Systems, apparatus, and methods for protecting electronic components from high-power noise induced by high-voltage pulses.

Abstract

The present invention provides a system, device, and method for electroporation ablation therapy, which utilizes protective devices to isolate electronic circuits, devices, and / or other components from the electrode set during cardiac ablation procedures. [Solution] The system may include a first set 212 of electrodes that can be positioned near the cardiac tissue of the heart 202, and a second set 232, 234, 271 of electrodes that can be positioned in contact with the patient's biological structure. The system may further include a signal generator 222 configured to generate pulse waveforms, which is coupled to the first set of electrodes and configured to repeatedly deliver pulse waveforms to the first set of electrodes. The system may further include a protection device 250 configured to selectively couple and uncouple an electronic device 228 to the second set of electrodes.

Description

Technical Field

[0001] The embodiments described in this specification generally relate to medical devices for delivering therapeutic electrical energy, and more particularly, to systems, devices, and methods for protecting electronic components (e.g., sensitive devices or circuits) during pulsed electric field ablation procedures.

Background Art

[0002] The biophysical mechanism of irreversible electroporation allows for the application of short-duration, ultrashort, high-voltage pulses to tissue to generate a localized area of ​​ablated tissue, thereby generating a high electric field within the tissue. In applications, including applications to the heart, the high-voltage pulses may be applied in synchronization with the subject's cardiac cycle. For example, the high-voltage pulses may be applied during specific periods of the cardiac cycle (e.g., refractory periods of the cardiac chambers), thereby avoiding the risk of induced arrhythmias such as ventricular fibrillation. In some applications, a cardiac stimulator may be used to establish periodicity in the electrocardiogram (ECG) activity of the heart by pacing or stimulating the cardiac chambers in a regular cycle of periodic pacing signals with a clearly defined time period, in order to ensure the synchronization of the pulse-field ablation pulse with the cardiac cycle. Other devices, such as sensing and / or mapping systems, monitoring instruments, or devices, may also be used to monitor the subject's cardiac cycle or to detail the subject's cardiac activity. Cardiac stimulators may also be used in clinical procedures where pacing functionality is required to maintain periodic and regular electrical activity in the cardiac chambers for at least part of the procedure. Cardiac stimulators and these other devices may use intracardiac devices (e.g., catheters) that can be appropriately positioned within one or more cardiac chambers to deliver signals to or receive signals from the heart, or external surface patches or surface leads for recording patient surface ECG records. However, when these devices are used during pulsed field ablation procedures, they may be exposed to high voltages. Such exposure may result in large, generally unbalanced currents and / or large common-mode voltages relative to ground induced in the electrodes or leads of cardiac catheters. Large unbalanced currents and / or voltages span a frequency band and can disrupt the operation of cardiac stimulators and / or these other devices, and thus interrupt pacing, sensing, mapping, magnetic sensor operation, and / or pulsed field ablation functions.This confusion may be due to hardware responses to voltage and current, or to equipment that actively monitors patients for abnormal signals for safety reasons. [Overview of the Initiative] [Problems that the invention aims to solve]

[0003] Therefore, it may be desirable to have systems, apparatus, and methods for addressing this problem. [Means for solving the problem]

[0004] This specification describes systems, devices, and methods for protecting electronic components (e.g., circuits, devices, and / or other components) from exposure to induced current and high voltage during pulsed field ablation procedures.

[0005] In some embodiments, the ablation devices used in these systems may be deployed in the epicardium or endocardium when applied to the heart. The pulse waveforms delivered by the ablation devices may include predetermined parameters or may be automatically generated by a signal generator.

[0006] In some embodiments, the system may include a first set of electrodes and a second set of electrodes. Generally, the second set of electrodes may be positioned near cardiac tissue, or they may be part of a surface patch or similar external recording or monitoring device. A signal generator may be configured to generate pulse waveforms. The signal generator may be coupled to the first set of electrodes and, in some embodiments, may be configured to repeatedly deliver pulse waveforms to the first set of electrodes in synchronization with a set of cardiac cycles. In other embodiments, the signal generator may be configured to repeatedly deliver pulse waveforms to the first set of electrodes without establishing synchronization with a cardiac cycle. In this latter case, protecting other electronic components (e.g., laboratory equipment such as cardiac stimulators (commonly used for pacing functions), mapping systems, magnetic tracking devices, imaging devices, etc.) may still be beneficial. The first set of electrodes may be configured to generate pulsed electric fields in response to the delivery of pulse waveforms in order to ablate cardiac tissue. A protective device may be configured to selectively couple and uncouple electronic devices to the second set of electrodes. A control element (e.g., a processor, switch, control signal) may be coupled to a protective device and configured to control the protective device to decouple the electronic device from a second set of electrodes for a time interval that begins before each delivery of a pulse waveform to a first set of electrodes and ends afterward.

[0007] In some embodiments, the apparatus may include a first set of electrodes that can be positioned near the cardiac tissue of the heart. A signal generator may be coupled to the first set of electrodes and configured to generate pulse waveforms. A switch component may be coupled to the signal generator. The switch component may be configured to switch between a conductive state in which the electronic device is coupled to a second set of electrodes and a non-conductive state in which the electronic device is uncoupled from the second set of electrodes. The second set of electrodes may be positioned near the first set of electrodes, or generally within a cardiac chamber or biological cavity, or it may be positioned on or near the outer surface of the subject. A processor may be coupled to the switch component. The processor may be configured to receive trigger signals, each trigger signal associated with the cardiac cycle or an ablation output from the signal generator. In response to receiving each trigger signal, the processor may be configured to set the switch component to a non-conductive state so that the electronic device is uncoupled from the second set of electrodes. The processor may be configured to deliver a pulse waveform to the first set of electrodes from a signal generator, after setting the switch component to a non-conductive state, so that the first set of electrodes generates a pulsed electric field. The processor may be configured to set the switch component to a conductive state after delivering a pulse waveform so that the electronic device is coupled to a second set of electrodes. In some embodiments, the control signal coupled to the switch component can set the state of the switch in order to perform the functions described above.

[0008] In some embodiments, the method may include the step of delivering pacing signals to the heart by a second set of electrodes positioned near the cardiac tissue of the heart. After each pacing signal is delivered to the heart, a switch component that can selectively couple to an electronic device may be set to a non-conductive state so that the second set of electrodes is discoupled from the electronic device. After setting the switch component to a non-conductive state, a pulse waveform may be delivered to the first set of electrodes positioned near the cardiac tissue of the heart so that the first set of electrodes generates a pulsed electric field for ablation of the cardiac tissue. After delivering the pulse waveform, the switch component may be set to a conductive state so that the second set of electrodes couples to the electronic device. [Brief explanation of the drawing]

[0009] [Figure 1] A schematic diagram of the components of a signal generator and cardiac stimulator placed inside the heart, according to an embodiment. [Figure 2] A schematic diagram of a signal generator and cardiac stimulator components placed inside the heart, using passive filtering for the protection of the cardiac stimulator according to an embodiment. [Figure 3A] A schematic diagram of a system for protecting electronic components from high-voltage signals, according to an embodiment. [Figure 3B] A schematic diagram of a system for protecting electronic components from high-voltage signals, according to an embodiment, which includes externally and / or internally positioned electrodes that can be connected to a variety of medical devices, including but not limited to cardiac stimulators, ECG recording systems, ECG or other patient data monitoring systems, electroanatomical mapping systems, device navigation / tracking systems, other monitoring systems and devices, and combinations thereof. [Figure 4]A schematic diagram of a signal generator and one or more components of medical electronic equipment, connected to electrodes placed within the heart / cardiac biostructure or on the patient surface, with protective devices for protecting the medical electronic equipment, according to an embodiment. [Figure 5] A schematic diagram of a protective device for protecting electronic components from high-voltage signals, according to an embodiment. [Figure 6A] A diagram illustrating a method for protecting electronic components from high-voltage signals according to an embodiment. [Figure 6B] A diagram illustrating a method for protecting electronic components from high-voltage signals for asynchronous delivery of ablation, according to an embodiment. [Figure 7A] A diagram illustrating the time sequence of cardiac pacing signal, energy delivery, and device isolation according to an embodiment. [Figure 7B] A diagram illustrating the time sequence of cardiac pacing signal, cardiac activity, energy delivery, and device isolation according to an embodiment. [Figure 8] A schematic diagram of a system for protecting electrical components from high-voltage signals, according to an embodiment. [Figure 9] A diagram illustrating the time sequence of cardiac pacing signal, cardiac activity, energy delivery, and device isolation according to an embodiment. [Figure 10A] A block diagram of an alternative arrangement of a protective device and a high-voltage generator according to an embodiment. [Figure 10B] A block diagram of an alternative arrangement of a protective device and a high-voltage generator according to an embodiment. [Figure 10C] A block diagram of an alternative arrangement of a protective device and a high-voltage generator according to an embodiment. [Figure 10D] A block diagram of an alternative arrangement of a protective device and a high-voltage generator according to an embodiment. [Figure 10E] A block diagram of an alternative arrangement of a protective device and a high-voltage generator according to an embodiment. [Figure 11]Schematic diagram of a protection device for controlling connections between electronic components operating in a high-voltage exposure area according to an embodiment. [Figure 12] Schematic diagram of a system for protecting an electronic component from a high-voltage signal according to an embodiment. [Figure 13] Diagram illustrating the time sequence of a cardiac pacing signal, cardiac activity, energy delivery, and device insulation according to an embodiment. [Figure 14] Schematic diagram of a protection device for controlling connections between electronic components operating in a high-voltage exposure area according to an embodiment. [Figure 15] Schematic diagram of a protection device for controlling connections between electronic components operating in a high-voltage exposure area according to an embodiment. [Figure 16] Schematic diagram of a protection device for controlling connections between electronic components operating in a high-voltage exposure area according to an embodiment. [Figure 17A] Diagram illustrating the time sequence of a cardiac pacing signal, cardiac activity, energy delivery, and device insulation according to an embodiment. [Figure 17B] Diagram illustrating the time sequence of a cardiac pacing signal, cardiac activity, energy delivery, and device insulation according to an embodiment. [Figure 18] Schematic diagram of a protection device for controlling connections between electronic components operating in a high-voltage exposure area according to an embodiment. [Figure 19] Schematic diagram of a system for protecting an electrical component from a high-voltage signal according to an embodiment. [Figure 20A] Diagram illustrating the time sequence of signal connection and energy delivery according to an embodiment. [Figure 20B] Diagram illustrating the time sequence of signal connection and energy delivery according to an embodiment. [Figure 20C] Diagram illustrating the time sequence of signal connection and energy delivery according to an embodiment.

MODE FOR CARRYING OUT THE INVENTION

[0010] This specification describes systems, devices, and methods for protecting circuits from high-power noise induced during pulsed field ablation. Pulsed field ablation generates a large electric field in a desired region of interest by using ultrashort, high-voltage pulses to generate a localized area of ​​ablated tissue via irreversible electroporation. In some applications, including applications to the heart, it may be desirable to generate pulses for pulsed field ablation in synchronization with the cardiac cycle. Synchronizing the delivery of ablation energy with the cardiac cycle may reduce the risk of induced arrhythmias such as atrial and / or ventricular fibrillation. One method of synchronizing pulse delivery may be to pace or stimulate one or more cardiac chambers using a periodic pacing signal having a predefined time duration. For example, a cardiac stimulator may be used to deliver pacing pulses to one or more cardiac chambers so that the patient's heart rhythm is synchronized with the pacing pulses.

[0011] In some embodiments, pacing pulses can be delivered to cardiac chambers via a cardiac catheter appropriately positioned within the chambers. For example, Figure 1 depicts a cardiac stimulator (28) coupled to a cardiac catheter (30) appropriately positioned within the chambers of the heart (2). The catheter (30) may have one or more electrodes (32, 34) used to transmit pacing signals to the heart. In embodiments, a pair of electrodes on the catheter (30) (e.g., the most distal electrode (32) and an electrode (34) immediately proximal to the most distal electrode (32)) may be used as a bipolar pair for delivering pacing signals, thus providing forward and return current paths for the pacing signals. The cardiac chambers respond to the pacing pulses by timing their ECG signal generation (e.g., QRS waveform) in synchronization with the pacing pulses (referred to in this specification as "pacing capture"). Thus, periodicity of the cardiac ECG activity can be established. Once such periodicity is established and confirmed by a physician (for example, from displayed ECG activity acquired for various recording or sensing electrodes), the delivery of pulsed-field ablation pulses can be timed to begin in sync with the pacing pulse, including any predetermined offset, and the delivery can be completed within a refractory window following the QRS waveform of the ECG signal.

[0012] In cardiac applications, pulsed-field ablation energy can be delivered through a customized ablation catheter containing multiple electrodes. For example, as shown in Figure 1, a signal generator (22) (e.g., a pulsed-field ablation pulse generator) can be coupled to an ablation catheter (10) having electrodes (12) appropriately positioned within the heart (2). The delivery of pulsed-field ablation voltage pulses can be synchronized with the delivery of a pacing signal with an appropriate offset, as shown by (60). The pacing catheter (30) can also be placed within the cardiac environment (e.g., in the same or nearby cavity of the heart (2)), so that the high-voltage pulse waveform applied to cardiac tissue can be coupled to the pacing catheter (30) and induce current in one or more of the pacing catheter (30) and devices coupled thereto (e.g., a cardiac stimulator (28)).

[0013] During the normal delivery of pacing pulses, the forward and return currents of the electrodes (32, 34) of the pacing catheter (30) are balanced (e.g., equal in magnitude and opposite in direction). However, the electrical coupling of high-voltage ablation energy to the pacing catheter (30) can induce large, generally unbalanced currents and / or common-mode voltages in the leads of the pacing catheter (30). These large, unbalanced currents and / or voltages can span a frequency band and may disrupt the operation of the pacing system or the cardiac stimulator (28), or any other electronic equipment coupled to them. For example, exposure of the pacing catheter (30) to large voltages may exceed the common-mode rejection of the cardiac stimulator (28), causing system failure and / or a reset of the stimulator (which may be pacing for synchronous delivery of ablation or pacing the cardiac chambers for other medical reasons). High voltage and current levels associated with induced noise imply a large power level for the noise, which can lead to undesirable effects.

