System and method of unipolar pfa

Abstract

To provide systems and methods for unipolar Pulse-Field Ablation (PFA).SOLUTION: Systems and methods for unipolar Pulse-Field Ablation (PFA) are disclosed for reducing spasm and / or other adverse effects of nerve stimulation during delivery of PFA pulses. The system includes or is connected to one or more motion sensors to be placed at one or more regions of a patient's body for monitoring spasm thereat. The system includes a signal switch capable of selectively connecting a PFA energy generator to selected one or more of return electrode patches for delivery of PFA pulses and / or pacing signals through the selected electrode patches; and a processor that monitors motion sensed by the motion sensors during delivery of the PFA pulses or pacing signals to identify nerve stimulation effects, such as spasm, to facilitate, based on the monitoring, selection of certain electrode patches by which the PFA pulses may be delivered with no or reduced spasm or other adverse effects of excessive nerve stimulation.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to a medical system, and more particularly, but not limited thereto, to cardiac ablation using irreversible electroporation (IRE) by unipolar pulsed field ablation (PFA).

Background Art

[0002] The diagnosis and treatment of cardiac arrhythmias involve mapping the electrical properties of cardiac tissue, particularly the endocardium, and selectively ablating cardiac tissue by applying energy. Such ablation can stop or correct the propagation of unwanted electrical signals from one part of the heart to another. The ablation process breaks unwanted electrical circuits by forming non-conductive lesions. Various energy delivery modalities have been disclosed heretofore for forming the lesion, including the use of microwaves, lasers, and more generally radiofrequency energy to create a conduction block along the cardiac tissue wall. In a two-step procedure where mapping is followed by ablation, typically a catheter containing one or more electrical sensors is advanced into the heart and the electrical activity at points within the heart is sensed and measured by acquiring data at multiple points. These data are then used to select the endocardial target area where ablation is to be performed.

[0003] A typical ablation procedure involves inserting an ablation catheter having one or more electrodes at its distal end into the heart cavity such that at least one of the electrodes is in electrical contact with the site of abnormal electrical activity therein, and operating the electrode with an electrical signal that affects the ablation of the site having abnormal electrical activity.

[0004] One ablation technique commonly used in medical procedures is thermal ablation (also known as RF ablation). In this technique, an RF (radio frequency) current is applied through the tip electrode of an ablation catheter, and the current flows through the medium surrounding the tip electrode, namely blood and tissue, between the tip electrode and a reference electrode that is typically provided / taped on the patient's skin or positioned within or near the heart by a second catheter. The current distribution is determined by the amount of ablation electrode surface in contact with the tissue, compared to blood which has a higher conductivity than tissue. Heating of the tissue occurs due to its electrical resistance. When the tissue is sufficiently heated, cell destruction is caused in the heart tissue, and as a result, a lesion that is electrically non-conductive is formed within the heart tissue.

[0005] Another ablation technique that has been more recently practiced is pulsed field ablation (PFA), in which irreversible electroporation (IRE) is applied via short electrical pulses referred to as the following PFA pulses, and the electrical pulses generate an electric field that is high enough to irreversibly damage cells (typically over 450 volts / cm). Pulsed field ablation (PFA) is generally a non-thermal IRE ablation that can be used in treating different types of tumors and other unwanted tissues without causing thermal damage to surrounding tissues. In this technique, at least one relatively small ablation electrode is disposed in proximity to the target tissue, and short high-voltage electrical pulses are applied between the ablation electrode and another electrode, which can be another ablation electrode disposed in the target tissue near the first ablation electrode (e.g., in bipolar PFA) or can be a return electrode (e.g., in monopolar PFA), and the return electrode typically has a relatively large surface that comes into contact with the body so as not to affect the ablation of the tissue near the return electrode and is provided / tape-fixed on the patient's skin or by a second catheter. The short high-voltage electrical pulses applied by PFA increase the resting transmembrane potential of nearby cells, and as a result, nanopores are formed in the plasma membrane. When the electricity applied to the tissue exceeds the electric field threshold of the target tissue, the cells become permanently permeable from the formation of nanopores. As a result, the cells cannot repair the damage due to the lack of homeostasis and die, and the cells typically die by apoptosis.

[0006] PFA can be used for cardiac ablation as an alternative to other cardiac ablation techniques, such as radiofrequency (RF) cardiac ablation. Since PFA is generally a low-heat technique, PFA reduces the risk of collateral cell damage that exists with other techniques, such as that which exists in RF cardiac ablation.

Brief Description of the Drawings

[0007] To better understand the subject matter disclosed herein and to exemplify how the subject matter can actually be carried out, embodiments will now be described by way of merely non-limiting examples with reference to the accompanying drawings.

Figure 1

Figure 2A

Figure 2B

Figure 3A

Figure 3B

[0008] Pulsed Field Ablation (PFA) uses the delivery of energy to the target tissue to be ablated via high voltage pulses generated by an ablation energy / signal generator. The high voltage pulses are typically delivered via electrodes that are electrically connected to the first and second poles of the ablation energy / signal generator and are coupled and arranged on the subject's body in a monopolar or bipolar-like manner, such that, in bipolar PFA, typically, the electrodes connected to both the first and second poles are arranged / disposed in proximity to the target tissue to be ablated, and in monopolar PFA, only the electrode connected to one of the poles (hereinafter referred to as the ablation electrode and, without limitation, considered to be connected to the first pole) is disposed in proximity to the target tissue to affect the ablation of the target tissue, while the electrode connected to the other pole (hereinafter referred to as the return electrode and, without limitation, considered to be connected to the second pole) is typically coupled to the subject's skin / tissue away from the target tissue and is typically configured with a larger surface area than the ablation electrode so as not to affect the ablation in the region where they are coupled to the subject.

[0009] In both types of PFA ablation, the energy flow through the subject's body between the electrodes connected to the first and second poles of the ablation energy / signal generator can affect the stimulation of nerves that may be present in the path of the ablation energy flow through the subject's body. This can, in turn, potentially cause muscle spasms associated with the stimulated nerves, wherefore the term "spasm" is used herein to refer to, for example, the involuntary contraction of a muscle or group of muscles caused by abnormal nerve stimulation during PFA ablation treatment. Such spasms may be accompanied by a burst of pain and discomfort to the subject and, in some cases, may provide an indication of the risk of causing permanent damage to the stimulated nerves.

[0010] For example, when applying PFA ablation to the target heart, the phrenic nerve may be inadvertently stimulated, which may be manifested by diaphragmatic spasm and, in severe cases, may lead to damage to the phrenic nerve. PFA ablation, specifically monopolar PFA, often has the return electrode placed on a skin patch away from the target tissue to be ablated, which may cause stimulation of other nerves and affect spasms in other muscles such as skeletal muscle.

[0011] For this purpose, avoidance or reduction of spasms during PFA treatment is desirable to reduce the discomfort of the subject during treatment and also to avoid / reduce the risk of causing nerve damage. The techniques of the present invention are designed to achieve these goals and reduce or avoid spasms in monopolar PFA treatment. In fact, in both monopolar and bipolar PFA treatments, certain spasm effects can be avoided or reduced by changing the location of the ablation electrode (e.g., of the ablation catheter). However, this actually typically involves moving away from the designated target tissue, e.g., ablating nearby tissue instead.

[0012] However, as recognized by the present invention, advantageously, in monopolar PFA, instead, by changing the location where the return electrode of the monopolar ablation is coupled to the body, specific spasm effects can be reduced or avoided without changing the target tissue / location to be ablated. This, in turn, can affect / change the path of the ablation energy flow through the subject's body, thereby changing, reducing, or eliminating specific nerve stimulation and related spasms.

[0013] For this purpose, the present invention utilizes these advantages of monopolar PFA treatment and provides a method and system for reducing / eliminating spasm in monopolar PFA treatment through appropriate monitoring of spasm-related effects when using a PFA return electrode at one or more locations, and appropriate selection of the return electrode (e.g., according to their locations on / within the subject's body) such that excessive nerve stimulation and / or its effects (e.g., spasm and / or nerve damage) are reduced or eliminated.

[0014] Referring initially to FIG. 1, FIG. 1 is a schematic illustration of a system 10 for ablating tissue of a subject 14 while avoiding / reducing spasm or other effects of nerve stimulation, according to some embodiments of the present invention. More specifically, the system 10 is configured and operable to perform pulsed field ablation (PFA), also known as IRE ablation, and is specifically adapted to perform monopolar PFA.

[0015] The system 10 includes an ablation catheter 12 having a distal tip 13 that includes an ablation electrode 19 of relatively small surface area adapted to contact a designated tissue region where ablation is contemplated. The catheter 12 is inserted into the subject 14 by a physician 16. For example, the catheter 12 can be inserted into the subject's vasculature through an insertion point 30 and then its distal tip 13 can be navigated to a specific location within the subject's body (e.g., within the heart where the target tissue to be ablated is located).

[0016] Typically, catheter 12 includes, at its distal end 13, a position sensor (not specifically shown) that provides data / signals indicating the real-time position of the distal end 13 of the catheter. (The following term "position" in this specification should be understood to refer to the location and / or orientation relative to the body of subject 14.) Thus, the position of ablation electrode 19 within the body / target tissue of the subject (relative thereto) can be tracked by system 10, and thus, physician 16 can position ablation electrode 19 at the specific target tissue where ablation is desired and apply PFA at that location. In various embodiments, the system may include additional position sensors that can be disposed, for example, on other medical devices and / or may be connectable to additional position sensors and may be adapted to track the positions of these sensors as well.

