CN116157084A - Electroporation ablation catheter - Google Patents

Abstract

At least some embodiments of the present disclosure are directed to hybrid electroporation ablation catheters. In some embodiments, a hybrid electroporation ablation catheter includes a catheter shaft having a proximal end and an opposite distal end and an electrode assembly extending from the distal end of the catheter shaft, and the electrode assembly includes a plurality of energy delivery electrodes. The electrode assembly is configured to be selectively operable in a plurality of different modes of operation.

Description

Electroporation ablation catheter

Cross Reference to Related Applications

The present application claims priority from provisional application number 63/056,300 filed on 7/24 2020, the entire contents of which are incorporated herein by reference.

Technical Field

The present disclosure relates to medical systems and methods for ablating tissue in a patient. More particularly, the present disclosure relates to medical systems and methods for ablating tissue by electroporation.

Background

Ablation surgery is used to treat many different diseases in patients. Ablation may be used to treat cardiac arrhythmias, benign tumors, cancerous tumors, and to control bleeding during surgery. Typically, ablation is accomplished by thermal ablation techniques, including Radio Frequency (RF) ablation and cryoablation. In RF ablation, a probe is inserted into a patient and radio frequency waves are transmitted through the probe to surrounding tissue. The radio frequency waves generate heat, which destroys surrounding tissue and cauterizes blood vessels. In cryoablation, a hollow needle or cryoprobe is inserted into the patient and a cold, thermally conductive fluid is circulated through the probe to freeze and kill surrounding tissue. RF ablation and cryoablation techniques kill tissue indiscriminately by necrotizing cells, which may damage or kill other healthy tissue such as esophageal tissue, diaphragmatic nerve cells, and coronary artery tissue.

Another ablation technique uses electroporation. In electroporation or electroosmosis, an electric field is applied to cells to increase the permeability of the cell membrane. Electroporation may be reversible or irreversible depending on the strength of the electric field. If electroporation is reversible, an increase in permeability of the cell membrane can be used to introduce chemicals, drugs, and/or deoxyribonucleic acid (DNA) into the cell prior to cell healing and recovery. If electroporation is irreversible, the affected cells will be killed by apoptosis.

Irreversible electroporation can be used as a non-thermal ablation technique. In irreversible electroporation, short, high voltage bursts are used to generate an electric field strong enough to kill cells by apoptosis. Irreversible electroporation can be a safe and effective alternative to indiscriminate killed thermal ablation techniques, such as radio frequency ablation and cryoablation, in the ablation of cardiac tissue. Irreversible electroporation can kill targeted tissue, such as myocardial tissue, by using the strength and duration of an electric field that kills the targeted tissue but does not permanently damage other cells or tissue, such as non-targeted myocardial tissue, erythrocytes, vascular smooth muscle tissue, endothelial tissue, and nerve cells.

Disclosure of Invention

As recited in the examples, example 1 is a hybrid electroporation ablation catheter. The hybrid electroporation ablation catheter includes a catheter shaft having a proximal end and an opposite distal end, and an electrode assembly extending from the distal end of the catheter shaft, the electrode assembly including a plurality of energy delivery electrodes. The electrode assembly is configured to selectively operate in a first mode of operation and a second mode of operation. The electrode assembly includes an inner shaft adapted to extend from and retract to the catheter shaft. The plurality of energy delivery electrodes includes a plurality of first electrodes and a plurality of second electrodes. When operating in the first mode of operation, the inner shaft extends from the catheter shaft and the plurality of first electrodes and the plurality of second electrodes are activated. When operating in the second mode of operation, the inner shaft is at least partially retracted into the catheter shaft, the plurality of first electrodes are activated, and the plurality of second electrodes are deactivated.

Example 2 is the hybrid electroporation ablation catheter of example 1, wherein in a first mode of operation the electrode assembly is configured to deliver ablation energy to form a circumferential ablation lesion having a diameter between 20 millimeters and 28 millimeters, and wherein in a second mode of operation the electrode assembly is configured to deliver ablation energy to form a focal ablation lesion having a diameter between 5 millimeters and 20 millimeters.

Example 3 is the hybrid electroporation ablation catheter of example 1, wherein the electrode assembly further comprises a plurality of splines connected to the inner shaft at the distal end of the inner shaft, wherein the plurality of energy delivery electrodes are disposed on the plurality of splines.

Example 4 is the hybrid electroporation ablation catheter of example 3, wherein the plurality of splines form a first cavity having a first diameter in a first mode of operation, wherein the plurality of splines form a second cavity having a second diameter in a second mode of operation, and wherein the first diameter is greater than the second diameter.

Example 5 is the hybrid electroporation ablation catheter of example 1, wherein the plurality of second electrodes are disposed closer to the distal end of the inner shaft than the plurality of first electrodes.

Example 6 is the hybrid electroporation ablation catheter of any of examples 1-5, wherein the catheter shaft is deflectable.

Example 7 is the hybrid electroporation ablation catheter of any of examples 1-6, wherein the plurality of second electrodes are retracted into the catheter shaft in the second mode of operation.

Example 8 is the hybrid electroporation ablation catheter of example 1, further comprising: one or more return electrodes disposed on the catheter shaft.

Example 9 is the hybrid electroporation ablation catheter of any of examples 1-8, further comprising: an actuator configured to move the inner shaft relative to the catheter shaft, and a sensor configured to detect a position of the actuator.

Example 10 is the hybrid electroporation ablation catheter of example 9, wherein the hybrid electroporation ablation catheter is configured to be set to one of the first mode of operation and the second mode of operation based on the detected actuator position.

Example 11 is the hybrid electroporation ablation catheter of example 1, wherein the plurality of first electrodes are individually controllable.

Example 12 is the hybrid electroporation ablation catheter of example 1, wherein the plurality of second electrodes are individually controllable.

Example 13 is a system, comprising any of the hybrid electroporation ablation catheters of examples 1-12.

Example 14 is the system of example 13, further comprising: a pulse generator configured to generate and deliver electroporation pulses to the hybrid electroporation ablation device.

