CN118021426A - Electrode catheter with corrugated support structure - Google Patents

Abstract

An actuator having a support frame with one or more corrugated struts is presented herein. The corrugations of the strut increase the transverse stiffness of the strut and decrease the axial bending stiffness of the strut compared to a linear, non-corrugated strut of similar thickness. The geometry of the corrugations may be selected to provide conformal contact of the end effector with tissue while maintaining a desired spatial relationship between the electrodes of the end effector. The geometry may be selected to include the amplitude of the undulations, the wavelength of the undulations, and the placement of a particular geometry within the end effector.

Description

Electrode catheter with corrugated support structure

Cross-reference to related patent applications

The present application claims priority from U.S. provisional patent application No. 63/383,445, previously filed on 11/2022, which provisional patent application is hereby incorporated by reference in its entirety.

Technical Field

The present invention relates generally to catheter-based medical devices, and in particular to catheters having multi-electrode end effectors.

Background

When a region of cardiac tissue abnormally conducts electrical signals to adjacent tissue, an arrhythmia, such as atrial fibrillation, will occur, disrupting the normal cardiac cycle and causing arrhythmia. The source of unwanted signals may be located in the tissues of the atria or ventricles. Unwanted signals are conducted through the heart tissue elsewhere where they can cause or sustain an arrhythmia.

Procedures for treating arrhythmias may include mapping electrical properties of endocardium and heart volume, and selectively ablating cardiac tissue by applying electrical energy, typically in the form of Radio Frequency (RF) signals, and more recently in the form of pulsed signals, to induce irreversible electroporation (IRE). By this procedure, the propagation of unwanted electrical signals from one part of the heart to another can be stopped or modified. Ablation methods destroy unwanted electrical pathways by forming non-conductive ablation foci.

The procedure typically utilizes at least one catheter having a multi-electrode end effector. Such multi-electrode end effectors are configured to map and/or ablate tissue. Multi-electrode end effectors have several geometries, typical of which are spherical, planar, and radial. Some multi-electrode end effectors include ridges that provide structural support to the end effector when the end effector is manipulated during surgery.

Disclosure of Invention

Examples presented herein generally include a catheter end effector having a support frame with one or more corrugated struts. The corrugations of the struts increase the transverse stiffness of the struts and decrease the axial bending stiffness of the struts as compared to linear, non-corrugated struts of similar thickness. The geometry of the corrugations may be selected to provide conformal contact of the end effector with tissue while maintaining a desired spatial relationship between the electrodes of the end effector. The geometry of the selectable corrugations may include the amplitude of the undulations, the wavelength of the undulations, and the placement of the particular geometry within the end effector. End effectors having various geometries that currently utilize rigid or semi-rigid support frames to support electrode placement may be modified to include one or more corrugated struts in accordance with aspects of the present invention. The present disclosure also contemplates the inclusion of corrugated struts in end effector geometries that are to be developed by the manufacturer.

An example catheter may include a corrugated strut, an electrically insulating structure disposed around at least a portion of the corrugated strut, and one or more electrodes coupled to the electrically insulating structure. The corrugated struts may extend along a longitudinal axis and may have undulations having an amplitude on a first orthogonal axis orthogonal to the longitudinal axis. The electrically insulating structure may have a width that is greater than the amplitude of the wave motion. The width is measured along a second orthogonal axis orthogonal to the longitudinal axis and orthogonal to the first orthogonal axis.

The catheter may also include a plurality of corrugated struts and an electrode array. The struts may each extend along a longitudinal axis and may each have undulations on a first orthogonal axis. The one or more electrically insulating structures may be disposed around the plurality of corrugated struts. An electrode array may be disposed on the one or more electrically insulating structures. The electrode array may be arranged in a plane orthogonal to the first orthogonal axis.

The amplitude of the fluctuations may define a gap along the first orthogonal axis such that the one or more electrodes are disposed primarily outside the gap. The gap may be defined as a post extending between the peak and trough of the wave. Thus, the size of the electrode surrounding the ridge is greater than the amplitude of the fluctuations along the first orthogonal axis.

The wavelength of the wave motion may vary along the length of the corrugated strut.

The catheter may also include a shaft and an end effector. The shaft may extend along a longitudinal axis. The end effector may be disposed at a distal end of the shaft. The end effector may include a corrugated strut, an electrically insulating structure, and one or more electrodes. The end effector may have a planar configuration, a multi-ray configuration, a basket configuration, or a lasso configuration.

The catheter may also include a linear ridge including a corrugated strut, an electrically insulating structure, and one or more electrodes. The insulating structure of the linear spine may include an elongated member having a lumen therethrough such that at least a portion of the corrugated struts extend through the lumen. The width of the elongate member through which the corrugated struts extend may be greater than the amplitude of the undulations of the portion of the corrugated struts within the lumen. The elongate member may have a rounded outer surface.

The one or more electrodes may comprise a ring electrode surrounding a corrugated strut. The ring electrode may have an inner diameter greater than the amplitude of the undulations.

The insulating structure may include a pair of planar substrates orthogonal to the first orthogonal axis such that the corrugated struts are positioned between the pair of planar substrates. The one or more electrodes may include a pair of electrodes positioned opposite each other on the pair of planar substrates on opposite sides of the corrugated strut.

An example end effector of a catheter may include a plurality of ring members and a first support frame. The plurality of ring members may be arranged in a planar configuration such that the longitudinal axis of the catheter is parallel to the plane of the end effector, the first orthogonal axis is orthogonal to the plane of the end effector, and the second orthogonal axis is orthogonal to the longitudinal axis and to the first orthogonal axis. The first support frame may include a first corrugated strut extending through a first ring member of the plurality of ring members.

The end effector may further comprise a second support frame comprising a second corrugated strut extending through a second ring member of the plurality of ring members. The first corrugated struts may be parallel to the second corrugated struts. The first and second corrugated struts may extend parallel to the longitudinal axis.

The plurality of ring members may include an outer ridge parallel to the longitudinal axis. The first and second corrugated struts may be positioned within the outer ridge, respectively. The plurality of ring members may include an inner ridge parallel to the longitudinal axis. As an alternative to the first and second corrugated struts being positioned within the outer spine, the first and second corrugated struts may be positioned within the inner spine, respectively. The end effector may include a corrugated strut passing through the outer spine or the inner spine or some subset thereof.

The plurality of ring members may include a first ring member, a second ring member, and a third ring member. The first and third ring members may each include an outer ridge and an inner ridge, respectively. The second ring member may include central ridges, each located between the outer and inner ridges of the first and second ring members.

