Catheter end effector with nonplanar substrate

Abstract

To provide an end effector for catheter.SOLUTION: An end effector for a catheter can include a substrate extending along a longitudinal axis from a proximal portion of the end effector to a distal portion of the end effector. The substrate can include: a longitudinal plane, the longitudinal axis running through the longitudinal plane; a first face disposed on a first side of the substrate and oblique to the longitudinal plane; a second face, opposite the first face, disposed on a second side of the substrate; a first group of electrodes disposed on the first face; and a second group of electrodes disposed on the second face.SELECTED DRAWING: Figure 1

Description

[Technical field]

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

[0002] Cardiac arrhythmias, such as atrial fibrillation, occur when electrical signals are abnormally conducted from an area of ​​cardiac tissue to adjacent tissue, disrupting the normal cardiac cycle and causing an asynchronous rhythm. The source of the unwanted signals may be located in the tissue of the atria or ventricles. The unwanted signals may be conducted through the cardiac tissue to other locations and cause or perpetuate the arrhythmia.

[0003] Procedures for treating arrhythmias include surgically disrupting the source of the signals that cause the arrhythmia and disrupting the conduction pathways of such signals. More recently, it has been found that it is possible to interrupt or modify the propagation of undesired electrical signals from one portion of the heart to another by mapping the electrical properties and cardiac volumes of the endocardium and selectively ablating cardiac tissue through the application of energy. The ablation process disrupts the undesired electrical pathways by the formation of non-conducting foci.

[0004] In this two-step procedure, which involves mapping followed by ablation, electrical activity at points within the heart is sensed and measured, typically by advancing a catheter equipped with one or more electrical sensors into the heart and acquiring data at multiple points, which are then used to select a target area where ablation will be performed.

[0005] For higher mapping resolution, it is desirable for the end effector of 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 more data signals in a shorter time. It is also desirable for such a catheter to enable sufficient electrode contact with various tissue surfaces, e.g., flat, curved, uneven, or non-planar surface tissue, and be foldable for non-invasive advancement and retraction through the patient's vascular system. Existing catheters generally require a stiff internal structural member to ensure that a predetermined configuration is maintained. If the internal member is too stiff, it may be difficult to manipulate the catheter within the body organ and may prevent the electrodes from contacting the tissue. Summary of the Invention [Means for solving the problem]

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

[0007] The disclosed technology includes a non-planar end effector for a mapping catheter. The end effector can include a sloped substrate extending along a longitudinal plane extending along a longitudinal axis from a proximal end of the end effector to a distal end of the end effector. The substrate can be progressively thinner in a direction perpendicular to the longitudinal plane. The non-planar end effector can include a first plurality of electrodes disposed on a first surface of the sloped substrate and a second plurality of electrodes disposed on a second surface of the sloped substrate.

[0008] The disclosed technology includes a system for performing a medical procedure. The system can include an elongate shaft extending along a longitudinal axis from a proximal end to a distal end, and an end effector disposed at the distal end of the elongate shaft. The end effector can include a substrate extending along the longitudinal axis from a proximal portion of the end effector to a distal portion of the end effector. The substrate can include a first surface disposed on a first side of a longitudinal plane and oblique to the longitudinal plane, a second surface disposed on a second side of the longitudinal plane and oblique 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.

[0009] The disclosed technology includes a method of providing a reinforced flexible end effector. The method can include forming a substrate along a longitudinal plane extending along a longitudinal axis from a proximal end to a distal end, forming a first surface on a first side of the substrate, forming a second surface on a second side of the substrate opposite the first side, and sloping 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. The method can include forming a first group of electrodes along the first surface and forming a second group of electrodes along the second surface. [Brief description of the drawings]

[0010] [Figure 1] FIG. 1 is a schematic, pictorial illustration of a medical system including a catheter with an end effector having a non-planar substrate, according to an example of the present invention. [Diagram 2] 1 is a top view of a system for medical procedures according to an example of the present invention. [Figure 3A] FIG. 2 is a cross-sectional view of an end effector according to an example of the present invention. [Figure 3B] FIG. 3B is a detailed view of the end effector of FIG. 3A. [Figure 4A] FIG. 2 is a cross-sectional view of an end effector according to an example of the present invention. [Figure 4B] FIG. 4B is a detailed view of a distal portion of the end effector of FIG. 4A. [Figure 4C] FIG. 4B is a detailed view of a proximal portion of the end effector of FIG. 4A. [Figure 5A] FIG. 2 illustrates a top view of an end effector according to an example of the present invention. [Figure 5B] FIG. 2 is a bottom view of an end effector according to an example of the present invention. [Figure 6] FIG. 2 illustrates an end effector encapsulated in a flexible material, according to an example of the present invention. [Figure 7A] 1 is a flowchart of a method for providing a reinforced flexible end effector according to an example of the present invention. [Figure 7B] 1 is a flowchart of a method for providing a reinforced flexible end effector according to an example of the present invention. [Figure 7C] 1 is a flowchart of a method for providing a reinforced flexible end effector according to an example of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0011] The technology of the present disclosure relates to improving the performance of end effectors, such as end effectors 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, electrode contact with the target anatomy, delivery of the end effector to the target anatomy, biocompatibility, end effector stiffness, and atraumaticity. Various aspects of the present disclosure enhance the ability of the end effector to conform to the 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 tapered nature of the end effector's substrate 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 the height and angle of the electrodes, the angle at which the end effector is tilted, and the addition of slots, frameworks, and flexible encapsulation materials, can be used to adjust the ability of the end effector to conform to the tissue surface.

[0012] The following detailed description should be read with reference to the drawings, in which like elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of the invention. The detailed description illustrates, by way of example and not by way of limitation, the principles of the invention. The description clearly enables one skilled in the art to make and use the invention and describes several embodiments, adaptations, modifications, alternatives and uses of the invention, including what is currently construed to be the best mode for carrying out the invention.

[0013] As used herein, the term "about" or "approximately" with respect to any numerical value or range indicates a suitable dimensional tolerance that allows a portion or collection of components to function for the intended purpose described herein. More specifically, "about" or "approximately" may refer to a range of values ​​of ±20% of the recited value, e.g., "about 90%" may refer to a range of values ​​of 71% to 110%. Additionally, as used herein, the terms "patient," "host," "user," and "subject" refer to any human or animal subject, and while use of the invention in a human patient represents a preferred example, they are not intended to limit the system or method to human use. 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.

[0014] As discussed herein, the tissues, vasculature, or organs of a "patient," "host," "user," and "subject" may be human or any animal. It should be understood that the animal may be of any of a variety of applicable types, including, but not limited to, mammals, veterinary animals, livestock animals, or pet animals. As an example, the animal may be a laboratory animal (e.g., rats, dogs, pigs, monkeys, etc.) that is specifically selected to have certain characteristics similar to humans. It should be understood that the subject may be, for example, any applicable human patient.

[0015] As discussed herein, a "physician" may include a physician, surgeon, engineer, scientist, operator, or any other individual or delivery instrument involved in the delivery of a multi-electrode catheter for the treatment of drug refractory atrial fibrillation to a subject.

