Electrode attachment for basket catheter

Abstract

The disclosed techniques include an electrode attachment for a medical probe that includes an electrode body configured to deliver electrical energy to biological tissue. The elongate member of the medical probe may include one or more apertures, and the electrode may include one or more electrode apertures aligned with the apertures of the elongate member. A pin is placed into the aligned hole to secure the electrode to the elongate member.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority under 35 U.S.C. §119 to U.S. Provisional Patent Application No. 63 / 514,504 (Agent File Number: BIO6842USPSP1–253757.000368), previously filed on July 19, 2023, the entire contents of which are hereby incorporated by reference into this document as if fully set forth herein. Technical Field

[0003] The present invention relates generally to medical devices, and in particular to medical probes having electrodes, and further, but not exclusively, to medical probes suitable for inducing irreversible electroporation (IRE) of cardiac tissue. Background Art

[0004] 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.

[0005] Many current ablation methods in the art utilize radiofrequency (RF) electrical energy to heat tissue. RF ablation may have certain risks associated with thermal heating that may result in tissue charring, burning, steam bursts, phrenic nerve paralysis, pulmonary vein stenosis, and esophageal fistulas.

[0006] Cryoablation is an alternative to RF ablation that generally reduces the thermal risks associated with RF ablation. However, manipulating a cryoablation device and selectively applying cryoablation is generally more challenging than RF ablation; therefore, cryoablation is not feasible in certain anatomical geometries that can be reached by electroablation devices.

[0007] 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 probe to deliver IRE energy to tissue. Examples of systems and devices configured for IRE ablation are disclosed in U.S. Patent Publications 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 this document.

[0008] Areas of cardiac tissue may be mapped by catheters to identify abnormal electrical signals. Ablation may be performed using the same or different medical probes. Some example probes 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 the use of adhesives. However, due to the small size of the ridges and electrodes, brazing, welding, or adhering the electrodes to the ridges may be a difficult task, which increases manufacturing time and cost, and increases the chances of electrode failure due to improper bonding, misalignment, or ridge strain. Therefore, what is needed is a system and method for attaching electrodes to the ridges of a basket assembly without the need for brazing, welding, or the use of adhesives. Summary of the invention

[0009] According to one embodiment of the present invention, a spine assembly is provided. The assembly may include an elongated member extending along a longitudinal axis member, the elongated member including a first hole along the length of the member. The assembly may include a first electrode that can slide along the length of the member. The first electrode includes a first electrode hole. The assembly may include a first pin that is disposed within the first hole and the first electrode hole when the first hole and the first electrode hole are aligned along the length of the member.

[0010] The first pin may include a non-conductive material. The first electrode hole may have a non-conductive inner surface. The pin head of the first pin may have a bevel profile.

[0011] The first pin may include a rivet having a bottom portion that is compressible to form a second head portion opposite the first head portion. The first head portion and the second head portion of the rivet may be positioned at opposite sides of the first electrode.

[0012] The assembly may include a second electrode that can slide along the length of the component. The second electrode may include a second electrode hole. The assembly may include a second pin. The component may include a second hole along the length of the component. The second pin may be disposed within the second hole and the second electrode hole when the second hole and the second electrode hole are aligned along the length of the component.

[0013] The assembly may include a second pin. The member may include a second hole. The first electrode may include a second electrode hole, and the second pin may be disposed within the second hole and the second electrode hole when the second hole and the second electrode hole are aligned along the length of the member. The assembly may include a first tab and a second tab. The first tab may include the first electrode hole, and the second tab may include the second electrode hole. The first tab and the second tab may be positioned at opposite ends of the first electrode in a direction along the length of the member. The second electrode hole may have a non-conductive inner surface.

[0014] The disclosed technology may include an expandable basket assembly. The assembly may include at least one ridge extending along a longitudinal axis and configured to bend radially outward from the longitudinal axis. The ridge may include a first ridge hole and a second ridge hole disposed along the length of the ridge. The assembly may include a first electrode capable of sliding along the length of the ridge. The first electrode may include a first electrode hole and a second electrode hole. The assembly may include a first pin disposed within the first ridge hole and the first electrode hole when the first ridge hole and the first electrode hole are aligned along the length of the ridge. The assembly may include a second pin disposed within the second ridge hole and the second electrode hole when the second ridge hole and the second electrode hole are aligned along the length of the ridge.

[0015] The first pin and the second pin may include a non-conductive material. The first electrode hole and the second electrode hole may have a non-conductive inner surface. The first pin head of the first pin may have an inclined profile, and the second pin head of the second pin may have an inclined profile. The first pin and the second pin may include a rivet that can be compressed to form a beveled end.

[0016] The assembly may include a first tab and a second tab. The first tab may include a first electrode hole, and the second tab may include a second electrode hole. The first tab and the second tab may be positioned at opposite ends of the first electrode in a direction along the length of the ridge. In some examples, the first tab and the second tab may be connected to the first electrode and extend from the first electrode. The first electrode hole and the second electrode hole may have a non-conductive inner surface.

[0017] The disclosed technology may include an expandable basket assembly. The assembly may include at least one ridge extending along a longitudinal axis. The ridge may include a first ridge hole along the length of the ridge. The assembly may include a first electrode capable of sliding along the length of the ridge. The first electrode may include a first electrode hole. The assembly may include a first rivet disposed within the first ridge hole and the first electrode hole when the first ridge hole and the first electrode hole are aligned along the length of the ridge.

[0018] The first rivet may include a non-conductive material. The first electrode hole may have a non-conductive inner surface. The rivet head of the first rivet may have a bevel profile. The rivet may include a multi-piece component having a rivet top that can be connected to a rivet bottom. The rivet top and the rivet bottom may be positioned at opposite sides of the first electrode when connected.

[0019] The assembly may include a second electrode capable of sliding along the length of the ridge, the second electrode including a second electrode hole. The assembly may include a second rivet. The ridge may include a second ridge hole along the length of the ridge. The second rivet may be disposed within the second ridge hole and the second electrode hole when the second ridge hole and the second electrode hole are aligned along the length of the ridge.

[0020] The assembly may include a second rivet. The ridge may include a second ridge hole. The first electrode may include a second electrode hole. The second rivet may be disposed within the second ridge hole and the second electrode hole when the second ridge hole and the second electrode hole are aligned along the length of the ridge.

[0021] The assembly may include a first tab and a second tab. The first tab may include a first electrode aperture, and the second tab may include a second electrode aperture. The first tab and the second tab may be positioned at opposite ends of the first electrode in a direction along the length of the ridge. The second electrode aperture may have a non-conductive inner surface.

[0022] The disclosed technology may include an expandable basket assembly. The assembly may include at least one ridge extending along a longitudinal axis. The ridge may include a first ridge attachment along the length of the ridge. The first ridge attachment may be a hole, or a location along the length of a slot along the length of the ridge. The assembly may include a first electrode that can slide along the length of the ridge. The first electrode may include an extension that can be inserted into the first ridge attachment and can be compressed to form a compression base.

[0023] The disclosed technology may also include a method of attaching an electrode to an elongated member. The method may include placing a first electrode at an end of the elongated member. The method may include sliding the first electrode along the length of the member until a first electrode hole of the first electrode is aligned with a first hole of the member. The method may include inserting a first pin into the first electrode hole and the first hole to attach the first electrode to the member. Placing the first electrode at the end of the member may include placing the end of the member into a slot of the first electrode. The member is capable of sliding through the slot.

[0024] The method may include inserting a second pin into the second electrode hole and the second hole to attach the first electrode to the member. The first electrode hole may be disposed in the first tab, and the second electrode hole may be disposed in the second tab. The first tab and the second tab may extend from a body of the first electrode.

[0025] The first pin may include a rivet having a first rivet head. The method may also include deforming a bottom of the first pin to secure the first pin within the first electrode hole and the first hole. The first pin may include a rivet having a first rivet head. The method may also include connecting a rivet bottom to the first pin to secure the first pin within the first electrode hole and the first hole.

[0026] Sliding the first electrode along the length of the component until the first electrode hole of the first electrode is aligned with the first hole of the component may include sliding the first electrode through the second hole. The method may also include placing the second electrode at the end of the component. The method may also include sliding the second electrode along the length of the component until the second electrode hole of the second electrode is aligned with the second hole. The method may also include inserting a second pin into the first electrode hole and the second hole to attach the second electrode to the component.

[0027] The disclosed technology may also include a method of attaching an electrode to a spine of a basket catheter. The method may include sliding a first electrode along the length of the spine until a first electrode hole of the first electrode is aligned with a first spine hole of the spine and a second electrode hole of the first electrode is aligned with a second spine hole of the spine. The method may include inserting a first pin into the first electrode hole and the first spine hole to attach the first electrode to the spine. The method may include inserting a second pin into the second electrode hole and the second spine hole.

[0028] The method may include placing an end of a ridge into a ridge slot of the first electrode, the ridge being able to slide through the ridge slot. The first electrode aperture may be disposed in the first tab, and the second electrode aperture may be disposed in the second tab. The first tab and the second tab may extend from a body of the first electrode.