[0017] In some embodiments, the position sensor is a magnetic position sensor that operates in conjunction with a location pad 42 that includes a plurality of location signal transmitters (e.g., magnetic coils) that generate / transmit electromagnetic location signals (e.g., magnetic fields) within a predetermined working volume surrounding the patient. The real-time position of the distal tip 13 of catheter 12 can then be tracked relative to the patient's body based on the magnetic / electromagnetic location signals generated using location pad 42 and sensed by the magnetic-based position sensor. Details of magnetic-based position sensing techniques are described in U.S. Pat. Nos. 5,539,199, 5,443,489, 5,558,091, 6,172,499, 6,239,724, 6,332,089, 6,484,118, 6,618,612, 6,690,963, 6,788,967, 6,892,091, each of which is incorporated herein by reference.

[0018] Alternatively or additionally, in some embodiments, the position of the distal end 13 of the catheter 12 can be tracked / determined by impedance-based location tracking. In such embodiments, the position sensors on the distal end 13 can include ECG sensors / electrodes, and impedance-based location tracking can be used to determine their positions using impedance-based tracking techniques. For impedance-based tracking, a current is directed to the electrodes (e.g., the ECG electrodes if included on / in the distal end portion 13). The current is then sensed at skin ECG electrodes (not specifically shown) such that the location of the ECG sensors / electrodes on the distal end portion 13 can be triangulated via the skin ECG electrodes. Details of impedance-based location tracking techniques are described in U.S. Patent Nos. 7,536,218, 7,756,576, 7,848,787, 7,869,865, and 8,456,182.

[0019] According to embodiments of the present invention, the system 10 is adapted to perform monopolar PFA ablation by delivering / supplying a PFA signal to pass between the ablation electrode 19 on the distal end 13 of the catheter 12 and at least one electrode patch, e.g., 28a, disposed on the body / skin of the subject 14. For this purpose, the system 10 further includes or is associated with one or more electrode patches 28 each including at least one electrode 29 (also referred to herein as a return electrode) to be coupled to the body / skin of the subject 14. The return electrode 29 typically has a surface area / contact area that is relatively large compared to the surface area of the ablation electrode 19 such that when an electrical PFA pulse is applied between the ablation electrode 19 and the return electrode 29 during ablation, the IRE is substantially permanently affected at the ablation electrode 19 having a substantially smaller surface area, but is substantially unaffected or not permanently affected in the vicinity of the return electrode 29 of the patch 28 involved in the ablation.

[0020] In the specific example shown in FIG. 1, system 10 includes two ablation electrode patches 28a and 28b that are coupled to a target's skin, such as near the target's buttocks / thighs / back / chest / legs. Notwithstanding the foregoing, it should be noted that, generally, system 110 can include any suitable number (at least one) of electrode patches 28 coupled to the target in any suitable arrangement.

[0021] Generally, according to embodiments of the present invention, system 10 can include or be associated with one or more motion sensors 50 that are arranged to sense the movement of a patient's tissue / skin at a particular location of interest (e.g., arranged near a particular muscle associated with a nerve that can optionally be stimulated by an ablation treatment) and adapted to provide a signal indicative of this movement.

[0022] For example, in some embodiments, one or more accelerometers 50 (in the non-limiting example of FIG. 1, a single accelerometer is illustrated) are arranged within / on or near each of the one or more electrode patches 28. In fact, often, as the path of the ablation energy through the body between the ablation electrode 19 and an electrode patch used for a particular tissue ablation, such as 28a, nerves near the electrode patch are stimulated, thereby often affecting the muscle spasms of the muscle near the involved electrode patch, such as 28a. Thus, in some embodiments, one or more accelerometers 50 include at least one accelerometer 50 arranged near one (or more) of the electrode patches 28. For example, in some embodiments, at least one of the electrode patches 28 used in the ablation, such as 28a, can include respective motion sensors adapted to sense the movement (e.g., motion / acceleration) of the patient's tissue / skin near the patch.

[0023] Embodiments of the electrode patch 28 that can include or be coupled to a motion sensor, are configured and operable in accordance with embodiments of the present invention, are schematically illustrated in FIGS. 2A and 2B. FIG. 2A illustrates a front view and a back view of the electrode patch 28, and FIG. 2B is a perspective view of the electrode patch 28 including disposable portion and reusable components 28.1 and 28.2, respectively. As illustrated in these figures, the electrode patch 28 adapted to incorporate the motion sensor 50 is - an electrode 29 (also referred to herein as a return electrode), associated with an ablation signal wire / cable 32 that is connected or connectable thereto via an optional connector 52 for supplying an ablation signal to the return electrode 29 (the return electrode 29 is configured to have a relatively large surface area (e.g., several times larger than the surface area of the ablation electrode 19) so as to avoid tissue ablation in its vicinity.) - an adhesion patch (skin patch) 54 adapted to adhere to the subject's skin / tissue and facilitate electrical coupling of the return electrode 29 to the skin / tissue, and - a motion sensor 50 for sensing motion such as acceleration / vibration of the patch 28. The motion sensor 50 may include, for example, one or more inertial sensors (e.g., inertial measurement unit (IMU)), and / or an accelerometer and / or one or more gyroscopes, and / or a position sensor operable at a measurement frequency (time resolution) sufficient to facilitate detection of spasms, e.g., on the order of 10 KHz or more, e.g., 32 KHz. In some embodiments, the motion sensor 50 is associated with or includes an optional wired signal cable 51 adapted to communicate the measured motion signal measured by the sensor 50 to the system 10 and optionally provide power supply to the sensor 50. Alternatively, in some embodiments, the motion sensor 50 is configured as a wireless sensor (e.g., battery-operated), capable of wireless data / signal connection to the system 10, and includes an optional wireless communication utility 53 such as a WIFI or Bluetooth network adapter adapted to communicate the motion signal measured by the sensor 50 to the system 10.

[0024] Note that the electrode patch 28 shown in FIG. 2A can be an entirely disposable or non-disposable patch, or can be partially disposable including a disposable portion and a non-disposable / reusable portion. FIG. 2B illustrates an example of an electrode patch 28 that includes a disposable portion 28.1 and a reusable portion 28.2. The disposable portion 28.1 and the reusable portion 28.2 can be mechanically connectable / attachable to each other via an attachment element / assembly 55. The attachment element / assembly 55 can include, for example, a pocket element (e.g., a pocket within the disposable portion 28.1 capable of containing / holding the reusable portion 28.2), and / or a two-piece snap-on or Velcro assembly disposed on the disposable portion 28.1 and the reusable portion 28.2 respectively, and / or any other attachment mechanism that can be suitable for mechanically attaching the disposable portion 28.1 and the reusable portion 28.2 to each other. In the specific non-limiting example of FIG. 2B, the disposable portion 28.1 includes a return electrode 29, an adhesive patch (skin patch) 54 that is brought into contact with the target skin / tissue, and optionally an attachment element / assembly 55 or a portion thereof, and the reusable portion 28.2 typically includes relatively expensive electronic components (e.g., generally not brought into contact with the target) including, in this example, a motion sensor 50 (along with its associated wired or wireless communication utilities 51 / 53), and optionally includes an attachment element / assembly 55 or a portion thereof (not specifically shown on the reusable portion 28.2 from the perspective illustrated in the figure).

[0025] Referring back to FIG. 1, as illustrated in FIGS. 2A and 2B, the use of the electrode patch 28 incorporating the motion sensor 50 is optional, and in various implementations, one or more or all of the motion sensors 50 incorporated into the system 10 may or may not be incorporated into respective electrode patches 28, for example, and can be disposed at spaced locations on the target skin / tissue separately from the electrode patch 28.

[0026] System 10 monitors motion signals obtained from motion sensor 50 during or after the provision of an ablation PFA pulse or pacing signal between ablation electrode 19 and one or more (optionally) participating patches, such as patch 28a of patch 28, and processes these motion signals to determine whether spasms, such as skeletal muscle spasms, are affected by the delivery of a PFA pulse or pacing signal between the participating patch, such as 28a, and ablation electrode 19.

[0027] System 10 includes a console 18 that includes one or more units that facilitate the implementation of the techniques described herein. The ablation electrode 19 of catheter 12, as well as the return electrode patch 29 of electrode patch 28, are typically connected to the console 18 of the system via a cable 32 and an electrical interface (such as a port or socket). The motion sensor 50 is typically connected to the console 18 by a wireless or wired connection (not specifically shown in FIG. 1) to provide data indicative of the motion sensed thereby to the console 18. Additionally, a position sensor (43 in FIG. 3A), which is typically located on the distal tip 13 of catheter 12 (not specifically shown), can also be connected to the console 18 (e.g., by cable 32) to provide position data / signals indicative of the real-time position of the distal end 13 of the catheter, particularly its ablation electrode 19.