[0016] As discussed herein, the term "ablate" or "ablation" refers to components and structural features that are configured to reduce or prevent the occurrence of irregular cardiac signals within cells, as understood by those skilled in the art. For example, by utilizing thermal energy, such as radio frequency (RF) ablation, or non-thermal energy, such as irreversible electroporation (IRE), it may be referred to as pulsed electric field (PEF) and pulsed field ablation (PFA). As it relates to the devices and corresponding systems of the present disclosure, ablation or ablation is used throughout the present disclosure with reference to thermal or non-thermal ablation of cardiac tissue for specific conditions, including, but not limited to, arrhythmias, atrial flutter ablation, pulmonary vein isolation, supraventricular tachycardia ablation, and ventricular tachycardia ablation. The term "ablate" or "ablation" also includes known methods, devices, and systems for achieving various forms of body tissue ablation, as will be understood by those skilled in the art.

[0017] As discussed herein, the terms "tubular" and "tube" are to be interpreted broadly and are not limited to right cylindrical structures, or structures that are strictly circular in cross section, or structures that are uniform in cross section throughout their length. For example, a tubular structure is generally illustrated as a substantially right cylindrical structure. However, a tubular structure may have a tapered or curved outer surface without departing from the scope of the present disclosure.

[0018] The present disclosure relates to systems, methods, or uses and devices for mapping and ablation of cardiac tissue to treat cardiac arrhythmias. Ablation energy is typically delivered to the cardiac tissue by a distal portion of a catheter that can deliver the ablation energy along the tissue to be ablated. Some exemplary catheters include a three-dimensional structure at the distal portion and are configured to administer the ablation energy from various electrodes positioned on the three-dimensional structure. Ablation procedures incorporating such exemplary catheters can be visualized using fluoroscopy.

[0019] Ablation of cardiac tissue applying radio frequency (RF) energy and thermal techniques such as cryoablation to improve a failing heart is a well-known procedure. Typically, to successfully ablate using thermal techniques, cardiac potentials must be measured at various locations in the myocardium. In addition, temperature measurements during ablation provide data that allows for the effectiveness of the ablation. Typically, in ablation procedures using thermal techniques, electrode potentials and temperatures are measured before, during, and after the actual ablation. RF approaches may have risks that may lead to tissue charring, burning, steam popping, phrenic nerve paralysis, pulmonary vein stenosis, and esophageal fistula. Cryoablation is an alternative approach to RF ablation that can reduce some of the thermal risks associated with RF ablation. However, operating a cryoablation device and selectively applying cryoablation is generally more difficult compared to RF ablation. Thus, cryoablation is not feasible in certain anatomical geometries that can be reached by electrical ablation devices.

[0020] The present disclosure may include electrodes configured for RF ablation, cryoablation, and / or irreversible electroporation (IRE). IRE may be interchangeably referred to as pulsed electric field (PEF) ablation and pulsed field ablation (PFA). IRE as discussed in this disclosure is a non-thermal cell death technique that can be used to ablate atrial arrhythmias. To ablate using IRE / PEF, biphasic voltage pulses are applied to destroy cellular structures in the myocardium. The biphasic pulses are non-sinusoidal waveforms and can be tailored to the target cells based on the electrophysiology of the cells. In contrast, to ablate using RF, a sinusoidal voltage waveform is applied to generate heat in the treatment area, indiscriminately heating all cells within the treatment area. Thus, IRE has the ability to spare adjacent heat-sensitive structures or tissues, which may be beneficial in reducing possible complications known with ablation or isolation modalities. Additionally or alternatively, monophasic pulses may be utilized.

[0021] Please refer to FIG. 1, which shows an exemplary catheter-based electrophysiological mapping and ablation system 10. The system 10 includes multiple catheters that are percutaneously inserted by a physician 24 through the vascular system of a patient 23 and into a cavity or vasculature of a heart 12. Typically, a delivery sheath catheter is inserted into the left or right atrium near a desired location of the heart 12. The multiple catheters can then 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 configured to sense IEGMs is illustrated herein. The physician 24 brings the distal tip of the catheter 14 (i.e., end effector 100) into contact with the heart wall to sense a target site within the heart 12. For ablation, the physician 24 similarly brings the distal end of an ablation catheter to a target site for ablation.

[0022] Catheter 14 is an exemplary catheter including one, and preferably multiple electrodes, optionally distributed over end effector 100 and configured to sense IEGM signals, as described herein. Catheter 14 may additionally include a position sensor embedded in or near end effector 100 for tracking the position and orientation of end effector 100. Optionally and preferably, the position sensor is a magnetic-based position sensor including multiple magnetic coils for sensing three-dimensional (3D) position and orientation.

[0023] The magnetic-based position sensor may operate in conjunction with a location pad 25 that includes a plurality of magnetic coils 32 configured to generate a magnetic field within a predetermined working volume. The real-time position of the end effector 100 of the catheter 14 may be tracked based on the magnetic field generated by the location pad 25 and sensed by the magnetic-based position sensor. Details of magnetic-based position sensing technology 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; and 6,892,091, each of which is attached as an appendix hereto.

[0024] The system 10 includes one or more electrode patches 38 positioned for skin contact on the patient 23 to establish a positional reference for the location pads 25 and impedance-based tracking of the electrodes 26. For impedance-based tracking, a current is directed to the electrodes and sensed at the electrode skin patch 38, so that the location of each electrode can be triangulated via the electrode patch 38. Details of impedance-based position tracking technology 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 attached as an appendix hereto.

[0025] Recorder 11 displays electrograms 21 captured by the body surface ECG electrodes 18 and intracardiac electrograms (IEGMs) captured by the electrodes of catheter 14. Recorder 11 may include pacing capability for pacing the cardiac rhythm and / or may be electrically connected to a stand-alone pacer.

[0026] The system 10 may include an ablation energy generator 50 adapted to deliver ablation energy to one or more of the electrodes at the distal tip 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 unipolar or bipolar high voltage direct current pulses, such as may be used to effect irreversible electroporation (IRE), or a combination thereof.

[0027] The patient interface unit (PIU) 30 is an interface configured to establish electrical communication between the catheters, the electrophysiological equipment, a power source, and a workstation 55 that controls the operation of the system 10. The electrophysiological equipment of the system 10 may include, for example, multiple catheters, location pads 25, body 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 implementing real-time calculations of the catheter positions and performing ECG calculations.

[0028] The workstation 55 includes a processor unit having a memory, a memory or storage device loaded with appropriate operating software, and a user interface function. The workstation 55 may optionally provide multiple functions including: (1) modeling the endocardial anatomical structures in three dimensions (3D) and rendering a model or anatomical map 20 for display on the display device 27; (2) displaying activation sequences (or other data) compiled from recorded electrograms 21 in a representative visual display or image superimposed on the rendered anatomical map 20 on the display device 27; (3) displaying real-time positions and orientations of multiple catheters within the cardiac chambers; and (5) displaying sites of interest, such as where ablation energy has been applied, on the display device 27. One commercially available product embodying elements of the system 10 is available as the CARTO™ 3 system, commercially available from Biosense Webster, Inc., 31 Technology Drive, Suite 200, Irvine, CA 92618.

