Ablation and mapping using a single multi-electrode catheter

Abstract

To provide an adapter and a method of using the adapter which are usable to perform mapping and ablation with a single catheter.SOLUTION: An adapter 100 can include circuitry that can toggle between a mapping state and an ablation state. In the mapping state, the circuitry connects such that the catheter can measure electrical signals from multiple independent electrodes. In the ablation state, the circuitry connects such that the catheter can apply electrical signals to the electrodes to ablate using IRE and / or RF techniques. The circuitry can short together a group of electrodes in the ablation state, and electrically isolate the electrodes in the group from each other in the mapping state, thereby making it possible to ablate and map at a treatment site without having to be repositioned between the mapping and ablation steps.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to a method for facilitating the performance of intravascular ablation and mapping using a single multi - electrode catheter, and related methods.

Background Art

[0002] Cardiac arrhythmias, such as atrial fibrillation, occur when electrical signals abnormally conduct from a specific region of heart tissue to adjacent tissue, thereby disrupting the normal cardiac cycle and causing an asynchronous rhythm. The unwanted signal source is typically located in atrial or ventricular tissue. Regardless of the source, unwanted signals can travel through the heart tissue to other locations and may cause or sustain an arrhythmia.

[0003] As treatments for arrhythmias, there are surgical destruction of the signal source causing the arrhythmia and destruction of the conduction path of such signals. More recently, it has been found possible to interrupt or modify the propagation of unwanted electrical signals from one part of the heart to another by mapping the electrical properties and cardiac volume of the endocardium and selectively ablating heart tissue by application of energy. The ablation process destroys unwanted electrical pathways by forming non - conductive damaged areas.

[0004] Therefore, such procedures typically involve a two-step process: (1) mapping and (2) ablation. During mapping, a catheter with an end-effector equipped with high-density electrodes moves across the target tissue, and electrical signals are acquired from each electrode, generating a map based on the acquired signals. During ablation, damage is formed in areas selected based on the map, disrupting the electrical signals through those areas. Currently, the most common ablation techniques involve applying radio frequency (RF) electrical signals to the tissue via electrodes to generate heat. Irreversible electroporation (IRE) ablation, which involves applying short bursts of high-voltage pulses to the entire tissue to induce cell death, is a more recently developed technique. Because the objectives of the ablation and mapping steps are different, the goals of the catheter design are also different, and therefore, ablation and mapping are typically performed using different catheters. [Overview of the project] [Means for solving the problem]

[0005] An adapter and a method of using the adapter are presented herein, which can be used to perform mapping and ablation with a single catheter. The adapter may include a circuit that can switch between a mapping state and an ablation state. When the circuit is in the mapping state, the catheter can measure electrical signals from multiple independent electrodes on the catheter's end effector. When the circuit is in the ablation state, the catheter can apply electrical signals for ablation to multiple electrodes. The circuit can switch the electrodes on the end effector between being connected to a mapping system and being connected to an ablation generator. The circuit can short-circuit a group of electrodes together in the ablation state and electrically isolate the electrodes within the group from each other in the mapping state. The short-circuited electrodes within the group can collectively provide a surface area large enough to facilitate ablation using IRE and / or RF techniques. Using the adapter, the catheter can perform ablation and mapping at the treatment site without needing to be repositioned between the mapping and ablation steps.

[0006] An exemplary adapter includes a first set of contacts, a second set of contacts, a third set of contacts, and a circuit configured to switch between a mapping state and an ablation state. The first set of contacts is configured to electrically connect to the electrodes of a multi-electrode catheter. The second set of contacts is configured to electrically connect to a catheter mapping system. The third set of contacts is configured to electrically connect to an ablation generator. The first set of contacts communicates electrically with the second set of contacts in the mapping state. The first set of contacts communicates electrically with the third set of contacts in the ablation state.

[0007] When the circuit is in the mapping state, the first and second contacts of the first set of contacts can be electrically isolated from each other. When the circuit is in the ablation state, the first and second contacts can be electrically short-circuited from each other. The first and second contacts can be configured to electrically connect to the first and second electrodes on a common projection of the catheter, respectively. Alternatively, the first and second contacts can be configured to electrically connect to the first electrode on the first projection of the catheter and to the second electrode on a second projection of the catheter that is different from the first projection, respectively. When the circuit is in the ablation state, the first and second contacts can be electrically short-circuited to additional contacts of the first set of contacts, thereby configuring the circuit to short-circuit the circularly arranged electrodes of the catheter.

[0008] When the circuit is in a mapping state, each contact of the first plurality of contacts can be electrically isolated from each other, and when the circuit is in an ablation state, the first portion of the first plurality of contacts can be electrically short-circuited from each other, the second portion of the first plurality of contacts can be electrically short-circuited from each other, and the first portion can be electrically isolated from the second portion. The first portion can be configured to electrically contact an electrode on a first projection of the catheter. The second portion can be configured to electrically contact an electrode on a second projection of the catheter, which is different from the first projection.

[0009] When the circuit is in an ablation state, it may be configured to enable thermal ablation by at least a portion of the catheter electrodes by transmitting radio frequency (RF) electrical energy from a third set of contacts to a first set of contacts. Additionally or alternatively, when the circuit is in an ablation state, it may be configured to enable irreversible electroporation ablation by at least a portion of the catheter electrodes by transmitting voltage pulses from a third set of contacts to a first set of contacts.

[0010] When the circuit is in an ablation state, some of the first set of contacts can be short-circuited to provide at least the minimum electrode surface area required for irreversible electroporation ablation. The minimum electrode surface area includes one or more electrodes that are electrically connected to each other, and one or more electrodes can be combined to provide a large surface area electrode for ablation.

[0011] The adapter may further include a user interface configured to switch the circuit between a mapping state and an ablation state. The user interface may include a mechanical switch.