[0014] This high-power induced noise can be difficult to suppress, and therefore, in pulsed field ablation energy delivery applications, it may be desirable to have systems, devices, and methods for suppressing induced currents in auxiliary devices. In some embodiments, currents induced by pulsed field ablation can be suppressed through the implementation of passive filtering systems, devices, and methods, as described in U.S. Patent Application No. 62 / 667,887, filed May 7, 2018, entitled "Systems, Apparatuses, and Methods for Filtering High Voltage Noise Induced by Pulsed Electric Field Ablation," the contents of which are incorporated into this specification in whole. Figure 2 illustrates an example of a system including passive filtering. A cardiac stimulator (28') can be coupled to a pacing catheter (30') including multiple electrodes (32', 34'). A signal generator (22') can be coupled to an ablation catheter (10') which includes multiple electrodes (12'). The electrodes (32', 34') of the pacing catheter (30'), along with the electrodes (12') of the ablation catheter (10'), can be placed inside the heart (2'). A filter element (50') can be coupled between a cardiac stimulator (28') and the pacing catheter (30'). The filter element (50') can passively filter the signals from the pacing catheter (30') before they are received by the cardiac stimulator (28'), thereby suppressing some induced current. For example, in A, a long wire can pick up high voltage, but in B, after passive filtering, residual voltage and current can be passed to the cardiac stimulator (28').

[0015] However, in some cases, coupled noise with large amplitude (e.g., large voltage spikes) may be difficult to remove using passive filtering techniques, and thus, equipment failure and / or reset, including cardiac stimulators, may still occur. Commercial stimulators may also include different design parameters such that one level of protection may be sufficient for one type of stimulator but insufficient for a second type.

[0016] The systems, devices, and methods disclosed in this specification provide protection to sensitive electronic and auxiliary devices in pulsed field ablation applications by using actively driven rapid switching of signal paths. In some embodiments, a protective device may be coupled to a pacing device to actively and selectively electrically isolate the pacing device from other electronic components of the ablation system. In particular, the pacing device may be electrically isolated from the system for a predetermined period of time corresponding to the delivery of pulse waveforms to tissue. During the period of high-voltage energy delivery, the electrical connection may be re-established to allow operation of the pacing device. In some embodiments, the protective device may include a high-speed switch coupled between the ablation system and the pacing device. As a result, components of the system, such as a cardiac stimulator, can be protected from currents that may be induced in the pacing device by the high-voltage pulse waveforms applied by the ablation device. In addition, or alternatively, the protective device may further provide passive circuit protection.

[0017] In some embodiments, sensitive circuits or parts of assistive devices (e.g., cardiac stimulators, electroanatomical mapping systems, ECG recording or monitoring systems) can be protected from high-voltage pulsed-field ablation signals present in a subject by electrically isolating such circuits or devices. Electrical isolation can be performed manually by cutting the wires between the circuit or device and the subject, although manual methods may not be feasible in some cases. For example, in the case of certain types of devices that perform repeated functions, such as cardiac stimulators intended to provide continuous pacing of a subject's heart during pulsed-field ablation procedures, it is necessary that the physical connection between the device and the subject remains intact. In these cases, it may be desirable to achieve physical disconnection using electronic components. For example, electronic components can be used to provide bidirectional open-circuit isolation between the subject and the assistive device to be protected over a certain time interval during which high voltage is present, and to re-establish the connection over other time intervals so as not to, allowing the device to perform its intended function.

[0018] As used in this specification, the term “electroporation” refers to the application of an electric field to a cell membrane to alter the permeability of the cell membrane to the extracellular environment. As used in this specification, the term “reversible electroporation” refers to the application of an electric field to a cell membrane to temporarily alter the permeability of the cell membrane to the extracellular environment. For example, a cell undergoing reversible electroporation may show the temporary and / or intermittent formation of one or more pores in its cell membrane that close when the electric field is removed. As used in this specification, the term “irreversible electroporation” refers to the application of an electric field to a cell membrane to permanently alter the permeability of the cell membrane to the extracellular environment. For example, a cell undergoing irreversible electroporation may show the formation of one or more pores in its cell membrane that persist even when the electric field is removed.

[0019] Pulse waveforms for electroporation energy delivery, as disclosed in this specification, can enhance the safety, efficiency, and effectiveness of energy delivery to tissue by reducing the electric field threshold associated with irreversible electroporation, thus resulting in a more effective ablation lesion with reduced total energy delivered. In some embodiments, the voltage pulse waveforms disclosed in this specification may be hierarchical and have a nested structure. For example, the pulse waveform may include a hierarchical grouping of pulses having associated timescales. In some embodiments, the methods, systems, and devices disclosed in this specification may comprise one or more of the methods, systems, and devices described in International Application PCT / US2019 / 014226, filed on January 18, 2019, and published on July 25, 2019, as International Publication WO / 2019 / 143960, entitled “Systems, Devices, and Methods for Focal Ablation,” the contents of which are incorporated into this specification as a whole. Systems and devices This specification discloses systems and devices configured to suppress induced currents in connection with tissue ablation. Generally, the systems described herein for ablating tissue using high-voltage pulse waveforms may include a cardiac stimulator for generating cardiac pacing signals, which are delivered to the heart by a pacing device. The cardiac pacing signals are used to synchronize the delivery of pulse waveforms generated by the signal generator, and the pulse waveforms are delivered using an ablation device having one or more electrodes. In another embodiment, ablation using high-voltage pulse waveforms can be performed asynchronously (i.e., without synchronization with cardiac stimulation). In these embodiments, it is generally desirable to also protect other electronic devices, such as cardiac stimulators, electroanatomical mapping systems, device navigation / tracking systems, ECG recording or monitoring systems, which may be connected to the patient via device electrodes (e.g., needle electrodes, pacing leads, etc.) located inside or outside the patient, or attached to the patient's surface. Accordingly, the systems, methods, and practices described herein are applicable to asynchronous ablation delivery. Furthermore, as described in this specification, the system and device may be deployed on the epicardium and / or endocardium to treat atrial fibrillation. The voltage may be applied to a selected subset of electrodes, and independent subset selection is used for the selection of anode and cathode electrodes.

[0020] Figure 3A illustrates an example system (1700) including an integrated protective element (1750). The protective element (1750) can be positioned between electrical components (1730) and a target area (TA) (e.g., the patient's heart). The protective element (1750) can be configured to have a voltage rating corresponding to the expected exposure voltage on the patient side of a pulsed field ablation procedure, which can be several thousand volts. The protective element (1750) can function as an isolation component configured to transition to an open-circuit configuration and back to a closed-circuit configuration based on a control signal. The protective element (1750) can be configured to respond quickly (e.g., rapidly switch between its open and closed configurations) to reduce the open-circuit duty cycle so that the protective element (1750) electrically isolates certain electrical components (1730) (e.g., monitoring equipment or devices, cardiac stimulators, etc.) over the duration of high-voltage exposure, but otherwise allows those electrical components to be connected to the target area (TA).

[0021] Examples of suitable protective elements (1750) include electromechanical relays (e.g., reed relays), solid-state relays, and / or high-voltage metal-oxide-semiconductor field-effect transistor (MOSFET) devices. Reed relays may be a less suitable choice for isolation component implementations because such relays operate slower than other types of protective devices and are more susceptible to damage / contact melting if switched during exposure to high current. When the system (1700) is used with protective elements (1750) implemented as reed relays, the adjustments and timings of the system (1700) must be adjusted to accommodate the slower response time of such relays. A preferred implementation of protective elements (1750) uses two back-to-back MOSETs with a common source terminal, as further illustrated with reference to Figure 5 below.

[0022] Figure 3B illustrates an example system (1800) including an integrated protective element (1805). The protective element (1805) can be positioned between the electrical components (1801) and the patient's anatomical structures (1808). The protective element (1805) can be configured to have a voltage rating corresponding to the expected exposure voltage on the patient side of the pulsed field ablation procedure, which can be several thousand volts. Such high-voltage exposure can occur via internally placed device electrodes or sensors (1819) (relative to the patient) or externally placed / mounted electrodes or sensors (1821) (on the patient surface). Such electrodes or sensors can be connected to a variety of medical electronic devices, including, but not limited to, electroanatomical mapping systems, device navigation / tracking systems, ECG recording / monitoring systems, and combinations thereof, which are commonly used in clinical laboratories or treatment rooms. In the embodiments described herein, the sensor may be a general-purpose sensor, including a dedicated electromagnetic sensor, an electrode for receiving voltage signals generated by a location tracking system, an electrode for monitoring native cardiac electrical activity, and more generally, a sensor for sensing various types of electrical signals. The protective element (1805) may function as an isolation component configured to transition to an open-circuit configuration and back to a closed-circuit configuration based on a control signal (1812). The protective element (1805) is configured to respond quickly (e.g., to rapidly switch between its open and closed configurations) to reduce the open-circuit duty cycle so that the protective element (1805) electrically isolates electrical components (1801), such as those described above, over the duration of high-voltage exposure, but otherwise allows those electrical components to be connected to the patient's biological structures (1808).

[0023] Examples of suitable protection elements (1805) include electromechanical relays (e.g., reed relays), solid-state relays, and / or high-voltage metal-oxide-semiconductor field-effect transistor (MOSFET) devices. Reed relays may be a less suitable choice for isolation component implementations because such relays operate slower than other types of protection devices and are more susceptible to damage / contact melting if switched during exposure to high current. When a system (1800) is used with a protection element (1805) implemented as a reed relay, the tuning and timing of the system (1800) must be adjusted to accommodate the slower response time of such relays. In some embodiments, the protection element (1805) may include two back-to-back MOSFETs with a common source terminal, as further described with reference to Figure 5 below.

[0024] Figure 4 is a schematic diagram of an electroporation system placed inside the heart (202) of a patient (200). The electroporation system may include an ablation device (210), a signal generator (222), an electrical component (e.g., medical electronic equipment or device) (228), a catheter device (230), and a protective device (e.g., a protective circuit) (250). In some embodiments, the electrical component (228) may be implemented as a cardiac pacing system. The signal generator (222) may be coupled to the ablation device (210) and configured to receive a pacing / synchronization signal (260) generated by the cardiac pacing system. The signal generator (222) may be configured to generate an ablation pulse waveform that is delivered to the tissue by the electrode (212) of the ablation device (210). In some embodiments, the catheter device (230), implemented as a pacing device (230), may be configured to pace the heart and measure cardiac activity using its respective pacing electrodes (232) and signal electrodes (234). In some embodiments, the electrical component (228) may be implemented as a monitoring device or instrument, which can be coupled to one or more sensors (e.g., electrodes) (232, 234, 271) for measuring the patient's physiological data. In some embodiments, the sensors (e.g., electrodes (271)) may be placed externally on the patient's surface. A protective device (250) may be coupled between the electrical component (228) and the electrodes (232, 234) or electrode (271) of the catheter device (230). In some embodiments, the protective device (250) is configured to synchronize the electrical isolation of the pacing device (230) with the delivery of ablation energy by the ablation device (210).

[0025] In some embodiments, the distal portion of the ablation device (210) may be introduced into the endocardial space of the heart (202) (e.g., the left atrium) through the atrial septum, for example, by transseptal puncture. The distal portion of the ablation device (210) may include a set of electrodes (212) configured to deliver ablation energy (e.g., pulsed electric field energy) to the tissue. For example, the ablation device (210) may be positioned near the inner diameter surface of the lumen (e.g., one or more pulmonary vein orifices) (not shown) for delivery of pulsed waveforms for ablation of the tissue. In some embodiments, the electrodes (212) of the ablation device (216) may be a set of independently addressable electrodes. Each electrode may include an insulated electrical lead wire configured to maintain a potential of at least about 700 V without dielectric breakdown of its corresponding insulator. In some embodiments, the insulator in each of the electrical leads can maintain a potential difference of about 200 V to about 3000 V across its thickness without dielectric breakdown. In some embodiments, the set of electrodes may include multiple electrodes. Multiple electrodes may be grouped into one or more anode-cathode subsets, such as a subset including one anode and one cathode, a subset including two anodes and two cathodes, a subset including two anodes and one cathode, a subset including one anode and two cathodes, a subset including three anodes and one cathode, and / or a subset including three anodes and two cathodes.

[0026] The signal generator (222) may be configured to generate an ablation pulse waveform for irreversible electroporation of tissue, such as a pulmonary vein ostium. For example, the signal generator (222) may be a voltage pulse waveform generator that can deliver a pulse waveform to the ablation device (210).

[0027] In some embodiments, the signal generator (222) is configured to generate an ablation pulse waveform (for example, within a common refractory window) in synchronization with the indication of the pacing signal. For example, in some embodiments, the common refractory window may begin substantially immediately (or after a very small delay) following the ventricular pacing signal and then persist for a duration of approximately 250 milliseconds (ms) or less. In such embodiments, the entire pulse waveform may be delivered within this duration.

[0028] A protective device (250) may be coupled between an electrical component (228) and a catheter device (230). As described in more detail in this specification, a control signal (also referred to in this specification as a protective signal) may be generated to synchronize the operation of the protective device (250) with the generation of a pulse waveform by a signal generator (222). The protective device (250) may be configured to receive a control signal to control the state of the electrical connection between the catheter device (230) and the electrical component (228). For example, the protective device (250) may be configured to form an open circuit between the electrical component (228) and the catheter device (230) at least during the delivery of ablation energy by the ablation device (210). Otherwise, the protective device (250) may be configured to electrically couple the pacing device (230) with the electrical component (228). In some embodiments, the protective device (250) may be configured to provide bidirectional open-circuit isolation during high-energy ablation energy delivery. In some embodiments, the protective device (250) may be formed separately from the electrical components (228) and / or the catheter device (230), and in other embodiments, the protective device (250) may be integrated into one or more electrical components (228) and / or the catheter device (230). In some embodiments, the protective device (250) may include one or more power connectors for coupling to an internal power source (e.g., a battery) and an external power source (e.g., a medical-grade power supply, a wall outlet). The internal power source may reduce ground noise injection.