[0029] To achieve the desired stiffness, mapping resolution, electrode contact with the target anatomy, and conformance of the end effectors disclosed herein to flat, curved, irregular, and / or non-planar tissue surfaces found in the target anatomy, the end effectors have a sloped substrate, among other components.

[0030] The disclosed technology includes a system 200 for performing a medical procedure as shown in FIG. 2. The system 200 can include an elongate shaft 230 extending along a longitudinal axis LL from a proximal end 234 to a distal end 232, and an end effector 100 disposed at the distal end 232 of the elongate shaft 230. The elongate shaft 230 can be configured to deliver the end effector 100' from a sheath 210. For simplicity, only a portion of the sheath 210 is shown in FIG. 2. It should be noted that the end effector 100' has alternative configurations relative to the end effector 100 depending on the use case, but the disclosure provided herein is applicable to both embodiments.

[0031] A physician can use the handle 220 to manipulate the elongate shaft 230 and the end effector 100'. Suitable examples of the system 200, as well as its subcomponents, such as the handle 220, the sheath 210, the elongate shaft 230, and others 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 can further include a pull wire (not shown) extending through the elongate shaft 230 and including a distal end (not shown) coupled to the proximal portion 102 (shown in FIG. 3A) of the end effector 100 or 100'. Details of the manipulation of the end effector via the pull wire are described in U.S. Patent Publication No. 2021 / 0369339, which is incorporated herein by reference and included in the appendix attached hereto.

[0032] 3A shows a cross-sectional side view of the end effector 100 or 100' in more detail. The end effector 100 can include a substrate 110 that extends along a longitudinal axis LL from a proximal portion 102 of the end effector 100 or 100' to a distal portion 104 of the end effector 100. The substrate 110 is aligned along a longitudinal plane L. p The longitudinal axis LL is aligned with the longitudinal plane L p A longitudinal plane L extending throughp In other words, the longitudinal plane L p 3A, extends along the longitudinal axis and in a direction into and out of the page, and can effectively bisect the end effector 100, with approximately half of the end effector 100 lying in a longitudinal plane L. p and the other half is located on one side of 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 other side of the longitudinal plane L p (i.e., the first surface 112 may extend in a direction oblique to the longitudinal plane L p 3B , the electrodes 120, 130 may vary in thickness as well. In other words, the end effector 100, i.e., the substrate 110, may be thicker at the proximal portion 102 and narrower toward the distal end 104, which has the effect of gradually reducing the stiffness of the end effector from the proximal portion 102 to the distal portion 104. As will be discussed in more detail in connection with FIG. 3B below, the electrodes 120, 130 may similarly vary in thickness.

[0033] In other words, the first surface 112 at the proximal end and the longitudinal plane L p The distance between the first surface 112 at the distal end and the longitudinal plane L p A second surface 114 opposite the first surface 112 may be disposed on a second side S2 of the substrate 110. The end effector may further include a first group of electrodes 120 disposed on the first surface 112 and a second group of electrodes 130 disposed on the second surface 114.

[0034] The term "surface" refers to both the first surface 112 and the second surface 114, as well as the surface that they lie on in the longitudinal plane L. pAlthough the terms are used to describe how the first and second surfaces 112, 114 relate to each other, it should be understood that the first and second surfaces 112, 114 do not necessarily have to be perfectly planar. The first and second surfaces 112, 114 may have wavy profiles, through holes, scallops, etc., all of which may be included to tailor the stiffness and / or tissue conformity of the end effector 100. Generally, the end effector 100 is generally spatula-shaped. The end effector 100 may further include a substrate having a hollow profile. Additionally, the end effector 100 may include inserts or frame members made from a composite matrix of materials (metal, polymer, ceramic, etc.) stacked in various orientations (longitudinally, vertically, axially, etc.) that may form an array. Such inserts or frame members may be woven, spun, knitted, molded, cast, printed (including three-dimensional printing), or manufactured using any other suitable manufacturing process.

[0035] In some examples, the second surface 114 is aligned with the longitudinal plane L p That is, the second surface 114 may be oblique to the longitudinal plane L p and may be non-parallel to the first surface 112. The second surface 114 is aligned with the longitudinal plane L p , the first surface 112 is aligned with the longitudinal plane L p , such that the second surface 114 is oriented at an angle substantially equal to and opposite to the angle oriented relative to the longitudinal plane L. p In other words, the second surface 114 at the proximal end is a mirror image of the first surface 112 taken across the longitudinal plane L. p The distance between the second surface 114 at the distal end and the longitudinal plane L p may be greater than the distance between

[0036] Alternatively, the first surface 112 may be aligned with the longitudinal plane L p The angle that the first surface 112 lies with respect to the longitudinal plane L pIn other examples, only the first surface 112 or the second surface 114 may be aligned at an angle relative to the longitudinal plane L. p , and the other of the first surface 112 or the second surface 114 may extend in a direction oblique to the longitudinal plane L p It extends in a direction substantially parallel to the

[0037] The end effector 100 is offset from the first surface 112 and aligned with the longitudinal plane L p a first offset plane P1 that is parallel to the first surface 114 and offset from the second surface 114 and parallel to the longitudinal plane L p and a second offset plane P2 that is parallel to the longitudinal plane L. In some examples, the first group of electrodes 120 can extend outward from the first surface 112 to the first offset plane P1, and the second group of electrodes 130 can extend outward from the second surface 114 to the second offset plane P2. In other words, the first group of electrodes 120 can be aligned with the longitudinal plane L when the end effector 100 is placed on a flat surface. p Alternatively, the plane P1 may be offset from the first surface 112 and may extend parallel to the longitudinal plane L. p , such that some or all of the first group of electrodes 120 can protrude from the first face 112, and when the end effector 100 is placed on a flat surface, the first face 112 lies approximately parallel to the flat surface. Any of these configurations for the first group of electrodes 120 can be combined with a similar configuration for the second group of electrodes 130.

[0038] In other words, the disclosed technology includes a non-planar end effector 100 for a mapping or ablation catheter. Although the end effector 100 and the substrate 110 may be described as non-planar, some subcomponents may reside in a planar plane. For example, as described in more detail below, the contact surfaces 122 of the first group of electrodes 120 may lie in a planar plane, and the non-conductive flexible material 150 may result in the end effector 100 having a generally flat outer profile. The term "non-planar" used in connection with the end effector 100 is not meant to exclude these examples. The end effector 100 is defined by a longitudinal plane L that extends from the proximal end 102 of the end effector 100 to the distal end 104 of the end effector 100 along a longitudinal axis LL. p The substrate 110 may include a slanted substrate 110 extending along a longitudinal plane L. p The non-planar end effector 100 may be gradually thinner in a direction OO perpendicular to the direction of the tilted substrate 110. The non-planar end effector 100 may include a first plurality of electrodes 120 disposed on a first side 112 of the tilted substrate 110 and a second plurality of electrodes 130 disposed on a second side 114 of the tilted substrate 110. In some examples, the tilted substrate 110 may be a flexible circuit. In some examples, the flexible circuit may be made primarily of polyimide. In other examples, it may be made of either biocompatible polyimide, glass-reinforced epoxy laminate material, copper, or graphene, alone or in combination with other biocompatible materials or in combination with each other. The flexible circuit may include conductive traces connecting the first group of electrodes 120 and the second group of electrodes 130 to components of the system 10 for at least the purposes of acquiring signals and delivering energy.