Example 15 is the system of example 14, further comprising: a controller coupled to the pulse generator and the hybrid electroporation ablation device and configured to select an operating mode of the hybrid electroporation ablation device.

Example 16 is a hybrid electroporation ablation catheter. A hybrid electroporation ablation catheter includes a catheter shaft having a proximal end and an opposite distal end and an electrode assembly extending from the distal end of the catheter shaft, the electrode assembly including a plurality of energy delivery electrodes. The electrode assembly is configured to selectively operate in a first mode of operation and a second mode of operation. The electrode assembly includes an inner shaft adapted to extend from and retract to the catheter shaft. The plurality of energy delivery electrodes includes a plurality of first electrodes and a plurality of second electrodes. When operating in the first mode of operation, the inner shaft extends from the catheter shaft and the plurality of first electrodes and the plurality of second electrodes are activated. When operating in the second mode of operation, the inner shaft is at least partially retracted into the catheter shaft, the plurality of first electrodes are activated, and the plurality of second electrodes are deactivated.

Example 17 is the hybrid electroporation ablation catheter of example 16, wherein in the first mode of operation the electrode assembly is configured to deliver ablation energy to form a circumferential ablation lesion having a diameter between 20 millimeters and 28 millimeters, and wherein in the second mode of operation the electrode assembly is configured to deliver ablation energy to form a focal ablation lesion having a diameter between 5 millimeters and 20 millimeters.

Example 18 is the hybrid electroporation ablation catheter of example 16, wherein the electrode assembly further comprises a plurality of splines connected to the inner shaft at the distal end of the inner shaft, wherein the plurality of energy delivery electrodes are disposed on the plurality of splines.

Example 19 is the hybrid electroporation ablation catheter of example 18, wherein the plurality of splines form a first cavity having a first diameter in a first mode of operation, wherein the plurality of splines form a second cavity having a second diameter in a second mode of operation, and wherein the first diameter is greater than the second diameter.

Example 20 is the hybrid electroporation ablation catheter of example 16, wherein the plurality of second electrodes are disposed closer to the distal end of the inner shaft than the plurality of first electrodes.

Example 21 is the hybrid electroporation ablation catheter of example 16, wherein the catheter shaft is deflectable.

Example 22 is the hybrid electroporation ablation catheter of example 16, wherein the plurality of second electrodes are retracted into the catheter shaft in the second mode of operation.

Example 23 is the hybrid electroporation ablation catheter of example 16, further comprising: one or more return electrodes disposed on the catheter shaft.

Example 24 is the hybrid electroporation ablation catheter of example 16, further comprising: an actuator configured to move the inner shaft relative to the catheter shaft, and a sensor configured to detect a position of the actuator.

Example 25 is the hybrid electroporation ablation catheter of example 24, wherein the hybrid electroporation ablation catheter is configured to be set to one of the first mode of operation and the second mode of operation based on the detected actuator position.

Example 26 is the hybrid electroporation ablation catheter of example 16, wherein the plurality of first electrodes are individually controllable.

Example 27 is the hybrid electroporation ablation catheter of example 16, wherein the plurality of second electrodes are individually controllable.

Example 28 is a hybrid electroporation ablation system. The hybrid electroporation ablation system includes a hybrid electroporation ablation catheter, a pulse generator configured to generate and deliver electroporation pulses to a hybrid electroporation ablation device, and a controller coupled to the pulse generator and the electroporation ablation device. A hybrid electroporation ablation catheter includes a catheter shaft having a proximal end and an opposite distal end and an electrode assembly extending from the distal end of the catheter shaft, the electrode assembly including a plurality of energy delivery electrodes. The electrode assembly is configured to selectively operate in a first mode of operation and a second mode of operation. The electrode assembly includes an inner shaft adapted to extend from and retract to the catheter shaft. The plurality of energy delivery electrodes includes a plurality of first electrodes and a plurality of second electrodes. When operating in the first mode of operation, the inner shaft extends from the catheter shaft and the plurality of first electrodes and the plurality of second electrodes are activated. When operating in the second mode of operation, the inner shaft is at least partially retracted into the catheter shaft, the plurality of first electrodes are activated, and the plurality of second electrodes are deactivated.

Example 29 is the hybrid electroporation ablation system of example 28, wherein in the first mode of operation the electrode assembly is configured to deliver ablation energy to form a circumferential ablation lesion having a diameter between 20 millimeters and 28 millimeters, and wherein in the second mode of operation the electrode assembly is configured to deliver ablation energy to form a focal ablation lesion having a diameter between 5 millimeters and 20 millimeters.

Example 30 is the hybrid electroporation ablation system of example 28, wherein the electrode assembly further comprises a plurality of splines connected to the inner shaft at the distal end of the inner shaft, wherein the plurality of energy delivery electrodes are disposed on the plurality of splines.

Example 31 is the hybrid electroporation ablation system of example 28, wherein the controller is configured to select an operational mode of the hybrid electroporation ablation device.

Example 32 is a method of electroporation ablation. The method comprises the following steps: deploying a hybrid electroporation ablation catheter proximate the targeted tissue, the hybrid electroporation ablation catheter operable in a plurality of modes of operation, the plurality of modes of operation including a first mode of operation and a second mode of operation, the hybrid electroporation ablation catheter configured to deliver ablation energy in the first mode of operation to form a circumferential ablation lesion and configured to deliver ablation energy in the second mode of operation to form a focal ablation lesion; selecting an operating mode from a plurality of operating modes of the hybrid electroporation ablation catheter; operating the hybrid electroporation ablation catheter in the selected mode of operation; and generating an electric field at the plurality of electrodes of the catheter according to the selected mode of operation, the electric field having an electric field strength sufficient to ablate the targeted tissue via irreversible electroporation.

Example 33 is the method of example 32, wherein the hybrid electroporation ablation catheter comprises a catheter shaft and an electrode assembly extending from a distal end of the catheter shaft.

Example 34 is the method of example 33, wherein the electrode assembly includes a plurality of electrodes, and wherein at least one of the plurality of electrodes is deactivated in one of a plurality of modes of operation.

