Encapsulated catheters, systems, and associated methods

Abstract

Disclosed herein is an end effector for a catheter, the end effector comprising a flexible circuit, the flexible circuit comprising a plurality of electrodes. The flexible circuit is at least partially positioned within the insulating material. In some examples, the end effector includes a frame spaced apart from the flex circuit, and one or more position sensing loops.

Description

[0001] Cross - Reference to Related Applications

[0002] This application claims the benefit of priority of the following patent applications: U.S. Provisional Patent Application No. 63 / 615,600, filed on December 28, 2023 (Attorney Docket No.: BIO6917USPSP1–253757.000438), U.S. Provisional Patent Application No. 63 / 615,902, filed on December 29, 2023 (Attorney Docket No.: BIO6926USPSP1--253757.000471), U.S. Provisional Patent Application No. 63 / 615,534, filed on December 28, 2023 (Attorney Docket No.: BIO6925USPSP1--253757.000472), U.S. Provisional Patent Application No. 63 / 615,556, filed on December 28, 2023 (Attorney Docket No.: BIO6924USPSP1--253757.000473), U.S. Provisional Patent Application No. 63 / 615,574, filed on December 28, 2023 (Attorney Docket No.: BIO6923USPSP1--253757.000474), and U.S. Provisional Patent Application No. 63 / 615,947, filed on December 29, 2023 (Attorney Docket No.: BIO6922USPSP1--253757.000475), all of which are hereby incorporated by reference as if fully set forth herein. Field of the Invention

[0003] The present disclosure generally relates to minimally invasive medical devices and, more particularly, to cardiac mapping catheters having flexible end effectors. Background of the Invention

[0004] When a region of cardiac tissue abnormally conducts electrical signals to adjacent tissue, arrhythmias such as atrial fibrillation occur, disrupting the normal cardiac cycle and causing an irregular heartbeat. The source of the unwanted signals can be located in the tissue of the atria or ventricles. The unwanted signals conduct through the cardiac tissue to other locations, where these signals can initiate or sustain an arrhythmia.

[0005] Procedures for treating arrhythmias include surgically disrupting the source of the arrhythmia-causing signals and disrupting the conduction pathways for such signals. Recently, it has been found that by mapping the electrical properties of the endocardium and cardiac volume and selectively ablating cardiac tissue by applying energy, the propagation of unwanted electrical signals from one part of the heart to another can be stopped or altered. Ablation methods disrupt unwanted electrical pathways by forming non-conductive ablation lesions.

[0006] In this two-step procedure (including mapping and ablation), electrical activity at various points in the heart is sensed and measured, typically by advancing a catheter containing one or more electrical sensors into the heart and acquiring data at multiple points. This data is then used to select a target region for ablation.

[0007] To obtain higher mapping resolution, it is desirable for the mapping catheter to closely conform to the target anatomy. For mapping within the atrium or ventricle (e.g., the apex of the ventricle), it is desirable for the catheter to collect a relatively large amount of data signals over a short time span. It is also desirable for such a catheter to allow sufficient contact of the electrodes with different tissue surfaces, e.g., flat, curved, irregular, or non-planar surface tissues, and to be collapsible for non-invasive advancement and withdrawal through the patient's vasculature. Existing catheters typically require a rigid internal structural member to ensure maintenance of a pre-determined configuration. However, this rigidity is disadvantageous when operating within a human organ as it can prevent electrode contact with the tissue.

[0008] Other catheters may include a flexible end effector designed to overcome this drawback. These catheters can include layered components that are time-consuming, complex, and expensive to manufacture and assemble. Many times, the electrode contact surfaces of these end effectors must be exposed through the encapsulating material via laser cutting or mechanical removal, both of which increase labor time and production costs. In addition, when these catheters are advanced through the heart, it is not easy to track their position using conventional methods. Moreover, the design of the rigid internal structural member has many drawbacks, such as the flexible circuit interconnects being prone to breakage and the contraction pattern being difficult to predict. Therefore, an improved end effector for a catheter that addresses these problems is needed.

[0009] In addition, to prevent unwanted damage to the area surrounding the target anatomy, it may be desirable to provide an end effector with the smallest possible footprint. It may also be desirable to provide a large number of electrodes on the end effector to collect a larger amount of data signals and / or make full use of the available surface area provided by the end effector. However, a larger number of electrodes increases the number of corresponding electrical traces required for precise signal transmission. Given the small footprint of the end effector, it may be difficult to provide a large number of electrical traces. Therefore, an improved end effector for a catheter that addresses these problems is needed. Summary of the Invention

[0010] The following disclosure presents solutions to the above problems.

[0011] To achieve a time- and cost-effective manufacture of an end effector that enhances the functionality of the mapping and ablation catheter mentioned in the background section, the present disclosure relates to an end effector that can be easily manufactured and has enhanced performance aspects of mapping and ablation catheters, including but not limited to: mapping resolution, contact of the electrodes with the target anatomy, delivery of the end effector to the target anatomy, biocompatibility, end effector stiffness, and atraumaticity.

[0012] According to the disclosed technology, an end effector is provided. The end effector may include an insulating material having a first outer surface and a second outer surface. The end effector may include a frame disposed within the insulating material. The end effector may include a first flexible circuit that includes a plurality of first electrodes. 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 abuts a first plane and a second portion of the first flexible circuit abuts a second plane. The first plane is a first distance from the frame and the second plane is a second distance from the frame. The second distance is less than the first distance.

[0013] According to the disclosed technology, an end effector is provided. The end effector may include an insulating material having a first outer surface and a second outer surface. The end effector may include a frame disposed within the insulating material. The end effector may include a first flexible circuit that includes a plurality of first electrodes. The first flexible circuit is disposed on or within the insulating material, and each of the plurality of first electrodes includes a first contact surface. The insulating material abuts the first contact surface such that only the first contact surfaces of at least a portion of the plurality of electrodes are exposed to the surrounding environment. A first support layer is located within the insulating material between the frame and the first flexible circuit.

[0014] According to the disclosed technology, an end effector is provided. The end effector may include an insulating material having a first outer surface and a second outer surface. The end effector may include a frame disposed within the insulating material. The end effector may include a first flexible circuit having a wavy profile and disposed within the insulating material. The first flexible circuit includes a first portion that abuts the insulating material and is exposed to the surrounding environment. The first flexible circuit is spaced apart from the frame.

[0015] According to the disclosed technology, an end effector for a catheter is provided, the end effector including: 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 coplanar with the first flexible circuit in the distal portion of the end effector and disposed on top of the first flexible circuit in the proximal portion of the end effector. The first flexible circuit may include one or more first electrodes disposed on the distal portion of the first flexible circuit. The proximal portion of the first flexible circuit may include one or more first electrical contacts corresponding to the one or more first electrodes. The first flexible circuit may 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 may include a plurality of first electrode pairs disposed on the distal portion of the first flexible circuit. Each first electrode in each first electrode pair may be spaced apart a first predetermined longitudinal distance, and each first electrode pair may be spaced apart from an adjacent first electrode pair a second predetermined longitudinal distance, the second predetermined longitudinal distance being greater than the first predetermined longitudinal distance. The first predetermined longitudinal distance by which the electrodes in a pair are spaced apart may be about 100 micrometers. Each electrode may include a length of about 500 micrometers and a width of approximately 500 micrometers. The second flexible circuit may include one or more second electrodes disposed on the distal portion of the second flexible circuit. The proximal portion of the second flexible circuit may include one or more second electrical contacts corresponding to the one or more second electrodes. The second flexible circuit may 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 may include a plurality of second electrode pairs disposed on the distal portion of the second flexible circuit. Note that the design provided herein overcomes many drawbacks of existing mapping catheters. Specifically, commercially available ECG electrodes in mapping or diagnostic catheters are typically cylindrical in shape, contacting tissue portions and blood portions. While this allows for collection of ECG signals through myocardial tissue, other electrical signals propagated through blood and tissue (e.g., far-field signals) will be collected using traditional cylindrical electrodes. Thus, flat electrodes on opposite sides, where one electrode contacts tissue while the other flat electrodes contact blood (but not tissue), allow for elimination 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 does not physically contact tissue), which is crucial for the concept of unipolar signals. Traditionally, the reference signal for unipolar signal mapping has been the WCT, or a single electrode without tissue contact located at a position remote from the tissue contact electrode.Therefore, cylindrical electrodes and single discrete reference electrodes have their own drawbacks because the reference signal location is different for different electrodes. The new design provided herein addresses these drawbacks, where dedicated reference (non-tissue contacting) electrodes are present at nearly the same location for each tissue contacting electrode.

[0016] The end effector may further include a frame on which the distal portion of the first flexible circuit may be disposed and the distal portion of the second flexible circuit may be disposed, and the proximal portion of the first flexible circuit may be disposed on the frame and the proximal portion of the second flexible circuit may be disposed on a portion of the proximal portion of the first flexible circuit. The frame may include a first ridge, a second ridge, a third ridge, and a fourth ridge. The distal portion of the first flexible circuit may include a first loop disposed on the first ridge and the second ridge; and the distal portion of the second flexible circuit includes a second loop disposed on the third ridge and the fourth ridge. The frame may further include at least partial gaps between the first ridge, the second ridge, the third ridge, and the fourth ridge. The frame may include nitinol. The distal portion of the end effector may include a width of about 9 millimeters and a length of about 20 millimeters.

[0017] According to the disclosed technology, an end effector for a catheter is provided, the end effector including: a frame that extends 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; and a second flexible circuit extending along the longitudinal axis from the proximal portion of the frame to the distal portion, the second flexible circuit being disposed on the first side of the frame at the distal portion of the frame and on top of the first flexible circuit at the proximal portion of the frame. The first flexible circuit may include one or more first electrodes disposed on the distal portion of the first flexible circuit, and the second flexible circuit includes one or more second electrodes disposed on the distal portion of the second flexible circuit. The first electrodes and the second electrodes may be arranged as electrode pairs. Each electrode in the electrode pair may be spaced apart by a first predetermined longitudinal distance, and each electrode pair may be spaced apart from an adjacent electrode pair by a second predetermined longitudinal distance. The second predetermined longitudinal distance may be greater than the first predetermined longitudinal distance. The first predetermined longitudinal distance corresponding to the distance between the electrodes in a pair may be about 100 micrometers.

[0018] The end effector may further include a third flexible circuit disposed on the second side of the frame and extending along the longitudinal axis from the proximal portion to the distal portion of the frame; and a fourth flexible circuit extending along the longitudinal axis from the proximal portion 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 top of the third flexible circuit at the proximal portion of the frame. The third flexible circuit may include electrodes disposed on the distal portion of the third flexible circuit, and the fourth flexible circuit may include electrodes disposed on the distal portion of the second flexible circuit.

[0019] 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 being substantially coplanar with the first flexible circuit in the distal portion of the end effector and disposed on top of the first flexible circuit in the proximal portion of the end effector. The first flexible circuit may include a first set of electrodes disposed on one side of the first flexible circuit and a second set of electrodes disposed on an 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 an opposite side of the second flexible circuit. The end effector may further include a substrate disposed between the first flexible circuit and the second flexible circuit at the proximal portion and coplanar with the first flexible circuit and the second flexible circuit at the distal portion.

[0020] According to the disclosed technology, an end effector for a catheter is provided. The end effector includes an insulating material, a frame, and a position sensing loop. The frame is disposed within the insulating material and is substantially planar along a longitudinal axis. The position sensing loops are spaced apart from the frame and coupled to the insulating material. The position sensing loops include a center loop and a pair of side loops. The center loop is disposed on the longitudinal axis in a region near the distal portion of the insulating material. The pair of side loops are disposed generally symmetrically about the longitudinal axis, wherein each side loop extends along the longitudinal axis from the proximal portion to the distal portion of the insulating material.

[0021] According to the disclosed technology, an end effector for a catheter is provided. The end effector includes an insulating material, a frame, and a position sensing loop. The frame is disposed within the insulating material and is substantially planar along a longitudinal axis. The position sensing loop is disposed generally parallel to the frame and is separated from the frame by the insulating material. The position sensing loops include a center loop, a first side loop, and a second side loop. The center loops extend along the longitudinal axis and include a cumulative center loop surface area. The first side loop extends along the longitudinal axis and includes a cumulative first side loop surface area. The second side loop extends along the longitudinal axis and includes a cumulative second side loop surface area. The cumulative center loop surface area, the cumulative first side loop surface area, and the cumulative second side loop surface area are each in the range of about one hundred square millimeters to about three hundred square millimeters.

[0022] According to the disclosed technology, a frame for an end effector of a medical device is provided. The frame includes a base and a first ridge loop. The base is configured to connect to an elongate shaft of the medical device and extends distally along a longitudinal axis. The first ridge loop extends from the base along the longitudinal axis and includes a first segment to a seventh segment. A curved first segment is connected to the base and extends distally from the base along the longitudinal axis. The second segment has an arcuate configuration connected to and extending from the curved first segment. The third segment is connected to the second segment and extends proximally from the second segment along the longitudinal axis. A curved fourth segment is connected to the base and extends distally from the base along the longitudinal axis. An arcuate fifth segment is connected to and extends from the fourth segment. The sixth segment is connected to the fifth segment and extends proximally from the fifth segment along the longitudinal axis. The arcuate seventh segment connects the third segment and the sixth segment.

[0023] According to the disclosed technology, another frame for an end effector of a medical device is also provided. The frame includes a base, a first ridge circuit, a second ridge circuit, a third ridge circuit, and a finger opening. The base is configured to be connected to the elongate shaft of the medical device and extends along a longitudinal axis. The first ridge circuit 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 from the base in a distal direction along the longitudinal axis. The second segment is connected to the first segment and extends inwardly from the first segment toward the longitudinal axis. The third segment is connected to the second segment and extends from the second segment in the distal direction along the longitudinal axis. The second ridge circuit 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 from the base in the distal direction along the longitudinal axis. The second segment is connected to the first segment and extends inwardly from the first segment toward the longitudinal axis. The third segment is connected to the second segment and extends from the second segment in the distal direction along the longitudinal axis. The third ridge circuit connects the third segment of the first ridge circuit and the third segment of the second ridge circuit. The finger opening is defined by the base, the first ridge circuit, the second ridge circuit, and the third ridge circuit.

[0024] According to the disclosed technology, an end effector for a medical device is also provided. The end effector includes a frame, an insulating material disposed on the frame, and a flexible circuit. The frame includes a base, a first ridge circuit, a second ridge circuit, a third ridge circuit, and a finger opening. The base is configured to be connected to the elongate shaft of the medical device and extends along a longitudinal axis. The first ridge circuit extends from the base along the longitudinal axis. The second ridge circuit extends from the base along the longitudinal axis. The third ridge circuit connects the first ridge circuit and the second ridge circuit. The finger opening is defined by the base, the first ridge circuit, the second ridge circuit, and the third ridge circuit. The flexible circuit includes a first segment and a second segment. The first segment is vertically spaced from the frame by the insulating material along a vertical axis. The second segment is offset from the first segment along the vertical axis and extends within the finger opening.

[0025] According to the disclosed technology, there is also provided yet another frame for an end effector of a medical device. The frame extends along a longitudinal axis coaxial with a longitudinal center of the frame and includes a base, a first ridge circuit, and a second ridge circuit. The base is configured to connect to an elongate shaft of the medical device and extends along the longitudinal axis. The first ridge circuit 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 ridge circuit extends from the base on a second side of the longitudinal axis. The second ridge circuit includes a first distal end and a 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 disposed along the longitudinal axis such that the frame is asymmetric with respect to the longitudinal axis.

[0026] According to the disclosed technology, there is also provided an end effector for a medical device. The end effector includes: a frame that is substantially planar along a longitudinal axis; a flexible circuit that is vertically spaced apart from the frame along a vertical axis; and an insulating material, with the frame and the flexible circuit disposed within the insulating material. The insulating material defines a first outer edge of the end effector. The first outer edge includes a treatment portion configured to facilitate retraction of the end effector into a sheath. The treatment portion includes at least one of the following: 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 cut-in cutouts defined along at least a portion of the first outer edge; or a lubricating coating extending along at least a portion of the first outer edge.

[0027] According to the disclosed technology, there is also provided a method of using a medical device. The method includes: retracting an end effector from a deployed configuration into a sheath along a longitudinal axis, the end effector having a substantially planar shape in the deployed configuration. The method includes: contracting the end effector into a retracted configuration such that outer edges of the end effector slide past one another. The end effector has a substantially cylindrical shape or a helical shape in the retracted configuration. A first outer edge of the outer edges includes a treatment portion that includes at least one of the following: 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 cut-in cutouts defined along at least a portion of the first outer edge; or a lubricating coating extending along at least a portion of the first outer edge.

[0028] According to the disclosed technology, a method of manufacturing an end effector for a medical device is also provided. The method includes: forming a frame that is substantially planar along a longitudinal axis. The method includes: disposing a flexible circuit on the frame. The method includes: heating an insulating material. The method includes: reflowing the insulating material such that the insulating material encapsulates the frame and the flexible circuit. The method includes: treating an outer edge of the insulating material such that the outer edge includes at least one of a reduced hardness or a reduced coefficient of friction relative to the outer edge before treatment.

[0029] To achieve a time- and cost-effective manufacture of an end effector that enhances the functionality of the mapping and ablation catheter mentioned in the background section, the present disclosure also relates to an end effector that can be easily manufactured and has enhanced mapping and ablation catheter performance aspects, including but not limited to: mapping resolution, contact of the electrodes with the target anatomy, delivery of the end effector to the target anatomy, biocompatibility, end effector stiffness, and atraumaticity.

[0030] According to the disclosed technology, an end effector for a medical device is provided. The end effector includes a frame that defines a neutral plane. The end effector includes a first insulating material disposed on at least one side of the frame. The end effector includes a first flexible circuit that is disposed in the first insulating material and is spaced apart from the frame along a vertical axis that is orthogonal to the neutral plane. The first flexible circuit includes a planar transition region located proximate a proximal end of the first flexible circuit. The first flexible circuit transitions from a first plane close to the neutral plane to a second plane away from the neutral plane in the planar transition region.

[0031] According to the disclosed technology, an end effector is provided. The end effector includes a frame having a first strut that extends along a longitudinal axis. The end effector includes a flexible circuit that is aligned with the first strut and includes a substrate that supports electrical traces. The flexible circuit includes a plurality of bends such that the flexible circuit includes a serpentine shape as it extends along the longitudinal axis of the strut. The first strut of the frame includes alternating wide sections and narrow sections that extend along the longitudinal axis of the strut. The narrow sections can be located proximate respective vertices of the plurality of bends.

[0032] According to the disclosed technology, an end effector is provided. The end effector includes a frame that includes a first strut extending along a longitudinal axis. The end effector includes a flexible circuit that is aligned with the first strut and includes a substrate that supports electrical traces. The flexible circuit may include a plurality of bends such that the flexible circuit has a serpentine shape when extending along the longitudinal axis of the strut. The electrical traces include rolled annealed metal. The serpentine shape may be formed by the rolled annealed metal along the direction of a single grain of the rolled annealed metal such that the single grains extend parallel to the longitudinal axis of the strut.

[0033] According to the disclosed technology, a method of manufacturing an end effector for a medical catheter is provided. The method includes: forming a strut for a frame of the end effector, and providing alternating wide sections and narrow sections extending along a longitudinal axis of the strut. 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 strut such that vertices of the plurality of bends are positioned at corresponding locations of narrow sections of the strut. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 is a schematic illustration of a medical system including a planar catheter according to the disclosed technology;

[0035] Figure 2 is an illustration of a perspective view of an end effector according to the disclosed technology;

[0036] Figure 3 is according to the disclosed technology Figure 2 an illustration of an exploded perspective view of an end effector;

[0037] Figure 4A is an illustration of a cross-section of an end effector according to the disclosed technology;

[0038] Figure 4B is an illustration of a cross-section of an end effector according to the disclosed technology;

[0039] Figure 4C is according to the disclosed technology Figure 4B a variant where the frame is not encapsulated in insulating material but is adjacent thereto;

[0040] Figure 4D is an illustration of a cross-section of an end effector according to the disclosed technology;

[0041] Figure 5A is an illustration of an exploded perspective view of an end effector having a support layer according to the disclosed technology;

[0042] Figure 5B is a diagram of a cross-section of an end effector having two support layers according to the disclosed technology;

[0043] Figure 5C is a diagram of a cross-section of an end effector having a single support layer according to the disclosed technology;

[0044] Figure 5D is a diagram of a cross-section of an end effector having a single support layer and only one surface with an electrode according to the disclosed technology;

[0045] Figure 5E is a diagram of a cross-section of an end effector having a single support layer and only one surface with an electrode according to the disclosed technology;

[0046] Figure 6A is a cross-sectional view of an end effector having a flexible circuit displaced in a plane according to the disclosed technology;

[0047] Figure 6B is a cross-sectional view of an end effector having a flexible circuit displaced in a plane according to the disclosed technology, the circuits including an intermediate plane section;

[0048] Figure 6C is a cross-sectional view of an end effector having a flexible circuit displaced in a plane according to the disclosed technology, the circuits including an intermediate plane section that contacts a central frame;

[0049] Figure 6D is a cross-sectional view of an end effector having a flexible circuit displaced in a plane according to the disclosed technology, the circuits including an intermediate plane section and a superficial plane section;

[0050] Figure 6E is a cross-sectional view of an end effector having a flexible circuit with a wavy profile according to the disclosed technology, the circuits including an intermediate plane section and a superficial plane section;

[0051] Figure 6F is a cross-sectional view of an end effector having a flexible circuit with a wavy profile according to the disclosed technology, the circuits including an intermediate plane section and a superficial plane section;

[0052] Figure 7 is a cross-sectional view of an end effector having two support layers and a flexible circuit displaced in a plane according to the disclosed technology;

[0053] Figure 8 is a diagram of a catheter assembly according to the disclosed technology;

[0054] Figure 9is a schematic illustration of a medical system including a planar catheter according to the disclosed technology;

[0055] Figure 10A is a schematic illustration of an end effector according to the disclosed technology;

[0056] Figure 10B is a schematic illustration showing a detailed view of an electrode arrangement of 10A according to the disclosed technology;

[0057] Figure 10C is a schematic illustration of an end effector according to the disclosed technology;

[0058] Figure 11A is a schematic illustration of an end effector according to the disclosed technology;

[0059] Figure 11B is a schematic illustration showing the Figure 11A right side view of an end effector according to the disclosed technology;

[0060] Figure 12A is a schematic illustration of an end effector according to the disclosed technology;

[0061] Figure 12B is a schematic illustration showing the Figure 12A right side view of an end effector according to the disclosed technology;

[0062] Figure 13 is a schematic illustration of a medical system including a planar catheter according to the disclosed technology;

[0063] Figure 14 is a schematic illustration showing an exploded view of a part of an end effector according to the disclosed technology;

[0064] Figure 15A is a schematic illustration showing the Figure 14 central circuit of an end effector according to the disclosed technology;

[0065] Figure 15B is a schematic illustration showing the Figure 14 two side circuits of an end effector according to the disclosed technology;

[0066] Figure 16 is a schematic illustration showing the Figure 14 central circuit and two side circuits of an end effector according to the disclosed technology disposed on an insulating material and a ridge frame;

[0067] Figure 17 is a schematic illustration showing the Figure 14Schematic diagram of an exploded view of a portion of a modified configuration of an end effector;

[0068] Figure 18 Shows according to the disclosed technology Figure 14 Schematic diagram of two modified side loops of an end effector;

[0069] Figure 19 Shows according to the disclosed technology, disposed on an insulating material and a ridge frame Figure 15A Central loop of Figure 18 And schematic diagrams of two side loops of;

[0070] Figure 20 Illustration of a catheter assembly according to the disclosed technology;

[0071] Figure 21 Schematic diagram of a medical system including a catheter according to the disclosed technology;

[0072] Figure 22 Schematic diagram of an exploded view of a portion of an end effector according to the disclosed technology;

[0073] Figure 23 Shows according to the disclosed technology Figure 22 Schematic diagram of a frame of an end effector embedded in an insulating material;

[0074] Figure 24 Schematic diagram of a view of an end effector with a force applied thereto Figure 23 In the proximal direction;

[0075] Figure 25 Shows according to the disclosed technology Figure 23 Schematic diagram of a detailed view of a ridge of a frame of;

[0076] Figure 26 Shows according to the disclosed technology, similar to the frame of Figure 23 Schematic diagram of a modified frame embedded in an insulating material;

[0077] Figure 27 Schematic diagram of a view of an end effector with a force applied thereto Figure 26 In the proximal direction;

[0078] Figure 28 Shows according to the disclosed technology Figure 26 Schematic diagram of a detailed view of a ridge of a frame of;

[0079] Figure 29is a schematic diagram showing another frame of an end effector according to the disclosed technology;

[0080] Figure 30 is a schematic diagram showing a frame that is embedded in an insulating material and has a flexible circuit assembled therewith; Figure 29 ;

[0081] Figure 31 is a schematic diagram showing a cross-sectional view taken along line 31-31 in; Figure 30 according to the disclosed technology;

[0082] Figure 32 is a schematic diagram showing a cross-sectional view taken along line 32-32 in; Figure 30 according to the disclosed technology;

[0083] Figure 33 is a schematic diagram showing another frame embedded in an insulating material according to the disclosed technology;

[0084] Figure 34 is a schematic diagram showing a further modified frame similar to the frame of; Figure 33 and embedded in an insulating material according to the disclosed technology;

[0085] Figure 35 is a schematic diagram showing an end effector using the frame of; Figure 33 or; Figure 34 being inserted into a guide;

[0086] Figure 36 is a schematic diagram showing an end effector of; Figure 35 according to the disclosed technology being inserted into a guide;

[0087] Figure 37A is a schematic top view showing an end effector having a first edge treatment portion according to the disclosed technology;

[0088] Figure 37B is a schematic diagram showing an end effector of; Figure 37A according to the disclosed technology being inserted into a guide;

[0089] Figure 38A is a schematic top view showing an end effector having a second edge treatment portion according to the disclosed technology;

[0090] Figure 38B is a schematic diagram showing an end effector of; Figure 38A according to the disclosed technology being inserted into a guide;

[0091] Figure 39A is a schematic illustration showing a top view of an end effector having a third edge treatment section according to the disclosed technology;

[0092] Figure 39B is showing according to the disclosed technology Figure 39A of the end effector inserted into the introducer;

[0093] Figure 40A is a schematic illustration showing a top view of an end effector having a fourth edge treatment section according to the disclosed technology;

[0094] Figure 40B is showing according to the disclosed technology Figure 41 A of the end effector inserted into the introducer;

[0095] Figure 41 is a flowchart showing a method of using an end effector for a medical catheter according to the disclosed technology;

[0096] Figure 42 is a flowchart showing a method of manufacturing an end effector for a medical catheter according to the disclosed technology;

[0097] Figure 43 is a schematic illustration of a medical system including a planar catheter according to the disclosed technology;

[0098] Figure 44 is an illustration of a perspective view of an end effector according to the disclosed technology;

[0099] Figure 45 is according to the disclosed technology Figure 2 of an exploded perspective view illustration of the end effector;

[0100] Figure 46A is an illustration of a cross-section of an end effector according to the disclosed technology;

[0101] Figure 46B is an illustration of a cross-section of an end effector according to the disclosed technology;

[0102] Figure 46C is according to the disclosed technology Figure 46B variant, wherein the frame is not encapsulated in the insulating material but is adjacent thereto;

[0103] Figure 46D is an illustration of a cross-section of an end effector according to the disclosed technology;

[0104] Figure 47Illustration of a perspective view of an end effector with a planar transition region on the proximal side according to the disclosed technology;

[0105] Figure 48A Top plan view of an end effector with a planar transition region on the proximal side according to the disclosed technology, with only one surface of the end effector including electrodes;

[0106] Figure 48B According to the disclosed technology Figure 48A Bottom plan view of the illustrated end effector;

[0107] Figure 48C According to the disclosed technology for 48A and Figure 48B Side view of the illustrated end effector;

[0108] Figure 49A Top plan view of an end effector with a planar transition region on the proximal side according to the disclosed technology, with the first surface of the end effector having electrodes and the second surface having electromagnetic coils;

[0109] Figure 49B According to the disclosed technology Figure 49A Bottom plan view of the illustrated end effector;

[0110] Figure 49C According to the disclosed technology for 49A and Figure 49B Side view of the illustrated end effector;

[0111] Figure 50A Illustration of an exploded perspective view of an end effector with a planar transition region on the proximal side and alternating layers of insulating sheet layers according to the disclosed technology;

[0112] Figure 50B Illustration of an exploded perspective view of an end effector with a planar transition region on the proximal side, alternating layers of insulating sheet layers, and a flexible circuit layer on both sides of the end effector according to the disclosed technology;

[0113] Figure 51 Illustration of a catheter assembly according to the disclosed technology;

[0114] Figure 52 Schematic illustration of a medical system including a planar catheter according to the disclosed technology;

[0115] Figure 53 Illustration of a perspective view of an end effector according to the disclosed technology;

[0116] Figure 54Ais a detailed view of a trace according to the disclosed technology, showing sections in the crystal structure of these traces having alternating grain lengths;

[0117] Figure 54B is a detailed view of a rolled and annealed metal according to the disclosed technology;

[0118] Figure 55 is according to the disclosed technology and has as Figure 54B shown a top plan view of a serpentine flexible circuit with traces applied to a substrate;

[0119] Figure 56 is according to the disclosed technology and is a top plan view of a flexible circuit applied to a support frame; Figure 55 of

[0120] Figure 57 is an illustration of a catheter assembly according to the disclosed technology; and

[0121] Figure 58 is a flow chart showing a method of manufacturing an end effector for a medical catheter according to the disclosed technology. DETAILED DESCRIPTION

[0122] The following detailed description should be read in conjunction with the accompanying drawings, in which like reference numerals in different drawings identify the same elements. The drawings (not necessarily to scale) depict selected examples and are not intended to limit the scope of the disclosure. The detailed description illustrates, by way of example and not limitation, the principles of the technology disclosed herein. This description will clearly enable those skilled in the art to make and use the technology disclosed herein, and describes several embodiments, adaptations, variations, alternative forms, and uses of the technology disclosed herein, including what is presently believed to be the best mode of implementing the technology disclosed herein.