[0039] As shown in FIG. 3B, the first group of electrodes 120 each have an individual height H from the first surface 112 to the first offset plane P1. I1 In some examples, the second group of electrodes 130 may each have an individual height H from the second surface 114 to the second offset plane P2. I2As can be seen in FIG. 3B, the individual height H of the more distal first electrodes 120 I1 is 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 the individual height H of the more proximal second electrode 130 I2 In some examples, such as that shown in FIG. 3A, this trend may be true for the entire end effector 100, where the individual heights H I1 and H I2 is greater than the height of the electrodes 120, 130 positioned more proximally, i.e., closer to the proximal end 102 of the end effector 100. In some examples, the individual height H I1 is the individual height H of each second electrode 130 that is similarly positioned relative to the longitudinal axis, or in other words, the second electrodes 130 that are equally distant from the proximal end 102 of the end effector 100. I2 The first offset plane P1 can be equal to the longitudinal plane L p The second offset plane P2 may be parallel to the longitudinal plane L and separated from the longitudinal plane by a first distance D1. p Parallel to the longitudinal plane L by a second distance D2 p 3B. 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 can include a respective plurality of first contact surfaces 122. The second plurality of electrodes 130 can include a respective plurality of second contact surfaces 132. The plurality of first contact surfaces 122 and the plurality of second contact surfaces 132 are aligned along a longitudinal plane L, as shown in FIG. p1. The contact surface 122 is a surface of the electrode 120 that lies in the first offset plane P1 and is configured to contact tissue targeted for sensing and / or ablation. As used herein, the term "contact" can refer to a component that contacts tissue or can refer to electrical contact. For example, the contact surface 122 can be coated or otherwise prevented from touching tissue, but still be capable of delivering (e.g., ablating tissue) or receiving (e.g., acquiring a physiological signal such as propagating a current through cardiac tissue) electrical current passing through the tissue.

[0040] In another example shown in FIG. 4A, the end effector 100 is aligned along a longitudinal plane L p 1, and the electrodes 120, 130 are flat relative to the first face 112 and the second face 114. Thus, the first electrode 120 and the second electrode 130 extend to a first offset plane P1 and a second offset plane P2, respectively, having the same height. In other words, the distal end 106a of the first face 112 is spaced apart from the first distal distance D D1 4B), and the proximal end 108a of the first face 112 is separated from the first offset plane P1 by a first proximal distance D P1 4C ) from a first offset plane P1 by a first distal distance D D1 is the first proximal distance D P1 That is, the first proximal distance D P1 is the first distal distance D D1 In some examples, this results in the first group of electrodes 120 having a uniform height and lying flat and parallel to the first surface 112.

[0041] In some examples, the distal end 106b of the second surface 114 is spaced apart from the second distal distance D D2 4B), and the proximal end 108b of the second surface 114 is separated from the second offset plane P2 by a second proximal distance D P24C ) from a second offset plane P2 by a second distal distance D D2 is the second proximal distance D P2 That is, the second proximal distance D P2 is the second distal distance D D2 4B, the plurality of first contact surfaces 122 can be parallel to the first surface 112 and the plurality of second contact surfaces 132 can be parallel to the second surface 114. Again, this can result in the end effector 100 in some instances being narrower at the distal end 104 than at the proximal end 102, and thus having a gradually decreasing stiffness in the distal direction DD. This narrowing can increase the ability of the end effector 100 to conform to a tissue surface, thus allowing the electrodes 120, 130 to better contact the tissue and more effectively acquire signals and / or deliver ablation energy.

[0042] In some examples, for example, the end effector 100 is aligned along the longitudinal plane L p When the first proximal distance D P1 is the second proximal distance D P2 and the first distal distance D D1 is the second distal distance D D2 Therefore, the longitudinal plane L p The amount of substrate 110 located on side S1 and side S2 is equal.

[0043] In some examples, the first group of electrodes 120 can include at least one first mapping electrode and / or at least one first ablation electrode. The second group of electrodes 130 can include at least one second mapping electrode and / or at least one second ablation electrode. The electrodes 120 and 130 can be configured to detect electrophysiological signals or deliver ablation energy (AC or DC) from an energy generator to tissue according to various ablation methods (e.g., RF, IRE, etc.) previously described. The cross-sectional profile as shown in Figures 3A-4C and the non-planar nature of the end effector 100 improves the ability of the end effector 100 (and thus the electrodes 120, 130) to conform to tissue, acquire signals, and deliver energy.

[0044] 5A illustrates a view of a first side 112 of the end effector. As shown, the first group of electrodes 120 can be arranged on the first side 112 such that a distal subset 128 of the first group of electrodes 120 is closer to the distal portion 104 than a proximal subset 126 of the first group of electrodes 120. The distal subset 128 of the first group of electrodes 120 can include approximately twice as many electrodes as the proximal subset 126 of the first group of electrodes 120. In general, there can be more first electrodes 120 in the distal subset 128 than in the proximal subset 126.

[0045] The same may be true for the second surface 114 and the distribution of the second group of electrodes 130. As shown in Figure 5B, the second group of electrodes 130 may be arranged on the second surface 114 such 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, the distal subset 138 of the second group of electrodes 130 including approximately twice as many electrodes as the proximal subset 136 of the second group of electrodes 130.

[0046] 3A-4C, at least a portion of the first group of electrodes 120 are aligned along the longitudinal plane L pIn a direction OO perpendicular to the axial direction, the first electrodes 120 and the second electrodes 130 may be aligned with at least a portion of the second group of electrodes 130 to form respective aligned pairs of the first electrodes 120 and the second electrodes 130.

[0047] The aligned pair of electrodes may be aligned generally transverse to the longitudinal axis LL. As will be appreciated by one skilled in the art, opposing electrode pairs may be utilized to provide noise cancellation, with one electrode sensing tissue directly and the opposing electrode sensing the far-field signal, which may typically include noise.

[0048] 5A and 5B are diagrams showing a structure of a substrate 110 and a longitudinal plane L p 1 shows a framework 140 that is coplanar with the end effector 100. The framework 140 can include a plurality of tines 142 that are joined proximate to and extend distally from the proximal end 108 of the end effector 100. The plurality of tines 142 can include two outer tines 144 and two inner tines 146, the outer tines 144 and the inner tines 146 being disposed on opposite sides of the longitudinal axis LL. In some examples, the two inner tines 146 progressively narrow in the distal direction DD. The narrowing of the tines 142 can be configured to adjust the bending stiffness of the end effector 100. The aligned pair of first and second electrodes can be aligned with the framework 140 in the orthogonal direction OO. In some examples, the substrate 110 can further define a plurality of elongated slots 116 that lie substantially parallel to the longitudinal axis LL and are disposed between each outer tine 144 and inner tine 146. The elongated slots 116 may be shaped to modify the bending and torsional stiffness (rotation about the longitudinal axis LL) of the end effector 100 to allow the end effector 100 to conform to the tissue surface.

