CN118216996A - Multi-electrode basket end effector for catheter - Google Patents

Abstract

Examples presented herein illustrate various end effector designs having a plurality of ridges that are expandable from a collapsed configuration when the end effector traverses the vasculature to an expanded configuration when the end effector is at a treatment site. In some examples, the end effector includes three frame rings that each include a pair of ridges. At least one of the three frame rings may have a bend at the distal end of the end effector such that the ridges of the frame ring do not directly oppose each other relative to the longitudinal axis. In some examples, the end effector includes an inner frame and an outer frame each having a plurality of ridges and configured such that one or both of the inner frame and the outer frame are rotatable from an aligned configuration to a non-aligned configuration.

Description

Multi-electrode basket end effector for catheters

Cross-references to related patent applications

This application claims the benefit of U.S. Provisional Patent Application No. 63/476,275, previously filed on December 20, 2022, which is hereby incorporated by reference in its entirety.

Technical Field

The present invention relates generally to medical devices, and in particular to multi-electrode catheters for mapping and/or ablating tissue within a patient.

Background technique

Arrhythmias, such as atrial fibrillation (AF), occur when an area of cardiac tissue abnormally conducts electrical signals to adjacent tissue. This disrupts the normal cardiac cycle and causes an irregular heartbeat. Certain procedures are used to treat arrhythmias, including surgically disrupting the source of the signal causing the arrhythmia and disrupting the conduction pathways for such signals. By selectively ablating cardiac tissue through the application of energy via a catheter, it is sometimes possible to stop or alter the propagation of unwanted electrical signals from one part of the heart to another.

Many current ablation methods in the art tend to utilize radiofrequency (RF) electrical energy to heat tissue. RF ablation may have certain rare disadvantages, such as an increased risk of thermal cell damage, which may lead to tissue charring, burns, steam bursts, phrenic nerve paralysis, pulmonary vein stenosis, and esophageal fistulas, depending on the operator's skill. Cryoablation is an alternative to RF ablation that can reduce some of the thermal risks associated with RF ablation, but due to the extremely low temperature nature of such devices, tissue damage may occur. However, manipulating a cryoablation device and selectively applying cryoablation is generally more challenging than RF ablation; therefore, cryoablation is not feasible in certain anatomical geometries that can be reached by electrical ablation devices.

Some ablation methods use irreversible electroporation (IRE) to ablate cardiac tissue using a non-thermal ablation method. IRE delivers short pulses of high voltage to tissue and generates irreversible cell membrane permeabilization. It has been previously proposed in the patent literature to use a multi-electrode catheter to deliver IRE energy to tissue. Examples of systems and devices constructed for IRE ablation are disclosed in U.S. Patent Publication Nos. 2021/0169550A1, 2021/0169567A1, 2021/0169568A1, 2021/0161592A1, 2021/0196372A1, 2021/0177503A1, and 2021/0186604A1, each of which is incorporated herein by reference and attached to the appendix of priority patent application No. 63/476,275.

Areas of cardiac tissue may be mapped by a catheter to identify abnormal electrical signals. The same or different catheters may be used for ablation. Some exemplary catheters include a plurality of ridges on which electrodes are disposed. The electrodes are typically attached to the ridges and secured in place by brazing, welding, or using an adhesive. In addition, a plurality of linear ridges are typically assembled together by attaching the two ends of the linear ridges to a tubular shaft (e.g., a push tube) to form a spherical basket. However, due to the small size of the ridges and electrodes, adhering the electrodes to the ridges and then forming a spherical basket from a plurality of linear ridges may be a difficult task, which increases manufacturing time and cost, and increases the chances of failure of the electrodes due to improper bonding or misalignment. Therefore, what is needed is an apparatus and method for forming a basket assembly that can help reduce the time required to manufacture a basket assembly, alternative catheter geometries, and a support frame that can support alternative electrode shapes and sizes.

Summary of the invention

The examples presented herein show various end effector designs with multiple ridges that can expand from a collapsed configuration when the end effector traverses the vascular system to an expanded configuration when the end effector is located at the treatment site. In some examples, the end effector includes three frame rings, each of which includes a pair of ridges. At least one of the three frame rings may have a bend at the distal end of the end effector so that the ridges of the frame rings are not directly opposite to each other relative to the longitudinal axis. In some examples, the end effector includes an inner frame and an outer frame, each of which has multiple ridges and is configured so that one or both of the inner frame and the outer frame can be rotated from an aligned configuration to a non-aligned configuration. In the aligned configuration, the electrodes of the inner frame are prevented from contacting the tissue by the outer frame. In the non-aligned configuration, the electrodes of the inner frame are positioned to contact the tissue.

An exemplary end effector of a catheter may include a plurality of ridges, a first frame ring, a second frame ring, a third frame ring, and one or more electrodes. The plurality of ridges may be configured to expand away from the longitudinal axis of the end effector to form a basket shape. The first frame ring may include a first pair of ridges in the plurality of ridges, such that the ridges in the first pair of ridges are disposed relative to each other relative to the longitudinal axis. The second frame ring is different from the first frame ring and may include a second pair of ridges in the plurality of ridges, such that the ridges in the second pair of ridges are disposed on a first side of the first frame ring. The third frame ring is different from the first frame ring and the second frame ring, and includes a third pair of ridges in the plurality of ridges, such that the ridges in the third pair of ridges are disposed on a second side of the first frame ring, the second side being opposite to the first side. The one or more electrodes of the exemplary end effector are coupled to the plurality of ridges.

The first frame ring includes a distal portion proximate a distal end of the end effector and transverse to the longitudinal axis.

Each of the second and third frame rings respectively includes an angled portion proximate a distal end of the end effector.The angled portion of each of the second and third frame rings may be coupled to the first frame ring.

The ridges of the plurality of ridges may be symmetrically arranged about the longitudinal axis.

The ridges of the first pair of ridges, the second pair of ridges, and the third pair of ridges may be symmetrically arranged about the longitudinal axis.

The first pair of ridges may be disposed approximately 180° from each other relative to an imaginary circle about the longitudinal axis. The second pair of ridges may be disposed approximately 60° from each other relative to the imaginary circle. The third pair of ridges may be disposed approximately 60° from each other relative to the imaginary circle.

The first frame ring may include a distal portion located at the distal end of the end effector. The distal portion may traverse the longitudinal axis. Each of the second frame ring and the third frame ring may include an angled portion, respectively, proximate the distal end of the end effector, such that each angled portion overlaps the distal portion of the first frame ring.

The first frame ring may include a distal portion located at the distal end of the end effector and transverse to the longitudinal axis. Each of the second frame ring and the third frame ring may include an angled portion proximate the distal end of the end effector such that each angled portion abuts the distal portion of the first frame ring.

The second frame ring may be disposed entirely on the first side of the first frame ring.The third frame ring may be disposed entirely on the second side of the first frame ring.

The end effector may further include a retainer coupling the first frame ring, the second frame ring, and the third frame ring at a location proximate the distal end of the end effector.

Each of the one or more electrodes may define a lumen therethrough such that each of the plurality of ridges extends through the lumen of each of the one or more electrodes.

The basket shape may be approximately spherical.

The basket shape may be approximately an oblate spheroid.

The one or more electrodes may be configured to deliver electrical pulses for irreversible electroporation, the pulses having a peak voltage of at least 900 volts (V).

Another exemplary end effector of the catheter may include a plurality of ridges, a first frame ring, a second frame ring, a third frame ring, and one or more electrodes. The plurality of ridges may be configured to expand from the longitudinal axis of the end effector to form a basket shape. The first frame ring may include a first pair of ridges in the plurality of ridges and a first angled portion near the distal end of the end effector. The second frame ring is different from the first frame ring and includes a second pair of ridges in the plurality of ridges and a second angled portion near the distal end of the end effector, such that the second angled portion overlaps the first angled portion, the inner ridges in the first pair of ridges are positioned between the ridges in the second pair of ridges, and the inner ridges in the second pair of ridges are positioned between the ridges in the first pair of ridges. The third frame ring is different from the first frame ring and the second frame ring, and includes a third pair of ridges in the plurality of ridges and a third angled portion near the distal end of the end effector, such that the ridges in the third pair of ridges are each disposed between the outer ridges in the first pair of ridges and the outer ridges in the second pair of ridges. The one or more electrodes are coupled to the plurality of ridges.

The ridges of the plurality of ridges may be symmetrically arranged about the longitudinal axis.

The ridges of the first pair of ridges, the second pair of ridges, and the third pair of ridges may be symmetrically arranged about the longitudinal axis.

The first pair of ridges may be disposed at approximately 120° to each other relative to an imaginary circle about the longitudinal axis. The second pair of ridges may be disposed at approximately 120° to each other relative to the imaginary circle. The third pair of ridges may be disposed at approximately 60° to each other relative to the imaginary circle.

The outer ridges of the first pair of ridges may be disposed opposite the outer ridges of the second pair of ridges relative to the longitudinal axis.

The first angled portion and/or the second angled portion may overlap the third angled portion at a location proximate the distal end of the end effector.