[0029] In some embodiments, the electrical components (228), the protection device (250), and / or the signal generator (220) may communicate with each other, for example, to coordinate the timing of pulse waveform delivery, pacing signal delivery, and / or protection device control signal delivery. In some embodiments, the protection device (250), together with the signal generator (222), may be integrated into a single console.

[0030] In some embodiments, electrical components (228), protective devices (250), and / or signal generators (220) may communicate with other devices (not shown) via one or more networks, each of which may be any type of network. A wireless network may refer to any type of digital network that is not connected by any kind of cable. However, a wireless network may be connected to a wired network to interface with the Internet, other carriers' voice and data networks, business networks, and personal networks. Wired networks are generally carried on copper twisted pair, coaxial cable, or fiber optic cable. There are many different types of wired networks, including wide area networks (WANs), metropolitan area networks (MANs), local area networks (LANs), campus area networks (CANs), global area networks (GANs) such as the Internet, and virtual private networks (VPNs). Hereafter, "network" refers to any combination of combined wireless, wired, public, and private data networks that are generally interconnected via the Internet to provide a unified networking and information access solution. The system (100) may further include one or more output devices, such as a display, an audio device, a touchscreen, and a combination thereof.

[0031] The electrical components (228), protective devices (250), and / or signal generators (220) may include one or more processors, which can be any suitable processing devices configured to execute and / or perform a set of instructions or codes. The processors may be, for example, general-purpose processors, field-programmable gate arrays (FPGAs), application-specific integrated circuits (ASICs), and / or digital signal processors (DSPs). The processors may be configured to execute and / or perform application processes, as well as other modules, processes, and / or functions, associated with a system and / or associated network (not shown). The underlying device technologies may be provided in various component types, for example, metal-oxide-semiconductor field-effect transistor (MOSFET) technologies such as complementary metal-oxide-semiconductor (CMOS), bipolar technologies such as emitter-coupled logic (ECL), polymer technologies (e.g., silicon-conjugated polymers and metal-conjugated polymer metal structures), and / or mixed analog and digital.

[0032] The electrical components (228), protective devices (250), and / or signal generators (220) may include one or more memory or storage devices, which may be, for example, random access memory (RAM), memory buffers, hard drives, erasable programmable read-only memory (EPROM), electrically erasable read-only memory (EEPROM), read-only memory (ROM), flash memory, etc. The memory may store instructions for causing any one of the processors of the electrical components (228), protective devices (250), and / or signal generators (220) to perform modules, processes, and / or functions, such as pulse waveform generation, isolation / protection, and / or cardiac pacing.

[0033] Figure 4 depicts a system including an electrical component (228) separated from the signal generator (220), however, in some embodiments, one or more electrical components (228) may form part of the signal generator (222) and / or be integrated into the signal generator (222). In some embodiments, one or more electrodes (212, 232, 234) may function as sensing electrodes.

[0034] Figure 5 is a circuit diagram of a protection device (300) including a first MOSFET (310) and a second MOSFET (320). The MOSFETs (310, 320) can be arranged as back-to-back MOSFETs with a common source terminal, such that the body diodes of the MOSFETs (310, 320) face in opposite directions. Such an arrangement can provide bidirectional isolation with precise timing control. The MOSFETs (310, 320) can be driven by isolated gate driver circuits (330, 340). Specifically, the first MOSFET (310) can be coupled to a first gate driver (330), and the second MOSFET (320) can be coupled to a second gate driver (340). The first and second gate drivers (330, 340) can be coupled to a coupling (350) (e.g., isolated / optical coupling) that can receive a control signal 352. The protective device (300) may be configured to reduce high-voltage coupling of connected devices. For example, the protective device (300) may be configured to withstand voltages up to approximately 3000V delivered by the ablation device. The protective device (300) may be configured to transition between a closed-circuit configuration and an open-circuit configuration based on a received protective signal (352) (e.g., a control signal), such that the protective device (300) is in an open-circuit configuration for the duration of high-voltage ablation energy delivery and in a closed-circuit configuration at other times, for example, to allow delivery of a pacing signal.

[0035] The protective devices described herein may be separate devices or may be integrated into auxiliary devices or pulsed field ablation stimulers. Figures 10A to 10E are block diagrams of a set of systems including both protective devices integrated with other system components and protective devices separated from other system components. In Figures 10A to 10E, protective devices may include components that are structurally and / or functionally similar to any of the other protective devices described herein (e.g., protective devices depicted in Figures 3A, 3B, 4, 5, 8, 11, 12, 14 to 16, 18, and 19). Figure 10A illustrates a signal generator (800) (e.g., for pulsed field ablation) equipped with a protective device (810) integrated therewith. For example, one or more of the signal generator (800), protective devices (810), electrical components (e.g., electrical components (228) including monitoring equipment, cardiac stimulators, etc.), and signal analyzers (e.g., signal detectors (670)) may be integrated into a single enclosure (e.g., housing, signal generator console). This may allow sensitive electronic circuits to be protected from high-voltage noise within the same enclosure. External electrical components (e.g., auxiliary equipment) may also be protected by coupling such components to protective devices (810) at a point further downstream from the high-voltage exposure point (e.g., patient). External equipment may be protected by forwarding signals received by the system through protective devices (810) before they reach the patient, so that protective devices (810) can time their blanking intervals to coincide with the duration of potential high-voltage exposure. When using the integrated configuration shown in Figure 10A, a digital "blanking" signal (e.g., a control signal) can be provided to the protective device by a signal generator (800) to indicate the required time for isolation (e.g., protection) of sensitive electronic components.The "blanking" signal may be configured to control a protective device to electrically isolate a set of internal and external electronic components of the signal generator (800), thereby providing coordinated and robust protection.

[0036] In some embodiments, manually operated switches can be configured to serve as protective devices for protecting electronic components or equipment from ablation-induced noise.

[0037] In some embodiments, the signal generator and the protection device may be separate devices (e.g., formed in different enclosures). In such embodiments, the control signal may be transmitted between the signal generator and the protection device via wired or wireless communication; however, wired control signals are more robust and can avoid the risks of delay that are more frequently associated with wireless communication. When an external or separate protection device is used, the protection device may be battery-powered or wall-powered using, for example, medical-grade isolation; however, a battery-powered protection device may be more desirable to reduce ground noise injection to the patient from an isolated wall power supply. Figure 10B illustrates a signal generator (800) coupled to a protection device (810) via a wired connection (820) (e.g., a power / data cable). Figure 10C illustrates a signal generator (800) coupled to a protection device (810) via a wireless connection. For example, the protection device (810) may include a wireless transceiver (830) configured to receive control signals (e.g., transmitted from a signal generator (800)).

[0038] In embodiments where the protective device is implemented independently of the signal generator (e.g., a pulse-field ablation generator), the protective device requires a mechanism for synchronizing with such delivery so that it can effectively isolate certain electronic components during the delivery of high-voltage pulses. In some embodiments, the protection signal may synchronize the electrical isolation of an electronic component (e.g., a stimulator) with the delivery of ablation energy to the tissue, based on one or more of the following: a timed trigger pulse from the stimulator, stimulation pulse sensing (e.g., stimulation pulse for cardiac capture), measured cardiac activity (e.g., R-wave detection), and / or high voltage sensing (e.g., with rapid application of isolation when a high voltage spike is detected on the patient side). Such is further described below with reference to Figure 12. Figures 10D and 10E illustrate two configurations that perform synchronization. Such configurations are similar to those described with reference to Figures 7A to 9. Figure 10D illustrates a signal generator (800) and a protection device (810), both configured to receive signals from a cardiac stimulator (840). 40) can be configured to synchronize the ablation energy delivery by the signal generator (800) with the electrical isolation by the protection device (810) through the output of signals (e.g., trigger or control signal) to the signal generator (800) and the protection device (810). Figure 10E illustrates the signal generator (800) and the protection device (810) coupled together to a patient (850) and configured to operate synchronously with each other based on measured data (e.g., cardiac stimulation or pacing pulse, R-wave detection, high voltage detection). When synchronization is performed based on stimulation pulse detection, a sufficiently high predetermined threshold (e.g., 5V) can be set to reduce the possibility of false positive sensing, which could undesirably lead to an increased occurrence of isolation and disconnection of the protected electrical component from the patient.

[0039] Protective devices, as described herein, can be configured to isolate multiple electrical components (e.g., sensitive circuits or devices) from high voltage and induced currents. Figure 11 is a block diagram of a system (910) coupled to a patient (900). One or more devices of the system (910) (e.g., pacing devices, catheters, stylets, probes, electrodes, etc.) can be coupled to the patient (900) and may be susceptible to induced currents from high-voltage ablation energy delivery. Each device of the system (910) can be coupled to a protective device (920) configured to selectively electrically isolate electrical components located downstream of the protective device (920) from those parts of devices located in the heart and exposed to high voltage. The protection device (920) may include components that are structurally and / or functionally similar to any of the other protection devices described herein (e.g., the protection devices depicted in Figures 3A, 3B, 4, 5, 8, 10A-10E, 12, 14-16, 18, and 19). In some embodiments, a single protection signal (924) may be configured to control the protection device (920) and simultaneously provide electrical isolation of multiple electronic components through protection elements implemented as, for example, multiple switches (922). In some embodiments, one or more of the switches (922) may include electromechanical relays (e.g., reed relays), solid-state relays, and / or MOSFET devices. For example, one or more of the switches (922) may include two back-to-back MOSFETs with a common source terminal, as depicted in Figure 5.

[0040] For example, in some embodiments where the protective device is implemented as an independent system that does not use signals communicated from a high-voltage pulse generator (e.g., for pulsed-field ablation), the operation of the protective device can be synchronized based on stimulation pulse sensing, trigger pulses from a cardiac stimulator, R-wave sensing, or high-voltage sensing. Figure 12 is a schematic diagram of an electroporation system placed in the heart (1002) of a patient (1000), including an ablation device (1010), a signal generator (1022), a cardiac stimulator (1028), a pacing device (1030), and a protective device (1050). The signal generator (1022) may be coupled to the ablation device (1010). The signal generator (1022) may be configured to generate a pulse waveform that is delivered to the electrode (1012) of the ablation device (1010) to generate a pulsed electric field for ablation. The pacing device (1030) may be configured to pace the heart (1002) using pacing electrodes (1032, 1034) and / or to measure the cardiac activity (e.g., electrocardiogram) of the heart (1002) using one or more electrodes (e.g., electrodes (1032, 1034), or other electrodes (not depicted)). A protective device (1050) may be coupled between the cardiac stimulator (1028) and the pacing device (1030). The protective device (1050) may include components structurally and / or functionally similar to any of the other protective devices described herein (e.g., protective devices depicted in Figures 3A, 3B, 4, 5, 8, 10A-10E, 11, 14-16, 18, and 19).

[0041] In some embodiments, the protective device (1050) may be configured to synchronize the electrical isolation of the cardiac stimulator (1028) with the pulse waveform delivery by the ablation device (1010) based on one or more signals. The protective device (1050) may be synchronized based on one or more of the following: stimulation signals (1060) from the cardiac stimulator (1028) (which may also be sent to the signal generator (1022)); measured data (e.g., stimulation pulse detection signals (1070), R-wave detection signals (1090), and high-voltage detection signals (1092)); and signal generator signals (1080), either on the same signals or combinations of signals as the signal generator (1022) or independently. In alternative embodiments, the protective device (1050) and the signal generator (1022) may be activated based on different signals or different combinations of signals. For example, a protective device (1050) may be controlled based on a cardiac pacing signal (1060), and pulse waveform delivery may be based on a detected R-wave signal (1090). In embodiments using stimulation pulse sensing, sensing may be performed using a predetermined threshold (e.g., about 5V) to reduce false positives, which may increase the number of disconnections between the cardiac stimulator (1028) and / or other protected electronic components and the patient (1000). To provide another layer of safety, a protective device for any external electronic component may be configured to provide a low-impedance connection between the protected electronic component and the patient when not powered. Figure 14 is a block diagram of electrical components (1210) (including, for example, sensitive equipment or circuits) coupled to the patient (1220) via a protective device (1200). One or more electrical components (1210) (e.g., monitoring devices, cardiac stimulators, etc., as described herein) may be coupled to a patient (1220) and may be susceptible to the effects of induced currents from high-voltage ablation energy delivery.Each of the electrical components (1210) may be coupled to a protective device (1200) to selectively electrically isolate those components from devices placed in the patient's (1220) heart. The protective device (1200) may include components that are structurally and / or functionally similar to any of the other protective devices described in this specification (e.g., the protective devices depicted in Figures 3A, 3B, 4, 5, 8, 10A-10E, 11, 12, 15, 16, 18, and 19).

[0042] The protective device (1200) may be configured such that when the protective device (1200) is not powered, the electrical component (1210) is electrically coupled to the patient (1220) (e.g., through a low-impedance connection). This safety feature may enable a default patient connection and allow the electrical component (1210) to operate even if power to the protective device (1200) is lost. For example, a cardiac stimulator (e.g., cardiac stimulator (28)) included in the electrical component (1210) may provide pacing to the patient (1220) when the protective device (1200) is powered off.

[0043] A first signal (1202) (e.g., a control signal) may be configured to control the protection device (1200) and provide electrical isolation through a first switch (1206), as described in this specification. A second signal (1204) (e.g., a power signal) may be configured to control the protection device (1200) through a second switch (1208). In some embodiments, the second switch (1208) may comprise a relay (e.g., a reed switch or a solid-state type switch) configured in parallel with the first switch (1206) used for isolation / blanking and configured to switch open when the protection device (1200) is powered. In some embodiments, the first switch (1206) may include an electromechanical relay (e.g., a reed relay), a solid-state relay, and / or a MOSFET device. For example, the first switch (1206) may include two back-to-back MOSFETs with a common source terminal, as shown in Figure 5. The second path, provided via the second switch (1208), can normally be set to a closed state to provide a low-impedance connection between the electrical component (1210) and the patient (1220).

