Catheter end effector with non-planar substrate

Abstract

An end effector for a catheter. The end effector may include a base extending along a longitudinal axis from a proximal portion of the end effector to a distal portion of the end effector. The substrate may include: a longitudinal plane through which the longitudinal axis passes; a first face disposed on the first side of the substrate and inclined to the longitudinal plane; a second face opposite the first face, the second face disposed on a second side of the substrate; the first group of electrodes are arranged on the first surface; and a second set of electrodes disposed on the second face.

Description

Technical Field

[0001] The present invention relates generally to minimally invasive medical devices, and particularly to sensing catheters, and further, but not exclusively, to cardiac mapping catheters. Background Art

[0002] Arrhythmias such as atrial fibrillation occur when an area of ​​cardiac tissue abnormally conducts electrical signals to adjacent tissue, 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 are conducted through cardiac tissue to other locations where they can initiate or perpetuate the arrhythmia.

[0003] Procedures used to treat cardiac arrhythmias involve surgically disrupting the source of the signals that cause the arrhythmia, as well as disrupting the conduction pathways used for such signals. Recently, it has been discovered that by mapping the electrical properties of the endocardium and cardiac volumes, and selectively ablating cardiac tissue by applying energy, it is possible to stop or alter the propagation of unwanted electrical signals from one part of the heart to another. Ablation methods destroy unwanted electrical pathways by creating non-conductive lesions.

[0004] In this two-step procedure (which includes 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 area to be ablated.

[0005] In order to obtain higher mapping resolution, it is expected that the end effector of the mapping catheter can fit closely with the target anatomical structure. For mapping within the atria or ventricles (e.g., the apex of the ventricle), it is expected that the catheter collects a larger amount of data signals in a shorter time span. It is also expected that such catheters can allow electrodes to fully contact different tissue surfaces, for example, flat, curved, irregular or non-planar surface tissues, and can be retracted to be non-invasively advanced and withdrawn through the patient's vascular system. Existing catheters generally require hard internal structural components to ensure that a predetermined configuration is maintained. If the internal components are too hard, it may be difficult to manipulate the catheter in the body's organs and may prevent the electrodes from contacting the tissue. Summary of the invention

[0006] According to one example of the present invention, an end effector for a catheter is provided. The end effector may include a substrate extending from a proximal portion of the end effector to a distal portion of the end effector along a longitudinal axis. The substrate may include a longitudinal plane, wherein the longitudinal axis passes through the longitudinal plane. A first face may be disposed on a first side of the substrate and inclined to the longitudinal plane, and a second face opposite to the first face may be disposed on a second side of the substrate. A first set of electrodes may be disposed on the first face, and a second set of electrodes may be disposed on the second face.

[0007] The disclosed technology includes a non-planar end effector for a mapping catheter. The end effector may include an inclined base extending along a longitudinal plane, the longitudinal plane extending along a longitudinal axis from a proximal end of the end effector to a distal end of the end effector. The base may taper in a direction orthogonal to the longitudinal plane. The non-planar end effector may include a first plurality of electrodes disposed on a first face of the inclined base and a second plurality of electrodes disposed on a second face of the inclined base.

[0008] The disclosed technology includes a system for performing a medical procedure. The system may include an elongated shaft extending from a proximal end to a distal end along a longitudinal axis, an end effector disposed on the distal end of the elongated shaft. The end effector may include a substrate extending from a proximal portion of the end effector to a distal portion of the end effector along the longitudinal axis. The substrate may include a first face disposed on a first side of a longitudinal plane and inclined to the longitudinal plane, a second face disposed on a second side of the longitudinal plane and inclined to the longitudinal plane, a first set of electrodes disposed on the first face, and a second set of electrodes disposed on the second face.

[0009] The disclosed technology includes a method of providing a reinforced flexible end effector. The method may include: forming a substrate along a longitudinal plane extending from a proximal end to a distal end along a longitudinal axis; forming a first face on a first side of the substrate; forming a second face on a second side of the substrate opposite the first side; and tilting the first face toward the longitudinal plane as the first face extends from the proximal end of the substrate to the distal end of the substrate. The method may include forming a first set of electrodes along the first face and forming a second set of electrodes along the second face. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] Figure 1 is a schematic illustration of a medical system including a catheter having an end effector having a non-planar base according to an example of the present invention;

[0011] Figure 2 is an illustration of a top view of a system for a medical procedure according to an example of the present invention;

[0012] Figure 3A is an illustration of a cross-section of an end effector according to an example of the present invention;

[0013] Figure 3B Illustrated Figure 3A Detailed view of the end effector;

[0014] Figure 4A is an illustration of a cross-section of an end effector according to an example of the present invention;

[0015] Figure 4B Illustrated Figure 4A A detailed view of a distal portion of an end effector;

[0016] Figure 4C Illustrated Figure 4A A detailed view of a proximal portion of an end effector of;

[0017] Figure 5A is an illustration of a top view of an end effector according to an example of the present invention;

[0018] Figure 5B is an illustration of a bottom view of an end effector according to an example of the present invention;

[0019] Figure 6 is an illustration of an end effector encapsulated in a flexible material according to an example of the present invention;

[0020] Fig. 7A is a flow chart of a method of providing a reinforced flexible end effector according to an example of the present invention;

[0021] Figure 7B is a flow chart of a method of providing a reinforced flexible end effector according to an example of the present invention; and

[0022] Figure 7C is a flow chart of a method of providing a reinforced flexible end effector according to an example of the present invention. DETAILED DESCRIPTION

[0023] The disclosed technology relates to improving the performance of end effectors, such as those used with cardiac mapping catheters. The systems, devices, and methods of the disclosed technology enhance various aspects of mapping and ablation catheter performance, including but not limited to mapping resolution, contact of electrodes with target anatomical structures, delivery of end effectors to target anatomical structures, biocompatibility, end effector stiffness, and non-traumatic properties. Various aspects of the present disclosure enhance the ability of an end effector to conform to target tissue by adjusting the stiffness along the length of the end effector and the torsional stiffness (rotation about the longitudinal axis) of the end effector. The tilted nature of the base of the end effector generally helps to reduce the stiffness and torsional stiffness along the length of the end effector. Other aspects and / or components of the end effector, such as electrode height and angle, angle of end effector tilt, and the addition of slots, frames, and flexible packaging materials, can be used to adjust the ability of the end effector to conform to the tissue surface.

[0024] The following detailed description should be read in conjunction with the accompanying drawings, in which the same elements are labeled the same in different drawings. The accompanying drawings (not necessarily drawn to scale) depict selected examples and are not intended to limit the scope of the invention. The detailed description illustrates the principles of the invention by way of example and not by way of limitation. This specification will clearly enable those skilled in the art to prepare and use the invention, and describes several examples, adaptations, variations, alternatives, and uses of the invention, including the best modes currently believed to be implemented in the invention.

[0025] As used herein, the term "about" or "approximately" for 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" may refer to a range of ±20% of the value of the recited value, for example, "about 90%" may refer to a range of values ​​from 71% to 110%. In addition, as used herein, the terms "patient", "receptor", "user" and "subject" refer to any human or animal subject, and are not intended to limit the system or method to human use, but the use of the subject invention in human patients represents a preferred example. Similarly, the term "proximal" refers to a position closer to an operator or physician, while "distal" refers to a position farther away from an operator or physician.