[0012] The adapter may further include a first connector, a second connector, a third connector, and a portable adapter body that provides structural support for the first, second, and third connectors. The first connector may accommodate a first set of contacts and be configured to mate with a catheter. The second connector may accommodate a second set of contacts and be configured to mate with a catheter mapping system. The third connector may accommodate a third set of contacts and be configured to mate with an ablation generator.

[0013] The adapter may further include a communication system configured to receive commands from an external computing device. The communication system may be supported by the portable adapter body. The external computing device may be located outside the adapter body. The circuit may be configured to switch between a mapping state and an ablation state in response to commands received by the communication system from the external computing device.

[0014] An exemplary method for treating cardiac arrhythmias may include one or more of the following steps, which may be performed in various sequences with additional steps, as will be understood by those skilled in the art in accordance with the teachings herein. The method may include positioning the electrodes of a multi-electrode catheter relative to cardiac tissue in a first orientation; measuring the potential of the tissue while the electrodes are in the first orientation; and ablating the tissue through the electrodes while maintaining the position of the electrodes in the first orientation.

[0015] This method may include measuring the potential of an additional electrode in a multi-electrode catheter. This method may also include stopping the operation of the additional electrode while tissue is being ablated.

[0016] Measuring the potential of electrodes may include measuring the potential between a first electrode and a second electrode. Ablating tissue may include synchronously applying an electrical signal to the first and second electrodes for tissue ablation. The method may include positioning the first and second electrodes so that they are on a common projection of the catheter. The method may also include positioning the first and second electrodes so that the first electrode is on a first projection of the catheter and the second electrode is on a second projection of the catheter that is different from the first projection.

[0017] Ablation of tissue via electrodes may include ablating a circular area of ​​tissue with electrodes.

[0018] Measuring the potential of electrodes may include measuring separate potentials at each electrode. Ablating tissue may include applying a first electrical signal to a first portion of electrodes that are electrically short-circuited with each other, and applying a second electrical signal, different from the first electrical signal, to a second portion of electrodes that are electrically short-circuited with each other.

[0019] The method may include ablation of tissue via a first portion of an electrode positioned on a first projection of a catheter. The method may also include ablation of tissue via a second portion of an electrode positioned on a second projection of a catheter, which is different from the first projection.

[0020] This method may include thermally ablating the tissue by applying radio frequency (RF) electrical energy to the tissue from an electrode.

[0021] This method may include ablation of tissue by irreversible electroporation by applying voltage pulses to electrodes. This method may also include applying voltage pulses to electrodes such that the cumulative electrode surface area is at least the minimum electrode surface area required for irreversible electroporation ablation.

[0022] This method may include switching the electrodes of a multi-electrode catheter between a mapping state and an ablation state via a user interface, where, in the mapping state, the electrodes electrically communicate with a mapping system configured to measure the potential of the electrodes, and in the ablation state, the electrodes electrically communicate with an ablation generator configured to ablate tissue through the electrodes. Switching the electrodes via a user interface may include moving a mechanical switch.

[0023] The method may include connecting a first connector of the adapter to a catheter so that the electrode communicates electrically with a first set of contacts of the first connector. The method may also include connecting a second connector of the adapter to a mapping system configured to measure the potential of the electrode. The method may also include connecting a third connector of the adapter to an ablation generator configured to ablate tissue via the electrode.

[0024] This method involves sending commands from an external computing system to an adapter to cause the catheter to switch between measuring the potential of an electrode and ablating tissue through the electrode, and the external computing system can be located outside the portable body of the adapter.

Brief Description of the Drawings

[0025] The above and further aspects of the present invention will be further considered in conjunction with the following description referring to the accompanying drawings, in which like numerals in the various drawings indicate like structural elements and features. The drawings are not necessarily to scale and instead are primarily focused on illustrating the principles of the present invention. The figures depict one or more implementations of the device of the present invention by way of illustration and not limitation. [Figure 1] FIG. Exemplary adapter according to an aspect of the present invention. [Figure 2A] FIG. Catheter connector, mapping system connector, and ablation generator connector according to an aspect of the present invention. [Figure 2B] FIG. Catheter connector, mapping system connector, and ablation generator connector according to an aspect of the present invention. [Figure 2C] FIG. Catheter connector, mapping system connector, and ablation generator connector according to an aspect of the present invention. [Figure 3] FIG. Exemplary system configured to perform mapping and ablation with a single catheter according to an aspect of the present invention. [Figure 4] FIG. Exemplary system used during treatment according to an aspect of the present invention. [Figure 5] FIG. Exemplary end effector of a catheter according to an aspect of the present invention. [Figure 6] FIG. Another exemplary end effector of a catheter according to an aspect of the present invention. [Figure 7]This is a diagram of another exemplary end effector of a catheter according to an aspect of the present invention. [Figure 8] This is a diagram of another exemplary end effector of a catheter according to an aspect of the present invention. [Figure 9] This is a diagram of another exemplary end effector of a catheter according to an aspect of the present invention. [Figure 10] This is a diagram of another exemplary end effector of a catheter according to an aspect of the present invention. [Figure 11] This is a flowchart of another exemplary treatment method according to an aspect of the present invention. [Modes for carrying out the invention]

[0026] The following description of specific embodiments of the present invention should not be used to limit the scope of the invention. The drawings are not necessarily to scale and illustrate selected embodiments, and are not intended to limit the scope of the invention. The detailed description illustrates the principles of the invention as examples, not as limitations. Other examples, features, aspects, embodiments and advantages of the invention will be apparent to those skilled in the art from the following description, which includes as an example one of the best modes conceivable for carrying out the invention. As will be recognized, the invention can be made into other different or equivalent embodiments without departing from the invention. Therefore, the drawings and description should be considered illustrative and not limiting.

[0027] The teachings, formulas, modifications, and examples described herein may be combined with other teachings, formulas, modifications, and examples described herein, including the examples provided in the references attached to U.S. Provisional Application No. 63 / 220,269, to which this application claims priority. Therefore, the teachings, expressions, modifications, and examples described below should not be considered in isolation. Various preferred ways in which the teachings herein can be combined will be apparent to those skilled in the art. Such modifications and variations are intended to be included within the claims.