[0044] Figure 15 provides another example embodiment of the system, including a protective device (1300). Specifically, Figure 15 is a block diagram of electrical components (1310) coupled to a patient (1320) via a protective device (1300). One or more electrical components (1310) (e.g., monitoring equipment, cardiac stimulator) may be coupled to a patient (1320) via a protective device (1300) configured to selectively electrically isolate those electrical components (1310) from devices placed inside the patient's (1320) heart, for example, via a first signal (1302). The protective device (1300) may include components structurally and / or functionally similar to any of the other protective devices described herein (e.g., the protective devices depicted in Figures 3A, 3B, 4, 5, 8, 10A-10E, 11, 12, 14, 16, 18, and 19). In a manner similar to that described with respect to Figure 14, the electrical component (1310) may electrically couple the protective device (1300) to the patient (1320) when it is not powered, via a normally closed switch positioned in parallel with the blanking / protective component. When power is supplied to the protective device (1300), a signal (1304) corresponding to the power may open the normally closed switch. In some embodiments, the protective device (1300) may include additional circuit protection and filtering functionality configured to reduce high slew-rate peak-to-peak voltages and / or high-voltage signals even when the protective device (1300) is not powered and / or when the electrical component (1310) is not isolated from the patient (1320).The protection device (1300) may include one or more of the following: passive filter devices (1330) (as described above with reference to Figure 2), common-mode protection devices (1340), and differential / high-voltage protection devices (1350), which may include one or more common and differential-mode chokes using ferrite / magnetic material, inductor and capacitor-based filters, and differential high-voltage and differential clamping components, including one or more of the following: transient suppression (TVS) diodes / transorbs, gas discharge tubes, and thyristors. In some embodiments, the methods, systems, and devices disclosed herein may comprise one or more of the methods, systems, and devices described in U.S. Patent Application No. 62 / 667,887, filed on May 7, 2018, “Systems, Apparatuses, and Methods for Filtering High Voltage Noise Induced by Pulsed Electric Field Ablation,” which is incorporated in whole above.

[0045] In some cardiac stimulators (e.g., electrophysiology laboratory stimulator systems), the patient connection may be monitored for high impedance to warn the user of disconnection. To prevent undesirable alarms while using protective devices (e.g., during blanking intervals), a fixed, known impedance may be provided to the connection to the stimulator (by a fixed resistor having a value within the range expected by the stimulator, e.g., 1 kilohm). Figure 16 is a block diagram of electrical components (1410) coupled to a patient (1420). One or more electrical components (1410) (e.g., monitoring equipment, cardiac stimulator) may be coupled to the patient (1420) via protective devices (1400) configured to selectively electrically isolate such components from devices placed inside the patient's (1420) heart via signals (1402). The protective device (1400) may include components that are structurally and / or functionally similar to any of the other protective devices described in this specification (e.g., the protective devices depicted in Figures 3A, 3B, 4, 5, 8, 10A-10E, 11, 12, 14, 15, 18, and 19).

[0046] A cardiac stimulator contained within an electrical component (1410) continuously monitors the electrical connection to the patient (1420) and may generate a disconnection signal (e.g., an alarm signal to the user) when a disconnection (e.g., high impedance) is detected. In some embodiments, to prevent the system (1410) from generating a disconnection signal during the protection interval of the protection device (1400), the protection device (1400) may provide the cardiac stimulator with a predetermined impedance (1440) (e.g., between about 100 ohms and about 10 kiloohms) within a range in which the stimulator is expected to respond to normal operation. For example, the protection device (1400) operating during the protection interval may send a signal to close a switch in series with a resistor (1440) which can then provide a fixed impedance value. The rapid transition between “patient connection” and “open circuit with fixed resistor load” can be fast enough to prevent any alarm or warning from the cardiac stimulator. In some embodiments, it may be beneficial to initially switch on the load to the electrical component during a short time interval (e.g., on the order of 1us to 100us) before disconnecting the patient connection. If this is done, there is no small amount of time during which the electrical component sees an open circuit. The patient connection can then be connected before (e.g., immediately before) the resistive load is disconnected. Another implementation optimization is to provide "load resistors" on both sides (including the patient side) so that symmetry exists in the implementation and the protective device can be plugged in on either side.

[0047] In some cases with protective devices such as those implemented in Figure 16, the introduction of switching artifacts and short voltage spikes to the patient may occur. Figures 17A and 17B are schematic time sequences of the cardiac stimulation (1510) channel, the electrocardiogram (1520) channel, the pulsed-field ablation delivery (1530) channel, and the protective interval (1540) channel, where a switching artifact (1526) may occur when the protective interval ends. Figure 17A illustrates a single cardiac cycle, and Figure 17B illustrates multiple cardiac cycles, as described in more detail in this specification. The stimulation or pacing signal (1510) may be periodic and may comprise a rectangular pulse with a width between approximately 0.1 ms and approximately 100 ms. In some embodiments, the pacing pulse (1512) may be delivered using any of the pacing devices described herein (e.g., pacing devices (230, 630, 1030)). The pacing pulse (1512) may correspond to one or more of the ventricular and atrial cardiac pacing. In response to the pacing pulse (1512), the cardiac cycle may be synchronized with the pacing pulse (1512). For example, the QRS waveform (1522) in Figures 17A and 17B is synchronized with the pacing pulse (1512).

[0048] In some embodiments, the pulse waveform (1532) and the protection interval (1542) may be synchronized with one or more of the pacing signal (1512) and the cardiac cycle (e.g., via R-wave detection), as described in the embodiments described above. For example, the pulse waveform (1532) may have a first length, and the protection interval (1542) may have a second length that is at least the same as the first length. The pulse waveform (1532) may be delivered only after a first delay (1534) from the falling edge (1514) of the cardiac pacing pulse (1512). The first delay (1534) may be a predetermined value. For example, the first delay (1534) may be between about 1 ms and about 20 ms. Similarly, the protection interval (1542) may be synchronized with the cardiac pacing pulse (1512) after a second delay (1544). In this system, the cardiac pacing signal (1512) may be configured to trigger a pulse waveform (1532) and a protection interval (1542).

[0049] In embodiments including a protective device as implemented in Figure 16, a switching artifact (1526) (e.g., a voltage spike) may be introduced to the patient and picked up in the electrocardiogram (1520) (e.g., via an electrocardiogram recording system), which may interfere with the analysis of cardiac activity. For example, the protective artifact (1526) may coincide with the falling edge (1528) of a protective interval (1542). Figure 17B illustrates an embodiment in which a protective interval (1542) is provided for each heartbeat, and for example, an artifact (1526) may be generated for each protective interval / heartbeat. In some embodiments in which coordinated control of the protective device is not readily available, one or more protective intervals (1542) may be provided without a corresponding pulse waveform (1532). This may occur in embodiments in which the pulse waveform (1530) and the protective signal (1540) are synchronized independently using different signals.

[0050] When artifacts (1526) are sufficiently large, they can lead to clinical misinterpretations of cardiac activity. Several options are available to mitigate this risk. First, a protection module can be integrated with the signal generator such that a protection interval (1542) is provided only when a corresponding pulse waveform (1532) is present, and not provided when the pulse waveform (1532) is not delivered. Thus, the protection interval (1542) is provided when it is necessary to electrically isolate the cardiac stimulator or other protected electrical components (e.g., monitoring equipment) from the high-voltage pulse waveform. With this implementation, unnecessary protection switching does not occur, and for artifacts (1526) generated with the pulse waveform, the high-voltage ablation energy delivered to the cardiac tissue saturates the heartbeat so that the artifact (1526) does not present a problem.

[0051] Secondly, for independent protection devices where coordinated control with the pulse-field ablation device is not very possible, switching artifacts (1526) can be reduced in the protection device by using, for example, the placement of low-value capacitors across the isolation switch or between the protected channels to absorb some of the high-frequency local switching energy. The implementation of the passive filtering component described earlier, see, for example, Figure 2, can also be implemented to reduce artifacts (1526). Other options include using an additional switch / MOSFET to temporarily short-circuit the signal pair (e.g., stimulator + / - and patient + / -) together before reconnecting to the patient, or temporarily switching on the patient-side resistive load during blanking intervals.

[0052] Figure 18 is a block diagram of electrical components (1610) coupled to a patient (1620) via a protective device (1600) which includes one or more capacitors for reducing artifacts. One or more electrical components (1610) (e.g., monitoring equipment, cardiac stimulator) may be coupled to a patient (1620) via a protective device (1600) configured to selectively electrically isolate such components from devices placed inside the patient's (1620) heart. In some embodiments, the protective device (1600) may be configured to reduce the magnitude of artifacts (e.g., artifact (1526)). The protective device (1600) may include components structurally and / or functionally similar to any of the other protective devices described in this specification (e.g., protective devices depicted in Figures 3A, 3B, 4, 5, 8, 10A-10E, 11, 12, 14-16, and 19).

[0053] The protection device (1600) may include one or more series-connected protection switches (1602) and resistors (1606). The protection device (1600) may further include one or more capacitors (1604) connected in parallel to the corresponding switches (1602) and resistors (1606). The capacitors (1604) may be configured to receive any portion of any voltage spikes generated by the switching operation of the protection device (1600). In addition, or alternatively, the protection device (1600) may include one or more circuit components (e.g., a filter device (1330), a common-mode protection device (1340), a differential / overvoltage protection device (1350)) as described in Figure 15, configured to reduce switching artifacts.

[0054] A resistor (1606) can be placed in series with a switch and configured to close before the series protective switch (1602) closes in order to reduce artifacts generated by the switching of the protective switch (1602). For example, a switch in series with a resistor (1606) may be configured to close before the series protective switch (1602) closes in order to provide a temporary path to one or more of the electrical components (1610) and the patient (1620), thereby reducing the risk of artifacts from the series protective switch (1602) when the load is subsequently disconnected.

[0055] Figure 19 is a schematic diagram of a system for irreversible electroporation ablation, including a protective device (1900). The system may include a signal generator (1930), an ablation device (1932), and an electronic component (1940). In some embodiments, the electronic component (1940) may be implemented as a signal detector, for example, a monitoring device for monitoring physiological data of a patient (1920). The protective device (1900) may include components that are structurally and / or functionally similar to other protective devices described in this specification (e.g., protective devices depicted in Figures 3A, 3B, 4, 5, 8, 10A-10E, 11, 12, 14-16, 18, and 19).

[0056] A signal generator (1930) may be configured to generate a pulse waveform that is delivered to tissue by electrodes (not shown) of an ablation device (1932). In some embodiments, the signal generator (1930) may be configured to generate a high-voltage ablation pulse waveform for irreversible electroporation of tissue, such as at a pulmonary vein orifice. In some embodiments, a protective device (1900) may be electrically coupled to the patient (1920) via a set of patient connections (1924). For example, one or more electrodes and / or sensors may be placed outside and / or inside the patient (1920) to measure, for example, physiological data of the patient (1920). The protective device (1900) may be coupled between the patient (1920) and an electronic component (1940).

[0057] In some embodiments, the signal generator (1922) may be configured to generate a pulse waveform in synchronization with the indication of the pacing signal and / or within a common refractory window. For example, in some embodiments, the common refractory window may begin substantially immediately following the pacing signal (or after a very small delay) and then persist for a duration of approximately 250 milliseconds (ms) or less. In such embodiments, the entire pulse waveform may be delivered within this duration.

[0058] In some embodiments, the electronic components (1940), the protective device (1900), and / or the signal generator (1930) may communicate with each other, for example, to coordinate the timing of pulse waveform delivery and / or protective device control signal delivery. For example, the signal generator (1930) may be operably coupled to the protective device (1900) so that the signal generator (1930) can deliver a signal (e.g., a synchronization signal (1912)) to the protective device (1900) to synchronize the operation of one or more components of the protective device (1900) with the delivery of ablation pulse waveforms. In embodiments, the signal generator (1930) may periodically deliver a synchronization signal (1912) to the protective device (1900) indicating the timing of pulse waveform delivery to the protective device (1900). As depicted in Figure 19, the signal generator (1930) and the protective device (1900) may be separate devices. Alternatively, in some embodiments, the protection device (1900) may be integrated with the signal generator (1930) within a single console.

[0059] The protective device (1900) may be configured to form an open circuit between an electronic component (1940) and one or more patient connections (1924), for example, sensors or electrodes placed near the ablation site, at least during the delivery of ablation energy by the ablation device (1932). The patient connections (1924) may allow the electronic component 1940 to monitor physiological data of the patient (1920). As described herein, the delivery of pulse waveforms to the patient (1920) may induce high voltages and / or currents in the patient connections (1924). Therefore, by isolating these connections (1924) from the electronic component (1940), the protective device (1900) can reduce or prevent the transmission of such induced voltages and / or currents to the electronic component (1940), thereby reducing noise interference that enters and / or damages such component. When the pulse waveform is not being delivered to the patient (1920), for example, to allow the electronic component (1940) to continue monitoring the patient's (1920) physiological data, the protective device (1900) may be configured to electrically couple the electronic component (1940) with the patient connection (1924).

[0060] The protective device (1900) may comprise a set of one or more switches (e.g., components in series) (1902) configured to form an open circuit between the patient connection (1924) and the electronic component (1940). The set of switches (1902) may include one or more of the following: electromechanical relays (e.g., reed relays), solid-state relays, and / or MOSFET devices.

[0061] In some embodiments, components can be introduced that can electrically connect protected patient signals to a common node (1906). The protection device (1900) may include, for example, channels extending from each input into electronic components (1940) and connecting them to the common node (1906). Each channel may include a switch (1903) and a resistive element (1904) (e.g., a resistor). When the switch (1903) is closed, the channel can connect the input to the electronic components (1940) to the common node (1906). The resistive element (1904) may be coupled between the input and the common node (1906). The resistive element (1904) may be configured to reduce or minimize resistance when connecting the input to the common node (1906). During pulse-field ablation (e.g., delivery of pulse waveforms), the inputs can be short-circuited together to reduce the noise present at the inputs of an electronic component (1940) (e.g., monitoring equipment) so as to reduce the amplitude of any differential noise. A switch (1902) can be opened, for example, to isolate the electronic component (1940) from a patient connection (1924), but during pulse-field ablation delivery, any residual noise transmitted or picked up through an open-circuit series component (e.g., switch (1902)) can be coupled to a common node (1908), and the signal amplitude detected at the electronic component (1940) (e.g., measured by monitoring equipment) can be reduced or reduced.

