Localized ablation device with foldable elements, and systems and methods thereof

Abstract

The endocardial catheter includes an outer shaft having an outer shaft lumen, an inner shaft slidably disposed within the outer shaft lumen, a spline assembly including a plurality of flexible splines, each of the plurality of 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 foldable membrane having an outer peripheral portion attached to one or more of the plurality of splines. The foldable membrane includes an electrically insulating material.

Description

[Technical field]

[0001] The embodiments described herein relate generally to systems, devices, and methods for therapeutic electrical energy delivery, and more particularly, to systems, devices, and methods for the application of pulsed electric fields to ablate tissue by irreversible electroporation using local ablation devices. [Background technology]

[0002] Pulsed electric field ablation, which uses the application of high voltage pulses, has been demonstrated to be suitable for 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 localized high electric fields that can drive cell membrane disruption and result in cell death, a process also called 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] In the presence of a relatively highly conductive fluid medium (such as blood), the high voltage pulses of pulsed electric field ablation can drive current between the electrodes of the ablation device, with a significant percentage of the net current flowing through the fluid medium rather than through the tissue. This can result in suboptimal lesion characteristics for some applications, such as, for example, creating deeper lesions in thicker tissue (e.g., ventricular tissue). Therefore, it may be desirable to have an ablation device design that can improve the creation of deeper lesions in tissue. Summary of the Invention

[0004] In Example 1, an 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 interior space of the spline assembly. The foldable membrane is disposed within the interior space of the spline assembly, the foldable membrane having an outer peripheral portion attached to one or more of the plurality of splines.

[0005] In Example 2, the endocardial catheter of Example 1, the collapsible membrane is formed of an electrically insulating material. In Example 3, in the endocardial catheter of Example 2, 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.

[0006] In Example 4, the endocardial catheter of Example 3, the spline assembly has a minimum diameter in the undeployed 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 defining a proximal spline electrode set, and the distal spline electrodes of the plurality of splines collectively defining a distal spline electrode set.

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

[0009] In Example 7, in the endocardial catheter of Example 5, an outer edge portion of the foldable membrane is attached to one or more splines at a longitudinal position between proximal and distal spline electrodes 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 a deployed configuration, and the foldable membrane is attached to one or more splines at a point of maximum curvature thereof, the point of maximum curvature being located closer to a distal end of each spline than to a proximal end of each spline.

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

[0012] In Example 11, the endocardial catheter of Example 5, wherein the outer edge portion of the collapsible membrane has a plurality of recessed portions when the spline assembly is in the deployed configuration. In Example 12, the endocardial catheter of Example 5, 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.

[0013] In Example 13, the endocardial catheter of Example 5, wherein the collapsible membrane includes an opening and the inner shaft extends through the opening. In Example 14, the endocardial catheter of Example 13, the inner shaft includes a hub, and an inner edge of the opening in the collapsible membrane 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 as the spline assembly transitions between the deployed and undeployed configurations.

[0015] In Example 16, a system for localized 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 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 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 interior space of the spline assembly. The foldable membrane is disposed within the interior space of the spline assembly, the foldable membrane having an outer peripheral portion attached to one or more of the plurality of splines. The signal generator is configured to generate and deliver a pulse waveform to the plurality of electrodes.

[0016] In Example 17, in the system of Example 16, 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 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, an outer edge portion of the foldable membrane is attached to one or more splines at a longitudinal location thereof corresponding to a maximum diameter of the spline assembly in a fully deployed configuration.

[0018] In Example 19, an endocardial catheter includes an outer shaft, an inner shaft, an expandable and contractible spline assembly, and a foldable membrane. The outer shaft has an outer shaft distal end, and the inner shaft is disposed within the outer shaft and includes an inner shaft distal end. The expandable and contractible spline assembly includes a plurality of splines, each of the plurality of splines connected to the outer shaft distal end and the inner shaft distal end, each spline further including 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 location between the proximal and distal electrodes disposed thereon.

