Localized ablation device with foldable element, and system and method thereof

Abstract

To provide an endocardial catheter.SOLUTION: The endocardial catheter comprises: an outer shaft having an outer shaft lumen; an inner shaft slidably disposed within the outer shaft lumen; a spline assembly comprising a plurality of flexible splines, each of the splines having a spline proximal end attached to a distal end of the outer shaft, an opposing spline distal end attached to a distal end of the inner shaft, and an electrode, the plurality of splines collectively defining an interior space of the spline assembly, and a foldable membrane disposed within the interior space of the spline assembly, the collapsible membrane having an outer edge portion attached to one or more of the plurality of splines. The foldable membrane comprises an electrically insulating material.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The embodiments described herein generally relate to systems, devices, and methods for delivering therapeutic electrical energy, and more particularly, to systems, devices, and methods for applying a pulsed electric field to excise tissue by irreversible electroporation using a local ablation device.

Background Art

[0002] Pulsed electric field ablation using the application of high voltage pulses has been demonstrated to be suitable for the rapid and effective ablation of cardiac tissue as well as other target biological structures. Pulsed electric field energy delivery utilizes short pulses of high voltage that generate locally high electric fields capable of driving cell membrane disruption and causing cell death, a process also referred to as irreversible electroporation. For example, in the case of the heart, an endocardial local ablation catheter can be used to deliver pulsed electric field ablation to cardiac tissue via irreversible electroporation.

[0003] When a relatively highly conductive fluid medium (e.g., blood, etc.) is present, the high voltage pulses of pulsed electric field ablation can conduct current between the electrodes of the ablation device, and a significant proportion of the net current flows through the fluid medium rather than the tissue. As a result, suboptimal lesion characteristics can result, for example, for some applications such as creating deeper lesions in thicker tissues (e.g., ventricular tissue). Thus, it may be desirable to have an ablation device design that can improve the creation of deep lesions in tissue.

Summary of the Invention

[0004] In Example 1, the endocardial catheter comprises an outer shaft, an inner shaft, a spline assembly, and a foldable membrane. The outer shaft has a proximal end and an opposite distal end, and an outer shaft lumen extending through the proximal end and the distal end. The inner shaft is slidably disposed within the outer shaft lumen, the inner shaft has a proximal portion and an opposite distal end, and the inner shaft has a size that extends beyond the distal end of the outer shaft. The spline assembly comprises a plurality of flexible splines, each of the plurality of splines having a spline proximal end attached to the distal end of the outer shaft, an opposite spline distal end attached to the distal end of the inner shaft, and a plurality of electrodes, and the plurality of splines collectively define an internal space of the spline assembly. The foldable membrane is disposed within the internal space of the spline assembly, and the foldable membrane has an outer edge portion attached to one or more of the plurality of splines.

[0005] In Example 2, in the endocardial catheter of Example 1, the foldable membrane is formed of an electrically insulating material. In Example 3, in the endocardial catheter of Example 2, the spline assembly is capable of transitioning between a non-deployed configuration and a deployed configuration by causing relative axial movement between the inner shaft and the outer shaft.

[0006] In Example 4, in the endocardial catheter of Example 3, the spline assembly has a minimum diameter in the non-deployed configuration and a maximum diameter in the fully deployed configuration.

[0007] In Example 5, in the endocardial catheter of Example 4, the plurality of electrodes on each spline includes a proximal spline electrode and a distal spline electrode, the proximal spline electrodes of the plurality of splines collectively define a proximal spline electrode set, and the distal spline electrodes of the plurality of splines collectively define a distal spline electrode set.

[0008] In Example 6, in the endocardial catheter of Example 5, the outer edge portion of the foldable membrane is attached to one or more splines at its longitudinal position corresponding to the maximum diameter of the spline assembly in the fully deployed configuration.

[0009] In Example 7, in the endocardial catheter of Example 5, the outer edge portion of the foldable membrane is attached to one or more splines at the longitudinal position between the proximal spline electrode and the distal spline electrode disposed on each of the one or more splines.

[0010] In Example 8, in the endocardial catheter of Example 7, each of the plurality of splines has a curved shape when the spline assembly is in the deployed configuration, and the foldable membrane is attached to one or more splines at its maximum curvature point, and the maximum curvature point is located closer to the distal end of each spline than to the proximal end of each spline.

[0011] In Example 9, in the endocardial catheter of Example 5, the foldable membrane takes a circular shape when the spline assembly is in the deployed configuration. In Example 10, in the endocardial catheter of Example 9, the outer edge portion of the foldable membrane has a plurality of arcuate notches at positions corresponding to the attachment points of the foldable membrane to one or more splines.

[0012] In Example 11, in the endocardial catheter of Example 5, the outer edge portion of the foldable membrane has a plurality of concave portions when the spline assembly is in the deployed configuration. In Example 12, in the endocardial catheter of Example 5, the foldable membrane includes a plurality of folds, and each one of the plurality of folds is located between adjacent splines of the spline assembly.

[0013] In Example 13, in the endocardial catheter of Example 5, the foldable membrane includes an opening, and the inner shaft extends through the opening. In Example 14, in the endocardial catheter of Example 13, the inner shaft includes a hub, and the inner edge of the foldable membrane opening is attached to the hub.

[0014] In Example 15, the endocardial catheter of Example 14 further includes a plurality of radial struts coupled to the foldable membrane, configured to facilitate folding and unfolding of the foldable membrane when transitioning between a deployed configuration and a non-deployed configuration of the spline assembly.

[0015] In Example 16, a system for local pulsed electric field ablation of cardiac tissue includes an endocardial catheter and a signal generator. The endocardial catheter includes an outer shaft, an inner shaft, a spline assembly, and a foldable membrane. The outer shaft has a proximal end and an opposite distal end, and an outer shaft lumen extending through the proximal and distal ends. The inner shaft is slidably disposed within the outer shaft lumen, the inner shaft has a proximal portion and an opposite distal end, and the inner shaft is sized to extend beyond the distal end of the outer shaft. The spline assembly includes a plurality of flexible splines, each of the plurality of splines having a spline proximal end attached to the distal end of the outer shaft, an opposite spline distal end attached to the distal end of the inner shaft, and a plurality of electrodes, the plurality of splines collectively defining an internal space of the spline assembly. The foldable membrane is disposed within the internal space of the spline assembly, the foldable membrane having an outer edge portion attached to one or more of the plurality of splines. The signal generator is configured to generate a pulse waveform and deliver the pulse waveform to the plurality of electrodes.

[0016] In Example 17, in the system of Example 16, the plurality of electrodes on each spline include proximal spline electrodes and distal spline electrodes, the proximal spline electrodes of the plurality of splines collectively defining a proximal spline electrode set, and the distal spline electrodes of the plurality of splines collectively defining a distal spline electrode set.

[0017] In Example 18, in the system of Example 16, the outer edge portion of the foldable membrane is attached to one or more splines at its longitudinal position corresponding to the maximum diameter of the spline assembly in the fully deployed configuration.

[0018] In Example 19, the endocardial catheter includes an outer shaft, an inner shaft, an expandable and contractable spline assembly, and a foldable membrane. The outer shaft has a distal end of the outer shaft, and the inner shaft is disposed within the outer shaft and includes a distal end of the inner shaft. The expandable and contractable spline assembly includes a plurality of splines, each of the plurality of splines being connected to the distal end of the outer shaft and the distal end of the inner shaft, and each spline further includes a plurality of electrodes including a proximal electrode and a distal electrode. The foldable membrane includes a polymeric material attached to one or more of the plurality of splines at an attachment position between the proximal electrode and the distal electrode disposed thereon.