[0062] In some embodiments, a component can be introduced that can connect to a common node (1906) to ground (1909) (e.g., chassis or earth) in order to further reduce noise that may be picked up at the input to an electronic component (1940) during pulse-field ablation delivery. By coupling inputs that are electrically coupled together to the ground connection (e.g., via the common node (1906)), the protective device (1900) can reduce the amplitude of common-mode noise and prevent large DC voltages above ground from being transmitted to the electronic component (1940) (e.g., the input amplifier of a monitoring device). Coupling the common node (1906) to ground (1909) can also reduce the possibility of interference from pulse-field ablation delivery affecting the electronic component (1940).

[0063] In some embodiments, components can be introduced that can filter high-frequency signals over the ground connection (e.g., earth connection) in the signal generator (1930) and / or the protection device (1900) (or other protection circuit). For example, the signal generator (1930) may be coupled to ground via an inductance filter (e.g., a ferrite clamp, ferrite toroid, or series inductor) (1914). In addition, or alternatively, the protection device (1900) may be coupled to ground via an inductance filter (e.g., ferrite) (1901). Noise created by the signal generator (1930) during ablation delivery can be transmitted through the patient to the patient connection (1902), but it can also be emitted over the ground connection of the signal generator (1930). To reduce noise caused by the connection of the signal generator (1930) to ground, components such as ferrite clamps, ferrite toroids, or series inductors (e.g., filters (1914)) may be used to filter high-frequency noise on these connections and reduce the amplitude measured at the ground connection of the electronic component 1940.

[0064] Figures 20A to 20C are schematic time sequences illustrating the establishment of connections between one or more inputs or signals to the electronic component (1940), common node (1906), and ground (1909) during pulse-field ablation delivery. The time sequences (2012, 2014, 2016) represent the timing of connecting the input to the electronic component (1940) to the common node (1906); the time sequences (2022, 2024, 2026) represent the timing of connecting the common node (1906) to ground (1909); the time sequences (2032, 2034, 2036) represent the timing of forming an open circuit between the patient connection (1924) and the electronic component (1940) using a series component or switch (1902); and the time sequences (2042, 2044, 2046) represent the timing of pulse waveform delivery (e.g., via a signal generator (1930)).

[0065] Figure 20A illustrates a time sequence (2010) for operating the components of a protective device (1900), which connects the inputs to the electronic component (1940) together via a common node (1906) and simultaneously connects the common node (1906) to ground (1909), as shown by (2012, 2022). As depicted, the time sequence (2010) allows the electronic component (1940) to continue seeing a low impedance load during its input (e.g., from the patient connection (1924)) throughout the ablation delivery procedure, ensuring that the common-mode DC level is low. The time sequence (2010) ensures that the input to the electronic component (e.g., from the patient connection (1924)) is not high impedance, which could undesirably allow for large noise pickup. After the inputs to the electronic component (1940) are coupled together and connected to ground (1909), the series components can form an open circuit between the patient connection (1924) and the electronic component (1940), isolating the electronic component (1940) from the patient (1920), as shown by (2032) (for example, the switch (1902) can be set to the open position). After the open circuit is established, pulse waveforms can be delivered to ablate the tissue, as shown by (2042). After the ablation procedure is complete and pulse waveforms are no longer delivered to the patient (1920), the series components can reconnect the patient (1920) to the electronic device (1940). Next, the input to the electronic component (1940) can be released from its common node and ground connections (for example, the switch (1903) can be set to the open state), and the electronic component (1940) can again be configured to receive data (e.g., physiological data) from the patient connection (1924) without any pulse-field ablation interference.

[0066] Figure 20B depicts another time sequence (2020) for operating the components of the protective device (1900). The time sequence (2020) in Figure 20B is similar to the time sequence (2010) in Figure 20A, except that the connection of the common node (1906) to ground (1909) does not occur simultaneously with the connection of the input of the electronic component (1940) to the common node (1906). In some embodiments, the connection of the common node (1906) to ground (1909) (e.g., switching of switch (1908) to the closed state) may occur when the series components of the protective device (1900) transition to an open-circuit configuration (e.g., when switch (1902) transitions to the open state), as shown by (2024, 2034). This ensures that patient (1920) is not temporarily grounded (i.e., patient connection (1924) is not coupled to ground (1909)) when the input to electronic component 1940 has been connected to the common node (1906), but the series components have not yet transitioned to the open state. By not temporarily grounding patient (1920), no residual current in the system has a path to ground through patient (1920). Then, once the patient signal is open (e.g., switch (1902) transitions to the open state), energy (e.g., ablation pulse waveform) can be delivered to patient (1920), and upon completion of energy delivery, the ground connection can be released (e.g., switch (1908) switches to its previous open state), and at the same time, the patient signal can be reconnected (e.g., switch (1902) transitions to its previous closed state). Following these events, the input to the electronic component (1940) can be released from the common node (1906) to allow the electronic component (1940) to measure the patient signal again via the patient connection (1924) without interference or noise from ablation energy delivery.

[0067] Figure 20C depicts another time sequence (2030) for operating the components of the protective device (1900). Time sequence (2030) in Figure 20C is similar to time sequences (2010, 2020) in Figures 20A and 20B, except that no connection is formed between the common node (1906) and ground at any point in the sequence, so that the common node (1906) remains floating. This can ensure that the ground (1909) input connection does not interfere with the input of the electronic component (1940). As described above, during the ablation procedure, high-frequency signals may be transmitted to ground (1909) from the signal generator (1030) and / or other components of the system. Therefore, establishing a connection with ground (1909) could cause such signals to interfere with the operation of the electronic component (1940), for example by generating noise. While the inductance filters (1901, 1914) described above can be used to reduce some of these high-frequency signals, such inductance filters (1901, 1914) may need to be adjusted based on whether various components of the system are open or closed, and therefore may be imperfect in filtering high-frequency signals. Similar to the time sequence (2010, 2020), the series components can be switched to an open-circuit state, and while the series components are in the open-circuit state, ablation energy can be delivered. Following the delivery of ablation energy, the series components can be switched to their previous closed-circuit state, and the patient connection (1924) can be reconnected to the electronic component (1940), and the input to the electronic component 1940 can be released from the common node (1906) connection. method Methods for protecting electronic circuits from induced currents and voltages during a tissue ablation process performed in one or more cardiac chambers using the systems and devices described herein are also described herein. In embodiments, the cardiac chamber may be the left atrial chamber and include its associated pulmonary veins. Generally, the methods described herein involve introducing and positioning a pacing device (e.g., pacing device (230)) in contact with one or more cardiac chambers. The pacing device may use a cardiac stimulator (e.g., cardiac stimulator (28, 28')) to deliver pacing signals to the heart and / or measure cardiac activity. An ablation device (e.g., ablation device (210)) may be introduced and positioned in contact with one or more pulmonary vein orifices or cavity regions. A pulse waveform may be delivered by one or more electrodes (e.g., electrode (212)) of the ablation device to ablate the tissue. In some embodiments, a protective device (e.g., protective device (250)) may be in an open-circuit configuration to isolate one or more sensitive electrical components (e.g., cardiac stimulator, monitoring equipment) during the delivery of a pulse waveform. Such electrical components may otherwise be electrically coupled to a pacing device and configured to deliver a pacing signal to the heart and / or receive cardiac activity measurements. In some embodiments, a control signal may be generated to control the open-circuit interval (e.g., protective interval) of the protective device. The control signal may be based on one or more of the following: cardiac pacing signals, pulse waveform signals (e.g., signal generator signals), measured cardiac activity (e.g., R-wave detection), and combinations thereof.

[0068] In addition, or alternatively, the pulse waveform may include multiple levels of hierarchies to reduce the total energy delivery, as described, for example, in International Application PCT / US2019 / 031135, filed on 7 May 2019, entitled "Systems, Apparatuses and Methods for Delivery of Ablative Energy to Tissue," which is incorporated herein by reference.

[0069] In some embodiments, the ablation devices described herein (e.g., ablation device (210)) may be used for epicardial and / or endocardial ablation. Examples of suitable ablation catheters are described in International Application PCT / US2019 / 014226, which is incorporated above.

[0070] Figure 6A shows a method (400) which is an example of tissue ablation in which ablation energy is delivered in sync with cardiac pacing. In some embodiments, in order to avoid disruption of the sinus rhythm of the heart, the voltage pulse waveform described herein may be applied during the refractory period of the cardiac cycle. Method (400) includes, in (402), the introduction of a pacing device (e.g., pacing device (230)) into, for example, the endocardial space of the right ventricle. The pacing device may be, in (404), positioned in contact with cardiac tissue. For example, sensor electrodes may be configured for measuring cardiac activity (e.g., ECG signals), and pacing electrodes may be configured for delivering pacing signals, for example, in the right ventricle, positioned in contact with the inner endocardial surface. An ablation device (e.g., ablation device (210)) may be introduced, in (406), into, for example, the endocardial space of the left atrium. The ablation device may be positioned in contact with the pulmonary vein orifice in (408). In some embodiments, a pacing signal may be generated in (410) by a cardiac stimulator (e.g., cardiac stimulator (28, 28')) for cardiac stimulation of the heart. The pacing signal may then be applied to the heart in (412) using the pacing electrodes of the pacing device. For example, the heart may be electrically paced with a pacing signal to ensure pacing capture in order to establish periodicity and predictability of the cardiac cycle. One or more of atrial and ventricular pacing may be applied. Examples of pacing signals applied in relation to the patient's cardiac activity are described in more detail in this specification, for example, in Figure 7B.

[0071] In some embodiments, pacing acquisition may be automatically confirmed by a signal generator (e.g., signal generator (222)), a cardiac stimulator, or one or more other processors operably coupled to one or more components of the system. In some embodiments, pacing acquisition may be confirmed by a user. For example, a user may confirm pacing acquisition based on a measured cardiac activity signal using a user interface (e.g., an input / output device such as a touchscreen monitor or other type of monitor). If the user, observing the signal generator, processor, and / or displayed cardiac output, determines that pacing acquisition is not present, pulse waveform generation may be prohibited, and the user may be prompted to adjust system parameters, for example, by repositioning the pacing device to improve contact with tissue and / or changing pacing signal parameters (e.g., pulse width, pulse amplitude, pulse frequency, etc.).

[0072] In some embodiments, the pacing device may measure cardiac activity (e.g., an ECG signal) in (414) that corresponds to the electrical cardiac activity of the heart. For example, the measured cardiac activity may include the measured cardiac pacing pulse, R wave, etc.

[0073] Control signals or protection signals may be generated and applied to a protection device in (418) based on one or more of the following: cardiac pacing signals, pulse waveform signals (e.g., signals received from a signal generator), measured cardiac activity (e.g., R-wave detection, predetermined voltage thresholds), and combinations thereof. For example, a protection signal may be generated based on cardiac pacing signals received from a cardiac stimulator (e.g., cardiac stimulator (28)) or ECG signals measured by a pacing device (e.g., pacing device (230)). As another example, a protection signal may be generated at least in part based on pulse waveform signals received from a signal generator (e.g., signal generator (222)). The protection signal may have a predetermined time period and length. The cardiac stimulator and / or other electronic components may be electrically isolated in (418) in response to the protection signal over the protection interval. For example, a protective device coupled to a pacing device may electrically isolate the cardiac stimulator from high-voltage pulsed field ablation signals delivered by an ablation system (e.g., a signal generator (222), an ablation device (210), etc.) based on a received protective signal.

[0074] In some embodiments, protective signals may synchronize the electrical isolation of the cardiac stimulator with the delivery of ablation energy to the tissue. For example, protective signals may be generated based on one or more of the cardiac pacing signal, measured cardiac activity, and signal generator signals, as described in detail in this specification. In addition, or alternatively, protective devices may generate protective signals even when the cardiac stimulator is not actively delivering pacing signals during pulsed field ablation procedures. This may be beneficial, for example, in cases of medical emergencies requiring rapid cardiac pacing. Such protection may also be beneficial for isolating electronic components often present in clinical treatment rooms (medical electronics other than the ablation device, including, but not limited to, ECG recording or monitoring equipment, electroanatomical mapping systems, and device navigation / tracking systems). It is important to note that after the delivery of a set of ablation pulses, the protective devices are deactivated (424) so ​​that connections are restored between the medical device electrodes and their respective electronic components (e.g., medical electronic equipment, cardiac stimulators, electroanatomical mapping systems, ECG recording or monitoring systems, device navigation / tracking systems, etc.).

[0075] A signal generator (e.g., signal generator (222)), or any processor associated therewith, may be configured to generate a pulse waveform in (420) in synchronization with the protection interval, for example, based on a predetermined criterion. For example, the pulse waveform may be generated during a refractory period that begins after the protection interval and ends before it. The refractory period may follow the pacing signal. For example, a common refractory period may be between both the atrial refractory time window and the ventricular refractory time window. A voltage pulse waveform may be applied during the common refractory period. In some embodiments, the pulse waveform and / or protection signal may be generated with a time offset relative to the indication of the pacing signal. For example, the start of the refractory period may be shifted from the pacing signal by a time offset. A voltage pulse waveform may be applied to a series of heartbeats over the corresponding common refractory period. In some embodiments, the pulse waveform and protection signal may be generated based on the same or different signals or information (e.g., pacing signal, sensed R wave).