[0019] In Example 20, the endocardial catheter of Example 19, the attachment location corresponds to the maximum diameter of the spline assembly in a fully deployed configuration. While multiple embodiments are disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive. [Brief description of the drawings]

[0020] [Figure 1] FIG. 1 is a schematic perspective view of an ablation device in an undeployed configuration, in accordance with an embodiment. [Diagram 2] FIG. 2 is a schematic front view of a membrane of an ablation device, according to an embodiment. [Figure 3A]3A and 3B are schematic perspective views of an ablation device in a deployed configuration, according to an embodiment. [Figure 3B] 3A and 3B are schematic perspective views of an ablation device in a deployed configuration, according to an embodiment. [Figure 4] FIG. 4 is a schematic front view of a membrane of an ablation device, according to an embodiment. [Diagram 5] FIG. 5 is a schematic front view of a membrane of an ablation device, according to an embodiment. [Figure 6] FIG. 6 is a schematic perspective view of an ablation device in an undeployed configuration, according to an embodiment. [Figure 7] FIG. 7 is a schematic perspective view of an ablation device in a deployed configuration, according to an embodiment. [Figure 8] FIG. 8 is a schematic perspective view of an ablation device in an undeployed configuration, according to an embodiment. [Figure 9] FIG. 9 is a schematic perspective view of an ablation device in a deployed configuration, according to an embodiment. [Figure 10] FIG. 10 is a schematic perspective view of an ablation device in a deployed configuration abutting a tissue wall and creating lesions, in accordance with an embodiment. [Figure 11] FIG. 11 is a schematic diagram of an ablation system, according to an embodiment. [Figure 12] FIG. 12 illustrates a method for tissue ablation, according to an embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0021] While the invention is amenable to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. The intention, however, is not to limit the invention to the specific 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] Described herein are local ablation devices and associated systems and methods for generating pulsed electric fields that can be delivered to tissue (e.g., cardiac tissue) for ablation. Such delivery of pulsed electric fields for ablation is sometimes referred to herein as pulsed field ablation or PFA. In some embodiments, the local ablation devices described herein can be used to treat cardiac arrhythmias in atrial or ventricular cardiac tissue.

[0023] Pulsed electric field energy delivery utilizes short pulses of high voltage that generate locally high electric fields that can drive cell membrane disruption and result in cell death, a process also referred to as irreversible electroporation. Examples of endocardial regional catheters configured for delivery of PFA are described in (1) U.S. Patent Application No. 15 / 874,721, filed January 18, 2018, entitled "SYSTEMS, DEVICES, AND METHODS FOR FOCAL ABLATION," published as U.S. Patent No. 10,130,423, (2) International Patent Application No. PCT / US19 / 14226, filed January 18, 2019, entitled "SYSTEMS, DEVICES, AND METHODS FOR FOCAL ABLATION," published as International Patent Application Publication No. WO2019 / 143960, and (3) International Patent Application No. PCT / US19 / 14226, filed January 18, 2019, entitled "SYSTEMS, DEVICES, AND METHODS FOR FOCAL ABLATION," published as International Patent Application Publication No. WO2020 / 206328. and in International Patent Application PCT / US20 / 26682, filed April 3, 2020, entitled "ABLATION OF A BLOOD STRESS SYSTEM FOR AN IMMUNE SURFACE STRESS" ("ABLATION"), the contents of which are incorporated herein by reference in their entireties.

[0024] In some embodiments, a signal generator can be used to generate waveforms for pulsed electric field ablation. The signal generator can be coupled to an ablation device described herein and can generate waveforms suitable for use with such devices. Such pulse 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, thus resulting in more effective ablative lesions while reducing (e.g., minimizing) the total energy delivered. In some embodiments, the voltage pulse waveforms disclosed herein can be hierarchical and have a nested structure. For example, the pulse waveforms can include a hierarchical grouping of pulses with associated time scales. Examples of suitable pulse waveforms including multiple levels of hierarchy are disclosed in International Application No. PCT / US2016 / 057664, filed October 19, 2016, entitled "SYSTEMS, APPARATUSES AND METHODS FOR DELIVERY OF ABLATIVE ENERGY TO TISSUE," and International Application No. PCT / US2019 / 031135, filed May 7, 2019, entitled "SYSTEMS, APPARATUSES AND METHODS FOR DELIVERY OF ABLATIVE ENERGY TO TISSUE," the contents of each of which are incorporated herein by reference in their entirety.

[0025] In endocardial clinical applications of pulsed electric field ablation, it may be desirable to create a localized lesion in which a localized region of tissue is ablated. In some instances, such lesions may be transmural, e.g., the lesion extends throughout the entire depth of the tissue wall. In thicker cardiac tissue, as is common, e.g., in the left ventricle, the tissue thickness may be significantly greater, e.g., 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 create deeper lesions. The systems, devices, and methods described herein can be configured to deliver pulsed electric field ablation to tissue for the creation of deeper lesions.