[0028] The embodiments included herein generally include circuits that allow a catheter to function as both a mapping catheter and an ablation catheter. For the competing purposes of mapping and ablation, currently, the mapping catheter is used to identify abnormal signals, and the mapping catheter is removed, with the ablation catheter positioned to destroy the abnormal signals measured by the mapping catheter. Advanced computer-generated images are used by the physician to guide the ablation catheter to the correct position. A catheter capable of performing both mapping and ablation can eliminate the need to guide a second ablation catheter to the abnormal signal. By using the same catheter for both mapping and ablation, once an abnormal tissue signal is detected, the catheter can be kept in position for subsequent ablation. Energy can be delivered through the same electrode that recorded the abnormal signal, and ablation can be performed immediately without the risk of losing the location of the abnormal signal.

[0029] To achieve this function with minimal modification to existing ablation and mapping systems, an adapter can be positioned between the catheter connector and the cable connector (or between the cable connector and the system), and all or some of the electrical channels used for the end-effector mapping electrodes can be short-circuited together to form one or more electrode groups that can function collectively in a large effective area for ablation. Energy (RF or IRE) can then be delivered via existing cables or systems, or via dedicated cables or systems routed to the adapter. The catheter can have electrodes with sufficient density to achieve the desired mapping resolution and a sufficiently large effective electrode contact surface area when the electrical channels are short-circuited to effectively deliver ablation energy to the tissue. A physical switch can be placed on the adapter, where the user can switch between open and short-circuited states. Alternatively, the switch may be available on the user interface of an external computing device, such as a graphical user interface (GUI) of the mapping and ablation system. Or, the adapter circuit described herein can be integrated into the handle of the catheter and / or mapping and ablation system by standard engineering techniques, which may be preferable to the adapter if treatments utilizing the mapping and ablation techniques described herein become common.

[0030] Various short-circuit patterns can be devised to take advantage of the various form factors of existing, conventional, or future catheter end-effectors. Exemplary end-effectors shown herein include eight radial projections (Figure 5), five radial projections (Figure 6), six substantially planar projections joined to form three loop members (Figure 7), a basket with curved projections (Figure 8), a circular lasso (Figure 9), and a linear geometric shape (Figure 10). Such end-effectors accommodate too many short-circuit patterns to be described in detail herein. Alternative patterns that are not expressly enumerated or described herein but become apparent to those skilled in the art according to the teachings herein are within the scope of the invention. Furthermore, alternative end-effector geometric shapes that are not expressly enumerated or described herein but become apparent to those skilled in the art according to the teachings herein, including end-effectors to be developed in the future, are within the scope of the invention.

[0031] Common geometric shapes of shunt patterns most likely to be used during treatment include localized, large-area, circular, linear, and symmetrical groupings. The shunt pattern may be modified as clinically required for the targeted arrhythmia / ablation injury strategy or energy modality. For example, the configuration of the ablation electrode may be optimized for circular injury, linear injury, or focal ablation (applicable to pulmonary vein isolation, isthmus lines between the tricuspid valve and vena cava, or micro-reentry circuits). Alternatively, the ablation electrode may be configured to allow the application of an ideal energy dose (e.g., higher wattage / voltage) to the tissue.

[0032] The short-circuit pattern can also be selected to choose the effective surface area of ​​the short-circuit electrode. The electrode surface area affects the current density at the electrode / tissue interface. Low current density allows users to apply high-power / current RF damage without increasing the risk of steam popping. A large surface area can also affect the voltage / pulse waveform that can be sustained in the IRE waveform.

[0033] Figure 1 shows an exemplary portable adapter 100 that includes a circuit for switching between a mapping state and an ablation state so that the catheter can function as a mapping catheter and an ablation catheter. The adapter 100 includes a first catheter connector 120, a second mapping system connector 130, and a third ablation generator connector 140. The adapter 100 may have a portable body 102 so that the adapter 100 can be used with various types of catheters, mapping systems, and ablation systems. The portable body 102 can provide structural support for the connectors 120, 130, 140, the circuit, and other adapter components.

[0034] The adapter 100 is also shown to include a user interface 104 in the form of a mechanical switch for switching the circuit between a mapping state and an ablation state. The user interface 104 may have a variety of alternative form factors (buttons, touchscreens, knobs, etc.) comparable to user interfaces on known electronic devices. Additionally or alternatively, the adapter 100 may include a communication system configured to receive commands from an external computing device and switch the circuit between a mapping state and an ablation state. The external device may be located outside the body 102 of the adapter 100. For example, the communication system may include a wireless transmitter configured to respond to wireless transmissions from a computing system or device which may or may not be integrated with the mapping system and / or the ablation generator. As another alternative, the adapter may include a wired connection between the communication system of the adapter 100 and the mapping system, and / or a wired connection between the communication system of the adapter 100 and the ablation generator.

[0035] Figure 2A is an end view of the catheter connector 120. The catheter connector 120 can be configured to mate with the handle of a catheter and may include contacts 124 configured to electrically connect electrodes on the end effector of the catheter to potentially other catheter electronic devices such as thermal sensors, navigation sensors, and force sensors. The catheter connector 120 may further include key features 122 so that the catheter connector 120 cannot mate with a mapping system and also cannot mate with an ablation generator.

[0036] Figure 2B is an end view of the mapping system connector 130. The mapping system connector 130 can be configured to mate with a mapping system. The mapping system connector 130 includes a contact 134 that electrically connects to the contact 124 of the catheter connector 120 via the adapter circuit when the circuit of the adapter 100 is in a mapping state. The mapping system connector 130 may further include one or more adapter communication contacts 136. The adapter communication contacts 136 can provide a communication link between the mapping system and the adapter 100. Preferably, the contact 134 to the end effector electrode of the catheter electrically isolates the end effector electrodes from each other in the mapping system connector 130. The mapping system connector 130 may further include a key feature 132 such that the mapping system connector 130 cannot mate with a catheter or with an ablation generator.

