CN118924414A - Multi-piece basket catheter including hinge - Google Patents

Abstract

The disclosed technology includes a medical probe including a tubular shaft and an expandable basket assembly, the tubular shaft including a proximal end and a distal end, the expandable basket assembly being coupled to the distal end of the tubular shaft. The basket assembly may include: a first plurality of spines coupled to the distal end of the tubular shaft; and a second plurality of spines, each of the second plurality of spines being rotatably coupled to a corresponding spine of the first plurality of spines. The basket assembly may include a plurality of electrodes attached to at least the second plurality of spines and a push rod connected to the distal end of the second plurality of spines. The push rod may be configured to slide longitudinally between a proximal position and a distal position to transition the expandable basket assembly between an expanded configuration and a collapsed configuration.

Description

Multi-piece basket catheter including hinge

Cross-reference to related patent applications

The present application is based on the priority and benefit of U.S. patent application Ser. No.63/501,183 (attorney docket number: BIO6834USPSP 1-253757.000373), filed on 5/10/2023, as claimed in 35 U.S. C. ≡119 (e), the entire contents of which are incorporated herein by reference.

Technical Field

The present invention relates generally to medical devices, and more particularly to basket catheters configured to transition between a collapsed configuration and an expanded configuration.

Background

Arrhythmia, such as Atrial Fibrillation (AF), may occur when areas of heart tissue abnormally conduct electrical signals to adjacent tissue. This can disrupt the normal cardiac cycle and lead to arrhythmia. Certain protocols are used to treat cardiac arrhythmias, including surgically disturbing the source of the signals responsible for the arrhythmia and disturbing the conduction pathways for such signals. By selectively ablating cardiac tissue by applying energy through the catheter, it is sometimes possible to stop or alter the propagation of unwanted electrical signals from one portion of the heart to another. Medical probes may utilize Radio Frequency (RF) electrical energy to heat tissue. Some ablation methods use irreversible electroporation (IRE) to ablate cardiac tissue using non-thermal ablation methods.

Areas of cardiac tissue may be mapped through the catheter to identify abnormal electrical signals. Ablation may be performed using the same or different catheters. Some example catheters include a plurality of ridges on which electrodes are disposed. The electrodes are typically attached to the ridges and secured in place by brazing, welding, or using an adhesive. Further, the plurality of linear ridges are typically assembled together by attaching the ends of the linear ridges to a tubular shaft (e.g., a pusher tube) to form a spherical basket. Some basket catheters can occupy a significant amount of space and are difficult to insert through an insertion catheter. Furthermore, due to the configuration of the basket, the ridge may break when manipulated or inserted or retracted through the sheath. Accordingly, there is a need in the art for alternative designs of basket catheters that help reduce the likelihood of ridge fracture. This and other problems are addressed by the techniques disclosed herein.

Disclosure of Invention

The disclosed technology includes a medical probe including a tubular shaft including a proximal end and a distal end, and an expandable basket assembly coupled to the distal end of the tubular shaft. The basket assembly may include: a first plurality of ridges coupled to the distal end of the tubular shaft; and a second plurality of ridges, each ridge of the second plurality of ridges rotatably coupled to a respective ridge of the first plurality of ridges. The basket assembly may include a plurality of electrodes attached to at least the second plurality of ridges and a pushrod connected to a distal end of the second plurality of ridges. The push rod may be configured to longitudinally slide between a proximal position and a distal position to transition the expandable basket assembly between an expanded configuration and a collapsed configuration.

The disclosed technology includes a medical probe including a tubular shaft including a proximal end and a distal end. The tubular shaft may extend along a longitudinal axis. The medical probe may include an expandable basket assembly coupled to the distal end of the tubular shaft. The basket assembly may include: a first plurality of ridges coupled to the distal end of the tubular shaft; and a second plurality of ridges. Each ridge of the second plurality of ridges may be rotatably coupled to a respective ridge of the first plurality of ridges. The second plurality of ridges may be biased to flex distally relative to the first plurality of ridges to transition the expandable basket assembly to an expanded configuration.

The disclosed technology may include a method of constructing a medical probe. The method may include attaching a first plurality of ridges to the tubular shaft. The tubular shaft may extend along a longitudinal axis. The method may further include attaching a second plurality of ridges to the distal ends of the first plurality of ridges. The second plurality of ridges may be rotatably attached to the first plurality of ridges. The first plurality of ridges and the second plurality of ridges may form an expandable basket assembly. The method may further include attaching a distal end of the second plurality of ridges to a pushrod. The push rod may be configured to longitudinally slide between a proximal position and a distal position to transition the expandable basket assembly between an expanded configuration and a collapsed configuration. The method may include attaching a plurality of electrodes to at least the second plurality of ridges.

The disclosed technology may include a medical probe including a tubular shaft including a proximal end and a distal end. The tubular shaft may extend along a longitudinal axis. The medical probe may include an expandable basket assembly coupled to the distal end of the tubular shaft. The basket assembly may include: a first plurality of ridges coupled to the distal end of the tubular shaft and including a hook member; and a second plurality of ridges. Each ridge of the second plurality of ridges includes a hole and is rotatably coupled to a corresponding ridge of the first plurality of ridges. The basket assembly may include a plurality of electrodes attached to at least the second plurality of ridges. The medical probe may also include a pushrod connected to a distal end of the second plurality of ridges. The push rod may be configured to longitudinally slide between a proximal position and a distal position to transition the expandable basket assembly between an expanded configuration and a collapsed configuration.