[0026] system The present disclosure describes embodiments of apparatus and devices for pulsed electric field ablation delivery to generate deep lesions in cardiac tissue, as well as related methods of use. In some embodiments, the device may be a catheter including 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 comprising 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 may be 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 may collectively form a basket-like shape. In some embodiments, the inner shaft may 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 multiple semi-deployed (e.g., partially deployed) configurations between the undeployed and deployed configurations. For example, in the undeployed configuration, the inner shaft may be extended beyond the distal end of the outer shaft such that the basket-like shape formed by the splines has a minimum diameter or cross-section. When the inner shaft is retracted, the splines can expand (e.g., via buckling or outward movement) into a basket-like structure having a larger cross-section (e.g., a larger cross-section having a larger maximum diameter than in the undeployed configuration). In some embodiments, a range of deployment from undeployed to fully deployed is generally available, with the basket-like shape achieving its widest cross-section when the device is fully deployed.

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

[0029] In some embodiments, the membrane including the insulating material may be generally disposed at a middle or central portion of the splines. To facilitate attachment of the membrane to one or more of the splines, the membrane may define one or more recesses (e.g., notches) along an outer edge of the membrane configured to attach to one or more of the splines. In some embodiments, an inner portion of the membrane may define an opening (e.g., a hole) configured to receive an inner shaft. In some embodiments, the membrane 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 membrane's surface area on one side may be greater than the cross-sectional area formed by the splines in the undeployed configuration. In some embodiments, in the undeployed configuration, the membrane may define one or more edges (e.g., fold lines) that allow the membrane to naturally fold between adjacent splines. In the undeployed configuration, in which the basket is expanded, the membrane may be open (e.g., unfolded) and assume a relatively taut or flat configuration between the splines. In some embodiments, the membrane may have a surface area that is about 50% or greater than the maximum cross-sectional area formed by the splines in the undeployed configuration.

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

[0032] In some embodiments, a membrane including an insulator disposed between the distal set of spline electrodes and the proximal set of spline electrodes may be configured to redirect the electric field lines generated by the device such that the electric field strength is increased distal to the distal electrodes, thereby generating a relatively deeper lesion than would be generated in the absence of the membrane. The membrane may be configured to facilitate deeper lesions from an undeployed configuration to a fully deployed configuration, and any partially deployed configurations therebetween. In some embodiments, a device with a membrane as described herein can generate lesions having a depth of about 20% or more greater than a device without a membrane.

[0033] In general, the systems and devices described herein include one or more catheters configured to ablate tissue in 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 an apparatus (1120) including a signal generator (1122), a processor (1124), a memory (1126), and optionally a cardiac stimulation device (1128). The apparatus (1120) may be coupled to the 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, for example, a pulmonary vein ostium or other cardiac location. For example, the signal generator (1122) may be a voltage pulse waveform generator and may deliver a pulse waveform to the ablation device (1110). The processor (1124) may incorporate data received from the memory (1126) to determine parameters (e.g., amplitude, width, duty cycle, etc.) of the pulse waveform generated by the signal generator (1122). The memory (1126) may further store instructions that cause the signal generator (1122) to perform 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 waveform 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 a pulsed waveform as described in more detail herein. For example, the ablation device (1110) may be introduced into the endocardial space of the heart and positioned to position one or more electrodes (1112) and membrane (1113) in proximity to tissue, and then deliver a pulsed waveform to ablate 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 breakdown of its corresponding insulation. In some embodiments, the insulation on each electrical lead is capable of maintaining a potential difference of about 200V to about 2500V across its thickness without breakdown. For example, the electrodes (1112) may be grouped into one or more anode-cathode subsets, such as, for example, a subset including 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 splines of the electrodes (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) may be coupled to the apparatus (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, locating, protecting, pacing, etc. In some embodiments, the electronic device (1130) may include one or more of a sensor, a mapping catheter, a protecting device, and a pacing device. For example, the electronic device (1130) may be a pacing device suitably coupled to a patient (not shown) and configured to receive a cardiac pacing signal generated by a cardiac stimulator (1128) of the apparatus (1120) for cardiac stimulation. An indication of the pacing signal may be transmitted by the cardiac stimulator (1128) to the signal generator (1122). Based on the pacing signal, an ablation voltage pulse waveform may be selected, calculated, and / or otherwise identified 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 synchronously (e.g., within a common refractory window) with the indication of the pacing signal. For example, in some embodiments, the common refractory window may begin substantially immediately (or after a very small delay) after the ventricular pacing signal and then last 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., delivered asynchronously.

[0037] The processor (1124) may be any suitable processing device configured to run 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 run and / or execute application processes and / or other modules, processes and / or functions associated with the system and / or its associated network (not shown). The underlying device technology may be provided with a variety of component types, for example, metal oxide semiconductor field effect transistor (MOSFET) technology such as complementary metal oxide semiconductor (CMOS), bipolar technology such as emitter coupled logic (ECL), polymer technology (e.g., silicon-conjugated polymer and metal-conjugated polymer-metal structures), mixed analog and digital, and / or the like.