The end effector may further comprise a second support frame and a third support frame. The second support frame may extend through the second ring member. The third support frame may extend through the third ring member. The first support frame may be corrugated over a majority of the length of the first ring member. The third support frame may be corrugated over a majority of the length of the third ring member. The second support frame may be non-corrugated.

The first corrugated strut may be positioned on the distal curved portion of the first ring member.

The first ring member may include a first tubular housing at least partially surrounding the first support frame. The tubular housing may have a circular outer surface.

The first tubular housing may have a width that is greater than the amplitude of the undulations of the first corrugated strut. The width may be measured along a second orthogonal axis. The amplitude of the fluctuations may be measured along a first orthogonal axis.

The end effector may further comprise one or more electrodes disposed on the first tubular housing. The one or more electrodes may comprise a plurality of electrodes arranged linearly. The plurality of electrodes may be in the plane of the end effector.

The one or more electrodes may comprise a ring electrode surrounding a corrugated strut. The ring electrode may have an inner diameter greater than the amplitude of the undulations of the first corrugated strut. The amplitude may be measured along a first orthogonal axis.

The wavelength of the wave motion of the first corrugated strut may vary along the length of the first corrugated strut.

Another exemplary end effector of a catheter may comprise an electrode array and a plurality of elongate struts. The electrode array may be arranged in a plane. The plane may extend along a longitudinal axis of the catheter and be orthogonal to the first orthogonal axis. The plurality of corrugated struts may each extend along a longitudinal axis. The struts may each be configured to maintain a spatial arrangement of the electrode array.

The end effector may further comprise a plurality of ridges extending along the longitudinal axis. The plurality of corrugated struts may extend through the plurality of ridges. An electrode array may be disposed on the plurality of ridges.

The end effector may further comprise a first membrane supported by one or more struts on a first side of the end effector to define a first surface that is substantially planar. An electrode array may be attached to the first surface. The end effector may further comprise a second membrane supported by one or more struts on a second side of the end effector to define a generally planar second surface parallel to the first surface.

Drawings

The above-described and further aspects of the present invention will be further discussed with reference to the following description, taken in conjunction with the accompanying drawings, in which like numerals indicate like structural elements and features in the various figures. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention. The drawings depict one or more implementations of the present apparatus by way of example only and not by way of limitation.

FIG. 1 is an illustration of a catheter having an end effector at a distal portion of the catheter and a proximal handle at a proximal portion of the catheter, in accordance with aspects of the present invention.

FIG. 2A is an illustration of an isometric view of a support frame of an end effector according to aspects of the present invention.

Fig. 2B is an illustration of a plan view of the support frame shown in fig. 2A.

FIG. 3A is an illustration of another support frame of an end effector according to aspects of the present invention.

FIG. 3B is an illustration of another support frame of an end effector according to aspects of the present invention.

Fig. 4A is an illustration of a portion of a ridge in accordance with aspects of the present invention.

Fig. 4B is an illustration of a cross-section of a ridge as shown in fig. 4A, in accordance with aspects of the present invention.

Fig. 4C is an illustration of a cross-section of a ridge as shown in fig. 4A, in accordance with aspects of the present invention.

FIG. 5A is an illustration of a cross-section of a ridge having a wavelength that varies along the length of the ridge, in accordance with aspects of the present invention.

Fig. 5B is an illustration of a cross-section of a ridge having variable amplitude that varies along the length of the ridge, in accordance with aspects of the present invention.

Fig. 5C is an illustration of a cross-section of a ridge having a variable thickness that varies along the length of the ridge, in accordance with aspects of the present invention.

Fig. 5D is an illustration of a corrugated waveform in accordance with aspects of the present invention.

Fig. 6A, 6B, 6C, and 6D are illustrations of exemplary support frames deformed by application of various forces in accordance with aspects of the present invention.

FIG. 7A is an illustration of another exemplary end effector in accordance with aspects of the present invention.

FIG. 7B is an illustration of a cross-section of the end effector as shown in FIG. 7A, in accordance with aspects of the present invention.

FIG. 8 is an illustration of another exemplary end effector having a ray shape in accordance with aspects of the present invention.

FIG. 9 is an illustration of another exemplary end effector having a basket shape in accordance with aspects of the present invention.

FIG. 10 is an illustration of another exemplary end effector having a rounded or lasso shape of a catheter in accordance with aspects of the present technique.

Fig. 11 is an illustration of an exemplary catheter-based electrophysiology mapping and ablation system according to aspects of the present invention.

Detailed Description

The following detailed description should be read with reference to the drawings, in which like elements in different drawings are numbered identically. 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. This description will clearly enable one skilled in the art to make and use the invention, and describes several embodiments, adaptations, variations, alternatives and uses of the invention, including what is presently believed to be the best mode of carrying out the invention.

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 the intended purpose thereof as described herein. More specifically, "about" or "approximately" may refer to a range of values of ±10% of the recited values, for example "about 90%" may refer to a range of values from 81% to 99%.

In addition, as used herein, the terms "patient," "host," "user," and "subject" refer to any human or animal subject and are not intended to limit the system or method to human use, but use of the subject invention in a human patient represents a preferred embodiment. Likewise, the term "proximal" refers to a location closer to the operator, while "distal" refers to a location further from the operator or physician.

Any one or more of the teachings, expressions, patterns, examples, etc. described herein can be combined with any one or more of the other teachings, expressions, patterns, examples, etc. described herein. Thus, the following teachings, expressions, versions, examples, etc. should not be considered as being separate from each other. Various suitable ways in which the teachings herein may be combined will be apparent to those skilled in the relevant art(s) in view of the teachings herein. Such modifications and variations are intended to be included within the scope of the appended claims.

The multi-electrode end effector may include a rigid or semi-rigid support frame to support electrode placement. The support frame may comprise nitinol or other biocompatible material, and the insulating material, electrodes, conductors of the electrodes, and other end effector components may be mounted on the support frame. The support frame is configured to maintain a spatial relationship between the electrodes when the end effector is manipulated and opposed to tissue. For certain catheter geometries, particularly planar end effector geometries, mechanical design requirements may conflict with each other, resulting in design compromises. For example, between the load conditions shown in fig. 6A-6D, it is desirable to have increased lateral stiffness to resist deformation under the load conditions shown in fig. 6A and 6B, while having minimized axial stiffness to allow deflection under the load conditions shown in fig. 6D, and while also maintaining bending stiffness to resist and allow deformation over the load condition range shown in fig. 6C.