[0037] Figure 2C is an end view of the ablation generator connector 140. The ablation generator connector 140 can be configured to mate with an ablation generator. The ablation generator connector 140 includes contacts 144 that electrically connect to the contacts 124 of the catheter connector 120 via the adapter circuit when the adapter circuit is in an ablation state. Preferably, the contacts 144 to the electrodes of the catheter's end effector are short-circuited together as a group in the ablation generator connector 140. As a result, the ablation generator connector 140 can have fewer contacts 144 to the end effector electrodes compared to the contacts 124 of the catheter connector 120 to the end effector electrodes. The ablation generator connector 140 may further include one or more adapter communication contacts 146. The adapter communication contacts 146 can provide a communication link between the ablation generator and the adapter 100. The ablation generator connector 140 may further include a key feature portion 142 such that the ablation generator connector 140 cannot be mated with a catheter or with a mapping system.

[0038] Figure 3 shows an exemplary system 10 configured to perform mapping and ablation with a single catheter 200. The catheter 200 includes an end effector 215 at the distal end of an elongated shaft 212. A control handle 216 at the proximal end of the shaft 212 may be configured to manipulate the catheter 200 and position the end effector 215 relative to the tissue of the treatment site in the patient, for example, in a blood vessel or heart. The control handle 216 may further include an irrigation port 265 for supplying irrigation fluid to the end effector 215. The control handle 216 may include a control handle connector 204 configured to mate with a catheter connector 120 of an adapter 100.

[0039] The illustrated system 10 includes an integrated mapping and ablation console 40. A suitable integrated mapping and ablation console 40 is, for example, the CARTO3 developed by Biosense Webster in California, USA, which allows physicians to visualize catheter end effectors in a three-dimensional virtual model of the heart.

[0040] As shown in Figure 3, the integrated mapping and ablation console 40 includes a mapping system port 70 containing three connector receptacles 72, 74, and 76, and an ablation generator port 69 containing a single receptacle. The CARTO3 system includes multiple mapping system connector receptacles 72, 74, and 76 for accommodating various catheters with varying numbers of end-effector electrodes, i.e., the more end-effector electrodes a catheter has, the more mapping system receptacles can be utilized. The system 10 includes a cable assembly 300 configured to mate a catheter 200 into the mapping system port 70. The cable assembly 300 includes an adapter 100 and an adapter / catheter connector 302 configured to mate a breakout cable 310 to multiple mapping system connectors 312, 322, and 332 that can be plugged into the corresponding receptacles 72, 74, and 76 of the mapping system port 70. The cable assembly 300 can be modified to include more or fewer breakout cables 310 depending on the number of end-effector electrodes of the catheter 200. The ablation generator connector 140 of the adapter 100 can be configured to mate directly with the ablation generator port 69 of the integrated mapping and ablation console 20, or to mate indirectly via an extension cable.

[0041] Figure 4 shows an exemplary system 10 used during treatment. The console 40 is shown to have a larger form factor, but the same principle applies. The console 40 is connected as part of a mapping and ablation system 20, which includes a user interface 42 and a display 44 that shows a virtual image of the heart 68 and an end effector 215. The adapter 100 is shown to connect directly to the proximal end of the catheter handle 216 using two cables that extend to the ablation generator port 69 and the mapping system port 70 of the console 40, respectively. Alternatively, the adapter 100 can be configured to connect directly to the console 40, or the circuitry of the adapter 100 can be integrated into the console 40.

[0042] To begin the procedure, physician 22 puts the adapter circuit into mapping mode by operating the user interface 104 of the adapter 100. Physician 22 inserts the catheter 200 into the subject 24 and then navigates the catheter 200 to the appropriate location inside or outside the heart 52 using the control handle 216. Subsequently, physician 22 brings some or all of the electrodes of the end effector 215 into contact with tissue 58, such as myocardial or epicardial tissue of the heart 52. Signals from the electrodes of the end effector 215 are transmitted through the adapter 100 to the mapping system port 70 to detect the electrical activity of the heart 52. Indicators of electrical activity are presented on the display 44. If an abnormal signal is detected, physician 22 puts the adapter circuit into ablation mode by operating the user interface 104 of the adapter 100. Physician 22 can provide ablation setting parameters 66 by operating the user interface 42 of the mapping and ablation system 20. The physician 22 may select an electrode pattern to which ablation energy is applied, and / or characteristics of the electrical signal to which ablation energy is applied. Finally, the electrical signal is delivered into the tissue 58 from the ablation generator port 69 of the console 40 through the adapter 100 and end effector 215, thereby allowing the tissue 58 to be ablated. Abnormal signal detection and ablation can be performed without moving the end effector 215 to the tissue 58 between the detection step and the ablation step.

[0043] The illustrated ablation system 20 includes a processor 32, an IRE module 34, an RF module 35, an electrocardiogram (ECG) module 46, a tracking module 60, and a temperature module 54. Modules 34, 35, 46, 60, and 54 may collectively or individually contain non-temporary memory having instructions that can be executed by the processor to perform various functions, including functions described herein and functions understood by those skilled in the art according to the teachings herein. The console 40 does not need to include all modules when a module is not required for an exemplary treatment. For example, system 10 can be adapted for IRE ablation, RF ablation, or both.