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

[0039] The system (1100) may communicate with other devices (not shown) via one or more networks, each of which may be any type of network, for example. A wireless network may refer to any type of digital network that is not connected by any type of cable. However, a wireless network may be connected to a wired network to interface with the Internet, other carrier voice and data networks, business networks, and personal networks. Wired networks are 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 combined 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 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 a distal end (131) of the outer shaft (101). The plurality of splines (105, 119) may be attached at their proximal ends to an inner surface of the distal end (131) of the outer shaft (101). The distal ends of the 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 greater than the maximum distance the distal end of the inner shaft (103) may extend beyond the distal end of the outer shaft (101). Thus, the splines may collectively form a basket-like structure. In some embodiments, the inner shaft (103) may be translated (e.g., retracted and 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 spline of the plurality of splines has a set of distal electrodes and a set of proximal electrodes. For example, spline (105) may have a 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 locations (135, 137), respectively. An inner portion of membrane (111) may define an opening through which inner shaft (103) is received (e.g., passes through). Optionally, inner shaft may include a hub (117) to which inner portion (140) of membrane may be attached, as shown in FIG. 1. The hub (117) can be made from a polymeric material such as, for example, Pebax or silicone, and the membrane (111) may include a polymeric material such as, for example, polyurethane, Pebax, silicone, etc. In the undeployed configuration, the membrane (111) may have creases (113) located between adjacent splines where the membrane (111) folds inwardly against the splines (105, 119). In some embodiments, the membrane (111) may have a pattern or cuts configured to define lines along which the membrane (111) folds.

[0042] In the undeployed configuration shown in FIG. 1, the inner shaft (103) is fully extended 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 electrical 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 subranges and values ​​therebetween. The spacing between the nearest edges of adjacent proximal electrodes on a given spline (if there are multiple proximal electrodes on a given spline) or the nearest 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 subranges and values ​​therebetween.

[0043] In some embodiments, the arc length of the splines may range from about 8 mm to about 55 mm, including any subranges and values ​​therebetween. In some embodiments, the average diameter of each spline may range from about 0.5 mm to about 3 mm, including any subranges and values ​​therebetween. In embodiments, the cross section of the splines may be approximately elliptical or oval, or the spline cross section may be circular. In some embodiments, the number of splines on 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] FIG. 2 is a schematic diagram of a membrane (200) of an endocardial catheter device described herein. The membrane (200) may be structurally and / or functionally similar to other membranes described herein and may be used with systems and / or devices as described with reference to such membranes. For example, the membrane (200) may 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., periphery) and an inner portion (202) that defines a circular hole (e.g., aperture). As shown in FIG. 2, the outer edge (212) may be approximately circular with arcuate divots, notches, or recesses (205, 206, 207, 208). Each divot may be configured as a mounting edge for mounting to a spline of the device, with adjacent divots 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 bonded to the spline. In some embodiments, the inner portion (202) defines an opening capable of receiving an inner shaft (not shown) of a catheter. In some embodiments, the inner shaft may be attached to a hub (such as hub (117) in FIG. 1) and the inner portion (202) of the membrane may be attached to the hub (e.g., by 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 subranges and values ​​therebetween, while the divot or notch may have an average diameter that may range from about 1 mm to about 3 mm, including any subranges 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 subranges and values ​​therebetween.

[0045] FIG. 3A is a schematic diagram of an endocardial catheter device (300) in a deployed configuration, including a multi-spline basket with an deployed (e.g., unfolded) membrane (310). The endocardial catheter device (300) may include structurally and / or functionally similar components to other ablation devices described herein (e.g., ablation devices (100, 1110)) and may be used in a system as described with respect to such devices. FIG. 3A shows an outer shaft (303) and an inner shaft (321). The inner shaft (321) may be in a fully retracted configuration or a fully deployed configuration. In this fully deployed configuration, the splines, such as (305) and (307), may be bent such that the intermediate portion (e.g., midpoint) of each spline is located farther from the inner shaft (321) compared to the undeployed configuration. For example, the distal electrode (319) and the proximal electrodes (315, 317) are disposed on the splines (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 through 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, the membrane (310) may be stretched into a flat or planar (e.g., disk-like) shape as the splines flex outward. In some embodiments, the membrane may be attached to the splines at a longitudinal location on the splines that is at or near the maximum diameter of the basket in the fully deployed configuration, with a distal set of spline electrodes, such as (319), distal to the membrane (310) and a proximal set of spline electrodes, such as (315, 317), proximal to the membrane (310). In some embodiments, the membrane may be attached to the spline at a location on the spline offset from the location of 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 location up to about 30% of d1 closer to the distal end of the spline than the location of maximum diameter. Alternatively, the membrane may be attached to the spline at a location up to about 30% of d2 closer to the proximal end of the spline than the location of maximum diameter.