[0026] As discussed herein, references to a "patient," "recipient," "user," and "subject" tissue, vasculature, or organ may be references to a human or any animal tissue, vasculature, or organ. It should be understood that the animal may be of any suitable type, including, but not limited to, a mammal, a veterinary animal, a livestock animal, or a pet animal, etc. For example, the animal may be a laboratory animal (e.g., a rat, dog, pig, monkey, etc.) that is specifically selected to have certain characteristics similar to those of a human. It should be understood that the subject may be, for example, any suitable human patient.

[0027] As discussed herein, a "physician" may include a doctor, surgeon, technician, scientist, operator, or any other individual or delivery instrumentation associated with delivering a multi-electrode catheter for treating drug-refractory atrial fibrillation to a subject.

[0028] As discussed herein, the term "ablation" when referring to the devices and corresponding systems of the present disclosure refers to components and structural features configured to reduce or prevent the generation of unstable cardiac signals in cells. For example, by utilizing thermal energy such as radiofrequency (RF) ablation, or non-thermal energy such as irreversible electroporation (IRE), IRE may sometimes be referred to as pulsed electric field (PEF) and pulsed field ablation (PFA). "Ablation" as used throughout this disclosure, when referring to the devices and corresponding systems of the present disclosure, refers to thermal ablation or non-thermal ablation of cardiac tissue for certain conditions, including but not limited to arrhythmias, 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 body tissue ablation as understood by those skilled in the relevant art.

[0029] As discussed herein, the terms "tubular" and "tube" should be interpreted broadly and are not limited to structures that are perfect cylinders or have a completely circular cross-section or a uniform cross-section throughout their length. For example, tubular structures are often illustrated as structures that are substantially perfect cylinders. However, tubular structures may have tapered or curved outer surfaces without departing from the scope of the present disclosure.

[0030] The present disclosure relates to systems, methods or uses and devices for mapping and ablating cardiac tissue to treat arrhythmias. Ablation energy is typically provided to cardiac tissue by a distal portion of a catheter that can deliver ablation energy along the tissue to be ablated. Some exemplary catheters include a three-dimensional structure at the distal portion and are configured to apply ablation energy from various electrodes positioned on the three-dimensional structure. Fluoroscopy can be used to visualize ablation procedures incorporating such exemplary catheters.

[0031] Ablation of cardiac tissue to correct a malfunctioning heart using the application of thermal techniques such as radiofrequency (RF) energy and cryoablation is a well-known procedure. Typically, in order to successfully ablate using thermal techniques, it is necessary to measure cardiac electrode potentials at various locations of the myocardium. In addition, temperature measurements during ablation provide data that can achieve ablation efficacy. Typically, for ablation procedures using thermal ablation, electrode potentials and temperatures are measured before, during, and after the actual ablation. RF methods may have the risk of causing tissue charring, burns, steam bursts, 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, manipulating a cryoablation device and selectively applying cryoablation is generally more challenging than RF ablation; therefore, cryoablation is not feasible in certain anatomical geometries that can be reached by electrical ablation devices.

[0032] The present disclosure may include electrodes configured for RF ablation, cryoablation, and / or irreversible electroporation (IRE). IRE is sometimes interchangeably referred to as pulsed electric field (PEF) ablation and pulsed field ablation (PFA). IRE as discussed in the present disclosure is a non-thermal cell death technique that can be used for ablation of atrial arrhythmias. In order to ablate using IRE / PEF, biphasic voltage pulses are applied to destroy the cellular structure of the myocardium. Biphasic pulses are non-sinusoidal and can be tuned to target cells based on the electrophysiology of the cells. In contrast, in order to ablate using RF, a sinusoidal voltage waveform is applied to generate heat at the treatment area, heating all cells in the treatment area indiscriminately. Therefore, IRE has the ability to avoid adjacent heat-sensitive structures or tissues, which will have benefits in reducing possible complications known to be affected by ablation or separation modalities. In addition or alternatively, monophasic pulses can be used.

[0033] refer to Figure 1 , which shows an exemplary catheter-based electrophysiological mapping and ablation system 10. The system 10 includes multiple catheters that are inserted into the chambers or vascular structures of the heart 12 by a physician 24 through the vascular system of a patient 23 through the skin. Typically, a delivery sheath catheter is inserted into the left atrium or right atrium near a desired location in the heart 12. Then, multiple catheters can be inserted into the delivery sheath catheter to reach the desired location. The multiple catheters may include catheters dedicated to sensing intracardiac electrogram (IEGM) signals, catheters dedicated to ablation, and / or catheters dedicated to both sensing and ablation. An exemplary catheter 14 constructed for sensing IEGM is shown herein. The physician 24 brings the distal end of the catheter 14 (i.e., the end effector 100) into contact with the heart wall for sensing a target site in the heart 12. For ablation, the physician 24 would similarly bring the distal end of the ablation catheter to the target site for ablation.

[0034] The catheter 14 is an exemplary catheter including one and preferably a plurality of electrodes, optionally distributed over the end effector 100, configured to sense IEGM signals, as described herein. The catheter 14 may additionally include a position sensor embedded in or near the end effector 100 for tracking the position and orientation of the end effector 100. Optionally and preferably, the position sensor is a magnetically based position sensor including a plurality of magnetic coils for sensing three-dimensional (3D) position and orientation.

[0035] The magnetic-based position sensor can operate with a positioning pad 25 that includes a plurality of magnetic coils 32 configured to generate a magnetic field in a predetermined workspace. The real-time position of the end effector 100 of the catheter 14 can be tracked based on the magnetic field generated by the positioning pad 25 and sensed by the magnetic-based position sensor. The details of the 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 and attached to the appendix of this document.

[0036] The system 10 includes one or more electrode patches 38 positioned in contact with the skin of the patient 23 to establish a position reference for impedance-based tracking of the positioning pad 25 and the electrodes 26. For impedance-based tracking, current is directed toward the electrodes and sensed at the electrode skin patches 38 so that the position of each electrode can be triangulated via the electrode patches 38. 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 and is attached as an appendix to this document.

[0037] Recorder 11 displays electrograms 21 captured using body surface ECG electrodes 18 and intracardiac electrograms (IEGMs) captured using electrodes of catheter 14. Recorder 11 may include pacing capabilities for pacing the cardiac rhythm and / or may be electrically connected to a separate pacemaker.

[0038] The system 10 may include an ablation energy generator 50 adapted to conduct ablation energy to one or more electrodes at the distal end of a catheter configured for ablation. The energy generated by the ablation energy generator 50 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.

[0039] The patient interface unit (PIU) 30 is an interface configured to establish electrical communication between catheters, electrophysiology equipment, a power source, and a workstation 55 for controlling the operation of the system 10. The electrophysiology equipment of the system 10 may include, for example, multiple catheters, a positioning pad 25, surface ECG electrodes 18, electrode patches 38, an ablation energy generator 50, and a recorder 11. Optionally and preferably, the PIU 30 additionally includes processing capabilities for enabling real-time calculation of the position of the catheter and for performing ECG calculations.