Drawings

FIG. 1 is a schematic illustration of a medical system including a medical probe having a distal end with basket assemblies with electrodes coupled together in accordance with an embodiment of the disclosed technology;

FIG. 2A is a perspective view of an expandable basket assembly in an expanded configuration in accordance with the disclosed technology;

FIG. 2B is a detailed view of the hinge of the expandable basket assembly of FIG. 2A in an assembled configuration in accordance with the disclosed technology;

FIG. 2C is a detailed view of a hinge of an expandable basket assembly in a disassembled configuration in accordance with the disclosed technology;

FIG. 2D is a perspective view of an expandable basket assembly in a semi-collapsed configuration in accordance with the disclosed technology;

FIG. 2E is a detailed view of the hinge of the expandable basket assembly of FIG. 2D in an assembled configuration in accordance with the disclosed technology;

FIG. 2F is a side view of an expandable basket assembly in a collapsed configuration in accordance with the disclosed technology;

FIG. 3A is another perspective view of an expandable basket assembly in an expanded configuration in accordance with the disclosed technology;

FIG. 3B is another perspective view of an expandable basket assembly in a semi-collapsed configuration in accordance with the disclosed technology;

FIG. 4A is an exploded view of the spine and pins of an expandable basket assembly according to the disclosed technology;

FIG. 4B is another exploded view of the ridges of the expandable basket assembly with one ridge having a protrusion in accordance with the disclosed technology;

FIG. 5A is an exploded view of the spine and hinge members of an expandable basket assembly in accordance with the disclosed technology;

FIG. 5B is another exploded view of the spine and hinge members of the expandable basket assembly in accordance with the disclosed technology;

FIG. 6A is a perspective view of another example of a spine of an expandable basket assembly in accordance with the disclosed technology;

FIG. 6B is a side view of another example of a spine of an expandable basket assembly in accordance with the disclosed technology;

FIG. 6C is an exploded view of another example of a spine of an expandable basket assembly in accordance with the disclosed technology;

FIG. 7A is another perspective view of an expandable basket assembly in an expanded configuration in accordance with the disclosed technology;

FIG. 7B is another perspective view of an expandable basket assembly in a semi-collapsed configuration in accordance with the disclosed technology; and

FIG. 8 is a flow chart of a method of assembling an expandable basket assembly in accordance with the disclosed technology.

Detailed Description

The following detailed description should be read with reference to the drawings, in which like elements in different drawings are numbered identically. The drawings, which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of the invention. The detailed description illustrates by way of example, and not by way of limitation, the principles of the invention. This description will clearly enable one skilled in the art to make and use the invention, and describes several embodiments, adaptations, variations, alternatives and uses of the invention, including what is presently believed to be the best mode of carrying out the invention.

As used herein, the term "about" or "approximately" for any numerical value or range indicates a suitable dimensional tolerance that allows a collection of parts or components to achieve the intended purpose thereof as described herein. More specifically, "about" or "approximately" may refer to a range of values of ±20% of the recited values, for example "about 90%" may refer to a range of values of 71% to 110%.

As used herein, the terms "patient," "subject," "user," and "subject" refer to any human or animal subject, and are not intended to limit the system or method to human use, but use of the subject invention in a human patient represents a preferred embodiment. Furthermore, the vasculature of a "patient," "subject," "user," and "subject" may be that of a human or any animal. It should be understood that the animal may be of any suitable type including, but not limited to, a mammal, a veterinary animal, a livestock animal or a companion animal, and the like. For example, the animal may be a laboratory animal (e.g., rat, dog, pig, monkey, etc.) specifically selected to have certain characteristics similar to humans. It should be appreciated that the subject may be, for example, any suitable human patient. Likewise, the term "proximal" refers to a location closer to an operator or physician, while "distal" refers to a location further from the operator or physician.

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

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), interchangeably referred to in the present disclosure as Pulsed Electric Field (PEF) and Pulsed Field Ablation (PFA). "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, arrhythmia, atrial flutter ablation, pulmonary vein isolation, supraventricular tachycardia ablation, and ventricular tachycardia ablation. The term "ablation" also includes known methods, devices and systems for effecting various forms of ablation of body tissue as understood by those skilled in the relevant art.

As discussed herein, the terms "bipolar" and "monopolar" when used in reference to an ablation scheme describe an ablation scheme that differs in terms of current path and electric field distribution. "bipolar" refers to an ablation protocol that utilizes a current path between two electrodes, both of which are positioned at a treatment site; the current density and the current flux density at each of the two electrodes are typically approximately equal. "monopolar" refers to an ablation procedure utilizing a current path between two electrodes, wherein one electrode comprising a high current density and a high electrical flux density is positioned at the treatment site and a second electrode comprising a relatively lower current density and a lower electrical flux density is positioned away from the treatment site.

As discussed herein, the terms "biphasic pulse" and "monophasic pulse" refer to the corresponding electrical signals. A "biphasic pulse" refers to an electrical signal comprising a positive voltage phase pulse (referred to herein as a "positive phase") and a negative voltage phase pulse (referred to herein as a "negative phase"). "monophasic pulse" refers to an electrical signal that includes only a positive or negative phase. Preferably, the system providing biphasic pulses 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. Voltage amplitudes of biphasic and/or monophasic pulses are described herein, it being understood that the expressed voltage amplitudes are absolute values of the approximate peak amplitudes 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 that includes a substantially constant voltage amplitude during most of the phase's duration. The phases of the biphasic pulse are separated in time by an inter-phase delay. The inter-phase delay duration is preferably less than or approximately equal to the duration of the phase of the biphasic pulse. The inter-phase delay duration is more preferably about 25% of the duration of the phase of the biphasic pulse.

As discussed herein, the terms "tubular" and "tube" are to be understood in a broad sense and are not limited to structures that are right circular cylinders or that are entirely circumferential in cross-section or have a uniform cross-section throughout their length. For example, while the tubular structure may be generally illustrated as a substantially right cylindrical structure, the tubular structure may have a tapered or curved outer surface without departing from the scope of the present disclosure.

As used herein, the term "temperature rating" is defined as the maximum continuous temperature that a component can withstand during its lifetime without causing thermal damage such as melting or thermal degradation (e.g., charring and chipping) of the component.