[0029] The first pin and the second pin are rivets and may have rivet heads.The method may also include deforming the bottoms of the first pin and the second pin to secure the pins within the first electrode hole and the first ridge hole.

[0030] The first pin may include a rivet having a first rivet head. The second pin may include a rivet having a second rivet head. The method further includes connecting the bottom of the first rivet to the first pin to secure the first pin within the first electrode hole and the first ridge hole. The method further includes connecting the bottom of the second rivet to the second pin to secure the second pin within the second electrode hole and the second ridge hole.

[0031] Sliding the first electrode along the length of the ridge until the first electrode hole of the first electrode is aligned with the first ridge hole of the ridge may include sliding the first electrode through the third ridge hole and the fourth ridge hole. The method may also include sliding the second electrode along the length of the ridge until the third electrode hole of the second electrode is aligned with the third ridge hole of the ridge and the fourth electrode hole of the second electrode is aligned with the fourth ridge hole of the ridge. The method may also include inserting a third pin into the third electrode hole and the third ridge hole to attach the second electrode to the ridge. The method may also include inserting a fourth pin into the fourth electrode hole and the fourth ridge hole.

[0032] The disclosed technology may also include a method of securing an electrode to an elongated member. The method may include sliding a first tab along the length of a ridge until a first electrode hole of the first tab is aligned with a first ridge hole of the ridge. The method may include inserting a first pin into the first electrode hole and the first ridge hole to attach the first tab to the ridge. The method may include sliding the first electrode along the length of the ridge until the first electrode contacts the first tab. The method may include sliding a second tab along the length of the ridge until a second electrode hole of the second tab is aligned with a second ridge hole of the ridge. The method may include inserting a second pin into the second electrode hole and the second ridge hole to attach the second tab to the ridge.

[0033] The disclosed technology may also include a method of attaching an electrode to a spine of a basket catheter. The method may include sliding a first electrode along the length of the spine until a first electrode hole of the first electrode is aligned with a first spine hole of the spine. The method may include inserting a first rivet into the first electrode hole and the first spine hole. The method may include riveting the first rivet to attach the first electrode to the spine.

[0034] The method may include placing an end of the ridge into a ridge slot of the first electrode. The ridge is capable of sliding through the ridge slot. Riveting the first rivet may include connecting the bottom of the rivet to the first rivet to attach the first electrode to the ridge. Sliding the first electrode along the length of the ridge until the first electrode hole of the first electrode is aligned with the first ridge hole of the ridge may include sliding the first electrode through the second ridge hole. The method may also include sliding the second electrode along the length of the ridge until the second electrode hole of the second electrode is aligned with the second ridge hole. The method may also include inserting a second rivet into the second electrode hole and the second ridge hole. The method may also include riveting the second rivet to attach the second electrode to the ridge.

[0035] The disclosed technology may also include a method of securing an electrode to an elongated member. The method may include sliding a first electrode along the length of a ridge until it reaches a ridge attachment on the ridge. The method may include compressing an extension of the first electrode to form a compressed base at an end of the extension, thereby securing the first electrode to the ridge at the location of the ridge attachment. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] Figure 1 is a schematic illustration of a medical system including a medical probe according to one embodiment of the present invention, the distal end of the medical system including a medical probe having electrodes;

[0037] Figure 2A is a schematic illustration showing a perspective view of a medical probe with electrodes in an expanded form according to one embodiment of the present invention;

[0038] Figure 2B is a schematic illustration showing a side view of a medical probe in a collapsed form according to the disclosed technology;

[0039] Figure 3A is a schematic illustration showing a top view of a ridge and electrodes disposed thereon according to the disclosed technology;

[0040] Figure 3B is a schematic illustration of a top view showing a ridge and an electrode at a final placement position on the ridge according to the disclosed technology;

[0041] Figure 3C is a schematic illustration showing a top view of an electrode attached to a ridge with a pin in accordance with the disclosed technology;

[0042] Figure 3D According to the disclosed technology, Figure 3C Schematic illustration of a side view of an electrode attached to a ridge as shown in;

[0043] Figure 3E According to the disclosed technology FIG. 3A to FIG. 3D A schematic illustration of an end view of an electrode;

[0044] Figure 3F is a schematic diagram showing an example pin according to the disclosed technology;

[0045] Figure 4A is a schematic illustration showing a top view of a ridge and electrodes disposed thereon according to the disclosed technology;

[0046] Figure 4Bis a schematic illustration of a top view showing a ridge and an electrode at a final placement position on the ridge according to the disclosed technology;

[0047] Figure 4C is a schematic illustration showing a top view of an electrode attached to a ridge with two pins according to the disclosed technology;

[0048] Figure 4D According to the disclosed technology, Figure 4C Schematic illustration of a side view of an electrode attached to a ridge as shown in;

[0049] Figure 4E According to the disclosed technology 4A to 4D A schematic illustration of an end view of an electrode;

[0050] Figure 4F is a schematic diagram showing an example pin according to the disclosed technology;

[0051] Figure 5A is a schematic illustration showing a top view of a ridge and electrodes disposed thereon according to the disclosed technology;

[0052] Figure 5B is a schematic illustration of a top view showing a ridge and an electrode at a final placement position on the ridge according to the disclosed technology;

[0053] Figure 5C is a schematic illustration showing a top view of an electrode attached to a ridge with a pin including a rivet in accordance with the disclosed technology;

[0054] Figure 5D According to the disclosed technology, Figure 5C Schematic illustration of a side view of an electrode attached to a ridge as shown in;

[0055] Figure 5E According to the disclosed technology FIG. 5A to FIG. 5D A schematic illustration of an end view of an electrode;

[0056] Fig. 5F is a schematic diagram showing an example deformable rivet according to the disclosed technology;

[0057] Figure 5G is a schematic diagram showing an example multi-piece rivet according to the disclosed technology;

[0058] Fig. 6A is a schematic illustration showing an electrode having an extension portion and a compressible base according to the disclosed technology;

[0059] Figure 6Bis a schematic illustration showing an electrode having an extension attached to a ridge according to the disclosed technology;

[0060] Figure 6C is a schematic illustration showing an electrode having an extension with a rectangular cross-section according to the disclosed technology;

[0061] Fig.6D is a schematic illustration showing an electrode having an extension with a rectangular cross-section sliding along a slot in a ridge according to the disclosed technology;

[0062] Figure 7 is a flow chart illustrating a method of attaching an electrode to an elongated member according to one embodiment of the present invention;

[0063] Figure 8 is a flow chart illustrating a method of attaching an electrode to a spine of a basket catheter according to one embodiment of the present invention;

[0064] Fig. 9 is a flow chart illustrating a method of securing an electrode to an elongated member according to one embodiment of the present invention;

[0065] Fig.10 is a flow chart illustrating a method of attaching an electrode to a spine of a basket catheter according to one embodiment of the present invention; and

[0066] Fig.11 is a flow chart illustrating a method of securing an electrode to an elongated member according to one embodiment of the present invention. DETAILED DESCRIPTION

[0067] The following specific embodiments should be read in conjunction with the accompanying drawings, wherein the same elements are labeled the same in different drawings. The accompanying drawings (not necessarily drawn to scale) depict selected embodiments and are not intended to limit the scope of the invention. The detailed description illustrates the principles of the invention by way of example and not by way of limitation. This description will clearly enable those skilled in the art to prepare and use the invention, and describes several embodiments, adaptations, variations, alternatives, and uses of the invention, including the best modes currently believed to be implemented in the invention.

[0068] As used herein, the term "about" or "approximately" for any numerical value or range indicates a suitable dimensional tolerance that allows a collection of parts or components to achieve its intended purpose as described herein. More specifically, "about" or "approximately" may refer to a range of ±20% of the value of the recited value, for example, "about 90%" may refer to a range of values ​​from 71% to 110%. In addition, as used herein, the terms "patient", "receptor", "user" and "subject" refer to any human or animal subject, and are not intended to limit the system or method to human use, but the use of the subject invention in human patients represents a preferred embodiment. Similarly, the term "proximal" refers to a position closer to an operator or physician, while "distal" refers to a position farther away from an operator or physician.

[0069] As discussed herein, the vasculature of a "patient," "recipient," "user," and "subject" can be that of a human or any animal. It should be understood that the animal can be of any suitable type, including, but not limited to, a mammal, a veterinary animal, a livestock animal, or a pet animal, etc. For example, the animal can be a laboratory animal (e.g., a rat, dog, pig, monkey, etc.) that is specifically selected to have certain characteristics similar to those of a human. It should be understood that the subject can be, for example, any suitable human patient.

[0070] As discussed 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.

[0071] As discussed herein, when referring to the devices and corresponding systems of the present disclosure, the term "ablation" refers to components and structural features configured to reduce or prevent the generation of unstable cardiac signals in cells by utilizing non-thermal energy (such as irreversible electroporation (IRE)), which 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 term "ablation" also includes known methods, devices, and systems for achieving various forms of body tissue ablation as understood by those skilled in the relevant art.