[0076] The ablation device (422) can generate an electric field (e.g., a pulsed electric field) delivered to the tissue in response to the reception of a pulse waveform. In some embodiments, nested hierarchical voltage pulse waveforms and time interval hierarchies, as described herein, may be beneficial for irreversible electroporation and provide control and selectivity in different tissue types. For example, pulse waveforms may be generated by a signal generator (e.g., signal generator (222)) and may include multiple levels within the hierarchy. Various hierarchical waveforms may be generated using signal generators as disclosed herein. For example, a pulse waveform may include a first level of pulse waveform hierarchy, which includes a first set of pulses. Each pulse has a pulse duration and a first time interval separating consecutive pulses. A second level of pulse waveform hierarchy may include a plurality of first sets of pulses as a second set of pulses. The second time interval may separate consecutive first sets of pulses. The second time interval may have a duration at least three times that of the first time interval. A third level of pulse waveform hierarchy may include a plurality of second sets of pulses as a third set of pulses. The third time interval can separate a second set of consecutive pulses. The third time interval may have a duration at least 30 times that of the second level time interval.

[0077] In some embodiments, a pulse waveform can be delivered via a set of splines of an ablation device (e.g., ablation device (210)) to a device positioned at any location in the patient's pulmonary vein orifice, or in the cardiac biostructure, or more generally, in other parts of the patient's anatomical structure. In some embodiments, a voltage pulse waveform, as described herein, can be selectively delivered to an electrode subset, such as an anode-cathode subset for ablation and isolation of the pulmonary veins. For example, a first electrode of the group of electrodes may be configured as the anode, and a second electrode of the group of electrodes may be configured as the cathode. These steps can be repeated for a desired number of pulmonary vein orifice or cavity regions to be ablated (e.g., one, two, three, or four orifices). Suitable examples of ablation devices and methods are described in International Application PCT / US2019 / 014226, incorporated above.

[0078] Figure 6B shows an example of a method (1900) of tissue ablation in which ablation energy is delivered asynchronously (without cardiac pacing). The ablation device is introduced into the patient's biostructure (1905) and positioned in the region of interest to be ablated, for example, in the biostructure of the heart. The protective device can be activated (1909) by appropriate control signals, which can be coupled directly, for example, to a hardware-switched isolation circuit or to a processor that controls the switching isolation circuit. As used in this specification, the control element may refer to one or more of the control signals, processors, and switching circuits (e.g., a switching isolation circuit). Thus, the electronic component or device to be protected is isolated from possible pickup of ablation pulses over an isolation time interval. A pulse waveform is generated (1913) and delivered to the tissue (1917) within the isolation time interval. Following the delivery of the ablation pulse in (1917), the protective device is deactivated in (1920) to restore the electrical connection between the electronic component or instrument and any associated patient contact electrodes. Such protected electronic devices may include one or more cardiac stimulators, electroanatomical mapping systems, ECG recording / monitoring systems, device navigation / tracking systems, etc.

[0079] For example, in embodiments where a cardiac stimulator is used to pace the heart over a portion of a pulsed field ablation procedure, the patient connection between the cardiac stimulator and the heart must remain unimpaired over the duration of the pacing or stimulation pulse. In such embodiments, a protection signal (e.g., a control signal for activating a protection device) can synchronize the electrical isolation of the cardiac stimulator with the delivery of ablation energy to the tissue. Figure 7A is a schematic diagram of the time sequence of the cardiac stimulation (510) channel, the pulsed field ablation delivery (530) channel, and the protection interval (540) (e.g., blanking or open circuit) channel. Figure 7B is a schematic diagram of the time sequence of the cardiac stimulation (510) channel, the electrocardiogram (520) channel, the pulsed field ablation delivery (530) channel, and the protection interval (540) channel. The cardiac stimulation (510) may comprise a set of periodic pacing pulses (512). Each pacing pulse (512) may comprise a rectangular pulse with a width between approximately 0.1 ms and approximately 20 ms. The pacing pulse (512) may be generated by a stimulator (e.g., stimulator (28, 28')) and delivered to cardiac tissue using a pacing device (e.g., pacing device (230)). The pacing pulse (512) may correspond to one or more of the ventricular and atrial cardiac pacing. In response to the pacing pulse (512), the cardiac cycle may be synchronized with the pacing pulse (512). For example, the QRS waveform (522) in Figure 7B is synchronized with each pacing pulse (512). The T wave (524) following the QRS waveform (522) corresponds to the beginning of repolarization occurring in the cardiomyocytes. In some embodiments, the electrocardiogram (520) may be measured using a pacing device.

[0080] In some embodiments, the high-voltage application of pulsed field ablation can be synchronized with the cardiac cycle, as depicted in Figures 7A and 7B. Pacing can be synchronized with the high-voltage application in several ways. For example, atrial pacing, ventricular pacing, or multi-chamber pacing can be performed. It may be desirable to perform ventricular pacing because the ventricles are more prone to causing arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation) when stimulated during their repolarization period (e.g., T wave). When the stimulation pulse is applied, the high-voltage output of pulsed field ablation can occur simultaneously with pacing or after a predetermined delay from the stimulation pulse.

[0081] In some embodiments, the delivery of a pulse waveform (532) may begin after a first delay (534) (e.g., a time interval or period) from the falling edge (514) of each pacing pulse (512). Each pulse waveform (532) may be applied for the duration of the interval (532). In some embodiments, the first delay (534) may be a predetermined value (e.g., entered by the user). For example, the first delay (534) may be between approximately 1 ms and approximately 100 ms. A second pulse delay (536) may separate the end of pulse waveform (532) delivery from the beginning of the T wave. As described above, it may be desirable to deliver pulse waveforms during the refractory period associated with the cardiac cycle. Thus, this second pulse delay (536) represents a safety margin between the pulse waveform (532) and the T wave (524).

[0082] The blanking interval or protection interval (542) can be configured to begin immediately or shortly after each pacing pulse (512). The protection interval (542) can be configured to encompass the duration during which the pulse waveform (532) is delivered. For example, the protection interval (542) can begin only a third delay (544) after the falling edge (514) of the pacing pulse (512), where the third delay (544) is smaller than the first delay (534) of the pulse waveform (532). For example, the third delay (544) may be less than about 5 ms. Since the stimulator and pacing device require a closed-circuit connection to deliver the pacing pulse (512), the third delay (544) can be close to zero but non-zero so that the protection interval (542) (e.g., open-circuit state, blanking interval) does not overlap with the pacing pulse (512). In some embodiments, the protection interval (542) is at least equal to, and preferably greater than, a first length of the pulse waveform (532), such that the protection interval (542) overlaps (e.g., encompasses) at least the entire pulse waveform (532). In Figures 7A and 7B, the rising and falling edges (550) of the pulse waveform (532) and the protection interval (542) are such that the protection interval (542) is longer than the pulse waveform (532).

[0083] If the timing of the high-voltage application of pulsed field ablation is known (for example, for pacing or stimulation pulses of a cardiac stimulator), the protection interval (542) can be timed to coincide with the duration of the high-voltage application to ensure that the isolation protection covers the high-voltage application interval. The signal generator for the high-voltage application can be configured to have a predetermined amount of delay (e.g., a first delay (534)) between the stimulation pulse (e.g., a pacing pulse (512)) and the start of the high-voltage application to the patient (e.g., the rising edge (550) of the pulse waveform (532)). This delay can provide sufficient time for the protection element to transition to its isolation state (e.g., open-circuit state or configuration) and begin the protection interval (542). The protection interval (542) then continues for a longer duration than the high-voltage application interval. The timing of the protection interval (542) and the pulse waveform (532) can be repeated for each cardiac cycle.

[0084] In some embodiments, cardiac sensing or monitoring of the R wave (e.g., ventricular depolarization / contraction) can be used to synchronize the delivery of ablation energy to tissue with the cardiac cycle. For example, the patient's intrinsic R wave can be sensed and used as a trigger for one or more of the ablation energy delivery and electrical isolation. In some embodiments, this R wave sensing can be used instead of pacing the heart. In alternative embodiments, R wave sensing can be used in conjunction with pacing. For example, pacing can be performed in either the atrium or ventricle, and the R wave response of the captured heartbeat can be sensed and used for synchronization. Figure 8 is a schematic diagram of an electroporation system placed in the heart (602) of a patient (600). An electroporation system may include an ablation device (610), a signal generator (622) (e.g., a pulsed-field ablation generator), a cardiac stimulator (628), a pacing device (630), a protective device (650), and one or more signal detectors (670, 672). Although two signal detectors (670, 672) are depicted in Figure 8, it can be understood that a single signal detector, rather than two independent detectors, may be used to achieve the method described herein.

[0085] A signal generator (622) may be coupled to the ablation device (610) and a signal detector (672). The signal generator (622) may be configured to generate a pulse waveform that is delivered to the electrodes (612) of the ablation device (610) in order to deliver ablation energy to the heart (602). A pacing device (630) may be configured to pace the heart using the pacing electrodes (632) of the pacing device (630). One or more diagnostic devices (636) may be configured to measure the cardiac activity (e.g., electrocardiogram) of the heart (600) using, for example, externally placed electrode pads or intracardiac electrodes (634). Alternatively, in some embodiments, one or more electrodes of the pacing device (630) and / or ablation device (610) may be used as sensing electrodes, which can be connected to a processor (e.g., signal detectors (670, 672)) for further detection and / or analysis of components of the cardiac cycle.

[0086] A protective device (650) may be coupled between the cardiac stimulator (628) and the pacing device (630). In some embodiments, the protective device (650) may be configured to synchronize the electrical isolation of the cardiac stimulator (628) with the delivery of ablation energy by the ablation device (610). One or more signal detectors (670, 672) may be coupled to one or more of the signal generator (622), pacing device (630), protective device (650), and cardiac stimulator (628). As shown in Figure 8, the first signal detector (670) is coupled to the protective device (650), and the second signal detector (672) is coupled to the signal generator (622). However, in alternative embodiments, a single signal detector may be coupled to both the protective device (650) and the signal generator (622).

[0087] Each signal detector (670, 672) may be coupled to its respective diagnostic device (636) coupled to the patient (600). Alternatively, the signal detectors (670, 672) may be integrated with one or more of the signal generator (622), pacing device (630), protective device (650), and cardiac stimulator (628). The signal analyzer (670) may be configured to receive and analyze the electrocardiogram signal to detect one or more R waves. In some embodiments, R waves may be detected using an R wave amplitude threshold along with some rejection criteria for noise. When an R wave is detected, the signal detectors (670, 672) may be configured to output a signal to the protective device (650) and the signal generator (622). Specifically, when a signal detector (672) coupled to a signal generator (622) detects an R wave, it sends a signal to the signal generator (622) to indicate the timing of the R wave, and thus can notify the signal generator (622) of when to deliver pulsed field ablation. When a signal detector (670) coupled to a protection device (650) detects an R wave, it sends a signal (e.g., a control signal as described above) to the protection device (650) to indicate the timing of the R wave, and thus can notify the protection device (650) of when to start a protection or blanking interval, as further explained with reference to Figure 9.

[0088] Figure 9 is a schematic diagram of the time sequences for the cardiac stimulation (710) channel, the electrocardiogram (720) channel, the pulsed-field ablation delivery (730) channel, and the protective interval (740) channel. The time sequences depicted in Figure 9 may include similar embodiments to those of the time sequences depicted in Figure 7B. For example, cardiac stimulation (710) by a cardiac stimulator (628) as depicted in Figure 8 can provide a patient (e.g., patient (600)) with an optional and / or periodic stimulation pulse (712). In embodiments, the stimulation pulse may be periodic and may include a rectangular pulse having a width between about 1 ms and about 5 ms. In some embodiments, the pacing pulse (712) may be delivered using one of the pacing devices described herein (e.g., pacing device (630)). The pacing pulse (712) may correspond to one or more of ventricular and atrial cardiac pacing. The electrocardiogram (720) may include one or more P waves (721), QRS waveforms (722), and T waves (724). The P wave (721) corresponds to atrial depolarization. The T wave (724) following the QRS waveform (722) corresponds to the beginning of repolarization occurring in the cardiomyocytes. In some embodiments, the delivery of the pulse waveform (732) may be synchronized with the detection of the R wave (726), for example, immediately upon R wave detection or after a first delay (734). In embodiments where a protective device (e.g., protective device (650)) is used to isolate certain electronic components from the patient during pulsed field ablation delivery, it may be desirable to implement a predetermined delay after R wave detection and before pulsed field ablation delivery so that there is sufficient time for the protective device to isolate such electronic components. In some embodiments, the first delay (734) may be a predetermined value. For example, the first delay (734) may be between approximately 1 ms and approximately 5 ms. In some embodiments, the pulse waveform (732) may be separated from the T wave (724) by a second delay (736), for example, to provide a safety margin.

[0089] In some embodiments, a protective device (e.g., protective device (650)) implementing a protective interval (742) (e.g., an open-circuit or blanking interval) can use R-wave (726) detection for synchronization. The protective device may start the protective interval (742) only a third delay (744) after the R-wave (726). The third delay (744) may be smaller than the first delay (734). The third delay (744) may be less than about 5 ms. When the protective device is used with cardiac stimulation, the protective interval (742) (e.g., an open-circuit state, a blanking interval) may be configured not to overlap with the stimulation or pacing pulse (712). The protective interval (742) may be at least equal to, and preferably greater than, the length of the pulse waveform (732) so that the protective interval (742) overlaps (e.g., encompasses) at least the entire pulse waveform (732). In some embodiments, the pulse waveform (732) and the protection interval (742) can be performed independently (e.g., using separate R-wave detectors (670, 672)) or simultaneously (e.g., using a single R-wave detector (670)). By starting the protection interval (742) immediately or soon after R-wave (726) detection and continuing it for longer than the expected pulse-field ablation delivery duration, the protection interval (742) can protect electronic components (e.g., sensitive devices such as cardiac stimulators) even when intracardiac pacing is not actively used during the pulse-field ablation procedure. In the event of a medical emergency, such as a cardiac stimulator, protecting such electronic components can be important even when such devices are not actively used during the ablation procedure, as rapid pacing or other types of pacing may be required and therefore would allow such electronic components to function, be connected and available for use at any time throughout the procedure.

