System and method for unipolar PFA

Abstract

Systems and methods for unipolar pulsed field ablation (PFA) are disclosed for reducing spasticity and / or other adverse neurostimulation effects 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 spasticity at that region. The system includes a signal switch capable of selectively connecting the PFA energy generator to a selected one or more of the return electrode patches for delivering PFA pulses and / or pacing signals through the selected electrode patch; and a processor that monitors motion sensed by the motion sensor during delivery of the PFA pulse or pacing signal to identify a neurostimulation effect, such as spasm, to facilitate selection of a particular electrode patch by which the PFA pulse may be delivered based on the monitoring, and no or reduced spasm or other adverse effects of excessive nerve stimulation can be generated.

Description

Technical Field

[0001] The present invention relates to medical systems and, in particular but not exclusively, to cardiac ablation using irreversible electroporation (IRE) via monopolar pulsed field ablation (PFA). Background Art

[0002] The diagnosis and treatment of cardiac arrhythmias involve mapping the electrical properties of cardiac tissue (especially the endocardium) and selectively ablating cardiac tissue by applying energy. Such ablation can stop or alter the propagation of unwanted electrical signals from one part of the heart to another. Ablation methods disrupt unwanted electrical pathways by forming non-conductive ablation lesions. A variety of forms of energy delivery for forming ablation lesions have been disclosed and include the use of microwaves, lasers, and more commonly radiofrequency energy to form conduction blocks along the walls of cardiac tissue. In a two-step protocol (mapping followed by ablation), electrical activity at various points within the heart is typically sensed and measured by advancing a catheter incorporating one or more electrical sensors into the heart and collecting data at multiple points. This data is then used to select the endocardial target regions to be ablated.

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

[0004] One ablation technique commonly used in medical practice is thermal ablation (also known as RF ablation). In this technique, an RF (radiofrequency) current is applied through the tip electrode of the ablation catheter, and the current flows through the medium surrounding the tip electrode, i.e., blood and tissue, between the tip electrode and a reference electrode, which is typically placed / stuck on the patient's skin or is placed / stuck by means of a second catheter positioned in or near the heart. The distribution of the current depends on the amount of contact of the ablation electrode surface with tissue compared to blood, which has a higher conductivity than tissue. Due to the resistance of the tissue, heating of the tissue occurs. The tissue is heated sufficiently to cause cell destruction in the cardiac tissue, resulting in the formation of a non-conductive ablation lesion within the cardiac tissue.

[0005] Another ablation technique in recent practice is pulsed field ablation (PFA), where irreversible electroporation (IRE) is applied via short electrical pulses (hereinafter referred to as PFA pulses), which generate an electric field high enough (usually greater than 450 volts per centimeter) to irreversibly damage cells. Pulsed field ablation (PFA) is generally non-thermal IRE ablation, which can be used to treat 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 placed close to the target tissue, and short high-voltage electrical pulses are applied between the ablation electrode and another electrode, which can be (for example, in bipolar PFA) another ablation electrode placed at the target tissue near the first ablation electrode, or (for example, in monopolar PFA) a return electrode, which is usually provided / stuck on the patient's skin or provided / stuck by means of a second catheter, and the return electrode has a relatively large surface to contact the body so as not to affect the ablation of the tissue near the return electrode. The short high-voltage electrical pulses applied by PFA increase the resting transmembrane potential of nearby cells, causing nanopores to form in the plasma membrane. When the electricity applied to the tissue is higher than the electric field threshold of the target tissue, the cells become permanently permeable due to the formation of nanopores. Therefore, the cells cannot repair the damage and die due to the loss of homeostasis, and the cells usually die by apoptosis.

[0006] PFA can be used for cardiac ablation as an alternative to other cardiac ablation techniques (e.g., radiofrequency (RF) cardiac ablation). Since PFA is generally a low-heat technique, it can reduce the risk of collateral cell damage present in other techniques (e.g., in RF cardiac ablation). BRIEF DESCRIPTION OF THE DRAWINGS

[0007] To better understand the subject matter disclosed herein and to illustrate how the subject matter can be implemented in practice, various embodiments are now described by way of non-limiting examples only with reference to the accompanying drawings, in which:

[0008] Figure 1 is a schematic diagram of an ablation system 10 for pulsed field tissue ablation in the presence of reduced spasm or other adverse nerve stimulation effects according to some embodiments of the present invention;

[0009] Figure 2A and Figure 2B is a schematic diagram of an electrode patch for monopolar pulsed field ablation adapted to incorporate a motion sensor according to an embodiment of the present invention; and

[0010] Figure 3A and Figure 3BSchematically illustrates a technique for controlling monopolar pulsed - field ablation during ablation therapy to reduce spasms or other adverse nerve - stimulation effects, where: Figure 3A is a block diagram illustrating the configuration of a monopolar pulsed - field ablation control system 100; and Figure 3B is a flowchart illustrating a method 200 for monopolar PFA control. Detailed Description

[0011] Pulsed - field ablation (PFA) employs energy delivery to a 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 a first pole and a second pole of the ablation energy / signal generator and are arranged to be coupled to the subject's body in a monopolar or bipolar manner. Thus, in bipolar PFA, electrodes that are typically connected to both the first pole and the second pole are arranged / placed in close proximity to the target tissue to be ablated, and in monopolar PFA, only the electrode connected to one of these poles (hereinafter referred to as the ablation electrode and considered to be connected without limitation to the first pole) is placed in close proximity to the target tissue to effect its ablation, while the electrode connected to the other pole (hereinafter referred to as the return electrode and considered to be connected without limitation to the second pole) is typically coupled to the subject's skin / tissue away from the target tissue and is typically configured to have a larger surface area than the ablation electrode so as not to affect ablation at the area where they are coupled to the subject.

[0012] In both types of PFA ablation, the energy flowing through the subject's body between the electrodes connected to the first pole and the second pole of the ablation energy / signal generator can affect nerve stimulation, which can reside in the path of the ablation energy flowing through the subject's body. This in turn can cause muscle spasms associated with the stimulated nerve, where the term spasm is used herein to refer to, for example, the involuntary contraction of a muscle or muscle group caused by abnormal nerve stimulation during PFA ablation therapy. Such spasms can be accompanied by sudden pain and discomfort to the subject and, in some cases, can provide an indication of the risk of permanent damage to the stimulated nerve.

[0013] For example, when PFA ablation is applied to a subject's heart, the phrenic nerve may be inadvertently stimulated, which can become apparent through spasms of the diaphragm and, in severe cases, lead to damage to the phrenic nerve. PFA ablation and specifically monopolar PFA (where the return electrode is typically arranged at a skin patch away from the target tissue to be ablated) can also cause stimulation of other nerves and affect spasms of other muscles (such as skeletal muscles).

[0014] To this end, it is necessary to avoid or reduce spasms during PFA treatment in order to reduce discomfort in the subject during treatment and to avoid / reduce the risk of causing nerve damage. The techniques of the present invention are designated to achieve these goals and to reduce or avoid spasms in monopolar PFA treatment. In fact, in both monopolar and bipolar PFA treatment, certain spasm effects can be avoided or reduced by changing the positioning of the ablation electrode (e.g., ablation catheter). However, this actually typically requires moving away from the designated target tissue, e.g., alternatively ablating nearby tissue.

[0015] However, as recognized by the present invention, advantageously in monopolar PFA, by alternatively changing the positioning at which the return electrode of the monopolar ablation is coupled to the body, certain spasm effects can be reduced or avoided without changing the target tissue / location to be ablated. This in turn can affect / change the pathway through which the ablation energy flows through the body of the subject and thereby alter, reduce or eliminate certain nerve stimulations and the associated spasms.

[0016] To this end, the present invention takes advantage of these benefits of monopolar PFA treatment and provides methods and systems for reducing / eliminating spasms in monopolar PFA treatment, which, via appropriate monitoring of spasm-related effects and appropriate selection of the return electrode (e.g., based on their positioning on / in the body of the subject) when using the PFA return electrode at one or more positions, reduce or eliminate excessive nerve stimulation and / or its effects (e.g., spasms and / or nerve damage).