Each of the one or more electrodes may define a lumen therethrough such that each of the plurality of ridges extends through the lumen of each of the one or more electrodes.

The basket shape may be approximately spherical.

The basket shape may be approximately an oblate spheroid.

The one or more electrodes may be configured to deliver electrical pulses for irreversible electroporation, the pulses having a peak voltage of at least 900 volts (V).

Another exemplary end effector of a catheter may include an outer electrode assembly and an inner electrode assembly. The outer electrode assembly may include a first plurality of ridges and a first plurality of electrodes. The first plurality of ridges may be configured to expand from the longitudinal axis of the end effector to form a basket shape. The first plurality of electrodes may be coupled to each of the first plurality of ridges. The inner electrode assembly may include a second plurality of electrodes. The inner electrode assembly may be configured to move between a non-contact configuration and a contact configuration, such that in the non-contact configuration, the second plurality of electrodes are prevented from contacting tissue by the outer electrode assembly, and such that in the contact configuration, the second plurality of electrodes are positioned to contact tissue.

The outer electrode assembly may include a first integral tripod structure such that the first plurality of ridges has exactly three ridges. The inner electrode assembly may include a second integral tripod structure such that the second plurality of ridges has exactly three ridges. The second integral tripod structure is rotatable to align with the first integral tripod structure in a non-contact configuration and rotatable to be out of alignment with the first integral tripod structure in a contact configuration. Each tripod structure may be formed from a respective planar sheet of material including three linear ridges converging at respective central ridge intersections. Each ridge of each tripod structure may include a respective end disposed at a proximal end of the end effector. The central ridge intersection of each tripod structure may be positioned on the longitudinal axis at the distal end of the end effector.

The inner electrode assembly may include a second plurality of ridges. The second plurality of electrodes may be coupled to the second plurality of ridges. The second plurality of ridges may be aligned with the first plurality of ridges in a non-contact configuration. The second plurality of ridges are not aligned with the first plurality of ridges in a contact configuration.

Each electrode of the first plurality of electrodes and the second plurality of electrodes may define a lumen therethrough such that each ridge of the plurality of ridges extends through the lumen of each electrode of the one or more electrodes.

The basket shape may be approximately spherical.

The basket shape may be approximately an oblate spheroid.

The electrodes in the first plurality of electrodes may be configured to deliver electrical pulses for irreversible electroporation.The pulses may have a peak voltage of at least 900 volts (V).

The electrodes of the second plurality of electrodes may be configured to map cardiac electrical signals passing through tissue.

Another exemplary end effector may include an expandable basket assembly comprising a first integral structure, a second integral structure, and a plurality of electrodes. The first integral structure may include four ridges and may be formed from a planar sheet of material including four linear ridges converging at a central ridge intersection. The second integral structure is different from the first integral structure and may include at least two ridges. A plurality of electrodes may be coupled to each ridge of the first integral structure and the second integral structure. The ridges of the first integral structure and the second integral structure may be configured to expand from a longitudinal axis of the end effector to collectively form a basket shape.

The second unitary structure may be formed from a planar sheet of material including at least two ridges converging at a central ridge intersection. Each ridge of each unitary structure may include a corresponding connection end disposed at a proximal end of the end effector. The central ridge intersection of each unitary structure may be located on the longitudinal axis at a distal end of the end effector.

The second unitary structure may be formed from a tube of material including at least two ridges joined at one end by a ring.

At least two ridges may have exactly four ridges. Alternatively, at least two ridges may have exactly three ridges. Alternatively, at least two ridges may have exactly two ridges.

The second monolithic structure may include a loop extending across the central ridge intersection of the first monolithic structure such that two ridges of the first monolithic structure are disposed on a first side of the loop and two ridges of the first monolithic structure are disposed on a second side of the loop.

The ridges of the first and second monolithic structures may be symmetrically positioned about the longitudinal axis.

Each electrode of the plurality of electrodes may define a lumen therethrough such that each ridge of the plurality of ridges extends through the lumen of each electrode of the one or more electrodes.

The basket shape may be approximately spherical.

The basket shape may be approximately an oblate spheroid.

The one or more electrodes may be configured to deliver electrical pulses for irreversible electroporation, the pulses having a peak voltage of at least 900 volts (V).

BRIEF DESCRIPTION OF THE DRAWINGS

The above aspects and additional aspects of the present invention will be further discussed with reference to the following description and in conjunction with the accompanying drawings, in which like numbers indicate similar structural elements and features in the various figures. The accompanying drawings are not necessarily drawn to scale, but instead, emphasis is placed on illustrating the principles of the present invention. The accompanying drawings depict one or more specific implementations of the present invention by way of example only and not by way of limitation.

1 is a diagram of an exemplary catheter-based electrophysiological mapping and ablation system in accordance with aspects of the present invention.

2A is an illustration of a first exemplary basket assembly having three frame rings in accordance with aspects of the present invention.

2B is an illustration of a distal end view of a first exemplary basket assembly according to aspects of the present invention.

3A is an illustration of a second exemplary basket assembly having three frame rings in accordance with aspects of the present invention.

3B is an illustration of a distal end view of a second exemplary basket assembly according to aspects of the present invention.

4A is an illustration of a third exemplary basket assembly having three frame rings in accordance with aspects of the present invention.

4B is an illustration of a distal end view of a third exemplary basket assembly according to aspects of the present invention.

5A is an illustration of a fourth exemplary basket assembly with an inner electrode assembly in a contact configuration in accordance with aspects of the present disclosure.

5B is an illustration of a portion of a fourth exemplary basket assembly with an inner electrode assembly in a non-contact configuration in accordance with aspects of the present disclosure.

6A is an illustration of an arrangement of electrodes of a fourth exemplary basket assembly with an inner electrode assembly in a non-contact configuration in accordance with aspects of the present disclosure.

6B is an illustration of the arrangement of electrodes of a fourth exemplary basket assembly with the inner electrode assembly in a contact configuration in accordance with aspects of the present disclosure.

FIG. 6C illustrates an exemplary basket made from two separate tubular blanks, designated 410 and 420 , having different outer diameters, in accordance with aspects of the present invention.

FIG. 6D shows a cross-sectional view of a smaller tubular blank 420 (from FIG. 6C ) having three separate ridges, in accordance with aspects of the present invention.

FIG. 6E shows a cross-sectional view of a larger tubular blank 410 (from FIG. 6C ) having three separate ridges, in accordance with aspects of the present invention.

7A is an illustration of a first overall structure of a fifth exemplary basket assembly according to aspects of the present invention.

7B is an illustration of a second overall structure of a fifth exemplary basket assembly according to aspects of the present invention.

7C is an illustration of the structures of FIGS. 7A and 7B assembled to form a fifth exemplary basket assembly in accordance with aspects of the present invention.

8A is an illustration of a first overall structure of a sixth exemplary basket assembly according to aspects of the present invention.

8B is an illustration of a second overall structure of a sixth exemplary basket assembly according to aspects of the present invention.

8C is an illustration of the structures of FIGS. 8A and 8B assembled to form a sixth exemplary basket assembly in accordance with aspects of the present disclosure.

9A is an illustration of a first overall structure of a seventh exemplary basket assembly according to aspects of the present invention.

9B is an illustration of a second overall structure of a seventh exemplary basket assembly according to aspects of the present invention.

9C is an illustration of the structures of FIGS. 9A and 9B assembled to form a seventh exemplary basket assembly in accordance with aspects of the present invention.

10A is an illustration of a first overall structure of an eighth exemplary basket assembly according to aspects of the present invention.

10B is an illustration of a second overall structure of an eighth exemplary basket assembly according to aspects of the present invention.

10C is an illustration of the structures of FIGS. 10A and 10B assembled to form an eighth exemplary basket assembly in accordance with aspects of the present invention.

11 is a diagrammatic representation of electrodes according to aspects of the present invention.

12A is an illustration of a frame ring having an approximately circular cross-section in accordance with aspects of the present invention.

12B is an illustration of a frame ring having an oblate cross-section in accordance with aspects of the present invention.

Detailed ways

The following detailed description should be read with reference to the accompanying drawings, which depict selected embodiments and are not intended to limit the scope of the invention. The detailed description illustrates the principle of the invention by way of example and not by way of limitation. This description will clearly enable those skilled in the art to prepare and use the invention, and describes several embodiments, adaptations, variations, alternative forms and uses of the invention, including the best mode currently believed to be implemented in the invention. Any one or more of the teachings, expressions, patterns, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, patterns, examples, etc. described herein. Therefore, the following teachings, expressions, patterns, examples, etc. should not be considered to be separated from each other. With reference to the teachings herein, the various suitable ways in which the teachings herein can be combined will be apparent to those skilled in the relevant art. Such modifications and variations are intended to be included within the scope of the claims.

As used herein, the term "about" or "approximately" for any numerical value or range indicates a suitable dimensional tolerance that allows a part or a collection of components to achieve its intended purpose as described herein. More specifically, "about" or "approximately" may refer to a range of ±10% of the value of the recited value, 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 systems or methods to human use, but the use of the subject invention in human patients represents a preferred embodiment. Likewise, the term "proximal" refers to a position closer to an operator, while "distal" refers to a position farther from an operator or physician.