[0047] In some embodiments, the longitudinal location of the basket's maximum diameter may be closer to the distal end of the inner shaft than to 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) may be attached to the splines (356) at a longitudinal location of the splines that coincides with the basket's maximum diameter. The distances d1 and d2 from the membrane (350) to the distal end of the basket (352) and the proximal end of the basket (354), respectively, 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 positioned such that the point of maximum curvature of the splines (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 subranges and values ​​therebetween.

[0048] FIG. 4 is a schematic front view of a membrane (400) of an endocardial catheter device including a multi-spline basket with a foldable membrane. The membrane (400) may be structurally and / or functionally similar to other membranes described herein and may be used with systems and / or devices as described with reference to such membranes. For example, the membrane (400) may 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 has 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, portions (410, 412, 414, 416) may be straight and / or may include a set of cuts and / or a set of creases to facilitate deployment (e.g., folding) of the membrane. In some embodiments, one or more portions (410, 412, 414, 416) may be concave while other portions (410, 412, 414, 416) may be straight or have a different shape or curvature.

[0049] In some embodiments, the membrane has an inner portion (420) (e.g., an opening, a central hole). Each divot may be configured as a mounting edge for attachment to a spline of an ablation device, with adjacent divots attached to adjacent splines of the ablation device. In some embodiments, each divot or notch may be glued or heat bonded to the spline. In some embodiments, the inner portion (420) defines an opening capable of receiving an inner shaft of a catheter. Additionally or alternatively, the inner shaft may be coupled to a hub, and the inner portion (420) of the membrane may be attached (by glue or heat bond) to the hub. 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 subranges and values ​​therebetween, while the divot or notch may have an average diameter between about 1 mm and about 3 mm, including any subranges and values ​​therebetween.

[0050] 5 is a schematic front view of a membrane (500) of an ablation device having a recess along the outer edge (e.g., periphery) 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 may be used with systems and / or devices as described with reference to such membranes. For example, the membrane (500) may be used with any of the ablation devices as 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, with at least a portion of this line (517) having the property that it is outside the outer edge of the membrane (500), and therefore 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 section attached between adjacent splines. In such embodiments, the membrane in an undeployed configuration may naturally fold inward without a portion extending radially outward between the splines. This may facilitate smooth passage of a catheter device, for example, through a delivery device such as a sheath. In some embodiments, the relatively long concave portion of the outer edge of the membrane may be arcuate with a mean radius of curvature ranging from about 5 mm to about 50 mm, including any subranges and values ​​therebetween.

[0052] FIG. 6 provides a schematic diagram 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) may include structurally and / or functionally similar components to other ablation devices described herein (e.g., ablation devices (700, 1110)) and may be used in systems as described with respect to such devices. In some embodiments, the catheter includes an outer shaft (602) with an inner lumen and an inner shaft (621) that extends beyond the distal end (603) of the outer shaft. A number of splines (605, 607) may be attached at their proximal ends to the inside of the outer shaft's distal end (603) and their distal ends may be attached to the distal end of the inner shaft (621) at the device tip (630). In some embodiments, the length of each spline may 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 may collectively form a basket structure. In some embodiments, the inner shaft (621) may be translated (e.g., retracted and extended) relative to the outer shaft (602), or the outer shaft (602) may 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 a distal electrode (614) and two proximal electrodes (610, 612). In some embodiments, a foldable insulating membrane (617) may be attached to the splines at its outer edge. In some embodiments, the inner portion of the membrane (617) may have an opening that can receive the inner shaft (621). In some embodiments, the inner shaft may have a hub (619) to which the inner portion of the membrane (617) may be attached, as shown in FIG. 6. In some embodiments, the hub (619) may be made from a polymeric material, such as, for example, Pebax or silicone, and the insulating membrane (617) may be made from a polymeric material, such as polyurethane, Pebax, silicone, etc. In the undeployed configuration, the membrane (617) may have creases (625) located between adjacent splines where the membrane folds inward against the splines.