[0049] The framework 140 can be thought of as a number of fork-like stiffening members that act to provide support to the end effector 100 .

[0050] The framework 140 can be formed from a planar or cylindrical stock of material using any suitable method. For example, the framework 140 can be formed by cutting, laser cutting, stamping, etc. In some examples, the substrate 110 can include a flexible circuit. In some examples, the substrate 110 can include a framework, such as the framework 140 described above. The framework 140 can include Nitinol.

[0051] As shown in FIG. 6, the end effector 100 can be at least partially encapsulated by a non-conductive flexible material 150. The non-conductive flexible material 150 can enhance the atraumatic nature of the end effector 100 and function at least partially to protect the subject from sharp edges. In some examples, the flexible non-conductive material 150 can include a biocompatible silicone. In other examples, the flexible non-conductive material 150 can include a biocompatible flexible polymer, a thermoelastic polymer material, and a dielectric material. The flexible non-conductive material 150 can optionally be colored to facilitate laser cutting. In some examples, the framework 140 can be secured to the substrate 110 by the non-conductive flexible encapsulating material 150. The contact surfaces 122 and 132 can be exposed to the surrounding environment through the non-conductive flexible material 150.

[0052] Additionally, the non-conductive flexible material 150 can be thickened at various points in the longitudinal direction LL and the orthogonal direction OO to have a profile that complements the variable stiffness of the substrate 110. For example, the framework 150 can be shaped to contribute 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 additionally, the flexible material 150 can be formed to facilitate folding / creasing of the end effector between columns, rows, and / or portions (e.g., portions 126, 128, 136, and 138 shown in Figures 5A and 5B) or electrodes. The flexible non-conductive material 150 can also form a blunt distal end 104.

[0053] 7A-7C illustrate a method 700 for providing a reinforced flexible end effector. The method 700 may, in some examples, provide the end effector 100 detailed above, along with all of its components and subcomponents. As shown in FIG. 7A, the method 700 may include forming a substrate along a longitudinal plane extending along a longitudinal axis from a proximal end to a distal end (702), forming a first face on a first side of the substrate (704), forming a second face on a second side of the substrate opposite the first side (706), sloping the first face toward the longitudinal plane (708) as the first face extends from the proximal end of the substrate to the distal end of the substrate (710), and forming a first group of electrodes along the first face and forming a second group of electrodes along the second face (712).

[0054] 7B illustrates a method further including sloping (709) the second surface toward the longitudinal plane as the second surface extends from the proximal end of the substrate to the distal end of the substrate. The method may further include sizing (714) each electrode of the first group of electrodes to include a first electrode height that extends from the first surface to the first offset plane. The method 700 may include sizing (716) each electrode of the second group of electrodes to include a second electrode height that extends from the second surface to the second offset plane.

[0055] As shown in FIG. 7C , forming the first group of electrodes (710) can include distributing the first group of electrodes (711) such 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, the distal subset of the first group of electrodes including approximately twice as many electrodes as the proximal subset of the first group of electrodes.

[0056] The method 700 may further include forming 712 a second group of electrodes. Forming 712 the second group of electrodes may include distributing 713 the second group of electrodes such that a distal subset of the second group of electrodes is closer to a distal portion than a proximal subset of the second group of electrodes, the distal subset of the second group of electrodes including approximately twice as many electrodes as the proximal subset of the second group of electrodes.

[0057] Additionally, the method 700 may include aligning (718) at least a portion of the electrodes of the first group with at least a portion of the electrodes of the second group in a direction orthogonal to the longitudinal plane to form respective aligned pairs of the first and second electrodes. The method 700 may include forming (720) a framework that resides substantially in the longitudinal plane and aligning (722) the aligned pairs of the first and second electrodes with the framework in the orthogonal direction. The method 700 may further include encapsulating (724) the end effector with a non-conductive flexible material.

[0058] It should be understood that the just-described method 700 may include more or less steps or features than those described. Additionally, the steps or features may be performed in different orders and should not be construed as requiring performance in any particular order.

[0059] The techniques of the present disclosure described herein can be further understood according to the following sections.

[0060] Clause 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, the substrate comprising a longitudinal plane, the longitudinal axis extending through the longitudinal plane, a first surface disposed on a first side of the substrate and oblique to the longitudinal plane, a second surface disposed on a second side of the substrate opposite the first surface, a first group of electrodes disposed on the first surface, and a second group of electrodes disposed on the second surface.

[0061] Clause 2: The end effector of clause 1, wherein the second surface is oblique to the longitudinal plane.

[0062] Clause 3: The end effector described in Clause 1, further comprising a first offset plane offset from the first surface and parallel to the longitudinal plane, and a second offset plane offset from the second surface and parallel to the longitudinal plane.

[0063] Clause 4: An end effector as described in clause 3, wherein the first group of electrodes extend outward from the first surface to a first offset plane.

[0064] Clause 5: An end effector as described in clause 4, wherein the second group of electrodes extend outwardly from the second surface to a second offset plane.

[0065] Clause 6: An end effector as described in clause 3, wherein the first group of electrodes each include an individual height from the first surface to the first offset plane.

[0066] Clause 7: An end effector as described in clause 6, wherein the second group of electrodes each include an individual height from the second surface to the second offset plane.

[0067] 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.

[0068] 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.

[0069] Clause 10: The end effector of clause 9, wherein the second distance is equal to the first distance.

[0070] Clause 11: An end effector as described in Clause 3, wherein a distal end of the first surface is separated from the first offset plane by a first distal distance and a proximal end of the first surface is separated from the first offset plane by a first proximal distance, the first distal distance not equal to the first proximal distance.

[0071] Clause 12: An end effector as described in Clause 11, wherein a distal end of the second surface is separated from the second offset plane by a second distal distance and a proximal end of the second surface is separated from the second offset plane by a second proximal distance, the second distal distance not equal to the second proximal distance.

[0072] Clause 13: The end effector of clause 12, wherein the first proximal distance is equal to the second proximal distance and the first distal distance is equal to the second distal distance.

[0073] Clause 14: An end effector described in any of clauses 1 to 13, wherein the first group of electrodes are arranged on the first surface such 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 comprises approximately twice as many electrodes as the proximal subset of the first group of electrodes.

[0074] Clause 15: An end effector described in any of clauses 1 to 14, wherein the second group of electrodes are arranged on the second surface such that a distal subset of the second group of electrodes is closer to a distal portion than a proximal subset of the second group of electrodes, and the distal subset of the second group of electrodes comprises approximately twice as many electrodes as the proximal subset of the second group of electrodes.

[0075] Clause 16: An end effector described in any of clauses 1 to 15, wherein at least a portion of the electrodes of the first group are aligned with at least a portion of the electrodes of the second group in a direction perpendicular to the longitudinal plane so as to form respective aligned pairs of the first electrodes and the second electrodes.

[0076] Clause 17: An end effector described in any of clauses 1-16, further comprising a framework present within the substrate and coplanar with the longitudinal plane.

