JP2023535080A - 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 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 delivery electrodes. The electrode assembly is configured to be selectively operable in a plurality of different modes of operation.

Description

The present disclosure relates to medical systems and methods for ablating patient tissue. More specifically, the present disclosure relates to medical systems and methods for tissue ablation by electroporation.

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. Ablation is typically accomplished by thermal ablation techniques, including radio-frequency (RF) ablation and cryoablation. In RF ablation, a probe is inserted into the patient and radio waves are transmitted through the probe into the surrounding tissue. Radiofrequency 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, freezing and killing surrounding tissue. RF ablation and cryoablation techniques indiscriminately kill tissue through cell necrosis, which includes otherwise healthy tissue such as tissue within the esophagus, phrenic nerve cells, and tissue within the coronary arteries. can damage or kill

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

Irreversible electroporation can be used as a non-thermal ablation technique. Irreversible electroporation uses short high voltage pulse trains to generate electric fields strong enough to kill cells via apoptosis. In heart tissue ablation, irreversible electroporation may be a safe and effective alternative to the indiscriminate killing of thermal ablation techniques such as RF ablation and cryoablation. Irreversible electroporation kills 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) By using duration, it can be used to kill target tissue, such as myocardial tissue.

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 mode of operation and a second mode of operation. The electrode assembly includes an inner shaft extending from 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 within the catheter shaft, the plurality of first electrodes are activated, and the plurality of second electrodes are deactivated. activated.

Example 2 is wherein, in said first mode of operation, said electrode assembly is configured to deliver ablation energy to form a circumferential ablation lesion having a diameter of 20 millimeters to 28 millimeters; The hybrid electroporation ablation catheter of Example 1, wherein, in an operational mode, the electrode assembly is configured to deliver ablation energy to form a localized ablation lesion having a diameter of 5 millimeters to 20 millimeters. .

Example 3 is an example 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 disposed on the plurality of splines. 1. The hybrid electroporation ablation catheter of 1.

Example 4 is wherein the plurality of splines form a first cavity having a first diameter in the first mode of operation and the plurality of splines have a second diameter in the second mode of operation. 4. The hybrid electroporation ablation catheter of Example 3, forming a second cavity 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 positioned 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 one of Examples 1-5, wherein the catheter shaft is deflectable.

Example 7 is the hybrid electroporation ablation catheter of any one 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 further comprises an actuator configured to move the inner shaft relative to the catheter shaft and a sensor configured to detect the position of the actuator. One said hybrid electroporation ablation catheter.

Example 10 is configured such that the hybrid electroporation ablation catheter is configured to be set in one of the first operating mode and the second operating mode based on the detected position of the actuator. 10 is the hybrid electroporation ablation catheter of Example 9;

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 the hybrid electroporation ablation catheter of any one 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 a mode of operation of the hybrid electroporation ablation device.

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 includes an inner shaft extending from the catheter shaft 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 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 plurality of first electrodes are activated, and the plurality of second electrodes are deactivated. activated.

Example 17 is wherein in said first mode of operation said electrode assembly is configured to deliver ablation energy to form a circumferential ablation lesion having a diameter of 20 millimeters to 28 millimeters; 17. The hybrid electroporation ablation catheter of Example 16, wherein, in an operational mode, the electrode assembly is configured to deliver ablation energy to form a localized ablation lesion having a diameter of 5 millimeters to 20 millimeters. .

Example 18 is an example 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 disposed on the plurality of splines. 16 said hybrid electroporation ablation catheters.

Example 19 is wherein the plurality of splines form a first cavity having a first diameter in the first mode of operation and the plurality of splines have a second diameter in the second mode of operation. 19. The hybrid electroporation ablation catheter of Example 18, forming a second cavity 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 positioned 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 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. method ablation catheter.