[0072] As discussed herein, the terms "bipolar" and "monopolar" when used to refer to ablation protocols describe ablation protocols that differ in current paths and electric field distribution. "Bipolar" refers to an ablation protocol that utilizes a current path between two electrodes as described below, both electrodes being positioned at a treatment site; the current density and electric flux density at each of the two electrodes are generally approximately equal. "Monopolar" refers to an ablation protocol that utilizes a current path between two electrodes as described below, 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.

[0073] As discussed herein, the terms "biphasic pulse" and "monophasic pulse" refer to corresponding electrical signals. "Biphasic pulse" refers to an electrical signal having a positive voltage phase pulse (referred to herein as "positive phase") and a negative voltage phase pulse (referred to herein as "negative phase"). "Monophasic pulse" refers to an electrical signal having only a positive phase or only a negative phase. Preferably, the system providing the biphasic pulse is configured to prevent the application of a direct current voltage (DC) to the patient. For example, the average voltage of the biphasic pulse may be zero volts relative to ground or other common reference voltage. Additionally or alternatively, the system may include a capacitor or other protective component. The voltage amplitude of the biphasic and / or monophasic pulses is described herein, and it should be understood that the voltage amplitude expressed is the absolute value of the approximate peak amplitude of each of the positive voltage phase and / or the negative voltage phase. Each phase of the biphasic pulse and the monophasic pulse preferably has a square shape, which has a substantially constant voltage amplitude during most of the phase duration. The phases of the biphasic pulse are separated in time by an interphase delay. The interphase delay duration is preferably less than or approximately equal to the duration of the phase of the biphasic pulse. More preferably the interphase delay duration is about 25% of the duration of a phase of the biphasic pulse.

[0074] As discussed herein, the terms "tubular" and "tube" should be interpreted broadly and are not limited to structures that are perfect cylinders or have a completely circular cross-section or a uniform cross-section throughout their length. For example, tubular structures are often illustrated as structures that are substantially perfect cylinders. However, tubular structures may have tapered or curved outer surfaces without departing from the scope of the present disclosure.

[0075] The present disclosure relates to systems, methods or uses and devices for performing IRE ablation of cardiac tissue to treat arrhythmias. Ablation energy is typically provided to cardiac tissue by a distal portion of a catheter that can deliver ablation energy along the tissue to be ablated. Some exemplary catheters include a three-dimensional structure at the distal portion and are configured to apply ablation energy from various electrodes positioned on the three-dimensional structure. Fluoroscopy can be used to visualize ablation procedures incorporating such exemplary catheters.

[0076] Ablation of cardiac tissue to correct a malfunctioning heart using the application of thermal techniques such as radiofrequency (RF) energy and cryoablation is a well-known procedure. Typically, in order to successfully ablate using thermal techniques, it is necessary to measure cardiac electrode potentials at various locations of the myocardium. In addition, temperature measurements during ablation provide data that can achieve ablation efficacy. Typically, for ablation procedures using thermal ablation, electrode potentials and temperatures are measured before, during, and after the actual ablation. RF methods may have the risk of causing tissue charring, burns, steam bursts, phrenic nerve paralysis, pulmonary vein stenosis, and esophageal fistulas. Cryoablation is an alternative to RF ablation that can reduce some of the thermal risks associated with RF ablation. However, manipulating a cryoablation device and selectively applying cryoablation is generally more challenging than RF ablation; therefore, cryoablation is not feasible in certain anatomical geometries that can be reached by electrical ablation devices.

[0077] The present disclosure may include electrodes configured for RF ablation, cryoablation, and / or irreversible electroporation (IRE). Throughout the present disclosure, IRE may be referred to interchangeably as pulsed electric field (PEF) ablation and pulsed field ablation (PFA). IRE as discussed in the present disclosure is a non-thermal cell death technique that can be used for ablation of atrial arrhythmias. In order to ablate using IRE / PEF, biphasic voltage pulses are applied to destroy the cellular structure of the myocardium. Biphasic pulses are non-sinusoidal and can be tuned to target cells based on the electrophysiology of the cells. In contrast, in order to ablate using RF, a sinusoidal voltage waveform is applied to generate heat at the treatment area, heating all cells in the treatment area indiscriminately. Therefore, IRE has the ability to avoid adjacent heat-sensitive structures or tissues, which will have benefits in reducing possible complications known to be affected by ablation or separation modalities. In addition or alternatively, monophasic pulses can be used.

[0078] Electroporation can be induced by applying a pulsed electric field across biological cells to cause holes to be reversibly (temporarily) or irreversibly (permanently) produced in the cell membrane. When a pulsed electric field is applied, the cell has a transmembrane electrostatic potential that is elevated above the static potential. When the transmembrane electrostatic potential remains below the threshold potential, electroporation is reversible, which means that the hole can be closed when the applied pulsed electric field is removed, and the cell can self-repair and survive. If the transmembrane electrostatic potential is elevated above the threshold potential, electroporation is irreversible and the cell becomes permanently permeable. Therefore, the cell dies due to the loss of homeostasis and usually dies by apoptosis. Typically, different types of cells have different threshold potentials. For example, cardiac cells have a threshold potential of approximately 500V / cm, while for bones, the threshold potential is 3000V / cm. These differences in threshold potentials allow IRE to selectively target tissues based on the threshold potential.

[0079] The solution of the present disclosure includes a system and method for applying an electrical signal from a catheter electrode positioned near myocardial tissue to generate ablation energy to ablate myocardial tissue. In some examples, the system and method can effectively ablate the targeted tissue by inducing irreversible electroporation. In some examples, the system and method can effectively induce reversible electroporation as part of a diagnostic procedure. Reversible electroporation occurs when the electricity applied by the electrode is lower than the electric field threshold of the target tissue that allows cell repair. Reversible electroporation does not kill cells, but allows physicians to view the effects of reversible electroporation on electrical activation signals near the target location. Exemplary systems and methods for reversible electroporation are disclosed in U.S. Patent Publication 2021 / 0162210, the entire contents of which are incorporated herein by reference and attached to the appendix of this document.

[0080] The effectiveness of pulsed electric field and its induction of reversible electroporation and / or irreversible electroporation may be affected by the physical parameters of the system and the biphasic pulse parameters of the electrical signal. The physical parameters may include electrode contact area, electrode spacing, electrode geometry, etc. The examples proposed herein generally include physical parameters suitable for effectively inducing reversible electroporation and / or irreversible electroporation. The biphasic pulse parameters of the electrical signal may include voltage amplitude, pulse duration, pulse phase delay, pulse delay, total application time, energy delivered, etc. In some examples, the parameters of the electrical signal may be adjusted to induce both reversible and irreversible electroporation given the same physical parameters. Examples of various ablation systems and methods including IRE are provided in U.S. Patent Publications 2021 / 0169550A1, 2021 / 0169567A1, 2021 / 0169568A1, 2021 / 0161592A1, 2021 / 0196372A1, 2021 / 0177503A1, and 2021 / 0186604A1, the entire contents of each of which are incorporated herein by reference and are attached as an appendix to this document.

[0081] refer to Figure 1, which shows an exemplary catheter-based electrophysiological mapping and ablation system 10. The system 10 includes multiple catheters that are inserted into the chambers or vascular structures of the heart 12 by a physician 24 through the vascular system of a patient 23 through the skin. Typically, a delivery sheath catheter is inserted into the left atrium or right atrium near a desired location in the heart 12. Then, multiple catheters can be inserted into the delivery sheath catheter to reach the desired location. The multiple catheters may include catheters dedicated to sensing intracardiac electrogram (IEGM) signals, catheters dedicated to ablation, and / or catheters dedicated to both sensing and ablation. An exemplary catheter 14 configured for sensing IEGM is shown herein. The physician 24 brings the distal end of the catheter 14 (i.e., in this case, the basket assembly 28) into contact with the heart wall for sensing a target site in the heart 12. The catheter 14 with a distal basket assembly can be referred to as a basket catheter. For ablation, the physician 24 would similarly bring the distal end of the ablation catheter to the target site for ablation.

[0082] The catheter 14 is an exemplary catheter that includes one (preferably multiple) electrodes 26, optionally distributed on a plurality of spines 22 at a basket assembly 28 and configured to sense IEGM signals. The catheter 14 may additionally include a position sensor embedded in or near the basket assembly 28 for tracking the position and orientation of the basket assembly 28. Optionally and preferably, the position sensor is a magnetic-based position sensor that includes three magnetic coils for sensing three-dimensional (3D) position and orientation.

[0083] The magnetic-based position sensor can operate with a positioning pad 25 that includes a plurality of magnetic coils 32 configured to generate a magnetic field in a predetermined workspace. The real-time position of the basket assembly 28 of the catheter 14 can be tracked based on the magnetic field generated by the positioning pad 25 and sensed by the magnetic-based position sensor. The details of the magnetic-based position sensing technology are described in U.S. Patents 5,391,199, 5,443,489, 5,558,091, 6,172,499, 6,239,724, 6,332,089, 6,484,118, 6,618,612, 6,690,963, 6,788,967, 6,892,091, each of which is incorporated herein by reference and attached to the appendix of this document.

