Expandable basket assemblies, and expandable basket assemblies with electrode wire strain relief
The expandable spine assembly with a slit and wire configuration securely attaches electrodes to catheter spines without soldering or adhesives, addressing alignment issues and reducing manufacturing time and costs, enhancing the efficiency of cardiac ablation procedures.
Patent Information
- Application Number
- JP2024090523
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-05-01
- Filing Date
- 2024-06-04
- Publication Date
- 2024-12-17
AI Technical Summary
Current methods for attaching electrodes to spines of basket assemblies in catheters for cardiac ablation require soldering, welding, or adhesives, which are difficult, costly, and prone to misalignment, increasing manufacturing time and risk of improper bonding.
An expandable spine assembly with a connecting portion featuring a slit and a wire configuration that secures electrodes without soldering, welding, or adhesives, allowing for a straighter path when expanded, and includes an insulating jacket for electrical isolation.
Facilitates secure and efficient attachment of electrodes to spines, reducing manufacturing time and costs while ensuring proper alignment and electrical integrity, suitable for irreversible electroporation procedures.
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Figure 2024174846000001_ABST
Abstract
Description
[Technical field]
[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of priority to earlier-filed U.S. Provisional Patent Application No. 63 / 506,217, filed June 05, 2023 (Attorney Docket No. BIO6845USPSP 1-253757.000351), the entire contents of which are incorporated herein by reference as if fully set forth herein.
[0002] FIELD OF THEINVENTION The present invention relates generally to medical devices, particularly catheters having electrodes, and more particularly, but not exclusively, to catheters suitable for use in inducing irreversible electroporation (IRE) of cardiac tissue. [Background technology]
[0003] Cardiac 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 asynchronous rhythm. Certain procedures that exist for treating arrhythmias include surgically destroying the source of the signals that cause the arrhythmia and destroying the conduction pathways of such signals. By selectively ablating cardiac tissue with 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.
[0004] Many current ablation approaches in the art utilize radiofrequency (RF) electrical energy to heat tissue. RF ablation can have certain risks associated with thermal heating that can lead to tissue charring, burning, steam popping, phrenic nerve paralysis, pulmonary vein stenosis, and esophageal fistulas.
[0005] Cryoablation is an alternative approach to RF ablation that reduces the thermal risks typically associated with RF ablation. However, maneuvering cryoablation devices and selectively applying cryoablation is generally more difficult compared to RF ablation, and thus cryoablation is not feasible in certain anatomical geometries that may be achieved by electrical ablation devices.
[0006] Some ablation approaches use irreversible electroporation (IRE) to ablate cardiac tissue using non-thermal ablation methods. IRE delivers short pulses of high voltage to tissue, causing irreversible permeabilization of cell membranes. Delivery of IRE energy to tissue using multi-electrode catheters has been previously proposed in the patent literature. Examples of systems and devices configured for IRE ablation are disclosed in U.S. Patent Application Publication Nos. 2021 / 0169550(A1), 2021 / 0169567(A1), 2021 / 0169568(A1), 2021 / 0161592(A1), 2021 / 0196372(A1), 2021 / 0177503(A1), and 2021 / 0186604(A1), each of which is incorporated by reference in its entirety into this specification.
[0007] Regions of cardiac tissue can be mapped by the catheter to identify abnormal electrical signals. Ablation can be performed using the same or different catheters. Some exemplary catheters include multiple spines on which electrodes are positioned. The electrodes are typically attached to the spines and fixed in place by soldering, welding, or using adhesives. However, due to the small size of the spines and electrodes, soldering, welding, or gluing the electrodes to the spines can be a difficult task, increasing manufacturing time and costs, and may result in the electrodes failing due to improper bonding or misalignment. Summary of the Invention [Problem to be solved by the invention]
[0008] Therefore, what is needed is a system and method for attaching electrodes to the spine of a basket assembly without requiring the use of soldering, welding, or adhesives. [Means for solving the problem]
[0009] According to one example of the present invention, the provided expandable spine assembly may include an expandable spine with a connecting portion that may include a first slit facing an interior space formed by the expandable spine when the expandable spine is in an expanded state. A first electrode is attached to the expandable spine and disposed at a distal end of the first slit. A second electrode is attached to the expandable spine and disposed proximal to the first electrode and at a proximal end of the first slit. A wire is configured to electrically connect the first electrode and the second electrode and is configured to be positioned within the first slit when the expandable spine is in a collapsed state and positioned outside the first slit when the expandable spine is in an expanded state such that the wire travels in a straighter path compared to the path of the connecting portion of the first electrode and the second electrode.
[0010] According to one example of the present invention, an expandable basket assembly is provided that may include a plurality of spines extending along a longitudinal axis and configured to bend radially outward from the longitudinal axis when the expandable basket assembly transitions from a collapsed configuration to an expanded configuration. The expandable basket assembly may further include a plurality of electrode pairs, each electrode pair of the plurality of electrode pairs attached to one of the plurality of spines. The expandable basket assembly may further include a plurality of slits facing an interior space formed by the expandable basket assembly when the expandable basket assembly is in the expanded configuration. The expandable basket assembly may further include a plurality of wires configured to electrically connect the plurality of electrode pairs, the plurality of wires being configured to be positioned in the plurality of slits when the expandable basket assembly is in a collapsed state and positioned outside the plurality of slits such that the plurality of wires travel in a straighter path compared to the path of the plurality of spines connecting the plurality of electrode pairs.