Example 35 is the method of example 32, wherein the electrode assembly is configured to form a plurality of shapes in the plurality of modes of operation, and wherein the plurality of shapes have volumes that are different from one another.

While multiple embodiments are disclosed, other embodiments of the 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 as restrictive.

Drawings

Fig. 1 depicts an illustrative system diagram of an electroporation ablation system or apparatus according to an embodiment of the presently disclosed subject matter.

Fig. 2A is a diagram illustrating a hybrid electroporation ablation catheter in a first mode of operation according to an embodiment of the presently disclosed subject matter.

Fig. 2B is a diagram illustrating the hybrid electroporation ablation catheter shown in fig. 2A in a second mode of operation according to an embodiment of the presently disclosed subject matter.

Fig. 2C is a diagram illustrating the hybrid electroporation ablation catheter shown in fig. 2A with additional components in accordance with an embodiment of the presently disclosed subject matter.

Fig. 3 is another diagram illustrating a hybrid electroporation ablation catheter according to an embodiment of the presently disclosed subject matter.

Fig. 4 is an example flowchart describing an illustrative method of using a hybrid electroporation ablation catheter in accordance with some embodiments of the present disclosure.

While the invention is susceptible to various modifications and alternative forms, specific embodiments are shown by way of example in the drawings and will be described in detail below. However, it is not intended that the invention be limited to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the scope of the invention as defined by the appended claims.

Detailed Description

As the terms are used herein with respect to measurements (e.g., dimensions, features, attributes, components, etc.) and ranges thereof of tangible things (e.g., products, inventory, etc.) and/or intangible things (e.g., electronic representations of data, currency, accounts, information, portions of things (e.g., percentages, scores), calculations, data models, dynamic system models, algorithms, parameters, etc.), as well as to the extent that "about" and "approximately" are used interchangeably to refer to measurements that include the recited measurement values and also to include any measurements that are reasonably close to the recited measurement values, but can have reasonably small differences, such as being understood and readily determinable by individuals having ordinary skill in the relevant arts, attributable to measurement errors; measuring and/or manufacturing equipment calibration differences; human error in reading and/or setting up the measurement; adjustments made to optimize performance and/or structural parameters in view of other measurements (e.g., measurements associated with other things); a specific implementation scenario; imprecise adjustments and/or manipulations of things, settings and/or measurements by humans, computing devices, and/or machines; system tolerances; a control loop; machine learning; foreseeable changes (e.g., statistically insignificant changes, chaotic changes, system and/or model instability, etc.); preference; and/or the like.

Although the illustrative methods may be represented by one or more drawings (e.g., flowcharts, communication flows, etc.), the drawings should not be construed as implying any requirement for, or a particular order among or between, the various steps herein disclosed. However, certain embodiments may require certain steps and/or a certain order between certain steps, as explicitly described herein and/or as may be appreciated from the nature of the steps themselves (e.g., the performance of certain steps may depend on the outcome of previous steps). Further, a "set," "subset," or "group" of items (e.g., inputs, algorithms, data values, etc.) may include one or more items, and similarly, a subset or subgroup of items may include one or more items. "plurality" means more than one.

As used herein, the term "based on" is not meant to be limiting, but rather indicates that the determining, identifying, predicting, calculating, and/or the like is performed by using at least the term after "based on" as input. For example, the same determination may additionally or alternatively be made based on another piece of information based on a particular piece of information prediction.

Cryogenic energy and Radio Frequency (RF) energy kill tissues indiscriminately through cellular necrosis, which can damage the esophagus, diaphragmatic nerve, coronary arteries, among other adverse effects. Irreversible electroporation (IRE) kills cells by apoptosis using high voltage, short (e.g., 100 microseconds or less) pulses. IRE is able to specifically kill the myocardium while retaining other adjacent tissues including esophageal vascular smooth muscle and endothelium.

The present disclosure describes devices and methods for implementing multiple ablation strategies (i.e., circumferential and focal ablation) using a single IRE ablation catheter. Circumferential ablation includes annular ablation lesions of relatively large diameter that form a generally circular shape, and is particularly useful for ablating pulmonary vein ostia in so-called "pulmonary vein isolation" (PVI) procedures for treating paroxysmal AF. This requires an IRE ablation catheter with an electrode set that has a relatively large footprint to treat the pulmonary vein ostia, ideally with a single energy application. In contrast, focal ablation creates lesions that are significantly smaller than the circumferential lesions formed in PVI procedures, and are typically employed to create electrical blocking lines (lines of electrical block) using continuous energy application (e.g., along the ventricular wall) to treat atrial tachycardia, AV reentry arrhythmia, persistent AF, and the like. Focal ablation via IRE requires an IRE ablation catheter with an electrode assembly disposed in a smaller footprint than the catheters described above for forming circumferential lesions. Currently, circumferential and focal ablation require catheters specifically designed for each ablation strategy, which in turn requires removal of one ablation catheter, e.g., a circumferential ablation catheter after PVI, and replacement with a focal ablation catheter if both circumferential and focal ablation strategies are necessary in a single clinical procedure.

Embodiments of the present disclosure are directed to systems/devices and methods for IRE that are capable of implementing two or more ablation strategies (e.g., circumferential ablation and focal ablation) using a single catheter, referred to as a hybrid electroporation ablation catheter. In some embodiments, the hybrid probe ablation catheter is configured to have two modes of operation, one adapted for circumferential ablation and one adapted for focal ablation. In some cases, the hybrid catheter in different modes of operation has differently shaped electrode assemblies. In some cases, the hybrid catheter in different modes of operation has different sets of electrodes activated in the electrode assembly. In some cases, the hybrid catheter in different modes of operation has different sets of electrodes activated and different shapes in the electrode assembly. In some embodiments, two or more modes of operation can be selected by an operator depending on the intended ablation strategy. In some embodiments, two or more modes of operation can be automatically selected by the controller depending on the intended ablation strategy and/or sensed data.