[0077] Clause 18: An end effector as described in clause 17, wherein the framework comprises a plurality of tines, the plurality of tines being joined proximate to a proximal end of the end effector and extending distally therefrom.

[0078] Clause 19: An end effector as described in clause 18, wherein the plurality of tines includes two outer tines and two inner tines, the outer tines and the inner tines being arranged on opposite sides of the longitudinal axis.

[0079] Clause 20: The end effector of clause 19, wherein the two inner tines progressively narrow in a distal direction.

[0080] Clause 21: An end effector described in any of clauses 16 to 20, wherein the aligned pair of first and second electrodes are aligned with the framework in an orthogonal direction.

[0081] Clause 22: An end effector described in any of clauses 19 to 21, wherein the substrate further defines a plurality of elongated slots, the elongated slots being generally parallel to the longitudinal axis and positioned between each outer tine and inner tine.

[0082] Clause 23: An end effector described in any one of clauses 1 to 22, wherein the substrate comprises a flexible circuit.

[0083] Clause 24: An end effector described in any one of clauses 1 to 16, wherein the substrate comprises a framework.

[0084] Clause 25: An end effector as described in clause 24, wherein the framework comprises a plurality of tines, the plurality of tines being joined proximate to a proximal end of the end effector and extending distally therefrom.

[0085] Clause 26: An end effector as described in clause 25, wherein the plurality of tines includes two outer tines and two inner tines, the outer tines and the inner tines being arranged on opposite sides of the longitudinal axis.

[0086] Clause 27: The end effector of clause 26, wherein the two inner tines progressively narrow in a distal direction.

[0087] Clause 28: An end effector described in any of clauses 24 to 27, wherein the framework comprises Nitinol.

[0088] Clause 29: An end effector described in any of clauses 1 to 28, at least partially encapsulated by a non-conductive flexible material.

[0089] Clause 30: An end effector described in any of clauses 1 to 29, wherein the first group of electrodes comprises at least one first mapping electrode.

[0090] Clause 31: An end effector described in any of clauses 1 to 30, wherein the first group of electrodes comprises at least one first ablation electrode.

[0091] Clause 32: An end effector described in any of clauses 1 to 31, wherein the second group of electrodes comprises at least one second mapping electrode.

[0092] Clause 33: An end effector described in any of clauses 1 to 32, wherein the second group of electrodes comprises at least one second ablation electrode.

[0093] Clause 34: A non-planar end effector for a mapping catheter, the end effector comprising: a sloped substrate extending along a longitudinal plane extending along a longitudinal axis from a proximal end of the end effector to a distal end of the end effector, the substrate gradually thinning in a direction perpendicular to the longitudinal plane; and a first plurality of electrodes disposed on a first surface of the sloped substrate and a second plurality of electrodes disposed on a second surface of the sloped substrate.

[0094] Clause 35: The end effector of clause 34, wherein the substrate further defines a plurality of elongated slots, the elongated slots being generally parallel to the longitudinal axis.

[0095] Clause 36: An end effector described in any of clauses 34 to 35, wherein the first plurality of electrodes have respective multiple first contact surfaces, the multiple first contact surfaces being parallel to the first plane.

[0096] Clause 37: A non-planar end effector described in any of clauses 34 to 35, wherein the first plurality of electrodes have respective plurality of first contact surfaces, the plurality of first contact surfaces being parallel to the longitudinal plane.

[0097] Clause 38: An end effector described in any of clauses 34 to 37, wherein the second plurality of electrodes have respective multiple second contact surfaces, the multiple second contact surfaces being parallel to the second plane.

[0098] Clause 39: An end effector described in any of clauses 34 to 37, wherein the second plurality of electrodes have respective multiple second contact surfaces, the multiple second contact surfaces being parallel to the longitudinal plane.

[0099] Clause 40: An end effector described in any of clauses 34 to 39, wherein the first plurality of electrodes are arranged on the first surface such that a distal subset of the first plurality of electrodes is closer to a distal end than a proximal subset of the first plurality of electrodes, and the distal subset of the first plurality of electrodes comprises approximately twice as many electrodes as the proximal subset of the first plurality of electrodes.

[0100] Clause 41: An end effector described in any of clauses 34 to 40, wherein the second plurality of electrodes are arranged on the second surface such that a distal subset of the second plurality of electrodes is closer to a distal end than a proximal subset of the second plurality of electrodes, and the distal subset of the second plurality of electrodes comprises approximately twice the number of electrodes as the proximal subset of the second plurality of electrodes.

[0101] Clause 42: An end effector described in any one of clauses 34 to 41, wherein the inclined substrate is a flex circuit.

[0102] Clause 43: An end effector described in any of clauses 34 to 42, wherein the end effector further comprises a framework secured to the substrate by a non-conductive flexible encapsulating material.

[0103] Clause 44: An end effector described in any one of clauses 34 to 41, wherein the inclined substrate is a framework.

[0104] Clause 45: An end effector described in any of clauses 43 to 44, wherein the framework comprises a plurality of tines, the plurality of tines being joined proximate to a proximal end of the end effector and extending distally therefrom.

[0105] Clause 46: An end effector as described in Clause 45, wherein the plurality of tines includes two outer tines and two inner tines, the outer tines and the inner tines being arranged on opposite sides of the longitudinal axis.

[0106] Clause 47: The end effector of clause 46, wherein the two inner tines progressively narrow in a distal direction.

[0107] Clause 48: An end effector described in any of clauses 43 to 47, wherein each of the first plurality of electrodes is aligned with a respective second electrode and framework in an orthogonal direction.

[0108] Clause 49: An end effector described in any of clauses 43 to 48, wherein the framework comprises Nitinol.

[0109] Clause 50: An end effector described in any of clauses 34 to 48, wherein the first plurality of electrodes comprises at least one first mapping electrode.

[0110] Clause 51: An end effector described in any of clauses 34 to 50, wherein the first plurality of electrodes comprises at least one first ablation electrode.

[0111] Clause 52: An end effector described in any of clauses 34 to 51, wherein the second plurality of electrodes comprises at least one second mapping electrode.

[0112] Clause 53: An end effector described in any of clauses 34 to 52, wherein the second plurality of electrodes comprises at least one second ablation electrode.

[0113] Clause 54: A system for performing a medical procedure, the system comprising: an elongate shaft extending along a longitudinal axis from a proximal end to a distal end; and an end effector disposed at the distal end of the elongate shaft, the end effector comprising a substrate extending along the longitudinal axis from a proximal portion of the end effector to a distal portion of the end effector, the substrate comprising a first surface disposed on a first side of a longitudinal plane and oblique to the longitudinal plane, a second surface disposed on a second side of the longitudinal plane and oblique 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.

[0114] Clause 55: The system described in Clause 54, further comprising a pull wire extending through the elongate shaft and having a distal end coupled to a proximal portion of the end effector.

[0115] Clause 56: The system described in clause 54, wherein the second surface is oblique to the longitudinal plane.

[0116] Clause 57: The end effector described in Clause 54, further comprising a first offset plane offset from the first surface and parallel to the longitudinal plane, and a second offset plane offset from the second surface and parallel to the longitudinal plane.