[0011] According to one example of the present invention, an expandable spine assembly is provided that includes an expandable spine that includes a connecting portion. The expandable spine assembly may also include a first electrode attached to the expandable spine at a distal end of the connecting portion. The expandable basket assembly may also include a second electrode attached to the expandable spine and disposed proximal to the first electrode and at a proximal end of the connecting portion. The expandable basket assembly may also include a wire configured to electrically connect centers of the first electrode and the second electrode, disposed separate from the connecting portion, and disposed within an interior space formed by the expandable spine in an expanded state. [Brief description of the drawings]
[0012] [Figure 1] 1 is a schematic, pictorial illustration of a medical system including a medical probe, the distal end of the medical probe including a basket assembly having an electrode, according to one embodiment of the present invention. [Figure 2A]1 is a schematic, pictorial diagram showing a perspective view of a medical probe in an extended configuration having wires connecting adjacent electrodes to the ends of the electrodes, in accordance with an embodiment of the present invention; [Figure 2B] FIG. 2B is a schematic, pictorial diagram showing a side view of the medical probe of FIG. 2A in a folded configuration, in accordance with the disclosed technology. [Figure 2C] FIG. 1 is a schematic, pictorial diagram illustrating a top view of a spine of a basket assembly in a folded configuration with connecting wires disposed in grooves in the spine in accordance with the disclosed technology; [Figure 2D] 1 is a schematic, pictorial diagram illustrating a perspective view of a medical probe in an extended configuration having wires connecting the electrode centers, in accordance with an embodiment of the present invention; [Figure 2E] FIG. 1 is a schematic, pictorial diagram showing a side view of a spine of a basket assembly in an expanded configuration with connecting wires disposed within grooves in the spine along their arc lengths in accordance with the disclosed technology; [Figure 2F] FIG. 13 is a schematic, pictorial diagram showing a side view of a spine of a basket assembly in an expanded configuration with connecting wires extending outside the grooves of the spine with a straight length, in accordance with the disclosed technology; [Figure 3A] FIG. 1 is a schematic pictorial diagram showing an exploded view of the tubular shaft and spine of a basket assembly, illustrating how the spine can be assembled with the tubular shaft, according to one embodiment of the present invention. [Figure 3B] FIG. 1 is a schematic pictorial diagram showing an exploded view of the tubular shaft and spine of a basket assembly, illustrating how the spine can be assembled with the tubular shaft, according to one embodiment of the present invention. [Figure 4] FIG. 1A is a schematic pictorial diagram showing a front perspective view of an electrode before it has been crimped, while FIG. 1B is a schematic pictorial diagram showing a front perspective view of an electrode after it has been crimped, according to one embodiment of the present invention. [Diagram 5] FIG. 1A is a schematic pictorial diagram showing a side perspective view of an electrode before it has been crimped, while FIG. 1B is a schematic pictorial diagram showing a side perspective view of the electrode after it has been crimped, according to one embodiment of the present invention. [Figure 6]FIG. 1A is a schematic pictorial diagram showing a front perspective view of an electrode and spine before the electrode is crimped to the spine, while FIG. 1B is a schematic pictorial diagram showing a front perspective view of the electrode and spine after the electrode has been crimped to the spine, in accordance with one embodiment of the present invention. [Figure 7A] 1 illustrates a side view of an electrode, according to an embodiment of the present invention. [Figure 7B] 1 illustrates a side view of an electrode, according to an embodiment of the present invention. [Figure 7C] 1 illustrates a side view of an electrode, according to an embodiment of the present invention. [Figure 7D] 1 illustrates a side view of an electrode, according to an embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0013] The following detailed description should be read with reference to the drawings, in which like elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of the invention. The detailed description illustrates, by way of example and not by way of limitation, the principles of the invention. The description clearly enables one skilled in the art to make and use the invention and describes several embodiments, adaptations, variations, alternatives and uses of the invention, including what is currently contemplated to be the best mode for carrying out the invention.
[0014] As used herein, the term "about" or "approximately" with respect to any numerical value or range indicates suitable dimensional tolerances that allow a portion or collection of components to function for the intended purpose described herein. More specifically, "about" or "approximately" may refer to a range of values of ±10% of the recited value, e.g., "about 90%" may refer to a range of values of 81% to 99%. Additionally, as used herein, the terms "patient," "host," "user," and "subject" refer to any human or animal subject, and while use of the invention in a human patient represents a preferred embodiment, it is not intended to limit the system or method to human use. Similarly, the term "proximal" refers to a location closer to the operator or physician, while "distal" refers to a location farther from the operator or physician.
[0015] As discussed herein, the vascular system of a "patient," "host," "user," and "subject" may be that of a human or any animal. It should be understood that the animal may be of any of a variety of applicable types, including, but not limited to, mammals, veterinary animals, livestock animals, or pet animals. As an example, the animal may be a laboratory animal (e.g., rats, dogs, pigs, monkeys, etc.) that is specifically selected to have certain characteristics similar to humans. It should be understood that the subject may be, for example, any applicable human patient.
[0016] As discussed herein, an "operator" may include a physician, surgeon, technician, scientist, or any other individual or delivery instrument associated with the delivery of a multi-electrode catheter for the treatment of drug-refractory atrial fibrillation to a subject.
[0017] As discussed herein, the term "ablate" or "ablation," in the context of the devices and corresponding systems of the present disclosure, refers to components and structural features configured to reduce or prevent the generation of irregular cardiac signals in cells by utilizing non-thermal energy, such as irreversible electroporation (IRE), sometimes interchangeably referred to as pulsed electric field (PEF) and pulsed field ablation (PFA). In the context of the devices and corresponding systems of the present disclosure, ablation or ablation is used throughout this disclosure in reference to non-thermal ablation of cardiac tissue in certain conditions, including, but not limited to, arrhythmias, atrial flutter ablation, pulmonary vein isolation, supraventricular tachycardia ablation, and ventricular tachycardia ablation. The term "ablate" or "ablation" also includes known methods, devices, and systems for achieving various forms of body tissue ablation, as will be understood by those skilled in the art.
[0018] As discussed herein, the terms "bipolar" and "monopolar", when used to refer to ablation schemes, describe different ablation schemes with respect to current paths and electric field distribution. "Bipolar" refers to an ablation scheme that utilizes a current path between two electrodes, both positioned at the treatment site. The current density and electric flux density are typically approximately equal at each of the two electrodes. "Monopolar" refers to an ablation scheme that utilizes a current path between two electrodes, where one electrode with a high current density and high electric flux density is positioned at the treatment site, and a second electrode with a relatively low current density and lower electric flux density is positioned remotely from the treatment site.
[0019] As discussed herein, the terms "tubular" and "tube" are to be interpreted broadly and are not limited to right cylindrical structures, or structures that are strictly circular in cross section, or structures that are uniform in cross section throughout their length. For example, a tubular structure is generally illustrated as a substantially right cylindrical structure. However, a tubular structure may have a tapered or curved outer surface without departing from the scope of the present disclosure.
[0020] The present disclosure relates to systems, methods, or uses and devices for IRE ablation of cardiac tissue to treat cardiac arrhythmias. Ablation energy is typically delivered to cardiac tissue by a distal portion of a catheter that can deliver the ablation energy along the tissue to be ablated. Some exemplary catheters include a three-dimensional structure at the distal portion and are configured to administer the ablation energy from various electrodes positioned on the three-dimensional structure. Ablation procedures incorporating such exemplary catheters can be visualized using X-ray fluoroscopy.
[0021] Ablation of cardiac tissue applying radio frequency (RF) energy and thermal techniques such as cryoablation to improve a failing heart is a well-known procedure. Typically, to successfully ablate using thermal techniques, cardiac potentials must be measured at various locations in the myocardium. In addition, temperature measurements during ablation provide data that allows for the effectiveness of the ablation. Typically, in ablation procedures using thermal techniques, electrode potentials and temperatures are measured before, during, and after the actual ablation. RF approaches may have risks that may lead to tissue charring, burning, steam popping, phrenic nerve paralysis, pulmonary vein stenosis, and esophageal fistula. Cryoablation is an alternative approach to RF ablation that can reduce some of the thermal risks associated with RF ablation. However, operating a cryoablation device and selectively applying cryoablation is generally more difficult compared to RF ablation. Thus, cryoablation is not feasible in certain anatomical geometries that may be achieved by electrical ablation devices.