[0019] In Example 20, in the endocardial catheter of Example 19, the attachment position corresponds to the maximum diameter of the spline assembly in the fully deployed configuration. Although a plurality of embodiments are disclosed, further other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description showing and explaining exemplary embodiments of the present invention. Therefore, the drawings and the detailed description should be considered to be essentially exemplary and not restrictive.

Brief Description of the Drawings

[0020]

Figure 1

Figure 2

Figure 3A

Figure 3B

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

Figure 10

Figure 11

Figure 12

DETAILED DESCRIPTION OF THE INVENTION

[0021] The present invention is subject to various modifications and alternative forms, and specific embodiments are shown by way of example in the drawings and will be described in detail below. However, the intention is not to limit the invention to the particular embodiments described. On the contrary, the invention is intended to cover all modifications, equivalents, and alternatives falling within the scope of the invention as defined by the appended claims.

[0022] A local ablation device, as well as related systems and methods, for generating a pulsed electric field that can be delivered to tissue (e.g., heart tissue) for ablation are described herein. Such delivery of a pulsed electric field for ablation may also be referred to herein as pulsed field ablation or PFA. In some embodiments, the local ablation device described herein can be used to treat cardiac arrhythmias in atrial or ventricular heart tissue.

[0023] Pulse electric field energy delivery utilizes high-voltage short pulses that generate locally high electric fields capable of driving cell membrane disruption and causing cell death, and this process is also called irreversible electroporation. Examples of endocardial local catheters configured for PFA delivery include (1) U.S. Patent Application No. 15 / 874,721, filed January 18, 2018, titled "SYSTEMS, DEVICES, AND METHODS FOR FOCAL ABLATION," issued as U.S. Patent No. 10,130,423; (2) International Patent Application PCT / US19 / 14226, filed January 18, 2019, titled "SYSTEMS, DEVICES, AND METHODS FOR FOCAL ABLATION," published as International Patent Application Publication WO2019 / 143960; and (3) International Patent Application PCT / US20 / 26682, filed April 3, 2020, titled "SYSTEMS, DEVICES, AND METHODS FOR FOCAL ABLATION," published as International Patent Application Publication WO2020 / 206328, including multi-electrode basket structures with deployable splines, the contents of which are hereby incorporated by reference in their entirety.

[0024] In some embodiments, a signal generator can be used to generate waveforms for pulsed electric field ablation. The signal generator may be coupled to an ablation device described herein and can generate waveforms suitable for use with such a device. Such pulsed waveforms can be designed to enhance one or more of the safety, efficiency, and effectiveness of energy delivery to tissue by reducing the electric field threshold associated with irreversible electroporation, and thus result in a more effective ablative lesion while reducing (e.g., minimizing) the total energy delivered. In some embodiments, the voltage pulse waveforms disclosed herein may be hierarchical and may have an nested structure. For example, the pulse waveform may include a hierarchical grouping of pulses having an associated time scale. Examples of suitable pulse waveforms including multiple levels of hierarchy are disclosed in International Application PCT / US2016 / 057664, entitled "SYSTEMS, APPARATUSES AND METHODS FOR DELIVERY OF ABLATIVE ENERGY TO TISSUE", filed Oct. 19, 2016, and International Application PCT / US2019 / 031135, entitled "SYSTEMS, APPARATUSES AND METHODS FOR DELIVERY OF ABLATIVE ENERGY TO TISSUE", filed May 7, 2019, the contents of each of which are incorporated herein by reference in their entirety.

[0025] In the endocardial clinical use of pulsed electric field ablation, it may be desirable to create a local lesion in which a local area of tissue is excised. In some examples, such a lesion may be transmural; for example, the lesion extends across the depth of the tissue wall. In thicker heart tissue, such as is common in the left ventricle, the tissue thickness can be significantly thicker, for example, about 8 mm to about 10 mm, or more. Thus, in applications such as the treatment of ventricular arrhythmias such as ventricular tachycardia (VT), it may be desirable to be able to form deeper lesions. The systems, devices, and methods described herein can be configured to deliver pulsed electric field ablation to tissue for the generation of deeper lesions.

[0026] System This disclosure describes embodiments of devices and apparatuses for the delivery of pulsed electric field ablation for creating deep lesions in heart tissue, as well as related methods of use. In some embodiments, the device may be a catheter that includes an outer shaft and an inner shaft. The inner shaft may be configured to translate (e.g., extend) beyond the distal end of the outer shaft. The device may include a spline assembly having a plurality of splines coupled (e.g., attached) between the distal end of the outer shaft and the distal end of the inner shaft. For example, the proximal end of each spline may be attached to the distal end of the outer shaft, and the distal end of each spline may be attached to the distal end of the inner shaft. In some embodiments, the length of each spline can be made longer than the maximum distance that the distal end of the inner shaft extends beyond the distal end of the outer shaft. Thus, the splines can collectively form a basket-like shape. In some embodiments, the inner shaft can be translated (e.g., retracted) relative to the outer shaft via a handle.

[0027] In some embodiments, the device may be configured to transition between an undeployed configuration and a deployed configuration, including a plurality of semi-deployed (e.g., partially deployed) configurations between the undeployed and deployed configurations. For example, in the undeployed configuration, the inner shaft may extend beyond the distal end of the outer shaft such that the basket-shaped shape formed by the splines has a minimum diameter or cross-section. As the inner shaft is retracted, the splines can deploy into a basket-shaped structure having a larger cross-section (e.g., a larger cross-section having a maximum diameter larger than that of the undeployed configuration, such as via buckling or outward movement). In some embodiments, the range of deployment from undeployed to fully deployed is generally available, and the basket-shaped shape achieves its widest cross-section when the device is fully deployed.

[0028] In some embodiments, each spline may include a plurality of electrodes, and a set of one or more distal electrodes and a set of two or more proximal electrodes are located proximal to the set of distal electrodes. For ablation delivery of a pulsed electric field ablation waveform, various subsets of the distal electrodes may be of a first electrical polarity, while various subsets of the proximal electrodes may be of a second electrical polarity opposite the first electrical polarity. The waveform applied can be either single-phase (e.g., a single relative polarity) or two-phase (e.g., alternating relative polarities). Exemplary waveforms for pulsed electric field ablation are described in International Applications PCT / US2016 / 057664 and PCT / US2019 / 031135, each of which is incorporated herein by reference.

[0029] In some embodiments, the film including the insulating material may generally be disposed in the middle or central portion of the spline. To facilitate attachment of the film to one or more of the splines, the film may define one or more recesses (e.g., notches) along the outer edge of the film configured to be attached to one or more of the splines. In some embodiments, the inner portion of the film may define an opening (e.g., a hole) configured to receive the inner shaft. In some embodiments, the film may be coupled to one or more splines between a set of distal electrodes and a set of proximal electrodes of one or more of the splines.

[0030] In some embodiments, the surface area of one side of the film may be greater than the cross-sectional area formed by the spline in the undeployed configuration. In some embodiments, in the undeployed configuration, the film may define one or more edges (e.g., fold lines) that allow the film to fold naturally between adjacent splines. In the deployed configuration where the basket is expanded, the film may be open (e.g., not folded) and assume a relatively pinned or flat configuration between the splines. In some embodiments, the film may have a surface area that is about 50% or more of the maximum cross-sectional area formed by the spline in the deployed configuration.

[0031] In some embodiments, the inner shaft may include a hub (e.g., a protrusion, a stop, a guide, a rail, a fastener) configured to couple to the edge of the opening of the film to facilitate deployment of the film. For example, the hub may generally be fixed to the inner shaft to provide structural support to the film or may be allowed translational movement over a predetermined tolerance (e.g., limited or bounded by a stop or a nub along the inner shaft).