In the examples illustrated herein, one or more struts of a support frame of an end effector may be corrugated. The corrugations of the struts increase the transverse stiffness of the struts and decrease the axial bending stiffness of the struts as compared to linear, non-corrugated struts of similar thickness. The geometry of the corrugations may be selected to provide conformal contact of the end effector with tissue while maintaining a desired spatial relationship between the electrodes of the end effector. Alternative geometries may include the amplitude of the undulations, the wavelength of the undulations, and the placement of a particular geometry within the end effector. While the corrugated struts may be particularly advantageous for planar end effectors, the corrugated struts may also be used in many other end effector geometries to achieve the desired mechanical function of the end effector support frame. The corrugation may be particularly advantageous in achieving improved conformal tissue contact, and thus higher mapping details in trabecular and pectinate muscle structures.

Fig. 1 is an illustration of a catheter 100 that includes an end effector 110 at a distal portion of the catheter 100, a proximal handle 106 at a proximal portion of the catheter 100, and a shaft 109 extending between the end effector 110 and the handle 106. The elongate shaft 109 has a proximal portion 102, an intermediate deflection section 104, and a distal portion 104A in the shape of an elongate catheter body. A deflection control handle 106 is attached to the proximal end of the catheter body 102. The distal portion 104A of the shaft 109 is coupled to the end effector 110 via the connector tubing 105. The elongate shaft 109 forms a tubular catheter body that is sized and otherwise configured to traverse the vasculature. The end effector 110 has a plurality of ring members 1, 2, 3 that overlap at a common distal apex 50 and are joined at the distal apex using mechanical couplings.

When the device is unconstrained and aligned, the proximal portion 102, the intermediate section 104, the distal portion 104A, and the end effector 110 are generally aligned along the longitudinal axis L-L. The intermediate section 104 may be configured to bend to deflect the distal portion 104A and the end effector 110 from the longitudinal axis L-L.

The end effector 110 may collapse (compress toward the longitudinal axis L-L) to fit within a guide sheath or catheter (not shown). Shaft 109 can be pushed distally to move end effector 110 distally through the guide sheath. The end effector 110 may be moved away from the distal end of the guide sheath via the steering shaft 109 and/or the control handle 106. An example of a suitable guide sheath for this purpose is Preface Braided Guiding Sheath, which is commercially available from businessman Webster company (inc.) (erwan, california, usa).

The end effector 110 has a first ring member 1, a second ring member 2, and a third ring member 3. Each ring member 1,2, 3 has two ridges 1A, 1B, 2A, 2B, 3A, 3B and a connector 1C, 2C, 3C connecting the two ridges of the respective ring member 1,2, 3. The ridges 1A, 1B of the first ring member 1 are connected by a first connector 1C; the ridges 2A, 2B of the second ring member 2 are connected by a second connector 2C; and the ridges 3A, 3B of the third ring member 3 are connected by a third connector 3C. The connectors 1C, 2C, 3C may be arcuate members as shown, or may have alternative shapes.

For each ring member 1,2,3, the ridges 1A, 1B, 2A, 2B, 3A, 3B of a respective pair of ridges may be substantially parallel to each other along a majority of their respective lengths when the end effector 100 is expanded to the unconstrained configuration as shown in fig. 1. The end effector 110 may include a support frame assembly including one or more support frames extending through one or more of the ring members 1,2, 3. The support frame assembly may include one or more corrugated struts through some or all of the ridges 1A, 1B, 2A, 2B, 3A, 3B to provide a desired lateral stiffness of the ridges and to reduce the axial bending stiffness of the ridges. The geometry of the corrugations may be selected to provide conformal contact of the end effector with tissue while maintaining a desired spatial relationship between the electrodes of the end effector.

Preferably, when the end effector 100 is in the unconstrained configuration, all of the ridges in the end effector are parallel to one another along a substantial portion of their respective lengths. The end effector provides an array of electrodes 37 generally in plane P1. When unconstrained, the electrodes are substantially coplanar such that when the end effector 110 is pressed to a flat surface by manipulating the handle 106 and shaft 109, the electrodes 37 each contact the flat surface and become precisely flat. When the intermediate section 104 of the shaft 109 is undeflected, the longitudinal axis L-L is parallel to the plane P1. The first orthogonal axis O1 is orthogonal to the plane P1 and the longitudinal axis L-L. The second orthogonal axis O2 is orthogonal to the longitudinal axis L-L and the first orthogonal axis O1. The plane P1 is parallel to the second orthogonal axis O2.

The length of each ridge 1A, 1B, 2A, 2B, 3A, 3B may be in the range between about 5mm and 50mm, preferably in the range between about 10mm and 35mm, and more preferably about 28mm. The parallel portions of each ridge 1A, 1B, 2A, 2B, 3A, 3B may be spaced apart from each other by a distance in the range between about 1mm and 20mm, preferably in the range between about 2mm and 10mm, and more preferably about 4 mm. Or parallel portions of at least some of the ridges may be in contact, individual ridges may be adhered together, or a plurality of struts may extend through a single ridge. Each ridge 1A, 1B, 2A, 2B, 3A, 3B preferably carries at least eight electrodes per ridge member. The end effector preferably includes six ridges as shown. In the case of eight electrodes on each of the six ridges, the end effector 100 includes forty-eight electrodes. The number of ridges, the number of electrodes, the size of the ridges, and the spacing of the electrodes can be varied to meet the design goals of a particular end effector design.

Distal electrode 103D and proximal electrode 103P are positioned near distal portion 104A of shaft 109. Electrodes 103D and 103P may be configured to mate (e.g., by masking a portion of one electrode and masking a different portion on the other electrode) to define a reference electrode (electrode that is not in contact with tissue). The one or more impedance sensing electrodes 103R may be configured to allow position sensing by impedance position sensing techniques, as described in U.S. patent 5,944,022, 5,983,126, and 6,445,864, copies of which are attached in the appendix of the priority patent application US 63/383,445 and incorporated herein by reference. The configuration and placement of the electrodes 103D, 103P, 103R on the distal portion 104 of the shaft 109 may be varied to meet the design goals of a particular catheter design.

Fig. 2A is an illustration of an isometric view of a support frame assembly 180 of an end effector in an unconstrained configuration. The support frame assembly 180 includes a first support frame 181, a second support frame 182, and a third support frame 183. The first support frame 181 is corrugated, and the third support frame 183 is corrugated. The second support frame 182 is not corrugated. As will be appreciated by those skilled in the relevant arts, the support frame assembly 180 may be configured to support an end effector similar to the end effector 110 shown in fig. 1 by modifying the loop paths of the first and third support frames 181 and 183 or by modifying the loop paths of the first and third loops 1 and 3. The support frames 181, 182, 183 may comprise plastic or metal spacer sheets, plastic or metal round wires, plastic or metal square wires, or other suitable biocompatible materials. In a preferred embodiment, the support frame is made of a shape memory material such as nitinol.