[0028] Console 18 includes a PFA energy generator 22 configured to generate an electrical PFA pulse that passes through the target tissue between the ablation electrode 19 of catheter 12 and at least one return electrode 29 of electrode patch 28 during ablation, thereby affecting the ablation of the tissue located near ablation electrode 19. Optionally, the PFA energy generator 22 is also adapted to generate a pacing current / signal that can be directed to pass in the same manner as the electrical PFA pulse, but does not affect the ablation.

[0029] Additionally, the console 18 also typically processes position data / signals obtained from a position sensor that may be provided on a medical device connected to the system 10, and includes / implements a position tracking system 21 that determines their positions relative to / within the patient's body. Specifically, as shown above, the ablation catheter 12 typically includes such a position sensor (not specifically shown in FIG. 1, but shown as 43 in FIG. 3A), and the position tracking system 21 operates to determine the location thereof relative to the patient's body, particularly the location of the ablation electrode 19 (e.g., a specific location within or on the patient's heart), and provides it as shown to the physician 16 performing the ablation treatment.

[0030] According to an embodiment of the present invention, the console 18 is typically connected to an ablation energy generator 22 and is adapted to monitor spasms that occur during PFA ablation, particularly during monopolar ablation, or during the delivery of pacing signals prior to actual ablation. The system 100 processes motion signals / data received from a motion sensor 50 (which may be provided on one or more of the electrode patches 28 and / or at other locations on the patient's body) to determine whether the motion sensed by the motion sensor 50 in response to PFA / pacing signal delivery via activation of each particular electrode patch, e.g., 28a, 28b, indicates a muscle spasm (the term "activation" as used herein is used to indicate the connection of an electrode patch to the second pole of the ablation energy generator 22). Thus, the system 100 can determine / associate the activation of each particular patch, e.g., 28a, 28b, with spasms that are or are not affected in the vicinity of each of the motion sensors 50. Based on the association between the activation of each of the one or more electrode patches 28 and the affected spasms at different locations where the motion sensors are provided, the system facilitates the automatic and / or manual selection of one or more electrode patches 28 that are activated during ablation (e.g., during ablation of a particular target tissue or throughout the treatment) so as to avoid / reduce the impact of spasms.

[0031] In fact, in some embodiments / implementations of the present invention, one or more of the motion sensors 50 can be attached on or near each specific one or more of the electrode patches 28. In this case, the motion sensor 50 attached on / near a specific electrode path 28 is referred to herein as being associated with that patch 50. The principle underlying this arrangement is that the path of the energy flow through the body between the ablation electrode 19 functioning as the first pole and the activated electrode patch such as 28a functioning as the second pole is typically expected to concentrate near the electrode patch 28a. Therefore, when a spasm occurs, it is highly likely to occur in the region near the electrode patch 28a. Thus, by attaching at least one or all of the motion sensors 50 to each patch 28, it becomes possible to monitor the occurrence of spasms near these patches and apply an appropriate selection of the electrode patches for activation so as to reduce or avoid spasms near the activated patches. Moreover, attaching one or more motion sensors on the electrode patch can reduce the time and complexity of the preparation for the ablation procedure.

[0032] Alternatively or additionally, in some embodiments / implementations of the present invention, one or more of the motion sensors 50 can be disposed in / near a region of interest (ROI) on the patient's body (skin / tissue), where spasms can be affected by ablation caused by the stimulation of nearby nerves (it is not necessary to be a region proximal to the electrode location of the patch 28. This is because the patch should typically be preferably located away from the nerves that can be stimulated by the PFA ablation pulses). This makes it possible to monitor the occurrence of spasms in those ROIs and apply an appropriate selection of the electrode patches for activation so as to reduce or avoid spasms in those ROIs.

[0033] For this purpose, after a pacing or PFA signal is delivered via one or more electrode patches 28 activated as a second pole, the ablation control system 100 may be adapted to monitor the motion signals obtained from the motion sensor 50 and activate to identify the occurrence of muscle spasms near the sensor 50 associated with the activated electrode patch 28. For example, during the preliminary / preparation stage of the treatment or during the actual ablation treatment, this monitoring, which can be performed one or more times using different activated electrode patches 28 or different combinations of patches, functions to facilitate the selection of the electrode patch (e.g., 28b) or, optionally, the combination of electrode patches 28 that are activated to function as the second pole of the ablation, so that nerve stimulation and / or associated spasms are avoided / reduced or at least limited to areas that may have less damage or discomfort (e.g., areas away from the ROI where spasms should be avoided).

[0034] In various implementations, the selection of the electrode patch 28 to be operated as the second pole of the ablation can be performed automatically by the ablation system 100 or manually, whereby the ablation control system 100 provides an indication of the occurrence of spasms to the physician 16 and, in response, obtains an operation instruction indicating the electrode patch 28 to be selected for activation.

[0035] For this purpose, in some embodiments, typically, the system 10 is further adapted to include a user interface (UI) 34, typically including a display and a user input device (e.g., a joystick, a mouse, a keyboard, and / or other devices), which is adapted to display relevant information to the physician 16 and receive respective instructions / inputs from there to facilitate the execution of the ablation treatment.

[0036] For example, ablation system 100 can operate to cause UI 34 to display to physician 16 an indication of patch electrode 28 as a second ablation pole as to whether activation affects or does not affect the seizure, and in response, receive from UI 34 data indicating the patch electrode 28 selected for activation as the second ablation pole. Moreover, system 10 (e.g., its position tracking system 21) can be adapted to cause UI 34 to display the location / position of catheter 12, for example, by overlaying an icon representing the distal tip 13 of the catheter or its ablation electrode 19 on an image of the target anatomical structure (the heart in this particular example).

[0037] Typically, system 10 includes one or more processors 20 on which specific functions of the system and / or its subsystems 100, 21, and 22 are implemented. Generally, the processor 20 can be embodied as a single processor or as a set of processors networked or clustered cooperatively. In some embodiments, the processor 20 is implemented solely as hardware, using, for example, one or more application-specific integrated circuits (ASICs) or field-programmable gate arrays (FPGAs), analog and / or digital signal processing circuits, and the like. In other embodiments, the processor is implemented at least partially as software. For example, the processor 20 can be implemented with a programmed digital computing device that includes a central processing unit (CPU), random access memory (RAM), a non-volatile secondary storage device such as a hard drive or CD ROM drive, a network interface, and / or peripheral devices. Program code, including software programs, and / or data are loaded into the RAM for execution and processing by the CPU and results are generated for display, output, transmission, or storage, as is known in the art. The program code and / or data can be downloaded to the computer in electronic form, for example, through a network, or alternatively or additionally, can be provided and / or stored on a non-transitory tangible medium such as magnetic, optical, or electronic memory. Such program code and / or data, when provided to the processor, create a machine or special purpose computer configured to perform the tasks described herein.

[0038] Next, refer together to FIGS. 3A and 3B, which schematically illustrate in more detail an ablation control system 100 and method 200 according to some embodiments of the present invention. The system 100 and method 200 monitor for the occurrence of spasms during or in preparation for monopolar PFA ablation (when pacing signals can be delivered) and are adapted to facilitate the automatic or manual selection of the electrode patch 28 to avoid / reduce the effects of spasms or nerve stimulation causing spasms. More specifically, FIG. 3A is a block diagram illustrating the configuration of an ablation control system 100 for the control of monopolar pulsed field ablation (PFA), and FIG. 3B is a flowchart illustrating a method 200 for monopolar PFA, which can be implemented, for example, by the system 100.

[0039] As illustrated, the system 100 is connected to or connectable to an ablation catheter 12 having at least one ablation electrode 19 at its distal end 13. The system 100 is also connected to or connectable to a plurality of electrode patches 28 (at least two: 28a and 28b, and optionally additional ones, such as 28n), whereby each electrode patch includes at least one return electrode 29 suitable for use in monopolar PFA ablation.

[0040] The system is further connected to, or connectable to, one or more motion sensors 50 (50a - 50m illustrated in the figures). For example, as illustrated in FIG. 3A, the motion sensors 50 may optionally include motion sensors such as 50a, 50b, and / or 50c, which may be associated with one or more of the electrode patches 28 (i.e., disposed / included on or near each of the electrode patches 28 such as patches 28a, 28b, and / or 28n shown in the figure). Alternatively or additionally, as also shown above, the motion sensors 50 may optionally include motion sensors such as 50m associated with a particular region of interest (ROI) of the patient's body. That is, these may be strategic locations disposed near / on these ROIs where the effects of spasms or other nerve stimulations are preferably to be monitored. For example, ROIs where motion sensors may be disposed can include regions / skin areas near the patient's diaphragm for monitoring diaphragmatic spasms associated with phrenic nerve stimulation, and / or regions / skin areas near the patient's chest or near the patient's heart for monitoring changes in heart rate that may be associated with vagus nerve stimulation.

[0041] Moreover, the system 100 may be further connected to additional sensors 60 such as ECG sensors / electrodes, thereby enabling identification of specific effects of nerve stimulation resulting from ablation therapy, such as changes in the electrical activation of the heart due to vagus nerve stimulation.

[0042] The system includes an ablation energy generator 22, specifically a pulsed field ablation (PFA) energy generator, having first and second electrodes, and this ablation energy generator 22 is configured and operable to deliver one or more PFA pulses or pacing signals via these electrodes. Typically, at least the first electrode is electrically connected to the ablation electrode 19 of the catheter 12 to enable ablation of tissue proximal thereto. In the case of a monopolar ablation procedure, the second electrode of the ablation energy generator 22 should be electrically connected to at least one of the electrode patches 28.