[0022] While RF ablation and cryoablation are based on thermal energy transfer to induce localized tissue necrosis, the solution of the present disclosure can solve these and other problems by utilizing irreversible electroporation (IRE), sometimes interchangeably referred to as pulsed electric field (PEF) and pulsed electric field ablation (PFA). IRE, as discussed in this disclosure, is a non-thermal cell death technique that can be used to ablate atrial arrhythmias. To ablate using IRE / PEF, biphasic voltage pulses are applied to destroy cellular structures of the myocardium. The biphasic pulses are non-sinusoidal waveforms and can be tailored to the target cells based on the electrophysiology of the cells. In contrast, to ablate using RF, a sinusoidal voltage waveform is applied to generate heat in the treatment area, indiscriminately heating all cells within the treatment area. Thus, IRE has the ability to spare adjacent heat-sensitive structures or tissues, which would be beneficial in reducing possible complications known with ablation or isolation modalities. Additionally or alternatively, monophasic pulses can be utilized.
[0023] Electroporation can be induced by applying a pulsed electric field to biological cells to cause the reversible (temporary) or irreversible (permanent) generation of pores in the cell membrane. Cells have a transmembrane electrostatic potential that increases above the resting potential upon application of the pulsed electric field. While the transmembrane electrostatic potential remains below a threshold potential, electroporation is reversible, meaning that the pores can close when the applied pulsed electric field is removed and the cell can repair itself and survive. If the transmembrane electrostatic potential increases above the threshold potential, electroporation is irreversible and the cell becomes permanently permeable. As a result, the cell dies due to loss of homeostasis, typically by apoptosis. In general, different types of cells have different threshold potentials. For example, cardiac cells have a threshold potential of approximately 500V / cm, while bone has a threshold potential of 3000V / cm. These differences in threshold potentials allow IRE to selectively target tissues based on the threshold potential.
[0024] The solutions of the present disclosure include systems and methods for applying an electrical signal from a catheter electrode positioned near myocardial tissue to generate a pulsed electric field effective to induce electroporation in the myocardial tissue. The systems and methods may be effective for ablation of target tissue by inducing irreversible electroporation. In some examples, the systems and methods may be effective for inducing reversible electroporation as part of a diagnostic procedure. Reversible electroporation occurs when electricity applied at the electrode falls below the electric field threshold of the target tissue, allowing cells to repair. Reversible electroporation does not kill cells, but allows the physician to see the effect of reversible electroporation on the electrical activation signal near the target location. Exemplary systems and methods for reversible electroporation are disclosed in U.S. Patent Application Publication No. 2021 / 0162210, which is incorporated by reference in its entirety.
[0025] The pulsed electric field and its effectiveness in inducing reversible and / or irreversible electroporation can be influenced by the physical parameters of the system and the biphasic pulse parameters of the electrical signal. The physical parameters can include electrode contact area, electrode spacing, electrode geometry, etc., and the examples presented herein generally include physical parameters adapted to effectively induce reversible and / or irreversible electroporation. The biphasic pulse parameters of the electrical signal can include voltage amplitude, pulse duration, pulse interphase delay, interpulse delay, total application time, delivery energy, etc. In some examples, the parameters of the electrical signal can be adjusted to induce both reversible and irreversible electroporation given the same physical parameters. Examples of various systems and methods of ablation, including IRE, are provided in U.S. Patent Application Publication Nos. 2021 / 0169550(A1), 2021 / 0169567(A1), 2021 / 0169568(A1), 2021 / 0161592(A1), 2021 / 0196372(A1), 2021 / 0177503(A1), and 2021 / 0186604(A1), each of which is incorporated by reference in its entirety into this specification.
[0026] To deliver pulsed field ablation (PFA) in an IRE (irreversible electroporation) procedure, the electrodes must contact the tissue to be ablated over a sufficiently large surface area. As described below, the medical probe includes a flexible insertion tube having a proximal end and a distal end, and a basket assembly at the distal end of the flexible insertion tube. The basket assembly includes at least one spine and a plurality of electrodes, each given electrode having a lumen that fits into a given spine therethrough. The electrodes are crimped to the spine and locked in place by locking stubs to prevent the electrodes from sliding proximally or distally along the length of the spine.
[0027] Please refer to FIG. 1, which shows an exemplary catheter-based electrophysiology mapping and ablation system 10. The system 10 includes multiple catheters that are percutaneously inserted by an operator 24 through the vascular system of a patient 23 into a cavity or vasculature of a heart 12. Typically, a delivery sheath catheter is inserted into the left or right atrium near a desired location of the heart 12. The multiple catheters can then be inserted into the delivery sheath catheter to reach the desired location. The multiple catheters may include catheters dedicated to sensing Intracardiac Electrogram (IEGM) signals, catheters dedicated to ablation, and / or catheters dedicated to both sensing and ablation. An exemplary catheter 14 configured to sense IEGMs is illustrated herein. The operator 24 brings a basket catheter 28 into contact with the heart wall to sense a target site within the heart 12. For ablation, the operator 24 similarly brings a distal end of an ablation catheter to a target site for ablation.
[0028] The catheter 14 is an exemplary catheter that includes one, and preferably multiple, electrodes 26, optionally distributed across multiple spines 22, forming a basket assembly 28 at the distal end and configured to sense IEGM signals. The catheter 14 may additionally include a position sensor 29 embedded in or near the distal tip for tracking the position and orientation of the basket assembly 28. Optionally and preferably, the position sensor 29 is a magnetic-based position sensor that includes three magnetic coils for sensing three-dimensional (3D) position and orientation.
[0029] The magnetic-based position sensor 29 may operate in conjunction with a location pad 25 that includes a plurality of magnetic coils 32 configured to generate a magnetic field within a predetermined working volume. The real-time position of the basket assembly 28 of the catheter 14 may be tracked based on the magnetic field generated by the location pad 25 and sensed by the magnetic-based position sensor 29. Details of magnetic-based position sensing technology are described in U.S. Patent Nos. 5,391,199; 5,443,489; 5,558,091; 6,172,499; 6,239,724; 6,332,089; 6,484,118; 6,618,612; 6,690,963; 6,788,967; and 6,892,091, each of which is incorporated herein by reference in its entirety.
[0030] The system 10 includes one or more electrode patches 38 positioned for skin contact on the patient 23 to establish a positional reference for the location pads 25 and impedance-based tracking of the electrodes 26. For impedance-based tracking, a current is directed to the electrodes 26 and sensed at the electrode skin patch 38, so that the location of each electrode can be triangulated via the electrode patch 38. Details of impedance-based position tracking 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 in its entirety.