[0123] As used herein, the term "about" or "approximately" or "substantially" in reference to any numerical value or range indicates a suitable dimensional tolerance that allows a collection of parts or components to achieve its intended purpose as described herein. More specifically, "about" or "approximately" can refer to a range of values ±20% of the recited value, e.g., "about 90%" can refer to a range of values from 70.1% or 71% to 109.9% or 110%. In addition, as used herein, the terms "patient", "recipient", "user", and "subject" refer to any human or animal subject, and are not intended to limit the system or method to human use, although the use of the subject technology in human patients represents a preferred embodiment. Similarly, the term "proximal" refers to a location closer to the operator or physician, while "distal" refers to a location farther from the operator or physician.

[0124] As discussed herein, the vasculature of a "patient", "recipient", "user", and "subject" can be that of a human or any animal. It should be understood that the animal can be of any suitable type, including but not limited to mammals, veterinary animals, livestock animals, or pet animals, etc. For example, the animal can be an experimental animal (e.g., rats, dogs, pigs, monkeys, etc.) specifically selected to have certain characteristics similar to humans. It should be understood that the subject can be, for example, any suitable human patient.

[0125] As discussed herein, a "physician" can include a doctor, surgeon, technician, scientist, operator, or any other individual or delivery instrumentation device associated with delivering a multi-electrode catheter for treating drug-refractory atrial fibrillation to a subject.

[0126] As discussed herein, an "operator" can include a doctor, surgeon, technician, scientist, or any other individual or delivery instrumentation device associated with delivering a multi-electrode catheter for treating drug-refractory atrial fibrillation to a subject.

[0127] As discussed herein, when referring to the devices and corresponding systems of the present disclosure, the term "ablation" refers to components and structural features configured to reduce or prevent the generation of unstable cardiac signals in cells by utilizing non-thermal energy (such as irreversible electroporation (IRE)), which may be interchangeably referred to as pulsed electric field (PEF) and pulsed field ablation (PFA) in the present disclosure. "Ablation" as used throughout the present disclosure, when referring to the devices and corresponding systems of the present disclosure, refers to non-thermal ablation of cardiac tissue for certain conditions, including but not limited to arrhythmia, atrial flutter ablation, pulmonary vein isolation, supraventricular tachycardia ablation, and ventricular tachycardia ablation. The term "ablation" also includes known methods, devices, and systems for achieving various forms of ablation of body tissue understood by those skilled in the relevant art.

[0128] As discussed herein, the terms "bipolar" and "unipolar", when used to refer to ablation protocols, describe ablation protocols that differ in terms of current path and electric field distribution. "Bipolar" refers to an ablation protocol that utilizes the current path between two electrodes as described below, both of which are positioned at the treatment site; the current density and electric flux density at each of the two electrodes are typically approximately equal. "Unipolar" refers to an ablation protocol that utilizes the current path between two electrodes as described below, where one electrode with a high current density and high electric flux density is positioned at the treatment site, and a second electrode with a relatively lower current density and lower electric flux density is positioned away from the treatment site.

[0129] As discussed herein, the terms "tubular", "tube", and "shaft" should be understood broadly and are not limited to structures that are circular cylinders, have a fully circular cross-section, or have a uniform cross-section along their entire length. For example, tubular / shaft structures are typically illustrated as structures that are substantially circular cylinders. However, without departing from the scope of the present disclosure, the tubular / shaft structure can have a tapered or curved outer surface.

[0130] The present disclosure relates to systems, methods, uses, and devices for mapping and ablating cardiac tissue to treat arrhythmias. Ablation energy is typically delivered to cardiac tissue by a distal portion of a catheter that can be advanced along the tissue to be ablated. Some example catheters include a three-dimensional structure at the distal portion and are configured to deliver ablation energy from various electrodes positioned on the three-dimensional structure. Fluoroscopy can be used to visualize ablation procedures incorporating such example catheters.

[0131] The use of thermal techniques such as radiofrequency (RF) energy and cryoablation for ablating cardiac tissue in a malfunctioning heart is a well-known procedure. Generally, in order to successfully ablate using a thermal technique, cardiac electrode potentials need to be measured at various locations in the myocardium. Additionally, temperature measurements during ablation provide data that can enable ablation efficacy. Typically, for ablation procedures using thermal ablation, electrode potentials and temperatures are measured before, during, and after actual ablation. RF methods can have risks that can lead to tissue charring, burns, steam pops, phrenic nerve paralysis, pulmonary vein stenosis, and esophageal fistulas. Cryoablation is an alternative to RF ablation that can reduce some of the thermal risks associated with RF ablation. However, compared to RF ablation, manipulating cryoablation devices and selectively applying cryoablation is generally more challenging; thus, cryoablation is not feasible in certain anatomical geometries that can be reached by electroablation devices.

[0132] The present disclosure can include electrodes configured for RF ablation, cryoablation, and / or irreversible electroporation (IRE). Throughout the present disclosure, IRE can be interchangeably referred to as pulsed electric field (PEF) ablation and pulsed field ablation (PFA). As discussed in the present disclosure, IRE is a non-thermal apoptosis-inducing technique that can be used for atrial arrhythmia ablation. To ablate using IRE / PEF, biphasic voltage pulses are applied to disrupt the cellular structure of the myocardium, thereby causing apoptosis. The biphasic pulses are non-sinusoidal and can be tuned based on the electrophysiology of the cells to target the cells. In contrast, to ablate using RF, a sinusoidal voltage waveform is applied to generate heat at the treatment area, heating all cells indiscriminately in the treatment area. Thus, IRE has the ability to avoid adjacent thermally sensitive structures or tissues, which will be beneficial in reducing possible complications known to be affected by ablation or dissection modalities. Additionally or alternatively, monophasic pulses can be used.

[0133] Electroporation can be induced by applying a pulsed electric field across a biological cell, resulting in the reversible (temporary) or irreversible (permanent) formation of pores in the cell membrane. When a pulsed electric field is applied, the cell has a transmembrane electrostatic potential that rises above the static potential. When the transmembrane electrostatic potential remains below the threshold potential, electroporation is reversible, meaning that the pores can close when the applied pulsed electric field is removed and the cell can repair itself and survive. If the transmembrane electrostatic potential rises above the threshold potential, electroporation is irreversible and the cell becomes permanently permeable. As a result, the cell dies due to the loss of homeostasis and typically dies by apoptosis, leaving little or no scar. Generally, different types of cells have different threshold potentials. For example, cardiac cells have a threshold potential of approximately 500 V / cm, while for bone, the threshold potential is 3000 V / cm. These differences in threshold potential allow IRE to selectively target tissues based on the threshold potential.

[0134] The techniques of the present disclosure include systems and methods for applying an electrical signal from a catheter electrode positioned near myocardial tissue to generate ablation energy to ablate myocardial tissue. In some examples, the systems and methods can effectively ablate the target tissue by inducing irreversible electroporation. In some examples, the systems and methods can effectively induce reversible electroporation as part of a diagnostic procedure. Reversible electroporation occurs when the electricity applied using the electrode is below the electric field threshold of the target tissue that allows the cell to repair. Reversible electroporation does not kill the cell but allows the physician to view the effect of reversible electroporation on the electrical activation signals near the target location. Exemplary systems and methods for reversible electroporation are disclosed in U.S. Patent Publication 2021 / 0162210, the entire content of which is incorporated herein by reference.

[0135] The pulsed electric field and its efficacy in inducing reversible 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 geometry, etc. The examples presented herein generally include physical parameters suitable for effectively inducing reversible and / or irreversible electroporation. The biphasic pulse parameters of the electrical signal can include voltage amplitude, pulse duration, pulse interphase delay, interpulse delay, total application time, delivered energy, etc. In some examples, the parameters of the electrical signal can be adjusted to induce both reversible and irreversible electroporation given the same physical parameters. Examples of various ablation systems and methods including IRE are presented in U.S. Patent Publications 2021 / 0169550A1, 2021 / 0169567A1, 2021 / 0169568A1, 2021 / 0161592A1, 2021 / 0196372A1, 2021 / 0177503A1, and 2021 / 0186604A1, the entire content of each of these patent publications being incorporated herein by reference.

[0136] The following description relates to various exemplary configurations of a medical probe (and / or portions thereof), systems associated with the medical probe, and methods of using and / or manufacturing the medical probe.

[0137] Encapsulated planar catheter with planar offset and support layer ( Figures 1 to 8 )

[0138] Reference Figure 1 , which shows an exemplary catheter-based electrophysiological mapping and ablation system 1010. System 1010 includes a plurality of catheters that are inserted by a physician 24 through a patient's 1023 vascular system via the skin into a chamber or vascular structure of the heart 12. Typically, a delivery sheath catheter is inserted into the left atrium or right atrium near a desired location in the heart 1012. Then, a plurality of catheters can be inserted into the delivery sheath catheter to reach the desired location. The plurality of catheters can 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 1014 configured for sensing IEGM is illustrated herein. The physician 1024 contacts the catheter shaft 1090 having the distal end of the catheter 1014 (i.e., the multi-layer end effector 10100) with the heart wall for sensing a target site in the heart 1012. For ablation, the physician 1024 similarly brings the distal end of the ablation catheter to the target site for ablation.

[0139] Catheter 1014 is an exemplary catheter that includes one and preferably a plurality of electrodes 1026 optionally distributed over the end effector 10100, which is coupled to the catheter shaft 1090 and configured to sense IEGM signals, as described in more detail below. Catheter 14 may additionally include a position sensor embedded in or near the end effector 10100 for tracking the position and orientation of the 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.

[0140] A magnetic-based position sensor can operate with a positioning pad 1025 that includes a plurality of magnetic coils 1032 configured to generate a magnetic field in a predefined 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 positioning pad 1025 and sensed by the magnetic-based position sensor. Details of the magnetic-based position sensing technique 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.

[0141] System 1010 includes one or more electrode patches 1038 positioned to contact the skin of the patient 1023 to establish a position reference for impedance-based tracking of the positioning pad 1025 and the electrodes 1026. For impedance-based tracking, current is directed toward the electrodes 1026 and sensed at the electrode skin patches 1038 such that the position of each electrode can be triangulated via the electrode patches 1038. Details of the impedance-based position tracking technique 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.

[0142] Recorder 1011 displays the electrogram 1021 captured using the body surface ECG electrodes 1018 and the intracardiac electrogram (IEGM) captured using the electrodes 1026 of the catheter 1014. Recorder 1011 can include pacing capabilities for pacing the heart rhythm and / or can be electrically connected to an independent pacemaker.

[0143] System 1010 can include an ablation energy generator 1050 adapted to conduct ablation energy to one or more of the electrodes 1026 at the distal end of a catheter configured for ablation. The energy generated by the ablation energy generator 1050 can include, but is not limited to, radiofrequency (RF) energy or pulsed field ablation (PFA) energy (including monopolar or bipolar high voltage DC pulses that can be used to effect irreversible electroporation (IRE)), or a combination thereof.

[0144] The Patient Interface Unit (PIU) 1030 is an interface configured to establish electrical connectivity between a catheter, electrophysiology equipment, a power source, and a workstation 1055 for controlling the operation of system 1010. The electrophysiology equipment of system 1010 can include, for example, a plurality of catheters, positioning pads 1025, body surface ECG electrodes 1018, electrode patches 1038, an ablation energy generator 1050, and a recorder 1011. Optionally and preferably, the PIU 1030 additionally includes processing capabilities for performing real-time calculations of the position of the catheter and for performing ECG calculations.

[0145] The workstation 1055 includes a memory, a processor unit with a memory or storage device loaded with appropriate operating software, and user interface capabilities. The workstation 1055 can provide a plurality of functions, optionally including: (1) performing three-dimensional (3D) modeling of the endocardial anatomy and rendering a model or anatomic map 1020 for display on a display device 1027; (2) displaying on the display device 1027 an activation sequence (or other data) compiled from the recorded electrograms 1021 as representative visual markers or images superimposed on the rendered anatomic map Figure 20 ; (3) displaying the real-time position and orientation of a plurality of catheters within the heart chambers; and (4) displaying on the display device 1027 sites of interest, such as where ablation energy has been applied. A commercial product embodying the elements of system 1010 can be used in combination with the energy generator TruPulse TM and the CARTO TM 3 System, available from Biosense Webster, Inc., 31 Technology Drive, Suite 200, Irvine, CA 92618.

[0146] Figure 2An end effector 10100 is provided in accordance with embodiments of the present disclosure to achieve simplicity of manufacture, reduced cost, and enhanced end effector characteristics such as desired stiffness, mapping resolution, contact of the electrodes with the target anatomy, and conformance of the end effector disclosed herein with flat, curved, irregular, and / or non-planar tissue surfaces found in the target anatomy. The end effector 10100 may include a flexible circuit 10110 that includes a plurality of electrodes 10112, each of the plurality of electrodes 10112 including a contact surface 10112c. As used herein, the term "flexible circuit" includes thin film circuits, flexible printed circuit boards, thin film depositions implemented on a substrate (such as polyimide, copper, LCP, nitinol substrate, TPU, silicone, thermosetting resin, or other polymer substrate) via lithography and etching processes, as shown and described in the technical references incorporated herein by reference in the manner of the appendix attached to priority application number 63 / 615,600. In some examples, the flexible circuits described herein may be made primarily of polyimide. In other examples, it may be made of any one of biocompatible polyimide, glass-reinforced epoxy laminate, copper, or graphene, alone or in combination. In some examples, the electrodes described herein may include at least one mapping electrode and / or at least one ablation electrode and may be configured to detect electrophysiological signals or transmit ablation energy, AC or DC, from an energy generator to tissue according to the various ablation methods described previously (e.g., RF, IRE, etc.).

[0147] The flexible circuit 10110 may be disposed on an insulating material 10120. The insulating material 10120 may be adjacent to 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 surrounding environment. As used herein, the term "contact surface" includes the portion of the electrode having a generally flat surface and one or more edges directly surrounding the flat surface. When the end effector 10100 is placed against tissue, the electrodes 10112 may have slightly rounded, filleted, or chamfered edges that contact the tissue and a generally flat surface. As used herein, "surrounding environment" refers to the external environment, such as the organ in which the end effector 10100 is deployed or the operating room in which the end effector is located prior to deployment within a biological organ.

[0148] Note that not all of the electrodes on the end effector 10100 described herein need to be exposed through the insulating material 10120, as these unexposed electrodes can be used to sense far-field signals for noise reduction of tissue-proximal contact electrodes. Similarly, for an entire end effector having reference electrodes that do not contact tissue but only contact blood, far-field signals including noise or artifacts can be reduced or eliminated. Flushing can be provided using a flushing port 10163a (on one side) and a flushing port 10162b (on the other side) that are in fluid communication with a flushing line (not shown) disposed within the catheter shaft 1090. Instead of a flushing line separate from the catheter shaft 1090, an inner lumen can be formed by squeezing the catheter shaft 90 to provide an inner lumen channel. Note that the port 10163a or 10162b can be configured to have sufficient flow diverter characteristics to cause the flushing fluid to cover the mapping electrodes during flushing flow to prevent or reduce thrombus formation.

[0149] The flexible circuit 10110 can also include a frame 10130 adjacent to or within the insulating material. In an example where the flexible circuit 10110 includes the frame 10130, the frame 10130 can be disposed directly on the flexible circuit 10110 with little or no insulating material 10120 therebetween.

[0150] In other words, one aspect of the present disclosure provides an end effector 10100 having a planar frame 10130 that bisects two flat thermoformed portions 10120a, 10120b of a flexible insulating block 10120, where at least one flexible circuit 10110 is disposed on one side of the frame 10130, and where the contact surface 10112c of the electrode 10112 extends up to or slightly beyond the outer surface of the flexible insulating block 10120. In an additional or alternative example, the contact surface 10112c of the electrode 10112 can be slightly recessed, and there can be an opening through the insulating material 10120 to ensure exposure of the electrode 10112.

[0151] Figure 3 An exploded view of the end effector 10100 is shown, where its components are exploded 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 plurality of first electrodes 10112, where each first electrode 10112 includes a first contact surface 10112c. The end effector 10100 can also include a second flexible circuit 10140 having a plurality of second electrodes 10142. The first flexible circuit 10110 can be spaced apart from the second flexible circuit 10140, and each electrode of the plurality of second electrodes 10142 can have a second contact surface 10142c.

[0152] In an example having a first flexible circuit 10110 and a second flexible circuit 10140, an insulating material 10120 may be disposed between the first flexible circuit 10110 and the second flexible circuit 10140, and the insulating material 10120 may be adjacent to 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 the way the first electrode 10112 is disposed in and exposed through the insulating material.

[0153] The electrodes 10112, 10142 may sense or receive signals generated by tissue or transmit energy AC or DC from an energy generator to tissue. In some examples, there are approximately 92 electrodes. In some examples, there are approximately 48 electrodes. In some examples, there are approximately 64 electrodes. In some examples, there are approximately 72 electrodes. In some examples, there are approximately 98 electrodes. Details of the spacing between each pair of electrodes vs. the spacing between discrete sets of electrode pairs can be found in U.S. Provisional Patent Application S.N. 63 / 406,673, which was filed on September 14, 2022 and is included in the appendix of priority application number 63 / 615,600.

[0154] In an example, the end effector 10100 includes a frame 10130 disposed between the first flexible circuit 10110 and the second flexible circuit 10140.

[0155] The frame 10130 may be a component of the end effector 10100 that is separate and distinct from the first flexible circuit 10110 and is disposed to be close to the first flexible circuit 10110. In this case, the insulating material 10120 may be further disposed between the frame 10130 and the second flexible circuit 10140. The frame 10130 may be formed from planar or cylindrical raw materials using any suitable method. For example, the frame 10130 may be formed by cutting, laser cutting, stamping, etc.

[0156] The insulating material 10120 may include a first insulating material sheet 10120a and a second insulating material sheet 10120b that are melted together close to the frame 10130 to form a single, adjacent, substantially planar insulating block 10120. The insulating material 10120 is also used to enhance the atraumatic nature of the end effector 10100 and protect the subject from sharp edges. The insulating material 10120 may comprise a polymer. The insulating material 10120 may be thermoformed around at least a portion of the first flexible circuit 10110, the second flexible circuit 10140, and the frame 10130. The polymer may comprise thermoplastic polyurethane (TPU) or other thermoformable or formable material suitable for the thermoforming.

[0157] In addition, although the insulation material 10120 is shown as flat in these figures, the insulation material 10120 can be shaped, scalloped, ribbed, ridged, concave, convex, or otherwise configured such that the overall profile of the insulation material 10120 produces the physical and / or mechanical properties required of the end effector 10100 mentioned above, such as rigidity and flexure along multiple axes.

[0158] Figure 4A A cross-section taken as shown Figure 3 is shown. The first contact surface 10112c lies substantially flat and parallel to the first outer surface 10122a of the insulation block 10120. A plurality of first electrodes 10112 extend vertically and outwardly from this first outer surface a first distance. Similarly, the second contact surface 10142c can lie substantially flat and parallel to the second outer surface 10122b of the insulation block 10120 and extend substantially vertically and outwardly from this second outer surface a second distance.

[0159] Figure 4B A similar cross-section is shown, but from an exemplary end effector 10100 that does not have the second flexible circuit 10140. That is, compared to an end effector (or bilateral end effector) having electrodes on opposite sides Figure 4A the end effector in Figure 4B has electrodes on only one side (unilateral end effector). Figure 4C A variant of Figure 4B is shown in which the frame 10130 is not encapsulated in the insulation material but is disposed outside the insulation material 10120. It should be noted that although the frame 10130 is shown as a rectangle in cross-section, the frame 10130 is not limited to such a cross-section and can utilize any suitable cross-section.

[0160] Figure 4D A cross-section similar to that of Figure 4A is shown, but from an exemplary end effector 10100 that does not have the frame 10130. It should be noted that in examples such as Figure 4D the insulation material 10120 may or may not have additional strength or be formed thicker compared to the insulation material 10120 of an example having the frame 10130. The additional strength of the insulation material 10120 can compensate for the lack of the frame 10130.

[0161] Importantly, the end effector 10100 having flush or outwardly protruding electrode contact surfaces 10112c, 10142c can be manufactured by the methods and / or fixtures described in more detail below without the need to remove material to expose the electrode contact surfaces 10112c, 10142c.

[0162] In other examples, the first contact surface 10112c may be flush and substantially coplanar with the first outer surface 10122a of the insulating block 10120, and the second contact surface 10142c may be flush and coplanar with the second outer surface 10122b of the insulating block 10120.

[0163] Figure 5A is an exploded perspective view of an end effector 10100 having support layers (e.g., a first support layer 10302 and a second support layer 10304) according to the disclosed technology. Figure 5A The end effector 10100 shown is substantially similar to the end effector shown and described with respect to Figure 3 the end effector shown and described, but with the addition of support layers 10302, 10304. Suspending flexible circuits such as flexible circuit 10110 and second flexible circuit 10140 in an insulating material 10120 such as a polymer matrix allows the flexible circuits to maintain a degree of independence from each other. Introducing one or more support layers 10302, 10304 into the insulating material 10120 allows the end effector 10100 to utilize the different properties of different types of materials while maintaining the independence of the flexible circuits from each other and from any structural metal components (e.g., frame 10130). It should be noted that the support layers 10302, 10304 are depicted in Figure 5A as being “above” their respective insulating materials 10120a, 10120b, but it should be understood that the support layers 10302, 10304 can be located at any number of positions within or on the insulating materials 10120a, 10120b.

[0164] The materials of the support layers 10302, 10304 may 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 may allow the end effector 10100 to remain flexible while also providing tensile support to prevent overstretching of the flexible circuits. In some examples, the support layers 10302, 10304 may be mesh polymers, thereby providing the aforementioned tensile resistance while also providing the flexibility required for the end effector 10100.

[0165] Now referring to Figure 5B, the figure shows an example end effector 10100 including two separate support layers 10302, 10304. The first support layer 10302 is positioned (i) within a first sheet of insulating material 10120a and (ii) between the frame 10130 and the electrode 10112 on this side of the end effector 10100. The second support layer 10304 is positioned (i) within a second sheet of insulating material 10120b and (ii) between the frame 10130 and the electrode 10112 on the other side of the end effector 10100. This configuration can provide firm axial support for the flexible circuit. However, in some examples, a support layer may be needed only on one side of the frame 10130 to provide the necessary support for the flexible circuit. For example, Figure 5C shows an example end effector 10100 having electrodes 10112 on two surfaces of the end effector. However, the device includes a single support layer 10302 positioned between the frame 10130 and one surface of the end effector that includes the electrode 10112. As Figure 5D and Figure 5E shown, and as described above with respect to Figure 4B , the end effector 10100 may include electrodes on only one surface. With this in mind, in one example, the single support layer 10302 may be positioned between the frame 10130 and the first outer surface 10122a having the electrode (see Figure 5D ); in other examples, the single support layer 10302 may be positioned between the frame 10130 and the opposite surface that does not have the electrode (see Figure 5E ).

[0166] Now referring to Figures 6A to 6F , the example shown includes a flexible circuit having a planar shift along its longitudinal axis 10L-L (see Figure 3 , for reference). For example, each of these examples includes an embodiment in which a flexible circuit (e.g., a first flexible circuit 10110 and a second flexible circuit 10140) is positioned longitudinally along an insulating material (e.g., insulating materials 10120a, 10120b) and at least partially within the insulating material, and is also positioned such that a first portion of the flexible circuit abuts a first plane and a second portion of the flexible circuit abuts a second plane, the first plane being a first distance from the frame 10130 and the second plane being a second distance from the frame 10130, the second distance being less than the first distance. This shift in the plane can be positioned to be known when passing through a blood vessel or an outer sheath (e.g., Figure 8The region that undergoes a tight bending radius when the tubular member 10230 is present. 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 the tight bending occurs) ensures that the flexible circuit layer remains intact. Shifting the flexible circuit plane closer to the neutral axis (e.g., if the end effector 10100 includes a frame 10130 centered as in Figures 6A to 6F then for the frame 10130) can limit the amount of stress and strain caused by tension and compression on the circuit. The shift can also enable the entire end effector 10100 to undergo a tighter bend while the flexible circuit is slightly less tight.

[0167] Figure 6A An example end effector 10100 with two flexible circuits 10110, 10140 is shown. These two flexible circuits extend from the surface-exposed electrodes 10120b, into the insulating materials 10120a, 10120b, and then back to another surface-exposed electrode 10120b. First, referring to Figure 6A the top flexible circuit in which is the first flexible circuit 10110. The flexible circuit 10110 extends from the surface electrode in the first plane 10320, then extends into the insulating material 10120a, reaches the second plane 10322, and then extends back to the surface electrode in the first plane 10320. In this example, the flexible circuit 10110 is in the shape of a triangular wave, where (i) the valley of the flexible circuit 10110 is the second plane 10322, (ii) the peak is at the surface electrode 10112, and (iii) the peak and valley are connected by an angled section 10344.

[0168] The second flexible circuit 10140 is substantially the same on the other side of the end effector 10100. For example, the second flexible circuit 10140 extends from the surface electrode in the fourth plane 10326, then extends into the insulating material 10120b, reaches the third plane 10324, and then extends back to the surface electrode in the fourth plane 10326.