[0040] Workstation 55 includes memory, a processor unit with memory or storage loaded with appropriate operating software, and user interface capabilities. Workstation 55 can provide multiple functions, optionally including: (1) three-dimensional (3D) modeling of endocardial anatomy and rendering of the model or anatomical map 20 for display on display device 27; (2) displaying on display device 27 an activation sequence (or other data) compiled from recorded electrograms 21 as representative visual markers or images superimposed on the rendered anatomical map 20; (3) displaying the real-time position and orientation of multiple catheters within the heart chamber; and (5) displaying on display device 27 sites of interest, such as where ablation energy has been applied. A commercial product embodying elements of system 10 may be CARTO TM 3System was purchased from Biosense Webster, Inc., 31 Technology Drive, Suite 200, Irvine, CA 92618.

[0041] To achieve desired stiffness, mapping resolution, electrode contact with the target anatomy, and conformity of the end effector disclosed herein to flat, curved, irregular, and / or non-planar tissue surfaces found in the target anatomy, the end effector has an angled base as well as other features.

[0042] The disclosed technology includes a system 200 for performing a medical procedure, such as Figure 2As shown. The system 200 may include an elongated shaft 230 extending from a proximal end 234 to a distal end 232 along a longitudinal axis LL, and an end effector 100 disposed on the distal end 232 of the elongated shaft 230. The elongated shaft 230 may be configured to deliver the end effector 100' out of the sheath 210. For simplicity, Figure 2 Only a portion of sheath 210 is shown in FIG. Note that end effector 100 ′ has alternative configurations of end effector 100 depending on the application, but the disclosure provided herein is applicable to both embodiments.

[0043] The physician can manipulate the elongated shaft 230 and the end effector 100' using the handle 220. Suitable examples of the system 200 and its subcomponents (such as the handle 220, the sheath 210, the elongated shaft 230, and other components not mentioned herein) are described in U.S. Patent Publication No. 2021 / 0369339, which is incorporated herein by reference and included in the appendix attached hereto. The system 200 may also include a traction wire (not shown) extending through the elongated shaft 230 and including a proximal portion 102 ( Figure 3A The distal end (not shown) of the end actuator is shown in FIG. 1 . Details of manipulating the end actuator via a traction wire are described in U.S. Patent Publication No. 2021 / 0369339, which is incorporated herein by reference and included in the appendix attached hereto.

[0044] Figure 3A The end effector 100 or 100' is shown in more detail in a side cross-sectional view. The end effector 100 may include a base 110 extending from a proximal portion 102 of the end effector 100 or 100' to a distal portion 104 of the end effector 100 along a longitudinal axis LL. The base 110 may include a longitudinal plane L p , wherein the longitudinal axis LL passes through the longitudinal plane L p In other words, when observing Figure 3A When the longitudinal plane L p The end effector 100 may extend along the longitudinal axis and in a direction into and out of the page, thereby effectively bisecting the end effector 100, wherein approximately half of the end effector 100 lies in the longitudinal plane L p on one side and the other half is located on the longitudinal plane L p The first surface 112 may be disposed on the first side S1 of the substrate 110. The first surface 112 may be disposed on the first side S1 of the substrate 110. p The first surface 112 may extend in a direction that is neither parallel to the longitudinal plane L p Nor with the longitudinal plane L pIn other words, the end effector 100 (i.e., the base 110) may be thicker at the proximal portion 102 and narrower toward the distal end 104, such that the stiffness of the end effector gradually decreases from the proximal portion 102 to the distal portion 104. Figure 3B As discussed in more detail, the thickness of the electrodes 120, 130 may also vary.

[0045] In other words, the first surface 112 is aligned with the longitudinal plane L at the proximal end. p The distance between the first surface 112 and the longitudinal plane L at the distal end may be greater than p The second surface 114 opposite to the first surface 112 may be disposed on the second side S2 of the substrate 110. The end effector may further include a first set of electrodes 120 disposed on the first surface 112 and a second set of electrodes 130 disposed on the second surface 114.

[0046] Although the term "face" is used for both the first face 112 and the second face 114 and how they are related to the longitudinal plane L p The first face 112 and the second face 114 are related, but it should be understood that the first face 112 and the second face 114 are not necessarily completely planar. The first face 112 and the second face 114 may have a wavy profile, through holes, a fan shape, etc., all of which may be included to adjust the stiffness of the end effector 100 and / or the conformability of the end effector to the tissue. Typically, the end effector 100 is roughly spatula-shaped. The end effector 100 may also include a substrate having a hollow profile. In addition, the end effector 100 may include an insert or frame member made of a composite matrix of materials (metals, polymers, ceramics, etc.) stacked in various orientations (longitudinal, vertical, axial, etc.), which may form an array. Such inserts or frame members may be woven, spun, braided, molded, cast, printed (including three-dimensional printing) or manufactured using any other suitable manufacturing process.

[0047] In some examples, the second surface 114 may be inclined relative to the longitudinal plane L p That is, the second surface 114 may not be parallel to the longitudinal plane L p and the first surface 112. The second surface 114 is relative to the longitudinal plane L p The angle of the first surface 112 relative to the longitudinal plane L p The angles of the second surface 114 are substantially equal and opposite, so that the second surface 114 is across the longitudinal plane L p In other words, the second surface 114 is aligned with the longitudinal plane L at the proximal end. p The distance between the second surface 114 and the longitudinal plane L at the distal end may be greater than p The distance between.

[0048] Alternatively, the first surface 112 is relative to the longitudinal plane L p The angle at which the first surface 112 is located may be different from the angle at which the first surface 112 is located relative to the longitudinal plane L p In other examples, only the first surface 112 or the second surface 114 may be inclined relative to the longitudinal plane L. p The other of the first surface 112 and the second surface 114 is substantially parallel to the longitudinal plane L. p extends in the direction of .

[0049] The end effector 100 can further define a first surface 112 offset from the first surface 112 and parallel to the longitudinal plane L. p The first offset plane P1 is offset from the second surface 114 and parallel to the longitudinal plane L p In some examples, the first set of electrodes 120 can extend outwardly from the first face 112 to the first offset plane P1, and the second set of electrodes 130 can extend outwardly from the second face 114 to the second offset plane P2. In other words, the first set of electrodes 120 can protrude from the first face 112 so that if the end effector 100 is resting on a flat surface, the longitudinal plane L p Alternatively, the plane P1 may be offset from the first face 112 and inclined to the longitudinal plane L p , so that some or all of the electrodes in the first set of electrodes 120 may protrude from the first face 112, and if the end effector 100 rests on a flat surface, the first face 112 is substantially parallel to the flat surface. Any of these configurations of the first set of electrodes 120 may be combined with a similar configuration of the second set of electrodes 130.