[0031] Recorder 11 displays electrograms 21 captured by the body surface ECG electrodes 18 and intracardiac electrograms (IEGMs) captured by electrodes 26 of catheter 14. Recorder 11 may include pacing capability for pacing the cardiac rhythm and / or may be electrically connected to a stand-alone pacer.
[0032] The system 10 may include an ablation energy generator 50 adapted to deliver ablation energy to one or more electrodes at the distal tip of a catheter configured for ablation. The energy generated by the ablation energy generator 50 may include, but is not limited to, radio frequency (RF) energy or pulsed field ablation (PFA) energy, including unipolar or bipolar high voltage direct current pulses such as may be used to effect irreversible electroporation (IRE), or combinations thereof. The signal may be biphasic or monophasic.
[0033] The patient interface unit (PIU) 31 is an interface configured to establish electrical communication between the catheters, the electrophysiological equipment, a power source, and a workstation 55 that controls the operation of the system 10. The electrophysiological equipment of the system 10 may include, for example, multiple catheters, location pads 25, body surface ECG electrodes 18, electrode patches 38, an ablation energy generator 50, and a recorder 11. Optionally and preferably, the PIU 31 additionally includes processing capabilities for implementing real-time calculations of the catheter positions and performing ECG calculations.
[0034] The workstation 55 includes a processor unit having a memory, a memory or storage device loaded with suitable operating software, and a user interface function. The workstation 55 may optionally provide multiple functions including: (1) modeling the endocardial anatomical structures in three dimensions (3D) and rendering the model or anatomical map 20 for display on the display device 27; (2) displaying activation sequences (or other data) compiled from the recorded electrograms 21 with representative visual indicators or images superimposed on the rendered anatomical map 20 on the display device 27; (3) displaying real-time positions and orientations of multiple catheters within the cardiac chambers; and (5) displaying sites of interest, such as locations where ablation energy has been applied, on the display device 27. One commercially available product embodying elements of the system 10 is available as the CARTO™ 3 system, available from Biosense Webster, Inc., 31 Technology Drive, Suite 200, Irvine, CA 92618, USA.
[0035] 2A is a schematic pictorial diagram showing a perspective view of a medical probe 200 having a basket assembly 28 in an expanded configuration when unconstrained, such as by being advanced from an insertion tube lumen 80 at the distal end 36 of the insertion tube 31. FIG. 2B shows the basket assembly in a collapsed configuration within the insertion tube 31. In the expanded configuration (FIG. 2A), the spines 22 are curved radially outward from the longitudinal axis 86 of the medical probe 200, and in the collapsed configuration (FIG. 2B), the spines are aligned generally along the longitudinal axis 86 of the medical probe 200.
[0036] 2A, the basket assembly 28 includes a plurality of flexible spines 22 formed on the end of a tubular shaft 84 and connected at both ends. During a medical procedure, the medical professional 24 can deploy the basket assembly 28 by extending the tubular shaft 84 from the insertion tube 31, causing the basket assembly 38 to exit the insertion tube and transition to an expanded configuration. The spines 22 can have an elliptical (e.g., circular) or rectangular (which may appear flat) cross-section and can comprise a flexible, resilient material (e.g., a shape memory alloy such as nickel titanium (also known as Nitinol), cobalt chrome, stainless steel, titanium, or any other suitable material or combination of materials).
[0037] In the embodiments described herein, the electrodes 26 may be configured to deliver ablation energy (RF and / or IRE) to tissue within the heart 12. For example, the electrodes 26 may be configured to deliver 20-30 amps of current to the cardiac tissue to facilitate ablation of the cardiac tissue. Furthermore, the electrodes 26 may be configured for bipolar or monopolar ablation schemes depending on the particular application. Alternatively or additionally, the electrodes may be used to determine the location of the basket assembly 28 and / or measure physiological properties such as local surface potentials at respective locations on the tissue within the heart 12.
[0038] Examples of materials ideally suited for forming the electrodes 26 include gold, platinum, and palladium (and their respective alloys). These materials also have high thermal conductivity, which allows the minimal heat generated on the tissue (i.e., due to the ablation 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 inside the spine) and then to the blood pool within the heart 12.
[0039] The basket assembly 28 has a distal end 94 and includes a stem 96 extending longitudinally from the distal end 36 of the shaft 84 toward the distal end 94 of the basket assembly 28. The control console or workstation 55 may include an irrigation module (not shown) that controls the delivery of irrigation fluid to the distal end 36. The stem 96 includes a number of spray ports 98, each of which may be angled to direct the delivery of irrigation fluid to either a given electrode 26 or tissue within the heart 12.
[0040] Because the electrode 26 does not include a spray port for delivering irrigation fluid, the configuration described thus far allows heat to be transferred from the tissue (i.e., during an ablation procedure) to the portion of the electrode 26 inside the spine 22, and the electrode 26 may be cooled by directing irrigation fluid through the spray port 98 to the portion of the electrode 26 inside the spine 22.
[0041] As shown in Figures 2A-2F, the spine 22 of the basket assembly 28 includes a slit 24 (see Figure 2C) configured to accommodate a wire 202 connecting adjacent ends of the electrodes 26 in a folded state (see Figures 2B and 2C). The wire 202 is configured to electrically connect the first electrode 26 and is connected to the spine 22 and is configured to be positioned within the first slit 24 when the expandable spine 22 is in a folded state and positioned outside the first slit when the expandable spine 22 is in an expanded state such that the wire travels in a straighter path compared to the path of the connection portion 22A (see Figure 2C) of the first electrode 26 and the second electrode 26 when the expandable spine 22 is in an expanded state. The arc length ArL of the connection portion 22A is greater than the length SL of the wire 202 between the first electrode 26 and the second electrode 26 when the expandable spine 22 is in an expanded state. In some embodiments, the basket assembly 28 may include an electrically insulating jacket disposed between the first and second electrodes 26 and the expandable spine, thereby electrically insulating the first and second electrodes from the expandable spine, where the electrically insulating jacket includes a second slit corresponding to the first slit and including polyether ketone (PEEK), liquid crystal polymer (LCP), or both.
[0042] In other words, the expandable basket assembly 28 may include a plurality of spines 22 extending along the longitudinal axis 86 and configured to bend radially outward from the longitudinal axis 86 when the expandable basket assembly 28 transitions from the collapsed configuration to the expanded configuration. The expandable basket assembly may include a plurality of electrode pairs 26, where each electrode 26 pair of the plurality of electrode 26 pairs may be attached to one spine 22 of the plurality of spines 22. The plurality of slits 24 face an interior space formed by the expandable basket assembly 28 when the expandable basket assembly 28 is in the expanded configuration. The plurality of wires 202 are configured to electrically connect the plurality of electrode 26 pairs and are configured to be positioned within the plurality of slits 24 and positioned outside the plurality of slits 24 when the expandable basket assembly 28 is in the collapsed state such that the plurality of wires 202 travel in a straighter path compared to the path of the plurality of spines 22 connecting the plurality of electrode 26 pairs.