Example 25 is configured such that the hybrid electroporation ablation catheter is configured to be set in one of the first operating mode and the second operating mode based on the detected position of the actuator. 25 is the hybrid electroporation ablation catheter of Example 24;

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 comprises a hybrid electroporation ablation catheter, a pulse generator configured to generate and deliver electroporation pulses to a hybrid electroporation ablation device, the pulse generator and the a controller coupled to the electroporation ablation device. 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 includes an inner shaft extending from the catheter shaft 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 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 plurality of first electrodes are activated, and the plurality of second electrodes are deactivated. activated.

Example 29 is configured, in said first mode of operation, said electrode assembly to deliver ablation energy to form a circumferential ablation lesion having a diameter of 20 millimeters to 28 millimeters; 29. The hybrid electroporation ablation system of Example 28, wherein in a mode of operation the electrode assembly is configured to deliver ablation energy to form a localized ablation lesion having a diameter of 5 millimeters to 20 millimeters. .

Example 30 is an example 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 disposed on the plurality of splines. 28, said hybrid electroporation ablation system.

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

Example 32 is a method for electroporation ablation. The method includes deploying a hybrid electroporation ablation catheter proximate a target tissue, the hybrid electroporation ablation catheter operating in a plurality of modes of operation comprising a first mode of operation and a second mode of operation. operable and configured to deliver ablation energy to form a circumferential ablation lesion in the first mode of operation and to deliver ablation energy to form a local ablation lesion in the second mode of operation; selecting an operating mode from the plurality of operating modes of the hybrid electroporation ablation catheter; and operating the hybrid electroporation ablation catheter in the selected operating mode. and generating an electric field at a plurality of electrodes of the catheter according to the selected mode of operation and having sufficient field strength to ablate target 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 comprises a plurality of electrodes, at least one of the plurality of electrodes being deactivated in one of the 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, the plurality of shapes having volumes that differ from one another.

While multiple embodiments are disclosed, still other embodiments of the invention will become apparent to those skilled in the art from the following detailed description, which shows and describes exemplary embodiments of the invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.

1 shows an exemplary system schematic of an electroporation ablation system or device, according to an embodiment of the disclosed subject matter; FIG. 1 is a schematic illustration of a hybrid electroporation ablation catheter in a first mode of operation, according to an embodiment of the disclosed subject matter; FIG. 2B is a schematic diagram illustrating the hybrid electroporation ablation catheter shown in FIG. 2A in a second mode of operation, in accordance with an embodiment of the presently disclosed subject matter; FIG. 2B is a schematic diagram illustrating the hybrid electroporation ablation catheter shown in FIG. 2A with additional components, according to an embodiment of the disclosed subject matter; FIG. FIG. 4 is another schematic diagram illustrating a hybrid electroporation ablation catheter, in accordance with an embodiment of the disclosed subject matter; 4 is an exemplary flow chart showing an exemplary method of use of a hybrid electroporation ablation catheter, in accordance with some embodiments of the present disclosure;

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

tangible (e.g., products, inventory, etc.) and/or intangible (e.g., data, electronic representations of currency, accounts, information, parts of things (e.g., percentages, fractions), calculations, data models, dynamic system models, As terms used herein with respect to measurements (e.g., dimensions, properties, attributes, components, etc.) and ranges thereof, "about" and "approximately" refer to the referenced measurements measurements, measurements and such as optimizing performance and/or construction parameters considering differences in manufacturing equipment calibration, human error in reading and/or setting measurements, and other measurements (e.g., measurements on other objects). adjustments, specific implementation scenarios, human, computing device and/or machine objects, imprecise adjustments and/or manipulations of settings and/or measurements, system tolerances, control loops, machine learning, predictable variations ( For example, statistically insignificant variation, random variation, system and/or model instability, etc.), and/or preference, etc., may be used interchangeably.

