses subordinate to Clause 178.

[0458] Clause 192: The serpentine connection extends completely within the second plane, and the end effector described in Clause 191.

[0459] Clause 193: The first insulating material includes a distal insulating material sheet disposed between the framework and the first plurality of electrodes, and an intermediate insulating material sheet disposed within the transition plane zone, and at least a part of the first flexible circuit is disposed between the intermediate insulating material sheet and the framework, and the end effector described in Clause 178.

[0460] Clause 194: The proximal end of the first flexible circuit includes a tail extending proximally from the transition plane zone, and the first insulating material includes a proximal insulating material sheet positioned between the framework and the tail. The end effector according to Clause 193.

[0461] Clause 195: The end effector according to Clause 193 or 194 further includes a second insulating material disposed on at least one side of the framework and a second flexible circuit including a second plurality of electrodes and disposed within the second insulating material, the second flexible circuit transitioning within the transition plane zone from a third surface closer to the neutral plane to a fourth surface farther from the neutral plane.

[0462] Clause 196: The second insulating material includes a second distal insulating material sheet disposed between the framework and the second plurality of electrodes and a second intermediate insulating material sheet disposed within the transition plane zone. At least a portion of the first flexible circuit is disposed between the second intermediate insulating material sheet and the framework. The end effector according to Clause 195.

[0463] Clause 197: The proximal end of the second flexible circuit includes a second tail extending proximally from the transition plane zone and away from the second plurality of electrodes, and the second insulating material includes a second proximal insulating material sheet positioned between the framework and the second tail. The end effector according to Clause 196.

[0464] Clause 198: The second insulating material is disposed on the side of the framework opposite the first insulating material. The end effector according to Clause 195.

[0465] Clause 199: The first insulating material and the second insulating material include a single insulating material. The end effector according to any one of Clauses 177 to 198.

[0466] Clause 200: At least a portion of the first plurality of electrodes is embedded in the surface defined by the first insulating material. The end effector according to any one of Clauses 178 to 180.

[0467] Clause 201: An end effector comprising a framework with a first strut extending along a longitudinal axis, and a flexible circuit aligned with the first strut and having a substrate supporting an electrical trace, the flexible circuit having a plurality of bends such that when extending along the longitudinal axis of the strut it has a serpentine shape, and the first strut of the framework having alternating wide sections and narrow sections extending along the longitudinal axis of the strut, the narrow sections being positioned adjacent to respective vertices of the plurality of bends.

[0468] Clause 202: The end effector according to clause 201, wherein the narrow section defines a notch, and the vertices of the plurality of bends extend into the notch so as to project at least partially beyond the first strut.

[0469] Clause 203: The end effector according to clause 201 or 202, wherein the first strut comprises a first plurality of electrodes positioned between separate sections of the plurality of bends.

[0470] Clause 204: The end effector according to any one of clauses 1 to 203, wherein the electrical trace comprises rolled annealed metal.

[0471] Clause 205: The end effector according to clause 204, wherein the rolled annealed metal is rolled annealed copper.

[0472] Clause 206: The end effector according to clause 204 or 205, wherein the serpentine shape is formed from the rolled annealed metal along the direction of individual crystal grains of the rolled annealed metal such that the individual crystal grains extend parallel to the longitudinal axis of the strut.

[0473] Clause 207: The end effector according to any one of clauses 204 to 206, wherein the electrical trace has long crystal grain sections and short crystal grain sections arranged alternately.

[0474] Clause 208: The end effector according to clause 207, wherein the longer grain section is positioned at the locations of the plurality of bends.

[0475] Clause 209: The end effector according to clause 208, wherein the electrical trace transitions to a shorter grain section that is intermediate the plurality of bends.

[0476] Clause 210: The first strut is one of a plurality of struts on the framework, the flexible circuit includes electrical traces extending along each of the plurality of struts, and each of the electrical traces includes a plurality of bends within the flexible circuit; the end effector according to any one of clauses 201 - 209. 【0477...

Claims

1. An end effector for a catheter, comprising: an insulating material, a framework disposed within the insulating material, the framework being substantially planar along a longitudinal axis and having a first plane and a second plane opposite the first plane; a plurality of generally planar electrodes aligned along each of the first plane and the second plane, each electrode being spaced apart from the first plane or the second plane; and a position sensing loop spaced from the framework and coupled to the insulating material, the position sensing loop comprising: a central loop disposed above the longitudinal axis over a region near a distal portion of the insulating material; and a pair of side loops disposed generally symmetrically with respect to the longitudinal axis, each side loop extending along the longitudinal axis from a proximal portion to a distal portion of the insulating material. The position sensing loop. The end effector.