[0043] System 100 further includes a patch switch / selector 120 connected to / connectable between the second electrode of the PFA energy generator 22 and one or more electrode patches 28. Specifically, the patch switch / selector 120 is adapted to selectively connect to the return electrode 29 of the plurality of electrode patches 28 and is operable to selectively deliver a PFA pulse or pacing signal generated by the PFA energy generator 22 from its second pole and at least one selected return electrode of the electrode patches 28. For this purpose, the patch switch / selector 120 may include or be implemented by an electronic signal distribution circuit 122 optionally including one or more switches 124 and / or optionally one or more current / voltage controllers 126 such that the delivery of the PFA pulse or pacing signal to the electrode patches 28 can be controlled.

[0044] Processor 20 includes / implements a spasm / motion processing capability 110 connected directly or indirectly, wirelessly, or by a wired connection to one or more motion sensors 50 (this processor is hereinafter also referred to as a spasm / motion processor without loss of generality). The spasm motion processor 110 is adapted to monitor the motion indicated by the signals obtained from the motion sensors 50 connected thereto and to identify spasm-related motion patterns in its vicinity. Further, note that in some embodiments, the spasm / motion processor 110 may be further adapted to connect to additional sensors 60 (such as ECG sensors / electrodes) for sensing other effects of specific nerve stimulations that may occur during ablation therapy (such as changes in cardiac activation due to stimulation of the vagus nerve).

[0045] Specifically, for example, following the delivery of one or more PFA pulses or pacing signals to one or more electrode patches 28, the spasm movement processor 110 acquires and processes the signals received from one or more motion sensors 50 to determine whether the sensed movement indicates a spasm-related movement pattern. The spasm movement processor 110 may not necessarily monitor all of the motion sensors in each activation of the PFA pulse or pacing signal. For example, if there are motion sensors associated with the active electrode patch (functioning as the second pole during activation), and / or motion sensors associated with a specific ROI as shown above, only those may be monitored.

[0046] In some embodiments, the system 100 is adapted to perform a pre-ablation screening procedure (also referred to herein as a patch spasm test) to determine the association between the activation of a specific electrode patch 28 or combination of patches and spasm that is affected by such activation at different body locations where the motion sensors are disposed, and / or by other effects indicative of nerve stimulation that may be caused during PFA treatment. Such a pre-ablation screening procedure may be performed, for example, at a preliminary stage or during PFA treatment, and may include one or more cycles. Each cycle includes the delivery of a PFA pulse or pacing signal in which different electrode patches or combinations of patches 28 are activated in different cycles, and the monitoring of spasm-related movement patterns sensed by the motion sensors 50, or other spasm effects sensed by other sensors 60, for example, during each cycle. Thus, the association between the activation of a specific electrode patch 28 and the stimulation of a specific nerve can be determined, facilitating the information-based selection of specific ones of the electrode patches 28 to be further used during ablation treatment to avoid / reduce other effects such as excessive nerve stimulation and / or spasms manifested by such stimulation.

[0047] Optionally, in some embodiments of the present invention, based on the monitoring shown above and / or based on the pre-ablation screening procedure, the spasm movement processor 110 can automatically select one or more electrode patches 28 that function as a second electrode for the entire monopolar PFA treatment and / or for the specific activation of PFA pulses during the PFA treatment. Thus, the spasm movement processor 110 operates a patch selector / switch to electrically connect the second electrode of the ablation energy generator 22 to the return electrode 29 of the selected electrode patch, whereby the PFA pulses or pacing signals further generated by the generator 22 are delivered to the patient's body via the selected electrode patch, and thus the selected electrode patch functions as an active patch to which the PFA pulse or pacing signal is delivered.

[0048] Alternatively or additionally, in some embodiments, system 100 comprises or is associated with a user interface 34. The spasm movement processor 110 is configured and operable to issue an indication regarding the identified spasm-related movement pattern to the physician 16 upon detection of spasm-related movement by the above-described monitoring, which may be performed throughout the ablation treatment or at selected times thereof. Further alternatively or additionally, the spasm movement processor 110 is configured and operable to implement the patch ablation pre-screening procedure described above, for example, automatically and / or in response to an indication from the user (e.g., from the physician 16), and issue an indication regarding the spasm-related movement pattern identified thereby and / or regarding the association between the activation of a particular electrode patch 28 and the stimulation of a particular nerve determined by the above ablation pre-screening procedure. The indication regarding the movement pattern associated with the identified spasm and / or the indication regarding the association between the activated patch or combination of patches may be issued to the physician 16 via, for example, the user interface 34. In response to such an indication, the spasm movement processor 110 may be adapted to obtain, for example, via the user interface 34, a user command SEL for a desired patch selection, e.g., for a particular one or more selected electrode patches preferred by the physician 16 to be used as the active patch (i.e., as the second pole) during monopolar ablation treatment or for a particular PFA pulse activation (e.g., for ablation of a particular region).

[0049] In this regard, in some embodiments of the present invention, the motion sensors 50, or any one or more of them, are also included in the system 100 and / or the system 10 illustrated in FIG. 1, and can be aligned within the patient (e.g., based on the alignment of the location pad 42 illustrated in FIG. 1 with the body), and include or can be implemented by a position sensor that can be tracked by a position tracking system 21. In such embodiments, the indicators regarding the identified spasm-related movement patterns sensed by any of the motion sensors 50 and / or regarding the association between the activation patch and the stimulated nerve can be presented within the display of the UI34 (e.g., to the physician 16) on an anatomical map that illustrates the nearby organs or nerves (e.g., ROI) where the spasm-related movement pattern was sensed by one or more of the sensors.

[0050] Accordingly, in various embodiments, the system 100 automatically and / or manually (i.e., based on the user's indication) determines one or more selected electrode patches SEL, and operates to deliver a further PFA pulse or pacing signal via the return electrodes of the one or more selected electrode patches, thereby avoiding or reducing such spasms of the skeletal muscle near the electrode patches used for spasm, monopolar ablation, and / or avoiding or reducing other unwanted effects of spasms and / or nerve stimulation during PFA treatment in other ROIs.

[0051] The operation of the system 100 is illustrated in more detail below with reference to FIG. 3B, which illustrates a method 200 for monopolar PFA implemented by the system 100 according to some embodiments of the present invention. In operations 210-230, an ablation catheter 12 having at least one ablation electrode 19 that functions as the first pole of the monopolar PFA and a plurality of (at least two) electrode patches 28 having a return electrode 29 suitable for functioning as one or more second poles of the monopolar PFA are provided together with one or more motion sensors 50, and are located in various ROIs of the patient's body or near / on one or more of the electrode patches 28.

[0052] Optionally, in some embodiments, the association between the motion sensor 50 and their associated electrode patches 28 and / or associated ROIs can be aligned to the FPA system 100 (e.g., by the motion / spasm processor 110). In various embodiments, such alignment can be performed manually (by the system operator / user) or automatically. For example, when a coupling is detected by a coupling detector (which can be included in either the electrode patch or the motion sensor, but not specifically shown), it may be performed based on an alignment signal communicated from the associated patch or motion sensor, and / or it may be performed based on a position sensor 43 communicating with the position tracking system 21 (e.g., if the motion sensor is implemented thereby or may include a motion sensor).

[0053] In some implementations, not all electrode patches 28 are permanently attached to or include the motion sensor 50 coupled thereto. For example, one motion sensor 50 can be supplied with or moved between different electrode patches 28 to monitor the occurrence of spasms near, for example, a selected / activated electrode patch, such as 28a, currently being used as the second pole of the PFA treatment during PFA treatment, e.g., according to the preference of the physician 16. Thus, in such an implementation, the system 100 can facilitate performing an alignment between the motion sensor 50 and the associated electrode patch (e.g., 28a) or the ROI where it is located dynamically during operation.

[0054] Accordingly, when the electrode patch 28 is positioned, for example, at one or more locations on a patient's tissue / skin and the catheter 12 having the ablation electrode 19 at its distal tip is carried / navigated to an appropriate tissue location where ablation may be desired (e.g., a specific location within a patient's heart), operations 260 - 280 may be performed to determine one or more selected ones of the electrode patches 28, which, when activated as a second electrode during PFA ablation, prevent or reduce excessive nerve stimulation or its effects (e.g., spasms).

[0055] In this regard, optionally, in some embodiments, the pre - ablation screening operation 240 may be performed automatically by the system 100 and / or in response to an instruction INS (e.g., from the physician 16 via the UI34). In the pre - ablation screening operation, operations 250 and 260, described below, may be repeated one cycle / one time or more than two cycles / time (e.g., as described below with reference to operation 250) for the delivery of pacing signals and / or PFA pulses, with activation of different electrode patches or combinations of electrode patches 28 as the second electrode in each cycle, while monitoring for spasms or other effects resulting from excessive nerve stimulation associated with the activated electrode patch (e.g., as described below with reference to operation 260). Accordingly, an association between the activation of a particular selection of patch electrodes 28 and the spasms / nerve stimulation affected by such a selection is determined. This association may then be used for the automatic and / or manual selection of one or more selected patches to be activated during ablation treatment or during ablation of a particular tissue, in a manner similar to that described below with reference to operation 270.