Fig. 2B is an illustration of a plan view of the support frame assembly 180 shown in fig. 2A. When the end effector is unconstrained, each of the respective support frames 181, 182, 183 defines a respective annular path of its respective ring member (e.g., similar to ring members 1,2,3 shown in fig. 1). Each support frame 181, 182, 183 includes a respective parallel segment 181A, 182A, 183A, 181B, 182B, 183B that extends through a corresponding ridge of the end effector 100 (e.g., similar to the ridges 1A, 2A, 3A, 1B, 2B, 3B shown in fig. 1). Each support frame 181, 182, 183 includes a respective proximal section 181d, 182d, 183d, 181e, 182e, 183e that extends through a corresponding proximal section of the respective ring member. The proximal sections 181d, 182d, 183d, 181e, 182e, 183e extend into the connector tubing 105 to engage the end effector 110 to the shaft 109. Each support frame 181, 182, 183 includes a respective connection segment 181C, 182C, 183C that extends between a respective pair of parallel segments 181a, 182a, 183a, 181b, 182b, 183b and through a respective connector of a respective ring member (e.g., similar to connectors 1C, 2C, 3C shown in fig. 1).

The connection segments 181c, 183c of the first and third support frames 181, 183 may each include a respective curved portion 181f, 183f proximate to the apex of the connection segment 182c of the second support frame 182 such that the connection segments 181c, 183c of the first and third support frames 181, 183 do not overlap one another at the distal apex of the support frame assembly 180.

The support frame assembly 180 shown in fig. 2A and 2B includes four corrugated struts 181a, 181B, 183a. The corrugated struts are parallel to each other and approximately planar. Or any combination of the six struts 181a, 182a, 181b, 183b, 182a, 183a of the support frame assembly 180 may be corrugated. Preferably, at least the outer struts 181a, 183a are corrugated to provide increased lateral stiffness to resist deformation of the end effector under the loaded conditions shown in fig. 6A and 6B. The inner ridge 181b of the first support frame 181, the inner ridge 183b of the third support frame 183, the central ridges 182a, 182b of the second support frame 182, and any combination thereof, may be corrugated to reduce axial stiffness to allow bending under the load condition shown in fig. 6D.

While the corrugations are shown along the entire length of the corrugated struts 181a, 181b, 183a, one or more portions of the corrugated struts 181a, 181b, 183a may be non-corrugated to provide the desired mechanical function of the support frame assembly 180. Further, while the corrugations are shown as being uniform along the entire length of the corrugated struts 181a, 181b, 183a, the geometry (such as amplitude and/or wavelength) of the corrugations may vary along the length of the corrugated struts 181a, 181b, 183a to provide the desired mechanical function of the support frame assembly 180.

The connection sections 181c, 182c, 183c may be corrugated. As shown, the connection portion 181c of the first support frame 181 and the connection portion 183c of the third support frame 183 are corrugated. The corrugation of these connection sections 181c, 183c may increase the resistance to deformation under the load conditions shown in fig. 6A and/or 6B. The corrugations of any of the connection segments 181C, 182C, 183C may be used to achieve the desired deformation of the support frame assembly 180 under the load conditions shown in fig. 6C.

Although the illustrated support frame assembly 180 has a support frame having a substantially uniform width and thickness along the annular path of the respective support frames 181, 182, 183, the cross-section of the support frame may vary along the annular path to provide the desired mechanical function of the support frame assembly 180. For example, the cross-sectional area of the support frame may vary similarly to that disclosed in U.S. patent publication 2021/0369339, which is incorporated herein by reference and is attached in the appendix of the priority patent application U.S.63/383,445.

Fig. 3A and 3B are illustrations of alternative planar end effector support frame assembly configurations. Many alternative planar end effector geometries may include corrugations as would be understood by one of ordinary skill in the relevant art in light of the present disclosure.

Fig. 3A is an illustration of an alternative support frame 280 of an end effector having a circular path similar to the end effector 110 shown in fig. 1. The first support frame 218 includes a first support frame 281, a second support frame 282, and a third support frame 283. Each support frame 281, 282, 283 includes a respective parallel section 281A, 282A, 283A, 281B, 282B, 283B that extends through a corresponding spine 1A, 2A, 3A, 1B, 2B, 3B of the end effector 110. Each support frame 281, 282, 283 includes a respective proximal section 281D, 282D, 283D, 281E, 282E, 283E that extends through a corresponding proximal section of the respective ring member 1, 2, 3. Proximal sections 281D, 282D, 283D, 281E, 282E, 283E extend into connector tubing 105 to engage end effector 110 to shaft 109. Each support frame 281, 282, 283 includes a respective connection section 281C, 282C, 283C that extends between a respective pair of parallel sections 281A, 282A, 283A, 281B, 282B, 283B and through a respective connection section 1C, 2C, 3C of a respective ring member 1, 2, 3.

The parallel segments 281A, 282A, 283A, 281B, 282B, 283B may be substantially coplanar when unconstrained and become precisely coplanar when the proximal portion 102 of the shaft 109 is manipulated to press the end effector 110 to a flat surface.

Portions of any of the support frames 281, 282, 283 may be corrugated to achieve a desired mechanical function.

Fig. 3B is an illustration of another support frame assembly 380 of an end effector, including a first support frame 381, a second support frame 382, and a third support frame 383. The support frames 381, 382, 383 overlap at a common distal vertex 50. The support frame assembly 380 includes proximal and parallel sections 381D, 382D, 383D, 381A, 381B, 382A, 382B, 383A, 383B that are configured similar to the proximal and parallel sections of the exemplary support frames 180, 280 shown in fig. 2A, 2B, and 3A.

The first support frame 381 includes a first connection member 381C having a curved shape between distal ends of the first pair of parallel segments 381A, 381B. The second support frame 382 includes a second connection member 382C having a pair of bends 382F extending from the distal ends of the parallel segments 382A, 382B, distally turned away from the longitudinal axis L-L, and turned toward the longitudinal axis L-L. The second connection member 382C has an arc of a bent shape between the pair of bent portions 382F. The third support frame 383 includes a third connection member 383C having a pair of bends 383F that extend from the distal ends of the parallel sections 383A, 383B, away from the longitudinal axis L-L, turn distally, and turn toward the longitudinal axis L-L. The second connection member 383C has an arc of a bent shape between the pair of bent portions 383F.