[0017] First refer to Figure 1 , which is a schematic diagram of a system 10 for ablating tissue of a subject 14 while avoiding / reducing spasms or other nerve stimulation effects 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 for performing monopolar PFA.

[0018] The system 10 includes an ablation catheter 12, which includes a distal end 13 that includes an ablation electrode 19 having a relatively small surface area, which is adapted to contact a designated tissue area to be ablated. The catheter 12 is inserted into the subject 14 by a doctor 16. For example, the catheter 12 can be inserted into the vasculature of the subject via an insertion point 30, and its distal end 13 can then be navigated to a specific location within the body of the subject (e.g., within the heart where the target tissue to be ablated is located).

[0019] Typically, catheter 12 includes a position sensor (not specifically shown in the figures) at its distal end 13 that provides data / signals indicative of the real-time position of the distal end 13 of the catheter (the term position herein shall be understood hereinafter to refer to the positioning and / or orientation relative to the body of the subject 14). Thus, the position of the ablation electrode 19 within the body / target tissue of the subject (relative to the body / target tissue of the subject) can be tracked by the system 10, enabling the doctor 16 to place the ablation electrode 19 at a specific target tissue to be ablated and apply PFA at this location. It should be understood that in various embodiments, the system may include / or be connected to additional position sensors, which may be arranged, for example, in other medical devices and are also adapted to track the positions of these sensors.

[0020] In some embodiments, the position sensor is a magnetic position sensor that operates in conjunction with a positioning pad 42, which includes a plurality of positioning signal emitters (e.g., magnetic coils) that generate / transmit electromagnetic positioning signals (e.g., magnetic fields) in a predefined working volume around the patient. Then, the real-time position of the distal end 13 of the catheter 12 can be tracked relative to the patient's body based on the magnetic / electromagnetic position signals generated by the positioning 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, which are incorporated herein by reference.

[0021] Alternatively or additionally, in some embodiments, the position of the distal end 13 of the catheter 12 can be tracked / determined by impedance-based positioning tracking. In such embodiments, the position sensor on the distal end 13 may include an ECG sensor / electrode, and impedance-based positioning tracking can be employed to determine their positions using impedance-based tracking techniques. For impedance-based tracking, current is directed to the electrodes (e.g., the ECG electrodes in the case where the ECG electrodes are included at / on the distal end portion 13). The current is then sensed at skin ECG electrodes (not specifically shown), enabling triangulation of the position of the ECG sensor / electrode on the distal end portion 13 via the skin ECG electrodes. Details of impedance-based position tracking techniques are described in U.S. Pat. Nos. 7,536,218, 7,756,576, 7,848,787, 7,869,865, and 8,456,182.

[0022] According to an embodiment of the present invention, system 10 is adapted to perform monopolar PFA ablation by delivering / feeding a PFA signal through between an ablation electrode 19 on the distal end 13 of catheter 12 and at least one electrode patch (e.g., 28a) placed on the body / skin of a subject 14. To this end, system 10 also includes one or more electrode patches 28 or is associated with the one or more electrode patches, and each of the one or more electrode patches includes at least one electrode 29 (also referred to herein as a return electrode) coupled to the body / skin of the subject 14. The return electrode 29 generally has a relatively large surface / contact area relative to the surface / contact area of the ablation electrode 19, such that during ablation, when a PFA electrical pulse is applied between the ablation electrode 19 and the return electrode 29, the IRE is substantially permanently affected at the ablation electrode 19, which has a substantially smaller surface area, while being substantially unaffected or not permanently affected near the return electrode 29 of the patch 28 involved in ablation.

[0023] In Figure 1 In the specific example shown, system 10 includes two ablation electrode patches 28a and 28b, which are coupled to the skin of the subject, such as near his hip / thigh / back / chest / leg. Nevertheless, it should be noted that generally, system 10 may include any suitable number of electrode patches 28 (at least one) coupled to the subject in any suitable arrangement.

[0024] Generally, according to an embodiment of the present invention, system 10 includes one or more motion sensors 50 or is associated with the one or more motion sensors, and the one or more motion sensors can be arranged to sense the movement of the patient's tissue / skin at certain locations of interest (e.g., arranged near certain muscles associated with nerves that may optionally be stimulated by ablation treatment) and are adapted to provide a signal indicating the movement.

[0025] For example, in some embodiments, one or more accelerometers 50 (in Figure 1In non-limiting examples, a single accelerometer (illustrated) is disposed in, on, or near a respective one or more electrode patches 28. In fact, as is the case with the path of ablation energy through the body typically delivered between the ablation electrode 19 and an electrode patch such as 28a used in certain tissue ablations, it is generally expected that nerves near the electrode patch will be stimulated and thereby affect muscle spasms in the vicinity of the participating electrode patch such as 28a. Thus, in some embodiments, one or more accelerometers 50 include at least one accelerometer 50 disposed near one (or more) of the electrode patches 28. For example, in some embodiments, at least one electrode patch such as 28a of the electrode patches 28 used in ablation may include a respective motion sensor adapted to sense movement (e.g., movement / acceleration) of the patient's tissue / skin near the patch.

[0026] In Figure 2A and Figure 2B FIGS. illustrate embodiments of electrode patches 28 configured and operative in accordance with embodiments of the present invention and including motion sensors or being couplable to motion sensors. Figure 2A Front and rear views of the electrode patch 28 are illustrated, and Figure 2B FIG. is a perspective view of the electrode patch 28 including a disposable part 28.1 and a reusable part 28.2, respectively. As illustrated in these figures, the electrode patch 28 adapted to incorporate a motion sensor 50 includes:

[0027] - An electrode 29 (also referred to herein as a return electrode), which is associated with an ablation signal line / cable 32 that is connected or connectable via an optional connector 52 to supply 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) to avoid tissue ablation in its vicinity.

[0028] - An adhesion patch (skin patch) 54 adapted to adhere to the skin / tissue of the subject to facilitate electrical coupling of the return electrode 29 to the skin / tissue; and

[0029] - 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., an inertial measurement unit (IMU); and / or an accelerometer and / or one or more gyroscopes) and / or a position sensor, with a sufficient measurement frequency (temporal resolution)

[0030]

[0031] ​For example, it operates at about 10 KHz or above, such as 32 KHz, for easier detection of spasms. In some embodiments, the motion sensor 50 is associated with or includes an optional wired signal cable 51, which is adapted to transmit the measured motion signal measured by the sensor 50 to the system 10 and optionally provide a power supply to the sensor 50. Alternatively, in some embodiments, the motion sensor 50 is configured as a wireless sensor (e.g., battery-operated) and includes an optional wireless communication means 53, such as a WIFI or Bluetooth network adapter, which is capable of making a wireless data / signal connection with the system 10 and is adapted to transmit the motion signal measured by the sensor 50 to the system 10.

[0032] It should be noted that Figure 2A the electrode patch 28 shown as a whole can be a disposable or non-disposable patch, or a partially disposable patch including disposable parts and non-disposable / reusable parts. Figure 2B An example of the electrode patch 28 including a disposable part 28.1 and a reusable part 28.2 is illustrated. The disposable part 28.1 and the reusable part 28.2 can be mechanically connected / attached to each other via an attachment element / component 55. The attachment element / component 55 can include, for example: a pocket element (e.g., a pocket in the disposable part 28.1 that can accommodate / hold the reusable part 28.2); and / or two-part snap or Velcro components respectively arranged in the disposable part 28.1 and the reusable part 28.2, and / or any other attachment mechanism suitable for mechanically attaching the disposable part 28.1 and the reusable part 28.2 to each other. In Figure 2B a specific non-limiting example, the disposable part 28.1 includes a return electrode 29 and an adhesion patch (skin patch) 54 that contact the subject's skin / tissue, and optionally the attachment element / component 55 or a part thereof; the reusable part 28.2 generally includes relatively expensive electronic components (e.g., which generally do not contact the subject), and in this example, the relatively expensive electronic components include a motion sensor 50 (e.g., together with its associated wired or wireless communication means 51 / 53), and optionally the attachment element / component 55 or a part thereof (not specifically shown from the angle shown in the figure on the reusable part 28.2).

