Electroporation ablation catheter

Abstract

To provide a medical system and method for ablation of tissues by electroporation.SOLUTION: At least some embodiments of the present disclosures are directed to a hybrid electroporation ablation catheter. In some embodiments, the hybrid electroporation ablation catheter comprises 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 comprises a plurality of energy-delivering electrodes. The electrode assembly is configured to be selectively operable in a plurality of different operation modes.SELECTED DRAWING: Figure 2A

Description

[Technical field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates to medical systems and methods for ablating tissue in a patient, and more particularly, to medical systems and methods for ablation of tissue by electroporation. [Background technology]

[0002] Ablation procedures are used to treat many different conditions in patients. Ablation can 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 radiofrequency (RF) ablation and cryoablation. In RF ablation, a probe is inserted into the patient and radiofrequency waves are transmitted through the probe to the surrounding tissue. The radiofrequency waves generate heat, which destroys the 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, freezing and killing the surrounding tissue. RF ablation and cryoablation techniques indiscriminately kill tissue through cell necrosis, which can damage or kill otherwise healthy tissue, such as tissue in the esophagus, phrenic nerve cells, and tissue in the coronary arteries.

[0003] Another ablation technique uses electroporation. In electroporation or electropermeabilization, an electric field is applied to cells to increase the permeability of the cell membrane. Electroporation can be reversible or irreversible, depending on the strength of the electric field. If electroporation is reversible, the increased permeability of the cell membrane can be used to introduce chemicals, drugs, and / or deoxyribonucleic acid (DNA) into the cells prior to cell healing and recovery. If electroporation is irreversible, the affected cells are killed by apoptosis.

[0004] Irreversible electroporation can be used as a non-thermal ablation technique. Irreversible electroporation uses a train of short high-voltage pulses to generate an electric field strong enough to kill cells through apoptosis. In cardiac tissue ablation, irreversible electroporation can be a safe and effective alternative to the indiscriminate killing of thermal ablation techniques such as RF ablation and cryoablation. Irreversible electroporation can be used to kill target tissue such as myocardial tissue by using an electric field strength and duration that kills the target tissue but does not permanently damage other cells or tissues (e.g., non-target myocardial tissue, red blood cells, vascular smooth muscle tissue, endothelial tissue, and nerve cells). Summary of the Invention

[0005] As described in the Examples, Example 1 is a hybrid electroporation ablation catheter. The hybrid electroporation ablation catheter comprises 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 comprising a plurality of energy delivery electrodes. The electrode assembly is configured to be selectively operable in a first operation mode and a second operation mode. The electrode assembly comprises an inner shaft extending from the catheter shaft and adapted to be retracted into the catheter shaft. The plurality of energy delivery electrodes comprises a plurality of first electrodes and a plurality of second electrodes. When operated in the first operation mode, the inner shaft extends from the catheter shaft and the plurality of first electrodes and the plurality of second electrodes are activated. When operated in the second operation mode, 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.

[0006] Example 2 is the hybrid electroporation ablation catheter of Example 1, wherein in the first operating mode, the electrode assembly is configured to deliver ablation energy to form a circumferential ablation lesion having a diameter of 20 millimeters to 28 millimeters, and in the second operating mode, the electrode assembly is configured to deliver ablation energy to form a focal ablation lesion having a diameter of 5 millimeters to 20 millimeters.

[0007] Example 3 is the hybrid electroporation ablation catheter of Example 1, wherein the electrode assembly further comprises a plurality of splines coupled to the inner shaft at a distal end of the inner shaft, the plurality of energy delivery electrodes being disposed on the plurality of splines.

[0008] 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 the first operating mode, and the plurality of splines form a second cavity having a second diameter in the second operating mode, the first diameter being larger than the second diameter.

[0009] Example 5 is the hybrid electroporation ablation catheter of Example 1, wherein the plurality of second electrodes are positioned closer to a distal end of the inner shaft than the plurality of first electrodes.

[0010] Example 6 is any one of the hybrid electroporation ablation catheters of Examples 1 to 5, wherein the catheter shaft is deflectable.

[0011] Example 7 is the hybrid electroporation ablation catheter of any one of Examples 1 to 6, wherein the plurality of second electrodes are retracted within the catheter shaft in the second mode of operation.

[0012] Example 8 is the hybrid electroporation ablation catheter of Example 1, further comprising one or more return electrodes disposed on the catheter shaft.

[0013] Example 9 is the hybrid electroporation ablation catheter of any one of Examples 1 to 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.

[0014] 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 operating mode and the second operating mode based on the detected position of the actuator.

[0015] Example 11 is the hybrid electroporation ablation catheter of Example 1, wherein the plurality of first electrodes are individually controllable.

[0016] Example 12 is the hybrid electroporation ablation catheter of Example 1, wherein the plurality of second electrodes are individually controllable.

[0017] Example 13 is a system comprising the hybrid electroporation ablation catheter of any one of Examples 1 to 12.

[0018] 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.

[0019] 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 operation mode of the hybrid electroporation ablation device.