[0043] FIG. 2D is the same as FIG. 2A, except that wire 202 in FIG. 2D connects centers 26A of adjacent electrodes 26 disposed on spine 22. FIG.
[0044] 3A and 3B are schematic pictorial diagrams showing an exploded view of the tubular shaft 84 and spine 22 of basket assembly 28 to provide an example of how spine 22 may be assembled with tubular shaft 84, according to one embodiment of the present invention. As shown in FIG. 3A, spine 22 may form spine assembly 28. Spine 22 may be formed from a single sheet of planar material to form a general star shape. In other words, spine 22 may be formed from a single sheet of planar material such that spine 22 converges toward a central intersection 211. Intersection 211 may be a solid piece of material or may include one or more apertures.
[0045] The spine 22 may be folded or otherwise bent so that the proximal end 216 of the spine 22 may be inserted into the distal end 36 of the tubular shaft 84 (see FIGS. 2A and 2D ), as shown in FIG. 3B . Although not shown in FIGS. 3A and 3B , it will be understood that the electrodes 26 may be attached to the spine 22 before the spine is inserted into the tubular shaft 84 to form the basket assembly 28. As previously mentioned, the spine 22 may comprise a flexible, resilient material (e.g., a shape memory alloy such as nickel titanium, also known as Nitinol) that may enable the basket assembly 28 to transition from its folded configuration (as shown in FIG. 2B ) to its expanded configuration (as shown in FIG. 2A ) when the basket assembly 28 is deployed from the insertion tube 31.
[0046] Each of the spines 22 can define an aperture 215 that can be sized and positioned to receive a locking stub 71 of the electrode 26, as described in further detail herein. By receiving the locking stub 71, the aperture 215 can help prevent the electrode 26 from sliding proximally or distally along the length of the spine 22. In other words, the aperture 215 can help secure the electrode 26 to the spine 22 as the locking stub 71 extends through the aperture 215 without the need for welding, fasteners, adhesives, or other fastening devices or methods. As a non-limiting example, the spine 22 can include at least two apertures 215 positioned in the length of the spine 22 between a proximal end of the spine 22 and a distal end of the spine 22. In this manner, the basket assembly 28 can have at least two electrodes 26 along each length of the spine 22 extending between the proximal and distal ends of the basket assembly 28 such that the basket assembly 28 can have a total of twelve electrodes. The apertures 215 can be positioned to receive electrodes (e.g., FIGS. 4A, 4B, 5A, 5B, 6A, 6B, 7A-7D) and maintain such electrodes via a mechanical lock between the electrodes and the spine by the apertures 215.
[0047] As will be appreciated by one of ordinary skill in the art having the benefit of this disclosure, the basket assembly 28 shown in FIGS. 2A-3B, formed from a single sheet of planar material and having spines 22 that converge at a central intersection, is provided for illustrative purposes only, and the techniques of the present disclosure may be applicable to other configurations of the basket assembly 28. For example, the techniques of the present disclosure may be applicable to a basket assembly 28 formed from a single spine 22 or multiple spines 22, with each spine 22 attached to both ends. In other examples, the basket assembly 28 may include a central hub that connects multiple spines 22 together at the distal end 94 of the basket assembly 28. In still other examples, the basket assembly 28 may include a single spine 22 configured to form a spiral, multiple spines 22 configured to form a spiral, multiple spines 22 configured to form one or more tripods, or any other shape of the basket assembly 28. Similarly, the spine assembly 28 may be formed by laser cutting a cylindrical hollow stock material whereby the laser is mounted to rotate about (and translate relative to) the longitudinal axis of the cylindrical stock during cutting. Thus, although Figures 2A-3B show particular configurations of the basket assembly 28, the technology of this disclosure should not be construed as so limited.
[0048] FIG. 4A is a schematic pictorial diagram illustrating a front perspective view of electrode 26 before crimping, while FIG. 4B is a schematic pictorial diagram illustrating a front perspective view of electrode 26 after crimping, according to one embodiment of the present invention. Similarly, FIG. 5A is a schematic pictorial diagram illustrating a side perspective view of electrode 26 before crimping, while FIG. 5B is a schematic pictorial diagram illustrating a side perspective view of electrode 26 after crimping, according to one embodiment of the present invention. As shown in FIGS. 4A-5B, electrode 26 can have an elongated body having a cross-sectional shape that extends along the length of electrode 26. Electrode 26 can be made from a malleable and conductive material, such as gold, platinum, and palladium (and their respective alloys), as described above. As will be appreciated, by forming electrode 26 from a malleable material, electrode 26 can be crimped or otherwise plastically deformed to transition from an uncrimped first shape (i.e., FIGS. 4A and 5A) to a crimped second shape (i.e., FIGS. 4B and 5B). As described in more detail herein, the electrodes 26 can be crimped around the spine 22 to secure the electrodes 26 to the spine 22 without the need for soldering, welding, or adhesives.
[0049] The electrode 26 can define a first lumen 70 and a second lumen 72, both of which extend through the elongated body of the electrode 26 from a first end to a second end of the electrode 26. The electrode 26 can have an outer surface 74 facing outwardly from the electrode 26, a first inner surface 76 facing inwardly toward the electrode 26 and having a first lumen 70 formed therethrough, and a second inner surface 78 facing inwardly toward the electrode 26 and having a second lumen 72 formed therethrough. The first lumen 70 can be sized and configured to receive the spine 22 as shown in FIG. 6A such that the spine 22 can pass through the first lumen 70. Although not shown, the second lumen 72 can be sized to receive a wire of the medical probe 22, thereby allowing the electrode 26 to be attached to the wire. The wire can be electrically insulated from the spine 22. In some examples, the first lumen 70 and / or the second lumen 72 can each pass through the electrode 26 in a generally longitudinal direction of the electrode 26. In other examples, the first lumen 70 and / or the second lumen 72 can pass through the electrode 26 in a generally transverse direction of the electrode 26. Additionally, the first lumen 70 and / or the second lumen 72 can be positioned within the electrode 26 toward the bottom, toward the top, or toward the center of the electrode 26, depending on the particular configuration.
[0050] By including the first lumen 70 sized to receive the spine 22 of the medical probe 22, the techniques of the present disclosure can ensure that the electrode 26 is secured to the spine 22 to prevent dislodgement. Thus, even if the electrode 26 becomes dislodged, the electrode 26 will remain attached to the spine 22 by the nature of the struts 430 passing through the first lumen 70.
[0051] The electrode 26 may further include a locking stub 80, which may extend inwardly into the first lumen 70. The locking stub 80 may extend longitudinally along the length of the electrode 26 from a first end of the electrode 26 to a second end of the electrode 26. The locking stub 80 may be sized to extend at least partially through the aperture 215 of the spine 22 when the electrode 26 is coupled to the spine 22.