[0169] In addition, in Figure 6AIn the example shown, the plane within the end effector 10100 that is closer to the frame 10130 is separated from the frame 10130 by a certain distance. In other words, the first outer surface 10122a is at a position that is at a first height 10310 from the frame 10130, and in this example, the first distance 10328 between the frame 10130 and the first plane 10320 is thus equal to the first height 10310; the second outer surface 10122b is at a position that is at a second height 10312 from the frame 10130, and in this example, the second distance 10332 between the frame 10130 and the fourth plane 10326 is thus equal to the second height 10312. However, the embedding plane is separated from the frame 10130 such that there is a third distance 10330 between the frame 10130 and the second plane 10322, and there is a fourth distance 10332 between the frame 10130 and the third plane 10324. The third distance 10330 and the fourth distance 10334 are greater than zero to maintain a specific gap between the frame 10130 and the flexible circuits 10110, 10140.

[0170] Figure 6B shows a construction similar to that of Figure 6A shown, but rather than 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 angled segments 10344, then extend parallel to the frame 10130 for a certain length, and then tilt back towards the surface electrodes 10112. In this case, the first flexible circuit 10110 includes a first intermediate planar segment 10336 that extends parallel to the frame 10130 for a certain length. The second flexible circuit 10140 includes a second intermediate planar segment 10340 that extends parallel to the frame 10130 for a certain length. The first intermediate planar segment 10336 is embedded within the second plane 10322 of the first insulating material 10120a, and the second intermediate planar segment 10340 is embedded within the third plane 10324 of the second insulating material 10120b. In Figure 6B the example shown, the embedding planes 10322, 10324 are separated from the frame 10130 such that there is a specific gap between the frame 10130 and the flexible circuits 10110, 10140. For example, the third distance 10330 between the frame 10130 and the second plane 10322 is greater than zero, and the fourth distance 10334 between the frame 10130 and the third plane 10324 is greater than zero.

[0171] Figure 6C shows a construction similar to that of Figure 6Ba similar configuration as shown, but instead of having gaps (e.g., at a third distance 10330 and a fourth distance 10334) between the frame 10130 and the embedding planes 10322, 10324, the embedding planes 10322, 10324 are adjacent to the frame 10130. For example, a first intermediate plane section 10336 extends along the length of the frame 10130, in direct contact with or close to the frame 10130, and a second intermediate plane section 10340 extends along the length of the frame 10130, in direct contact with or close to the frame 10130.

[0172] Figure 6D illustrates a structure similar to Figure 6B and Figure 6C the structure shown, but the corresponding circuit has a longitudinal cross-section along the outermost plane. For example, and first referring to the first sheet of insulating material 10120a, the first flexible circuit 10110 includes a first superficial plane section 10338 that is parallel to the frame 10130 and extends a certain length within the first plane 10320. As shown, the first superficial plane section 10338 may be embedded or partially embedded within the insulating material 10120a, or the first superficial plane section 10338 may extend along the first outer surface 10122a. Before the first flexible circuit 10110 extends inwardly towards the second plane 10322, the first superficial plane section 10338 enables more than one electrode on the first outer surface 10122a to be connected to the first superficial plane section. Now referring to the second sheet of insulating material 10120b, the second flexible circuit 10140 includes a second superficial plane section 10342 that is parallel to the frame 10130 and extends a certain length within the fourth plane 10326. As shown, the second superficial plane section 10342 may be embedded or partially embedded within the insulating material 10120b, or the second superficial plane section 10342 may extend along the second outer surface 10122b. Before the second flexible circuit 10140 extends inwardly towards the fourth plane 10324, the second superficial plane section 10342 enables more than one electrode on the second outer surface 10122b to be connected to the second superficial plane section.

[0173] The bend between the reference plane sections (e.g., sections 10338 and 10342) and the angled section 10344 can extend the radius of curvature 10346 therebetween to prevent the curling of the flexible circuit. For example, the angle of the angled section can change as the first part (e.g., the superficial plane section) bends or moves relative to the second part (e.g., the intermediate plane section). In the case where the radius of curvature 10346 is larger, the flexible circuits 10110, 10140 can have greater slack to move without curling. However, in some examples, and as Figure 6EAs shown, one or more flexible circuits 10110, 10140 may have a wavy profile in or at least partially within the insulating materials 10120a, 10120b. Similar to the above example, the wavy profile of the flexible circuit may have peaks and valleys. Referring to the first flexible circuit 10110 (which is on the top of the end effector 10100 shown in Figure 6E ), the "peaks" of the wavy profile extend to the exposed or at least partially exposed electrodes 10112. Thus, the first plane 10320 of the "peaks" is along or close to the first outer surface 10122a. The "valleys" of the first flexible circuit 10110 are at the second plane 10322, and the "valleys" may contact the frame 10130, or as shown, the third distance 10330 may be greater than zero to provide a gap between the first flexible circuit 10110 and the frame 10130. Referring to the second flexible circuit 10140 (which is on the bottom of the end effector 10100 shown in Figure 6E ), the "valleys" of the wavy profile extend to the exposed or at least partially exposed electrodes 10142. Thus, the fourth plane 10326 of the "valleys" is along or close to the second outer surface 10122b. The "peaks" of the second flexible circuit 10140 are at the third plane 10324, and the "peaks" may contact the frame 10130, or as shown, the fourth distance 10334 may be greater than zero to provide a gap between the second flexible circuit 10140 and the frame 10130.

[0174] Figure 6E And Figure 6F shows a substantially similar end effector 10100, but the two designs differ in the placement of the electrodes 10120b. For example, in Figure 6E , a plurality of first electrodes 10112 are directly aligned opposite a plurality of second electrodes 10142. In Figure 6F , a first position of a plurality of first electrodes 10112 is longitudinally offset from a second position of a plurality of second electrodes 10142 along the length of the end effector 10110. This offset of the electrodes 10120b may increase and / or even out the surface area of contact with the target tissue.

[0175] As will be appreciated, any features of the exemplary end effector 10100 described herein may be combined with any other features as needed to improve contact with the target tissue while also providing operability and strength. Figure 7Examples of such feature combinations are provided, as the figure shows an end effector 10100 having a first flexible circuit 10110 that extends from a surface electrode 10112 in a first plane, then extends into an insulating material 10120a to reach a second plane, and then extends back to the surface electrode 10112 in the first plane (e.g., as Figure 6A shown). In this example, the insulating material 10120a includes a first support layer 10302 embedded therein, and the first support layer 10302 can be substantially similar to the first support layer referred to above with reference to Figure 5A described. Figure 7 The end effector 10100 in Figure 6A also includes a second flexible circuit 10140 that extends from a surface electrode 10142 in a fourth plane, then extends into an insulating material 10120b to reach a third plane, and then extends back to the surface electrode 10142 in the fourth plane (e.g., as Figure 5A shown). In this example, the insulating material 10120b includes a second support layer 10304 embedded therein, and the second support layer 10304 can be substantially similar to the second support layer referred to above with reference to

[0176] This disclosure provides a catheter assembly 10200 as Figure 8 shown, which may include a tubular member 10230 that extends along a longitudinal axis 10L-L and is configured to deliver the end effector 10100 outside a sheath 10210. A physician 1024 can manipulate the catheter 200 using a handle 10220. Suitable examples of the catheter assembly 10200 and its sub-components such as the handle 10220, the sheath 10210, the tubular member 10230, and other components not mentioned herein are described in U.S. Patent Publication No. 2021 / 0369339, which is incorporated herein by reference and attached to the appendix of priority application No. 63 / 615,600.

[0177] End effector with offset flexible circuit( Figures 9 to 12B )

[0178] Reference Figure 9, which shows an exemplary catheter-based electrophysiological mapping and ablation system 2010. The system 2010 includes a plurality of catheters that are inserted by a physician 2024 through the vasculature of a patient 2023 via the skin into a chamber or vascular structure of the heart 2012. Generally, a delivery sheath catheter is inserted into the left atrium or right atrium near a desired location within the heart 2012. Then, a plurality of catheters can be inserted into the delivery sheath catheter to reach the desired location. The plurality of catheters can 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 places the catheter shaft 2090 having the distal end (i.e., the end effector 20100) of the catheter 2014 in contact with the heart wall for sensing a target site within the heart 2012. For ablation, the physician 2024 similarly brings the distal end of the ablation catheter to the target site for ablation.

[0179] The catheter 2014 is an exemplary catheter that includes one and preferably a plurality of electrodes 2026 optionally distributed over the end effector 20100, which is coupled to the 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 in or near the end effector 20100 for tracking 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.

[0180] The magnetic-based position sensor can operate in conjunction with a positioning pad 2025 that includes a plurality of magnetic coils 2032 configured to generate a magnetic field within a predefined 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 positioning 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.

[0181] System 2010 includes one or more electrode patches 2038 positioned in contact with the skin of patient 2023 to establish a position reference for impedance-based tracking of the positioning pad 2025 and electrodes 2026. For impedance-based tracking, current is directed toward electrodes 2026 and sensed at the electrode skin patches 2038 such that the position of each electrode can be triangulated via the electrode patches 2038. 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.

[0182] Recorder 2011 displays an electrogram 2021 captured using the body surface ECG electrodes 2018 and an intracardiac electrogram (IEGM) captured using the electrodes 2026 of catheter 2014. Recorder 2011 may include pacing capabilities for pacing the heart rhythm and / or may be electrically connected to an independent pacemaker.

[0183] System 2010 may include an ablation energy generator 2050 adapted to conduct ablation energy to one or more of the electrodes 2026 at the distal end of a catheter configured for ablation. The energy generated by ablation energy generator 2050 may include, but is not limited to, radiofrequency (RF) energy or pulsed field ablation (PFA) energy (including monopolar or bipolar high voltage DC pulses that may be used to effect irreversible electroporation (IRE)), or combinations thereof.

[0184] The patient interface unit (PIU) 2030 is an interface configured to establish electrical connectivity between the catheter, electrophysiology equipment, power supply, and a workstation 2055 for controlling the operation of system 2010. The electrophysiology equipment of system 2010 may include, for example, multiple catheters, positioning pad 2025, body surface ECG electrodes 2018, electrode patches 2038, ablation energy generator 2050, and recorder 2011. Optionally and preferably, PIU 2030 further includes processing capabilities for performing real-time calculations of the position of the catheter and for performing ECG calculations.

[0185] Workstation 2055 includes a memory, a processor unit with a memory or storage device loaded with appropriate operating software, and user interface capabilities. Workstation 2055 can provide multiple functions, optionally including: (1) performing three-dimensional (3D) modeling of endocardial anatomy and rendering a model or anatomical map 2020 for display on a display device 2027; (2) displaying an activation sequence (or other data) compiled from the recorded electrogram 2021 as a representative visual marker or image superimposed on the rendered anatomical map 2020 on the display device 2027; (3) displaying the real-time position and orientation of multiple catheters within a heart chamber; and (4) displaying a site of interest on the display device 2027, such as where ablation energy has been applied. A commercial product embodying the elements of system 2010 can be CARTO TM 3System, available from Biosense Webster, Inc., 31 Technology Drive, Suite 200, Irvine, CA 92618.

[0186] FIG. 10a and Figure 10C is a schematic illustration depicting a multi-layer end effector 20100 in the form of a generally flat / plane. To achieve the desired stiffness, mapping resolution, contact of the electrodes with the target anatomy, and conformance of the end effector 20100 disclosed herein to flat, curved, irregular, and / or non-planar tissue surfaces found in the target anatomy, the end effector 20100 has at least a planar ridge frame 20110, flexible circuits (e.g., flexible circuits 20122, 20132, 20212, 20222), and an insulating material forming a substrate 20130. In some examples, the substrate 20130 can include a suitable substrate, such as, for example, 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.

[0187] The end effector 20100 can extend along a longitudinal axis 20180 from a proximal portion 20106 to a distal portion 20104. In some examples, the end effector 20100 includes one or more flexible circuits disposed on a substrate 20130 of the end effector 20100. The flexible circuits 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 examples, it can be made of any one of biocompatible polyimide, glass-reinforced epoxy laminate, copper, or graphene alone or in combination. The flexible circuit layer can include conductive traces. As used herein, the term "flexible circuit" includes thin-film circuits, flexible printed circuit boards, and thin-film depositions implemented on a substrate (such as a polyimide or even a nitinol substrate) via lithography and etching processes. Each flexible circuit can include a plurality of electrodes disposed on the distal portion 20104 of the end effector 20100. Electrical contacts corresponding to each electrode can be disposed in the proximal portion of the circuit, and the circuit can be disposed in the proximal portion of the end effector. Traces disposed within each circuit can provide electrical contacts that are in electrical communication with the electrodes of the circuit, such that these electrical contacts can transmit electrical signals to and from the electrodes.

[0188] In some examples, the substrate 20130 comprises an insulating material. The frame 20110 of the end effector 20100 can be disposed within the substrate 20130 and can be generally planar along the longitudinal axis 20180 such that the longitudinal axis 20180 is parallel to or coincides 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 examples, the frame 20110 is formed of a flexible elastic material. As an example, the frame 20110 can be formed of a shape memory alloy, such as nickel-titanium (also known as nitinol), cobalt-chromium, stainless steel, and / or other alloys that exhibit pseudoelastic properties.

[0189] The substrate 20130 can be formed of an insulating material and can at least partially encapsulate and separate the frame 20110 and the flexible circuits. The substrate 20130 can also be used to enhance the atraumatic nature of the end effector 20100 and protect the subject from sharp edges.

[0190] Figure 10ADepicts a first side of an exemplary end effector 20100 including a first flexible circuit 20122 and a second flexible circuit 20132. In some examples, the first flexible circuit 20122 and the second flexible circuit 20132 are disposed on a first side of a substrate 20130. In some examples, the first flexible circuit 20122 and the second flexible circuit 20132 are disposed on the same side of the substrate 20130. In some examples, in a distal portion 20104 of the end effector 20100, the first flexible circuit 20122 is disposed opposite the second flexible circuit 20132 with respect to a longitudinal axis 20180. In some examples, the first flexible circuit 20122 includes one or more electrodes 20151 disposed on the distal portion 20104 of the end effector 20100, and one or more electrical contacts 20128 disposed 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 examples, the second flexible circuit 20132 includes one or more electrodes 20152 disposed on the distal portion 20104 of the end effector 20100, and one or more electrical contacts 20138 disposed 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.

[0191] In some examples, to accommodate the small area of the end effector 20100, the first flexible circuit 20122 and the second flexible circuit are coplanar in the distal portion 20104 of the end effector 20100 and are stacked on top of each other in 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 arrangement may enable both the electrical contacts 20128 of the first flexible circuit 20122 and the electrical contacts 20138 of the second flexible circuit 20132 to be disposed on the proximal portion 20106 of the end effector 20100.

[0192] Figure 10CDepicts a second side of an exemplary end effector 20100 including a third flexible circuit 20212 and a fourth flexible circuit 20222. In some examples, the third flexible circuit 20212 and the fourth flexible circuit 20222 are disposed on a second side of a substrate 20130. In some examples, the third flexible circuit 20212 and the fourth flexible circuit 20222 are disposed on the same side of the substrate 20130. In some examples, in a distal portion 20104 of the end effector 20100, the third flexible circuit 20212 is disposed opposite the fourth flexible circuit 20222 relative to a longitudinal axis 20180. In some examples, the third flexible circuit 20212 includes one or more electrodes 20251 disposed on the distal portion 20104 of the end effector 20100, and one or more electrical contacts 20218 disposed on a 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 examples, the fourth flexible circuit 20222 includes one or more electrodes 20252 disposed on the distal portion 20104 of the end effector 20100, and one or more electrical contacts 20228 disposed on a 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.

[0193] Figure 10B Is a schematic diagram showing a detailed view of an exemplary electrode arrangement disposed on the end effector 20100. In some examples, the electrodes 20150 of the end effector are arranged in pairs. The electrodes 20150 in each pair may be spaced apart by a first predetermined longitudinal distance 20Lg. Each pair of electrodes may be spaced apart from an adjacent pair of electrodes by a second predetermined longitudinal distance 20158. The second predetermined longitudinal distance 20158 may be greater than the first predetermined longitudinal distance 20Lg. In some examples, the first predetermined longitudinal distance 20Lg between the electrodes 20150 in a pair of electrodes is about 100 micrometers. In some examples, the second predetermined longitudinal distance 20158 between adjacent pairs of electrodes 20150 is about 1300 micrometers. In some examples, each electrode 150 includes a width 20153 of about 500 micrometers and a length 20154 of about 500 micrometers.

[0194] In some forms, the spacing gap distance 20Lg separating each electrode 20150 in a pair (also referred to herein as a microelectrode) is in the range of about 50 microns to about 300 microns. In some forms, the spacing gap distance 20Lg separating each microelectrode (20150) in a pair is in the range of about 100 microns to about 200 microns. In some forms, the spacing gap distance Lg separating each microelectrode 20150 in a pair is about 50 microns. Additionally, in some forms, each microelectrode 20150 itself may have a width 20153 in the range of about 50 microns to about 100 microns. Each pair of microelectrodes 20150 is spaced apart from an adjacent pair of microelectrodes 20150 by a distance of about 5.0 mm, where each microelectrode 20150 has a width 20153 of about 50 microns and a length 20154 of about 2.56 mm. In some

[0195] In the present example, the width 20153 of the microelectrode 20150 is equal to the width 20153 of the other microelectrode 20150 in the pair of microelectrodes, and the length 20154 of the microelectrode 20150 is equal to the length 20154 of the other microelectrode 20150 in the pair of microelectrodes 20150. Thus, in the present example, 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 mounted, such that the width 20153 extends generally parallel to the longitudinal axis 20Le - 20Le of the electrodes or generally perpendicular to the longitudinal axis 20180 of the structure to which the microelectrodes 20150, 20150 are mounted. 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 mounted, such that the gap 20Lg extends between the two closest surfaces 20150a, 20150a of the microelectrodes. For ease of nomenclature with respect to this embodiment, the gap 20Lg is also considered to be generally parallel to the longitudinal axis 20180 of the structure to which the microelectrodes 20150, 20150 are mounted. Although the microelectrodes 20150, 20150 are rectangular in the present example, the microelectrodes 20150, 20150 may alternatively have any other suitable shape.

[0196] Note that any arrangement of electrodes may require the electrode pairs of all embodiments described herein to conform to the following empirical rules: (1) the length 20154 of the electrodes must always be at least the same as the spacing gap 20Lg between the electrode pairs, 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. In short, this can be rephrased as: (1) 20154 ≥ 20Lg, and (2) 20Ag / 20Ae ≤ 1. In some forms, the gap distance 20Lg can be determined by the product of an electrode area 20Ae of up to one square millimeter and a conversion factor of about 1.25 mm -1 or less.

[0197] Figure 10C An exemplary frame 20110 of the end effector 20100 is depicted in . In some examples, the frame 20110 of the end effector 20100 is embedded in a substrate 20130. As shown, the frame 20110 may include a first ridge 20112, a second ridge 20114, a third ridge 20116, and a fourth ridge 20118 disposed in the distal portion 20104 of the end effector 20100. The ridges 20112, 20114, 20116, 20118 may extend along a longitudinal axis 20180 from a base 20119 disposed in the proximal section 20106 of the end effector 20100. The ridges 20112, 20114, 20116, 20118 may be arranged to resist bending when a force (e.g., torsion) is applied thereto. A gap may be provided between each of the ridges to increase the flexibility of the frame. These forces may occur at different times during use (such as when inserted into a guide). This design helps prevent disconnection of the electrical interconnections on the flexible circuit.

[0198] In some examples, the distal portions of the first flexible circuit 20122 and the third flexible circuit 20212 may each include a loop disposed on the first and second ridges. In some examples, the distal portions of the second flexible circuit 20132 and the fourth flexible circuit 20222 each include a second loop disposed on the third and fourth ridges.

[0199] Figure 11A and Figure 11B is a schematic illustration depicting an example in the form of a generally flat / plane multi-layer end effector 20300 according to the disclosed technology, where Figure 11A is a front view of the end effector 20300 and Figure 11Bis a right side view thereof. In some examples, 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 coplanar and disposed on a first side of the substrate 20330, and the third flexible circuit 20332 and the fourth flexible circuit 20342 are coplanar and disposed on a second side of the substrate 20330. Each circuit may 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 may be disposed in the proximal portion of the circuit. In some examples, the end effector 20300 is configured such that the proximal portion 20316 of the first circuit 20312 and the proximal portion 20336 of the third circuit 20332 are disposed on the same side of the substrate 20330, and the proximal portion 20326 of the second circuit 20322 and the proximal portion 20346 of the fourth circuit 20342 are disposed on the same side of the substrate 20330. 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.

[0200] Figure 12A and Figure 12B is a schematic illustration depicting an example of a generally flat / plane multi-layer end effector 20400 in accordance with the disclosed technology, where Figure 12A is a front side view of the end effector 20400 and Figure 12B is a right side view thereof. In some examples, the end effector 20400 includes a first flexible circuit 20412 having an electrode 20411 disposed at a distal end of the end effector 20400. The end effector may further include a second flexible circuit 20422 having an electrode 20421 disposed proximal to the electrode 20411 of the first circuit. In some examples, the first circuit 20412 and the second circuit 20422 are coplanar in a distal portion of the end effector 20400. In some examples, the proximal portion 20416 of the first circuit 20412 is disposed on a side of the substrate 20430 opposite to the proximal portion 20426 of the second circuit 20422.

[0201] In some examples, the end effector 20400 further includes a third flexible circuit 20432 and a fourth flexible circuit 20442. In some examples, the third flexible circuit 20432 includes an electrode 20431 disposed on 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 coplanar and disposed on a first side of the substrate 20430, and the third flexible circuit 20432 and the fourth flexible circuit 20442 are coplanar and disposed on a second side of the substrate 20430. Each circuit may include a proximal portion having electrical contacts corresponding to the electrodes 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 may be disposed in the proximal portion of the circuit. In some examples, the end effector 20300 is configured such that the proximal portion 20416 of the first circuit 20412 and the proximal portion 20436 of the third circuit 20432 are disposed on the same side of the substrate 20430, and the proximal portion 20426 of the second circuit 20422 and the proximal portion 20446 of the fourth circuit 20442 are disposed on the same side of the substrate 20430. 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, or 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 examples, the first circuit and the third circuit may be collectively referred to as the first circuit, and the second circuit and the fourth circuit may be collectively referred to as the second circuit.

[0202] Encapsulated planar catheter with a positioning sensing coil( Figures 13 to 20 )

[0203] Reference Figure 13, which shows an exemplary catheter-based electrophysiological mapping and ablation system 3010. System 3010 includes a plurality of catheters that are inserted by physician 3024 through the vasculature of patient 3023 via the skin into the chambers or vascular structures of heart 3012. Generally, a delivery sheath catheter is inserted into the left atrium or right atrium near the desired location within heart 3012. Then, a plurality of catheters can be inserted into the delivery sheath catheter to reach that desired location. The plurality of catheters can 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 for sensing IEGM is illustrated herein. Physician 3024 places the catheter shaft 3090 with the distal end of catheter 3014 (i.e., the multi-layer end effector 30100) in contact with the heart wall for sensing a target site within heart 3012. For ablation, physician 3024 would similarly bring the distal end of the ablation catheter to the target site for ablation.

[0204] Catheter 3014 is an exemplary catheter that includes one and preferably a plurality of electrodes 3026 optionally distributed over end effector 30100, which is coupled to catheter shaft 3090 and configured to sense IEGM signals, as described in more detail below. Catheter 3014 may additionally include a position sensor (such as Figure 14 shown in B) embedded in or near end effector 30100 for tracking the position and orientation of 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.

[0205] The magnetic-based position sensor can operate with a positioning pad 3025 that includes a plurality of magnetic coils 3032 configured to generate a magnetic field within a predefined workspace. The real-time position of end effector 30100 of catheter 3014 can be tracked based on the magnetic field generated by positioning pad 3025 and sensed by the magnetic-based position sensor. Details of the magnetic-based position sensing technique 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.

[0206] System 3010 includes one or more electrode patches 3038 positioned to contact the skin of patient 3023 to establish a position reference for impedance-based tracking of positioning pad 3025 and electrodes 3026. For impedance-based tracking, current is directed toward electrodes 3026 and sensed at the electrode-skin patches 3038 such that 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.

[0207] Recorder 3011 displays electrocardiogram 3021 captured using body surface ECG electrodes 3018 and intracardiac electrogram (IEGM) captured using electrodes 3026 of catheter 3014. Recorder 3011 may include pacing capabilities for pacing the heart rhythm and / or may be electrically connected to an independent pacemaker.

[0208] System 3010 may include an ablation energy generator 3050 adapted to conduct ablation energy to one or more of electrodes 3026 at the distal end of a catheter configured for ablation. The energy generated by ablation energy generator 3050 may include, but is not limited to, radiofrequency (RF) energy or pulsed field ablation (PFA) energy (including monopolar or bipolar high voltage DC pulses that can be used to effect irreversible electroporation (IRE)), or combinations thereof.

[0209] Patient interface unit (PIU) 3030 is an interface configured to establish electrical connectivity between the catheter, electrophysiology equipment, power supply, and workstation 3055 for controlling the operation of system 3010. The electrophysiology equipment of system 3010 may include, for example, multiple catheters, positioning pad 3025, body surface ECG electrodes 3018, electrode patches 3038, ablation energy generator 3050, and recorder 3011. Optionally and preferably, PIU 3030 further includes processing capabilities for performing real-time calculations of the position of the catheter and for performing ECG calculations.

[0210] The workstation 3055 includes a memory, a processor unit with a memory or storage device loaded with appropriate operating software, and user interface capabilities. The workstation 3055 can provide multiple functions, optionally including: (1) performing three-dimensional (3D) modeling of endocardial anatomy and rendering the model or anatomical map 3020 for display on a display device 3027; (2) displaying the activation sequence (or other data) compiled from the recorded electrograms 3021 as representative visual markers or images superimposed on the rendered anatomical map 3020 on the display device 3027; (3) displaying the real-time positions and orientations of multiple catheters within the heart chambers; and (4) displaying sites of interest on the display device 3027, such as where ablation energy has been applied. A commercial product embodying the elements of the system 3010 can be the CARTO TM 3System, which is available from Biosense Webster, Inc., 31 Technology Drive, Suite 200, Irvine, CA 92618.

[0211] Figure 14 FIG. is a schematic illustration showing an exploded view of a portion of a multi-layer end effector 30100 in the form of a generally flat / plane. To achieve the desired stiffness, mapping resolution, contact of the electrodes with the target anatomy, and conformance of the end effector 30100 disclosed herein with flat, curved, irregular, and / or non-planar tissue surfaces found in the target anatomy, the end effector 30100 has at least a flexible circuit layer 30110, a frame 30120, an insulating material 30130 including one or more flexible non-conductive layers 30130a, 30130b, and one or more positioning sensing loops 30140 stacked along a vertical axis 3062 that is substantially orthogonal to the longitudinal axis 3060 of the end effector. In Figure 14 FIG., the flexible circuit 30110 is provided with a plurality of electrodes 30111 (e.g., generally planar electrodes), where the contact surfaces of the plurality of electrodes face upward in this figure. It should be noted that another flexible circuit 30110 can be provided below the frame 30120, where the electrodes are configured to face downward in this figure.

[0212] The end effector 30100 is illustrated as being exploded in an orthogonal direction along the vertical axis 3062. Although only one side of the end effector 30100 (relative to the frame 30120) is depicted (e.g., the upper side relative to the Figure 13 orientation shown), and as mentioned above, it should be understood that the opposite side (e.g., the lower side) of the end effector can also include other structures, such as but not limited to insulating materials, one or more additional flexible circuits, and one or more additional positioning sensing loops.