The exemplary systems, methods, and devices of the present invention may be particularly useful for IRE ablation of cardiac tissue to treat cardiac arrhythmias. Ablation energy is typically provided to the heart tissue by electrodes that can deliver ablation energy along the tissue to be ablated. Fluoroscopy may be used to visualize the ablation procedure in combination with such exemplary catheters.

Cardiac tissue ablation using thermal techniques such as Radio Frequency (RF) energy and cryoablation to correct for a malfunctioning heart is a well-known procedure. Typically, for successful ablation using thermal techniques, the cardiac electrode potentials need to be measured at various locations in the myocardium. Furthermore, temperature measurements during ablation provide data that enables ablation efficacy. Typically, for ablation protocols using thermal ablation, electrode potential and temperature are measured before, during, and after the actual ablation.

IRE as discussed in this disclosure is a non-thermal cell death technique that may be used for atrial arrhythmia ablation. To ablate using IRE/PEF, biphasic voltage pulses are applied to disrupt the cellular structure of the myocardium. The biphasic pulse is non-sinusoidal and can be tuned to target cells based on the electrophysiology of the cells. In contrast, to ablate using RF, a sinusoidal voltage waveform is applied to generate heat at the treatment region, heating all cells indiscriminately in the treatment region. Thus, IRE has the ability to avoid adjacent heat sensitive structures or tissue, which would be beneficial in reducing the possible complications known to be affected by ablation or separation modalities. In addition or alternatively, monophasic pulses may be used.

Electroporation can be induced by applying a pulsed electric field across the biological cells to cause reversible (temporary) or irreversible (permanent) creation of pores in the cell membrane. Upon application of a pulsed electric field, the cell has a transmembrane electrostatic potential that rises above the static potential. Electroporation is reversible when the transmembrane electrostatic potential remains below the threshold potential, meaning that the pores can close when the applied pulsed electric field is removed and the cells can repair and survive themselves. If the transmembrane electrostatic potential rises above the threshold potential, electroporation is irreversible and the cell becomes permanently permeable. Thus, cells die from a loss of homeostasis, typically from programmed cell death or apoptosis, which is believed to leave less scar tissue than other modes of ablation. Typically, different types of cells have different threshold potentials. For example, cardiac cells have a threshold potential of about 500V/cm, whereas for bone, the threshold potential is 3000V/cm. These differences in threshold potential allow IRE to selectively target tissue based on the threshold potential.

The manufacture and construction of IRE-enabled medical probes as discussed above will now be discussed. The solution of the present disclosure includes a system and method for constructing a basket assembly. By coupling the plurality of spine struts together to form a plurality of hinges, the basket assembly may be configured to transition between an expanded configuration and a collapsed configuration. Further, the hinge enables the basket assembly to form a more compact shape when in the collapsed configuration. In addition, the hinge reduces stress concentrations that may be present in the spine, thereby reducing the likelihood that the spine may fracture when bent.

Referring to fig. 1, an exemplary catheter-based electrophysiology mapping and ablation system 10 is shown. The system 10 includes a plurality of catheters that are percutaneously inserted by a physician 24 into a chamber or vascular structure of the heart 12 through the vascular system of a patient 23. Typically, the delivery sheath catheter is inserted into the left atrium or the right atrium near the desired location in the heart 12. A plurality of catheters may then be inserted into the delivery sheath catheter in order to reach the desired location. The plurality of catheters may include catheters dedicated to sensing Intracardiac Electrogram (IEGM) signals, catheters dedicated to ablation, and/or catheters dedicated to both sensing and ablation. An exemplary catheter 14 configured for sensing IEGM is shown herein. The physician 24 brings the distal tip 28 of the catheter 14 into contact with the heart wall for sensing a target site in the heart 12. For ablation, the physician 24 would similarly bring the distal end of the ablation catheter to the target site for ablation.

The catheter 14 is an exemplary catheter that includes one and preferably a plurality of electrodes 26 optionally distributed over a plurality of ridges 22 at a distal tip 28 (also referred to herein as "basket assemblies" or "expandable basket assemblies") and configured to sense IEGM signals. Catheter 14 may additionally include a position sensor 29 embedded in or near distal tip 28 for tracking the position and orientation of distal tip 28. Optionally and preferably, the positioning sensor 29 is a magnetic-based positioning sensor comprising three magnetic coils for sensing three-dimensional (3D) positioning and orientation.

The magnetic-based position sensor 29 is operable with a placemat 25 that includes a plurality of magnetic coils 32 configured to generate a magnetic field in a predetermined workspace. The real-time position of the distal tip 28 of the catheter 14 may be tracked based on the magnetic field generated with the location pad 25 and sensed by the magnetic-based position sensor 29. Details of magnetic-based position sensing techniques are described in U.S. Pat. nos. 5,391,199, 5,443,489, 5,558,091, 6,172,499, 6,239,724, 6,332,089, 6,484,118, 6,618,612, 6,690,963, 6,788,967, and 6,892,091, each of which is incorporated herein by reference as if fully set forth herein and included in the appendices appended hereto.

The system 10 includes one or more electrode patches 38 that are positioned in contact with the skin of the patient 23 to establish a positional reference for impedance-based tracking of the placemat 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 location tracking techniques are described in U.S. patent nos. 7,536,218, 7,756,576, 7,848,787, 7,869,865, and 8,456,182, each of which is incorporated by reference as if fully set forth herein and included in the appendices attached hereto.

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

The system 10 may include an ablation energy generator 50 adapted to conduct ablation energy to one or more electrodes at a distal tip of a catheter configured for ablation. The energy generated by ablation energy generator 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.