[0052] As illustrated in FIGS. 4A-6B, the electrode 26 can be crimped from a first shape (i.e., as illustrated in FIGS. 4A, 5A, and 6A) to a second shape (i.e., as illustrated in FIGS. 4B, 5B, and 6B). For example, the electrode 26 can be crimped toward the longitudinal axis of the elongated body of the electrode 26 and can have a substantially rounded outer surface 74 before being crimped and a substantially flat outer surface 74 after being crimped. The electrode 26 can be crimped by using a tool to press the electrode 26 until the electrode 26 plastically deforms from the first shape to the second shape. As illustrated in FIGS. 6A and 6B, the spine 22 can be inserted into the electrode 26 and the aperture 215 of the spine 22 can be aligned with the locking stub 80 of the electrode 26. Once the locking stub 80 is aligned with the aperture 215, the electrode 26 can be crimped until the distance between the locking stub 80 and the first inner luminal surface 76 is reduced to secure the spine 22 in place. In other words, the spine 22 can be inserted into the first lumen 70, and then the electrode 26 can be crimped until it is tightly secured around the spine 22. When the electrode 26 is crimped around the spine 22, the locking stub 80 can extend through the aperture 215 of the spine 22 and can prevent the electrode 26 from moving proximally or distally along the length of the spine 22. Unless otherwise stated, once the electrode 26 is crimped onto the spine 26, the locking stub 80 can contact the inner surface of the aperture 215 of the spine 22 and the first inner luminal surface 76 can contact the spine 22 such that the spine 22 cannot be removed from the electrode 26 without deforming the electrode 26. In some examples, the locking stub 80 can form an interference fit with the spine 22 at the aperture 215 to secure the electrode 26 in place.
[0053] 7A-7D illustrate side views of electrode 26 having differently shaped locking stubs 780A-780C. As shown in FIG. 7A, locking stub 771A can have a generally rounded or circular cross-section. Alternatively, as shown in FIG. 7B, locking stub 771B can have a generally rectangular cross-section, or as shown in FIG. 7C, locking stub 771C can have at least a portion having a generally triangular shape. As will be appreciated, a generally rounded locking stub 771A can aid in allowing locking stub 771A to slide into aperture 215 of spine 22 to form an interference fit with spine 215. Alternatively, locking stub 771B having a generally rectangular shape may be able to form a tighter interference fit. Additionally, the locking stub 771C having a generally triangular shape may lock the spine 22 onto the locking stub 71 in a triangular shape, allowing the electrode 26 to be further secured to the spine 22. In Fig. 7D, the active electrode surface 26 is now a bulging member having two side projections 772A and 772B such that the retainer 771A may be inserted into the aperture 215 and the electrode 26A is swaged or crimped over the spine member 22. In an alternative arrangement, the side projections 772A and 772B may be eliminated such that only the retainer 771A protrudes into the aperture 215 and the electrode 26A may be crimped into a substantially three-dimensional trapezoid (i.e., a rounded trapezoidal prism or a rounded truncated pyramid). 7A-7D are provided for illustrative purposes, and the techniques of the present disclosure should not be limited to the particular examples of locking stubs 771A-771C illustrated and described herein. For example, the locking stub 71 can include a generally trapezoidal shape, a generally pentagonal shape, a generally hexagonal shape, a generally octagonal shape, a generally oval shape, a generally cross shape, a generally curved shape, or other suitable shapes. Additionally, the locking stub 71 can have a cross-section that varies along the length of the locking stub 71 from one end of the locking stub 71 to another end of the locking stub 71.For example, the locking stub 71 can have a thicker cross-section at either end of the locking stub 71 or can have a thicker cross-section at the center of the locking stub 71. Additionally, although described as extending from one side of the electrode 26 to the second side of the electrode 26, the locking stub 71 can extend less than the entire length of the electrode 26 or can have portions removed between the first and second ends (e.g., the locking stub 71 can have portions of material at both ends of the electrode 26 without having material in the center of the electrode 26). Furthermore, although a single locking stub 71 is shown and described herein, the electrode 26 can include one or more locking stubs 71, and the locking stub 71 can extend into the first lumen 70 from a portion of the first lumen 70 other than the lower portion of the lumen 70 (e.g., the upper portion of the lumen 70). Thus, the technology of the present disclosure should not be construed as limited to the specific configurations shown and described herein.
[0054] 5A and 5B, the electrode 26 can include a conductive portion 90 and an insulating portion 92. The conductive portion 90 can be configured to allow electricity to pass therethrough (i.e., to ablate or map cardiac tissue) and can face generally outwardly from the basket assembly 71 and toward the cardiac tissue in use. Meanwhile, the insulating portion 92 can be configured to prevent electricity from passing therethrough and help electrically insulate the spine 22 from the electrode 26. In this manner, the insulating portion 92 can prevent a short circuit from forming between the electrode 26 and the spine 22. Alternatively or in addition, the spine 22 can be made from an insulating material or can have an insulating coating or sleeve applied to the spine to electrically insulate the electrode 26 from the spine 22. As yet another example, an electrically insulating material can be disposed between the electrode 26 and the spine 22 to electrically insulate the electrode 26 from the spine 22.
[0055] As will be appreciated by those skilled in the art, the embodiments described above have been cited by way of example, and the present invention is not limited to what has been specifically shown and described hereinbefore. Rather, the scope of the present invention includes both combinations and subcombinations of the various features hereinbefore described, as well as variations and modifications thereof not disclosed in the prior art that will occur to those skilled in the art upon reading the above description.
[0056] In some examples, the disclosed devices (e.g., spines, basket assemblies, electrodes, and / or medical probes) and methods may include one or more of the following provisions: Clause 1: An expandable spine comprising: an expandable spine including a connecting portion including a first slit facing an interior space formed by the expandable spine when the expandable spine is in an expanded state; a first electrode attached to the expandable spine and disposed at a distal end of the first slit; a second electrode attached to the expandable spine and disposed proximal to the first electrode and at a proximal end of the first slit; and a wire configured to electrically connect the first electrode and the second electrode, the wire configured to be positioned within the first slit when the expandable spine is in a collapsed state and positioned outside the first slit when the expandable spine is in an expanded state such that the wire travels in a straighter path compared to the path of the connecting portion of the first electrode and the second electrode.
[0057] Clause 2: The expandable spine assembly described in clause 1, wherein when the expandable spine is in an expanded state, the arc length of the connecting portion is longer than the length of the wire between the first electrode and the second electrode.
[0058] Clause 3: The expandable spine of clause 1, comprising nitinol, cobalt chrome, stainless steel, titanium, or a combination thereof.
[0059] Clause 4: The expandable spine assembly of clause 1, wherein the expandable spine is configured to curve away from the interior space when in the expanded state.