[0084] The system 10 includes one or more electrode patches 38 positioned in contact with the skin of the patient 23 to establish a position reference for impedance-based tracking of the positioning pad 25 and the electrodes 26. For impedance-based tracking, current is directed toward the electrodes 26 and sensed at the electrode skin patches 38 so that the position of each electrode can be triangulated via the electrode patches 38. Details of impedance-based position tracking techniques are described in U.S. Patent Nos. 7,536,218, 7,756,576, 7,848,787, 7,869,865, and 8,456,182, each of which is incorporated herein by reference and is attached as an appendix to this document.

[0085] Recorder 11 displays electrograms 21 captured using surface ECG electrodes 18 and intracardiac electrograms (IEGMs) captured using electrodes 26 of catheter 14. Recorder 11 may include pacing capabilities for pacing the cardiac rhythm and / or may be electrically connected to a separate pacemaker.

[0086] The system 10 may include an ablation energy generator 50 adapted to conduct ablation energy to one or more electrodes at the distal end of a catheter configured for ablation. The energy generated by the ablation energy generator 50 may include, but is not limited to, radio frequency (RF) energy or pulsed field ablation (PFA) energy (including monopolar or bipolar high voltage DC pulses that may be used to achieve irreversible electroporation (IRE)), or a combination thereof.

[0087] 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 additionally includes processing capabilities for enabling real-time calculation of the position of the catheter and for performing ECG calculations.

[0088] Workstation 55 includes memory, a processor unit with memory or storage loaded with appropriate operating software, and user interface capabilities. Workstation 55 can provide multiple functions, optionally including: (1) three-dimensional (3D) modeling of endocardial anatomy and rendering of the model or anatomical map 20 for display on display device 27; (2) displaying 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 (5) displaying sites of interest on display device 27, such as where ablation energy has been applied. A commercial product embodying elements of system 10 is available as the CARTO™ 3 system from Biosense Webster, Inc., 31 Technology Drive, Suite 200, Irvine, CA 92618 USA.

[0089] Figure 2A is a schematic illustration showing a perspective view of a medical probe 39 having an electrode 26 in an expanded form, such as by being pushed out of a tubular shaft lumen 80 at the distal end of a tube 31 , in accordance with one embodiment of the present invention. Figure 2B A medical probe 39 with electrodes 26 is shown in a collapsed form within a tube 31. In an expanded form ( Figure 2A ), one or more ridges 22 are curved radially outwardly, and in the collapsed form ( Figure 2B ), the ridges 22 are generally arranged along the longitudinal axis 86 of the tubular shaft 84.

[0090] like Figure 2A As shown, the medical probe 39 includes a plurality of flexible ridges 22 that may be formed at the ends of a tubular shaft 84 and connected at the two ends. During a medical procedure, the medical professional 34 may deploy the medical probe 39 by extending the tubular shaft 84 from the tube 31, thereby causing the medical probe 39 to exit the tube 31 and transition to an expanded form. The ridges 22 may have an elliptical (e.g., circular) or rectangular (which may appear flat) cross-section and include a flexible, resilient material (e.g., a shape memory alloy such as nickel titanium, also known as nitinol) that forms a strut, as will be described in more detail herein.

[0091] As will be appreciated by those skilled in the art having the benefit of this disclosure, FIG. 2A to FIG. 2BThe basket assembly 28 shown in has ridges 22 formed from a single piece of planar material and converging at a central intersection is provided for illustrative purposes only, and the disclosed technology may be applied to other configurations of the basket assembly 28. For example, the disclosed technology may be applied to a basket assembly 28 formed from a single ridge 22 or a plurality of ridges 22, wherein each ridge 22 is attached at two ends. In other examples, the basket assembly 28 may include a central hub connecting the plurality of ridges 22 together at the distal end of the basket assembly 28. In still other examples, the basket assembly 28 may include a single ridge 22 configured to form a spiral, a plurality of ridges 22 configured to form a spiral, a plurality of ridges 22 configured to form one or more tripods, or any other shape of the basket assembly 28. Thus, while FIG. 2A to FIG. 2B A specific configuration of the basket assembly 28 is shown, but the disclosed technology should not be construed as being limited thereto. Likewise, the basket assembly 28 can be formed by laser cutting a cylindrical hollow stock material, wherein the laser is mounted for rotation about (and translation to) the longitudinal axis of the cylindrical stock material while cutting. It should be understood that a catheter device including a basket assembly 28 (as shown herein) can be referred to as a basket catheter.

[0092] The ridges 22 may be formed from a single sheet of planar material to form a generally star-shaped shape. In other words, the ridges 22 may be formed from a single piece of planar material such that the ridges 22 converge toward a central intersection. The intersection may be a solid sheet of material or include one or more holes.

[0093] As will be appreciated, the ridge 22 may be electrically isolated from the electrode 26 to prevent arcing from the electrode 26 to the ridge 22. For example, an insulating sheath may be provided between the ridge 22 and the electrode 26, but one skilled in the art will appreciate that other insulating coverings are also contemplated. For example, an insulating coating may be applied to the ridge 22, the electrode 26, or both. The insulating sheath may be made of a biocompatible, electrically insulating material such as a polyamide-polyether (Pebax) copolymer, polyethylene terephthalate (PET), polyurethane, polyimide, polyparaxylene, silicone, and the like. In some examples, the insulating material may include a biocompatible polymer, including, but not limited to: polyetheretherketone (PEEK), polyglycolic acid (PGA), poly(lactic-co-glycolic acid) (PLGA), polycaprolactone (PCL), poly(3-hydroxybutyrate-co-3-hydroxyvalerate) (PHBV), poly-L-lactide, polydioxanone, polycarbonate, and polyanhydride, wherein the proportions of certain polymers are selected to control the extent of the inflammatory response. The insulating jacket may also include one or more additives or fillers, such as polytetrafluoroethylene (PTFE), boron nitride, silicon nitride, silicon carbide, aluminum oxide, aluminum nitride, zinc oxide, and the like.

[0094] In the embodiments described herein, the electrodes 26 may be configured to deliver ablative energy (RF and / or IRE) to tissue in the heart 12. In addition to using the electrodes 26 to deliver ablative energy, the electrodes may also be used to determine the location of the medical probe 39 and / or measure physiological properties such as local surface potential at corresponding locations on tissue in the heart 12. The electrodes 26 may be biased so that a greater portion of the electrodes 26 faces outward from the medical probe 39, such that the electrodes 26 deliver a greater amount of electrical energy outwardly away from the medical probe 39 (i.e., toward the heart 12 tissue) rather than inwardly toward the medical probe 39.

[0095] Examples of materials ideally suited for forming electrode 26 include gold, platinum, and palladium (and their respective alloys). These materials also have high thermal conductivity, which allows minimal heat generated on the tissue (i.e., by the ablative energy delivered to the tissue) to be conducted through the electrode to the back side of the electrode (i.e., the portion of the electrode on the inside of the ridge), and then to the blood pool in the heart 12.

[0096] FIG. 3A to FIG. 3F is a schematic illustration showing the electrode 326 and its engagement with the medical probe 39 . FIG. 3A to FIG. 3C The process of assembling and attaching the electrode 326 to a component of the medical probe 39 (eg, to the spine 22 of the medical probe 39) is shown. FIG. 3A to FIG. 3F The electrode 326 shown in FIG. 3 may be similar to the electrode 26 described above. Figure 3A In the embodiment shown in FIG. 1 , the electrode 326 is not fully attached but rather partially slides along the ridge 22. The ridge 22 may include a hole 322 positioned along the length L1 of the ridge 22 that corresponds to the intended location of the electrode 326. The hole 322 may align with the electrode hole 328 on the electrode 326 when the electrode 326 is placed into its assembled position. Figure 3B The electrode 326 is shown slid into the placement position so that the hole 322 is aligned with the electrode hole 328. At this point, the pin 350 can be inserted into the aligned hole 322 / electrode hole 328 to connect the electrode 326 in its final position on the spine 22 (see Figure 3C ).

[0097] by FIG. 3A to FIG. 3D Assembled in the manner shown and described in (and as described below with respect to 4A to 4D and FIG. 5A to FIG. 5D ) enables the medical probe 39 to be assembled without the use of certain locking mechanisms that may make it difficult to place more than one electrode along the spine 22. For example, and with reference to Figure 2AFor illustration, certain embodiments of the basket catheter include more than one electrode along the length L1 of one spine. In order to place the distal-most electrode, the electrode must slide past the proximal electrode placement location. Systems that include attachment features (e.g., tabs, etc.) formed directly into the spine to engage with the electrode make it difficult to advance the distal-most electrode past the proximal electrode placement location. The present design enables easier placement of the distal-most electrode because the locking mechanism on the spine 22 is itself a hole, such as hole 322, and the distal-most electrode can easily slide through the hole. Therefore, it should be understood that each spine 22 may have one electrode, two electrodes, etc., and each electrode may be attached to the spine 22 according to any embodiment described in the present disclosure.