[0213] The flexible circuit 30110 can extend along the longitudinal axis 3060 from the proximal portion of the end effector 30100 (i.e., Figure 14 the upper right section) to the distal portion (i.e., Figure 14 the lower left section). In some examples, the flexible circuit layer 30110 can be made primarily of polyimide. In other examples, it can be made of any one or a combination of biocompatible polyimide, glass-reinforced epoxy laminate, copper, or graphene. The flexible circuit layer can include conductive traces. As used herein, the term "flexible circuit" includes thin film circuits, flexible printed circuit boards, and thin film depositions on a substrate such as a polyimide or even a nitinol substrate via photolithography and etching processes.

[0214] The frame 30120 is disposed in the insulating material 30130 and is substantially planar along the longitudinal axis 3060 such that the longitudinal axis 3060 is parallel to or coincides with the frame 30120. The frame 30120 can include a first side 30122 (which forms a first planar surface) and an opposite second side 30124 (which forms a second planar surface) relative to the longitudinal axis 3060. The frame 30120 is also generally parallel to the plane defined by the flexible circuit 30110 such that the planar electrodes 30111 are aligned along at least one of the first planar surface or the second planar surface, such that each electrode is spaced apart from the first planar surface or the second planar surface. In Figure 14 the example shown, a plurality of positioning sensing loops 30140 are provided, which can be sandwiched between the flexible circuit 30110 and the spine frame 30120 and are generally parallel to the flexible circuit and the spine frame. In some examples, the frame 30120 is formed of a flexible elastic material. As an example, the frame can be formed of 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.

[0215] The first non-conductive flexible layer 30130a can at least partially encapsulate one side of the sensing loop 30140 and the frame 30120 and separate the two. In addition, the second non-conductive flexible layer 30130b can at least partially encapsulate the other side of the sensing loop 30140 and the flexible circuit 30110 and separate the two. The insulating material 30130 is also used to enhance the atraumatic nature of the end effector 30100 and protect the subject from sharp edges.

[0216] Each sensing loop 30140 has one or more coils 30140a, each of which has a surface area (i.e., the area enclosed by the respective coil 30140a of loop 30140). In addition, 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 in loop 30140). When subjected to a magnetic field, the amount of energy received by each sensing loop 30140 is proportional to the size of the coils 30140a (e.g., proportional to the cumulative surface area of the coils 30140a). The cumulative surface area of each loop 30140 defines the cumulative position sensing area of that loop 30140. To enable the magnetic field to function to most effectively track the position of the end effector 30100, the cumulative surface area in the presently disclosed technology is from about one hundred square millimeters to about three hundred square millimeters. In some examples, the cumulative surface area is at least about 200 square millimeters.

[0217] Reference Figures 14 to 16 , the sensing loop 30140 of this example includes a central loop 30142 and a pair of side loops 30144, 30146. In some examples (e.g., as Figure 14 shown), the sensing loops 30140 may be coplanar. As best visible in Figure 14 and Figure 16 , when viewed in the direction along the vertical axis 3062, the central loop 30142 partially overlaps both the first loop 30144 and the second loop 30146. However, it should be understood that in other examples, the loops 30142, 30144, 30146 do not overlap, provided that the cumulative surface area of each loop 30142, 30144, 30146 falls within the above range.

[0218] As previously discussed, each loop 30142, 30144, 30146 is configured to generate a current when subjected to a magnetic field. Each loop 30142, 30144, 30146 may include the conductive material of the loop formed as one or more coils 30140a. The loops 30142, 30144, 30146 may include electrical leads for conducting the current induced on each loop 30142, 30144, 30146 to the PIU 3030. As will be appreciated, by attaching multiple loops 30142, 30144, 30146 to the end effector 30100, the position of the end effector can be detected. In this way, the physician 3024 can more accurately determine the position of the end effector 30100 before using the end effector 30100 for the purposes mentioned above.

[0219] In combination with the above, when viewed in the direction along the vertical axis 3062, the central circuit 30142 is disposed on the longitudinal axis 3060 (specifically refer to Figure 16 ). In this example, the central circuit 30142 is disposed in a plane that is substantially parallel to and extends along the longitudinal axis 3060, such that the central circuit has a design that is symmetric with respect to the longitudinal axis. In an alternative example, the central circuit 30142 need not be symmetric with respect to the longitudinal axis 3060. The central circuit 30142 is also disposed on a region near the distal portion 30130a1 of the insulating material 30130 (as exemplified by its extent relative to the first non-conductive flexible layer 30130a, as Figure 14 and Figure 16 show). The central circuit 30142 conforms to the configuration of the segment / section 30130a3 of the first non-conductive flexible layer 30130a.

[0220] In this example, the pair of side circuits 30144, 30146 (referred to herein as the first side circuit 30144 and the second side circuit 30146) are disposed substantially symmetrically with respect to the longitudinal axis 3060. In other examples, the side circuits 30144, 30146 need not be symmetric. Each is disposed in a plane. In the Figure 14 illustrated example, the side circuit planes are coplanar with each other and parallel or coplanar with the plane of the central circuit 30142 (as well as the plane of the flexible circuit 30110 and the plane of the frame 30120). Each side circuit 30144, 30146 extends from the proximal portion 30130a1 of the insulating material 30130 to the distal portion 30130a2, as exemplified by its extent relative to the first non-conductive flexible layer 30130a in Figure 16 . The pair of side circuits 30144, 30146 conform to the configuration of the segment / section 30130a3 of the first non-conductive flexible layer 30130a.

[0221] In combination with the above, each coil 30140a of the central circuit 30142 has a central circuit surface area 30143, each coil 30140a of the first side circuit 30144 has a first side circuit surface area 30145, and each coil 30140a of the second side circuit 30146 has a second side circuit surface area 30147. For each circuit 30142, 30144, 30146, the product of the circuit surface area 30143, 145, 147 and its number of coils yields the above cumulative surface area of the circuits 30142, 30144, 30146.

[0222] In some examples, the surface area 30143 of a coil 30140a of the central loop 30142 is at least about 69 square millimeters. In some examples, the surface area 30145 of a coil 30140a of the first side loop 30144 and the surface area 30147 of a coil 30140a of the second side loop 30146 are each at least 59 square millimeters. Since the respective loops are wound such that they have multiple coils 30140a, the cumulative surface area of each loop 30142, 30144, 30146 can be made to fall within the ranges discussed above.

[0223] In combination with the above and with reference to Figure 16 , the end effector 30100 has a total length 30L1 (e.g., about 20 mm to 25 mm) and a total width 30W1 (e.g., about 9 mm to 12 mm) and a total area 30101 (i.e., the area of the planar surface substantially defined by the end effector 30100 along the vertical axis 3062). In some examples, the total area 30101 is about 100 square millimeters to 350 square millimeters.

[0224] Figure 15A is a schematic illustration showing Figure 14 the central loop 30142 of the end effector 30100. Specifically referring to Figure 15A, the central loop 30142 may include a first segment to a fifth segment 30142a - 30142e. The first segment 30142a extends arcuately and defines the distal end of the central loop 30142. The second segment 30142b extends substantially linearly from the first segment 30142a in the proximal direction 30PD of the end effector 30100 and is angled relative to the longitudinal axis 3060 (i.e., not parallel to the longitudinal axis). The third segment 30142c extends substantially linearly from the second segment 30142b in the distal direction 30DD of the end effector 30100 and is angled relative to the longitudinal axis 3060 (i.e., not parallel to the longitudinal axis). The fourth segment 30142d extends substantially linearly from the third segment 30142c in the proximal direction of the end effector 30100 and is angled relative to the longitudinal axis 3060 (i.e., not parallel to the longitudinal axis). The fifth segment 30142e extends substantially linearly from the fourth segment 30142d in the distal direction 30DD of the end effector 30100, connects to the first segment 30142a to form a loop, and is angled relative to the longitudinal axis 3060 (i.e., not parallel to the longitudinal axis). Additionally, a plurality of central loop engagement sections 30142f connect the respective above - mentioned segments 30142a - 30142e. Of course, it should be understood that the depicted central loop 30142 is exemplary, and in other specific embodiments, different shapes / forms may be employed without departing from the essence and scope of the present disclosure.

[0225] Figure 15B is a schematic illustration Figure 14 of the two side loops 30144, 30146 of the end effector 30100. Compared with the central loop 30142, in this example, when viewed in the direction along the vertical axis 3062, the two side loops 30144, 30146 are laterally offset from the longitudinal axis 3060.

[0226] Specifically referring to Figure 15B, the first side loop 30144 may include a sixth segment to a ninth segment 30144a - 30144d (numbered continuously from the numbering of the central loop 30142 to clearly distinguish in the description). The sixth segment 30144a defines the distal end of the first side loop 30144 and extends arcuately. The seventh segment 30144b extends linearly from the sixth segment 30144a in the proximal direction PD of the end effector 30100 and is substantially parallel to the longitudinal axis 3060. The eighth segment 30144c extends arcuately from the seventh segment 30144b in the proximal direction 30PD of the end effector 30100. The ninth segment 30144d extends linearly from the eighth segment 30144c in the distal direction 30DD of the end effector 30100, is substantially parallel to the longitudinal axis 3060, and is connected to the sixth segment 30144a to form a loop. In addition, a plurality of first side loop engagement segments 30144e connect the respective above - mentioned segments 30144a - 30144d. As Figure 14 and Figure 16 best seen in, all segments 30144a - 30144d of the first side loop 30144 are designed such that these segments extend along the segments / sections 30130a3 of the insulating material 30130 (see Figure 14 ). Of course, it should be understood that the depicted first side loop 30144 is exemplary, and in other specific embodiments, without departing from the essence and scope of the present disclosure, different shapes / forms may be adopted (such as those discussed below with respect to Figure 18 and Figure 19 ).

[0227] Continuing to refer to Figure 15B, the second side loop 30146 may include a tenth segment to a thirteenth segment 30146a - 30146d (numbered consecutively from the numbering of the first side loop 30144 to clearly distinguish in the description). As mentioned above, the second side loop 30146 is symmetric with respect to the longitudinal axis 3060 to the first side loop 30144. In other words, in this example, the second side loop 30146 is a mirror image of the first side loop 30144 with respect to the longitudinal axis. However, it should be noted that asymmetries and symmetries in different planes are contemplated examples. The tenth segment 30146a defines the distal end of the second side loop 30146 and extends arcuately. The eleventh segment 30146b extends linearly from the tenth segment 30146a in the proximal direction 30PD of the end effector 30100. The twelfth segment 30146c extends arcuately from the eleventh segment 30146b in the proximal direction 30PD of the end effector 30100. The thirteenth segment 30146d extends linearly from the twelfth segment 30146c in the distal direction 30DD of the end effector 30100, substantially parallel to the longitudinal axis 3060, and is connected to the tenth segment 30146a to form a loop. Additionally, a plurality of second side loop engagement segments 30146e connect the respective segments 30146a - 30146d described above. As Figure 16 best seen in, all segments 30146a - 30146d of the second side loop 30146 are designed such that these segments extend along the segments / sections 30130a3 of the insulating material 30130. Of course, it should be understood that the depicted second side loop 30146 is exemplary, and in other specific implementations, without departing from the essence and scope of the present disclosure, different shapes / forms may be adopted (such as those discussed below with respect to Figure 18 and Figure 19 ).

[0228] Figure 17 is a schematic diagram showing Figure 14 a partial exploded view of a modified configuration of the end effector 30100. In addition to the layering of the central loop 30142 and the side loops 30144, 30146, Figure 17 the example of Figures 14 to 16 can be implemented and function in the same manner as the example described above with respect to Figure 17 As shown in, instead of arranging the positioning sensing loop 30140 along the vertical axis 3062 in the same layer and on the same side of the frame 30120, the loop 30140 can be positioned in different layers and / or on opposite sides / planes with respect to the plane of the frame 30120.

[0229] As Figure 17As illustrated, the first non-conductive flexible layer 30130a may at least partially encapsulate and separate the lower side of the frame 30120 and the central loop 30142. The second non-conductive flexible layer 30130b may at least partially encapsulate and separate one side of the side loops 30142, 30144 and the upper side of the frame. Additionally, the third non-conductive flexible layer 30130c may at least partially encapsulate and separate the other side of the side loops 30142, 30144 and the flexible circuit 30110. Of course, any layered configuration may be employed without departing from the spirit and scope of the present disclosure.

[0230] Turning now to Figure 18 and Figure 19 , a variant configuration of the side loops 30144', 30146' is shown. This configuration is the same as the example described above with respect to Figures 14 to 17 except for the routing of the ninth segment 30144d' and the thirteenth segment 30146d'. In this example, the ninth segment 30144d' includes a proximal section 30144d1' that is not parallel to the longitudinal axis 3060 and a distal section 30144d2' that is substantially parallel to the longitudinal axis 3060 ( Figure 18 B), where the proximal section 30144d1' is curved away from the longitudinal axis 3060. Otherwise, it should be understood that the other segments / junctions 30144a'-30144c', 30144e' and 30146a’-30146c’, 30146e' may be configured to be the same as their corresponding parts 30144a-30144c, 30144e and 30146a-30146c, 30146e in the previously described example (and as shown in Figure 15B and Figure 16 ).

[0231] The currently described example employs the use of three loops 30140. Of course, it should be understood that any number of loops (e.g., 1, 2, 3, 4, 5, etc.) may be employed without departing from the spirit and scope of the present disclosure, provided that the cumulative surface area of each loop 30140 (each loop including one or more coils 30140a) falls within the range discussed above.

[0232] The present disclosure provides as Figure 20The catheter assembly 30200 shown may include a tubular member 30230 that extends along a longitudinal axis 3060 and is configured to deliver an end effector 30100 to a sheath 30210 and outside the sheath. A physician 3024 may manipulate the catheter 30200 using a handle 30220. Suitable examples of the catheter assembly 30200 and its sub-components such as the handle 30220, the sheath 30210, the tubular member 30230, and other components not mentioned herein are described in U.S. Patent Publication No. 2021 / 0369339, which is incorporated herein by reference.

[0233] Encapsulated catheter with a frame( Figures 21 to 42 )

[0234] Reference Figure 21 , which shows an exemplary catheter-based electrophysiological mapping and ablation system 4010. The system 4010 includes a plurality of catheters that are inserted by a physician 4024 through the vascular system of a patient 4023 via the skin into a chamber or vascular structure of the heart 4012. Generally, a delivery sheath catheter is inserted into the left atrium or right atrium near a desired location in the heart 4012. Then, a plurality of catheters may be inserted into the delivery sheath catheter to reach that 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 for sensing IEGM is illustrated herein. The physician 4024 brings the distal end of the catheter 4014 (i.e., the multi-layer end effector 40100) into contact with the heart wall for sensing a target site in the heart 4012. For ablation, the physician 4024 similarly brings the distal end of the ablation catheter to the target site for ablation.

[0235] The catheter 4014 is an exemplary catheter that includes one and preferably a plurality of electrodes 4026 optionally distributed over the end effector 40100, which is coupled to a catheter shaft 4090 and configured to sense IEGM signals, as described in more detail below. The catheter 4014 may additionally include a position sensor embedded in or near the end effector 40100 for tracking the position and orientation of the 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.

[0236] Magnetically based position sensors can operate with a positioning pad 4025 that includes a plurality of magnetic coils 4032 configured to generate a magnetic field in a predefined 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 positioning pad 4025 and sensed by the magnetically based position sensor. Details of magnetically 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.

[0237] System 4010 includes one or more electrode patches 4038 positioned to contact the skin of the patient 4023 to establish a position reference for impedance-based tracking of the positioning pad 4025 and the electrodes 4026. For impedance-based tracking, current is directed toward the electrodes 4026 and sensed at the electrode skin patches 4038 such that 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.

[0238] Recorder 4011 displays the electrogram 4021 captured using the body surface ECG electrodes 4018 and the intracardiac electrogram (IEGM) captured using the electrodes 4026 of the catheter 4014. Recorder 4011 can include pacing capabilities for pacing the heart rhythm and / or can be electrically connected to an independent pacemaker.

[0239] System 4010 can include an ablation energy generator 4050 adapted to conduct ablation energy to one or more of the electrodes 4026 at the distal end of a catheter configured for ablation. The energy generated by the ablation energy generator 4050 can include, but is not limited to, radiofrequency (RF) energy or pulsed field ablation (PFA) energy (including monopolar or bipolar high voltage DC pulses that can be used to effect irreversible electroporation (IRE)), or a combination thereof.

[0240] The Patient Interface Unit (PIU) 4030 is an interface configured to establish electrical connectivity between a catheter, electrophysiology equipment, a power source, and a workstation 4055 for controlling the operation of the system 4010. The electrophysiology equipment of the system 4010 can include, for example, multiple catheters, positioning pads 4025, body surface ECG electrodes 4018, electrode patches 4038, an ablation energy generator 4050, and a recorder 4011. Optionally and preferably, the PIU 4030 further includes processing capabilities for performing real-time calculations of the position of the catheter and for performing ECG calculations.

[0241] The workstation 4055 includes a memory, a processor unit with a memory or storage device loaded with appropriate operating software, and user interface capabilities. The workstation 4055 can provide multiple functions, optionally including: (1) performing three-dimensional (3D) modeling of the endocardial anatomy and rendering a model or anatomical map 4020 for display on a display device 4027; (2) displaying, on the display device 4027, an activation sequence (or other data) compiled from the recorded electrograms 4021 as representative visual markers or images superimposed on the rendered anatomical map 4020; (3) displaying the real-time position and orientation of multiple catheters within the heart chambers; and (4) displaying on the display device 4027 sites of interest, such as where ablation energy has been applied. A commercial product embodying the elements of the system 4010 can be the CARTO TM 3System, which is available from Biosense Webster, Inc., 31 Technology Drive, Suite 200, Irvine, CA 92618.

[0242] Figure 22 is a schematic illustration showing an exploded view of a portion of an end effector 40100 in the form of a generally flat multi-layer. To achieve the desired stiffness, mapping resolution, contact of the electrodes with the target anatomy, and conformance of the end effector 40100 disclosed herein with flat, curved, irregular, and / or non-tissue surfaces found in the target anatomy, the end effector 40100 has a flexible circuit top layer 40120A, a frame 40110, and a flexible bottom circuit layer 40120B, where an insulating material 40130 (see Figure 23 ) partially encapsulates the circuit layers and the frame while keeping these components separated from each other in an orthogonal direction with respect to the longitudinal axis 4060.

[0243] It should be understood that the end effector may also include other structures, such as but not limited to one or more position sensing loops (not shown).

[0244] The flexible circuit 40120A or 40120B can extend along the longitudinal axis 4060 from the proximal portion of the end effector 40100 (i.e.,Figure 22 the upper right section of circuit 40120 in) extends to the distal portion (i.e., Figure 22 the lower left section of circuit 40120 in). In some examples, the flexible circuit layer 40120 may be made primarily of polyimide. In other examples, it may be made of any one or a combination of biocompatible polyimide, glass-reinforced epoxy laminate, copper, or graphene. The flexible circuit layer 40120 may include conductive traces. As used herein, the term "flexible circuit" includes thin-film circuits, flexible printed circuit boards, and thin-film depositions on substrates such as polyimide or even nitinol substrates via lithography and etching processes. For ease of understanding, one or both of flexible circuits 40120A and 40120B will be referred to as flexible circuit 40120 in the following description.

[0245] The frame 40110 is disposed in the insulating material 40130 (see Figure 23 ), and generally along the longitudinal axis 4060 such that the longitudinal axis 4060 is parallel or coincident with the frame plane 40FP of the frame 40110. The longitudinal axis 4060 is parallel or coaxial with the longitudinal center LC of the frame 40110, and the longitudinal center 40LC is an imaginary line that equally divides the frame 40110 in the width direction. The frame plane 40FP is also generally parallel to the plane defined by the flexible circuit 40120. In some examples, the frame 40110 is formed of a superelastic material. As an example, the frame 40110 may be formed of 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.

[0246] The first non-conductive flexible layer 40130A of the insulating material 40130 may at least partially encapsulate the frame 40110 and the flexible circuit 40120 and separate the two. Additionally, the second non-conductive flexible layer 40130B may at least partially encapsulate the other side of the sensing loop 40140 and the flexible circuit 40120 and separate the two. The insulating material 40130 is also used to enhance the atraumatic nature of the end effector 40100 and protect the subject from sharp edges.

[0247] Figure 23 is a schematic illustration showing the frame 40110 of the end effector 40100 embedded in the insulating material 40130. As shown, the frame 40110 includes a base 40112, a central first ridge loop 40114, and two side ridges 40116, 40118 (i.e., the left ridge 40116 and the right ridge 40118) on opposite lateral sides of the first ridge loop 40114. The base 40112 is connected to the elongate shaft 4014A of the medical device 4014 ( Figure 21) are connected and extend along the longitudinal axis 4060. The ridges 40114, 40116, 40118 extend from the base 40112 along the longitudinal axis 4060.

[0248] As Figure 24 seen, the central first ridge circuit 40114 is configured to increase the stiffness along the center of the frame 40110 and resist bending when a force 40F (e.g., torsion) is applied thereto. These forces 40F may occur at different times during use (such as when inserted into a guide). This design helps prevent disconnection of the electrical interconnections extending along the longitudinal center 40LC on the flexible circuit 40120.

[0249] Combining the above and referring to Figure 25, more particularly showing a first ridge circuit 40114 including features resistant to bending. The first ridge circuit 40114 includes a first segment to a seventh segment 40114A - 40114G. The curved first segment 40114A is connected to the base 40112 and extends from the base 40112 in the distal direction 40DD along the longitudinal axis 4060. The curved first segment 40114A includes (1) a first section 40114A1 that is directly connected to the base 40112 angled with respect to the longitudinal axis 4060; and (2) a second section 40114A2 that is connected to the first section 40114A1 substantially parallel to the longitudinal axis 4060. 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 from the second segment in the proximal direction 40PD along the longitudinal axis 4060. The fourth segment 40114D2 The curved fourth segment 40114D is connected to the base 40112 and extends from the base in the distal direction 40DD along the longitudinal axis 4060. Similar to the curved first segment 40114A, the fourth segment 40114D2 The curved fourth segment 40114D includes: (1) a first section 40114D1 that is directly connected to the base 40112 angled with respect to the longitudinal axis 4060; and (2) a second section 40114D2 that is connected to the first section 40114D1 substantially parallel to the longitudinal axis 4060. The fifth segment 40114E is arcuate and is connected to and extends from the curved fourth segment 40114D2 The curved fourth segment 40114D. The sixth segment 40114F is connected to the fifth segment 40114E and extends from the fifth segment in the proximal direction 40PD along the longitudinal axis 4060. The seventh segment 40114G is arcuate (in a teardrop - like form), bisected by the longitudinal axis 4060, and connects the third segment 40114C and the sixth segment 40114F to contribute to the aforementioned bending resistance.

[0250] Taken together, the segments 40114A - 40114G of the first ridge circuit 40114 define an opening 40115 including two finger - like openings 40F1, 40F2 (thus, it should be noted that the opening 40115 is also referred to as a finger - like opening herein because it includes two openings of this form). Additionally, 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 40114D2 The curved fourth segment 40114D, the fifth segment 40114E, and the sixth segment 40114F.

[0251] The base 40112 includes: (1) a first section 40112A that is connected to the elongate shaft 4014A; and (2) a second section 40112B that extends within the finger-like opening 40115 to connect to the seventh segment 40114G. Thus, the second section 40112B effectively divides the finger-like opening 40115 into two halves (i.e., two finger-like openings 40F1, 40F2).

[0252] Specifically as Figure 25 shown, the second ridge circuit 40116 is connected to the first section 40112A of the base 40112 via a pair of terminal sections 40116A. Similarly, the third ridge circuit 118 is connected to the opposite side of the first section 40112A of the base 40112 via a pair of terminal sections 40118A.

[0253] Figure 26 is a schematic illustration showing a slightly modified frame 40110' (relative to the previously discussed frame 40110) of the end effector 40100' embedded in the insulating material 40130. As shown and similar to the previous example, the frame 40110’ includes a base 40112', a central first ridge circuit 40114' and two side ridges 40116', 40118' (i.e., a left ridge 40116' and a right ridge 40118') on opposite lateral sides of the first ridge circuit 40114'. The base 40112' is connected to the elongate shaft 4014A of the medical device 4014 ( Figure 21 ) and extends along the longitudinal axis 4060. The ridges 40114', 40116', 40118' extend from the base 40112' along the longitudinal axis 4060.

[0254] As Figure 27 seen and similar to the previous example, the central first ridge circuit 40114' is configured to increase the stiffness along the center of the frame 40110' and resist bending when a force 40F (e.g., torsion) is applied thereto. These forces 40F can occur at different times during use (such as when being inserted into a introducer). As discussed above, this design helps prevent the disconnection of the electrical interconnections extending along the longitudinal center 40LC on the flexible circuit 40120.

[0255] Combining the above and referring to Figure 28 , the first ridge circuit 40114' including features that resist bending is shown in more detail. The first ridge circuit 40114' includes a first segment to a seventh segment 114A'-114G', and these segments are in Figures 22 to 25Constructed in a manner similar to the examples described in [reference]. The curved first segment 40114A' is connected to the base 40112' and extends from the base 40112' in the distal direction 40DD along the longitudinal axis 4060. The curved first segment 40114A' includes: (1) a first section 40114A1', which is directly connected to the base 40112' that is angled relative to the longitudinal axis 4060; and (2) a second section 40114A2', which is connected to the first section 40114A1' that is substantially parallel to the longitudinal axis 4060. 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 from the second segment in the proximal direction 40PD along the longitudinal axis 4060. The fourth segment 40114D2 The curved fourth segment 40114D' is connected to the base 40112' and extends from the base in the distal direction 40DD along the longitudinal axis 4060. Similar to the curved first segment 40114A', the fourth segment 40114D2 The curved fourth segment 40114D' includes: (1) a first section 40114D1', which is directly connected to the base 40112' that is angled relative to the longitudinal axis 4060; and (2) a second section 40114D2', which is connected to the first section 40114D1' that is substantially parallel to the longitudinal axis 4060. 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 from the fifth segment in the proximal direction 40PD along the longitudinal axis 4060. The seventh segment 40114G is arcuate (similar to the shape of a teardrop), bisected by the longitudinal axis 4060, and connects the third segment 40114C' and the sixth segment 40114F' to contribute to the aforementioned bending resistance.

[0256] Taken together, the segments 40114A'-40114G' of the first ridge circuit 40114' define a finger-like opening 40115' that includes two finger-like openings 40F1', 40F2'. In addition, 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 to the curved fourth segment 40114D' of the fourth segment 40114D2, the fifth segment 40114E', and the sixth segment 40114F'.

[0257] The base 40112' includes: (1) a first section 40112A' that is connected to the elongate shaft 4014A; and (2) a second section 40112B' that extends within the finger-like opening 40115' to connect to the seventh segment 40114G'. Thus, the second section 40112B' effectively divides the opening 40115' into two halves (i.e., two finger-like openings 40F1', 40F2'). In addition, each of the first section 40112A' and the second section 40112B' defines one or more holes 40113' therein.

[0258] Specifically as Figure 28 shown, the second ridge circuit 40116' has a pair of terminal sections 40116A'. One terminal section 40116A' is connected to the first section 40112A' of the base 40112', while the other terminal section 40116A' is connected to the curved first section 40114A' of the first ridge circuit 40114. Similarly, the third ridge circuit 40118 has a pair of terminal sections 40118A'. One terminal section 40118A' is connected to the opposite side of the first section 40112A' of the base 40112', while the other terminal section 40118A' is connected to the curved fourth section 40114D' of the fourth section 40114D2 of the first ridge circuit 40114'.