Exemplary methods may be illustrated by one or more drawings (e.g., flowcharts, communication flows, etc.), wherein the drawings illustrate any requirements for, or specifics between, the various steps disclosed herein. should not be construed to imply the order of However, certain embodiments may be explicitly described herein and/or may be understood from the nature of the steps themselves (e.g., performance of some steps may differ from previous may depend on the results of the steps), may require particular steps and/or a particular order between particular steps. Additionally, a "set," "subset," or "group" of items (e.g., inputs, algorithms, data values, etc.) may include one or more items; , which may contain one or more items. "plurality" means two or more;

As used herein, the term "based on" is not meant to be limiting, but rather at least by using the terms following "based on" as input, determine, identify, predict, and/or indicate that a calculation or the like is to be performed. For example, predicting an outcome based on certain information may additionally or alternatively make the same decision based on other information.

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

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 relatively large diameter, substantially circular, annular ablation lesion to ablate the pulmonary venous ostium in the so-called "pulmonary vein isolation" (PVI) procedure for treating paroxysmal AF. is particularly useful for This requires an IRE ablation catheter with a relatively large area electrode set to ideally treat the pulmonary vein ostium with a single energy application. In contrast, focal ablation produces lesions that are significantly smaller than the circumferential lesion produced in PVI procedures and commonly treats atrial tachycardia, atrioventricular reentrant arrhythmias, and persistent AF, among others. For example, it is used to generate electrical block lines using continuous energy application along the ventricular wall. Local ablation via IRE requires an IRE ablation catheter with electrode sets placed over a smaller area compared to the catheters described above for creating circumferential lesions. Circumferential and focal ablation currently require specially designed catheters for each ablation strategy, which is the case when both circumferential and focal ablation strategies are required in a single clinical procedure. , requiring removal of one ablation catheter, eg, a circumferential ablation catheter after PVI, and replacement with a local ablation catheter.

Embodiments of the present disclosure are capable of performing two or more ablation strategies (e.g., circumferential ablation and focal ablation) using a single catheter, referred to as a hybrid electroporation ablation catheter. Systems/devices and methods for In some embodiments, the hybrid exploratory ablation catheter is configured to have two modes of operation, one suitable for circumferential ablation and one suitable for local ablation. In some cases, hybrid catheters in different modes of operation have differently shaped electrode assemblies. In some cases, hybrid catheters in different modes of operation have different sets of electrodes activated in the electrode assemblies. In some cases, hybrid catheters in different modes of operation have both different sets of electrodes and different geometries activated in the electrode assemblies. In some embodiments, two or more modes of operation may be selected by the operator depending on the intended ablation strategy. In some embodiments, two or more modes of operation may be automatically selected by the controller depending on the intended ablation strategy and/or sensing data.

FIG. 1 shows an exemplary system diagram of an electroporation ablation system or device 100, according to an embodiment of the disclosed subject matter. Electroporation ablation system/device 100 includes one or more hybrid electroporation ablation catheters 110 , introducer sheath 130 , controller 140 , pulse generator 150 and memory 160 . In embodiments, 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, rendering the tissue incapable of conducting electrical signals. In some cases, the electroporation ablation system/device 100 may interface with other system(s) 170, such as mapping systems and/or electrophysiology systems.

In embodiments, the hybrid electroporation ablation catheter 110 is designed to have two or more modes of operation, each mode of operation representing the type of ablation operation (e.g., circumferential or single-shot ablation, focal ablation, segmental ablation). ablation, etc.). Catheter 110 is designed to be positioned by a target ablation location in an intracardiac chamber. As used herein, intracardiac chambers refer to the ventricles and surrounding vessels (eg, pulmonary veins). Pulse generator 150 is configured to generate what are referred to as ablation pulses/energy or electroporation pulses/energy that are 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/device 100 . In embodiments, electroporation controller 140 is configured to control pulse generator 150 for generating and delivering ablation energy to the electrodes of catheter 110 . In an embodiment, controller 140 is configured to control the mode of operation of hybrid electroporation ablation catheter 110 .