[0056] Alternatively, the ablation pre-screening operation 240 may itself not be implemented or may be skipped. In response to an instruction INS from the physician / operator 16 (e.g., UI 34), the system 100 may operate to deliver pacing signals and / or PFA pulses between the ablation electrode 19 and at least one selected patch, e.g., the return electrode 29 of 28a, and method operations 250-260 may be executed by the system 100 in response to the issuance of such an instruction. In operation 250, one or more PFA pulses or pacing signals may be delivered by the system 100 (e.g., by the ablation energy generator 22 and the patch selector / switch 120) between the ablation electrode 19 of the catheter 12 (functioning as the first pole of monopolar PFA) and one or more selected electrode patches, e.g., the return electrode 29 of 28a (functioning as the second pole of monopolar PFA). During and / or subsequent to the delivery of the PFA pulse or pacing signal, operation 260 is executed to monitor the movement sensed by the motion sensor 50 (e.g., at least the motion sensor 50 associated with the selected / activated electrode patch and also the motion sensor 50 and / or other optional sensors 60 disposed at the specific ROI of the subject / patient). The signals / data obtained from these motion sensors are processed (e.g., by the motion / spasm processor 110) to identify spasm-related motion patterns in the vicinity of the electrode patch and / or ROI. Additionally, signals / data obtained from other optional sensors 60, such as the ECG sensor shown above, can be processed to identify other possible effects of excessive nerve stimulation.

[0057] As shown above, each motion sensor can be implemented by, or can include, a position sensor and / or an inertial measurement unit (e.g., an accelerometer and / or optionally also a gyro). The motion sensor 50 can be adapted to provide signals indicative of changes in the velocity or acceleration of their associated electrode patches 28 and / or the patient tissue near the ROI to the system 100 via a wireless or wired connection (e.g., based on inertial measurements performed by their IMU / accelerometer). In either case, as will be understood by those skilled in the art, a change in the position, acceleration velocity, or any one of the patches associated therewith of the tissue in the ROI where the motion sensor is disposed can be derived from the signals obtained from each motion sensor in any of the implementation forms shown above.

[0058] Thus, monitoring of the motion sensed by the motion sensors typically involves processing / filtering the signals obtained from each motion sensor 50 to identify spasm-related motion patterns therein. Such processing can involve, for example, applying a signal filter to the signals from each motion sensor and / or applying spectral analysis such as a Fourier Transform (FFT) thereto to identify frequency components related to spasm. For example, the spasm-related motion pattern is associated with at least one change in the position, velocity, and acceleration of the tissue near the electrode patch, and the processing / filtering includes spectral analysis of the signals of each motion sensor, and it can be determined whether the amplitude of the frequency components of these signals within that frequency range exceeds a specific threshold indicative of the spasm-related motion pattern near each particular motion sensor 50 being monitored. In this regard, those skilled in the art can readily understand the characteristics (their characteristic frequencies and amplitudes) of the various spasm-related motion patterns that can be identified by the system, and after knowing the present invention, will readily understand how to implement such processing to identify these patterns.

[0059] Thus, based on the monitoring operation 260, when the processing of the movement sensed by the motion sensor associated with a particular electrode patch such as 28a reveals a movement pattern related to the spasm occurring there, the indicator can be provided to the physician 16 (e.g., via the UI34), or the system 100 can automatically switch to another electrode patch, such as 28b, that functions as the second pole of the monopolar PFA.

[0060] Alternatively or additionally, as described above in some embodiments, the monitoring operation 260 can be performed during the pre-ablation screening stage 240 for the purpose of determining the conditions (e.g., maximum / effective level / intensity) of the pacing signal or PFA pulse that can be delivered through one or more of the electrode patches 28 without or with reduced influence of nerve stimulation such as spasm. In such an implementation, the operation 260 for monitoring the occurrence of spasm can be performed simultaneously / synchronously with the varying intensity of the pacing signal / PFA pulse, thereby revealing the intensity of the pacing signal / PFA pulse when the spasm-related movement pattern begins to appear near each motion sensor 50. This can be performed, for example, by individually activating each electrode patch of the electrode patches 28 connected to the system 100 or some of them, and the maximum / effective intensity that does not cause spasm can be recorded by the system 100 (e.g., by the motion / spasm processor 110) and / or presented to the physician 16 (via the UI34) to assist in the appropriate selection (automatically or manually) of at least one electrode patch (e.g., 28a) or combination of patches (e.g., 28a and 28b) that will further function / activate as the second pole of the monopolar PFA ablation treatment.

[0061] Based on the spasm monitoring operation 260, in operation 270 of method 100, one or more of the plurality of electrode patches 28 (e.g., 28a) are selected to function / activate as one or more second poles of the monopolar PFA. Typically, operation 270 can be performed following the identification of the occurrence of a spasm-related movement pattern by monitoring 260 during the performance of the PFA treatment. Alternatively or additionally, operation 270 can be performed after the ablation pre-screening 240 of the PFA treatment, during which the level of the signal / pulse that can be delivered through each patch can be evaluated without affecting the spasm.

[0062] As shown above, in some implementations, operation 270 can be operated in a "manual mode", in which case the occurrence of a spasm-related movement SPSM, or conditions that affect spasm or other adverse effects of nerve stimulation by the activation of one or more electrode patches, are presented / shown by, for example, UI34 to warn the physician 16 about the occurrence of a spasm or other adverse effects, or to inform the physician about the available options for patch selection and / or PFA signal / pulse intensity that are expected to affect / not affect the spasm. In such a "manual mode" in response to such an indicator SPSM about the occurrence / state of a spasm by the activation of any one or more of the patches, the system 100 can receive input data / instructions INS that indicate one or more of the selected electrode patches 28 that function / activate individually or collectively as the second pole of the monopolar ablation. Optionally, the input data / instructions INS can also indicate the intensity / level or relative portion of the PFA pulse that is to be transferred through each of the selected / activated electrode patches (e.g., if more than one patch is selected).

[0063] Alternatively or additionally, as also shown above, in some implementations, system 100 can be operated in “automatic mode,” in which case, following the occurrence of spasm-related movements detected by monitoring 260, based on the conditions that affect the spasm determined by ablation pre-screening operation 240, system 100, e.g., movement / spasm processor 110, automatically selects at least one or a combination of electrode patches 28 that are further used as a second pole during PFA treatment, and also optionally selects the rate / level / intensity of the PFA pulses delivered through each of the selected patches. Typically, in this case, the system makes such a selection based on the information obtained by monitoring 250 for the purpose of avoiding the occurrence of adverse effects of spasm or other nerve stimulation near the selected patch or ROI where the motion sensor is provided, and / or reducing the duration and / or intensity of spasm or other adverse effects.

[0064] For example, in some embodiments, system 100 can set only one or more than one patch that is not detected by spasm / adverse effects by motion sensor 50 and / or optional sensor 60 and / or is detected at the lowest spasm amplitude / intensity as the selected patch 28. Alternatively or additionally, based on the monitoring, the system can balance the intensity of the PFA signals passing through each selected patch to minimize the adverse effects of nerve stimulation / spasm. In this regard, those skilled in the art, after knowing the present invention, can easily understand the various optimization methods and / or algorithms that can be implemented by system 100 for selecting electrode patches that function individually or collectively as the second PFA pole, and in the latter case, for optionally optimizing the PFA pulse level / intensity delivered through each selected electrode patch based on the information obtained by monitoring 260 as described above.

[0065] Next, in operation 280, system 100 operates to deliver a PFA pulse between ablation electrode 19 of catheter 12 and a selected electrode patch (e.g., 28a). To achieve this, patch selector / switch 120 is operated by processor 20 to activate the selected patch (e.g., electrically connect them to the second pole of ablation energy generator 22 and substantially disconnect other electrode patches therefrom. This can be accomplished by controllably operating one or more switches 124 and / or current / voltage controller 126 to perform such connection / disconnection. Additionally, optionally, patch selector / switch 120 (e.g., its current / voltage controller 126) can be operated by processor 20 to adjust the level / portion of the PFA signal that will be delivered through each of the selected electrode patches according to the maximum / effective level / intensity of the PFA signal optionally determined in operation 260).

Example

[0066] Example 1. A method 200 for monopolar pulsed field ablation (PFA), the method comprising providing a PFA system, the PFA system comprising at least one catheter having at least one electrode that functions as a first pole of monopolar PFA and is provided at a distal tip of the catheter to facilitate tissue ablation near the distal tip, and a plurality of at least two electrode patches for coupling at several locations on the skin of a subject, each electrode patch comprising at least one return electrode suitable for functioning as a second pole of monopolar PFA; providing at least one motion sensor for coupling to at least one region of the subject's body and / or in the vicinity thereof; Deliver one or more PFA pulses or pacing signals between at least one ablation electrode of a catheter that functions as a first pole of monopolar PFA and a return electrode of one or more of a plurality of electrode patches configured to function as one or more second poles of monopolar PFA during delivery of the one or more PFA pulses or pacing signals. Subsequent to delivery of the one or more PFA pulses or pacing signals, monitor movement indicated by a signal from a motion sensor to identify a spasm-related movement pattern in the vicinity of at least one motion sensor. Based on the monitoring, select a particular one or more of the plurality of electrode patches that will further function as one or more second poles of monopolar PFA, and deliver one or more additional PFA pulses or pacing signals via the return electrode of the selected particular one or more electrode patches. A method comprising the steps of:

[0067] Example 2. The method according to Example 1, wherein at least one motion sensor includes a position sensor adapted to respectively provide signals indicating changes in the position of tissue near the at least one motion sensor.