[0259] Figure 29 is a schematic illustration showing another frame 40210 of the other end effector 40200. Figure 30 is a schematic illustration showing the frame 40210 embedded in the insulating material 40130 and the flexible circuit 40220 assembled therewith. Figures 31 to 32 is taken from Figure 30 a cross-sectional view.

[0260] Now turning to Figures 29 to 32 , as mentioned above, another example of the frame 40210 for the other end effector 40200 is shown. Specifically as Figures 30 to 32 seen in, the end effector 40200 also includes the insulating material 40130 disposed on the frame 40210 and the flexible circuit 40220. During use, the flexible circuit 40220 is subject to stresses / loads that can cause it to fail at one or more points. The examples shown in these figures reduce the stresses applied thereto by routing sections of the flexible circuit to the neutral plane 40NP of the frame 40210 and are discussed in more detail below.

[0261] Similar to the previous example, the frame 40210 can be formed of a superelastic material. As an example, the frame can be formed of a shape memory alloy such as nitinol, cobalt-chrome, stainless steel, and / or other alloys that exhibit pseudoelastic and / or superelastic properties.

[0262] The frame 40210 includes a base 40212, a first ridge circuit 40214, a second ridge circuit 40216, and a third ridge circuit 40218. The base 40212 is connected to the elongate shaft 4014A of the medical device 4014 and extends along a longitudinal axis 4060. The frame 40210 also has a frame plane 40FP that extends along a neutral plane 40NP of the frame 40210.

[0263] The first ridge circuit 40214 extends along the longitudinal axis 4060 from the base 40212 and includes a first section 40214A, a second section 40214B, and a third section 40214C. The first section 40214A is connected to the base 40212 and extends distally from the base along the longitudinal axis 4060. The second section 40214B is connected to the first section 40214A and extends inwardly from the first section toward the longitudinal axis 4060. The third section 40214C is connected to the second section 40214B and extends distally from the second section along the longitudinal axis 4060. In some examples, the third section 40214C extends generally parallel to the longitudinal axis 4060.

[0264] The second ridge circuit 40216 extends along the longitudinal axis 4060 from an opposite side of the base 40212 (compared to the first ridge circuit 40214) and includes a first section 40216A, a second section 40216B, and a third section 40216C. The first section 40216A is connected to the base 40212 and extends distally from the base along the longitudinal axis 4060. The second section 40216B is connected to the first section 40216A and extends inwardly from the first section toward the longitudinal axis 4060. The third section 40216C is connected to the second section 40216B and extends distally from the second section along the longitudinal axis 4060. In some examples, the third section 40216C extends generally parallel to the longitudinal axis 4060.

[0265] The third ridge circuit 40218 connects the third section 40214C of the first ridge circuit 40214 and the third section 40216C of the second ridge circuit 40216 and is bisected by the longitudinal axis 4060 and the longitudinal center of the frame 40210 (where the longitudinal center 40LC is coaxial with the longitudinal axis 4060, similar to the previous example). In some examples, the third ridge circuit 40218 has a wave form that contributes to the lateral flexibility and collapsibility of the frame 40210. In these examples, the wave structure can be modified to adjust the lateral resistance of the frame 40210. In other examples, the third ridge circuit 40218 can be omitted.

[0266] To easily allow the flexible circuit 40220 to have a section extending along the neutral plane 40NP, the frame 40210 is provided with a hollow design. In other words, the frame 40210 has finger-like openings 40211 defined by its base 40212, first ridge loop 40214, second ridge loop 40216, and third ridge loop 40218.

[0267] As Figure 31 best seen in and exemplified by this figure, the flexible circuit 40220 has a first section 40222 that is vertically spaced from the frame 40210 by an insulating material 40130 along a vertical axis 4062 and is disposed parallel to the frame plane FP. The first section 40222 also includes a peripheral section 40222A that is directly disposed above the first ridge loop 40214, second ridge loop 40216, and third ridge loop 40218.

[0268] As Figure 32 best seen in and exemplified by this figure, the flexible circuit 40220 also includes a second section 40224 that is offset from the first section 40222 along the vertical axis 4062 (see Figure 32 , as compared with Figure 31 ) and extends within the finger-like openings 40211 defined by the frame 40210 along the frame plane 40FP. The second section 40224 of the flexible circuit 40220 also includes a peripheral section 40224A that extends from an intermediate section of the frame 40210 to the base 40212 along the inner surfaces of the first ridge loop 40214 and the second ridge loop 40216.

[0269] In combination with the above, the flexible circuit 40220 includes a transition section 40223 that connects the first section 40222 and the second section 40224 of the flexible circuit. Referring to Figure 29 and Figure 30 , the transition section 40223 is disposed proximally to the second sections 40214B of the first ridge loop 40214 and 40216B of the second ridge loop 40216 along a longitudinal axis 4060, where both the second sections 40214B, 40216B serve as connection segments between the first and third sections of the first ridge loop 40214 and the second ridge loop 40216, respectively.

[0270] Figure 33FIG. 0 is a schematic illustration showing yet another design of a frame 40310 embedded in an insulating material 40130 of an end effector 40300 for a medical device 4014. The frame 40310 extends along a longitudinal axis 4060 coaxial with a longitudinal center 40LC of the frame 40310. The frame 40310 includes a base 40312, a first ridge circuit 40314 extending from the base 40312 on one side of the longitudinal axis 4060, and a second ridge circuit 40316 extending from the base 40312 on an opposite side of the longitudinal axis 4060. In some examples, the base 40312 and the ridges 40314, 40316 are integral members (i.e., a single unitary piece).

[0271] The base 40312 includes a first section 40312A and a second section 40312B. The first section 40312A is connected to the elongate shaft 4014A, and the second section 40312B extends distally away from the first section 40312A in a distal direction 40DD. In some examples, the base 40312 is bisected by the longitudinal axis 4060 and is generally symmetric with respect to the longitudinal axis.

[0272] The first ridge circuit 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 so as to define a first finger opening 40315. Note that a "longitudinal position" (in this and other examples) refers to the longitudinal component of the position of the element referred to and does not include the lateral component of the position (i.e., the distance of the element referred to from the longitudinal axis). As for Figure 13 the orientation of the frame 40310 in, the longitudinal component is analogous to the y - coordinate in a Cartesian coordinate system.

[0273] Similarly, the second ridge circuit 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 so as to define a second finger opening 40317.

[0274] The first longitudinal position, second longitudinal position, third longitudinal position, and fourth longitudinal position of the respective distal ends 40314A, 40314B, 40316A, 40316B are arranged along the longitudinal axis 4060 such that the frame 40310 is asymmetric with respect to the longitudinal axis 4060.

[0275] Specifically, in ​In the example shown, the first distal end 40314A of the first ridge circuit 40314 and the first distal end 40316A of the second ridge circuit 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 approximately the same. Additionally, the second distal end 40314B of the first ridge circuit 40314 and the second distal end 40316B of the second ridge circuit 40316 are connected to the second section 40312B. More specifically, the second distal end 40314B of the first ridge circuit 40314 is connected to the proximal end of the second section 40312B, and the second distal end 40316B of the second ridge circuit 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 partially results in the first finger-like opening 40315 having an area smaller than the area of the second finger-like opening 4040317.

[0276] ​ is a schematic illustration showing another example of a frame 40310' embedded in an insulating material 40130 for an end effector 40300' of a medical device 4014, the frame being similar to ​ the frame 40310. The frame 40310' extends along a longitudinal axis 4060 coaxial with the longitudinal center LC of the frame 40310'. The frame 40310' includes a base 40312', a first ridge circuit 40314' extending from the base 40312' on one side of the longitudinal axis 4060, and a second ridge circuit 40316' extending from the base 40312' on the opposite side of the longitudinal axis 4060. In some examples, the base 40312' and the ridges 40314', 40316' are integral members.

[0277] The base 40312' includes a first section 40312A' and a second section 40312B'. The first section 40312A' is connected to the elongate shaft 4014A', and the second section 40312B' extends away from the first section 40312A' in the distal direction 40DD. In some examples, the base 40312' is bisected by the longitudinal axis 4060 and is approximately symmetric with respect to that longitudinal axis.

[0278] The first ridge circuit 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 so as to define a first finger-like opening 40315'.

[0279] Similarly, the second ridge circuit 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 so as to define a second finger-like opening 4040317'.

[0280] 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 frame 40310' is asymmetric with respect to the longitudinal axis 4060.

[0281] Specifically, in ​ the example shown, the first distal end 40314A' of the first ridge circuit 40314' and the first distal end 40316A' of the second ridge circuit 40316' are connected to a first section 40312A' of the base 40312' such that the first longitudinal position and the third longitudinal position are spaced apart by a predetermined distance 40D1' along the longitudinal axis 4060 (where the third longitudinal position is closer to the proximal end of the base 40312' than the first longitudinal position). Additionally, the second distal end 40314B' of the first ridge circuit 40314' and the second distal end 40316B' of the second ridge circuit 40316' are connected to a second section 40312B' such that the second longitudinal position and the fourth longitudinal position are the same or approximately the same along the longitudinal axis 4060. This configuration of the ends 40314A', 40314B', 40316A', 40316B' partially results in the first finger-like opening 40315' having an area smaller than the area of the second finger-like opening 40317'.

[0282] ​ is a schematic illustration of the end effectors 40300, 40300' shown ​ and ​ being inserted into a guide 4080 having an inlet section 4082 and a sheath 4084. ​It is a schematic illustration showing the end effectors 40300, 40300' inserted into the finger openings 4084A of the insertion guide 4080. To contract the previously shown end effectors 40300, 40300', the guide 4080 is used. Due to the asymmetric design of the corresponding sides 40302, 40302' and 40304, 40304' of the end effectors 40300, 40300', one side of the end effectors 40300, 40300' can: (1) start to be inserted into the guide 4080 first, and / or (2) require less force from the side wall of the guide 4080 to contract within the finger opening 4084A. In this way, the contraction mode of the end effectors 40300, 40300' can be made more predictable.

[0283] It should be noted that although the frame 40110 is shown in a common plane, the following is also fully within the scope of the present disclosure: the ridge circuit can be offset in different planes or the frame 40110 itself can be bent around a central axis to define a cylindrical frame.

[0284] Now turning to ​ , these figures depict schematic illustrations of exemplary end effectors 40300", 40300A", 40300B", 40300C" that include treated edges for optimizing their retraction and / or folding. Similar to the foregoing examples such as ​ , these examples of the end effectors 40300", 40300A", 40300B", 40300C" are capable of achieving a consistent contraction shape and reducing the retraction force of the end effectors. It should be noted that without departing from the essence and scope of the present disclosure, the treated edges described herein can be applied to any end effector described in this application.

[0285] Referring to ​ , a top view of the end effector 40300" is depicted. Similar to the example of ​ , the end effector 40300" includes a frame (not explicitly shown in these figures; see, for example, ​)。The end effector 40300" extends along a longitudinal axis 4060 that is coaxial with the longitudinal center of the end effector 40300". The frame can be symmetric or asymmetric and is substantially planar along its longitudinal axis 4060. It should be noted that, as used herein and similar to the terms "about" and "approximately" discussed above, the term "substantially planar" includes a frame that has a slight curvature in its profile along the longitudinal axis 4060. In other words, a frame that is not completely flat is fully within the scope and spirit of the present disclosure. Additionally, those skilled in the art will understand that the presently described end effector 40300" may include other features of the previously described examples. For example, the end effector 40300" may include one or more flexible circuit layers 40120A, 40120B that include substantially planar electrodes and / or sensing loop layers, where the flexible circuits are disposed in insulating materials 40302", 40304" and are vertically spaced from the frame 40110 along a vertical axis.

[0286] As ​ shown, the insulating materials 40302", 40304" of the end effector 40300" are divided into a first side 40302" and a second side 40304" relative to the longitudinal axis 4060, with each side having a respective outer edge (e.g., a first outer edge 40303" and a second outer edge 40305") at the extent where it is furthest from the longitudinal axis 4060. At least one of the edges 40303", 40305" includes a treatment portion that facilitates the shrinking / folding of the end effector 40300".

[0287] In ​ the current example, both of the outer edges 40303", 40305" include tapered cuts such that the outer edges 40303", 40305" form a non - perpendicular angle relative to the substantially planar front and back surfaces of the insulating material (see ​ the upper and lower portions of the end effector 40300" in

[0288] ​ is a view showing the insertion into the opening 4084A of a guide 4080 having an inlet section 4082 and a sheath 4084 (refer to ​ ) ​Schematic illustration of an end effector 40300". In order to retract the end effector 40300", a guide 4080 is used. Due to the tapered cut design of one or more of the corresponding outer edges 40303", 40305" of the end effector 40300", the outer edges 40303", 40305" of the end effector 40300" can more easily slide over and pass each other (rather than abutting and causing the end effector 40300" to bend irregularly). In this way, the retraction pattern of the end effector 40300 can be made more predictable.

[0289] Figure 38A is with Figure 37A Top view of another end actuator 40300A" that is identical to the end actuator 40300" but has a different and / or additional end processing portion. Specifically, the insulating materials 40302A", 40304A" of the end actuator 40300A" are divided into a first side 40302A" and a second side 40304A" relative to the longitudinal axis 4060, and each side has a corresponding outer edge (e.g., a first outer edge 40303A" and a second outer edge 40305A") at its farthest range from the longitudinal axis 4060. At least one of these edges (e.g., the second edge 40305A") includes a processing portion 40306A" that facilitates the contraction / folding of the end actuator 40300A.

[0290] exist Figures 38A to 38B In the current example, at least a portion of the second outer edge 40305A" includes a lubricating coating 40306A", such as but not limited to polytetrafluoroethylene (PTFE). In some examples, the two outer edges 40303A", 40305A" may have a portion coated with a lubricating coating 40306A" (or their entirety is coated with a lubricating coating). It should be noted that the exemplary end actuator 40300A" also includes rounded cuts at the two outer edges 40302A", 40304A".

[0291] Figure 38B The insertion device is shown having an entry section 4082 and a sheath 4084 (ref. Figure 35 ) in the opening 4084A of the guide 4080 Figure 38ASchematic illustration of an end actuator 40300A". In order to retract the end actuator 40300A", a guide 4080 is used. Due to the rounding of the lubricating coating 40306A" and / or one or more of the corresponding outer edges 40303A", 40305A" of the end actuator 40300A", the reduced friction allows the outer edges 40303A", 40305A" of the end actuator 40300A" to slide over and past each other more easily. In this additional or alternative manner, the retraction pattern of the end actuator 40300A" can be made more predictable.

[0292] Figure 39A is with Figures 37A to 38B A top view of yet another end effector 40300B" that is identical to the end effectors 40300", 40300A" but has different and / or additional end processing portions. Specifically, the insulating material 40302B", 40304B" of the end effector 40300B" is divided into a first side 40302B" and a second side 40304B" relative to the longitudinal axis 4060, and each side has a corresponding outer edge (e.g., a first outer edge 40303B" and a second outer edge 40305B") at its farthest range from the longitudinal axis 4060. At least one of these edges (e.g., the second edge 40305B") includes a processing portion 40306B" that facilitates the contraction / folding of the end effector 40300B".

[0293] exist Figures 39A to 39B In the current example, at least a portion of the second outer edge 40305B" includes a plurality of cutouts 40306B" formed in the insulating material in a direction toward the longitudinal axis 4060 and substantially perpendicular to the longitudinal axis. In some examples, both outer edges 40303B", 40305B" may have a portion with cutouts 40306B" (or their entirety has cutouts). The cutouts 40306B" are used to soften at least one side of the insulating material to make it more capable of deformation.

[0294] Figure 39B The insertion device is shown having an entry section 4082 and a sheath 4084 (ref. Figure 35 ) in the opening 4084A of the guide 4080 Figure 39ASchematic illustration of an end effector 40300B". In order to retract the end effector 40300B", a guide 4080 is used. Due to the cut-in cut 40306B" of at least a portion of the second outer edge 40305B" of the end effector 40300B", when the two edges 40305B", 40303B" are engaged with each other, the increased flexibility of the second outer edge 40305B" enables it to retract inwardly relative to the first outer edge 40303B". In this additional or alternative manner, the retraction pattern of the end effector 40300B" can be made more predictable.

[0295] Figure 40A is with Figures 37A to 39B A top view of yet another end effector 40300C" that is identical to the end effectors 40300", 40300A", 40300C" but has different and / or additional end processing portions. Specifically, the insulating material 40302C", 40304C" of the end effector 40300C" is divided into a first side 40302C" and a second side 40304C" relative to the longitudinal axis 4060, and each side has a corresponding outer edge (e.g., a first outer edge 40303C" and a second outer edge 40305C") at its farthest range from the longitudinal axis 4060. At least one of these edges (e.g., the second edge 40305C") includes a processing portion that facilitates the contraction / folding of the end effector 40300C" similar to the processing of the end effector 40300".

[0296] exist Figures 40A to 40B In the current example, a single outer edge 40305C" includes a tapered cutout such that a second outer edge 40305C" forms a non-perpendicular angle relative to the substantially planar front and rear surfaces of the insulating material (see Figure 40A The upper and lower portions of the middle end actuator 40300C". In a version employing a single tapered cut, the cut may extend a distance 40D" in a direction toward the longitudinal axis 4060. The distance 40D" is optimized to increase the flexibility of the second outer edge 40305C" so that the second outer edge can retract inwardly relative to the first outer edge 40303C" when the two edges 40303C", 40305C" are engaged with each other.

[0297] Figure 40B The insertion device is shown having an entry section 4082 and a sheath 4084 (ref. Figure 35 ) in the opening 4084A of the guide 4080 Figure 40ASchematic illustration of an end actuator 40300C". In order to retract the end actuator 40300", a guide 4080 is used. Due to the tapered cut design of the second outer edge 40305C" of the end actuator 40300C", when the two edges 40303C", 40305C" are engaged with each other, the second outer edge 40305C" is able to retract inwardly relative to the first outer edge 40303C". In this way, the retraction pattern of the end actuator 40300C" can be made more predictable.

[0298] As will be appreciated by those skilled in the art, Figures 37A to 40B The examples described may be combined with each other without departing from the spirit and scope of the present disclosure. As a non-limiting example, Figures 37A to 37B A lubricating coating 40306A" is applied to the tapered cutout of the end actuator 40300" described herein.

[0299] Combination Figures 37A to 40B The above examples and reference Figure 41 , a method of using a medical procedure 40410 may include the following steps. Retracting 40412 the end effector from the expanded configuration into the sheath along the longitudinal axis. As discussed above, the end effector includes a substantially planar shape in the expanded configuration. Retracting 40414 the end effector into the retracted configuration such that the outer edges of the end effector slide past each other. In the retracted configuration, the end effector has one of a substantially cylindrical shape or a helical shape in the retracted position. In addition, a first of the outer edges has one or more of the above-mentioned treatment portions that facilitate retraction of the end effector.

[0300] Combination Figures 37A to 40B The above examples and reference Figure 42 , a method 40420 of manufacturing an end effector for a medical device may include the following steps. A frame is formed 40422 that is substantially planar along a longitudinal axis. A flexible circuit is disposed 40424 on the frame and vertically spaced relative to the frame. An insulating material is heated 40426 and reflowed 40428 such that the insulating material at least partially encapsulates the frame and the flexible circuit. An outer edge of the insulating material is treated 40430 such that the outer edge has a reduced hardness and / or a reduced coefficient of friction relative to an initial coefficient of friction and / or initial hardness of the outer edge (i.e., prior to treatment).

[0301] Encapsulated flat catheter with a flexible circuit extending to a neutral axis( Figures 43 to 51 )

[0302] refer to Figure 43, which shows an example catheter-based electrophysiological mapping and ablation system 5010. The system 5010 includes a plurality of catheters that are inserted into a chamber or vascular structure of a heart 5012 by a physician 5024 through the vascular system of a patient 5023 via the skin. Typically, a delivery sheath catheter is inserted into the left atrium or right atrium near a desired location in the heart 5012. Then, a plurality of catheters may 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 example catheter 5014 configured for sensing IEGM is illustrated herein. The physician 5024 brings a catheter shaft having a distal end of the catheter 5014 (i.e., a multilayer end effector 50100) into contact with the heart wall for sensing a target site in the heart 5012. For ablation, the physician 5024 would similarly bring the distal end of the ablation catheter to the target site for ablation.

[0303] The catheter 5014 is an exemplary catheter including one and preferably a plurality of electrodes 50112, optionally distributed over the end effector 50100, coupled to the catheter shaft and configured to sense IEGM signals, as described in more detail below. The catheter 5014 may further include a position sensor embedded in or near the end effector 50100 for tracking the position and orientation of the end effector 50100 (see, e.g., Figures 49A to 49C Optionally and preferably, the position sensor is a magnetic-based position sensor comprising a plurality of magnetic coils for sensing three-dimensional (3D) position and orientation (see Figure 49B The distal circuit 50334, the first side circuit 50336a and the second side circuit 50336b).

[0304] The magnetic-based position sensor can operate with a positioning pad 5025 that includes a plurality of magnetic coils 5032 configured to generate a magnetic field in a predefined workspace. The real-time position of the end effector 50100 of the catheter 5014 can be tracked based on the magnetic field generated by the positioning pad 5025 and sensed by the magnetic-based position sensor. Details of magnetic-based position sensing technology are described in U.S. Patents 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.

[0305] The system 5010 includes one or more electrode patches 5038 positioned in contact with the skin of the patient 5023 to establish a position reference for impedance-based tracking of the positioning pad 5025 and the electrodes 50112. For impedance-based tracking, current is directed toward the electrodes 50112 and sensed at the electrode skin patches 5038 so that the position of each electrode can be triangulated via the electrode patches 5038. Details of impedance-based position tracking techniques are described in U.S. Patents 7,536,218, 7,756,576, 7,848,787, 7,869,865, and 8,456,182, each of which is incorporated herein by reference.

[0306] The recorder 5011 displays electrograms 5021 captured using the surface ECG electrodes 5018 and intracardiac electrograms (IEGMs) captured using electrodes 50112 of the catheter 5014. The recorder 5011 may include pacing capabilities for pacing the cardiac rhythm and / or may be electrically connected to a separate pacemaker.

[0307] The system 5010 may include an ablation energy generator 5050 adapted to conduct ablation energy to one or more of the electrodes 50112 at the distal tip of a catheter configured for ablation. The energy generated by the ablation energy generator 5050 may include, but is not limited to, radio frequency (RF) energy or pulsed field ablation (PFA) energy (including monopolar or bipolar high voltage DC pulses that may be used to achieve irreversible electroporation (IRE)), or a combination thereof.

[0308] The patient interface unit (PIU) 5030 is an interface configured to establish electrical communication between catheters, electrophysiology equipment, a power source, and a workstation 5055 for controlling the operation of the system 5010. The electrophysiology equipment of the system 5010 may include, for example, multiple catheters, a positioning pad 5025, 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 enabling real-time calculation of the position of the catheter and for performing ECG calculations.

[0309] Workstation 5055 includes memory, a processor unit with memory or storage loaded with appropriate operating software, and user interface capabilities. Workstation 5055 can provide multiple functions, optionally including: (1) three-dimensional (3D) modeling of endocardial anatomy and rendering of the model or anatomical map 5020 for display on display device 5027; (2) displaying activation sequences (or other data) compiled from recorded electrograms 5021 on display device 5027 as representative visual markers or images superimposed on the rendered anatomical map 5020; (3) displaying real-time positions and orientations of multiple catheters within the heart chamber; and (4) displaying sites of interest on display device 5027, such as where ablation energy has been applied. A commercial product embodying elements of system 5010 is available from Biosense Webster, Inc., 31 Technology Drive, Suite 200, Irvine, CA 92618 as the CARTO™ 3 system.

[0310] Figure 44 An end effector 50100 according to an embodiment of the present disclosure is provided to achieve ease of manufacturing, reduced cost, and enhanced end effector characteristics, such as desired stiffness, mapping resolution, contact of electrodes with target anatomy, and conformity of the end effector disclosed herein with flat, curved, irregular, and / or non-planar tissue surfaces found in target anatomy. The end effector 50100 may include a flexible circuit 50110 including a plurality of electrodes 50112, each of the plurality of electrodes 50112 including a contact surface 50112c. As used herein, the term "flexible circuit" includes thin film circuits, flexible printed circuit boards, thin film deposition achieved via photolithography and etching processes on a substrate such as a polyimide, copper, LCP, nitinol substrate, TPU, silicone, thermoset resin, or other polymer substrate, as shown and described in the attached technical references incorporated herein by way of an appendix to priority application No. 63 / 615,574. In some examples, the flexible circuits described herein may be made primarily of polyimide. In other examples, they may be made of any one of biocompatible polyimide, glass-reinforced epoxy laminate, copper, or graphene, alone or in combination. In some examples, the electrodes described herein may include at least one mapping electrode and / or at least one ablation electrode, and may be configured to detect electrophysiological signals or transmit ablation energy AC or DC from an energy generator to tissue according to the various ablation methods previously described (e.g., RF, IRE, etc.).

[0311] The flexible circuit 50110 may be disposed on the insulating material 50120. The insulating material 50120 may be adjacent to the contact surface 50112c such that only the contact surface 50112c of at least a portion of the plurality of electrodes 50112 is exposed to the surrounding environment. As used herein, the term "contact surface" includes a portion of an electrode having a generally flat surface and one or more edges immediately surrounding the flat surface. When the end effector 50100 is placed against tissue, the electrode 50112 may have slightly rounded, filleted, or chamfered edges and a generally flat surface that contacts the tissue. As used herein, "surrounding environment" refers to the external environment, such as an organ in which the end effector 50100 is deployed or an operating room prior to the end effector being deployed in a biological organ.

[0312] It should be noted that not all electrodes on the end effector 50100 described herein need to be exposed through the insulating material 50120, as these unexposed electrodes can be used to sense far-field signals for noise reduction close to the tissue contact electrode. Similarly, for the entire end effector having a reference electrode that is not in contact with the tissue but only in contact with the blood, far-field signals including noise or artifacts can be reduced or eliminated. Flushing can be provided using flushing ports 50163a (on one side) and flushing ports 50162b (on the other side) that are fluidly connected to a flushing line (not shown) disposed in the catheter shaft. Instead of a flushing line separate from the catheter shaft, an inner cavity can be formed by extruding the catheter shaft to provide an inner cavity channel. It should be noted that the port 50163a or 50162b can be configured to have sufficient flow diverter characteristics to allow the flushing fluid to cover the mapping electrode during the flushing flow in order to prevent or reduce thrombosis.

[0313] The flexible circuit 50110 can also include a frame 50130 adjacent to or within the insulating material. In examples where the flexible circuit 50110 includes the frame 50130, the frame 50130 can be disposed directly on the flexible circuit 50110 with no or very little insulating material 50120 therebetween.

[0314] In other words, one aspect of the present disclosure provides an end effector 50100 having a planar frame 50130 bisecting two planar heat-formed portions 50120a, 50120b of a flexible insulating block 50120, wherein at least one flexible circuit 50110 is disposed on one side of the frame 50130, and wherein a contact surface 50112c of an electrode 50112 extends up to or slightly beyond the outside of the flexible insulating block 50120. In additional or alternative examples, the contact surface 50112c of the electrode 50112 may be slightly recessed, wherein there may be an opening through the insulating material 50120 to ensure that the electrode 50112 is exposed.

[0315] Figure 45 A exploded view of the end effector 50100 is shown, where its components are vertically exploded along the vertical axis 50V-V. The flexible circuit 50110 can be the first flexible circuit 50110, and the plurality of electrodes 50112 can be the plurality of first electrodes 50112, where each first electrode 50112 includes a first contact surface 50112c. The end effector 50100 may further include a second flexible circuit 50140 having a plurality of second electrodes 50142. The second flexible circuit 50140 may be spaced apart from the first flexible circuit 50110, and each electrode of the plurality of second electrodes 50142 may have a second contact surface.