Fig. 1 depicts an illustrative system diagram of an electroporation ablation system or apparatus 100 according to an embodiment of the presently disclosed subject matter. The electroporation ablation system/apparatus 100 includes one or more hybrid electroporation ablation catheters 110, an introducer sheath 130, a controller 140, a pulse generator 150, and a memory 160. In an embodiment, the electroporation ablation system/device 100 is configured to deliver electric field energy to targeted tissue in a patient's heart to create tissue apoptosis, thereby disabling the tissue from conducting electrical signals. In some cases, the electroporation ablation system/device 100 may be coupled with one or more other systems 170, such as a mapping system, an electrophysiology system, and/or the like.

In an embodiment, the hybrid electroporation ablation catheter 110 is designed to have two or more modes of operation, each mode of operation being suitable for one type of ablation operation (e.g., circumferential or single ablation, focal ablation, segmented ablation, etc.). Catheter 110 is designed to be deployed in a heart chamber to target an ablation site. As used herein, a heart chamber refers to the heart chamber and its surrounding blood vessels (e.g., pulmonary veins). Pulse generator 150 is configured to generate ablation pulses/energy (alternatively referred to as electroporation pulses/energy) to be delivered to the electrodes of catheter 110. Electroporation pulses are typically high voltage and short pulses. Electroporation controller 140 is configured to control functional aspects of electroporation ablation system/apparatus 100. In an embodiment, electroporation controller 140 is configured to control generation of ablation energy by pulser 150 and delivery of the ablation energy to the electrodes of catheter 110. In an embodiment, the controller 140 is configured to control the mode of operation of the hybrid electroporation ablation catheter 110.

In one embodiment, catheter 110 has one or more electrodes. In some embodiments, catheter 110 includes an electrode assembly including one or more electrodes. In some cases, the electrode assemblies are configured to deliver different magnitudes of electric field energy in different modes of operation. In some cases, the electrode assembly includes an expandable member configured to have different expanded shapes in different modes of operation. In some cases, the mode of operation varies with the shape and/or diameter of the electrode assembly. In some cases, each of the one or more electrodes of catheter 110 is individually addressable and controllable. In some cases, the controller 140 may control the delivery of ablation energy to each electrode such that the electric field formed by the plurality of electrodes can be controlled and adjusted. In some cases, a portion of one or more electrodes can be deactivated by the controller 140.

In some cases, a particular set of electrodes can be activated for one mode of operation by the electrode controller 140. In some cases, a portion of one or more electrodes can be retracted into the shaft of catheter 110 in a particular mode of operation. In some cases, the distance between adjacent active electrodes is substantially the same in all or a subset of the active electrodes. In one example, in an operational mode, for example, when the electrode assembly has a relatively small operational diameter, every other electrode is active. In one embodiment, the distance between adjacent activated electrodes at a first operation (e.g., circumferential ablation) is substantially the same as at a second distance (e.g., focal ablation), with the other electrodes deactivated (e.g., having a variation within 10% from the average distance).

In some cases, electroporation controller 140 receives sensor data collected by one or more sensors of one or more catheters. In some cases, electroporation controller 140 is capable of changing the mode of operation of catheter 110 in response to the received sensed data. In some cases, electroporation system/apparatus 100 may include an actuator 120 configured to change the operational shape of the electrode assembly of catheter 110. In some cases, electroporation system/apparatus 100 may further include a position sensor to monitor the position of the actuator. In one example, the controller 140 can receive sensed data generated by the position sensor and change the operating mode of the catheter in response to the position of the actuator. In an embodiment, actuator 120 is integrated with or connected to catheter 110.

In some cases, electroporation controller 140 can vary the ablation energy delivered to the electrodes in response to the sensed data. In some cases, electroporation controller 140 is configured to model the electric field that may be generated by catheter 110, which generally includes consideration of the physical characteristics of electroporation ablation catheter 110, including the electrodes and the spatial relationship of the electrodes on electroporation ablation catheter 110. In an embodiment, electroporation controller 140 is configured to control the electric field strength of the electric field formed by the electrodes of catheter 110 to be no higher than 1500 volts/cm.

In an embodiment, electroporation controller 140 includes one or more controllers, microprocessors, and/or computers that execute code in memory 160 (e.g., a non-transitory machine readable medium) to control and/or perform functional aspects of electroporation ablation system/apparatus 100. In an embodiment, the memory 160 can be part of one or more controllers, microprocessors, and/or computers, and/or part of a memory capacity accessible over a network (such as the world wide web). In an embodiment, memory 160 includes a data store 165 configured to store ablation data (e.g., location, energy, etc.), sensed data, modeled electric field data, treatment planning data, and/or the like.

In an embodiment, the introducer sheath 130 is operable to provide a delivery catheter through which the hybrid electroporation ablation catheter 110 can be deployed to a specific target site within a patient's heart chamber.

In embodiments, other systems 170 include an electro-anatomical mapping (EAM) system. In some cases, the EAM system is operable to track the location of various functional components of the electroporation ablation system/apparatus 100 and generate high-fidelity three-dimensional anatomies and electroanatomical maps of the heart chamber of interest. In an embodiment, the EAM system can be RYTMMIA sold by Boston science, inc ^TM HDx mapping system. Furthermore, in an embodiment, the mapping and navigation controller of the EAM system includes one or more controlsA processor, a microprocessor, and/or a computer that execute code from memory to control and/or perform functional aspects of the EAM system.

The EAM system generates a localization field via a field generator to define a localization volume around the heart, and one or more position sensors or sensing elements on one or more tracked devices (e.g., the electroporation ablation catheter pair 105) generate outputs that can be processed by a mapping and navigation controller to track the positions of the sensors and thus the corresponding devices within the localization volume. In one embodiment, device tracking is accomplished using magnetic tracking technology, wherein the field generator is a magnetic field generator that generates a magnetic field defining a positioning volume, and the position sensor on the tracked device is a magnetic field sensor.