[0032] In some embodiments, a membrane including an insulator disposed between a distal set of spline electrodes and a proximal set of spline electrodes may be configured to change the direction of electric field lines generated by the device such that the electric field strength distal to the distal electrode is increased, thereby creating a damage that is relatively deeper than the damage that would be created in the absence of the membrane. The membrane may be configured to facilitate deeper damage from a non-deployed configuration to a fully deployed configuration and any partially deployed configurations therebetween. In some embodiments, a device having a membrane as described herein can create a damage having a depth that is about 20% or more deeper than a device without the membrane.

[0033] Generally, the systems and devices described herein include one or more catheters configured to excise tissue of the left atrium of the heart. FIG. 11 shows an ablation system (1100) configured to deliver a voltage pulse waveform. The system (1100) may include a device (1120) including a signal generator (1122), a processor (1124), a memory (1126), and optionally a cardiac stimulator (1128). The device (1120) may be coupled to an ablation device (1110) and optionally an electronic device (1130).

[0034] The signal generator (1122) may be configured to generate a pulse waveform for irreversible electroporation of tissue, such as at the pulmonary vein ostium or other cardiac locations. For example, the signal generator (1122) may be a voltage pulse waveform generator and can deliver the pulse waveform to the ablation device (1110). The processor (1124) can incorporate data received from the memory (1126) to determine parameters of the pulse waveform (such as amplitude, width, duty cycle, etc.) generated by the signal generator (1122). The memory (1126) may further store instructions that cause the signal generator (1122) to execute modules, processes, and / or functions associated with the system (1100), such as pulse waveform generation, mapping, sensing, and / or cardiac pacing synchronization. For example, the memory (1126) may be configured to store pulse waveforms and / or cardiac pacing data for pulse waveform generation and / or cardiac pacing, respectively.

[0035] In some embodiments, the ablation device (1110) may include a catheter configured to receive and / or deliver the pulse waveforms described in more detail herein. For example, the ablation device (1110) may be introduced into the endocardial space of the heart and positioned in the vicinity of tissue with one or more electrodes (1112) and membranes (1113), and then deliver a pulse waveform to excise the tissue. The ablation device (1110) may include one or more electrodes (1112), and in some embodiments may include at least one set of independently addressable electrodes. Each electrode may include an insulated electrical lead configured to maintain a potential of at least about 700V without dielectric breakdown of its corresponding insulator. In some embodiments, the insulator on each electrical lead can maintain a potential difference of about 200V to about 2500V across its thickness without dielectric breakdown. For example, the electrodes (1112) may be grouped into one or more anode-cathode subsets, such as a subset including, for example, one anode and one cathode, a subset including two anodes and two cathodes, a subset including two anodes and one cathode, a subset including one anode and two cathodes, a subset including three anodes and one cathode, a subset including three anodes and two cathodes, and / or the like. In some embodiments, the membrane (1113) may be coupled to the spline of the electrode (1112) and configured to shape and / or direct the electric field generated by the ablation device (1110).

[0036] Optionally, one or more electronic devices (1130) can be coupled to the device (1120) to provide additional functionality to the system (1100). For example, the electronic device (1130) may be configured to perform one or more of sensing, mapping, positioning, protecting, pacing, etc. In some embodiments, the electronic device (1130) may include one or more of a sensor, a mapping catheter, a protection device, and a pacing device. For example, the electronic device (1130) may be a pacing device that is appropriately coupled to a patient (not shown) and configured to receive a cardiac pacing signal generated by the cardiac stimulator (1128) of the device (1120) for cardiac stimulation. An indication of the pacing signal can be transmitted by the cardiac stimulator (1128) to the signal generator (1122). Based on the pacing signal, an ablation voltage pulse waveform can be selected, calculated, and / or otherwise determined by the processor (1124) and generated by the signal generator (1122). In some embodiments, the signal generator (1122) may be configured to generate the pulse waveform in synchronization with an indication of the pacing signal (e.g., within a common refractory window). For example, in some embodiments, the common refractory window may begin substantially immediately (or after a very small delay) after a ventricular pacing signal and then persist for a duration of about 250 ms or less. In such embodiments, the entire pulse waveform may be delivered within this duration. In alternative embodiments, the ablation waveform may be delivered without a pacing signal, e.g., asynchronously.

[0037] The processor (1124) may be any suitable processing device configured to initiate and / or execute a set of instructions or code. The processor may be, for example, a general-purpose processor, a field-programmable gate array (FPGA), an application-specific integrated circuit (ASIC), a digital signal processor (DSP), and / or the like. The processor may be configured to initiate and / or execute application processes and / or other modules, processes, and / or functions associated with the system and / or a network (not shown) associated therewith. The underlying device technology may be provided by various component types, such as metal-oxide semiconductor field-effect transistor (MOSFET) technology like complementary metal-oxide semiconductor (CMOS), bipolar technology like emitter-coupled logic (ECL), polymer technology (e.g., silicon-conjugated polymers and metal-conjugated polymer-metal structures), hybrid analog and digital, and / or the like.

[0038] The memory (1126) may include a database (not shown) and may be, for example, random access memory (RAM), a memory buffer, a hard drive, erasable programmable read-only memory (EPROM), electrically erasable read-only memory (EEPROM), read-only memory (ROM), a field-programmable gate array (FPGA), flash memory, and the like. The memory (1126) may store instructions for causing the processor (1124) to execute modules, processes, and / or functions associated with the system (1100), such as pulse waveform generation, mapping, location identification, and / or cardiac pacing.

[0039] System (1100) can communicate with other devices (not shown) via one or more networks, each of which can be any type of network, for example. A wireless network can refer to any type of digital network that is not connected by any type of cable. However, a wireless network can be connected to a wired network to interface with the Internet, other carrier voice and data networks, business networks, and personal networks. A wired network is typically transmitted over copper twisted pair, coaxial cable, or fiber optic cable. There are many different types of wired networks, including wide area networks (WANs), metropolitan area networks (MANs), local area networks (LANs), campus area networks (CANs), global area networks (GANs) such as the Internet, and virtual private networks (VPNs). Hereinafter, a network refers to any combination of integrated wireless, wired, public, and private data networks that are typically interconnected via the Internet to provide an integrated networking and information access solution.

[0040] FIG. 1 is a schematic perspective view of a device (100) (e.g., an endocardial catheter, an ablation device) in an undeployed configuration, including a plurality of splines having a basket-like shape and a foldable membrane defining a set of folds. The device (100) may be an ablation device such as, for example, the ablation device (1100) described with respect to FIG. 11. In some embodiments, the catheter (100) may have an outer shaft (101) defining an inner lumen and an inner shaft (103) disposed therein. The inner shaft (103) may be configured to extend beyond the distal end (131) of the outer shaft (101). The plurality of splines (105, 119) may be attached at their proximal ends to the inner surface of the distal end (131) of the outer shaft (101). The distal ends of the plurality of splines (105, 119) may be attached to the device tip (122) and the distal end of the inner shaft (103). In some embodiments, the length of each spline (105, 119) may be longer than the maximum distance that the distal end of the inner shaft (103) can extend beyond the distal end of the outer shaft (101). Thus, the plurality of splines can collectively form a basket-like structure. In some embodiments, the inner shaft (103) may be translated (e.g., retracted, extended) relative to the outer shaft (101), or the outer shaft (101) may be translated relative to the inner shaft (103) via a handle mechanism (not shown).