[0316] In an example having the first flexible circuit 50110 and the second flexible circuit 50140, an insulating material 50120 may be disposed between the first flexible circuit 50110 and the second flexible circuit 50140, and the insulating material 50120 may be adjacent to 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 the way the first electrodes 50112 are disposed in and exposed through the insulating material.

[0317] The electrodes 50112, 50142 can sense or receive signals generated by tissue or transmit energy AC or DC from an energy generator to the tissue. In some examples, there are approximately 92 electrodes. In some examples, there are approximately 48 electrodes. In some examples, there are approximately 64 electrodes. In some examples, there are approximately 72 electrodes. In some examples, there are approximately 98 electrodes. Details of the spacing between each pair of electrodes vs. the spacing between discrete sets of electrode pairs can be found in U.S. Provisional Patent Application S.N. 63 / 406,673, which was filed on September 14, 2022 and is included in the appendix of priority application number 63 / 615,574 for incorporation by reference.

[0318] In an example, the end effector 50100 includes a frame 50130 disposed between the first flexible circuit 50110 and the second flexible circuit 50140.

[0319] The frame 50130 can be a component of the end effector 50100 that is separate and distinct from the first flexible circuit 50110 and is disposed close to the first flexible circuit 50110. In this case, the insulating material 50120 can be further disposed between the frame 50130 and the second flexible circuit 50140. The frame 50130 can be formed from planar or cylindrical raw materials using any suitable method. For example, the frame 50130 can be formed by cutting, laser cutting, stamping, etc.

[0320] The insulating material 50120 may include a first insulating material sheet 50120a and a second insulating material sheet 50120b. The first insulating material sheet and the second insulating material sheet are close to the frame 50130 and are fused together to form a single, adjacent, substantially planar insulating block 50120. The insulating material 50120 is also used to enhance the atraumatic nature of the end effector 50100 and to protect the subject from sharp edges. The insulating material 50120 may comprise a polymer. The insulating material 50120 may be thermoformed around at least a portion of the first flexible circuit 50110, the second flexible circuit 50140, and the frame 50130. The polymer may comprise thermoplastic polyurethane (TPU) or other thermoformable or formable material suitable for the thermoforming.

[0321] In addition, although the insulating material 50120 is shown as flat in these figures, the insulating material 50120 may be shaped, serrated, ribbed, ridged, concave, convex, or otherwise configured such that the overall profile of the insulating material 50120 produces the physical and / or mechanical properties required for the end effector 50100 mentioned above, such as rigidity and flexure along multiple axes.

[0322] Figure 46A A cross-section taken as Figure 45 indicated is shown. The first contact surface 50112c lies substantially flat and parallel to the first outer surface 50122a of the insulating block 50120. A plurality of first electrodes 50112 extend vertically and outwardly from the first outer surface a first distance. Similarly, the second contact surface 50142c may lie substantially flat and parallel to the second outer surface 50122b of the insulating block 50120 and extend substantially vertically and outwardly from the second outer surface a second distance.

[0323] Figure 46B A similar cross-section is shown, but from an exemplary end effector 50100 that does not have the second flexible circuit 50140. That is, compared to an end effector (or bilateral end effector) having electrodes on opposite sides Figure 46A the end effector in Figure 46B has electrodes on only one side (unilateral end effector). Figure 46C A variant of Figure 46B is shown in which the frame 50130 is not encapsulated in the insulating material but is disposed outside the insulating material 50120. It should be noted that although the frame 50130 is shown as rectangular in cross-section, the frame 50130 is not limited to such a cross-section and may have any suitable cross-section.

[0324] Figure 46D A view of Figure 46AThe cross-section is similar to the cross-section, but from the exemplary end effector 50100 that does not have the frame 50130. It should be noted that in Figure 46D In examples such as, compared with the insulating material 50120 of the example with the frame 50130, the insulating material 50120 may or may not have additional strength or may be formed thicker. The additional strength of the insulating material 50120 can compensate for the lack of the frame 50130.

[0325] Importantly, the end effector 50100 having the flush or outwardly protruding electrode contact surfaces 50112c, 50142c can be manufactured by the methods and / or fixtures described in more detail below without removing material to expose the electrode contact surfaces 50112c, 50142c.

[0326] In other examples, the first contact surface 50112c can be laid flat substantially coplanar with the first outer surface 50122a of the insulating block 50120, and the second contact surface 50142c is laid flat coplanar with the second outer surface 50122b of the insulating block 50120.

[0327] As described throughout this disclosure, the end effector 50100 according to the example is flexible to pass through the patient's vasculature. However, when the flexible circuits (e.g., the first flexible circuit 50110 and the second flexible circuit 50140) are positioned further away from the neutral axis (e.g., the frame 50130), such as when there is an insulating material layer 50120 as shown in Figure 45 , Figure 46A and Figure 46B considerable tensile and compressive strains can be placed on both the insulating material 50120 and the flexible circuits. The strain can be highest at the location where the end effector 50100 is bent the most. Accordingly, this disclosure provides a solution to the problem of the strain applied to these circuits when the circuits are bent. Figures 47 to 50B Such an exemplary solution is shown, which is to provide a planar transition region 50300 that is positioned proximal to the end effector 50100 at the location where the amount of bending of the end effector is the greatest when the end effector 50100 passes through the vasculature. In this planar transition region 50300, the flexible circuits positioned on this side of the end effector 50100 transition from a first plane closer to the neutral plane (see 50130P in Figure 48C and Figure 49C ) to a second plane further away from the neutral plane.

[0328] Now referring to Figure 47 , the end effector 50100 shown in this figure is similar to Figure 45The end effector shown, but with a planar transition region 50300 added. The example shown in the figure includes the frame 50130 as described above, and also includes a first flexible circuit 50110 on one side of the frame 50130 and a second flexible circuit 50140 on a second side of the frame 50130. As referenced Figure 48A as described, it is conceivable that the end effector 50100 includes a flexible circuit only on one side. The proximal end 50250 of the end effector 50100 includes tails of the respective components that extend into the sheath 50210 (see Figure 44 ) and support the end effector 50100. For illustration, the flexible circuit may include one or more circuit tails 50310. Figure 47 The example shown includes a first flexible circuit 50110 having a first circuit tail 50310a, and includes a second flexible circuit 50140 having a second circuit tail 50310b. The frame 50130 also includes a frame tail 50320 (also see Figure 48B ).

[0329] 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 experience maximum bending strain when the end effector 50100 is deployed or used, and thus this may be the location of the planar transition region 50300, i.e., the planar transition region 50300 may be positioned distal to the tail section (e.g., tails 50310, 50310a, 50310b, and / or 50322). Now referring to the first flexible circuit 50110, the circuitry near the first circuit tail 50310a may be positioned in a plane that is a first distance 50302 from the frame 50130. Moving distally, the first flexible circuit 50110 transitions to a second plane that is a second distance 50304 from the frame 50130, where the second distance 50304 is less than the first distance 50302 (i.e., is a shorter distance than the first distance). Moving distally, the first flexible circuit 50110 then transitions to a third plane that is a third distance 50306 from the frame 50130, where the third distance 50306 is greater than the second distance 50304 (i.e., is a longer distance than the second distance). Thus, the first flexible circuit 50110 transitions in the planar transition region 50300 from a plane closer to the neutral plane 50130P to a different plane that is farther from the neutral plane 50130P (also see Figure 48C and 49C ). The flexible circuit is spaced apart from the frame along a vertical axis 50L-L that is orthogonal to the neutral plane 50130P (also see Figure 48C and Figure 49C ). Figure 47The neutral plane in the example shown is the plane in which the frame 50130 extends. However, it is conceivable that the end effector 50100 does not include the frame 50130 (see Figure 46D ), and in these examples, the neutral plane 50130P can be located at some point within or on the insulating material 50120. It is also conceivable that the end effector 50100 having the frame 50130 has a neutral axis that is not coplanar with the frame 50130. Referring again to the transition region, in some examples, the first distance 50302 and the third distance 50306 are the same, such that the section of the first flexible circuit 50110 having the electrodes 50112 near the distal end 50252 is coplanar with the tail 50310a at the proximal end 50250 (also see the tail 50310 in Figures 48A to 48C ).

[0330] As Figure 47 shown, the end effector 50100 can include flexible circuits (e.g., the first flexible circuit 50110 and the second flexible circuit 50140), which include serpentine connections 50322 that are distal to the planar transition region 50300 in a plane. 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 nonlinear pattern shown, which enables the first flexible circuit 50110 to have a greater degree of bending. In other words, the serpentine connection 50322 enables the first flexible circuit 50110 to bend more easily in the same plane but about an axis that is transverse to the longitudinal axis 50L-L. The serpentine connection 50322 can start distal to the planar transition region 50300, as shown, or the serpentine connection 50322 can start within the planar transition region 50300.

[0331] Figures 48A to 48C Shows an embodiment similar to the embodiment shown in Figure 47 , but the end effector 50100 includes the first flexible circuit 50110 on one side of the frame 50130 and does not include a second circuit on the other side (see the second flexible circuit in Figure 47 ). This example can be similar to the example shown in Figure 46B , but with the addition of the planar transition region 50300 as shown. This example shows how the electrodes 50112 are placed only on one side of the end effector 50100. Figure 48A Is a top plan view of the end effector 50100, showing the side of the end effector 50100 having the first flexible circuit 50110, which has the electrodes 50112; Figure 48Bis a bottom plan view of the end effector 50100, showing the side of the end effector 50100 that does not have a flexible circuit. These views also show a single circuit tail 50310 (see Figure 48A ) and a frame tail 50320 that also extends proximally with the circuit tail 50310 (see Figure 48B ).

[0332] Figure 48C is a side view of the end effector 50100 and shows details of the distance between the first flexible circuit 50110 and the neutral plane 50130P at different positions along the longitudinal axis 50L-L. In Figure 48C , according to some examples, the neutral plane 50130P is marked as coplanar with the frame 50130. Proximal to the planar transition region 50300, the first flexible circuit 50110 is at a first distance 50302, and then in the planar transition region 50300, the first flexible circuit 50110 transitions closer to the neutral plane 50130P (i.e., a second distance 50304). Distally, the first flexible circuit 50110 is at the second distance 50304 within this region, and then the first flexible circuit 50110 transitions further away from the neutral plane 50130P (i.e., a third distance 50306). The end effector 50100 may include a first insulating layer 50120, as described above, and the first flexible circuit 50110 may transition within or on the first insulating layer 50120. In some examples, at least a portion of the plurality of first electrodes 50112 may extend from a first outer surface 50122a defined by the insulating material 50120, as Figure 48C shown. Additionally, the first outer surface 50122a may remain planar and parallel to the neutral plane 50130P, and the first flexible circuit 50110 may transition within or on the first insulating layer 50120 relative to the vertical axis 50V-V. As will be understood, Figure 47 the example shown may look substantially similar to Figure 48C shown, but the device will be mirrored along the plane of the frame 50130 such that the left side will include the first flexible circuit 50110 and the first insulating material 50120, and the right side will include the second flexible circuit 50140 and the second insulating material. As will be understood and as described above, the first insulating material and the second insulating material in this example may be a continuous material, i.e., the insulating material 50120 may include a first insulating material sheet 50120a and a second insulating material sheet 50120b that are fused together near the frame 50130 to form a single, contiguous, generally planar insulating block 50120.

[0333] Figures 49A to 49C shows in connection with Figure 47 and Figures 48A to 48CThe illustrated embodiments are similar to the embodiments described, but the end effector 50100 includes a first flexible circuit 50110 on one side of the frame 50130 and a second flexible circuit on the opposite side, the second flexible circuit including an electromagnetic coil 50330. Figures 49A to 49C The first flexible circuit 50110 in Figures 48A to 48C is substantially the same as the circuit discussed with reference to Figure 49B . The electromagnetic coil 50330 on the opposite side ( Figure 43 ) can be used as a position sensor for positioning the end effector 50100 within a patient, as described above with reference to Figure 43 . For example, the magnetic coil 5032 (see Figure 49B ) 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 examples, the electromagnetic coil 50330 can be divided into separate loops, such as

[0334] the distal loop 50334, the first side loop 50336a, and the second side loop 50336b shown in Figure 49C . The distal loop 50334, the first side loop 50336a, and the second side loop 50336b can individually detect the magnetic field, and the currents generated at each of these loops can be triangulated to map the position of the end effector 50100.

[0334] Now referring to Figure 49C , the electromagnetic coil 50330 on one side of the end effector 50100 can also include the planar shift discussed above. In the planar transition region 50300, the electromagnetic coil 50330 positioned on that side of the end effector 50100 moves from being closer to the neutral plane (see Figure 49Cfrom a first plane closer to the neutral plane 50130P to a second plane further away from the neutral plane. The electromagnetic coil 50330 may include a coil tail 50332 similar to the circuit tail 50310 described above. When the end effector 50100 is deployed or used, the transition between the coil tail 50332 and the more distal portion of the electromagnetic coil 50330 may be subjected to maximum bending strain. Thus, the planar transition region 50300 is positioned distally of the coil tail 50332. Now referring to the electromagnetic coil 50330, the coils near the coil tail 50332 may be positioned in a plane at a first distance 50338 from the frame 50130. Moving distally, the electromagnetic coil 50330 transitions to a second plane at a second distance 50340 from the frame 50130, the second distance 50340 being less than the first distance 50338 (i.e., is a shorter distance than the first distance). Moving distally, the electromagnetic coil 50330 then transitions to a third plane at a third distance 50342 from the frame 50130, the third distance 50342 being greater than the second distance 50340 (i.e., is a longer distance than the second distance). Thus, the electromagnetic coil 50330 transitions in the planar transition region 50300 from a plane closer to the neutral plane 50130P (see Figure 49C ) to a different plane further away from the neutral plane 50130P.

[0335] As described herein, the end effector 50100 here may include any combination of the circuits described herein on either side of the end effector 50100. By way of illustration, the end effector 50100 may have an electrode circuit on only one side (e.g., a first flexible circuit 50110 having electrodes 50112, as Figures 48A to 48C shown); the end effector 50100 may 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 Figure 47 shown); the end effector 50100 may 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 Figures 49A to 49C shown); and the end effector 50100 may have only an electromagnetic coil 50330 on one side and no electrode circuit on the other side.

[0336] Figure 50AFIG. is an illustration of an exploded perspective view of an end effector 50100 having a planar transition region 50300 on the proximal side and alternating layers of insulating sheets (e.g., distal insulating sheet 50420a, intermediate insulating sheet 50420b, and / or proximal insulating sheet 50420c). As described above, the flexible circuits and / or electromagnetic coils described herein may be embedded in and / or on the insulating material (see insulating material 50120, first insulating sheet 50120a, and second insulating sheet 50120b above). Accordingly, the corresponding circuits may make a planar transition as described herein by varying their position within successive insulating sheets. It is also contemplated that the planar transition portion is created by a separate sheet of material having a thickness equal to the above distance from 50130P (see, e.g., Figure 48C and 49C ). Now referring to the example in Figure 50A , the end effector 50100 may include a distal insulating sheet 50420a positioned between the frame 50130 and a plurality of first electrodes 50112 (it will be understood that the example shown in Figure 50A includes electrodes on the distal side, but the embodiments shown in Figure 50A and Figure 50B are equally applicable to any example described herein, including those having an electromagnetic coil 50330). The distal insulating sheet 50420a may taper proximally near the planar transition region 50300 such that the circuits on that side of the end effector 50100 can transition closer to the neutral plane 50130P. The end effector 50100 may include an intermediate insulating sheet 50420b positioned within the planar transition region 50300 such that at least a portion of the circuit / coil on that side of the end effector 50100 is positioned between the intermediate insulating sheet 50420b and the frame 50130. For example, in this section, the circuit (e.g., first flexible circuit 50110) is closer to the neutral plane 50130P and more insulating material is positioned over the circuit. The end effector 50100 may also include a proximal insulating sheet 50420c positioned between the frame 50130 and a tail (e.g., circuit tail 50310). The proximal insulating sheet 50420c may taper distally to effect a planar transition of the first flexible circuit 50110. The distal insulating sheet 50420a may have a thickness equal to the third distances 50306, 50342, the intermediate insulating sheet 50420b may have a thickness equal to the second distances 50304, 50340, and the proximal insulating sheet 50420c may have a thickness equal to the first distances 50302, 50338.

[0337] Figure 50BIllustrated is an exploded perspective view of an end effector 50100 having, on opposite sides of the end effector 50100, a proximal planar transition region 50300, alternating layers of insulating sheets and flexible circuit layers. Figure 50B The example shown is substantially similar to Figure 50A the example shown, except that Figure 50B the example shown includes a circuit (e.g., a second flexible circuit 50140) on a side of the end effector opposite the first circuit 50110. The top side of the image is the same as Figure 50A that shown, but the circuit tail is labeled as a first circuit tail 50310a. The opposite side includes a second distal insulating sheet 50420d, a second intermediate insulating sheet 50420e, and a second proximal insulating sheet 50420f.

[0338] The second distal insulating sheet 50420d may taper proximally near the planar transition region 50300 such that the circuit on that side of the end effector 50100 can transition closer to the neutral plane 50130P. The end effector 50100 may include a second intermediate insulating sheet positioned within the planar transition region 50300 such that at least a portion of the circuit / coil on that side of the end effector 50100 is positioned between the second intermediate insulating sheet 50420e and the frame 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 positioned at a more superficial location on the circuit. The end effector 50100 may also include a second proximal insulating sheet 50420f positioned between the frame 50130 and the tail (e.g., the second circuit tail 50320b). The second proximal insulating sheet 50420f may taper distally to effect a planar transition of the second flexible circuit 50140. The second distal insulating sheet 50420d may have a thickness equal to the third distance 50306, 50342, the second intermediate insulating sheet 50420e may have a thickness equal to the second distance 50304, 50340, and the second proximal insulating sheet 50420f may have a thickness equal to the first distance 50302, 50338.

[0339] The present disclosure provides as Figure 51The catheter assembly 50200 shown may include a tubular member 50230 that extends along a longitudinal axis 50L-L and is configured to deliver an end effector 50100 outside of a sheath 50210. A physician 5024 may manipulate 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 other components not mentioned herein are described in U.S. Patent Publication No. 2021 / 0369339, which is incorporated herein by reference and is included in the appendix of priority application No. 63 / 615,574.

[0340] Serpentine Flexible Circuit for Medical Probe( Figures 52 to 58 )

[0341] Reference Figure 52 , which shows an exemplary catheter-based electrophysiological mapping and ablation system 6010. The system 6010 includes a plurality of catheters that are inserted by a physician 6024 through a patient 6023's vascular system via the skin into a chamber or vascular structure of the heart 6012. Generally, a delivery sheath catheter is inserted into the left atrium or right atrium near a desired location in the heart 6012. Then, a plurality of catheters may be inserted into the delivery sheath catheter to reach that 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 6014 configured for sensing IEGM is illustrated herein. The physician 6024 places the distal end of the catheter 6014 (i.e., the multi-layer end effector 60100) in contact with the heart wall for sensing a target site in the heart 6012. For ablation, the physician 6024 similarly brings the distal end of the ablation catheter to the target site for ablation.

[0342] The catheter 6014 is an exemplary catheter that includes one and preferably a plurality of electrodes 60112 optionally distributed over the end effector 60100, which are coupled to the catheter shaft and configured to sense IEGM signals, as described in more detail below. The catheter 6014 may additionally include a position sensor embedded in or near the end effector 60100 for tracking 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.

[0343] A magnetic-based position sensor can operate with a positioning pad 6025 that includes a plurality of magnetic coils 6032 configured to generate a magnetic field in a predefined workspace. The real-time position of the end effector 60100 of the catheter 6014 can be tracked based on the magnetic field generated by the positioning pad 6025 and sensed by the magnetic-based position sensor. Details of the magnetic-based position sensing technique 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.

[0344] System 6010 includes one or more electrode patches 6038 positioned to contact the skin of the patient 6023 to establish a position reference for impedance-based tracking of the positioning pad 6025 and the electrodes 60112. For impedance-based tracking, current is directed toward the electrodes 60112 and sensed at the electrode skin patches 6038 such that the position of each electrode can be triangulated via the electrode patches 6038. Details of the impedance-based position tracking technique 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.

[0345] Recorder 6011 displays an electrogram 6021 captured using the body surface ECG electrodes 6018 and an intracardiac electrogram (IEGM) captured using the electrodes 60112 of the catheter 6014. Recorder 6011 can include pacing capabilities for pacing the heart rhythm and / or can be electrically connected to an independent pacemaker.

[0346] System 6010 can include an ablation energy generator 6050 adapted to conduct ablation energy to one or more of the electrodes 60112 at the distal end of a catheter configured for ablation. The energy generated by the ablation energy generator 6050 can include, but is not limited to, radiofrequency (RF) energy or pulsed field ablation (PFA) energy (including monopolar or bipolar high voltage DC pulses that can be used to effect irreversible electroporation (IRE)), or a combination thereof.

[0347] The Patient Interface Unit (PIU) 6030 is an interface configured to establish electrical connectivity between a catheter, electrophysiology equipment, a power source, and a workstation 6055 for controlling the operation of the system 6010. The electrophysiology equipment of the system 6010 may include, for example, a plurality of catheters, positioning pads 6025, body surface ECG electrodes 6018, electrode patches 6038, an ablation energy generator 6050, and a recorder 6011. Optionally and preferably, the PIU 6030 further includes processing capabilities for performing real-time calculations of the position of the catheter and for performing ECG calculations.

[0348] The workstation 6055 includes a memory, a processor unit with a memory or storage device loaded with appropriate operating software, and user interface capabilities. The workstation 6055 may provide a plurality of functions, optionally including: (1) performing three-dimensional (3D) modeling of the endocardial anatomy and rendering a model or anatomical map 6020 for display on a display device 6027; (2) displaying, on the display device 6027, an activation sequence (or other data) compiled from the recorded electrograms 6021 as representative visual markers or images superimposed on the rendered anatomical map 6020; (3) displaying the real-time position and orientation of a plurality of catheters within the heart chambers; and (4) displaying on the display device 27 a site of interest, such as where ablation energy has been applied. An article of commerce embodying the elements of the system 6010 may be purchased as the CARTOTM 3 system from Biosense Webster, Inc., 31 Technology Drive, Suite 200, Irvine, CA 92618.

[0349] Figure 53 An end effector 60100 according to an embodiment of the present disclosure is provided to achieve enhanced end effector characteristics, such as desired stiffness, contact of the electrodes with the target anatomy, and conformance of the end effector disclosed herein to flat, curved, irregular, and / or non-planar tissue surfaces found in the target anatomy. The end effector 60100 may include a flexible circuit 60110 that includes a plurality of electrodes 60112, each of the plurality of electrodes 60112 including a contact surface 60112c. As used herein, the term "flexible circuit" includes components of electrical traces (e.g., electrical traces 60200) positioned on a substrate (e.g., substrate 60206). Below with respect to FIGS. 54 to Figure 56Additional information regarding exemplary traces and substrates is provided. The end effector 60100 may also include a second flexible circuit 60140 having a plurality of second electrodes (positioned below the electrodes 60112). The second flexible circuit 60140 may be substantially similar to the first flexible circuit 60110, and each of the plurality of second electrodes may have a second contact surface. In some examples, the electrodes described herein may include at least one mapping electrode and / or at least one ablation electrode and may be configured to detect electrophysiological signals or deliver ablation energy (AC or DC) from an energy generator to tissue according to the various ablation methods described previously (e.g., RF, IRE, etc.).

[0350] The first flexible circuit 60110 and / or the second flexible circuit 60140 (collectively referred to as the flexible circuits 60110, 60140) may be disposed on or within an insulating material 60120. The insulating material 60120 may be adjacent to the contact surface 60112c such that only the contact surface 60112c of at least a portion of the plurality of electrodes 60112 is exposed to the surrounding environment. As used herein, the term "contact surface" includes the portion of the electrode having a generally flat surface and one or more edges directly surrounding the flat surface. When the end effector 60100 is placed against tissue, the electrodes 60112 may have a slightly rounded, chamfered, or beveled edge that contacts the tissue and a generally flat surface. As used herein, "surrounding environment" refers to the external environment, such as the organ in which the end effector 60100 is deployed or the operating room in which the end effector is located prior to deployment within a biological organ.

[0351] Note that not all of the electrodes 60112 on the end effector 60100 described herein need to be exposed through the insulating material 60120 because these unexposed electrodes may be used to sense far-field signals for noise reduction of tissue-contact electrodes. Similarly, for an entire end effector having a reference electrode that does not contact tissue but only contacts blood, far-field signals including noise or artifacts may be reduced or eliminated. Flushing may be provided using a flushing port 60163a (on one side) and a flushing port 60162b (on the other side) that are in fluid communication with a flushing line (not shown) disposed within the catheter shaft. Instead of a flushing line separate from the catheter shaft, an internal lumen may be formed by squeezing the catheter shaft to provide an internal lumen channel. Note that the port 60163a or 60162b may be configured to have sufficient flow diverter characteristics to cause the flushing fluid to cover the mapping electrodes during flushing flow in order to prevent or reduce thrombus formation.

[0352] The end effector 60100 also includes a frame 60130 that supports flexible circuits 60110, 60140. The frame 60130 can be a flexible material that allows the end effector 60100 to pass through the vasculature. It is contemplated that the frame 60130 is a shape memory material, such as a copper-aluminum-nickel or preferably a nickel-titanium (NiTi / Nitinol) alloy and / or an alloy including zinc, copper, and gold. Additional information regarding an exemplary frame 60130 is provided below with respect to Figure 56 The frame 60130 can be adjacent to or within an insulating material 60120. The flexible circuits 60110, 60140 can be disposed directly on the frame 60130 with little or no insulating material 60120 therebetween. In other examples, the frame 60130 and the flexible circuits 60110, 60140 can be spaced apart along a vertical axis 60V-V in different planes. The frame 60130 can include one or more struts 60142 that extend along a longitudinal axis 60L-L of the end effector 60100. Each strut 60145 can include a single strand of an electrical trace 60200 that extends along a longitudinal axis 60L'-L' of each strut 60142.

[0353] Figure 54A is a detailed view of the electrical trace 60200 according to the disclosed technology, which shows sections having alternating grain lengths in the crystal structure of these traces; and Figure 54B is a detailed view of the rolled and annealed metal according to the disclosed technology. The electrical trace 60200 in any of the embodiments described herein is an electrical conductor that connects one or more electrodes 60112 (see Figure 53 ) to a signal and / or current generator (e.g., Figure 52 the PIU 6030 in Figure 55 ) or a receiver. The electrical trace 60200 can be positioned on a substrate 60206, as will be described with reference to Figure 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 can simply be adhered or otherwise applied to the substrate 60604. The electrical trace 60200 includes a rolled and annealed metal, such as a rolled and annealed metal including copper or an alloy thereof (e.g., a copper, manganese, and nickel alloy). In a preferred embodiment, rolled and annealed copper is used for the electrical trace 60200, as will be described below. The rolled and annealed metal is preferred due to its flexibility. In terms of manufacturing, the rolled and annealed metal can start as an electrodeposited metal having a more vertical crystalline grain structure. These electrodeposited metals are then subjected to a rolling and annealing process that stretches and elongates the grain structure, thereby increasing its flexibility and mechanical bending ability. Additionally, the rolled structure forms a single grain (i.e., Figure 54BThe individual longer grains 60202 shown, all of these individual grains extending generally parallel to the rolling direction of the rolled and annealed metal.