The Patient Interface Unit (PIU) 30 is an interface configured to establish electrical communication between a catheter, electrophysiological equipment, a power source, and a workstation 55 for controlling operation of the system 10. The electrophysiological equipment of system 10 can include, for example, a plurality of catheters, location pads 25, body surface ECG electrodes 18, electrode patches 38, an ablation energy generator 50, and a recorder 11. Optionally and preferably, the PIU 30 additionally includes processing power for enabling real-time calculation of the position of the catheter and for performing ECG calculations.

The workstation 55 includes memory, a processor unit with memory or storage loaded with appropriate operating software, and user interface capabilities. Workstation 55 may provide a number of functions, including optionally: (1) Three-dimensional (3D) modeling of endocardial anatomy and rendering of the model or anatomical map 20 for display on display device 27; (2) Displaying the activation sequence (or other data) compiled from the recorded electrogram 21 on a display device 27 with a representative visual marker or image superimposed on the rendered anatomic map 20; (3) Displaying real-time positions and orientations of a plurality of catheters within a heart chamber; and (4) displaying the site of interest (such as where ablation energy has been applied) on a display device 27. A commercial product embodying elements of system 10 is available from Biosense Webster, inc.,31 Technology Drive,Suite 200,Irvine,CA 92618,USA as the CARTO ^TM system.

Fig. 2A is a perspective view of an expandable basket assembly 28 in an expanded configuration in accordance with the disclosed technology. As shown in fig. 2A, the basket assembly 28 may include a plurality of ridges 22A, 22B that curve radially outward from the longitudinal axis 86 when in the expanded configuration. The plurality of ridges 22A, 22B may further include a plurality of electrodes 26 disposed thereon, which may be configured to map electrophysiological signals and/or ablate tissue.

The ridges 22A, 22B may include a first plurality of ridges 22A that may be attached to the distal end of the tubular shaft 84, and a second plurality of ridges 22B that may be rotatably attached to the first plurality of ridges 22A by a plurality of hinges 220. In this manner, the second plurality of ridges 22B may be configured to rotate relative to the first plurality of ridges 22A, thereby facilitating transition between the expanded configuration and the collapsed configuration. In other words, the first ridge 22A may form a proximal portion of the basket assembly 28 and the second ridge 22B may form a distal portion of the basket assembly 28, and the second ridge 22B may rotate outwardly and inwardly relative to the first ridge 22A such that the distal portion of the basket assembly 28 may move relative to the proximal portion.

The basket assembly 28 may also include a pushrod 250 that may be attached to the spine intersection 210 disposed at the distal end of the second plurality of spines 22B. The push rod 250 may be configured to slide along the longitudinal axis 86 to transition the basket assembly 28 between the collapsed configuration and the expanded configuration. Ridge intersections 210 may form atraumatic tips to prevent damage to tissue. Further, the ridge intersections 210 may connect each of the second plurality of ridges 22B to one another to form an integral assembly. In some examples, the ridge intersections 210 and the second plurality of ridges 22B may be a single piece of continuous material, such as nitinol, cobalt chrome, stainless steel, titanium, or another resilient biocompatible material such as a polymeric material. Similarly, the first plurality of ridges 22A may be made of nitinol, cobalt chromium, stainless steel, titanium, or another resilient biocompatible material such as a polymeric material. The first plurality of ridges 22A and the second plurality of ridges 22B may be configured to form a basket assembly 28 that is approximately spherical or approximately oblate spheroid in shape.

Electrode 26 may be any type of electrode configured as an electrode suitable for sensing electrophysiological signals, ablation, position sensing, reference electrode, and the like, including but not limited to. The electrode 26 may be a ring electrode, a protrusion electrode, a rectangular electrode, a circular electrode, or the like. Furthermore, electrode 900 may be configured to deliver an electrical pulse for irreversible electroporation, the pulse having a peak voltage of at least 900 volts (V).

As shown in fig. 2B and 2C, the hinge 220 may include a protrusion 222 that may extend through a hole 224. As shown in fig. 2B and 2C, the protrusion 222 may extend outwardly from the second ridge 22B, and the aperture 224 may extend through the first ridge 22A. Alternatively, the protrusion 222 may extend outwardly from the first ridge 22A and the aperture 224 may extend through the second ridge 22B. The protrusions 222 may be configured to form a snap fit with the holes 224 when assembled together, thereby securing the first ridge 22A to the second ridge 22B, but allowing the second ridge 22B to rotate relative to the first ridge 22A. The protrusion 222 may have a smooth or rounded edge and be configured to be substantially flush with the outward facing surface of the first ridge 22A to reduce sharp edges that may damage tissue. Further, as shown in fig. 2C, the first and second ridges 22A, 22B may each have rounded ends 228 to reduce the likelihood of the basket assembly 28 damaging tissue and to reduce the likelihood of the hinge 220 being tethered or otherwise unable to rotate.

Fig. 2D is a perspective view of an expandable basket assembly 28 in a semi-collapsed configuration in accordance with the disclosed technology. As shown in fig. 2D and 2E, the second ridge 22B may rotate and at least partially nest in the portion of the basket assembly 28 formed by the first ridge 22A. For example, when push rod 250 is pulled proximally, ridge intersection 210 and second ridge 22B will be pulled inwardly into basket assembly 28 and eventually nest in first ridge 22A. For example, the basket assembly 28 may be collapsed when the physician 24 retracts the basket assembly 28 into the insertion sheath 260 to remove the basket assembly 28 from the patient 23. Fig. 2F shows basket assembly 28 retracted or otherwise positioned within insertion sheath 260. As shown, the second ridges 22B may nest in the first ridges 22A or between the first ridges 22A when the basket assembly 28 is in the collapsed configuration.