[0044] The IRE module includes an IRE generator 36 and an IRE controller 38. The RF module 35 includes an RF generator 37 and an RF controller 39. The RF controller 39 and the IRE controller 38 may be integrated or configured to function in coordination. IRE pulses are generated and applied, either alone or in combination with RF ablation, in the various treatments described in U.S. Patent Publication 2021 / 0169550, U.S. Patent Publication 2021 / 0169567, U.S. Patent Publication 2021 / 0169568, U.S. Patent Application 62 / 949,999 (Agent Reference Number BIO6206USPSP1), U.S. Patent Publication 2021 / 0161592, U.S. Patent Application 16 / 731,238 (Agent Reference Number BIO6208USNP1), U.S. Patent Application 16 / 710,062 (Agent Reference Number BIO6209USNP1), and U.S. Patent Publication 2021 / 0186604, etc., which are incorporated herein by reference and attached to the priority documents of U.S. Provisional Patent Application 63 / 220,269. U.S. Patent Application No. 16 / 989,445 claims priority over U.S. Patent No. 62 / 949,999 and is published as U.S. Patent Publication No. 2021 / 0191642, incorporated herein by reference. U.S. Patent Application No. 16 / 731,238 is published as U.S. Patent Publication No. 2021 / 0196372, incorporated herein by reference. U.S. Patent Application No. 16 / 710,062 is published as U.S. Patent Publication No. 2021 / 0177503, incorporated herein by reference.

[0045] In response to receiving the setting parameters 66, the processor 32 transmits these parameters to the IRE controller 38 and / or RF controller 39, which then instructs the IRE generator 36 and / or RF generator 37 to generate IRE signals and / or RF signals according to the settings requested by the physician 22. Furthermore, the processor 32 may display the setting parameters 66 on the display screen 44.

[0046] Although the RF module 35 and IRE module 34 are shown as separate modules for illustrative purposes, it should be understood that the modules may share common hardware and software components. The processor 32, IRE controller 38, and RF controller 39 may each include a programmable processor programmed with software and / or firmware to perform the functions described herein. Alternatively or additionally, the IRE controller 38, RF controller 39, and / or processor 32 may each include hardwired and / or programmable hardware logic circuits that perform at least some of these functions. Although the processor 32 is shown as a separate functional block from the IRE controller 38 and RF controller 39, in practice some of these functions may be combined within a single processing control unit having a suitable interface for receiving and outputting the illustrated and described signals. For example, the IRE controller 38 may reside in the IRE module 34 to transmit high-speed control signals from the IRE controller to the IRE generator 36. However, the IRE controller 38 may reside in the processor if sufficiently high-speed signals can be transmitted from the processor 32 to the IRE generator 36.

[0047] The processor 32 and IRE module 34 can reside within the console 40. The electrocardiogram (ECG) module 46, temperature module 54, and / or tracking module 60 can reside within the console 40 and connect to appropriate interfaces and devices within the system 20. The electrocardiogram (ECG) module 46 is coupled via cable 48 to ECG electrodes 50 attached to the subject 24. The ECG module 46 is configured to measure the electrical activity of the subject 24's heart 52.

[0048] The temperature module 54 is coupled to any temperature sensor (not shown) on the distal portion of the catheter 200. The temperature module 54 can be connected to a mapping system port 70 which can receive signals from the temperature sensor in the catheter 200 by connecting to one or more of the connectors 134 of the mapping system connector 130 of the adapter 100 when the circuit of the adapter 100 is in a mapping state. Additionally or alternatively, the temperature module 54 can be connected to an ablation generator port 69 which can receive signals from the temperature sensor in the catheter 200 by connecting to one or more of the contacts 144 of the ablation generator connector 140 of the adapter 100 when the circuit of the adapter 100 is in an ablation state.

[0049] The tracking module 60 is coupled to one or more electromagnetic position sensors (not shown) on the distal portion of the catheter 200. In the presence of an external magnetic field generated by one or more magnetic field generators 62, the electromagnetic position sensors output signals that change with the position of the sensors. Based on these signals, the tracking module 60 may determine the position of the end effector 215 within the heart 52. The tracking module 60 can be connected to the electromagnetic position sensors in the catheter 200 via one or more of the mapping system port 70 and the connectors 134 of the mapping system connector 130 of the adapter 100 when the circuit of the adapter 100 is in a mapping state. Additionally or alternatively, the tracking module 60 can be connected to the electromagnetic position sensors in the catheter 200 via one or more of the ablation generator port 69 and the contacts 144 of the ablation generator connector 140 of the adapter 100 when the circuit of the adapter 100 is in an ablation state.

[0050] Modules 46, 54, and 60 described above typically include both analog and digital components and are configured to receive analog signals and transmit digital signals. Each module may further include hardwired and / or programmable hardware logic circuits that perform at least some of the module's functions.

[0051] One or more external electrodes 65 or “return patches” can be coupled to the outside of the subject 24, typically the subject’s torso and console 40 (not shown). The return patch(s) 65 can provide a return path(s) for the unipolar ablation signal applied to one or more electrodes of the end effector 215. RF ablation and IRE ablation can each be applied in a unipolar ablation scheme. Furthermore, RF ablation and IRE ablation can each be applied in a bipolar ablation scheme. Currently, it is more common for RF ablation to be performed in a unipolar ablation scheme and for IRE ablation to be performed in a bipolar ablation scheme. The exemplary catheter 200 and exemplary system 10 can be adapted to perform unipolar RF ablation, unipolar IRE ablation, bipolar RF ablation, unipolar IRE ablation, or any combination thereof.

[0052] During unipolar RF ablation, RF energy is delivered from the short-circuited electrode of the end effector 215 to the return patch 65. The alternating current flowing through the tissue faces resistance, and the energy is converted into heat. This energy-resistive heat destroys the tissue near the activated catheter electrode(s). The heat is then transferred to the surrounding tissue by conduction and radiation, resulting in the formation of damage. Even if only a small amount of energy is delivered to the tissue, scar formation is related to the electrode size, the energy power, the contact force between the electrode and the tissue, and the cooling effect of the ambient fluid. Cooling the electrode reduces the risk of overheating the tissue, thereby allowing for the formation of deeper damage. System 10 may include irrigation (not shown) as understood by those skilled in the art. Reducing the distance between the electrode of the end effector 215 and the return patch 65 can result in a higher current density with greater resistive heat, leading to the formation of deeper damage. Bipolar RF ablation is performed when the RF current flows between two of the catheter electrodes. Damage created by bipolar RF ablation is generally narrower and deeper than damage created by unipolar RF ablation, resulting in transwall scars that can reach a depth of approximately 25 mm within the tissue.