[0041] In some embodiments, each of the plurality of splines has a set of distal electrodes and a set of proximal electrodes. For example, spline (105) may have distal electrode (107) and two proximal electrodes (109). In some embodiments, a flexible element, such as a foldable membrane (111) (e.g., a deployable membrane), may be attached to one or more of the splines along its periphery (e.g., outer edge). For example, membrane (111) may be attached to splines (105, 119) at positions (135, 137), respectively. The inner portion of membrane (111) may define an opening through which inner shaft (103) is received (e.g., passes). Optionally, the inner shaft may comprise a hub (117) to which the inner portion (140) of the membrane may be attached, as shown in FIG. 1. Hub (117) can be made of a polymeric material such as, for example, Pebax or silicone, and membrane (111) may comprise a polymeric material such as, for example, polyurethane, Pebax, silicone. In an undeployed configuration, membrane (111) may have a crease (113) located between adjacent splines, where membrane (111) is folded inwardly with respect to splines (105, 119). In some embodiments, membrane (111) may have a pattern or cutout configured to define a line along which membrane (111) is folded.

[0042] In the undeployed configuration shown in FIG. 1, the inner shaft (103) extends completely beyond the distal end (131) of the outer shaft (101) such that the basket structure formed by the splines has a minimum diameter or cross-section. In some embodiments, the electrodes on the splines may be made from any of a variety of biocompatible conductors such as stainless steel, gold, platinum-iridium alloy, etc. In some embodiments, the length of the electrodes may range from about 0.5 mm to about 7 mm, including any sub-range and value therebetween. The spacing between the closest edges of adjacent proximal electrodes on a given spline (if there are multiple proximal electrodes on a given spline), or the spacing between the closest edges of adjacent distal electrodes on a given spline (if there are multiple distal electrodes on a given spline) may range from about 0.5 mm to about 5 mm, including any sub-range and value therebetween.

[0043] In some embodiments, the arc length of the splines may range from about 8 mm to about 55 mm, including any sub-range and value therebetween. In some embodiments, the average diameter of each spline may range from about 0.5 mm to about 3 mm, including any sub-range and value therebetween. In embodiments, the cross-section of the spline may be substantially elliptical or oval, or the spline cross-section may be circular. In some embodiments, the number of splines of the device may range from about 3 to about 16 splines. In some embodiments, the outer diameter of the outer shaft (101) of the catheter may range from about 5F or 5 French (or 5 / 3 mm) to about 18F (or 6 mm).

[0044] Figure 2 is a schematic diagram of the membrane (200) of the endocardial catheter device described herein. The membrane (200) may be structurally and / or functionally similar to other membranes described herein and can be used with systems and / or devices as described with reference to such membranes. For example, the membrane (200) can be used with any of the ablation devices as described herein. In some embodiments, the membrane (201) may have an outer edge (212) (e.g., a peripheral edge) and an inner portion (202) that defines a circular hole (e.g., an opening). As shown in FIG. 2, the outer edge (212) may be generally circular and have arcuate divots, notches, or recesses (205, 206, 207, 208). Each divot may be configured as an attachment edge for attachment to the spline of the device, and adjacent divots are attached to adjacent splines of the basket. In other embodiments, adjacent divots may be attached to non-adjacent splines of the basket. Each divot may be adhesively or thermally joined to the spline. In some embodiments, the inner portion (202) defines an opening that can receive the inner shaft of the catheter (not shown). In some embodiments, the inner shaft may be attached to a hub (such as hub (117) of FIG. 1), and the inner portion (202) of the membrane may be attached to the hub (e.g., by an adhesive or thermal bonding). In some embodiments, the average diameter of the opening in the inner portion (202) may range from about 1 mm to about 8 mm, including any sub-range and values therebetween, while the divots or notches may have an average diameter ranging from about 1 mm to about 3 mm, including any sub-range and values therebetween. In some embodiments, the average diameter of the outer edge may range from about 6 mm to about 25 mm, including any sub-range and values therebetween.

[0045] Figure 3A is a schematic view of an endocardial catheter device (300) in a deployed configuration, including a multi-spline basket with a deployed (e.g., not folded) membrane (310). The endocardial catheter device (300) can include components that are structurally and / or functionally similar to other ablation devices described herein (e.g., ablation devices (100, 1110)) and can be used in a system as described for such devices. Figure 3A shows an outer shaft (303) and an inner shaft (321). The inner shaft (321) can be in a fully retracted configuration or a fully deployed configuration. In this fully deployed configuration, splines such as (305) and (307) can be bent such that an intermediate portion (e.g., midpoint) of each spline is located further from the inner shaft (321) compared to the non-deployed configuration. For example, the distal electrode (319) and the proximal electrodes (315, 317) are disposed on the spline (305).

[0046] In some embodiments, the membrane (310) may be attached to a hub (312) on the inner shaft (321). Additionally or alternatively, the inner portion of the membrane (310) may be an opening into which the inner shaft (321) is received. In some embodiments, the outer edge of the membrane may be attached to each of the splines, as described herein. Thus, in a fully deployed configuration, as the splines bend outwardly, the membrane (310) may be stretched into a flat or planar (e.g., disc-shaped) shape. In some embodiments, the membrane may be attached to the spline at a longitudinal position on the spline that is at or near the maximum diameter of the basket in the fully deployed configuration, and a distal set of spline electrodes, such as (319), is on the distal side of the membrane (310), and a proximal set of spline electrodes, such as (315, 317), is on the proximal side of the membrane (310). In some embodiments, the membrane may be attached to the spline at a position on the spline that is offset from the position of the maximum diameter by ± about 30% of d1 or d2, where d1 and d2 are shown in FIG. 3B. For example, the membrane may be attached to the spline at a position that is up to about 30% of d1 closer to the distal end of the spline than the position of the maximum diameter. Alternatively, the membrane may be attached to the spline at a position that is up to about 30% of d2 closer to the proximal end of the spline than the position of the maximum diameter.

[0047] In some embodiments, the longitudinal position of the maximum diameter of the basket may be closer to the distal end of the inner shaft than the distal end of the outer shaft. FIG. 3B is a schematic diagram of an endocardial catheter device (300) in a deployed configuration, including a multi-spline basket with an unfolded membrane. The membrane (350) can be attached to the spline (356) at the longitudinal position of the spline that coincides with the maximum diameter of the basket. The respective distances d1 and d2 from the membrane (350) to the distal end of the basket (352) and the proximal end of the basket (354) are shown in FIG. 3B. In some embodiments, the distance d1 may be less than the distance d2. For example, the set of proximal electrodes may be arranged such that the point of maximum curvature of the spline (356), where the membrane is attached, is located closer to the distal end of the basket. In some embodiments, the ratio d1 / d2 may range from about 0.1 to about 0.9, including any sub-range and value therebetween.

[0048] Figure 4 is a schematic front view of a membrane (400) of an endocardial catheter device that includes a multi-spline basket with a foldable membrane. The membrane (400) may be structurally and / or functionally similar to other membranes described herein and can be used with systems and / or devices as described with reference to such membranes. For example, the membrane (400) can be used with any of the ablation devices as described herein. In FIG. 4, the membrane (400) has an outer edge with relatively long concave portions (410, 412, 414, 416) and relatively short arcuate divots or notches (402, 404, 406, 408) between adjacent relatively long concave portions. In some embodiments, the relatively long portions of the membrane are concave along at least a portion thereof. Additionally or alternatively, the portions (410, 412, 414, 416) may be straight and / or may include a set of cuts and / or a set of folds to facilitate deployment (e.g., folding) of the membrane. In some embodiments, one or more of the portions (410, 412, 414, 416) are concave while other portions (410, 412, 414, 416) may be straight or have different shapes or curvatures.