[0050] In other words, the disclosed technology includes a non-planar end effector 100 for use in mapping or ablation catheters. Although the end effector 100 and the substrate 110 may be described as non-planar, some subcomponents may be located in a flat plane. For example, as discussed in more detail below, the contact surface 122 of the first set of electrodes 120 may be located in a flat plane, and the non-conductive flexible material 150 may produce an end effector 100 with an overall flat outer contour. The term "non-planar" used in connection with the end effector 100 is not meant to exclude these examples. The end effector 100 may include a non-planar surface along the longitudinal plane L p The base 110 may be provided with an inclined base 110 extending along the longitudinal plane LL from the proximal end 102 of the end effector 100 to the distal end 104 of the end effector 100. The base 110 may be provided with an inclined base 110 extending along the longitudinal plane LL. pThe non-planar end effector 100 may include a first plurality of electrodes 120 disposed on a first surface 112 of the inclined substrate 110 and a second plurality of electrodes 130 disposed on a second surface 114 of the inclined substrate 110. In some examples, the inclined substrate 110 may be a flexible circuit. In some examples, the flexible circuit may be primarily made of polyimide. In other examples, it may be made of any one of biocompatible polyimide, glass-reinforced epoxy laminate, copper or graphene alone, in combination with other biocompatible materials, or in combination with each other. The flexible circuit may include conductive traces that connect the first set of electrodes 120 and the second set of electrodes 130 to components of the system 10, at least for collecting signals and delivering energy.

[0051] like Figure 3B As shown, the first set of electrodes 120 may each include a separate height H from the first face 112 to the first offset plane P1. I1 In some examples, second set of electrodes 130 can each include a separate height H from second face 114 to second offset plane P2. I2 .like Figure 3B As shown, the individual height H of the further distal first electrode 120 I1 Greater than the individual height H of the more proximal first electrode 120 I1 Similarly, the individual height H of the more distal second electrode 130 is I2 is greater than the individual height H of the more proximal second electrode 130 I2 In some examples, such as Figure 3A , this trend is true for the entire end effector 100, which means that the individual height H of each electrode 120, 130 I1 , H I2 102 is greater than the height of electrodes 120, 130 positioned more proximally (ie, closer to the proximal end 102 of the end effector 100). In some examples, the individual height H of each of the first electrodes is I1 may be equal to the individual height H of the corresponding second electrode 130 similarly positioned relative to the longitudinal axis. I2 , or in other words, the individual heights of the second electrodes 130 that are equal distances from the proximal end 102 of the end effector 100. The first offset plane P1 may be parallel to the longitudinal plane L p The second offset plane P2 may be parallel to the longitudinal plane L and spaced apart from the longitudinal plane L by a first distance D1. pand spaced apart from the first distance D2. In some examples, the second distance D2 is equal to the first distance D1, while in other examples, the second distance D2 is different from the first distance D1. The first plurality of electrodes 120 may include a corresponding plurality of first contact surfaces 122. The second plurality of electrodes 130 may include a corresponding plurality of second contact surfaces 132. The plurality of first contact surfaces 122 and the plurality of second contact surfaces 132 may be parallel to the longitudinal plane L. p ,like Figure 3B As shown. The contact surface 122 is the surface of the electrode 120 located in the first offset plane P1 and is configured to contact the tissue targeted for sensing and / or ablation. As used herein, the term "contact" may refer to a component that contacts the tissue or may refer to electrical contact. For example, the contact surface 122 may be coated or otherwise prevented from contacting the tissue, but still be able to deliver (e.g., tissue ablation) or receive current passing through the tissue (e.g., collecting physiological signals, such as the propagation of current through cardiac tissue).

[0052] In another example, Figure 4A As shown, the end effector 100 spans the longitudinal plane L p The first and second surfaces 112 and 114 are symmetrical, and the electrodes 120 and 130 are flat against the first and second surfaces 112 and 114. In this way, the first and second electrodes 120 and 130 extend upward to the first offset plane P1 and the second offset plane P2, respectively, each having the same height. In other words, the distal end 106a of the first surface 112 is separated from the first offset plane P1 by a first distal distance D D1 (like Figure 4B As shown), the proximal end 108a of the first surface 112 is separated from the first offset plane P1 by a first proximal distance D P1 (like Figure 4C As shown), and the first distal distance D D1 Not equal to the first proximal distance D P1 That is, the first proximal distance D P1 Can be greater than the first distal distance D D1 In some examples, this results in first set of electrodes 120 having a uniform height and lying flat against and parallel to first face 112 .

[0053] In some examples, the distal end 106b of the second face 114 is spaced apart from the second offset plane P2 by a second distal distance D D2 (like Figure 4B As shown), the proximal end 108b of the second surface 114 is separated from the second offset plane P2 by a second proximal distance D P2 (like Figure 4C As shown), and the second distal distance D D2 Not equal to the second proximal distance D P2 That is, the second proximal distance D P2Can be greater than the second distal distance D D2 The second set of electrodes 130 may have a uniform height and be placed flat against and parallel to the second surface 114. Figure 4B As shown, the plurality of first contact surfaces 122 may be parallel to the first face 112, and the plurality of second contact surfaces 132 may be parallel to the second face 114. In addition, in some examples, this may result in the end effector 100 being narrower at the distal end 104 than at the proximal end 102, so that its stiffness gradually decreases in the distal direction DD. This narrowing may increase the ability of the end effector 100 to conform to the tissue surface, thereby allowing the electrodes 120, 130 to better contact the tissue and more effectively collect signals and / or deliver ablation energy.

[0054] In some examples, for example, when the end effector 100 crosses the longitudinal plane L p When symmetrical, the first proximal distance D P1 Equal to the second near side distance D P2 , and wherein the first distal distance D D1 Equal to the second distal distance D D2 Therefore, in the longitudinal plane L p There are equal amounts of substrates 110 on the side S1 and the side S2 of the substrate.

[0055] In some examples, the first set of electrodes 120 may include at least one first mapping electrode and / or at least one first ablation electrode. The second set of electrodes 130 may include at least one second mapping electrode and / or at least one second ablation electrode. The electrodes 120 and 130 may be configured to detect electrophysiological signals or transmit ablation energy (AC or DC) from an energy generator to tissue according to various ablation methods previously described (e.g., RF, IRE, etc.). FIG. 3A to FIG. 4C The illustrated cross-sectional profile and non-planar nature of the end effector 100 enhance the ability of the end effector 100 (and therefore the electrodes 120 , 130 ) to conform to tissue, acquire signals, and deliver energy.

[0056] Figure 5A A view of the first side 112 of the end effector is illustrated. As shown, the first set of electrodes 120 can be arranged on the first face 112 such that a distal subset 128 of the first set of electrodes 120 is closer to the distal portion 104 than a proximal subset 126 of the first set of electrodes 120. The distal subset 128 of the first set of electrodes 120 can include approximately twice as many electrodes as the proximal subset 126 of the first set of electrodes 120. Typically, there can be more first electrodes 120 in the distal subset 128 than in the proximal subset 126.

[0057] The same applies to the distribution of the second surface 114 and the second group of electrodes 130. Figure 5BAs shown, the second group of electrodes 130 may be arranged on the second surface 114 so that a distal subset 138 of the second group of electrodes 130 is closer to the distal portion 104 than a proximal subset 136 of the second group of electrodes 130, wherein the distal subset 138 of the second group of electrodes 130 includes approximately twice as many electrodes as the proximal subset 136 of the second group of electrodes 130.