Each of the parallel segments 381A, 381B, 382A, 382B, 383A, 383B may be substantially equal in length to each other as measured parallel to the longitudinal axis L-L. Similarly, the ridges of the end effector are substantially equal in length to one another as measured parallel to the longitudinal axis L-L.

Each of the support frames 381, 382, 383 may define a respective annular path having a cross-sectional shape orthogonal to the annular path that varies along the annular path. The cross-sectional shape may have a smaller area at the curved portions 381K, 382K. The cross-sectional shape may have a smaller area on a majority of the circular path through the connection members 381C, 382C, 383C than on a majority of the circular path through the parallel segments 381A, 381B, 382A, 382B, 383A, 383B.

The illustrated support frame assembly 380 includes three support frames 381, 382, 383. Alternatively, the support frame assembly 380 may include two support frames, including an outer support frame configured similarly to the first support frame 381 and an inner support frame configured similarly to the second support frame 382 and the third support frame 383.

Portions of any of the support frames 381, 382, 383 may be corrugated to achieve the desired mechanical function.

Fig. 4A is a diagram of a portion of the ridge 1. The spine 1 comprises a portion of an end effector that carries one or more electrodes 137 and is supported by struts 81 of a support frame. The ridge 1 shown is linear. Or the ridge 1 may be curved. As shown, the ridge 1 is linearly aligned with the longitudinal axis L-L, and the electrode 137 on the ridge 1 is linearly aligned with the longitudinal axis L-L.

Fig. 4B is a diagram of a cross section of the ridge 1 as shown in fig. 4A.

Fig. 4C is a schematic representation of a cross-section of the ridge 1 as shown in fig. 4A.

Referring collectively to fig. 4B and 4C, the spine 1 includes an elongate member 90 having a lumen therethrough, a flush tube 96 extending through the lumen of the elongate member 90, corrugated struts 81 extending through the lumen of the elongate member 90, an electrical conductor 40 (e.g., a wire) extending through the lumen of the elongate member 90, and an electrode 137 coupled to an outer surface of the elongate member 90. Elongate member 90 is an exemplary electrically insulating structure configured to carry electrode 137. As shown, the elongate member 90 can comprise an outer tube. The outer tube may have a circular cross-section as shown, an oval cross-section, a rectangular cross-section, or alternative cross-sections as will be appreciated by those skilled in the relevant art. The electrode 137 may have an annular shape, as shown, surrounding the elongate member 90, or may be punctiform or have other shapes as will be appreciated by those skilled in the art. The flush tube 96 is optional. The electrical conductors 40 may include insulated wires as shown, may have alternative cross-sectional shapes, may be mounted in a flexible circuit, or otherwise configured as will be appreciated by those skilled in the art.

The elongated member 90 has a width W1 measured along a second orthogonal axis O2 orthogonal to the longitudinal axis L-L. The post 81 has a width W2 along the second orthogonal axis O2 that is less than the width W1 of the elongated member 90. The strut 81 has a fluctuation with an amplitude A1 measured along the first orthogonal axis O1. Amplitude A1 is less than width W1 of elongate member 90. The post 81 has a thickness T1. The elongate member 90 housing the post 81 is substantially linear in length as shown, with the post undulating in a plurality of peaks and troughs (two cycles of undulations are shown). The elongate member 90 need not be circular as shown and may be oval, longer in the first orthogonal direction O1 than in the second orthogonal direction O2. In this case, the amplitude A1 may be greater than the width W1 of the elongated member 90 while the elongated member 90 remains substantially linear over a plurality of undulating periods of the strut. For example, the amplitude A1 of the struts may be 1.5 times the width W1 of the elongated member 90.

The electrode 137 may be annular, encircling the elongate member 90. The inner diameter of the electrode 137 may thus be greater than the width W2 of the post 81 and greater than the amplitude A1 of the fluctuations of the post 81. The amplitude A1 of the undulations is small enough that the path of the ridge 1 (e.g., a linear path as shown) does not follow the undulations. The wave motion is shaped such that the amplitude A1 defines a gap and the electrode is disposed entirely outside the gap. The inner diameter of electrode 137 is greater than amplitude A1 such that post 81 extends through electrode 137, and the arrangement of electrode 137 does not follow the shape of the wave. This is in contrast to end effectors having a support frame with a waveform having a larger amplitude than the diameter of the ring electrode thereon; such ring electrodes must have at least a portion of the electrode positioned between the troughs and peaks of the larger amplitude waveform.

Alternatively, the undulations may be shaped such that the amplitude A1 defines a gap, and the ridges 81 may follow the undulations to a small extent such that the electrodes 137 are disposed primarily outside the gap.

Fig. 5A is an illustration of a cross-section of a ridge having a variable wavelength lambda ₁、λ₁ that varies along the length of the ridge 81. The wavelength lambda ₁、λ₁ can be varied to achieve the desired mechanical properties of the support frame assembly.

Fig. 5B is an illustration of a cross section of a ridge having variable magnitudes A1, A2 that vary along the length of the ridge 81. The amplitude A1, A2 may be varied to achieve the desired mechanical properties of the support frame assembly.

Fig. 5C is an illustration of a cross-section of a ridge having variable thicknesses T1, T2 that vary along the length of the ridge 81. The thicknesses T1, T2 may be varied to achieve desired mechanical properties of the support frame assembly.

Fig. 5D is an illustration of a corrugated waveform. The undulations may be sinusoidal like that shown in fig. 4C and 5A, half-moon like that shown in fig. 5B and 5C, triangular wave, triangular or zig-zag like that shown in fig. 5D, other corrugated shape as shown in fig. 5D, or other corrugated waveforms known in the art. Other dimensions of the corrugated waveform, such as the duty cycle, may be varied to achieve the desired mechanical characteristics of the support frame assembly. The ridges 81 may have different waveforms on different sections to achieve the desired mechanical properties of the support frame assembly.

Fig. 6A, 6B, 6C, and 6D are illustrations of the deformation of the example support frame assembly 80 as a result of the application of various forces. The exemplary support frame assembly 80 includes a first annular support frame 81, a second annular support frame 82, and a third annular support frame 83.

Fig. 6A illustrates the application of a lateral force F1 from the wedge W to the outer struts 83B of the third support frame 83 of the support frame assembly 80. The opposite outer struts of the first support frame 81 rest against the planar surface S. This deformation causes the outer leg 83B of the third support frame 83 to come into contact with the leg of the second support frame 82. It may be desirable to design the support frame assembly 80 to resist this type of deformation of the support frame assembly 80 during use of the end effector, thereby maintaining separation between the electrode carried on the outer post 83B and the electrode carried by the adjacent post of the second support frame 82. Corrugating the outer struts 83B may strengthen the outer struts 83B against deformation as shown, as compared to non-corrugated struts of similar thickness.