As used herein, the term "proximal" refers to a position closer to an operator or physician, while "distal" refers to a position farther from an operator or physician.

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

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

As discussed herein, the terms "bipolar" and "unipolar/monopolar" when used to refer to ablation regimens describe ablation regimens that differ in terms of current paths and electric field distributions. "Bipolar" refers to an ablation regimen that utilizes a current path between two electrodes as described below, both of which are positioned at a treatment site; the current density and electric flux density at each of the two electrodes are typically approximately equal. "Unipolar" and "monopolar" are used interchangeably herein to refer to an ablation regimen that utilizes a current path between two electrodes, wherein one electrode having a high current density and a high electric flux density is positioned at the treatment site, and a second electrode having a relatively lower current density and a lower electric flux density is positioned away from the treatment site.

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

Alternative basket assembly configurations are presented herein. Fig. 1 shows a catheter-based electrophysiological mapping and ablation system 10 including an exemplary catheter 14. The exemplary catheter 14 has electrodes 40 supported by spines 110 of a support frame assembly. The support frame assembly can have a variety of configurations, including the configurations shown in Figures 2A to 10C, wherein: the first exemplary basket assembly 100, the second exemplary basket assembly 200, and the third exemplary basket assembly 300 shown in Figures 2A to 4B each include at least one frame ring having a bend at the distal end of the support frame assembly; the fourth exemplary basket assembly 400 shown in Figures 5A to 6B has an inner support frame and an outer support frame, which allow the inner electrode assembly to move between a contact configuration and a non-contact configuration; the fifth exemplary basket assembly 500, the sixth exemplary basket assembly 600, and the seventh exemplary basket assembly 700 each have a first integral structure and a second integral structure, the first integral structure having four ridges and the second integral structure having at least two ridges; and the eighth exemplary basket assembly 800 has a combination of a planar tripod structure and a tubular tripod structure. The compatible features of each of the exemplary basket assemblies 100, 200, 300, 400, 500, 600, 700, 800 may be combined as disclosed herein and as understood by a person skilled in the relevant art. Each of the exemplary basket assemblies 100, 200, 300, 400, 500, 600, 700, 800 may include an electrode, such as the exemplary electrode 40 shown in FIG. 11. The contour shape of the support frame of any of the exemplary basket assemblies 100, 200, 300, 400, 500, 600, 700, 800 may be approximately circular as shown in FIG. 12A (forming an approximately spherical basket) or may be oblate as shown in FIG. 12B (forming an approximately oblate spheroid basket). Examples are described in detail below in conjunction with the accompanying drawings.

FIG. 1 is a diagram showing an exemplary catheter-based electrophysiological mapping and ablation system 10. The system 10 includes a plurality of catheters that are inserted into a chamber or vascular structure of a heart 12 by a physician 24 through the patient's vascular system via the skin. Typically, a delivery sheath catheter is inserted into the left atrium or right atrium near a desired location in the heart 12. Multiple catheters may then be inserted into the delivery sheath catheter to reach the desired location. The multiple catheters may include a catheter dedicated to sensing intracardiac electrogram (IEGM) signals, a catheter dedicated to ablation, and/or a catheter dedicated to both sensing and ablation. An exemplary catheter 14 constructed for sensing IEGM is shown herein. The physician 24 brings the distal end 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 catheter 14 shown is an exemplary catheter that includes one and preferably a plurality of electrodes 40, which are optionally distributed on a plurality of ridges 110 of a basket assembly 100, the catheter forming an end effector at the distal end 28, and is configured to sense IEGM signals and/or provide ablation signals. As disclosed herein, the basket assembly 100 shown in FIG. 1 is compatible with each of the features of the basket assemblies 100, 200, 300, 400, 500, 600, 700, 800 and variations thereof shown in FIGS. 2A to 10C. Thus, the catheter 14 can be modified to include any of the features associated with the exemplary basket assemblies 100, 200, 300, 400, 500, 600, 700, 800. The features of a given exemplary basket assembly 100, 200, 300, 400, 500, 600, 700, 800 are compatible with each other within a given example. For any of the exemplary basket assemblies 100, 200, 300, 400, 500, 600, 700, 800, the overall basket shape may be approximately spherical (FIG. 12A) or approximately an oblate spheroid (FIG. 12B).

The ridges 110 can collapse toward the longitudinal axis 86 so that the end effector of the basket assembly 100 (hereinafter referred to as the "basket assembly") can be delivered to the treatment site through a sheath or intermediate catheter. As shown in the outlines in Figures 12A and 12B, the basket assembly 100 can be configured to expand to the basket shape shown when deployed, having an approximately spherical shape or an approximately oblate spheroid shape. Preferably, the support frame assembly 100 is self-expandable when leaving the intermediate catheter or sheath, and can include nickel-titanium alloy or other shape memory materials suitable for promoting self-expansion and biocompatibility.

The proximal end of each spine 110 is coupled together within the shaft 84 near the proximal end of the basket assembly 100 and the distal end of the shaft 84. The catheter 14 may include a spine retaining hub 90 extending longitudinally through the distal end of the shaft 84. The spine retaining hub 90 may include a cylindrical member configured to attach the proximal ends of the spines 110 within the shaft 84. The spine retaining hub 90 may include irrigation openings and/or electrodes.

Each ridge 110 may include a resilient support frame and an insulating sheath, sleeve, or other structure that electrically insulates the electrode 40 from the support frame material, the resilient support frame comprising a suitable biocompatible material to provide structural support. Each ridge 110 may also include an electrical conductor, such as a wire and/or a flexible circuit, in electrical communication with the electrode 40 to provide electrical communication between the electrode 40 and other components of the system 10 (e.g., the patient interface unit 30) to facilitate navigation, mapping, and/or ablation.

The catheter 14 may further include a position sensor 29 embedded in or near the distal tip 28 for tracking the position and orientation of the distal tip 28. Optionally and preferably, the position sensor 29 is a magnetic-based position sensor that includes three magnetic coils for sensing three-dimensional (3D) position and orientation. The magnetic-based position sensor 29 can operate with a positioning pad 25 that includes a plurality of magnetic coils 32 configured to generate a magnetic field in a predefined workspace. The real-time position of the distal tip 28 of the catheter 14 can be tracked based on the magnetic field generated using the positioning pad 25 and sensed by the magnetic-based position sensor 29. 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, which are incorporated herein by reference and attached as an appendix to priority patent application No. 63/476,275.

The system 10 includes one or more electrode patches 38 positioned in contact with the skin of the patient 23 to establish a position reference for impedance-based tracking of the positioning pad 25 and the electrodes 40. For impedance-based tracking, current is directed toward the electrodes 40 and sensed at the electrode skin patches 38 so that the position of each electrode can be triangulated via the electrode patches 38. Details of impedance-based position tracking techniques are described in U.S. Patent Nos. 7,536,218, 7,756,576, 7,848,787, 7,869,865, and 8,456,182, which are incorporated herein by reference and are attached as an appendix to priority patent application No. 63/476,275.

Recorder 11 displays electrograms 21 captured using body surface ECG electrodes 18 and intracardiac electrograms (IEGMs) captured using electrodes 40 of catheter 14. Recorder 11 may include pacing capabilities for pacing the cardiac rhythm and/or may be electrically connected to a separate pacemaker.

The system 10 may include an ablation energy generator 50 adapted to conduct ablation energy to one or more electrodes at the distal end of a catheter configured for ablation. The energy generated by the ablation energy generator 50 may include, but is not limited to, radio frequency (RF) energy or pulsed field ablation (PFA) energy (including unipolar or bipolar high voltage DC pulses that can be used to achieve irreversible electroporation (IRE)), or a combination thereof. For example, the electrodes 40 may be configured to deliver a peak voltage of at least 900 volts (V) between the electrodes 40 to achieve IRE.

The patient interface unit (PIU) 30 is an interface configured to establish electrical communication between catheters, electrophysiology equipment, a power source, and a workstation 55 for controlling the operation of the system 10. The electrophysiology equipment of the system 10 may include, for example, multiple catheters, positioning pads 25, surface ECG electrodes 18, electrode patches 38, ablation energy generator 50, and 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.

Workstation 55 includes memory, a processor unit with memory or storage loaded with appropriate operating software, and user interface capabilities. Workstation 55 can 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 activation sequences (or other data) compiled from recorded electrograms 21 on display device 27 as representative visual markers or images superimposed on the rendered anatomical map 20; (3) displaying real-time positions and orientations of multiple catheters within the heart chambers; and (4) displaying on display device 27 sites of interest such as where ablation energy is applied. A commercial product embodying elements of system 10 is available as the CARTO ^™ 3 system from Biosense Webster, Inc., 31A Technology Drive, Irvine, CA 92618.

The system 10 may also include an irrigation source (not shown) configured to provide an irrigation fluid to the catheter 14. The workstation 55 may be configured to control the irrigation source to provide irrigation at the distal end 28 of the catheter 14.