In one embodiment, catheter 110 has one or more electrodes. In some embodiments, catheter 110 includes an electrode assembly that includes one or more electrodes. In some cases, the electrode assembly is configured to deliver different magnitudes of electric field energy in different modes of operation. In some cases, the electrode assembly includes expandable components 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 are individually addressable and controllable. In some cases, controller 140 may control the delivery of ablation energy to each electrode such that the electric fields created by multiple electrodes may be controlled and adjusted. In some cases, a portion of one or more electrodes may be deactivated by controller 140 .

In some cases, a particular set of electrodes may be activated by controller 140 for a mode of operation. In some cases, portions of one or more electrodes may be retracted into the shaft of catheter 110 in certain modes of operation. 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 alternately in the operating mode, eg, when the electrode assembly has a relatively small operating diameter. In one embodiment, the distance between adjacent active electrodes is roughly the same (e.g., within 10% of the average distance) as the second distance (e.g., local ablation) in a first operation (e.g., circumferential ablation) variation), but the other electrodes are deactivated.

In some cases, electroporation controller 140 receives sensor data collected by sensor(s) of catheter(s). In some cases, electroporation controller 140 may change the operating mode of catheter 110 in response to receiving sensed data. In some cases, electroporation system/device 100 may include actuator 120 configured to change the operational geometry of the electrode assembly of catheter 110 . In some cases, 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 sensing data generated by the position sensor and change the operating mode of the catheter in response to the position of the actuator. In embodiments, actuator 120 is integrated with or coupled to catheter 110 .

In some cases, electroporation controller 140 may alter the ablation energy delivered to the electrodes in response to sensed data. In some cases, electroporation controller 140 is configured to model the electric field that may be generated by catheter 110, which often includes the physical properties of electroporation ablation catheter 110, including electrodes and The spatial relationship of the electrodes on the electroporation ablation catheter 110 is considered. In embodiments, electroporation controller 140 is configured to control the electric field strength of the electric field created by the electrodes of catheter 110 to no greater than 1500 volts/centimeter.

In embodiments, electroporation controller 140 executes 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; It includes one or more controllers, microprocessors, and/or computers. In embodiments, memory 160 may be part of one or more controllers, microprocessors, and/or computers and/or memory capacity accessible through a network such as the World Wide Web. In embodiments, memory 160 includes data repository 165, which stores ablation data (eg, position, energy, etc.), sensed data, modeled electric field data, and/or treatment planning data, and the like. configured to store.

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

In embodiments, the other system 170 includes an electroanatomical mapping (EAM) system. In some cases, the EAM system tracks the location of various functional components of the electroporation ablation system/device 100 and provides a high fidelity three-dimensional anatomical map and electroanatomical map of the ventricle of interest. can be manipulated to generate a target map. In embodiments, the EAM system may be the RHYTHMIA® HDx mapping system sold by Boston Scientific Corporation. Also, in embodiments, an EAM system mapping and navigation controller 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. .

The EAM system generates a localization field via a field generator to define a localization volume around the heart and the device(s) being tracked, such as one on electroporation ablation catheter pair 105 . These position sensors or sensing elements produce outputs that can be processed by a mapping and navigation controller to track the position of the sensor, and thus the position of the corresponding device, within the localization volume. In one embodiment, device tracking is accomplished using magnetic tracking technology, whereby the field generator is a magnetic field generator that generates a magnetic field that defines a localization volume and a location on the device to be tracked. The sensor 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), by an internal or intracardiac device (e.g., an intracardiac catheter), or both. be. In these embodiments, the position sensing element is an electrode on the tracked device that produces output that is received and processed by the mapping and navigation controller to track the position of the various position sensing electrodes within the localization volume. can be constructed.

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

Regardless of the tracking method used, the EAM system can track the location of various tracked devices along with cardiac electrical activity acquired, for example, by an electroporation ablation catheter pair 105 or another catheter or probe with sensing electrodes. The information is used to generate a detailed three-dimensional geometric anatomical map or display of the ventricle as well as an electroanatomical map in which the cardiac electrical activity of interest is superimposed on the geometric anatomical map. , to view through the display. Additionally, the EAM system may generate image representations of various tracked devices within the geometric and/or electroanatomical maps.