[0058] Return to reference FIG. 3A to FIG. 4C At least a portion of the first set of electrodes 120 may be disposed on the longitudinal plane L p The orthogonal direction OO is aligned with at least a portion of the second set of electrodes 130 to form a corresponding aligned pair of first electrodes 120 and second electrodes 130 .

[0059] The aligned electrode pairs may be aligned generally transverse to the longitudinal axis LL. Oppositely facing electrode pairs may be used to cancel noise, where one electrode senses tissue directly and the opposing electrode senses far field signals that may typically include noise, as understood by those skilled in the relevant art.

[0060] FIG. 5A to FIG. 5B The longitudinal plane L is shown in the base 110. p Coplanar frame 140. The frame 140 may include a plurality of tines 142 that engage near the proximal end 108 of the end effector 100 and extend distally therefrom. The plurality of tines 142 may include two outer tines 144 and two inner tines 146, wherein the outer tines 144 and the inner tines 146 are disposed on either side of the longitudinal axis LL. In some examples, the two inner tines 146 taper in the distal direction DD. The narrowing of the tines 142 may be configured to adjust the bending stiffness of the end effector 100. The aligned first and second electrode pairs may be aligned with the frame 140 in an orthogonal direction OO. In some examples, the base 110 may further define a plurality of elongated slots 116 that are substantially parallel to the longitudinal axis LL and disposed between each outer tines 144 and the inner tines 146. The elongated slot 116 may be shaped to alter the bending stiffness and torsional stiffness (rotation about the longitudinal axis LL) of the end effector 100 to enable it to conform to a tissue surface.

[0061] The frame 140 may be considered as a plurality of fork-shaped stiffening members for providing support to the end effector 100 .

[0062] Frame 140 can be formed from planar or cylindrical raw material using any suitable method. For example, frame 140 can be formed by cutting, laser cutting, stamping, etc. In some examples, substrate 110 can include a flexible circuit. In some examples, substrate 110 can include a frame, such as frame 140 described above. Frame 140 can include nitinol.

[0063] like Figure 6 As shown, the end effector 100 may be at least partially encapsulated by a non-conductive flexible material 150. The non-conductive flexible material 150 may be used at least in part to enhance the atraumatic nature of the end effector 100 and protect the subject from sharp edges. In some examples, the flexible non-conductive material 150 may include a biocompatible silicone. In other examples, the flexible non-conductive material 150 may include a biocompatible flexible polymer, a thermoelastic polymer material, and a dielectric material. The flexible non-conductive material 150 may optionally be colored to facilitate laser cutting. In some examples, the frame 140 may be fixed to the substrate 110 by the non-conductive flexible encapsulating material 150. The contact surfaces 122 and 132 may be exposed to the surrounding environment by the non-conductive flexible material 150.

[0064] In addition, the non-conductive flexible material 150 may be thickened at different points in the longitudinal direction LL and the orthogonal direction OO to contour it to the variable stiffness of the substrate 110. For example, the frame 150 may be shaped so that it contributes more to the overall stiffness of the end effector 100 in torsional stiffness (rotation about the longitudinal axis LL) than in the longitudinal direction LL. Alternatively or in addition, the flexible material 150 may be formed so that it facilitates the end effector 100 to be arranged in columns, rows, and / or sections (e.g., Figure 5A and Figure 5B The flexible non-conductive material 150 may also form the distal end 104 without being sharp.

[0065] FIG. 7A to FIG. 7C A method 700 of providing a reinforced flexible end effector is shown. In some examples, the method 700 can provide the end effector 100 as described in detail above, and all of its components and subcomponents. Fig. 7A As shown, method 700 may include: forming 702 a substrate along a longitudinal plane extending from a proximal end to a distal end along a longitudinal axis; forming 704 a first surface on a first side of the substrate; forming 706 a second surface on a second side of the substrate opposite to the first side; tilting 708 the first surface toward the longitudinal plane as the first surface extends from the proximal end of the substrate to the distal end of the substrate; forming 710 a first group of electrodes along the first surface; and forming 712 a second group of electrodes along the second surface.

[0066] Figure 7BThe method is shown, the method also includes: when the second face extends from the proximal end of the substrate to the distal end of the substrate, tilting the second face toward the longitudinal plane 709. The method may also include: sizing each electrode in the first set of electrodes 714 to include a first electrode height extending from the first face to the first offset plane. The method 700 may include: sizing each electrode in the second set of electrodes 716 to include a second electrode height extending from the second face to the second offset plane.

[0067] like Figure 7C As shown, forming 710 the first group of electrodes may include: dispersing 711 the first group of electrodes so that a distal subset of the first group of electrodes is closer to the distal portion than a proximal subset of the first group of electrodes, and the distal subset of the first group of electrodes includes approximately twice as many electrodes as the proximal subset of the first group of electrodes.

[0068] The method 700 may further include forming 712 the second set of electrodes. Forming 712 the second set of electrodes 712 may include dispersing 713 the second set of electrodes such that a distal subset of the second set of electrodes is closer to the distal portion than a proximal subset of the second set of electrodes, the distal subset of the second set of electrodes including approximately twice as many electrodes as the proximal subset of the second set of electrodes.

[0069] Additionally, the method 700 may include aligning 718 at least a portion of the first set of electrodes with at least a portion of the second set of electrodes in a direction orthogonal to the longitudinal plane to form respective aligned first and second electrode pairs. The method 700 may include forming 720 a frame substantially in the longitudinal plane; and aligning 722 the aligned first and second electrode pairs with the frame in the orthogonal direction. The method 700 may also include encapsulating 724 the end effector with a non-conductive flexible material.

[0070] It should be understood that the method 700 just described may include more or fewer steps or features than those described. In addition, these steps or features may be performed in different orders and should not be interpreted as requiring execution in any particular order.

[0071] The disclosed technology described herein can be further understood according to the following terms:

[0072] Item 1: An end actuator for a catheter, the end actuator comprising: a base extending along a longitudinal axis from a proximal portion of the end actuator to a distal portion of the end actuator, and the base comprising: a longitudinal plane, the longitudinal axis passing through the longitudinal plane; a first surface, the first surface being disposed on a first side of the base and inclined to the longitudinal plane; and a second surface, the second surface being opposite to the first surface and the second surface being disposed on a second side of the base; a first group of electrodes, the first group of electrodes being disposed on the first surface; and a second group of electrodes, the second group of electrodes being disposed on the second surface.

[0073] Clause 2: The end effector of clause 1, wherein the second surface is inclined relative to the longitudinal plane.

[0074] Clause 3: The end effector according to clause 1 further includes: a first offset plane, which is offset from the first surface and parallel to the longitudinal plane; and a second offset plane, which is offset from the second surface and parallel to the longitudinal plane.

[0075] Clause 4: The end effector of clause 3, wherein the first set of electrodes extends outwardly from the first face to the first offset plane.

[0076] Clause 5: The end effector of clause 4, wherein the second set of electrodes extends outwardly from the second face to the second offset plane.