FIG2A is an illustration of a first exemplary basket assembly 100 having a plurality of ridges 110a to 110f and electrodes 40 coupled to the ridges 110a to 110f. The ridges 110a to 110f are distributed between a first frame ring 111, a second frame ring 112, and a third frame ring 113. The ridges 110a to 110f are configured to expand away from the longitudinal axis 86 of the end effector to form a basket shape. The basket shape may be approximately spherical, approximately oblate spheroidal, or other suitable shapes as understood by those skilled in the art.

The first frame ring 111 includes a first pair of ridges 110a, 110d disposed opposite each other relative to the longitudinal axis 86. The second frame ring 112 is different from the first frame ring 111 and includes a second pair of ridges 110b, 110c disposed on a first side of the first frame ring 111. The third frame ring 113 is different from the first frame ring 111 and the second frame ring 112 and includes a third pair of ridges 110f, 110e disposed on a second side of the first frame ring 111. The first frame ring 111, the second frame ring 112, and the third frame ring 113 converge at the distal end 104 of the basket assembly 100.

The first exemplary basket assembly 100 can be configured to be coupled to the shaft 84 via the retaining hub 90 to form the catheter 14 disclosed with respect to FIG. 1 , or otherwise coupled to the shaft 84 as understood by those skilled in the relevant art. As disclosed with respect to FIG. 1 , the electrode 40 can be configured for navigation, mapping, and/or ablation. Each spine 110a to 110f can include a support frame, an insulator that electrically insulates the support frame from the electrode 40, an electrical conductor that electrically communicates with the electrode 40, and other compatible features such as disclosed with respect to FIG. 1 and otherwise understood by those skilled in the relevant art.

FIG. 2B is an illustration of a view of the distal end 104 of the first exemplary basket assembly 100. The first frame ring 111 includes a distal portion 121 proximate the distal end 104 of the end effector and transverse to the longitudinal axis 86. The first frame ring 111 bisects the basket assembly 100 such that a first side (right side in FIG. 2B ) on which the second frame ring 112 is primarily disposed is opposite a second side (left side in FIG. 2B ) on which the third frame ring 113 is primarily disposed. Each of the second frame ring 112 and the third frame ring 113 includes an angled portion 122, 123, respectively, located at the distal end 104 of the end effector of the basket assembly 100. The angled portion 122, 123 of each of the second frame ring and the third frame ring can be coupled to the distal portion 121 of the first frame ring 111.

The ridges 110a to 110f are symmetrically arranged about the longitudinal axis 86, so that the first pair of ridges 110a, 110d of the first frame ring 111, the second pair of ridges 110b, 110c of the second frame ring 112 and the third pair of ridges 110f, 110e of the third frame ring 113 are collectively symmetrically arranged about the longitudinal axis 86.

The first pair of ridges 110a, 110d are disposed at an angle 131 of approximately 180° to one another relative to an imaginary circle 70 about the longitudinal axis 86. The second pair of ridges 110b, 110c are disposed at an angle 132 of approximately 60° to one another relative to the imaginary circle 70. The third pair of ridges 110e, 110f are disposed at an angle 133 of approximately 60° to one another relative to the imaginary circle 70.

Each of the angled portions 122, 123 of the second frame ring 112 and the third frame ring 113 overlaps the distal portion 121 of the first frame ring 111. As shown, the distal portion 121 of the first frame ring 111 is located distal to the angled portions 122, 123. So configured, the distal portion 121 of the first frame ring 111 can protect the angled portions 122, 123 from contacting tissue, thereby providing an atraumatic distal end 104 for the basket assembly 100. As will be appreciated by those skilled in the relevant art, one or both of the angled portions 122, 123 can be located distal to the distal portion 121 of the first frame ring 111, and the basket assembly 100 can be configured in other ways to provide an atraumatic distal end 104, such as by providing an atraumatic shape at one or both of the angled portions 122, 123, by covering the distal end 104 of the basket assembly 100 with an atraumatic cover or coating, etc.

FIG3A is an illustration of a second exemplary basket assembly 200 having a plurality of ridges 110a-110f and electrodes 40 coupled to the ridges 110a-110f. The configuration of the ridges 110a-110f and electrodes 40 is similar to the ridges 110a-110f and electrodes 40 disclosed with respect to FIG2A. As disclosed with respect to FIG1, the electrodes 40 may be configured for navigation, mapping, and/or ablation. Each ridge 110a-110f may include a support frame, an insulator that electrically insulates the support frame from the electrodes 40, an electrical conductor that electrically communicates with the electrodes 40, and other compatible features such as disclosed with respect to FIG1 and otherwise understood by those skilled in the art.

The ridges 110a to 110f are distributed between the first frame ring 111, the second frame ring 212, and the third frame ring 213. The ridges 110a to 110f are configured to expand away from the longitudinal axis 86 of the end effector to form a basket shape. The basket shape can be approximately spherical, approximately oblate spheroidal, or other suitable shapes understood by those skilled in the art.

The first frame ring 111 includes a first pair of ridges 110a, 110d disposed opposite each other relative to the longitudinal axis 86. The second frame ring 212 is different from the first frame ring 111 and includes a second pair of ridges 110b, 110c disposed on a first side of the first frame ring 111. The third frame ring 213 is different from the first frame ring 111 and the second frame ring 212 and includes a third pair of ridges 110f, 110e disposed on a second side of the first frame ring 211. The first frame ring 211, the second frame ring 212, and the third frame ring 113 converge at the distal end 204 of the second exemplary basket assembly 200.

The second exemplary basket assembly 200 may be configured to engage with the shaft 84 via the retaining hub 90 to form the catheter 14 disclosed with respect to FIG. 1 , or otherwise engage with the shaft 84 , as understood by those skilled in the relevant art(s).

The second example basket assembly 200 is similar to the first example basket assembly shown in FIGS. 2A and 2B , but the configuration of the distal end 204 of the second example basket assembly 200 is different from the distal end 104 of the first example basket assembly 100 .

FIG. 3B is an illustration of the distal end 204 of the second exemplary basket assembly 200. Similar to the first frame ring 111 of the first exemplary basket assembly 100, the first frame ring 111 includes a distal portion 121 that is proximal to the distal end 204 of the end effector and transverse to the longitudinal axis 86. The first frame ring 111 bisects the second exemplary basket assembly 200 such that a first side (right side in FIG. 3B ) on which the second frame ring 212 is primarily disposed is opposed to a second side (left side in FIG. 3B ) on which the third frame ring 213 is primarily disposed. Each of the second frame ring 212 and the third frame ring 213 includes an angled portion 222, 223, respectively, located at the distal end 204 of the end effector of the basket assembly 200. Each angled portion 222, 223 abuts the distal portion 121 of the first frame ring, rather than overlapping the distal portion 121 of the first frame ring as in the first exemplary basket assembly 100.

The angled portions 222, 223 of each of the second and third frame rings may be coupled to the distal portion 221 of the first frame ring 211. The second exemplary basket assembly 200 includes a retainer 208. Although not shown in FIGS. 2A and 2B, the first exemplary basket assembly 100 may also include a retainer 208. The retainer 208 is shown as a band, but may have other alternative configurations as understood by those skilled in the relevant art, such as a circular hub. The retainer 208 may be configured to provide an atraumatic distal end 204 of the second exemplary basket assembly 200 (or the first exemplary basket assembly 100). The second exemplary basket assembly 200 may be configured to provide an atraumatic distal end 204 in other ways, such as by providing an atraumatic shape at one or both of the angled portions 222, 223, by covering the distal end 204 of the basket assembly 200 with an atraumatic cover or coating, etc.

The ridges 110a to 110f are symmetrically arranged about the longitudinal axis 86, so that the first pair of ridges 110a, 110d of the first frame ring 111, the second pair of ridges 110b, 110c of the second frame ring 212 and the third pair of ridges 110f, 110e of the third frame ring 213 are collectively symmetrically arranged about the longitudinal axis 86.

The first pair of ridges 110a, 110d are disposed at an angle 131 of approximately 180° to one another relative to an imaginary circle 70 about the longitudinal axis 86. The second pair of ridges 110b, 110c are disposed at an angle 132 of approximately 60° to one another relative to the imaginary circle 70. The third pair of ridges 110e, 110f are disposed at an angle 133 of approximately 60° to one another relative to the imaginary circle 70.

Each angled portion 222 , 223 of the second frame ring 212 and the third frame ring 213 abuts the distal portion 121 of the first frame ring 111 .

FIG4A is an illustration of a third exemplary basket assembly 300 having a plurality of ridges 110a-110f and electrodes 40 coupled to the ridges 110a-110f. The configuration of the ridges 110a-110f and electrodes 40 is similar to the ridges 110a-110f and electrodes 40 disclosed with respect to FIG2A. As disclosed with respect to FIG1, the electrodes 40 may be configured for navigation, mapping, and/or ablation. Each ridge 110a-110f may include a support frame, an insulator that electrically insulates the support frame from the electrodes 40, an electrical conductor that electrically communicates with the electrodes 40, and other compatible features such as disclosed with respect to FIG1 and otherwise understood by those skilled in the art.