[0354] For example, an alternating structure can be formed by annealing and / or rolling the metal foil to a greater extent at the location of the longer grain section 60202. Figure 54A An example is shown where the crystal structure is alternating. However, in practice, manufacturing these alternating crystal structures can be difficult, and the alternation of the crystal structure may be undesirable as they may provide regions of fracture or other failures. Thus, an alternative design is to provide the longer grain section 60202 and the shorter grain section 60204 via a cutting process. Figure 54B An example of a trace 60200 is shown, which is rolled such that all of the longer grain sections 60202 are positioned parallel to the rolling direction; the rolling direction can be parallel to the direction of each individual strut 60145 (see Figure 55 ). The rolling is substantially uniform along its length, and the trace 60200 is formed parallel to the rolling (i.e., elongated grains) of the rolled and annealed metal, rather than having a different grain structure throughout. The longer grain section 60202 and the shorter grain section 60204 can thus be produced by a process of cutting out or forming the trace 60200 from the rolled and annealed metal. The rolled and annealed metal sheet can be provided with longitudinally extending elongated grains. Then, a serpentine-shaped trace 60200 can be cut out from the long rolled and annealed metal sheet such that the sections in the bends of the serpentine shape will have longer grains (i.e., the longer grain section 60202) as the cutting is parallel to the metal rolling direction, and the sections between the bends of the serpentine shape will have shorter grains (i.e., the shorter grain section 60204) as the cutting is perpendicular to the metal rolling direction. Thus, the alternating structure of the longer grain section 60202 at the bends 60212 and the shorter grain section 60204 outside the bends 60212 will facilitate and promote the bending of the trace 60200 at the apexes 60216 (see Figure 56 ). This example of cutting out a serpentine-shaped trace 60200 in the rolling direction of the rolled and annealed metal is shown in the examples provided in Figure 55 and Figure 56 . It should be understood that the trace 60200 can be cut out from the rolled and annealed metal via photolithography, masking and etching, laser cutting, or similar processes.

[0355] Figure 55 is according to the disclosed technology and has as Figure 54BA top plan view of a flexible circuit 60110 of an electrical trace 60200 applied to a substrate 60206 is shown. The substrate 60206 may be made primarily of polyimide. In other examples, the substrate 60206 may be made of any of a biocompatible polyimide, a glass reinforced epoxy laminate, copper, or graphene, alone or in combination. As shown, the flexible circuits 60110, 60140 described herein may have a serpentine structure that enables the first flexible circuit 60110 to have a greater degree of bending. In other words, the serpentine layout may enable the flexible circuits 60110, 60140 to more easily flex left / right in their plane (i.e., flex left / right on an axis transverse to the longitudinal axis 60L-L). Referring again to the layered structure of the electrical trace 60200, the rolled annealed metal therein is flexed in the grain direction (i.e., along the longitudinal axis 60L-L, see Figure 52 ) has good bending resistance, but has less bending resistance in the direction orthogonal to the grain direction. Therefore, the alternating grain structure described above can be combined with the bend 60212 of the electrical trace 60200 (see Figure 56 The longest continuous segments of the grains are thus positioned at the locations of the multiple bends 60212 in the serpentine structure, and the shorter grain segments 60204 are positioned outside the bends (e.g., in segments of the serpentine pattern that extend more perpendicular to the longitudinal axis 60L'-L'). This orientation of the grains is intended to promote the apex of the bends (see Figure 56 Bend at vertex 60214).

[0356] Figure 56 is applied to the support frame 60130 according to the disclosed technology Figure 55 60140. To further encourage and facilitate bending at the bend 60212 of the electrical trace 60200, each strut 60145 of the end effector 60100 can include a wide section 60208 and a narrow section 60210 extending 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 cut 60218. The wide section 60208 provides more support, so the strut 60145 will be encouraged to bend at the narrow section 60210. Each bend 60212 includes an apex 60214, and the apex 60214 of the plurality of bends 60212 extends into the cutout 60218 such that the plurality of bends overhang at least a portion of the strut 60145. Figure 56is marked as the overhang portion 60216 in. In view of this design, the vertex 60214 of the bend 60212 in the trace line 60200 is positioned at the narrow section 60210, the above-mentioned longer grain 60202 of the trace line 60200 is positioned at the bend 60212 in the narrow section 60210, and the strut 60145 is urged and promoted to bend at the narrow section 60210.

[0357] As will be appreciated, it is not necessary to combine all of the above features, since any of the beneficial features described herein may be used alone or in combination with any other novel features. For example, the formation of the trace line 60200 having the longer grain section 60202 / shorter grain section 60204 described herein may be used in any flexible circuit including a bend; the strut 60145 having the wide section 60208 and the narrow section 60210 may be used in any flexible circuit including the bend 60212, or even in any flexible circuit without the serpentine bend 60212; and Figure 55 The exemplary flexible circuits 60110, 60140 shown may be used on a frame 60130 that does not include the wide section 60208 and the narrow section 60210.

[0358] The present disclosure provides a catheter assembly 60300 as Figure 57 shown, which may include a tubular member 60230 extending along a longitudinal axis 60L-L and configured to deliver an end effector 60100 outside a sheath 60240. A physician 6024 may manipulate the catheter 60300 using a 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 other components not mentioned herein are described in U.S. Patent Publication No. 2021 / 0369339, which is incorporated herein by reference and is included in the appendix of priority application No. 63 / 615,947.

[0359] Figure 58FIG. 60700 is a flow chart showing a method 60700 of manufacturing an end effector 60100 for a medical catheter according to the disclosed technology. Method 60700 includes: forming 60705 struts 60145 of a frame 60130 for the end effector 60100, and setting alternating wide sections 60208 and narrow sections 60210 extending along a longitudinal axis 60L'-L' of the struts 60145. Method 60700 includes: setting 60710 electrical traces 60200 on a substrate 60206. Method 60700 includes: forming 60715 a plurality of bends 60212 in the substrate 60206 and the electrical traces 60200. Method 60700 includes: aligning 60720 the substrate 60206 and the electrical traces 60200 with the struts 60145 such that vertices 60214 of the plurality of bends 60212 are positioned at corresponding locations of the narrow sections 60210 of the struts 60145. As mentioned above, the electrical traces 60200 may include rolled annealed metal, preferably rolled annealed copper or a copper alloy.

[0360] Method 60700 may end after step 60720, while in other examples, additional steps may be performed in accordance with the present disclosure. For example, method 60700 may include: forming a serpentine shape from rolled annealed metal by cutting the electrical traces along the direction of a single grain of the rolled annealed metal such that the single grains extend parallel to the longitudinal axis of the strut. The electrical traces may have longer grain sections and shorter grain sections. The longer grain sections 60202 may be positioned at the locations of the plurality of bends 60212. The narrow sections 60210 define cutouts 60218, and the vertices 60214 of the plurality of bends 60212 extend into the cutouts 60218 such that the plurality of bends overhang at least a portion of the first strut 60145 (see Figure 56 the overhangs 60216 in).

[0361] The disclosed technology described herein may be further understood in accordance with the following clauses:

[0362] Clause 1: An end effector, the end effector comprising: an insulating material having a first outer surface and a second outer surface; a frame disposed in the insulating material; and a first flexible circuit including a plurality of first electrodes, the first flexible circuit being disposed longitudinally along the insulating material and at least partially within the insulating material and being positioned such that a first portion of the first flexible circuit abuts a first plane and a second portion of the first flexible circuit abuts a second plane, the first plane being a first distance from the frame and the second plane being a second distance from the frame, the second distance being less than the first distance.

[0363] Clause 2: The end effector according to Clause 1, wherein each of the plurality of first electrodes includes a first contact surface positioned at the first outer surface.

[0364] Clause 3: The end effector according to Clause 1 or 2, wherein the first outer surface is at a first height from the frame, and the first distance is equal to the first height.

[0365] Clause 4: The end effector according to any one of the preceding clauses, wherein the first flexible circuit includes a first superficial planar section extending a first length in the first plane, and the first superficial planar section extends parallel to the frame.

[0366] Clause 5: The end effector according to Clause 4, wherein the first electrode of the plurality of first electrodes is disposed within the first superficial planar section.

[0367] Clause 6: The end effector according to Clause 4, wherein the first electrode and the second electrode of the plurality of first electrodes are disposed within the first superficial planar section.

[0368] Clause 7: The end effector according to any one of Clauses 4 to 6, wherein the first superficial planar section is positioned on the first outer surface.

[0369] Clause 8: The end effector according to any one of the preceding clauses, wherein the first flexible circuit includes a first intermediate planar section extending a second length in the second plane, and the first intermediate planar section extends parallel to the frame.

[0370] Clause 9: The end effector according to Clause 8 when dependent on any one of Clauses 4 to 7, further including a plurality of intermediate planar sections and a plurality of superficial planar sections.

[0371] Clause 10: The end effector according to any one of the preceding clauses, wherein the second distance is approximately zero, such that the second portion of the first flexible circuit contacts the frame.

[0372] Clause 11: The end effector according to any one of the preceding clauses, wherein the second portion of the first flexible circuit is positioned at a portion of the end effector configured to bend during use.

[0373] Clause 12: The end effector according to any one of the preceding clauses, wherein the first portion and the second portion are connected by an angled section.

[0374] Clause 13: The end effector according to Clause 12, wherein the angle of the angled section changes as the first portion bends or moves relative to the second portion.

[0375] Clause 14: For the end effector according to any one of the foregoing clauses, at a position of the second outer surface at a second height from the frame, the end effector further includes: a second flexible circuit, the second flexible circuit includes a plurality of second electrodes, the second flexible circuit is longitudinally disposed along the insulating material and at least partially disposed within the insulating material, and is positioned such that a third portion of the second flexible circuit abuts a third plane and a fourth portion of the second flexible circuit abuts a fourth plane, the third plane is at a third distance from the frame and the fourth plane is at a fourth distance from the frame, and the fourth distance is shorter than the third distance.

[0376] Clause 15: For the end effector according to Clause 14, each of the plurality of second electrodes includes a second contact surface positioned on the second outer surface.

[0377] Clause 16: For the end effector according to Clause 14 or 15, the third distance is equal to the second height.

[0378] Clause 17: For the end effector according to any one of Clauses 14 to 16, the second flexible circuit includes a second superficial planar section extending a second length in the third plane, and the second superficial planar section extends parallel to the frame.

[0379] Clause 18: For the end effector according to Clause 17, a third electrode among the plurality of second electrodes is disposed within the second superficial planar section.

[0380] Clause 19: For the end effector according to Clause 17, a third electrode and a fourth electrode among the plurality of first electrodes are disposed within the second superficial planar section.

[0381] Clause 20: For the end effector according to any one of Clauses 17 to 19, the second superficial planar section is positioned on the second outer surface.

[0382] Clause 21: For the end effector according to any one of Clauses 14 to 20, the first flexible circuit includes a second intermediate planar section extending a second length in the second plane, and the second intermediate planar section extends parallel to the frame.

[0383] Clause 22: For the end effector according to any one of the foregoing clauses, it further includes a first support layer, and the first support layer is positioned between the frame and the first flexible circuit within the insulating material.

[0384] Clause 23: For the end effector according to Clause 22, the first support layer includes a polymer film.

[0385] Clause 24: For the end effector according to Clause 22, the first support layer includes a reticulated polymer.

[0386] Clause 25: The end effector according to any one of Clauses 22 to 24, wherein the insulating material comprises at least one of thermoplastic polyurethane (TPU), silicone, or siloxane.

[0387] Clause 26: The end effector according to any one of Clauses 22 to 25, wherein the first support layer comprises at least one of polyamide or ethylene tetrafluoroethylene (ETFE).

[0388] Clause 27: The end effector according to Clause 1, wherein the first flexible circuit has a wavy profile and is disposed within the insulating material.

[0389] Clause 28: An end effector comprising: an insulating material having a first outer surface and a second outer surface; a frame disposed within the insulating material; a first flexible circuit including a plurality of first electrodes, the first flexible circuit being disposed on or within the insulating material, and each electrode of the plurality of first electrodes including a first contact surface, the insulating material being adjacent to the first contact surface such that only the first contact surfaces of at least a portion of the plurality of first electrodes are exposed to the surrounding environment; and a first support layer positioned between the frame and the first flexible circuit within the insulating material.

[0390] Clause 29: The end effector according to Clause 28, wherein the first support layer comprises a polymer film.

[0391] Clause 30: The end effector according to Clause 28 or 29, wherein the first support layer comprises a reticulated polymer.

[0392] Clause 31: The end effector according to any one of Clauses 28 to 30, wherein the insulating material comprises at least one of thermoplastic polyurethane (TPU), silicone, or siloxane.

[0393] Clause 32: The end effector according to any one of Clauses 28 to 31, wherein the first support layer comprises at least one of polyamide or ethylene tetrafluoroethylene (ETFE).

[0394] Clause 33: The end effector according to any one of Clauses 28 to 32, further comprising: a second flexible circuit including a plurality of second electrodes, the second flexible circuit being disposed on or within the insulating material, and each electrode of the plurality of second electrodes including a second contact surface, the insulating material being adjacent to the second contact surface such that only the second contact surfaces of at least a portion of the plurality of second electrodes are exposed to the surrounding environment.

[0395] Clause 34: The end effector according to Clause 33 further includes a second support layer positioned between the frame and the second flexible circuit within the insulating material.

[0396] Clause 35: The end effector according to Clause 34, wherein the second support layer comprises a polymer film.

[0397] Clause 36: The end effector according to Clause 34, wherein the second support layer comprises a reticulated polymer.

[0398] Clause 37: The end effector according to any one of Clauses 34 to 36, wherein the second support layer comprises at least one of polyamide or ethylene tetrafluoroethylene (ETFE).

[0399] Clause 38: The end effector according to any one of Clauses 28 to 37, wherein 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 adjacent to a first plane and a second portion of the first flexible circuit is adjacent to a second plane, the first plane being a first distance from the frame and the second plane being a second distance from the frame, the second distance being shorter than the first distance.

[0400] Clause 39: The end effector according to Clause 38, wherein the first outer surface is at a position a first height from the frame, and the first distance is equal to the first height.

[0401] Clause 40: The end effector according to Clause 38 or 39, wherein the first flexible circuit includes a first superficial planar section extending a first length within the first plane, the first superficial planar section extending parallel to the frame.

[0402] Clause 41: The end effector according to Clause 40, wherein a first electrode of the plurality of first electrodes is disposed within the first superficial planar section.

[0403] Clause 42: The end effector according to Clause 40, wherein a first electrode and a second electrode of the plurality of first electrodes are disposed within the first superficial planar section.

[0404] Clause 43: The end effector according to any one of Clauses 40 to 42, wherein the first superficial planar section is positioned on the first outer surface.

[0405] Clause 44: The end effector according to any one of Clauses 38 to 43, wherein the first flexible circuit includes a first intermediate planar section extending a second length within the second plane, the first intermediate planar section extending parallel to the frame.

[0406] Clause 45: The end effector according to clause 44 when dependent on any one of clauses 39 to 42 further includes a plurality of intermediate planar sections and a plurality of superficial planar sections.

[0407] Clause 46: For the end effector according to any one of clauses 38 to 45, the second distance is approximately zero such that the second portion of the first flexible circuit contacts the frame.

[0408] Clause 47: For the end effector according to any one of clauses 38 to 46, the second portion of the first flexible circuit is positioned at the bent portion of the end effector.

[0409] Clause 48: For the end effector according to any one of clauses 38 to 47, the first portion and the second portion are connected by an angled section.

[0410] Clause 49: For the end effector according to clause 48, the angle of the angled section changes as the first portion bends or moves relative to the second portion.

[0411] Clause 50: For the end effector according to any one of clauses 38 to 49, at a position of the second outer surface at a second height from the frame, the end effector further includes: a second flexible circuit including a plurality of second electrodes, the second flexible circuit being longitudinally disposed along the insulating material and at least partially disposed within the insulating material, and being positioned such that a third portion of the second flexible circuit abuts a third plane and a fourth portion of the second flexible circuit abuts a fourth plane, the third plane being at a third distance from the frame and the fourth plane being at a fourth distance from the frame, the fourth distance being shorter than the third distance.

[0412] Clause 51: For the end effector according to clause 50, each of the plurality of second electrodes includes a second contact surface positioned on the second outer surface.

[0413] Clause 52: For the end effector according to clause 50 or 51, the third distance is equal to the second height.

[0414] Clause 53: For the end effector according to any one of clauses 50 to 52, the second flexible circuit includes a second superficial planar section extending a second length in the third plane, the second superficial planar section extending parallel to the frame.

[0415] Clause 54: For the end effector according to clause 53, a third electrode of the plurality of second electrodes is disposed within the second superficial planar section.

[0416] Clause 55: For the end effector according to Clause 53, the third and fourth electrodes among the plurality of first electrodes are disposed within the second superficial planar section.

[0417] Clause 56: For the end effector according to any one of Clauses 53 to 55, the second superficial planar section is positioned on the second outer surface.

[0418] Clause 57: For the end effector according to any one of Clauses 50 to 56, the first flexible circuit includes a second intermediate planar section extending a second length within the second plane, and the second intermediate planar section extends parallel to the frame.

[0419] Clause 58: An end effector, the end effector comprising: an insulating material having a first outer surface and a second outer surface; a frame disposed within the insulating material; and a first flexible circuit having a wavy profile, disposed within the insulating material, the first flexible circuit having a first portion adjacent to the insulating material and exposed to the surrounding environment, and the first flexible circuit being spaced apart from the frame.

[0420] Clause 59: The end effector according to Clause 58 further includes a second flexible circuit having a wavy profile disposed within the insulating material, the second flexible circuit having a second portion adjacent to the insulating material and exposed to the surrounding environment, and the second flexible circuit being spaced apart from the frame.

[0421] Clause 60: For the end effector according to Clause 59, the first portion of the first flexible circuit includes a plurality of first electrodes, and the second portion of the second flexible circuit includes a plurality of second electrodes.

[0422] Clause 61: For the end effector according to Clause 60, the plurality of first electrodes are longitudinally aligned opposite to the plurality of second electrodes along the length of the end effector.

[0423] Clause 62: For the end effector according to Clause 60, a first position of the plurality of first electrodes is longitudinally offset from a second position of the plurality of second electrodes along the length of the end effector.

[0424] Clause 63: The end effector according to Clause 58 further includes a first support layer positioned between the frame and the first flexible circuit within the insulating material.

[0425] Clause 64: For the end effector according to Clause 63, the first support layer includes a polymer film.

[0426] Clause 65: For the end effector according to Clause 63, the first support layer includes a reticulated polymer.

[0427] Clause 66: The end effector according to any one of Clauses 63 to 65, wherein the insulating material comprises at least one of thermoplastic polyurethane (TPU), silicone, or siloxane.

[0428] Clause 67: The end effector according to any one of Clauses 63 to 66, wherein the first support layer comprises at least one of polyamide or ethylene tetrafluoroethylene (ETFE).

[0429] Clause 68: An end effector for a catheter, the 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 coplanar with the first flexible circuit in the distal portion of the end effector and disposed on top of the first flexible circuit in the proximal portion of the end effector.

[0430] Clause 69: The end effector according to Clause 68, wherein the first flexible circuit comprises one or more first electrodes disposed on a distal portion of the first flexible circuit.

[0431] Clause 70: The end effector according to Clause 69, wherein a proximal portion of the first flexible circuit comprises one or more first electrical contacts corresponding to the one or more first electrodes.

[0432] Clause 71: The end effector according to Clause 70, wherein the first flexible circuit comprises one or more first traces connecting the one or more first electrical contacts to the one or more first electrodes.

[0433] Clause 72: The end effector according to any one of Clauses 69 to 71, wherein the one or more first electrodes comprise a plurality of first electrode pairs disposed on the distal portion of the first flexible circuit.

[0434] Clause 73: The end effector according to Clause 72, wherein each first electrode in each first electrode pair is spaced apart by a first predetermined longitudinal distance, and each first electrode pair is spaced apart from an adjacent first electrode pair by a second predetermined longitudinal distance, the second predetermined longitudinal distance being greater than the first predetermined longitudinal distance.

[0435] Clause 74: The end effector according to Clause 73, wherein the first predetermined longitudinal distance is about 100 micrometers.

[0436] Clause 75: The end effector according to any one of Clauses 69 to 74, each of the one or more first electrodes having a length of about 500 microns and a width of approximately 500 microns.

[0437] Clause 76: The end effector according to any one of Clauses 69 to 75, the second flexible circuit including one or more second electrodes disposed on a distal portion of the second flexible circuit.

[0438] Clause 77: The end effector according to Clause 76, a proximal portion of the second flexible circuit including one or more second electrical contacts corresponding to the one or more second electrodes.

[0439] Clause 78: The end effector according to Clause 77, the second flexible circuit including one or more second traces connecting the one or more second electrical contacts to the one or more second electrodes.

[0440] Clause 79: The end effector according to any one of Clauses 76 to 78, the one or more second electrodes including a plurality of second electrode pairs disposed on the distal portion of the second flexible circuit.

[0441] Clause 80: The end effector according to any one of Clauses 75 to 79, the end effector further including a frame, a distal portion of the first flexible circuit being disposed on the frame and a distal portion of the second flexible circuit being disposed on the frame, and a proximal portion of the first flexible circuit being disposed on the frame and a proximal portion of the second flexible circuit being disposed on a portion of the proximal portion of the first flexible circuit.

[0442] Clause 81: The end effector according to Clause 80, the frame including a first ridge, a second ridge, a third ridge, and a fourth ridge; the distal portion of the first flexible circuit including a first loop disposed on the first ridge and the second ridge; and the distal portion of the second flexible circuit including a second loop disposed on the third ridge and the fourth ridge.

[0443] Clause 82: The end effector according to Clause 81, the frame further including at least partial gaps between the first ridge, the second ridge, the third ridge, and the fourth ridge.

[0444] Clause 83: The end effector according to any one of Clauses 80 to 82, the frame comprising nitinol.

[0445] Clause 84: The end effector according to any one of Clauses 68 to 83, the distal portion of the end effector having a width of about 9 millimeters.

[0446] Clause 85: The distal portion of the end effector according to any one of Clauses 68 to 84 has a width of approximately 20 millimeters.

[0447] Clause 86: An end effector for a catheter, the end effector 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 a proximal portion of the frame to a distal portion; and a second flexible circuit extending along the longitudinal axis from the proximal portion of the frame to the distal portion, the second flexible circuit being disposed on the first side of the frame at the distal portion of the frame and on top of the first flexible circuit at the proximal portion of the frame.

[0448] Clause 87: The end effector according to Clause 86, wherein the first flexible circuit includes one or more first electrodes disposed on a distal portion of the first flexible circuit, and the second flexible circuit includes one or more second electrodes disposed on a distal portion of the second flexible circuit.

[0449] 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 in electrode pairs, each electrode pair being spaced apart by a first predetermined longitudinal distance, and each electrode pair being spaced apart from an adjacent first electrode pair by a second predetermined longitudinal distance, the second predetermined longitudinal distance being greater than the first predetermined longitudinal distance.

[0450] Clause 89: The end effector according to Clause 88, wherein the first predetermined longitudinal distance is approximately 100 micrometers.

[0451] Clause 90: The end effector according to any one of Clauses 86 to 89, further comprising: 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; and a fourth flexible circuit extending along the longitudinal axis from the proximal portion of the frame to the distal portion, the fourth flexible circuit being disposed on the second side of the frame at the distal portion of the frame and on top of the third flexible circuit at the proximal portion of the frame.

[0452] Clause 91: The end effector according to Clause 90, wherein the third flexible circuit includes one or more first electrodes disposed on a distal portion of the third flexible circuit, and the fourth flexible circuit includes one or more fourth electrodes disposed on a distal portion of the second flexible circuit.

[0453] Clause 92: An end effector for a catheter, the 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 coplanar with the first flexible circuit in the distal portion of the end effector and disposed on top of the first flexible circuit in the proximal portion of the end effector.

[0454] Clause 93: The end effector according to Clause 92, the first flexible circuit comprising a first set of electrodes disposed on one side of the first flexible circuit and a second set of electrodes disposed on an opposite side of the first flexible circuit, the second flexible circuit comprising a first set of electrodes disposed on one side of the second flexible circuit and a second set of electrodes disposed on an opposite side of the second flexible circuit.

[0455] Clause 94: The end effector according to Clause 93, further comprising a substrate disposed between the first flexible circuit and the second flexible circuit at the proximal portion and coplanar with the first flexible circuit and the second flexible circuit at the distal portion.

[0456] Clause 95: An end effector for a catheter, the end effector comprising: an insulating material; a frame disposed within the insulating material, the frame being substantially planar along a longitudinal axis; and positioning sensing loops spaced from the frame and coupled to the insulating material, the positioning sensing loops comprising: a center loop disposed on a region near a distal portion of the insulating material on the longitudinal axis; and a pair of side loops disposed substantially symmetrically about the longitudinal axis, each side loop extending along the longitudinal axis from a proximal portion to a distal portion of the insulating material.

[0457] Clause 96: The end effector according to Clause 95, the pair of side loops comprising a first side loop and a second side loop.

[0458] Clause 97: An end effector for a catheter, the end effector comprising: an insulating material; a frame disposed within the insulating material, the frame being substantially planar along a longitudinal axis; and a position sensing loop disposed generally parallel to the frame and separated from the frame by the insulating material, the position sensing loop comprising: a center loop extending along the longitudinal axis and including a cumulative center loop surface area; a first side loop extending along the longitudinal axis and including a cumulative first side loop surface area; and a second side loop extending along the longitudinal axis and including a cumulative second side loop surface area, the cumulative center loop surface area, the cumulative first side loop surface area, and the cumulative second side loop surface area each being in the range of about one hundred square millimeters to three hundred square millimeters.

[0459] Clause 98: The end effector according to Clause 97, the center loop comprising one or more center loop coils, each center loop coil defining a center loop surface area, the first side loop comprising one or more first side loop coils, each first side loop coil defining a first side loop surface area, and the second side loop comprising one or more second side loop coils, and each second side loop coil defining a second side loop surface area, wherein the cumulative center loop surface area is the sum of the center loop surface areas of the one or more center loop coils, the cumulative first side loop surface area is the sum of the first side loop surface areas of the one or more first side loop coils, and the cumulative second side loop surface area is the sum of the second side loop surface areas of the one or more second side loop coils.

[0460] Clause 99: The end effector according to any one of Clauses 95 to 98, the center loop comprising: a first segment defining a distal end of the center loop; a second segment extending from the first segment in a proximal direction of the end effector; a third segment extending from the second segment in a distal direction of the end effector; a fourth segment extending from the third segment in the proximal direction of the end effector; and a fifth segment extending from the fourth segment in the distal direction of the end effector and connected to the first segment.

[0461] Clause 100: The end effector according to Clause 99, the first segment extending arcuately, and the second segment, the third segment, the fourth segment, and the fifth segment extending substantially linearly.

[0462] Clause 101: The end effector according to Clause 100, the second segment, the third segment, the fourth segment, and the fifth segment being angled with respect to the longitudinal axis.

[0463] Clause 102: The end effector according to any one of Clauses 95 to 101, wherein the central circuit includes a plurality of central circuit engagement segments.

[0464] Clause 103: The end effector according to any one of Clauses 96 to 102, wherein the first side circuit includes: a sixth segment that defines a distal end of the first side circuit; a seventh segment that extends from the sixth segment in a proximal direction of the end effector; an eighth segment that extends from the seventh segment in the proximal direction of the end effector; and a ninth segment that extends from the eighth segment in a distal direction of the end effector and is connected to the sixth segment.

[0465] Clause 104: The end effector according to Clause 103, wherein the seventh segment and the ninth segment extend substantially parallel to the longitudinal axis.

[0466] Clause 105: The end effector according to Clause 103, wherein the ninth segment includes: a proximal segment that is not parallel to the longitudinal axis; and a distal segment that is substantially parallel to the longitudinal axis.

[0467] Clause 106: The end effector according to Clause 105, wherein the proximal segment is curved away from the longitudinal axis.