[0054] In the undeployed configuration shown in FIG. 6, the inner shaft (621) may be fully extended beyond the distal end (603) of the 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 from any biocompatible electrical 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 subranges and values ​​therebetween. In some embodiments, the spacing between the nearest edges of adjacent proximal electrodes on a given spline (if there are multiple proximal electrodes on a given spline) or the spacing between the nearest 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 subranges 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 subranges 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 subranges and values ​​therebetween. In some embodiments, the cross section of each spline may be approximately elliptical or oval, or the spline cross section may be circular. In some embodiments, the number of splines that make up 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 subranges and values ​​therebetween.

[0056] FIG. 7 illustrates a schematic of an endocardial catheter device (700) (e.g., the basket of FIG. 6) in a deployed configuration. The endocardial catheter device (700) may include structurally and / or functionally similar components to other ablation devices described herein (e.g., ablation devices (600, 1110)) and may be used in systems as described with respect to 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 (e.g., bent outward) such that a middle portion of each spline is located farther from the inner shaft (723) 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 (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 flex outward, the membrane (721) may be stretched (e.g., taut) and form a flattened or planar shape. In some embodiments, the membrane may be attached to the splines at a longitudinal location on the splines at or near the basket's maximum diameter, with the distal set of spline electrodes (717) distal to the membrane (721) and the proximal set of spline electrodes (709, 711) proximal to the membrane (721). As described herein, the longitudinal location of the basket's maximum diameter 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 diagram of an endocardial catheter device (800) in an undeployed configuration with a multi-spline basket coupled to a foldable membrane with support struts. The endocardial catheter device (800) may include structurally and / or functionally similar components to other ablation devices described herein and may be used in systems as described with respect to such devices. For example, the catheter may have an outer shaft (803) with an inner lumen and an inner shaft (830) that extends beyond the distal end (804) of the outer shaft (803). A number of splines (805, 807) may be attached at their proximal ends inside the distal end (804) of the outer shaft (803) and their distal ends may be attached at the device tip to the distal end of the inner shaft (830). In some embodiments, the length of each spline may 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 and 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 splines 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) may be made of a polymeric material, such as, for example, Pebax or silicone, and the insulating membrane (813) may 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 creases (815) located between adjacent splines where the membrane folds inwardly against the splines. In some embodiments, the membrane may include one or more structural supports (820, 822) in the form of radial struts (e.g., struts) that extend at least partially from the inner portion of the membrane (813) to the outer edge along a direction that leads to the attachment points 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 glued or bonded to the membrane (813) itself. In some embodiments, the struts may add additional structural support to the membrane (813) and facilitate folding and unfolding of the membrane (813) when the basket is undeployed and deployed, respectively.

[0061] In some embodiments, the inner shaft may be fully extended beyond the distal end (804) of the outer shaft such that in the undeployed configuration as shown in FIG. 8, 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 number of biocompatible electrical 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 all subranges 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 subranges 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 subranges 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 subranges and values ​​therebetween. In some embodiments, the cross section of each spline may be approximately elliptical or oval, or the spline cross section may be circular. In some embodiments, the number of splines that make up 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 diagram of an endocardial catheter device (900) in a deployed configuration including a multi-spline basket with an unfolded membrane (914) having peripheral recesses and support struts similar to the device shown in FIG. 8. The endocardial catheter device (900) may include structurally and / or functionally similar components to other ablation devices described herein and may be used in systems as described with respect to such devices. For example, the device (900) includes an outer shaft (902) and an inner shaft (925) in a fully retracted configuration. In the fully deployed configuration, the splines (904, 906) are bent (e.g., bent outward) such that a middle portion of each spline may be located farther 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 the proximal electrodes (907, 909) may be disposed on a spline (906).

[0064] In some embodiments, the membrane (914) may be attached to a hub (916) on the inner shaft (925). Additionally or alternatively, an inner portion of the membrane (914) may define an opening capable of receiving the inner shaft (925). In some embodiments, an outer edge of the membrane may be attached to each of the splines as described herein. Thus, in a fully deployed configuration, the membrane (914) may be flattened or stretched into a planar shape as the splines flex outward. In some embodiments, the membrane may be attached to the splines at a longitudinal location on the splines at or near the maximum diameter of the basket, with a distal set of spline electrodes (911) distal to the membrane (914) and a proximal set of spline electrodes (907, 909) proximal to the membrane (914).