[0098] Reference Figure 3E , which shows an exploded electrode 326, which may have a rectangular cross-section as shown, or another cross-sectional geometry such as an elliptical (e.g., circular) cross-section. The electrode hole 328 may have a non-conductive inner surface 330. For example, the interior of the hole that receives the pin 350 may be coated with a biocompatible electrically insulating material such as Pebax copolymer, PET, polyurethane, polyimide, polyparaxylene, silicone, PEEK, PGA, PLGA, PCL, PHBV, poly-L-lactide, polydioxanone, polycarbonate, etc. Insulating the junction between the pin 350 and the electrode hole 328 can protect the pin 350 from becoming a conductive point, and thus the entire upper surface of the electrode 326 continues to be an ablation surface. The electrode 326 may have a ridge slot 332 disposed therethrough, which may be sized and shaped to receive the ridge 22. Thus, the electrode 326 can slide down the length L1 of the ridge 22 via the engagement of the ridge 22 within the ridge slot 332. In some examples, the inner surface of the ridge slot 332 can have a coating to provide additional friction between the electrode 326 and the ridge 22, such as silicone or the like. In an alternative embodiment, the periphery of the ridge hole 322 can be coated with a non-conductive material, and the pin 350 and the electrode hole 328 can remain conductive. The goal is to keep the electrode 326 and the ridge 22 electrically isolated from each other, but the surfaces in contact (i.e., the pin 350, the electrode hole, and the ridge hole 322) can be interchanged so that there is an insulating connection between the surfaces.

[0099] Reference Figure 3F, pin 350 may be made of a non-conductive material. For example, pin 350 may be made of a biocompatible electrically insulating material (such as Pebax copolymer, PET, polyurethane, polyimide, polyparaxylene, silicone, PEEK, PGA, PLGA, PCL, PHBV, poly-L-lactide, polydioxanone, polycarbonate, etc.). Alternatively, pin 350 may be made of a metallic material or another potentially conductive material. In these examples, pin 350 may be coated with the non-conductive material. Non-conductivity may again protect pin 350 from becoming a conductive point, and thus the entire upper surface of electrode 326 continues to be an ablation surface. Pin 350 may include a feature that helps to secure pin 350 within electrode hole 328. For example, pin 350 may be a ball lock pin, a threaded pin, a spring pin, etc. In some examples, pin 350 may be a rivet, as will be described herein with respect to FIG. 5A to FIG. 5G Described.

[0100] In some examples, the head of the pin 350 may have a beveled profile to provide an atraumatic profile (see Figure 3D In some examples, the head of pin 350 may extend above the surface of electrode 326, such as Figure 3D In other examples, the head of the pin 350 can be recessed into the body of the electrode. For example, the electrode hole 328 can also include a countersunk portion to accommodate and lower the head of the pin 350.

[0101] 4A to 4F is a schematic illustration showing the electrode 426 and its engagement with the medical probe 39 . FIG. 4A to FIG. 4C A process of assembling and attaching the electrode 426 to a component of the medical probe 39 (eg, to the spine 22 of the medical probe 39) is shown. 4A to 4F The electrode 426 shown in FIG. 4 can be similar to the electrode 26 and the electrode 326 described above. 4A to 4F The electrodes 426 in provide two connection points with the ridge 22. Figure 4A , electrode 426 is not fully attached but partially slides down along the length L1 of ridge 22. Ridge 22 may include a first ridge hole 422 positioned along the length L1 of ridge 22, and may include a second ridge hole 423 positioned along the length L1 of ridge 22. Electrode 426 may include a first electrode hole 428 and a second electrode hole 429. A distance L2 between first ridge hole 422 and second ridge hole 423 may be the same as a distance L3 between first electrode hole 428 and second electrode hole 429. Figure 4BThe electrode 426 is shown slid into a resting position so that the first electrode hole 428 is aligned with the first ridge hole 422, and the second electrode hole 429 is aligned with the second ridge hole 423. At this point, the first pin 450 can be inserted into the aligned first ridge hole 422 / first electrode hole 428, and the second pin 451 can be inserted into the second ridge hole 423 / second electrode hole 429 (see Figure 4C ).

[0102] Reference again Figure 4A In some examples, electrode 426 may include tabs extending from the electrode body so that pins 450 / 451 do not interfere with the ablation surface of electrode 426 . Figure 4D The side view in also shows an example of such a layout, where the electrode 426 is located between a first tab 434 including a first electrode hole 428 and a second tab 436 including a second electrode hole 429. The first tab 434 and the second tab 436 may have a shorter profile than the body of the electrode 426, so that once the pins 450 / 451 are inserted into their respective holes, the heads of the pins 450 / 451 do not extend above the top surface of the electrode 426. In some examples, the first tab 434 and the second tab 436 may be attached to the electrode 426 or integral with the electrode. For example, the first tab 434 and the second tab 436 may extend from the ends of the electrode 426 as wings. In this example, the electrode 426 may be slid into the corresponding holes with the tabs and then secured. In another example, the first tab 434 and the second tab 436 may be separate components that secure the electrode 426 between the two. For example, two tabs (e.g., Figure 4A The distal-most tab 434 in the proximal portion of the electrode 426 can be slid into its corresponding ridge hole 422 and secured with a pin 450. The electrode 426 can be slid to contact the distal tab 434, and then the proximal tab ( Figure 4A The tabs 436 in the ridge can be slid into their corresponding ridge holes 423 and secured with pins 451.

[0103] Reference Figure 4E, which shows an exploded electrode 426, which may have a rectangular cross-section as shown, or another cross-sectional geometry such as an elliptical (e.g., circular) cross-section. In some examples, the electrode hole 428 / 429 may have a non-conductive inner surface 430. For example, the interior of the hole receiving the pin 450 / 451 may be coated with a biocompatible electrically insulating material such as Pebax copolymer, PET, polyurethane, polyimide, polyparaxylene, silicone, PEEK, PGA, PLGA, PCL, PHBV, poly-L-lactide, polydioxanone, polycarbonate, etc. Insulating the joint between the pin 450 / 451 and the electrode hole 428 / 429 can protect the pin 450 / 451 from becoming a conductive point. The electrode 426 may have a ridge slot 432 arranged to pass through it, and the size and shape of the ridge slot may be set to receive the ridge 22. Thus, electrode 426 may slide down length L1 of ridge 22 via engagement of ridge 22 with ridge slot 432. In some examples, the inner surface of ridge slot 432 may have a coating to provide additional friction between electrode 426 and ridge 22, such as silicone or the like.

[0104] Reference Figure 4F , pin 450 / 451 can be made of non-conductive material. For example, pin 450 / 451 can be made of biocompatible electrical insulating material (such as Pebax copolymer, PET, polyurethane, polyimide, polyparaxylene, silicone, PEEK, PGA, PLGA, PCL, PHBV, poly-L-lactide, polydioxanone, polycarbonate, etc.). Alternatively, pin 450 / 451 can be made of metal material or another potential conductive material. In these examples, pin 450 / 451 can be coated with the non-conductive material. Non-conductivity can protect pin 450 / 451 from becoming a conductive point again, and therefore the surface of electrode 426 continues to become an ablation surface. Pin 450 / 451 may include a feature that helps to fix pin 450 / 451 in electrode hole 428 / 429. For example, pin 450 / 451 can be a ball lock pin, a threaded pin, a spring pin, etc. In some examples, the pins 450 / 451 may be rivets, as will be described with respect to FIG. 5A to FIG. 5G Described.

[0105] In some examples, the head of the pin 450 / 451 may have a beveled profile to provide an atraumatic profile (see Figure 4D ). In some examples, such as Figure 4D As shown, the heads of the pins 450 / 451 can extend from the surface of their corresponding protrusions 432 / 434. In other examples, the heads of the pins 450 / 451 can be recessed into the body of their corresponding tabs 432 / 434. For example, the electrode holes 428 / 429 can also include countersunk portions to accommodate and lower the heads of the pins 450 / 451.

[0106] FIG. 5A to FIG. 5G is a schematic illustration showing the electrode 526 and its engagement with the medical probe 39 . FIG. 5A to FIG. 5C A process of assembling and attaching the electrode 526 to a component of the medical probe 39 (eg, to the spine 22 of the medical probe 39) is shown. FIG. 5A to FIG. 5G The electrode 526 shown in FIG. 5 can be similar to the electrode 26, the electrode 326, and the electrode 426 described above. Figure 5A 5 , the electrode 526 is not fully attached, but rather partially slides along the ridge 22. The ridge 22 may include a hole 522 positioned along the length L1 of the ridge 22 that corresponds to the intended location of the electrode 526. The hole 522 may align with the electrode hole 528 on the electrode 526 when the electrode 526 is placed into its assembled position. Figure 5B The electrode 526 is shown slid into position so that the hole 522 is aligned with the electrode hole 528. A pin (in this case a rivet 550) can be inserted into the aligned hole 522 / electrode hole 528 to connect the electrode 526 in its final position on the spine 22 (see Figure 5C ).