In some embodiments, impedance tracking methods may be employed to track the location of various devices. In such embodiments, the localization field is an electric field generated, for example, by an external field generator arrangement (e.g., surface electrodes), an internal body or an intracardiac device (e.g., an intracardiac catheter), or both. In these embodiments, the position sensing elements can constitute electrodes on the tracked device that generate outputs that are received and processed by the mapping and navigation controller to track the position of the various position sensing electrodes within the localization volume.

In an embodiment, the EAM system is equipped with both magnetic and impedance tracking capabilities. In such embodiments, in some cases, impedance tracking accuracy may be enhanced by first creating an electric field map induced by an electric field generator within the heart chamber of interest using a probe with a magnetic position sensor, as may be possible using RYTMMIA HDx described above ^TM Mapping systems. An exemplary probe is INTELLAMAP ORION sold by Boston science Inc ^TM Mapping the catheter.

Regardless of the tracking method employed, the EAM system utilizes positional information of the various tracked devices and the electrocardiographic activity acquired by, for example, the electroporation ablation catheter pair 105 or another catheter or probe equipped with sensing electrodes to generate and display via a display a detailed three-dimensional geometric anatomic map or representation of the heart chamber and an electroanatomical map in which the electrocardiographic activity of interest is superimposed on the geometric anatomic map. Furthermore, the EAM system is capable of generating graphical representations of various tracked devices within the geometric anatomic and/or electroanatomic map.

According to an embodiment, the various components of the electrophysiology system 100 (e.g., the controller 140) can be implemented on one or more computing devices. The computing device may include any type of computing device suitable for implementing embodiments of the present disclosure. Examples of computing devices include special purpose or general purpose computing devices such as "workstations," "servers," "notebook computers," "desktop computers," "tablet computers," "handheld devices," "general purpose graphics processing units (gpgpgpu)," and the like, all of which are contemplated within the scope of fig. 1 with reference to various components of system 100.

In some embodiments, a computing device includes a bus that directly and/or indirectly couples the following devices: a processor, memory, input/output (I/O) ports, I/O components, and a power supply. Any number, combination, and/or combination of additional components may also be included in a computing device. A bus represents what may be one or more busses (such as, for example, an address bus, data bus, or combination thereof). Similarly, in some embodiments, a computing device may include several processors, several memory components, several I/O ports, several I/O components, and/or several power supplies. Further, any number or combination of these components may be distributed and/or replicated across multiple computing devices.

In some embodiments, memory 160 includes computer-readable media in the form of volatile and/or nonvolatile memory, transitory and/or non-transitory storage media, and may be removable, non-removable, or a combination thereof. Examples of media include Random Access Memory (RAM); read Only Memory (ROM); an Electrically Erasable Programmable Read Only Memory (EEPROM); a flash memory; an optical or holographic medium; magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices; data transmission; and/or any other medium that can be used to store information and that is accessible by a computing device, such as a quantum state memory and/or the like. In some embodiments, memory 160 stores computer-executable instructions for causing a processor (e.g., controller 140) to implement aspects of embodiments of the system components discussed herein and/or to perform aspects of embodiments of the methods and programs discussed herein.

The computer-executable instructions may include, for example, computer code, machine-useable instructions, and the like, such as program components capable of being executed by one or more processors associated with a computing device. The program element may be programmed using any number of different programming environments, including various languages, development kits, frameworks, and/or the like. Some or all of the functionality contemplated herein may also or alternatively be implemented in hardware and/or firmware.

The data store 165 may be implemented using any of the configurations described below. The data store may include random access memory, flat files, XML files, and/or one or more database management systems (DBMSs) executing on one or more database servers or data centers. The database management system may be a Relational (RDBMS), hierarchical (HDBMS), multidimensional (MDBMS), object-oriented (ODBMS or OODBMS), or object relational (ordms) database management system, or the like. The data store may be, for example, a single relational database. In some cases, the data store may include multiple databases that are capable of exchanging and aggregating data through a data integration process or software application. In an exemplary embodiment, at least a portion of the data store 165 may be hosted in a cloud data center. In some cases, the data store may be hosted on a single computer, server, storage device, cloud server, or the like. In some other cases, the data store may be hosted on a series of networked computers, servers, or devices. In some cases, the data store may be hosted on various layer data storage devices including local, regional, and central.

The various components of the system/device 100 may communicate via a communication interface (e.g., a wired or wireless interface) or be coupled to communication via a communication interface. The communication interface includes, but is not limited to, any wired or wireless short-range and long-range communication interface. The wired interface can use a cable, umbilical, or the like. The short-range communication interface may be, for example, a Local Area Network (LAN), an interface conforming to a known communication standard, such as

Standard, IEEE 802 standard (e.g. IEEE 802.11), or->

Or similar specifications, such as those based on the IEEE 802.15.4 standard, or other public or proprietary wireless protocols. The remote communication interface may be, for example, a Wide Area Network (WAN), a cellular network interface, a satellite communication interface, and the like. The communication interface may be within a private computer network, such as an intranet, or over a public computer network, such as the internet.

Fig. 2A is a diagram illustrating a portion of a hybrid electroporation ablation catheter 200 in a first mode of operation, in accordance with an embodiment of the presently disclosed subject matter; fig. 2B is a diagram illustrating the hybrid electroporation ablation catheter 200 in a second mode of operation. As shown, catheter 200 includes a catheter shaft 202 and an inner shaft 203 disposed within catheter shaft 202 and extending distally from a distal end 206 of catheter shaft 202. It will be appreciated that the catheter shaft 202 is coupled at its proximal end to a handle assembly (not shown) configured to be manipulated by a user during an electroporation ablation procedure. As further shown, the catheter 200 includes an electrode assembly 220 at a distal end extending from the distal end 206 of the catheter shaft 202.