[0077] Clause 6: The end effector of clause 3, wherein the first set of electrodes each comprises a separate height from the first face to the first offset plane.

[0078] Clause 7: The end effector of clause 6, wherein each of the second set of electrodes comprises a separate height from the second face to the second offset plane.

[0079] Clause 8: The end effector of clause 3, wherein the first offset plane is parallel to the longitudinal plane and separated from the longitudinal plane by a first distance.

[0080] Clause 9: The end effector of clause 8, wherein the second offset plane is parallel to the longitudinal plane and separated from the longitudinal plane by a second distance.

[0081] Clause 10: The end effector of clause 9, wherein the second distance is equal to the first distance.

[0082] Clause 11: According to the end actuator of Clause 3, the distal end of the first surface is separated from the first offset plane by a first distal distance, the proximal end of the first surface is separated from the first offset plane by a first proximal distance, and the first distal distance is not equal to the first proximal distance.

[0083] Clause 12: According to the end effector of Clause 11, the distal end of the second surface is separated from the second offset plane by a second distal distance, the proximal end of the second surface is separated from the second offset plane by a second proximal distance, and the second distal distance is not equal to the second proximal distance.

[0084] Clause 13: The end effector of clause 12, wherein the first proximal distance is equal to the second proximal distance, and wherein the first distal distance is equal to the second distal distance.

[0085] Item 14: According to the end actuator described in any one of items 1 to 13, the first group of electrodes is arranged on the first surface so that a distal subset of the first group of electrodes is closer to the distal portion than a proximal subset of the first group of electrodes, and the distal subset of the first group of electrodes includes approximately twice as many electrodes as the proximal subset of the first group of electrodes.

[0086] Item 15: According to the end actuator described in any one of items 1 to 14, the second group of electrodes is arranged on the second surface so that the distal subset of the second group of electrodes is closer to the distal portion than the proximal subset of the second group of electrodes, and the distal subset of the second group of electrodes includes approximately twice as many electrodes as the proximal subset of the second group of electrodes.

[0087] Clause 16: The end effector of any one of clauses 1 to 15, wherein at least a portion of the first set of electrodes is aligned with at least a portion of the second set of electrodes in a direction orthogonal to the longitudinal plane to form respective aligned first and second electrode pairs.

[0088] Clause 17: The end effector of any of clauses 1 to 16, further comprising a frame located in the base and coplanar with the longitudinal plane.

[0089] Clause 18: The end effector of clause 17, the frame comprising a plurality of tines engaging proximate a proximal end of the end effector and extending distally therefrom.

[0090] Clause 19: The end effector of clause 18, wherein the plurality of tines comprises two outer tines and two inner tines, the outer tines and the inner tines being disposed on either side of the longitudinal axis.

[0091] Clause 20: The end effector of clause 19, wherein the two inner tines gradually narrow in the distal direction.

[0092] Clause 21: The end effector of any of clauses 16 to 20, wherein the aligned first and second electrode pairs are aligned with the frame in an orthogonal direction.

[0093] Clause 22: The end effector of any of clauses 19 to 21, the base further defining a plurality of elongated slots generally parallel to the longitudinal axis and disposed between each outer tine and inner tine.

[0094] Clause 23: The end effector of any of clauses 1 to 22, wherein the substrate comprises a flexible circuit.

[0095] Clause 24: The end effector of any one of clauses 1 to 16, wherein the base comprises a frame.

[0096] Clause 25: The end effector of clause 24, the frame comprising a plurality of tines engaging proximate a proximal end of the end effector and extending distally therefrom.

[0097] Clause 26: The end effector of clause 25, wherein the plurality of tines comprises two outer tines and two inner tines, the outer tines and the inner tines being disposed on either side of the longitudinal axis.

[0098] Clause 27: According to the end effector of clause 26, the two inner tines gradually narrow in the distal direction.

[0099] Clause 28: The end effector of any of clauses 24 to 27, wherein the frame comprises nitinol.

[0100] Clause 29: The end effector of any of clauses 1 to 28, the end effector being at least partially encapsulated by a non-conductive flexible material.

[0101] Clause 30: The end effector of any of clauses 1 to 29, the first set of electrodes comprising at least one first mapping electrode.

[0102] Clause 31: The end effector of any of clauses 1 to 30, wherein the first set of electrodes comprises at least one first ablation electrode.

[0103] Clause 32: The end effector of any one of clauses 1 to 31, wherein the second set of electrodes comprises at least one second mapping electrode.

[0104] Clause 33: The end effector of any of clauses 1 to 32, wherein the second set of electrodes comprises at least one second ablation electrode.

[0105] Item 34: A non-planar end actuator for a mapping catheter, the end actuator comprising: an inclined base, the inclined base extending along a longitudinal plane, the longitudinal plane extending along a longitudinal axis from the proximal end of the end actuator to the distal end of the end actuator, the base gradually becoming thinner in a direction orthogonal to the longitudinal plane; a first plurality of electrodes, the first plurality of electrodes being disposed on a first surface of the inclined base; and a second plurality of electrodes, the second plurality of electrodes being disposed on a second surface of the inclined base.

[0106] Clause 35: The end effector of clause 34, wherein the base further defines a plurality of elongated slots that are substantially parallel to the longitudinal axis.

[0107] Clause 36: The end effector of any of clauses 34-35, the first plurality of electrodes comprising a respective plurality of first contact surfaces parallel to the first face.

[0108] Clause 37: The end effector of any of clauses 34-35, the first plurality of electrodes comprising a respective plurality of first contact surfaces parallel to the longitudinal plane.

[0109] Clause 38: The end effector of any of clauses 34 to 37, the second plurality of electrodes comprising a respective plurality of second contact surfaces parallel to the second face.

[0110] Clause 39: The end effector of any of clauses 34 to 37, the second plurality of electrodes comprising a respective plurality of second contact surfaces parallel to the longitudinal plane.

[0111] Item 40: An end actuator according to any one of items 34 to 39, wherein the first plurality of electrodes are arranged on the first surface so that a distal subset of the first plurality of electrodes is closer to the distal end than a proximal subset of the first plurality of electrodes, and the distal subset of the first plurality of electrodes includes approximately twice as many electrodes as the proximal subset of the first plurality of electrodes.

[0112] Item 41: According to an end actuator according to any one of items 34 to 40, the second plurality of electrodes are arranged on the second surface so that a distal subset of the second plurality of electrodes is closer to the distal end than a proximal subset of the second plurality of electrodes, and the distal subset of the second plurality of electrodes includes approximately twice as many electrodes as the proximal subset of the second plurality of electrodes.

[0113] Clause 42: The end effector of any of clauses 34 to 41, wherein the angled substrate is a flexible circuit.

[0114] Clause 43: The end effector of any of clauses 34 to 42, further comprising: a frame secured to the substrate by a non-conductive flexible encapsulation material.

[0115] Clause 44: The end effector of any of clauses 34 to 41, wherein the angled base is a frame.

[0116] Clause 45: The end effector of any of clauses 43 to 44, said frame comprising a plurality of tines engaging proximate said proximal end of said end effector and extending distally therefrom.