[0020] Example 16 is a hybrid electroporation ablation catheter. The hybrid electroporation ablation catheter comprises 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 comprising a plurality of energy delivery electrodes. The electrode assembly is configured to be selectively operable in a first mode of operation and a second mode of operation. The electrode assembly comprises an inner shaft extending from the catheter shaft and adapted to be retracted into the catheter shaft. The plurality of energy delivery electrodes comprises a plurality of first electrodes and a plurality of second electrodes. When operated 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 operated 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.

[0021] Example 17 is the hybrid electroporation ablation catheter of Example 16, wherein in the first operating mode, the electrode assembly is configured to deliver ablation energy to form a circumferential ablation lesion having a diameter of 20 millimeters to 28 millimeters, and in the second operating mode, the electrode assembly is configured to deliver ablation energy to form a focal ablation lesion having a diameter of 5 millimeters to 20 millimeters.

[0022] Example 18 is the hybrid electroporation ablation catheter of Example 16, wherein the electrode assembly further comprises a plurality of splines coupled to the inner shaft at a distal end of the inner shaft, the plurality of energy delivery electrodes being disposed on the plurality of splines.

[0023] 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 the first operating mode, and the plurality of splines form a second cavity having a second diameter in the second operating mode, the first diameter being larger than the second diameter.

[0024] Example 20 is the hybrid electroporation ablation catheter of Example 16, wherein the plurality of second electrodes are positioned closer to a distal end of the inner shaft than the plurality of first electrodes.

[0025] Example 21 is the hybrid electroporation ablation catheter of Example 16, wherein the catheter shaft is deflectable.

[0026] Example 22 is the hybrid electroporation ablation catheter of Example 16, wherein the plurality of second electrodes are retracted within the catheter shaft in the second mode of operation.

[0027] Example 23 is the hybrid electroporation ablation catheter of Example 16, further comprising one or more return electrodes disposed on the catheter shaft.

[0028] 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.

[0029] 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 operating mode and the second operating mode based on the detected position of the actuator.

[0030] Example 26 is the hybrid electroporation ablation catheter of Example 16, wherein the plurality of first electrodes are individually controllable.

[0031] Example 27 is the hybrid electroporation ablation catheter of Example 16, wherein the plurality of second electrodes are individually controllable.

[0032] 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. 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 be selectively operable in a first mode of operation and a second mode of operation. The electrode assembly includes an inner shaft extending from the catheter shaft and adapted to be retracted into the catheter shaft. The plurality of energy delivery electrodes includes a plurality of first electrodes and a plurality of second electrodes. When operated 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 operated in the second mode of operation, the inner shaft is at least partially retracted within the catheter shaft, the first plurality of electrodes is activated, and the second plurality of electrodes is deactivated.

[0033] Example 29 is the hybrid electroporation ablation system of Example 28, wherein in the first operating mode, the electrode assembly is configured to deliver ablation energy to form a circumferential ablation lesion having a diameter of 20 millimeters to 28 millimeters, and in the second operating mode, the electrode assembly is configured to deliver ablation energy to form a focal ablation lesion having a diameter of 5 millimeters to 20 millimeters.

[0034] Example 30 is the hybrid electroporation ablation system of Example 28, wherein the electrode assembly further comprises a plurality of splines coupled to the inner shaft at a distal end of the inner shaft, the plurality of energy delivery electrodes being disposed on the plurality of splines.

[0035] Example 31 is the hybrid electroporation ablation system of Example 28, wherein the controller is configured to select an operation mode of the hybrid electroporation ablation device.

[0036] Example 32 is a method for electroporation ablation, the method including: deploying a hybrid electroporation ablation catheter proximate a target tissue, the hybrid electroporation ablation catheter operable in a plurality of operation modes comprising a first operation mode and a second operation mode, the hybrid electroporation ablation catheter configured to deliver ablation energy and form a circumferential ablation lesion in the first operation mode and configured to deliver ablation energy and form a focal ablation lesion in the second operation mode, selecting an operation mode from the plurality of operation modes of the hybrid electroporation ablation catheter, operating the hybrid electroporation ablation catheter in the selected operation mode, and generating an electric field at a plurality of electrodes of the catheter in accordance with the selected operation mode, the electric field having an electric field strength sufficient to ablate the target tissue via irreversible electroporation.

[0037] 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.

[0038] Example 34 is the method of example 33, wherein the electrode assembly comprises a plurality of electrodes, and at least one of the plurality of electrodes is deactivated in one of the plurality of operational modes.

[0039] Example 35 is the method of example 32, wherein the electrode assembly is configured to form a plurality of shapes in the plurality of operational modes, the plurality of shapes having different volumes from one another.

[0040] 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]

[0041] [Figure 1] 1 shows an exemplary system schematic of an electroporation ablation system or device according to an embodiment of the presently disclosed subject matter. [Figure 2A] 1 is a schematic diagram illustrating a hybrid electroporation ablation catheter in a first mode of operation, according to an embodiment of the presently disclosed subject matter. [Figure 2B] 2B is a schematic 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. [Figure 2C] FIG. 2B is a schematic diagram illustrating the hybrid electroporation ablation catheter shown in FIG. 2A having additional components, according to an embodiment of the presently disclosed subject matter. [Diagram 3] 1 is another schematic diagram showing a hybrid electroporation ablation catheter according to an embodiment of the presently disclosed subject matter. [Figure 4] 1 is an exemplary flow chart illustrating an exemplary method of use of a hybrid electroporation ablation catheter, according to some embodiments of the present disclosure.