[0468] Clause 107: The end effector according to any one of Clauses 103 to 106, wherein the sixth segment and the eighth segment extend arcuately.

[0469] Clause 108: The end effector according to any one of Clauses 96 to 107, wherein the first side circuit includes a plurality of first side circuit engagement segments.

[0470] Clause 109: The end effector according to any one of Clauses 96 to 108, wherein the second side circuit includes: a tenth segment that defines a distal end of the second side circuit; an eleventh segment that extends from the tenth segment in a proximal direction of the end effector; a twelfth segment that extends from the eleventh segment in the proximal direction of the end effector; and a thirteenth segment that extends from the twelfth segment in a distal direction of the end effector and is connected to the tenth segment.

[0471] Clause 110: The end effector according to Clause 109, wherein the eleventh segment and the thirteenth segment extend substantially parallel to the longitudinal axis.

[0472] Clause 111: The end effector according to Clause 109, wherein the thirteenth segment includes: a proximal segment that is not parallel to the longitudinal axis; and a distal segment that is substantially parallel to the longitudinal axis.

[0473] Clause 112: The end effector according to Clause 111, wherein the proximal section is bent away from the longitudinal axis.

[0474] Clause 113: The end effector according to any one of Clauses 109 to 112, wherein the tenth segment and the third second loop segment extend arcuately.

[0475] 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 engagement segments.

[0476] 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.

[0477] 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.

[0478] 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.

[0479] Clause 118: The end effector according to Clause 98, wherein each central loop surface area is at least about 69 square millimeters.

[0480] 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.

[0481] Clause 120: The end effector according to Clause 98 and any one of Clauses 118 to 119, wherein each second side loop surface area is at least about 59 square millimeters.

[0482] Clause 121: The end effector according to any one of Clauses 96 to 120, wherein the central loop, the first side loop, the second side loop, and the frame are stacked along a vertical axis that is substantially orthogonal to the longitudinal axis.

[0483] Clause 122: The end effector according to any one of Clauses 96 to 121, wherein 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 frame by the first non-conductive flexible layer.

[0484] Clause 123: The end effector according to any one of Clauses 96 to 121, wherein the insulating material comprises: a first non-conductive flexible layer; and a second non-conductive flexible layer, the central loop being separated from the frame by the first non-conductive flexible layer, and the first side loop and the second side loop being separated from the frame by the second non-conductive flexible layer.

[0485] Clause 124: The end effector according to any one of Clauses 96 to 123, wherein the frame 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.

[0486] 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.

[0487] Clause 126: The end effector according to any one of Clauses 124 to 125, wherein the third plane and the fourth plane are coplanar.

[0488] 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.

[0489] Clause 128: The end effector according to any one of Clauses 124 to 126, wherein the second plane is located on a first side of the first plane along a vertical axis, and the second plane and the third plane are located on a second opposite side of the first plane along the vertical axis.

[0490] Clause 129: The end effector according to any one of Clauses 97 to 128, wherein the end effector has a total length of approximately 20 millimeters to 25 millimeters and a total width of approximately 9 millimeters to 12 millimeters.

[0491] Clause 130: The end effector according to any one of Clauses 95 to 129, further comprising at least one flexible circuit disposed substantially parallel to the frame and separated from the frame by the insulating material, the flexible circuit including a plurality of electrodes disposed on the flexible circuit.

[0492] Clause 131: A frame for an end effector of a medical device, the frame comprising: a base configured to be connected to an elongate shaft of the medical device, the base extending distally along a longitudinal axis; and a first ridge circuit extending along the longitudinal axis from the base, the first ridge circuit including: a curved first segment connected to the base and extending distally from the base along the longitudinal axis; a second segment having an arcuate configuration connected to and extending from the curved first segment; a third segment connected to the second segment and extending proximally from the second segment along the longitudinal axis; a curved fourth segment connected to the base and extending distally from the base along the longitudinal axis; an arcuate fifth segment connected to and extending from the fourth segment; a sixth segment connected to the fifth segment and extending proximally from the fifth segment along the longitudinal axis; and an arcuate seventh segment connecting the third segment and the sixth segment.

[0493] Clause 132: The frame according to Clause 131, wherein the arcuate seventh segment is connected to the base.

[0494] Clause 133: The frame according to Clause 132, wherein the first ridge circuit defines two finger openings, and the base includes: a first section configured to be connected to the elongate shaft; and a second section extending within the finger openings to connect to the seventh segment.

[0495] Clause 134: The frame according to Clause 133, wherein the second section of the base defines one or more holes therein.

[0496] Clause 135: The frame according to Clause 133, further comprising: a second ridge circuit connected to the first section of the base and extending along the longitudinal axis from the first section.

[0497] Clause 136: The frame according to Clause 135, wherein the second ridge circuit includes a pair of terminal sections connected to the first section of the base.

[0498] Clause 137: The frame according to Clause 135, wherein the second ridge circuit includes a pair of terminal sections, one terminal section connected to the first section of the base and the other terminal section connected to the first segment of the first ridge circuit.

[0499] Clause 138: The framework according to any one of Clauses 135 to 137 further includes: a third ridge circuit that is connected to the first section of the base and extends along the longitudinal axis from the first section.

[0500] Clause 139: The framework according to Clause 138, wherein the third ridge circuit includes a pair of terminal sections that are connected to the first section of the base.

[0501] Clause 140: The framework according to Clause 138, wherein the third ridge circuit includes a pair of terminal sections, one terminal section is connected to the first section of the base, and the other terminal section is connected to the fourth section of the first ridge circuit.

[0502] Clause 141: The framework according to any one of Clauses 131 to 140, wherein the first section, the second section, and the third section are symmetric with respect to the longitudinal axis to the fourth section, the fifth section, and the sixth section.

[0503] Clause 142: The framework according to any one of Clauses 131 to 141, wherein the longitudinal axis substantially bisects the seventh section.

[0504] Clause 143: The framework according to any one of Clauses 131 to 142, wherein the longitudinal axis is coaxial with the longitudinal center of the framework.

[0505] Clause 144: The framework according to any one of Clauses 131 to 143 includes a superelastic material.

[0506] Clause 145: A frame for an end effector of a medical device, the frame comprising: a base configured to be connected to an elongate shaft of the medical device, the base extending along a longitudinal axis; a first ridge circuit extending along the longitudinal axis from the base, the first ridge circuit comprising: a first section connected to the base and extending from the base in a distal direction along the longitudinal axis; a second section connected to the first section and extending inwardly from the first section towards the longitudinal axis; and a third section connected to the second section and extending from the second section in the distal direction along the longitudinal axis; a second ridge circuit extending along the longitudinal axis from the base, the second ridge circuit comprising: a first section connected to the base and extending from the base in the distal direction along the longitudinal axis; a second section connected to the first section and extending inwardly from the first section towards the longitudinal axis; and a third section connected to the second section and extending from the second section in the distal direction along the longitudinal axis; a third ridge circuit connecting the third section of the first ridge circuit and the third section of the second ridge circuit; and a finger opening defined by the base, the first ridge circuit, the second ridge circuit, and the third ridge circuit.

[0507] Clause 146: The frame according to Clause 145, wherein the third ridge circuit comprises a wave form.

[0508] Clause 147: The frame according to any one of Clauses 145 to 146, wherein the third section of the first ridge circuit and the third section of the second ridge circuit extend generally parallel to the longitudinal axis.

[0509] Clause 148: The frame according to any one of Clauses 145 to 147, wherein the longitudinal axis bisects the third section.

[0510] Clause 149: The frame according to any one of Clauses 145 to 148, wherein the longitudinal axis is coaxial with the longitudinal center of the frame.

[0511] Clause 150: The frame according to any one of Clauses 145 to 149, comprising a superelastic material.

[0512] Clause 151: An end effector for a medical device, the end effector comprising: a frame including a base configured to be coupled to an elongate shaft of the medical device, the base extending along a longitudinal axis; a first ridge circuit extending along the longitudinal axis from the base; a second ridge circuit extending along the longitudinal axis from the base; a third ridge circuit connecting the first ridge circuit and the second ridge circuit; and a finger opening defined by the base, the first ridge circuit, the second ridge circuit, and the third ridge circuit; an insulating material disposed on the frame; and a flexible circuit including a first section vertically spaced from the frame along a vertical axis through the insulating material, and a second section offset from the first section along the vertical axis and extending within the finger opening.

[0513] Clause 152: The end effector according to Clause 151, wherein the first section of the flexible circuit is disposed parallel to a frame plane of the frame.

[0514] 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 frame plane of the frame.

[0515] Clause 154: The end effector according to any one of Clauses 152 to 153, wherein the frame plane extends along a neutral plane of the end effector.

[0516] 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 ridge circuit, the second ridge circuit, and the third ridge circuit.

[0517] Clause 156: The end effector according to any one of Clauses 151 to 155, wherein the second section of the flexible circuit includes a peripheral section that extends along an inner surface of the first ridge circuit and an inner surface of the second ridge circuit.

[0518] Clause 157: The end effector according to any one of Clauses 151 to 156, further comprising a transition section connecting the first section and the second section, the transition section being disposed along the longitudinal axis proximal to a connection segment of the first ridge circuit and a connection segment of the second ridge circuit.

[0519] Clause 158: A frame for an end effector of a medical device, the frame extending along a longitudinal axis coaxial with the longitudinal center of the frame and including: a base configured to be connected to the elongate shaft of the medical device and extending along the longitudinal axis; a first ridge circuit extending from the base on a first side of the longitudinal axis, the first ridge circuit including: 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; and a second ridge circuit extending from the base on a second side of the longitudinal axis, the second ridge circuit including: 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, the first longitudinal position, the second longitudinal position, the third longitudinal position, and the fourth longitudinal position being disposed along the longitudinal axis such that the frame is asymmetric with respect to the longitudinal axis.

[0520] Clause 159: The frame according to Clause 158, wherein the first ridge circuit and the base define a first finger opening, and the second ridge circuit and the base define a second finger opening, the first finger opening having an area smaller than the area of the second finger opening.

[0521] Clause 160: The frame according to any one of Clauses 158 to 159, wherein the base is symmetric about the longitudinal axis.

[0522] Clause 161: The frame according to any one of Clauses 158 to 160, wherein the base includes: a first section configured to be connected to the elongate shaft, the first distal ends of the first ridge circuit and the second ridge circuit being connected to the first section; and a second section extending from the first section, the second distal ends of the first ridge circuit and the second ridge circuit being connected to the second section.

[0523] Clause 162: The frame according to Clause 161, wherein the second distal end of the first ridge circuit is connected to the proximal end of the second section, and the second distal end of the second ridge circuit is connected to the distal end of the second section.

[0524] Clause 163: The frame according to Clause 161, wherein the second distal end of the first ridge circuit is connected to the distal end of the second section, and the second distal end of the second ridge circuit is connected to the distal end of the second section.

[0525] Clause 164: In the frame according to any one of Clauses 158 to 162, the first longitudinal position and the third longitudinal position are the same.

[0526] Clause 165: In the frame according to any one of Clauses 158 to 162 and 164, the second longitudinal position and the fourth longitudinal position are spaced apart by a predetermined distance along the longitudinal axis.

[0527] Clause 166: In the frame according to any one of Clauses 158 to 161 and 163, the first longitudinal position and the third longitudinal position are spaced apart by a predetermined distance along the longitudinal axis.

[0528] Clause 167: In the frame according to any one of Clauses 158 to 161, 163 and 166, the second longitudinal position and the fourth longitudinal position are the same.

[0529] Clause 168: In the frame according to any one of Clauses 158 to 167, the base, the first ridge circuit and the second ridge circuit are integral components.

[0530] Clause 169: An end effector for a medical device, the end effector comprising: a frame that is substantially planar along a longitudinal axis; a flexible circuit that is vertically spaced apart from the frame along a vertical axis; and an insulating material, the frame and the flexible circuit being disposed within the insulating material, the insulating material defining a first outer edge of the end effector, the first outer edge including a treatment portion configured to facilitate the end effector being retracted into a sheath, the treatment 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 cut-in cutouts defined along at least a portion of the first outer edge; or a lubricating coating extending along at least a portion of the first outer edge.

[0531] Clause 170: The end effector according to Clause 169, the treatment portion includes the rounded cutout, and the insulating material further includes a second outer edge, the second outer edge including a second outer edge treatment portion configured to facilitate the end effector being retracted into a sheath, the second outer edge treatment portion including at least one of: a rounded cutout extending along at least a portion of the second outer edge; a tapered cutout extending along at least a portion of the second outer edge; a plurality of cut-in cutouts defined along at least a portion of the second outer edge; or a lubricating coating extending along at least a portion of the second outer edge.

[0532] Clause 171: The end effector according to Clause 169, the processing portion includes the tapered cutout, and the insulating material further includes a second outer edge, the second outer edge including a second outer edge processing portion configured to facilitate the shrinkage of the end effector into the sheath, the second outer edge processing portion including at least one of the following: a rounded cutout extending along at least a portion of the second outer edge; a tapered cutout extending along at least a portion of the second outer edge; a plurality of cut-in cutouts defined along at least a portion of the second outer edge; or a lubricating coating extending along at least a portion of the second outer edge.

[0533] Clause 172: The end effector according to any one of Clauses 169 to 171, the processing portion includes the plurality of cut-in cutouts.

[0534] Clause 173: The end effector according to any one of Clauses 169 to 172, the processing portion includes a lubricating coating.

[0535] Clause 174: A method of using a medical device, the method includes: retracting an end effector from a deployed configuration to a sheath along a longitudinal axis, the end effector including a substantially planar shape in the deployed configuration; and contracting the end effector into a retracted configuration such that outer edges of the end effector slide past each other, and the end effector includes one of a substantially cylindrical shape or a helical shape in the retracted configuration, wherein a first outer edge of the outer edges includes a processing portion, the processing portion including at least one of the following: 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 cut-in cutouts defined along at least a portion of the first outer edge; or a lubricating coating extending along at least a portion of the first outer edge.

[0536] Clause 175: A method of manufacturing an end effector for a medical device, the method includes: forming a frame that is substantially planar along a longitudinal axis; disposing a flexible circuit on the frame; heating an insulating material; reflowing the insulating material such that the insulating material encapsulates the frame and the flexible circuit; and processing an outer edge of the insulating material such that the outer edge includes at least one of a reduced hardness or a reduced coefficient of friction relative to the hardness or the coefficient of friction of the outer edge before processing.

[0537] Clause 176: An end effector includes a plurality of planar frames extending along a plane, each of the frames having a first planar surface and an opposing second planar surface, each of the first planar surface and the second planar surface including at least one pair of electrodes configured to contact cardiovascular tissue, each pair of electrodes including a first electrode and a second electrode spaced apart from each other along a longitudinal axis by a gap region located between the electrodes, the gap region having a gap distance relative to the longitudinal axis such that: (i) the length of one of the electrodes along the longitudinal axis is equal to or greater than the gap distance; and (ii) the ratio of the area defined by the gap region to the area of one electrode is equal to or less than 1, the gap distance being determined by the product of the area of the one electrode reaching 1 square millimeter and a conversion factor of about 1.25 mm -1 or less.

[0538] Clause 177. An end effector includes: a frame defining a neutral plane; a first insulating material disposed on at least one side of the frame; and a first flexible circuit disposed in the first insulating material and spaced apart from the frame along a vertical axis orthogonal to the neutral plane, the first flexible circuit including a planar transition region positioned proximate a proximal end of the first flexible circuit, the first flexible circuit transitioning in the planar transition region from a first plane closer to the neutral plane to a second plane farther from the neutral plane.

[0539] Clause 178: The end effector according to Clause 177, wherein the first flexible circuit further includes a plurality of first electrodes positioned on a portion of the first flexible circuit adjacent to the second plane and distal to the planar transition region.

[0540] Clause 179: The end effector according to Clause 177 or 178, wherein the proximal end of the first flexible circuit includes a tail extending proximally from the planar transition region, the tail transitioning in the planar transition region from the first plane to a proximal plane farther from the neutral plane.

[0541] Clause 180: The end effector according to Clause 179, wherein the proximal plane and the second plane are coplanar.

[0542] Clause 181: The end effector according to any one of Clauses 178 to 180, wherein at least a portion of the plurality of first electrodes extends from a surface defined by the first insulating material.

[0543] Clause 182: The end effector according to any one of Clauses 177 to 181 further comprises: a second insulating material disposed on at least one side of the frame; and a second flexible circuit disposed in the second insulating material, the second flexible circuit being spaced from the frame along a vertical axis and transitioning in the plane transition region from a third plane closer to the neutral plane to a fourth plane further away from the neutral plane.

[0544] Clause 183: The end effector according to Clause 182, wherein the second flexible circuit comprises a plurality of second electrodes.

[0545] Clause 184: The end effector according to Clause 183, wherein at least a portion of the plurality of second electrodes extends from a surface defined by the second insulating material.

[0546] Clause 185: The end effector according to Clause 183 or 184, wherein the plurality of second electrodes are positioned on a portion of the second flexible circuit that is within the fourth plane and distal to the plane transition region.

[0547] Clause 186: The end effector according to Clause 182, wherein the second flexible circuit further comprises an electromagnetic planar coil.

[0548] Clause 187: The end effector according to Clause 182, wherein the second insulating material is disposed on a side of the frame opposite to the first insulating material.

[0549] Clause 188: The end effector according to Clause 187, wherein the electromagnetic coil of the second flexible circuit comprises a distal loop and two side loops positioned adjacent to a surface defined by the second insulating material.

[0550] Clause 189: The end effector according to Clause 187, wherein the proximal end of the second flexible circuit comprises a tail extending proximally from the plane transition region and away from the electromagnetic coil, the tail transitioning in the plane transition region from the third plane to a proximal plane further away from the neutral plane.

[0551] Clause 190: The end effector according to Clause 189, wherein the proximal plane and the fourth plane are coplanar.

[0552] Clause 191: The end effector according to any one of the preceding clauses subordinate to Clause 178, wherein two adjacent electrodes among the plurality of first electrodes are connected by a serpentine connection.

[0553] Clause 192: The end effector according to Clause 191, wherein the serpentine connection extends entirely within the second plane.

[0554] Clause 193: For the end effector according to Clause 178, the first insulating material includes: a distal insulating material sheet positioned between the frame and the plurality of first electrodes; and an intermediate insulating material sheet positioned within the planar transition region such that at least a portion of the first flexible circuit is positioned between the intermediate insulating material sheet and the frame.

[0555] Clause 194: For the end effector according to Clause 193, the proximal end of the first flexible circuit includes a tail extending proximally from the planar transition region, and the first insulating material includes a proximal insulating material sheet positioned between the frame and the tail.

[0556] 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 frame; and a second flexible circuit including a plurality of second electrodes and disposed within the second insulating material, the second flexible circuit transitioning from a third plane closer to the neutral plane to a fourth plane farther from the neutral plane within the planar transition region.

[0557] Clause 196: For the end effector according to Clause 195, the second insulating material includes: a second distal insulating material sheet positioned between the frame and the plurality of second electrodes; and a second intermediate insulating material sheet positioned within the planar transition region such that at least a portion of the first flexible circuit is positioned between the second intermediate insulating material sheet and the frame.

[0558] Clause 197: For the end effector according to Clause 196, the proximal end of the second flexible circuit includes a second tail extending proximally and away from the plurality of second electrodes from the planar transition region, and the second insulating material includes a second proximal insulating material sheet positioned between the frame and the second tail.

[0559] Clause 198: For the end effector according to Clause 195, the second insulating material is disposed on a side of the frame opposite the first insulating material.

[0560] Clause 199: For the end effector according to any one of Clauses 177 to 198, wherein the first insulating material and the second insulating material comprise a single insulating material.

[0561] Clause 200: For the end effector according to any one of Clauses 178 to 180, at least a portion of the plurality of first electrodes is recessed into a surface defined by the first insulating material.

[0562] Clause 201: An end effector comprising: a frame including a first strut extending along a longitudinal axis; and a flexible circuit aligned with the first strut and including a substrate supporting electrical traces, the flexible circuit including a plurality of bends such that the flexible circuit includes a serpentine shape when extending along the longitudinal axis of the strut, the first strut of the frame including alternating wide and narrow sections extending along the longitudinal axis of the strut, the narrow sections being positioned adjacent corresponding vertices of the plurality of bends.

[0563] Clause 202: The end effector according to Clause 201, the narrow sections defining cutouts, and the vertices of the plurality of bends extending into the cutouts such that the plurality of bends overhang at least a portion of the first strut.

[0564] Clause 203: The end effector according to Clause 201 or 202, the first strut including a plurality of first electrodes positioned between separate sections of the plurality of bends.

[0565] Clause 204: The end effector according to any one of the preceding clauses, the electrical traces including rolled annealed metal.

[0566] Clause 205: The end effector according to Clause 205, the rolled annealed metal being rolled annealed copper.

[0567] Clause 206: The end effector according to Clause 204 or 205, the serpentine shape being formed by the rolled annealed metal along the direction of a single grain of the rolled annealed metal such that the single grains extend parallel to the longitudinal axis of the strut.

[0568] Clause 207: The end effector according to any one of Clauses 204 to 206, the electrical traces having alternating longer grain sections and shorter grain sections.

[0569] Clause 208: The end effector according to Clause 207, the longer grain sections being positioned at the locations of the plurality of bends.

[0570] Clause 209: The end effector according to Clause 208, the electrical traces transitioning to shorter grain sections between the plurality of bends.

[0571] Clause 210: The end effector according to any one of Clauses 201 to 209, the first strut being one of a plurality of struts on the frame, the flexible circuit including electrical traces extending along each of the plurality of struts, and each of the electrical traces including the plurality of bends in the flexible circuit.

[0572] Clause 211: The end effector according to Clause 210, wherein each of the plurality of struts includes alternating wide sections and narrow sections extending along its respective longitudinal axis.

[0573] Clause 212: The end effector according to any one of Clauses 201 to 211, wherein the frame and the flexible circuit are spaced apart along a vertical axis in different planes.

[0574] Clause 213: An end effector, the end effector including: a frame including a first strut extending along a longitudinal axis; and a flexible circuit aligned with the first strut and including a substrate supporting electrical traces, the flexible circuit including a plurality of bends such that the flexible circuit has a serpentine shape when extending along the longitudinal axis of the strut, the electrical traces including rolled annealed metal, the serpentine shape being formed by the rolled annealed metal along the direction of a single grain of the rolled annealed metal such that the single grains extend parallel to the longitudinal axis of the strut.

[0575] Clause 214: The end effector according to Clause 213, wherein the rolled annealed metal is rolled annealed copper.

[0576] Clause 215: The end effector according to Clause 213, wherein the electrical traces include longer grain sections and shorter grain sections.

[0577] Clause 216: The end effector according to Clause 215, wherein the longer grain sections are located at positions of the plurality of bends.

[0578] Clause 217: The end effector according to Clause 214, wherein the electrical traces transition to shorter grain sections between the plurality of bends...

Claims

1. An end effector for a catheter, the end effector comprising: Insulation materials; a frame disposed in the insulating material, the frame being substantially planar along a longitudinal axis and having a first planar surface and a second planar surface opposite the first planar surface; a plurality of substantially planar electrodes aligned along each of the first planar surface and the second planar surface such that each electrode is spaced apart from the first planar surface or the second planar surface; and a positioning sensing loop, the positioning sensing loop being spaced apart from the frame and coupled to the insulating material, the positioning sensing loop comprising: a central loop disposed on the longitudinal axis at an area proximate a distal portion of the insulating material; and A pair of side loops are generally symmetrically disposed about the longitudinal axis, each side loop extending from a proximal portion to a distal portion of the insulating material along the longitudinal axis.

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

3. The end effector according to claim 2, wherein the first side circuit comprises: a sixth segment defining a distal end of the first side loop; a seventh segment extending from the sixth segment in a proximal direction of the end effector; an eighth segment extending from the seventh segment in the proximal direction of the end effector; and A ninth segment, the ninth segment extending from the eighth segment in the distal direction of the end effector and connected to the sixth segment.

4. The end effector of claim 2, the first side loop comprising a plurality of first side loop engagement sections.

5. The end effector according to claim 2, wherein the second side circuit comprises: a tenth segment, the tenth segment defining a distal end of the second side loop; an eleventh segment, the eleventh segment extending from the tenth segment in a proximal direction of the end effector; a twelfth segment extending from the eleventh segment in the proximal direction of the end effector; and A thirteenth segment extends from the twelfth segment in a distal direction of the end effector and is connected to the tenth segment.

6. The end effector of claim 2, the second side loop comprising a plurality of second side loop engagement sections.

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

8. The end effector of claim 2, the second side loop being a mirror image of the first side loop relative to the longitudinal axis.

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

10. The end effector of claim 2, wherein the insulating material comprises: a first non-conductive flexible layer, The center loop, the first side loop, and the second side loop are separated from the frame by the first non-conductive flexible layer.

11. The end effector of claim 2, wherein the insulating material comprises: a first non-conductive flexible layer; and a second non-conductive flexible layer, The center loop is separated from the frame by the first non-conductive flexible layer, and the first and second side loops are separated from the frame by the second non-conductive flexible layer.

12. The end effector of claim 2, said frame extending in a first plane, said intermediate loop extending in a second plane, said first side loop extending in a third plane, and said second side loop extending in a fourth plane.

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

14. The end effector of claim 12, the second plane being located on a first side of the first plane along a vertical axis, and the second plane and the third plane being located on opposite second sides of the first plane along the vertical axis.

15. The end effector of claim 1, wherein said central loop is symmetrical relative to said longitudinal axis.

16. The end effector of claim 1, wherein the central loop comprises: a first segment defining a distal end of the central loop; a second segment extending from the first segment in a proximal direction of the end effector; a third segment extending from the second segment in a distal direction of the end effector; a fourth segment extending from the third segment in the proximal direction of the end effector; and A fifth segment extends from the fourth segment in the distal direction of the end effector and is connected to the first segment.

17. The end actuator according to claim 1, wherein the insulating material defines a first outer edge of the end actuator, the first outer edge includes a processing portion configured to facilitate retraction of the end actuator into the sheath, the processing portion including at least one of the following: a rounded cut extending along at least a portion of the first outer edge; a tapered cut extending along at least a portion of the first outer edge; a plurality of incision cuts defined along at least a portion of the first outer edge; or a lubricating coating extending along at least a portion of the first outer edge.

18. The end effector according to claim 1 further includes at least one flexible circuit, which is arranged substantially parallel to the frame and separated from the frame by the insulating material, and the flexible circuit includes a plurality of electrodes arranged on the flexible circuit.

19. An end effector for a catheter, the end effector comprising: Insulation materials; a frame disposed in the insulating material, the frame being substantially planar along a longitudinal axis; and A positioning sensing circuit, the positioning sensing circuit is arranged substantially parallel to the frame and is separated from the frame by the insulating material, the positioning sensing circuit comprising: a central loop extending along the longitudinal axis and comprising a cumulative central loop surface area; a first side loop extending along the longitudinal axis and comprising a cumulative first side loop surface area; and a second side loop extending along the longitudinal axis and comprising a cumulative second side loop surface area, The cumulative center loop surface area, the cumulative first side loop surface area, and the cumulative second side loop surface area are each in a range from about one hundred square millimeters to about three hundred square millimeters.

20. The end effector of claim 19, wherein the center loop comprises one or more center loop coils, each center loop coil defining a center 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, and the second side loop comprises one or more second side loop coils, each second side loop coil defining a second side loop surface area, wherein The accumulated center loop surface area comprises a sum of the center loop surface areas of the one or more center loop coils, The accumulated first side loop surface area comprises a sum of the first side loop surface areas of the one or more first side loop coils, and The accumulated second side loop surface area includes a sum of the second side loop surface areas of the one or more second side loop coils.

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