[0068] Example 3. The method according to Example 1 or 2, wherein at least one motion sensor comprises an inertial measurement unit (IMU), and the inertial measurement unit (IMU) is adapted to respectively provide signals indicating changes in the velocity or acceleration of tissue near the at least one motion sensor based on inertial measurements performed by the IMU.

[0069] Example 4. The method according to any one of Examples 1 to 3, wherein the inertial measurement unit (IMU) includes at least one accelerometer.

[0070] Example 5. The method according to any one of Examples 1 to 4, wherein at least one motion sensor is a wireless motion sensor including a wireless communication utility capable of wirelessly communicating a signal to a PFA system.

[0071] Example 6. The spasm-related movement pattern is associated with at least one change in the position, velocity, and acceleration of the tissue near at least one motion sensor having a frequency within a specific frequency range, and the monitoring of the movement includes processing the signal acquired from the motion sensor to determine whether the amplitude of the frequency component of the signal within the frequency range exceeds a specific threshold value. The method according to any one of Examples 1 to 5.

[0072] Example 7. The processing includes at least one of spectral analysis and filtering to identify the frequency components within the frequency range. The method according to Example 6.

[0073] Example 8. When the selection of one or more electrode patches based on the monitoring identifies a spasm-related movement pattern, - Issuing an indicator regarding the identified spasm-related movement pattern in relation to one or more electrode patches in response to the activation of one or more electrode patches as one or more second poles, where the spasm-related movement pattern is identified; - Obtaining a user command for the selection of a specific one or more electrode patches in response to the indicator, and Thereby, delivering one or more PFA pulses or pacing signals through the return electrodes of the selected one or more electrode patches according to the user command. The method according to any one of Examples 1 to 7.

[0074] Example 9. The selection of one or more electrode patches is automatically performed based on monitoring the spasm-related movement pattern sensed by at least one motion sensor. The method according to any one of Examples 1 to 8.

[0075] Example 10. Providing at least one motion sensor includes - Providing at least one motion sensor disposed on or near each of at least one of the plurality of electrode patches -The method according to any one of Examples 1 to 9, comprising at least one of: providing at least one motion sensor disposed in or near at least one region of interest of a subject's body, wherein a spasm-related movement pattern can occur due to nerve stimulation affected by the delivery of a PFA pulse or pacing signal.

[0076] Example 11. The method according to any one of Examples 1 to 10, wherein selecting one or more electrode patches based on monitoring can include selecting two or more electrode patches that function as a second pole.

[0077] Example 12. When two or more electrode patches are selected, delivering a PFA pulse or pacing signal includes adjusting the relative portion / intensity (e.g., voltage / current) of the PFA pulse or pacing signal delivered through each of the selected electrode patches based on monitoring, thereby avoiding or reducing spasm or other adverse effects of nerve stimulation near the selected electrode patches. The method according to Example 11.

[0078] Example 13. The method according to any one of Examples 1 to 12, wherein at least one of the electrode patches includes a coupling member suitable for attaching one of the motion sensors thereto.

[0079] Example 14. The method according to any one of Examples 1 to 13, wherein the PFA system is configured and operable to perform PFA treatment by delivering a PFA pulse, which is a high-voltage direct current electrical signal, between at least one electrode of a catheter and at least one selected electrode patch of a plurality of electrode patches.

[0080] Example 15. A system for monopolar pulsed field ablation (PFA), The system is connectable to an ablation catheter having at least one ablation electrode at a distal end, a plurality of at least two electrode patches, each having at least one return electrode suitable for use in monopolar ablation, and at least one motion sensor for coupling to at least one region of a subject's body or in the vicinity thereof. The system includes a PFA energy generator adapted to deliver one or more than two PFA pulses or pacing signals between a first electrode and a second electrode, whereby at least the first electrode is electrically connectable directly or indirectly to an ablation electrode of a catheter functioning as a first pole of monopolar PFA, enabling ablation of tissue proximal to the ablation electrode. The system A signal switch, connected to the PFA energy generator and adapted to be electrically connected directly or indirectly to the return electrodes of the plurality of electrode patches, is operable to selectively deliver PFA pulses or pacing signals between the return electrodes of one or more selected electrode patches of the plurality of electrode patches configured to function as one or more than two second poles of monopolar PFA. The system includes at least one processor adapted to monitor motion indicated by a signal from at least one motion sensor following delivery of one or more than two PFA pulses or pacing signals, identify a spasm-related motion pattern in the vicinity of the at least one motion sensor, select a particular one or more than two of the plurality of electrode patches based on the monitoring, cause the particular one or more than two selected electrode patches to further function as one or more than two second poles, and operate the signal switch to connect the PFA energy generator to the return electrodes of the particular one or more than two selected electrode patches for further delivery of one or more than two PFA pulses or pacing signals through the particular one or more than two selected electrode patches.

[0081] Example 16. The system according to Example 15, wherein at least one motion sensor includes at least one of a position sensor and an inertial measurement unit.

[0082] Example 17. The system according to Example 15 or 16, wherein the motion sensor is a wireless motion sensor, and the system includes a wireless communication utility capable of wirelessly communicating with the motion sensor to obtain a signal indicating the motion sensed by the motion sensor from the motion sensor.

[0083] Example 18. The system according to any one of Examples 15 to 17, wherein the spasm-related motion pattern is associated with at least one change in the position, velocity, and acceleration of the tissue near at least one motion sensor having a frequency within a specific frequency range, and monitoring includes processing a signal obtained from at least one motion sensor to identify the frequency components of the motion within the specific frequency range indicating the spasm-related motion pattern.

[0084] Example 19. When the spasm-related motion pattern is identified by monitoring, the selection of a specific one or more electrode patches - operates a user interface to issue an indicator regarding the identified spasm-related motion pattern, - in response to the indicator, obtains instructions for the selection of a specific one or more electrode patches via the user interface, and thereby, according to the instructions, delivers one or more PFA pulses or pacing signals via the return electrodes of the selected specific one or more electrode patches. The system according to any one of Examples 15 to 18.

[0085] Example 20. The system according to any one of Examples 15 to 19, which is adapted to automatically perform the selection of a specific one or more electrode patches based on monitoring the spasm-related motion pattern sensed by at least one motion sensor.

[0086] Example 21. - at least one motion sensor disposed on or near each of at least one of the plurality of electrode patches, - at least one motion sensor disposed on or near at least one region of interest of the subject's body where a spasm-related movement pattern can occur due to nerve stimulation affected by the delivery of a PFA pulse or pacing signal, at least one of which comprises at least one motion sensor adapted to connect to at least one of the motion sensors described in any one of Examples 15-20.

[0087] Example 22. The system according to any one of Examples 15-21, wherein selecting one or more specific electrode patches based on monitoring may include selecting two or more electrode patches that function as a second pole.

[0088] Example 23. The signal switch is configured and operable to adjust the relative portion (voltage / current) of the PFA pulse or pacing signal delivered through each of the selected electrode patches, and when two or more electrode patches are selected, the processor adjusts the relative portion based on monitoring to avoid or reduce spasms sensed by the motion sensor. The system according to Example 22.

[0089] Example 24. Adapted to connect to at least one additional sensor capable of sensing additional effects of nerve stimulation resulting from the delivery of a PFA pulse or pacing signal, and at least one processor is adapted to further select one or more specific electrode patches based on further monitoring of signals obtained from the additional sensor. The system according to any one of Examples 15-23.

[0090] Example 25: A PFA electrode patch for use as a second non-ablation electrode in monopolar PFA treatment. The PFA electrode patch includes a return electrode that is a skin surface electrode adapted to couple to a patient's skin over a surface area that is substantially larger than the contact surface area of the ablation electrode used in monopolar PFA treatment, an electrical connector for connecting the return electrode to a PFA energy generator that functions as an energy source of a PFA ablation system, and a coupling member that couples at least one motion sensor to the PFA electrode patch and is adapted to facilitate identification of muscle spasms occurring during monopolar PFA treatment in a muscle of the patient located in the vicinity of the skin area to which the PFA electrode patch is attached during monopolar PFA treatment.

[0091] Example 26. The PFA electrode patch according to Example 25, comprising a motion sensor integrally coupled to the PFA electrode patch.

[0092] Example 26. Configured as a disposable patch and - the PFA electrode patch includes a motion sensor as an integral part thereof, - the PFA electrode patch functions as a disposable part of a PFA electrode patch assembly, the PFA electrode patch assembly including a reusable part that is attachable to the disposable part via a coupling member and includes a motion sensor, the PFA electrode patch according to Example 25 being at least one of the above.