[0117] Clause 46: The end effector of clause 45, wherein the plurality of tines comprises two outer tines and two inner tines, the outer tines and the inner tines being disposed on either side of the longitudinal axis.

[0118] Clause 47: According to the end effector of clause 46, the two inner tines gradually narrow in the distal direction.

[0119] Clause 48: The end effector of any of clauses 43 to 47, each electrode of the first plurality of electrodes being aligned with a corresponding second electrode and the frame in the orthogonal direction.

[0120] Clause 49: The end effector of any of clauses 43 to 48, wherein the frame comprises nitinol.

[0121] Clause 50: The end effector of any of clauses 34 to 48, the first plurality of electrodes comprising at least one first mapping electrode.

[0122] Clause 51: The end effector of any of clauses 34 to 50, wherein the first plurality of electrodes comprises at least one first ablation electrode.

[0123] Clause 52: The end effector of any of clauses 34 to 51, wherein the second plurality of electrodes comprises at least one second mapping electrode.

[0124] Clause 53: The end effector of any of clauses 34 to 52, the second plurality of electrodes comprising at least one second ablation electrode.

[0125] Item 54: A system for performing a medical procedure, the system comprising: an elongated shaft extending along a longitudinal axis from a proximal end to a distal end; an end effector disposed on the distal end of the elongated shaft, the end effector comprising: a base extending along the longitudinal axis from a proximal portion of the end effector to a distal portion of the end effector, and the base comprising: a first surface disposed on a first side of a longitudinal plane and inclined to the longitudinal plane; a second surface disposed on a second side of the longitudinal plane and inclined to the longitudinal plane; a first group of electrodes disposed on the first surface; and a second group of electrodes disposed on the second surface.

[0126] Clause 55: The system of clause 54, further comprising a pull wire extending through the elongated shaft and comprising a distal end coupled to the proximal portion of the end effector.

[0127] Clause 56: The system of clause 54, wherein the second surface is inclined relative to the longitudinal plane.

[0128] Clause 57: The system of clause 54, further comprising: a first offset plane, the first offset plane being offset from the first face and parallel to the longitudinal plane; and a second offset plane, the second offset plane being offset from the second face and parallel to the longitudinal plane.

[0129] Clause 58: The system of clause 57, wherein the first set of electrodes extends outward from the first face to the first offset plane.

[0130] Clause 59: The system of clause 58, wherein the second set of electrodes extends outward from the second face to the second offset plane.

[0131] Clause 60: The system of clause 57, the first set of electrodes each comprising a separate height from the first face to the first offset plane.

[0132] Clause 61: The system of clause 60, wherein the second set of electrodes each comprises a separate height from the second face to the second offset plane.

[0133] Clause 62: The system of clause 57, wherein the first offset plane is parallel to the longitudinal plane and is separated from the longitudinal plane by a first distance.

[0134] Clause 63: The system of clause 62, wherein the second offset plane is parallel to the longitudinal plane and separated from the longitudinal plane by a second distance.

[0135] Clause 64: The system of clause 63, wherein the second distance is equal to the first distance.

[0136] Clause 65: According to the system of clause 57, the distal end of the first surface is separated from the first offset plane by a first distal distance, the proximal end of the first surface is separated from the first offset plane by a first proximal distance, and the first distal distance is not equal to the first proximal distance.

[0137] Clause 66: According to the system of clause 65, the distal end of the second surface is separated from the second offset plane by a second distal distance, the proximal end of the second surface is separated from the second offset plane by a second proximal distance, and the second distal distance is not equal to the second proximal distance.

[0138] Clause 67: The system of clause 66, wherein the first proximal distance is equal to the second proximal distance, and wherein the first distal distance is equal to the second distal distance.

[0139] Item 68: According to a system described in any one of items 54 to 67, the first group of electrodes is arranged on the first surface so that a distal subset of the first group of electrodes is closer to the distal portion than a proximal subset of the first group of electrodes, and the distal subset of the first group of electrodes includes approximately twice as many electrodes as the proximal subset of the first group of electrodes.

[0140] Item 69: According to a system described in any one of items 54 to 68, the second group of electrodes is arranged on the second surface so that a distal subset of the second group of electrodes is closer to the distal portion than a proximal subset of the second group of electrodes, and the distal subset of the second group of electrodes includes approximately twice as many electrodes as the proximal subset of the second group of electrodes.

[0141] Clause 70: The system of any of clauses 54 to 69, wherein at least a portion of the first set of electrodes is aligned with at least a portion of the second set of electrodes in a direction orthogonal to the longitudinal plane to form respective aligned first and second electrode pairs.

[0142] Clause 71: The system of any of clauses 54 to 70, further comprising a frame located in the base and coplanar with the longitudinal plane.

[0143] Clause 72: The system of clause 71, the frame comprising a plurality of tines engaged proximate a proximal end of the end effector and extending distally therefrom.

[0144] Clause 73: The system of clause 72, wherein the plurality of tines comprises two outer tines and two inner tines, the outer tines and the inner tines being disposed on either side of the longitudinal axis.

[0145] Clause 74: The system of clause 73, wherein the two inner tines taper in a distal direction.

[0146] Clause 75: The system of any of clauses 70 to 74, wherein the aligned first and second electrode pairs are aligned with the frame in the orthogonal direction.

[0147] Clause 76: The system of any of clauses 73 to 75, the base further defining a plurality of elongated slots generally parallel to the longitudinal axis and disposed between the outer tines and the inner tines.

[0148] Clause 77: The system of any of clauses 54 to 76, wherein the substrate comprises a flexible circuit.

[0149] Clause 78: The system of any of clauses 54 to 70, wherein the substrate comprises a frame.

[0150] Clause 79: The system of clause 78, the frame comprising a plurality of tines engaged proximate a proximal end of the end effector and extending distally therefrom.

[0151] Clause 80: The system of clause 79, the plurality of tines comprising two outer tines and two inner tines, the outer tines and the inner tines disposed on either side of the longitudinal axis.

[0152] Clause 81: The system of clause 80, wherein the two inner tines taper in a distal direction.

[0153] Clause 82: The system of any of clauses 78 to 81, wherein the frame comprises nitinol.

[0154] Clause 83: The system of any of clauses 54 to 82, wherein the end effector is at least partially encapsulated by a non-conductive flexible material.

[0155] Clause 84: The system of any of clauses 54 to 83, wherein the first set of electrodes comprises at least one first mapping electrode.

[0156] Clause 85: The system of any of clauses 54 to 84, the first set of electrodes comprising at least one first ablation electrode.

[0157] Clause 86: The system of any of clauses 54 to 85, wherein the second set of electrodes comprises at least one second mapping electrode.

[0158] Clause 87: The system of any of clauses 54 to 86, wherein the second set of electrodes comprises at least one second ablation electrode.

[0159] Item 88: A method for providing a reinforced flexible end actuator, the method comprising: forming a base along a longitudinal plane, the longitudinal plane extending from a proximal end to a distal end along a longitudinal axis; forming a first surface on a first side of the base; forming a second surface on a second side of the base opposite to the first side; tilting the first surface toward the longitudinal plane as the first surface extends from the proximal end of the base to the distal end of the base; forming the first group of electrodes along the first surface; and forming a second group of electrodes along the second surface.