[0090] Protection or isolation coverage of an electronic component during a high-voltage interval can be performed using a fixed blanking interval with a sufficiently long duration to cover the longest expected ablation interval, or an adjustable or configurable blanking interval (which can be set by the user or system to a value based on the expected pulse-field ablation time, for example). Figure 13 is a schematic diagram of the time sequence of the cardiac stimulation (1110) channel, the electrocardiogram (1120) channel, the pulse-field ablation delivery (1130) channel, and the protection interval (1140) channel. The cardiac stimulation (1110) channel may optionally include a pacing or stimulation signal (1112) which may be periodic and comprise a rectangular pulse with a width between approximately 0.1 ms and approximately 100 ms. In some embodiments, the pacing pulse (1112) may be delivered using one of the pacing devices (e.g., pacing devices (230, 630, 1030)) described herein. The pacing pulse (1112) may correspond to one or more of the ventricular and atrial cardiac pacing. In response to the pacing pulse (1112), the cardiac cycle may be synchronized with the pacing pulse (1112). For example, the P wave (1121), QRS waveform (1122), and T wave (1124) in Figure 13 can be synchronized with the pacing pulse (1112). The P wave (1121) corresponds to atrial depolarization, and the T wave (1124) following the QRS waveform (1122) corresponds to the beginning of repolarization occurring in the cardiomyocytes.

[0091] In some embodiments, the pulse waveform (1132) and the protection interval (1142) may be synchronized based on one or more of pacing or stimulation pulse sensing (1144) and R-wave detection (1124). The pulse waveform (1132) may have a first length or duration (1134), and the protection interval (1142) may have a second length or duration (1148) which is at least the same length as the duration of the pulse waveform (1132). The duration (1148) of the protection interval (1142) may be fixed or adjustable. The pulse waveform (1134) may be delivered only a first delay (1136) after the falling edge (1114) of a cardiac pacing pulse (1112) (e.g., signaled or detected by a cardiac stimulator). The first delay (1136) may be a predetermined value. For example, the first delay (1136) may be between approximately 1 ms and approximately 5 ms. Similarly, the protection interval (1142) may be synchronized with a cardiac pacing pulse (1112) (e.g., signaled or detected by a cardiac stimulator) after a second delay (1144). In this scheme, the cardiac pacing signal (1112) may be configured to trigger the protection interval (1142). The protection interval (1142) (e.g., open-circuit state, blanking interval) may overlap the entire pulse waveform (1132).

[0092] In some embodiments, the pulse waveform (1132) and protection interval (1142) can be synchronized with R-wave detection (1124) after, for example, a third delay (1138) and a fourth delay (1146), respectively. In this scheme, R-wave detection (1124) may be configured to trigger the protection interval (1142). R-wave detection can be performed using any of the systems described herein. The third delay (1138) may be a predetermined value. For example, the third delay (1138) may be between about 1 ms and about 20 ms. In some embodiments, the pulse waveform (1132) and protection interval (1142) may start substantially simultaneously with R-wave detection (1124).

[0093] In some embodiments, one or both of the second delay (1144) and the fourth delay (1146) may be adjustable so that the protection interval (1142) may have an adjustable duration (1148).

[0094] The examples and illustrations in this disclosure are for illustrative purposes only, and it should be understood that deviations and variations, such as the number of electrodes, sensors, and devices, can be brought about and developed in accordance with the teachings of this specification without departing from the scope of the invention. In particular, whether the ablation energy having a high-voltage pulse waveform is delivered synchronously with cardiac pacing or asynchronously (e.g., without cardiac pacing), the systems, devices, and methods disclosed in this specification can be configured to protect a wide variety of medical electronic devices, including but not limited to cardiac stimulators, electroanatomical mapping systems, ECG recording systems, ECG monitoring systems, and device navigation or tracking systems. It should be understood that embodiments of protective devices described in this specification can be implemented in a multi-channel format capable of protecting multiple device electrodes or multiple sets of device electrodes that may be connected to such electronic devices. For example, a protective device may incorporate 2, 4, 6, 8, 64, 256, or 512 channels of protection. Furthermore, the control signals used to activate the protection device can be output to multiple such devices, thus providing an expandable protection device in which the number of protection channels can be expanded in a modular manner.

[0095] When used in this specification, the terms “about” and “approximately” when used in conjunction with numerical values ​​and / or ranges generally refer to numerical values ​​and / or ranges that are close to those mentioned. In some embodiments, the terms “about” and “approximately” may mean within ±10% of the mentioned value. For example, in some examples, “about 100 [units]” may mean within ±10% of 100 (e.g., from 90 to 110). The terms “about” and “approximately” may be used interchangeably.

[0096] Some embodiments described in this specification relate to computer memory products accompanied by a non-temporary computer-readable medium (sometimes called a non-temporary processor-readable medium) having instructions or computer code thereon for performing various computer-implemented operations. The computer-readable medium (or processor-readable medium) is non-temporary in the sense that it does not contain the temporary, propagating signals themselves (e.g., propagating electromagnetic waves that carry information on a transmitting medium such as space or a cable). The medium and the computer code (sometimes called code or algorithm) may be designed and constructed for one or more specific purposes. Examples of non-temporary computer-readable media include, but are not limited to, magnetic storage media such as hard disks, floppy disks, and magnetic tapes; optical storage media such as compact disks / digital video discs (CDs / DVDs), compact disk read-only memory (CD-ROMs), and hologram devices; magneto-optical storage media such as optical disks; carrier signal processing modules; and hardware devices specifically configured to store and execute program code, such as application-specific integrated circuits (ASICs), programmable logic devices (PLDs), read-only memory (ROMs), and random access memory (RAM) devices. Other embodiments described in this specification relate, for example, to computer program products that may include instructions and / or computer code disclosed in this specification.

[0097] The systems, devices, and / or methods described in this specification may be implemented by software (performed on hardware), hardware, or a combination thereof. Hardware modules may include, for example, general-purpose processors (or microprocessors or microcontrollers), field-programmable gate arrays (FPGAs), and / or application-specific integrated circuits (ASICs). Software modules (performed on hardware) may be expressed in a variety of software languages ​​(e.g., computer code), including C, C++, Java®, Ruby, Visual Basic®, and / or other object-oriented, procedural, or other programming languages ​​and development tools. Examples of computer code include, but are not limited to, microcode or microinstructions, machine instructions such as those generated by a compiler, code used to generate web services, and files containing higher-level instructions that are performed by a computer using an interpreter. Additional examples of computer code include, but are not limited to, control signals, encrypted code, and compressed code.

[0098] The specific examples and descriptions in this specification are illustrative in nature, and embodiments can be developed by those skilled in the art based on the materials taught herein without departing from the scope of the invention.

Claims

1. A first set of electrodes that can be placed near the cardiac tissue of the heart, A second set of electrodes positioned in contact with the patient's biological structure, A signal generator configured to generate a pulse waveform, wherein the signal generator is coupled to a first set of electrodes and configured to repeatedly deliver the pulse waveform to the first set of electrodes, and the first set of electrodes is configured to generate a pulsed electric field in response to the delivery of the pulse waveform in order to ablate the cardiac tissue, A protective device configured to selectively couple and uncouple electronic devices to the second set of electrodes, A control element coupled to the protective device and configured to control the protective device to decouple the electronic device from the second set of electrodes for a time interval that begins before each delivery of the pulse waveform to the first set of electrodes and ends thereafter; A system equipped with these features.

2. The system according to claim 1, wherein the control element includes at least one of a circuit or a processor configured to be activated by a control signal.

3. The system according to claim 1 or 2, wherein the electronic device is a cardiac stimulator configured to generate a pacing signal, and the cardiac stimulator is configured to deliver the pacing signal to the heart via a second set of electrodes to control the timing of a set of cardiac cycles.

4. The control element is A step of receiving a trigger signal from the cardiac stimulator, each trigger signal indicating when a pacing signal has been delivered to the heart, and the control element is configured to control the protective device to uncouple the cardiac stimulator from the second set of electrodes in response to receiving each trigger signal, The cardiac stimulator is coupled to a second set of electrodes after each delivery of the pulse waveform to the first set of electrodes, so that the cardiac stimulator can deliver subsequent pacing signals to the heart. The system according to claim 3, further configured to perform the following:

5. The system according to claim 3, wherein the signal generator is configured to deliver the pulse waveform to the first set of electrodes at intervals equal to a time delay from the delivery of each pacing signal to the heart.

6. The system according to claim 5, wherein the time delay is a first time delay, and the control element is configured to control the protective device to uncouple the cardiac stimulator from the second set of electrodes a second time delay after the delivery of each pacing signal, the second time delay being smaller than the first time delay so that the cardiac stimulator is uncoupled from the second set of electrodes before each delivery of the pulse waveform.

7. The aforementioned electronic device An electroanatomical mapping system configured to generate a map of cardiac electrical activity, A device tracking and navigation system configured to generate an anatomical map of the cardiac chambers, or An electrocardiogram (ECG) system configured to monitor cardiac electrical activity. The system according to claim 1, comprising at least one of the following.

8. The system further includes a sensing device configured to detect the R wave associated with each cardiac cycle in a set of cardiac cycles, The system according to claim 1 or 2, wherein the signal generator is configured to deliver the pulse waveform after detecting the R wave of each cardiac cycle in the set of cardiac cycles.

9. The system according to claim 8, wherein the signal generator is configured to deliver the pulse waveform at a time delay interval from the R wave of each cardiac cycle in the set of cardiac cycles, the time delay allowing the electronic device to be uncoupled from the second set of electrodes before the delivery of the pulse waveform.

10. The control element is A step of receiving a trigger signal from the sensing device, each trigger signal indicating the detection of an R wave, and the control element is configured to control the protective device to uncouple the electronic device from the second set of electrodes in response to the receipt of each trigger signal, The process involves coupling the electronic device to the second set of electrodes after each delivery of the pulse waveform. The system according to claim 8, further configured to perform the following:

11. The system according to claim 1 or 2, wherein the protective device is integrated into the signal generator.

12. The system according to claim 11, wherein the control element is further configured to coordinate the delivery of the pulse waveform to the first set of electrodes with the uncoupling of the electronic devices from the second set of electrodes.

13. The system according to claim 1 or 2, wherein the protective device includes a switch component configured to switch between a conductive state in which the electronic device is coupled to the second set of electrodes and a non-conductive state in which the electronic device is uncoupled from the second set of electrodes.

14. The aforementioned switch component includes a pair of metal-oxide-semiconductor field-effect transistors (MOSFETs), The system according to claim 13, wherein the pair of MOSFETs has a common source terminal and gate terminals coupled to one or more isolated gate drive circuits, and the one or more isolated gate drive circuits are configured to send control signals to the gate terminals in order to switch the pair of MOSFETs between the conductive state and the non-conductive state.

15. The system according to claim 13 or 14, wherein the switch component is a first switch component, and the protective device further includes a second switch component configured such that the protective device is conductive when the power is off and non-conductive when the power is on, the second switch component is arranged in parallel with the first switch component such that the protective device is coupled to the second set of electrodes when the power is off.

16. The system according to any one of claims 13 to 15, wherein the protection device further comprises one or more of a common-mode choke, a differential-mode choke, or a filter circuit.

17. The system according to any one of claims 13 to 16, wherein the protective device further comprises at least (i) one or more capacitors, or (ii) a switch-in resistor configured to absorb energy associated with the switch component that switches between the conductive state and the non-conductive state.

18. The system according to any one of claims 1 to 17, wherein the protective device is configured to selectively couple and uncouple a plurality of electronic devices to a plurality of second sets of electrodes, the plurality of electronic devices includes the electronic devices, and the plurality of second sets of electrodes includes the second sets of electrodes.

19. A first set of electrodes that can be placed near the cardiac tissue of the heart, A signal generator coupled to the first set of electrodes and configured to generate a pulse waveform, A switch component coupled to the signal generator, wherein the switch component is configured to switch between a conductive state in which an electronic device is coupled to a second set of electrodes and a non-conductive state in which the electronic device is uncoupled from the second set of electrodes, and the second set of electrodes is locatable near the first set of electrodes. A control element coupled to the signal generator and the switch component, wherein the processor A step of receiving a trigger signal, wherein each trigger signal is associated with the cardiac cycle of the heart, In response to each trigger signal received, A step of setting the switch component to the non-conductive state so that the electronic device is discoupled from the second set of electrodes, The process involves setting the switch component to the non-conductive state so that the first set of electrodes generates a pulsed electric field, and then delivering the pulse waveform to the first set of electrodes via the signal generator. The steps include: setting the switch component to the conductive state after delivering the pulse waveform so that the electronic device is coupled to the second set of electrodes; A control element configured to perform the following: A device equipped with the following features.

20. The apparatus according to claim 19, wherein the control element includes at least one of a circuit or a processor configured to be activated by a control signal.

21. The apparatus according to claim 19 or 20, wherein the control element is configured to receive the trigger signal from a cardiac stimulator configured to generate a pacing signal, and each trigger signal indicates the delivery of a pacing signal to the heart.

22. The apparatus according to claim 19 or 20, wherein the control element is configured to receive the trigger signal from a sensing device configured to detect R waves associated with the cardiac cycle of the heart, and each trigger signal indicates that the sensing device has detected the R waves.

23. The aforementioned switch component includes a pair of metal-oxide-semiconductor field-effect transistors (MOSFETs), The apparatus according to any one of claims 19 to 22, wherein the pair of MOSFETs has a common source terminal and gate terminals coupled to one or more isolated gate drive circuits, and the one or more isolated gate drive circuits are configured to send control signals to the gate terminals in order to switch the pair of MOSFETs between the conductive state and the non-conductive state.

24. The apparatus according to any one of claims 19 to 23, wherein the switch component is a first switch component, and the apparatus further comprises a second switch component configured to be conductive when power is not being delivered to the first switch component and non-conductive when power is being delivered to the first switch component, the second switch component being arranged in parallel with the first switch component such that when power is not being delivered to the first switch component, the electronic device is coupled to the second set of electrodes.