[0053] During bipolar IRE ablation, a biphasic pulse is applied between catheter electrodes (typically in pairs) to generate an electric field between the electrodes. Cells on and between the electrodes undergo electroporation through the maximum electric field. During unipolar IRE ablation, a biphasic pulse is applied between the short-circuit catheter electrode and the return patch(s) 65 to generate an electric field between the end effector 215 and the return patch(s) 65.

[0054] The processor 32 is configured to receive setting parameters 66 from the physician 22 or another user or device. Using one or more suitable input devices 42, the physician 22 can input parameters for the ablation signals for RF ablation and / or IRE ablation. The end effector electrodes can be short-circuited together as a group by the adapter circuit in the mapping state, and the group can be activated individually during ablation. The physician 22 can select the groups of short-circuited end effector electrodes for activation (for receiving IRE pulses and / or RF signals) and the order in which they are activated. When setting up IRE ablation, the physician 22 can also select the synchronization mode of the IRE pulses with respect to the heart cycle 52.

[0055] Figure 5 shows the distal portion of an exemplary catheter 200. The catheter includes an elongated shaft 212 that navigates the catheter 200 through the vascular system and an end effector 215 on the distal end of the shaft 212. The end effector includes eight projections 215A–H. The projections are shown in an expanded configuration molded to press against tissue 58, as shown in Figure 4. The projections 215A–H extend radially from the shaft 212. The projections 215A–H can contract together so that the end effector 215 can navigate through the vascular system. The end effector 215 may further include an irrigation port 206 configured to irrigate tissue 58 in the vicinity of an electrode.

[0056] Each projection includes electrodes A1-6, B1-6, C1-6, D1-6, E1-6, F1-6, G1-6, and H1-6 distributed along the corresponding projections 215A-H. As shown in the figure, the end effector 215 includes six electrodes per projection on the eight projections. The end effector 215 can be modified to include an alternative number of projections and electrodes per projection, as will be understood by those skilled in the art.

[0057] The electrodes can be dispersed to detect electrical signals passing through the tissue 58. When the circuit is in an ablation state, some or all of the electrodes can be short-circuited together in one or more groups by the adapter 100. In one embodiment, all 48 electrodes can be short-circuited together for a single large tip ablation. In another embodiment, the eight innermost electrodes A6, B6, C6, D6, E6, F6, G6, and H6 can be short-circuited together for a small ablation area. The remaining electrodes can be short-circuited together in groups to form a concentric ring. In another embodiment, the protrusions 215A-H can be subdivided into four sectors, thereby forming a first sector by short-circuiting 12 electrodes from a first pair of adjacent protrusions 215A, 215B together; a second sector by short-circuiting 12 electrodes from a second pair of adjacent protrusions 215C, 215D together; a third sector by short-circuiting 12 electrodes from a third pair of adjacent protrusions 215E, 215F together; and a fourth sector by short-circuiting 12 electrodes from a fourth pair of adjacent protrusions 215G, 215H together. In the embodiments described herein, the minimum surface area of ​​one electrode (or group of electrodes) for effective ablation using pulsed field (DC) bipolar ablation (IRE) is considered to be about 6 millimeters squared.

[0058] Figure 6 shows another exemplary end effector 415 having five projections 415A–E. The projections can carry electrodes that can be short-circuited, similar to the end effector having eight projections 215A–H shown in Figure 5. Alternatively, the catheter may be configured similarly to the catheter described in U.S. Patent No. 7,228,164, which is incorporated herein by reference and is attached to the accessory to Provisional Patent Application No. 63 / 220,269, priority.

[0059] Figure 7 shows another exemplary end effector 515 at the distal end of the shaft 502 of another exemplary catheter. The end effector 515 includes six projections 515A-F arranged substantially parallel to each other. The projections 515A-F are substantially planar except for the overlap of segments at the distal and proximal ends of the end effector 515. The end effector 515 includes outer projections 515A, 515F, each having 10 electrodes A1-10, F1-10. The end effector includes three inner projections 515C-E, each having 8 electrodes C1-8, D1-8, E1-8. The end effector 515 includes an inner projection 515B, having 9 electrodes B1-9. The end effector 515 can be modified to include an alternative number of projections and electrodes per projection, as will be understood by those skilled in the art. The end effector 515 can be configured similarly to that described in U.S. Patent Application No. 17 / 029890 (Agent Reference Number 253757.000053), which is incorporated herein by reference and attached to the priority document of U.S. Provisional Patent Application No. 63 / 220, 269. U.S. Patent Application No. 17 / 029890 is published as U.S. Patent Publication No. 2021 / 0369132, which is incorporated herein by reference.

[0060] The electrodes can be dispersed to detect electrical signals passing through the tissue 58. The electrodes can be short-circuited together to form various geometric patterns when the circuit is in a mapping state. All electrodes can be short-circuited together for a single large tip ablation catheter. Alternatively, a flat surface can be subdivided into halves, quarters, sixths, etc.

[0061] Figure 8 shows another exemplary end effector 615 located at the distal end of the catheter shaft 602. The end effector 615 is shown in an expanded basket shape and can be retracted into a delivery tube 604 delivered through the vascular system. The end effector 615 includes eight curved projections 615A-F having electrodes arranged in a three-dimensional array thereon. Alternatively, the catheter may be configured similarly to the catheter described in U.S. Patent Publication 2020 / 0206461, which is incorporated herein by reference and is attached to the appendix to Provisional Patent Application No. 63 / 220,269, priority.

[0062] The electrodes can be dispersed to detect electrical signals passing through the tissue 58. All electrodes can be short-circuited together for a single large tip ablation catheter. Alternatively, all electrodes along a specific spherical range can be short-circuited for circumferential injury. A specific quadrant can be short-circuited together for local or small linear injury with parallel tissue contact.