[0160] Clause 89: The method of clause 88, further comprising: tilting the second face toward the longitudinal plane as the second face extends from the proximal end of the base to the distal end of the base.

[0161] Clause 90: The method of any of clauses 88 to 89, further comprising: sizing each electrode of the first set of electrodes to include a first electrode height extending from the first face to a first offset plane.

[0162] Clause 91: A method according to any one of clauses 88 to 90, further comprising:

[0163] Each electrode of the second set of electrodes is dimensioned to include a second electrode height extending from the second face to a second offset plane.

[0164] Clause 92: The method of clause 91, wherein the first offset plane is parallel to and separated from the longitudinal plane, and the second offset plane is parallel to and separated from the longitudinal plane.

[0165] Clause 93: The method of clause 90, wherein the first offset plane is inclined to and separated from the longitudinal plane, and the second offset plane is inclined to and separated from the longitudinal plane.

[0166] Item 94: A method according to any one of items 88 to 93, wherein forming the first group of electrodes includes dispersing the first group of electrodes so that a distal subset of the first group of electrodes is closer to a distal portion than a proximal subset of the first group of electrodes, and the distal subset of the first group of electrodes includes approximately twice as many electrodes as the proximal subset of the first group of electrodes.

[0167] Clause 95: A method according to any one of clauses 88 to 94, wherein forming the second group of electrodes includes dispersing the second group of electrodes so that a distal subset of the second group of electrodes is closer to the distal portion than a proximal subset of the second group of electrodes, and the distal subset of the second group of electrodes includes approximately twice as many electrodes as the proximal subset of the second group of electrodes.

[0168] Clause 96: The method of clause 95, further comprising aligning at least a portion of the first set of electrodes with at least a portion of the second set of electrodes in a direction orthogonal to the longitudinal plane to form corresponding aligned first and second electrode pairs.

[0169] Clause 97: The method of clause 96, further comprising: forming a frame that lies substantially in the longitudinal plane.

[0170] Clause 98: The method of clause 97, further comprising: aligning the aligned first and second electrode pairs with the frame in the orthogonal direction.

[0171] Clause 99: The method of clause 98, further comprising: encapsulating the end effector with a non-conductive flexible material.

[0172] Clause 100: The method of any one of clauses 88 to 99, wherein the first set of electrodes comprises at least one first mapping electrode.

[0173] Clause 101: The method of any of clauses 88 to 100, wherein the first set of electrodes comprises at least one first ablation electrode.

[0174] Clause 102: The method of any one of clauses 88 to 101, wherein the second set of electrodes comprises at least one second mapping electrode.

[0175] Clause 103: The method of any of clauses 88 to 102, wherein the second set of electrodes comprises at least one second ablation electrode.

Claims

1. An end effector for a catheter, the end effector comprising: a substrate extending along a longitudinal axis from a proximal portion of the end effector to a distal portion of the end effector, and comprising: a longitudinal plane through which the longitudinal axis passes; a first face disposed on a first side of the substrate and inclined to the longitudinal plane; a second surface, the second surface being opposite to the first surface, the second surface being disposed on a second side of the substrate; a first set of electrodes, the first set of electrodes being disposed on the first surface; and A second group of electrodes is disposed on the second surface.

2. The end effector of claim 1, wherein the second surface is inclined relative to the longitudinal plane.

3. The end effector according to claim 1, further comprising: a first offset plane, the first offset plane being offset from the first face and parallel to the longitudinal plane; as well as A second offset plane is offset from the second face and parallel to the longitudinal plane.

4. The end effector of claim 3, wherein the first set of electrodes extends outwardly from the first face to the first offset plane.

5. The end effector of claim 4, wherein the second set of electrodes extends outwardly from the second face to the second offset plane.

6. The end effector of claim 3, wherein each of the first set of electrodes comprises a separate height from the first face to the first offset plane.

7. The end effector of claim 6, the second set of electrodes each comprising a separate height from the second face to the second offset plane.

8. According to the end actuator of claim 7, the first group of electrodes is arranged on the first surface so that a distal subset of the first group of electrodes is closer to the distal portion than a proximal subset of the first group of electrodes, and the distal subset of the first group of electrodes includes approximately twice as many electrodes as the proximal subset of the first group of electrodes.

9. According to the end actuator of claim 8, the second group of electrodes is arranged on the second surface so that a distal subset of the second group of electrodes is closer to the distal portion than a proximal subset of the second group of electrodes, and the distal subset of the second group of electrodes includes approximately twice as many electrodes as the proximal subset of the second group of electrodes.

10. The end effector of claim 9, at least a portion of the first set of electrodes being aligned with at least a portion of the second set of electrodes in a direction orthogonal to the longitudinal plane to form respective aligned first and second electrode pairs.

11. The end effector of claim 10, further comprising a frame located in the base and coplanar with the longitudinal plane.

12. The end effector of claim 3, the first offset plane being parallel to the longitudinal plane and spaced a first distance from the longitudinal plane.

13. The end effector of claim 12, wherein the second offset plane is parallel to the longitudinal plane and is separated from the longitudinal plane by a second distance.

14. The end effector of claim 3, wherein a distal end of the first face is spaced apart from the first offset plane by a first distal distance, A proximal end of the first face is spaced a first proximal distance from the first offset plane, and The first distal distance is not equal to the first proximal distance.

15. The end effector of claim 14, wherein the distal end of the second surface is spaced apart from the second offset plane by a second distal distance, A proximal end of the second face is spaced a second proximal distance from the second offset plane, and The second distal distance is not equal to the second proximal distance.

16. The end effector according to claim 15, wherein: The first proximal distance is equal to the second proximal distance, and wherein the first distal distance is equal to the second distal distance.

17. A non-planar end effector for a mapping catheter, the non-planar end effector comprising: an inclined substrate extending along a longitudinal plane extending along a longitudinal axis from a proximal end of the non-planar end effector to a distal end of the non-planar end effector, the inclined substrate tapering in a direction orthogonal to the longitudinal plane; a first plurality of electrodes disposed on a first face of the inclined substrate; and a second plurality of electrodes disposed on a second face of the inclined substrate.

18. The non-planar end effector of claim 17, the first plurality of electrodes comprising a corresponding plurality of first contact surfaces parallel to the first face.

19. The non-planar end effector of claim 17, wherein the first plurality of electrodes comprises a corresponding plurality of first contact surfaces parallel to the longitudinal plane.

20. A system for performing a medical procedure, the system comprising: an elongated shaft extending along a longitudinal axis from a proximal end to a distal end; An end actuator, which is arranged on the distal end of the slender shaft, and the end actuator includes: a base, which extends along a longitudinal axis from a proximal portion of the end actuator to a distal portion of the end actuator, and the base includes: a first surface, which is arranged on a first side of a longitudinal plane and inclined to the longitudinal plane; a second surface, which is arranged on a second side of the longitudinal plane and inclined to the longitudinal plane; a first group of electrodes, which are arranged on the first surface; and a second group of electrodes, which are arranged on the second surface.

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