25. A first set of electrodes that can be placed near the cardiac tissue of the heart, A signal generator coupled to the first set of electrodes and configured to generate a pulse waveform, A switch component coupled to the signal generator, wherein the switch component is configured to switch between a conductive state in which an electronic device is coupled to a second set of electrodes and a non-conductive state in which the electronic device is uncoupled from the second set of electrodes, and the second set of electrodes is locatable near the first set of electrodes. A control element coupled to the signal generator and the switch component, wherein the processor The steps include determining to deliver the pulse waveform to the first set of electrodes during a set of cardiac cycles, For each cardiac cycle in the aforementioned set of cardiac cycles, A step of setting the switch component to the non-conductive state so that the electronic device is discoupled from the second set of electrodes, The process involves setting the switch component to the non-conductive state so that the first set of electrodes generates a pulsed electric field, and then delivering the pulse waveform to the first set of electrodes via the signal generator. The steps include: setting the switch component to the conductive state after delivering the pulse waveform so that the electronic device is coupled to the second set of electrodes; A control element configured to perform the following: A device equipped with the following features.

26. The aforementioned switch component includes a pair of metal-oxide-semiconductor field-effect transistors (MOSFETs), The apparatus according to claim 25, wherein the pair of MOSFETs has a common source terminal and gate terminals coupled to one or more isolated gate drive circuits, and the one or more isolated gate drive circuits are configured to send control signals to the gate terminals in order to switch the pair of MOSFETs between the conductive state and the non-conductive state.

27. The apparatus according to claim 25 or 26, wherein the switch component is a first switch component, and the apparatus further comprises a second switch component configured to be conductive when power is not being delivered to the first switch component and non-conductive when power is being delivered to the first switch component, the second switch component being arranged in parallel with the first switch component such that when power is not being delivered to the first switch component, the electronic device is coupled to the second set of electrodes.

28. A step of placing a first set of electrodes in close proximity to the cardiac tissue of the heart, A step of positioning a second set of electrodes connected to an electronic device so that they are in contact with the patient's biological structure, A step of setting a switch component that can be selectively coupled to the electronic device to a non-conductive state so that the second set of electrodes is discoupled from the electronic device, The process involves setting the switch component to a non-conductive state so that the first set of electrodes generates a pulsed electric field for ablating the cardiac tissue, and then delivering a pulsed waveform to the first set of electrodes. The steps include: setting the switch component to a conductive state after delivering the pulse waveform so that the second set of electrodes is coupled to the electronic device; A method for providing this.

29. The aforementioned electronic device Electroanatomical mapping system Device navigation and tracking systems, or ECG Monitoring System The method according to claim 28, comprising at least one of the following.

30. The electronic device is a cardiac stimulation device configured to generate a pacing signal, and the method is The process involves delivering a pacing signal to the heart using the second set of electrodes positioned in contact with the patient's biological structure, The switch component is set to the non-conductive state after each pacing signal has been delivered. The method according to claim 28, further comprising:

31. A set of electrodes that can be placed near the cardiac tissue of the heart, A set of sensors that can be placed near the patient's biological structure, A signal generator configured to generate a pulse waveform, wherein the signal generator is coupled to the set of electrodes and configured to repeatedly deliver the pulse waveform to the set of electrodes, and the set of electrodes is configured to generate a pulsed electric field in response to the delivery of the pulse waveform in order to ablate the cardiac tissue, A protection circuit configured to selectively couple and uncouple electronic devices to the set of sensors, A processor coupled to the protection circuit and configured to control the protection circuit to transition between a closed-circuit configuration and an open-circuit configuration, wherein the protection circuit in the closed-circuit configuration is configured to couple the electronic device to the set of sensors so that a signal can be transmitted between the set of sensors and the electronic device, and the protection circuit in the open-circuit configuration is configured to uncouple the electronic device from the set of sensors so that the electronic device is electrically isolated from the set of sensors, and the processor is configured to control the protection device to transition to the open-circuit configuration for a time interval that begins before and ends after each delivery of the pulse waveform to the set of electrodes, so that the electronic device is isolated from voltages and currents induced in response to the delivery of the pulse waveform to the set of electrodes. A system equipped with these features.

32. The system according to claim 1, wherein the processor includes at least one of a circuit or processor configured to be activated by a control signal.

33. The aforementioned electronic device An electroanatomical mapping system configured to generate a map of cardiac electrical activity, A device tracking and navigation system configured to generate an anatomical map of the cardiac chambers, or An electrocardiogram (ECG) system configured to monitor cardiac electrical activity. The system according to claim 1 or 2, comprising at least one of the following.

34. The system further comprises a signal detector configured to detect the R wave associated with each cardiac cycle in a set of cardiac cycles, The system according to any one of claims 31 to 33, wherein the signal generator is configured to deliver the pulse waveform after detecting the R wave of each cardiac cycle in the set of cardiac cycles.

35. The system according to claim 34, wherein the signal generator is configured to deliver the pulse waveform at a time delay interval from the R wave of each cardiac cycle in the set of cardiac cycles, the time delay allows the electronic device to be uncoupled from the set of sensors before the delivery of the pulse waveform.

36. The aforementioned processor A step of receiving a trigger signal from the signal detector, wherein each trigger signal indicates when the R wave is detected. It is further configured to do the following: The processor is configured to control the protection circuit in order to transition to the open-circuit configuration in response to receiving each trigger signal. The system according to claim 34, wherein the processor is configured to control the protection circuit to transition to the closed circuit configuration after each delivery of the pulse waveform.

37. The system according to any one of claims 31 to 36, wherein the protection circuit is integrated into the signal generator.

38. The system according to claim 37, wherein the processor is further configured to coordinate the delivery of the pulse waveform to the set of electrodes with the transition of the protection circuit to the open circuit configuration.

39. The system according to any one of claims 31 to 37, wherein the protection circuit includes at least one switch component configured to switch between a conductive state in which the electronic device is coupled to the set of sensors and a non-conductive state in which the electronic device is uncoupled from the set of sensors.

40. The at least one switch component includes a pair of metal-oxide-semiconductor field-effect transistors (MOSFETs), The system according to claim 39, wherein the pair of MOSFETs has a common source terminal and gate terminals coupled to one or more isolated gate drive circuits, and the one or more isolated gate drive circuits are configured to send control signals to the gate terminals in order to switch the pair of MOSFETs between the conductive state and the non-conductive state.

41. The system according to claim 39 or 40, wherein the at least one switch component is a first switch component, and the protection circuit further includes a second switch component configured to be conductive when the protection circuit is powered off and non-conductive when the protection circuit is powered on, the second switch component being positioned in parallel with the first switch component such that when the protection circuit is powered off, the electronic device is coupled to the set of sensors.

42. The system according to any one of claims 39 to 41, wherein the protection circuit further comprises one or more of a common-mode choke, a differential-mode choke, or a filter circuit.

43. The system according to any one of claims 39 to 42, wherein the protection circuit further comprises at least (i) one or more capacitors, or (ii) a switch-in resistor configured to absorb energy associated with the switch component that switches between the conductive state and the non-conductive state.

44. The protection circuit is configured to selectively couple and uncouple a plurality of electronic devices to a plurality of sets of sensors, wherein the plurality of electronic devices includes the electronic devices, and the plurality of sets of sensors includes the sets of sensors, according to any one of claims 31 to 43.

45. The system according to any one of claims 31 to 36, wherein the protective device is coupled between the electronic device and the set of sensors.

46. The system according to claim 31 or 32, wherein the electronic device is a cardiac stimulator configured to deliver pacing signals to the heart.

47. The system according to claim 31 or 32, wherein at least one of the set of sensors is an electrode.

48. The system according to claim 31 or 32, wherein at least one of the set of sensors is an electromagnetic tracking sensor.

49. The system according to any one of claims 31 to 48, wherein the at least one switch component is a relay switch.

50. A set of electrodes that can be placed near the cardiac tissue of the heart, A signal generator coupled to the set of electrodes and configured to generate a pulse waveform, A set of sensors that can be placed near the patient's biological structure, At least one switch component coupled between the set of electronic devices and sensors, wherein the switch component is configured to switch between a conductive state in which the electronic device is coupled to the set of sensors and a non-conductive state in which the electronic device is disconnected from the set of sensors. A processor coupled to the signal generator and the switch component, wherein the processor is The process of receiving a trigger signal from the signal generator, In response to each trigger signal received, A step of setting the switch component to the non-conductive state so that the electronic device is uncoupled from the set of sensors, The process involves setting the switch component to the non-conductive state so that the set of electrodes generates a pulsed electric field, and then delivering the pulse waveform to the set of electrodes via the signal generator. The steps include: after delivering the pulse waveform, setting the switch component to the conductive state so that the electronic device is coupled to the set of sensors and can send signals to or receive signals from the set of sensors; A processor and A system equipped with these features.

51. The system according to claim 50, wherein the processor is configured to receive the trigger signals from a cardiac stimulator configured to generate pacing signals, and each trigger signal indicates the delivery of a pacing signal to the heart.

52. The system according to claim 50, wherein the processor is configured to receive the trigger signal from a signal detector configured to detect R waves associated with the cardiac cycle of the heart, and each trigger signal indicates that the signal detector has detected the R waves.

53. The at least one switch component includes a pair of metal-oxide-semiconductor field-effect transistors (MOSFETs), The system according to any one of claims 50 to 52, wherein the pair of MOSFETs has a common source terminal and a gate terminal coupled to one or more isolated gate drive circuits, and the one or more isolated gate drive circuits are configured to send control signals to the gate terminals in order to switch the pair of MOSFETs between the conductive state and the non-conductive state.

54. The system according to any one of claims 50 to 53, wherein the at least one switch component is a first switch component, and the device further comprises a second switch component configured to be conductive when power is not being delivered to the first switch component and non-conductive when power is being delivered to the first switch component, the second switch component being positioned in parallel with the first switch component so that the electronic device is coupled to the set of sensors when power is not being delivered to the first switch component.

55. The system according to any one of claims 50 to 54, wherein the switch component in a non-conductive state isolates the electronic device from the set of sensors in order to protect the electronic device from voltages and currents induced in the set of sensors in response to the delivery of the pulse waveform to the set of electrodes.

56. The system according to any one of claims 50 to 55, wherein the at least one switch component is a relay switch.

57. A set of electrodes that can be placed near the cardiac tissue of the heart, A signal generator coupled to the set of electrodes and configured to generate a pulse waveform, A set of sensors that can be placed near the patient's biological structure, At least one switch component coupled between the set of electronic devices and sensors, wherein the switch component is configured to switch between a conductive state in which the electronic device is coupled to the set of sensors and a non-conductive state in which the electronic device is disconnected from the set of sensors. A processor coupled to the signal generator and the at least one switch component, wherein the processor is The steps include determining whether to deliver the pulse waveform to the set of electrodes during a set of cardiac cycles, For each cardiac cycle in the aforementioned set of cardiac cycles, A step of setting the switch component to the non-conductive state so that the electronic device is uncoupled from the set of sensors, The process involves setting the switch component to the non-conductive state so that the set of electrodes generates a pulsed electric field, and then delivering the pulse waveform to the set of electrodes via the signal generator. The steps include: after delivering the pulse waveform, setting the switch component to the conductive state so that the electronic device is coupled to the set of sensors and can send signals to or receive signals from the set of sensors; A processor and A system equipped with these features.

58. The aforementioned switch component includes a pair of metal-oxide-semiconductor field-effect transistors (MOSFETs), The system according to claim 57, wherein the pair of MOSFETs has a common source terminal and gate terminals coupled to one or more isolated gate drive circuits, and the one or more isolated gate drive circuits are configured to send control signals to the gate terminals in order to switch the pair of MOSFETs between the conductive state and the non-conductive state.

59. The system according to claim 57 or 58, wherein the switch component is a first switch component, and the device further comprises a second switch component configured to be conductive when power is not being delivered to the first switch component and non-conductive when power is being delivered to the first switch component, the second switch component being positioned in parallel with the first switch component so that the electronic device is coupled to the set of sensors when power is not being delivered to the first switch component.

60. The apparatus according to any one of claims 57 to 59, wherein the switch component in a non-conductive state isolates the electronic device from the set of sensors in order to protect the electronic device from voltages and currents induced in the set of sensors in response to the delivery of the pulse waveform to the set of electrodes.

61. A set of electrodes that can be placed near the cardiac tissue of the heart, A set of sensors that can be placed near the patient's biological structure, A signal generator configured to generate a pulse waveform, wherein the signal generator is coupled to the set of electrodes and configured to repeatedly deliver the pulse waveform to the set of electrodes, and the set of electrodes is configured to generate a pulsed electric field in response to the delivery of the pulse waveform in order to ablate the cardiac tissue, A protective device configured to selectively couple and uncouple electronic devices to the set of sensors, The protection device is coupled to the protection device and controls the protection device to selectively couple the electronic device to the set of sensors and to uncouple the electronic device from the set of sensors, Selectively, a set of inputs to the electronic device is connected to and disconnected from a common node, or Selectively connect the common node to ground and disconnect it from ground. A control element configured to perform at least one of the following: A system equipped with these features.

62. The system according to claim 61, wherein the control element is configured to simultaneously perform the steps of coupling the set of inputs to the common node and coupling the common node to the ground, before uncoupling the electronic devices from the set of sensors and before delivering the pulse waveform to the set of electrodes.

63. The system according to claim 61 or 62, wherein the control element is configured to disconnect the electronic device from the set of sensors for a time interval that begins before and ends each delivery of the pulse waveform to the set of electrodes.

64. The system according to claim 61, wherein the control element is configured to connect the common node to the ground, disconnect the electronic device from the set of sensors, and connect the set of inputs to the common node before delivering the pulse waveform to the set of electrodes.

65. The system according to claim 64, wherein the control element is configured to substantially simultaneously perform the steps of coupling the set of sensors to the electronic device and uncoupling them from the electronic device, and coupling the common node to the ground and uncoupling it from the ground.

66. The system according to claim 61, wherein the control element is configured to disconnect the electronic device from the set of sensors while the common node is disconnected from the ground, and to connect the set of inputs to the common node before delivering the pulse waveform to the set of electrodes.

67. The system according to any one of claims 61 to 66, further comprising at least one of a first inductance filter coupled between the signal generator and the ground, or a second inductance filter coupled between the protection device and the ground.

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