[0063] Figure 9 shows another exemplary end effector 715 of the catheter. The end effector 715 has a circular shape with 10 electrodes 720A-J dispersed around a circular outer circumference. Alternatively, the catheter may be configured similarly to the catheter described in U.S. Patent No. 6,987,995, which is incorporated herein by reference and is attached to the appendix to Provisional Patent Application No. 63 / 220,269. For example, the catheter may have about 6 to about 20 electrodes.

[0064] The electrodes can be dispersed to detect electrical signals passing through the tissue 58. All electrodes can be short-circuited together for a single large tip ablation catheter. Quarter-circular, hemispherical, or simple paired electrodes can be short-circuited together, resulting in different electrode configurations / geometric shapes for IRE. Short-circuiting across the diameter of a circle may also be useful for "debulking" ablation strategies or for large isolation targets such as the posterior wall, in the development of safer RF single tip ablation catheters.

[0065] Figure 10 shows another exemplary end effector 815 of the catheter. The end effector 815 has a linear shape with 10 ring electrodes 820A-J, including a tip electrode 820J, which are linearly distributed. The electrodes can be dispersed to detect electrical signals passing through the tissue 58. All electrodes can be short-circuited together for a single large tip ablation catheter. Alternatively, a small group of electrodes can be short-circuited together to achieve RF and / or IRE ablation.

[0066] Figure 11 is a flowchart of an exemplary treatment method 900. This method 900 can be performed using the adapter 100 and / or system 10 disclosed herein, its variations, and alternatives as can be understood by those skilled in the art according to the teachings herein. In step 902, the electrodes of the multi-electrode catheter can be positioned relative to the cardiac tissue in a first orientation. In step 904, while the electrodes are in the first orientation, the potential of the electrodes, and thus the potential of the tissue, can be measured. In step 906, while maintaining the position of the electrodes in the first orientation, the tissue can be ablated through the electrodes.

[0067] [Implementation Method] (1) An adapter, A first set of multiple contacts configured to electrically connect to the electrodes of a multi-electrode catheter, A second set of multiple contacts configured to electrically connect to the catheter mapping system, A third set of contacts configured to be electrically connected to the ablation generator, A circuit configured to switch between a mapping state and an ablation state, wherein in the mapping state, the first plurality of contacts electrically communicate with the second plurality of contacts, and in the ablation state, the first plurality of contacts electrically communicate with the third plurality of contacts. An adapter equipped with [the following features]. (2) When the circuit is in the mapping state, the first contact and the second contact of the first plurality of contacts are electrically isolated from each other. The adapter according to Embodiment 1, wherein when the circuit is in the ablation state, the first contact and the second contact are electrically short-circuited to each other. (3) The adapter according to Embodiment 2, wherein the first contact and the second contact are configured to be electrically connected to the first electrode and the second electrode on the common projection of the catheter, respectively. (4) The first contact and the second contact are configured to be electrically connected to a first electrode on a first projection of the catheter and to a second electrode on a second projection of the catheter that is different from the first projection, The adapter according to Embodiment 2, wherein when the circuit is in the ablation state, the first contact and the second contact are electrically short-circuited to an additional contact among the first plurality of contacts, thereby causing the circuit to short-circuit the circularly arranged electrodes of the catheter. (5) When the circuit is in the mapping state, each of the first plurality of contacts is electrically isolated from each other, When the circuit is in the ablation state, the first portions of the first plurality of contacts are electrically short-circuited with each other, the second portions of the first plurality of contacts are electrically short-circuited with each other, and the first portion is electrically isolated from the second portion. The first portion is configured to electrically contact an electrode on the first projection of the catheter, The adapter according to Embodiment 1, wherein the second portion is configured to electrically contact an electrode on a second projection of the catheter that is different from the first projection.

[0068] (6) The adapter according to Embodiment 1, wherein when the circuit is in the ablation state, the circuit is configured to transmit radio frequency (RF) electrical energy from the third plurality of contacts to the first plurality of contacts, thereby enabling thermal ablation by at least a portion of the electrodes of the catheter. (7) When the circuit is in the ablation state, the circuit is configured to transmit voltage pulses from the third plurality of contacts to the first plurality of contacts, thereby enabling irreversible electroporation ablation by at least a portion of the electrodes of the catheter. The adapter according to Embodiment 1, wherein when the circuit is in the ablation state, some of the first plurality of contacts are short-circuited to provide at least the minimum electrode surface area required for irreversible electroporation ablation, the minimum electrode surface area includes one or more electrodes electrically connected to each other, and the one or more electrodes are combined to provide a large surface area electrode for ablation. (8) The adapter according to Embodiment 1, further comprising a user interface including a mechanical switch configured to switch the circuit between the mapping state and the ablation state. (9) A first connector having the first plurality of contacts and configured to mate with the catheter, A second connector having the aforementioned second set of contacts and configured to mate with the catheter mapping system, A third connector having the aforementioned third set of contacts and configured to mate with an ablation generator, A portable adapter body that provides structural support for the first connector, the second connector, and the third connector, The adapter according to embodiment 1, further comprising the following: (10) Further comprising a communication system configured to receive commands from an external computing device, The communication system is supported by the portable adapter body. The external computing device is located outside the adapter body. The adapter according to embodiment 9, wherein the circuit is configured to switch between the mapping state and the ablation state in response to a command received by the communication system from the external computing device.

[0069] (11) A method for treating cardiac arrhythmias, Positioning the electrodes of the multi-electrode catheter relative to the cardiac tissue in a first orientation, While the electrode is in the first orientation, the potential of the electrode, and thus the tissue, is measured. Ablation of the tissue via the electrode while maintaining the position of the electrode in the first orientation, Methods that include... (12) Measuring the potential of the additional electrodes of the multi-electrode catheter, The operation of the additional electrode is stopped while the tissue is being ablated. The method according to embodiment 11, further comprising: (13) Measuring the potential of the electrodes includes measuring the potential between the first electrode and the second electrode, The method according to Embodiment 11, wherein ablation of the tissue includes synchronously applying an electrical signal for ablation of the tissue to the first electrode and the second electrode. (14) The method according to embodiment 13, further comprising positioning the first electrode and the second electrode such that the first electrode and the second electrode are on a common projection of the catheter. (15) The method according to embodiment 13, further comprising positioning the first electrode and the second electrode such that the first electrode is on a first projection of the catheter and the second electrode is on a second projection of the catheter that is different from the first projection.