[0033] Returning to Figure 1 it should be understood that as Figure 2A and Figure 2BAs shown, the use of the electrode patch 28 in combination with the motion sensor 50 is optional, and in various embodiments, one or more or all of the motion sensors 50 combined with the system 10 may or may not be incorporated within the respective electrode patch 28 and may be arranged, for example, at spaced-apart locations on the subject's skin / tissue separate from the electrode patch 28.

[0034] The system 10 is adapted to monitor motion signals obtained from the motion sensor 50 during or after providing an ablation PFA pulse or a pacing signal between the ablation electrode 19 and one or more (optionally) participating patches of the patch 28, such as 28a, and to process these motion signals to determine whether spasms, such as skeletal muscle spasms, are affected by the delivery of the PFA pulse or pacing signal between the participating patch, such as 28a, and the ablation electrode 19.

[0035] The system 10 includes a console 18 that includes one or more units facilitating the performance of the techniques described herein. The ablation electrode 19 of the catheter 12 and the return electrode 29 of the 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 wirelessly or by a wired connection ( Figure 1 not specifically shown therein) for providing data indicative of the motion sensed thereby to the console 18. Additionally, a position sensor ( Figure 3A 43 in ) may also be connected to the console 18 (such as via the cable 32) to provide position data / signals indicative of the real-time position of the distal end 13 of the catheter (and specifically its ablation electrode 19) thereto.

[0036] The console 18 includes a PFA energy generator 22 configured to generate electrical PFA pulses that will pass between the ablation electrode 19 of the catheter 12 and at least one return electrode 29 of the electrode patch 28 through the subject's tissue during ablation, thereby affecting the ablation of the tissue located near the ablation electrode 19. Optionally, likewise, the PFA energy generator 22 is also adapted to generate a pacing current / signal that can be directed to pass in a manner similar to the electrical PFA pulses but without affecting ablation.

[0037] Additionally, the console 18 typically also includes / implements a position tracking system 21 that processes position data / signals obtained from the position sensor to determine their position relative to / within the patient's body, the position sensor being provided on a medical device connected to the system 10. Specifically, as indicated above, the ablation catheter 12 typically includes such a position sensor ( Figure 1 not specifically shown therein;Figure 3A in 43), and the position tracking system 21 operates to determine the positioning of the ablation catheter, and specifically the positioning of the ablation electrode 19 of the ablation catheter relative to the patient's body (e.g., its specific positioning in / on the patient's heart), and provides an indication of the positioning of the ablation catheter to the doctor 16 applying the ablation treatment.

[0038] According to an embodiment of the present invention, the console 18 generally includes an ablation control system 100 that is connected to the ablation energy generator 22 and is adapted to monitor spasms that occur during PFA ablation treatment, specifically during monopolar ablation or during the delivery of pacing signals prior to actual ablation. The system 100 is adapted to process motion signals / data received from the motion sensors 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 sensors 50 in response to the delivery of PFA / pacing signals via the activation of each specific electrode patch (e.g., 28a, 28b) indicates muscle spasms (the term activation is used herein to indicate the connection of the electrode patch to the second magnetic pole of the ablation energy generator 22). Thus, the system 100 can determine the activation of each specific patch (e.g., 28a, 28b) / associate the activation of each specific patch with affected or unaffected spasms near each of the motion sensors 50. Based on the association between the activation of one or more of the 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 of the electrode patches 28 to be activated during ablation (e.g., during the ablation of a specific target tissue or during the entire procedure) in a manner that avoids / reduces the spasm effect.

[0039] In fact, in some embodiments / specific implementations of the present invention, one or more of the motion sensors 50 may be mounted on or near corresponding specific ones of the electrode patches 28. In this case, the motion sensor 50 mounted on / near a specific electrode path 28 is referred to herein as being associated with this patch 50. The underlying rationale for this arrangement is that the path of the energy flow through the body between the ablation electrode 19 serving as the first magnetic pole and the activated electrode patch such as 28a serving as the second magnetic pole is expected to generally be concentrated near the electrode patch 28a, and thus spasms (if they occur) may occur in the area near the electrode patch 28a. Therefore, mounting at least one or all of the motion sensors 50 on the corresponding patches 28 enables the monitoring of the occurrence of spasms near those patches and the application of an appropriate selection of the electrode patches to be activated in order to reduce or avoid spasms near the activated patches. Additionally, mounting one or more motion sensors on the electrode patches can reduce the time and complexity of preparing for the ablation procedure.

[0040] Alternatively or additionally, in some embodiments / implementations of the present invention, one or more of the motion sensors 50 may be disposed at or near a region of interest (ROI) on the patient's body (skin / tissue), where spasm may be affected by ablation due to the stimulation of nearby nerves (not necessarily in the region proximal to the electrode positioning of the patch 28, as the latter should generally preferably be away from the nerve positioning that can be stimulated by the PFA ablation pulse). This enables the monitoring of the occurrence of spasm at those ROIs and the application of an appropriate selection of the electrode patches to be activated in order to reduce or avoid spasm at those ROIs.

[0041] To this end, the ablation control system 100 may be adapted to monitor the motion signals obtained from the motion sensors 50 after delivering a pacing signal or a PFA signal via activating one or more of the electrode patches 28 acting as the second magnetic pole, and activate to identify the occurrence of muscle spasm near the sensors 50 associated with the activated electrode patches 28. This monitoring (e.g., may be performed one or more times using different activated electrode patches 28 or different patch combinations during the preparation / preliminary phase of the procedure or during the actual ablation treatment) is used to facilitate the selection of the electrode patches (e.g., 28b) or optionally a combination of the electrode patches 28 to be activated for use as the second magnetic pole for ablation, such that nerve stimulation and / or the associated spasm are avoided / reduced, or at least limited to regions where their possible impact is less damaging or uncomfortable (e.g., away from the ROIs where spasm should be avoided).

[0042] In various implementations, the selection of the electrode patches 28 to be operated as the second magnetic pole for ablation may be performed automatically or manually by the ablation system 100, whereby the ablation control system 100 provides an indication of the occurrence of spasm to the doctor 16 and, in response, obtains an operation instruction indicating the electrode patches 28 to be selected for activation.

[0043] To this end, in some embodiments, generally, the system 10 further includes a user interface (UI) 34, which generally includes a display and user input devices (e.g., a joystick, a mouse, a keyboard, and / or other devices), and is adapted to facilitate the execution of the ablation procedure / treatment by displaying relevant information to the doctor 16 and receiving corresponding instructions / inputs from him for implementing the ablation procedure.

[0044] For example, the ablation system 100 may cause the UI 34 to display to the doctor 16 an indication of the patch electrodes 28 whose activation as a second ablation magnetic pole may or may not affect spasm, and the ablation system operates to receive, in response, data indicating the selected patch electrodes 28 to be activated as a second ablation magnetic pole from the UI 34. Additionally, the system 10 (e.g., its position tracking system 21) may be adapted to cause the UI 34 to display the positioning / position of the catheter, for example, by superimposing an icon representing the distal end 13 of the catheter 12 or its ablation electrode 19 over an image of the subject's anatomy (the heart in this particular example).