[0107] Reference Figure 5E , which shows an exploded electrode 526, which may have a rectangular cross-section as shown, or another cross-sectional geometry such as an elliptical (e.g., circular) cross-section. In some examples, the electrode hole 528 may have a non-conductive inner surface 530. For example, the interior of the hole that receives the rivet 550 may be coated with a biocompatible electrically insulating material such as Pebax copolymer, PET, polyurethane, polyimide, polyparaxylene, silicone, PEEK, PGA, PLGA, PCL, PHBV, poly-L-lactide, polydioxanone, polycarbonate, etc. Insulating the joint between the rivet 550 and the electrode hole 528 can protect the rivet 550 from becoming a conductive point, and thus the entire upper surface of the electrode 526 continues to be an ablation surface. The electrode 526 may have a ridge slot 532 disposed therethrough, which may be sized and shaped to receive the ridge 22. Thus, electrode 526 may slide down length L1 of ridge 22 via engagement of ridge 22 with ridge slot 532. In some examples, the inner surface of ridge slot 532 may have a coating to provide additional friction between electrode 526 and ridge 22, such as silicone or the like.

[0108] Reference Fig. 5F and Figure 5G, rivet 550 may be made of or include a non-conductive material. For example, rivet 550 may be made of a biocompatible electrically insulating material (such as Pebax copolymer, PET, polyurethane, polyimide, polyparaxylene, silicone, PEEK, PGA, PLGA, PCL, PHBV, poly-L-lactide, polydioxanone, polycarbonate, etc.). Alternatively, rivet 550 may be made of a metallic material or another potentially conductive material. In these examples, rivet 550 may be coated with the non-conductive material. Non-conductivity may again protect rivet 550 from becoming a conductive point, and thus the entire upper surface of electrode 526 continues to be an ablation surface.

[0109] Reference Fig. 5F , the rivet 550 may have a first rivet head 552 and a bottom portion that may be compressed to form a second head 554 opposite the first rivet head 552. To assemble this type of deformable rivet 550, the rivet 550 may be inserted into the aligned hole 522 / electrode hole 528 and then compressed so that the bottom portion of the rivet 550 is deformed to form the second head 554. Once the second head 554 is formed, the electrode 526 is attached to the ridge 22. The first rivet head 552 and / or the second rivet head 554 may have an anti-traumatic profile, such as Fig. 5F shown.

[0110] Reference Figure 5G , the rivet 550 can be a multi-piece component including a rivet top 556 that can be connected to a rivet bottom 558. The rivet top 556 can have a first rivet head 552, and the rivet bottom 558 can have a second rivet head 554. The rivet top 556 can be engaged with the rivet bottom 558 to form a fixed rivet 550, thereby connecting the electrode 526 to the ridge 22. For example, the rivet bottom 558 can have an opening on the end opposite the rivet head 554 that is larger than the bottom end of the rivet top 556, so that the rivet top 556 can be inserted into the rivet bottom 558. For assembly, the rivet top 556 can be inserted into the aligned hole 522 / electrode hole 528, and then the rivet bottom 558 can be slid over and engaged with the bottom of the rivet top 556 to secure the electrode 526 to the ridge 22. The first rivet head 552 and the second rivet head 554 can have an anti-traumatic profile, such as Figure 5G In some examples, the electrode hole 528 in the electrode 526 may have an oversize portion 534 at one end to account for the larger rivet bottom 558 (see Figure 5E ) to account for the larger diameter of the rivet base 558.

[0111] FIG. 6A to FIG. 6Dis a schematic diagram showing an electrode 626 having an extension 634 with a compressible base according to the disclosed technology. For other examples described herein, the hole in the electrode is used to receive a pin or rivet. FIG. 6A to FIG. 6D In the example shown, the electrode 626 can function as its own pin and rivet in that the extension 634 can be inserted into the ridge attachment 622 of the spine 22 and then compressed to secure the electrode 626. The ridge attachment 622 can be a hole into which the end 650 of the extension 634 can be inserted and then compressed to form a compression base 654 in a manner similar to the second head 554 of the rivet described above. Fig. 6A The electrode 626 is shown with the extension 634 compressed. Figure 6B Electrode 626 is shown secured to ridge 622 by compressing the end of extension 634 into compression base 654 on ridge 22 .

[0112] In some examples, the ridge attachment 622 may be a slot 624 extending a length L4 along the length L1 of the ridge 22. The extension 634 of the electrode 626 may be a rectangular cross-section having a width 660 that matches the width 662 of the slot 624. The extension 634 may be inserted into the end of the slot 624 and then slid along the length L1 of the ridge to a desired position, whereupon the extension 634 may be compressed to secure the electrode 626 to the ridge 22. In some examples, the end 650 of the extension 634 may have a larger footprint, or a larger width 664, than the rest of the extension 634. In this way, the extension 634 may be constrained within the slot 624 as it slides to its position along the ridge 22.

[0113] Figure 7 is a flow chart showing a method 700 of attaching an electrode (e.g., electrode 26, 326, 426, and / or 526) to an elongated member according to one embodiment of the present invention. The method 700 may include placing 702 a first electrode at an end of the elongated member. The elongated member may be, for example, any of the ridges 22 described herein. In some examples, placing the first electrode at the end of the member may include placing the end of the member into a slot (e.g., ridge slot 332) of the first electrode. The member can slide through the slot.

[0114] The method 700 may include sliding 704 the first electrode along the length of the component until the first electrode hole of the first electrode is aligned with the first hole of the component. The method 700 may include inserting 706 a first pin (e.g., pin 350, pin 450 / 451, and / or rivet 550) into the first electrode hole and the first hole to attach the first electrode to the component.

[0115] The method 700 can end after inserting to step 706. In other examples, additional steps can be performed according to the examples described herein. For example, in some examples, the method 700 can include inserting a second pin into the second electrode hole and the second hole to attach the first electrode to the member via another pin.

[0116] Figure 8 8 is a flow chart illustrating a method 800 of attaching an electrode (e.g., electrode 26, 326, 426, and / or 526) to a spine (e.g., spine 22) of a basket catheter according to one embodiment of the present invention. The method 800 may include sliding 802 a first electrode along a length (e.g., L1) of the spine until (i) a first electrode hole (e.g., 428) of the first electrode is aligned with a first spine hole (e.g., 422) of the spine, and (ii) a second electrode hole (e.g., 429) of the first electrode is aligned with a second spine hole (e.g., 423) of the spine. In some examples, electrode 428 may include tabs (e.g., first tab 434 and second tab 436) having electrode holes. In this case, sliding 802 the first electrode along the length of the spine may include sliding the electrode until (i) a first electrode hole on the first tab 434 is aligned with the first spine hole, and a second electrode hole on the second tab 436 is aligned with the first spine hole.

[0117] The method 800 may include inserting a first pin (e.g., pin 350, pin 450, and / or rivet 550) into the first electrode hole and the first ridge hole to attach the first electrode to the ridge 804. The method 800 may include inserting 806 a second pin (e.g., pin 350, pin 451, and / or rivet 550) into the second electrode hole and the second ridge hole.

[0118] The method 800 may end after inserting into step 806. In other examples, additional steps may be performed according to the examples described herein. For example, in some examples, the method 800 may include sliding the second electrode along the length of the ridge until (iii) the third electrode hole of the second electrode is aligned with the third ridge hole of the ridge, and (iv) the fourth electrode hole of the second electrode is aligned with the fourth ridge hole of the ridge. The method 800 may also include inserting a third pin into the third electrode hole and the third ridge hole to attach the second electrode to the ridge (e.g., step 804 may be repeated for the second electrode). The method 800 may also include inserting a fourth pin into the fourth electrode hole and the fourth ridge hole to attach the second electrode to the ridge (e.g., step 806 may be repeated for the second electrode).

[0119] Fig. 9900 is a flow chart illustrating a method 900 of securing an electrode (e.g., electrode 26, 326, 426, and / or 526) to an elongated member according to one embodiment of the present invention. This method 900 may be performed to secure an electrode using tabs (e.g., first tab 434 and second tab 436) that are separate from the electrode. The method 900 may include sliding 902 the first tab along the length of the ridge until the first electrode hole of the first tab is aligned with the first ridge hole of the ridge. The method 900 may include inserting 904 a first pin into the first electrode hole and the first ridge hole to attach the first tab to the ridge. The method 900 may include sliding 906 the first electrode along the length of the ridge until the first electrode contacts the first tab. The method 900 may include sliding 908 the second tab along the length of the ridge until the second electrode hole of the second tab is aligned with the second ridge hole of the ridge. The method 900 may include inserting 910 a second pin into the second electrode hole and the second ridge hole to attach the second tab to the ridge.

[0120] Fig.10 1 is a flow chart illustrating a method 1000 of attaching an electrode (e.g., electrode 26, 326, 426, and / or 526) to a spine (e.g., spine 22) of a basket catheter according to one embodiment of the present invention. The method 1000 may include sliding 1002 a first electrode along the length of the spine until a first electrode hole of the first electrode is aligned with a first spine hole of the spine. The method 1000 may include inserting 1004 a first rivet (e.g., rivet 550) into the first electrode hole and the first spine hole. The method 1000 may include riveting 1006 the first rivet to attach the first electrode to the spine. The method 1000 may end after the riveting 1006 step. In other examples, additional steps may be performed according to the examples described herein.