[0070] (16) Measuring the potential of the electrodes includes measuring a separate potential at each of the electrodes, The method according to Embodiment 11, wherein ablation of the tissue includes applying a first electrical signal to a first portion of the electrodes that are electrically short-circuited with each other, and applying a second electrical signal different from the first electrical signal to a second portion of the electrodes that are electrically short-circuited with each other. (17) The method according to embodiment 11, further comprising thermally ablating the tissue by applying radio frequency (RF) electrical energy to the tissue from the electrodes. (18) The method according to Embodiment 11, further comprising ablating the tissue by irreversible electroporation by applying a voltage pulse to the electrode, wherein the cumulative electrode surface area of ​​the electrode is at least the minimum electrode surface area required for irreversible electroporation ablation. (19) Further comprising switching the electrodes of the multi-electrode catheter between a mapping state and an ablation state via a user interface, wherein in the mapping state, the electrodes electrically communicate with a mapping system configured to measure the potential of the electrodes, and in the ablation state, the electrodes electrically communicate with an ablation generator configured to ablate the tissue via the electrodes. The method according to embodiment 11, wherein switching the electrodes via the user interface includes moving a mechanical switch. (20) Connecting the first connector of the adapter to the catheter such that the electrode communicates electrically with the first plurality of contacts of the first connector, The second connector of the adapter is connected to a mapping system configured to measure the potential of the electrode, The third connector of the adapter is connected to an ablation generator configured to ablate the tissue via the electrodes, The method involves transmitting commands from an external computing system to the adapter to cause the catheter to switch between measuring the potential of the electrode and ablating the tissue via the electrode, wherein the external computing system is located outside the portable body of the adapter. The method according to embodiment 11, further comprising:

Claims

1. It is an adapter, A first set of multiple contacts configured to electrically connect to multiple electrodes of a multi-electrode catheter, It is configured to be electrically connected to a catheter mapping system, and comprises a second set of contacts that are electrically communicative with the first set of contacts, It is configured to be electrically connected to an ablation generator, and comprises a third plurality of contacts that are electrically communicative with the first plurality of contacts, A circuit configured to switch between a mapping state and an ablation state, wherein in the mapping state, the first plurality of contacts electrically communicate with the second plurality of contacts, and in the ablation state, the first plurality of contacts electrically communicate with the third plurality of contacts. Equipped with, The ablation state comprises a first ablation state and a second ablation state. When the circuit is in the first ablation state, the first plurality of contacts include a first contact group including the first contact and the second contact, and a second contact group including the third contact and the fourth contact, When the circuit is in the first ablation state, the first contact and the second contact in the first contact group are electrically insulated from the third contact and the fourth contact in the second contact group, the first contact and the second contact in the first contact group are electrically short-circuited from each other, and the third contact and the fourth contact in the second contact group are electrically short-circuited from each other. When the circuit is in the second ablation state, the first plurality of contacts include a third contact group including the first contact and the third contact, and a fourth contact group including the second contact and the fourth contact. In the second ablation state of the circuit, the first contact and the third contact in the third contact group are electrically insulated from the second contact and the fourth contact in the fourth contact group, the first contact and the third contact in the third contact group are electrically short-circuited from each other, and the second contact and the fourth contact in the fourth contact group are electrically short-circuited from each other. The mapping state comprises a first mapping state and a second mapping state. When the circuit is in the first mapping state, all of the first plurality of contacts are electrically isolated from each other. When the circuit is in the second mapping state, the first plurality of contacts include a fifth contact group including a plurality of contacts, and a sixth contact group including a plurality of contacts different from the plurality of contacts in the fifth contact group. An adapter in which, when the circuit is in the second mapping state, each of the plurality of contacts in the fifth contact group is electrically insulated from each of the plurality of contacts in the sixth contact group, the plurality of contacts in the fifth contact group are electrically short-circuited from each other, and the plurality of contacts in the sixth contact group are electrically short-circuited from each other.

2. The adapter according to claim 1, wherein, when the circuit is in the ablation state, the circuit is configured to transmit radio frequency (RF) electrical energy from the third plurality of contacts to the first plurality of contacts, thereby enabling thermal ablation by at least a portion of the electrodes of the catheter.

3. When the circuit is in the ablation state, the circuit is configured to transmit voltage pulses from the third plurality of contacts to the first plurality of contacts, thereby enabling irreversible electroporation ablation by at least a portion of the electrodes of the catheter. The adapter according to claim 1, wherein when the circuit is in the ablation state, a portion of the first plurality of contacts is short-circuited to provide at least the minimum electrode surface area required for the irreversible electroporation ablation, the minimum electrode surface area includes one or more electrodes electrically connected to each other, and the one or more electrodes are combined to provide a large surface area electrode for the irreversible electroporation ablation.

4. The adapter according to claim 1, further comprising a user interface including a mechanical switch configured to switch the circuit between the mapping state and the ablation state.

5. A first connector having the aforementioned plurality of contacts and configured to engage with the catheter, A second connector having the aforementioned second set of contacts and configured to mate with the catheter mapping system, A third connector having the aforementioned third set of contacts and configured to mate with the ablation generator, A portable adapter body that provides structural support for the first connector, the second connector, and the third connector, The adapter according to claim 1, further comprising the following:

6. It further includes a communication system configured to receive commands from an external computing device, The communication system is supported by the portable adapter body. The aforementioned external computing device is located outside the main body of the portable adapter. The adapter according to claim 5, wherein the circuit is configured to switch between the mapping state and the ablation state in response to a command received by the communication system from the external computing device.

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