FIG4B is an illustration of a distal end 304 of a third exemplary basket assembly 300. Referring to FIGS. 4A and 4B together, ridges 110a to 110f are distributed between a first frame ring 311, a second frame ring 312, and a third frame ring 313. The ridges 110a to 110f are configured to expand away from the longitudinal axis 86 of the end effector to form a basket shape. The basket shape may be approximately spherical, approximately oblate spheroidal, or other suitable shapes as understood by those skilled in the art.

The first frame ring 311 includes a first pair of ridges 110a, 110e and a first angled portion 321 near the distal end 304 of the end effector. The second frame ring 312 is different from the first frame ring 311 and includes a second pair of ridges 110d, 110f and a second angled portion 322 near the distal end 304 of the end effector, such that the second angled portion 322 overlaps the first angled portion 321, the inner ridge 110e of the first pair of ridges 110a, 110e is positioned between the ridges of the second pair of ridges 110d, 110f, and the inner ridge 110f of the second pair of ridges 110d, 110f is positioned between the ridges of the first pair of ridges 110a, 110e. The third frame ring 313 is different from the first frame ring 311 and the second frame ring 312, and includes a third pair of ridges 110b, 110c and a third angled portion 323 near the distal end 304 of the end actuator, so that the ridges in the third pair of ridges 110b, 110c are each arranged between the outer ridge 110a in the first pair of ridges and the outer ridge 110d in the second pair of ridges.

The second exemplary basket assembly 200 may be configured to engage with the shaft 84 via the retaining hub 90 to form the catheter 14 disclosed with respect to FIG. 1 , or otherwise engage with the shaft 84 , as understood by those skilled in the relevant art(s).

The first angled portion 321 and/or the second angled portion 322 may overlap with the third angled portion 323 at a position proximal to the distal end 304 of the end effector to provide an atraumatic distal end 304. The angled portions 321, 322, 323 of each of the first frame ring 311, the second frame ring 312, and the third frame ring 313 may be coupled to each other. Although not shown in FIGS. 4A and 4B, the third exemplary basket assembly 300 may also include a retainer similar to the retainer 208 shown in FIGS. 3A and 3B. The retainer 208 is shown as a band, but may have other alternative configurations, such as a circular hub, as understood by a person skilled in the relevant art. The retainer 208 may be configured to provide an atraumatic distal end 304 of the third exemplary basket assembly 300. The third exemplary basket assembly 300 may be configured in other ways to provide an atraumatic distal end 304, such as by providing an atraumatic shape at one or more of the angled portions 321, 322, 323, by covering the distal end 304 of the basket assembly 200 with an atraumatic covering or coating, etc.

The ridges 110a to 110f are symmetrically arranged about the longitudinal axis 86, so that the first pair of ridges 110a, 110e of the first frame ring 311, the second pair of ridges 110d, 110f of the second frame ring 312 and the third pair of ridges 110b, 110c of the third frame ring 313 are collectively symmetrically arranged about the longitudinal axis 86.

The first pair of ridges 110a, 110e are disposed at an angle 331 of approximately 120° to one another relative to an imaginary circle 70 about the longitudinal axis 86. The second pair of ridges 110d, 110f are disposed at an angle 332 of approximately 120° to one another relative to the imaginary circle 70. The third pair of ridges 110b, 110c are disposed at an angle 333 of approximately 60° to one another relative to the imaginary circle 70.

The outer ridge 110a of the first pair of ridges may be disposed opposite the outer ridge 110d of the second pair of ridges relative to the longitudinal axis 86. The inner ridge 110e of the first pair of ridges and the inner ridge 110f of the second pair of ridges may be positioned opposite the corresponding ridges of the third pair of ridges 110b, 110c.

FIG5A is an illustration of a fourth exemplary basket assembly 400 having an inner electrode assembly 420 and an outer electrode assembly 420 in a contact configuration. The electrodes 40b, 40a of the inner electrode assembly 420 and the outer electrode assembly 410 are coupled to the ridges 110a-110f. The configuration of the ridges 110a-110f and the electrodes 40a, 40b is similar to the ridges 110a-110f and the electrodes 40 disclosed with respect to FIG2A. The electrodes 40a, 40b may be configured for navigation, mapping, and/or ablation, as disclosed with respect to the electrodes 40 of FIG1. Each ridge 110a-110f may include a support frame, an insulator electrically insulating the support frame from the electrodes 40a, 40b, an electrical conductor in electrical communication with the electrodes 40a, 40b, and other compatible features such as disclosed with respect to FIG1 and otherwise understood by those skilled in the art.

The outer electrode assembly 410 includes a first plurality of ridges 110a, 110c, 110e and a first plurality of electrodes 40a. The first plurality of electrodes 40a are coupled to each of the first plurality of ridges 110a, 110c, 110e. The inner electrode assembly 420 includes a second plurality of ridges 110b, 110d, 110f and a second plurality of electrodes 40b. The second plurality of electrodes 40b are coupled to each of the second plurality of ridges 110b, 110d, 110f.

The first plurality of ridges 110a, 110c, 110e are configured to expand from the longitudinal axis 86 to form a basket shape, and the second plurality of ridges 110b, 110d, 110f are configured to expand from the longitudinal axis 86 to form a basket shape. The inner electrode assembly 420 and the outer electrode assembly 410 may together form a basket shape. The basket shape may be approximately spherical, approximately oblate spheroidal, or other suitable shapes as understood by those skilled in the art.

The inner electrode assembly 420 is configured to move between a non-contact configuration and a contact configuration. FIG. 5A shows the inner electrode assembly 420 in a contact configuration. In the contact configuration, the second plurality of electrodes 40b are positioned to contact tissue. The second plurality of ridges 110b, 110d, 110f are not aligned with the first plurality of ridges 110a, 110c, 110e in the contact configuration.

5B is an illustration of the alignment of the ridges 110d of the inner electrode assembly 420 with the ridges 110c of the outer electrode assembly 410 when the inner electrode assembly 420 is in a non-contact configuration. The second plurality of ridges 110b, 110d, 110f are aligned with the first plurality of ridges 110a, 110c, 110e in the non-contact configuration. In the non-contact configuration, the second plurality of electrodes 40b are prevented from contacting tissue by the outer electrode assembly 410.

5A and 5B , the inner electrode assembly 420 can be configured to move between a non-contact configuration ( FIG. 5B ) and a contact configuration ( FIG. 5A ) by virtue of one or both of the inner electrode assembly 420 and the outer electrode assembly 410 rotating about the longitudinal axis 86. For example, the fourth exemplary basket assembly 400 can be configured to move the inner electrode assembly 420 between a non-contact configuration and a contact configuration in one of three ways: (1) the inner electrode assembly 420 can rotate about the longitudinal axis 86 while the outer electrode assembly 410 remains stationary; (2) the outer electrode assembly 410 can rotate about the longitudinal axis 86 while the inner electrode assembly 420 remains stationary; or (3) both the inner electrode assembly 420 and the outer electrode assembly 410 can rotate about the longitudinal axis 86.

The outer electrode assembly 410 may include a first integral tripod structure including a first plurality of ridges 110a, 110c, 110e such that the first plurality of ridges has exactly three ridges. The inner electrode assembly 420 may include a second integral tripod structure including a second plurality of ridges 110b, 110d, 110f such that the second plurality of ridges has exactly three ridges. Each tripod structure may be formed from a respective planar sheet of material including three linear ridges converging at a respective central ridge intersection 406. Each ridge of each tripod structure may include a respective end disposed at a proximal end of the fourth exemplary basket assembly 400. The central ridge intersection 406 of each tripod structure may be positioned on the longitudinal axis 86 at the distal end of the end effector.

Each electrode 40a, 40b of the first plurality of electrodes 40a and the second plurality of electrodes 40b can define an inner cavity through the electrode so that each ridge 110a to 110f extends through the inner cavity of each electrode in the electrode. Electrodes 40a, 40b can be shaped to be similar to the shape shown in Figure 11, its variation and its alternative form, as understood by those skilled in the relevant art. The electrodes in the first plurality of electrodes 40a can be configured to deliver electrical pulses for irreversible electroporation. These pulses can have a peak voltage of at least 900 volts (V). The electrodes in the second plurality of electrodes 40b can be configured to map the cardiac electrical signals passing through the tissue.

6A is an illustration of the arrangement of electrodes 40a, 40b of a fourth exemplary basket assembly 400 with the inner electrode assembly 420 in a non-contact configuration.

6B is an illustration of the arrangement of electrodes 40a, 40b of a fourth exemplary basket assembly 400 with the inner electrode assembly 420 in a contacting configuration.

In FIGS. 6A and 6B , an inner imaginary circle 72 is drawn to illustrate the circular arrangement of the second plurality of electrodes 40 b , and an outer imaginary circle 71 is drawn to illustrate the circular arrangement of the first plurality of electrodes 40 a .