[0121] Fig.11 1 is a flow chart illustrating a method 1100 of securing an electrode (e.g., electrode 26, 326, 426, 526, and / or 626) to an elongated member according to one embodiment of the present invention. The method 1100 may include sliding 1102 a first electrode along the length of a ridge until it reaches a ridge attachment on the ridge. In some examples, the ridge attachment may be a single hole along the length of the ridge. In other examples, the ridge attachment may be a slot or track along the length of the ridge, and the ridge attachment may be a location along the length of the slot, including at the end or any location along the length of the slot. The method 1100 may include compressing 1104 an extension of the first electrode to form a compression base at the end of the extension, thereby securing the first electrode to the ridge at the location of the ridge attachment.

[0122] The disclosed technology described herein can be further understood according to the following terms:

[0123] Item 1. A ridge assembly comprising: an elongated member extending along a longitudinal axis member, the elongated member comprising a first hole along the length of the member; a first electrode, the first electrode being capable of sliding along the length of the member, the first electrode comprising a first electrode hole; and a first pin, the first pin being disposed within the first hole and the first electrode hole when the first hole and the first electrode hole are aligned along the length of the member.

[0124] Clause 2. The assembly of clause 1, wherein the first pin comprises a non-conductive material.

[0125] Clause 3. The assembly of clause 1 or 2, wherein the first electrode hole comprises a non-conductive inner surface.

[0126] Clause 4. The assembly of any one of clauses 1 to 3, the pin head of the first pin comprising a bevel profile.

[0127] Clause 5. The assembly of any of clauses 1 to 4, the first pin comprising a rivet including a base compressible to form a second head opposite the first head.

[0128] Clause 6. The assembly of Clause 5, the first head and the second head of the rivet being positioned at opposite sides of the first electrode.

[0129] Clause 7. A component according to any one of clauses 1 to 6, further comprising: a second electrode capable of sliding along the length of the member, the second electrode comprising a second electrode hole; and a second pin, the member comprising a second hole along the length of the member, and the second pin being disposed within the second hole and the second electrode hole when the second hole and the second electrode hole are aligned along the length of the member.

[0130] Clause 8. A component according to any one of clauses 1 to 6, further comprising a second pin, the member comprising a second hole, the first electrode comprising a second electrode hole, and the second pin being disposed within the second hole and the second electrode hole when the second hole and the second electrode hole are aligned along the length of the member.

[0131] Clause 9. The assembly of Clause 8, further comprising a first tab and a second tab, the first tab comprising the first electrode aperture, and the second tab comprising the second electrode aperture.

[0132] Clause 10. The assembly of Clause 9, the first tab and the second tab being positioned at opposite ends of the first electrode in a direction along the length of the member.

[0133] Clause 11. The assembly of any one of Clauses 8 to 10, the second electrode aperture comprising a non-conductive inner surface.

[0134] Clause 12. The assembly of any of clauses 8 to 11, the first tab and the second tab being attached to and extending from the first electrode.

[0135] Item 13. An expandable basket assembly comprising: at least one ridge extending along a longitudinal axis and configured to bend radially outward from the longitudinal axis, the ridge comprising a first ridge hole and a second ridge hole disposed along the length of the ridge; a first electrode capable of sliding along the length of the ridge, the first electrode comprising a first electrode hole and a second electrode hole; a first pin disposed within the first ridge hole and the first electrode hole when the first ridge hole and the first electrode hole are aligned along the length of the ridge; and a second pin disposed within the second ridge hole and the second electrode hole when the second ridge hole and the second electrode hole are aligned along the length of the ridge.

[0136] Clause 14. The assembly of clause 13, the first pin and the second pin comprising a non-conductive material.

[0137] Clause 15. The assembly of clause 13 or 14, the first electrode aperture and the second electrode aperture comprising a non-conductive inner surface.

[0138] Clause 16. The assembly of any of clauses 13 to 15, the first pin head of the first pin comprising a bevel profile, and the second pin head of the second pin comprising a bevel profile.

[0139] Clause 17. The assembly of any of clauses 13 to 16, the first pin and the second pin comprising rivets, the rivets being compressible to form beveled ends.

[0140] Clause 18. The assembly of Clause 13, further comprising a first tab and a second tab, the first tab comprising the first electrode aperture, and the second tab comprising the second electrode aperture.

[0141] Clause 19. The assembly of Clause 18, the first tab and the second tab being positioned at opposite ends of the first electrode in a direction along the length of the ridge.

[0142] Clause 20. The assembly of Clause 18 or 19, the first electrode aperture and the second electrode aperture comprising a non-conductive inner surface.

[0143] Clause 21. The assembly of any of clauses 18 to 20, the first tab and the second tab being attached to and extending from the first electrode.

[0144] Item 22. An expandable basket assembly comprising: at least one ridge extending along a longitudinal axis, the ridge comprising a first ridge hole along the length of the ridge; a first electrode, the first electrode being capable of sliding along the length of the ridge, the first electrode comprising a first electrode hole; and a first rivet, the first rivet being disposed within the first ridge hole and the first electrode hole when the first ridge hole and the first electrode hole are aligned along the length of the ridge.

[0145] Clause 23. The assembly of Clause 22, wherein the first rivet comprises a non-conductive material.

[0146] Clause 24. The assembly of clause 22 or 23, the first electrode aperture comprising a non-conductive inner surface.

[0147] Clause 25. The assembly of any one of Clauses 22 to 24, wherein the rivet head of the first rivet comprises a beveled profile.

[0148] Clause 26. The assembly of any of Clauses 22 to 25, wherein the rivet can include a multi-piece component including a rivet top connectable to a rivet bottom.

[0149] Clause 27. The assembly of Clause 26, the rivet top and the rivet bottom positioned at opposite sides of the first electrode when connected.

[0150] Clause 28. A component according to any one of clauses 22 to 27, further comprising: a second electrode capable of sliding along the length of the ridge, the second electrode comprising a second electrode hole; and a second rivet, the ridge comprising a second ridge hole along the length of the ridge, and the second rivet being disposed within the second ridge hole and the second electrode hole when the second ridge hole and the second electrode hole are aligned along the length of the ridge.

[0151] Clause 29. A component according to any one of clauses 22 to 27, further comprising a second rivet, the ridge comprising a second ridge hole, the first electrode comprising a second electrode hole, and the second rivet being disposed within the second ridge hole and the second electrode hole when the second ridge hole and the second electrode hole are aligned along the length of the ridge.

[0152] Clause 30. The assembly of Clause 29, further comprising a first tab and a second tab, the first tab comprising the first electrode aperture, and the second tab comprising the second electrode aperture.

[0153] Clause 31. The assembly of Clause 30, the first tab and the second tab being positioned at opposite ends of the first electrode in a direction along the length of the ridge.

[0154] Clause 32. The assembly of any of clauses 30 to 31, the first tab and the second tab being attached to and extending from the first electrode.

[0155] Clause 33. The assembly of any one of Clauses 27 to 29, the second electrode aperture comprising a non-conductive inner surface.

[0156] Item 34. An expandable basket assembly comprising: at least one ridge extending along a longitudinal axis, the ridge comprising a first ridge attachment along the length of the ridge; and a first electrode capable of sliding along the length of the ridge, the first electrode comprising an extension capable of being inserted into the first ridge attachment and capable of being compressed to form a compression base.

[0157] Clause 35. The assembly of clause 34, the first ridge attachment being a hole along the length of the ridge.

[0158] Clause 36. The assembly of clause 34, wherein the at least one ridge comprises a slot along at least a portion of the length of the ridge, and the first ridge attachment is a location along the length of the ridge at which the first electrode is secured to the at least one ridge.

[0159] Clause 37. The assembly of any one of clauses 34 to 36, the extension comprising a non-conductive material.

[0160] Item 38. A method of attaching an electrode to an elongated member, the method comprising: placing a first electrode at the end of the elongated member; sliding the first electrode along the length of the member until a first electrode hole of the first electrode is aligned with a first hole of the member; and inserting a first pin into the first electrode hole and the first hole to attach the first electrode to the member.

[0161] Clause 39. The method of clause 38, placing the first electrode at the end of the member comprises placing the end of the member in a slot of the first electrode, the member being slidable through the slot.

[0162] Clause 40. The method of clause 38 or 39, further comprising inserting a second pin into the second electrode hole and the second aperture to attach the first electrode to the member.

[0163] Clause 41. The method of Clause 40, the first electrode aperture being disposed in a first tab and the second electrode aperture being disposed in a second tab, the first tab and the second tab being positioned on opposite sides of a body of the first electrode.

[0164] Clause 42. The method of any one of clauses 38 to 41, wherein the first pin may include a rivet having a first rivet head, and the method further includes deforming a bottom of the first pin to secure the first pin within the first electrode hole and the first hole.