[0045] Generally, the system 10 includes one or more processors 20 through which certain functions of the system and / or its subsystems 100, 21, and 22 are implemented. Generally speaking, the processor 20 may be embodied as a single processor or as a group of cooperative, networked, or clustered processors. In some embodiments, the processor 20 is implemented only in hardware, for example, using one or more application-specific integrated circuits (ASICs) or field-programmable gate arrays (FPGAs), analog and / or digital signal processing circuitry, etc. In other embodiments, the processor is implemented at least partially in software. For example, the processor 20 may be implemented using a programmed digital computing device that includes a central processing unit (CPU), random access memory (RAM), non-volatile auxiliary storage (such as a hard disk drive or a CD ROM drive), a network interface, and / or peripherals. As is well known in the art, program code and / or data including software programs are loaded into the RAM for execution and processing by the CPU, and results are generated for display, output, transmission, or storage. For example, the program code and / or data may be downloaded electronically to a computer over a network, or alternatively or in addition thereto, it may be provided and / or stored on a non-transitory tangible medium (such as magnetic memory, optical memory, or electronic memory). Such program code and / or data, when provided to the processor, produce a machine or a special-purpose computer configured to perform the tasks described herein.

[0046] Now referring together to Figure 3A and Figure 3B , more particularly, an ablation control system 100 and a method 200 according to some embodiments of the present invention are schematically illustrated in greater detail. The system 100 and the method 200 are adapted to monitor the occurrence of spasms during or in preparation for monopolar PFA ablation therapy (where pacing signals may be delivered) and facilitate the automatic or manual selection of electrode patches 28 to avoid / reduce spasm effects or nerve stimulation effects that cause spasm. More specifically, Figure 3A is a block diagram illustrating an example configuration of an ablation control system 100 for controlling monopolar pulsed field ablation (PFA); and Figure 3BFIG. 0 is a flow chart illustrating method 200 for unipolar PFA, which may be implemented, for example, by system 100.

[0047] As shown, system 100 is connected to or capable of being connected to ablation catheter 12, which has at least one ablation electrode 19 at its distal end 13. System 100 is also connected to or capable of being connected to a plurality of electrode patches 28 (at least two: 28a and 28b and optionally additional electrode patches, such as 28n), where each electrode patch includes at least one return electrode 29 adapted for use in unipolar PFA ablation.

[0048] The system is also connected to or capable of being connected to one or more motion sensors 50 (50a to 50m illustrated in the figure). For example, as Figure 3A shown, 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., arranged / included on or near the respective electrode patches of electrode patches 28, such as on patches 28a, 28b, and / or 28n shown in the figure). Alternatively or additionally, as also indicated above, motion sensors 50 may optionally include motion sensors such as 50m associated with certain regions of interest (ROIs) of the patient's body, i.e., arranged near / on these ROIs, which may be key locations where spasms or other nerve stimulation effects should preferably be monitored. For example, ROIs where motion sensors may be placed may include regions / skin areas near the patient's diaphragm to monitor diaphragm spasms associated with phrenic nerve stimulation, and / or regions / skin areas on or otherwise near the patient's chest near their heart in order to monitor changes in the heartbeat that may be associated with stimulation of the vagus nerve.

[0049] In addition, system 100 may also be connected to additional sensor 60, such as an ECG sensor / electrode, through which certain nerve stimulation effects due to the ablation treatment, such as changes in the electrical activation of the heart due to vagus nerve stimulation, may be identified.

[0050] The system includes ablation energy generator 22, specifically a pulsed field ablation (PFA) energy generator, which has a first electromagnetic pole and a second electromagnetic pole, and ablation energy generator 22 is configured and operable to deliver one or more PFA pulses or pacing signals via the first electromagnetic pole and the second electromagnetic pole. Generally, at least the first electromagnetic pole is electrically connected to ablation electrode 19 of catheter 12 so as to enable ablation of tissue proximal thereto. For a unipolar ablation protocol, the second electromagnetic pole of ablation energy generator 22 should be electrically connected to at least one of electrode patches 28.

[0051] System 100 also includes a patch switch / selector 120 that is connected / can be connected between a second electromagnetic pole of the PFA energy generator 22 and one or more of the electrode patches 28. Specifically, the patch switch / selector 120 is adapted to selectively connect to the return electrode 29 of a plurality of electrode patches 28 and is operable to selectively deliver a PFA pulse or a pacing signal generated by the PFA energy generator 22 from at least one of the second magnetic pole of the PFA energy generator 22 and the return electrode of the selected one or more of the electrode patches 28. To this end, the patch switch / selector 120 may include or be implemented, for example, by an electronic signal distribution circuit 122, which optionally includes one or more switches 124 and / or optionally one or more current / voltage controllers 126, and the delivery of the PFA pulse or the pacing signal to the electrode patch 28 can be controlled by the one or more current / voltage controllers.

[0052] The processor 20 includes / implements a spasm / motion processing capability 110 (hereinafter referred to as a spasm / motion processor without loss of generality), which is directly or indirectly, wirelessly or through a wired connection, connected to one or more motion sensors 50. The spasm / motion processor 110 is adapted to monitor the motions indicated by the signals obtained from the motion sensors 50 connected thereto and to identify spasm-related motion patterns in its vicinity. In addition, it should be noted that in some embodiments, the spasm / motion processor 110 may also be adapted to connect to an additional sensor 60 (such as an ECG sensor / electrode) for sensing other specific nerve stimulation effects (such as changes in cardiac activation due to stimulation of the vagus nerve) that may occur during the ablation treatment.

[0053] Specifically, for example, after delivering one or more PFA pulses or pacing signals to one or more of the electrode patches 28, the spasm / motion processor 110 obtains and processes the signals received from one or more of the motion sensors 50 to determine whether the motions sensed thereby exhibit spasm-related motion patterns. The spasm / motion processor 110 does not have to monitor all motion sensors at each activation of the PFA pulse or pacing signal and may, for example, only monitor the motion sensors associated with the active electrode patches (if any, which serve as the second magnetic pole during activation), and / or the motion sensors associated with certain ROIs indicated as above.

[0054] In some embodiments, system 100 may be adapted to perform a pre-patch ablation screening protocol (also referred to herein as a patch spasm test) to determine the association between the activation of certain electrode patches 28 or combinations of patches and the spasms affected by such activation at different body locations where the motion sensors are placed, and / or the association with other effects indicative of nerve stimulation that may be caused during PFA treatment. Such pre-ablation screening protocols may be performed, for example, during a preparatory phase or during PFA treatment, and may include one or more cycles, each cycle including: delivering a PFA pulse or a pacing signal, where different electrode patches or combinations of patches 28 are activated under different cycles; and monitoring, during each cycle, the spasm-related motion patterns sensed by the motion sensor 50, or other spasm effects sensed, for example, by other sensors 60. Thus, the association between the activation of certain electrode patches 28 and the stimulation of certain nerves can be determined, facilitating an informed selection of certain electrode patches among the electrode patches 28 to be further used during ablation treatment to avoid / reduce excessive nerve stimulation and / or other effects such as spasms manifested by such stimulation.

[0055] Optionally, in some embodiments of the present invention, based on the monitoring pointed out above and / or based on the pre-ablation screening protocol, the spasm motion processor 110 may automatically select one or more electrode patches 28 to be used as the second magnetic pole for the entire monopolar PFA treatment and / or for certain activations of the PFA pulses during PFA treatment. Thus, the spasm motion processor 110 operates the patch selector / switch to electrically connect the second magnetic pole of the ablation energy generator 22 to the return electrode 29 of the selected electrode patch, such that the PFA pulses or pacing signals further generated by the generator 22 will be delivered to the patient's body via the selected electrode patch - the selected electrode patch thus serving as the active patch through which the PFA pulses or pacing signals are delivered.

[0056] Alternatively or additionally, in some embodiments, system 100 includes or is associated with a user interface 34. The spasm movement processor 110 may be configured and operative to issue an indication regarding an identified spasm-related movement pattern to the doctor 16 when a spasm-related movement is detected by the monitoring indicated above, which may be implemented throughout the ablation treatment or at a selected time thereof. Yet alternatively or additionally, the spasm movement processor 110 may be configured for and operative to implement, for example, automatically and / or in response to a user instruction (e.g., from doctor 16), the pre-patch ablation screening protocol described above, 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 determined by the pre-ablation screening protocol and a particular nerve stimulation. An indication regarding the identified spasm-related movement pattern and / or regarding the association between the patch or combination of patches activated with the identified spasm-related movement pattern may be issued to doctor 16, for example, via 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 instruction SEL for a desired patch selection (e.g., a particular one or more selected electrode patches preferred by doctor 16 to be used as the active patch (i.e., as the second magnetic pole) during monopolar ablation treatment or for a particular PFA pulse activation (e.g., for ablation of a particular area)).