[0060] Clause 5: The expandable spine assembly described in clause 1, further comprising an electrically insulating jacket disposed between the first and second electrodes and the expandable spine, thereby electrically insulating the first and second electrodes from the expandable spine.
[0061] Clause 6: The expandable spine assembly of clause 5, wherein the electrically insulating jacket has a second slit corresponding to the first slit and comprises polyether etherketone (PEEK), liquid crystal polymer (LCP), or both.
[0062] Clause 7: An expandable spine assembly as described in Clause 1, wherein the first electrode and the second electrode are coupled to the expandable spine, the first electrode and the second electrode each defining a lumen such that the expandable spine extends through the respective lumen.
[0063] Clause 8: The expandable spine assembly described in clause 1, wherein the first electrode and the second electrode are configured to deliver an electrical pulse for irreversible electroporation, the electrical pulse having a peak voltage of at least 900 volts (V).
[0064] Clause 9: An expandable basket assembly comprising: a plurality of spines extending along a longitudinal axis and configured to bend radially outward from the longitudinal axis when the expandable basket assembly transitions from a collapsed configuration to an expanded configuration; a plurality of electrode pairs, each electrode pair of the plurality of electrode pairs being attached to one of the plurality of spines; a plurality of slits facing an interior space formed by the expandable basket assembly when the expandable basket assembly is in the expanded configuration; and a plurality of wires configured to electrically connect the plurality of electrode pairs, the plurality of wires being positioned within the plurality of slits when the expandable basket assembly is in a collapsed state and configured to be positioned outside the plurality of slits such that the plurality of wires move in a straighter path compared to the path of the plurality of spines connecting the plurality of electrode pairs.
[0065] Clause 10: An expandable basket assembly as described in Clause 9, wherein at least one of the plurality of spines comprises a connection portion arranged between a pair of electrodes of the plurality of electrode pairs, the connection portion comprising a slit configured to receive one of the plurality of wires when the expandable basket assembly is in a folded state.
[0066] Clause 11: The expandable basket assembly described in clause 10, wherein the arc length of the connecting portion is greater than the length of the wire when the expandable basket assembly is in the expanded configuration.
[0067] Clause 12: The expandable basket assembly described in clause 9, wherein at least one spine of the plurality of spines comprises nitinol, cobalt chromium, stainless steel, titanium, or a combination thereof.
[0068] Clause 13: An expandable basket assembly as described in clause 9, wherein the plurality of spines form a generally spherical or generally oblate spheroid shape.
[0069] Clause 14: An expandable basket assembly as described in clause 9, wherein a plurality of electrode pairs are coupled to respective spines of the plurality of spines, each defining a lumen such that each spine extends through the lumen.
[0070] Clause 15: An expandable basket assembly as described in Clause 9, wherein the multiple electrode pairs are configured to deliver an electrical pulse for irreversible electroporation, the electrical pulse having a peak voltage of at least 900 volts (V).
[0071] Clause 16: An expandable spine assembly comprising: an expandable spine having a connecting portion; a first electrode attached to the expandable spine at a distal end of the connecting portion; a second electrode attached to the expandable spine and positioned proximal to the first electrode and at the proximal end of the connecting portion; and a wire configured to electrically connect centers of the first electrode and the second electrode, positioned separate from the connecting portion and positioned within an internal space formed by the expandable spine in an expanded state.
[0072] Clause 17: The expandable spine assembly described in clause 16, wherein when the expandable spine is in an expanded state, the arc length of the connecting portion is longer than the length of the wire between the first electrode and the second electrode.
[0073] Clause 18: The expandable spine assembly of clause 16, comprising nitinol, cobalt chrome, stainless steel, titanium, or a combination thereof.
[0074] Clause 19: The expandable spine assembly of clause 16, wherein the expandable spine is configured to curve away from the interior space when in an expanded state.
[0075] Clause 20: An expandable spine assembly as described in Clause 16, wherein the first electrode and the second electrode are coupled to the expandable spine, the first electrode and the second electrode each defining a lumen such that the expandable spine extends through the lumen.
[0076] [Embodiment] (1) An expandable spine assembly, comprising: an expandable spine, comprising a connecting portion including a first slit facing an internal space formed by the expandable spine when the expandable spine is in an expanded state; a first electrode attached to the expandable spine and disposed at a distal end of the first slit; a second electrode attached to the expandable spine and disposed proximal to the first electrode and at a proximal end of the first slit; and a wire configured to electrically connect the first electrode and the second electrode, the wire being configured to be positioned within the first slit when the expandable spine is in a collapsed state and to be positioned outside the first slit when the expandable spine is in an expanded state such that the wire travels in a straighter path compared to a path of the connection portion of the first electrode and the second electrode. (2) The expandable spine assembly of embodiment 1, wherein when the expandable spine is in the expanded state, the arc length of the connecting portion is longer than the length of the wire between the first electrode and the second electrode. (3) The expandable spine of embodiment 1, comprising nitinol, cobalt chrome, stainless steel, titanium, or a combination thereof. (4) The expandable spine assembly of embodiment 1, wherein the expandable spine is configured to curve away from the interior space when in the expanded state. (5) The expandable spine assembly of embodiment 1, further comprising an electrically insulating jacket disposed between the first and second electrodes and the expandable spine, thereby electrically insulating the first and second electrodes from the expandable spine.
[0077] (6) The expandable spine assembly of claim 5, wherein the electrically insulating jacket has a second slit corresponding to the first slit and comprises polyether keytone (PEEK), liquid crystal polymer (LCP), or both. (7) The expandable spine assembly of embodiment 1, wherein the first electrode and the second electrode are coupled to the expandable spine, and the first electrode and the second electrode each define a lumen, whereby the expandable spine extends through the respective lumen. (8) The expandable spine assembly of embodiment 1, wherein the first electrode and the second electrode are configured to deliver an electrical pulse for irreversible electroporation, the electrical pulse having a peak voltage of at least 900 volts (V). (9) An expandable basket assembly comprising: a plurality of spines extending along a longitudinal axis and configured to bend radially outward from the longitudinal axis when the expandable basket assembly transitions from a collapsed configuration to an expanded configuration; a plurality of electrode pairs, each electrode pair of the plurality of electrode pairs attached to one spine of the plurality of spines; a plurality of slits facing an interior space defined by the expandable basket assembly when the expandable basket assembly is in the expanded configuration; an expandable basket assembly comprising: a plurality of wires configured to electrically connect the plurality of electrode pairs, the plurality of wires being configured to be positioned within the plurality of slits when the expandable basket assembly is in a collapsed state and to be positioned outside the plurality of slits such that the plurality of wires travel in a straighter path compared to the path of the plurality of spines connecting the plurality of electrode pairs. (10) The expandable basket assembly of embodiment 9, wherein at least one of the plurality of spines comprises a connection portion disposed between one pair of electrodes of the plurality of electrode pairs, the connection portion comprising a slit configured to receive one of the plurality of wires when the expandable basket assembly is in a folded state.