Fig. 6B shows the application of a lateral force F2 from the two flat surfaces S1, S2 against the outer struts 83B, 81A of the support frame assembly 80. This deformation causes the outer struts 83B, 81A to contact the struts of the second support frame 82. It may be desirable to design the support frame assembly 80 to resist this type of deformation of the support frame assembly 80 during use of the end effector, thereby maintaining separation between the electrodes carried on the outer struts 83B, 81A and the electrodes carried by the respective adjacent struts of the second support frame 82. Corrugating the outer struts 83B, 81A may strengthen the outer struts 83B, 81A against deformation as shown, as compared to non-corrugated struts of similar thickness.

Fig. 6C is a graphical representation of the axial force F3 applied from the planar surface S to the connection segments 81C, 83C of the support frame assembly 80. The connection segments 81C, 83C and other portions of the support frame assembly 80 may be corrugated to provide the desired deflection due to the axial force F3.

Fig. 6D is a graphical representation of a bending load force F4 applied to the distal end of the support frame assembly 80. The bending load force F4 causes the support frame assembly 80 to deflect from the longitudinal axis L-L. It is desirable to allow deflection due to bending load force F4 so that the end effector easily conforms to tissue when the end effector is pressed against the tissue. The parallel sections and other portions of the support frame assembly 80 may be corrugated to provide the desired deflection due to the bending load force F4.

Fig. 7A is an illustration of another exemplary end effector 710 that is substantially planar.

Fig. 7B is an illustration of a cross-section of the end effector 710 shown in fig. 7A.

Referring collectively to fig. 7A and 7B, the end effector 710 includes a first membrane 712a, a first electrode 737A, a second membrane 712B, a second electrode 737B, a corrugated strut 81, and a flexible filler 714 (e.g., a polymer). The first membrane 712a may be positioned on a first side 701a of the end effector 710 and the second membrane 712b may be positioned on a second side 701b of the end effector 710. The first electrode 737a may be coupled to the first film 712a and exposed to the ambient environment on the first surface 701 a. The second electrode 737b may be coupled to the second film 712b and exposed to the ambient environment on the second surface 701 b.

The corrugated struts 81 are positioned between the first membrane 712a and the second membrane 712 b. The films 712a, 712b may be parallel to each other and orthogonal to the first orthogonal axis. The amplitude of the corrugated struts 81 may define a gap and the electrodes 737a, 737b may be disposed entirely outside the gap. At least a portion of the first electrode 737a may be positioned opposite at least a portion of the second electrode 737b such that one or more pairs of electrodes 737a, 737b are positioned opposite each other on a pair of planar membranes 712a, 712b on opposite sides of the corrugated strut 81.

Fig. 8 is an illustration of another exemplary end effector 400 having a ray shape. Ridge 410 has a proximal end joined to the distal end of shaft 409 and a free distal end. One or more of ridges 410 may be configured similar to ridge 1 shown in fig. 4A-4C.

FIG. 9 is an illustration of another example end effector 500 having a basket shape. The ridge 510 has a proximal end joined to the distal end of the shaft 509 and a distal end joined at a hub. One or more of the ridges 510 may be configured similar to the ridge 1 shown in fig. 4A-4C.

Fig. 10 is an illustration of another example end effector 600 having a round or lasso shape. The end effector 600 includes a single ridge 610 extending from a shaft 609. The catheter may include pull wires extending through the spine 610 and shaft 609 to move the spine from a straight configuration to a circular shape, and/or struts within the spine 610 may be preset to move the spine 610 to a lasso shape when unconstrained. The ridge 610 may be configured similar to the ridge 1 shown in fig. 4A to 4C.

Fig. 11 is a diagram illustrating an exemplary catheter-based electrophysiology mapping and ablation system 10. The system 10 includes a plurality of catheters that are percutaneously inserted by a physician 24 through the vascular system of a patient into a chamber or vascular structure of the heart 12. Typically, the delivery sheath catheter is inserted into the left atrium or the right atrium near the desired location in the heart 12. A plurality of catheters may then be inserted into the delivery sheath catheter in order to reach the desired location. The plurality of catheters may include catheters dedicated to sensing Intracardiac Electrogram (IEGM) signals, catheters dedicated to ablation, and/or catheters dedicated to both sensing and ablation. An exemplary catheter 14 configured for sensing IEGM is shown herein. The physician 24 brings the distal tip 28 of the catheter 14 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.

The illustrated catheter 14 is an exemplary catheter that includes an electrode(s) 26 optionally distributed over a plurality of ridges 22 at a distal tip 28 and configured to sense IEGM signals. Catheter 14 may additionally include a position sensor 29 embedded in or near distal tip 28 for tracking the position and orientation of distal tip 28. Optionally and preferably, the position sensor 29 is a magnetic-based position sensor comprising three magnetic coils for sensing three-dimensional (3D) position and orientation. The catheter 14 may be otherwise configured similar to other exemplary catheters, variations thereof, and alternatives thereof presented herein, as will be appreciated by those of skill in the relevant arts. The distal portion 28 may include one or more corrugated struts.

The magnetic-based position sensor 29 is operable with a placemat 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 distal tip 28 of the catheter 14 may be tracked based on the magnetic field generated with the location pad 25 and sensed by the magnetic-based position sensor 29. Details of magnetic-based position sensing techniques are described in U.S. Pat. nos. 5,391,199, 5,443,489, 5,558,091, 6,172,499, 6,239,724, 6,332,089, 6,484,118, 6,618,612, 6,690,963, 6,788,967, 6,892,091, which are incorporated herein by reference and in the appendix of the priority patent application u.s.63/383,445.

The system 10 includes one or more electrode patches 38 that are positioned in contact with the skin of the patient 23 to establish a positional reference for impedance-based tracking of the location pad 25 and the electrode 26. For impedance-based tracking, current is directed toward the electrodes 26 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 location 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, which are incorporated by reference herein and are attached to the appendix of the priority patent application U.S.63/383,445.

Recorder 11 displays an electrogram 21 captured with body surface ECG electrodes 18 and an Intracardiac Electrogram (IEGM) captured with electrodes 26 of catheter 14. Recorder 11 may include pacing capabilities for pacing the heart rhythm and/or may be electrically connected to a separate pacemaker.

The system 10 may include an ablation energy generator 51 adapted to conduct ablation energy to one or more electrodes at a distal tip of a catheter configured for ablation. The energy generated by ablation energy generator 51 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.