[0093] It should be understood that the examples described above are cited by way of example, and the present disclosure is not limited to those specifically illustrated and described above. Rather, the scope of the present disclosure includes both combinations and sub-combinations of the various features described hereinabove, as well as those variations and modifications that would occur to those skilled in the art upon reading the description of the present invention and that are not disclosed in the prior art.

[0094] 〔Embodiments〕 (1) A method for monopolar pulsed field ablation (PFA), the method comprising To provide a PFA system, wherein the PFA system comprises: - at least one catheter having at least one electrode that functions as a first pole of the monopolar PFA and is provided at a distal tip of the catheter to facilitate tissue ablation near the distal tip; - a plurality of at least two electrode patches for attachment at several locations on the skin of a subject, each electrode patch comprising at least one return electrode suitable for functioning as a second pole of the monopolar PFA; To provide at least one motion sensor for attachment to at least one region of the body of the subject or in the vicinity thereof; To deliver one or more PFA pulses or pacing signals between at least one ablation electrode of the catheter functioning as the first pole of the monopolar PFA and a return electrode of one or more of the plurality of electrode patches configured to function as one or more second poles of the monopolar PFA during delivery of the one or more PFA pulses or pacing signals; Following delivery of the one or more PFA pulses or pacing signals, to monitor movement indicated by a signal from the motion sensor and to identify a spasm-related movement pattern in the vicinity of the at least one motion sensor; Based on the monitoring, to select a particular one or more of the plurality of electrode patches that will further function as one or more second poles of the monopolar PFA and to deliver one or more additional PFA pulses or pacing signals via the return electrode of the selected particular one or more electrode patches. (2) The method according to embodiment 1, wherein the at least one motion sensor comprises a position sensor adapted to respectively provide a signal indicating a change in position of tissue near the at least one motion sensor. (3) At least one motion sensor includes an inertial measurement unit (IMU), and the inertial measurement unit (IMU) is adapted to provide the signal indicating a change in velocity or acceleration of tissue near the at least one motion sensor, respectively based on inertial measurements performed by the IMU, the method according to embodiment 1. (4) The inertial measurement unit (IMU) includes at least one accelerometer, the method according to embodiment 3. (5) The at least one motion sensor is a wireless motion sensor including a wireless communication utility capable of wirelessly communicating the signal to the PFA system, the method according to embodiment 1.

[0095] (6) The spasm-related motion pattern is associated with at least one change in position, velocity, and acceleration of the tissue near the at least one motion sensor having a frequency within a specific frequency range, and the monitoring of the motion includes processing the signal obtained from the motion sensor to determine whether an amplitude of a frequency component of the signal within the frequency range exceeds a specific threshold value, the method according to embodiment 1. (7) The processing includes at least one of spectral analysis and filtering to identify the frequency component within the frequency range, the method according to embodiment 6. (8) The selection of the one or more electrode patches based on the monitoring, when the spasm-related motion pattern is identified by the monitoring, - issuing an indicator regarding the identified spasm-related motion pattern in relation to the one or more electrode patches in response to activation of the one or more electrode patches as the one or more second poles, the spasm-related motion pattern being identified; issuing, - obtaining a user command for selection of the specific one or more electrode patches in response to the indicator, and implementing, The method according to embodiment 1, comprising delivering, in accordance with the user instruction, the one or more PFA pulses or pacing signals via the return electrode of the selected one or more electrode patches. (9) The method according to embodiment 1, wherein the selecting of the one or more electrode patches is automatically performed based on monitoring the spasm-related movement pattern sensed by the at least one motion sensor. (10) The providing of the at least one motion sensor is - providing at least one motion sensor disposed on or near at least one respective electrode patch of the plurality of electrode patches, (10) The method according to embodiment 1, wherein the providing of the at least one motion sensor comprises at least one of: providing at least one motion sensor disposed on or near at least one region of interest of the subject's body where a spasm-related movement pattern may occur due to nerve stimulation affected by the delivery of the PFA pulse or pacing signal.

[0096] (11) The method according to embodiment 1, wherein the selecting of the one or more electrode patches based on the monitoring may include selecting two or more electrode patches that function as the second pole. (12) When the two or more electrode patches are selected, the delivering of the PFA pulse or pacing signal comprises adjusting relative portions of the PFA pulse or pacing signal delivered through each of the selected electrode patches based on the monitoring, thereby avoiding or reducing spasms or other adverse effects of nerve stimulation. The method according to embodiment 11. (13) The method according to embodiment 1, wherein at least one of the electrode patches comprises a coupling member suitable for attaching one of the motion sensors thereto. (14) A system for monopolar pulsed field ablation (PFA), wherein the system is An ablation catheter having at least one ablation electrode at a distal end, A plurality of at least two electrode patches, each comprising at least one return electrode suitable for use in monopolar ablation, At least one motion sensor connectable to at least one region of the subject's body or in the vicinity thereof, The system being A PFA energy generator adapted to deliver one or more PFA pulses or pacing signals between a first electrode and a second electrode, whereby at least the first electrode is electrically connectable directly or indirectly to the ablation electrode of the catheter functioning as the first pole of the monopolar PFA, enabling ablation of tissue proximal to the ablation electrode, a PFA energy generator, A signal switch connected to the PFA energy generator and adapted to make electrical connection directly or indirectly to the return electrodes of the plurality of electrode patches, operable to selectively deliver the PFA pulse or pacing signal between the return electrodes of one or more selected electrode patches of the plurality of electrode patches configured to function as one or more second poles of the monopolar PFA, a signal switch, Following delivery of the one or more PFA pulses or pacing signals, monitor the movement indicated by the signal from the at least one motion sensor to identify a spasm-related movement pattern in the vicinity of the at least one motion sensor, and based on the monitoring, select a particular one or more of the plurality of electrode patches to further function as the one or more second poles, and for further delivery of the one or more PFA pulses or pacing signals through the selected particular one or more electrode patches, at least one processor adapted to operate the signal switch to connect the PFA energy generator to the return electrodes of the selected particular one or more electrode patches, a system comprising. (15) The system according to embodiment 14, wherein the at least one motion sensor comprises at least one of a position sensor and an inertial measurement unit.

[0097] (16) The system according to embodiment 14, wherein the motion sensor is a wireless motion sensor, and the system comprises a wireless communication utility capable of wirelessly communicating with the motion sensor to obtain from the motion sensor a signal indicative of the motion sensed by the motion sensor. (17) The spasm-related movement pattern is associated with at least one change in the position, velocity, and acceleration of tissue near the at least one motion sensor having a frequency within a particular frequency range, and the monitoring includes processing the signal obtained from the at least one motion sensor to identify the frequency components of the motion within the particular frequency range indicative of the spasm-related movement pattern. The system according to embodiment 14. (18) Comprising a user interface, when the spasm-related movement pattern is identified by the monitoring, the selection of the particular one or more electrode patches based on the monitoring, - operating the user interface to issue an indicator regarding the identified spasm-related movement pattern, - In response to the indicator, obtaining, via the user interface, instructions for selection of the specific one or more electrode patches. Thereby, a system according to Embodiment 14, including delivering the one or more PFA pulses or pacing signals via the return electrodes of the selected specific one or more electrode patches according to the instructions. (19) A system according to Embodiment 14, adapted to automatically perform the selection of the specific one or more electrode patches based on monitoring the spasm-related movement patterns sensed by the at least one motion sensor. (20) - At least one motion sensor disposed on or near each of at least one of the plurality of electrode patches. - At least one motion sensor connected to at least one of: at least one motion sensor disposed on or near at least one region of interest of the subject's body where a spasm-related movement pattern can occur due to nerve stimulation affected by the delivery of the PFA pulse or pacing signal. A system according to Embodiment 14.

[0098] (21) A system according to Embodiment 14, wherein selecting the specific one or more electrode patches based on the monitoring can include selecting two or more electrode patches that function as the second pole. (22) The signal switch is configured and operable to adjust the relative portions of the PFA pulse or pacing signal delivered through each of the selected electrode patches, and when the two or more electrode patches are selected, the processor adjusts the relative portions based on the monitoring to avoid or reduce spasms near the selected electrode patches. A system according to Embodiment 21. Adapted to connect to at least one additional sensor capable of sensing additional effects of nerve stimulation resulting from the delivery of the PFA pulse or pacing signal, the at least one processor further monitors the signal obtained from the additional sensor and is adapted to further select the particular one or more than two electrode patches based on further monitoring of the signal from the additional sensor, the system of embodiment 14. (24) A PFA electrode patch for use as a second non-ablation pole in monopolar PFA treatment, the PFA electrode patch being a skin surface electrode adapted to couple to a patient's skin over a surface area substantially larger than the contact area of the ablation electrode used in the monopolar PFA treatment, a return electrode, an electrical connector for connecting the return electrode to a PFA energy generator functioning as an energy source of a PFA ablation system, and at least one motion sensor coupled to the PFA electrode patch and adapted to facilitate identification of muscle spasms occurring during monopolar PFA treatment in a muscle of the patient located in the vicinity of the skin area to which the PFA electrode patch is attached during the monopolar PFA treatment. (25) The PFA electrode patch of embodiment 24, comprising the motion sensor integrally coupled to the PFA electrode patch.