In an embodiment, the electrode assembly 220 includes a plurality of energy delivery electrodes 225, wherein the electrode assembly 220 is configured to be selectively operable in a first mode of operation and a second mode of operation. In some cases, in a first mode of operation, the electrode assembly is configured to deliver ablation energy to form a circumferential ablation lesion having a diameter between twenty (20) millimeters and twenty-eight (28) millimeters. In some cases, in a first mode of operation, the electrode assembly is configured to deliver ablation energy to form a circumferential ablation lesion having a diameter between twenty-two (22) millimeters and thirty-five (35) millimeters. In some cases, in a first mode of operation, the electrode assembly is configured to deliver ablation energy to form a circumferential ablation lesion having a diameter between twenty (20) millimeters and thirty-five (35) millimeters. In some cases, in the second mode of operation, the electrode assembly is configured to deliver ablation energy to form a focal ablation lesion having a diameter between five (5) millimeters and twenty (20) millimeters. In some cases, in the second mode of operation, the electrode assembly is configured to deliver ablation energy to form a focal ablation lesion having a diameter between two (2) millimeters and sixteen (16) millimeters. In some cases, in the second mode of operation, the electrode assembly is configured to deliver ablation energy to form a focal ablation lesion having a diameter between two (2) millimeters and twenty (20) millimeters. In some cases, in a first mode of operation, the electrode assembly is configured to deliver ablation energy to form a circumferential ablation lesion having a depth of three (3) millimeters and four (4) millimeters.

In some embodiments, the electrode assembly 220 includes an inner shaft 203, wherein the inner shaft 203 is adapted to extend from the catheter shaft 202 and retract into the catheter shaft 202. In some cases, electrode assembly 220 includes a plurality of splines 204 connected to inner shaft 203 at distal end 211 of inner shaft 203. In some cases, electrode assembly 220 further includes a central shaft 203a having a proximal end 211a (overlapping distal end 211 of inner shaft 203) and a distal end 212. In some cases, the plurality of splines 204 are connected to a distal end 212 of the central shaft 203a. In an embodiment, the electrode 225 includes a plurality of first electrodes 208 and a plurality of second electrodes 210 disposed on the plurality of splines 204. In one example, the plurality of second electrodes 210 are disposed proximate to the distal end 212 of the central shaft 203a and the plurality of first electrodes 208 are disposed proximate to the proximal end 211a of the central shaft 203a.

In some cases, when operating in the first mode of operation, the inner shaft 203 and the central shaft 203a extend from the catheter shaft 202, for example as shown in fig. 2A. In some cases, in the first mode of operation, both the plurality of first electrodes 208 and the plurality of second electrodes 210 are selectively activated to form a relatively large diameter circumferential ablation lesion, such as created in a PVI procedure, for example.

In some embodiments, when operating in the second mode of operation, the inner shaft 203 and the central shaft 203a are at least partially retracted into the catheter shaft 202 such that all or a portion of the plurality of first electrodes 208 are retracted into the catheter 202, e.g., as shown in fig. 2B. In some cases, in the second mode of operation, the plurality of first electrodes 208 are deactivated (e.g., by electrically disconnecting the first electrodes 208 from any pulser circuitry), and the plurality of second electrodes 210 are activated and used to create a focal ablation lesion by electroporation.

The hybrid electroporation ablation catheter 200 has a longitudinal axis 222. As used herein, a longitudinal axis refers to a line passing through the centroid of a cross section of an object. In an embodiment, the plurality of splines 204 form a cavity 224. The plurality of splines 204 form a cavity 224a in a first mode of operation and a cavity 224b in a second mode of operation. In an embodiment, cavity 224a is larger in volume than cavity 224b. In some embodiments, in the first mode of operation, the largest cross-sectional area that is substantially perpendicular to the longitudinal axis 222 of the cavity 224a has a diameter d1. In some embodiments, in the second mode of operation, the largest cross-sectional area that is substantially perpendicular to the longitudinal axis 222 of the cavity 224b has a diameter d2. In some cases, diameter d1 is greater than diameter d2. In some examples, diameter d1 is in the range of twenty (20) millimeters and thirty-five (35) millimeters. In some examples, the diameter d2 is in the range of five (5) millimeters and sixteen (16) millimeters. In one example, diameter d1 is 30% to 100% greater than diameter d2. In one example, diameter d1 is at least 30% greater than diameter d2. In one example, diameter d1 is at least 100% greater than diameter d2 (i.e., at least twice diameter d 2). In one example, diameter d1 is at least 150% greater than diameter d2 (i.e., at least 2.5 times diameter d 2).

In some cases, the catheter shaft 202 is deflectable, implemented using techniques well known in the art. In some cases, catheter 200 includes an inflatable balloon (not shown) disposed in cavity 224 of spline 204. Fig. 2C is a diagram illustrating the hybrid electroporation ablation catheter shown in fig. 2A with additional features in accordance with an embodiment of the presently disclosed subject matter. In some embodiments, catheter 200C includes one or more return electrodes 205. In some cases, one or more return electrodes 205 are disposed on the catheter shaft 202. In some cases, catheter 200C can include an actuator (not shown) configured to move inner shaft 203 relative to catheter shaft 202. In some cases, the actuator is external to catheter 200C, but connected to catheter 200C. In some cases, catheter 200 may include a sensor 213 configured to detect the position of the actuator. In one embodiment, the mode of operation of the hybrid electroporation ablation catheter 200 is set based on the detected actuator position. In one embodiment, the mode of operation of the hybrid electroporation ablation catheter 200 is set based on sensor signals generated by the sensor 213.

In some cases, the first set of electrodes 208 is disposed at or near the circumference of the plurality of splines 204 and the second set of electrodes 210 is disposed near the distal end 212 of the catheter 200. In some cases, the first set of electrodes 208 is referred to as proximal electrodes and the second set of electrodes 210 is referred to as distal electrodes, wherein the distal electrodes 210 are disposed closer to the distal end 212 of the electroporation ablation catheter 200 than the proximal electrodes 208. In some embodiments, the electrode 225 can include a conductive film or an optical ink. The ink may be polymer-based. The ink may additionally include materials such as carbon and/or graphite in combination with conductive materials. The electrodes can comprise biocompatible low resistance metals such as silver, silver flakes, gold, and platinum, which are otherwise radiopaque.