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

In some embodiments, a computing device is a bus that directly and/or indirectly couples the following devices (processor, memory, input/output (I/O) ports, I/O components, and power supply): including. Any number of additional components, different components, and/or combinations of components may also be included in the computing device. A bus indicates what may be one or more buses (eg, an address bus, a data bus, a combination thereof, etc.). Similarly, in some embodiments, a computing device may include several processors, some memory components, some I/O ports, some I/O components, and/or some power supplies. can include Additionally, any number or combination of these components may be distributed and/or replicated across several computing devices.

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, removable, non-removable, or combinations thereof. can be 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 tape, magnetic It includes disk storage devices or other magnetic storage devices, any other medium that can be used to transmit data and/or store information and that is accessible by a computing device such as, for example, quantum state memory. In some embodiments, memory 160 causes a processor (eg, controller 140) to implement aspects of embodiments of the system components discussed herein and/or the methods discussed herein. and store computer-executable instructions for performing aspects of the embodiment of the procedure.

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

Data repository 165 may be implemented using any one of the configurations described below. A 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 system can be a relational (RDBMS), hierarchical (HDBMS), multidimensional (MDBMS), object oriented (ODBMS or OODBMS) or object relational (ORDBMS) database management system, or the like. A data repository can be, for example, a single relational database. In some cases, a data repository may include multiple databases whose data can be exchanged and integrated by a data integration process or software application. In an exemplary embodiment, at least a portion of data repository 165 may be hosted in a cloud data center. In some cases, a data repository may be hosted on a single computer, server, storage device, cloud server, or the like. In some other cases, data repositories may be hosted on a series of networked computers, servers, or devices. In some cases, data repositories may be hosted on a hierarchy of data storage devices including local, regional, and central.

The various components of system/device 100 may communicate or be connected via communication interfaces (eg, wired or wireless interfaces). Communication interfaces include, but are not limited to, any wired or wireless short-range and long-range communication interfaces. Wired interfaces may use cables, umbilicals, and the like. The short-range communication interface may be, for example, a local area network (LAN), the Bluetooth standard, the IEEE 802 standard (eg IEEE 802.11), ZigBee or similar specification (IEEE 802.15.4 standards-based, etc.), or other public or proprietary wireless protocols. A long range communication interface may be, for example, a wide area network (WAN), a cellular network interface, a satellite communication interface, or 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 illustrates a portion of a hybrid electroporation ablation catheter 200 in a first mode of operation and FIG. 2B illustrates a hybrid electroporation catheter in a second mode of operation, according to an embodiment of the disclosed subject matter. 2 shows a surgical ablation catheter 200. FIG. 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 . As will be appreciated, 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, catheter 200 includes an electrode assembly 220 at its distal end extending from distal end 206 of catheter shaft 202 .

In an embodiment, electrode assembly 220 comprises a plurality of energy delivery electrodes 225, and electrode assembly 220 is configured to be selectively operable in first and second modes 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 localized 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 localized 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 localized ablation lesion having a diameter of 2 millimeters to 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 of 3 millimeters and 4 millimeters.

In some embodiments, electrode assembly 220 includes an inner shaft 203 that extends from catheter shaft 202 and is adapted to be retracted therein. In some cases, electrode assembly 220 includes multiple splines 204 coupled to inner shaft 203 at distal end 211 of inner shaft 203 . In some cases, electrode assembly 220 further includes central shaft 203a having proximal end 211a (overlapping distal end 211 of inner shaft 203) and distal end 212. As shown in FIG. In some cases, multiple splines 204 are coupled to distal end 212 of central shaft 203a. In an embodiment, the electrodes 225 include a plurality of first electrodes 208 and a plurality of second electrodes 210 arranged 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.