[0099] (26) Configured as a disposable patch and - the PFA electrode patch comprises the motion sensor as an integral part thereof, (26) - the PFA electrode patch functions as a disposable part of a PFA electrode patch assembly, the PFA electrode patch assembly being attachable to the disposable part via the coupling member and comprising a reusable part comprising the motion sensor, the PFA electrode patch of embodiment 24 being at least one of the above.

Claims

1. 1. A system for monopolar pulsed field ablation (PFA), comprising: The system further comprises: an ablation catheter having at least one ablation electrode at a distal end; a plurality of at least two electrode patches, each comprising at least one return electrode suitable for use in monopolar ablation; and at least one motion sensor connectable to or respectively coupled to at least one region of the subject's body; The system further comprises: a PFA energy generator adapted to deliver one or more PFA pulses or pacing signals between a first electrode and a second electrode, whereby at least the first electrode is electrically connectable, directly or indirectly, to the ablation electrode of the catheter that functions as the first pole of the unipolar PFA, enabling ablation of tissue proximal to the ablation electrode; a signal switch connected to the PFA energy generator and adapted to directly or indirectly electrically connect with return electrodes of the plurality of electrode patches and operable to selectively deliver the PFA pulses or pacing signals between return electrodes of one or more selected electrode patches of the plurality of electrode patches configured to function as one or more second poles of the unipolar PFA; and at least one processor adapted to monitor the movement indicated by a signal from the at least one motion sensor following delivery of the one or more PFA pulses or pacing signals to identify a seizure-related movement pattern in a vicinity of the at least one motion sensor, and based on the monitoring, select specific one or more electrode patches of the plurality of electrode patches to further function as the one or more second poles, and operate the signal switch to connect the PFA energy generator to a return electrode of the selected specific one or more electrode patches for further delivery of the one or more PFA pulses or pacing signals via the selected specific one or more electrode patches.

2. The system of claim 1 , wherein the at least one motion sensor comprises at least one of a position sensor and an inertial measurement unit.

3. 10. The system of claim 1, wherein the motion sensor is a wireless motion sensor, the system comprising a wireless communication utility capable of wirelessly communicating with the motion sensor to obtain a signal from the motion sensor indicative of motion sensed by the motion sensor.

4. 2. The system of claim 1, wherein the seizure-related motion pattern is associated with changes in at least one of position, velocity, and acceleration of tissue near the at least one motion sensor having frequencies within a particular frequency range, and wherein the monitoring includes processing the signals obtained from the at least one motion sensor to identify frequency components of the motion within the particular frequency range that are indicative of the seizure-related motion pattern.

5. a user interface, wherein the selection of the particular one or more electrode patches based on the monitoring is performed when the seizure-related movement pattern is identified by the monitoring; - operating the user interface to issue an indication regarding the identified seizure-related movement pattern; - in response to said indication, obtaining, via said user interface, an instruction for selection of said particular one or more electrode patches, The system of claim 1 , thereby comprising delivering the one or more PFA pulses or pacing signals via the return electrodes of the selected particular one or more electrode patches in accordance with the instructions.

6. 2. The system of claim 1, adapted to perform the selection of the particular one or more electrode patches automatically based on the monitoring of the seizure-related movement patterns sensed by the at least one movement sensor.

7. at least one motion sensor disposed on or near a respective electrode patch of at least one of said plurality of electrode patches; - at least one motion sensor positioned in or near at least one region of interest of the subject's body where a seizure-related movement pattern may result from neural stimulation affected by the delivery of the PFA pulses or pacing signals.

8. The system of claim 1 , wherein selecting the particular one or more electrode patches based on the monitoring can include selecting two or more electrode patches to function as the second pole.

9. 9. The system of claim 8, wherein the signal switch is configured and operable to adjust a relative portion of the PFA pulse or pacing signal delivered through each of the selected electrode patches, and when two or more electrode patches are selected, the processor adjusts the relative portions based on the monitoring to avoid or reduce spasms near the selected electrode patches.

10. 2. The system of claim 1, further adapted to connect to at least one additional sensor capable of sensing an additional effect of neural stimulation resulting from the delivery of a PFA pulse or pacing signal, wherein the at least one processor is adapted to further monitor the signals obtained from the additional sensor and further select the particular one or more electrode patches based on the further monitoring of the signals from the additional sensor.

11. 1. A PFA electrode patch for use as a second, non-ablative pole in a monopolar PFA treatment, the PFA electrode patch comprising: a return electrode that is a skin surface electrode adapted to be coupled to a patient's skin over a surface area substantially greater than the contact area of ​​an ablation electrode used in the monopolar PFA treatment; an electrical connector for connecting the return electrode to a PFA energy generator that serves as an energy source for a PFA ablation system; and a coupling member adapted to couple at least one motion sensor to the PFA electrode patch to facilitate identification of muscle spasms occurring during the monopolar PFA treatment in a patient's muscle located proximate to the skin area to which the PFA electrode patch is attached during the monopolar PFA treatment.

12. The PFA electrode patch of claim 11 , comprising the motion sensor integrally coupled to the PFA electrode patch.

13. It is configured as a disposable patch, and - said PFA electrode patch comprises said motion sensor as an integral part thereof; The PFA electrode patch of claim 11, wherein the PFA electrode patch functions as a disposable part of a PFA electrode patch assembly, and the PFA electrode patch assembly comprises a reusable part that is attachable to the disposable part via the connecting member and comprises the motion sensor.

14. 1. A method for monopolar pulsed field ablation (PFA), the method comprising: A PFA system is provided, the PFA system comprising: at least one catheter, the at least one catheter functioning as a first pole of the monopolar PFA and having at least one electrode located at a distal tip of the catheter to facilitate tissue ablation near the distal tip; - providing a plurality of at least two electrode patches for coupling at several locations on the skin of a subject, whereby each electrode patch comprises at least one return electrode suitable to function as a second pole of said monopolar PFA; providing at least one motion sensor for coupling respectively to or near at least one region of the subject's body; delivering one or more PFA pulses or pacing signals between the at least one ablation electrode of the catheter, which serves as the first pole of the unipolar PFA, and a return electrode of one or more electrode patches of the plurality of electrode patches configured to serve as one or more second poles of the unipolar PFA during delivery of the one or more PFA pulses or pacing signals; monitoring movement indicated by signals from the motion sensors following delivery of the one or more PFA pulses or pacing signals to identify seizure-related movement patterns in the vicinity of the at least one motion sensor; and selecting, based on the monitoring, certain one or more electrode patches of the plurality of electrode patches that will further function as the one or more second poles of the unipolar PFA, and delivering one or more additional PFA pulses or pacing signals via the return electrodes of the selected certain one or more electrode patches.

15. The method of claim 14 , wherein the at least one motion sensor comprises a position sensor adapted to respectively provide a signal indicative of a change in position of tissue proximate the at least one motion sensor.

16. 15. The method of claim 14, wherein at least one motion sensor comprises an inertial measurement unit (IMU), the IMU being adapted to provide the signal indicative of a change in velocity or acceleration of tissue near the at least one motion sensor, each based on inertial measurements performed by the IMU.

17. The method of claim 16 , wherein the inertial measurement unit (IMU) comprises at least one accelerometer.

18. The method of claim 14 , wherein the at least one motion sensor is a wireless motion sensor with wireless communication utility capable of wirelessly communicating the signal to the PFA system.

19. 15. The method of claim 14, wherein the seizure-related motion patterns are associated with changes in at least one of position, velocity, and acceleration of the tissue proximate the at least one motion sensor having frequencies within a particular frequency range, and wherein the monitoring of the motion includes processing the signals obtained from the motion sensors to determine whether amplitudes of frequency components of the signals within the frequency range exceed a particular threshold.

20. 20. The method of claim 19, wherein the processing includes at least one of spectral analysis and filtering to identify the frequency components within the frequency range.

21. the selecting of the one or more electrode patches based on the monitoring, when the monitoring identifies the seizure-related movement pattern; - issuing an indication of the identified seizure-related movement pattern in association with the one or more electrode patches in response to activation of the one or more second poles, the seizure-related movement pattern being identified; - obtaining a user instruction for selection of said particular one or more electrode patches in response to said indication; 15. The method of claim 14, thereby comprising delivering the one or more PFA pulses or pacing signals via the return electrodes of the selected one or more electrode patches in accordance with the user command.

22. 15. The method of claim 14, wherein the selecting of the one or more electrode patches is performed automatically based on the monitoring of the seizure-related movement patterns sensed by the at least one movement sensor.

23. providing the at least one motion sensor, - provision of at least one motion sensor arranged on or near a respective electrode patch of at least one of said plurality of electrode patches; - providing at least one motion sensor positioned at or near at least one region of interest of the subject's body where seizure-related movement patterns may result from neural stimulation affected by the delivery of the PFA pulses or pacing signals.

24. The method of claim 14 , wherein the selecting the one or more electrode patches based on the monitoring can include selecting two or more electrode patches to function as the second pole.

25. 25. The method of claim 24, wherein if the two or more electrode patches are selected, the delivering of the PFA pulses or pacing signals includes adjusting relative portions of the PFA pulses or pacing signals delivered through each of the selected electrode patches based on the monitoring, thereby avoiding or reducing spasms or other adverse effects of neural stimulation.

26. The method of claim 14 , wherein at least one of the electrode patches comprises a coupling member suitable for attaching one of the motion sensors thereto.

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