Fig. 3A and 3B illustrate another expandable basket assembly 328 in an expanded configuration (fig. 3A) and in a collapsed configuration (fig. 3B) in accordance with the disclosed technology. Basket assembly 328 may include all of the same features as basket assembly 28, except that basket assembly 328 does not include ridge intersection 210. Instead, the distal end of the second ridge 22B of the basket assembly 328 is directly attached to the push rod 250. Depending on how the second ridge 22B is attached to the push rod 250, the ridge 22B may naturally be biased outward to help expand the basket assembly 328 to the expanded state when the push rod 250 is pushed distally. In some examples, the second ridge 22B may be coated or otherwise covered in a polymeric material to help form an atraumatic tip. For example, the distal end of the second ridge 22B may be immersed in a polymeric material, which helps prevent the second ridge 22B from damaging tissue.

Fig. 4A is an exploded view of the first ridge 22A, the second ridge 22B, and the pin 426 of the expandable basket assembly 28 in accordance with the disclosed technology. As shown, the first and second ridges 22A, 22B may be attached to one another with a pin 426 that may be inserted into a first hole 424A on the first ridge 22A and a second hole 424B on the second ridge 22B. The pin 426 may be configured to form a snap fit with the first and second holes 424A, 424B to attach the first ridge 22A to the second ridge 22B.

Fig. 4B is another exploded view of the first and second ridges 22A, 22B of the expandable basket assembly 28 in accordance with the disclosed technology. As described above, another method of attaching the first ridge 22A to the second ridge 22B is to extend the tab 422 through the aperture 424. The protrusion 422 may be on the first ridge 22A and the aperture 424 may be on the second ridge 22B. Alternatively, the protrusion 422 may be on the second ridge 22B and the aperture 424 may be on the first ridge 22A. The tab 424 may be configured to form a snap fit with the aperture 424, thereby securing the first ridge 22A to the second ridge 22B, but allowing the second ridge 22B to rotate relative to the first ridge 22A. In other examples, the tab 422 may be inserted into the hole 424, and then the end of the tab 422 may be bent or otherwise enlarged to prevent the tab 422 from being pulled out of the hole 424.

Fig. 5A and 5B are exploded views of a first ridge 22A, a second ridge 22B, and a hinge member 540 in accordance with the disclosed technology. By having the hinge member 540, the basket assembly 28 may allow a greater degree of movement of the second ridge 22B relative to the first ridge 22A. This may help facilitate easier transition between the collapsed and expanded configurations.

As shown in fig. 5A, the first ridge 22A and the second ridge 22B may each have holes 424A, 424B, and a hinge member 540 may be positioned between the first ridge 22A and the second ridge 22B. Hinge member 540 may have a first projection 542A positioned closer to the proximal side than a second projection 542B. Similar to the example described above, the first projection 542A may be configured to extend through the first aperture 424 to connect the first spine 22A to the hinge member 540, and the second projection 542B may be configured to extend through the second aperture 424A to connect the hinge member 540 to the second spine 22B. As previously described, the projections 542A, 542B may be configured to form a snap fit with the holes 424A, 424B or otherwise prevent removal from the holes 424A, 424B.

Fig. 5B shows a similar configuration to fig. 5A except that the first and second ridges 22A, 22B each have protrusions 422A, 422B and the hinge member 540 has holes 544A, 544B. As previously described, the protrusions 422A, 422B may be configured to extend at least partially through the apertures 544A, 544B to attach the first and second ridges 22A, 22B to the hinge member 540.

Although not shown, it will be understood by those skilled in the art that the example shown in fig. 5A and 5B may further include holes formed in each of the first ridge 22A, the second ridge 22B, and the hinge member 540, and a pin may extend through each of these holes to connect the first ridge 22A and the second ridge 22B to the hinge member 540.

Fig. 6A, 6B, and 6C illustrate another example of ridges 622A, 622B configured as hinges. For example, the disclosed technique may include a first ridge 622A having a hook member 670 configured to bend through a hole 624 of a second ridge 622B. The hook member 670 may be configured to remain slightly relaxed about the second ridge 622 such that the first ridge 622A may rotate relative to the first ridge 622B. As shown, the hook member 670 may be an end of the first ridge 622A that is bent or otherwise formed into a hook shape that may fit through the hole 624 of the second ridge 622B to rotatably connect the first ridge 622A to the second ridge 622B. It should be appreciated that in other examples, the second ridge 622B may have a hook member 670 and the first ridge 622A may include a hole 624 without departing from the scope of the present disclosure.

Fig. 7A and 7B illustrate another example basket assembly 728 in an expanded configuration (fig. 7A) and in a semi-collapsed configuration (fig. 7B) in accordance with the disclosed techniques. Except that basket assembly 728 does not include push rod 250, basket assembly 728 may include each of the same features described with respect to basket assembly 28. Conversely, at least one of the first and second ridges 22A, 22B may be formed with a bias such that the first and second ridges 22A, 22B are naturally biased to be in an expanded configuration. Thus, as basket assembly 728 is pushed from delivery sheath 260, basket assembly 728 may naturally transition to the expanded configuration. For example, the first ridge 22A, the second ridge 22B, or both may be formed from nitinol, and formed such that the first ridge 22A and/or the second ridge 22B have a natural tendency to expand outwardly to an expanded configuration.

Fig. 8 is a flow chart of a method 800 of assembling an expandable basket assembly in accordance with the disclosed technology. The basket assembly may include all of the same features as the basket assemblies 28, 328, 728 described further herein. The method 800 may include attaching 802A first plurality of ridges (e.g., first ridges 22A) to a tubular shaft (e.g., tubular shaft 84). The method 800 may include attaching 804 a second plurality of ridges (e.g., second ridges 22B) to the first plurality of ridges. Attaching 804 the second plurality of ridges to the first plurality of ridges may comprise any of the attachment methods described herein. Further, although not shown in fig. 8, according to examples shown and described herein, attaching 804 the second plurality of ridges to the first plurality of ridges may include attaching the first plurality of ridges and the second plurality of ridges to a hinge member (e.g., hinge member 540). The method 800 may further include attaching 806 a second plurality of ridges to the pushrod (e.g., pushrod 250) and attaching 808 a plurality of electrodes (e.g., electrode 26) to the first and second plurality of ridges.