In some cases, when operated in the first mode of operation, inner shaft 203 and central shaft 203a extend from catheter shaft 202, eg, 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 circumferentially of relatively large diameter, such as those created in PVI procedures, for example. It is selectively energized and activated to form an ablation lesion.

In some embodiments, when operated in the second mode of operation, the inner shaft 203 and the central shaft 203a are configured such that all or a portion of the plurality of first electrodes 208 are catheterized, for example, as shown in FIG. 2B. It is at least partially retracted into catheter shaft 202 as it is retracted into shaft 202 . In some cases, in the second mode of operation, plurality of first electrodes 208 are deactivated (eg, by electrically disconnecting first electrodes 208 from any pulse generator circuitry). , a plurality of second electrodes 210 are activated and used to create local ablation lesions via electroporation.

Hybrid electroporation ablation catheter 200 has a longitudinal axis 222 . As used herein, longitudinal axis refers to a line passing through the center of gravity of a cross-section of an object. In an embodiment, multiple splines 204 form cavity 224 . Plurality of splines 204 form cavity 224a in a first mode of operation and 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 generally perpendicular to longitudinal axis 222 of cavity 224a has diameter d1. In some embodiments, in the second mode of operation, the largest cross-sectional area generally perpendicular to longitudinal axis 222 of cavity 224b has diameter d2. In some cases, diameter d1 is greater than diameter d2. In some examples, diameter d1 ranges from 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 (ie, at least twice as large as diameter d2). In one example, diameter d1 is at least 150% larger than diameter d2 (ie, at least 2.5 times diameter d2).

In some cases, the catheter shaft 202 is deflectable and implemented using techniques commonly known in the art. In some cases, catheter 200 includes an expandable balloon (not shown) disposed within cavity 224 of 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 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 catheter shaft 202 . In some cases, catheter 200C may include an actuator (not shown) configured to move inner shaft 203 relative to catheter shaft 202. As shown in FIG. In some cases, the actuator is external to catheter 200C, but is coupled to catheter 200C. In some cases, catheter 200 may include sensor 213 configured to detect the position of the actuator. In one embodiment, the mode of operation of hybrid electroporation ablation catheter 200 is set based on the detected position of the actuator. In one embodiment, the mode of operation of hybrid electroporation ablation catheter 200 is set based on sensor signals generated by sensor 213 .

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 at the distal end 212 of the catheter 200 . placed in close proximity to In some cases, the electrodes 208 of the first group are referred to as proximal electrodes, the electrodes 210 of the second group are referred to as distal electrodes, and the distal electrodes 210 are more electroporated than the proximal electrodes 208. is positioned near the distal end 212 of the ablation catheter 200 . In some implementations, electrode 225 may include a thin film of conductive ink or optical ink. The ink can be polymer-based. The ink may further include materials such as carbon and/or graphite in combination with the conductive material. Electrodes may also include biocompatible low resistance metals such as silver, silver flakes, gold, and platinum that are radiopaque.

Each electrode in the first group of electrodes 208 and each electrode in the second group of electrodes 210 conducts electricity and is controlled by a controller (eg, controller 140 in FIG. 1) and an ablation energy generator (eg, pulse in FIG. 1). configured to be operably connected to the generator 150). In embodiments, 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, multiple first electrodes 208 are individually controllable. In some cases, the multiple second electrodes are individually controllable. In some cases, all or some 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.

The electrodes in the first group of electrodes 208 are spaced apart from the electrodes in the second group of electrodes 210 . A first group of electrodes 208 includes electrodes 208a through 208f and a second group of electrodes 210 includes electrodes 210a through 210f. Also, electrodes within the first group of electrodes 208, such as electrodes 208a through 208f, are spaced apart from each other, and electrodes within the second group of electrodes 210, such as electrodes 210a through 210f, are spaced apart from each other.