[0078] (11) The expandable basket assembly of embodiment 10, wherein the arc length of the connecting portion is greater than the length of the wire when the expandable basket assembly is in the expanded configuration. (12) The expandable basket assembly of embodiment 9, wherein at least one spine of the plurality of spines comprises nitinol, cobalt chromium, stainless steel, titanium, or a combination thereof. (13) The expandable basket assembly of embodiment 9, wherein the plurality of spines form a generally spherical or generally oblate spheroid shape. (14) The expandable basket assembly of embodiment 9, wherein the plurality of electrode pairs are coupled to respective spines of the plurality of spines, each defining a lumen, whereby the respective spines extend through the lumen. (15) The expandable basket assembly of embodiment 9, wherein the plurality of electrode pairs are configured to deliver an electrical pulse for irreversible electroporation, the electrical pulse having a peak voltage of at least 900 volts (V).
[0079] (16) An expandable spine assembly, comprising: an expandable spine having a connection portion; a first electrode attached to the expandable spine at a distal end of the connecting portion; a second electrode attached to the expandable spine and disposed proximal to the first electrode and at a proximal end of the connecting portion; a wire configured to electrically connect a center of the first electrode and the second electrode, the wire being disposed away from the connection portion and disposed within an interior space formed by the expandable spine in an expanded state. (17) The expandable spine assembly of embodiment 16, wherein when the expandable spine is in the expanded state, the arc length of the connecting portion is longer than the length of the wire between the first electrode and the second electrode. (18) The expandable spine assembly of embodiment 16, comprising nitinol, cobalt chrome, stainless steel, titanium, or a combination thereof. (19) The expandable spine assembly of embodiment 16, wherein the expandable spine is configured to curve away from the interior space when in the expanded state. (20) The expandable spine assembly of embodiment 16, wherein the first electrode and the second electrode are coupled to the expandable spine, and the first electrode and the second electrode each define a lumen, whereby the expandable spine extends through the lumen.
Claims
1. 1. An expandable spine assembly, comprising: an expandable spine, comprising a connecting portion including a first slit facing an internal space formed by the expandable spine when the expandable spine is in an expanded state; a first electrode attached to the expandable spine and disposed at a distal end of the first slit; a second electrode attached to the expandable spine and disposed proximal to the first electrode and at a proximal end of the first slit; and a wire configured to electrically connect the first electrode and the second electrode, the wire being configured to be positioned within the first slit when the expandable spine is in a collapsed state and to be positioned outside the first slit when the expandable spine is in an expanded state such that the wire travels in a straighter path compared to a path of the connection portion of the first electrode and the second electrode.
2. 2. The expandable spine assembly of claim 1, wherein when the expandable spine is in the expanded state, an arc length of the connecting portion is longer than a length of the wire between the first electrode and the second electrode.
3. 10. The expandable spine of claim 1, comprising nitinol, cobalt chrome, stainless steel, titanium, or combinations thereof.
4. The expandable spine assembly of claim 1 , wherein the expandable spine is configured to curve away from the interior space when in the expanded state.
5. 10. The expandable spine assembly of claim 1, further comprising an electrically insulating jacket disposed between the first and second electrodes and the expandable spine, thereby electrically insulating the first and second electrodes from the expandable spine.
6. 6. The expandable spine assembly of claim 5, wherein the electrically insulating jacket comprises a second slit corresponding to the first slit and comprises polyetherketone (PEEK), liquid crystal polymer (LCP), or both.
7. 2. The expandable spine assembly of claim 1, wherein the first electrode and the second electrode are coupled to the expandable spine, the first electrode and the second electrode each defining a lumen, whereby the expandable spine extends through the respective lumen.
8. 2. The expandable spine assembly of claim 1, wherein the first electrode and the second electrode are configured to deliver an electrical pulse for irreversible electroporation, the electrical pulse having a peak voltage of at least 900 volts (V).
9. 1. An expandable basket assembly comprising: a plurality of spines extending along a longitudinal axis and configured to bend radially outward from the longitudinal axis when the expandable basket assembly transitions from a collapsed configuration to an expanded configuration; a plurality of electrode pairs, each electrode pair of the plurality of electrode pairs attached to one spine of the plurality of spines; a plurality of slits facing an interior space defined by the expandable basket assembly when the expandable basket assembly is in the expanded configuration; an expandable basket assembly comprising: a plurality of wires configured to electrically connect the plurality of electrode pairs, the plurality of wires being configured to be positioned within the plurality of slits when the expandable basket assembly is in a collapsed state and to be positioned outside the plurality of slits such that the plurality of wires travel in a straighter path compared to the path of the plurality of spines connecting the plurality of electrode pairs.
10. 10. The expandable basket assembly of claim 9, wherein at least one of the plurality of spines comprises a connection portion disposed between a pair of electrodes of the plurality of electrode pairs, the connection portion comprising a slit configured to receive one of the plurality of wires when the expandable basket assembly is in a folded state.
11. The expandable basket assembly of claim 10, wherein an arc length of the connecting portion is greater than a length of the wire when the expandable basket assembly is in the expanded configuration.
12. The expandable basket assembly of claim 9 , wherein at least one spine of the plurality of spines comprises nitinol, cobalt chrome, stainless steel, titanium, or a combination thereof.
13. The expandable basket assembly of claim 9 , wherein the plurality of spines form a generally spherical or generally oblate spheroid shape.
14. The expandable basket assembly of claim 9, wherein the plurality of electrode pairs are coupled to respective spines of the plurality of spines, each defining a lumen, whereby the respective spine extends through the lumen.
15. The expandable basket assembly of claim 9, wherein the plurality of electrode pairs are configured to deliver an electrical pulse for irreversible electroporation, the electrical pulse having a peak voltage of at least 900 volts (V).
16. 1. An expandable spine assembly, comprising: an expandable spine having a connection portion; a first electrode attached to the expandable spine at a distal end of the connecting portion; a second electrode attached to the expandable spine and disposed proximal to the first electrode and at a proximal end of the connecting portion; a wire configured to electrically connect a center of the first electrode and the second electrode, the wire being disposed away from the connecting portion and disposed within an interior space formed by the expandable spine in an expanded state.
17. 17. The expandable spine assembly of claim 16, wherein an arc length of the connecting portion is greater than a length of the wire between the first electrode and the second electrode when the expandable spine is in the expanded state.
18. 17. The expandable spine assembly of claim 16, comprising nitinol, cobalt chrome, stainless steel, titanium, or combinations thereof.
19. The expandable spine assembly of claim 16 , wherein the expandable spine is configured to curve away from the interior space when in the expanded state.
20. 17. The expandable spine assembly of claim 16, wherein the first electrode and the second electrode are coupled to the expandable spine, the first electrode and the second electrode each defining a lumen, whereby the expandable spine extends through the lumen.