FIG6C shows an exemplary basket catheter 400 having two formed tubular blanks 421 and 411. When each respective tubular blank 411, 421 expands, they become respective three-ridge baskets. Electrodes 40a, 40b, conductors and other features may be attached to the tubular blanks 421, 411 to form the inner electrode assembly 420 and the outer electrode assembly 410.

FIG6D shows a cross-sectional view of the tubular blank 421 of the inner electrode assembly 420 indicated in FIG6C. The tubular blank 421 has an outer diameter D2 and is cut to have ridges with a width W2 and gaps G2 between the ridges. The ridge width W2 is about 72% of the outer diameter D2. The gap G2 is about 24% of the diameter D2 or about 33% of the ridge width W2.

FIG6E shows a cross-sectional view of the tubular blank 411 of the outer electrode assembly 410 indicated in FIG6C. The tubular blank 411 has an outer diameter D1 and is cut to have ridges having a width W1 and gaps G1 between the ridges. The ridge width W1 is approximately equal to the ridge width W2 of the inner tubular blank 421. The ridge width W1 is approximately 57% of the outer diameter D1. The gap G1 is approximately 43% of the outer diameter D1 or approximately 75% of the ridge width W1. The inner diameter D2' of the outer tubular blank 411 is approximately equal to the outer diameter D2 of the inner tubular blank 421. When the inner tubular blank 421 and the outer tubular blank 411 are expanded into a basket, the distal end hole 412 of the outer tubular blank 411 may have a diameter that is approximately the same as the outer diameter D2 of the inner tubular blank 421.

7A is an illustration of a first unitary structure 510 of a fifth exemplary basket assembly 500. The first unitary structure 510 includes four ridges and may be formed from a planar sheet of material including four linear ridges converging at a central ridge intersection.

FIG7B is an illustration of a second monolithic structure 520 of the fifth exemplary basket assembly 500. The second monolithic structure 520 is different from the first monolithic structure 510 and includes four ridges. The second monolithic structure 520 can be formed identically to the first monolithic structure 510, but need not be. The second monolithic structure 520 can be formed from a planar sheet of material including four ridges that converge at a central ridge intersection.

FIG7C is an illustration of the structures 510, 520 of FIGS. 7A and 7B assembled to form a support frame of the fifth exemplary basket assembly 500. The fifth exemplary basket assembly 500 may also include an electrode coupled to each ridge of the first monolithic structure 510 and the second monolithic structure 520. The configuration of the electrodes may be similar to the electrodes 40 disclosed with respect to FIGS. 1 and with respect to FIG. 11. Each electrode may define a lumen through the electrode such that each ridge extends through the lumen of each electrode. The electrodes may be configured to deliver an electrical pulse for irreversible electroporation having a peak voltage of at least 900 volts (V).

The ridges of the first monolithic structure 510 and the second monolithic structure 520 can be configured to expand from the longitudinal axis of the end effector to form a basket shape together. The basket shape can be approximately spherical or approximately oblate. The ridges of the first monolithic structure 510 and the second monolithic structure 520 can be symmetrically positioned about the longitudinal axis 86.

Each spine of each monolithic structure 510, 520 may include a respective connection end disposed at the proximal end of the fifth exemplary basket assembly 500. The central spine intersection of each monolithic structure 510, 520 may be located on the longitudinal axis 86 at the distal end of the basket assembly 500.

8A is an illustration of a first unitary structure 610 of a sixth exemplary basket assembly 600. The first unitary structure 610 includes four ridges and may be formed from a planar sheet of material including four linear ridges converging at a central ridge intersection.

8B is an illustration of a second monolithic structure 620 of the sixth exemplary basket assembly 600. The second monolithic structure 620 is different from the first monolithic structure 610 and includes three ridges. The second monolithic structure 620 may be formed from a planar sheet of material including three ridges converging at a central ridge intersection.

FIG8C is an illustration of the structures 610, 620 of FIGS. 8A and 8B being assembled to form a support frame of the sixth exemplary basket assembly 600. The sixth exemplary basket assembly 600 may also include an electrode coupled to each ridge of the first monolithic structure 610 and the second monolithic structure 620. The configuration of the electrodes may be similar to the electrodes 40 disclosed with respect to FIGS. 1 and with respect to FIG. 11. Each electrode may define a lumen through the electrode such that each ridge extends through the lumen of each electrode. The electrodes may be configured to deliver an electrical pulse for irreversible electroporation having a peak voltage of at least 900 volts (V).

The ridges of the first and second monolithic structures 610, 620 can be configured to expand from the longitudinal axis of the end effector to form a basket shape together. The basket shape can be approximately spherical or approximately oblate. The ridges of the first and second monolithic structures 610, 620 can be positioned symmetrically about the longitudinal axis 86.

Each spine of each monolithic structure 610, 620 may include a respective connection end disposed at a proximal end of the sixth exemplary basket assembly 600. A central spine intersection of each monolithic structure 610, 620 may be positioned on the longitudinal axis 86 at a distal end of the basket assembly 600.

9A is an illustration of a first unitary structure 710 of a seventh exemplary basket assembly 700. The first unitary structure 710 includes four ridges and may be formed from a planar sheet of material including four linear ridges converging at a central ridge intersection.

FIG. 9B is an illustration of a second monolithic structure 720 of the seventh exemplary basket assembly 700. The second monolithic structure 720 is different from the first monolithic structure 710 and includes two ridges. The second monolithic structure 720 may be formed from a single elongated ridge that is shaped to form a loop. The second monolithic structure 720 may be formed from a planar sheet of material. The center point of the loop is considered to be the center ridge intersection point.

9C is an illustration of the structures 710, 720 of FIGS. 9A and 9B being assembled to form a support frame of the seventh exemplary basket assembly 700. The second monolithic structure 720 may include a ring extending across a central ridge intersection of the first monolithic structure 710 such that two ridges of the first monolithic structure 710 are disposed on a first side of the ring 720 and two ridges of the first monolithic structure 710 are disposed on a second side of the ring 720.

The seventh exemplary basket assembly 700 may also include an electrode coupled to each ridge of the first monolithic structure 710 and the second monolithic structure 720. The configuration of the electrode may be similar to the electrode 40 disclosed with respect to FIG. 1 and with respect to FIG. 11. Each electrode may define a lumen through the electrode such that each ridge extends through the lumen of each electrode. The electrode may be configured to deliver an electrical pulse for irreversible electroporation having a peak voltage of at least 900 volts (V).

The ridges of the first and second monolithic structures 710, 720 can be configured to expand from the longitudinal axis of the end effector to form a basket shape together. The basket shape can be approximately spherical or approximately oblate. The ridges of the first and second monolithic structures 710, 720 can be positioned symmetrically about the longitudinal axis 86.

Each spine of each monolithic structure 710, 720 may include a respective connection end disposed at a proximal end of the seventh exemplary basket assembly 700. A central spine intersection of each monolithic structure 710, 720 may be located on the longitudinal axis 86 at a distal end of the basket assembly 700.

10A is an illustration of a first unitary structure 810 of an eighth exemplary basket assembly 800. The first unitary structure 810 includes three ridges and may be formed from a planar sheet of material including three linear ridges converging at a central ridge intersection.

10B is an illustration of a second monolithic structure 820 of the eighth exemplary basket assembly 800. The second monolithic structure 820 is different from the first monolithic structure 810 and includes three ridges. The second monolithic structure 820 may be formed from a tube of material including at least two ridges joined at one end by a ring.

FIG. 10C is an illustration of the structures 810 , 820 of FIGS. 10A and 10B assembled to form a support frame of an eighth exemplary basket assembly 800 .

The eighth exemplary basket assembly 800 may also include an electrode coupled to each ridge of the first monolithic structure 810 and the second monolithic structure 820. The configuration of the electrode may be similar to the electrode 40 disclosed with respect to FIG. 1 and with respect to FIG. 11. Each electrode may define a lumen through the electrode such that each ridge extends through the lumen of each electrode. The electrode may be configured to deliver an electrical pulse for irreversible electroporation having a peak voltage of at least 900 volts (V).

The ridges of the first and second monolithic structures 810, 820 can be configured to expand from the longitudinal axis of the end effector to collectively form a basket shape. The basket shape can be approximately spherical or approximately oblate. The ridges of the first and second monolithic structures 810, 820 can be positioned symmetrically about the longitudinal axis 86.

Each spine of each monolithic structure 810, 820 may include a respective connection end disposed at the proximal end of the eighth exemplary basket assembly 800. The central spine intersection of each monolithic structure 810, 820 may be located on the longitudinal axis 86 at the distal end of the basket assembly 800.