[0117] Clause 58: The system described in Clause 57, wherein the first group of electrodes extends outwardly from the first surface to a first offset plane.

[0118] Clause 59: The system described in clause 58, wherein a second group of electrodes extends outwardly from the second surface to a second offset plane.

[0119] Clause 60: The system described in Clause 57, wherein the first group of electrodes each include an individual height from the first surface to the first offset plane.

[0120] Clause 61: The system described in Clause 60, wherein the second group of electrodes each include an individual height from the second surface to the second offset plane.

[0121] Clause 62: The system described in Clause 57, wherein the first offset plane is parallel to the longitudinal plane and separated from the longitudinal plane by a first distance.

[0122] 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.

[0123] Clause 64: The system of clause 63, wherein the second distance is equal to the first distance.

[0124] Clause 65: The system described in Clause 57, wherein a distal end of the first surface is separated from the first offset plane by a first distal distance and a proximal end of the first surface is separated from the first offset plane by a first proximal distance, the first distal distance not equal to the first proximal distance.

[0125] Clause 66: The system described in Clause 65, wherein a distal end of the second surface is separated from the second offset plane by a second distal distance and a proximal end of the second surface is separated from the second offset plane by a second proximal distance, the second distal distance not equal to the second proximal distance.

[0126] Clause 67: The system described in Clause 66, wherein the first proximal distance is equal to the second proximal distance and the first distal distance is equal to the second distal distance.

[0127] Clause 68: A system described in any of clauses 54 to 67, wherein the first group of electrodes are arranged on the first surface such 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 comprises approximately twice as many electrodes as the proximal subset of the first group of electrodes.

[0128] Clause 69: A system described in any of clauses 54 to 68, wherein the second group of electrodes are arranged on the second surface such that a distal subset of the second group of electrodes is closer to a distal portion than a proximal subset of the second group of electrodes, and the distal subset of the second group of electrodes comprises approximately twice as many electrodes as the proximal subset of the second group of electrodes.

[0129] Clause 70: A system described in any of clauses 54 to 69, wherein at least a portion of the electrodes of the first group are aligned with at least a portion of the electrodes of the second group in a direction perpendicular to the longitudinal plane so as to form respective aligned pairs of the first and second electrodes.

[0130] Clause 71: A system described in any of clauses 54 to 70, further comprising a framework present within the substrate and coplanar with the longitudinal plane.

[0131] Clause 72: The system described in Clause 71, wherein the framework comprises a plurality of tines, the plurality of tines being joined proximate to a proximal end of the end effector and extending distally therefrom.

[0132] Clause 73: The system described in Clause 72, wherein the plurality of tines includes two outer tines and two inner tines, the outer tines and the inner tines being arranged on opposite sides of the longitudinal axis.

[0133] Clause 74: The system described in Clause 73, wherein the two inner tines progressively narrow in the distal direction.

[0134] Clause 75: A system described in any of clauses 70 to 74, wherein the aligned pair of first and second electrodes are aligned with the framework in an orthogonal direction.

[0135] Clause 76: A system described in any of clauses 73 to 75, wherein the substrate further defines a plurality of elongated slots, the elongated slots being generally parallel to the longitudinal axis and positioned between the outer tines and the inner tines.

[0136] Clause 77: A system described in any one of clauses 54 to 76, wherein the substrate comprises a flexible circuit.

[0137] Clause 78: A system described in any one of clauses 54 to 70, wherein the substrate comprises a framework.

[0138] Clause 79: The system described in Clause 78, wherein the framework comprises a plurality of tines, the plurality of tines being joined proximate to a proximal end of the end effector and extending distally therefrom.

[0139] Clause 80: The system described in Clause 79, wherein the plurality of tines includes two outer tines and two inner tines, the outer tines and the inner tines being arranged on opposite sides of the longitudinal axis.

[0140] Clause 81: The system described in clause 80, wherein the two inner tines progressively narrow in the distal direction.

[0141] Clause 82: A system described in any of clauses 78 to 81, wherein the framework comprises Nitinol.

[0142] Clause 83: A system described in any of clauses 54 to 82, at least partially encapsulated by a non-conductive flexible material.

[0143] Clause 84: A system described in any of clauses 54 to 83, wherein the first group of electrodes comprises at least one first mapping electrode.

[0144] Clause 85: A system described in any of clauses 54 to 84, wherein the first group of electrodes includes at least one first ablation electrode.

[0145] Clause 86: A system described in any of clauses 54 to 85, wherein the second group of electrodes includes at least one second mapping electrode.

[0146] Clause 87: A system described in any of clauses 54 to 86, wherein the second group of electrodes includes at least one second ablation electrode.

[0147] Clause 88: A method of providing a reinforced flexible end effector, the method comprising: forming a substrate along a longitudinal plane extending along a longitudinal axis from a proximal end to a distal end; forming a first surface on a first side of the substrate; forming a second surface on a second side of the substrate opposite the first side; inclining 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 a first group of electrodes along the first surface; and forming a second group of electrodes along the second surface.

[0148] Clause 89: The method of clause 88, further comprising inclining the second surface toward the longitudinal plane as the second surface extends from the proximal end of the substrate to the distal end of the substrate.

[0149] Clause 90: The method of any of clauses 88-89, further comprising sizing each electrode of the first group of electrodes to include a first electrode height extending from the first surface to the first offset plane.

[0150] Article 91: The method of any of clauses 88-90, further comprising sizing each electrode of the second group of electrodes to include a second electrode height extending from the second surface to the second offset plane.

[0151] Clause 92: The method of clause 91, wherein the first offset plane is parallel to and separate from the longitudinal plane, and the second offset plane is parallel to and separate from the longitudinal plane.

[0152] Clause 93: The method of clause 90, wherein the first offset plane is oblique to and separate from the longitudinal plane, and the second offset plane is oblique to and separate from the longitudinal plane.

[0153] Clause 94: A method according to any of clauses 88 to 93, wherein forming the first group of electrodes includes distributing the first group of electrodes such 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, the distal subset of the first group of electrodes comprising approximately twice as many electrodes as the proximal subset of the first group of electrodes.

[0154] Clause 95: A method according to any of clauses 88 to 94, wherein forming the second group of electrodes includes distributing the second group of electrodes such 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, the distal subset of the second group of electrodes comprising approximately twice as many electrodes as the proximal subset of the second group of electrodes.

[0155] Clause 96: The method of clause 95, further comprising aligning at least a portion of the electrodes of the first group with at least a portion of the electrodes of the second group in a direction perpendicular to the longitudinal plane to form respective aligned pairs of the first electrodes and second electrodes.

[0156] Clause 97: The method of clause 96, further comprising forming a framework that lies substantially in a longitudinal plane.

[0157] Clause 98: The method of clause 97, further comprising aligning the aligned pair of first and second electrodes with the framework in an orthogonal direction.

[0158] Clause 99: The method of clause 98, further comprising encapsulating the end effector with a non-conductive flexible material.

[0159] Clause 100: A method according to any of clauses 88 to 99, wherein the first group of electrodes comprises at least one first mapping electrode.