Each electrode of the first set of electrodes 208 and each electrode of the second set of electrodes 210 are configured to be electrically conductive and are operably connected to a controller (e.g., controller 140 in fig. 1) and an ablation energy generator (e.g., pulse generator 150 in fig. 1). In an embodiment, one or more of the first set of electrodes 208 and the second set of electrodes 210 comprise a flexible circuit. In some cases, the plurality of first electrodes 208 are individually controllable. In some cases, the plurality of second electrodes are individually controllable. In some cases, all or a portion of the plurality of first electrodes 208 are deactivated in the second mode of operation. In some cases, a portion of the plurality of second electrodes 210 is deactivated in the second mode of operation.

The electrodes in the first set of electrodes 208 are spaced apart from the electrodes in the second set of electrodes 210. The first set of electrodes 208 includes electrodes 208a-208f and the second set of electrodes 210 includes electrodes 210a-210f. In addition, electrodes in the first set of electrodes 208 (such as electrodes 208a-208 f) are spaced apart from one another, and electrodes in the second set of electrodes 210 (such as electrodes 210a-210 f) are spaced apart from one another.

The spatial relationship and orientation of the electrodes in the first set of electrodes 208 with respect to other electrodes on the same catheter 200, and the spatial relationship and orientation of the electrodes in the second set of electrodes 210 with respect to other electrodes on the same catheter 200 are known or determinable. In an embodiment, once the catheter is deployed, the spatial relationship and orientation of the electrodes in the first set of electrodes 208 with respect to the other electrodes on the same catheter 200, and the spatial relationship and orientation of the electrodes in the second set of electrodes 210 are constant with respect to the other electrodes on the same catheter 200.

As to the electric field, in embodiments, each electrode of the first set of electrodes 208 and each electrode of the second set of electrodes 210 can be selected to be either an anode or a cathode such that an electric field can be established between any two or more electrodes of the first set of electrodes 208 and the second set of electrodes 210. Further, in an embodiment, each electrode of the first set of electrodes 208 and each electrode of the second set of electrodes 210 can be selected to be bipolar such that the electrodes switch or alternate between anode and cathode. Further, in embodiments, the electrode population in the first set of electrodes 208 and the electrode population in the second set of electrodes 210 can be selected to be anodic or cathodic or bipolar such that an electric field can be established between any two or more electrode populations in the first set of electrodes 208 and the second set of electrodes 210.

In an embodiment, the electrodes of the first set of electrodes 208 and the second set of electrodes 210 can be selected as bipolar electrodes such that during a pulse train comprising a biphasic pulse train, the selected electrodes switch or rotate between anode and cathode, and the electrodes are not degraded to monophasic delivery—one always anode and the other always cathode. In some cases, an electrode of the first set of electrodes 208 and the second set of electrodes 210 can form an electric field with one or more electrodes of another catheter. In this case, the electrodes of the first set of electrodes 208 and the second set of electrodes 210 may be anodes of the field or cathodes of the field.

Further, as described herein, the electrode is selected to be one of an anode and a cathode, however, it should be understood that, without illustration, in the present disclosure, the electrode can be selected to be a bipolar such that they switch or alternate between an anode and a cathode. In some cases, one or more electrodes in the first set of electrodes 208 are selected to be cathodes and one or more electrodes in the second set of electrodes 210 are selected to be anodes. In an embodiment, one or more electrodes of the first set of electrodes 208 may be selected as cathodes and another one or more electrodes of the first set of electrodes 208 may be selected as anodes. Further, in an embodiment, one or more electrodes of the second set of electrodes 210 can be selected as cathodes and another one or more electrodes of the second set of electrodes 210 can be selected as anodes.

Fig. 3 is a diagram illustrating a hybrid electroporation ablation catheter 300 according to an embodiment of the presently disclosed subject matter. Catheter 300 includes an electrode assembly 305 extending from a distal end 306 of catheter shaft 302. In the example shown, the electrode assembly 305 includes an expandable support structure 307 (e.g., a spline assembly as shown, although other expandable structures, such as an inflatable balloon, may be used as well), a proximal first electrode set 310 disposed proximate to a maximum diameter of the support structure 307, and a distal second electrode set 320 disposed on the support structure 307 proximate to a distal end thereof.

As shown in fig. 3, the proximal first electrode set 310 defines a ring of electrode pairs having a relatively large diameter and can be adapted to form a relatively large substantially circumferential lesion, e.g., for isolating a pulmonary vein ostium during a PVI procedure. In contrast, the distal second electrode set 320 defines a ring of electrode pairs having a relatively small diameter (as compared to the diameter formed by the first electrode set 310), and can be specifically configured for forming a relatively small diameter focal ablation lesion on the ventricular wall, which can be delivered individually or sequentially through a series of energy delivery to create adjacent interconnectivity lesion lines (solid lines forming electrical conduction blocks).

In an embodiment, the electrodes forming the first electrode set 310 and the second electrode set 320 are each individually addressable (e.g., by the controller 140 described above) by the hybrid electroporation ablation catheter 300. As such, in some embodiments, the hybrid electroporation ablation catheter 300 has a first mode of operation (e.g., circumferential ablation) and a second mode of operation (e.g., focal ablation). In one example, in a first mode of operation, the first set of electrodes 310 is activated and the second set of electrodes 320 is deactivated. In one example, in the second mode of operation, the first set of electrodes 310 is deactivated and the second set of electrodes 320 is activated. Thus, the hybrid electroporation ablation catheter 300 provides the same dual use capabilities as the electroporation ablation tube 200 described above, but without requiring the user to change the geometry of the electrode assembly 305.

Fig. 4 is an example flowchart describing an illustrative method 400 of using a hybrid electroporation ablation catheter in accordance with some embodiments of the present disclosure. Aspects of the embodiments of method 400 may be performed, for example, by an electroporation ablation system/device (e.g., system/device 100 depicted in fig. 1). One or more steps of method 400 are optional and/or can be modified by one or more steps of other embodiments described herein. Furthermore, one or more steps of other embodiments described herein may be added to the method 400. First, the electroporation ablation system/apparatus deploys a hybrid electroporation ablation catheter proximate to targeted tissue (410). In one embodiment, the hybrid electroporation ablation catheter is operable in a plurality of modes of operation. In some cases, the plurality of modes of operation includes a first mode of operation and a second mode of operation, wherein the hybrid electroporation ablation catheter is configured to deliver ablation energy in the first mode of operation to form a circumferential ablation lesion and is configured to deliver ablation energy in the second mode of operation to form a focal ablation lesion.