The spatial relationship and orientation of the electrodes within the first group of electrodes 208 and the electrodes within the second group of electrodes 210 with respect to other electrodes on the same catheter 200 are known. There is or can be measured. In an embodiment, when the catheter is deployed, the spatial relationship and orientation of the electrodes within the first group of electrodes 208 and the electrodes within the second group of electrodes 210 with respect to other electrodes on the same catheter 200 are determined. The spatial relationship and orientation of are constant.

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 is such that the electric field exceeds any of the first and second groups of electrodes 208 and 210 It can be chosen to be an anode or a cathode so that it can be set between two or more electrodes. Also, in embodiments, each electrode in the first group of electrodes 208 and each electrode in the second group of electrodes 210 are bi-polarized so that the electrodes switch or alternate between being anodes and cathodes. It can be chosen to be phase polar. Also, in embodiments, the group of electrodes in the first group of electrodes 208 and the group of electrodes in the second group of electrodes 210 are such that the electric field is any can be chosen to be anodic or cathodic or biphasic poles, as can be set between groups of two or more electrodes of .

In an embodiment, the electrodes in the first group of electrodes 208 and the second group of electrodes 210 may be selected to be biphasic polar electrodes, whereby during a pulse train comprising a biphasic pulse train: The selected electrodes switch or alternate between anodic and cathodic, and the electrodes are not relegated to monophasic delivery where one is always anodic and the other is always cathodic. In some cases, electrodes in the first and second groups of electrodes 208 and 210 may form an electric field with another catheter's electrode(s). In such cases, the electrodes in the first and second groups of electrodes 208 and 210 may be field anodes or field cathodes.

Further, as described herein, the electrodes are selected to be one of an anode and a cathode, although throughout this disclosure the electrodes are switched or alternated between anode and cathode. It should be understood without stating that a two-phase pole may be chosen such that 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 cathodes. selected to be the anode. In embodiments, one or more of the electrodes in the first group of electrodes 208 may be selected as the cathode and another one or more of the electrodes in the first group of electrodes 208 may be selected as the anode. may be selected. Further, in embodiments, one or more of the electrodes in the second group of electrodes 210 may be selected as the cathode, and another one or more of the electrodes in the second group of electrodes 210 may be selected as cathodes. may be selected as the anode.

FIG. 3 is a schematic diagram illustrating a hybrid electroporation ablation catheter 300, according to an embodiment of the disclosed subject matter. Catheter 300 includes electrode assembly 305 extending from distal end 306 of catheter shaft 302 . In the example shown, the electrode assembly 305 is an expandable support structure 307 (eg, a spline assembly as shown, although other expandable structures such as an inflatable balloon may be used). ), a proximal first set of electrodes 310 positioned close to the maximum diameter of the support structure 307 and a more distal second set positioned on the support structure 307 near the distal end. and electrodes 320 of .

As seen in FIG. 3, the proximal first set of electrodes 310 defines a ring of electrode pairs having a relatively large diameter, for example to form a relatively large substantially circumferential lesion. , may be suitable for isolating the pulmonary vein ostia in PVI procedures. 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 in particular: ventricular wall with relatively small diameter focal ablation lesions that can be delivered individually or sequentially via a series of energy deliveries to produce a continuous line of interconnected lesions forming a solid line of electrical conduction blocks; can be configured to form a

In an embodiment, the electrodes forming the hybrid electroporation ablation catheter 300, the first and second sets of electrodes 310, 320 are each individually addressable (eg, by the controller 140 described above). Thus, in some embodiments, hybrid electroporation ablation catheter 300 has a first mode of operation (eg, circumferential ablation) and a second mode of operation (eg, focal ablation). In one example, the first set of electrodes 310 are activated and the second set of electrodes 320 are deactivated in the first mode of operation. In one example, the first set of electrodes 310 are deactivated and the second set of electrodes 320 are activated in the second mode of operation. Thus, hybrid electroporation ablation catheter 300 provides the same dual-use capabilities as electroporation ablation catheter 200 described above, but does not require the user to change the geometry of electrode assembly 305 .