As will be appreciated by those of skill in the art, the method 800 may include any of the various features of the disclosed technology described herein and may vary depending on the particular configuration. Thus, the method 800 should not be construed as limited to the particular steps and sequence of steps explicitly described herein. Furthermore, the order of steps provided herein is provided as an example, and steps may be performed in various other orders or include other steps between those set forth above.

The disclosed technology described herein may be further understood in light of the following clauses:

Clause 1: a medical probe, comprising: a tubular shaft including a proximal end and a distal end, the tubular shaft extending along a longitudinal axis; and an expandable basket assembly coupled to the distal end of the tubular shaft, the basket assembly comprising: a first plurality of ridges coupled to the distal end of the tubular shaft; a second plurality of ridges, each ridge of the second plurality of ridges rotatably coupled to a respective ridge of the first plurality of ridges; and a plurality of electrodes attached to at least the second plurality of ridges; and a pushrod connected to a distal end of the second plurality of ridges, the pushrod configured to longitudinally slide between a proximal position and a distal position to transition the expandable basket assembly between an expanded configuration and a collapsed configuration.

Clause 2: the medical probe of clause 1, the first plurality of ridges forming a proximal portion of the expandable basket assembly, and the second plurality of ridges forming a distal portion of the expandable basket assembly.

Clause 3: the medical probe of clause 2, the second plurality of ridges being configured to rotate outwardly relative to the first plurality of ridges to transition to an expanded configuration.

Clause 4: the medical probe of any of clauses 2 or 3, the second plurality of ridges being configured to rotate inwardly relative to the first plurality of ridges such that a distal portion of the expandable basket assembly is at least partially nested within the proximal portion of the expandable basket assembly.

Clause 5: the medical probe of any one of the preceding clauses, the second plurality of ridges being attached to one another to form an integral ridge assembly.

Clause 6: the medical probe of clause 5, the second plurality of ridges comprising a single piece of continuous biocompatible material.

Clause 7: the medical probe of any of the preceding clauses, each ridge of the first plurality of ridges including a first hole extending therethrough at a distal end thereof, each ridge of the second plurality of ridges including a second hole extending therethrough at a proximal end thereof, and further including a plurality of pins, each pin of the plurality of pins configured to extend through a respective first hole and a respective second hole to rotatably couple the first plurality of ridges to the second plurality of ridges.

Clause 8: the medical probe of clause 4, the pin forming a snap fit with the first and second pluralities of ridges to secure the first plurality of ridges to the second plurality of ridges.

Clause 9: the medical probe of any one of clauses 1-6, each ridge of the first plurality of ridges comprising a protrusion, each ridge of the second plurality of ridges comprising a hole extending therethrough configured to receive the protrusion to rotatably couple the first plurality of ridges to the second plurality of ridges.

Clause 10: the medical probe of clause 9, the protrusion forming a snap fit with the aperture to secure the first plurality of ridges to the second plurality of ridges.

Clause 11: the medical probe of any of clauses 1-6, each ridge of the second plurality of ridges comprising a protrusion, each ridge of the first plurality of ridges comprising a hole extending therethrough configured to receive the protrusion to rotatably couple the first plurality of ridges to the second plurality of ridges.

Clause 12: the medical probe of clause 11, the protrusions forming a snap fit with the aperture to secure the first plurality of ridges to the second plurality of ridges.

Clause 13: the medical probe of any one of clauses 1-6, further comprising a plurality of hinge members, each hinge member of the plurality of hinge members being coupled to a distal end of a respective ridge of the first plurality of ridges and to a proximal end of a respective ridge of the second plurality of ridges.

Clause 14: the medical probe of clause 13, each hinge member comprising a proximal aperture and a distal aperture, the proximal aperture configured to receive a protrusion of a respective one of the first plurality of ridges, and the distal aperture configured to receive a protrusion of a respective one of the second plurality of ridges to rotatably attach the first plurality of ridges, the second plurality of ridges, and the plurality of hinge members to one another.

Clause 15: the medical probe of clause 13, each hinge member comprising a proximal protrusion configured to be inserted into a hole of a respective one of the first plurality of ridges and a distal protrusion configured to be inserted into a hole of a respective one of the second plurality of ridges to rotatably attach the first plurality of ridges, the second plurality of ridges, and the plurality of hinge members to one another.

Clause 16: the medical probe of any one of the preceding clauses, wherein each ridge of the first and second pluralities of ridges comprises a material selected from the group consisting of nitinol, cobalt chromium, stainless steel, and titanium.

Clause 17: the medical probe of any one of the preceding clauses, wherein each ridge of the first and second pluralities of ridges comprises a polymer.

Clause 18: the medical probe of any of the preceding clauses, wherein each electrode of the plurality of electrodes comprises a ring electrode.

Clause 19: the medical probe of any one of clauses 1-18, wherein each electrode of the plurality of electrodes comprises a protruding electrode.

Clause 20: the medical probe of any of clauses 1-18, wherein each electrode of the plurality of electrodes comprises a rectangular electrode.

Clause 21: the medical probe of any one of the preceding clauses, wherein the plurality of electrodes are configured to deliver an electrical pulse for irreversible electroporation, the pulse having a peak voltage of at least 900 volts (V).

Clause 22: the medical probe of any of the preceding clauses, wherein the expandable basket assembly is configured to form an approximately spherical basket assembly when in an expanded form.

Clause 23: the medical probe of any of clauses 1-22, wherein the expandable basket assembly is configured to form an approximately spheroid basket assembly when in the expanded form.