[0049] In some embodiments, the membrane has an inner portion (420) (e.g., an opening, a central hole). Each dimple may be configured as an attachment edge for attachment to a spline of the ablation device, and adjacent dimples are attached to adjacent splines of the ablation device. In some embodiments, each dimple or notch may be adhesively or thermally bonded to the spline. In some embodiments, the inner portion (420) defines an opening that can receive the inner shaft of the catheter. Additionally or alternatively, the inner shaft may be coupled to the hub, and the inner portion (420) of the membrane may be attached to the hub (by adhesive or thermal bonding). In some embodiments, the average diameter of the central hole or inner portion may range between about 1 mm and about 8 mm, including any sub - range and values therebetween, while the dimple or notch may have an average diameter ranging between about 1 mm and about 3 mm, including any sub - range and values therebetween.

[0050] FIG. 5 is a schematic front view of a membrane (500) of an ablation device having recesses along an outer edge (e.g., a peripheral edge) and an inner portion or opening (515) of the membrane (500). The membrane (500) may be structurally and / or functionally similar to other membranes described herein (e.g., membrane (400)) and can be used with systems and / or devices as described with reference to such membranes. For example, the membrane (500) can be used with any of the ablation devices described herein. The outer edge has at least one relatively long concave edge portion (520) having a first end (502) corresponding to point A and a second end (506) corresponding to point B. Two points (509) and (511) are marked along the path from A to B. A straight line (517) is drawn from A to B, and at least a portion of this line (517) has the property of being outside the outer edge of the membrane (500), and thus at least a portion (520) of the outer edge is concave.

[0051] In some embodiments, the outer edge of the membrane has one or more recesses or longer recesses in the sections attached between adjacent splines. In such embodiments, the membrane in the undeployed configuration can fold naturally inward without a portion extending radially outward between the splines. This can facilitate the smooth passage of the catheter device through a delivery device, such as a sheath. In some embodiments, the relatively long concave portion of the outer edge of the membrane can be in the range of about 5 mm to about 50 mm and can be arcuate with an average radius of curvature having any sub-range and value therebetween.

[0052] FIG. 6 provides a schematic view of an endocardial catheter device (600) in an undeployed configuration, including a membrane with folds and a multi-spline basket. The endocardial catheter device (600) can include components that are structurally and / or functionally similar to other ablation devices described herein (e.g., ablation devices (700, 1110)) and can be used in a system as described for such devices. In some embodiments, the catheter includes an outer shaft (602) with an inner lumen and an inner shaft (621) extending beyond the distal end (603) of the outer shaft. The plurality of splines (605, 607) can be attached inside the distal end (603) of the outer shaft at their proximal ends, and their distal ends can be attached to the distal end of the inner shaft (621) at the device tip (630). In some embodiments, the length of each spline can be longer than the maximum distance that the distal end of the inner shaft (621) extends beyond the distal end of the outer shaft (602). Thus, the splines can collectively form a basket structure. In some embodiments, the inner shaft (621) can be translated (e.g., retracted, extended) relative to the outer shaft (602), or the outer shaft (602) can be translated relative to the inner shaft (621) via a handle mechanism (not shown).

[0053] In some embodiments, each spline may have a set of distal electrodes and a set of proximal electrodes. For example, spline (605) has distal electrode (614) and two proximal electrodes (610, 612). In some embodiments, a foldable insulating membrane (617) may be attached to the spline at its outer edge. In some embodiments, the inner portion of membrane (617) may have an opening that can receive inner shaft (621). In some embodiments, the inner shaft may have a hub (619) to which the inner portion of membrane (617) can be attached, as shown in FIG. 6. In some embodiments, hub (619) can be made of a polymeric material such as, for example, Pebax or silicone, and insulating membrane (617) can be made of a polymeric material such as polyurethane, Pebax, silicone. In an undeployed configuration, membrane (617) may have a crease (625) located between adjacent splines, where the membrane is folded inward with respect to the splines.

[0054] In the undeployed configuration shown in FIG. 6, inner shaft (621) may extend fully beyond distal end (603) of outer shaft (602) such that the basket structure formed by the splines has a minimum diameter or cross-section. In some embodiments, the electrodes on the splines may be made of any biocompatible conductor such as stainless steel, gold, platinum-iridium alloy. In some embodiments, the length of the electrodes may range from about 0.5 mm to about 7 mm, including all sub-ranges and values therebetween. In some embodiments, the spacing between the closest edges of adjacent proximal electrodes on a given spline (if there are multiple proximal electrodes on a given spline), or the spacing between the closest edges of adjacent distal electrodes on a given spline (if there are multiple distal electrodes on a given spline) may range from about 0.5 mm to about 5 mm, including all sub-ranges and values therebetween.

[0055] In some embodiments, the arc length of each spline may range from about 8 mm to about 55 mm, including all sub - ranges and values therebetween. In some embodiments, the average diameter of each spline may range from about 0.5 mm to about 3 mm, including all sub - ranges and values therebetween. In some embodiments, the cross - section of each spline may be substantially elliptical or oval, or the spline cross - section may be circular. In some embodiments, the number of splines constituting the basket may range from about 3 to about 16 splines. In some embodiments, the outer diameter of the outer shaft (602) of the catheter may range from about 5F (or 5 / 3 mm) to about 18F (or 6 mm), including all sub - ranges and values therebetween.

[0056] Figure 7 schematically shows an endocardial catheter device (700) (e.g., the basket of FIG. 6) in a deployed configuration. The endocardial catheter device (700) can include components that are structurally and / or functionally similar to other ablation devices described herein (e.g., ablation devices (600, 1110)) and can be used in a system as described for such devices. For example, the device (700) includes a multi - spline basket with an unfolded membrane (721) having an outer edge recess. In some embodiments, the device (700) includes an outer shaft (703) and an inner shaft (723) in a fully retracted or fully deployed configuration. In the fully deployed configuration, the splines (705, 707) may be bent such that the middle portion of each spline is located farther from the inner shaft (723) compared to the non - deployed configuration (e.g., bent outward). In some embodiments, each spline may have a set of distal electrodes and a set of proximal electrodes. For example, the distal electrode (717) and the proximal electrodes (709, 711) are disposed on the spline (705).

[0057] In some embodiments, the membrane (721) may be attached to a hub (714) on the inner shaft (723). In some embodiments, the inner portion of the membrane (721) may define an opening capable of receiving the inner shaft (723). In some embodiments, the outer edge of the membrane (721) may be attached to each of the splines, as described herein. Thus, in a fully deployed configuration, as the splines bend outwardly, the membrane (721) can be stretched (e.g., tautened) and flattened or formed into a planar shape. In some embodiments, the membrane may be attached to the splines at a longitudinal position on the splines at or near the maximum diameter of the basket, the distal set (717) of spline electrodes being on the distal side of the membrane (721), and the proximal sets (709, 711) of spline electrodes being on the proximal side of the membrane (721). As described herein, the longitudinal position of the maximum diameter of the basket may be closer to the distal end of the inner shaft than to the distal end of the outer shaft.