[0057] In this regard, it should be noted that in some embodiments of the present invention, the motion sensors 50 or any one or more of them may also include or be implemented by a position sensor that can be tracked by a position tracking system 21, which may be included in Figure 1 the system 100 and / or system 10 shown and registered to the patient's body (e.g., based on Figure 1 the registration of the positioning pad 42 shown with the body). In such embodiments, an indication regarding the identified spasm-related movement pattern sensed by any of the motion sensors 50 and / or regarding the association between the activated patch and the stimulated nerve may be presented on top of an anatomical diagram (e.g., ROI) of the illustrated organ or nerve (e.g., presented to doctor 16) in the display of the UI 34, near which the spasm-related movement pattern is sensed by one or more of these sensors.

[0058] Thus, in various embodiments, system 100 automatically and / or based on a user's instructions (i.e., manually) determines one or more selected electrode patches SEL and is operable to deliver additional PFA pulses or pacing signals via the return electrode of the one or more selected electrode patches in order to avoid or reduce spasms, such spasms as skeletal muscle spasms near the electrode patch used in monopolar ablation, and / or to avoid or reduce spasms and / or other unwanted nerve stimulation effects at other ROIs during PFA treatment.

[0059] The operation of system 100 is illustrated in more detail below with reference to method 200 for monopolar PFA implemented by system 100 according to some embodiments of the present invention. Figure 3B In operations 210 to 230, an ablation catheter 12 having at least one ablation electrode 19 serving as a first magnetic pole for monopolar PFA and a plurality (at least two) of electrode patches 28 having a return electrode 29 adapted to serve as one or more second magnetic poles for monopolar PFA are provided, as well as one or more motion sensors 50 at various ROIs of the patient's body or attached to one or more of the electrode patches 28.

[0060] Optionally, in some embodiments, the association between the motion sensor 50 and its associated electrode patch 28 and / or associated ROI may be registered with the FPA system 100 (e.g., by the motion / spasm processor 110). In various embodiments, such registration may be performed manually (by the operator / user of the system) or, for example, automatically based on a registration signal transmitted from the corresponding patch or its associated motion sensor once the coupling between the corresponding patch and the motion sensor can be detected, for example, by a coupling detector (which may be included on either the electrode patch or the motion sensor - not specifically shown), and / or based on a position sensor 43 communicating with a position tracking system 21 (e.g., by which the motion sensor may be implemented or which may be included together with the motion sensor).

[0061] In some specific implementations, not all electrode patches 28 are permanently equipped with or include a motion sensor 50 coupled thereto. For example, one motion sensor 50 may be set or moved between different electrode patches 28 during PFA treatment, for example, according to the preference of the doctor 16, to monitor the occurrence of spasms near the electrode patch (e.g., 28a) currently selected / activated as the second magnetic pole for PFA treatment. Thus, in such specific implementations, system 100 may facilitate the dynamic registration of the motion sensor 50 with its associated electrode patch (e.g., 28a) or the ROI where the electrode patch resides during operation.

[0062] Thus, once the electrode patch 28 is disposed at one or more locations, such as on patient tissue / skin, and the catheter 12 having the ablation electrode 19 at its distal end is brought / navigated to a suitable tissue location where ablation may be desired (e.g., a specific location in a patient's heart), operations 260 to 280, as described in more detail below, may be implemented to determine a selected one or more of the electrode patches in the electrode patch 28 that, when activated as the second magnetic pole during PFA ablation, prevent or reduce excessive nerve stimulation or its effects (e.g., spasms).

[0063] In this regard, optionally, in some embodiments, the pre-ablation screening operation 240 may be automatically implemented by the system 100 and / or implemented in response to an instruction INS (e.g., from the doctor 16 via the UI 34). In the pre-ablation screening operation, operations 250 and 260, described below, may be repeated one or more times / one or more cycles for: delivering pacing signals and / or PFA pulses (e.g., similar to those described below with reference to operation 250), where different electrode patches or combinations of electrode patches 28 are activated as the second magnetic pole under each cycle, while monitoring (e.g., in a manner similar to that described below with reference to operation 260) other effects caused by spasms or excessive nerve stimulation associated with the activated patch electrodes. Thus, the association between the activation of a particular selection of the patch electrodes 28 and the spasms / nerve stimulation affected by such selection is determined. This association may then be used to automatically and / or manually select one or more of the selected patches to be activated during the ablation treatment or during the ablation of a particular tissue in a manner similar to that described below with reference to operation 270.

[0064] Alternatively, the pre-ablation screening operation 240 itself may not be implemented or skipped. In response to an instruction INS from the doctor / operator 16 (e.g., via the UI 34), the system 100 may be operable to deliver a pacing signal and / or a PFA pulse between the ablation electrode 19 and the return electrode 29 of a particular at least one selected patch (e.g., 28a), and method operations 250 to 260 may be performed 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 (which serves as the first magnetic pole of the unipolar PFA) and the return electrode 29 of one or more selected electrode patches such as 28a (which serves as the second magnetic pole of the unipolar PFA). During and / or after the delivery of the PFA pulse or pacing signal, operation 260 is performed to monitor the movement sensed by the motion sensors 50 (e.g., at least monitor those motion sensors 50 associated with the selected / activated electrode patch and the motion sensors 50 placed at a particular ROI of the subject / patient and / or other optional sensors 60). The signals / data obtained from these motion sensors are processed (e.g., by the motion / spasm processor 110) to identify spasm-related motion patterns near one or more electrode patches and / or the ROI. Additionally, the signals / data obtained from other optional sensors 60 (such as the ECG sensor indicated above) may also be processed to identify other possible over-neural stimulation effects.

[0065] As indicated above, each motion sensor may be implemented by a position sensor and / or an inertial measurement unit (such as an accelerometer, and / or optionally also including a gyroscope), or include a position sensor and / or an inertial measurement unit. The motion sensor 50 may be adapted to (e.g., based on the inertial measurements performed by its IMU / accelerometer) wirelessly or through a wired connection provide the system 100 with a signal indicating a change in the velocity or acceleration of the patient tissue near its associated electrode patch 28 and / or the ROI. In any case, as will be recognized by those skilled in the art, a change in either the position of the tissue at the ROI where the motion sensor is placed or the patch associated therewith, or the acceleration velocity, can be derived from the signal obtained from the corresponding motion sensor in any of its specific implementations pointed out above.

[0066] Accordingly, monitoring the motion sensed by the motion sensors typically involves processing / filtering the signals obtained from the respective motion sensors 50 to identify spasm-related motion patterns in the signals. Such processing may involve, for example, applying a signal filter to the signals from the respective motion sensors and / or applying spectral analysis such as Fourier transform (FFT) thereto to identify the frequency components in the signals associated with spasms. For example, the spasm-related motion patterns are associated with a change in at least one of the position, velocity, and acceleration of the tissue near the electrode patch, and the processing / filtering may include spectral analysis of the signals of each motion sensor to determine whether the amplitude of the frequency components of these signals in this frequency range exceeds a specific threshold, which specific threshold indicates a spasm-related motion pattern near each specific motion sensor 50 being monitored. In this regard, those of ordinary skill in the art will readily understand the characteristics (their characteristic frequencies and amplitudes) of the various spasm-related motion patterns that can be recognized by the system, and will readily understand how to implement such processing to identify these patterns after understanding the present invention.

[0067] Accordingly, based on the monitoring operation 260, once the processing of the motion sensed by the motion sensor associated with a particular electrode patch such as 28a reveals a spasm-related motion pattern occurring there, an indication of the spasm-related motion pattern can be provided to the doctor 16 (e.g., via the UI 34), or the system 100 can automatically switch to another electrode patch such as 28b for use as the second magnetic pole for monopolar PFA.