[0042] 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. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0043] As used herein with respect to measurements (e.g., dimensions, characteristics, attributes, components, etc.) of tangible (e.g., products, inventory, etc.) and / or intangible (e.g., data, electronic representations of currency, accounts, information, portions of things (e.g., percentages, fractions), calculations, data models, dynamic system models, algorithms, parameters, etc.) and ranges thereof, "about" and "approximately" refer to measurements that include the referenced measurement and also include any measurements that are reasonably close to the referenced measurement but may differ by a reasonably small amount as would be understood and readily ascertained by one of ordinary skill in the art due to measurement error. , differences in measurement and / or manufacturing equipment calibration, human error in reading and / or setting measurements, adjustments to optimize performance and / or structural parameters taking into account other measurements (e.g., measurements of other objects), specific implementation scenarios, imprecise adjustments and / or manipulations of objects, settings and / or measurements by humans, computing devices, and / or machines, system tolerances, control loops, machine learning, predictable variations (e.g., statistically insignificant variations, chaotic variations, system and / or model instability, etc.), and / or preferences, etc.

[0044] An example method may be illustrated by one or more drawings (e.g., flow charts, communication flows, etc.), but the drawings should not be construed as implying any requirement of, or a particular order between, the various steps disclosed herein. However, certain embodiments may require certain steps and / or a particular order between certain steps, as may be explicitly described herein and / or as may be understood from the nature of the steps themselves (e.g., performance of some steps may depend on the results of previous steps). In addition, 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 two or more.

[0045] As used herein, the term "based on" is not meant to be limiting, but rather indicates that a determination, identification, prediction, and / or calculation, etc. is performed by using at least the term following "based on" as an input. For example, predicting an outcome based on particular information may additionally or alternatively result in the same determination based on other information.

[0046] Cryoenergy and radiofrequency (RF) energy kill tissue indiscriminately through cell necrosis, which can damage the esophagus, phrenic nerve, and coronary arteries, among other undesirable effects. Irreversible electroporation (IRE) uses short (e.g., 100 microseconds or less) pulses of high voltage to kill cells through apoptosis. IRE can be aimed at killing myocardium while sparing other adjacent tissues, including esophageal vascular smooth muscle and endothelium.

[0047] The present disclosure describes devices and methods for performing multiple ablation strategies, namely circumferential and focal ablation, using a single IRE ablation catheter. Circumferential ablation involves forming a substantially circular annular ablation lesion of relatively large diameter and is particularly useful for ablating the pulmonary vein ostium in a so-called "pulmonary vein isolation" (PVI) procedure for treating paroxysmal AF. This requires an IRE ablation catheter with an electrode set having a relatively large area to ideally treat the pulmonary vein ostium with a single energy application. In contrast, focal ablation creates a lesion significantly smaller than the circumferential lesion created in a PVI procedure and is commonly used to create an electrical block line, for example, using continuous energy application along the ventricular wall, to treat atrial tachycardia, atrioventricular reentrant arrhythmia, and persistent AF, etc. Focal ablation via IRE requires an IRE ablation catheter with an electrode set arranged in a smaller area compared to the aforementioned catheters for forming circumferential lesions. Currently, circumferential and focal ablation require specially designed catheters for each ablation strategy, which necessitates removal of one ablation catheter, e.g., the circumferential ablation catheter after PVI, and exchange it for a focal ablation catheter, if both circumferential and focal ablation strategies are needed in a single clinical procedure.

[0048] Embodiments of the present disclosure are directed to systems / devices and methods for IRE that are capable of performing two or more ablation strategies (e.g., circumferential and focal ablation) using a single catheter, referred to as a hybrid electroporation ablation catheter. In some embodiments, the hybrid exploratory ablation catheter is configured to have two operation modes, one suitable for circumferential ablation and one suitable for focal ablation. In some cases, the hybrid catheter in the different operation modes has an electrode assembly of different shapes. In some cases, the hybrid catheter in the different operation modes has a different set of electrodes activated in the electrode assembly. In some cases, the hybrid catheter in the different operation modes has both a different set of electrodes activated in the electrode assembly and a different shape. In some embodiments, the two or more operation modes can be selected by an operator depending on the intended ablation strategy. In some embodiments, the two or more operation modes can be automatically selected by a controller depending on the intended ablation strategy and / or the sensed data.

[0049] 1 shows an exemplary system diagram of an electroporation ablation system or device 100 according to an embodiment of the presently disclosed subject matter. The electroporation ablation system / device 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 target tissue within a patient's heart to cause tissue apoptosis and render the tissue unable to conduct electrical signals. In some cases, the electroporation ablation system / device 100 may interface with other system(s) 170, such as a mapping system and / or an electrophysiology system.