2. The end effector according to claim 1, wherein the pair of side loops includes a first side loop and a second side loop.

3. The first side loop comprises: a sixth leg defining a distal end of the first side loop; a seventh leg extending proximally from the sixth leg of the end effector; an eighth leg extending proximally from the seventh leg of the end effector; and a ninth leg extending distally from the eighth leg of the end effector and connecting to the sixth leg. The end effector according to claim 2.

4. The end effector according to claim 2, wherein the first side loop comprises a plurality of first side loop connectors.

5. The second side loop comprises: a tenth leg defining a distal end of the second side loop; an eleventh leg extending proximally from the tenth leg of the end effector; a twelfth leg extending proximally from the eleventh leg of the end effector; and a thirteenth leg extending distally from the twelfth leg of the end effector and connecting to the tenth leg. The end effector according to claim 2.

6. The end effector according to claim 2, wherein the second side loop comprises a plurality of second side loop connectors.

7. The end effector according to claim 2, wherein the first side loop and the second side loop are offset laterally from the longitudinal axis.

8. The end effector according to claim 2, wherein the second side loop is a mirror image of the first side loop with respect to the longitudinal axis.

9. The end effector according to claim 2, wherein the central loop, the first side loop, the second side loop, and the framework are stacked along a vertical axis that is substantially perpendicular to the longitudinal axis.

10. The insulating material includes a first non-conductive flexible layer, and the central loop, the first side loop, and the second side loop are separated from the framework by the first non-conductive flexible layer. The end effector according to claim 2.

11. The insulating material includes a first non-conductive flexible layer and a second non-conductive flexible layer, the central loop is separated from the framework by the first non-conductive flexible layer, and the first side loop and the second side loop are separated from the framework by the second non-conductive flexible layer. The end effector according to claim 2.

12. The end effector according to claim 2, wherein the framework extends in a first plane, the intermediate loop extends in a second plane, the first side loop extends in a third plane, and the second side loop extends in a fourth plane.

13. The end effector according to claim 12, wherein the first plane is parallel to the second plane, the third plane, and the fourth plane.

14. The end effector according to claim 12, wherein the second plane is on a first side of the first plane along a vertical axis, and the second plane and the third plane are on a second opposite side of the first plane along the vertical axis.

15. The end effector according to claim 1, wherein the central loop is symmetric with respect to the longitudinal axis.

16. The central loop includes a first leg defining a distal end of the central loop, a second leg extending proximally from the first leg in a proximal direction of the end effector, and a third leg extending distally from the second leg in a distal direction of the end effector. A fourth leg extending proximally of the end effector from the third leg; A fifth leg extending distally of the end effector from the fourth leg and connected to the first leg; The end effector according to claim 1, comprising:

17. The insulating material defines a first outer edge of the end effector, the first outer edge comprising a processing portion configured to facilitate folding the end effector within a sheath, the processing portion being a rounded cutout extending along at least a portion of the first outer edge, a tapered cutout extending along at least a portion of the first outer edge, a plurality of incisions defined along at least a portion of the first outer edge, or a lubricious coating extending along at least a portion of the first outer edge, the end effector according to claim 1, including at least one of the foregoing.

18. The end effector according to claim 1, further comprising at least one flexible circuit disposed generally parallel to the framework and separated from the framework by the insulating material, the flexible circuit including a plurality of electrodes disposed on the flexible circuit.

19. An end effector for a catheter, comprising: Insulating material; A framework disposed within the insulating material, the framework being substantially planar along a longitudinal axis; and A position sensing loop disposed generally parallel to the framework and separated from the framework by the insulating material, the position sensing loop including: A central loop extending along the longitudinal axis and including a cumulative central loop surface area; A first side loop extending along the longitudinal axis and including a first cumulative side loop surface area; A second side loop extending along the longitudinal axis and including a second cumulative side loop surface area; The end effector, comprising a position sensing loop; The cumulative central loop surface area, the first cumulative side loop surface area, and the second cumulative side loop surface area are each in the range of about 100 to about 300 square millimeters.

20. The central loop includes one or more central loop coils, each central loop coil defining a central loop surface area, the first side loop includes one or more first side loop coils, each first side loop coil defining a first side loop surface area, the second side loop includes one or more second side loop coils, each second side loop coil defining a second side loop surface area, The cumulative central loop surface area includes the sum of the central loop surface areas of the one or more central loop coils, The first cumulative side loop surface area includes the sum of the first side loop surface areas of the one or more first side loop coils, The second cumulative side loop surface area includes the sum of the second side loop surface areas of the one or more second side loop coils, the end effector according to claim 19.

Images