Clause 24: a medical probe, comprising: a tubular shaft including a proximal end and a distal end, the tubular shaft extending along a longitudinal axis; and an expandable basket assembly coupled to the distal end of the tubular shaft, the basket assembly comprising: a first plurality of ridges coupled to the distal end of the tubular shaft; a second plurality of ridges, each ridge of the second plurality of ridges rotatably coupled to a respective ridge of the first plurality of ridges, the second plurality of ridges biased to flex distally relative to the first plurality of ridges to transition the expandable basket assembly to an expanded configuration.

Clause 25: a method of constructing a medical probe, the method comprising: attaching a first plurality of ridges to a tubular shaft extending along a longitudinal axis; attaching a second plurality of ridges to a distal end of the first plurality of ridges, the second plurality of ridges rotatably attached to the first plurality of ridges, the first plurality of ridges and the second plurality of ridges forming an expandable basket assembly; attaching a distal end of the second plurality of ridges to a pushrod, the pushrod configured to longitudinally slide between a proximal position and a distal position to transition the expandable basket assembly between an expanded configuration and a collapsed configuration; and attaching a plurality of electrodes to at least the second plurality of ridges.

Clause 26: the method of clause 25, the first plurality of ridges forming a proximal portion of the expandable basket assembly, and the second plurality of ridges forming a distal portion of the expandable basket assembly.

Clause 27: the method of clause 26, the second plurality of ridges being configured to rotate outwardly relative to the first plurality of ridges to transition to an expanded configuration.

Clause 28: the method of any of clauses 26 or 27, the second plurality of ridges being configured to rotate inwardly relative to the first plurality of ridges such that a distal portion of the expandable basket assembly is at least partially nested within the proximal portion of the expandable basket assembly.

Clause 29: the method of any one of clauses 25-27, wherein the second plurality of ridges are attached to each other to form an integral ridge assembly.

Clause 30: the method of clause 29, the second plurality of ridges comprising a single piece of continuous biocompatible material.

Clause 31: the method of any one of clauses 25-30, each ridge of the first plurality of ridges including a first hole extending therethrough at a distal end thereof, each ridge of the second plurality of ridges including a second hole extending therethrough at a proximal end thereof, and the method further comprising: the first aperture is aligned with the second aperture, and pins are inserted into the first aperture and the second aperture, a plurality of pins configured to extend through the respective first aperture and the respective second aperture to rotatably couple the first plurality of ridges to the second plurality of ridges.

Clause 32: the method of clause 31, the pin forming a snap fit with the first and second pluralities of ridges to secure the first plurality of ridges to the second plurality of ridges.

Clause 33: the method of any of clauses 25-30, each ridge of the first plurality of ridges comprising a protrusion, each ridge of the second plurality of ridges comprising a hole extending therethrough, the method further comprising inserting the protrusion into the hole to rotatably couple the first plurality of ridges to the second plurality of ridges.

Clause 34: the method of clause 33, the protrusions forming a snap fit with the holes to secure the first plurality of ridges to the second plurality of ridges.

Clause 35: the method of any of clauses 25-30, each ridge of the second plurality of ridges comprising a protrusion, each ridge of the first plurality of ridges comprising a hole extending therethrough, the method further comprising inserting the protrusion into the hole to rotatably couple the first plurality of ridges to the second plurality of ridges.

Clause 36: the method of clause 35, the protrusions forming a snap fit with the holes to secure the first plurality of ridges to the second plurality of ridges.

Clause 37: the method of any one of clauses 25 to 30, further comprising: attaching each ridge of the first plurality of ridges to a hinge member of a plurality of hinge members; and attaching each ridge of the second plurality of ridges to the hinge member of the plurality of hinge members to rotatably attach the first plurality of ridges, the second plurality of ridges, and the plurality of hinge members to one another.

Clause 38: the method of clause 37, each hinge member comprising a proximal aperture configured to receive the protrusion of a respective ridge of the first plurality of ridges and a distal aperture configured to receive the protrusion of a respective ridge of the second plurality of ridges.

Clause 39: the method of clause 37, each hinge member comprising a proximal protrusion configured to be inserted into a hole of a respective ridge of the first plurality of ridges and a distal protrusion configured to be inserted into a hole of a respective ridge of the second plurality of ridges.

Clause 40: the method of any one of clauses 25-39, wherein each ridge of the first and second pluralities of ridges comprises a material selected from the group consisting of nitinol, cobalt chromium, stainless steel, and titanium.

Clause 41: the method of any one of clauses 25 to 40, wherein each ridge of the first and second pluralities of ridges comprises a polymer.

Clause 42: the method of any one of clauses 25-41, wherein each of the plurality of electrodes comprises a ring electrode.

Clause 43: the method of any one of clauses 25-41, wherein each of the plurality of electrodes comprises a protruding electrode.

Clause 44: the method of any one of clauses 25-41, wherein each of the plurality of electrodes comprises a rectangular electrode.

Clause 45: the method of any of clauses 25-44, wherein the plurality of electrodes are configured to deliver an electrical pulse for irreversible electroporation, the pulse having a peak voltage of at least 900 volts (V).

Clause 46: the method of any of clauses 25-45, wherein the expandable basket assembly is configured to form an approximately spherical basket assembly when in an expanded form.

Clause 47: the method of any of clauses 25-45, wherein the expandable basket assembly is configured to form an approximately spheroid basket assembly when in the expanded form.

Clause 48: a medical probe, comprising: a tubular shaft including a proximal end and a distal end, the tubular shaft extending along a longitudinal axis; and an expandable basket assembly coupled to the distal end of the tubular shaft, the basket assembly comprising: a first plurality of ridges coupled to the distal end of the tubular shaft and comprising a hook member; a second plurality of ridges, each ridge of the second plurality of ridges comprising a hole and being rotatably coupled to a respective ridge of the first plurality of ridges; and a plurality of electrodes attached to at least the second plurality of ridges; and a pushrod connected to a distal end of the second plurality of ridges, the pushrod configured to longitudinally slide between a proximal position and a distal position to transition the expandable basket assembly between an expanded configuration and a collapsed configuration.