[0050] In an embodiment, the hybrid electroporation ablation catheter 110 is designed to have two or more operation modes, each suitable for a type of ablation operation (e.g., circumferential or single shot ablation, focal ablation, segment ablation, etc.). The catheter 110 is designed to be positioned by a target ablation location in an intracardiac chamber. As used herein, intracardiac chamber refers to the cardiac chamber and its surrounding blood vessels (e.g., pulmonary veins). The pulse generator 150 is configured to generate ablation pulses / energy, or what are called electroporation pulses / energy, that are delivered to the electrodes of the catheter 110. Electroporation pulses are typically high voltage and short pulses. The electroporation controller 140 is configured to control the functional aspects of the electroporation ablation system / device 100. In an embodiment, the electroporation controller 140 is configured to control the pulse generator 150 with respect to the generation and delivery of ablation energy to the electrodes of the catheter 110. In an embodiment, controller 140 is configured to control the operational mode of hybrid electroporation ablation catheter 110 .

[0051] In one embodiment, the catheter 110 has one or more electrodes. In some embodiments, the catheter 110 includes an electrode assembly including one or more electrodes. In some cases, the electrode assembly is configured to deliver electric field energy with different magnitudes in different operation modes. In some cases, the electrode assembly includes an expandable component configured to have different expanded shapes in different operation modes. In some cases, the operation mode varies depending on the shape and / or diameter of the electrode assembly. In some cases, each of the one or more electrodes of the catheter 110 is individually addressable and controllable. In some cases, the controller 140 can control the delivery of ablation energy to each electrode such that the electric field formed by the multiple electrodes can be controlled and adjusted. In some cases, a portion of the one or more electrodes can be deactivated by the controller 140.

[0052] In some cases, a particular set of electrodes may be activated by the controller 140 for an operation mode. In some cases, a portion of one or more electrodes may be retracted into the shaft of the catheter 110 in a particular operation mode. In some cases, the distance between adjacent active electrodes is generally the same between all active electrodes or a subset of active electrodes. In one example, the electrodes are activated every other electrode in an operation mode, for example, when the electrode assembly has a relatively small operation diameter. In one embodiment, the distance between adjacent active electrodes is roughly the same (e.g., within 10% variation from the average distance) in a first operation (e.g., circumferential ablation) as in a second distance (e.g., focal ablation), while the other electrodes are deactivated.

[0053] In some cases, the electroporation controller 140 receives sensor data collected by the sensor(s) of the catheter(s). In some cases, the electroporation controller 140 may change the operation mode of the catheter 110 in response to receiving the sensor data. In some cases, the electroporation system / device 100 may include an actuator 120 configured to change the operation geometry of the electrode assembly of the catheter 110. In some cases, the electroporation system / device 100 may further include a position sensor for monitoring the position of the actuator. In one example, the controller 140 may receive the sensor data generated by the position sensor and change the operation mode of the catheter in response to the position of the actuator. In an embodiment, the actuator 120 is integrated with or coupled to the catheter 110.

[0054] In some cases, electroporation controller 140 may vary the ablation energy delivered to the electrodes in response to the sensed data. In some cases, electroporation controller 140 is configured to model an electric field that may be generated by catheter 110, often taking into account the physical properties 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 1500 volts / centimeter or less.

[0055] In an embodiment, electroporation controller 140 includes one or more controllers, microprocessors, and / or computers that execute code from memory 160, e.g., a non-transitory machine-readable medium, to control and / or perform functional aspects of electroporation ablation system / device 100. In an embodiment, memory 160 can be part of one or more controllers, microprocessors, and / or computers, and / or part of a memory capacity accessible through a network, such as the World Wide Web. In an embodiment, memory 160 includes a data repository 165, which is configured to store ablation data (e.g., position, energy, etc.), sensed data, modeled electric field data, and / or treatment planning data, etc.

[0056] In an embodiment, introducer sheath 130 is operable to provide a delivery conduit through which hybrid electroporation ablation catheter 110 may be deployed to a specific target site within a patient's cardiac chamber.

[0057] In an embodiment, the other system 170 includes an electroanatomical mapping (EAM) system. In some cases, the EAM system is operable to track the positions of various functional components of the electroporation ablation system / device 100 and generate high fidelity three-dimensional anatomical and electroanatomical maps of the ventricle of interest. In an embodiment, the EAM system may be a RHYTHMIA® HDx mapping system sold by Boston Scientific Corporation. Also, in an embodiment, the mapping and navigation controller of the EAM system includes one or more controllers, microprocessors, and / or computers that execute code from memory to control and / or perform functional aspects of the EAM system.

[0058] 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 the tracked device(s), e.g., electroporation ablation catheter pair 105, generate outputs that can be processed by the mapping and navigation controller to track the position of the sensor within the localization volume, and thus the position of the corresponding device. In one embodiment, device tracking is achieved using magnetic tracking techniques, whereby the field generator is a magnetic field generator that generates a magnetic field that defines the localization volume, and the position sensors on the tracked devices are magnetic field sensors.