[0165] Clause 43. The method of any one of clauses 38 to 41, wherein the first pin may include a rivet having a first rivet head, and the method further includes connecting a rivet bottom to the first pin to secure the first pin within the first electrode hole and the first hole.

[0166] Clause 44. According to a method described in any one of clauses 38 to 43, sliding the first electrode along the length of the component until the first electrode hole of the first electrode is aligned with the first hole of the component includes sliding the first electrode through a second hole, and the method further includes: placing a second electrode at the end of the component; sliding the second electrode along the length of the component until the second electrode hole of the second electrode is aligned with the second hole; and inserting a second pin into the first electrode hole and the second hole to attach the second electrode to the component.

[0167] Item 45. A method of attaching an electrode to a spine of a basket catheter, the method comprising: sliding a first welding rod along the length of the spine until: a first electrode hole of the first electrode is aligned with a first ridge hole of the spine; and a second electrode hole of the first electrode is aligned with a second ridge hole of the spine; inserting a first pin into the first electrode hole and the first ridge hole to attach the first electrode to the spine; and inserting a second pin into the second electrode hole and the second ridge hole.

[0168] Clause 46. The method of Clause 45, further comprising placing an end of the ridge into a ridge slot of the first electrode, the ridge being able to slide through the ridge slot.

[0169] Clause 47. The method of clause 45 or 46, the first electrode aperture being disposed in a first tab and the second electrode aperture being disposed in a second tab, the first tab and the second tab extending from opposite ends of a body of the first electrode.

[0170] Clause 48. The method of any one of clauses 45 to 47, wherein the first pin and the second pin are rivets having rivet heads, and the method further comprises deforming the bottoms of the first pin and the second pin to secure the pins within their respective holes.

[0171] Clause 49. According to a method described in any one of clauses 45 to 48, the first pin may include a rivet having a first rivet head, the second pin may include a rivet having a second rivet head, and the method further includes: connecting a first rivet bottom to the first pin to fix the first pin in the first electrode hole and the first ridge hole; and connecting a second rivet bottom to the second pin to fix the second pin in the second electrode hole and the second ridge hole.

[0172] Clause 50. According to a method described in any one of clauses 45 to 49, sliding the first electrode along the length of the ridge until the first electrode hole of the first electrode is aligned with the first ridge hole of the ridge includes sliding the first electrode through a third ridge hole and a fourth ridge hole, and the method further includes: sliding the second electrode along the length of the ridge until: the third electrode hole of the second electrode is aligned with the third ridge hole of the ridge; and the fourth electrode hole of the second electrode is aligned with the fourth ridge hole of the ridge; inserting a third pin into the third electrode hole and the third ridge hole to attach the second electrode to the ridge; and inserting a fourth pin into the fourth electrode hole and the fourth ridge hole.

[0173] Item 51. A method of securing an electrode to an elongated member, the method comprising: sliding a first tab along the length of a ridge until a first electrode hole of the first tab is aligned with a first ridge hole of the ridge; inserting a first pin into the first electrode hole and the first ridge hole to attach the first tab to the ridge; sliding the first electrode along the length of the ridge until the first electrode contacts the first tab; sliding a second tab along the length of the ridge until a second electrode hole of the second tab is aligned with a second ridge hole of the ridge; and inserting a second pin into the second electrode hole and the second ridge hole to attach the second tab to the ridge.

[0174] Clause 52. The method of Clause 51, further comprising placing an end of the ridge into a ridge slot of the first electrode, the ridge being able to slide through the ridge slot.

[0175] Clause 53. The method of clause 51 or 52, wherein the first pin and the second pin are rivets having rivet heads, and the method further comprises deforming the bottoms of the first pin and the second pin to secure the pins within the corresponding electrode holes.

[0176] Item 54. A method of attaching an electrode to a spine of a basket catheter, the method comprising: sliding a first welding rod along the length of the spine until: a first electrode hole of the first electrode is aligned with a first ridge hole of the spine; inserting a first rivet into the first electrode hole and the first ridge hole; and riveting the first rivet to attach the first electrode to the spine.

[0177] Clause 55. The method of Clause 54, further comprising placing an end of the ridge into a ridge slot of the first electrode, the ridge being able to slide through the ridge slot.

[0178] Clause 56. The method of clause 54 or 55, riveting the first rivet comprises connecting a rivet base to the first rivet to attach the first electrode to the ridge.

[0179] Clause 57. According to a method described in any one of clauses 54 to 56, sliding the first electrode along the length of the ridge until the first electrode hole of the first electrode is aligned with the first ridge hole of the ridge includes sliding the first electrode through a second ridge hole, and the method further includes: sliding the second electrode along the length of the ridge until the second electrode hole of the second electrode is aligned with the second ridge hole; inserting a second rivet into the second electrode hole and the second ridge hole; and riveting the second rivet to attach the second electrode to the ridge.

[0180] Item 58. A method of securing an electrode to an elongated member, the method comprising: sliding a first electrode along the length of a ridge until the first electrode reaches a ridge attachment on the ridge; and compressing an extension of the first electrode to form a compression base at the end of the extension, thereby securing the first electrode to the ridge at the location of the ridge attachment portion.

[0181] Clause 59. The method of Clause 58, wherein the ridge attachment is a hole in the ridge.

[0182] Clause 60. The method of Clause 58, wherein the ridge attachment is located along a slot that extends at least a portion of the length of the ridge.

[0183] Clause 61. The method of Clause 60, wherein the extension has a rectangular cross-section having a width corresponding to the second width of the slot.

[0184] The above embodiments are cited by way of example, and the present invention is not limited by what is specifically shown and described above. On the contrary, the scope of the present invention includes combinations and sub-combinations of the various features described above, as well as variations and modifications thereof, which will occur to those skilled in the art upon reading the above description, and which are not disclosed in the prior art.

Claims

1. A spine assembly comprising: an elongated member extending along a longitudinal axis member, the longitudinal axis member including a first aperture along the length of the member; a first electrode slidable along the length of the member, the first electrode comprising a first electrode aperture; and A first pin is disposed within the first hole and the first electrode hole when the first hole and the first electrode hole are aligned along the length of the member.

2. The assembly of claim 1, the first pin comprising a non-conductive material.

3. The assembly of claim 1, the first electrode aperture comprising a non-conductive inner surface. The assembly of claim 1 , the pin head of the first pin comprising a beveled profile.

5. The assembly of claim 1, the first pin comprising a rivet including a base compressible to form a second head opposite the first head.

6. The assembly of claim 5, the first head and the second head of the rivet being positioned at opposite sides of the first electrode.

7. The assembly of claim 1, further comprising: a second electrode, the second electrode being slidable along the length of the member, the second electrode comprising a second electrode aperture; and Second pin, The member includes a second hole along the length of the member, and The second pin is disposed within the second hole and the second electrode hole when the second hole and the second electrode hole are aligned along the length of the member.

8. The assembly of claim 1 further comprising a second pin, the member comprising a second hole, the first electrode comprising a second electrode hole, and the second pin being disposed within the second hole and the second electrode hole when the second hole and the second electrode hole are aligned along the length of the member. 9 . The assembly of claim 8 , further comprising a first tab and a second tab, the first tab comprising the first electrode hole, and the second tab comprising the second electrode hole.

10. The assembly of claim 9, the first tab and the second tab being positioned at opposite ends of the first electrode in a direction along the length of the member.

11. The assembly of claim 8, the second electrode aperture comprising a non-conductive inner surface.

12. The assembly of claim 8, the first tab and the second tab being attached to and extending from the first electrode.

13. An expandable basket assembly comprising: at least one ridge extending along a longitudinal axis and configured to curve radially outward from the longitudinal axis, the ridge comprising a first ridge aperture and a second ridge aperture disposed along a length of the ridge; a first electrode capable of sliding along the length of the ridge, the first electrode comprising a first electrode aperture and a second electrode aperture; a first pin disposed within the first ridge aperture and the first electrode aperture when the first ridge aperture and the first electrode aperture are aligned along the length of the ridge; and A second pin is disposed within the second ridge aperture and the second electrode aperture when the second ridge aperture and the second electrode aperture are aligned along the length of the ridge.

14. The assembly of claim 13, the first pin and the second pin comprising a non-conductive material.

15. The assembly of claim 13, the first electrode aperture and the second electrode aperture comprising a non-conductive inner surface.

16. The assembly of claim 13, further comprising a first tab and a second tab, the first tab comprising the first electrode aperture, and the second tab comprising the second electrode aperture.

17. The assembly of claim 16, the first tab and the second tab being positioned at opposite ends of the first electrode in a direction along the length of the ridge.

18. An expandable basket assembly comprising: at least one ridge extending along a longitudinal axis, the ridge comprising a first ridge aperture along a length of the ridge; a first electrode capable of sliding along the length of the ridge, the first electrode comprising a first electrode aperture; and A first rivet is disposed within the first ridge aperture and the first electrode aperture when the first ridge aperture and the first electrode aperture are aligned along the length of the ridge.

19. The assembly of claim 18, the first rivet comprising a non-conductive material.

20. The assembly of claim 18, the first electrode aperture comprising a non-conductive inner surface.

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