The above embodiments are cited by way of example, and the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and sub-combinations of the various features described and illustrated above, as well as variations and modifications thereof which would occur to persons skilled in the art upon reading the foregoing description and which are not disclosed in the prior art.

Claims (20)

1. A medical probe, comprising: a tubular shaft comprising a proximal end and a distal end, the tubular shaft extending along a longitudinal axis; and an expandable basket assembly coupled to the distal end of the tubular shaft, the basket assembly comprising: a first plurality of ridges coupled to the distal end of the tubular shaft; a second plurality of ridges, each ridge of the second plurality of ridges being rotatably coupled to a corresponding ridge of the first plurality of ridges; and a plurality of electrodes attached to at least the second plurality of ridges; and A push rod is connected to the distal end of the second plurality of spines, the push rod being configured to slide longitudinally between a proximal position and a distal position to transition the expandable basket assembly between an expanded configuration and a collapsed configuration. 2. The medical probe of claim 1, the first plurality of ridges forming a proximal portion of the expandable basket assembly and the second plurality of ridges forming a distal portion of the expandable basket assembly. 3. The medical probe of claim 2, the second plurality of ridges being configured to rotate outwardly relative to the first plurality of ridges to transition to an expanded configuration. 4. The medical probe of claim 2, wherein the second plurality of spines are configured to rotate inwardly relative to the first plurality of spines such that the distal portion of the expandable basket assembly is at least partially nested within the proximal portion of the expandable basket assembly. 5. The medical probe of claim 1, the second plurality of spines being attached to one another to form a unitary spine assembly. 6. The medical probe of claim 5, the second plurality of ridges comprising a single continuous piece of biocompatible material. 7. The medical probe of claim 1, each ridge of the first plurality of ridges comprising a first hole extending therethrough at a distal end thereof, Each ridge of the second plurality of ridges includes a second aperture extending therethrough at a proximal end thereof, and The medical probe further includes a plurality of pins, each pin of the plurality of pins being configured to extend through a respective first hole and a respective second hole to rotatably couple the first plurality of spines to the second plurality of spines. 8. The medical probe of claim 7, the pin forming a snap fit with the first plurality of ridges and the second plurality of ridges to secure the first plurality of ridges to the second plurality of ridges. 9. The medical probe of claim 1, each ridge of the first plurality of ridges comprising a protrusion, Each ridge of the second plurality of ridges includes a hole extending therethrough configured to receive the protrusion to rotatably couple the first plurality of ridges to the second plurality of ridges. 10. The medical probe of claim 9, the protrusion forming a snap fit with the hole to secure the first plurality of ridges to the second plurality of ridges. 11. The medical probe of claim 1 , each ridge of the second plurality of ridges comprising a protrusion, Each ridge of the first plurality of ridges includes a hole extending therethrough, the hole being configured to receive the protrusion to rotatably couple the first plurality of ridges to the second plurality of ridges. 12. The medical probe of claim 11, the protrusion forming a snap fit with the hole to secure the first plurality of ridges to the second plurality of ridges. 13. The medical probe of claim 1, further comprising a plurality of hinge members, each of the plurality of hinge members coupled to a distal end of a corresponding ridge of the first plurality of ridges and to a proximal end of a corresponding ridge of the second plurality of ridges. 14. The medical probe of claim 13 , each hinge member comprising a proximal hole and a distal hole, the proximal hole being configured to receive a protrusion of a corresponding ridge of the first plurality of ridges, and the distal hole being configured to receive a protrusion of a corresponding ridge of the second plurality of ridges, so as to rotatably attach the first plurality of ridges, the second plurality of ridges, and the plurality of hinge members to each other. 15. The medical probe of claim 13 , each hinge member comprising a proximal protrusion and a distal protrusion, the proximal protrusion being configured to be inserted into a hole of a corresponding ridge among the first plurality of ridges, and the distal protrusion being configured to be inserted into a hole of a corresponding ridge among the second plurality of ridges, so as to rotatably attach the first plurality of ridges, the second plurality of ridges, and the plurality of hinge members to each other. 16. The medical probe of claim 1, wherein the plurality of electrodes are configured to deliver electrical pulses for irreversible electroporation, the pulses having a peak voltage of at least 900 volts (V). 17. The medical probe of claim 1, wherein the expandable basket assembly is configured to form a substantially spherical basket assembly when in an expanded form. 18. The medical probe of claim 1, wherein the expandable basket assembly is configured to form an approximately oblate spheroidal basket assembly when in the expanded form. 19. A medical probe, comprising: a tubular shaft comprising a proximal end and a distal end, the tubular shaft extending along a longitudinal axis; and an expandable basket assembly coupled to the distal end of the tubular shaft, the basket assembly comprising: a first plurality of ridges coupled to the distal end of the tubular shaft; A second plurality of spines, each of the second plurality of spines being rotatably coupled to a corresponding spine of the first plurality of spines, the second plurality of spines being biased to bend distally relative to the first plurality of spines to transition the expandable basket assembly into an expanded configuration. 20. A medical probe, comprising: a tubular shaft comprising a proximal end and a distal end, the tubular shaft extending along a longitudinal axis; and an expandable basket assembly coupled to the distal end of the tubular shaft, the basket assembly comprising: a first plurality of spines coupled to the distal end of the tubular shaft and comprising hook members; a second plurality of ridges, each ridge of the second plurality of ridges comprising an aperture and rotatably coupled to a corresponding ridge of the first plurality of ridges; and a plurality of electrodes attached to at least the second plurality of ridges; and A push rod is connected to the distal end of the second plurality of spines, the push rod being configured to slide longitudinally between a proximal position and a distal position to transition the expandable basket assembly between an expanded configuration and a collapsed configuration.