The Patient Interface Unit (PIU) 30 is an interface configured to establish electrical communication between a catheter, electrophysiological equipment, a power source, and a workstation 55 for controlling operation of the system 10. The electrophysiological equipment of system 10 can include, for example, a plurality of catheters, location pads 25, body surface ECG electrodes 18, electrode patches 38, an ablation energy generator 51, and a recorder 11. Optionally and preferably, the PIU 30 includes processing capabilities for enabling real-time calculation of the position of the catheter and for performing ECG calculations.

The workstation 55 includes memory, a processor unit with memory or storage loaded with appropriate operating software, and user interface capabilities. Workstation 55 may be configured to provide a variety of 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 the activation sequence (or other data) compiled from the recorded electrogram 21 on the display device 27 with a representative visual marker or image superimposed on the rendered anatomical map 20; (3) Displaying real-time positions and orientations of a plurality of catheters within a heart chamber; and (4) displaying the region of interest where the ablation energy is applied, for example, on the display device 27. A commercial product embodying elements of system 10 is available from the Biosense Webster, inc.,31A Technology Drive,Irvine,CA 92618 as a CARTO ^TM system.

The following clauses list non-limiting embodiments of the present disclosure:

Clause 1. A catheter comprising: a corrugated strut extending along a longitudinal axis and comprising undulations having an amplitude on a first orthogonal axis orthogonal to the longitudinal axis; an electrically insulating structure disposed about at least a portion of the corrugated struts and having a width greater than the magnitude of the undulations, the width measured along a second orthogonal axis orthogonal to the longitudinal axis and orthogonal to the first orthogonal axis; and one or more electrodes coupled to the electrically insulating structure.

Clause 2 the catheter of clause 1, further comprising: a plurality of corrugated struts each extending along the longitudinal axis and each comprising undulations on the first orthogonal axis; one or more electrically insulating structures disposed about the plurality of corrugated struts; and an electrode array disposed on the one or more electrically insulating structures.

Clause 3 the catheter of clause 2, wherein the electrode array is disposed in a plane orthogonal to the first orthogonal axis.

Clause 4 the catheter of any of clauses 1 to 3, the amplitude of the fluctuations defining a gap along the first orthogonal axis such that the one or more electrodes are disposed primarily outside of the gap.

Clause 5 the catheter of any of clauses 1 to 4, wherein the wavelength of the wave motion varies along the length of the corrugated strut.

Clause 6 the catheter of any of clauses 1 to 5, further comprising: a shaft extending along the longitudinal axis; and an end effector disposed at a distal end of the shaft, the end effector comprising the corrugated strut, the electrically insulating structure, and the one or more electrodes.

Clause 7. The catheter of clause 6, wherein the end effector comprises a planar configuration, a multi-ray configuration, a basket configuration, or a lasso configuration.

Clause 8 the catheter of any of clauses 1 to 7, further comprising: a linear ridge comprising the corrugated struts, the electrically insulating structure, and the one or more electrodes.

Clause 9. The catheter of clause 8, the insulating structure of the linear ridge comprising an elongated member having a lumen therethrough such that at least a portion of the corrugated struts extend through the lumen, and a width of the elongated member through which the corrugated struts extend is greater than the amplitude of the undulations of the portion of the corrugated struts within the lumen.

Clause 10 the catheter of clause 9, wherein the elongated member comprises a rounded outer surface.

Clause 11 the catheter of any of clauses 1 to 10, wherein the one or more electrodes comprise a ring electrode surrounding the corrugated struts, the ring electrode having an inner diameter greater than the amplitude of the undulations.

The conduit of any one of clauses 1-7, the insulating structure comprising a pair of planar membranes orthogonal to the first orthogonal axis, such that the corrugated strut is positioned between the pair of planar membranes.

Clause 13 the catheter of clause 12, the one or more electrodes comprising a pair of electrodes on the pair of planar membranes positioned opposite each other on opposite sides of the corrugated strut.

Clause 14. An end effector of a catheter, the end effector comprising: a plurality of ring members arranged in a planar configuration such that a longitudinal axis of the catheter is parallel to a plane of the end effector, a first orthogonal axis is orthogonal to the plane of the end effector, and a second orthogonal axis is orthogonal to the longitudinal axis and to the first orthogonal axis; and a first support frame including a first corrugated strut extending through a first ring member of the plurality of ring members.

Clause 15 the end effector of clause 14, further comprising: a second support frame including a second corrugated strut extending through a second ring member of the plurality of ring members.

Clause 16 the end effector of clause 15, the first corrugated strut being parallel to the second corrugated strut.

Clause 17 the end effector of clause 15 or 16, the first and second corrugated struts extending parallel to the longitudinal axis.

Clause 18 the end effector of any of clauses 15-17, wherein the plurality of ring members include outer ridges parallel to the longitudinal axis, and the first and second corrugated struts are positioned within the outer ridges, respectively.

Clause 19 the end effector of any of clauses 15-17, wherein the plurality of ring members include an inner ridge parallel to the longitudinal axis, and the first and second corrugated struts are positioned within the inner ridge, respectively.

Clause 20 the end effector of any of clauses 15-19, wherein the plurality of ring members comprises the first, second, and third ring members, each comprising an outer ridge and an inner ridge, respectively, and the second ring member comprising a central ridge, each positioned between the outer and inner ridges of the first and second ring members.

Clause 21 the end effector of clause 20, further comprising: a second support frame extending through the second ring member; and a third support frame extending through the third ring member.

Clause 22 the end effector of clause 21, the first support frame being corrugated over a majority of the length of the first ring member, and the third support frame being corrugated over a majority of the length of the third ring member.

Clause 23 the end effector of clause 21 or 22, wherein the second support frame is non-corrugated.

Clause 24 the end effector of clause 14, the first corrugated strut being positioned on the distal curved portion of the first ring member.

Clause 25 the end effector of any of clauses 14-24, wherein the first ring member comprises a first tubular housing at least partially surrounding the first support frame.

Clause 26 the end effector of clause 25, wherein the tubular housing has a circular outer surface.

Clause 27 the end effector of clause 25 or 26, the first tubular housing having a width greater than an amplitude of the undulations of the first corrugated strut, the width measured along the second orthogonal axis and the amplitude measured along the first orthogonal axis.

Clause 28 the end effector of any of clauses 25-27, further comprising: one or more electrodes disposed on the tubular housing.

Clause 29 the end effector of clause 28, wherein the one or more electrodes comprise a plurality of electrodes arranged linearly.