[0058] FIG. 8 provides a schematic view of an undeployed configuration of an endocardial catheter device (800) with a multi-spline basket coupled to a foldable membrane having support struts. The endocardial catheter device (800) can include components that are structurally and / or functionally similar to other ablation devices described herein and can be used in a system as described for such devices. For example, the catheter can have an outer shaft (803) with an inner lumen and an inner shaft (830) extending beyond the distal end (804) of the outer shaft (803). A plurality of splines (805, 807) can be attached inside the distal end (804) of the outer shaft (803) at their proximal ends, and their distal ends can be attached to the distal end of the inner shaft (830) at the device tip. In some embodiments, the length of each spline can be longer than the maximum distance that the distal end of the inner shaft (830) extends beyond the distal end of the outer shaft. Thus, the splines can collectively form a basket structure. In some embodiments, the inner shaft (830) can be translated (e.g., retracted, extended) relative to the outer shaft (803), or the outer shaft (803) can be translated relative to the inner shaft (830) via a handle mechanism (not shown).

[0059] In some embodiments, each spline may have a set of distal electrodes and a set of proximal electrodes. For example, spline (807) has a distal electrode (809) and two proximal electrodes (810, 811). In some embodiments, a foldable insulating membrane (813) is attached to the spline along the periphery of the membrane (813). In some embodiments, the inner portion of the membrane may have an opening through which the inner shaft (830) passes. In some embodiments, the inner shaft may have a hub (825) to which the inner portion of the membrane (813) is attached, as shown in FIG. 8. In some embodiments, the hub (825) can be made of a polymeric material such as, for example, Pebax or silicone, and the insulating membrane (813) can be made of a polymeric material such as, for example, polyurethane, Pebax, silicone, etc.

[0060] In some embodiments, in the undeployed configuration, the membrane (813) may have a crease (815) located between adjacent splines, where the membrane is folded inwardly with respect to the splines. In some embodiments, the membrane may include one or more structural supports (820, 822) (e.g., struts) in the form of radial struts that extend at least partially from the inner portion to the outer edge of the membrane (813) along a direction leading to the points of attachment of the membrane to the splines. The struts (820, 822) may be made of a polymeric material such as, for example, nylon or Kevlar® and may be adhered or joined to the membrane (813) itself. In some embodiments, the struts can add additional structural support to the membrane (813) and can facilitate folding and deployment of the membrane (813), respectively, when the basket is undeployed and deployed.

[0061] In some embodiments, in an undeployed configuration as shown in FIG. 8, the inner shaft may extend completely beyond the distal end (804) of the outer shaft such that the basket structure formed by the splines has a minimum diameter or cross-section. In some embodiments, the electrodes on the splines may be made from any of a biocompatible conductor such as stainless steel, gold, platinum-iridium alloy, etc. In some embodiments, the length of the electrodes may range from about 0.5 mm to about 7 mm, including all sub-ranges and values therebetween. In some embodiments, the spacing between the closest edges of adjacent proximal electrodes on a given spline (if there are multiple proximal electrodes on a given spline), or the spacing between the closest edges of adjacent distal electrodes on a given spline (if there are multiple distal electrodes on a given spline) may range from about 0.5 mm to about 5 mm, including all sub-ranges and values therebetween.

[0062] In some embodiments, the arc length of each spline may range from about 8 mm to about 55 mm, including all sub-ranges and values therebetween. In some embodiments, the average diameter of each spline may range from about 0.5 mm to about 3 mm, including all sub-ranges and values therebetween. In some embodiments, the cross-section of each spline may be substantially oval or oblong, or the spline cross-section may be circular. In some embodiments, the number of splines forming the basket may range from about 3 to about 16 splines. In some embodiments, the outer diameter of the outer shaft (803) of the catheter may range from about 5F (or 5 / 3 mm) to about 18F (or 6 mm).

[0063] FIG. 9 is a schematic view of an endocardial catheter device (900) in a deployed configuration, including a multi-spline basket with an undeployed membrane (914) having an outer edge recess and support struts similar to those of the device shown in FIG. 8. The endocardial catheter device (900) can include components that are structurally and / or functionally similar to other ablation devices described herein and can be used in a system as described for such devices. For example, the device (900) includes an outer shaft (902) and an inner shaft (925) in a fully retracted configuration. In a fully deployed configuration, the splines (904, 906) are bent (e.g., bent outwardly) such that the middle portion of each spline can be located further from the inner shaft (925) compared to the undeployed configuration. In some embodiments, each spline may have a set of distal electrodes and a set of proximal electrodes. For example, the distal electrode (911) and proximal electrodes (907, 909) may be disposed on the spline (906).

[0064] In some embodiments, the membrane (914) may be attached to a hub (916) on the inner shaft (925). Additionally or alternatively, the inner portion of the membrane (914) may define an opening that can receive the inner shaft (925). In some embodiments, the outer edge of the membrane may be attached to each of the splines as described herein. Thus, in a fully deployed configuration, as the splines bend outwardly, the membrane (914) can be flattened or extended into a planar shape. In some embodiments, the membrane may be attached to the spline at a longitudinal position on the spline at or near the maximum diameter of the basket, the distal set of spline electrodes (911) is on the distal side of the membrane (914), and the proximal set of spline electrodes (907, 909) is on the proximal side of the membrane (914).

[0065] In some embodiments, a membrane (914) having an outer edge recess may have a structural support (920, 922), such as a radial strut, that extends at least partially from an inner portion of the membrane (914) to the outer edge along a direction leading to the membrane attachment point to the spline. In some embodiments, the strut may be made of a polymeric material such as nylon or Kevlar, and may be adhered or joined to the membrane itself. In some embodiments, the strut can add additional structural support to the membrane and can facilitate folding and deployment of the membrane when the basket is not deployed and when it is deployed, respectively. In some embodiments, the longitudinal position of the maximum diameter of the basket may be closer to the distal end of the inner shaft than to the distal end of the outer shaft.

[0066] FIG. 10 is a schematic perspective view of a deployed device (1000) having a deployed distal portion of a device (1000) that abuts a tissue wall, depicting the damage created in the tissue wall during ablation delivery along with the depth of damage. The device (1000) can include components that are structurally and / or functionally similar to those of other ablation devices described herein and can be used in a system as described for such devices. For example, the device (1000) includes a deployed multi-spline basket with an unfolded membrane (1012) having an outer edge recess as described herein. The catheter device (1000) has an outer shaft (1002), an inner shaft (1022), and a plurality of splines (1030, 1032). In a fully deployed configuration, the splines (1030, 1032) are bent such that an intermediate portion of each spline is located further from the inner shaft (1022) compared to the non-deployed configuration (e.g., bent outwardly). In some embodiments, each spline may have a set of distal electrodes and a set of proximal electrodes. For example, distal electrode (1005) and proximal electrodes (1007, 1009) are disposed on spline (906).

[0067] In some embodiments, the membrane (1012) may be attached to a hub on the inner shaft (1022). Additionally or alternatively, the inner portion of the membrane defines an opening that can receive the inner shaft (1022). In some embodiments, the outer edge of the membrane may be attached to each of the splines, as described herein. Thus, in a fully deployed configuration, as the splines bend outwardly, the membrane (1012) can be flattened or extended into a planar shape. In some embodiments, the membrane may be attached to the spline at a longitudinal position on the spline at or near the maximum diameter of the basket, the distal set (1005) of the spline electrodes is on the distal side of the membrane (1012), and the proximal sets (1007, 1009) of the spline electrodes are on the proximal side of the membrane (1012).