[0059] In some embodiments, impedance tracking methods may be employed to track the location of various devices. In such embodiments, the localization fields are electric fields generated, for example, by external field generator arrangements (e.g., surface electrodes), by intrabody or intracardiac devices (e.g., intracardiac catheters), or both. In these embodiments, the position sensing elements may constitute electrodes on the tracked devices that generate outputs that are received and processed by the mapping and navigation controller to track the location of the various position sensing electrodes within the localization volume.

[0060] In embodiments, the EAM system is equipped with both magnetic and impedance tracking capabilities. In such embodiments, impedance tracking accuracy may be enhanced in some cases by first creating a map of the electric field induced by the electric field generator within the subject's ventricle using a probe equipped with a magnetic position sensor, as is possible using the aforementioned RHYTHMIA HDx® mapping system. One exemplary probe is the INTELLAMAP ORION® mapping catheter sold by Boston Scientific Corporation.

[0061] Regardless of the tracking method used, the EAM system utilizes the position information of the various tracked devices along with cardiac electrical activity acquired, for example, by 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 geometrical anatomical map or representation of the cardiac chambers, as well as an electroanatomical map in which the cardiac electrical activity of interest is superimposed on the geometrical anatomical map. Additionally, the EAM system may generate pictorial representations of the various tracked devices within the geometrical anatomical map and / or the electroanatomical map.

[0062] According to embodiments, various components of electrophysiology system 100 (e.g., controller 140) may be implemented on one or more computing devices. The computing devices may include any type of computing device suitable for implementing embodiments of the present disclosure. Examples of computing devices include special purpose computing devices or general purpose computing devices (e.g., "workstations," "servers," "laptops," "desktops," "tablet computers," "handheld devices," and "general purpose graphics processing units (GPGPUs)," etc.), all of which are considered within the scope of FIG. 1 with respect to the various components of system 100.

[0063] 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 of additional components, different components, and / or combinations of components may also be included in a computing device. A bus refers to what may be one or more buses (e.g., an address bus, a data bus, or combinations thereof, etc.). 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. Additionally, any number of these components or combinations thereof may be distributed and / or replicated across several computing devices.

[0064] In some embodiments, memory 160 includes computer readable media in the form of volatile and / or non-volatile memory, temporary and / or non-transitory storage media, which may be removable, non-removable, or a combination thereof. Examples of media include random access memory (RAM), read only memory (ROM), electronically erasable programmable read only memory (EEPROM), flash memory, optical or holographic media, magnetic cassettes, magnetic tapes, magnetic disk storage devices or other magnetic storage devices, data transmission, and / or any other media usable to store information and accessible by a computing device, such as, for example, quantum state memory. 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 perform aspects of embodiments of the methods and procedures discussed herein.

[0065] Computer-executable instructions may include, for example, computer code, machine-usable instructions, and the like (e.g., program components capable of being executed by one or more processors associated with a computing device). The program components may be programmed using any number of different programming environments, including a variety of languages, development kits, and / or frameworks, and the like. Some or all of the functionality contemplated herein may also or alternatively be implemented in hardware and / or firmware.

[0066] The data repository 165 may be implemented using any one of the configurations described below. The data repository may include random access memory, flat files, XML files, and / or one or more database management systems (DBMS) running on one or more database servers or data centers. The database management systems may be relational (RDBMS), hierarchical (HDBMS), multidimensional (MDBMS), object-oriented (ODBMS or OODBMS), or object-relational (ORDBMS) database management systems, etc. The data repository may be, for example, a single relational database. In some cases, the data repository may include multiple databases whose data may be exchanged and integrated by a data integration process or software application. In an exemplary embodiment, at least a portion of the data repository 165 may be hosted in a cloud data center. In some cases, the data repository may be hosted on a single computer, server, storage device, cloud server, etc. In some other cases, the data repository may be hosted on a series of networked computers, servers, or devices. In some cases, the data repository may be hosted on a hierarchy of data storage devices including local, regional, and central.

[0067] The various components of the system / device 100 may communicate or be connected via a communication interface (e.g., a wired or wireless interface). The communication interface includes, but is not limited to, any wired or wireless short-range and long-range communication interface. Wired interfaces can use cables, umbilicals, and the like. Short-range communication interfaces can include, for example, local area networks (LANs), Bluetooth® standards, IEEE 802 standards (e.g., IEEE 802.11), ZigBee®, or similar specifications (IEEE The long-range communication interface may be, for example, a wide area network (WAN), a cellular network interface, a satellite communication interface, etc. The communication interface may be within a private computer network, such as an intranet, or may be on a public computer network, such as the Internet.

[0068] 2A is a diagram illustrating a portion of a hybrid electroporation ablation catheter 200 in a first mode of operation, and FIG. 2B is a diagram illustrating the hybrid electroporation ablation catheter 200 in a second mode of operation, according to an embodiment of the presently disclosed subject matter. As shown, the catheter 200 includes a catheter shaft 202 and an inner shaft 203 disposed within the catheter shaft 202 and extending distally from a distal end 206 of the catheter shaft 202. As can be seen, 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.