[0068] Alternatively or additionally, as described above, in some embodiments, the monitoring operation 260 can be performed during the pre-ablation screening phase 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 each of one or more of the electrode patches 28 without or with reduced nerve stimulation effects such as spasms. In such embodiments, the operation 260 for monitoring the occurrence of spasms can be performed concurrently / synchronously with the varying intensity of the pacing signal / PFA pulse, thereby revealing the intensity (if any) at which spasm-related motion patterns begin to appear near the respective motion sensors 50. This can be performed, for example, by individually activating each of the electrode patches 28 connected to the system 100 or to some of these motion sensors and the maximum / effective intensity that does not cause spasms can be recorded by the system 100 (e.g., by the motion / spasm processor 110) and / or presented (e.g., via the UI 34) to the doctor 16 to assist in the proper 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 be used / activated as the second magnetic pole for monopolar PFA ablation therapy.

[0069] 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 be used / activated as one or more second magnetic poles of a monopolar PFA. Generally, during PFA treatment, operation 270 may be performed after the occurrence of a spasm-related movement pattern is identified by monitoring 260. Alternatively or additionally, operation 270 may be performed after the pre-ablation screening 240 of the PFA treatment, during which the level of signals / pulses that can be delivered through each patch without affecting the spasm may be evaluated.

[0070] As indicated above, in some embodiments, operation 270 may operate in a "manual mode", in which case, for example, the occurrence of a spasm-related movement SPSM or the conditions for affecting the spasm or other adverse nerve stimulation effects by activating one or more of the electrode patches are presented / indicated via the UI 34, in order to alert the doctor 16 about the occurrence of a spasm or other adverse effects, or to inform him about the available options for patch selection and / or the PFA signal / pulse intensity that is expected to affect / not affect the spasm. In such a "manual mode" in response to such an indication SPSM of the occurrence / conditions of a spasm by activating any one or more of the patches, the system 100 may receive input data / instructions INS, which may indicate that one or more of the selected electrode patches 28 are to be used / activated as second magnetic poles for monopolar ablation, either individually or jointly. Optionally, the input data / instructions INS may also indicate the intensity / level or relative portion of the PFA pulses to be transmitted through each of the selected / activated electrode patches (e.g., in the case where more than one patch is selected).

[0071] Alternatively or additionally, also as pointed out above, in some embodiments, the system 100 may operate in an "automatic mode", in which case, after the occurrence of a spasm-related movement detected by monitoring 260 and / or based on the conditions determined by the pre-ablation screening operation 240 for affecting the spasm, the system 100 (e.g., the movement / spasm processor 110) automatically selects at least one or a combination of the electrode patches 28 that will be further used as second magnetic poles during the PFA treatment, and the system optionally also selects the ratio / level / intensity of the PFA pulses to be delivered through each of the selected patches. Generally, in such a case, the system performs such a selection based on the information obtained through monitoring 250, with the aim of avoiding the occurrence of a spasm or other adverse nerve stimulation effects near the selected patches or the ROI equipped with movement sensors, and / or reducing the duration and / or intensity of the spasm or other adverse effects.

[0072] For example, in some embodiments, the system 100 may set only one or more patches as the selected patches 28 for which spasm / adverse effects are not detected by the motion sensor 50 and / or by the optional sensor 60 and / or are detected at the lowest spasm amplitude / intensity. Alternatively or additionally, based on the monitoring, the system may balance the intensity of the PFA signals through each selected patch to minimize adverse nerve stimulation effects / spasms. In this regard, after understanding the present invention, those of ordinary skill in the art will readily understand the various optimization methods and / or algorithms that may be implemented by the system 100 for selecting electrode patches to be used individually or jointly as the second PFA magnetic pole, and in the latter case, optionally optimizing the PFA pulse levels / intensities to be delivered via each selected electrode patch, as described above for example.

[0073] Then, in operation 280, the system 100 operates to deliver PFA pulses between the ablation electrode 19 of the catheter 12 and the selected one or more electrode patches (e.g., 28a). To achieve this, the patch selector / switch 120 may be operated by the processor 20 to activate the selected patches (e.g., electrically connect them to the second magnetic pole of the ablation energy generator 22 and substantially disconnect the other electrode patches therefrom. This may be performed by controllably operating one or more switches 124 and / or current / voltage controllers 126 to effect such connections / disconnections. Additionally, optionally, the patch selector / switch 120 (e.g., its current / voltage controller 126) may be operated by the processor 20 to adjust the level / portion of the PFA signal to be delivered via each of the selected electrode patches according to the maximum / effective level / intensity of the PFA signal optionally determined in operation 260.

[0074] Embodiment

[0075] Example 1. A method 200 for monopolar pulsed field ablation (PFA), the method comprising:

[0076] Providing a PFA system, the PFA system comprising: at least one catheter having at least one electrode that serves as a first magnetic pole for the monopolar PFA and is disposed at a distal end of the catheter to facilitate tissue ablation near the distal end; and a plurality of at least two electrode patches for coupling at a plurality of locations on the skin of a subject, wherein each electrode patch includes at least one return electrode adapted to serve as a second magnetic pole for the monopolar PFA;

[0077] Providing at least one motion sensor configured to be coupled to or disposed near at least one region of a body of the subject, respectively; and

[0078] Delivering one or more PFA pulses or pacing signals between at least one ablation electrode of the catheter serving as the first magnetic pole of the monopolar PFA and a return electrode of one or more of the plurality of electrode patches, the one or more electrode patches being configured to serve as one or more second magnetic poles of the monopolar PFA during delivery of the one or more PFA pulses or pacing signals;

[0079] Monitoring motion indicated by a signal from the motion sensor after the delivery of the one or more PFA pulses or pacing signals to identify a spasm-related motion pattern near the at least one motion sensor; and

[0080] Based on the monitoring, selecting a particular one or more of the plurality of electrode patches that will further serve as the one or more second magnetic poles of the monopolar PFA and delivering additional one or more PFA pulses or pacing signals via the return electrode of the selected particular one or more electrode patches.

[0081] Example 2. The method according to Example 1, wherein the at least one motion sensor includes a position sensor adapted to provide signals indicative of a change in position of tissue near the at least one motion sensor, respectively.

[0082] Example 3. The method according to Example 1 or 2, wherein the at least one motion sensor includes an inertial measurement unit (IMU) adapted to provide the signals indicative of a change in velocity or acceleration of tissue near the at least one motion sensor, respectively, based on inertial measurements performed by the IMU.

[0083] Example 4. The method according to any one of Examples 1 to 3, wherein the inertial measurement unit (IMU) includes at least one accelerometer.

[0084] Example 5. The method according to any one of Examples 1 to 4, wherein the at least one motion sensor is a wireless motion sensor including a wireless communication means capable of wirelessly transmitting the signals to the PFA system.

[0085] Example 6. The method according to any one of Examples 1 to 5, wherein the spasm-related movement pattern is associated with a change in at least one of the position, velocity, and acceleration of the tissue near the at least one motion sensor when the frequency is within a specific frequency range, and wherein the monitoring of the movement includes processing the signals obtained from the motion sensor to determine whether the amplitude of the frequency components of the signals within the frequency range exceeds a specific threshold.

[0086] Example 7. The method according to Example 6, wherein the processing includes at least one of spectral analysis and filtering to identify the frequency components within the frequency range.

[0087] Example 8. The method according to any one of Examples 1 to 7, wherein the selection of the one or more electrode patches based on the monitoring includes performing the following steps when the spasm-related movement pattern is identified by the monitoring:

[0088] - Issuing an indication of the identified spasm-related movement pattern in association with one or more electrode patches, in response to activation of the one or more electrode patches as the one or more second magnetic poles, the spasm-related movement pattern being identified; and

[0089] - Obtaining a user instruction for selecting the specific one or more electrode patches in response to the indication;

[0090] Thereby delivering the one or more PFA pulses or pacing signals via the return electrodes of the selected one or more electrode patches according to the user instruction.