FIG. 11 is a diagram of an electrode 40. The electrode defines a lumen 48 passing through the electrode 40 so that the ridges can extend through the lumen 48. The electrode has an outer surface 44 exposed to the surrounding environment and an inner surface 46 within the lumen 48. The electrode 40 may include a conductive material (e.g., gold, platinum, and palladium (and their respective alloys)). The electrode 40 may have various cross-sectional shapes, curvatures, lengths, number of lumens, and lumen shapes. The electrodes 40 shown in FIG. 11 and elsewhere herein are provided to illustrate various configurations of the electrode 40 that can be used with the catheter 14, but should not be construed as limiting. Those skilled in the art will appreciate that various other configurations of the electrode 40 can be used with the disclosed technology without departing from the scope of the present disclosure. The electrode 40 may include a wire release 42 that forms a recess or depression in the electrode 40 adjacent to the lumen 48 for passing one or more wires through the lumen 48 together with the corresponding ridges 110. The release 42 may be sized to provide space for the wires of the electrode 40 to pass through the electrode 40 so that the electrode 40 may be in electrical communication with the console PIU 30 ( FIG. 1 ).

12A is an illustration of a frame ring having an approximately circular cross-section, showing the profile of a basket assembly having an approximately spherical basket shape.Any of the exemplary basket assemblies 100, 200, 300, 400, 500, 600, 700, 800 may be formed to have an approximately spherical basket shape.

12B is an illustration of a frame ring having an oblate cross section showing the profile of a basket assembly having an approximately oblate spheroidal basket shape.Any of the exemplary basket assemblies 100, 200, 300, 400, 500, 600, 700, 800 may be shaped to have an approximately oblate spheroidal basket shape.

Exemplary embodiments of the subject matter contained herein have been shown and described, and further improvements of the methods and systems described herein may be achieved by appropriate modifications without departing from the scope of the claims. In addition, where the above methods and steps indicate that specific events occur in a specific order, it is intended that the specific steps do not necessarily have to be performed in the order described, but may be performed in any order, as long as these steps enable the implementation to achieve its intended purpose. Therefore, if there are variations of the present invention and the variations belong to the substantial scope of the disclosure of the present invention or equivalents that can be found in the claims, this patent is intended to also cover these variations. Many such modifications will be obvious to those skilled in the art. For example, the examples, embodiments, geometries, materials, dimensions, ratios, steps, etc. described above are all exemplary. Therefore, the claims should not be limited to the specific details of the structure and operation shown in this written description and the drawings.

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

Item 1. An end actuator of a catheter, the end actuator comprising: a plurality of ridges configured to expand away from a longitudinal axis of the end actuator to form a basket shape; a first frame ring comprising a first pair of ridges among the plurality of ridges, such that the ridges in the first pair of ridges are disposed relative to each other relative to the longitudinal axis; a second frame ring, different from the first frame ring, the second frame ring comprising a second pair of ridges among the plurality of ridges, such that the ridges in the second pair of ridges are disposed on a first side of the first frame ring; a third frame ring, different from the first frame ring and the second frame ring, the third frame ring comprising a third pair of ridges among the plurality of ridges, such that the ridges in the third pair of ridges are disposed on a second side of the first frame ring, the second side being opposite to the first side; and one or more electrodes coupled to the plurality of ridges.

Clause 2. The end effector of clause 1, wherein the first frame ring comprises a distal portion proximate a distal end of the end effector and transverse to the longitudinal axis.

Clause 3. In the end actuator according to clause 1 or 2, each of the second frame ring and the third frame ring includes an angled portion, the angled portion is close to the distal end of the end actuator, and the angled portion of each of the second frame ring and the third frame ring is connected to the first frame ring.

Clause 4. The end effector of any one of clauses 1 to 3, wherein the ridges of the plurality of ridges are symmetrically arranged about the longitudinal axis.

Clause 5. The end effector of Clause 1, wherein the ridges of the first pair of ridges, the second pair of ridges, and the third pair of ridges are symmetrically arranged about the longitudinal axis.

Clause 6. An end actuator according to any one of clauses 1 to 5, wherein the first pair of ridges are arranged at approximately 180° to each other relative to an imaginary circle around the longitudinal axis, the second pair of ridges are arranged at approximately 60° to each other relative to the imaginary circle, and the third pair of ridges are arranged at approximately 60° to each other relative to the imaginary circle.

Clause 7. An end actuator according to any one of clauses 1 to 6, wherein the first frame ring includes a distal portion, which is located at the distal end of the end actuator and crosses the longitudinal axis, and each of the second frame ring and the third frame ring includes an angled portion, which is close to the distal end of the end actuator, so that each angled portion overlaps with the distal portion of the first frame ring.

Clause 8. An end actuator according to any one of clauses 1 to 6, wherein the first frame ring includes a distal portion, which is located at the distal end of the end actuator and crosses the longitudinal axis, and each of the second frame ring and the third frame ring includes an angled portion, which is close to the distal end of the end actuator, so that each angled portion is adjacent to the distal portion of the first frame ring.

Clause 9. The end effector of Clause 8, wherein the second frame ring is disposed entirely on the first side of the first frame ring, and the third frame ring is disposed entirely on the second side of the first frame ring.

Clause 10. The end actuator according to any one of clauses 1 to 9, further comprising: a retainer that connects the first frame ring, the second frame ring, and the third frame ring at a position near the distal end of the end actuator.

Clause 11. An end effector according to any one of clauses 1 to 10, wherein each of the one or more electrodes defines an inner cavity passing through the electrode, so that each of the plurality of ridges extends through the inner cavity of each of the one or more electrodes.

Clause 12. The end effector of any one of clauses 1 to 11, wherein the basket shape is approximately spherical.

Clause 13. The end effector of any one of clauses 1 to 11, wherein the basket shape is approximately an oblate spheroid.

Clause 14. An end effector according to any one of Clauses 1 to 13, wherein the one or more electrodes are configured to deliver electrical pulses for irreversible electroporation, the pulses having a peak voltage of at least 900 volts (V).

Item 15. An end actuator of a catheter, the end actuator comprising: a plurality of ridges, the plurality of ridges being configured to expand from a longitudinal axis of the end actuator to form a basket shape; a first frame ring, the first frame ring comprising a first pair of ridges among the plurality of ridges and a first angled portion near a distal end of the end actuator; a second frame ring, different from the first frame ring, the second frame ring comprising a second pair of ridges among the plurality of ridges and a second angled portion near the distal end of the end actuator, such that the second angled portion overlaps the first angled portion, the first pair of ridges an inner ridge of one of the plurality of ridges being positioned between the ridges of the second pair of ridges, and an inner ridge of the second pair of ridges being positioned between the ridges of the first pair of ridges; a third frame ring, different from the first frame ring and the second frame ring, the third frame ring including a third pair of ridges of the plurality of ridges and a third angled portion proximate the distal end of the end actuator, such that the ridges of the third pair of ridges are each disposed between an outer ridge of the first pair of ridges and an outer ridge of the second pair of ridges; and one or more electrodes coupled to the plurality of ridges.

Clause 16. The end effector of Clause 15, wherein the ridges of the plurality of ridges are symmetrically arranged about the longitudinal axis.

Clause 17. The end effector of clause 15 or 16, wherein the ridges in the first pair of ridges, the second pair of ridges, and the third pair of ridges are symmetrically arranged about the longitudinal axis.

Clause 18. An end actuator according to any one of clauses 15 to 17, wherein the first pair of ridges are arranged at approximately 120° to each other relative to an imaginary circle around the longitudinal axis, the second pair of ridges are arranged at approximately 120° to each other relative to the imaginary circle, and the third pair of ridges are arranged at approximately 60° to each other relative to the imaginary circle.

Clause 19. The end effector of any of Clauses 15 to 18, the outer ridge of the first pair of ridges being disposed opposite the outer ridge of the second pair of ridges relative to the longitudinal axis.

Clause 20. An end effector according to any one of clauses 15 to 19, wherein the first angled portion and/or the second angled portion overlaps the third angled portion at a position close to the distal end of the end effector.

Clause 21. An end effector according to any one of clauses 15 to 20, wherein each of the one or more electrodes defines an inner cavity passing through the electrode, so that each of the plurality of ridges extends through the inner cavity of each of the one or more electrodes.

Clause 22. The end effector of any one of clauses 15 to 21, wherein the basket shape is approximately spherical.

Clause 23. The end effector of any one of clauses 15 to 21, wherein the basket shape is approximately an oblate spheroid.

Clause 24. The end effector of any one of Clauses 15 to 23, wherein the one or more electrodes are configured to deliver electrical pulses for irreversible electroporation, the pulses having a peak voltage of at least 900 volts (V).

Item 25. An end effector of a catheter, the end effector comprising: an outer electrode assembly, the outer electrode assembly comprising a first plurality of ridges and a first plurality of electrodes, the first plurality of ridges being configured to expand from a longitudinal axis of the end effector to form a basket shape, and the first plurality of electrodes being coupled to each of the first plurality of ridges; and an inner electrode assembly, the inner electrode assembly comprising a second plurality of electrodes, the inner electrode assembly being configured to move between a non-contact configuration and a contact configuration, such that in the non-contact configuration, the second plurality of electrodes are prevented from contacting tissue by the outer electrode assembly, and such that in the contact configuration, the second plurality of electrodes are positioned to contact tissue.

Clause 26. The end effector of Clause 25, the outer electrode assembly comprising a first integral tripod structure such that the first plurality of ridges consists of three ridges.