[0065] In some embodiments, the membrane (914) with the outer edge recess may have structural supports (920, 922), such as radial struts, that extend at least partially from the inner portion of the membrane (914) to the outer edge along a direction that leads to the attachment point of the membrane to the spline. In some embodiments, the struts may be made of a polymeric material, such as nylon or Kevlar, for example, and may be glued or bonded to the membrane itself. In some embodiments, the struts may add additional structural support to the membrane and facilitate folding and unfolding of the membrane when the basket is undeployed and deployed, respectively. In some embodiments, the longitudinal location of the basket's maximum diameter 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) with a deployed distal portion of the device (1000) abutting a tissue wall, depicting the damage generated in the tissue wall during ablation delivery along with the damage depth. The device (1000) may include structurally and / or functionally similar components to other ablation devices described herein and may be used in systems as described with respect to 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 number of splines (1030, 1032). In a fully deployed configuration, the splines (1030, 1032) are bent (e.g., bent outward) such that the intermediate portion of each spline is located farther from the inner shaft (1022) 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, 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, an inner portion of the membrane defines an opening that can receive the inner shaft (1022). In some embodiments, an 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 flex outward, the membrane (1012) may be flattened or stretched into a planar shape. In some embodiments, the membrane may be attached to the splines at a longitudinal location on the splines that is at or near the maximum diameter of the basket, with a distal set of spline electrodes (1005) distal to the membrane (1012) and a proximal set of spline electrodes (1007, 1009) proximal to the membrane (1012).

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

[0069] In some embodiments, the lesions created by pulsed electric field ablation can be delivered in various deployed configurations, including partially or fully deployed. In some embodiments, one or more portions of the catheter device are deflectable and can be steered or navigated to access various cardiac anatomical locations via a deflection control mechanism (e.g., steering knob, plunger / rocker, lever). In some embodiments, the catheter device is inserted through 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 to access the desired target anatomical site. In some variations, one or more of the electrodes of the device can be configured to record diagnostic electrocardiogram signals when not delivering ablation energy, thereby allowing the same device to be used to evaluate localized sites for electrogram information before and after ablation.

[0070] In some embodiments, the catheter devices described herein may incorporate electromagnetic tracking sensors for use with an electromagnetic tracking or localization system (e.g., 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 showing its three-dimensional location within the cardiac anatomy. Electrogram recordings from the catheter electrodes also aid in the generation of electroanatomical maps that can serve as a diagnostic reference. Suitable examples of such devices are described in International Patent Application PCT / US20 / 61809, entitled "Methods, systems, and apparatuses for tracking ablation devices and generating lesion lines," published as International Patent Application Publication No. WO2021 / 108312, the contents of which are incorporated herein by reference in their entirety.

[0071] method Also described herein are methods of performing tissue ablation in or near one or more cardiac chambers using the systems and devices described herein. Generally, one or more catheters can be advanced through the vasculature to a target location in a minimally invasive manner. For example, an ablation device may be advanced through the vasculature over a guidewire and through a deflectable sheath. The sheath may be configured to deflect and assist in guiding the local ablation catheter through the vasculature and one or more predetermined targets (e.g., pulmonary vein ostia or other atrial or ventricular locations). A dilator may be advanced over the guidewire and configured for formation and dilation of a transseptal opening during and / or prior to use. The methods described herein include introducing and positioning an ablation device (e.g., the 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 stimulator (e.g., cardiac stimulator (1128)) may be used to deliver pacing signals to the heart or a measurement device may be used to measure cardiac activity. A pulse waveform may be delivered by one or more electrodes of the ablation device to ablate tissue. In some embodiments, the ablation energy may be delivered synchronously with the 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 waveform described herein may 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), the introduction of a device (e.g., the ablation device (1110) or any other ablation device described herein) into the endocardial space of the heart. For example, the device may be inserted through a delivery device, such as a deflectable sheath, and navigated to the anatomical region of interest. In some embodiments, the electrodes of the ablation device may be positioned near or adjacent to the endocardial surface of the heart. In some embodiments, one or more portions of the device may be deflectable to fine-tune the position and placement of a distal portion of the device. At (1204), the ablation device may be deployed, for example, as described with respect to exemplary embodiments herein. For example, the device may be deployed to be apposed to the tissue before the pulsed electric field ablation waveform is applied to the tissue using catheter electrodes.

[0073] At (1206), a pulse waveform may be generated. Various bipolar pair configurations of the respective subsets of distal and proximal electrodes may be implemented for ablation delivery and lesion creation. 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 indication of the pacing signal. 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 spanning a corresponding common refractory time window. In alternative embodiments, the ablation pulse waveform may be delivered, for example, asynchronously, without a pacing signal. At (1208), the generated pulse waveform may be delivered to tissue. In some embodiments, the pulse waveform may be delivered to 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 a subset of electrodes, 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 (using one or more of the catheter or sheath deflections) to a second anatomical location for ablation delivery at the second location. The deployment of the device may be adjusted as needed. In some embodiments, a more complete deployment may generate a relatively deep lesion if the orientation of the catheter basket relative to the local tissue wall is 45 degrees or less relative to the local surface normal at the endocardial surface. The process of ablation delivery may be repeated for multiple target sites, including the generation of a continuous line of ablated tissue.