[0091] Example 9. The method according to any one of Examples 1 to 8, wherein the selection of the one or more electrode patches is automatically performed based on the monitoring of the spasm-related movement pattern sensed by the at least one motion sensor.

[0092] Example 10. The method according to any one of Examples 1 to 9, wherein the providing of the at least one motion sensor includes at least one of the following:

[0093] - Providing at least one motion sensor at or near at least one corresponding electrode patch among the plurality of electrode patches; and

[0094] - Providing at least one motion sensor at 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 pulses or pacing signals.

[0095] Example 11. The method according to any one of Examples 1 to 10, wherein such selection of the one or more electrode patches based on the monitoring may include selection of more than one electrode patch to be used as the second magnetic pole.

[0096] Example 12. The method according to Example 11, wherein in the case where more than one electrode patch is selected, the delivery of the PFA pulse or pacing signal includes adjusting, based on the monitoring, the relative portion / intensity (e.g., voltage / current) of the PFA pulse or pacing signal delivered through each of the selected electrode patches, so as to avoid or reduce spasms or other adverse nerve stimulation effects near the selected electrode patches.

[0097] 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 adapted to attach one of the motion sensors thereto.

[0098] Example 14. The method according to any one of Examples 1 to 13, wherein the PFA system is configured and operable to effect PFA treatment by delivering, between the at least one electrode of the catheter and at least one selected electrode patch of the plurality of electrode patches, a PFA pulse as a high voltage direct current electrical signal.

[0099] Example 15. A system for monopolar pulsed field ablation (PFA),

[0100] The system is connectable to: an ablation catheter having at least one ablation electrode at its distal end; a plurality of at least two electrode patches, each of the plurality of at least two electrode patches including at least one return electrode adapted to be used in monopolar ablation; and at least one motion sensor for being coupled or coupled in the vicinity of at least one region of a subject's body, respectively;

[0101] The system includes a PFA energy generator adapted to deliver one or more PFA pulses or pacing signals between a first electromagnetic pole and a second electromagnetic pole; wherein at least the first electromagnetic pole is capable of being directly or indirectly electrically connected to the ablation electrode of the catheter serving as the first electromagnetic pole of the monopolar PFA, so as to enable ablation of tissue proximal to the ablation electrode; and

[0102] wherein the system includes:

[0103] A signal switch, which is connected to the PFA energy generator, adapted for direct or indirect electrical connection with the return electrodes of the plurality of electrode patches and operable to selectively deliver the PFA pulses or pacing signals between the return electrodes of one or more selected electrode patches among the plurality of electrode patches, and the one or more selected electrode patches are configured to serve as one or more second magnetic poles of the monopolar PFA; and

[0104] At least one processor, which is adapted to: monitor the movement indicated by the signal from the at least one motion sensor after the delivery of the one or more PFA pulses or pacing signals to identify a spasm-related movement pattern near the at least one motion sensor; based on the monitoring, select a specific one or more electrode patches among the plurality of electrode patches to further serve as the one or more second magnetic poles; and operate the signal switch to connect the PFA energy generator to the return electrodes 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.

[0105] Example 16. The system according to Example 15, wherein the at least one motion sensor includes at least one of a position sensor and an inertial measurement unit.

[0106] 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 means capable of wirelessly communicating with the motion sensor to obtain a signal indicating the motion sensed thereby.

[0107] Example 18. The system according to any one of Examples 15 to 17, wherein the spasm-related movement pattern is associated with a change in at least one of the position, velocity, and acceleration of the tissue near the at least one motion sensor when the frequency is within a specific frequency range, and wherein the monitoring includes processing the signal obtained from the at least one motion sensor to identify the frequency component of this motion within this specific frequency range, and the frequency component indicates the spasm-related movement pattern.

[0108] Example 19. The system according to any one of Examples 15 to 18, wherein the selection of the specific one or more electrode patches includes performing the following steps when the spasm-related movement pattern is identified by the monitoring:

[0109] - Operating the user interface to issue an indication of the identified spasm-related movement pattern;

[0110] And

[0111] - In response to the indication, obtain, via the user interface, an instruction for selection of the particular one or more electrode patches.

[0112] Thereby, deliver the one or more PFA pulses or pacing signals via the return electrode of the particular one or more selected electrode patches according to the instruction.

[0113] Example 20. The system according to any one of Examples 15 to 19, wherein the system is adapted to automatically perform the selection of the particular one or more electrode patches based on the monitoring of the spasm-related movement pattern sensed by the at least one motion sensor.

[0114] Example 21. The system according to any one of Examples 15 to 20, wherein the system is adapted to be connected to at least one motion sensor, and the at least one motion sensor includes at least one of the following:

[0115] - At least one motion sensor disposed at or near at least one corresponding electrode patch among the plurality of electrode patches;

[0116] - At least one motion sensor disposed at or near at least one region of interest of the body of the subject, where a spasm-related movement pattern can occur due to nerve stimulation affected by the delivery of the PFA pulse or pacing signal.

[0117] Example 22. The system according to any one of Examples 15 to 21, wherein the selection of the particular one or more electrode patches based on the monitoring can include the selection of more than one electrode patch to be used as the second magnetic pole.

[0118] Example 23. The system according to Example 22, wherein the signal switch is configured and operable to adjust the relative portions (voltage / current) of the PFA pulse or pacing signal delivered through each of the selected electrode patches; and in the case where more than one electrode patch is selected, the processor adjusts the relative portions based on the monitoring so as to avoid or reduce the spasm sensed by the motion sensor.

[0119] Example 24. The system according to any one of Examples 15 to 23, the system being adapted to connect to at least one additional sensor, the at least one additional sensor being capable of sensing additional nerve stimulation effects caused by the delivery of the PFA pulses or pacing signals; and 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 monitoring of the signals from the additional sensor.

[0120] Example 25. A PFA electrode patch for use as a second non-ablation magnetic pole in monopolar PFA treatment. The PFA electrode patch includes: a return electrode, which is a skin surface electrode adapted to be coupled to a patient's skin over a surface area that is substantially greater than the contact area of the 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 in a patient's muscle located near a skin area during monopolar PFA treatment, where the PFA electrode patch is attached at the skin area during the monopolar PFA treatment.

[0121] Example 26. The PFA electrode patch according to Example 25, wherein the PFA electrode patch includes the motion sensor integrally coupled thereto.

[0122] Example 26. The PFA electrode patch according to Example 25, wherein the PFA electrode patch is configured as a disposable patch, and wherein at least one of the following occurs:

[0123] - The PFA electrode patch includes the motion sensor as an integral part thereof;

[0124] - The PFA electrode patch serves as a disposable part of a PFA electrode patch assembly that includes a reusable part capable of being attached to the disposable part via the coupling member and includes the motion sensor on the reusable part.

[0125] It should be understood that the above examples are cited by way of illustration, and the present disclosure is not limited to what is specifically shown and described above. On the contrary, the scope of the present disclosure includes combinations and sub-combinations of the various features described above, as well as their variations and modifications, which will occur to those of ordinary skill in the art upon reading the description of the present invention and which are not disclosed in the prior art.

Claims

1. A method for unipolar pulsed field ablation (PFA), the method comprising: A PFA system is provided, the PFA system comprising: - at least one catheter having at least one electrode serving as a first magnetic pole of the monopolar PFA and disposed at a distal tip of the catheter to facilitate ablation of tissue near the distal tip; and - a plurality of at least two electrode patches for coupling at a plurality of locations on the skin of a subject, wherein each electrode patch comprises at least one return electrode adapted to serve as a second pole of the monopolar PFA; providing at least one motion sensor for coupling to or near at least one region of the subject's body, respectively; and delivering one or more PFA pulses or pacing signals between the at least one ablation electrode of the catheter that functions as the first magnetic pole of the unipolar PFA and a return electrode of one or more electrode patches of the plurality of electrode patches, the one or more electrode patches being configured to function as one or more second magnetic poles of the unipolar PFA during delivery of the one or more PFA pulses or pacing signals; monitoring movement indicated by signals from said motion sensors after said delivery of said one or more PFA pulses or pacing signals to identify a spasticity-related movement pattern in the vicinity of said at least one motion sensor; and Based on the monitoring, specific one or more electrode patches from the multiple electrode patches are selected to further serve as the one or more second magnetic poles of the unipolar PFA, and additional one or more PFA pulses or pacing signals are delivered via the return electrode of the selected specific one or more electrode patches.