[0069] In an embodiment, the electrode assembly 220 comprises a plurality of energy delivery electrodes 225, and 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 the first mode of operation, the electrode assembly is configured to deliver ablation energy to form a circumferential ablation lesion having a diameter of 20 millimeters to 28 millimeters. In some cases, in the first mode of operation, the electrode assembly is configured to deliver ablation energy to form a circumferential ablation lesion having a diameter of 22 millimeters to 35 millimeters. In some cases, in the first mode of operation, the electrode assembly is configured to deliver ablation energy to form a circumferential ablation lesion having a diameter of 20 millimeters to 35 millimeters. In some cases, in the second mode of operation, the electrode assembly is configured to deliver ablation energy to form a local ablation lesion having a diameter of 5 millimeters to 20 millimeters. In some cases, in the second mode of operation, the electrode assembly is configured to deliver ablation energy to form a local ablation lesion having a diameter of 2 millimeters to 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 2 millimeters and 20 millimeters. In some cases, in the first mode of operation, the electrode assembly is configured to deliver ablation energy to form a circumferential ablation lesion having a depth between 3 millimeters and 4 millimeters.

[0070] In some embodiments, the electrode assembly 220 includes an inner shaft 203 that extends from and is adapted to be retracted into the catheter shaft 202. In some cases, the electrode assembly 220 includes a plurality of splines 204 coupled to the inner shaft 203 at a distal end 211 of the inner shaft 203. In some cases, the electrode assembly 220 further includes a central shaft 203a having a proximal end 211a (overlapping the distal end 211 of the inner shaft 203) and a distal end 212. In some cases, the plurality of splines 204 are coupled to the distal end 212 of the central shaft 203a. In embodiments, the electrodes 225 include 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 positioned near the distal end 212 of the central shaft 203a, and the plurality of first electrodes 208 are positioned near the proximal end 211a of the central shaft 203a.

[0071] In some cases, when operated in a first mode of operation, the inner shaft 203 and the central shaft 203a extend from the catheter shaft 202, for example, as shown in Figure 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 energized and activated to form relatively large diameter circumferential ablation lesions, for example, as created in a PVI procedure.

[0072] In some embodiments, when operated 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 shaft 202, for example 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 pulse generator circuitry) and the plurality of second electrodes 210 are activated and used to create local ablation lesions via electroporation.

[0073] The hybrid electroporation ablation catheter 200 has a longitudinal axis 222. As used herein, a longitudinal axis refers to a line passing through the center of gravity 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, the cavity 224a is larger in volume than the cavity 224b. In some embodiments, in the first mode of operation, the maximum cross-sectional area generally perpendicular to the longitudinal axis 222 of the cavity 224a has a diameter d1. In some embodiments, in the second mode of operation, the maximum cross-sectional area generally perpendicular to the longitudinal axis 222 of the cavity 224b has a diameter d2. In some cases, the diameter d1 is larger than the diameter d2. In some examples, the diameter d1 is in the range of 20 millimeters to 35 millimeters. In some examples, diameter d2 ranges from 5 millimeters to 16 millimeters. In one example, diameter d1 is 30% to 100% larger than diameter d2. In one example, diameter d1 is at least 30% larger than diameter d2. In one example, diameter d1 is at least 100% larger than diameter d2 (i.e., at least 2 times larger than diameter d2). In one example, diameter d1 is at least 150% larger than diameter d2 (i.e., at least 2.5 times larger than diameter d2).

[0074] In some cases, the catheter shaft 202 is deflectable and is implemented using techniques commonly known in the art. In some cases, the catheter 200 includes an expandable balloon (not shown) disposed within the cavity 224 of the spline 204. FIG. 2C is a schematic diagram illustrating the hybrid electroporation ablation catheter shown in FIG. 2A with additional features according to an embodiment of the subject matter of the present disclosure. In some embodiments, the catheter 200C includes one or more return electrodes 205. In some cases, the one or more return electrodes 205 are disposed on the catheter shaft 202. In some cases, the catheter 200C may include an actuator (not shown) configured to move the inner shaft 203 relative to the catheter shaft 202. In some cases, the actuator is external to the catheter 200C but coupled to the catheter 200C. In some cases, the catheter 200 may include a sensor 213 configured to detect a position of the actuator. In one embodiment, the operation mode of the hybrid electroporation ablation catheter 200 is set based on the detected position of the actuator. In one embodiment, the operational mode of hybrid electroporation ablation catheter 200 is set based on the sensor signal generated by sensor 213 .

[0075] In some cases, the first group of electrodes 208 are positioned at or near the circumference of the plurality of splines 204, and the second group of electrodes 210 are positioned near the distal end 212 of the catheter 200. In some cases, the first group of electrodes 208 are referred to as proximal electrodes, the second group of electrodes 210 are referred to as distal electrodes, and the distal electrodes 210 are positioned closer to the distal end 212 of the electroporation ablation catheter 200 than the proximal electrodes 208. In some implementations, the electrodes 225 may include a thin film of conductive ink or optical ink. The ink may be polymer-based. The ink may further include materials such as carbon and / or graphite in combination with the conductive material. The electrodes may include biocompatible low-resistance metals such as silver, silver flake, gold, and platinum that are further radiopaque.