FIG. 4 is an exemplary flowchart illustrating an exemplary method 400 of using a hybrid electroporation ablation catheter, according to some embodiments of the present disclosure. Aspects of an embodiment of method 400 may be performed, for example, by an electroporation ablation system/device (eg, system/device 100 shown in FIG. 1). One or more steps of method 400 are optional and/or may be modified by one or more steps of other embodiments described herein. Additionally, one or more steps of other embodiments described herein may be added to method 400 . Initially, the electroporation ablation system/device deploys a hybrid electroporation ablation catheter (410) proximate to the target tissue. In one embodiment, the hybrid electroporation ablation catheter is operable in multiple 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 form a circumferential ablation lesion in the first mode of operation. configured to deliver ablation energy and configured to deliver ablation energy to form a localized ablation lesion in a second mode of operation.

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 comprises multiple electrodes. In some designs, at least one of the plurality of electrodes is deactivated in one of the plurality of modes of operation. In some designs, the electrode assembly is configured to form multiple shapes in multiple modes of operation, the multiple shapes having volumes that differ from each other. 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 relative to the catheter shaft along a longitudinal axis of the catheter. . In some cases, the electrode assembly is coupled 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/device selects 415 an operating mode from multiple operating modes of the hybrid electroporation ablation catheter. In some cases, the operating mode may be automatically selected, for example, by a controller (eg, controller 140 of FIG. 1). In some cases, the mode of operation is selected in response to sensing data collected by one or more sensors. In one embodiment, the mode of operation is selected in response to sensed data indicative of actuator position.

In embodiments, the electroporation ablation system/device is hybrid electroporation in selected modes of operation, e.g. The ablation catheter is manipulated (420). In some cases, the electroporation ablation system/device is configured 425 to generate an electric field according to a mode of operation selected by the hybrid electroporation ablation system/device, e.g. Generate. In some cases, the generated electric field has sufficient field strength to ablate 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 electrodes.

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

Various modifications and additions may be made to the exemplary embodiments discussed without departing from the scope of the invention. For example, while the embodiments described above exhibit certain features, the scope of the 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 invention is intended to embrace all such alternatives, modifications and variations that fall within the scope of the claims along with all equivalents thereof.

Claims (15)

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 and comprising a plurality of energy delivery electrodes configured to be selectively operable in first and second modes of operation; with
the electrode assembly comprises an inner shaft extending from 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 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. 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, and in the second mode of operation, 3. The hybrid electroporation ablation catheter of Claim 1, wherein the electrode assembly is configured to deliver ablation energy to form a localized ablation lesion having a diameter of 5 millimeters to 20 millimeters. 2. The electrode assembly of claim 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 disposed on the plurality of splines. hybrid electroporation ablation catheter. The plurality of splines form a first cavity having a first diameter in the first mode of operation and 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. The hybrid electroporation ablation catheter of claim 1, wherein the plurality of second electrodes are positioned 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. 3. The hybrid electroporation ablation catheter of Claim 1, further comprising one or more return electrodes disposed on said catheter shaft. an actuator configured to move the inner shaft relative to the catheter shaft;
9. The hybrid electroporation ablation catheter of any one of claims 1-8, further comprising a sensor configured to detect the position of the actuator. 10. The hybrid electroporation ablation catheter of claim 9, wherein the hybrid electroporation ablation catheter is configured to be set into one of the first mode of operation and the second mode of operation based on the detected position of the actuator. A hybrid electroporation ablation catheter as described. The hybrid electroporation ablation catheter of claim 1, wherein the plurality of first electrodes are individually controllable. The hybrid electroporation ablation catheter of claim 1, wherein the plurality of second electrodes are individually controllable. A system comprising the hybrid electroporation ablation catheter of any one 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 coupled to the pulse generator and the hybrid electroporation ablation device and configured to select a mode of operation of the hybrid electroporation ablation device.

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