[0160] Clause 101: A method according to any of clauses 88 to 100, wherein the first group of electrodes includes at least one first ablation electrode.

[0161] Clause 102: A method according to any of clauses 88 to 101, wherein the second group of electrodes includes at least one second mapping electrode.

[0162] Clause 103: A method according to any of clauses 88 to 102, wherein the second group of electrodes includes at least one second ablation electrode.

[0163] [Embodiment] (1) An end effector for a catheter, comprising: a substrate extending along a longitudinal axis from a proximal portion of the end effector to a distal portion of the end effector, the substrate comprising: a longitudinal plane, the longitudinal axis extending through the longitudinal plane; a first surface disposed on a first side of the substrate and oblique to the longitudinal plane; a second surface opposite the first surface disposed on a second side of the substrate; a first group of electrodes disposed on the first surface; a second group of electrodes disposed on the second surface. (2) An end effector as described in embodiment 1, wherein the second surface is oblique to the longitudinal plane. (3) a first offset plane that is offset from the first surface and parallel to the longitudinal plane; and An end effector as described in embodiment 1, further comprising a second offset plane offset from the second surface and parallel to the longitudinal plane. (4) An end effector as described in embodiment 3, wherein the first group of electrodes extend outward from the first surface to the first offset plane. (5) An end effector as described in embodiment 4, wherein the second group of electrodes extend outward from the second surface to the second offset plane.

[0164] (6) An end effector as described in embodiment 3, wherein the first group of electrodes each include an individual height from the first surface to the first offset plane. (7) An end effector as described in embodiment 6, wherein the second group of electrodes each includes an individual height from the second surface to the second offset plane. (8) The end effector of embodiment 7, wherein the first group of electrodes are arranged on the first surface such 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 comprises approximately twice as many electrodes as the proximal subset of the first group of electrodes. (9) The end effector of embodiment 8, wherein the second group of electrodes are arranged on the second surface such 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 comprises approximately twice as many electrodes as the proximal subset of the second group of electrodes. (10) An end effector as described in embodiment 9, wherein at least a portion of the first group of electrodes are aligned with at least a portion of the second group of electrodes in a direction perpendicular to the longitudinal plane to form respective aligned pairs of first and second electrodes.

[0165] (11) The end effector of claim 10, further comprising a framework present within the base material and coplanar with the longitudinal plane. (12) An end effector as described in embodiment 3, wherein the first offset plane is parallel to the longitudinal plane and separated from the longitudinal plane by a first distance. (13) The end effector of embodiment 12, wherein the second offset plane is parallel to the longitudinal plane and separated from the longitudinal plane by a second distance. (14) A distal end of the first surface is separated from the first offset plane by a first distal distance; a proximal end of the first surface is separated from the first offset plane by a first proximal distance; An end effector as described in embodiment 3, wherein the first distal distance is not equal to the first proximal distance. (15) A distal end of the second surface is separated from the second offset plane by a second distal distance; a proximal end of the second surface is separated from the second offset plane by a second proximal distance; An end effector as described in embodiment 14, wherein the second distal distance is not equal to the second proximal distance.

[0166] (16) The end effector of embodiment 15, wherein the first proximal distance is equal to the second proximal distance and 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: a sloped 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 sloped substrate tapering in a direction perpendicular to the longitudinal plane; a first plurality of electrodes disposed on a first surface of the sloped substrate; and a second plurality of electrodes disposed on a second surface of the sloped substrate. (18) The non-planar end effector of embodiment 17, wherein the first plurality of electrodes comprises a respective plurality of first contact surfaces, the plurality of first contact surfaces being parallel to the first plane. (19) The non-planar end effector of embodiment 17, wherein the first plurality of electrodes comprises a respective plurality of first contact surfaces, the plurality of first contact surfaces being parallel to the longitudinal plane. (20) A system for performing a medical procedure comprising: an elongate shaft extending along a longitudinal axis from a proximal end to a distal end; and an end effector disposed at the distal end of the elongate shaft, 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, the substrate comprising a first surface disposed on a first side of a longitudinal plane and oblique to the longitudinal plane, a second surface disposed on a second side of the longitudinal plane and oblique 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.

Claims

1. 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, the substrate comprising: a longitudinal plane, the longitudinal axis extending through the longitudinal plane; a first surface disposed on a first side of the substrate and oblique to the longitudinal plane; a second surface opposite the first surface disposed on a second side of the substrate; a first group of electrodes disposed on the first surface; a second group of electrodes disposed on the second surface.

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

3. a first offset plane offset from the first surface and parallel to the longitudinal plane; The end effector of claim 1 , further comprising a second offset plane offset from the second surface and parallel to the longitudinal plane.

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

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

6. The end effector of claim 3 , wherein the first group of electrodes each include a respective height from the first surface to the first offset plane.

7. The end effector of claim 6 , wherein the second group of electrodes each include a respective height from the second surface to the second offset plane.

8. 8. The end effector of claim 7, wherein the first group of electrodes are arranged on the first surface such 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, the distal subset of the first group of electrodes comprising approximately twice as many electrodes as the proximal subset of the first group of electrodes.

9. 9. The end effector of claim 8, wherein the second group of electrodes are arranged on the second surface such 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, the distal subset of the second group of electrodes comprising approximately twice as many electrodes as the proximal subset of the second group of electrodes.

10. 10. The end effector of claim 9, wherein at least a portion of the first group of electrodes are aligned with at least a portion of the second group of electrodes in a direction perpendicular to the longitudinal plane to form respective aligned pairs of first and second electrodes.

11. The end effector of claim 10 , further comprising a framework within the base material and coplanar with the longitudinal plane.

12. The end effector of claim 3 , wherein the first offset plane is parallel to the longitudinal plane and separated from the longitudinal plane by a first distance.

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

14. a distal end of the first surface is separated from the first offset plane by a first distal distance; a proximal end of the first surface is separated from the first offset plane by a first proximal distance; The end effector of claim 3 , wherein the first distal distance is not equal to the first proximal distance.

15. a distal end of the second surface is separated from the second offset plane by a second distal distance; a proximal end of the second surface is separated from the second offset plane by a second proximal distance; The end effector of claim 14 , wherein the second distal distance is not equal to the second proximal distance.

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

17. 1. A non-planar end effector for a mapping catheter, the non-planar end effector comprising: a beveled 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 beveled substrate tapering in a direction perpendicular to the longitudinal plane; a first plurality of electrodes disposed on a first surface of the beveled substrate; and a second plurality of electrodes disposed on a second surface of the beveled substrate.

18. The non-planar end effector of claim 17 , wherein the first plurality of electrodes comprises a respective plurality of first contact surfaces, the plurality of first contact surfaces being parallel to the first surface.

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

20. 1. A system for performing a medical procedure comprising: an elongate shaft extending along a longitudinal axis from a proximal end to a distal end; and an end effector disposed at the distal end of the elongate shaft, 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, the substrate comprising a first surface disposed on a first side of a longitudinal plane and oblique to the longitudinal plane, a second surface disposed on a second side of the longitudinal plane and oblique 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.

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