In some cases, a hybrid electroporation ablation catheter includes a catheter shaft and an electrode assembly extending from a distal end of the catheter shaft. In one example, the electrode assembly includes a plurality of electrodes. In some designs, at least one of the plurality of electrodes is deactivated in one of a plurality of modes of operation. In some designs, the electrode assembly is configured to form a plurality of shapes in a plurality of modes of operation, wherein the plurality of shapes have volumes that are different from one another. In some embodiments, the electrode assembly includes an inner shaft and a plurality of splines connected to the inner shaft, wherein the inner shaft is movable relative to the catheter shaft along a longitudinal axis of the catheter. In some cases, the electrode assembly is connected to or integrated with an actuator configured to control movement of the inner shaft relative to the catheter shaft.

In some embodiments, the electroporation ablation system/apparatus selects an operating mode from a plurality of operating modes of a hybrid electroporation ablation catheter (415). In some cases, the mode of operation can be automatically selected, for example, by a controller (e.g., controller 140 in fig. 1). In some cases, the operating mode is selected in response to sensed data collected by one or more sensors. In one embodiment, the operating mode is selected in response to sensed data indicative of the position of the actuator.

In an embodiment, the electroporation ablation system/apparatus operates the hybrid electroporation ablation catheter (420) in a selected mode of operation, for example, in a mode of operation for a particular ablation strategy (e.g., circumferential ablation, focal ablation, segmental ablation, etc.). In some cases, the electroporation ablation system/device is configured to generate an electric field (425) according to the selected mode of operation by the hybrid electroporation ablation device/device, e.g., at an electrode of a catheter. In some cases, the generated electric field has an electric field strength sufficient to ablate the targeted tissue via irreversible electroporation according to the selected mode of operation. In some cases, the electroporation ablation system/device is configured to deliver probe pulses to the electrodes.

In some cases, the electroporation ablation system/apparatus is further configured to modulate the electric field (430), for example, by changing the probe pulse and/or activated electrode. In one embodiment, the selected electrode set is activated. In some cases, the selected electrode sets are arranged in a particular spatial pattern.

Various modifications and additions can be made to the exemplary embodiments discussed without departing from the scope of the present invention. For example, although the embodiments described above refer to particular features, the scope of the invention also includes embodiments having different combinations of features and embodiments that do not include all of the features. Accordingly, the scope of the present invention is intended to embrace all such alternatives, modifications and variances which fall within the scope of the appended claims, and all equivalents thereof.

Claims (15)

1. A hybrid electroporation ablation catheter comprising:

a catheter shaft having a proximal end and an opposite distal end; and

an electrode assembly extending from a distal end of the catheter shaft, the electrode assembly comprising a plurality of energy delivery electrodes, wherein the electrode assembly is configured to selectively operate in a first mode of operation and a second mode of operation,

wherein the electrode assembly comprises an inner shaft adapted to extend from and retract into the catheter shaft,

Wherein the plurality of energy delivery electrodes comprises a plurality of first electrodes and a plurality of second electrodes,

when operating in the first mode of operation,

the inner shaft extends from the catheter shaft, and

the plurality of first electrodes and the plurality of second electrodes are activated,

when operating in the second mode of operation,

the inner shaft is at least partially retracted into the catheter shaft,

the plurality of first electrodes are activated, and

the plurality of second electrodes are deactivated.

2. The hybrid electroporation ablation catheter of claim 1, wherein in the first mode of operation the electrode assembly is configured to deliver ablation energy to form a circumferential ablation lesion having a diameter between 20 mm and 28 mm, and wherein in the second mode of operation the electrode assembly is configured to deliver ablation energy to form a focal ablation lesion having a diameter between 5 mm and 20 mm.

3. The hybrid electroporation ablation catheter of claim 1, wherein the electrode assembly further comprises a plurality of splines connected to the inner shaft at a distal end of the inner shaft, wherein the plurality of energy delivery electrodes are disposed on the plurality of splines.

4. The hybrid electroporation ablation catheter of claim 3, wherein the plurality of splines form a first cavity having a first diameter in the first mode of operation, wherein the plurality of splines form a second cavity having a second diameter in the second mode of operation, and wherein the first diameter is greater than the second diameter.

5. The hybrid electroporation ablation catheter of claim 1, wherein the plurality of second electrodes are disposed closer to the distal end of the inner shaft than the plurality of first electrodes.

6. The hybrid electroporation ablation catheter of any one of claims 1-5, wherein the catheter shaft is deflectable.

7. The hybrid electroporation ablation catheter of any one of claims 1-6, wherein the plurality of second electrodes are retracted into the catheter shaft in the second mode of operation.

8. The hybrid electroporation ablation catheter of claim 1, further comprising:

one or more return electrodes disposed on the catheter shaft.

9. The hybrid electroporation ablation catheter of any of claims 1-8, further comprising:

an actuator configured to move the inner shaft relative to the catheter shaft, an

A sensor configured to detect a position of the actuator.

10. The hybrid electroporation ablation catheter of claim 9, wherein the hybrid electroporation ablation catheter is configured to: is set to one of the first operation mode and the second operation mode based on the detected position of the actuator.

11. The hybrid electroporation ablation catheter of claim 1, wherein the plurality of first electrodes are individually controllable.

12. The hybrid electroporation ablation catheter of claim 1, wherein the plurality of second electrodes are individually controllable.

13. A system comprising any of the hybrid electroporation ablation catheters of claims 1-12.

14. The system of claim 13, further comprising:

a pulse generator configured to generate and deliver electroporation pulses to the hybrid electroporation ablation device.

15. The system of claim 14, further comprising:

a controller is coupled to the pulse generator and the hybrid electroporation ablation device and configured to select an operating mode of the hybrid electroporation ablation device.

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