[0076] Each electrode in the first group of electrodes 208 and each electrode in the second group of electrodes 210 are configured to conduct electricity and be operably connected to a controller (e.g., controller 140 of FIG. 1 ) and an ablation energy generator (e.g., pulse generator 150 of FIG. 1 ). In an embodiment, one or more of the electrodes in the first group of electrodes 208 and the second group of electrodes 210 include a flex 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 are deactivated in the second mode of operation.

[0077] The electrodes in the first group of electrodes 208 are spaced apart from the electrodes in the second group of electrodes 210. The first group of electrodes 208 includes electrodes 208a through 208f, and the second group of electrodes 210 includes electrodes 210a through 210f. Also, the electrodes in the first group of electrodes 208, such as electrodes 208a through 208f, are spaced apart from one another, and the electrodes in the second group of electrodes 210, such as electrodes 210a through 210f, are spaced apart from one another.

[0078] The spatial relationship and orientation of the electrodes in the first group of electrodes 208 and the second group of electrodes 210 relative to other electrodes on the same catheter 200 may be known or may be measured. In an embodiment, once the catheter is deployed, the spatial relationship and orientation of the electrodes in the first group of electrodes 208 and the second group of electrodes 210 relative to other electrodes on the same catheter 200 are constant.

[0079] With respect to the electric field, in embodiments, each electrode in the first group of electrodes 208 and each electrode in the second group of electrodes 210 may be selected to be an anodal or cathodal such that an electric field may be established between any two or more electrodes in the first and second groups of electrodes 208 and 210. Also, in embodiments, each electrode in the first group of electrodes 208 and each electrode in the second group of electrodes 210 may be selected to be a biphasic polarity such that the electrodes switch or alternate between an anodal and a cathodal polarity. Also, in embodiments, groups of electrodes in the first group of electrodes 208 and groups of electrodes in the second group of electrodes 210 may be selected to be an anodal or cathodal or biphasic polarity such that an electric field may be established between any two or more groups of electrodes in the first and second groups of electrodes 208 and 210.

[0080] In embodiments, the electrodes in the first group of electrodes 208 and the second group of electrodes 210 may be selected to be biphasic electrodes, such that during a pulse train that includes a biphasic pulse train, the selected electrodes switch or alternate between anode and cathode, and the electrodes are not forced into a monophasic delivery where one is always the anode and the other is always the cathode. In some cases, the electrodes in the first and second groups of electrodes 208 and 210 may form an electric field with electrodes of another catheter. In such cases, the electrodes in the first and second groups of electrodes 208 and 210 may be the anode of the field or the cathode of the field.

[0081] Further, as described herein, the electrodes are selected to be one of an anode and a cathode, but it should be understood throughout this disclosure that the electrodes may be selected to be biphasic, such as switching or alternating between an anode and a cathode, without stating. In some cases, one or more of the electrodes in the first group of electrodes 208 are selected to be cathodes and one or more of the electrodes in the second group of electrodes 210 are selected to be anodes. In embodiments, one or more of the electrodes in the first group of electrodes 208 may be selected as cathodes and another one or more of the electrodes in the first group of electrodes 208 may be selected as anodes. Further, in embodiments, one or more of the electrodes in the second group of electrodes 210 may be selected as cathodes and another one or more of the electrodes in the second group of electrodes 210 may be selected as anodes.

[0082] 3 is a schematic diagram showing a hybrid electroporation ablation catheter 300 in accordance with an embodiment of the presently disclosed subject matter. The catheter 300 includes an electrode assembly 305 extending from a distal end 306 of a catheter shaft 302. In the illustrated example, the electrode assembly 305 includes an expandable support structure 307 (e.g., a spline assembly as shown, although other expandable structures, such as inflatable balloons, may be used), a proximal first set of electrodes 310 disposed proximate a maximum diameter of the support structure 307, and a more distal second set of electrodes 320 disposed on the support structure 307 near a distal end.

[0083] 3, the proximal first set of electrodes 310 defines a ring of electrode pairs having a relatively large diameter and may be suitable for forming relatively large substantially circumferential lesions, for example, for isolating a pulmonary vein ostium in a PVI procedure. In contrast, the distal second set of electrodes 320 defines a ring of electrode pairs having a relatively small diameter (compared to that formed by the first set of electrodes 310) and may be configured for forming relatively small diameter localized ablation lesions in the ventricular wall that may be delivered individually or sequentially via a series of energy deliveries to generate a continuous line of interconnected lesions that form a solid line of electrical conduction block.

[0084] In embodiments, the electrodes forming the hybrid electroporation ablation catheter 300, the first and second sets of electrodes 310, 320 are each individually addressable (e.g., by the controller 140 described above). Thus, 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 the first mode of operation, the first set of electrodes 310 are activated and the second set of electrodes 320 are deactivated. In one example, in the second mode of operation, the first set of electrodes 310 are deactivated and the second set of electrodes 320 are activated. Thus, the hybrid electroporation ablation catheter 300 provides the same dual-use capabilities as the electroporation ablation catheter 200 described above, but without the user having to change the geometry of the electrode assembly 305.