2. The method according to claim 1, wherein: The at least one motion sensor comprises position sensors adapted to respectively provide signals indicative of a change in position of tissue proximate to the at least one motion sensor.

3. The method according to claim 1, wherein: At least one motion sensor comprises an Inertial Measurement Unit (IMU) adapted to provide said signal indicative of a change in velocity or acceleration, respectively, of tissue proximate to the at least one motion sensor based on inertial measurements performed by the IMU.

4. The method according to claim 3, wherein: The inertial measurement unit (IMU) includes at least one accelerometer.

5. The method according to claim 1, wherein: The at least one motion sensor is a wireless motion sensor comprising wireless communication means capable of wirelessly transmitting the signal to the PFA system.

6. The method according to claim 1, wherein: The spasm-related movement pattern is associated with a change in at least one of the position, velocity, and acceleration of the tissue near the at least one motion sensor when the frequency is within a specific frequency range, and wherein the monitoring of the movement includes processing the signal obtained from the motion sensor to determine whether the amplitude of the frequency component of the signal within the frequency range exceeds a specific threshold.

7. The method according to claim 6, wherein: The processing includes at least one of spectral analysis and filtering to identify that the frequency components are within the frequency range.

8. The method according to claim 1, wherein: The selecting of the one or more electrode patches based on the monitoring includes performing the following steps upon identifying the spasticity-related movement pattern through the monitoring: - issuing an indication in association with one or more electrode patches regarding an identified spasticity-related movement pattern, the spasticity-related movement pattern being identified in response to the one or more electrode patches being activated as the one or more second magnetic poles; as well as - in response to the indication, obtaining a user instruction for selecting the specific one or more electrode patches; The one or more PFA pulses or pacing signals are thereby delivered via the return electrode of the selected one or more electrode patches in accordance with the user instructions.

9. The method according to claim 1, wherein: The selecting of the one or more electrode patches is automatically performed based on the monitoring of the spasticity-related movement pattern sensed by the at least one motion sensor.

10. The method according to claim 1, wherein: The providing of the at least one motion sensor comprises at least one of: - provision of at least one motion sensor arranged at or near at least one respective electrode patch of the plurality of electrode patches; - Provision of at least one motion sensor arranged at or near at least one region of interest of the subject's body, where a spasticity-related movement pattern can occur due to neural stimulation affected by said delivery of said PFA pulses or pacing signals.

11. The method according to claim 1, wherein: The selecting of the one or more electrode patches based on the monitoring can include selecting more than one electrode patch to function as the second magnetic pole.

12. The method according to claim 11, wherein: Where more than one electrode patch is selected, the delivery of the PFA pulse or pacing signal includes adjusting the relative portion of the PFA pulse or pacing signal delivered through each of the selected electrode patches based on the monitoring so as to avoid or reduce spasm or other adverse effects of neural stimulation.

13. The method according to claim 1, wherein: At least one of the electrode patches comprises a coupling member adapted to attach one of the motion sensors thereto.

14. A system for unipolar pulsed field ablation (PFA), The system can be connected to: an ablation catheter having at least one ablation electrode at a distal end thereof; a plurality of at least two electrode patches, each of the plurality of at least two electrode patches comprising at least one return electrode adapted for use in monopolar ablation; as well as at least one motion sensor for coupling to or near at least one region of the subject's body, respectively; and The system comprises: A PFA energy generator adapted to deliver one or more PFA pulses or pacing signals between a first electromagnetic pole and a second electromagnetic pole; wherein at least the first electromagnetic pole is electrically connectable directly or indirectly to a unipolar the ablation electrode of the first magnetic pole of the PFA to enable ablation of tissue proximal to the ablation electrode; a signal switch connected to the PFA energy generator, adapted for direct or indirect electrical connection with return electrodes of the plurality of electrode patches and operable to selectively deliver the PFA pulse or pacing signal between return electrodes of one or more selected electrode patches of the plurality of electrode patches, the one or more selected electrode patches being configured to function as one or more second magnetic poles of the unipolar PFA; and At least one processor is adapted to: monitor movement indicated by a signal from the at least one motion sensor after delivery of the one or more PFA pulses or pacing signals to identify a spasm-related movement pattern near the at least one motion sensor; based on the monitoring, select a specific one or more electrode patches from the plurality of electrode patches to further serve as the one or more second magnetic 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.

15. The system of claim 14, wherein: The at least one motion sensor includes at least one of a position sensor and an inertial measurement unit.

16. The system of claim 14, wherein: The motion sensor is a wireless motion sensor, and the system includes wireless communication means capable of wirelessly communicating with the motion sensor to obtain therefrom a signal indicative of motion sensed thereby.

17. The system of claim 14, wherein: The spasm-related movement pattern is associated with a change in at least one of the position, velocity, and acceleration of the tissue near the at least one motion sensor when the frequency is within a specific frequency range, and wherein the monitoring includes processing the signal obtained from the at least one motion sensor to identify frequency components of the movement within the specific frequency range, the frequency components indicating the spasm-related movement pattern.

18. The system of claim 14, comprising a user interface, and wherein said selection of said particular one or more electrode patches based on said monitoring comprises performing the following steps upon identification of said spasticity-related movement pattern by said monitoring: - operating the user interface to issue an indication regarding the identified spasticity-related movement pattern; and - in response to the indication, obtaining, via the user interface, instructions for selecting the particular one or more electrode patches; The one or more PFA pulses or pacing signals are thereby delivered via the return electrode of the selected particular one or more electrode patches in accordance with the instructions.

19. The system of claim 14, said system being adapted to automatically implement said selection of said particular one or more electrode patches based on said monitoring of said spasticity-related movement pattern sensed by said at least one motion sensor.

20. The system of claim 14, adapted for connection with at least one motion sensor, the at least one motion sensor comprising at least one of: - at least one motion sensor arranged at or near at least one respective electrode patch of the plurality of electrode patches; - at least one motion sensor arranged at or near at least one region of interest of the subject's body where a spasticity-related movement pattern can occur due to neural stimulation affected by said delivery of said PFA pulses or pacing signals.

21. The system of claim 14, wherein: The selection of the particular one or more electrode patches based on the monitoring can include selection of more than one electrode patch to function as the second magnetic pole.

22. The system of claim 21, wherein: 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 more than one electrode patch is selected, the processor adjusts the relative portions based on the monitoring so as to avoid or reduce cramps near the selected electrode patches.

23. A system according to claim 14, wherein the system is adapted to be connected to at least one additional sensor, the at least one additional sensor being capable of sensing additional neural stimulation effects caused by the delivery of the PFA pulse or pacing signal; and wherein the at least one processor is adapted to further monitor the signals obtained from the additional sensor and further select the specific one or more electrode patches based on the further monitoring of the signals from the additional sensor.

24. A PFA electrode patch for use as a second non-ablative magnetic pole in a monopolar PFA treatment, the PFA electrode patch comprising: a return electrode, the return electrode being a skin surface electrode adapted to couple to the patient's skin over a surface area substantially larger than a 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 used 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 in a patient's muscle located near a skin area to which the PFA electrode patch is attached during monopolar PFA treatment.

25. The PFA electrode patch of claim 24, comprising the motion sensor integrally coupled thereto.

26. The PFA electrode patch of claim 24, configured as a disposable patch, and wherein at least one of the following occurs: - the PFA electrode patch includes the motion sensor as an integral part thereof; - the PFA electrode patch is used as a disposable part of a PFA electrode patch assembly, the PFA electrode patch assembly comprising a reusable part which is attachable to the disposable part via the coupling member and comprises the motion sensor.

Images