Item 27. According to the end actuator described in Item 26, the inner electrode assembly includes a second integral tripod structure, so that the second plurality of ridges are composed of three ridges, and the second integral tripod structure is rotatable to align with the first integral tripod structure in the non-contact configuration and not to align with the first integral tripod structure in the contact configuration.

Clause 28. An end effector according to clause 27, wherein each tripod structure is formed by a corresponding sheet of planar material, the sheet of planar material comprising three linear ridges converging at a corresponding central ridge intersection, each ridge of each tripod structure comprises a corresponding end disposed at the proximal end of the end effector, and the central ridge intersection of each tripod structure is positioned on the longitudinal axis at the distal end of the end effector.

Clause 29. An end actuator according to any one of clauses 25 to 28, wherein the inner electrode assembly includes a second plurality of ridges, the second plurality of electrodes are coupled to the second plurality of ridges, the second plurality of ridges are aligned with the first plurality of ridges in the non-contact configuration, and the second plurality of ridges are not aligned with the first plurality of ridges in the contact configuration.

Clause 30. An end effector according to any one of clauses 25 to 29, wherein each of the first plurality of electrodes and the second plurality of electrodes defines an inner cavity passing through the electrode, so that each of the plurality of ridges extends through the inner cavity of each of the one or more electrodes.

Clause 31. The end effector of any one of Clauses 25 to 30, wherein the basket shape is approximately spherical.

Clause 32. The end effector of any one of Clauses 25 to 30, wherein the basket shape is approximately an oblate spheroid.

Clause 33. An end effector according to any one of Clauses 25 to 32, wherein electrodes of the first plurality of electrodes are configured to deliver electrical pulses for irreversible electroporation, the pulses having a peak voltage of at least 900 volts (V).

Clause 34. The end effector of any one of Clauses 25 to 33, wherein electrodes of the second plurality of electrodes are configured to map cardiac electrical signals passing through tissue.

Item 35. An end actuator of a catheter, the end actuator comprising: an expandable basket assembly, the expandable basket assembly comprising: a first integral structure, the first integral structure comprising four ridges and formed by a planar material sheet, the planar material sheet comprising four linear ridges converging at a central ridge intersection; a second integral structure, different from the first integral structure, the second integral structure comprising at least two ridges; and a plurality of electrodes coupled to each ridge of the first integral structure and the second integral structure, the ridges of the first integral structure and the second integral structure being configured to expand from the longitudinal axis of the end actuator to collectively form a basket shape.

Item 36. According to the end actuator described in Item 35, the second integral structure is formed by a planar material sheet, the planar material sheet includes at least two ridges converging at a central ridge intersection, each ridge of each integral structure includes a corresponding connecting end arranged at the proximal end of the end actuator, and the central ridge intersection of each integral structure is positioned on the longitudinal axis at the distal end of the end actuator.

Clause 37. The end effector of clause 35, the second unitary structure being formed from a tube of material including the at least two ridges joined at one end by a ring.

Clause 38. The end effector of any one of Clauses 35 to 36, wherein the at least two ridges consist of four ridges.

Clause 39. The end effector of any one of Clauses 35 to 36, wherein the at least two ridges consist of three ridges.

Clause 40. The end effector of any one of Clauses 35 to 36, wherein the at least two ridges consist of two ridges.

Item 41. According to the end actuator described in Item 40, the second integral structure includes a ring that extends across the central ridge intersection of the first integral structure, so that two ridges of the first integral structure are arranged on a first side of the ring and two ridges of the first integral structure are arranged on a second side of the ring.

Clause 42. The end effector of any one of Clauses 35 to 41, the ridges of the first and second integral structures being positioned symmetrically about the longitudinal axis.

Clause 43. The end effector of any one of clauses 35 to 42, wherein each of the plurality of electrodes defines a lumen passing through the electrode such that each of the plurality of ridges extends through the lumen of each of the one or more electrodes.

Clause 44. The end effector of any one of clauses 35 to 43, wherein the basket shape is approximately spherical.

Clause 45. The end effector of any one of clauses 35 to 43, wherein the basket shape is approximately an oblate spheroid.

Clause 46. The end effector of any one of Clauses 35 to 45, wherein the one or more electrodes are configured to deliver electrical pulses for irreversible electroporation, the pulses having a peak voltage of at least 900 volts (V).

Claims (20)

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

a plurality of ridges configured to expand away from a longitudinal axis of the end effector to form a basket shape;

A first frame ring comprising a first pair of ridges of the plurality of ridges such that the ridges of the first pair of ridges are disposed opposite each other relative to the longitudinal axis;

A second frame ring, different from the first frame ring, the second frame ring comprising a second pair of ridges of the plurality of ridges such that a ridge of the second pair of ridges is disposed on a first side of the first frame ring;

A third frame ring, different from the first frame ring and the second frame ring, the third frame ring comprising a third pair of ridges of the plurality of ridges such that a ridge of the third pair of ridges is disposed on a second side of the first frame ring, the second side being opposite the first side; and

One or more electrodes coupled to the plurality of ridges.

2. The end effector of claim 1, the first frame ring comprising a distal portion proximate a distal end of the end effector and transverse to the longitudinal axis.

3. The end effector of claim 1, each of the second and third frame rings comprising an angled portion proximate a distal end of the end effector, the angled portion of each of the second and third frame rings coupled to the first frame ring.

4. The end effector of claim 1, ridges of the first, second, and third pairs of ridges being symmetrically disposed about the longitudinal axis.

5. The end effector of claim 1,

The first pair of ridges are disposed at about 180 deg. to each other relative to an imaginary circle about the longitudinal axis,

The second pair of ridges are disposed at about 60 ° to each other with respect to the imaginary circle, and the third pair of ridges are disposed at about 60 ° to each other with respect to the imaginary circle.

6. The end effector of claim 1,

The first frame ring includes a distal portion at a distal end of the end effector and transverse to the longitudinal axis, an

Each of the second and third frame rings includes an angled portion proximate a distal end of the end effector such that each angled portion overlaps the distal portion of the first frame ring.

7. The end effector of claim 1,

The first frame ring includes a distal portion at a distal end of the end effector and transverse to the longitudinal axis, an

Each of the second and third frame rings includes an angled portion proximate a distal end of the end effector such that each angled portion abuts the distal portion of the first frame ring.

8. The end effector of claim 7, the second frame ring disposed entirely on the first side of the first frame ring and the third frame ring disposed entirely on the second side of the first frame ring.

9. The end effector of claim 1, further comprising:

a retainer that couples the first, second, and third frame rings at a position proximate to a distal end of the end effector.

10. The end effector of claim 1, each electrode of the one or more electrodes defining a lumen therethrough such that each ridge of the plurality of ridges extends through the lumen of each electrode of the one or more electrodes.

11. The end effector of claim 1, wherein the basket shape is approximately spherical.

12. The end effector of claim 1, wherein the one or more electrodes are configured to deliver an electrical pulse for irreversible electroporation, the electrical pulse having a peak voltage of at least 900 volts (V).

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

a plurality of ridges configured to expand from a longitudinal axis of the end effector to form a basket shape;

A first frame ring comprising a first pair of ridges of the plurality of ridges and a first angled portion proximate a distal end of the end effector;

A second frame ring, different from the first frame ring, comprising a second pair of ridges of the plurality of ridges and a second angled portion proximate the distal end of the end effector such that the second angled portion overlaps the first angled portion, an inner ridge of the first pair of ridges being positioned between ridges of the second pair of ridges, and an inner ridge of the second pair of ridges being positioned between ridges of the first pair of ridges;

A third frame ring, different from the first and second frame rings, comprising a third pair of ridges of the plurality of ridges and a third angled portion proximate the distal end of the end effector such that the ridges of the third pair of ridges are each disposed between an outer ridge of the first pair of ridges and an outer ridge of the second pair of ridges; and

One or more electrodes coupled to the plurality of ridges.

14. The end effector of claim 13, ridges of said first pair of ridges, said second pair of ridges, and said third pair of ridges being symmetrically disposed about said longitudinal axis.

15. The end effector of claim 13,

The first pair of ridges are disposed at about 120 deg. to each other relative to an imaginary circle about the longitudinal axis,

The second pair of ridges are disposed at about 120 ° to each other with respect to the imaginary circle, and the third pair of ridges are disposed at about 60 ° to each other with respect to the imaginary circle.

16. The end effector of claim 13, the outer ridges of the first pair of ridges being disposed opposite the outer ridges of the second pair of ridges relative to the longitudinal axis.

17. The end effector of claim 13, wherein the first angled portion and/or the second angled portion overlap the third angled portion at a location proximate the distal end of the end effector.

18. The end effector of claim 13, each electrode of the one or more electrodes defining a lumen therethrough such that each ridge of the plurality of ridges extends through the lumen of each electrode of the one or more electrodes.

19. The end effector of claim 13, wherein the basket shape is approximately spherical.

20. The end effector of claim 13, wherein the one or more electrodes are configured to deliver an electrical pulse for irreversible electroporation, the electrical pulse having a peak voltage of at least 900 volts (V).