[0085] FIG. 4 is an exemplary flow chart illustrating an exemplary method 400 of using a hybrid electroporation ablation catheter according to some embodiments of the present disclosure. Aspects of the embodiment of the method 400 may be performed, for example, by an electroporation ablation system / device (e.g., the system / device 100 shown in FIG. 1). One or more steps of the method 400 are optional and / or may be modified by one or more steps of other embodiments described herein. In addition, one or more steps of other embodiments described herein may be added to the method 400. First, the electroporation ablation system / device deploys (410) a hybrid electroporation ablation catheter in proximity to a target tissue. In one embodiment, the hybrid electroporation ablation catheter is operable in multiple operation modes. In some cases, the multiple operation modes include a first operation mode and a second operation mode, where the hybrid electroporation ablation catheter is configured to deliver ablation energy to form a circumferential ablation lesion in the first operation mode and is configured to deliver ablation energy to form a focal ablation lesion in the second operation mode.

[0086] In some cases, the 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 comprises a plurality of electrodes. In some designs, at least one of the plurality of electrodes is deactivated in one of a plurality of operation modes. In some designs, the electrode assembly is configured to form a plurality of shapes in a plurality of operation modes, the plurality of shapes having different volumes from one another. In some embodiments, the electrode assembly includes an inner shaft and a plurality of splines coupled to the inner shaft, the inner shaft being movable along a longitudinal axis of the catheter relative to the catheter shaft. In some cases, the electrode assembly is coupled to or integral with an actuator configured to control movement of the inner shaft relative to the catheter shaft.

[0087] In some embodiments, the electroporation ablation system / device selects (415) an operation mode from a plurality of operation modes of the hybrid electroporation ablation catheter. In some cases, the operation mode may be selected automatically, for example, by a controller (e.g., controller 140 of FIG. 1). In some cases, the operation mode is selected in response to sensory data collected by one or more sensors. In one embodiment, the operation mode is selected in response to sensory data indicative of a position of an actuator.

[0088] In embodiments, the electroporation ablation system / device operates the hybrid electroporation ablation catheter in a selected mode of operation (420), e.g., in an operation mode for a particular ablation strategy (e.g., circumferential ablation, focal ablation, segment ablation, etc.). In some cases, the electroporation ablation system / device is configured to generate an electric field (425) according to the mode of operation selected by the hybrid electroporation ablation system / device, e.g., generate an electric field at an electrode of the catheter. In some cases, the generated electric field has an electric field strength sufficient to ablate the target tissue via irreversible electroporation according to the selected mode of operation. In some cases, the electroporation ablation system / device is configured to deliver an exploratory pulse to the electrode.

[0089] In some cases, the electroporation ablation system / device is further configured to adjust the electric field (430), for example, by varying the exploratory pulse and / or the activated electrodes. In one embodiment, a selected set of electrodes is activated. In some cases, the selected set of electrodes is arranged in a particular spatial pattern.

[0090] Various modifications and additions may be made to the exemplary embodiments discussed without departing from the scope of the present invention. For example, while the embodiments described above set forth 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. A hybrid electroporation ablation catheter comprising: a catheter shaft having a proximal end and an opposite distal end; an electrode assembly extending from the distal end of the catheter shaft, the electrode assembly comprising a plurality of energy delivery electrodes and configured to be selectively operable in a first mode of operation and a second mode of operation; the electrode assembly includes an inner shaft extending from and adapted to be retracted within the catheter shaft; the plurality of energy delivery electrodes comprises a plurality of first electrodes and a plurality of second electrodes; When operated in the first mode of operation: the inner shaft extends from the catheter shaft; the plurality of first electrodes and the plurality of second electrodes are activated; When operated in the second mode of operation: the inner shaft is at least partially retracted within the catheter shaft; the plurality of first electrodes are activated; and A hybrid electroporation ablation catheter, wherein the plurality of second electrodes are deactivated.

2. 10. 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 circumferential ablation lesions having a diameter of 20 to 28 millimeters, and in the second mode of operation, the electrode assembly is configured to deliver ablation energy to form focal ablation lesions having a diameter of 5 to 20 millimeters.

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

4. 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 operating mode, and the plurality of splines form a second cavity having a second diameter in the second operating mode, the first diameter being larger than the second diameter.

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

6. The hybrid electroporation ablation catheter of claim 1 , wherein the catheter shaft is deflectable.

7. The hybrid electroporation ablation catheter of claim 1 , wherein the plurality of second electrodes are retracted within 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. an actuator configured to move the inner shaft relative to the catheter shaft; The hybrid electroporation ablation catheter of claim 1 , further comprising: a sensor configured to detect a position of the actuator.

10. 10. The hybrid electroporation ablation catheter of claim 9, wherein the hybrid electroporation ablation catheter is configured to be set to one of the first and second operational modes 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. 13. A system comprising the hybrid electroporation ablation catheter of any one of claims 1 to 12.

14. 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. 15. The system of claim 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.

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