[0068] In some embodiments, the splines are deployed within the blood pool (1035), engage the tissue wall (1015) on a first side, and the second side (1031) of the tissue wall (1015) comprises solid tissue (e.g., heart tissue). In some embodiments, to create tissue damage, a suitable waveform having a predetermined voltage amplitude (e.g., in the range from several hundred volts to about 15 kV or more, including all sub - ranges and values therebetween) (e.g., a waveform suitable for efficiently creating pulsed electric field ablation lesions for use with devices as described in International Applications PCT / US2016 / 057664 and PCT / US2019 / 031135, which are incorporated herein by reference) may be applied to a subset of the spline electrodes paired with opposite electrical polarities to create a damage volume (1023) having a damage boundary represented by the interface (1019). In some embodiments, any of the devices described herein can create tissue damage having a depth (1023) deep enough to excise thicker heart tissue, such as ventricular tissue. In some embodiments, a device having a membrane as described herein can create a damage having a depth that is about 20% or more deeper than a device without a membrane.

[0069] In some embodiments, the ablation lesions generated by pulsed electric field ablation can be delivered in various deployed configurations, including being partially or fully deployed. In some embodiments, one or more portions of the catheter device are flexible and can be maneuvered or navigated via a deflection control mechanism (e.g., a steering knob, a plunger / rocker, a lever) to access various cardiac anatomical locations. In some embodiments, the catheter device is inserted via a delivery device such as a sheath that provides primary access to the anatomical region of interest, and the deflection of the catheter itself provides secondary access for fine control and manipulation for accessing the desired target anatomical site. In some variations, one or more of the electrodes of the device may be configured to record diagnostic intracardiac electrogram signals when not delivering ablation energy, thereby allowing the same device to be used to evaluate the local site for electrogram information before and after ablation.

[0070] In some embodiments, the catheter devices described herein may incorporate an electromagnetic tracking sensor for use with an electromagnetic tracking or localization system (e.g., an electronic device (1130)). When the catheter is connected to such a system or an electroanatomical mapping system, the catheter can be visualized on a display indicating its three-dimensional position within the cardiac anatomical structure. The electrogram recordings from the catheter electrodes also serve to generate an electroanatomical map that can be used as a diagnostic reference. A suitable example of such a device is described in International Patent Application PCT / US20 / 61809, published as International Patent Application Publication WO2021 / 108312 under the title "Methods, systems, and apparatuses for tracking ablation devices and generating lesion lines", the content of which is incorporated herein by reference in its entirety.

[0071] Method Methods are also described herein for performing tissue ablation at or near one or more intracardiac locations using the systems and devices described herein. Generally, one or more catheters can be advanced to a target location in a minimally invasive manner through a vasculature. For example, an ablation device may be advanced through a vasculature via a guidewire and through a flexible sheath. The sheath may be configured to flex and assist in guiding a local ablation catheter through the vasculature and to one or more predetermined targets (e.g., pulmonary vein ostia or other atrial or ventricular locations). A dilator may be advanced via a guidewire and may be configured for formation and dilation of a transseptal aperture during and / or prior to use. The methods described herein include introducing and positioning an ablation device (e.g., ablation device (1110) or any other ablation device described herein) near or in contact with a region of the heart. In some embodiments, a cardiac stimulation device (e.g., cardiac stimulation device (1128)) may be used to deliver pacing signals to the heart or a measurement device may be used to measure cardiac activity. Pulse waveforms may be delivered by one or more electrodes of an ablation device to excise tissue. In some embodiments, ablation energy may be delivered in synchronization with cardiac pacing. In some embodiments, the voltage pulse waveforms described herein may be applied during the refractory period of the cardiac cycle so as not to disrupt the sinus rhythm of the heart.

[0072] FIG. 12 is a method (1200) for one embodiment of a tissue ablation process. In some embodiments, the voltage pulse waveforms described herein can be applied during the refractory period of the cardiac cycle so as not to disrupt the sinus rhythm of the heart. The method (1200) includes, at (1202), introducing a device (e.g., an ablation device (1110) or any other ablation device described herein) into the endocardial space of the heart. For example, the device can be inserted through a delivery device such as a flexible sheath and navigated to the target anatomical region. In some embodiments, the electrodes of the ablation device can be positioned near or adjacent to the endocardial surface of the heart. In some embodiments, one or more portions of the device can be flexed to fine-tune the position and placement of the distal portion of the device. At (1204), the ablation device can be deployed, for example, as described with respect to the exemplary embodiments herein. For example, the device can be deployed so as to be juxtaposed with the tissue before a pulsed electric field ablation waveform is applied to the tissue using the catheter electrodes.

[0073] In (1206), a pulse waveform can be generated. Various bipolar pair arrangements of subsets of each of the distal and proximal electrodes can be implemented for ablation delivery and lesion generation. For example, the voltage pulse waveform may be applied in a refractory time window. In some embodiments, the pulse waveform may be generated with a time offset relative to the pacing signal indication. For example, the start of the refractory time window may be offset from the pacing signal by a time offset. The voltage pulse waveform may be applied over a series of heartbeats over a corresponding common refractory time window. In alternative embodiments, the ablation pulse waveform may be delivered without a pacing signal, e.g., asynchronously. In (1208), the generated pulse waveform can be delivered to tissue. In some embodiments, the pulse waveform may be delivered to the tissue of the patient's heart via one or more splines of a set of splines of the ablation device. In other embodiments, a voltage pulse waveform as described herein may be selectively delivered to an electrode subset, such as an anode-cathode subset, for ablation. For example, the first and second electrodes of the electrode group may be configured to have opposite polarities. These steps may be repeated for a desired number of tissue sites for ablation. For example, after completion of lesion delivery to the first target location, the device may be navigated to a second anatomical location (using one or more of the deflections of the catheter or sheath) for ablation delivery at the second location. The deployment of the device can be adjusted as needed. In some embodiments, when the orientation of the catheter basket with respect to the local tissue wall is 45 degrees or less relative to the local surface normal at the endocardial surface, a relatively deep lesion can be generated with more complete deployment. The process of ablation delivery can be repeated for multiple target sites, including the generation of a continuous line of excised tissue.

[0074] The devices and methods disclosed herein can provide for the efficient generation of deep cardiac lesions using pulsed electric field ablation waveforms. Although specific device embodiments are described herein for purposes of illustration, it will be apparent to those skilled in the art that other device embodiments can be readily implemented in accordance with the disclosure provided herein. For example, without departing from the scope of the present invention, modifications and variations such as the number of splines, the number of electrodes, etc., or various local ablation devices can be constructed and deployed in accordance with the teachings herein.

[0075] As used herein, the terms "about" and / or "approximately" when used in conjunction with a numerical value and / or range generally refer to a numerical value and / or range that is close to the recited numerical value and / or range. In some instances, the terms "about" and "approximately" can mean within ±10% of the recited value. For example, in some instances, "about 100 [units]" can mean within ±10% of 100 (e.g., 90 to 110). The terms "about" and "approximately" can be used interchangeably.

[0076] As used herein, the terms "set" and / or "subset" of components (e.g., electrodes) generally refer to one single one of those components or a plurality of those components.

[0077] Some embodiments described herein relate to a computer storage product having a non-transitory computer-readable medium (which may also be called a non-transitory processor-readable medium) having instructions or computer code for performing various computer-implemented operations. The computer-readable medium (or processor-readable medium) is non-transitory in the sense that it does not include a transitory propagated signal itself (e.g., a propagated electromagnetic wave that carries information on a transmission medium such as space or a cable). The medium and the computer code (which may also be called code or an algorithm) may be designed and constructed for a particular one or more purposes. Examples of non-transitory computer-readable media include magnetic storage media such as hard disks, floppy (registered trademark) disks, and magnetic tapes, optical storage media such as compact disks / digital video disks (CD / DVDs), compact disk read-only memories (CD-ROMs), and holographic devices, magneto-optical storage media such as optical disks, carrier wave signal processing modules, and hardware devices such as application specific integrated circuits (ASICs), programmable logic devices (PLDs), field programmable gate arrays (FPGAs), read-only memories (ROMs), and random access memory (RAM) devices that are particularly configured to store and execute program code, but are not limited thereto. Other embodiments described herein relate to, for example, computer program products that may include the instructions and / or computer code disclosed herein.