[0074] The apparatus and methods disclosed herein can provide for efficient creation of deep cardiac lesions using pulsed electric field ablation waveforms. Although certain device embodiments are described herein for illustrative purposes, it is clear that other device embodiments can be determined by those skilled in the art and advantageously implemented in accordance with the disclosure provided herein. For example, modifications and variations such as the number of splines, number of electrodes, etc., or various local ablation devices can be constructed and developed in accordance with the teachings herein without departing from the scope of the present invention.

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

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

[0077] Some embodiments described herein relate to computer storage products having a non-transitory computer-readable medium (which may also be referred to as 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 propagating signal itself (e.g., a propagating electromagnetic wave that carries information over a transmission medium such as space or a cable). The medium and the computer code (which may also be referred to as code or algorithms) may be designed and constructed for a specific purpose or purposes. Examples of non-transitory computer readable media include, but are not limited to, magnetic storage media such as hard disks, floppy disks, and magnetic tapes, optical storage media such as compact disks / digital video disks (CD / DVD), compact disk read only memory (CD-ROM), and holographic devices, magneto-optical storage media such as optical disks, carrier wave signal processing modules, and hardware devices specifically configured to store and execute program code, 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. Other embodiments described herein relate to computer program products that may include, for example, the instructions and / or computer code disclosed herein.

[0078] The systems, devices, and / or methods described herein may be performed by software (executed on hardware), hardware, or a combination thereof. Hardware modules may include, for example, general-purpose processors (or microprocessors or microcontrollers), field programmable gate arrays (FPGAs), and / or application-specific integrated circuits (ASICs). Software modules (executed on hardware) may be expressed 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] Various modifications and additions can be made to the exemplary embodiments described without departing from the scope of the present invention. For example, while the above embodiments refer to certain 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 that fall within the scope of the claims, together with all equivalents thereof.

Claims

1. 1. An endocardial catheter comprising: 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 opposed distal end and 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, 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; a foldable membrane disposed within the interior space of the spline assembly, the foldable membrane having an outer peripheral portion attached to one or more of the plurality of splines; the foldable membrane includes an opening, the inner shaft extending through the opening.

2. The endocardial catheter of claim 1 , wherein the collapsible membrane is formed of an electrically insulating material.

3. The endocardial catheter of claim 2 , wherein the spline assembly can be transitioned between an undeployed configuration and a deployed configuration by inducing relative axial movement between the inner shaft and the outer shaft.

4. The endocardial catheter of claim 3 , wherein the spline assembly has a minimum diameter in an undeployed configuration and a maximum diameter in a fully deployed configuration.

5. The endocardial catheter of claim 4 , wherein the outer edge portion of the foldable membrane is attached to one or more splines at a longitudinal location thereof corresponding to the maximum diameter of the spline assembly in a fully deployed configuration.

6. 5. The endocardial catheter of claim 4, wherein the outer edge portion of the foldable membrane is attached to one or more splines at a longitudinal location between the proximal and distal spline electrodes disposed on each of the one or more splines.

7. 7. The endocardial catheter of claim 6, wherein each of the plurality of splines has a curved shape when the spline assembly is in an deployed configuration, and the foldable membrane is attached to the one or more splines at a point of maximum curvature thereof, the point of maximum curvature being located closer to a distal end of each spline than to a proximal end of each spline.

8. The endocardial catheter of claim 4 , wherein the foldable membrane assumes a circular shape when the spline assembly is in a deployed configuration.

9. The endocardial catheter of claim 8 , wherein the outer edge portion of the foldable membrane has a plurality of arcuate notches at locations corresponding to attachment points of the foldable membrane to one or more splines.

10. The endocardial catheter of claim 4 , wherein the outer edge portion of the foldable membrane has a plurality of recessed portions when the spline assembly is in a deployed configuration.

11. The endocardial catheter of claim 4 , 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.

12. The endocardial catheter of claim 4 , wherein the inner shaft includes a hub, and an inner edge of the opening in the collapsible membrane is attached to the hub.

13. 13. The endocardial catheter of claim 12, further comprising a plurality of radial struts coupled to the foldable membrane configured to facilitate folding and unfolding of the foldable membrane as the spline assembly transitions between a deployed configuration and an undeployed configuration.

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