Clause 30 the end effector of clause 29, the plurality of electrodes being located in the plane of the end effector.

Clause 31 the end effector of any of clauses 28-29, wherein the one or more electrodes comprise ring electrodes surrounding the corrugated struts.

Clause 32 the end effector of clause 31, the ring electrode having an inner diameter that is greater than an amplitude of the undulations of the first corrugated strut, the amplitude measured along the first orthogonal axis.

Clause 33 the end effector of any of clauses 14-32, the wavelength of the undulations of the first corrugated strut varying along the length of the first corrugated strut.

Clause 34 an end effector of a catheter, the end effector comprising: an electrode array disposed in a plane along a longitudinal axis of the catheter and orthogonal to a first orthogonal axis; and a plurality of corrugated struts each extending along the longitudinal axis and configured to maintain a spatial arrangement of the electrode array.

Clause 35 the end effector of clause 34, further comprising: a plurality of ridges extending along the longitudinal axis, the plurality of corrugated struts extending through the plurality of ridges, and the electrode array disposed on the plurality of ridges.

Clause 36 the end effector of clause 34, further comprising: a first membrane supported by the one or more struts on a first side of the end effector to define a generally planar first surface to which the electrode array is attached; and a second membrane supported by the one or more struts on a second side of the end effector to define a generally planar second surface parallel to the first surface.

Having shown and described exemplary embodiments of the subject matter contained herein, further modifications may be made to achieve the methods and systems described herein without departing from the scope of the claims. Furthermore, where methods and steps described above represent specific events occurring in a particular order, it is contemplated herein that certain specific steps need not necessarily be performed in the order described, but may be performed in any order, provided that the steps enable an embodiment to achieve its intended purpose. Therefore, this patent is intended to cover such modifications as well, if they come within the spirit and scope of the present disclosure or equivalents as found in the claims. Many such modifications will be apparent to those skilled in the art. For example, the examples, embodiments, geometries, materials, dimensions, ratios, steps, and the like described above are illustrative. Therefore, the claims should not be limited to the exact details of construction and operation shown in the written description and drawings.

Claims (20)

1. A catheter, comprising:

A corrugated strut extending along a longitudinal axis and comprising undulations having an amplitude on a first orthogonal axis orthogonal to the longitudinal axis;

an electrically insulating structure disposed about at least a portion of the corrugated struts and comprising a width greater than the magnitude of the undulations, the width measured along a second orthogonal axis orthogonal to the longitudinal axis and orthogonal to the first orthogonal axis; and

One or more electrodes coupled to the electrically insulating structure.

2. The catheter of claim 1, further comprising:

A plurality of corrugated struts each extending along the longitudinal axis and each comprising undulations on the first orthogonal axis;

One or more electrically insulating structures disposed about the plurality of corrugated struts; and

An electrode array disposed on the one or more electrically insulating structures.

3. The catheter of claim 2, wherein the electrode array is arranged in a plane orthogonal to the first orthogonal axis.

4. The catheter of claim 1, the magnitude of the fluctuation defining a gap along the first orthogonal axis such that the one or more electrodes are disposed primarily outside of the gap.

5. The catheter of claim 1, the wavelength of the undulations varying along the length of the corrugated strut.

6. The catheter of claim 1, further comprising:

a shaft extending along the longitudinal axis; and

An end effector disposed at a distal end of the shaft, the end effector comprising the corrugated strut, the electrically insulating structure, and the one or more electrodes.

7. The catheter of claim 1, further comprising:

A linear ridge comprising the corrugated struts, the electrically insulating structure, and the one or more electrodes, the one or more electrodes comprising a ring electrode surrounding the electrically insulating structure, and the ring electrode comprising an inner diameter greater than the amplitude of the undulations.

8. The catheter of claim 7, the electrically insulating structure of the linear spine comprising an elongated member having a lumen therethrough such that at least a portion of the corrugated struts extend through the lumen and a width of the elongated member through which the corrugated struts extend is greater than the amplitude of the undulations of the portion of the corrugated struts within the lumen.

9. The catheter of claim 1, the electrically insulating structure comprising a pair of planar membranes orthogonal to the first orthogonal axis such that the corrugated struts are positioned between the pair of planar membranes.

10. The catheter of claim 9, the one or more electrodes comprising a pair of electrodes on the pair of planar membranes positioned opposite each other on opposite sides of the corrugated strut.

11. An end effector of a catheter, the end effector comprising:

A plurality of ring members arranged in a planar configuration such that a longitudinal axis of the catheter is parallel to a plane of the end effector, a first orthogonal axis is orthogonal to the plane of the end effector, and a second orthogonal axis is orthogonal to the longitudinal axis and to the first orthogonal axis; and

A first support frame including a first corrugated strut extending through a first ring member of the plurality of ring members.

12. The end effector of claim 11, further comprising:

A second support frame including a second corrugated strut extending through a second ring member of the plurality of ring members.

13. The end effector of claim 12, the first corrugated strut extending parallel to the second corrugated strut and parallel to the longitudinal axis.

14. The end effector of claim 12, the plurality of ring members comprising an outer ridge parallel to the longitudinal axis, and the first and second corrugated struts are positioned within the outer ridge, respectively.

15. The end effector of claim 12, the plurality of ring members comprising an inner ridge parallel to the longitudinal axis, and the first and second corrugated struts are positioned within the inner ridge, respectively.

16. The end effector of claim 12,

The plurality of ring members includes the first ring member, a second ring member and a third ring member,

The first ring member and the third ring member each include an outer ridge and an inner ridge, respectively, and

The second ring member includes a central ridge that is located between the outer ridge and the inner ridge of the first and second ring members, respectively.

17. The end effector of claim 11, the first corrugated strut being positioned on a distal curved portion of the first ring member.

18. The end effector of claim 11, the first ring member comprising a first tubular housing at least partially surrounding the first support frame, the first tubular housing comprising a width that is greater than an amplitude of a fluctuation of the first corrugated strut, the width measured along the second orthogonal axis and the amplitude measured along the first orthogonal axis.

19. The end effector of claim 18, the first ring member comprising a tubular housing at least partially surrounding the first support frame, the end effector further comprising:

one or more electrodes disposed on the tubular housing and disposed linearly in the plane of the end effector, the one or more electrodes comprising an annular electrode surrounding the tubular housing, and the annular electrode comprising an inner diameter that is greater than an amplitude of a fluctuation of the first corrugated strut, the amplitude measured along the first orthogonal axis.

20. The end effector of claim 11, the wavelength of the undulations of the first corrugated strut varying along the length of the first corrugated strut.