[0078] The systems, devices, and / or methods described herein may be implemented by software, hardware, or a combination thereof (executed on hardware). Hardware modules may include, for example, a general-purpose processor (or microprocessor or microcontroller), a field programmable gate array (FPGA), and / or an application specific integrated circuit (ASIC). Software modules (executed on hardware) may be represented in various software languages (e.g., computer code), including C, C++, Java®, Ruby, Visual Basic®, and / or other object-oriented, procedural, or other programming languages and development tools. Examples of computer code include, but are not limited to, microcode or microinstructions, machine instructions such as those generated by a compiler, code used to generate web services, and files containing high-level instructions executed by a computer using an interpreter. Further examples of computer code include, but are not limited to, control signals, encryption code, and compression code.

[0079] Without departing from the scope of the present invention, various modifications and additions can be made to the exemplary embodiments described. For example, while the above embodiments refer to specific features, the scope of the present invention also includes embodiments having different combinations of features and embodiments that do not include all of the described features. Accordingly, the scope of the present invention is intended to embrace all such alternatives, modifications, and variations, together with all of their equivalents, that fall within the scope of the claims.

[0080] The technical ideas included in the present disclosure are described below as appendices. [Appendix 1] An endocardial catheter, an outer shaft having a proximal end and an opposite distal end, and an outer shaft lumen extending through the proximal end and the distal end; An inner shaft slidably disposed within the outer shuttle lumen, having a proximal portion and an opposite distal end, and sized to extend beyond the distal end of the outer shaft, the inner shaft; A spline assembly comprising a plurality of flexible splines, each of the plurality of splines having a spline proximal end attached to the distal end of the outer shaft, an opposite spline distal end attached to the distal end of the inner shaft, and a plurality of electrodes, the plurality of splines collectively defining an internal space of the spline assembly, the spline assembly; A foldable membrane disposed within the internal space of the spline assembly, having an outer edge portion attached to one or more of the plurality of splines, the foldable membrane Comprising an endocardial catheter.

[0081] [Appendix 2] The endocardial catheter according to Appendix 1, wherein the foldable membrane is formed of an electrically insulating material.

[0082] [Appendix 3] The endocardial catheter according to Appendix 2, wherein the spline assembly is capable of transitioning between an undeployed configuration and a deployed configuration by causing relative axial movement between the inner shaft and the outer shaft.

[0083] [Appendix 4] The endocardial catheter according to Appendix 3, wherein the spline assembly has a minimum diameter in an undeployed configuration and a maximum diameter in a fully deployed configuration.

[0084] [Appendix 5] The plurality of electrodes on each spline include a proximal spline electrode and a distal spline electrode, and the proximal spline electrodes of the plurality of splines collectively define a set of proximal spline electrodes, and the distal spline electrodes of the plurality of splines collectively define a set of distal spline electrodes. The endocardial catheter according to supplementary note 4.

[0085] [Supplementary note 6] The outer edge portion of the foldable membrane is attached to one or more splines at its longitudinal position corresponding to the maximum diameter of the spline assembly in the fully deployed configuration. The endocardial catheter according to supplementary note 5.

[0086] [Supplementary note 7] The outer edge portion of the foldable membrane is attached to one or more splines at its longitudinal position between the proximal spline electrode and the distal spline electrode disposed on each of the one or more splines. The endocardial catheter according to supplementary note 5.

[0087] [Supplementary note 8] Each of the plurality of splines has a curved shape when the spline assembly is in the deployed configuration, and the foldable membrane is attached to the one or more splines at its maximum curvature point, and the maximum curvature point is located closer to the distal end of each spline than to the proximal end of each spline. The endocardial catheter according to supplementary note 7.

[0088] [Supplementary note 9] The foldable membrane takes a circular shape when the spline assembly is in the deployed configuration. The endocardial catheter according to supplementary note 5.

[0089] [Supplementary note 10] The outer edge portion of the foldable membrane has a plurality of arcuate notches at positions corresponding to the attachment points of the foldable membrane to one or more splines. The endocardial catheter according to supplementary note 9.

[0090] [Appendix 11] The outer edge portion of the foldable membrane has a plurality of concave portions when the spline assembly is in the deployed configuration. The endocardial catheter according to Appendix 5.

[0091] [Appendix 12] The foldable membrane includes a plurality of folds, and each one of the plurality of folds is located between adjacent splines of the spline assembly. The endocardial catheter according to Appendix 5.

[0092] [Appendix 13] The foldable membrane includes an opening, and the inner shaft extends through the opening. The endocardial catheter according to Appendix 5.

[0093] [Appendix 14] The inner shaft includes a hub, and the inner edge of the opening of the foldable membrane is attached to the hub. The endocardial catheter according to Appendix 13.

[0094] [Appendix 15] When transitioning between the deployed configuration and the non-deployed configuration of the spline assembly, the foldable membrane further includes a plurality of radial struts coupled to the foldable membrane and configured to facilitate folding and deployment of the foldable membrane. The endocardial catheter according to Appendix 14.

Claims

1. An endocardial catheter, an outer shaft having a proximal end and an opposite distal end and an outer shaft lumen extending through said proximal end and said distal end; an inner shaft slidably disposed within the outer shaft lumen, the inner shaft having a proximal portion and an opposite distal end, the inner shaft sized to extend beyond the distal end of the outer shaft; a spline assembly comprising a plurality of flexible splines, each of the plurality of splines having a spline proximal end attached to the distal end of the outer shaft, an opposing spline distal end attached to the distal end of the inner shaft, and a plurality of electrodes, the plurality of splines collectively defining an interior space of the spline assembly, the plurality of electrodes on each spline including a proximal spline electrode and a distal spline electrode; a foldable membrane disposed within the interior space of the spline assembly, the foldable membrane having an outer edge portion attached to one or more of the plurality of splines; An endocardial catheter comprising:

2. An endocardial catheter as described in claim 1, wherein the proximal spline electrodes of the plurality of splines collectively define a proximal spline electrode set, and the distal spline electrodes of the plurality of splines collectively define a distal spline electrode set.

3. An endocardial catheter as described in claim 1, wherein the foldable membrane includes an opening and the inner shaft extends through the opening.

4. An endocardial catheter as described in claim 3, wherein the inner shaft includes a hub and the inner edge of the opening in the foldable membrane is attached to the hub.

5. An endocardial catheter as described in claim 1, wherein the foldable membrane is formed of an electrically insulating material.

6. An endocardial catheter as described in claim 1, wherein the spline assembly can be transitioned between an undeployed configuration and a deployed configuration by causing relative axial movement between the inner shaft and the outer shaft.

7. An endocardial catheter as described in claim 6, wherein the outer edge portion of the foldable membrane is attached to one or more splines at a longitudinal position between the proximal spline electrode and the distal spline electrode located on each of the one or more splines.

8. An endocardial catheter as described in claim 6, wherein the outer edge portion of the foldable membrane has multiple recessed portions when the spline assembly is in an expanded configuration.

9. An endocardial catheter as described in claim 6, wherein the foldable membrane includes a plurality of folds, each one of the plurality of folds being located between adjacent splines of the spline assembly.

10. An endocardial catheter as described in claim 4, further comprising a plurality of radial struts coupled to the foldable membrane configured to facilitate folding and unfolding of the foldable membrane.

Images